dismissed
EB-1A
dismissed EB-1A Case: Medical Technology
Decision Summary
The appeal was dismissed because the petitioner did not establish the beneficiary's requisite extraordinary ability. The director determined that the petitioner failed to submit extensive documentation demonstrating the beneficiary's sustained national or international acclaim, and the AAO upheld this decision.
Criteria Discussed
Receipt Of Lesser Nationally Or Internationally Recognized Prizes Or Awards Membership In Associations Which Require Outstanding Achievements Published Material About The Alien In Professional Or Major Trade Publications Participation As A Judge Of The Work Of Others Original Scientific, Scholarly, Artistic, Athletic, Or Business-Related Contributions Of Major Significance Authorship Of Scholarly Articles Display Of The Alien'S Work At Artistic Exhibitions Or Showcases Leading Or Critical Role For Organizations Or Establishments That Have A Distinguished Reputation High Salary Or Other Significantly High Remuneration Commercial Successes In The Performing Arts
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-. .~r·;;' JL",_
identifying data deleted to
prevent clearly unwarranted
invasion of personal privacy
PUBLIC COpy
Fll..,E:
INRE: Petitioner:
Beneficiary:
U.S. Dcpartmentof Homeland Security
U.S. Citizenship and Immigration Services
Administrative Appeals Oftice (AAO)
20 Massachusetts Ave., N.W., MS 2090
Washim!ton. DC 20529-2090
U.S. Citizenship
and Immigratio~
Services
. Office: TEXAS SERVICE CENTER Date: FEB 0 8 2011
PETITION: Immigrant Petition for Alien Worker as an Alien of Extraordinary Abi'iity Pursuant to
Section 203(b)(l)(A) of the Immigration and Nationality Act, 8 U.S.C § 1153(b)(l)(A)
"
ON BEHALF OF PETITIONER:
INSTRUCTIONS:
Enclosed please find the decision of the Administrative Appeals Office in your case. All of the
documents related to this matter have been returned to the office that originally decided your case. Please
be advised that any further inquiry that you might have concerning your case must be made to that office.
If you believe the law was inappropriately applied by us in reaching our decision, or you have additional
information that you wish to have considered, you may file a motion to reconsider or a motion to reopen.
The specific r~quirements for filing such a request can be found at 8 C.F.R. § 103.5. All motions must be
submitted to the office that originally decided your case by filing a Form I-290B, Notice .of Appeal or
Motion, with a fee of $63,0. Please be aware that 8 C.F.R. § 103.5(a)(1)(i) requires that any motion must
be filed within 30 days of the decision that the motion seeks to reconsider or reopen.
Thank you,
~~~
7perry Rhew U
Chief, Administrative Appeals Office
www.uscis.gov
Page 2
DISCUSSION: The employment-based immigrant visa petition was denied by the Director,
Texas Service Center, and is now before the Administrative Appeals Office (AAO) on appeal. The
appeal will be dismissed. 1
The petitioner is a medical technology company. It seeks classification of the beneficiary' as an
employmept-based immigrant pursuant to section 203(b)(1)(A) of the Immigration and
Nationality Act (the Act), 8 U.S.c. § 1153(b)(1)(A), as an ,alien of extraord~nary ability in the
sciences. The directOr determined that the petitioner had not established the beneficiary's requisite
extraordinary ability and failed to submit extensive documentation of his sustained national or
international acclaim.
Congress set a very high benchmark for aliens of extraordinary ability by requiring through the
statute that the petitioner demonstrate the alien's "sustained national or international acclaim" and
present "extensive documentation" of the alien's achievements. See section 203(b)(1)(A)(i) of the
Act and 8 C.F.R. § 204.5(h)(3). The implementing reIDIlation at 8 C.F.R. § 204.5(h)(3) states that
an alien can establish sustained national or international acclaim through evidence of a one-time
achievement of a major, internationally recognized award. Absent the receipt of such an award, the
regulation outlines ten categories of specific objective evidence. 8 C.F.R. § 204.5(h)(3)(i) through
(x). The petitioner must submit qualifying evidence for the alien under at least three of the ten
regulatory categories of evidence to establish the basic eligibility requirements.
On appeal, counsel argues that the beneficiary meets at least three of the ten regulatory categories of
\
evidence at 8 c.F.R. § 204.5(h)(3). For the reasons discussed below, we uphold the director's
decision.
I. Law
Section 203(b) of the Act states, in pertinent part, that:
(1) Priority workers. -- Visas shall first be made available ... to qualified immigrants who
are aliens described in any of the following subparagraphs (A) through (C):
(A) Aliens with extraordinary ability. -- An alien is described in this subparagraph if--
(i) the alien has extraordinary ability in the sciences, arts, education,
business, or athletics which has been deinonstrated by sustained national
or international acclaim and whose achievements have been recognized
in the field through extensive documentation,
(ii) the alien seeks to enter the United States to continue work in the area
of extraordinary ability, and
!
(iii) the alien's entry into the United States will substantially benefit
prospectivrly the United States.
f
Page 3
U.S. Citizenship and Immigration SerVices (USCrS) and,~legacy Immigration and Naturalization
Service (INS) have consistently recognized that Congress intended to set a very high standard for
individuals seeking immigrant visas as aliens of extraordinary ability. See H.R. 723 101
st
Cong., 2d
Sess. 59 (1990); 56 Fed. Reg. 60897, 60898-99 (Nov. 29,1991). The term "extraordinary ability"
refers only to those individuals in that small percentage who have risen to the very top of the
field of endeavor. [d. and 8 c.F.R. § 204.5(h)(2).
The regulation at 8 c.F.R. § 204.5(h)(3) requires that an alien demonstrate his or her sustained
acclaim and the recognition of his or her achievements in the field. Such acclaim and achievements
must be established either through evidence, of a one-time achievement (that is, a major,
international recognized award) or through meeting at least three of the following ten categories of
evidence:
(i) Documentation of the alien's receipt of lesser nationally or' internationally
recognized prizes or awards for excellence in the field 'of endeavor;
(ii) Documentation of the alien's membership in associations in the field for which
classification is sought, which require outstanding achievements of their members,
as judged by recognized national or international experts in their disciplines or
" fields; ,
(iii) Published material about the alien in professional or major trade publications or
other major media, relating to the alien's work in the field for which classification is
sought. Such evidence shall include the title, date, and author of the material,and
any necessary translation;
(iv) Evidence of the alien's, participation, either individually or on a panel, as ajudge
of the work of others in' the same or an allied field of specialization for which
classification is sought;
(v) Evidence of the alien's original scientific, scholarly, artistic, athletic, or business
related contributions of major significance in the field;
(vi) Evidence of the alien's' authorship of scholarly articles ill the field, ill
professional or major trade publications or other major media;
(vii) Evidence of the display of the alien's work in the field at artistic exhibitions or
showcases;
(viii) Evidence that the alien has performed in a leading or critical role for
organizations or establishments that have a distinguished reputation;
(ix) Evidence that the alien has commanded a high salary or other significantly high
remuneration for services, in relation to others in the field; or
, _. i'
Page 4
(x) Evidence of commercial successes in the performing arts, hs shown by box office
receipts or record, cassette, compact disk, or video sales.
In 2010, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) reviewed the denial of a
petition filed under this classification. Kazarian v. USCIS, 596 F.3d 1115 (9
th
Cir. 2010). Although
the court upheld the AAO's decision to den-y the petition, the court took issue with the AAO's
evaluation of evidence submitted tomeet a given eviden~iary criterion.
l
With respect to the. criteria
<J.t 8 C.F.R. § 204.5(h)(3)(iv) and· (vi), the court concluded that while USCIS may have raised
legitimate concerns about the significance of the evidence submitted to meet' those two criteria,
those concerns should have been raised in a subsequent "fmal merits determination." Id. at 1121-
22.
The court stated that the AAO's evaluation rested on an improper understanding of the regulations.
Instead of parsing the significance of evidence as part of the initial inquiry, the court stated that "the
proper procedure is tocotint the types of evidence provided (which the AAO' did)," and if the
petitioner failed to submit sufficient evidence, "the proper conclusion is that the applicant has failed
to satisfy the regulatory requirement of three types of evidence (as the AAO concluded)." Id. at
1122 (citing to 8 C.F.R. § 204.5(h)(3». The court also explained the"fmal merits determination" as
the corollary to this procedure: .
. I
!fa petitioner has submitted therequisite evidence, USCIS determines whether the
evidence demonstrates both a "level of expertise indicating that the individual is one
of that small percentage who-have risen to the very top of the[ir] field of endeavor,"
8 C.F.R. § 204.5(h)(2), and "that the alien has sustained national- or international
acclaim and that. his or her achievements have been recognized in the field of
expertise." 8/C.F.R. § 204.5(h)(3). Only aliens whose achievements have garnered
"sustained national or international acclaim" are eligible for an "extraordinary
. ability" visa. 8 'U.S.C. § 1153(b)(1)(A)(i).
Id. at 1119-1120.
Thus, Kazarian sets forth a two-part approach where the evidence is first counted and then
considered in the context of a fmal merits determination. In reviewing Service Center decisions, the
AAO will apply the test set forth in Kazarian. As the AAO maintains de novo review, the AAO
will conduct a new analysis if the director reached his or her conclusion by using a one-step analysis
rather than the two-step analysis dictated by the Kazarian coUrt:. See Spencer Enterprises, Inc. v ..
United States, 229 F. Supp. 2d 1025, 1043 (E.D. Cal. 2001); dff'd, 345 F.3d 683 (9
th
Cir. 2003);
see also Soltane v. DOl, 381 F.3d 143, 145 (3d Cir. 2004) (noting that the AAO conducts
appellate review on a de novo basis).
I Specifically, the court stated that the AAO had unilateraJly imposed novel substantive or evidentiary requirements.
beyond those set forth in the regulations at 8 C.F.R. § 204.5(h)(3)(iv) and.8 C.F.R. § 204.5(h)(3)(vi).
\ ~- t' ••••
Page 5
II. Analysis
A. Evidentiary Criteria
This petition, filed on October 27, 2008, seeks to classify the beneficiary as an alien with
extraordinary ability in "nanotechnology? biomaterials and " At the time of
the was working as a Senior Scientist in
The petitioner has submitted documentation
pertaining to the following, categories of evidence at 8 CF.R. § 204.5(h)(3).2
Documentation of the alien IS receipt of lesser' nationally or internationally
; recognized prizes or awards for excellence in the field of endeavor.
The petitioner submitted the beneficiary's resume which lists the following information under
"Honors and A wards:"
• Scientist Presentation,_ [American Chemical Society] Fall Meeting:
• Prese~tation, Department of Chemistry,
The record, however, does not include documentary evidence of the preceding awar~s. Going on
. record without supporting documentary evidence is not sufficient for purposes of meeting the
burden of proof in these proceedings. Matter of Soffici, 22 I&N Dec. 158, 165 (COrnln. 1998)
'(citing Matter of Treasure Craft of California, 14 I&N Dec. 190 (Reg. Cornrn. 1972». Rather
than submitting primary evid~nce of the beneficiary's awards from the ACS and •••••
_ the petitioner,instead submitted only the beneficiary's resume and reference, letters
listing the awards. The self-serving claims in the beneficiary's resume and the attestations of his
references are not sufficient to meet the burden of proof for this regulatory criterion. A petition
must be filed with any initial evidence required by the regulation. 8 C.F.R. § 103.2(b)(1). The
nonexistence or other unavailability of primary evidence creates a presumption of ineligibility.
8 c.F.R. § l03.2(b)(2)(i). According to the same regulation, only where the petitioner
demonstrates that primary evidence does not exist or cannot be obtained may the petitioner rely on
secondary evidence and only where secondary evidence is demonstrated to be unavailable may the
petitioner rely on affidavits. Where a record does not exist, the petitioner must submit an original
written statement on letterhead from the relevant authority indicating ,the reason the record does'
not exist, and whether similar records for the time and place -are available. 8 C.F.R:
§ 103.2(b)(2)(ii). The petitioner has not established that primary evidence of the preceding
awards does not exist or cannot be obtained. Further, the beneficiary's resume and the reference '
letters do not equate to secondary evidence or affidavits. Moreover, the record does not include
infomll:ition from the presenting organizations indicating the significance of the beneficiary's
awards or their evaluation 'criteria. Further, then~ is no documentary evidence demonstrating that
2 The petitioner does not claim to meet or submit documentation relating to the categories of evidence not discussed
in this decision.
I
\ _ - i,
Page 6
the beneficiary's awards are recognized beyond the presenting organizations and therefore
commensurate with nationally or internationally recognized prizes or awards for excellence in
the field.
On appeal, counsel states: "We direct the reviewer's attention to the response to the RFE
[Request for Evidence] in which we confirm that no claim was made by Beneficiary to satisfy
this criterion."
In light of the above, the petitioner has not established that the beneficiary meets this criterion. ~
'.
Documentation of the alien's . membership in associations in the field for which
classification is sought, which require outstanding achievements of their
members, as judged by recognized national or international experts in their
disciplines or fields.
. ~ n
In order to demonstrate that membership in an association meets this criterion, a petitioner must
show that the 'association requires outstanding achievement as an essential condition for
admission to membership. Membership requirements based on employment or activity in a
given field, minimu~ education or experience;' standardized test scores, grade 'point average,
recommendations by colleagues or current members, or payment of dues, do not satisfy this
criterion as such requirements do not constitute outstanding achievements. Further, the overall
prestige of a given association is not determinative; the issue here is membership requirements
Tather than the association's overall reputation.
The petitioner initially submitted the beneficiary's membership card and paym~nt information
for the ACS. The record, however, does not Include evidence of the membership requirements
I '
(such as bylaws or rules of admission) for the ACS showing that it requires outstanding
achievements of its members; as judged by recognized national or international experts in the
beneficiary's field or an allied one. The petitioner's initial evidence for this criterion also
included documentation . that the benefiCiary joined the ••••••••••••
beneficiary's Resident Faculty position with NJCBM equates to a post-doctoral Lv"''''''''''''U\
rather than membership in an association in the field.
The
ition
On appeal, counsel states: "Beneficiary did not provide any evidence for this criterion and made
no claim it had been satisfied."
In light of the above, the petitioner has not established that the beneficiary meets this criterion.
Published material about the alien in professional or major trade publications or
other major media, relating to the alien's work in thefieldfor which classification is
sought. Such' evidence shall include the title, date, and author of the material, and
any necessary translation. :
\ -- i. \
Page 7
In general, in order for published material to meet this criterion, it must be primarily about the
beneficiary and, as stated in the regulations, be printed in professional or major trade publications or
other major media. To qualify as' major media, the publication should have significant national or
international distribution. An alien would not earn acclaim at the national level from a local
publication. Some newspapers, such as the New York Times, nominally serve a particular locality
but would qualify as major media because of significant national distribution, unlike small. local
community papers.3
'J
The petitioner initially submitted copies of seven research articles briefly citing to the beneficiary's
work.4 Articles which cite to the beneficiary's work are primarily about the author's own work, and
are riot about the beneficiary or even his work. The regulation at 8 C.F.R. § 204.5(h)(3)(iii) requires
that the published material be "about the alien." The sU):)fnitted articles do not discuss the merits of
the beneficiary's work, his standing in the field, any significant impact that his work has had on
the field, or any other aspects of his work so as to be considered published material about the
beneficiary as required by this criterion. With regard to this criterion, a footnoted reference to the
alien's work without evaluation is of minimal probative value. Finally, we note that the submitted
articles citing to the beneficiary's work similarly referenced numerous other authors.
On appeal, counsel states: "The Beneficiary made no claim to satisfy this criterion in either the
initial submission or. in response to the RFE." -The research articles citing to the beneficiary's
work' are more relevant to the regulatory criterion at 8 C.F.R. § 204.5(h)(3)(v) and will be
addressed theJ;'e.
In light of the above, the petitioner has not established that the beneficiary meets this criterion.
Evidence of the alien's partiCipation, either individually or on a panel, as a judge of
the work of others in the same or an allied field of specification for which
classification is sought.
submitted a December 6, 2005 e-mail from
to the beneficiary and a coworker stating:
~as requested I sent ~ou the attached JBMR [Journal of Bone 'and Mineral
Research] article on matrix metalloproteinase for review.
Please provide _your comments regarding: novelty, significance, manuscript
quality, soundness of methods and conclusions by December 17th.
3 Even with nationally:circulated newspapers, consideration must be given to the placement of the article. For
example, an article that appears in the Washington Post, but in a section that is distributed only in Fairfax County,
Virginia, for instance, cannot serve to spread an individual's reputation outside bf that county.
4 Two of the citing articles, entitled with
Oppositely Charged Polyelecirolytes" and "Investigation of local chain dynClmicsin poly(di-n-alkylitaconate)s,"
were submittec;l in duplicate.
Page 8
The limited infonnation provided in the preceding e-mail does no~ identify the title of the article
reviewed by the beneficiary. Further, there is no documentary evidence of the beneficiary's
response to_ .
pelHloner also submitted a December 20, 2005 e-mail from
beneficiary and two coworkers stating:
I am sending you a draft manuscript which I received for review. Because of the interest
you may have in the topic of this paper, I am sharing it with you. . .. Please look at the
manuscript and provide me with your comments and critique which I will collect as part of
my response to the editor.
The December 20, 2005 e-mail does not identify the title of the manuscript or the journal to which it
was submitted. Further, there is no documentary evidence of the beneficiary's response.
The petitioner's initial submission also induaed an October 23,2006 e-mail from_ to the.
beneficiary and two coworkers stating: "I have received the attached proposals' for evaluation ....
I ,
At this point, I, and you are the only 4 people in the group who have seen this most relevant
proposal. . . . Please read the propos"al and in a few days, I will convene a meeting for us to discuss
your thouglits about this proposal." The title and subject of the proposal are not specifically
identified and there is no documentary evidence of the beneficiary's contribll,tion to the evaluation .
. With regard to the preceding review requests received by the beneficiary while on the research
. faculty at the NJCBM, there is no documentary evidence demonstrating that the beneficiary
actually completed the preceding proposal and manuscript reviews. The plain language of this
criterion, however, requires "[e]vidence of the alien's part~cipation ... as a judge of the work of
others .. " Being asked to review a manuscript or proposal is not tantamount to evidence of one's
actual "participation" as a reviewer. Moreover, the regulation at 8 C.F.R. § 204.5(h)(3)(iv)
requires evidence that the beneficiary has served as "a judge of the work of others." The phrase
"a judge" implies a formal designation in a judging capacity, either on a panel or individually as
specified at 8 C.F.R. § 204.5(h)(3)(iv). The regulation cannot be read to include every informal
instance of a supervisor requesting input from his subordinates. Regarding the two e-mails from
December 2005, the submitted documentation indicates that the journals requested that _
review the manuscripts. _then assigned the duty to the beneficiary and his coworkers. The
record contains no evidence that the· beneficiary served as part of a fonnal judging process (such
as being specifically designated as a peer reviewer for a journal or evaluating a research proposal
as an independent reviewer at the request of the funding organization). Nevertheless, there is no .
evidence establishing that the beneficiary actually completed the preceding manuscript and
propo;;al reviews. Accordingly, the petitioner has. not submitted qualifying evidence that meets
the plain language requirements of the regulatiop. set forth at 8 C.F.R. § 204.5(h)(3)(iv).,
Additional deficiencies pertaining to the petitioner's evidence will be addressed below in our final
merits detyrmination regarding whether. the submitted evidence is commensurate with sustained
national or international acclaim, or being among that small" percentage at the very top of the field
of endeavor.
, • .. i,
Page 9
On appeal, counsel states: "In response to the RFE, ... no claim was made to satisfy this
criterion. "
In light of the above, the petitioner has not established that the beneficiary meets this criterion.
Evidence of the alien's original scientific, scholarly, artistic, athletic, or business
related contributions of major significance in the field.
The petitioner submitted several letters of support discussing the beneficiary's work.
_ Director of Human Resources, II, states:
is a publiCly traded medical technology company
engaged principally in the and sale of a broad range of medical supplies,
devices, laboratory equipment and diagnostic products used by healthcare institutions,
life science researchers, clin,icallaboratories, industry and the general public.
* * *
As a heavily research-oriented· company, _holds over 300,000 patents .and trademarks
and, in 2005, invested over $360 million in research and development.
& Company employs over 28,000 individuals and for 2007 recorded a gross
over $6.36 billion:.
Preanalytical Systems, the division [the beneficiary] works within, generated over one (1)
million USD in revenues· in 2007, and is the industry pioneer and leader in the area of
modem evacuated blood collection systems, ihcluding evacuated tubes and needles. Its
principal product lines include and families of
products in venous, capillary and urine collection, transfer and. transport. Specific
products within the line that [the beneficiary] is resporisible for are as follows:
•
•
•
•
• •
•
•
•
•
•
* * *
. Page 10
Specifically at II, [the beneficiary] is responsible for applying his extraordinary level of
expertise to extending the already elevated level of Pre-Analytical System (PAS)
knowledge and innovation at the interface between specimen containment products, . r . ....
anallytes and other compounds, and specimens and their interactions with diagnostic
chemistries. At present, he is actively engaged in high-level activity focused on
improving the technology and design of the and
has a provisional patent application pending fer a
safe method for blood collection i They p g and
specimen, spillage, thereby reducing the potential for exposure to blood borne pathogens.
This product line is in use in countries throughout the world and generates sales in the
multimillions per year.
* * *
Given his specialized education and Ph.D. degree in Physical Polymer Chemistry, as well
as hIs spectacular research experience at DSM~ Research in the Netherlands, and at the
New Jersey Center for Biomaterials, [the beneficiary] has the extraordinary ability
required, and he is uniquely qualified to lead_ithin the company's
Diagnostics Division, in the area of biomaterials research and the design of safety
coatings for important medical devices.
The plain language of the regulation at 8 C.F.R. § 204.5(h)(3)(v) requires that the contributions
:be "of major significance in the field" rather than limited to a single research institution or
.employer such as the petitioner. With regard to the beneficiary's occupation, the Department of
Labor's Qccupational Outlook Handbook (OOH), 2010-11 Edition (accessed at www.bls.gov/oco
on January 20, 2011 and incorporated into the ,record of proceedings), states:
Many chemists and materials scientists work in research and development (R&D). In
basic research, they investigate the properties, cofnposition, and structure of matter and
the laws that govern the combination of elements and reactions of substances to each
other. In applied R&D, these sCientists create new products and processes or improve
existing ones, often using knowledge gained from basic research.
(Emphasis added.) See http://www.bls.gov/oco/pdf/ocos049.pdf. If the regulation at 8 C.F.R.
§ 204.S(h)(3)(v) is to have any meaning, it must be presumed that merely performing r~utine
duties inherent to one's occupation is not necessarily indicative of scientific contributions of
major significance in the field. While the beneficiary has helped to improve. product lines,
there is no evidence showing that his level of contribution to the company's existing products
equates to original scientific contributions of "major significance" in the field. .
\
In response to the director's request for evidence, the petitioner submitted an August 31, 2009 letter
Since joining. [the beneficiary's] work continues to have a significant impact,
specifically on the PreAnalytical Medical Device Industry and Healthcare,.because,:'
l
• Co'}
Page 11
o He is directing a research team on Zenith P800, a blood collection diagnostic
device, capable of stabilizing bioactive peptides (metabolites) related to metabolic
diseases like Type II Diabetes, the fastest growing disease worldwide (estimated
130 MM additional people will be affected by metabolic disease in the next
twenty (20) years); /'
o As the Core Team Leader on this product launch, he is collaborating with key
Pharmaceutical and,Clinical Research Organizations, because the Pre-Analytical
" device is capable of stabilizing m.etabolites offering extremely valuable insight
into metabolic diseases like Type II Diabetes, a research area that consumes an
estimated $80 Billion dollars annually;
o [The beneficiary] advanced the improvement of serum speCimen purity by
dev,elopi!lg an unprecedented Enzyme Linked Immunoassay (ELISA) method
, capable of translating serum quality from clinically subjective observations to a
quantitative accura:tede~ermination which enabled him;
0' He determined the root cause for specimen contamination in diagnostic devices
(that use blood separation gel material), contamination that is a potential cause of
erroneous diagnostics results that can lead to inaccurate diagnosis posing a serious
threatto patient health;
o [The beneficiary] successfully led a project team to eliminate issues brought
forward through seven (7) Non-Compliant Material Requests (NCMRs) relating
to critical product component failur~s of a blood separation gel materials
exclusively manufactured at '
o [The ,beneficiary] drastically around time for diagnostic test results
by 'developing a novel formulation that rapidly coagulates blood upon collection
In in less than 2 minutes compared to
typically 30 minutes by conventional serum products on the market. [The
beneficiary] holds an Invention Disclosure Report (IRD) for this work and the
technology is scheduled to enter Product Development in 2010;
, I
o Leading research on products manufactured and distributed bi BD to hospitals
, (worldwide) which has improved existing products and prevented the erosion of a
product line at _that generates $150 MM annmillywhich is a huge business
contribution: \
1. Push Button Blood Collection Set, Blood
Collection Tubes, Blood Collection Set, Passive Shielding
Blood Collection Needle Eclipse™ Blood Collection Needle, Holders
2. Quikheel™ Lancet, Contact-Activated Lancet,
T. ;.
o ollection Tubes
3 .
. scusses the beneficiary'S activities at _but there is no evidence showing that the
s original work for the company equates to scientific' or business-related
contributions of major significance in the field. The submitted documentation does not establish
that the beneficiary's wor](.,for_has significantly impacted the field beyond his projects for his
. ..
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Page 12
immediate employer. Once again, a contribution to the beneficiary's employer is not necessarily
an original contribution of major significance to the field at large.
I
The petitioner's response also included $I August 31, 2009 letter from Senior
Vice President and Chief Technology Officer" stating:
After joining '[the beneficiary] has been working at an
extraordinary pace to provide solutions on critical' issues in several
Manufacturing, Technology and Product Development initiatives. [The beneficiary's]
exceptional work has identified the root case for specimen contamination. At the same
time, ,he was able to effect an elimination of customer complaints by' directing a
manufact~ring process change at the plant which resulted in a significant improvement in
product performance. [The beneficiary's] unparalleled talent in the field of bio-relevant
characterization of biomaterial surfaces and protein adsorption, as evidenced by his
extensive bibliography of peer reviewed publications and a patent, has uniquely qualified
him to address the difficult issue of quantifying specimen quality in
products at the molecular level. '
_discusses how the beneficiary's work at II has been beneficial to his company, but
he does not provide specific examples of how the beneficiary's projects have impacted the field
,at large. _ also comments on the beneficiary's "extensive bibliography of peer
,reviewed publications." The regulations contain a separate criterion regarding the beneficiary'S
,authorship of scholarly artiCles. 8 C.F.R. § 204.5(h)(3)(vi). We will not presume that evidence
Telating to or even meeting the scholarly articles criterion is presumptive evidence that the
'beneficiary also meets this criterion. Here it should be emphasized that the regulatory criteria are
separate and distinct from one another. ~ecause separate criteria exist for authorship of
scholarly articles and original contributions of major significance, USCIS clearly does not view
the two as being interchangeable. To hold otherwise would render meaningless the statutory
requirement for extensive evidence or the regulatory requirement that a beneficiary meet at least
three separ~te criteria! We will fully address the beneficiary's scholarly articles under the next
criterion. Regardless, there is no documentary evidence demonstrating that the beneficiary's peer
reviewed publications and patent application are frequently cited by independent researchers or
otherwise rise to the level of original contributions of major significance in the field.
I
sociate Research Professor at the,
Department of Chemistry and Biological Chemistry at ••••• states:
I have known [the beneficiary] since he joined the New Jersey Center for Biomaterials ....
Throughout his research and teaching work, [the beneficiary] has demonstrated~
outstanding knowledge of polyn\er chemistry and biomaterial surface characterization
methods. Most notably, [the beneficiary] has developed important predictive tools that
allow researchers to determine the compatibility of biomateriais surfa~es with living
cells, providing a new understanding of blood cell and serum protein interactions with
surfaces, such that materials can be designed and manufactured that s~lectively favor
mammalian cell attachment over infeCtious bacterial cell biofilm formation.
' ..
Page 13
[The beneficiary] has performed groundbreaking work in improved bio-relevant high
throughput screening methods, which has resulted in essential new techniques for
identifying novel polymeric biomaterial compositions. This state-of-tlie-art research,
_. I .
arising from a collaboration of Q-Sense AB, the world's leading industrial supplier of
acoustic resonator instruments, with our Center, did much to establish [the beneficiary's]
reputation intem"tionally as -one of the leading scientists in the design and integration of
quartz crystal:microbalance with dissipation -(QCM-D) and imunofluorescence assay
measurements for determining surface hemocompatibility (blood compatibility). This
work has been published ••••••••• IIiI •••••• ~ ••••••
• "The Application of QCM-D .Within a Biomaterials Discovery Process," Q-Sense
- but the true tribute to its real-
IS beneficiary's] writings have
lately been implemented by two Fortune 500 biotechnology companies.
not identify the "two Fortune 500 biotechnology companies" that have
implemented the beneficiary's screening methods for determining surface hemocompatibility or
indicate the extent of their implementation. Simply going on record without supporting
documentary. evidence is not sufficient for purposes of meeting the burden of proof in these
proceedings. Matter of Soffici, 22 I&N Dec. at 165. Further, there is no evidence showing that
the beneficiary's conference paper is frequently_ cited by other .researchers or that his findings
otherwise equate to original scientific contributions of major significance in the field.
states:
I served as [the beneficiary's] Advisor while he completed a Post Doctoral Research
assignment at my facility, the New Jersey Center for Biomaterials ....
*. * *
[The beneficiary's] appointment to the New Jersey Center for Biomaterials enabled him
to -achieve unparalleled advances in the field of biomatetials science and t;he rapid
screening of bio-relevant properties aimed at accelerating the discovery: of new
biomaterials.
_does not provide specific examples of how the benefiCiary's screening methods have
influenced the field at large or have been successfully utilized by independent research teams.
Associate Professor in the Department of Biomedical Engineering, and the
Department of Chemical and Biochemical Engineering at states:'
researchers at the Department of Biomedical Engineering at
engaged in an intensive collaboration with [the beneficiary] at
the New Jersey Center for Biomaterials and it is through his extraordinary work on the
project that I got to know him well. . .. The project objectives were to devise state of the
Page 14
art combmatorial workflows for the discovery of new biomaterials and to identify the
pitfalls and probl~ms associated with this, which was, at that time, a rather new area of
research. [The beneficiary]' directed the work so well that a very useful resource was
established, unique in that it makes It possible'to evaluate the bio-response of a large
number of potential biomaterials. This knowledge has already and wili continue in the
future to enable thr New Jersey Center for, Biomaterials to provide the best material
candidates for medical devices' while contributing strongly to the understanding of cell
materials interactions in scientific literature.
COIlllTlents that the beneficiary established a "ver~ useful" biomaterials resource for
the NJCBM, but there is no documentary evidence showing that the beneficiary's original work
for this project has significantly impacted others in the field. Once again, a contribution to the
beneficiary's research institution is not necessarily a contribution of major significance in the
field at large.
I am ... a Core Faculty member of the "Integrated
Technologies Resource for Polymeric Blomaterials" (RESBIO) within the New Jersey
Center for Biomaterials, where I am responsible 'leading research efforts in high
throughput screening experimentation of cell-material interactions.
* * *,
At the New Jersey Center for Biomaterials, Rutgers University, [the beneficiary] has
made significant and lasting contributions to the RESBIO initiative, which is focused on
developing new techniques to accelerate biomaterials discovery methods. [The
beneficiary's] research contributions have proven invaluable to the ongoing and future
collaborative research efforts between NIST and the New Jersey Center for Biomaterials .
. His efforts have dictated the research focus for a team of eight (8) postdoctoral fellows
and faculty members at the New Jersey Center for Biomaterial,s., working to exploit and
leverage the development of new automated combinatorial workflows, rapid screening of
bio-response characterization assays and computational methods for the prediction of
biomatc:rials properties. Evidence for the inherent merit and value of [the beneficiary's]
work include the fact that the system and results developed by [the beneficiary's]
research team were featured in a presentation to the Fall 2006
I
There is no evidence showing that the beneficiary's ACS conference paper is frequently cited by
independent researchers or that his work otherwise equates to an original scientific contribution
of major significance in the field.
\
• ••
(
Page 15
1
Assistant Professor of Chemical Engineering and Molecular and Cellular
states:
I worked as a Postdoctoral Fellow at the National Institutes of Health in the Department
-of Biomedical Engineering at where I conducted research on tissue
engineering and. had the pleasure of first meeting and collaborating with [the beneficiary].
* * *
I am very familiar with the ... research work that [the beneficiary] has carried out while
working at the - developing effic~ent combinatobal
synthetic methods methods. for improvin,g and
accelerating the discovery of new biomaterials for application in medical devices and
regenerative medicine, [The beneficiary's] excellent work, -namely the development of
predictive methods for determining surface herriocompatibility . and combinatorial
approaches for the .development of polymer suifaces exhibiting cell-specific adhesion, is
extremely important to a number of key advances within the medical device industry.
Without these -technologies and the creative -and elegant solutions developed by [the
beneficiary], the quality of many regenerative therapies and medical devices would be
substantially inferior~to their current state.
* * *
As a Research Faculty Member, [the beneficiary]'s group at the
has.performed a good deal of . work with my
Department of Biomedical Engineering at
the objective of which was to investiga~e better methods for characterizing cell response
on materials for development in medical devices and regenerative tissue scaffolds. Our
highly successful project generated more efficient procedures for imaging cell response
on polymer surfaces by developing high-throughput screening methods and
implementing them in material array formats. Notably, [the beneficiary] was the driving
force behind· many of the most significant and useful innovations derived during our
work. A testimony of [the beneficiary's] impact in this field is our seminal presentation
at the 2006 Material Research Society Fail Meeting in~d an article currently
under peer review for publication in the journal Biomaterials. - .
The beneficiary's field, like most science, is research-driven, and there would be little point in
publishing or presentlng research that did not add to the general pool of knowledge in the field.
According to the regulation at R C.F.R. -§ 204.5(h)(3)(v),an alien's contributions must be not
only original but of major significance. We must presume that the phrase "major significance" is
not superfluous and, thus, that it has some meaning. To be considered a contribution of major
significance in the field of science or medicine, it can be expected that the results would have
already been reproduced and· confirmed by other experts and applied in their work. Otherwise, it
is difficult to gauge the impact of the beneficiary's work. does not provide specific
examples of how the ben~ficiary' s predictive methods for _ determining surface
.. . ..
Page 16
hemocompatibility and combinatorial approaches for the development of polymer surfaces
exhibiting cell-specific adhesion are being successfully applied in the medical device industry.
Further, there is no evidence showing that the beneficiary's methods for characterizing cell
response on materials for development in medical devices and regenerative tissue scaffolds are .
. frequently cited, widely utilized, or otherwise constitute original scientific contributions of major
significance in the field.
./
Principal Scientist, Performance Materials, DSM Research, _ states:
At his position in ~erformance Materials at DSM Research, where I had the pleasure of
working with him, [the beneficiary] demonstrated his extraordinary skills in polymer
chemistry by developing a mechanically robust nonfouling coating. He was the first ) .
scientist to graft hydrophilic polymer chains to reactive nanoparticles and incorporate
them in a crosslinked polymer matrix to yield a superior mechanical and b'ioinert coating
for potential use in medical devices. [The beneficiary] was responsible for spearheading
the research collaborations at which allowed
him to characterize the bio-response of his nonfouling coatings, applying state-of-the-art
measurements and bringing knowledge of immense importance to DSM Research. The
coating technology [the beneficiary] developed is without question far superior to all
others in this emerging field. This invention resulted in a DSM owned'iinternational
patent application ....
(Emphasis added.)_comments about the "potential use" of the beneficiary's coating for
medical devices. The petitioner, however, must demonstrate the beneficiary's eligibility as of
the filing date. 8 C.F.R. §§ 103.2(b){l), (12); Matter of Katigbak, 14 I&N Dec. 45, 49 (Reg'I.
Comm'r. 1971). The burden is on the petitioner to establish that the beneficiary's work has already
significantly impacted the field as of the petition's filing date. To satisfy the criterion r~lating to
original contributions of major significance, the petitioner must demonstrate not only that the
beneficiary's work is. novel and useful, but also that it had a widespread impact on his field.
Research and Development Manager, DSM Research, discusses the
research position in Performance Materials at DSM Research"
[The beneficiary] showcased his exceptional skills in polymer chemistry in developing
mechanically robust, non-fouling coatings. This coating technology he developed is,
without question, superior to technology in this emerging field. The DSM coating
technology [the beneficiary] developed is mechanically robust (il.e., resistant to wear and
abrasive damage). By contrast, current non-fouling technologies published in peer
reviewed literature and colIlIhercially available on the market are intrinsically frail and
weak due to the nature of the soft materials used to generate their non-fouling surface
properties. Upon damage, these coatings lose their non-fouling properties, leading to the
adhesion of biological entities, such as bacterial cells. that may result in an implant
infection where medical devices are concerned.
• . ,I.
Page 17
[The beneficiary's] work resulted m a DSM-owned
scholarly publications,
The beneficiary's article was published subsequent
to the petition's October 27, 2008 filing date. As pre~iously discussed, the petitioner must
demonstrate the beneficiary's eligibility as of the filing date. 8 C.F.R. §§ 103;2(b)(1), (12);
Matter of Katigbak, 14I&N Dec. at '49. Nevertheless, there is no evidence showing that the'
beneficiary's fmdingsin '
are frequently cited or ,otherwise equate to original contributions of
major significance in the field. Regarding the comment from _that the beneficiary's
work at DSM Research resulted in an international patent application, the petitioner submitted,
documentation indicating that the beneficiary,_ and another scientist at DSMResearch
filed a for their invention entitled "Coating composition, coating
and object co "!-ted with the coating composition" in 2004. Even if the petitioner were to establish
that the application resulte~ in a European patent, which it has not, the grant of a patent
demonstrates only that an invention is original. , A patent is not necessarily evidence of a track
record of success with,some degree of influence over the field as a whole. See Matter' of New
York State Dep't. of Transp., 22 I&N Dec. 215, 221 n. 7, (Commr. 1998). Rather, the
significance of the innovation must be determined on a case-by-c'ase basis. [d.' In this instance,
there is no documentary evidence indicating that the invention has b~en successfully marketed in
the medical device industry or other comparable evidence of its significant influence in the field.
Thus, the impact of the beneficiary's invention is not documen~ed in the record. FWther, with
to that the beneficiary is improving "the technology and design of
has a provisional patent application pending,"
.",vJ'.vv , the beneficiary's innovation for. Accordingly,
... ol"~ .. "' ... £>r has not established that the beneficiary'S patent applications assigned to .and
uate to original contributions of major significance in the field. Moreover, we
cornment that II alone "holds over 300,000 p'atents and trademarks."
and Professor of '
I had the unique pleasure of ] as a part of the collaboration
he initiated with my, group at during his position at DSM
Research. The objective of ourstudy was to determine ability of his novel coatings to
resist bacterial adh~sion, employing a state-of~the-art parallel flow plate m~thod. This
highly successful project demonstrated the excellent non-foulmg properties of [the
beneficiary's] coatings which he had generated through his novel and efficient procedure
for creating and gesigning bioinert surfaces for application in medical and non-medical
devices that contact biological systems. '
With the full support of DSM Research, [the beneficiary] built up a fully marketable
technology with which, the potential of DSM Research Performance Materials was
greatly enhanced~ This initiative allowed us to continue efforts to bring hi [sic] new
L
... t t
Page 18
technology to commercial market, the b~st possible testament to the value of his work.
[The beneficiary's] impressive technique and clear expertise in the areas of
nanotechnology, biomaterials and materials chemistry distinguished him as a driving
force in this research project which contributed to our developing numerous new, very
useful materials. !
_ does not provide specific examples of how the beneficiary's coating technology is
~zed in the industry beyond DSM Research's collaborative project with
_. There is no evidence showing I that the beneficiary'S procedure for creating and
designing bioinert surfaces is frequently dted by independent researchers or that his work
otherwise equates to an original scientific corltribution of major significance in the field.
, t /'
Professor and Department Head ~t the Department of Biomedical
Engineering at the University Medical Centet states:
I met with [the beneficiary] the Univer~ity Medical Center where, in
2003-, h'e approached' my department with a collaborative proposal concerned with his
postdoctoral research at DSM Research. The project, devoted to the phenomenally
important area of creating nonfouling surfaces, involved the surface characteriza~ion of
protein adsorption and bacterial adhesi~n on coating materials he had designed and
invented. Due to his impressive internatibnalreputation in physical polymer chemistry, it
was my pleasure to collaborate with [the beneficiary] and allow him to. perform his
measurements in our laboratories. The objective was to create coatings resistant to the .
fouling of biological materials including proteins that can lead to the failure of 5mplanted
medical devices. I '-
In the highly competitive and technologfcally important market of materials for medical
devices such as that we experience todh, worldwide, the effective implementation of
coatings for medical devices, inert to biofouling and that resists bacterial infection, is one
of the crucial elements for creating a sucbessful, safe product. [The beneficiary's] expert
research project ultimately generated a patent and was published in several compelling
articles, greatly advancing the work being done in production of nonfouling coatings.
commerits that the beneficiary has published "several compelling articles," but the .
"UJ."U'''~ of submitted citations to the beneficiary's articles does establish that his work. is
indicative of contributions of "major significance" in the field.
states:
I came to know [the beneficiary] througp his exceptional whilst [sic] at DSM Research
where he was recruited into a Postdoctoral position within the Functional Coatings
I
Division. Applying his unusually broad and deep background in polymer science, he
~ent on to develop a significantly major contribution to the field, namely, rion-fouling
coatings .... [The beneficiary's] work :is expertly written and described in his recent,
peer-reviewed article "Surface-modifi~d nanoparticles as a new, versatile, and
No " .. t
Page 19
inechanically robust non-adhesive
bacterial adhesion" that appeared in the
As previously discussed, the beneficiary's article in
I
was published subsequent to the petition's 0ctober 27, 2008 filing date. The petitioner must
demonstrate the beneficiary's eligibility as :of the filing date. 8 C.F.R. §§ 103.2(b)(I), (12);
I
Matter of Katigbak, 14I&N Dec. at 49. Nevertheless, there is no evidence showing that the
beneficiary's work· is frequently cited or otherwise
equates to contribution Of major significance in the
Lecturer in Polymer Che'mistry at Heriot-Watt University, United Kingdom,
states:
[The beneficiary] completed his undergniduate dissertation project under my supervision
and, considering his impressive knowledge anq skills, it was my pleasure to accept his
application to undertake his Ph.D. dissertation' studies in my laboratory as well. [The
beneficiary's] Ph.D. research was devote~ to the complicated problem of correlating the
chemical structure of polymers with their physical properties .... The objective of these
measurements was to reveal structural ordering and dynamic information concerning the
- I
behavior in a class of nanostructured polymers which [the beneficiary] had synthesized in , I
the laboratory. [The beneficiary] expertly managed his Ph.D. research project, to the end
that he achieved a number of scientific ¥scoveiies that were previously unrep~rted and
led to publication of his compelling results, including six (6) articles in competitive peer-
I
reviewed journals which provided a :detailed and thorough understanding of the
nanostructured and physic;:al properties in:nanophase sepamted polymers. This was a clear
breakthrough in the area and the project':s success was clearly due to [the beneficiary's]
expert leadership. - '
While the beneficiary's research is no doubt lof value, it can be argued that any research must be
shown to be _ original and present some benefit if it is to receive funding and attention from the
scientific community. Any Ph.D. thesis or; postdoctoral research, in order tp be accepted for
graduation, publication, presentation, or funaing, must offer new and useful information to the
pool of knowledge. It does not follow that e:veryresearcher who performs original research that
adds to the general pool of knowledge has ir:ilierently made a contriblltion of major significance
to the field as a whole.
I _
Culminating- from -[the beneficiary's] 'distinguished body of work are numerous
publications, presentations and a paten~. [The beneficiary] has earned a tremendous
reputation among- the international com:tnunity of scientists, who have cited his work,
both within the U.S. and abroad. I
As previously discussed, the petitioner subn).itted copies of seven research articles citing to the
beneficiary's work. The petitioner also s~bmitted a citation list of 24 articles citing to the
- .,
Page 20
" beneficiary's body of published work. Two the listed citations were self-citations by the
beneficiary's coauthor and Ph.D. While a normal and expected process, the
self-citations cannot demonstrate the benefici¥y's influence beyond laboratory. The
source of the citation list compiled by the peti~ioner is not identified and copies of only seven citing
articles were submitted. Rather than subinitti~g evidence of citations records originating from an
official source (such as an online scientific d<;ltabase) for the remaining articles or copies of those
articles, the petitioner instead submitted a ~elf-serving list of citing articles compiled by the
petitioner. Going on record without supporting documentary evidence is not sufficient for purposes
of meeting the burden of proof in these proceedings. ,Matter of Soffici, 22I&N Dec. at 165.
Counsel provides no for the: did not submit a printout from an official.
source s~ch Even if we accepted the petitioner's self-
serving . list of citations, no has garnered more than twelve
independent citations. For instance, the list of thirteen articles citing to the beneficiary's 2000
article in. includes a self-citation by the beneficiary's
Ultimately, the limited number of submitted ci,tations to the beneficiary's articles is .not indicative of
contributions of major significance in the field!
Associate Profess'or of Medicine,
and independent
I am particularly impressed by' [the be*ficiary's] work related to the development of
combinatorial workflows and bio-relev'ant high-throughput screening assays for the
discovery of new biomaterials. His gr0undbreaking work, in this area has introduced
useful tools for predicting the hemoc6mpatibility of; biomaterial surfaces, allowing
researchers to assess the degree to whichl such materials resist adhesion of clotting blood
and bacterial cells to the medical device! thereby reducing risks of bacterial infection or
'vascular occlusion. [The beneficiary] I has developed screening assays that have
successfully identified materials whichl can be applied in regenerative medicine by
selectively favoring mammalian cell attachment and growth over that of bacteria; and this
, I
process is accomplished much more quic~ly than was ever previously P?ssible.
does not provid~ specific e~amples. of how the beneficiary's combinatorial
and bio-relevanthigli-throughput screening assays are being implemented by others
in the field beyond the NJCBM or otherwise;constitute contributions of major significance in the
field at large. '
, Departm¥t of Polymer Science and Engineering,
states:
,
[The beneficiary's] research is most ce~ainly extraordinary, not merely on a theoretical
lev~l, but also in regard to its viability! in real-world applications in medical deVIces.
Such examples that demonstrate extraordinary achievements are, for instance:
• creation of a non-fouling coating technology at DSM Research in
that resists th~ adhesion of proteins and biological cells to
... '",
\
Page 21
surfaces which received the American Chemical Society's Young Scientist Award '
at the,2005'Fall Meeting in Washihgton DC;
• The development of innovative techniques, such as the' state-of-the art Quartz
Crystal Microbalance with Dissipation, for the rapid and safe determination of
surface blood Gompatibility that Mias so innovative that it was selected to be
,presented at the Q-Sense World conference in Boston, 2006; and
• The development of combinatorial approaches for developing polymer surfaces
exhibiting cell specific ,adhesion that was likewise; so noteworthy that it was
identified for presentation at the Materials Research Society Fall meeting in
Boston, 2006.
As previously discussed, there is no documentary evidence of specific examples where the non
fouling coating technology developed by the beneficiary at DSM Research has been licensed,
commercialized, -or successfully utilized in the medical device industry. Moreover,_
~oes not explain how receiving an ACS award restricted to "young" scientists in the ,
early stages of their career equates to an original scientific contribution of major significance in
the field. The petitioner's evidence includes dQcumentation that thy beneficiary has presented
his findings at various sCientific conferences along with ,numerous other participants. Many
, professional fields regularly hold conferences and symposia to present new work~ discuss new j
findings, and to network with other professionals. These conferences are promoted and
sponsored by 'professional associations, businesses, educational institutions, and government
agencies. Participation in such events, however, does not equate to an 'original contribution of
major'significance inthe field. There is no evidence showing that the beneficiary's conference
,presentations have been freque~~ndependent researchers or have otherwise
significantly impacted the field. _oes not state that he has cited tci any of the
,beneficiary's conference presentations or journal articles in his own work and provides no
specific examples of any independent researchers who have applied the beneficiary's findings in
their work. '
On appeal, counsel argues that the director disregarded the information contained in the letters of
support. The opinions of experts In the field are not without weight and have been considered
above. users may, in its discretion, use as advisory opinions statements submitted as expert
testimony. See Matter of Caron International, 19 I&N Dec. 791, 795 (Comm'r. 1988).
However, USCIS is ultimately responsible for making the final determination regarding an
alien's eligibility for thebenefit sought. Id. The submission of letters from experts supporting
the petition is not presumptive evidence of elIgibility; USCIS may evaluate the content of those
letters as to whether they support the alien's eligibility. See id. at 795-796; see also Matter of v
K-, 24 I&N Dec. 500, n.2 (BIA 2008) (noting that expert opinion testimony does not purport to
be evidence as to "fact"). Thus, the content of the experts' statements and how they became aware
of the beneficiary's reputation are important considerations. Even when written oy independent
experts, letters solicited by an alien in support of an immigration petition are of less weight than
preexisting, independent ,evidence that one would expect of a research scientist who has made
original contributions of major ,significance. Without supporting evidence showing that the
'beneficiary's work equates to original contributions of major significance 'in his field, we cannot
conclude th'at he meets this criterion.
.. '., . ~
Page 22
Evidence of the alien's authorship of scholarly articles in the field, in professional or
major trade publications or other major media.
The petitioner has documented the beneficiary's authorship of scholarly articles in professional
journals and,thus, has submitted qualifying evidence pursuant to;8 C.F.R. § 204.5(h)(3)(vi) ..
Accordingly, we agree with cpunsel that the evidence submitted bY.the petitioner meets this
criterion.
Evidence that the alien has performed in a leading or critical role for organizations,
or establishments that have a distinguished reputation.
The aforementioned letters of sup~eneficiary performed research as a
Senior Scientist at BD, a student at _ and as a postdoctoral researcher for
both DSM Research and the NJCBM. The director's decision erroneously concluded that "since
all these' assignments were integral to the beneficiary's employment, they cannot be considered
. for this criterion." We withdraw the director's finding in that regard. On appeal, counsel argues
that the letters of support confirm that the beneficiary has performed in a leading or critical role
for the preceding institutions. Regarding the beneficiary's role at the NJCBM; the January 26,
2007 letter fro~tates:
[The beneficiary] manages and guides a team of fifteen (15) faculty members,
postdoctoral fellows and graduate students working on the development of combinatorial
synthetic workflows. and biorelevant screening characterization for the discovery of new
biomaterials. This program is a vital, core component o(our NIH-funded, multi-million
dollar National Center for Research Resource, "RESBIO," here' at Rutgers. [The
beneficiary] is the technical project leader for this core team and his unique combination
of technical and organizational skills have ensured the success of this project and helped
establish the as a major national resource for
biomedical
We acknowledge the beneficiary's service as a technical project leader for the NJCBM team
working on the development of combinatorial synthetic workflows and biorelevant screening
characterization for the discovery of new biomaterials, a component of RESBIO. However,
leading this co'mponent of the RESBIO project does not necessarily translate to a leading or
critical role for the NJCBM as a whole. The petitioner's initial evidence included informational
material about the Biomedical Engineering program at but the. submitted
documentation does not establish that the NJCBM has a reputatiofl. Going on
record without supporting documentary evidence is not sufficient for purposes of meeting the
burden of proof in these proceedings. Matter oj Sofjici, 22 I&N Dec. at 165. Further, while the
beneficiary has performed admirably on the projects to which he was assigned at
_ DSM Research, and the NJCBM, there is no evidence showing that his roles as a'
student and postdoctoral researcher were leading or critical for the preceding institutions. For
instance, the record does not include an organizational chart or other evidence documenting where
the beneficiary's positions fell within the general hierarchy of DSM Research and the NJCBM.
Page 23
We note th?t the beneficiary's postdoctoral research appointments at these institutions were
designed to provide specialized research experience and training in his field of endeavor. 5 The
petitioner's evidence does not. demonstrate how the beneficiary's temporary postdoctoral
appointments' differentiated him from the other research scientists employed by the pn~celamg
let alone the institutions' senior. management and tenured faculty such
The September 8, 2008 letter from_states that the beneficiary has worked for .as a
Senior Scientist in the PAS Division since March 2007. In response to the director's request for
evidence, the petitioner submitted an August 31, 2009 letter from_stating:
Recently the BD PAS Leadership Team (comprised of senior executives) selected [the
beneficiary] to become a Core Team Leader for a new product launch program. This
appointment was made· in recognition of his outstanding business acumen, execution
excellence, solid, cross-functional knowledge and the breadth of his technical,
organizational and leadership capability. In this capacity, [the b~neficiary] is accountable
to successfully lead and direct cross-functional team activities and deliver critical project
outcomes. He is accountable for the successful launch and commercialization of the
product on the worldwide market.,
_ states that the BD PAS Division Leadership Team "recently" selected the beneficiary
to become a "Core Team Leader," but he does not . specify the ~xact date of the beneficiary's
appointment. There is no evidence shing that the beneficiary had already performed as a
Core Team Leader for of the petition's October 27, 2008 filing date. As
previously discussed, a petitioner must establish the beneficiary' seligibility at the time of filing.
8 C.F.R. §§ 103.2(b)(1), (12); Matter of Katigbak, 14 I&N Dec. at 49. The petitioner'S response
to the director's request for evidence also included all August 31; 2009 letter from
stating that the beneficiary is "one (1) of only one hundred fifty (150)" Core Team Leaders
employed at. Without an organizati~nal chart or other evidence' documenting how the
beneficiary's position as Senior Scientist or Core Team Leader fits withm the general hierarchy of
or other evidence demonstrating what the alien does in his role that is
critical to the petitioner, we cannot conclude tha~ his role is leading or critical to the company as a
whole. The petitioner's evidence does not demonstrate how the beneficiary's roles differentiated
him from thenurnerous other Core Team Leaders and Senior Scientists employed by" let alone
the company's senior managers and executives (such as
In, this case, the documentation submitted by the petitioner does not establish that the beneficiary
was responsible for the preceding institutions' success or standing to a degree consistent with the
meaning of "leading or critical role." Accordingly, the petitioner has not established that the'
beneficiary meets this criterion.
5 "Biological scientists with a Ph.D. often take temporary postdoctoral research positions that provide specialized,
research experience." See http://www.bls.gov/oco/pdf/ocos047.pdf, accessed on January 20, 2011, copy incorporated
into the record of proceeding.
l~ .,) II·
Page 24
Evidence that the alien has commanded a high salary or other significantly high
remuneration jor services, in relation to others in the field.
The petitioner submitted copies of three of the beneficiary's pay statements from May and June'
2008 reflecting that he earns $3,193.85 biweekly or $83,040.10 annually. The plain language of
this regulatory criterion, however, requires the petitioher to submit evidence showing that the
beneficiary has commanded a high salary "in relation to others in the field." The petitioner offers
no basis for comparison showing that the beneficiary's e,arnmgs are significantly high in relation to
others in the field. On appeal, counsel states: "The Beneficiary made no claim to satisfy this
criterion in either the initial submission or response supplied to the RFE." Accordingly, the
petitioner has not established that the beneficiary meets this criterion.
Summary
In this case, we concur with the director's determInation that the petitioner has failed to
demonstrate the beneficiary's receipr of at major, int~rnationally recognized award; or that he
meets at least three of the ten categories of evidenc'e that must be satisfied to establish the
minimum eligibility, requirements necessary to qualify as an alien of extraordinary ability.
8 C.F.R. § 204.5(h)(3).
B. Final Merits Determination
,In accordance with the _ opinion, we will next conduct a [mal merits determination that
,[considers all of the evidence in the context of whether or not the petitioner has demonstrated: (1) a
"level of expertise indicating that the individual is one of that small percentage who have risen to
the very top of the[ir] field of endeavor," 8 C.F.R.§ 204.5(h)(2); and (2) "that the alien has
sustained national or international acclaim and that his or her achievements have been recognized in
the field of expertise." Section 203(b)(I)(A) of the Act; 8 C:F.R. §'204.5(h)(3). See also Kazarian,
596 F.3d at 1119-1120. In the present matter, several of the deficiencies in the documentation
submitted by the petitioner have already been addressed in our preceding discussion of the
regulatory criteria at 8 c.F.R. §§ 204.5(h)(3)(i), (ii), (iii), (iv), (v), and (viii).
Even if the petitioner were to submit primary evidence: of the beneficiary's ACS Yoimg Scientist
Award, which it has not, we cannot conclude that an : award won by the beneficiary in an age
restricted competition or a competition limited to scientists in the early stage of their career
indicates that he "is one of that small percentage who have risen to the very top of the field of
endeavor." See 8 C.F.R. § 204.5(h)(2). USCIS has long held that even athletes performing at the
major league level do' not automatically meet the "extraordinary abili~" standard. Matter oj Price,
20 I&N Dec. 953,954 (Assoc. Commr. 1994); 56 Fed. Reg. at 60899. ' Likewise, it does not follow
6 While we acknowledge that a dis!Tict court's decision is not binding precedent, we note that in Matter of Racine,
1995 WL 153319 at *4 (N.D. Ill. Feb. 16; 1995), the court stated:
[T]he plain reading of the statute suggests that the appropriate field of comparison is not a comparison of
Racine's ability with that of all the hockey players at all le~els of play; but rather, Racine's ability as a
( ,
Page 25
that a researcher who has had success in a competitro'n restricted to young scientists should
necessarily qualify for an extraordinary ability employment-based immigrant visa. To fmd
otherwise would contravene the regulatory requirement at 8 C.F.R. § 204.5(h)(2) that this visa
category be reserVed for "that small percentage of indiviquals that have risen to the very top of their
field of endeavor."
With regard to the ,documentation submitted for 8 C.F.R. § 204.5(h)(iv), the nature of the
benefi~iary' s judging experience is a relevant consideration as to whether the evidence is
indicative of his' recognition beyond his own circle of collaborators. /See Kazarian, 596 F. 3d at
1122. Even if the petitioner were to' submit evidence showing that the beneficiary actually
completed the proposal and manuscript reviews, which it has not, we cannot conclude that the
beneficiary's subordinate level of review demonstrates his sustained national or int~rnationar
acclaim or a level of expertise indicating that he is among that small percentage who have risen
to the very top of the field of endeavor. See section 203(b)(I)(A)(i) of the Act, 8 U.S.C.
§ 1153(b)(1)(A)(i), and 8 C.F.R. §§ 204.5(h)(2) and (3). The record reflects that the journal
manuscripts and proposal were first submitted to _or review who then assigned the duty to
multiple subordinates at the.NJCBM including th~ary. Being requested to review an artIcle
or proposal by one's supervisor is not evidence of natibnal or international acclaim. Further, we
note that peer'revi,ew is a routine element of the process by which articles are selected for
publication in scientific journals. Normally a journal's: editorial staff will enlist the assist,ance of
m~y professionals' in the field who agree to review submitted. papers. It is common for a
publication to ask multiple reviewers to review a manuscript and to offer comments. The
iPublication's editorial staff may accept or reject any reviewer's comments in determining
whether to publish or reject submitted papers. With'out evidence pre-dating'the filing of the .
petition that sets the beneficiary apart from others in his field, such as evidence that he served in
an editorial position for a distinguished journal or completed numerous manuscript reviews at the
direct request of a substantial number of journals, vJe cannot conclude that his level of peer
review is commensurate with sustained national or international acclaim at the very top of the
field of endeavor.
Regarding the beneficiary's original research, as stated above, it does not appear to rise to the level
of contributions of "major significance" in the field. Deinonstrating that the beneficiary's work was
"original" in that it did not merely duplicate' prior rese~ch is not useful in setting the beneficiary
apart through a "career·.of acclaimed work." H.R. Rep. No. 101-723,59 (Sept. 19; 1990). That
page (59) also says that "an alien must (1) demonstrate sustained national or international acclaim in
the sciences, arts, education, business or athletics (as shown through extensive documentation) ... "
Research work that is unoriginal would be unlikely to secure the beneficiary a master's degree, let
alone classification as a, scientist of extraordinary ability. To argue that all original research is, by
professional hockey player within the NHL. This interpretation is consistent with at least one other court in ,
this district, Grimson v. INS, No. 93 C 3354, (N.D. Ill. September 9, 1993), and the definition of the term
8 C.F.R. § 204.5(h)(2), and the discussion set forth in the preamble at 56 Fed. Reg. 60898-99.
Although'the present case arose within, the ji.Jrisdiction of another federal judicial district and circuit, the court's
reasoning indic'ates that USCIS' interpretation' of the regulation at: 8 c.F.R. § 204.5(h)(2) is reasonable.
Page 26
defmition, "extraordinary" is to weaken that adjective beyond any useful meaning, and to presume
that most research is "unoriginal." Notably, the Department of Labor's OOH, 2010-11 Edition
(accessed at www.bls.gov/oco on January 20, 2011 and incorporated into the record of
proceedings), contains the following infonnation on chemists and materials scientists:
Many chemists and materials scientists work in research and development (R&D). In
basic research, they mvestigate the properties, composition, and structure of matter and
the laws that govern' the combination of elements and reactions of substances to each
other. In applied R&D, these scientists create new products and processes or improve
existing ones, often using knowledge gained from basic research. For example, the
development of synthetic rubber and plastics resulted 'from research on small molecules
uniting tofonn large ones, a process called polymerization. R&D chemists and'materials
scientists use computers and a wide variety of sophistica~ed laboratory instrument,ation
for modeling, simulation, and experimental analysis. '
,;* * *
Materials scientists study the structures and chemical properties of various materials to
develop new products or enhance, existing ones. They also detennine ways to strengthen
or c091bine materials or develop new materials for use in a variety of products. Materials
science encompasses the natural and synthetic materials used in a wide range of products
and structures, from airplanes, cars, and bridges to clothing and household goods.
-Materials scientists often specialize in a specific type of material, such as ceramics or
metals.
See hup://www.bls.gov/oco/pdf/ocos049:pdf.As·researching chemicai properties, developing new
products or processes, and improving existing ones are inherent to chemists and materials scientists,
the mere originality of the beneficiary's work does not set the beneficiary among "that small
percentage of individuals that have risen to the very top of their field of endeavor."· 8 C.F.R.
§ 204.5(h)(2). For the reasons, discussed above, the record does not contain sufficient evidence
that the beneficiary's original innovation~ had major significance in the field, leLalone an impact
consistent with being nationally or internationally acclaimed as extraordinary:
at
OOH (accessed at www.bls.gov/oco on
anuary mto proceedings) provides infoimation about the
nature of employment as a postsecondary teacher and the requirements for such a position. See.
http://www.bls.gov/oco/pdf/ocos066.pdf. The handbook expressly states that faculty members are
pressUred to perfonn re~earch and publish their work and that the professor's research record is a .
consideration for tenure. Moreover, the doctoral programs traiiling students for faculty positions
require a dissertation, or written report on original research. . /d. This infonnation reveals that
original published research, whether arising from research at a university or private employer, does
not set the researcher apart from faculty in that researcher's field.
Page 27
Moreover, the beneficiary's citation history is a relevant consideration as to whether the evidence
is indicative 'of the beneficiary's recognition beyond his own circle of collaborators. See
Kazarian, 596 F. 3d at 1122. As previously discussed, the documentation submitted by the
petitioner indicates that the beneficiary's body of published work has been independently cited to
less than two dozen times. Moreover, there is no indication that any of the beneficiary's
individual journal articles have been independently cited to more than a dozen times. While the
submitted citations demonstrate some interest in his published work, they are not sufficient to
demonstrate that the beneficiary's articles have attracted a level of interest in his field
commensurate with sustained national or international acclaim at the very top of his field.
Ultimately, the evidence in the aggregate does not distinguish the beneficiary as one of the small
percentage who has risen to the very top of the field of endeavor. The petitioner relies primarily
upon the beneficiary's research work (including two patent applications); less tilan ten journal
articles published with his research supervisors (such as of the petition's
filing date; copies of only seven research articles by to the beneficiary's
published work; his positions as a ••••••••• ~ ••••••••••••
as a postdoctoral researcher for both DSM Research and the NJCBM; and the praise of members
of his field.
We note that many of the beneficiary's references' credentials are impressive. For example, _
~tates:
I am the Board of Governors Professor of Chemistry and Chemical Biology at
_ 'and an Adjunct Associate Professor af Ortho edics at the
Medical School. I have served as Director of the Center for Biomaterials
since its establishment in 1997. I am a Fellow of tlie mencan Institute for Medical and
Biological Engineering (AIMBE) and of. the International Union of Societies for
Biomaterials Science and Engineering (IUSBSE). I am the Principal Investigator of
several leading federally-funded R&D programs: NIH-funded postdoctoral training
program in Tissue Engineering, NSF-funded Partnership for Innovation designed to
explore new plant-synthetic hybrid biomaterials, NIH funded National Resource for
Polymeric Biomaterials (RESBIO), and the DoD-funded Center for Military Biomaterials
, Research (CeMBR).
* * *
I pioneered the use of combinatorial and computational methods for the optimization of
biomaterials for specific medical applications. . .. I have published over two hundred
(200) scientific manuscripts and reviews and hold thirtyfive (35) patents. ./ '
* * *
I' am the scientific founder of two spin-off companies, and served on the Life Science
Advisory Board of the _and as chair of the Scientific, Advisory Board of
. As Director of the Biomaterials, I initiated the
~,~ . '") . ..
Page 28
Center's industrial .membership program that has currently 20 member companies. I
currently serve on the Scientific Advisory Boards of three companies.
states:
I hold the position of Professor in the Department qf Polymer Science and Engineering at
I am the director of the UMASS Institute for
Interface Science. I have held the positions- of Head of the Department of Polymer
Science and Engineering. and . co-principal investigator for the. Center for UMASS-
Indus Research on Pol .'.. T have served on the Editorial Advisory Boards of
'In
addition, I serve 'on the Interi:lational Advisory Board of the ACS Polymer S
Interfaces Series. I have published over 125 peer reviewed publications and hold 6
patents.
states:
I am an Associate Director at the an Associate
Research Professor at the Department of Chemistry and Biological Chemistry at _
_ where I .hold the position of Chief Operating Officer for the Center for'
Military Biomaterials Research, leading programs to develop biomaterials for combat
casualty care and soldier .... My work is published in leading peer-reviewed
journals including My industrial experience
comprises over 36 patents and includes development and commercialization of a wide
array of specialty chemical products- including polymers and surfactants for such
applications as tissue engineering, coatings paper making, water and wastewater
treatment, and lubricants. -I have served
I hold the position of Lecturer in Polymer Chemistry at
_ wherell have worked since my appointment in 1996. lam preeminent in the
research fields of the miscibility and physical ageing ~n blends; nanophase separation in
polymers, polymer dynamics, ,liquid crystalline polymers, composites ane!. systems
containing nanoparticles. Much of this work has involved use' of neutron scattering
techniques and I have written various reviews and book chapters in this area, and served
on selection panels to allocate beam time at I regularly
review neutron proposals for the neutron scattering centre at NIST
My research is represented by in [sic] over 80 published papers, ~H"'lUU.Ul~
and articles for encyclopedias, and I have obtained funding from
am also a Fellow
OUbllicatlOrls in, the
states:
I am an Associate Professor in the Department of Biomedical L.JUj::.UlvvlUlj::.,
Department of Chemical and Biochemical Engineering I have,
published over 45 peer-reviewed publications and presented over 100 lectures at
international conferences in this field. . .. I have served as
and; now, as
Research Center on Polymeric Bionlatf~fl
, was elected as a Fellow of the American Institute of Medical and Biological Engineering
in 2004 and the American Academy of Nanomedicine (2006), and am the recipient of the
I also
I am Professor and Department Head at the at the
University'Medical Center a Ul~UUl:!.Ul,~ln;;u
the field of interaction forces between mIcroorganisms c '
surfaGes. My department has about seventy academic researchers ": .. My research has
resulted in over 425 peer-reviewed articles, two book[s] and several book contributions.
Over the past fourteen (14) years, now as Research and Development Program Manager
DSM Biomedical at DSM Research in the division of Performance Materials, I have
initiated and conducted fundamental research on various aspects of medical coatings. I.
am one of the principal founders of bSM Biomedical, established in 2005, now a 60
million dollar business that has ,been 'achieved b9th by organic growth and via an ,
acquisition strategy. . .. I have authored/co-authored more than 20 technic~l papers
published in several scholarly journals and hold over 30 pending international patents.
Finally
I j . in September, 2007, as Senior Vice President and Chief Tech11ology Officer.
This role is a new position at. designed to provide technology, strategy and
development leadership to the company as it focuses oninnovat~(m 'and impact in medical
devices, diagnostics and biesciences. I am responsible for the corporate strategic planning
1·
Page 30
function, corporate business development, and managing a corporate-
wide program to improve the product process across. 1 oversee an _
~than $400 million across 12 business units, consisting of more than 1,700
_ in mUltiple countries. In addition to my responsibilities 1 serve oh
the Advisory Councils of the
1 have a faculty appointment inth~ Medical School at Case as
patents on tissue engineering systems, and the biomedical
application of peptide assemblies in medical devices, and have published extensively ih
scientific journals, boo~s and the proceedings of national and international conferences.
The significance of my re.search has been recognized by my receipt of multiple awards
from the Orthopaedic Research Society, the American Academy of Orthopaedic
Surgeons, and :the Society for Bone and Joint Surgery.
While the petitioner need not demonstrate that there is no one more accomplished than the
beneficiary to qualify for the classification sought, it appears that the very top of the beneficiary's
field of endeavor is above the level he has attained. In this case, the petitioner has not established
that the beneficiary's achievements at the time of ,fIling were commensurate with sustained national
or international acclaim in nanotechnology, biomaterials, and polymer chemistry, or being among
that small percentage at the very top of the field of endeavor.
C. Prior 0-1 Nonimmigrant Visa Status
While USCIS has approved a prior 0-1 nonimmigrant visa petition fIled on behalf of the
beneficiary, this prior approval does not preclude USCIS from denying an immigrant visa petition
based on a different, if similarly phrased standard. Each case must decided on a case-by-case basis
upon review of the evidence of record. It must be noted that many 1-140 immigrant petitions are
denied after USCIS approve~ prior nonimmigrant petitions. See, e.g., Q Data Consulting, Inc. v.
INS, 293 F. Supp. 2d 25 (D.D.C. 2003); IKE A US v. US Dept. of Justice, 48 F. Supp. 2d 22
(D.D.C. 1999); Fedin Brothers Co. Ltd. v. Sava, 724 F. Supp. 1103 (E.D.N.Y. 1989). Because
USCIS spends less time reviewing 1-129 nonimmigrant petitions than 1-140 immigrant petitions,
. some nonimmigrant petitions are simply approved in error. Q Data Consulting, Inc. v. INS, 293
F. Supp. 2d at 29-30; see also Texas A&M Univ. v. Upchurch, 99 Fed. Appx. 556, 2004 WL
1240482 (5th Cir. 2004) (finding that prior approvals do not preclude USCIS from denying an
extension of the original visa based on a reassessment of the alien's qualifications) .
. The AAO is not required to approve applications or petitions where eligibility has not been
demonstrated, merely because of prior approvals that may have b~en erroneous. See, e.g., Matter of
Church Scientology International, 191&N Dec. 593, 597 (Comm. 1988). It would be absurd to
suggest that USCIS or any agency must treat acknowledged errors as binding precedent. Sussex
Engg. Ltd. v: Montgomery, 825 F.2d 1084, 1090 (6th Cir. 1987), cert. denied, 485 U.S. 1008 (1988).
Furthermore, the AAO's authority over the service centers is comparable to the relationship
between a court· of appeals and a district court. Even if a service center director has approved a
nonimmigrant petition on behalf of the alien, the AAO would not be bound to follow the
contradictory decision of a service center. Louisiana Philharmonic Orchestra v. INS, 2000 WL
282785 (E.D. La.), affd, 248 F.3d 1139 (5th Cir. 2001), cert. denied, 122 S.Ct. 51 (2001).
III. Conclusion
Review of the record does not establish that the beneficiary has distinguished himself to such an
extent that he may be said to have achieved sustained national or international acclaim and t6 be
within the small percentage at the very top of hi.s field. The evidence is not persuasive that the
beneficiary's achievements set him significantly above almost all others in his field at a national
or international level. Therefore, the petitioner has not established the beneficiary's eligibility'
pursuant to section 203(b)(1)(A) of the Act and the petition may not be approved.
An application or petition that fails to comply with the technical requirements of the -law may be
denied by the AAO even if the Service Center does not identify all of the groundS for denial in
the initial decision. .see Spencer Enterprises, Inc. v. United States, 229 F. Supp. 2d at 1043,
affd, 345 F.3d at 683; see also Soltane v. DOl, 381 F.3d at 145 (noting that the AAO conducts
appellate review on a de novo basis).
, The petition will be denied for the above stated reasons, with each considered as an 'independent
I
arid alternative basis for denial. In visa petition proceedings, the burden of proving eligibility for
the benefit sought remains entirely with the petitioner. Section 291 of the Act, 8 U.S.c. § 1361.
Here, that burderi has not been met.
ORDER: The appeal is dismissed.
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