dismissed EB-1B Case: Pharmaceutics

U.S. Department of Homeland Security 
U.S. Citizenship and Immigration Senices 
Ofice of Administrative Appeals, MS 2090 
identifYing data deleted to 
prevent clearly unwmnted 
invasion of personal privacy 
Washington, DC 20529-2090 
U. S. Citizenship 
and Immigration 
Services 
PUBLIC COPY 
FILE: Office: NEBRASKA SERVICE CENTER Date: 
LIN 07 205 52350 
 JuL 18 2804 
PETITION: 
 Immigrant Petition for Alien Worker as Outstanding Professor or Researcher Pursuant to 
Section 203(b)(l)(B) of the Immigration and Nationality Act, 8 U.S.C. 5 1153(b)(l)(B) 
ON BEHALF OF PETITIONER: 
INSTRUCTIONS : 
This is the decision of the Administrative Appeals Office in your case. All documents have been returned to 
the office that originally decided your case. Any further inquiry must be made to that office. 
If you believe the law was inappropriately applied or you have additional information that you wish to have 
considered, you may file a motion to reconsider or a motion to reopen. Please refer to 8 C.F.R. 3 103.5 for 
the specific requirements. All motions must be submitted to the office that originally decided your case by 
filing a Form 1-290B, Notice of Appeal or Motion, with a fee of $585. Any motion must be filed within 30 
days of the decision that the motion seeks to reconsider or reopen, as required by 8 C.F.R. fj 103.5(a)(l)(i). 
hn F. Grissom 
V Acting Chief, Administrative Appeals Office 
DISCUSSION: The Director, Nebraska Service Center, denied the employment-based immigrant visa 
petition, which is now before the Administrative Appeals Office (AAO) on appeal. The appeal will be 
dismissed. 
The petitioner is a pharmaceutical drug development company. It seeks to classifL the beneficiary as an 
outstanding researcher pursuant to section 203(b)(l)(B) of the Immigration and Nationality Act (the 
Act), 8 U.S.C. 5 1 153(b)(l)(B). The petitioner seeks to employ the beneficiary permanently in the 
United States as a senior scientist. The director determined that the petitioner had not established that 
the beneficiary had attained the outstanding level of achievement required for classification as an 
 , 
outstanding researcher. 
On appeal, the petitioner submits additional evidence. For the reasons discussed below, the petitioner 
has not overcome the director's valid bases for denial. 
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): 
(B) Outstanding professors and researchers. -- An alien is described in this subparagraph 
if -- 
(i) the alien is recognized internationally as outstanding in a specific 
academic area, 
(ii) the alien has at least 3 years of experience in teaching or research in the 
academic area, and 
(iii) the alien seeks to enter the United States -- 
(I) 
 for a tenured position (or tenure-track position) within a 
university or institution of higher education to teach in the 
academic area, 
( for a comparable position with a university or institution of 
higher education to conduct research 'in the area, or 
(ID) for a comparable position to conduct research in the area 
with a department, division, or institute of a private employer, if 
the department, division, or institute employs at least 3 persons 
Page 3 
full-time in research activities and has achieved documented 
accomplishments in an academic field. 
The regulation at 8 C.F.R. fj 204.5(i)(3) states that a petition for an outstanding professor or researcher 
must be accompanied by: 
(ii) Evidence that the alien has at least three years of experience in teaching and/or 
research in the academic field. Experience in teaching or research while working on an 
advanced degree will only be acceptable if the alien has acquired the degree, and if the 
teaching duties were such that he or she had full responsibility for the class taught or if 
the research conducted toward the degree has been recognized within the academic field 
as outstanding. Evidence of teaching and/or research experience shall be in the form of 
letter(s) from current or former employer(s) and shall include the name, address, and 
title of the writer, and a specific description of the duties performed by the alien. 
This petition was filed on July 1 1, 2007 to classify the beneficiary as an outstanding researcher in the 
field of pharmaceutics. Therefore, the petitioner must establish that the beneficiary had at least three 
years of research experience in the field as of that date, and that the beneficiary's work has been 
recognized internationally within the field as outstanding. The petitioner received his Ph.D. on 
December 17,2004, less than three years before the petition was filed. Thus, he must demonstrate that 
his Ph.D. research was outstanding if that research experience is to be accepted as part of his requisite 
three years of experience. 
The regulation at 8 C.F.R. 5 204.5(i)(3)(i) states that a petition for an outstanding professor or 
researcher must be accompanied by "[elvidence that the professor or researcher is recognized 
internationally as outstanding in the academic field specified in the petition." The regulation lists six 
criteria, of which the beneficiary must satis@ at least two. It is important to note here that the 
controlling purpose of the regulation is to establish international recognition, and any evidence 
submitted to meet these criteria must therefore be to some extent indicative of international recognition. 
More specifically, outstanding professors and researchers should stand apart in the academic 
community through eminence and distinction based on international recognition. The regulation at 
issue provides criteria to be used in evaluating whether a professor or researcher is deemed 
outstanding. Employment-Based Immigrants, 56 Fed. Reg. 30703, 30705 (proposed July 5, 1991) 
(enacted 56 Fed. Reg. 60897 (Nov. 29, 1991)). The petitioner claims to have satisfied the following 
criteria.' 
1 
 The petitioner does not claim that the beneficiary meets any criteria not discussed in this decision and the 
record contains no evidence relating to the omitted criteria. 
Page 4 
Published material in professional publications written by others about the alien j. work in the 
academicjeld. Such material shall include the title, date, and author of the material, and any 
necessary translation. 
Counsel has consistently listed articles that cite the beneficiary's work as evidence to meet this 
criterion. The director concluded that no evidence had been submitted to meet this criterion. On 
appeal, counsel discusses the nature of the citations themselves. While we concur with the director that 
the petitioner does not meet this criterion, more discussion is warranted. The regulation at 8 C.F.R. 
5 204.5(i)(3)(i)(C) requires evidence of published material "about the alien's work." Research articles 
which cite the beneficiary's work are primarily about the author's own work, not the beneficiary's 
work. We acknowledge that the beneficiary's work has also been cited in review articles. These 
articles, however, are about recent published research in general. As such, they cannot be considered 
published material about the beneficiary's work. 
While citations are relevant evidence and can be considered as evidence of the impact of the 
petitioner's contributions and the significance of his scholarly articles, they cannot serve to meet the 
plain language of this criterion. 
Evidence of the alien's participation, either individually or on a panel, as the judge of the work 
of others in the same or an allied academic field. 
Counsel asserts for the first time on appeal that the beneficiary meets this criterion. The petitioner 
submits a May 1, 2008 request for the beneficiary to review a manuscript for the Journal of 
Pharmaceutical Sciences and evidence that he completed the review. This review postdates the filing 
of the petition. Thus, it cannot be considered evidence of the beneficiary's eligibility as of that date. 
See 8 C.F.R. $8 103.2(b)(l), (12); Matter ofKatigbak, 14 I&N Dec. 45,49 (Reg'l. Comm'r. 1971). 
Regardless, we cannot ignore that scientific journals are peer reviewed and rely on many scientists to 
review submitted articles. Thus, peer review is routine in the field; not every peer reviewer enjoys 
international recognition. Without evidence that sets the beneficiary apart fiom others in his field, such 
as evidence that he has reviewed an unusually large number of articles, received independent requests 
fiom a substantial number of journals, or served in an editorial position for a distinguished journal, we 
cannot conclude that the beneficiary meets this criterion. 
Evidence of the alien's original scientz3c or scholarly research contributions to the academic 
field. 
Obviously, the petitioner cannot satisfy this criterion simply by listing the beneficiary's past projects 
and demonstrating that the beneficiary's work was "original" in that it did not merely duplicate prior 
research. Research work that is unoriginal would be unlikely to secure the beneficiary a master's 
degree, let alone classification as an outstanding researcher. Because the goal of the regulatory criteria 
is to demonstrate that the beneficiary has won international recognition as an outstanding researcher, it 
stands to reason that the beneficiary's research contributions have won comparable recognition. To 
argue that all original research is, by definition, "outstanding" is to weaken that adjective beyond any 
usefil meaning, and to presume that most research is "unoriginal." 
As stated above, outstanding researchers should stand apart in the academic community through 
eminence and distinction based on international recognition. The regulation at issue provides criteria 
to be used in evaluating whether a professor or researcher is deemed outstanding. 56 Fed. Reg. 
30703, 30705 (July 5, 1991). Any Ph.D. thesis, postdoctoral or other research, in order to be 
accepted for graduation, publication or funding, must offer new and useful information to the pool of 
knowledge. To conclude that every researcher who performs original research that adds to the 
general pool of knowledge meets this criterion would render this criterion meaningless. 
On appeal, 
 the petitioner's former Ph.D. advisor at the University of Utah, and 
, the petitioner's Chairman, assert that the very act of publishing constitutes a 
scholarly contribution. The regulations, however, include a separate criterion for scholarly articles. 
8 C.F.R. § 204.5(i)(3)(i)(F). Thus, the mere authorship of scholarly articles cannot serve as 
presumptive evidence to meet this criterion. To hold otherwise would render the regulatory 
requirement that a beneficiary meet at least two criteria meaningless. As will be discussed below under 
the last criterion, publication is inherent to the field of research. Thus, the interpretation proposed by 
these references would have the untenable result that every published researcher would qualifjr for the 
classification sought. By clarifying that this classification is limited to outstanding researchers with 
international recognition, Congress clearly did not intend for every published researcher to qualifjr. 
In a similar vein, the evidence that the beneficiary is a listed inventor on a U.S. provisional patent 
application establishes that his work purports to be original, but the very existence of a patent 
application does not show that the beneficiary's invention is more significant than those of others in his 
field. To establish the significance of the beneficiary's work, we turn to experts in hs field, whose 
letters we discuss below. 
The petitioner relies on several reference letters. The opinions of experts in the field, while not 
without weight, cannot form the cornerstone of a successfid claim of international recognition. U.S. 
Citizenship and Immigration Services (USCIS) may, in its discretion, use as advisory opinions 
statements submitted as expert testimony. See Matter of Caron International, 19 I&N Dec. 79 1, 795 
(Comm'r. 1988). However, USCIS is ultimately responsible for making the final determination 
regarding an alien's eligibility for the benefit 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. USCIS may even give 
less weight to an opinion that is not corroborated, in accord with other information or is in any way 
questionable. Id. at 795; see also Matter of SofJici, 22 I&N Dec. 158, 165 (Comm'r. 1998) (citing 
Matter of Treasure Craft of California, 14 I&N Dec. 190 (Reg'l. Comm'r. 1972)). 
Page 6 
In evaluating the reference letters, we note that letters containing mere assertions of widespread 
recognition and vague claims of contributions are less persuasive than letters that specifically 
identify contributions and provide specific examples of how those contributions have influenced the 
field. In addition, letters from independent references who were previously aware of the petitioner 
through his reputation and who have applied his work are the most persuasive. Ultimately, evidence 
in existence prior to the preparation of the petition carries greater weight than new materials prepared 
especially for submission with the petition. An individual with international recognition should be 
able to produce unsolicited materials reflecting that recognition. 
a professor at Musashino University in Japan, asserts that he is a long time 
collaborator with 
 dental mineral research. 
 asserts that the beneficiary, as part 
of this team, investigated the solubility of dental minerals. According to some of this work 
contradicted previous observations, supporting the use of fluoride toothpaste rather than requiring the 
ingestion of fluoride tablets during childhood. does not cite any formal dental guidelines 
issued based on this work or other examples of its influence. None of the other references discuss this 
work and the record lacks evidence that this work is widely and frequently cited. 
a visiting professor at the University of Utah during the petitioner's studies at that 
institution, asserts that the petitioner "made significant contributions in the area of pharmaceutics in 
[the] solid drug formulation field." Specifically, the beneficiary "developed a triple layers matrix tablet 
formulation of a low solubility drug" while studying for his Master's degree. concludes that the 
beneficiary's slow release formula was as good as the controlled release formulation of the same drug 
already on the market. While asserts that ths work "attracted a lot of global attention," the 
record lacks any media attention or significant coverage in the trade journals. does not claim to 
have been impacted by this work and provides no examples of independent research groups or 
pharmaceutical companies interested in pursuing the beneficiary's formula. 
In his initial letter, 
 asserts that the beneficiary has made significant contributions in the 
field of transdermal drug delivery using the novel method of alternating current (AC) iontophoresis. 
Specifically, the beneficiary developed a computer model that predicted flux enhancement over wide 
AC voltage and frequency ranges, confirmed that the model was in agreement with actual drug 
transport through human skin and developed a technology that can provide a constant drug delivery rate 
by controlling the magnitude of the AC current. While this work is clearly original in that it did not 
duplicate previous research, the petitioner must demonstrate that this work is internationally recognized 
as outstanding. 
, the petitioner's Chief Scientific Officer and co-founder, explains that he developed 
the petitioner's core technologies, including the following transdermal drug delivery technology: the 
controlled heat assisted drug delivery (CHADD) and DuraPeel technology platforms. - 
asserts that the beneficiary "has made crucial contributions to the novel transdermal pain-relief drug 
formulation, which will be submitted to the FDA for consideration of human clinical trials." Dr. 
does not explain specifically what the beneficiary added to the technology - 
originally developed. While 
 also discusses the beneficiary's work on another transdermal 
drug delivery platform, the beneficiary's work on this platform had yet to be presented or published 
as of the date of filing and, thus, cannot be considered. See 8 C.F.R. Ej$ 103.2(b)(l), (12); Matter of 
Katigbak, 14 I&N Dec. at 49. 
, a professor at the University of Utah, asserts that the petitioner was instrumental 
in developing a new system to measure phenylalanine levels without blood draws in Phenylketouria 
(PKU) patients, many of whom are children. does not provide examples of this system 
being used outside of the University of Utah where the beneficiary studied. 
an associate professor at the University of Cincinnati and one of the beneficiary's 
former coauthors, asserts that the beneficiary's research "can also help diabetic patients better 
maintain their blood glucose levels but provides no specifics as to the results of this research or 
whether it is being applied. 
a professor at the University of Cincinnati and a colleague of 
 explains 
that previous transdermal drug delivery efforts utilized direct current, which may cause skin damage. 
further explains that alternating nature of AC current "will cause much less skin damage 
as has been shown by the Utah group." According to , while it was believed that AC 
current would provide little drug enhancement, the beneficiary demonstrated that it does, in fact, 
have a drug enhancing effect. does not claim to be investigating AC transdermal drug 
delivery based on the beneficiary's results or identify research teams that have been impacted by the 
beneficiary's work. 
State University of New Jersey, asserts that he has never met the petitioner but knows of his work 
through his 2004 article in the Journal of Pharmaceutical Sciences. - states that 
he cited the beneficiary's work and utilized some of his mathematical equations, one of the 
contributions of the beneficiary's paper. While this work demonstrates that the beneficiary's work 
has applications, it does not demonstrate the widespread level of reliance that can be expected for 
work that is internationally recognized as outstanding. 
a professor at the University Queensland, positively evaluates the beneficiary's 
accomplishments based on a review of the beneficiary's curriculum vitae. He does not claim to have 
known of the beneficiary's work prior to being requested to provide a reference letter. 
, a professor at Mercer University, explains that hemet the petitioner in 2007 at a 
conference. 
 asserts that he requested a co 
 of the beneficiary's poster presentation on 
microneedles, own area of research. 
 concludes, based on his own research on 
transdermal drug delivery, that the beneficiary has made a significant contribution to the field, laying 
- - 
"the foundation" for understanding AC aided drug transport. None of the petitioner's articles on this 
subject, however, have been cited more than three times by independent research groups. The 
citations provided by the petitioner do not single out the benefici 
 's work as the foundation of this 
area of research. For example, an in their 2006 article in the 
Journal of Pharmaceutical Sciences, cited one of the petitioner's AC transdennal drug delivery 
articles as one of seven articles demonstrating that iontophoresis "has been investigated rather 
extensively." Similarly, coauthored another article in the Journal of Drug Delivery 
citing the beneficiary's articles as one of eight articles for the proposition that extensive research on 
iontophoresis has demonstrated that it is possible to control the onset an the rate of the delivery of 
drugs to the body as well as the extraction of substances from the blood stream for the purpose of 
- - - 
monitoring. coauthored an article in Pharmaceutical Research citing the 
beneficiary's work as one of "several studies" demonstrating that low molecular weight heparin has 
more antithrombotic activity with less anticoagulant activity than UFH or high molecular weight 
heparin. This level of citation is not consistent with international recognition of the beneficiary's 
work as the foundation of AC iontophoresis. Finally, in discussing the beneficiary's work on 
phenylalanine monitoring, 
 concludes only that this work is "promising." 
While the beneficiary's research is no doubt of 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 to be accepted for 
graduation, publication or funding, must offer new and useful information to the pool of knowledge. 
The record does not establish that the beneficiary's work has been recognized internationally as 
outstanding. 
Evidence of the alien's authorship of scholarly books or articles (in scholarly journals with 
international circulation) in the academic$eld. 
As of the date of filing, the petitioner had authored several published articles and presented his work at 
scientific conferences. The Department of Labor's Occupational Outlook Handbook, 2008-2009 
(accessed at www.bls.gov/oco on July 2, 2009 and incorporated into the record of proceedings), 
provides information about the nature of employment as a postsecondary teacher (professor) and the 
requirements for such a position. See www.bls.zrov/oco/ocos066.htm. The handbook expressly states 
that faculty members are pressured to perform research and publish their work and that the professor's 
research record is a consideration for tenure. Moreover, the doctoral programs training students for 
faculty positions require a dissertation, or written report on original research. Id. This information 
reveals that original published research, whether arising fi-om research at a university or private 
employer, does not set the researcher apart from faculty in that researcher's field. 
The record reflects that the beneficiary's article on slow release Nifedipine has been cited 10 times with 
the remaining articles cited no more than three times by independent research groups. This citation 
level is not consistent with international recognition of the beneficiary's scholarly articles. Even if we 
were to conclude that this criterion requires only evidence of authorship, and we reject such an 
interpretation as inconsistent with the statutory standard, for the reasons discussed above, the petitioner 
has not established that the beneficiary meets any other criterion. 
The petitioner has shown that the beneficiary is a talented and prolific researcher, who has won the 
respect of his collaborators, employers, and mentors, while securing some degree of international 
exposure for his work. The record, however, stops short of elevating the beneficiary to the level of an 
alien who is internationally recognized as an outstanding researcher or professor. Therefore, the 
petitioner has not established that the beneficiary is qualified for the benefit sought. 
The burden of proof in these proceedings rests solely with the petitioner. Section 291 of the Act, 
8 U.S.C. 5 1361. 
 The petitioner has not sustained that burden. Accordingly, the appeal will be 
dismissed. 
ORDER: The appeal is dismissed.