dismissed EB-1A Case: Biomedical Engineering

U.S. Citizenship 
and Immigration 
Services 
In Re: 4951737 
Appeal of Texas Service Center Decision 
Non-Precedent Decision of the 
Administrative Appeals Office 
Date : DEC. 19, 2019 
Form I-140, Immigrant Petition for Alien Worker (Extraordinary Ability) 
The Petitioner , a researcher in biomedical engineering , seeks classification as an alien of extraordinary 
ability. See Immigration and Nationality Act (the Act) section 203(b)(l)(A) , 8 U.S.C. § 1153(b)(l)(A). 
This first preference classification makes immigrant visas available to those who can demonstrate their 
extraordinary ability through sustained national or international acclaim and whose achievements have 
been recognized in their field through extensive documentation. 
The Director of the Texas Service Center denied the petition , concluding that the Petitioner had 
satisfied only two of the initial evidentiary criteria, of which he must meet at least three. 
In these proceedings , it is the Petitioner's burden to establi sh eligibility for the requested benefit. See 
Section 291 of the Act, 8 U.S.C. § 1361. Upon de nova review , we will dismiss the appeal. 
I. LAW 
Section 203(b )( 1) of the Act makes visas available to immigrants with extraordinary ability if: 
(i) the alien has extraordinary ability in the sciences , arts, education , business , or 
athletics which has been demonstrated 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 prospectively 
the United States. 
The tenn "extraordinary ability " refers only to those individuals in "that small percentage who have 
risen to the very top of the field of endeavor." 8 C.F.R. § 204 .5(h)(2) . The implementing regulation 
at 8 C.F.R . § 204.5(h)(3) sets forth a multi-part analysis . First , a petitioner can demonstrate sustained 
acclaim and the recognition of his or her achievements in the field through a one-time achievement 
(that is, a major, internationally recognized award). If that petitioner does not submit this evidence, 
then he or she must provide sufficient qualifying documentation that meets at least three of the ten 
categories listed at 8 C.F.R. § 204.5(h)(3)(i) - (x) (including items such as awards, published material 
in certain media, and scholarly articles). 
Where a petitioner meets these initial evidence requirements, we then consider the totality of the 
material provided in a final merits determination and assess whether the record shows sustained 
national or international acclaim and demonstrates that the individual is among the small percentage 
at the very top of the field of endeavor. See Kazarian v. USCIS, 596 F.3d 1115 (9th Cir. 2010). 
II. ANALYSIS 
The Petitioner indicated ~mployment as a _postdo9tora] fejjow atl I J Jnjyersity School of 
.__ _______ .,.... pursumg research on usmg new I~. _____________ _,J technology 
to correct mutations that cause disease. The record shows that gene therapy for the treatment of 
congenital diseases is a rapidly growing field, and the development of new I lagents is an 
important topic of current research internationally. 
Because the Petitioner has not indicated or established that he has received a major, internationally 
recognized award, he must satisfy at least three of the alternate regulatory criteria at 
8 C.F.R. § 204.5(h)(3)(i)-(x). In denying the petition, the Director determined that the Petitioner 
fulfilled two of the initial evidentiary criteria, judging at 8 C.F.R. § 204.5(h)(3)(iv) and scholarly 
articles at 8 C.F.R. § 204.5(h)(3)(vi). The record reflects that the Petitioner reviewed papers for 
journals. In addition, the Petitioner has authored scholarly articles in professional publications. 
Accordingly, we agree with the Director that the Petitioner fulfilled the judging and scholarly articles 
criteria. 
On appeal, the Petitioner asserts that he meets an additional evidentiary criterion, discussed below. 
After reviewing all of the evidence in the record, we conclude that the record does not support a finding 
that the Petitioner satisfies the requirements of at least three criteria. 
Evidence of the alien's original scient[fic, scholarly, artistic, athletic, or business­
related contributions of major sign[ficance in the field. 8 C.F.R. § 204.5(h)(3)(v) 
The Petitioner argues that the Director did not consider all of his documentation and mischaracterized 
some of the evidence submitted. He contends that the testimonial letters, citations to his work, and 
commercialization of and licensing interest in his work demonstrate his eligibility for this criterion. 
In order to satisfy the regulation at 8 C.F.R. § 204.5(h)(3)(v), a petitioner must establish that not only 
has he made original contributions but that they have been of major significance in the field. 1 For 
example, a petitioner may show that the contributions have been widely implemented throughout the 
1 See USCIS Policy Memorandum PM 602-0005.1, Evaluation of Evidence Submitted with Certain Form 1-140 Petitions; 
Revisions to the Adjudicator's Field Manual (AFM) Chapter 22.2, AFM Update ADll-14 8-9 (Dec. 22, 2010), 
https://www.uscis.gov/policymanual/HTML/PolicyManual.html (finding that although funded and published work may 
be "original," this fact alone is not sufficient to establish that the work is of major significance). 
2 
field, have remarkably impacted or influenced the field, or have otherwise risen to a level of major 
significance in the field. 
The Petitioner references his submission of letters from colleagues and other scientists and experts 
regarding his original contributions in his field.2 The letters summarize the Petitioner's research 
achievements and broadly discuss the potential impact of his research in the fields of biomedical 
engineering and gene therapy. However, they do not establish that his original contributions are 
already recognized as majorly significant within these fields. 
For example,.__ ________ ~·' the Petitioner's doctoral advisor at the University ofl I 
reviews some of the findings of the Petitioner's doctoral research involving thel I 
LJnanoparticle complexes used in gene therapy applications. He credits the Petitioner's research 
in gene therapy with having "identified a new, two-pronged strategy in which I ~s delivered using 
one type of nanoparticle and then intracellular release of the cargo is triggered by a separate agent." 
He lists several scientific teams that have cited to the Petitioner's work, including! I 
from Brazil who "describe an application of a two-pronged delivery strategy similar to [the 
Petitioner's] work." He states that the Petitioner's work provides new insights into the properties of 
I I nanoparticles . 
.__ _______ ~ the Petitioner's current postdoctoral mentor atl explains that the 
Petitioner's main area of research in the field of gene therapy involves the use of the protein 
I Ito correct mutations in the gene that causes He indicates that the 
Petitioner has worked to optimize the ability of.__ ____ ~ to be delivered into airway stem cells 
by modifyin cph:ure condjfions, and has designed correction sequences for nearly 100% of mutations 
that cause ~l ---~- states that the Petitioner's leadership of the I !editing group for 0 
at was critical for securing a $1.5 million research grant from the I I 
.__ ________ ~and $1 million in additional private funding. He praises the Petitioner's 
"leadership in developing a creative and novel approach to potentially curing a devastating genetic 
disease." He indicates that the Petitioner has published 10 journal articles, in highly-ranked journals 
such as Molecular Pharmaceutics, that have received 118 citations in total, which he characterizes as 
"a respectable amount for any scholar, and an impressive number among his peers in the field." 
However, the record does not support a finding that the Petitioner's research findings, while original, 
are already recognized as a contribution of major significance in the field. 
,,__ ___ ...i.....::a::;:;:ls;:..;o provides that the Petitioner has been part ofl l's collaboration with I~-~ 
~---.---~-~ to improve in vivo ene therapy, and the Petitioner's ongoing research has been used 
b to market the ariants that he identified. The record includes a letter fron0 
senior director of R&D, confirming that the company "commercialized 
.__p_r_o_d_u-ct_s_b_a_s_e_d_o_n_[t_h_e_P_e_t_.itioner's] research involvin~ !variants," and a letter froml~-~ 
I I expressing interest in licensing some of the Petitioner's work. However, the Petitioner 
has not provided evidence that the marketed research findings of the Petitioner, or the evidence of 
interest in licensing his work, have already affected the field of biomedical engineering or gene 
therapy, so that we can conclude that the Petitioner's research contribution has had a significant 
influence on his field. 
2 Although we discuss a sampling of letters, we have reviewed and considered each one. 
3 
~-------~ a postdoctoral research scientist at the University o ~--------~ 
states that his team has cited to the Petitioner's research findings and indicates that the Petitioner's 
"information on the behavior of nano articles within human cells" was "instrumental" in aiding their 
experiment's success . .......,. __________ ~ a professor of chemistry at the University of 
I ~ and CEO o asserts that the Petitioner's work indicating that the 
presence of th_~----~~ may affect the behavior of the studied nanoparticles "highlights a 
significant vulnerability of conventional research methods to characterize the biological activity of 
nanoparticle-based therapies." I I a professor of chemical engineering a~ I 
University, states that he has previously cited to the Petitioner's work on multiple occasions, and 
asserts that the Petitioner's research "provides critical information for the farther development o~ I 
I I agents necessary to advance gene therapy." 
Within the Petitioner's response to the Director's request for evidence (RFE), he provided a letter from 
~----------;::::=::::=..-=a~p:::..:r:...:::o:...:::fe=.:s:.:;sor of pediatrics and genetics atl I University 
and co-chair of thel I Foundation Grants Review Committee. He explains that although 
I I gene editing has been attempted, "the inability to achieve high level~ne correction 
in airway stern cells has prevented the clinical applicability of the technology to curq__J He indicates 
that the Petitioner's work is significant because he has successfully developed methods that achieve a 
high level of correction of a cornrnonOnutationJ l when compared to previous attempts. 
Overall, the letters recognize the originality, importance, and prospective benefit of the Petitioner's 
work, but do not contain detailed information showing the unusual influence or high impact the 
Petitioner's contributions have already had on the overall field. These and other letters not specifically 
mentioned, as well as other evidence in the record, show that the Petitioner's original Jork has added 
~cant value to the pool of knowledge in his field and opened avenues for farther I 
L__J gene therapy research. The evidence, however, is insufficient to confirm that the level of 
attention he has received reflects widespread commentary and acceptance of his work, or that the field 
of biomedical engineering or gene therapy has regarded his research as authoritative. Here, the 
Petitioner's letters do not contain specific, detailed information explaining the unusual influence or 
high impact his research or work has had on the overall field. Letters that specifically articulate how 
a petitioner's contributions are of major significance to the field and its impact on subsequent work 
add value. 3 On the other hand, letters that lack specifics and use hyperbolic language do not add value, 
and are not considered to be probative evidence that may form the basis for meeting this criterion. 4 
Moreover, USCIS need not accept primarily conclusory statements. 17 5 6, Inc. v. The US. Att '.r Gen., 
745 F. Supp. 9, 15 (D.C. Dist. 1990). 
In addition, within the Petitioner's RFE response, he submitted updated information from Google 
Scholar reflecting 159 cumulative citations to his published research. The Petitioner maintains that 
his two highest cited articles in 2016 earned more than the average number of citations for articles in 
the same field, published the same year, placing them among the "top 10% most cited papers across 
the entire field for their years of publication." The Petitioner's evidence in support of this claim 
3 See USCTS Policy Memorandum PM 602-0005.1, supra, at 8-9. 
4 Id. at 9. See also Kazarian, 580 F.3d at 1036, aff'd in part, 596 F.3d at 1115 (holding that letters that repeat the regulatory 
language but do not explain how an individual's contributions have already influenced the field are insufficient to establish 
original contributions of major significance in the field). 
4 
included a printout from Incites Essential Science Indicators by Thomson Reuters, showing a table of 
"Baseline-Citation Rates" for papers published by field for 2008-2018. The line for "Molecular 
Biology and Genetics" indicated that the documented citations of the Petitioner's two highest cited 
articles in 2016, cited 26 and 19 times, respectively, do, as claimed, exceed the 7. 99 average citations 
for that year in that field. Regardless, the comparative ranking to baseline or average citation rates 
does not automatically establish majorly significant contributions in the field. Once again, the issue 
for this criterion is whether the Petitioner has made original contributions of major significance in the 
field rather than where his citation rates rank among others in his field. Here, a more appropriate 
analysis, for example, would be to compare the Petitioner's citations to other similarly, highly cited 
articles that the field views as having been of major significance, as well as factoring in other 
corroborating evidence. The Petitioner has not demonstrated, as he asserts, that his published articles 
through citation numbers and percentiles resulted in an original contribution of major significance in 
the field. 5 
The Petitioner also submitted articles and excerpts of articles that cited to his work as evidence that he 
has made original contributions of major significance in the field. A review of the sample articles, 
though, does not show the significance of the Petitioner's research to the overall field be ond the 
authors who cited to his work. 6 For instance, the Petitioner rovided an article titled 
.__ ______________ ___, (Journal of Polymer Science, Part A: Polymer Chemistry), 
in which the authors cited to his 2016 Accounts of Chemical Research article. 7 However, the article 
does not distinguish or highlight the Petitioner's written work from the 63 other cited papers. In the 
case here, the Petitioner has not shown that his published articles through citations rise to a level of 
"major significance" consistent with this regulatory criterion. 
Further, the Petitioner states that his articles have been published in leading outlets in his field, 
including Accounts of Chemical Research, ACS Nano, Soft Matter, and Journal of Physical Chemistry 
C. This claim appears to be based on data compiled by Google Scholar and from "Impact Factor" data 
provided by the journals' own websites. However, the Petitioner has not demonstrated that publication 
of his articles in highly ranked journals establishes that the field considers his research to be an original 
contribution of major significance. Moreover, a publication that bears a high ranking or impact factor 
is reflective of the publication's overall citation rate. It does not show an author's influence or the 
impact of research on the field or that every article published in a highly ranked journal automatically 
indicates a contribution of major significance. Publications are not sufficient under 8 C.F.R. 
§ 204.5(h)(3)(v) absent evidence that they were of "major significance." See Kazarian v. USCIS, 
580 F.3d at 1036, aff'd in part, 596 F.3d at 1115. Here, the Petitioner has not established that 
publication in a popular or highly ranked journal alone demonstrates a contribution of major 
significance in the field. 
5 Id. at 8-9. (providing an example that peer-reviewed articles in scholarly journals that have provoked widespread 
commentary or received notice rrom others working in the field, or entries (particularly a goodly number) in a citation 
index which cite the individual's work as authoritative in the field, may be probative of the significance of the person's 
contributions to the field of endeavor). 
6 Id. at 8-9; see also Visinscaia v. Beers. 4 F. Supp. 3d 126, 134-35 (D.D.C. 2013) (upholding a finding that a ballroom 
dancer had not met this criterion because she did not corroborate her impact in the field as a whole). 
7 Although we discuss a sample article, we have reviewed and considered each one. 
5 
For the reasons discussed above, considered both individually and collectively, the Petitioner has not 
shown that he has made original contributions of major significance in the field. 
III. CONCLUSION 
The Petitioner has not submitted the required initial evidence of either a one-time achievement or 
documents that meet at least three of the ten criteria. As a result, we need not provide the type of final 
merits determination referenced in Kazarian, 596 F.3d at 1119-20. Nevertheless, we advise that we 
have reviewed the record in the aggregate, concluding that it does not support a finding that the 
Petitioner has established the acclaim and recognition required for the classification sought. 
The Petitioner seeks a highly restrictive visa classification, intended for individuals already at the top 
of their respective fields, rather than for individuals progressing toward the top. USCIS has long held 
that even athletes performing at the major league level do not automatically meet the "extraordinary 
ability" standard. Matter of Price, 20 I&N Dec. 953,954 (Assoc. Comm'r 1994). Here, the Petitioner 
has not shown that the significance of his work is indicative of the required sustained national or 
international acclaim or that it is consistent with a "career of acclaimed work in the field" as 
contemplated by Congress. H.R. Rep. No. 101-723, 59 (Sept. 19, 1990); see also section 203(b )(l)(A) 
of the Act. Moreover, the record does not otherwise demonstrate that the Petitioner has garnered 
national or international acclaim in the field, and he is one of the small percentage who has risen to 
the very top of the field of endeavor. See section 203(b)(l)(A) of the Act and 8 C.F.R. § 204.5(h)(2). 
Although the Petitioner has reviewed papers for journals and has authored scholarly articles, the 
Petitioner has not established that his professional accomplishments have placed him among the upper 
level of his field. 
For the reasons discussed above, the Petitioner has not demonstrated his eligibility as an individual of 
extraordinary ability. The appeal will be dismissed for the above stated reasons, with each considered 
as an independent and alternate basis for the decision. 
ORDER: The appeal is dismissed. 
6