dismissed EB-2 NIW Case: Medical Research

(b)(6)
DATE: FEB 0 4 2014 OFFICE: NEBRASKA SERVICE CENTER 
INRE: Petitioner: 
Beneficiary: 
U.S. Department of Homeland Security 
U.S. Citizenship and Immigration Services 
Administrative Appeals Office (AAO) 
20 Massachusetts Ave., N.W., MS 2090 
Washington, DC 20529-2090 
U.S. Citizenship 
and Immigration 
Services 
PETITION: Immigrant Petition for Alien Worker as a Member of the Professions Holdirig an Advanced 
Degree or an Alien of Exceptional Ability Pursuant to Section 203(b )(2) of the Immigration 
and Nationality Act, 8 U.S.C. § 1153(b )(2) 
ON BEHALF OF PETITIONER: 
SELF-REPRESENTED 
INSTRUCTIONS: 
Enclosed please find the decision of the Administrative Appeals Office (AAO) in your case. 
This is a non-precedent decision. The AAO does not announce new constructions of law nor establish agency 
policy through non-precedent decisions. If you believe the AAO incorrectly applied current law or policy to 
your case or if you seek to present new facts for consideration, you may file a motion to reconsider or a 
motion to reopen, respectively. Any motion must be filed on a Notice of Appeal or Motion (Form I-290B) 
within 33 days of the date of this decision. Please review the Form I-290B instructions at 
http://www.uscis.gov/forms for the latest information on fee, filing location, and other requirements. 
See also 8 C.F.R. § 103.5. Do not file a motion directly with the AAO. 
Thank you, 
):Ron Rosenberg 
Chief, Administrative Appeals Office 
www.uscis.gov 
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DISCUSSION: The Director, Nebraska Service Center, denied the employment-based immigrant visa 
petition. The matter is now before the AAO on appeal. The AAO will dismiss the appeal. 
The petitioner seeks classification under section 203(b )(2) of the lmmigration and Nationality Act (the 
Act), 8 U.S.C. § 1153(b)(2), as an alien of exceptional ability in business and as a member of the 
professions holding an advanced degree. The petitioner seeks employment as a medical researcher and 
president of Since June 2011, the petitioner has 
worked as a researcher at where he previously studied for a master's 
degree from August 2010 to April 2011. facilities currently host The 
petitioner asserts that an exemption 
from the requirement of a job offer, and thus of a labor certification, 
is in the national interest of the United States. The director found that the petitioner qualifies for 
classification as a member of the professions holding an advanced degree, but that the petitioner has not 
established that an exemption from the requirement of a job offer would be in the national interest of the 
United States. 
On appeal, the petitioner submits a statement and supporting exhibits. 
Before the filing of the appeal, attorney represented the petitioner. On appeal, the 
petitioner states: "I have prepared this appeal without the help of any attorney. I believe that my former 
attorney was not able to explain my diverse and multi-disciplinary background in an effective way and I 
would like to use this opportunity to present the case myself." Therefore, the petitioner is self­
represented, and the term "former counsel" in this decision shall refer to 
Section 203(b) of the Act states, in pertinent part: 
(2) Aliens Who Are Members of the Professions Holding Advanced Degrees or Aliens of 
Exceptional Ability.-
(A) In General. - Visas shall be made available ... to qualified immigrants who are 
members of the professions holding advanced degrees or their equivalent or who 
because of their exceptional ability in the sciences, arts, or business, will substantially 
benefit prospectively the national economy, cultural or educational interests, or welfare 
of the United States, and whose services in the sciences, arts, professions, or business 
are sought by an employer in the United States. 
(B) Waiver ofJob Offer -
(i) ... the Attorney General may, when the Attorney General deems it to be in 
the national interest, waive the requirements of subparagraph (A) that an alien's 
services in the sciences, arts, professions, or business be sought by an employer 
in the United States. 
The petitioner claims eligibility for classification as a member of the professions holding an advanced 
degree, and as an alien of exceptional ability in the sciences . The record readily establishes that the 
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petitiOner qualifies as a member of the professions holding an advanced degree. The director 
determined that an additional determination regarding the petitioner's claim of exceptional ability 
would be moot, and the petitioner does not contest this determination on appeal. The sole issue under 
consideration is whether the petitioner has established that a waiver of the job offer requirement, and 
thus a labor certification, is in the national interest. 
Neither the statute nor the pertinent regulations define the term "national interest." Additionally, 
Congress did not provide a specific definition of "in the national interest." The Committee on the 
Judiciary merely noted in its report to the Senate that the committee had "focused on national interest by 
increasing the number and proportion of visas for immigrants who would benefit the United States 
economically and otherwise .. . . " S. Rep. No. 55, lOlst Cong., 1st Sess., 11 (1989). 
Supplementary information to regulations implementing the Immigration Act of 1990, P.L. 101-649, 
104 Stat. 4978 (Nov. 29, 1990), published at 56 Fed. Reg. 60897, 60900 (Nov. 29, 1991), states: 
The Service [now U.S. Citizenship and Immigration Services (USCIS)] believes it 
appropriate to leave the application of this test as flexible as possible, although clearly 
an alien seeking to meet the [national interest] standard must make a showing 
significantly above that necessary to prove the "prospective national benefit" 
[required of aliens seeking to qualify as "exceptional."] The burden will rest with the 
alien to establish that exemption from, or waiver of, the job offer will be in the 
national interest. Each case is to be judged on its own merits . 
In re New York State Dep 't of Transportation, 22 I&N Dec. 215, 217-18 (Act. Assoc. Comm'r 1998) 
(NYSDOT), has set forth several factors which must be considered when evaluating a request for a 
national interest waiver. First, a petitioner must establish that the alien seeks employment in an area of 
· substantial intrinsic merit. !d. at 217. Next, a petitioner must establish that the proposed benefit will be 
national in scope. Id. Finally, the petitioner seeking the waiver must establish that the alien will serve 
the national interest to a substantially greater degree than would an available U.S. worker having the 
same minimum qualifications. !d. at 217-18. 
While the national interest waiver hinges on prospective national benefit, the petitioner must establish 
that the alien's past record justifies projections of future benefit to the national interest. Id. at 219. The 
petitioner's assurance that the alien will, in the future, serve the national interest cannot suffice to 
establish prospective national benefit. The term "prospective" is included here to require future 
contributions by the alien, rather than to facilitate the entry of an alien with no demonstrable prior 
achievements, and whose benefit to the national interest would thus be entirely speculative. Id. 
The USCIS regulation at 8 C.F.R. § 204.5(k)(2) defines "exceptional ability" as "a degree of 
expertise significantly above that ordinarily encountered " in a given area of endeavor. . By statute, 
aliens of exceptional ability are generally subject to the job offer/labor certification requirement; 
they are not exempt by virtue of their exceptional ability. Therefore, whether a given alien seeks 
classification as an alien of exceptional ability, or as a member of the professions holding an 
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advanced degree, that alien cannot qualify for a waiver just by demonstrating a degree of expertise 
significantly above that ordinarily encountered in his or her field of expertise. 
The petitioner filed the Form I-140, Immigrant Petition for Alien Worker, on November 16, 2011. 
On Part 6, line 3 of that form , the petitioner described himself as a "[ m ]edical researcher in the field 
of developing diagnostic technologies for the accurate and early detection of Chronic Kidney 
Disease ('CKD'), as well as a person who is uniquely qualified to bring this technology to market." 
Former counsel noted: "[s]ince [the petitioner] is the entrepreneur and owner , it is impossible for his 
company to obtain a labor certification ." The standard for waiving the job offer requirement is 
whether the waiver serves the national interest, not whether labor certification is unavailable. The 
NYSDOT precedent decision addresses this situation, stating: 
there are certain occupations wherein individuals are essentially self-employed, and 
thus would have no U.S. employer to apply for a labor certification. While this fact 
will be given due consideration in appropriate cases, the inapplicability or 
unavailability of a labor certification cannot be viewed as sufficient cause for a 
national interest waiver; the petitioner still must demonstrate that the self-employed 
alien will serve the national interest to a substantially greater degree than do others in 
the same field. 
!d. at 218 n.5. An entrepreneur can qualify for the national interest waiver , but he or she must meet 
the NYSDOT criteria. The act of starting a new business is not, itself, a qualifying event for the 
waiver. Entrepreneurship can be a route to eligibility ; but it is not a shortcut; an otherwise ineligible 
foreign worker does not become eligible by starting a business. Under the plain 
wording of section 
203(b )(2)(A) of the Act, aliens of exceptional ability in business are subject to the statutory job offer 
requirement; the statute does not distinguish between entrepreneurs and other foreign workers. The 
statutory language still applies, and NYSDOT remains binding precedent; there has been no change 
to the law that would entitle entrepreneurs to a lower standard. The three-pronged NYSDOT national 
interest test applies to self-employed aliens. 
Former counsel stated that the petitioner "has invented the compos1t10n, methods and kits for 
detecting CKD by using vitamin transporter 
proteins. This invention is being licensed-out to 
_ and has been granted a provisional patent by USPTO 
[the U.S. Patent and Trademark Office]." The record includes USPTO documentation , dated August 
25, 2011, less than three months before the petition ' s filing date . The documentation does not 
indicate that the petitioner's invention "has been 
granted a provisional patent." Rather, it states: 
"Receipt is acknowledged of this provisional patent application. It will not be examined for 
patentability and will become abandoned not later than twelve months after its filing date." 
As the preceding comment shows, a provisional patent application is not a substantive patent 
application. It is, rather, a placeholder to preserve the applicant ' s priority for the future filing of a 
complete patent application. Further information about provisional patent applications is available 
from the USPTO web site at http://www.uspto .gov/patents /resources /tvpes/pro vapp.jsp (partial 
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printout added to record January 9, 2014). The petitioner's initial submission does not contain any 
evidence that the USPTO had granted a patent as former counsel claimed, or that the petitioner (or 
any other involved party) had followed up on the provisional filing by filing a non-provisional 
application or converting the provisional application to a non-provisional application. 
Holding a patent on an invention does not ensure approval of a national interest waiver. See 
NYSDOT at 221 n.7. In this instance, the petitioner does not hold a patent. Rather, as the above 
discussion shows, UCI filed a provisional patent application which the USPTO would not consider 
on the merits until and unless a non-provisional application followed within 12 months. The record 
contains no evidence that UCI took that required second step. 
A copy of business plan discusses the company's goals, and does not indicate that the 
company has made progress toward those goals beyond preliminary testing stages: 
We have been successful in reaching our short term goals by securing intellectual 
property (IP) protection for this technology and by validating our technology in 
animal models. We are seeking funding for subsequent clinical development. We 
believe that we can conclude our research and development activities as well as fulfill 
government regulatory requirements with in [sic] a relatively short time frame of 24 
to 36 months .... 
has recently discovered 12 novel biomarkers that can be used 
to diagnose and screen various stages of CKD as well as provide novel therapeutic 
targets for treatment of various complications associated with CKD. We plan to 
commercialize this technology named CKD by developing tests and 
devices for all stages of CKD. 
The petitioner ' s national interest waiver claim hinges on his plan to build a business around his CKD 
testing method, but the business plan states, on page 20: "Initial funding must be used to achieve 
proof of concept involving in vitro diagnosis of CKD, so that additional funding can be obtained. 
The company intends to fund later stage R& D with federal grants and venture capital investment." 
The business plan 
indicates that the company seeks an initial investment of $3 million. 
The initial submission contained no evidence that the petitioner had a prior history of success as an 
entrepreneur. The petitioner claimed no prior experience running or owning a business; he earned a 
business-related master's degree in May 2011, six months before the petition 's filing date, and he 
founded later still, in August 2011. The petitioner signed the company ' s 
operating agreement 12 days before he filed the petition. The initial submission contained no 
evidence to indicate that had yet conducted business beyond its start-up stages. 
The business plan demonstrates the petitioner's intention to be an entrepreneur, but at the time of 
filing, was a new start-up company that was not yet in a position to enter the 
marketplace. The petitioner's involvement with this company does not constitute a past history of 
demonstrable achievement with some degree of influence on the field as a whole. The petitioner 
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must demonstrate specific prior achievements which establish his ability to benefit the national 
interest. NYSDOT at 219 n.6. 
The above discussion concerned the lack of evidence of the petitioner's success as an entrepreneur. 
The petitioner has indicated that he seeks the waiver not only as an entrepreneur, but also as a 
researcher. Discussion of that facet of the petitioner's claim follows. 
The petitioner submitted abstracts of a published article, two short reports, and five conference 
presentations , two of which relate to the petitioner's current and intended future work with CKD. 
The other materials concern breast cancer, disorders of the heart and lungs, and a device to detect 
"organisms associated with Hospital Acquired Infections." 
Former counsel asserted that the submitted materials relate to "some of the scholarly articles 
authored or co-authored by [the petitioner]." The phrase "some of the scholarly articles " implies the 
existence of others, but the petitioner neither submitted nor identified other articles, and therefore he 
provided no evidence that other articles exist. 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 (Comm'r 1998) (citing Matter of Treasure Craft of California, 
14 I&N Dec. 190 (Reg'l Comm'r 1972)). The unsupported assertions of counsel do not constitute 
evidence. See Matter of Obaigbena, 19 I&N Dec. 533, 534 n.2 (BIA 1988); Matter of Laureano, 
19 I&N Dec. 1, 3 n.2 (BIA 1983); Matter of Ramirez-Sanchez, 17 I&N Dec. 503, 506 (BIA 1980). 
Former counsel claimed that the petitioner's "work is widely cited by leading researchers" who 
study chronic kidney disease. The petitioner, however, did not support this claim with documentary 
evidence of citation. 
The petitioner submitted letters from seven witnesses, all of whom have demonstrable ties to the 
petitioner. Some witnesses emphasized the petitioner's research , others focused on his work in 
commercialization of biotechnology. 
The etitioner spent a year (February 2009 to February 2010) as a postdoctoral research scholar at 
the 
stated: 
[The petitioner's] post-doctoral work at focused on identifying specialized 
proteins involved in transport of vitamins in CKD and showed that vitamin 
transporter proteins are down-regulated in various tissues in an animal model of 
CKD. These transporters are now being investigated as a diagnostic marker for CKD. 
He is currently associated with the 
and is working to develop a multi-analytic bioassay to accurately and 
sensitively identify CKD at a much earlier stage compared to conventional methods. 
Moreover, his novel approach regarding the functional aspects of vitamin transporters 
in CKD will provide a basis for the design and development of therapeutic 
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interventions, which will give immense benefits to patients suffering from this major 
health problem. 
[The petitioner] has made a number of valuable scientific discoveries which have 
helped the understanding of the pathogenesis and molecular changes in the course of 
important clinical conditions, and more recently Chronic Kidney Disease. Earlier in 
his career, [the petitioner] identified and characterized the relationship of selective 
estrogen receptor modulators (SERMs) in the causation of cervical pathology in 
breast cancer patients. he 
was part of the multi-disciplinary team that discovered that leukemia /lymphoma 
patients that have cardiac failure can benefit from allogenic and autologous stem cell 
transplantation - a life saving treatment that has traditionally been denied to such 
patient populations. His research at was aimed at characterization of cellular and 
molecular effects of uremia on vitamin homeostasis. Further, his research is crucial 
to development of potential therapies for kidney disease .... 
Additionally, [the petitioner] is the inventor of a novel patent pending technology that 
involves a panel of multiple biomarkers for diagnosis of Chronic Kidney Disease .... 
More importantly , as an entrepreneur , [the petitioner] is uniquely qualified to bring 
this research and technology quickly to market, and to disseminate its use throughout 
the U.S., thereby saving lives. 
In my laboratory, [the petitioner] played a key role ip kidney research aimed at 
studying recently cloned cell and mitochondrial membrane vitamin transporters .... 
Our studies of the function of these transporters will enable us to understand the 
mechanism of the pathogenesis of various kidney diseases and their complications. 
, licensing officer for Office of Technolog y Alliances , stated: 
While working as a researcher at [the petitioner] studied an association between 
the profile of biomarkers and Chronic Kidney Disease. . . . filed a provisional 
patent application to protect IP rights for this invention and executed a Letter 
Agreement with is working with [the petitioner] on 
marketing this technology to potential investors .... 
Chronic Kidney Disease is a global healthcare problem, in United States alone more 
than 37 million patients suffer from Chronic Kidney Disease and 700,000 have end 
stage renal disease that requires constant dialysis or transplantation. Chronic Kidney 
Disease results in an economic burden in excess of 80 billion dollars annually in US. 
There is a large unmet need as current biomarkers are not adequate for early detection 
of Chronic Kidney Disease. A biomarker to diagnose Chronic Kidney Disease at an 
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early stage with high sensitivity could potentially help physicians prevent Chronic 
Kidney Disease and its various complications. 
, who supervised the petitioner ' s postdoctoral training at 
~-----------------~ 
, stated : 
I am aware of [the petitioner ' s] medical research at at 
.. There he investigated an important treatment modality for patients with 
hematologic malignancies - leukemia, lymphoma and myelomas - having cardiac 
ejection fraction (EF) of less than 35% .... Their group showed for the first time that 
there was no statistical difference between cardiac toxicity and non-relapse mortality 
(NRM) between normal and low EF groups. The results of his study were published 
in the 
[The petitioner's] research has been relied upon by other medical and scientific 
researchers, including myself, in the advancement of their own research , as evidenced 
by citations to his work by other journal authors. 
In February 2009, [the petitioner] joined my lab at the · _ 
Our group is respected and internationally well­
known in the field of ion/nutrient transport research. Our studies focus on the motion 
of vitamins and micronutrients passing through cell and sub-cellular membranes .... 
[The petitioner] studied the vitamin transport process of the liver and colon (large 
intestine) cells. . . . His main studies focused on absorption in 
various vital organs in experimental uremic animals. 
stated that the petitioner's research at "made a great contribution to the vitamin 
transport in various organs," providing information that "may assist physicians " treating patients 
with CKD, hyperhomocystenemia, diabetes , and other ailments. also asserted: "During 
his stay at [the petitioner] made significant contributions to the field of the business of 
biomedical sciences ." did not elaborate on this point. Regarding the petitioner ' s latest 
venture, stated: 
The diagnostics company - - that he has established is being 
supported by eminent institutions such as the 
to continue clinical development of the novel kidney biomarkers. Currently, he is 
negotiating with Venture Capitalists (VC) and corporate investors for funds. At the 
same time he is confident that his company would be able to get 
funds under their SBIR (small business innovative research) 
grants program. As further indication of the eminent standing [the petitioner] enjoys 
in the field, his company has attracted the attention and interest of various reputed 
names in academia and industry, as is evident from the research collaborators, 
management team and the scientific advisory board members of 
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Regarding the last sentence quoted above, business plan indicates that the 
company's management team consists of the petitioner and and its 
scientific advisory board comprises The involvement of 
professors is not evidence of the petitioner ' s reputation outside of those institutions. All of those 
individuals have provided letters in support of the petition. The enthusiasm of ; own officers 
and advisors, and others with a demonstrable vested interest in the company (such as UCI, a licensor 
of intellectual property to is not evidence of the company ' s impact or influence on the field, 
and the record does not show wider recognition of the company. 
The remaining witnesses are associated with the petitioner's work and studies at 
chief technology officer at stated: 
develops tools for research in nucleic acids, proteins, and diagnostics . 
The company sponsored a ~ , , 
The team mission was designed to support our funded project for 
developing a diagnostic assay for detecting Clostridium difficile from human stool. 
Specifically the team project was to test and optimize our sample preparation 
system as applied to mock stool samples and detect the anal yte organism by 
Additionally the team was assigned to prepare a commercialization plan for 
be included in our Phase II grant submission. 
[The petitioner] served on this team on both aspects of the mission, the testing 
and optimization and the commercialization plan. He demonstrated a professionally 
guided attention to critical issues of the molecular biology of the assay, the biology of 
the target organism, the customer perspective of healthcare facilities, and regulatory 
hurdles critical to the planning for commercialization. His work and insight was 
outstanding, and based on his contributions I believe he is ideally suited to the work 
of commercializing (bringing to market) biotechnology products, and that he would 
be a major contributor in any venture that includes the research, development and 
commercialization of diagnostic products. 
stated: "[The petitioner ' s] research was so promising that I agreed to 
JOlll ... as CTO [chieftechnology officer]." l described the 
"large unmet need . .. for early detection of CKD" using biomark ers such as those discovered by the 
petitioner , and that the petitioner 's "CKD biomarkers will improve patient health while saving 
millions, perhaps billions , of dollars in health care costs." Other materials in the record indicate that 
the diagnostic tests are still under development and, as of the filing date, unproven. Assertions of 
prospective national benefit from those tests, therefore , rests on speculation concerning their future 
effectiveness. 
letter includes the following passage: 
Chronic Kidney Disease (CKD) is a global healthcare problem, and in the United 
States the percentage of people who suffer from CKD is around 15% of total US 
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population, which is growing at an annual rate of 4%. Furthermore, more than half 
million patients have end stage renal disease (ESRD) that requires constant dialysis or 
transplantation. CKD is the ninth leading cause of death and results in an economic 
burden close to hundred billion dollars annually in US. There is a large unmet need 
as current biomarkers are not adequate for early detection of CKD. A biomarker to 
diagnose CKD at an early stage with high sensitivity will help physicians prevent 
CKD and its various complications. 
The above passage is similar to a passage from letter, which is dated a week earlier 
than letter (September 8 and 15, 2011, respectively). Another similarity between the 
two passages is the occasional absence of articles ("a" and "the"). The shared language and shared 
grammatical errors suggest common authorship of the two letters, or at least portions thereof. Cf 
Mei Chai Ye v. U.S. Dept. of Justice, 489 F.3d 517, 519 (2d Cir. 2007) (concluding that an 
immigration judge may reasonably infer that when an asylum applicant submits strikingly similar 
affidavits, the applicant is the common source). 
The director issued a request for evidence (RFE) on April 3, 2012, instructing the petitioner to 
submit further evidence to show the petitioner 's influence on his field as of the petition 's filing date. 
(An earlier RFE, issued March 16, 2012, concerned technical issues that the petitioner has since 
resolved.) 
In response, former counsel stated: "this petition would not have been filed, but for the new 
administration and USCIS policy, announced in July 2011, to apply existing eligibility criteria to 
facilitate immigrant visas for entrepreneurs." The petitioner repeats this assertion on appeal, and 
discussion will follow in that context. Former counsel also stated that the petitioner's "scientific 
background, inventions, and potential to create jobs demonstrate that he will serve the national 
interest (job creation) to a substantially greater degree than others in the field." 
A newly submitted printout of a electronic slide presentation described projected 
growth, stating: "Currently [third quarter 2012], we have 6 personal [sic] working on the project, and 
they are being supported by the university/research center's funds. . . . We will increase to 10 
employees by Q2-Q3 [of2013], once we have Venture capital funds from investors." The document 
predicted "25+ Employee[s]" by mid-2014, when is "in commercialization mode, getting 
FDA a proval and marketing/selling our diagnostic tests." The same printout quoted a 2002 article 
from as indicating that the "early stage" of a biotechnology company "usually 
ends when the company has about 25 employees."
1 
Former counsel did not explain how the petitioner's "potential to create jobs demonstrate[s] that he 
will serve the national interest (job creation) to a substantially greater degree than others in the 
field." The petitioner predicted that will have 25 employees at the end of its early stage, 
which, according to the article, is the number of employees that a startup 
1 
The article,'--~ - - -- - -- -------- -- -~-- ~ ___ ..... . 
June 2002 issue of - - . 
(printout added to record January 30, 2014). 
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biotech company "usually" has at that stage of its development. The article contains generalized 
observations, and does not establish that is likely to employ 25 workers at the end of its early 
stage. Even assuming that could meet this goal, conforming to the average growth rate does 
not 
"serve the national interest ... to a substantially greater degree than others in the field." 
Furthermore, the figures provided rest on speculation. The petitioner submitted no evidence of a 
prior history of job creation. At the time of filing, he was only employee . 
Speculation about future job creation does not establish that he was eligible for the waiver at the 
time he filed the petition. 
The petitioner submitted a letter from 
who discussed the project that the petitioner and other · researchers undertook for his company. 
stated that the petitioner's "well-written commercialization plan, in particular, played a 
pivotal role in us receiving a superb score from the review committee such that Phase II of our 
project will be funded for the next 3 years for nearly $3 million ." The petitioner was a graduate 
student , studying biotech management, at the time he participated in the The 
petitioner has not shown that the successful drafting of a commercialization plan is a distinguishing 
achievement, rather than a routine step in the business process. The petitioner's evidence does not 
satisfy the third prong of the NYSDOT national interest test. 
The director denied the petition on September 20, 2012, stating that the petitioner established the 
intrinsic merit and national scope of his occupation, meeting the first two prongs of the NYSDOT 
national interest test, but that the petitioner had not established his influence on his field. The 
director acknowledged the petitioner's witness letters, but found them insufficient to establish the 
petitioner ' s eligibility for the waiver. With respect to the petitioner ' s published and presented 
research, which the petitioner had previously represented as "widely cited," the director stated that 
the petitioner had not submitted any evidence of citation or otherwise shown "that the petitioner's 
contributions have enjoyed widespread implementation in the field." Concerning the petitioner's 
entrepreneurial work, the director stated: 
The petitioner has also submitted evidence of a patent application. While the 
evidence suggests the petitioner has submitted his work for consideration in issuance 
of a patent, the record lacks evidence to establish the material in the patent 
application has been produced , manufactured or sold in notable quantities. 
At this point the Service would like to acknowledge the petitioner's establishment of 
... A review of the petitioner's company indicates the 
business was established in October, 2011 [sic] with the petitioner as the only 
employee. The petitioner has submitted projections and business plans, but there has 
been no evidence to suggest that over the past 11 months the business has begun 
producing, manufacturing, selling or receiving orders for any goods or services. 
There is no evidence to suggest the business has hired additional staff, secured 
independent research, manufacturing and business facilities or completed any 
additional portions of the business plan. Based on the lack of reported progress at 
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the Service must conclude that this business has not distinguished the 
beneficiary from his peers. 
On appeal, the petitioner states: 
[M]y 1-140 NIW petition would not have been filed, but for the new administration 
and users policy, announced in July 2011, to apply existing eligibility criteria to 
facilitate immigrant Visas for entrepreneurs. A copy of a Q&A reflecting this new 
policy is attached as Supplement A. However, I believe that my petition was judged 
mainly on the basis of regular guidelines and my entrepreneurial work was not given 
due importance or my startup was judged at a very high level compared to what a 
biotech startup can accomplish within one year of being founded. The expectations 
from my startup are impractical from a business of biotech conventions .... 
The Q&A points out that the NYSDOT decision (at footnote 5, p. 218) ... does 
contemplate National Interest Waiver eligibility for entrepreneurs .... The Q&A ... 
mentions that the potential for employment creation by an entrepreneur would be 
[c]onsidered in addition to the entrepreneur's other contributions to the field. 
In a separate statement, the petitioner states: "I believe that my petition was submitted foremost to 
benefit from the new regulations regarding EB2 visa for entrepreneurs." 
The availability of the national interest waiver to entrepreneurs is not "new ... policy" as the 
petitioner (and, previously, former counsel) described it, and there are no "new regulations regarding 
EB2 visa for entrepreneurs." Only Congress has the authority to determine, by statute, which groups 
of foreign workers can qualify for the waiver. What the petitioner and former counsel described is a 
public awareness initiative to inform entrepreneurs of opportunities that are already available under 
what both the petitioner and former counsel acknowledged as "existing eligibility criteria." As such, 
it does not modify, expand, or overturn existing statute, regulations, or case law governing the 
national interest waiver. The petitioner alleges that the director erred by considering the petition "on 
the basis of regular guidelines" instead of giving special consideration to the petitioner's 
entrepreneurship, but the current statutory and regulatory eligibility requirements apply equally to 
entrepreneurs. 
A printout of "Frequently Asked Questions" from USCIS's web site, submitted in response to the 
RFE and again on appeal, reinforces the above discussion. The answer to question 14 on that 
printout indicated that "NYSDOT . . . contemplates that entrepreneurial or self-employed 
beneficiaries may qualify for the NIW [national interest waiver] under limited circumstances." The 
printout went on to explain those "limited circumstances," fully consistent with the three-proriged 
NYSDOT national interest test. 
The petitioner asserts: "My company was held at a higher level than biotech startups at the 
development stage of my company, the expectations for my startup to have sales or product ready 
within one year of establishment is very unconventional." A petitioner does not qualify for the 
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Page 13 
national interest waiver simply by being an entrepreneur. The pet1t10ner must show that his 
entrepreneurial track record sets him apart in his field to an extent that would justify a waiver of the 
job offer requirement that, by statute, normally applies not just to foreign businessmen and women 
but to aliens of exceptional ability in business. 
The third NYSDOT prong calls for a past history of demonstrable achievement with some degree of 
influence on the field as a whole. The petitioner claims no such history. He asserts that his 
company is so new that it would be unreasonable to expect job creation and commercial activity at 
such an early stage. This circumstance underscores the director's conclusion that the petitioner has 
not yet established a track record as an entrepreneur that would merit the national interest waiver -
he has started only one company, which had not yet created jobs or engaged in business as of the 
petition's filing date. 
An applicant or petitioner must establish that he or she is eligible for the requested benefit at the time 
of filing the benefit request. 8 C.F.R. § 103.2(b )(1). USCIS cannot properly approve the petition at 
a future date after the petitioner or beneficiary becomes eligible under a new set of facts. See Matter 
of Katigbak, 14 I&N Dec. 45, 49 (Reg'l Comm'r 1971). At the time of filing, _ 
was still awaiting needed funding and "proof of concept" for the company's intended flagship 
product. Accordingly, the petitioner has not established that he was eligible for the requested benefit 
at the time of filing. 
The petitioner states that "a biotechnology startup like ' ... needs at least 3-5 
years of research and development work before there is a product that can be sold." There exists no 
blanket waiver for the founders of biotechnology startups, and NYSDOT' s provisions regarding a 
record of influential achievement in the field apply to the petitioner ' s profession. 
The petitioner states that his "most important research work in academia has been the 
characterization of how chronic kidney disease affects health of patients." With respect to the new 
diagnostic technique he developed, the petitioner states that the " _ ... decided 
[to] patent the discovery" "when the importance of the technology became evident." The petitioner 
states: "It is critical for inventors to keep their technologies confidential if they are interested in 
commercializing their discoveries," and that therefore, his "further work on kidney diseases was not 
published " and he "could not go to independent leaders in this field for their recommendation 
letters." 
In visa petition proceedings, it is the petitioner's burden to establish eligibility for the immigration 
benefit sought. Section 291 of the Act, 8 U.S.C. § 1361; Matter of Otiende, 26 I&N Dec. 127, 128 
(BIA 2013). The non-existence or other unavailability of required evidence creates a presumption of 
ineligibility. 8 C.F.R. § 103.2(b)(2)(i). The petitioner has not established that his accomplishments are 
covered by confidentiality provisions. 
After stating that confidentiality considerations have limited third-party awareness of his work, the 
petitioner contends that his "expertise as a small biotech founder has been recognized internationally." 
The petitioner submits evidence showing that he received an invitation (on June 24, 2012) to be a 
(b)(6)
Page 14 
"distinguished speaker" at the 
October 30-31, 2012. 
NON-PRECEDENT DECISION 
. on 
The invitation (dated June 24, 2012) and the conference (in late October 2012) both took place after the 
petition's November 2011 filing date. The invitation (via electronic mail) is generically worded, 
inviting the petitioner "to share with the audience [y]our company's latest research findings in 
diagnostic/prognostic biomarkers OR [y ]our insights on commercialization and translation of 
biomarkers into diagnostics." The invitation contains no specific information about the petitioner's 
work, and the record does not show how many invitations the conference organizer issued or the 
selection criteria for those invitations. 
The petitioner declined the invitation to the conference owing to ongoing issues with his 
immigration status. The petitioner states: "Having a permanent status in the US will not only allow 
investors to have confidence in me and my long term status, but will also allow me the freedom to 
attend international conferences and overseas investors to bring in funds to my company." In this way, 
the petitioner does not state that his success as an entrepreneur demonstrates his eligibility for the 
waiver. Rather, he requests the waiver to increase his chances of future success as an entrepreneur. The 
USCIS regulation at 8 C.F.R. § 103.2(b )(1) requires the petitioner to be eligible for the benefit sought at 
the time he applies for that benefit. He cannot obtain the benefit first, in order to establish eligibility at a 
later time. 
The petitioner submits a March 15, 2012 press release from 
received "a $1.65 million grant from the The 
petitioner stated that received the grant "to help startup companies including 
The record does not indicate how much, if any, of the grant funding went to Furthermore, like 
the other events documented on appeal, the ·March 2012 grant 
occurred after the petition's filing date. 
Also taking place after the filing date was the 2012 
Marketplace, at which :was one of 154 "Selected Presenters." A promotional article 
submitted on appeal states: "the presenting companies have been hand-picked and mentored and the 
intellectual proprieties [sic] are the top picks form participation [sic] federal labs and universities." The 
submitted materials indicate that the purpose of the event is for the entrepreneurs to interact with 
venture capitalists and other potential funding sources: "Each candidate is seeking seed capital, venture 
capital, corporate licensing partners, or a strategic partner." Thus, even after the filing date, was 
still at a preliminary stage and had not yet entered the market. The company's undeveloped state would 
be a less serious concern if the petitioner had previous! y established a track record of success or impact 
as an entrepreneur with other ventures, but the petitioner does not claim to have started any other 
company before he started 
The petitioner cites ' device," described in previous submissions, to 
illustrate his "past success in bringing technologies to market place." The record shows that the 
petitioner's role with was limited; he tested technology invented by others, and helped to draft 
a commercialization plan, in conjunction with graduate studies narrowly tailored for that purpose. The 
record does not show the extend of commercial success, or the extent to which the petitioner 
(b)(6)
NON-PRECEDENT DECISION 
Page 15 
was responsible for that success. The petitioner's graduate project for does not 
establish that the petitioner's work as an entrepreneur has influenced the field as a whole. 
The petitioner worked with one product as a graduate student, and has started his own company to 
commercialize a product he developed. The available evidence, however, does not set the petitioner 
apart from other entrepreneurs who, generally, are subject to the job offer requirement at section 
203(b )(2)(A) of the Act. The petitioner has not met the third prong of the NYSDOT national interest 
test, and therefore he has not established eligibility for the national interest waiver. 
The petitioner has not established a past record of achievement at a level that would justify a waiver of 
the job offer requirement. The petitioner need not demonstrate notoriety on the scale of national 
acclaim, but the petitioner "must clearly present a significant benefit to the field of endeavor." 
NYSDOT at 218. See also id. at 219, n.6 (the alien must have "a past history of demonstrable 
achievement with some degree of influence on the field as a whole."). 
As is clear from a plain reading of the statute, it was not the intent of Congress that every person 
qualified to engage in a profession in the United States should be exempt from the requirement of a job 
offer based on national interest. Likewise, it does not appear to have been the intent of Congress to 
grant national interest waivers on the basis of the overall importance of a given profession, rather than 
on the merits of the individual alien. On the basis of the evidence submitted, the petitioner has not 
established that a waiver of the requirement of an approved labor certification will be in the national 
interest of the United States. 
The AAO will dismiss the appeal for the above stated reasons. In visa petition proceedings, it is the 
petitioner's burden to establish eligibility for the immigration benefit sought. Section 291 of the Act; 
Matter ofOtiende, 26 I&N Dec. 128. Here, the petitioner has not met that burden. 
ORDER: The appeal is dismissed.