sustained EB-2 NIW Case: Biomedical Engineering

U.S. Citizenship 
and Immigration 
Services 
MATTER 01' P-Y-G-
APPEAL OF TEXAS SERVICE CENTER DECISION 
Non-Precedent Decision of the 
Administrative Appeals Office 
DATE: JUNE 5, 2018 
PETITION: FORM I-140, IMMIGRANT PETITION FOR ALIEN WORKER 
The Petitioner, a biomedical engineering researcher, seeks second preference immigrant 
classification as a member of the professions holding an advanced degree, as well as a national 
interest waiver of the job offer requirement attached to this EB-2 classification. See Immigration 
and Nationality Act (the Act) section 203(b)(2), 8 U.S.C. § 1153(b)(2). After the petitioner has 
established eligibility for EB-2 classification, U.S. Citizenship and Immigration Services (USCIS) 
may, as matter of discretion, grant a national interest waiver if the petitioner demonstrates: ( 1) that 
the foreign national's proposed endeavor has both substantial merit and national importance; (2) that 
the foreign national is well positioned to advance the proposed endeavor; and (3) that, on balance, it 
would be beneficial to the United States to waive the requirements of a job offer and thus of a labor 
certification. Matter ofDhanasar, 26 I&N Dec. 884 (AAO 2016). 
The Director of the Texas Service Center denied the Form 1- I 40, Immigrant Petition for Alien 
Worker, finding that the Petitioner qualified for classification as a member of the professions 
holding an advanced degree, but that she had not established that a waiver of the required job offer, 
and thus of the labor certification, would be in the national interest. 
On appeal, the Petitioner submits additional evidence and contends that she is eligible for a national 
interest waiver under the Dhanasar framework. 
Upon de novo review, we will sustain the appeal. 
I. LAW 
To establish eligibility for a national interest waiver, a petitioner must first demonstrate qualification 
for the underlying EB-2 visa classification, as either an advanced degree professional or an 
individual of exceptional ability in the sciences, arts, or business. Because this classification 
requires that the individual's services be sought by a U.S. employer, a separate showing is required 
to establish that a waiver of the job otTer requirement is in the national interest. 
Section 203(b) of the Act sets out this sequential framework: 
Malter of P- Y-G-
(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) National interest waiver. ... [T]he 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. 
While neither the statute nor the pertinent regulations define the term "national interest," we recently 
set forth a new framework for adjudicating national interest waiver petitions. See Dhanasar, 26 l&N 
Dec. 884. 1 Dhanasar states that after EB-2 eligibility has been established, USCIS may, as a matter 
of discretion, grant a national interest waiver when the below prongs are met. 
The first prong, substantial merit and national importance, focuses on the specific endeavor that the 
foreign national proposes to undertake. The endeavor's merit may be demonstrated in a range of 
areas such as business, entrepreneurialism, science, technology, culture, health, or education. In 
determining whether the proposed endeavor has national importance, we consider its potential 
prospective impact. 
The second prong shifts the focus from the proposed endeavor to the foreign national. To determine 
whether he or she is well positioned to advance the proposed endeavor, we consider factors 
including, but not limited to: the individual's education, skills, knowledge and record of success in 
relate'd or similar efforts; a model or plan for future activities; any progress towards achieving the 
proposed endeavor; and the interest of potential customers, users, investors, or other relevant entities 
or individuals. · 
The third prong requires the petitioner to demonstrate that, on balance, it would be beneficial to the 
United States to waive the requirements of a job offer and thus of a labor certification. In 
perforn1ing this analysis, USC IS may evaluate factors such as: whether, in light of the nature of the 
foreign national's qualifications or the proposed endeavor, it would be impractical either for the 
1 
In announcing this new framework, \Ve vacated our prior precedent decision, Nfauer of New Vork Stale Department u.f 
Transportation, 221&N Dec. 215 (Acl. Assoc. Comm'r 1998) (NYSD07). 
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Matter of P-Y-G-
foreign national to secure a job offer or for the petitioner to obtain a labo r certification; whether , 
even assuming that other qualified U.S. workers are available, the United States would still benetit 
from the foreign national's contributions; and whether the nation al interest in the foreign national's 
contributions is sufficientl y urgent to warrant forgoing the labor certi ticati on process. In each case, 
the factor(s) considered must , take n togeth er, indic ate that on balance, it would be ben eficia l to the 
United States to waive the requirements ofajob offer and thu s of a labor certification. 2 
Il. ANAL YSlS 
The Director found that the Petitoner qualifies as a member of the professio ns holding an advance d 
degree. 3 The sole issue to be determined is whether the Petitioner has esta blished that a waiver of the 
requ ireme nt of a job offer , and thus a labo r certification , would be in the national interest. For the 
reasons discu ssed below, we tind she has established eligibilit y for a nationa l i nterest waiver under 
the ana lytical framework set forth in Dhanasar. 
A. Substantial Merit and National Import ance of the Proposed Endeavor 
The Petitioner is c urrentl y working as a biomedical engineering researcher in the 
at Her current research is aimed at developing novel drug delivery 
systems using biopolym ers as carriers for cancer treatme nt. She states that she intend s to utili ze her 
expe rtise in biomedical engineering of drug delivery sys tems and pharmacodynam ics to develop new 
cancer vaccin es that modul ate the immun e system to preven t the development of immunological 
cancers. Specif ica lly, she intends to further her work on album in-based dru g del iver y systems to 
"utilize the lymph nodes as a targeting system for cancer vacci nes." The record includes letter s of 
sup port indicatin g that the Petitioner's proposed work stands to contr ibute to the development and 
app lication of improved delivery of cancer treatment s. For example, a professor 
of genetics and bioengineering at in Turkey , ex plains t hat the Petitioner's 
"research is centered on targ eted drug delivery, a method for erad icatin g cancerous cells w hile 
sparing the surrounding healt h cell ," " boos ting the effectiveness and minimizing the side effects of 
cancer drug s." Accordingly, we find that the Petitione r's proposed work to advance research m 
biomedical engineering of advanced drug de livery systems tor cancer treatment has substantial merit. 
To satisfy the national importance requirement , the Petitioner must demonstrate the "potential 
prospective impact" of her work. She asse rts that her research furthers the development of "drug 
formulation s that can tar get tumors effec tively with minim al t oxic s ide etTects" "dramatically 
lower ing the cost associated with cancer therapies" and "pro longin g and sav ing the lives of 
Americans suffering from cancer." a pro fesso r at the 
at states that the Petitioner's continuing 
work "holds sign ificant utility for a w ide variety of conditions that beneti t from en hanced 
2 See Dhanasar, 26 I&N Dec. at 888-91, for elaboration on these three prongs. 
3 The record reflects that the Petitioner earned the equivalent of a master of science in biotechnology from the 
Iran in 2010. 
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Maller of P-Y-G-
therapeutic targeting" and that he has "made ample use of (her] discoveries" in his own 
investigation s into therapeutic targeting methods. further notes that she is a "pioneer 
in nanocarrier formulation for cancer medication s" and that the Petitioner 's researc h fundamentally 
advance s drug ~arrier design research in the United States. Follo wing a review of her work and 
implementation of her techniques in his own rese arch, recommended that Petitioner's 
configuration for achieving anti-tumor efficacy of drug delivery particles become universally 
implemented. 
The Petitioner has submitted documentation indicating that the benefit of her propo sed biomedical 
cancer research has broader implications, as the results are dissem inated to others in the tield through 
scientific journals and conferences. In addition , she provided resea rch from the 
repot1ing cancer diagnose s, treatment , and death rates along with the tormidable cost of the 
disease to individuals and the economy as a whole. As the Petitione r has documented both the 
substantial merit and national importance of her proposed research, we find that the record supports 
the Director 's finding that she meets the first prong of the Dhanasar framework. 
B. Well Positioned to Advance the Proposed Endeavor 
The second prong shitls the locu s from the proposed endeavor to the Petitioner's qualifications. The 
Petitioner submitted her curriculum vitae, academic record s, awards, evidence of the 
commercialization of her method s, and peer review activities. She also provided evidence of her 
published and presented work and documentation of articles that cited to her findings. In addition , 
the Petitioner oftered reterence letter s describing her expertise in developing advanced drug delivery 
systems using nanotechnology and biopolymers, and her past record of success as a biomedical 
engineering researcher. 
We find that the Petitioner's past experience renders her well positioned to advance her proposed 
endeavor aimed at developing novel drug delivery systems for cancer treatment. For example, 
a professor at the department of science and technology innovation at the 
in Italy, discusses the Petitioner' s research into the toxicity of doxorubicin as a 
cancer-fighting therapy through the use of carboh ydrate carrier dextran sulfate. He indicates that the 
Petitioner's results "shed new light on the role of electrostatic interaction in the dissemination of 
chemotherapy agents throughout the body" and explains that "she is one of a scare handful of scientists 
in this area that is capable of advancing kn~wledge about the attaching drugs to endogenous 
marcomolecules in the body." He explains that many scientists all over the world are " using [the 
Petitioner 's] method to improve the effectiveness of their own drug delivery method s." Similarly, 
professor of medical oncology at the 
writes. that he ha s directly implemented the Petitioner ' s drug deliver y method. He 
states that her "creation 
He notes that her "discoveries have had such a significant impact on my 
own." 
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Matter ofP-Y-G-
Additionally, the record includes evidence that the Petitioner 's discoveries have been impleme nted 
commercially and in several phase one clinical trials. Specifically, performed a phase one 
clinical study of her novel nanoparticle formulation. His study demonstrated a longer half-life and. 
bioavailability using the Petitioner's configuration when compared with the standard drug formulation, 
making her nanoparticle formation an "excellent candidate" for cance r treatment in human clinical 
trials. The record reflects that a pharmaceutical company specia lizing in the 
deve lopment of chemically modified nanomaterials into drugs , has taken steps to commercially 
develop the Petitioner's nanoparticle carrier platform delivering breast cancer drugs. Thus, the 
significance of the Petition er's research in her tield is corroborated by evidence that other prominent 
researchers are modifying their drug delivery protocols based upon her research and publication s. 
The record also includes citation evidence showing that the Petitioner's published work has been cited 
by independ ent researchers, and that the rate at which her work has been cited is high relative to others 
in her field. Such evidence helps show a past record of achievement that demon strates the Petitioner is 
well positioned to advance biomedical enginee ring research. Finally, we note that the record indicates 
that the Petitioner's current emplo yer, has offered her a postdoctoral position as a 
researche r developing genetically encoded biohybrid materials with the goal of develop ing novel drug 
delivery systems for cancer and diabetes treatment. 4 
In sum, the Petitioner's expertise in her field, publi shed and presented work, record of success 
contributing to various research project s, and progress· in the area of developing targeting drug 
delivery systems position her well to advance her proposed endeavor. Accordingly , we tind that she 
satisties the second prong of the Dhanasar fram~work. 
C. Balancing Factors to Determine Waiver's Benetit to the United States 
As exp lained above, the third prong requires the petitioner to demonstrate that , on balance, it would 
be beneticial to the United States to waive the requirement s of a j ob offer and thus of a labor 
certification. As a biomedical engineering researcher, the Petitioner possesses considerab le experience 
and expe rtise in nanotechnology , biohybrid materials, and drug delivery systems. The record also 
demon strates the widespread benetits associated with research developmen ts in her Held and their broad 
application in cancer research. The Petitioner has documented her past successes in advanc ing 
biomedical researc h and providing influential research findings . In addition, her work has garnered 
interest from other researchers throughout the greater scien tific community who have found it to be 
promising and useful. Based on the Petitioner's track record of successful research and the significance 
of her ongoing drug delivery systems studies that advance U.S. ·scientitic interests, we find that she 
offers contributions of such value that, on balance, they would benefit the United States even assum ing 
that other qualifi ed U.S. work ers are availab le. 
4 
As the Petitioner is applying for a waiver of the job offer requirement, it is not necessary for her to have a job offer 
from a specific employer. However, we consider information about her prospective position with to illustrate the 
capacity in which she intends to work and as evidence that she is well positioned to continue her work in this area. 
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Mauer ofP-Y-G-
Ill. CONCLUSION 
The Petitioner has met the requisite three prongs set forth in the Dhanasar analytical framework. We 
tind she has established eligibility for and otherwise merits a national interest waiver as a matter of 
discretion. 
ORDER: The appeal is sustained. 
Cite as Maller of P-Y-G-, ID# 1264440 (AAO June 5, 2018) 
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