sustained EB-2 NIW

sustained EB-2 NIW Case: Cancer Biology

📅 Date unknown 👤 Individual 📂 Cancer Biology

Decision Summary

The appeal was sustained because the petitioner, a biological researcher, provided sufficient evidence of her past achievements in the field of hematology and cancer biology. The AAO found that her significant contributions, including developing new drug therapies and murine models for cancer research, justified the projection of future benefit to the national interest, thereby meeting the criteria for a national interest waiver.

Criteria Discussed

Substantial Intrinsic Merit National In Scope Serving National Interest To A Substantially Greater Degree Than A U.S. Worker

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U.S. Citizenship 
and Immigration 
SRC 08 221 55307 
PETJl'lON: 
 Immigrant Petition fi3r Allen Worker as a Member of the Professions FIolciing at1 Advanced 
Degree or an Alien of Exceptiona! Abi!ity Purs~an! to Section 2*33(h)(2'1 of the Imrnigratioa 
and Nationality ,4ct. 8 U.S.C. $ ! i 53(b)(2) 
This is the decision of the Administrative Appeals Office in your casz. A11 documents have been returned to 
the office that originally decided your case. 4ny further inquiry must be made to that office. 
phn F. Grisso~n 
Acting Chief, Administrative Appeals Office 
Page 2 
DISCUSSION: 
 The Director, Texas Ser~ice Center, denied the employment-based immigrant visa 
petition. 'The matter is now before '.he Administrative Appeals Office (AAG) on appeal. The appeal 
will be sustained and the petition *ill be approved. 
The petitioner seeks classification pursuant to sectioi~ 203(b)(2) of the Immigration and Nationality Act 
(the Act), 8 U.S.C. 8 1153(b)(2), as an alien of exceptional ability and as a member of the professions 
holding 'an advanced degree. The petitioner seeks employment as a research scientist at the University 
of Texas M.D. Anderson Cancer Center (MDACC), Houston. 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 Statcs. The director found that the petitioner qualifies for classification as a member of the 
professions holding an advanced degree but that the petitioner had 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 brief from counsel and additional exhibits. 
Section 203(b) of the Act states, m pertinent part: 
(2) Aliens Who Are Merrihers of the Profesaicjns Holding Advanced Degrees or Aliens of 
Exceptional Ability. -- 
(A) In General. -- Visas shall be rnacle available . . . to qualified inmigrants who are 
members of the professions holding advanced degrees or their equivalent or ~ho 
because of their exceptional ability in the sciences, ads, or business, will silbstantially 
benefit prospectively the national economy, ailtual 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 of Job 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 director did nut dispute tha~ the petitioner qualifies as a member of the professions holding an 
advanced degree. Additional discussion regarding the petitioner's eligibility for classification as an 
alien of exceptional ability in the sciences would serve no constructive purpose, as the petitioner's 
doctoral degree and the nature of her occupation readily qualify her for the classification sought. The 
sole issue in contention 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 3tatute 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 
Page 3 
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, 101 st Cong., 1 st Sess., 1 1 (1 989). 
Supplementary information to the regulations implementing the Immigration Act of 1990 (IMMACT), 
published at 56 Fed. Reg. 60897,60900 (November 29, 1991), states: 
The Service [now U.S. Citizenship and Immigration Services] 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. 
Matter of New York State Dept. of Transportation, 22 I&N Dec. 2 15 (Cornrnr. 1998), has set forth 
several factors which must be considered when ?valuating a request for a national interest waiver. First. 
it must be shown that the alien seeks employment in an area of substantial intrinsic merit. Next, it must 
be shown that the proposed benefit will be national in scope. Finally, the petitioner seeking the waiver 
must establish that the alien will serve the national interest to a substanrially greater degree than would 
an available U.S. worker having the same mininlum qualifications. 
It rnust be noted that, while the national interest waiver hinges on prospective national benefit, it clearly 
rnust be established that the alien's past record justifies projections of future benefit to the national 
interest. The petitioner's subjective assurance that the alier, will, in the future, serve the national interest 
cannot suffice to establish prospective national benefit. The inclusion of the term "prospective" is used 
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. 
We also note that the regulation at 8 C.F.R. 5 204.5(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 offedlabor 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 
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 is a biological researcher focusing on hematology and cancer biology. Several letters, 
mostly from the petitioner's mentors and collaborators, accompanied the petitioner's initial submission. 
supervised the petitioner's doctoral st~~dies and postdoctoral training at 
Pavlov State Medical University, St. Petersburg, Russia. He stated: 
Page 4 
Under my guideness [sic] [the petitioner] investigated [the] efficacy [ofl interferon-alpha 
therapy in patients with CML [chronic myeloid leukemia]. She conducted the clinical 
trial testing the new drug Reaferon. . . . As a result of her clinical trial Reaferon-based 
therapy was included as a standard protocol for treatment [ofl patients with CML. . . . 
She was one of the first in Russia who introduced imatinib as a first line treatment in 
CML. Imatinib is the rationally designed drug that provides almost unlirnited survival in 
this formerly fatal disorder. Her activity became the basis for creating [an] all-country 
registry of CML patients, multicenter Russian trial and educational program for patients 
with CML and physicians all over Russia. . . . 
[The petitioner also] participated as an investigator in two clinical trials . . . [of a] new 
antiemetic drug, an essential component of supportive care of cancer patients. 'The 
significance of this research work is difficult to underestimate [sic]. 
MDACC Associate , who supervised the petitioner's early postdoctoral 
work at that institution, stated that the petitioner "for the first time created reliable murine model that 
can be used for testing novel target therapeutics [for myeloid leukemias] before trying them in clinical 
trials in patients. Therefore I can conclude that [the petitioner] made a crucial contribution in the field 
of studying leukemias." 
Chief of the Section of Molecular Hematology and Therapy at MDACC, 
supervises the petitioner's work at that institution. 
 Prof.praised the petitioner's past 
accomplishments and, with regard to her latest work, stated: 
[The petitioner] established breast, ovarian and pancreatic cancer murine models in 
order to test the efficacy of novel anti-cancer agents which provides critical information 
for approval of these agents for human clinical trials. . . . She showed for the first time 
that synthetic triterpenoid CDDO and its derivates can reduce tumor mass and increase 
survival of the mice bearing tumors. As a result of her and her co-workers titanic work 
currently these compounds are undergoing phase I clinical trials at MD Anderson 
Cancer Center. . . . 
[The petitioner] is currently working as an investigator on a vital research project 
entitled "Diabetes and Impaired Glucose Tolerance in Cancer Patients." . . . After only 
one year [the petitioner] has already made very significant contributions. Specifically, 
she is investigating the role of hormonal and metabolic determinants of tumor cell 
survival and chemoresistance in acute lymphocytic leukemia (ALL). . . . Her results 
suggest that upregulation of glycolysis via AKTImTORIHIFla pathway may be an 
important mechanism of chemoresistance in ALL, and that mTOR inhibition and 
glucose normalization may represent a new therapeutic modality in ALL. This is a very 
unique, break-through finding that has never been reported before, which for the first 
Page 5 
time links metabolic alterations and resistance to chemotherapy that remains till now the 
"gold" standard therapy of ALL. . . . 
Her discoveries stem not from following established protocols or recipes, but rather 
from looking at things in new ways and exploring them such that it has never been done 
before. 
collaborated with the petitioner, stated: "She has made major contributions to our joint research by 
discovering the new application of novel anti-leukemic drugs CDDO and CDDO-ME in GHVD 
treatment. Her finding is very inkportant to the hture clinical trials that will benefit to cure patients with 
different tumors by using stem cell transplantation." 
Baylor College of Medicine stated: 
we have been studying hematopoietic disorders. We have established a xenograft model 
for human leakenlias using immunodeficient strains of mice. As a member of Dr. 
research group, [the petitioner] is currently the leading person working on 
this particular model. Since 2005, I have been working closely with [the petitioner] on a 
collaborative study on radiation-induced leukemias, a project sponsored by NASA. . . . 
Under my guidance, [the petitioner] is actively involved in a NASA sponsored study on 
effects of distinct types of irradiation on human hematopoietic stem cells selected from 
l~oluntary cord blood donors. The primary radiation sources in the outer space [sic] are 
the galactic cosmic rays (GCR), protons and electrons trapped in the earth's magnetic 
field, and the solar particle events (SPE). . . . 
The main goal is to provide the information required to develop a rational scientific 
basis for estimation the risks [sic] of leukemogenesis in humans from exposure to 
radiation during space flight. . . . 
[The petitioner's] participation in the model establishment is crucial. 
Beyond the petitioner's mentors and collaborators, I Editor-in-Chief of 
Cell Cycle and Senior Scientist at Ordway Research Institute, Albany, New York, stated: 
I have not personally worked with [the petitioner] but had the pleasure of meeting her at 
the most recent American Society of Hematology Annual Meeting (2006 in Orlando, 
FL). First of al, I was greatly impressed by her poster presentation of her research - well 
articulated and insightfbl. . . . 
Page 6 
Secondly, I was impressed by [the petitioner's] focused efforts on understanding how 
metabolic alterations in cancer cells can lead to tumor progression and resistance to 
chemotherapy. . . . [The petitioner's] study is the first that specifically aims to identify 
biologic mechanisms of metabolic alterations in the ALL cells. 
. . . .In her current project [the petitioner] is pursuing several important goals. First she 
demonstrated that leukemic cells from patients and lymphoid cell line exhibit greatly 
increased glycolytic metabolism when the cells grow under high glucose and hypoxic 
conditions. Then she discovered that pro-glycolytic conditions. such as high glucose or 
hypoxia, promote chemoresistance of ALL blasts to conventional chemotherapy. This is 
indeed a very interesting finding, which for the first time links proglycolitic conditions 
and chemoresistance in ALL. . . . 
[The petitioner] has spent a lot of time and ef'fort and finally, the results of her 
experiments were striking: inhibition of the PI3/AKT/mTOR signaling pathway in the 
setting of pro-glycolytic conditions such as hypoxia or high glucose, results in 
chemosensitization via downregulation of glycolysis. These data are indeed very novel 
and exciting and have tremendous potential. 
The petitioner submitted copies of her peer-reviewed published =titles, and docunientation showing 14 
citations of her published work. The petitioner was the seventh of 15 authors of a 2006 article cited 
once, the fifth of ten authors of a 2006 article cited three times, and the fourth of five authors of a 1997 
article cited ten times. The petitioner also documented the impact factors of numerous journals that 
have published her work. The impact factor of a given journal is calculated based on the average 
citation rate of the articles in that journal. An article in a high-impact journal is not, itself, presumed to 
be high-impact by virtue of where it appeared; the impact of an individual article depends on its own 
citation history, not that of other articles in the same journal. 
On January 16, 2008, the director issued a request for evidence, stating "the record does not 
convincingly establish you personally have been responsible for groundbreaking discoveries andlor 
changes in the battle with leukemia or any other biologically-related endeavor" (emphasis in original). 
'The director also stated that the petitioner was not a principal author of the cited articles submitted 
previously. The director instructed the petitioner to submit evidence of her impact and influence on her 
field, including but not limited to independent witness letters. 
In response, the petitioner submitted additional exhibits, including letters. Prof. in his second 
letter, stated: 
[Blased on her pioneering experiments [that showed] the novel drug CDDO possesses 
multiple activities the clinical trial aimed at prevention of graft versus host disease is 
being prepared in the Department of Stem Cell Transplantation and Cellular Therapy. 
The goal of this trial is to treat the most dangerous and deadly complication of stem cell 
transplantation - graft versus host disease. If the goal of this trial is reached thousands 
of cancer patients will be cured and it would have direct impact on the US economy. 
[The petitioner] is currently working as the main investigator on a very competitive and 
timely research project entitled "Diabetes and Impaired Glucose Tolerance in Cancer 
Patients." . . . The main goal of [the petitioner] in the current project is to improve the 
success rate of leukernia treatment by development of new treatment modalities [that] 
are less toxic for the patients and more effective in eradication of the disease. 
1 have known [the petitioner] since 2004, when I first met her at 
 lab and 
then at an international meeting and have been impressed with her outstanding 
contributions ever since. . . . 
As a Postdoctoral Fellow she made a number of significant contributions to cancer 
research as follow: (i) establishment of a principal new mouse model of human acute 
myeloid leukemias . . . ; (ii) identification of MAPK and AKT kinases as constitutively 
activated proteins in primary leukemias that contribute critically to progression 
r:hemoresistance of leukemias . . . ; (iii) discovering a new approach to treat graft versus 
host disease and [at] tht: same time conserve antile[u]kemic effect of stem cell 
transplantation using administration of novei drug - synthetic triterpenoid CUD0 and its 
derivatives which e::hibit anti-inflammatory. anticarcinogenic. and antiproliferative 
prcperties. 
Her contrib~tions in these three related yet distinct areas of cancer research are highly 
significant and appraised by peers. . . . 
[The petitioner] is one of the principal investigators in the Multidisciplinary Research 
Program entitled "Diabetes and Impaired Glucose Tolerance in Cancer Patients." . . . 
Why cancer cells adopt glycolysis as a means of prodwing energy is still unclear. [The 
petitioner] hypothesized that the alterations . . . provide a survival advantage for the 
leukemia cells. . . . [S]he found that malignant cells cultured under pro-glycolytic 
conditions . . . [possess an] advantage in cell proliferation and survival. ),\,loreover later 
she discovered that malignant cells [that] underwent proglycolitic conditions become 
resistant to chemotherapeutical agents that implement in ALL treatment. . . . 
[The petitioner] for the first time found that mTOR inhibition of HIF-la-mediated 
glycolysis may play an important role in chemosensitization and improved outcomes in 
ALL. 
[The petitioner's] current ex[c]iting findings provide evidence that metabolic alterations 
of leukemic cells present a major challenge in cancer treatment. . . . However, the 
Page 8 
increased dependency of leukemic cells on glycolysis for energy generation also 
provides a biochemical basis to preferentially kill the malignant but not normal cells bj 
inhibition of glycolysis. 
of thr: University of Pennsylvania, who Grst met the petitioner at a 
2006 conference, stated: 
The most gro~md-brealung part of jthe petitioner's] current . . . research came from her 
challenging quest to find how to target the regulatory mechanisms that affect the 
expression or fwlctions of protein molecules that are directly or indirectly lnvoived in 
leukemia cells['] nietabolisn~. . . . T'his is a very exciting area of investigation which has 
tremendously advanced our !mowledge about metabolic alteration in cancer arrd 
provides us with the molecular 1001s to fight cancer with targeted therapy that does not 
affect normal cells. . . . 
Sh.e has made major contributions rc the 5eld of signal transduction and metabolic 
pathways. which . . . are crrtically invvlved in the leuken~ogenesis and chemoresistance, 
and !;he has trtlly risen to the top level in thiy field. 
Principal Ciinical Scitaltist at liottingharn University Hospital in the Urited 
Kingciom. stated: 
fri'he petitioner's] iulique and v;lluahie expertise in hlolecular Biology is essential to the , 
sticcess of the curretit research activities at M.D. 4nderson Cancer Center. . . . 
Although I haie not worked directly with [the petitioner], I have come to know her 
through her outstanding work in the field and her presentations at the international 
meetings [and] thus I can independently evaluate her research work . . . 
[The petitioned has already made, and will continue to make, an important contribution 
towards deciphering the :nolecular basis [ofl metabolic alterations in cancer. 
The petitioner documented 23 citations of her work, divided between four articles with eleven citations 
for the most-cited article. (The submitted documentation lists 25 citing articles, but two of the,. ~e are 
duplicates.) 
The director denied the petition on June 10, 2008, stating that while the petitioner had clearly earned 
respect through her work, her citation history did not indicate significant impact on the field. The 
director also observed that the petitioner was not a principal author of her cited work. The director 
stated that the petitioner had identified only one cited article, with six citations. The director also stated 
that the petitioner's RFE response discussed projects that the petitioner did not undertake until after the 
petition's filing date. 
On appeal, counsel correctly observes that the petitioner's citation history is not limited to six citations 
of one article. As noted above, the record documents 14 citations of the petitioner's work at the time of 
filing, and 23 citations at the time of the RFE response. We also find merit in counsel's assertion that 
the director mischaracterized witness descriptions of ongoing projects as entirely new endeavors. 
The petitioner, on appeal, documents an aggregate total of 38 citations of three of her articles. While 
the petitioner's cited articles were published before the petition's May 2007 filing date, most of the 
citations appeared after the filing date. In this instance, the primary significance of the citation 
infonnation is not the number as such. Rather, the accelerating rate of citation of the petitioner's pre- 
2007 articles corroborates witnesses' claims about the significance of the petitioner's work. New 
citations continue to appear, at an increasing rate, indicating that interest in the petitioner's pre-2007 
work at MDACC is building rather than subsiding. 
We acknowledge the director's concern that the petitioner was only one of multiple authors of the cited 
papers, and not the primary author, which can indicate that the petitioner was a lesser contributor to 
those papers. A waiver would likely not be in order if the petitioner's contributions to those projects 
had been limited simply to mastery of complex laboratory equipment or techniques developed by 
others. Mere, however, the petitioner has shown that t.he project leaders consider the petitioner's 
contributions to have been original and vital to the various projects, and independent witnesses have 
attested to the importance not only of the projects overall. but to the nature and significance of the 
petitioner's specific input into those projects. 
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 field of research, rather than on the merits of the individual alien. 
That being said, the evidence in the record establishes that the scientific community recognizes the 
significance of this petitioner's research rather than simply the general area of research. The benefit of 
retaining this alien's services outweighs the national interest that is inherent in the labor certification 
process. Therefore, on the basis of the evidence submitted, the petitioner has established that a waiver 
of the requirement of an approved labor certification will be in the national interest of the United States. 
The burden of proof in these proceedings rests solely with the petitioner. Section 291 of the Act, 
8 U.S.C. tj 1361. The petitioner has sustained that burden. Accordingly, the decision of the director 
denying the petition will be withdrawn and the petition will be approved. 
ORDER: 
 The appeal is sustained and the petition is approved. 
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