January 24, 2025
2025 年 1 月 24 日
U.S. Department of Homeland Security
美国国土安全部
U.S. Citizenship and Immigration Services
美国公民及移民服务局
Texas Service Center
德克萨斯服务中心
6046 N Belt Line Rd STE 140
Irving, TX 75038-0014
YIZHI LIN
c/o CHANGHAO SHEN
139 12 34TH RD, APT. D6
FLUSHING, NY 11354
法拉盛，纽约 11354
RE: YIZHI LIN
回复：YIZHI LIN
I-140, Immigrant Petition for Alien Worker
I-140，外籍工人移民申请
PREMIUM PROCESSING
加急处理
IMPORTANT: THIS NOTICE CONTAINS YOUR UNIQUE NUMBER. THE ORIGINAL NOTICE MUST BE SUBMITTED WITH THE REQUESTED EVIDENCE.
重要提示：此通知包含您的唯一编号。原始通知必须与请求的证据一起提交。
You are receiving this notice because U.S. Citizenship and Immigration Services (USCIS) requires additional evidence to process your form. Please provide the evidence listed on the attached page(s). Include duplicate copies if you are requesting consular notification.
您收到此通知是因为美国公民及移民服务局（USCIS）需要额外的证据来处理您的表格。请提供附页上列出的证据。如果您请求领事通知，请包括副本。
Your response must be received in this office by April 21, 2025.
您必须在 2025 年 4 月 21 日之前将您的回复送达本办公室。
- Please note that you have been allotted the maximum period allowed for responding to an RFE. The time period for responding cannot be extended. 8 Code of Federal Regulations (8 CFR 103.2(b)(8)(iv)). Because many immigration benefits are time sensitive, you are encouraged to respond to this request as early as possible, but no later than the deadline provided above. If you do not respond within the allotted time to this notice, your case may be denied. The regulations do not provide for an extension of time to submit the requested evidence.
请注意，您已被分配了回应 RFE 的最大期限。回应的时间期限无法延长。8 Code of Federal Regulations (8 CFR 103.2(b)(8)(iv))。由于许多移民福利是时间敏感的，建议您尽早回应此请求，但不得晚于上述截止日期。如果您未在规定时间内对此通知作出回应，您的案件可能会被拒绝。法规不提供提交所请求证据的时间延长。
You must submit all requested evidence at the same time. If you submit only some of the requested evidence, USCIS will consider your response a request for a decision on the record, 8 CFR 103.2(b)(11).
您必须同时提交所有请求的证据。如果您只提交部分请求的证据，USCIS 将视您的回应为对记录的决定请求，8 CFR 103.2(b)(11)。
If you submit a document in any language other than English, the document must be accompanied by a full and complete English translation. The translator must certify that the translation is accurate and he or she is competent to translate from that language to English. If you submit a foreign language translation in response to this request for evidence, you must also include a copy of the foreign language document.
如果您提交的文件是英语以外的任何语言，则该文件必须附有完整的英文翻译。翻译者必须证明翻译是准确的，并且他或她有能力将该语言翻译成英语。如果您提交外语翻译以回应此证据请求，您还必须包括外语文件的副本。
Processing of your I-140 will resume upon receipt of your response. If you have not heard from USCIS after 15 days of responding, you may contact the Texas Service Center Premium Processing at email address tsc-premium.processing@uscis.dhs.gov.
在收到您的回复后，您的 I-140 处理将恢复。如果在回复后 15 天内未收到 USCIS 的消息，您可以通过电子邮件联系 Texas Service Center Premium Processing，邮箱地址为 tsc-premium.processing@uscis.dhs.gov。
Reference is made to this Form I - 140, Immigrant Petition for Alien Worker, seeking E11 immigrant classification as an individual of extraordinary ability for YIZHI LIN (petitioner and beneficiary), filed on his own behalf on January 3, 2025.
提到此表格 140，外籍工人移民申请，寻求 E11 移民分类，作为 YIZHI LIN（申请人和受益人）这一具有非凡能力的个人，于 2025 年 1 月 3 日自行提交。
The petitioner intends to work as a Biomedical Engineer in the field of Biomedical Engineering.
申请人打算在生物医学工程领域担任生物医学工程师。
Translations
翻译
All foreign language documents must have a full and complete English translation. The regulation does not allow for only a partial translation of the submitted evidence.
所有外语文件必须有完整的英文翻译。法规不允许仅提供提交证据的部分翻译。
You submitted the following documents which are in a language other than English that did not include translations that meet the regulatory requirement:
您提交了以下文件，这些文件使用的语言不是英语，并且未包含符合监管要求的翻译：
- Media coverage of the third national “Most Beautiful Anti Tuberculosis Person” award;
第三届全国“最美抗结核人物”奖的媒体报道
- Media coverage of 2023 Huaxia Medical Award;
2023 华夏医学奖的媒体报道
- Constitution of Chinese Antituberculosis Association;
中国抗结核协会章程
- Information about the Chinese Antituberculosis Association;
关于中国抗结核协会的信息
- Media coverage about the Chinese Antituberculosis Association;
关于中国抗结核协会的媒体报道
- Information about the China Association of Medical Equipment;
关于中国医疗器械协会的信息
- Constitution for the China Association of Medical Equipment;
中国医疗设备协会章程
- Constitution of the Clinical Test Committee of the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing);
北京结核病诊断与治疗创新联盟临床试验委员会章程
- Constitution for the Zhejiang Pharmaceutical Association;
浙江药学会章程；
- Media coverage for the Zhejiang Pharmaceutical Association;
浙江药品协会的媒体报道
- Patents; and
专利；和
- “Vanguard” and Leading Goose” contract.
“先锋”和“领头雁”合同。
Please submit English language translations for the document(s) noted above. In addition, the translator must certify that:
请提交上述文件的英文翻译。此外，翻译者必须证明：
- The translations are accurate and complete; and
翻译是准确和完整的；并且
- He or she is competent to translate from the foreign language into English.
他或她有能力将外语翻译成英语。
The E11 immigrant classification applies to individuals with extraordinary ability in the sciences, arts, education, business, or athletics. The individual must demonstrate that he has sustained national or international acclaim and that his achievements have been recognized in the field of expertise, indicating that he is one of that small percentage who have risen to the very top of their field of endeavor. The individual must continue to work in his area of extraordinary ability and must substantially benefit prospectively the United States.
E11 移民分类适用于在科学、艺术、教育、商业或体育方面具有非凡能力的个人。该个人必须证明他在国家或国际上享有持续的声誉，并且他的成就已在专业领域得到认可，表明他是那小部分在其所从事领域中脱颖而出的顶尖人才之一。该个人必须继续在其非凡能力的领域工作，并且必须对美国未来产生实质性的利益。
To process the petition and determine if the petitioner is eligible, additional information is required. This request provides suggested evidence you could submit to satisfy each requested item. You may submit one, some, or all of these items. Or, you may choose to submit none of them, and instead submit other evidence to satisfy the request. You may also explain why or how the evidence in the record already establishes eligibility. Please note, however, that you are responsible for providing evidence that shows the petitioner meets all requirements. The evidence must show that the petitioner is eligible for the requested benefit when you filed the Form I - 140.
为了处理申请并确定申请人是否符合资格，需要提供额外的信息。此请求提供了您可以提交的建议证据，以满足每个请求的项目。您可以提交其中一个、一些或全部项目。或者，您可以选择不提交这些项目，而是提交其他证据以满足请求。您还可以解释为什么或如何记录中的证据已经证明了资格。然而，请注意，您有责任提供证据，证明申请人符合所有要求。证据必须表明，在您提交 I-140 表格时，申请人有资格获得所请求的利益。
A two - part analysis is used to determine whether the petitioner is an individual of extraordinary ability:
使用两部分分析来确定申请人是否为具有非凡能力的个人：
- First, we determine whether the petitioner has submitted evidence to show that the petitioner:
首先，我们确定申请人是否提交了证据以证明申请人：
- Has received a one - time achievement (a major internationally recognized award); or,
- 已获得一次性成就（一个国际公认的重要奖项）；或者，
- Qualifies under at least three of the ten criteria required for this classification.
符合该分类所需的十个标准中的至少三个。
- Second, if the petitioner establishes that the petitioner has received a one - time achievement (a major internationally recognized award), or meets at least three of the other criteria, we will then determine whether the petitioner has sustained national or international acclaim:
其次，如果申请人证明其获得了一次性成就（一个主要的国际认可奖项），或满足至少三个其他标准，我们将确定申请人是否获得了持续的国家或国际声誉：
- In determining whether the petitioner has enjoyed “sustained” national or international acclaim, such acclaim must be maintained. A petitioner may have achieved extraordinary ability in the past but then failed to maintain a comparable level of acclaim thereafter; and,
在确定申请人是否享有“持续的”国家或国际声誉时，这种声誉必须得到维持。申请人可能在过去取得了非凡的能力，但随后未能维持相应的声誉水平；并且，
- Has achievements that have been recognized in the field of expertise, indicating that the petitioner is one of that small percentage who has risen to the very top of the field of endeavor.
在其专业领域内有被认可的成就，表明申请人是那小部分已达到该领域顶尖水平的人。
- Documentation of the alien’s receipt of lesser nationally or internationally recognized prizes or awards for excellence in the field of endeavor;
外籍人士在其专业领域获得的较低国家或国际认可的奖项或荣誉的证明；
- Documentation of the alien’s membership in associations in the field for which classification is sought, which require outstanding achievements of their members, as judged by recognized national or international experts in their disciplines or fields;
证明外籍人士在所申请分类领域内的协会会员资格，这些协会要求其成员具备杰出成就，且该成就由其学科或领域内公认的国家或国际专家评定；
- Evidence of the alien’s participation, either individually or on a panel, as a judge of the work of others in the same or an allied field of specialization for which classification is sought;
证明外籍人士作为评审，单独或作为小组成员，参与同一或相关专业领域他人工作的证据；
- Evidence of the alien’s scientific, scholarly, artistic, athletic, or business - related contributions of major significance in the field; and
在该领域内，外籍人士在科学、学术、艺术、体育或商业相关方面的重大贡献的证据；以及
- Evidence that the alien has performed in a leading or critical role for organizations or establishments that have a distinguished reputation.
证明该外籍人士在具有卓越声誉的组织或机构中担任过领导或关键角色。
A discussion follows addressing the areas of insufficiency and what could be submitted to overcome them.
接下来将讨论不足之处以及可以提交的材料以克服这些不足。
Documentation of the petitioner’s receipt of lesser nationally or internationally recognized prizes or awards for excellence in the field of endeavor.
申请人获得的在该领域内较低的国家或国际认可的优秀奖项或奖励的证明。
The petitioner submitted the following evidence:
申请人提交了以下证据：
- Media coverage of the Third National “Most Beautiful Anti Tuberculosis Person” award;
第三届全国“最美抗结核人物”奖的媒体报道
- Information about the Chinese Antituberculosis Association;
关于中国抗结核协会的信息
- “Most Beautiful Anti Tuberculosis Person” award evaluation criteria;
“最美抗结核人物”奖评选标准;
- Third prize Huaxia Medical Award certificate;
第三届华夏医学奖证书；
- Media coverage of 2023 Huaxia Medical Award; and
2023 华夏医学奖的媒体报道；并
- Information about the China International Exchange and Promotive Association for Medical and Health Care and the Huaxia Medical Award.
关于中国国际交流与促进医学与健康护理协会及华夏医学奖的信息。
The plain language of this criterion requires evidence (1) of the petitioner’s receipt of a prize or award, (2) that the prize or award is in petitioner’s field, (3) that the prize or award is recognized nationally or internationally, and (4) that the award or prize is for excellence in the field of endeavor. The petitioner must satisfy all of these elements to meet the plain language requirements of this criterion.
该标准的简单语言要求提供证据：(1) 申请人获得奖项或奖励的证明，(2) 该奖项或奖励属于申请人的领域，(3) 该奖项或奖励在全国或国际上得到认可，以及 (4) 该奖项或奖励是为了在该领域的卓越表现。申请人必须满足所有这些要素，以符合该标准的简单语言要求。
This criterion has not been met as it has not been established that the prizes or awards are nationally or internationally recognized or that they were given for excellence in the petitioner’s field of endeavor, or that the primary purpose of the prizes or awards was to recognize excellence in the petitioner’s field.
该标准尚未满足，因为尚未确定这些奖项或荣誉在全国或国际上得到认可，或者它们是因申请人在其专业领域的卓越表现而颁发的，或者这些奖项或荣誉的主要目的是表彰申请人在其专业领域的卓越表现。
The petitioner submitted a translation of a foreign language document listing him as a recipient of the Third National “Most Beautiful Anti Tuberculosis Person” award. However, the petitioner did not submit a complete translation of the foreign language document. Thus, this evidence cannot be considered.
申请人提交了一份外语文件的翻译，列出了他作为第三届全国“最美抗结核人物”奖的获得者。然而，申请人并未提交该外语文件的完整翻译。因此，这项证据无法被考虑。
The remaining evidence for the Third National “Most Beautiful Anti Tuberculosis Person” award does not establish that it is for excellence in the field. The evidence for the award evaluation criteria indicates that the three conditions for selecting the “Most Beautiful Anti Tuberculosis Person” includes:
第三届全国“最美抗结核人物”奖的剩余证据并未证明该奖项是针对该领域的卓越表现。奖项评估标准的证据表明，选择“最美抗结核人物”的三个条件包括：
Love the cause of tuberculosis prevention and control in China, with noble character and the idea of serving the people wholeheartedly;
热爱中国的结核病预防和控制事业，具有高尚的品格和全心全意为人民服务的理念；
I am dedicated to my job, have a strong sense of career and responsibility, and have made selfless contributions to the cause of tuberculosis in our country;
我致力于我的工作，具有强烈的职业感和责任感，并为我国的结核病事业做出了无私的贡献；
Having touching and exemplary outstanding deeds, deeply respected by the vast number of medical and health workers, it is a model for national tuberculosis prevention and technology workers to learn from.
拥有感人和杰出的事迹，深受广大医务工作者的尊敬，是国家防治结核病和技术工作者学习的榜样。
In regards to the Huaxia Medical Award, the petitioner submitted foreign media coverage listing the petitioner as one of 44 recipients of the third prize. However, the petitioner did not submit a complete translation of the foreign language document. Thus, this evidence cannot be considered.
关于华夏医学奖，申请人提交了外媒报道，列出申请人为第三等奖的 44 名获奖者之一。然而，申请人并未提交外文文件的完整翻译。因此，这项证据无法被考虑。
The petitioner did submit a certificate that indicates that he did in fact receive the third prize Huaxia Medical Award.
申请人确实提交了一份证书，表明他确实获得了第三届华夏医学奖。
The remaining evidence does not establish that the third prize Huaxia Medical Award is nationally or internationally recognized or that they were given for excellence in the petitioner’s field of endeavor. The evidence may indicate that the first prize meets this criterion.
其余证据并未证明第三届华夏医学奖在全国或国际上得到认可，或该奖项是因申请人在其专业领域的卓越表现而颁发的。证据可能表明一等奖符合这一标准。
The petitioner submitted a printout that he titled as “Award Criteria”. However, the evidence does not provide enough detail to determine the exact criteria used for the award. For example, the evidence states:
申请人提交了一份他称为“奖项标准”的打印件。然而，证据没有提供足够的细节来确定用于颁发奖项的确切标准。例如，证据中指出：
In order to make the Huaxia Medical Award one of the most authoritative awards in the medical industry, our association plans to establish the Huaxia Medical Award Council since 2015, which will consist of Huaxia Medical Award Council units and directors, and hire well - known higher medical colleges, large tertiary hospitals, research institutes, prevention and other units as council units. And Academician Han Demin will be appointed as the Chairman of the Council of the Huaxia Medical Award; Hiring renowned academicians as vice chairmen; Hire the principal or vice principal as an executive director; Hire the dean or vice dean as a director. I believe that under the leadership of the Council, the Huaxia Medical Award will become a more influential and authoritative award in the medical field in China, making greater contributions to improving people’s health and the development of the medical field and health industry.
为了使华夏医学奖成为医学行业最权威的奖项之一，我协会自 2015 年起计划成立华夏医学奖理事会，理事会将由华夏医学奖理事会单位和理事组成，并聘请知名高等医学院、大型三级医院、研究机构、预防等单位作为理事会单位。并将聘请韩德民院士担任华夏医学奖理事会主席；聘请知名院士担任副主席；聘请校长或副校长担任执行董事；聘请院长或副院长担任理事。相信在理事会的领导下，华夏医学奖将成为中国医学领域更具影响力和权威性的奖项，为提高人民健康和医学领域及健康产业的发展做出更大贡献。
The evaluation committee of the Huaxia Medical Award is composed of renowned experts and scholars, relevant competent departments, and relevant personnel of the association. It has a main honorary chairman, chairman, vice chairman, secretary - general, and deputy secretary - general. Its main responsibility is to determine the evaluation rules for the Huaxia Medical Award; Responsible for the evaluation of the Huaxia Medical Award; Resolve the relevant issues that arise during the evaluation process of the Huaxia Medical Award; Provide guiding opinions for improving the various work of the Huaxia Medical Award rewards.
华夏医学奖评审委员会由知名专家学者、相关主管部门及协会相关人员组成。委员会设有主要荣誉主席、主席、副主席、秘书长和副秘书长。其主要职责是确定华夏医学奖的评审规则；负责华夏医学奖的评审；解决华夏医学奖评审过程中出现的相关问题；为改善华夏医学奖奖励的各项工作提供指导意见。
The Huaxia Medical Award Office is mainly responsible for daily work related to the Huaxia Medical Award. Implement the relevant resolutions of the Huaxia Medical Award Council; Accept the formal application, initial review, public announcement, final review, and release of the Huaxia Medical Award recommended projects; Responsible for recommending and applying for the National Science and Technology Award to the National Health and Family Planning Commission based on the selected award - winning projects.
华夏医学奖办公室主要负责与华夏医学奖相关的日常工作。执行华夏医学奖委员会的相关决议；接受华夏医学奖推荐项目的正式申请、初审、公告、复审和发布；根据选定的获奖项目，负责向国家卫生和计划生育委员会推荐和申请国家科技奖。
To demonstrate excellence in the field was the basis for the prizes or awards, the petitioner may submit:
为了证明在该领域的卓越表现，申请人可以提交：
- Documentary evidence describing how the prizes or awards relate to excellence in the petitioner’s field
- 描述奖项或荣誉如何与申请人领域的卓越相关的文件证据.
- Documentary evidence of the criteria used to grant the prizes or awards, including evidence that a criterion for winning the prizes or awards was excellence in the field.
授予奖项或奖励所使用标准的文件证据，包括获奖标准之一是该领域的卓越的证据。
If the petitioner believes that the prizes or awards are nationally or internationally recognized prizes or awards for excellence in the field, the petitioner may submit:
如果申请人认为这些奖项或荣誉是全国性或国际性认可的优秀奖项，申请人可以提交：
- The criteria used to give the prizes or awards.
授予奖项或奖励的标准。
- Information on the reputation of the organization granting the prizes or awards.
有关授予奖项或奖励的组织声誉的信息。
- Documentary evidence demonstrating:
证明的文件证据：
- The significance of the prizes or awards, to include the national or international recognition the prizes or awards share;
奖项或荣誉的重要性，包括奖项或荣誉所获得的国家或国际认可；
- The reputation of the organization granting the prizes or awards;
授予奖项或奖励的组织的声誉；
- Who is considered for the prizes or awards, including the geographic scope for which candidates may apply;
谁被考虑获得奖项或奖励，包括候选人可以申请的地理范围；
- How many prizes or awards are awarded each year;
每年颁发多少奖项或奖励；
- Previous winners who enjoy national or international acclaim; and,
享有国家或国际声誉的前获奖者；以及，
- Documentary evidence establishing how the award(s) was/were given for excellence in the petitioner’s field.
- 证明文件，说明奖项是如何因申请人在其领域的卓越表现而颁发的。
The petitioner may be submitted any other information about the prizes or awards that would help establish that the prizes or awards should be considered as nationally or internationally recognized prizes or awards for excellence in the field of endeavor.
申请人可以提交任何其他关于奖项或荣誉的信息，以帮助证明这些奖项或荣誉应被视为在该领域内具有国家或国际认可的卓越奖项或荣誉。
Documentation of the petitioner’s membership in associations in the field for which classification is sought. The association must require outstanding achievements of their members, as judged by recognized national or international experts in their disciplines or fields.
申请人所申请分类领域内协会会员资格的证明。该协会必须要求其成员具备杰出的成就，这些成就应由其学科或领域内公认的国家或国际专家进行评判。
The petitioner submitted the following evidence:
申请人提交了以下证据：
- Membership certificates for the Chinese Antituberculosis Association;
- 中国抗结核协会的会员证书;
- Constitution of Chinese Antituberculosis Association;
- 中国抗结核协会章程
- Information about the Chinese Antituberculosis Association;
- 关于中国抗结核协会的信息
- Media coverage about the Chinese Antituberculosis Association;
- 关于中国抗结核协会的媒体报道
- Membership certificate for the China Association of Medical Equipment;
- 中国医疗器械协会会员证书
- Information about the China Association of Medical Equipment;
- 关于中国医疗器械协会的信息
- Constitution for the China Association of Medical Equipment;
- 中国医疗设备协会章程;
- Media coverage for the China Association of Medical Equipment;
- 中国医疗设备协会的媒体报道;
- Membership certificate for the Clinical Test Committee of the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing);
- 创新联盟结核病诊断与治疗临床测试委员会会员证书（北京）；
- Information about the Clinical Test Committee of the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing);
- 关于创新联盟结核病诊断与治疗临床测试委员会的信息；
- Constitution of the Clinical Test Committee of the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing);
- 北京创新联盟结核病诊断与治疗临床试验委员会章程；
- Media coverage for the Clinical Test Committee of the Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing);
- 创新联盟结核病诊断与治疗临床测试委员会的媒体报道（北京）；
- Membership certificate for the In vitro Diagnostic Reagen Professional Committee of the Zhejiang Pharmaceutical Association;
- 浙江省药学会体外诊断试剂专业委员会会员证书;
- Information about the In vitro Diagnostic Reagen Professional Committee of the Zhejiang Pharmaceutical Association;
- 浙江省药学会体外诊断试剂专业委员会的信息；
- Constitution for the Zhejiang Pharmaceutical Association; and
- 浙江药学会章程；并
- Media coverage for the Zhejiang Pharmaceutical Association.
- 浙江药品协会的媒体报道。
The plain language of this criterion requires evidence (1) of membership in associations, (2) that the associations are in the petitioner’s field, (3) that the associations require outstanding achievements of their members, and (4) that membership eligibility is judged by recognized national or international experts in their field.
该标准的简单语言要求提供以下证据：(1) 会员资格的证明，(2) 这些协会属于申请人的领域，(3) 这些协会要求其成员具备杰出成就，以及 (4) 会员资格的评判由该领域内公认的国家或国际专家进行。
This criterion has not been met because the evidence does not show that the basis for granting memberships in the submitted associations was the petitioner’s outstanding achievements in the field of endeavor as judged by recognized national or international experts in the field.
该标准未得到满足，因为证据未能表明所提交协会的会员资格授予基础是由该领域公认的国家或国际专家评判的申请人在该领域的杰出成就。
The petitioner submitted foreign language documents that included the constitutions for the associations listed above. However, the petitioner did not submit a complete translation of the foreign language document. Thus, this evidence cannot be considered. Therefore, the petitioner did not submit independent objective evidence to establish that the petitioner’s membership meets the plain language of the criterion.
申请人提交了外语文件，其中包括上述协会的章程。然而，申请人并未提交外语文件的完整翻译。因此，这些证据无法被考虑。因此，申请人未提交独立的客观证据以证明申请人的会员资格符合标准的明文要求。
Note that memberships that only require the following for membership do not meet the plain language of this criterion:
请注意，仅要求以下内容作为会员资格的会员不符合该标准的明确语言：
- Support the constitution of our group;
- 支持我们团体的宪法；
- Willingness to join this group;
-愿意加入该小组；
- Has certain influence within the business (industry, discipline) field of this group.
- 在该团体的商业（行业、学科）领域内具有一定影响力。
- Unit members have independent legal personality.
- 单位成员具有独立的法律人格。
- Individual members are experts engaged in this field, with intermediate or above professional titles or a master’s degree of at least 3 years. Pharmaceutical workers with a bachelor’s degree or above or qualifications for junior technical positions in pharmacy and related majors, management workers who are enthusiastic and actively support the work of our association and have knowledge in pharmacy and related majors;
- 个人成员是从事该领域的专家，具有中级或以上专业职称或至少 3 年的硕士学位。拥有学士学位或以上的制药工作者，或在制药及相关专业中具备初级技术职位资格的人员，热情并积极支持我们协会工作的管理人员，并具备制药及相关专业知识；
- Possess intermediate or higher professional technical titles;
- 具备中级或更高的专业技术职称；
- Enthusiastic about association work, actively participating in activities of this branch, able to provide suggestions and recommendations for the development of the branch, and having a significant impact in this field;
- 对协会工作充满热情，积极参与本分支的活动，能够为分支的发展提供建议和推荐，并在该领域产生重大影响；
- The age of employment shall not exceed 65 years old.
- 就业年龄不得超过 65 岁。
To assist in determining that the petitioner’s memberships satisfy this criterion, the petitioner may submit:
为了帮助确定申请人的会员资格满足此标准，申请人可以提交：
- Information to establish that the individuals who review prospective members’ applications are recognized as national or international experts in their disciplines or fields.
- 信息以证明审查潜在成员申请的个人被认可为其学科或领域的国家或国际专家。
- The section of the association’s constitution or bylaws which discuss the qualifications required of the reviewers on the review panel of the association.
- 协会章程或细则中讨论审查小组审查员资格的部分。
Evidence of the petitioner’s participation, either individually or on a panel, as a judge of the work of others in the same or an allied field of specialization for which classification is sought.
申请人作为同一领域或相关领域的评审，单独或作为小组成员参与他人工作的证据。
The petitioner submitted the following evidence:
申请人提交了以下证据：
- Copy of book “Guidelines for Metrology Calibration and Quality Control of Nucleic Acid Testing Laboratory Equipment” listing petitioner as Deputy Editor in Chief;
- 书籍《Guidelines for Metrology Calibration and Quality Control of Nucleic Acid Testing Laboratory Equipment》的副本，列出申请人为副主编；
- Information about the Emergency Rescue Equipment Branch of China Medical Equipment Association; and
- 中国医疗器械协会应急救援设备分会的信息；
- Information about the National Institute of Metrology, China (NIM).
- 关于中国计量科学研究院（NIM）的信息。
The plain language of this criterion requires evidence (1) of the petitioner’s participation, either individually or on a panel (official capacity) as a judge, and (2) that the petitioner judge the work of others in the same or an allied field. The petitioner must satisfy all of these elements to meet the plain language requirements of this criterion.
该标准的简单语言要求提供证据（1）申请人作为评审，单独或以小组（官方身份）参与，和（2）申请人评审同一领域或相关领域其他人的工作。申请人必须满足所有这些要素，以符合该标准的简单语言要求。
This criterion has not been met because the evidence does not show that the petitioner served in the role of a judge of the work of others.
该标准未得到满足，因为证据未显示申请人在他人工作中担任评审的角色。
The evidence from the book indicates that the petitioner served as one of eight deputy editor - in - chiefs on the book. However, the petitioner did not submit evidence further detailing his duties in this role such as awarding ratings or exercised judgment in evaluating individuals. Thus the evidence regarding this role is insufficient.
书中的证据表明，请愿人担任该书的八位副主编之一。然而，请愿人并未提交进一步详细说明其在该角色中职责的证据，例如授予评级或在评估个人时行使判断。因此，关于该角色的证据不足。
Please provide evidence that establishes that the petitioner actually participated in the judging of the work of others for which they were invited.
请提供证据，证明申请人确实参与了对他们被邀请的他人作品的评审。
Evidence of the petitioner’s original scientific, scholarly, artistic, athletic, or business - related contributions of major significance in the field.
申请人原始的科学、学术、艺术、体育或商业相关的重大贡献的证据。
The petitioner submitted the following evidence:
申请人提交了以下证据：
- Patents;
- 专利;
- Emails for revision of SAC/TC136 Centralized Standards in 2024;
- 2024 年 SAC/TC136 集中标准修订的电子邮件;
- Notice on soliciting opinions on 20 national and industry standards;
- 关于征求对 20 项国家和行业标准意见的通知;
- “Vanguard” and “Leading Goose” contract;
- “先锋”和“领头雁”合同；
- Media coverage of “Vanguard” and Leading Goose”; and
- “Vanguard”和 Leading Goose 的媒体报道；以及
- Recommendation letters.
- 推荐信。
The plain language of this criterion requires evidence (1) of the petitioner’s contributions related to scientific, scholarly, artistic, athletic or business fields, (2) that the petitioner’s contribution is original, and (3) that the petitioner’s original contribution has been of major significance in the field of endeavor. The petitioner must satisfy all of these elements to meet the plain language requirements of this criterion.
该标准的简单语言要求提供证据：(1) 申请人在科学、学术、艺术、体育或商业领域的贡献；(2) 申请人的贡献是原创的；以及 (3) 申请人的原创贡献在所从事的领域具有重大意义。申请人必须满足所有这些要素，以符合该标准的简单语言要求。
This criterion has not been met because the evidence submitted does not show that the petitioner’s contributions are considered to be of major significance in the field of endeavor.
此标准未得到满足，因为提交的证据未能显示申请人的贡献在该领域被认为具有重大意义。
The petitioner submitted several foreign language patents that list him as one of the inventors. However, the petitioner did not submit a complete translation of the foreign language document. Thus, this evidence cannot be considered.
申请人提交了几项列出他为发明人的外语专利。然而，申请人并未提交外语文件的完整翻译。因此，这项证据无法被考虑。
Also, note that a patent is evidence of originality and may support that the petitioner’s contribution is original. The issuance of a patent, by itself, does not verify the significance of the innovation because the innovation’s significance is not evaluated during the application process. The contribution of the innovation to the field as a whole must be determined by USCIS on a case - by - case basis. There is no evidence that the innovation has resulted in a significant impact to the petitioner’s field. While the petitioner asserts that his patents have earned about one billion yuan, the petitioner did not submit independent objective evidence to support this claim or evidence to establish this is indicative of contributions of major significance.
此外，请注意，专利是原创性的证据，可能支持申请人的贡献是原创的。专利的颁发本身并不能验证创新的重要性，因为在申请过程中并未评估创新的重要性。创新对整个领域的贡献必须由 USCIS 逐案确定。没有证据表明该创新对申请人的领域产生了重大影响。虽然申请人声称他的专利赚取了大约十亿元人民币，但申请人并未提交独立的客观证据来支持这一主张，也没有证据表明这表明了重大贡献。
In regards to the industry standards and “Vanguard” and “Leading Goose”, it is not clear that this is an original contribution made by the petitioner or building on another individual’s contribution. Additionally, the petitioner did not submit independent objective evidence to establish his contribution is considered of major significance in the field.
关于行业标准以及“Vanguard”和“Leading Goose”，尚不清楚这是否是申请人所做的原创贡献，还是基于其他个人的贡献。此外，申请人没有提交独立的客观证据来证明他的贡献在该领域被认为具有重大意义。
The petitioner submitted several letters of recommendation. The letters speak highly of the petitioner and his work. However, the author of the letters do not provide specific detailed examples of how the petitioner’s work has been of major significance to the field as a whole. For example:
申请人提交了几封推荐信。这些信件高度评价了申请人及其工作。然而，信件的作者并未提供具体详细的例子来说明申请人的工作对整个领域的重要意义。例如：
Tan Weihong, Academician of the CAS Member, writes, “Mr. Lin Yizhi’s fundamental and groundbreaking discoveries have not only received widespread attention and praise from international peers, but his research results have also had a wide - ranging impact in practical applications, making breakthrough progress in the diagnosis and prevention of infectious diseases, and have profound significance for future research in the field of medical technology.”
中国科学院院士谭伟宏写道：“林毅志先生的基础性和开创性发现不仅受到国际同行的广泛关注和赞誉，而且他的研究成果在实际应用中也产生了广泛的影响，在传染病的诊断和预防方面取得了突破性进展，对未来医学技术领域的研究具有深远的意义。”
Ye Sheng, Dean of the School of Life Sciences, Tianjin University, writes, “The patents led by Lin Yizhi, including ‘A Method for Determining Nucleic Acid Amplification Results’, ‘A Mutated Recombinant Reverse Transcriptase and Its Preparation Method’, ‘A Self Driven Microfluidic Detection Device and Its Application’, ‘Nucleic Acid Amplification Detector’, ‘Pipette Equipment and Nucleic Acid Testing Workstation’ and ‘Nucleic Acid Products and Their Application’, have been applied for production and entered the market, generating great commercial benefits. As of October 2024, the total sales of these products exceeded 1 billion yuan. Since their release, they have been widely used in the field of infectious disease diagnosis and prevention with advantages such as accuracy, reliability, and precision, providing effective solutions for infectious disease diagnosis and prevention, and continuously promoting the high - quality development of the industry.”
天津大学生命科学学院院长叶生写道：“林毅志主导的专利，包括‘一种确定核酸扩增结果的方法’，‘一种突变重组逆转录酶及其制备方法’，‘一种自驱动微流体检测装置及其应用’，‘核酸扩增检测仪’，‘移液设备和核酸检测工作站’以及‘核酸产品及其应用’，已申请生产并进入市场，产生了巨大的商业利益。截至 2024 年 10 月，这些产品的总销售额超过 10 亿元。自发布以来，它们在传染病诊断和预防领域得到了广泛应用，具有准确性、可靠性和精确性等优势，为传染病的诊断和预防提供了有效的解决方案，并持续推动行业的高质量发展。”
Letters of support generally may not be sufficient to meet this criterion. Letters, though not without weight, cannot form the cornerstone of a successful extraordinary ability claim. USCIS may, in its discretion, use such letters as advisory opinions submitted by expert witnesses. However, USCIS is ultimately responsible for making the final determination of the petitioner’s eligibility (Matter of Caron, 19 I&N Dec. 791, 795 (Comm’r 1988)). Without documentation showing that the petitioner’s work has made original contributions of major significance to the field, USCIS cannot conclude this criterion has been met.
支持信通常可能不足以满足这一标准。尽管支持信有一定的分量，但不能成为成功的非凡能力申请的基石。USCIS 可以自行决定将这些信件视为专家证人的咨询意见。然而，USCIS 最终负责做出申请人资格的最终判断（Matter of Caron, 19 I&N Dec. 791, 795 (Comm’r 1988)）。如果没有证明申请人的工作对该领域做出了重大原创贡献的文件，USCIS 无法得出满足该标准的结论。
To assist in determining whether the petitioner’s contributions are original and of major significance in the field, the petitioner may submit:
为了帮助确定申请人的贡献是否在该领域中具有原创性和重大意义，申请人可以提交：
- Objective documentary evidence of the significance of the petitioner’s contribution to the field.
- 申请人对该领域贡献重要性的客观文献证据。
- Documentary evidence that people throughout the field consider the petitioner work important.
- 证明材料，表明该领域的人们认为申请人的工作很重要。
- Testimony and/or support letters from experts which discuss the petitioner’s contributions of major significance.
- 来自专家的证词和/或支持信，讨论申请人在重大贡献方面的贡献。
- Evidence that the petitioner’s major significant contribution(s) has provoked widespread public commentary in the field or has been widely cited.
- 证据表明申请人的重大贡献引发了该领域广泛的公众评论或被广泛引用。
- Evidence of the petitioner’s work being implemented by others. Possible evidence may include but is not limited to:
- 申请人工作被他人实施的证据。可能的证据包括但不限于：
- Contracts with companies using the petitioner’s products;
- 与使用申请人产品的公司签订合同；
- Licensed technology being utilized by others;
- 被他人使用的许可技术；
- Patents currently being used and shown to be significant to the field.
- 目前正在使用并被证明对该领域具有重要意义的专利。
Note: Letters and testimonies, if submitted, must provide as much detail as possible about the petitioner’s contribution and how and must explain, in detail, how the contribution was “original” (not merely replicating the work of others) and why it were of “major” significance. General statements regarding the importance of the endeavors which are not supported by documentary evidence are insufficient.
注意：如果提交信件和证词，必须尽可能详细地提供申请人贡献的相关信息，并详细解释该贡献是如何“原创”的（而不仅仅是复制他人的工作）以及为什么它具有“重大”意义。关于这些努力重要性的普遍陈述，如果没有文档证据支持，则是不够的。
Evidence that the petitioner has performed in a leading or critical role for organizations or establishments that have a distinguished reputation.
证据表明申请人在具有卓越声誉的组织或机构中担任过领导或关键角色。
The petitioner submitted the following evidence:
申请人提交了以下证据：
- Certificates of employment for Ustar Biotechnologies (Hangzhou) Ltd.; and
- Ustar Biotechnologies (Hangzhou) Ltd. 的雇佣证明；和
- Information about Ustar Biotechnologies (Hangzhou) Ltd.
- 关于 Ustar Biotechnologies (Hangzhou) Ltd.的信息
The plain language of this criterion requires evidence (1) that the petitioner performed a role for an organization or (2) that the petitioner’s role is/was leading or critical, and (3) that the petitioner’s role was for an organization or establishment with a distinguished reputation. The petitioner must satisfy all of these elements to meet the plain language requirements of this criterion.
该标准的简单语言要求提供证据：(1) 申请人为一个组织担任了角色，或 (2) 申请人的角色是/曾是领导或关键的，并且 (3) 申请人的角色是在一个声誉卓著的组织或机构中。申请人必须满足所有这些要素，以符合该标准的简单语言要求。
This criterion has not been met because the evidence does not indicate that the role the petitioner has performed for Ustar Biotechnologies (Hangzhou) Ltd. is/was leading or critical.
该标准未得到满足，因为证据并未表明申请人在 Ustar Biotechnologies (Hangzhou) Ltd.所担任的角色是/曾是领导或关键的。
Not every employee or capable service provider working for an organization meets the elements of this criterion. In general, a leading role is demonstrated by evidence of where a petitioner fits within the hierarchy and duties of an organization or establishment, while a critical role is demonstrated by evidence of her/his contributions to that he has held or establishment’s operational viability. Here the petitioner submitted evidence of the various titles evidence detailing his duties for Ustar Biotechnologies (Hangzhou) Ltd. However, the petitioner did not submit corroborating evidence.
并非每个为组织工作的员工或有能力的服务提供者都符合该标准的要素。一般来说，领导角色通过证据展示申请人在组织或机构中的层级和职责，而关键角色则通过证据展示他/她对所担任的职位或机构运营可行性的贡献。在这里，申请人提交了关于他在 Ustar Biotechnologies (Hangzhou) Ltd.的各种职称及其职责的证据。然而，申请人并未提交证实性证据。
To assist in determining that the petitioner has performed in a leading or critical role for Ustar Biotechnologies (Hangzhou) Ltd., the petitioner may submit:
为了帮助确定申请人在 Ustar Biotechnologies (Hangzhou) Ltd.中担任了领导或关键角色，申请人可以提交：
- Letters from current or former employer(s) or trainer(s) with personal knowledge of the significance of the petitioner’s leading or critical role.
- 来自当前或前雇主或培训师的信件，内容涉及对申请人领导或关键角色重要性的个人了解。
- The letters should contain detailed and probative information that specifically addresses how the petitioner’s role for the organization or establishment, or a division or department within the organization or establishment, is or was leading or critical. Details should include the specific tasks or accomplishments of the petitioner as compared to others who are employed in similar pursuits within the field of endeavor.
- 信件应包含详细且具有证明力的信息，具体说明申请人在组织或机构，或组织或机构内的一个部门或分部中的角色是或曾经是领导或关键的。细节应包括申请人与在该领域从事类似工作的其他员工相比的具体任务或成就。
- The letters should include the name, address, and title of the writer.
- 信件应包括写信人的姓名、地址和职称。
If letters from current or former employer(s) or trainer(s) with personal knowledge of the significance of the petitioner’s leading or critical role are unavailable, the petitioner may submit:
如果当前或前雇主或培训师的信件无法提供，且他们对申请人重要或关键角色的意义有个人了解，申请人可以提交：
- Documentary evidence to demonstrate how the petitioner’s role was/is leading or critical for the organizations or establishments or the division or department of an organization or establishment.
- 证明申请人角色在组织、机构或组织或机构的部门或分部中是/曾是领导或关键的文献证据。
- If a leading role, the evidence must establish that the petitioner is (or was) a leader. A title, with appropriate matching duties, can help to establish a role is (or was), in fact, leading within the organization or establishment, or a division or department thereof.
- 如果是领导角色，证据必须证明申请人是（或曾是）领导者。一个职称，配以适当的职责，可以帮助证明该角色在组织、机构或其下属的某个部门中确实是（或曾是）领导的。
- If a critical role, the evidence must establish that the petitioner has contributed in a way that is of significant importance to the outcome of the organization or establishment’s activities or the activities of a division or department within the organization or establishment. A supporting role may be considered “critical” if the petitioner’s performance in the role is (or was) important in that way. It is not the title of the petitioner’s role, but rather the petitioner’s performance in the role that determines whether the role is (or was) critical.
- 如果是关键角色，证据必须证明申请人在组织或机构的活动或组织或机构内某个部门的活动中以重要的方式做出了贡献。如果申请人在该角色中的表现（或曾经的表现）以这种方式重要，则支持角色可以被视为“关键”。决定角色是否是（或曾经是）关键的不是申请人的角色头衔，而是申请人在该角色中的表现。
As discussed above, the petitioner has not garnered a one - time achievement award or met at least three of the ten criteria. As such, USCIS is affording the petitioner the opportunity to submit additional evidence to establish that the petitioner meets the regulatory criteria. The response to this request should address the insufficiencies articulated by USCIS in this request.
如上所述，申请人未获得一次性成就奖或满足十项标准中的至少三项。因此，USCIS 给予申请人提交额外证据的机会，以证明申请人符合监管标准。对此请求的回应应针对 USCIS 在此请求中阐明的不足之处。
Additionally, meeting the minimum regulatory criteria outlined above, alone will not establish eligibility for the E11 immigrant classification. Any evidence submitted in response to this request, should also articulate how the evidence establishes that the petitioner possesses the required high level of expertise for the E11 immigrant classification.
此外，仅满足上述最低监管标准并不能确立 E11 移民分类的资格。任何针对该请求提交的证据还应阐明这些证据如何证明申请人具备 E11 移民分类所需的高水平专业知识。
This is the petitioner’s opportunity to articulate further details or provide additional evidence in regards to how the evidence submitted in the initial filing or in response to this Request for Evidence establishes that the petitioner meets the requirements regarding the required high - level of expertise for the immigrant classification.
这是申请人进一步阐述细节或提供额外证据的机会，以说明在初始申请或对此证据请求的回应中提交的证据如何证明申请人符合移民分类所需的高水平专业知识的要求。
Establishing eligibility for the high - level of expertise required for the E11 immigrant classification is based on the petitioner possessing:
确定符合 E11 移民分类所需的高水平专业知识的资格，基于申请人具备：
- Sustained national or international acclaim.
- 持续的国家或国际赞誉。
- In determining whether the petitioner has enjoyed “sustained” national or international acclaim, such acclaim must be maintained. A petitioner may have achieved extraordinary ability in the past but then failed to maintain a comparable level of acclaim thereafter; and,
- 在确定申请人是否享有“持续”的国家或国际声誉时，这种声誉必须得到维持。申请人可能在过去取得了非凡的能力，但随后未能维持相应的声誉水平；并且，
- Achievements that have been recognized in the field of expertise, indicating that the petitioner is one of that small percentage who has risen to the very top of the field of endeavor.
- 在专业领域内获得认可的成就，表明申请人是那小部分已达到该领域顶尖水平的人。
In conclusion, when ultimately making a final decision regarding eligibility, USCIS will first evaluate the evidence submitted by the petitioner to determine which regulatory criteria the petitioner meets in part one of the analysis. If the petitioner establishes that the petitioner has received a one - time achievement (a major internationally recognized award) or meets at least three of the antecedent evidentiary prongs, then USCIS will evaluate all of the evidence in the record to make a final merits determination as to whether or not the petitioner, by a preponderance of the evidence, has demonstrated that the petitioner has sustained national or international acclaim and that the petitioner’s achievements have been recognized in the field of expertise, indicating that the petitioner is one of that small percentage who has risen to the very top of the field of endeavor.
总之，在最终做出关于资格的最终决定时，USCIS 将首先评估申请人提交的证据，以确定申请人在分析的第一部分中符合哪些监管标准。如果申请人证明其获得了一次性成就（一个主要的国际认可奖项）或至少满足三个前提证据标准，则 USCIS 将评估记录中的所有证据，以最终确定申请人是否通过证据的优势证明其在国家或国际上获得了声誉，并且申请人的成就已在专业领域得到认可，表明申请人是那小部分在其领域中脱颖而出的人。
This is the petitioner’s opportunity to meet his legal burden of proof to establish eligibility in all respects. Whenever any person makes an application for an immigration benefit, he shall bear the burden of proof to establish eligibility for the benefit sought. Therefore, the petitioner must prove, by a preponderance of the evidence, in other words, that it is more likely than not, that the petitioner is fully qualified for the benefit sought. Accordingly, the decision will be based on the initial evidence submitted upon filing and all additional evidence submitted in response to this request.
这是申请人的机会，以满足其法律证明责任，确立在各方面的资格。每当任何人申请移民福利时，他应承担证明责任，以确立所寻求福利的资格。因此，申请人必须通过证据的优势来证明，换句话说，证明申请人更有可能符合所寻求的福利资格。因此，决定将基于提交申请时的初始证据以及对此请求所提交的所有额外证据。
PLACE THE ATTACHED COVERSHEET AND THIS ENTIRE LETTER ON TOP OF YOUR RESPONSE. SUBMISSION OF EVIDENCE WITHOUT THE COVERSHEET AND THIS LETTER WILL DELAY PROCESSING OF YOUR CASE AND MAY RESULT IN A DENIAL.
请将附加的封面页和整封信放在您的回复顶部。提交证据时如果没有封面页和这封信，将会延迟您案件的处理，并可能导致拒绝。
Sincerely,
诚挚地，
Mary Elizabeth Brennan Seng
玛丽·伊丽莎白·布伦南·森
Director, Texas Service Center
主任，德克萨斯服务中心
Officer: XM2272
官员：XM2272