Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 8/31/2022 wherein the abstract, specification and claims 1, 3-5, 9, and 10 were amended and claims 6 and 7 were canceled.
Note(s): Claims 1-5 and 8-10 are pending.
Priority and Priority Document
This application is a 371 of PCT/CN2021/087714 filed 4/16/2021 which claims benefit to CHINA CN202110380740.2 filed 4/9/2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy has been filed in with the pending application on 8/31/2022.
While a certified copy or copies of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to provide the certified translation may result in no benefit being accorded for the non-English document.
Note(s): The earliest effective filing date is 4/16/2021 as explained supra, an English translation of the prior document is not of record to ascertain whether or not the pending invention is fully supported in the priority document.
Claim Interpretation
Independent claim 1 is directed to a non-antibody binding peptide or analogs thereof dual-targeting to PD-1 and PD-L1, wherein the non-antibody binding peptide comprises a backbone and at least one side chain linked to the backbone, wherein an amino acid sequence of the side chain is SEQ ID NO 3, and an amino acid sequence of the backbone is at least one of SEQ ID NO 1, SEQ ID NO 2, and SEQ ID NO 7.
Claim 8 is directed to a preparation comprising the non-antibody binding peptide or analogs thereof of claim 1 wherein the preparation is a drug or a cell marker reagent.
Claim 9 is directed to a diagnosis raging comprising the non-antibody binding peptide or analogs of claim 1.
Claim 10 is directed to an immunoregulation drug or an antitumor drug comprising the non-antibody binding peptide analogs of claim 1.
Applicant’s Election
Applicant's election with traverse of Group I (pending claims 1 and 8-10) filed 3/24/2026 is acknowledged. The traversal is on the grounds that there is not a serious burden to search all the pending claims. This is found non-persuasive because Group II is distinct from that of Group I. Specifically, an polynucleotide that encodes a peptide is a different distinct product from that of the actually peptide that is generated. Thus, the invention encompasses multiple distinct products. Hence, the restriction requirement is still deemed proper and is therefore made FINAL.
Applicant elected the species wherein nABP486 is the non-antibody binding peptide comprising SEQ ID NO 2 and SEQ ID NO: 3. Applicant elected species was searched and no prior art was found to reject the claims. Thus, the full scope of Group I was searched.
Withdrawn Claims
Claims 2-5 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement filed 8/31/2022 was considered.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to drug components, cell marker and diagnostic reagents components, immunoregulation drug components, and antitumor drug components that are present/utilized to generate immunoregulation drugs, antitumor drugs, drugs in general, diagnostic reagents, and cell marker reagents. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 8-10: Independent claim 1 is ambiguous because it is unclear what analogs Applicant is referencing that are compatible with the pending invention. In particular, it is unclear what portion of the parent structure is present in the analog(s). The peptide of the pending invention comprises a backbone containing at least one of SEQ ID Nos 1, 2, or 7 and a side chain of SEQ ID NO 3. Is the analog(s) a derivative of SEQ NO 1, 2, 3, or 7 or a combination of all the sequences that form the peptide? Since claims 8-10 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claims 8-10: The claims each indicated that they are a different entity from that of claim 1 (e.g., a preparation (drug or cell marker reagent), diagnosis reagent, and a drug (immunoregulation or antitumor)), but do not include any additional components other than the peptide of independent claim 1. Thus, it is unclear how one is , for example, generating cell marker or diagnosis reagents absent a cell marking or diagnostic agent being present. In addition, it is unclear how one is generating an immunoregulation or antitumor drug absent identifying components that have those properties in the claims. In other words, it is unclear what components Applicant is intended to include and exclude that make the preparation a drug, cell marker reagent, diagnostic reagent, immunoregulating drug, or antitumor drug when only the sequences are present.
Comments/Notes
It should be noted that no prior art is cited against the pending claims. However, Applicant must address and overcome the 112 rejections above. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious a peptide comprising at least one of SEQ ID NOs: 1, 2, or 7 in combination with SEQ ID NO: 3.
Conclusion
Claims 1 and 8-10 are rejected. Claims 2-5 are withdrawn from consideration.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
March 28, 2026
Prosecution Insights