Prosecution Insights
Last updated: May 04, 2026
Application No. 18/380,834

KHL POLYPEPTIDE, AND USE THEREOF IN PREPARATION OF TABP-EIC CELL

Non-Final OA §102§112
Filed
Oct 17, 2023
Priority
Jul 14, 2021 — CN 202110797551.5 +1 more
Examiner
EDGINGTONGIORDANO, FRANCESCA
Art Unit
1643
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Allife Medicine (Zhuhai) Limited
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
1y 0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
70 granted / 95 resolved
+13.7% vs TC avg
Strong +31% interview lift
Without
With
+30.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
39 currently pending
Career history
134
Total Applications
across all art units

Statute-Specific Performance

§101
3.6%
-36.4% vs TC avg
§103
28.7%
-11.3% vs TC avg
§102
16.1%
-23.9% vs TC avg
§112
24.3%
-15.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 95 resolved cases

Office Action

§102 §112
DETAILED ACTION 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. Claim Status Claim s 1-11 as filed on 17 October 2023 are pendin g and under examination. Priority Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 07/14/2021 . It is noted, however, that applicant has not filed a certified copy of the CN202110797551.5 application as required by 37 CFR 1.55. No certified copy has been received and the filing receipt states No Access Code was Provided. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Claims 2 and 3 have an amino acid linker sequence without a SEQ ID NO: as well as the specification. Examiner notes the linker sequence GGGS is in SEQ ID NO: 5 and could be identified by amino acid position in that sequence. Claim Rejections - 35 USC § 112 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 appl icant regards as his invention. Claims 1-11 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. Claim 1 contains the term “KHL peptide” . The art provides no definition or examples of a KHL peptide. In view of the specification and sequence listing applicant appears to be referring to the first 3 amino acids of the sequence of SEQ ID NO: 1 which was used to identify the peptide sequence studied. The specification does not provide a definition and the art provides no definition or examples . As neither the specification nor the art provides a definition of a KHL peptide, the metes and bounds of the term and the claim are unclear. This renders the term and the claim indefinite. Claims 2-11 inherit this deficiency. Claim 1 was examined as “a peptide” that binds PSMA. Claim 3 allows for “a peptide” that binds PSMA or binds “a tumor antigen binding peptide” and was examined as such. Regarding claim 2, the claim repeatedly recites the limitation of an amino acid sequence (hinge/transmembrane domain/intracellular domain) selecting a species of that domain. It is unclear how a sequence could select a species of its genus. The claim was examined as the molecule comprising a CD8 α hinge of SEQ ID NO: 11, a 2B4 transmembrane domain of SEQ ID NO: 3, and a primary signal transduction domain of NKG2D of SEQ ID NO: 4. The limitation of a signal peptide recited in lines 25-26 are non-limiting. The indefinite language of claim 2 is repeated in claim 3. Regarding claim 3, claim 3 recites “an application of a KHL peptide . . .”. It is unclear what an application of a peptide is , rendering the claim indefinite. The claim was examined in view of its last 4 lines as a method of detecting PSMA. Dependent claims 4-11 would then be examined as “The method of claim 3,”. Regarding claim 6, the claim recites host cells and lists viruses. Viruses cannot be host cells as they are not cells. This renders the claim indefinite. 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 1-3 and 5-11 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. MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or it may be satisfied by the disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. “Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species. Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010). Scope of the Claimed Genus Claim 1 is to a peptide that binds to PSMA wherein the peptide is one of the following: SEQ ID NO: 1; A sequence derived from SEQ ID NO: 1; At least 90 % identity of SEQ ID NO: 1. This peptide is fused to a fluorescent molecule of FITC. There is no limiting definition in the specification or claim for derived meaning subpart 2 allows for any sequence of the peptide that binds PSMA. Subpart 3 allows for 1 amino acid substitution in SEQ ID NO: 1 meaning any amino acid in the sequence can be changed. Claim three further is to a peptide that binds PSMA or a tumor antigen binding peptide. This allows for peptides that do not bind PSMA. Claims 2-3 and 5-11 include any of the peptides of claim 1. The claims would include any type of protein with any amino acid sequence or length. Summary of Species Disclosed in the original specification The applicant describes 1 peptide that binds PSMA which is instant SEQ ID NO: 1 (Example 1 in particular [00161]-[00162]). State of the Relevant Art Prostate-specific membrane antigen (PSMA) is a 750 amino acid glycoprotein highly expressed in malignant prostrate tissues. PSMA can be detected using antibodies that bind a variety of epitopes ( Tino et. al. Hybridoma. 19(3):249-257. (2000) (PTO-892)) (Abstract). Tino teaches the preparation of over 30 anti-PSMA monoclonal antibodies (page 255 in col 2 in par 2). Peptide s consists of a polypeptide backbone with attached side chains (Albert. Et. al. Molecular Biology of the Cell. 4 th Edition. Shape and Structure of Proteins. (2002) (PTO-892) (Figure 3-2). The activity of peptides including binding is from the shape and structure of the protein which comes from it amino acid sequence which determine the formation of weak noncovalent bonds including hydrogen bonds, ionic bonds, and van der Waals attractions between the atoms of the polypeptide backbone and the amino acids of the side chains ( page 1 in par 3 and page 2 in par 2) . The folding of the protein is determined by its amino acid sequence and this confirmation determines protein shape and activity (page 3 in par 1 and Figure 3-8). Proteins in stable conformations have useful properties with these structures determine the classification which have shared activity (page 7 in par 4-5). Sequence homology can be used to identify proteins that share activity (page 9 in last 2 paragraphs and page 10 in par 1). But it has been shown that mutations to amino acids can change the confirmation and activity of proteins (page 10 in par 2-4). The art clearly teaches that peptide activity comes from its amino acid sequence determining its structure and peptide type. One of skill in the art would not consider the function of binding a target with no sequence or structure limitations as descriptive of a peptide. Are the disclosed species representative of the claimed genus? MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The specification disclose s one species of peptide capable of binding PSMA. Given the variability encompassed by the genu s of a peptide of any type and any sequence that binds PSMA described species cannot be considered representative of the genus. Identifying characteristics and structure/function correlation In the absence of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics; i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe structural features that the skilled artisan as of the effective filing date would have expected to convey the claimed binding activity. The applicant has required no core sequence or structure providing no structure that provides the required function of binding PSMA. Conclusion: For all of the reasons presented above, one of skill in the art would not know which of the countless other compositions encompassed by the claims that meet the highly general structural requirements of the claims would also possess the required functional activity . Therefore, the skilled artisan would not reasonably conclude that the inventors had full possession of compositions as broadly claimed at the time the application was fi led . Given the lack of shared structural properties that provide the claimed binding activity, the limited number of species described, and the fact that the species that were described cannot be considered representative of the broad genus, Applicant was not in possession of the invention as claimed. The activity of a peptide comes from its structure which is from its amino acid sequence. One of skill in the art would not consider the applicant as in possession of any peptide that binds PSMA. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tino et. al. Hybridoma. 19(3):249-257. (2000) (PTO-892). Claim 1 requires a peptide that binds PSMA that is conjugated to a fluorescent molecule detectable marker that is FITC. The claim has no limit on the sequence peptide in subpart (2). Tino teaches multiple antibodies that bind PSMA including 1G9, 3C6, and 4D4 (abstract) and Tino teaches the conjugation of these antibodies to FITC (page 251 in col 2 in par 2). Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yin (CN113402590A) (PTO-892). Regarding claim 1, Yin teaches a peptide that binds PSMA comprising SEQ ID NO: 1 which matches instant SEQ ID NO: 1 and is conjugated to FITC (claim 1). Regarding claim 2, Yin teaches a peptide that binds PSMA comprising 3 repeats of SEQ ID NO: 1 linked by a linker of GGGS, a CD8 α hinge of SEQ ID NO: 11, which matches instant SEQ ID NO: 11, a transmembrane domain of SEQ ID NO: 2, which matches instant SEQ ID NO: 2, a signaling domain of NKG2D of SEQ ID NO: 4, which matches instant SEQ ID NO: 4 (claim 2). Regarding claims 3 and 8, Yin teaches contacting a sample with the peptide and detecting PSMA (claims 8 and 10). Regarding claim 4. Yin teaches a DNA molecule encoding the PSMA binding peptide of claim 1 and further teaches SEQ ID NO: 10 which matches instant SEQ ID NO: 10 (claim 3). Regarding claim 5, Yin teaches a vector comprising the molecule (claim 4). Regarding claim 6, Yin teaches a e. coli host cell comprising the peptide of claim 1 (claim 5). Regarding claim 7, Yin teaches a pharmaceutical composition comprising the peptide of the instant claim 2 and pharmaceutically acceptable immunomodulators (claim 6). Regarding claim 9, Yin teaches a method of making the host cell by introducing the DNA that encodes the peptide of the invention (claim 7). Regarding claims 10-11, Yin teaches the kit comprising the reagents of the invention and instruments or devices for detecting PSMA (claim 8). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT FRANCESCA EDGINGTON-GIORDANO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8232 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon - Fri 8:00 - 5:00 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Julie Wu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-5205 . 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. /F.E./ Examiner, Art Unit 1643 /Meera Natarajan/ Primary Examiner, Art Unit 1643
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Prosecution Timeline

Oct 17, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §102, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+30.7%)
3y 6m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 95 resolved cases by this examiner. Grant probability derived from career allowance rate.

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