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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6) and the species listed below in the reply filed on 11/12/2025 is acknowledged. It is noted that new claims 11-12 fall under Group III and new claims 13-14 fall under Group IV, which are nonelected inventions.
Elected Species:
CDRH1, CDRH2, and CDRH3 corresponding to SEQ ID NOs: 1-3, respectively;
LCDR1, LCDR2, and LCDR3 corresponding to SEQ ID NOs: 4-6, respectively;
Heavy chain variable region corresponding to SEQ ID NO: 7; and
Light chain variable region corresponding to SEQ ID NO: 8.
Claim Status
Claims 3-10 have been amended; and, claims 11-14 have been newly added, as requested in the amendment filed on 11/12/2025. Following the amendment, claims 1-14 are pending in the instant application.
Claims 7-14 stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions in the Response filed 11/12/2025, there being no allowable generic or linking claim.
Claims 1-6 are under examination in the instant office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, it is noted that the claim to foreign priority has not been perfected as no English translation of the foreign priority document has been provided.
Claims 1-6 have an effective filing date of October 13, 2022 corresponding to PCT/CN2022/125196.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/13/2023, 04/17/2023, and 08/13/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the terms Tween, Brij, Triton, and Pluronic (surfactants), for example, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: the specification currently recites "SEQ ID NO: 5", however, SEQ ID NO:5 is indicated as "000" in the sequence listing. Applicants must delete reference to the SEQ ID NO and spell out the sequence in the specification. Appropriate correction is required.
Claim Interpretation
It is noted that claims 1-4 recite the language of “an amino acid sequence as set forth in…”. It is noted that this claim language as pertains to the recited CDR, heavy chain variable, and light chain variable sequences is being interpreted as open sequence claim language, wherein either the full-length sequences or fragments thereof (e.g., an amino acid sequence comprised therein that is at least two consecutive amino acids in length) satisfy the sequence limitations.
Art-Free Subject Matter
It is noted that the elected antibody species comprising full-length: CDRH1, CDRH2, and CDRH3 corresponding to SEQ ID NOs: 1-3, respectively; LCDR1, LCDR2, and LCDR3 corresponding to SEQ ID NOs: 4-6, respectively; heavy chain variable region corresponding to SEQ ID NO: 7; and light chain variable region corresponding to SEQ ID NO: 8 has been thoroughly searched, and both the set of CDRs and the corresponding heavy chain and light chain variable regions are free of the prior art.
The closest prior art made of record but not relied upon is CN 112442116 (herein after referred to as “Xu”; published 03/05/2021; Foreign Reference citation #2 on 02/13/2023 IDS; machine translation of the description provided). Xu discloses a micropeptide HMMW obtained by encoding human lncRNA, and a recombinant vector constructed to enable target cells to highly express the micropeptide; the micropeptide can inhibit proliferation and migration of various solid tumors (Abstract). However, Xu neither teaches nor suggests an antibody that binds to a human HMMW micropeptide, and as such Xu does not teach, suggest, or render obvious the instantly elected antibody species that binds to a human HMMW micropeptide.
Claim Objections
Claims 1-2 are objected to because of the following informalities: the claims currently recite "SEQ ID NO: 5", however, SEQ ID NO:5 is indicated as "000" in the sequence listing. Applicants must delete reference to the SEQ ID NO and spell out the sequence in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-6 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.
The claims are drawn to an antibody that specifically binds to a human HMMW micropeptide, wherein said antibody comprises a heavy chain variable region (VH); wherein: the VH comprises HCDR1, HCDR2 and HCDR3 with amino acid sequences as set forth in SEQ ID NOs: 1-3, respectively, and a light chain variable region (VL); wherein: the VL comprises LCDR1, LCDR2 and LCDR3 with amino acid sequences as set forth in SEQ ID NOs: 4-6, respectively.
Thus, the claims identify the antibody by the function of binding a human HMMW micropeptide, and a partial sequence structure that comprises HCDRs1-3 and LCDRs1-3 with any amino acid sequence as few as two consecutive amino acids as set forth in SEQ ID NOs: 1-3 and 4-6, respectively. Thus, the claims encompass a vast genus of antibody variants comprising variable HCDR1-3 and LCDR1-3 sequences and are required to bind a human HMMW micropeptide.
The instant specification discloses eight structurally distinct murine antibodies that bind a human HMMW micropeptide (see Table 1; reproduced below).
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Thus, the instant specification discloses making eight structurally distinct murine antibodies and describes the complete HCDR1-3, LCDR1-3, VH, and VL sequences the eight antibody species, that all function to bind a human HMMW micropeptide. The specification fails to disclose any other HCDR1-3, LCDR1-3, VH, and VL sequence variants having as few as two consecutive amino acids found in SEQ ID NOs: 1-3 and 4-6 that possess the function of binding to a human HMMW micropeptide.
To provide adequate written description and evidence of possession of the claimed antibody genus, the instant specification can structurally describe representative antibody variants that function to bind a human HMMW micropeptide, or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.).
In this case, the only factor present in the claims is a recitation of the antibody function, “specifically binding to a human HMMW micropeptide”, and partial sequence structure as stated above. The instant specification fails to describe structural features common to the members of the antibody genus, which features constitute a substantial portion of the genus because the instant specification fails to disclose representative antibody variant sequences that function as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the antibody does, rather than what it is. Other than for the antibodies disclosed in Table 1, the specification fails to provide the HCDR1-3, LCDR1-3, VH, and VL sequence structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of antibody sequence variants for the genus of antibodies that function as claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to make the claimed antibodies.
The claims broadly encompass any sequence variant having as few as two amino acids from HCDRs1-3 and LCDRs1-3 with any amino acid sequence as few as two consecutive amino acids as set forth in SEQ ID NOs: 1-3 and 4-6, respectively, that functions to bind a human HMMW micropeptide. Applicants have not established any reasonable structure-function correlation with regards to the sequences in the CDRs that can be altered and still maintain human HMMW micropeptide binding function. Given the well-known high level of polymorphism of antibody CDR sequences and structure, the skilled artisan would not have been in possession of the vast repertoire of antibodies encompassed by the claimed invention. One could not reasonably or predictably extrapolate the structure of a single antibody comprising HCDRs1-3 and LCDRs1-3 with amino acid sequences as set forth in SEQ ID NOs: 1-3 and 4-6, respectively, to the structure of any variants required to bind a human HMMW micropeptide as broadly claimed. Therefore, one could not readily envision members of the broadly claimed genus.
Although Applicants may argue that it is possible to screen for antibodies that bind a human HMMW micropeptide and function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future antibodies yet to be discovered that may function as claimed. The HMMW antigen provides no information about the structure of an antibody that binds to it.
Given the lack of representative examples to support the full scope of the claimed variant antibodies, and lack of reasonable structure-function correlation with regards to the unknown variable sequences in the CDRs that provide human HMMW micropeptide-binding function, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of antibody variants that bind a human HMMW micropeptide and comprise as few as two defined consecutive amino acids in each CDR from SEQ ID NOs: 1-3 and 4-6 that is required to practice the claimed invention.
Examiner Suggestion: Examiner suggests amending claim 1 to recite the specific CDR combinations adequately described by the instant specification and replacing the “an amino acid sequence as set forth in” language with “the amino acid sequence as set forth in”.
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 1-6 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1 and 3-4 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claims are drawn to thousands of possible CDR combinations and over 50 possible combinations of variable heavy chain/variable light chain combinations wherein the CDRs comprised by such combination differ in structure (i.e., sequence) wherein a "single structural similarity" conferring the ability to bind a human HMMW micropeptide is not shared across all possible combinations.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Conclusion
Claims 1-14 are pending. Claims 7-14 are withdrawn. Claims 1-6 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/Laura B Goddard/Primary Examiner, Art Unit 1642