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 .
Applicant’s amendment filed 10/14/2025 is acknowledged. New Claims 8-10 are added.
The amended Claims 1-10, filed 10/14/2025 are under examination on the merits.
Response to Arguments -- Summary
Applicant’s arguments, see pp. 2-4, & 7-10, filed 10/14/2025, with respect to objections to the claims, specification, and drawings, and rejections under 35 U.S.C. §§102 & 103 have been fully considered and are persuasive. The objections to the claims, drawings, and specification, and rejections under 35 U.S.C. §§102 & 103 have been withdrawn.
Applicant’s amendment to claim 7 necessitated a new ground of rejection under 35 U.S.C. §112(b), and a new objection to the specification. See below.
Applicant's arguments filed pp. 4-7 regarding the rejection under 35 U.S.C. §112(a) has been fully considered but they are not persuasive. See below.
Rejections Removed
The previous objections and rejections that are hereby withdrawn due to Applicant’s amendment filed 10/14/2025:
Claim objections: claims 2-6.
Drawings.
Specification.
35 U.S.C. §102: claims 1-4 and 7 as being anticipated by Qiu, et al. (Virus Res. 2009 Dec;146(1-2):58-65. doi: 10.1016/j.virusres.2009.08.011. Epub 2009 Sep 2).
35 U.S.C. §103: claims 5 and 6 as being as being unpatentable over JP2008122372A (published 5/29/2008, hereinafter referred to as “’372”; machine translation provided due to original document being in Japanese language) in view of Qiu (supra).
Maintained Rejections
Claim Rejections - 35 USC § 112
(Previous Rejection Maintained and New Claims 8-10 Added) Claims 1-10 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’s arguments: Applicants have amended the claims to require antigen-antibody binding to specifically identified amino acid regions of SEQ ID NO: 1. These discrete regions are expressly disclosed and experimentally mapped in the spec. The amended claims therefore track the structural features that the application actually exemplifies, rather than attempting to cover antibodies binding anywhere within the entire 21-944 sequence. This narrowing makes the claim scope commensurate with the disclosure and resolves the Examiner’s earlier concern about an unduly expansive genus.
The application describes not only the existence of antibodies against adenovirus hexon, but also their specific reactivity with precise epitopes. This disclosure establishes a representative number of species supporting the now-limited genus.
The disclosure demonstrates possession of antibodies defined by binding to the recited epitope sequences. The spec. (1) identifies the exact peptide sequences, (2) shows immunoassay results for antibodies raised, purified, and tested against those sequences, and (3) reports distinct binding sensitivity and specificity for the exemplified antibodies (Table 1). This correlation between structure (the defined epitope sequences) and function (antigen binding) provides direct evidence that the inventors were in possession of the claimed antibodies at the time of filing. As the Federal Circuit has recognized, written description is satisfied when the spec. “particularly point[s] out and distinctly circumscribe[s] the outer boundaries of the claimed invention.” AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). Here, the claims establish clear structural boundaries by identifying specific amino acid sequences to which the antibodies must bind, and by defining their use in standard immunoassay formats. The combination of defined epitopes and conventional assay context provides a sufficiently precise definition that allows an ordinary artisan to identify the antibodies falling within the scope of the claims. Moreover, monoclonal antibody generation is a well-developed and predictable field. Here, the spec.’s disclosure of precise epitope sequences, coupled with the maturity and predictability of antibody generation techniques, provides ample descriptive support for the claimed antibodies.
It is submitted that the Examiner has not given appropriate weight to the “underlying science” of the technology to which the application relates. It is submitted that because the “underlying science” at issue in this case (the production of such antibodies) is decades old and when appropriate weight is given to the underlying science, the evidence weighs heavily in favor of written description support. In Invitrogen Corp. v. Clontech Laboratories, Inc., 429 F.3d 1052, 1073 (Fed. Cir. 2005), the court upheld written description where representative sequences were known and no contrary evidence was presented. Similarly, the record here contains no evidence that, as of the filing date, a skilled artisan would have found the disclosure insufficient to describe monoclonal antibodies binding the identified epitope sequences that function in standard immunoassays. Accordingly, the spec. demonstrates possession of the claimed antibodies by correlating experimental binding data with specifically identified epitope sequences, and by enabling the skilled artisan to recognize the structural and functional boundaries of the invention without undue uncertainty.
Distinguishing Amgen v. Sanofi—the Supreme Court’s decision in Amgen v. Sanofi addressed genus claims to antibodies defined solely by function—blocking PCSK9-LDL receptor binding—without structural limitations or exemplified epitopes. The present claims are fundamentally different. The antibodies here are structurally anchored: they require binding to defined epitope sequences within SEQ ID NO: 1 that were expressly mapped and tested in the spec. The disclosure thus provides the necessary structure-function correlation to demonstrate possession of the claimed subject matter. The claims do not attempt to encompass all antibodies that bind adenovirus hexon, but are confined to those that bind the specifically identified epitope regions that were empirically determined and disclosed. The clear structural definition of the binding regions distinguishes these claims from the purely functional genus claims at issue in Amgen.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
The rejection of Claims 1-10 under 35 U.S.C. §112(a) for inadequate Written Description is appropriate. Ultimately, Applicant has narrowed the regions of SEQ ID NO: 1 with which the claimed antibodies or antigen-binding fragment thereof undergo antigen-antibody reaction with, but has not provided structural information of the antibodies or antigen-binding fragments thereof.
Applicant’s arguments about structure are not persuasive, because they contemplate structure of the target polypeptide, rather than the structure of the claimed antibodies themselves. Rather than providing structure of the claimed antibody or antigen-binding fragment thereof, the disclosure provides information regarding the target polypeptide with which the claimed antibodies undergo antigen-antibody reaction with. Notably, the disclosure does not provide structural information (such as CDR or variable chain sequence) of the claimed antibodies themselves. The structural boundaries of the claimed antibodies remain unclear. The claimed antibodies are not structurally anchored because they have no specific structures recited at all such as CDRs. Rather, they are defined only by function. That the function includes a structure such as an epitope is of no moment as it is still definition by function and not antibody structure. Possession of the peptides (epitopes) is not the same as possession of the antibody genus/genera and Applicant’s arguments are not commensurate in scope (because they are antibodies not peptides) with the claims, and conflict with the caselaw, as previously described in the rejection under 35 U.S.C. §112(a). Contrary to what Applicant argues, correlating experimental binding data with specifically identified epitope sequences does not provide structural information related to the claimed antibodies themselves. The specification’s (1) identification of the exact peptide sequences, (2) immunoassay results for antibodies raised, purified, and tested against those sequences, and (3) reported binding sensitivity and specificity for the exemplified antibodies (Table 1) also is insufficient to provide a structural anchor.
Although the underlying science of the process of making antibodies may be understood and predictable, that is not particularly persuasive in the instant case, because the rejection is for lacking adequate written description, rather than enablement—the argument is off-point. Similarly, even if the claims are definite under 35 U.S.C. §112(b), that does not mean that written description is met.
New Objection
Specification
(New Objection) The amended specification appears to have a typographical mistake in paragraph [0056], line 11, where it recites “Pepstars” rather than “Pepstar”. Appropriate correction is required.
New Rejections
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 applicant regards as his invention.
(New Rejection Necessitated by Amendment) Claims 7, 9, and 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.
Claim 7 encompasses “[a]n immunoassay device for adenovirus, comprising the monoclonal antibody or the antigen-binding fragment thereof, which undergoes antigen-antibody reaction with a polypeptide having at least one sequence selected from the group consisting of: the region of the 56th to 70th amino acids, the region of the 316th to 330th amino acids, the region of the 536th to 560th amino acids, the region of the 656th to 670th amino acids, the region of the 776th to 795th amino acids, and the region of the 911th to 925th amino acids.” However, claim 7 does not include a reference sequence for the claimed polypeptide or its amino acid regions.
Claim 7 recites the limitations "the monoclonal antibody" and “the antigen-binding fragment” in line 2. There is insufficient antecedent basis for these limitations in the claim. Claims 9 and 10 depend from claim 7 and are also indefinite due to lack of antecedent basis for the limitations "the monoclonal antibody" and “the antigen-binding fragment” that are present in claim 7.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671