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 the invention of Group II, drawn to a monoclonal antibody reactive with a C-terminus biomarker having the amino acid sequence PMKTMKGPFG (SEQ ID NO: 1) in the reply filed on 12/30/2025 is acknowledged.
Claims 1-19 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Claims 20-21 and 23-25 are examined on the merits in the present Office Action.
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 20 and 23-25 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.
Claims 20 and 23 do not disclose the amino acid sequences of six non-degenerate CDRs for the genus of monoclonal antibodies specifically reactive with a C-terminus biomarker having the amino acid sequence PMKTMKGPFG (SEQ ID NO: 1). Claims 24 and 25, which depend from claim 23, fail to cure the deficiencies of claim 23 and are thus also rejected.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or 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 genus (MPEP 2163).
In The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F. 3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the court also noted:
“A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin [e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.”
The court has further stated that “Adequate written description 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.” Id. at 1566, 43 USPQ2d at 1404 (quoting at 1171, 25 USPQ2d at 1606). Also see (CAFC 2002). Enzo-Biochem v. Gen-Probe Fiers, 984 F.2d 01-1230.
It is well-known in the art that, in order to bind antigen, an antibody or antigen-binding fragment must have six complementarity defining regions (CDRs) (Janeway, see selection, in particular section 3-6) (Janeway, Charles A. "Immunobiology: The Immune System in Health and Disease." 2001). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chain, and not either alone, that determines the final antigen specificity. As presently written, however, claims 20 and 23 do not disclose the amino acid sequences of six non-degenerate CDRs for the genus of monoclonal antibodies that are specifically reactive with a C-terminus biomarker having the amino acid sequence PMKTMKGPFG (SEQ ID NO: 1) derived from collagen XVI alpha 1 (COL16A1) (see Para. 0053 of the Specification). While Applicant has provided an example of an anti-COL16A1 antibody reactive against the amino acid sequence PMKTMKGPFG (SEQ ID NO: 1) (see, e.g. Para. 0056), such disclosure does not adequately represent the structural diversity of the claimed genus of monoclonal antibodies that are specifically reactive with the recited C-terminus biomarker. Without further testing, artisans would not be able to readily identify the structure of monoclonal antibodies that are specifically reactive against the amino acid sequence PMKTMKGPFG (SEQ ID NO: 1).
Therefore, the claimed genus of anti-COL16A1 monoclonal antibodies lacks adequate written description because there does not appear to be any correlation between the structure of the claimed monoclonal antibodies and the function of binding to a C-terminus biomarker having the amino acid sequence of PMKTMKGPFG (SEQ ID NO: 1). Thus, one of ordinary skill in the art would reasonably conclude that the applicant was not in possession of the full breadth of the claimed genus of anti-COL16A1 monoclonal antibodies at the time the instant application was filed.
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.
Claims 20 and 23-25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hackney et al (US20160178644A1), hereinafter Hackney.
Hackney teaches assay kits for use in methods of diagnosing inflammatory bowel disease – such as ulcerative colitis or Crohn’s disease (fibrotic/fibrostenotic) – in a subject comprising at least one reagent or probe for specifically detecting a biomarker protein, wherein the probe is/can be detectably labeled and the biomarker protein is COL16A1 (Abstract, Para. 0013, 0118, 0301-0302, and Claims 1, 5, 7, and 8). For diagnostic applications, an antibody can be used for the detection of an antigen of interest (e.g. the biomarker COL16A1) in a biological sample. The antibody is typically labeled with a detectable moiety such as a radioisotope, fluorescent tag, enzyme-substrate label such as horseradish peroxidase (HRP) (Para. 0269-0273). Alternatively, the label is indirectly conjugated to the antibody. For example, the antibody can be conjugated with biotin and any of the aforementioned labels can be conjugated with avidin. Biotin binds selectively to avidin and thus the label can be conjugated to the antibody indirectly (Para. 0279). In yet another embodiment, the antibody can be detected using a labeled antibody (secondary antibody) which binds to the antibody (Para. 0280). The term “antibody” includes monoclonal antibodies (Para. 0055). The instant claims encompass monoclonal antibodies that bind to any epitope present in COL16A1, which comprises the amino acid sequence of SEQ ID NO: 1. The term “having”, which is synonymous with “comprising”, is inclusive or open-ended and does not exclude additional, unrecited elements (see MPEP 2111.03). In other words, the phrase “a C-terminus biomarker having the amino acid sequence of PMKTMKGPFG (SEQ ID NO: 1), or “a synthetic peptide having the amino acid sequence of PMKTMKGPFG (SEQ ID NO: 1)” recited in the instant claims reads on the full-length amino acid sequence of COL16A1. Given that the assay kits are employed in methods for diagnosing inflammatory bowel disease, the kits necessarily comprise reagents required to perform such methods, including monoclonal antibodies (mAbs) targeting a specific biomarker, such as COL16A1, optionally labeled with a detectable moiety (e.g. a fluorescent label, radioisotope, biotin, or enzyme tag such as HRP) or conjugated to a labeled secondary antibody. Likewise, disclosed methods for diagnosing inflammatory bowel disease in which biomarker expression levels are determined by immunoassays such as ELISAs inherently require the components of the assay kits recited in the instant claims (Abstract, Para. 0013, and Claims 1, 5, 7, 8, 11, and 12). The term “kit” recited in the instant claims does not impose any structural limitations beyond the recited components. As such, an anti-COL16A1 mAb labeled with biotin, HRP, a radioisotope, a fluorescent tag, or biotin – or otherwise conjugated to a labeled secondary antibody— corresponds to the assay kits of the instant claims comprising the mAb together with an antibody biotinylation kit, an antibody HRP labeling kit, an antibody radiolabeling kit, an assay visualization kit, or a secondary antibody. Accordingly, the diagnostic assay kits and methods disclosed can comprise a monoclonal antibody that binds to the biomarker protein COL16A1 and other reagents/materials needed to diagnose inflammatory bowel disease in a subject.
Thus, Hackney meets the limitations of instant claims 20 and 23-25.
Claims 20 and 23-25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cohen et al (US20130316921A1), hereinafter Cohen.
Cohen discloses assays and kits for diagnosing Kawasaki disease in a subject comprising agents for detecting biomarkers of a panel comprising COL16A1 among other polypeptides in addition to other reagents and control samples for performing immunoassays, wherein an agent is an antibody that specifically binds to a biomarker such as COL16A1 (Para. 0155-0157). A variety of immunoassay formats are contemplated for the measurement of biomarker polypeptides, including immunohistochemistry (IHC), western blotting, enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), direct and indirect sandwich immunoassays, and immunofluorescent assay (IFA), wherein a monoclonal antibody that specifically binds to the biomarker is contacted with the biomarker (Para. 0016, 0059, 0084, 0096-0097, Claims 1, 7, 8, and 9). The antibodies used in the diagnostic assays can be labeled with a detectable moiety, wherein the detectable moiety is a radioisotope, a fluorescent or chemiluminescent compound, or an enzyme such as horseradish peroxidase (Para. 0059 and 0096). The instant claims encompass monoclonal antibodies that bind to any epitope present in COL16A1, which comprises the amino acid sequence of SEQ ID NO: 1. The term “having”, which is synonymous with “comprising”, is inclusive or open-ended and does not exclude additional, unrecited elements (see MPEP 2111.03). In other words, the phrase “a C-terminus biomarker having the amino acid sequence of PMKTMKGPFG (SEQ ID NO: 1), or “a synthetic peptide having the amino acid sequence of PMKTMKGPFG (SEQ ID NO: 1)” recited in the instant claims reads on the full-length amino acid sequence of COL16A1. Further, the term ‘kit’ of the instant claims does not impose additional structural limitations beyond the recited components. The ‘assay kit’ components of the instant claims are utilized in the disclosed diagnostic immunoassays for detecting biomarker polypeptides including COL16A1 in a biological sample. For example, an immunoassay in which a COL16A-specific mAb is labeled with HRP, a radioisotope, or a fluorescent tag inherently discloses the ‘assay kit’ components of the instant claims (e.g. an anti-COL16A1 antibody + an antibody HRP labeling kit, radiolabeling kit, or assay visualization kit). Lastly, it is noted that, the wherein clause recited in claim 25 is a recitation of intended use that does not place further limitations on the structure of the claimed assay kit or its components and thus does not add patentable weight to the claim. Accordingly, the immunoassays for diagnosing Kawasaki disease in a subject also anticipate the assay kit recited in the instant claims.
Thus, Cohen meets the limitations of instant claims 20 and 23-25.
Conclusion
No claims are allowable. Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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/LIA E TAYLOR/ Examiner, Art Unit 1641
/MISOOK YU/ Supervisory Patent Examiner, Art Unit 1641