DETAILED ACTION
The preliminary amendment submitted on June 20, 2023 has been entered. Claims 14-30 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions of the Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284 (2011). In the event the determination of the status of the application as subject to pre-AIA 35 U.S.C. 102 and 103 (or as subject to AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from pre-AIA to AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections – 35 USC § 112
The following is a quotation of the first two 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.
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 14-23 are rejected under pre-AIA 35 U.S.C. 112, first paragraph, because the specification, while being enabling for rheumatoid arthritis, does not reasonably provide enablement for any inflammatory disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The focus of the examination inquiry is whether everything within the scope of the claim is enabled. Accordingly, the first analytical step requires that the examiner determine exactly what subject matter is encompassed by the claims. The specification must teach those skilled in the art how to make and use the full scope of the claimed invention without “undue experimentation” or that any experimentation must be “reasonable.” The scope of enablement must bear a “reasonable correlation” to the scope of the claims, although the more one claims, the more one must enable. With respect to the breadth of a claim, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. See MPEP 2164.08 (enablement commensurate in scope with the claims).
The claims at issue are drawn to any inflammatory disorder. As applicant’s own specification explains, the 14-3-3 proteins are “diagnostic biomarkers for arthritis when those proteins are found in extracellular fluids” (specification at p. 1). The examiner acknowledges that the detection of these proteins is known in the art for arthritis. See, e.g., Chatterjee et al., Mol. Biol. Rep. 2025;52(1):956. The prior art search, however, reveals that the use these proteins in the diagnosis of the full scope of inflammatory diseases embraced by the claims would not be credible. Applicant’s own specification does not posit any rational explanation, and there are no working examples to support such a hypothesis, whereby one would reasonably expect them to be useful in diagnosing the full range of inflammatory disorders within the scope of claims 14-23. The examiner therefore concludes that one of skill in the art would be burdened with undue experimentation when attempting to practice the method as claimed.
Claims 14-30 are rejected under pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The phrase “the eta isoform” in claims 14, 19 and 24 lacks antecedent basis and is unclear because there are seven different isoforms of eta that exist for this protein (see, e.g., Example 1 in applicant’s specification at pp. 12-13). The specification discloses that there could be multiple isoforms. Further, at least two forms that are exemplified in the Figures and Example 2 (spec. at p. 14) are eta and gamma. Claims 14-30 are therefore indefinite.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possi-ble harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provi-sions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,791,458 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘458 Patent is directed to a method comprising obtaining a test biological sample from said patient, wherein said test sample is from a patient diagnosed with arthritis and is blood, serum, plasma, or synovial fluid; and detecting the presence or relative amount of the eta isoform of the 14-3-3 protein in the test sample. The specification of the ‘458 Patent explains that “the presence of specific proteins or peptides in a biological sample, or the relative levels of specific proteins or peptides in a biological sample may be detected by any of several methods known in the art,” such as “mass spectroscopy” (col. 7, ll. 13-20). One would therefore view instant claims 14, 19 and 24 as being prima facie obvious over the claims of the ‘458 Patent. Dependent claim 2-4 of the ‘458 Patent are directed to the 14-3-3 eta isoform comprising the amino acid sequence of SEQ ID NO: 3, as well as detecting a matrix metalloproteinase, which meets the limitations of instant claims 15-17, 20-22, and 25-27. Dependent claim 5 of the ‘458 Patent is drawn to rheumatoid arthritis, which meets the limitations of instant claim 29.
Claims 14-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,677,804 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above.
Claims 14-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,686,737 B2 for substantially the same reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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/interview practice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 8, 2026 (revised January 22, 2026)