Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 17, 2026 has been entered.
Response to Amendment
2. Claims 2, 3 and 10 have been amended, claims 9 and 11-20 canceled and claim 22 added as requested in the amendment filed on February 04, 2026. Following the amendment, claims 2, 3, 5-8, 10, 21 and 22 are pending in the instant application.
3. Claims 2, 3, 5-8, 10, 21 and 22 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
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.
5. Claims 2, 3, 5-8, 10, 21 and 22 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. This is a New Matter rejection under the provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), written description.
MPEP § 714.02 states that Applicant’s reply to the Office action must be fully responsive. Specifically, “Applicant should also specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06”. Further, MPEP § 2163.06 states that if new matter is added to the claims, the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) - written description requirement, is appropriate. The proscription against the introduction of new matter in a patent application serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981). Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph sets forth the written description requirement as follows: 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. Compliance with the written description requirement is a question of fact. See Vas-Cath lnc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991).
The basic function of a patent specification is to disclose an invention. The written description serves a quid pro quo function “in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’” Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922, 69 USPQ2d 1886, (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970, 63 USPQ2d 1609. 63 USPQ2d 1618, (Fed. Cir. 2002)). In other words, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,” Vas-Cath Inc., 935 F.2d at 1563-64, and demonstrate that by disclosure in the specification of the patent.
In the instant case, claims 2, 3, 5-8 and 21, previously amended to specifically exclude the only post-translational modification disclosed as an inventive concept within the instant patent application modification, lack written support for measuring oxidation, cysteinylation s-nitrosation and s-glutathyolation of GFAP, MBP and NRGN in any sample obtained from a subject having or suspected of having brain injury. Next, claim 10, as currently presented, specifically requires possession of a method to treat a subject for brain injury based on finding of an increase in the levels of post-translationally modified biomarker proteins at a first time point and at a second time point and relative to the levels of the corresponding unmodified brain injury biomarker proteins in a normal control. Claim 22 expressly indicates that the diagnostic measure of brain injury is indeed the presence of post-translationally modified biomarker protein, see “detecting in a sample.” The specification as originally filed does not provide support for the invention as now claimed, which is measuring different levels of modified proteins at different time points, comparing the levels to unmodified proteins, and, at the same time, simply detecting the presence of modified proteins as a diagnostic measure. Thus, the written support for the new limitation is not readily apparent in the specification as filed.
Because the instant claims now recite limitations which were not clearly disclosed in the specification as filed, these limitations introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. 112.
To obviate the instant rejection of record, Applicant is invited to provide sufficient written support for the limitations indicated above. See MPEP 714.02 and 2163.06.
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 possible 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 provisions 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 accompanied 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.
6. Claims 2, 3, 5-8, 10, 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 10,534,003 for reasons of record in section 15 of Paper mailed on September 05, 2025. Briefly, the instant claims specifically require practicing of detecting or measuring the levels of methylated GFAP, which is the subject matter of the claims for which patent protection has been already granted.
Conclusion
7. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, Jeffrey Stucker can be reached at (571)272-0911. 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.
/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
July 28, 2026
Prosecution Insights