Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendment
1. Claims 2, 5 and 8-10 has been amended, claim 4 canceled and claim 21 added as requested in the amendment filed on February 04, 2026. Following the amendment, claims 2, 3 and 5-21 are pending in the instant application.
2. Claims 11-20 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 13, 2025.
3. Claims 2, 3, 5-10 and 21 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on February 04, 2026 have been fully considered but found to be not persuasive for reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
6. Claims 2, 3, 5-10, as amended, and new claims 21 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.
7. Claim 2, as currently presented, is vague and ambiguous for reasons that follow. The claim is drawn to a process—method for detecting brain injury biomarker proteins having post-translational modification. The process comprises three steps, (a) to detect GFAP, MBP or NRGN protein, (b) to subject the biofluid sample containing GFAP, MBP or NRGN to a detection method, and (c) to detect post-translationally modification of GFAP, MBP or NRGN. It is not obvious and cannot be determined from the claim or the specification as filed what specific physical step differentiates steps (a) and (b). This renders the claim indefinite.
8. Claim 9, as amended, recites the limitation "administering brain injury therapy" in claim 2. There is insufficient antecedent basis for this limitation in the claim.
9. Claims 9 and 10, as amended, are vague and indefinite for reciting limitations “levels […] that trend toward [or away from] levels.” The metes and bounds of the limitations cannot be determined from the claim or the specification as filed.
10. Also, claim 10, as amended, recites the limitation "non-brain injury control," which lacks definition within the specification and is generally ambiguous. For instance, is injury to a leg considered a “non-brain injury?”
11. Claims 3, 5-8 and 21 are indefinite for being dependent from indefinite claim(s).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
12. Claim 9 stands rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more for reasons of record in section 13 of Paper mailed on September 05, 2025.
Applicant argues at pp. 15-16 of the Response that the claim has been amended to recite specific steps that are not routine and, further, because the claim depends from claim 2, which satisfies 35 U.S.C. 101, then claim 9 is eligible as well. Applicant’s arguments have been given full consideration but found to be not persuasive for reasons that follow.
Claim 9, as amended, is directed to a method of detecting brain injury therapy efficacy by observing the changes in naturally occurring factors during the naturally occurring pathology of brain injury. As fully explained earlier, claim 9 does not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claim—detecting proteins and measuring post-translational modification of markers—represent routine steps that are recited at a high level of generality and encompass well-understood and purely conventional routine techniques in the art (see base claim 2, for example, describing all known assays). Furthermore, steps of evaluating changes in the levels of biomarkers during active therapy read on data collecting and observing body reaction in response to treatment, the process that occurs naturally and without any knowledge or action by Applicant. The instant situation is similar to the one in Mayo, wherein the claims recited method of administering drugs to a patient and measuring the levels of certain metabolites in the blood, wherein the level of metabolites indicates whether to adjust the dosage. The Supreme Court held that the claims recited a natural law and did not “include any “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S., 132 S. Ct. 77, 101 USPQ2d 1961 (2012).
Finally, with respect to Applicant’s reference to claim 2, the base claim 2 satisfies the patentability because it does not recite the judicial exception. Claim 2 is limited to measuring proteins in a sample obtained from a subject with brain injury. In contrast, claim 9 adds additional elements that tie the levels of proteins to the pathology and thus set forth the judicial exception.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
13. No claim is allowed.
14. 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.
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
February 18, 2026