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 .
DETAILED ACTION
Response to Amendment
1. Claims 1, 2, 12, 14, 15 and 22 have been amended and claim 11 canceled as requested in the amendment filed on November 07, 2025. Following the amendment, claims 1, 2, 7-9, 12-15, 20-24, 26, 28, 29, 31, 33 and 34 are pending in the instant application.
2. Claims 1, 2, 7-9, 12-15, 20-24, 26, 28, 29, 31, 33 and 34 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on November 07, 2025 have been fully considered but they are not deemed to be persuasive for the 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.
5. 1, 2, 7-9, 12, 13, 20, 22-24, 26, 28, 29, 31, 33 and 34, as amended, 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.
6. Claim 1 has been amended to recite a method of performing an assay comprising performing an assay and identifying a subject as having certain levels of GFAP and UCH-L1 as greater than reference levels. In the current context, the claim does not allow clear interpretation of what stands for “identifying the subject as having” certain levels of factors in a sample, and further what stands for a “reference level.” Applicant is advised that if a claim is intended to measuring of the levels of factors in a sample obtained from a subject, then this is what the claim should recite to avoid ambiguity of interpretation of the claimed subject matter.
7. Claim 20 stands rejected for reasons of record in section 4 of Paper mailed on May 09, 2025. Applicant traverses the rejection on the premises that the claim has been either amended or canceled, p. 15 of the Response. However, claim 20 stans as “Previously presented,” and as such the rejection is maintained.
8. Claims 2, 7-9, 12, 13, 22-24, 26, 28, 29, 31, 33 and 34 are indefinite for being dependent from indefinite claim.
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.
9. Claims 14-15 and 20-21 stand 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 6 of Paper mailed on May 0, 2025.
Applicant traverses the rejection at p. 16 of the Response, by stating that claim 14 has been amended to recite “performing a head computerized tomography,” which remedies the rejection of record. While this has been fully considered, the argument is not persuasive for reasons that follow.
As fully explained earlier, to satisfy prong two of Step 2A of the subject matter patentability analysis, the claims must satisfy the requirement of “integration in to a practical application.” In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure naturally occurring factors during a naturally occurring pathology. (Step 2A/2: No). Note that performing an assay on a patient reads on judicial exception, such as observing the changes that occur naturally during pathology of head injury.
For reasons fully explained earlier and reasons above, the rejection is maintained.
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.
10. Claims 1, 2, 7-9, 11-15, 20-24, 26, 28, 29, 31, 33 and 34 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the following issued US Patents: U.S. Patent No. 10,849,548; 10,866,251;10,877,038; 10,877,048; 11,016,092; 11,016,105; 11,022,617; 11,931,161; 12,085,567; 12,092,647; 12,099,069; 12,105,098; 12,105,100 and 12,163,958 for reasons of record in section 8 of Paper mailed on May 09, 2025.
Conclusion
11. No claim is allowed.
12. 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.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
January 26, 2026