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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 02, 2026 has been entered.
Response to Amendment
2. Claims 1, 26, 30 and 41 have been amended and claim 8 canceled as requested in the amendment filed on March 02, 2026. Following the amendment, claims 1, 2, 5, 6, 9-11, 26-28, 30-33, 36, 41, 42 and 44-48 are pending in the instant application.
3. Claims 31, 32 and 42 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.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 December 19, 2024.
4. Claims 1, 2, 5, 6, 9-11, 26-28, 30, 33, 36, 41 and 44-48 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on March 02, 2026 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.
7. Claims 1, 2, 5, 6, 9-11, 26-28, 30, 33, 36, 41 and 44-48 stand rejected on the basis that they contain an improper Markush grouping of alternatives for reasons of record in section 6 of Paper mailed on January 13, 2025 and section 6 of Paper mailed on August 28, 2025.
At pp. 8-10 of the Response, Applicant cites relevant sections of MPEP and argues that the members of the Markush group of the instant claims are proper because they all are polypeptides, a recognized class, and they all serve as biomarkers for neurological disease, and as such have a common structure and common utility. Applicant’s arguments have been fully considered but found not persuasive for reasons that follow.
As fully explained earlier, the Markush grouping of claims 1, 26, 30 and 41 is improper because the recited biomarkers are independent and distinct products, which possess characteristic differences in structure and function. Claim 1, for instance, recites twenty-four independent and structurally unrelated polypeptides, each with its own know utility as disclosed within the relevant prior art of record. Thus, claim 1 effectively encompasses at least 276 independent combinations of two biomarkers out of twenty-four recited therein. For a proper Markush grouping, one combination that reads on one inventive concept must be defined either by reference to a common structure that supports practical utility of the invention, or a common chemical class, also with respect to practical utility of the invention. In the instant case, the different embodiments within the claims do not share a common structure and do not share a common class with respect to their asserted utility, which makes the grouping of alternatives not proper Markush.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
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.
8. Claims 41 and 44-48 stand 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.
9. Claim 41 stands vague and ambiguous for reasons of record in section 8 of Paper mailed on August 28, 2026. Applicant submits at p. 11 of the Response that the limitation “reference level of each biomarker” would be clearly understood by one of skilled in the art. While this has been fully considered, the argument is not persuasive for reasons that follow.
As explained earlier, claim 41 specifically requires possession of a “reference level of each biomarker […] wherein the reference level of each biomarker comprises a normalized measured level of the biomarker from one or more blood samples of human individuals without neurological disease,” and it is not obvious whether the level, as an essential part of the kit, a product, is a printed matter, an actual physical control sample at a certain concentration or anything else. Because the claim allows for multiple interpretations, then the claims is indefinite, and therefore stands rejected.
10. Claim 47 stands rejected for reasons of record in section 9 of Paper mailed on August 28, 2025. Applicant argues at pp. 11-12 of the Response that, “the rejection is the
result of failing to properly consider the claim as a whole. More specifically, Applicant notes that claim 47 recites "wherein the one or more reagents are configured to detect the expression level of the biomarkers through at least one of nucleic acid level, protein level, or functionally at the protein level," while claim 48 recites” specific assays. Applicant’s arguments have been fully considered and found to be persuasive in part as applied to claim 48. However, claim 47 does not recite any particular assays, which are the structural elements supporting the “configured to detect” functional limitation. Amending claim 47 to include limitations of claim 48 would obviate this ground of rejection.
11. Claims 44-46 and 48 are indefinite for being dependent from indefinite claim.
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.
12. Claims 1, 2, 5, 6, 9-11, 26-28, 30, 33 and 36 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement for reasons of record in section 19 of Paper mailed on January 13, 2025 and section 11 of Paper mailed on August 28, 2025. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
At pp. 12-13 of the Response, Applicant explains that the claims have been amended to recite specific diseases and further that the data presented within the examples and Figures support the use of the elected biomarkers. While this has been fully considered, the argument is not persuasive because currently the claims are not limited to the elected biomarkers but recited all 276 various combinations of biomarkers, wherein each biomarker is claimed to either be increased or decreased to be associated with the pathology of “Alzheimer’s Disease, Parkinson’s Disease, Down’s syndrome, Frontotemporal dementia, Dementia with Lewy Bodies, and neurodegenerative disease” in general. The Examiner maintains that it would require an extensive amount of undue research and experimentation for one skilled in the art to discover for himself how to practice Applicant’s invention, as claimed.
Amending the claims to be limited to specific changes with respect to specific biomarkers would obviate this ground of rejection.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
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.
13. Claims 1, 2, 5, 6, 9-11, 26-28, 30, 33 and 36 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 20 of Paper mailed on January 13, 2025 and section 12 in Paper mailed on August 28, 2025.
At pp. 13-14 of the Response, Applicant states that the rejection is improper for being irrational, the argument appears to be that referral for a treatment represents the treatment step itself. Applicant’s argument has been fully considered but found to be not persuasive because, as explained earlier, the referral, by broadest reasonable interpretation and consistent with common terminology, is a process of communicating specific information, a suggestion or providing an idea as what to do next. This by itself is judicial exception within the meaning of 35 U.S.C. 101.
Next, Applicant submits that claim 30 does not recite a diagnostic step and therefore is eligible under 35 U.S.C. 101. Applicant’s argument has been fully considered but found to be not persuasive for the following reasons. Claim 30 encompasses a process of screening biomarkers for a neurological disease by observing the changes in the levels of biomarkers during a respective pathology, the process that is governed by nature and runs independently from Applicant’s knowledge or discovery. This, as well as mental steps of comparing the data, sets forth a judicial exception. Furthermore, the claim fails integrate the exception into a practical application by adding a meaningful physical step, or to recite substantially more than the exception itself by reciting a novel inventive step of measuring the biomarkers, for example.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
14. 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.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
March 23, 2026