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, 26, 41 and 48 have been amended and claims 5, 9, 10, 33, 36 canceled and claims 53-60 added as requested in the amendment filed on September 24, 2026. Following the amendment, claims 1, 2, 6, 11, 26-28, 31, 32, 41, 42, 44-48 and 53-60 are pending in the instant application.
2. Claims 31, 32 and 42 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.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.
3. Claims 1, 2, 6, 11, 26-28, 41, 44-48 and 53-60 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.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 September 24, 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.
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 41, 44-48 and new claims 58 and 60 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 41, as amended, stands indefinite for reasons of record in section 8 of Paper mailed on August 28, 2025, and section 9 of Paper mailed on March 25, 2026. Briefly, the claim encompasses a product, reagents for detecting TNFα, CRP and IL-10, and “numeric reference level of each biomarker […] wherein the numeric level of each biomarker comprises a normalized measured value of the biomarker level from one or more blood samples of human individuals without neurological disease.” Applicant submits at p. 10 of the Response that “claim 41 does not allow for multiple reasonable interpretations.” The Examiner disagrees. As fully explained earlier and above, claim 41 encompasses a product which comprises chemical compounds and paper material on how to use the compounds, instructions. The product further comprises “a numeric reference level,” and it is not obvious what specific product, defined as a level, is intended to be added to the claimed kit to meet the claim’s limitations.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
8. Claims 47 and 48 stands rejected for reasons of record in section 9 of Paper mailed on August 28, 2025 and section 10 of Paper mailed on March 25, 2026. To traverses the rejection, Applicant cites MPEP, pp. 10-11 of the Response, and submits that the limitation
"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" sets “definitive boundaries of the patent protection sought,” p.12. Applicant’s arguments have been fully considered but found to be not persuasive. The Examiner maintains that claims 47 and 48 do not recite any structural elements supporting the “configured to detect” functional limitation, not in general as in claim 47, and not in particular, as in claim 48. The term “to be configured,” when applied to chemical compounds, is not known in the pertinent art of record as being associated with a particular modification(s). Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of the term, an artisan cannot determine if a reagent, which meets all of the other limitations of a claim, would be configured or not configured, and as such, then be included or excluded from the claimed subject matter by the presence of this limitation.
9. Claim 58 recites limitation “corresponding reference expression level,” which in the absence of any “reference” is vague and ambiguous. This renders the claim indefinite.
10. Claims 44, 45 and 60 are indefinite for being dependent from indefinite claim(s).
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.
11. Claims 26-28, and new claim 59 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 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 submits essentially the same line of argument as presented earlier, fully considered previously and fully answered. The Examiner maintains that same position. Briefly, the claims have been amended to recite three biomarkers that are evaluated to be either elevated or reduced during a clinical trial to identify a useful drug to treat any neurodegenerative disease in existence. Thus, the scope of the claimed methods is so broad that it is meaningless as practically any drug would cause some change to the expression of the recited biomarkers, and as such would satisfy the claims’ limitations. The specification fails to provide any guidance for the methods, as broadly claimed, and 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.
12. New claims 54-58 are 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 as applied to claims 1, 2, 5, 6, 9-11, 26-28, 30, 33 and 36 in section 20 of Paper mailed on January 13, 2025, section 12 in Paper mailed on August 28, 2025 and in section 13 of Paper mailed on March 25, 2026.
At p. 14 of the Response, Applicant states that “claim 54 recites the limitations removed from currently amended claim 1. However, it is also noted that newly added claim 54 recites specific treatment steps which go beyond simply referring a subject to a specialist. As such, newly added claim 54 incorporates the alleged judicial exception into a practical application.” Applicant’s argument has been fully considered but found to be not persuasive because “selecting a treatment” is a mental process of communicating information, as well as a “referral.” In case of claim 58, a step of “comparing” is also a mental step. Thus, new claims 54-58 recite a judicial exception, which is prohibited under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
13. Claim(s) 1, 2, 6, 11, as amended, and new claim 53 is/are rejected under 35 U.S.C. 102anticipated as being (a)(1) by US patent 7,598,049, reference 5 of IDS submitted on 02/09/2023.
Claims 1, 2, 6, 11 and 53 encompass methods of measuring expression levels of TNFα, CRP, IL-10 and IL-7 in a blood sample obtained from a subject with Alzheimer’s disease. The cited US patent teaches measuring the levels of the above recited biomarkers in blood samples, see title, abstract and Table 7, thus fully meeting the limitations of the claims.
Conclusion
14. No claim is allowed.
15. 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
October 6, 2026
