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 17 and 39 have been amended as requested in the amendment filed on October 03, 2025. Following the amendment, claims 17, 23-25 and 39 are pending in the instant application.
2. Claims 17, 23-25 and 39 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.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 May 27, 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. Claims 17, 23-25 and 39, 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. Claims 17 and 39, as currently presented are vague and indefinite for reasons that follow. First, the claims recite within the preamble, “a method of screening a subject […] for the need to undergo positron emission tomography (PET) amyloid screening,” emphasis added, while the final step clearly recites an active “PET amyloid imaging” or “performing PET amyloid imaging,” thus, making the final step in conflict with the goal set forth earlier, to screen. Second, section “using a Random Forest (RF) analysis” or “calculating by Random Forest (RF) analysis” is indecipherable as presented. It is not obvious and cannot be determined from the claims or the specification as filed what stands for active, physical and repeatable steps that associate the levels of expression of the recited factors and SP and NPV value. Moreover, the limitation “wherein the SP=0.90 and NPV=0.90 that the subject has cerebral Aβ” is grammatically awkward and perhaps missing essential words.
7. Claims 23-25 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.
8. Claims 17, 23-25 and 39 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 10 of Paper mailed on November 14, 2022, section 8 of Paper mailed on May 30, 2023, section 9 of Paper mailed on January 22, 2024, section 5 of Paper mailed on July 16, 2024 and section 8 of Paper mailed on February 27, 2025. See also section 26 of Paper mailed on October 19, 2020, section 18 of Paper mailed on March 09, 2021, section 14 of Paper mailed on November 16, 2021, section 8 of Paper mailed on April 01, 2022, section 9 of Paper mailed on November 14, 2024 and in section 9 of Paper mailed on June 04, 2025.
Applicant traverses the rejection at p. 6 of the Response. Specifically, Applicant submits that the claims have been amended, and as amended “amount to significantly more than the judicial exception. […] the invention as claimed provides a novel screening process that determines those who screen positive and that should undergo PET imaging.” Applicant further argues that, “when viewed as a whole the invention amounts to more than the judicial exception, namely, a novel blood biomarker test in a primary care setting is used in a method of screening for only those subjects that need to undergo positron emission tomography (PET) amyloid imaging. Moreover, the present invention is now claimed with particularity, namely, using the step of determining a specificity (SP) and negative predictive value (NPV) for cerebral Aβ, wherein the SP = 0.90 and NPV = 0.90 that the subject has cerebral Aβ. And then conducting the PET scan for cerebral Aβ on only those patients. That is, the present claims recite additional elements to integrate the alleged judicial exception into a practical application, namely, PET amyloid imaging on the subject if they meet the threshold for the blood-based biomarkers. Applicant submits that the detection of PET detectable amyloid is integrally connected to the measurement of biomarkers (claim 17) and biomarkers and neurocognitive test results (claim 39) (Step 2A/Prong 2: YES).” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
As fully explained earlier, the claims, by broadest reasonable interpretation and consistent with the specification as filed, encompass a law of nature, such as a correlation between the levels of expression of IL-5, IL-6, IL-7, TNF-a, and CRP in the blood or serum of the subject with pathological accumulation of cerebral amyloid and the pathology itself. This recitation of a natural phenomenon—a judicial exception— is not patentable under 35 U.S.C. 101. As explained earlier, IL-5, IL-6, IL-7, TNF-a, and CRP are all naturally occurring factors that are expressed differently during pathological cerebral amyloidosis as compared with a normal state. This process is governed by nature and exists independently of any action by Applicant, Applicant’s discovery, knowledge or disclosure.
Next, conducting a PET test to further confirm the presence of pathological cerebral amyloid represents additional testing, and as such does not integrate the judicial exception recited within the claims into a practical application, Step 2A/2: No.
For reasons of record in office actions of record enumerated earlier and reasons above, the rejection is maintained.
Conclusion
9. No claim is allowed.
10. 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
November 4, 2025