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 .
Status of the Claims
Claims 2-3, 14-15, 18-19, and 28 have been cancelled by Applicant. Claims 1, 7-10, 13, 16-17, and 23-25 are pending and are examined herein.
Priority
This application, filed 08/31/2021, is a 371 of PCT/US2020/018297, filed 02/14/2020, which is a CIP of 16/276,420, filed 02/14/2019. This priority is acknowledged and the claims herein are treated as having an effective filing date of 02/14/2019.
Withdrawn Rejections/Objections
The Objection to the Specification has been withdrawn in response to Applicant’s amendment to the Specification.
The rejection of claim 14 under 35 U.S.C. 112(b) has been withdrawn in response to Applicant’s cancellation of claim 14.
The rejection of claims 16-19, 23-25, and 28 has been withdrawn in response to Applicant’s arguments.
The rejection of claims 15 and 28 under 35 U.S.C. 112(a) has been withdrawn in response to Applicant’s cancellation of claims 15 and 28.
The rejection of claims 1-3, 7-10, and 13-14 under 35 U.S.C. 102(a)(1) has been withdrawn in response to Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 7-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over O’Bryant et al., “A blood screening test for Alzheimer’s disease” Alzheimer’s and Dementia (IDS dated 03/14/2022, published 06/25/2016, referred to herein as O’Bryant) in view of Gilbert et al., “Association between Peripheral Leptin and Adiponectin Levels and Cognitive Decline in Patients with Neurocognitive Disorders ≥ 65 Years” Journal of Alzheimer’s Disease (published 11/02/2018, referred to herein as Gilbert).
Regarding claim 1, O’Bryant teaches a method for detecting biomarkers in a primary care setting (p. 85, col. 1, para. 1, lines 3-10) comprising measuring B2M, IL6, and eotaxin3, among others (full list in Table 3) using an immunoassay (p. 85, col. 2, para. 4, lines 1-6) on samples from a human subject (p. 85, col. 2, para. 3, lines 1-3). O’Bryant teaches that this method is performed in samples from a subject suspected of having Lewy Body Dementia (p. 87, col. 1, para. 4, lines 1-4).
Regarding claim 7, O’Bryant teaches a method of detection using 10 biomarkers (p. 87, col. 1, para. 1, lines 6-8).
Regarding claim 8, O’Bryant teaches a method using serum (p. 85, col. 2, para. 3, lines 3-4).
Regarding claim 9, O’Bryant teaches obtaining age (Table 1) and a neurocognitive screening test result (p. 84, col. 1, para. 3, lines 4-8).
Regarding claim 10, O’Bryant teaches generating a profile comprising distinguishing Lewy Body Dementia and Parkinson’s Disease from normal controls (p. 87, col. 1, para. 4, lines 1-4) comprising the panel comprising B2M, IL6, and eotaxin3 (Table 3).
Regarding claim 13, O’Bryant teaches a method of using electrochemiluminescence for detection (p. 85, col. 2, para. 4, lines 1-4).
However, O’Bryant does not teach the use of the marker adiponectin.
Regarding claim 1, Gilbert teaches the use of adiponectin as a biomarker for neuro-cognitive diseases (p. 1256, col. 2, para. 4, lines 5-12). Gilbert teaches that adiponectin could be used for healthy patients, mild NCD, vascular dementia, and LBD or PD (p. 1259, col. 1, para. 5, lines 1-8). Gilbert teaches that adiponectin is higher in patients with AD or mixed dementia than those with mild NCD and is higher in patients with AD than those with mixed dementia (p. 1258, col. 2, para. 2, lines 6-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by O’Bryant to add adiponectin, as taught by Gilbert, as a biomarker to the panel used by O’Bryant. An artisan would have been motivated to add adiponectin and had a reasonable expectation of success because, as taught by Gilbert, adiponectin is useful for the diagnosis and characterization of neurodegenerative diseases, which is the purpose of the biomarker panel taught by O’Bryant.
Claims 16-17, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over O’Bryant in view of Gilbert, as applied to claim 1 above, and further in view of Zellner et al., “Fluorescence-based Western blotting for quantitation of protein biomarkers in clinical samples” Electrophoresis (published 09/19/2008, referred to herein as Zellner).
Regarding claims 16 and 17, O’Bryant in view of Gilbert teaches a method for detecting biomarkers in a primary care setting (O’Bryant p. 85, col. 1, para. 1, lines 3-10) comprising measuring B2M, IL6, and eotaxin3 among others (O’Bryant Table 3) using an immunoassay (O’Bryant p. 85, col. 2, para. 4, lines 1-6) on samples from a human subject (O’Bryant p. 85, col. 2, para. 3, lines 1-3). Gilbert teaches the use of adiponectin as a biomarker for neurodegenerative diseases (Gilbert p. 1256, col. 2, para. 4, lines 5-12). O’Bryant teaches the use of the MSD platform for detection of the biomarkers, which separates protein targets from the sample with primary antibodies on a solid support and detects the targets with secondary antibodies via electrochemiluminescence.
Regarding claim 23, O’Bryant teaches a method of detection using 10 biomarkers (p. 87, col. 1, para. 1, lines 6-8).
Regarding claim 24, O’Bryant teaches a method using serum (p. 85, col. 2, para. 3, lines 3-4).
Regarding claim 25, O’Bryant teaches generating a profile comprising distinguishing Lewy Body Dementia and Parkinson’s Disease from normal controls (p. 87, col. 1, para. 4, lines 1-4) comprising the panel comprising B2M, IL6, and eotaxin3 (Table 3).
O’Bryant does not teach a method of separating the proteins in the sample and a molecular marker by electrophoresis or detecting the proteins according to the molecular weight marker (claim 16).
However, Zellner teaches a method of separating the proteins in a sample and detecting them according to their molecular weight (Abstract, p. 3622, para. 2, lines 1-7). Zellner teaches that the use of Western blotting allows for the normalization of the detected signal by total protein load which improves the quantitative accuracy of the method (p. 3622, col. 1, para. 2, lines 7-10).
It would have been obvious to one of ordinary skill in the art to modify the detection method taught by O’Bryant in view of Gilbert with the detection method using electrophoresis and molecular weight taught by Zellner because doing so would allow for the normalization of the detected protein signals to be normalized with the total protein load. As taught by Zellner, normalizing the detected protein signal by the total protein load increases the quantitative accuracy of biomarker detection (p. 3622, col. 1, para. 2, lines 7-10). One would have a reasonable expectation of success in making this modification because the methods of O’Bryant and Zellner both detect protein biomarkers in human blood samples.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on pages 11 and 12 on the rejection under 35 U.S.C. 102, the rejection has been withdrawn in response to Applicant’s amendments.
Regarding the remarks on page 12 on the rejection under 35 U.S.C 103, the amended claims have been rejected under a new rejection, as described above, necessitated by Applicant’s amendments.
Regarding the remarks on pages 12 and 13, the Double patenting rejection has been withdrawn in response to Applicant’s amendment to this application and application 16/312,346.
Conclusion
No claims are allowable.
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.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 8, 2026