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 .
Election/Restrictions
Applicant’s election without traverse of Group II: Claim 44, species T231 in the reply filed on 19 MAY 2026 is acknowledged. Claims 2-4, 16, 19, 26 and 62 are directed to species T231.
In the election on 19 MAY 2026, Applicant has elected Group II: Claim 44 without traverse. In the REMARKS, Applicant has amended the previous other pending claims to depend from Claim 44, except Claim 62. Claim 62 is dependent upon cancelled Claim 1.
The pending claims which include species T231 are Claims 44, 2, 3, 16, 19, 26, 44 and 62.
Status of Claims
Applicant has elected Group II: Claim 44 , species T231.
The claims associated with Claim 44, species T231 are Claims 2, 3, 4, 16, 19, 26, 44 and 62.
Claim Objections
Claim 62 is objected to because of the following informalities:
Claim 62 is objected to under 37 CFR 1.75(c) as being in improper form because it is dependent upon a cancelled claim. See MPEP § 608.01(n). Accordingly, the claim 62 has not been further treated on the merits.
Appropriate correction is required.
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.
Claims 2, 3, 19, 26, 44 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 11, 13, 18 of U.S. Patent No. 11,698,378 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is directed towards a method for treating a subject with Alzheimer’s Disease with a sample of cerebrospinal fluid (instant Claim 44, 26, 19 and 3; ‘378 Claim 1, 2, 3, and 13). While the ‘378 reference is more specific in the method , ‘378 Claim 1; the method of instant Claim 44 is very broad and really only claims two steps of obtaining a PTM at a particular position and treating, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘378 to determine the position of the PTM location since it already determines the amount of tau PTMs based on tau peptide fragments and the position would give a better understanding of where the tau peptide fragment is located.
Instant Claim 2 is the same as ‘378 Claim 11, which describes the type of post-translational modification.
Specification/Abstract
The abstract of the disclosure is objected to because the phrase "i.e." renders the abstract indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 44 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by SINGH, FLEXIQuant: a novel tool for the absolute quantification of proteins…submitted on the Information Disclosure Statement on 08 NOVEMBER 2024, Other Documents Cite No. 103
Regarding Claim 44, the SINGH reference discloses a method for treating a subject having a tauopathy , the method comprising:
obtaining a biological sample form the subject that comprises one or more post translational modifications (PTMs) associated with one or more tau peptide fragments of a tau protein in the biological sample, wherein the one or more PTMs is located on the position selected from the positions listed in Table 1, abstract, page 2204, Figure 1, biological sample, absolute quantification of labeled standard page 2003, Steps 3-5;
administering an effective amount of a therapeutic agent that targets the one or more PTMs tau peptide fragments, thereby treating the subject having the tauopathy, page 2208, nocodazole treatment.
Claims 2-4, 16, 19, 26, 44 and 62 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by STEEN, US Publication No. 2019/0234966 A1, submitted on the Information Disclosure Statement on 08 NOVEMBER 2024, US Patent Documents, Cite No. 7.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 44, the reference STEEN discloses a method for treating a subject having a tauopathy , [0007], the method comprising:
obtaining a biological sample form the subject that comprises one or more post translational modifications (PTMs) associated with one or more tau peptide fragments of a tau protein in the biological sample, wherein the one or more PTMs is located on the position selected from the positions listed in Table 1, abstract, Claim 1, Table 1, page 35, Table 2, page 36 , Table 3, page 39;
administering an effective amount of a therapeutic agent that targets the one or more PTMs tau peptide fragments, thereby treating the subject having the tauopathy, [0105, 0201-0208].
Additional Disclosures Included are: Claim 2: wherein the method of claim 44, wherein the post-translational modification is phosphorylation, glycosylation, glycation, prolyl-isomerization, cleavage or truncation, nitration, polyamination, ubiquitination, acetylation, methylation, dimethylation, trimethylation or sumoylation, [0021].; Claim 3: wherein the method of claim 44, wherein the subject has an overall higher level of PTMs at the one or more PTM positions as compared to a control level, [0263, 0290].; Claim 4: wherein the method of claim 44, wherein the one or more PTM is selected from the group consisting of:phosphorylation at one or more positions selected from the group consisting of Y29, T30, T39, S46, S56, S68, T69, T71
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T102,Till1,5113, T153, T175, T181,S5184,S5185,Sl191,S5198, S 199,S5202, T205,S5210, T212,S5214, T217, T220, T231, Table 1, page 35, Table 2, page 36 , Table 3, page 39, S5235, S237, S238,S5241,S5258, S262, T263, S289, S293, S305, Y310, S316, S352, S356, T361, T386, Y394, S396, S400, T403, S404, S409, S412, S413, T414, S422, S433, and S435;acetylation at one or more positions selected from the group consisting of K24, K44, K240, K267, K274, K280, K281, K298, K311, K317, K331, K343, K347, K353, K369, K370, K375, K385, and K395;ubiquitination at one or more positions selected from the group consisting of K1 80, K240, K254, K257, K259, K267, K274, K281, K290, K298, K311, K317, K321, K343, K353, K369, and K395; and methylation at one or more positions selected from the group consisting of K67, K87, R406, and K438 (all numbering based on human 2N4R isoform). ; Claim 16: wherein the method of claim 44, wherein the one or more PTMs comprise phosphorylation at T181 and/or T231, Table 1, page 35, Table 2, page 36 , Table 3, page 39.; Claim 19 : wherein the method of claim 44, wherein the biological sample is brain tissue, plasma, or cerebrospinal fluid (CSF), Claim 4, [0166].; and Claim 26: wherein the method of claim 44, wherein the tauopathy is Alzheimer's disease (AD), Claim 5, [0010, 0107]. ; Claim 62: wherein the method of claim 1, wherein the one or more PTMs are located at position selected from (iii) one or more PTMs in T231, Table 1, page 35, Table 2, page 36 , Table 3, page 39.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lu KP, Kondo A, Albayram O, Herbert MK, Liu H, Zhou XZ. Potential of the Antibody Against cis–Phosphorylated Tau in the Early Diagnosis, Treatment, and Prevention of Alzheimer Disease and Brain Injury. JAMA Neurol. 2016;73(11):1356–1362. doi:10.1001/jamaneurol.2016
The Lu reference discloses an mentions treatment of Alzheimer’s Disease form a cerebrospinal fluid sample. The Lu reference mention the T231 of the PMTs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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