DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30, 2026 has been entered.
2. Claims 67-76 have been amended, claim 66 has been canceled, and new claims 75-94 have been added as requested in the amendment filed March 30, 2026. Following the amendment, claims 67-94 are pending in the present application.
3. Claims 67-94 are under examination in the current office action.
Withdrawn Claim Rejections
4. The rejection of claims 67-76 under 35 USC 103 as being unpatentable over Gygi et al., Memo et al., Meek et al. and DeHart et al., as discussed at sections 5-7 of the 10/01/2025 office action, is withdrawn in view of applicant’s claim amendments and persuasive arguments. In particular, the cited references do not teach the detection of the specific combinations of PTMs that the claimed methods are now limited to given their amended language.
5. The provisional rejection of claims 68-76 on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/699030 is withdrawn in view of applicant’s amendments to the claims.
6. The provisional rejection of claims 67-76 on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/007,088 is withdrawn in view of applicant’s amendments to the claims.
Claim Objections
7. Claims 67-73 are objected to because of the following informalities: the claims recite acronyms that are not spelled out in their first use in the claims (i.e., AD, MCI, FTD, LB, VD). It would be remedial to amend the claim language in claims 67-73 such that the acronyms are clearly defined. Appropriate correction is required.
Maintained Claim Rejections
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.
8. Claim 67 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/699,030 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims still encompass the detection of the same PTMs (1, 3, 4, 5, 6) and exclude the detection of PTM-7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claims 74-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/699,030 in view of Gygi et al. (US 2006/0148093 A1; of record).
The reasons why the copending claims anticipate present claim 67 are discussed above. However, the copending claim does not teach the limitations of present claims 74-76.
With respect to step (a) within the claims (enzymatic fragmentation of Up53) of claim 67 and claim 74 (protein fragmentation with trypsin), Gygi teaches that any biochemical, immunological or cell biological fractionation method that reduces sample complexity and enriches for proteins of low abundance may be used in conjunction with the disclosed detection techniques (see [0096]). Ubiquinated polypeptides, for instance, can be isolated by immunological means or using an affinity tag (see [0130]-[0135]). Gygi discloses that the sample is subjected to trypsin digestion to obtain peptide fragments that are used for determining the post-translational modifications (see [0048], [0075], [0126], [0148] and Figure 9A). The digested peptides are purified to isolate individual test peptides for analysis ([0127]). For example, digested, ubiquinated peptides are separated by at least one round of liquid chromatography, such as by HPLC (see [0034] and [0139]-[0140]), which addresses new claims 75-76.
Accordingly, it would have been obvious to have utilized the methods taught by Gygi to achieve the method of present claims 74-76. This is because the artisan has good reason to pursue the known options within his or her technical grasp to obtain predictable results. Such would amount to the combining of prior art elements according to known methods to achieve a predictable outcome.
This is a provisional nonstatutory double patenting rejection.
Conclusion
10. Claims 67 and 74-76 are rejected.
Claims 67-73 are objected to.
Claims 77-94 are objected to as being dependent upon an objected base claim.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
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