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 .
Claim Status
The amendment of 01/07/2025 has been entered. Claim 1 is currently pending in this US patent application and was examined on its merits.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US patent application publication 2019/0345534 filed by Kwong et al., published 11/14/2019.
Kwong teaches ex vivo analysis of protease activity by contacting ex vivo patient samples, such as blood, urine, or plasma, with a composition comprising at least one detectable peptide sequence linked/coupled to a scaffold. The presence of the detectable marker in the biological sample is indicative of an active enzyme or a substrate within the subject (see entire document, including paragraph 0114). The compositions include a scaffold, a linker coupled to the scaffold, at least one protease-specific peptide substrate coupled to the linker, and a detectable reporter domain coupled to the peptide substrate (paragraphs 0009-0010; reads on claim 1).
As such, claim 1 is anticipated by Kwong and is rejected under 35 U.S.C. 102(a)(1).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11851697. Although the claims at issue are not identical, they are not patentably distinct from each other because the method recited in the claims of ‘697 is narrower than the instantly recited method. As such, the instant claim is ‘anticipated’ by the claims of ‘697 and is rejected on the ground of nonstatutory double patenting.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12492422. Although the claims at issue are not identical, they are not patentably distinct from each other because the method recited in the claims of ‘422 is narrower than the instantly recited method. As such, the instant claim is ‘anticipated’ by the claims of ‘422 and is rejected on the ground of nonstatutory double patenting.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11604193. Although the claims at issue are not identical, they are not patentably distinct from each other because the method recited in the claims of ‘193 is narrower than the instantly recited method. As such, the instant claim is ‘anticipated’ by the claims of ‘193 and is rejected on the ground of nonstatutory double patenting.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12305217. Although the claims at issue are not identical, they are not patentably distinct from each other because the method recited in the claims of ‘217 is narrower than the instantly recited method. As such, the instant claim is ‘anticipated’ by the claims of ‘217 and is rejected on the ground of nonstatutory double patenting.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11028425 in view of US patent application publication 2019/0345534 filed by Kwong et al., published 11/14/2019. The claims of ‘425 recite a method that is narrower than the instantly claimed method but do not recite that the contacting of the sample and the molecule occurs ex vivo. However, Kwong teaches that the contacting of patient samples and molecules comprising cleavable linkers and detectable markers can occur ex vivo, as discussed above. As such, the instant claim is ‘rendered obvious’ by the claims of ‘425 in view of Kwong and is rejected on the ground of nonstatutory double patenting.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/705881 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘881 are narrower than the method recited in instant claim 1. As such, instant claim 1 is ‘anticipated by’ the claims of ‘881 and is provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/705899 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘899 are narrower than the method recited in instant claim 1. As such, instant claim 1 is ‘anticipated by’ the claims of ‘899 and is provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 03/11/2026