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 .
Claims 1-20 are pending and under examination.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11726096. Although the claims at issue are not identical, they are not patentably distinct from each other because the 096’ patent also recites analyzing at least one protein by mixing a protease enzyme with the sample, and digestion occurs on the emitter of electrospray followed by a tandem mass spectrometry analysis in a real-time fashion. Note, claim 28 of the 096’ patent recites identifying the post translational modifications of the protein sample. As to the procedures of the analysis, 096’ patent also recites using denaturant, sample size less than about 10 ug/uL, protease/protein sample ratio 1:1-1:10, positive voltage, and protease pepsin, or protease XIII.
The following is a statement of reasons for the indication of allowable subject matter: no prior art teaches or suggests the current invention for analyzing a post-translational modified protein, especially first mixing a protease enzyme with a protein sample to form a final sample, then contacting the final sample to an electrospray emitter, wherein digestion of said protein by said protease occurs on the electrospray emitter. The closest prior art is the reference of Zhao (Analytical Biochemistry 2006 359:167-175). Zhao teaches a method of integrating nanoelectrospray mass spectrometry for protein analysis (see Title and abstract). Zhao teaches contacting the samples on electrospray where trypsin is immobilized on emitter surface followed by tandem mass spectrometry analysis (see page 168, left bottom paragraph). Zhao also teaches sequencing the sample in identifying the structure of protein sample together with the mass data of the tested proteins (see Table 1-3; page 170). However, Zhao considers that immobilizing protease on the emitter surface for sample digestion provides advantages of reducing rate-limiting factor in allowing more samples digestion and avoiding autodigestion (page 168, left column, 2nd paragraph). This feature teaches away from the current invention because the protease in current method is not immobilized on the electrospray emitter. Rather the current method teaches mixing sample with protease to form a final sample, then contacting the final sample to an electrospray emitter wherein digestion of the protein occurs on the electrospray emitter.
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678