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 .
This action is responsive to the most recent claim set, filed on Dec. 2, 2024. Claims 1-20 are pending and examined below.
Priority
This application is a CON of U.S. App. Serial No. 17,577,519 (issued as U.S. Patent No. 12,194,194), which is a DIV of U.S. App. Serial No. 15/767,957 (issued as U.S. Patent No. 11,253,631), which is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US2016/056675, filed Oct. 12, 2016. Applicant’s claim for the benefit of a prior-filed parent provisional application 62/240,345 filed on Oct. 12, 2015 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is Oct. 12, 2016.
Information Disclosure Statement
The information disclosure statement filed March 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 14-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the “soft tissue protein composition of claim 5,” that is, the claim appears to depend from itself, which renders the claim indefinite.
For the purposes of examination, this claim is interpreted as depending from claim 4.
Claims 14 and 16 recite the composition of claims 1, 7, 13 and 15, and then recite
in a wherein clause that the composition "is implanted or otherwise administered to a subject".
This is confusing, as the claims recite a composition. Is this claim intending to claim a composition that is implanted in a subject? Is this claim intending to be adding a step to the
product-by-process claims, which would not make sense as the process claims recited as those
that are undertaken to form the product. It is also possible that this wherein limitation is
intended to recite intended use - that the product could be used therapeutically (by being
administered to a subject).
For the purposes of examination, the claims are being interpreted as reciting intended
use - as this interpretation allows the claims to be classified as "product."
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-10, 13, and 17-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-16 of prior U.S. Patent No. 12,194,194 (the ‘194 patent). This is a statutory double patenting rejection. With respect to the claims, claim 1-5 of the patent are identical to claims 1-5 of the application. Claim 6 of the ‘194 patent is the same as claim 15 of the application. Claim 7 of the ‘194 patent is the same as claim 6 of the application. Claim 8 of the ‘194 patent is the same as claim 7 of the application. Claim 9 of the ‘194 patent is the same as claim 8 of the application. Claim 10 of the ‘194 patent is the same as claim 8 of the application. Claim 11 of the ‘194 patent is the same as claim 10 of the application. Claim 12 of the ‘194 patent is the same as claim 13 of the application. Claim 13 of the ‘194 patent is the same as claim 17 of the application. Claim 14 of the ‘194 patent is the same as claim 18 of the application. Claim 15 of the ‘194 patent is the same as claim 19 of the application. Claim 16 of the ‘194 patent is the same as claim 20 of the application.
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 1-13, 15 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,253,631 (the ‘631 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the application recite that the dehydrated soluble soft tissue protein composition includes a bioactive factor, and the ‘631 patent teaches a method of making a composition but does not recite the presence of a bioactive factor; however this element must also be present in the method of making the composition taught by the ‘631 patent, as the steps recited for obtaining the composition are identical. Claims 2-6 of the ‘631 patent mirror claims 2-6 of the application. Claim 10 of the ‘631 patent mirrors claim 7 of the application. Claim 11 of the ‘631 patent mirrors claim 8 of the application. Claim 12 of the ‘631 patent mirrors claim 9 of the application. Claim 13 of the ‘631 patent mirrors claim 10 of the application. Claim 14 of the ‘631 patent mirrors claim 11 of the application. Claim 15 of the ‘631 patent mirrors claim 15 of the application. Claim 16 of the ‘631 patent mirrors claim 16 of the application and renders obvious claim 17-20.
Claims 11, 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No 12,194,194 (the ‘194 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the additional limitations added by claims 11, 12 and 15 do not add non-obvious limitations to those already taught by the ‘194 patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634
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