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 .
Application Status
Claim 1-21 are under examination.
Claim 1-21 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the composition comprises less than 10 mass% water, does not reasonably provide enablement for the cannabis (emphasis) composition comprises less than 10 mass% water in claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to pertains the invention commensurate in scope with these claims. The Examiner suggest amendment to remove the term “cannabis” in claim 1, line 12 to overcome the rejection. Claim 2-21 are also rejected since the claims are dependent upon rejected claim 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 1-21 are rejected on the ground of nonstatutory double patenting over claim 1-21 of U.S. Patent No. 12,225,913 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: a composition comprising a cannabis composition comprising a collection of dry granules, wherein the collection of dry granules comprises: (i) a solvent extracted cannabinoid or cannabinoids; (ii) a surfactant; (iii) a carrier oil; and (iv) a sugar alcohol, wherein the cannabis composition comprises a dose of the cannabinoid or cannabinoids present in a consistent amount and having less than 0.2 mg of deviation across sample portions of the composition, and wherein the cannabis composition comprises less than 10 mass% water; with overlapping ranges of the dose of the cannabinoid or cannabinoids to claim 1-21 of U.S. Patent No. 12,225,913.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
Claim 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-23 of U.S. Patent No. 11,980,204. Although the claims at issue are not identical, they are not patentably distinct from each other because the collection of dry granules comprises: (i) a solvent extracted cannabinoid or cannabinoids; (ii) a surfactant; (iii) a carrier oil; and (iv) a sugar alcohol, wherein the cannabis composition comprises a dose of the cannabinoid or cannabinoids present in a consistent amount and having less than 0.2 mg of deviation across sample portions of the composition, and wherein the cannabis composition comprises less than 10 mass% water; with overlapping ranges of the dose of the cannabinoid or cannabinoids to claim 1-23 of U.S. Patent No. 11,980,204.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ERIK KASHNIKOW can be reached at (571)270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG T YOO/Primary Examiner, Art Unit 1792
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