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 20-38 are pending and examined.
Claims
Claims 20, 23 and 31 are objected to because of the following informalities: Claims 20, 23, and 31 have a blank and is missing the NCMA deposit number for ‘SIL08XP03’. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: On page 257 of the specification in the section titled DEPOSIT INFORMATION the varieties listed in lines 5-7 do not reference any accession number for any depository for ‘CBD05’, and the NCIMB 42248 deposit does not indicate that the deposit is to tissue as recited in the instant claims. Previously NCIMB 42248 was claimed in U.S. Patent 9095554 and is drawn to deposited seeds not tissue; and similarly in U.S. Patent 9642317. It would appear that there is no antecedent basis for deposited tissue of ‘SIL08XP03’ in the specification on page 257 drawn to seed deposit NCIMB 42248. It is noted that Applicants have deposited tissue for CBD05 in U.S. Patent 10441617.
Appropriate correction is required.
Deposit Rejection
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.
Claims 20-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the claimed cannabis tissue of ‘CBD05’ and ‘SIL08XP-03’ is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If tissue of ‘CBD05’ and ‘SIL08XP-03’ is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same tissue of ‘CBD05’ and ‘SIL08XP-03’ in a predictable manner; and it is not apparent if such tissue is readily available to the public.
It is noted that Applicants have deposited tissue for CBD05 under NCMA No. 201904001 in U.S. Patent 10441617 and intends to deposit tissue of ‘SIL08XP03’ at the NCMA. However, the deposit information on page 257 does indicate any deposit information for either the tissue of ‘CBD05’ or ‘SIL08XP-03’ and thus it appears that the deposit information requires remediation. The mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement of an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
If it is Applicants’ intention that the deposit will not be made under the Budapest Treaty, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
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 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 10411216. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to a method of making an F1 progeny by crossing CBD05 (NCMA No. 201904001) with a different plant.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 9095554. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to a method of making an F1 progeny by crossing ‘SIL08XP03’ with a different cannabis plant.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 9642317. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to a method of making an F1 progeny by crossing ‘SIL08XP03’ with a different cannabis plant.
Claims 20-38 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL KALLIS whose telephone number is (571)272-0798. The examiner can normally be reached Monday-Friday 8AM-5PM.
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/RUSSELL KALLIS/Primary Examiner, Art Unit 1663