DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The listing of claims filed 14 February 2023 has been examined.
Claims 1, 5–10, 13, 14, 16–19, 21, 23, and 24 are pending. Claims 1, 5–10, 13, 14, 17–19, 21, 23, and 24 are currently amended. Claims 2–4, 11, 12, 15, 20, and 22 are canceled.
Priority
The instant application was filed 14 February 2023; is a national stage application of PCT/EP2021/072567, filed 13 August 2021, and claims priority to EP20191203.7, filed 14 August 2020, and EP21151744.6, filed 15 January 2021. Acknowledgment is made of applicant’s claim for foreign priority and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 February 2023 is acknowledged and has been considered.
Claim Objections
Claim 1 recites “A process for the preparation of a compound of formula (I) . . .” using the indefinite article “a” with respect to “process”.
Claims 5-10, 13, 14 and 17 are objected to because of the following informalities: Claims 5–10, 13, 14, and 21 depend from claim 1 either directly or indirectly, and therefore should recite the definite article “The” in the preamble (instead of “A”) to avoid any potential confusion of the claim referring to a different process.
Appropriate correction is required.
Claim Rejections - 35 USC 112(b)
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.
Claims 1, 5–10, 13, 14, 17-19, 21, 23 and 24 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 1 recites “[a] process for the preparation of a compound of formula (I) . . .” using the indefinite article “a” with respect to the “compound of formula (I).”
Claim 1 further recites in the last line “to give a compound of formula (I)”; and claim 6 recites “part of a compound of formula (I).” It is unclear whether the compound referred to in the final lines of claims 1 and 6 is the same or different from that introduced in claim one given the latter recitations appear to be introducing a new compound rather than referring to the previously introduced compound. Examiner suggests that the latter clauses in claims 1 and 6 be amended to recite definite article “the compound of formula (I)” to clarify the subject matter claimed.
Similarly, claim 1 recites “a compound of formula (IV)” using the indefinite article “a.” Claim 13 depends from claim 1 and recites “to give a compound of formula (IV),” which should be recited using the definite article “the” to avoid any potential confusion of the claim referring to a different compound.
Similarly, claim 13 recites “a compound of formula (II)” using the indefinite article “a.” Claim 21 depends from claim 13 and therefore should recite the definite article “the” when referring back to the “compound of formula (II)” (instead of “a compound of formula (II),” in the last line) to avoid any potential confusion of the claim referring to a different compound.
Appropriate corrections are required.
Claim Rejections - 35 U.S.C. § 101 and/or 35 U.S.C. § 112(b)
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
Claims 18, 23, and 24 are rejected under 35 U.S.C. § 101 and 35 U.S.C. § 112(b) for reciting a “use” without setting forth any affirmative steps (i.e., gerunds) involved in a process. The indefinite claim does not fall within any of the statutory categories of invention.
Examiner recommends canceling claims 18, 23, and 24.
Claim Rejections - 35 U.S.C. § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 19 is rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by U.S. 6,583,154 (“Norman”).
Norman discloses 2-(1-pyrrolidinylvinyl)-2-pyridine,
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111
214
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, which reads on formula (II-a) when A is formula A-VII; p=0; and R13 and R14 together with the nitrogen atom to which they are attached form a 5-membered heterocycle. (Norman, 95:60) (col:line).
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 17/759,236 (reference claim).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is directed to compounds of formulae (Ic) or (Id), and the reference claim is directed to a genus of compounds that encompasses the compounds of formulae (Ic) and (Id). Accordingly, an infringer of a patent granted based on the claims of the instant application would also be an infringer of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion and Allowable Subject Matter
Claims 1, 5–10, 13, 14, 16, 17, and 21 are objected to and/or rejected as indefinite but would be allowable if amended to overcome the objections and indefiniteness rejections. Claim 16 further requires the approval of a terminal disclaimer.
The compounds of formulae (Ic), (Id), and (IV) in claims 16 and 17 are novel. Because the compound of formula (IV) is novel, the method of using the compound of formula (IV) in claim 1 is also novel.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623