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 .
Status of the Claims
Claims 1-4, 6-11, 15-16, and 20-25 are pending in this application. Claims 5, 12-14, and 17-19 have been cancelled by Applicant.
Examiner Notes
Claims 1-4, 6-11, 15-16, and 20-25 are free of the prior art, however, they stand rejected/ objected over formal matters and/ or a provisional non-statutory double patenting rejection – see response to arguments section.
Claim Objections
Claim 11 is objected to because the claim references the intermediate of formula
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, wherein
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is defined.
As an initial matter, as mentioned in the 112(b) rejection below, claim 11 should be dependent upon the method claim 10 . . . then, formula
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can be referred to as Formula III-2. After these changes, claim 11 should read: “The method of claim 10, wherein in Formula III-2, the group corresponding to
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is . . . “ – thus, removing the wavy line bound to the nitrogen (since the group in this position of III-2 is always H).
Claim 24 should read: “The method of claim 11, wherein intermediate III-2 . . .” or something to that effect.
Appropriate correction is required.
Claims 10 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 11 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 11 is drawn to “a method of preparing a compound of Formula III according to claim 1, using an intermediate . . .” This claim is indefinite because claim 11 speaks to a process of making, however, claim 11 lacks an active step. Examiner believes Applicant intended for claim 11 to depend upon claim 10, which is properly drawn to a method of preparing the compounds of Formula III comprising reacting compounds III-1 and III-2. Examiner suggests making claim 11 dependent upon the method of claim 10 – Thus, claim 11 should read: “The method of claim 10, wherein in Formula III-2, the group corresponding to
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is . . . “ or something to that effect. See claim objection.
Claim 24 is rejected for depending upon the limitations of claim 11. Furthermore, claim 24 should read: “The method of claim 11, wherein intermediate III-2 . . .” or something to that effect. See claim objections.
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 1-4, 6-9, 15-16, and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/728,496 (Copending ‘496). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-4, 6-9, 15-16, and 20-23, Copending ‘496 claims a salt of compound I below, reading on salts of the instant compounds of Formulae III, IV, and V (Copending ‘496’s claim 1). Copending ‘496 claims methods of treating the instantly claimed ROCK mediated conditions (Copending ‘496’s claims 15-19)
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims/ Claim Objections
Claim amendments are acknowledged and have been entered. No new matter has been introduced. In view of claim amendments, claim objections have been withdrawn.
Claim Rejections - 35 USC § 112(a)
In view of claim amendments, 35 USC § 112(a) rejections of the claims have been withdrawn.
Claim Rejections - 35 USC § 112(b)
In view of claim amendments, 35 USC § 112(b) rejections of the claims have been withdrawn. However, in view of claim amendments, a new ground of rejections has been raised herein.
Claim Rejections - 35 USC § 112(d)
In view of claim amendments, 35 USC § 112(d) rejections of the claims have been withdrawn.
Claim Rejections - 35 USC § 102
In view of claim amendments, 35 USC § 102 rejections of the claims have been withdrawn.
Double Patenting
Per MPEP § 804(1)(B)(1)(b)(i), if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. In the present case, Copending Application No. 18/728,496 has an effective patent term date of 01/10/2023, while the instant Application has an effective patent term date of 07/08/2021. Since the provisional non-statutory double patenting rejection over Copending ‘496 is not the only pending rejection, the provisional non-statutory double patenting rejection over Copending ‘496 is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627