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 .
Priority
This application, filed 16 December, 2024, is a CON of 17/644,473 filed 15 December, 2021, CON of 16/789,655 filed 13 February, 2020, CON of 16/134,162 filed 18 September, 2018, DIV of 15/328,661 filed 24 January, 2017 which is a national stage application of PCT/IB2015/055561 filed 22 July, 2015, which claims prior benefit of application PRO 62/028,865 filed 25 July, 2014.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 July, 2025 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 28 July, 2025, in the matter of Application N° 18/982,128. Said documents have been entered on the record.
Claims 1-27 are canceled. Claims 28-48 are new. No new matter was introduced.
Thus, Claims 28-48 represent all claims currently under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 46 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 34, from which Claim 46 depends, already requires the dihydrochloric acid salt form of Compound I.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory 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.
Examiner notes the safe-harbor provision of 35 U.S.C. 121 is not applicable to the instant application which is a continuation rather than a divisional application filed as a result of the restriction requirement. Moreover, the original lines of demarcation between the restricted inventions have not been maintained throughout the continuation prosecution, wherein subject matter from the originally restricted groups has been recombined. Accordingly, 35 U.S.C. 121 does not preclude the nonstatutory double patenting rejections set forth below.
Claims 28-37 and 39-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-9 of U.S. Patent No. 12,208,101.
Although the claims at issue are not identical, they are not patentably distinct. The patented claims are directed to tablets comprising Compound I, including the dihydrochloride salt thereof, and recite the same excipients, formulation ranges, intra- and extra-granular formulation features, and dosage amounts encompassed by the instant claims. The presently claimed tablets therefore encompass, or constitute obvious variations of, the tablets already claimed in the patent.
In particular, the patented claims encompass the Compound I tablet and formulation limitations of claims 28-37 and 39-42; the recited free-base-equivalent dosage amounts of claims 43, 45, and 47; and the dihydrochloride salt limitations of claims 44, 46, and 48.
Claims 34-37 and 39-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 10,596,178.
Although the claims at issue are not identical, they are not patentably distinct because the patented claim recites a tablet comprising the same Compound I dihydrochloride salt and the same intra- and extra-granular components in amounts encompassed by the presently claimed ranges. The additional limitations recited in the patented claim merely further define subject matter encompassed by the instant claims.
Claims 38 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 10,085,993.
Although the claims at issue are not identical, they are not patentably distinct because Claim 38 is directed to a tablet comprising Compound I prepared by the same process recited in the patented claim. Recitation of the patented process as a product-by-process limitation does not render the resulting tablet patentably distinct from the subject matter of the patented process.
Regarding Claim 48, the dihydrochloride salt is a pharmaceutically acceptable salt encompassed by the patented claim and is specifically identified in the patent encompassed by the patented claim and is specifically identified in the patent as a salt used in the claimed process. Selection of the dihydrochloride salt from the pharmaceutically acceptable salts encompassed by the patented claim constitutes an obvious variation thereof.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney 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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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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