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 04/09/2024 is a Continuation of 17805875, filed 06/08/2022.
17805875 is a Continuation of 16772615, filed 06/12/2020.
16772615 is a National Stage entry of PCT/EP2018/084978, International Filing Date: 12/14/2018. PCT/EP2018/084978 claims foreign priority to 17207661.4, filed 12/15/2017.
Status of Claims
Claims 18-38 are currently pending. Claims 1-17 have been canceled.
Claims 18-38 were examined and are rejected.
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 19-38 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.
Claims 19-33 recite direct dependence to claim 1, however, claim 1 has been canceled. There is insufficient antecedent basis for the limitations in these claims, and as such the claims are indefinite. Claims 34-38 depend directly from claim 33, therefore indirectly from claim 1, and as such are similarly rejected for indefiniteness.
To overcome this rejection, it is suggested claims 19-33 be amended to depend directly from independent claim 18.
Claim Rejections-Nonstatutory 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-
Claims 18-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11384096 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compounds that overlap in scope structurally. In particular, the claims of the patent are drawn to compounds of formula (I):
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. The compounds shown above overlap with those of the instant claims, specifically when R1=phenyl or phenyl substituted with R3, wherein R3=halogen; R2=4-7 membered heterocyclyl, which can be optionally substituted with R4, wherein R4 includes -C(O)(ORx), and Rx=C1-4 alkyl. The instant claims also encompass the (R)-enantiomer compounds claimed in the patent (see instant claim 29). Moreover, both sets of claims are drawn to methods of treating a disease or disorder responsive to PDE4 inhibition, by administering a compound as described above (see instant claims 33-38 & patented claims 8-12). As such, the instant and patented claims are not patentably distinct.
Claims 18-20, 22-24, 27, and 29-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11981681 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compounds that overlap structurally in scope. For instance, the patented claims are drawn to the following compound, or a pharmaceutical salt, enantiomer, or mixture of enantiomers thereof:
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The compound is included within formula (I) of the instant claims, having R1=4-fluorophenyl; and R2=tetrahydropyranyl. Additionally, both sets of claims are drawn to methods of treating a disease or disorder responsive to PDE4 inhibition, by administering a compound as described above (see instant claims 33-38 & patented claims 17-21). As such, the instant and patented claims are not patentably distinct.
Information Disclosure Statement
The IDS filed on 8/23/24 has been considered by the examiner.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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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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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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