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 .
DETAILED ACTION
This office action is in response to applicant’s filing filed on October 24, 2024.
Status of Claims
Claims 7-10 are currently pending and are the subject of this office action.
Claims 7-10 are presently under examination.
Priority
The present application is a DIV of 17/414,246 (ABN) filed on 06/15/2021, which is a 371 of PCT/EP2019/084449filed on 12/10/2019, and claims priority to foreign application EPO EP18213216.7 filed on 12/17/2018.
Claim Rejections - 35 USC § 101
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.
Claims 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to neither a “product’ nor a “process" but rather embraces or overlaps two different statutory classes set forth in 35 U.S.C. 101 which is drafted so as to set forth the statutory classes in the alternative only (MPEP 2173.05(p) (II)).
In the instant case claims 7-8 embrace or overlap a product (the compound of formula (I)) and a process for using the product (administering a therapeutically effective amount….).
It is noted that claims 7-8 are also rejected under 35 U.S.C. 112(b) paragraph as being indefinite.
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 7-8 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 pre-AIA the applicant regards as the invention.
In the instant case claims 7-8 embrace or overlap a product (the compound of formula (I)) and a process for using the product (administering a therapeutically effective amount….).
A single claim that claims both product and method of using the product is ambiguous (MPEP 2173.05(p) (II).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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.
Claim(s) 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez Nunez et. al. (WO 2017/005725, January 12, 2017, cited by Applicant).
For claims 7-10, Jimenez Nunez teaches the following compounds:
PNG
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124
252
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(Claim 4),
and
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123
237
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(Claim 5)
which anticipate the compound of formula (I) wherein R1 represents trifluoromethyl or chlorine.
Jimenez Nunez also teaches medicaments of the above compounds (see claims 10-11)
Statements like: “for use in a method of treatment and/or prophylaxis of disorders in the cerebrovascular arteries and/or disorders of peripheral arteries, administering a therapeutically effective amount of a compound of the formula (I) to a patient in need thereof” are considered intended uses of known compounds, and do not add any new limitations to the claim. Catalina Mktg. Int’l, Inc. V. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (fed. Cir. 2002). “The recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
Similar arguments can be made for all the statements in claims 8, 9 and 10.
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 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,542,245. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘245 patent claim the same compound.
Claims 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 57 of U.S. Patent No. 11,180,471. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘471 patent claim the same compound.
Claims 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4 and 6 of U.S. Patent No. 10,421,742. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘742 patent claim the same compound.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 18, 2026.
