NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/EP2023/054494, filed Feb. 23, 2023, which claims benefit of foreign priority to EP 22158443.6, filed 02/24/2022
Claims 1-3 and 6-9, as amended, are pending.
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
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Aug. 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 8 is set forth as follows:
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The claim does not fall within at least one of the four categories of patent eligible subject matter because it does not recite a machine, composition, or article of manufacture; nor can it be construed as a process claim, because it refers to both manufacturing and treating, without reciting any active method steps.
Claim Rejections - 35 U.S.C. § 112(b) - Indefiniteness
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.
Claim 8 is 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.
As recognized by MPEP § 2173.05(q), attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Here, claim 8 recites the use of a compound for the manufacture of a medicament, as well as for the treatment of a disease, without setting forth any affirmative steps that delimit how the use is actually practiced. Thus, claim 8 is an incoherent hybrid, with no clear limitations setting forth a clearly defined process with active method steps.
Thus, the scope of claim 8 cannot be ascertained, because it recites a use without any active steps, and mixes manufacturing and treating so that applicant's intent is unclear.
The only active verb recited ("administered") is in the form of a "wherein" clause, which merely recites an intended use of the compound, and thus is given no patentable weight.
As recognized by MPEP § 2111.02 (II), a recitation of the intended use of the claimed product (for the manufacture of a medicament or for the treatment of a disease) must result in a structural difference between the claimed product and the prior art in order to patentably distinguish the product from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See also MPEP § 2111.04.
Because claim 8 fails to set forth any process with sufficient clarity, the scope of a "use" claim is inherently ambiguous, rendering the metes and bounds of the claim indefinite.
For examination purposes, claim 8 is construed as directed to a product (the claimed compound, [(2S)-1-(4-{[(3-chloro-4-methoxyphenyl)methyl]amino}-5-{[(pyrimidin-2-yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6-(nitrooxy)hexanoate).
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.
Claims 1-3 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Almirante et al. (WO 2020/030489, cited on the IDS dated 8/23/2024).
Almirante et al. exemplify the claimed compound, [(2S)-1-(4-{[(3-chloro-4-methoxyphenyl)methyl]amino}-5-{[(pyrimidin-2-yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6-(nitrooxy)hexanoate, as compound (9) (p. 23, lines 6-10; claim 16), having the structural formula,
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as recited by claims 1-3 and 6-9.
Almirante et al. exemplify the administration of the citrate salt of Compound (9) topically to the eye (Example 23), as recited by claims 1-3, 6, and 8.
The compounds of Almirante et al. are disclosed in an ophthalmic pharmaceutical composition together with a pharmaceutical acceptable excipient or vehicle (claim 23), as recited by claims 6 and 9.
The ophthalmic pharmaceutical compositions of Almirante et al. may comprise another active agent selected from, e.g., steroids (claims 24-25), e.g., dexamethasone (p. 28, lines 18-19), a corticosteroid. It is implicit in administering this combination that the patient receives concomitant treatment with a corticosteroid, as recited by claim 7.
The compounds of Almirante et al. are not explicitly disclosed "for use in the treatment of arteritic or non-arteritic anterior ischemic optic neuropathy in a patient in need thereof," as recited by claims 1-3, 8, and 9.
However, this merely recites the intended use of the compound, and is given no patentable weight. As recognized by MPEP § 2111.02 (II), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed compound and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
For the foregoing reasons, Almirante et al. anticipates claims 1-3 and 6-9.
Obviousness-Type 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.
1. Claims 1-3 and 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. application no. 17/760,012 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Specifically, the reference claims are drawn to ophthalmic compositions comprising [(2S)-1-(4-{[(3-chloro-4-methoxyphenyl)methyl]amino}-5-{[(pyrimidin-2-yl)methyl] carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6-(nitrooxy)hexanoate or a pharmaceutically acceptable salt thereof, and a prostaglandin analog.
The compound of the reference claims is identical to the compound recited by examined claims 1-3 and 6-9.
Further, reference claim 12 is drawn to an ophthalmic pharmaceutical formulation comprising the compound and a pharmaceutically acceptable excipient and/or vehicle, as recited by examined claim 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-3 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 9, and 11 of copending Application No. 18/251,283 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Specifically, the reference claims are drawn to methods for treating dry age-related macular degeneration and/or geographic atrophy, providing neuroprotection to a patient suffering from glaucoma, or treating or preventing retinal neuropathies, comprising administering the compound [(2S)-1-(4-{[(3-chloro-4-methoxyphenyl)methyl]amino}-5-{[(pyrimidin-2-yl) methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6-(nitrooxy)hexanoate (Compound (7)), which is identical to the compound recited by examined claims 1-3 and 6-9.
It is implicit in methods of treating an ophthalmic disease by administering the compound to a patient that the compound is in an ophthalmic composition comprising a pharmaceutically acceptable vehicle, as recited by examined claim 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-3 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/714,300 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Specifically, the reference claims are drawn to ophthalmic formulations comprising 0.8% to 1.8% w/w of [(2S)-1-(4-{[(3-chloro-4-methoxyphenyl)methyl]amino}-5-{[(pyrimidin-2-yl)methyl]-carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6-(nitrooxy)hexanoate, which is identical to the compound recited by examined claims 1-3 and 6-9.
Further, the formulation of the reference claims comprises a pharmaceutically acceptable vehicle, which falls within the scope of the ophthalmic composition recited by examined claim 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4. Claims 1-3 and 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 6, 7, and 10-12 of U.S. Patent No. 11,980,618. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Specifically, the reference claims are drawn to a compound of formula (II) or a stereoisomer or a pharmaceutically acceptable salt thereof, including (S)-(1-(4-(3-chloro-4-methoxybenzylamino)-5-(pyrimidin-2-yl-methylcarbamoyl) pyrimidin-2-yl)pyrrolidin-2-yl)methyl 6-(nitrooxy)hexanoate (Compound (9)), which is identical to the compound recited by examined claims 1-3 and 6-9.
Further, reference claims 10-12 are drawn to an ophthalmic pharmaceutical compositions comprising the compound, and a pharmaceutically acceptable excipient and/or vehicle, as recited by examined claim 9.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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