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 1-23 are pending. Claims 1-23 are rejected.
Priority
This application is a 371 of PCT/US2021/053577 filed 10/05/2021 which is a CIP of 17/065,795 filed 10/08/2020 (US PAT 11541039).
Information Disclosure Statement
The information disclosure statements (IDS) dated 07/12/2023, 11/22/2023, 04/09/2024, 05/03/2024, 05/15/2024, and 10/03/2024 have been considered. The information disclosure statement filed 07/31/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the following non-patent literature documents have not been included: Sessions et al., “Benzimidazole- and benzoxazole-based inhibitors of Rho Kinase,” Bioorganic and Medicinal Chemistry Letters 18, Elsevier, 2008 and Lin et al. “Bioisosteric replacement of anilide with benzoxazole: potent and orally bioavailable antagonists of VLA-4,” Bioorganic and Medicinal Chemistry Letters, 2004.
It has been placed in the application file, but the information referred to therein has not been considered as to the merits, except where noted by the Examiner. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Claims 1 and 13 and their dependent claims are objected to. The claims could be improved by including an article in front of the word “Compound”. The Examiner recommends amending the first line of each claim to “A compound of the formula (I)”.
Claims 2-12 and 14-19 could be improved by including an article in front of the word “Compound”. The Examiner recommends beginning each claim with the phrase “The compound according to…”.
Claim 1 and its dependent claims are objected to for being written in improper Markush format. The examiner recommends changing “or” to “and” in the second line of the paragraph beginning with “A is selected from…” .
Claims 2-5 state that the various R groups recited “have the same definition as above.” The Examiner recommends amending the phrase to “have the same definition as in claim 1” or “are as defined in claim 1”.
Claims 12 and 14 do not end in a period. Each claim should begin with a capital letter and end with a period. See MPEP 608.01 (m).
Claims 12 and 14 are objected to as being substantial duplicates since they recite the same explicit set of compounds and the intended use is not given patentable weight.
Claim 19 is objected to for being written in improper Markush format. The examiner recommends changing “or” to “and” on page 96, line 11.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 19-21 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 19, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may amend the claim by deleting the phrase “such as diabetes mellitus, sickle cell disease or radiation therapy”.
Claim 20 recites the limitation "The pharmaceutical composition…” in line 1. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the phrase to state “A pharmaceutical composition…”.
In claim 21, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may amend the claim by deleting the phrase “preferably intravitreal or suprachoroidal injection”.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-12 and 20-23 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-12 and 20-23 of prior U.S. Patent No. 11,541,039, as cited in IDS dated 7/12/2023. This is a statutory double patenting rejection.
Patent ‘039 teaches compound claims 1-12 are explicitly identical to the compounds recited in present claims 1-12. Additionally, patent ‘039 composition claims 20-23 are drawn to the same invention as present claims 20-23, as the intended use for treatment and/or prevention of a disease involving the retinal pigment epithelium is not given patentable weight. Thus, claims 1-12 and 20-23 are directed to the same invention as the patented invention.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 2) Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,541,039, as cited in IDS dated 7/12/2023. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the present claims.
Patent ‘039 teaches compounds 1-11 in claim 12 that anticipate instant claims 1-2, 4, and 6-24. For instance, patent ‘039 teaches compound 5
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in claim 12 which is embraced by instant formula (I)
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of claim 1 wherein X is NH; R11, R12, and R13 are each hydrogen; and A is the residue of formula (IV)
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wherein each of R2II, R4II and R5II are hydrogen and R3II is F. Since the compound is identified as a racemate, it is presumed that both enantiomers as described in claims 2 and 4 are anticipated. The structure anticipates claims 1-2, 4, 6, 8, and 10-24. As another example, patent ‘039 teaches compounds 10 and 11, both enantiomers of the following structure:
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in claim 12 which is embraced by instant formula (I)
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of claim 1 wherein X is O; R11, R12, and R13 are each hydrogen; and A is the residue of formula (IV)
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wherein each of R2II, R3II, R4II and R5II are hydrogen. The structure anticipates claims 1-2, 4, 6-7, 9 and 12-24.
Further, method claims 13-19 wherein a compound of formula (I) is used to treat a disease involving the retinal pigment epithelium. These patented claims are nearly identical to present claims 13-19 except that the present claims are compound claims with the same intended use as the patented claims.
Thus, claims 1-2, 4 and 6-23 are anticipated by the patent claims.
Instant claims 3 and 5 are drawn to different stereochemical configurations of formula (VII),
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and
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, respectively. Since patent ‘039 teaches the same chemical formulas in claims 3 and 5, a skilled artisan would be motivated to modify any of the short list of compounds 1-11 (patented claim 12) in accordance with formula (VII) (patented claims 3 and 5). In order to optimize the compounds’ utility toward diseases involving the retinal pigment epithelium, the skilled artisan would modify the structures of compounds 1-11 of formula (I)
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wherein A is (VII)
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, as presented in patented claim 1. When each of the claimed compounds 1-11 is modified in this way, the skilled artisan would produce up to a finite list of 11 obvious variants of the patented invention, assuming no changes in the substituents as described for said compounds. When patented compound 7
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, for instance, is substituted at the A site of formula (I) with the residue of formula (VII), present claims 3 and 5 would be embraced. Thus, claims 3 and 5 are obvious over the patented claims.
(2 of 2) Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,844,755. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the present claims.
Patent ‘055 teaches methods of treating a disease involving the retinal pigment epithelium using a compound selected from 1-11. See claim 1. Compounds 1-11 of the patented methods in ‘055 are identical to compounds 1-11 in present claims 12 and 14, and said compounds are embraced by Formula (I) of present claims 1-23. Further, present claim 13 is directed to the same intended use for compounds of Formula (I), namely as a treatment and/or prevention of a disease involving the retinal pigment epithelium. Thus, claims 1-23 are anticipated by the patent claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached on (571) 272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626