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 .1
Status of Claims
Claims 1, 6-7, 10-11, 13, 16, 19, 23-24, 26-27, 29, 33, 35, 41, 47, 50-51, 56, 60, 63, and 76 are under examination.
Election/Restrictions
Claims 7, 11, 13, 23 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 13, 2026.
Applicant’s election without traverse of species (aka Compound X) (1S,4s )-4-(2-Fluoro-4-methoxy-5-( ((1 S,2R,3 S,4R)-3-(((1-methylcyclobutyl) methyl) carbamoyl) bicyclo[2.2.1]heptan-2-yl)carbamoyl)phenoxy)-1-methylcyclohexane-1-carboxylic acid,
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in the reply filed on April 13, 2026 is acknowledged. Note, this claimed/elected compound was found to be allowable in the parent case of 17/457,953, issued as US PAT 11667602 (this case claims priority to as a continuation). The scope of compounds searched and considered has been expanded to include the prior art compound cited in the anticipation rejection below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 76 is objected to because of the following informalities:.
Claim 76 recites an underscore mark between “1” and the term “and.”
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Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6, 10, 16, 19, 24, 26, 27, 29, 33, 35, 47, 50, 51, 56, 63 and 76 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Claimed Invention
Claim 1 is broadly directed to a compound of formula I.
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or a pharmaceutically acceptable salt, where
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Certain narrower embodiments of the invention are presented in various dependent claims. Some of these claims further the claimed groups and substituents as detailed therein. Claim 60 recites the claimed and elected species which is NOT rejected for written description.
The Supporting Disclosure
Applicants’ supporting disclosure contains certain descriptions and embodiments of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of sufficient working examples of the invention as claimed, and the lack of predictability in the art.
In the present case there is no disclosure of compounds having the broad and full scope definitions of Ring A, which is further defined by ANY 4-10 membered cycloalkyl; heterocycloalkyl (O and N heteroatoms); heterocycloalkenyl (O and N heteroatoms); or cycloalkenyl;
Ring C is broadly 6-10 membered aryl, 5-10 membered heteroaryl; 4-10 membered cycloalkenyl/heterocycloalkenyl; and
R6 is broadly –(CR10R11)nR12, where
R12 is any of alkyl, heterocycloalkyl, phenyl and heteroaryl defined above.
In contrast to the broad claimed scope of Rings A, B, C, R6 and R12, the supporting disclosure (Tables 1-35 and associated 624 example compounds), merely describe Ring B as
Cyclobutyl (compound 301),
Cyclopentyl (for example compounds 299-318),
Cyclooctyl (for example compound 351),
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Bicyclo[2.2.1]heptan-2-yl (for example compounds 18-21),
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Bicyclo[2.2.1]hepten-2-yl (for example compounds 237-288),
Phenyl (compound 153),
Isothiazole (compound 20),
Thiophene (compound 154),
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Oxabicyclo[2.2.1]heptan-2-yl (for example compounds 322),
Tetrahydropyran (compound 341),
Tetrahydrofuran (compound 342),
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bicyclo [2.2.2] octan-2-yl (compound 368).
Further, R6, which is noted comprise R12, where the R6 and R12 scope of Tables 1-35 and 624 example compounds, is narrower than that claimed in claim 1, where R12 is exemplified by Tables 1-35 as merely being;
Substituted phenyl (compound 18),
Substituted pyrimidinyl (compound 331),
Non-substituted or substituted alkyl (compounds 39, 41, 167-168),
Unsubstituted or substituted cycloalkyl (compounds 72, 82, 87 and 121),
Alkoxy (compound 76),
Alkyl substituted with aryl (phenyl compound 108) or substituted with heteroaryl (pyrimidinyl compound 114) or heterocycloalkyl (tetrahydropyran compound 137), and
Heterocycloalkyl (piperidinyl compounds 311-312).
Further, the scope of R1-Z-Y-X- is narrower than that claimed in claim 1, where R1-Z-Y-X- is exemplified by Tables 1-35 as merely being :
Substituted azetidinyl, pyrrolidinyl and piperidinyl rings,
X is either only a bond or oxygen,
Substituted cyclohexyl (compound 167, note X is oxygen),
Substituted phenyl (compounds 248 and 250), pyridinyl (compound 249), thiophenyl (compound 285), thiazole (280—287),
Alkenyl,
Substituted hereroarylenyl (R1 is COOH) compounds 238, 240, 241, 242, 243, 246 and 249
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Substituted fused ring system (compounds 253-254),
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bicyclo [2.2.2] octan-2-yl (compound 441),
Substituted tetrahydropyran (compound 442), and
Various substituted cycloalkyls (cyclohexyl compound 443, cyclobutyl compound 445, etc.).
Applicant’s disclosure of Tables 1-35, representative of compounds 1-624 of the application, is not a sufficient representation of all the compounds of claim 1 (and dependent claims) as presently pending.
Other than the working examples of the specification (compounds 1-624), such as the subset of compounds of Tables 1-35, Applicant has not reasonably described a scientific or “systematic” approach to synthesize the full scope of claim 1 and claims dependent. See MPEP 2163.02, the standard for determining compliance with the written description.2
Although Applicant has written description support for example compounds 1-624, Applicant has not provided reasonably provided a description the support the broader scope of the claimed compounds of formula I.
Accordingly, Applicant has not adequately described the invention for the breadth that is claimed. It thus appears that Applicant was not in possession of the claimed invention at the time the application was filed, the full scope of compounds of formula I, and that Applicants’ species do not fully support the claimed genus.
Claim Rejections - 35 USC § 102
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, 16, 24, 35, 50 and 51 are rejected under 35 U.S.C. 102*a)(1) as being anticipated by STN Registry Record of CAS 41652-24-8, entered STN Nov 16 1984. This reference is cited on the PTO-892 form.
Claim 1 is directed to a compound of formula I or a pharmaceutically acceptable salt.
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, where R1-R5, U, V, W, Y, Y, A and A are defined above.
Claim 1 includes a species of compound where U, V and W are carbon, A is Ring C, where the C ring is the six membered aryl group phenyl; R1 is COOH; Z is a bond and R2, R3 and R4 are each independently H.
STN Registry Record of CAS 41652-24-8 discloses the below compound, that anticipates such a species of formula I, claim 1
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.
The above compound anticipates the claims, such as claims 1 and 50 as it discloses a species where U, V and W are carbon atoms.
As required by claim 16, the above compound discloses at similar position, where A is Ring C, where the C ring is the six membered aryl group phenyl.
As required by claim 24, the above compound discloses at an equivalent position, where R1 is COOH.
As required by claim 35, the above compound discloses at an equivalent position Z is a bond.
As required by claim 51, the above compound discloses at equivalent positions, where R2, R3 and R4 are each independently H.
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 1, 6, 10, 16, 19, 24, 26, 27, 29, 33, 35, 47, 50, 51, 56, 60, 63, and 76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. 11667602. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claims 1, 6, 10, 16, 19, 24, 26, 27, 29, 33, 35, 47, 50, 51, 56, 60, 63, and 76 are directed generically to the elected species of compound,
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Reference patent claims 1-6 claim the elected compound, pharmaceutically acceptable salts thereof and pharmaceutical compositions comprising said same elected compound.
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A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent claim would have found it prima facie obvious to arrive at the claimed compound claims, since the reference claims teach the elected compound, as well as pharmaceutically acceptable salts thereof and pharmaceutical compositions comprising the elected species. See MPEP 2143(a), the reference patent claim’s combined teaching of the elected species directed to the examined claims predictably yields the elected species.
Claims 1, 6, 10, 16, 19, 24, 26, 27, 29, 33, 35, 47, 50, 51, 56, 60, 63, and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/872313 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are directed to elected species.
Conflict application claims 1-11 are directed to methods of treating a subject with a condition that is resistant to hypertension or heart failure with pulmonary hypertension with the same compound, pharmaceutically acceptable salts and pharmaceutical compositions comprising said compound as elected. See claim 1, in particular compound 4.
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A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent claim would have found it prima facie obvious to arrive at the claimed compound claims, since the reference claims all teach the elected species of compound.
See MPEP 2143(a), the reference application claim’s combined teaching of the elected species for a method of treating a disease conditions predictably yields the elected species, as well as making it obvious to try (MPEP2143(e)) a pharmaceutical composition as claimed, since the reference claims teach a method of treating a subject in need. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion and Correspondence
In summary, now claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 17/457,953 12/07/2021 PAT 11667602
17/457,953 has PRO 63/122,690 12/08/2020
2 Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68,119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
Prosecution Insights