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 .
Election/Restrictions
Claim 1 is free of the prior art, however, it stands rejected over formal matters. For the purposes of compact prosecution, the restriction requirement between Groups I-IV, as set forth in the Office action mailed on 07/07/2025, has been reconsidered. The restriction requirement is hereby withdrawn. Specifically, the restriction requirement of 07/07/2025 is withdrawn. Claims 10-14 and 17-20, directed to methods of making the compounds of Formula I, an intermediate for preparing the compounds of Formula I, and uses or methods of use of the compounds of Formula I, are no longer withdrawn. New claims 21-24 are also rejoined.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of the Claims
Claims 1-4, 6-11, and 15-24 are pending in this application. Claims 5 and 12-14 have been cancelled by applicant.
Claim Objections
Claims 1, 7-8, 16, and 20 are objected to because of the following informalities:
In claim 1, the “each” after “q’, when present, is …” should be deleted (last line).
In claim 7, missing an “a” after “form” in “…they are connected via a bond, form C3-6…” in line 1 of page 10 of the claims.
Also in claim 7, the “each” after “q’, when present, is …” should be deleted (last line).
In claim 8, missing an “a” after “form” in “…they are connected via a bond, form C3-6…” in line 7 of page 11 of the claims.
Also in claim 8, the “each” after “q’, when present, is …” should be deleted (last line).
In claim 16, Applicant should add “and wherein” after “…excipient;” and before “the pharmaceutically acceptable …” to read “…excipient; and wherein the pharmaceutically acceptable …”
In claim 20, the acronym “COPD” is not defined in the claim.
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 1-4, 6-11, and 15-24 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.
Claim 1 is drawn to the compounds of Formula III, racemates, stereoisomers, tautomers, nitrogen oxides, isotopically labeled, solvates, polymorphs, metabolites, esters, pharmaceutically acceptable salts, or prodrugs thereof. Applicant is advised that to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). See MPEP 2163.02.
The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920 (Fed. Cir. 2004), (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)). To determine whether there is adequate written description support for the genus of methods and means of achieving the claimed properties, the Specification is reviewed for species that achieve the claimed results. "[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Ariad, 94 USPQ2d at 1170-1171.
In particular, the specification does not provide any examples of nitrogen oxides, isotopically labeled, solvates, polymorphs, metabolites, esters, or prodrugs of the compounds of Formula III, particularly not in the context of treating cancers or ROCK inhibition (as shown in Tables 1-4 of the specification, wherein none of the compounds tested were nitrogen oxides, isotopically labeled, solvates, polymorphs, metabolite, ester, or prodrugs). Furthermore, none of the compounds prepared were described as crystalline, but rather as “solids”, therefore there is no support for solvates or polymorphs.
In sum, while one of ordinary skill might conclude that Applicant was in possession of the compounds of Formula III, pharmaceutically acceptable salts thereof, racemates, stereoisomers, and perhaps tautomers thereof; one would not conclude that applicant was in possession of nitrogen oxides, isotopically labeled, solvates, polymorphs, metabolites, esters, or prodrugs thereof.
Claims 18-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating diseases caused by high ROCK expression or ROCK overactivation, does not reasonably provide enablement for prevention of the same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use of the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), where the court set forth eight factors to considers when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the examples; and (8) the quantity of experimentation necessary.
Breadth of Claims
Claim 18 broadly encompasses regulation of Rho-Kinase function in any individual in need, comprising administration of a pharmaceutical composition of claim 15, which comprises any one of the compounds of Formula III, racemate, stereoisomer, tautomer, nitrogen oxide, isotopically labeled, solvate, polymorph, metabolite, ester, or pharmaceutically acceptable salt thereof, to any individual in need thereof.
Claim 19 broadly encompasses treatment or prevention of one or more diseases caused by high expression of ROCK or excessive activation of ROCK, comprising administration of any one of the compounds of Formula III, racemate, stereoisomer, tautomer, nitrogen oxide, isotopically labeled, solvate, polymorph, metabolite, ester, or pharmaceutically acceptable salt thereof, to any individual in need thereof.
Claim 20 broadly encompasses treatment or prevention of one or more diseases (listed in the claim); comprising administration of a pharmaceutical composition according to claim 15 (which comprises any one of the compounds of Formula III, racemate, stereoisomer, tautomer, nitrogen oxide, isotopically labeled, solvate, polymorph, metabolite, ester, or pharmaceutically acceptable salt thereof)
Claim 21 broadly encompasses treating or preventing any cerebrovascular disease, neurological disease, fibrosis, ocular, tumors, arterial thrombotic disorders, radiation damage, and autoimmune disease comprising administration of any one of the compounds of Formula III, racemate, stereoisomer, tautomer, nitrogen oxide, isotopically labeled, solvate, polymorph, metabolite, ester, or pharmaceutically acceptable salt thereof to any individual in need.
Claim 22 also broadly names many diseases for treatment or prevention. And Claim 23 broadly encompasses treatment or prevention of any central neuronal degeneration or pulmonary fibrosis by administering any one of the compounds of Formula III, racemate, stereoisomer, tautomer, nitrogen oxide, isotopically labeled, solvate, polymorph, metabolite, ester, or pharmaceutically acceptable salt thereof to any individual in need.
The term “individual in need” was not defined in the specification, accordingly, the broadest reasonable interpretation of the term is taken to be any animal (humans, other primates, dogs, cats, squid, etc.).
The term “prevention” was also not defined in the specification, but the Oxford English Dictionary Online (2024) defines “prevent” as “to preclude the occurrence” and thus the instant claims are broadly being interpreted to include embodiments where the claimed compositions and compounds can preclude the occurrence of the many diseases encompassed by the claims. (See definition II.9.a Provided by the online dictionary at oed.com [retrieved 0n 2025-03-05] <URL:httos://www.oed.convdictionary/prevent_y?t=true>.)
Nature of the invention/ State of the Prior Art/ Predictability in the Art
The art provides no successful method of prevention for all cancers, as taught by Gu et al. (J. Cancer Prev. 25(3): 127-135, 2020) beyond: (i) eliminating or mitigating risk factors by adopting healthy behaviors and lifestyles, such as avoiding tobacco, alcohol, and UV radiation; (ii) screening to identify precancerous lesions and taking intervention measures to prevent disease progression to malignancy; or (iii) controlling the symptoms or morbidity caused by cancer therapy. Gu also recommends that high-risk populations take chemo-preventive agents such as selective estrogen receptor modulators for breast cancer, and non-steroidal anti-inflammatory drugs (aspirin) for colorectal cancer prevention etc. There is not one single drug that works for the prevention of all cancers.
The NHS states there are no certain ways to prevent Alzheimer’s disease (reading on central neurodegenerative conditions/disorders). Obtained from nhs.uk [retrieved on 01/30/2026] <URL: https://www.nhs.uk/conditions/alzheimers-disease/prevention/>). Pub. Date: 04 July 2024.
Finally, the medical arts are also generally considered to be unpredictable making the goal of achieving prevention in this case even less likely. See Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involve.”).
Level of One of Ordinary Skill
The level of one of ordinary skill in the art would be high, likely an M.D. or Ph.D. in the medical arts (e.g., studying treatment of cancers and neurodegenerative disorders, among many others claimed). See Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at 1381–82 (Fed. Cir. 1983) (Factors that may be considered in determining level of ordinary skill in the art include: … type of problems encountered in the art …”).
Guidance/Working Examples
The specification provides no working examples for treatment or prevention of all (or any) tumors or neurodegenerative conditions, or many other conditions claimed.
Starting on page 118 of the spec. discloses a biological assay for inhibition of ROCK1 and/or ROCK2. Table 1 (page 120) shows some of these results, in which some compounds of Formula III were tested (L001-L060).
Table 2 (starting on page 123) shows IC50 of some compounds in vitro against HepG2 (hepatocellular carcinoma cells). Table 3 of the spec. (page 124) shows metabolic stabilities of some compounds in human, rat, and guinea pig liver microsomes. Finally, Table 4 (page 125) shows some pharmacokinetic experiments for oral bioavailability in mice.
Examiner notes that compounds L001-L060 from page 16-27 of the specification, show no examples of racemates (none of the compounds is chiral), stereoisomers, tautomers, nitrogen oxides, isotopically labeled, metabolites, prodrugs, esters, etc. Therefore, one of ordinary skill would not be sure whether these derivatives of the claimed compounds would perform their intended function, as claimed.
Degree of Experimentation
To practice the invention as claimed, the skilled artisan would have to screen each of the many compounds encompassed by the broad genus in instant Formula III, racemates, stereoisomers, tautomers, nitrogen oxides, isotopically labeled, metabolites, prodrugs, esters, etc., in order to determine whether the compounds meet the functional limitations of the claim for the treatment and prevention of any of the many conditions claimed. In addition, the skilled artisan would need to determine which subjects would benefit from treatment and prevention of these diseases (humans, other primates, cats, dogs, squid, etc.) by administering the instantly claimed compounds to a statistically significant pool of subjects from each species. Prevention the aforementioned conditions would require long-term monitoring of each patient for appearance of any new case of the many diseases encompassed by the claims. Thus, the quantity of experimentation in this area would be extremely large, since there are a significant number of parameters that would have to be studied. Furthermore, the ultimate outcome of such experimentation is completely unpredictable.
In sum, taking into consideration the Wands factors outlined above, an undue amount of experimentation would be required here to make and use the full scope of the claimed invention.
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 1-4, 6-11, and 15-24 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.
Claim 1 is indefinite because it is unclear to which “following groups” applicant is referring when they mention “…and the following groups unsubstituted or optionally substituted with one, two, or more Rs selected from C1-20 alkyl and C1-20 alkoxy” (line 7). Is Rs selected from C1-20 alkyl and C1-20 alkoxy or are the “following groups” C1-20 alkyl and C1-20 alkoxy? – may be missing column “:” after Rs?
Claims 1-4, 6-11, and 15-24 are rejected for depending upon the limitations of claim 1.
Claims 2-3 recite the limitation "X is connected". There is insufficient antecedent basis for this limitation in the claim. There is no X variable in Formula III.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitations “neuronal degeneration” and “kidney dialysis”, and the claim also recites “(peripheral or central)” and “(epithelial stability)” which are the narrower statement of the range/limitation. Examiner suggests removing the parentheses and information therein.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11 and 24 are rejected for failing to further limit claim 1, from which they depend. Claim 1 is drawn to the compounds of Formula III, while claims 11 and 24 expands this limitation to encompass the entirely different compounds below:
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Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 11 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Swinnen et al. (WO 2006/008303 A1) (“Swinnen”).
Claim 11 is broader than claim 1, from which it depends, therefore, this rejection applies (see 112(d)).
Regarding claim 11, Swinnen discloses the compound below, which anticipates the instant claim when m is 0; n is 0; and Y is C-2 alkoxy.
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Applicant is advised that a recitation of the intended use of the claimed invention, such as the use of Swinnen’s compound as “an intermediate for preparing the compounds of Formula III” in the instant application, must result in a structural difference between the claimed invention 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. Note: MPEP 2111.02.
Claims 11 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Louise et al. (Eur. J. Org. Chem. 2019, 1341–1349) (“Louise”).
Claims 11 and 24 are broader than claim 1, from which they depend, therefore, this rejection applies (see 112(d)).
Regarding claims 11 and 24, Louise discloses the compound below, which anticipates the claimed compounds (Scheme 1, page 1342, col. 2).
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Applicant is reminded that a recitation of the intended use of the claimed invention, such as the use of Louise’s compound as “an intermediate for preparing the compounds of Formula III” in the instant application, must result in a structural difference between the claimed invention 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.
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 1-4, 6-9, and 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/728,496 (Copending ‘496). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-4, 6-9, and 15-23, Copending ‘496 claims a salt of compound I below, reading on salts of the instant compounds of Formulae III, IV, and V (Copending ‘496’s claim 1). Copending ‘496 claims methods of treating the instantly claimed ROCK mediated conditions (Copending ‘496’s claims 15-19)
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been introduced.
Specification
Amendments to the specification are acknowledged and have been entered. No new matter has been introduced.
Claim Objections
Applicant’s arguments, see page 23, filed 12/31/2025, with respect to the objection(s) of claim(s) have been fully considered and are persuasive. Therefore, the objection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made, not necessitated by amendments. Therefore, this action is non-final.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 24, filed 12/31/2025, with respect to the 35 USC § 112(b) rejection(s) of claim(s) have been fully considered and are persuasive. Therefore, the 35 USC § 112(b) rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made, not necessitated by amendments. Therefore, this action is non-final.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see page 24-25, filed 12/31/2025, with respect to the 35 USC § 103 rejection(s) of claim(s) have been fully considered and are persuasive. Therefore, the 35 USC § 103 rejection has been withdrawn.
Double Patenting
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
The provisional non-statutory double patenting (NSDP) rejection is not the only remaining rejection, therefore, claims stand rejected over the provisional NSDP of record.
This action is non-final.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627