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
Claims 21-30 and 33-41 are pending in the present application file.
AMENDMENTS
The amendment filed January 20, 2026 has been acknowledged and entered in the present application file.
Previous Claim Rejections - 35 USC § 112
Claims 21-33 were previously 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.
Applicant has amended the previous claims and traversed the rejection on grounds the present definition for R2 and R3 encompasses C5-C10 heterocycles which may be further substituted by moieties including -C1-C6 alkyl, -C3-C7 cycloalkyl or 3- to 11-membered heterocycle, where the moieties may be still further substituted. Applicant argues that when R2 or R3 is C11-C14 heterocycle, the structure of R2 or R3 is clearly defined.
Applicant’s arguments, see pgs. 10-11, filed January 20, 2026, with respect to claims 21-33 have been fully considered and are persuasive. The rejection of December 02, 2025 has been withdrawn.
Previous Claim Rejections - 35 USC § 103
Claims 21-28, 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0243338 A1.
Applicant traverses previous rejection on grounds US ’338 discloses a compound where R is H instead of methyl as required in present formula (I), US ’338 does not disclose kinase inhibitory activity for the compound 83, the present compounds where R is methyl display unexpected activity with respect to ROCK2 inhibitory activity, and the pending claims are not obvious in view of the prior art.
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ROCK2 inhibitory activity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the prior art does not disclose ROCK inhibitory activity or kinase activity for compound 83, a recitation of the intended use of the claimed invention 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. See MPEP 2111.02(II).
Applicant has amended the present claims to recite “A kinase inhibitor compound of Formula (I)”. This limitation is interpreted as an intended use for the compounds of present formula (I) and thus not given patentable weight. In this situation, the limitation does not affect the structure of the compound of formula (I). The present claims are interpreted for the purposes of applying prior art as a compound comprising the present formula (I) of present claim 1.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. See MPEP 2143.02(I). OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). The prior art does not need to disclose ROCK inhibitory activity for a specific compound or further working examples demonstrating the kinase activity to establish a reasonable expectation of success.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02 (d) and MPEP 716.02 (e).
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1. Table A disclosing ROCK inhibitor activity for exemplary compounds of US 2014/0243338 A1.
Applicant refers to alleged unexpected ROCK2 inhibitory activity results for compounds of the instant invention where R=C1 alkyl; however, in view of the results disclosed in Table A of US ‘338 where analogous compounds (see compound 65 below) have <1 nM ROCK2 IC50, and even as low as 0.85 nM for several compounds (see compound 6-8 and 65). The compounds relied upon in Applicant remarks filed January 20, 2026 – compounds 3, 5, 15 and 62 – each are compounds of formula (I) where Z1 is not pyrazole; therefore, the analysis is not relevant to the present claims.
Regardless, Applicant has not compared the unexpected results provided to the prior art to effectively rebut the prima facie case of obviousness previously set forth. While Applicant provides exemplary compounds where Z1 is pyrazole; Z2 is phenyl, pyridine or pyrazole; and R is methyl, as required by the present claims (see compounds 97, 104-105, 113 and 115), the results provided are not compared to the prior art to establish the unexpected nature and a prima facie case of nonobviousness.
“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
The issue of patentability over the replacement of alkyl groups for hydrogen has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that “one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious – at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound – at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results – at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification); Ex parte Fauque 121 USPQ 425 (where di(methyl-furyl)-methane was considered a higher homolog of difuryl-methane and unpatentable without a showing of unexpected results - at page 426).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds would have the same utility as the compounds taught by the prior art. In the interest of generating additional compounds that have the same utility as the compounds taught by the prior, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the prior art that have already been demonstrated to have the desired utility. As discussed above, the replacement of hydrogen for an alkyl group falls under the well-established doctrine of homology, which assumes that homologous compounds are likely to have similar properties. Therefore, the instantly claimed compound, which differs by hydrogen/alkyl, over a compound of prior art is unpatentable absent a showing of unexpected results. MPEP 2144.09 (VII) states “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).” In the instant case, Applicant has not established unexpected properties between the instantly claimed compound and the closest prior art homolog. In the instant case, a person having ordinary skill in the art at the time the invention was made would have been motivated to synthesize the instantly claimed homolog with the reasonable expectation that it would have the same utility as the closest structurally related compound taught by the prior and with the motivation of obtaining additional useful compounds.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). See MPEP 2145 (X), Subsection A.
Therefore, the previous rejection is maintained in an amended form necessitated by Applicant’s amendment and traversal.
Previous Double Patenting Rejection
Claims 21-33 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16 and 18-19 of U.S. Patent No. 10,738,007. Although the claims at issue are not identical, they are not patentably distinct from each other because both directed to phenylpyrazole compounds of formula (I).
Until the double patenting rejection is overcome, the previous rejection is maintained.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 02/17/2026 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Interpretation
Regarding the limitation “A kinase inhibitor compound”, recited in present claim 21, this limitation is interpreted as an intended use for the compounds of present formula (I) and thus not given patentable weight. A recitation of the intended use of the claimed invention 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.
Regarding an intended use limitation, MPEP 2111.02(II) notes:
“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”.
In this situation, the limitation does not affect the structure of the compound of formula (I).
If the prior art structure is capable of performing the intended use, then it meets the claim. The present claims are interpreted for the purposes of applying prior art as a compound comprising the present formula (I) of the present claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-28, 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0243338 A1.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
US ‘338 discloses phenylpyrazole derivatives of formula (I), compositions containing them, and methods of using them for the treatment or prophylaxis of disorders associated with aberrant Rho kinase activity. See abstract, paragraphs 12-16 and paragraphs 24-141 of US ‘338.
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2. Compound 83 of US '338.
US ‘338 discloses specific compound example 83 in Table 2 which corresponds to a compound of formula (I) wherein:
Z1 is pyrazole
Z2 is phenyl, substituted with -OR’
Where R’ is methyl
See also third recited alternative for Z2 in present claim 22
R1 is H
X is a bond
R2 is H
R3 is cyclopropyl substituted with -C1 alkyl
See present claims 21-24, 26-28 and 30.
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US ‘338 discloses specific compound example 65 in paragraph 295 which corresponds to a compound of formula (I) wherein:
Z1 is pyrazole
Z2 is phenyl, substituted with -OR’
Where R’ is methyl
See also third recited alternative for Z2 in present claim 22
R1 is H
X is a bond
R2 is H
R3 is -C1 alkyl
See present claims 21-24, 26-27 and 30.
US ‘338 discloses pharmaceutical compositions comprising a pharmaceutically acceptable carrier and at least one of the compounds of the present invention. See paragraph 14 and present claim 33.
US ‘338 discloses working examples demonstrating the inhibitory activity for compounds of the invention against ROCK1 and ROCK2. See page 14, paragraphs 210-213. US ‘338 discloses where compound 65 has 0.85 nM IC50 value in ROCK2 inhibitory assay. See Table A in paragraph 212.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The difference between the instant claims and the prior art compound examples 65 and 83 is that the instant claims replaces one H of the prior art compounds with a methyl at the R position.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 USPQ 137 (CCPA 1978) and In re Lohr, 137 USPQ 548, 549 (CCPA 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity.
One of ordinary skill would expect a compound of US ‘338 where R = C0 alkyl to have similar biological properties and activity inhibiting aberrant Rho kinase activity of compounds of the present invention.
“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
The issue of patentability over the replacement of alkyl groups for hydrogen has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that “one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious – at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound – at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results – at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification); Ex parte Fauque 121 USPQ 425 (where di(methyl-furyl)-methane was considered a higher homolog of difuryl-methane and unpatentable without a showing of unexpected results - at page 426).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds would have the same utility as the compounds taught by the prior art. In the interest of generating additional compounds that have the same utility as the compounds taught by the prior, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the prior art that have already been demonstrated to have the desired utility. As discussed above, the replacement of hydrogen for an alkyl group falls under the well-established doctrine of homology, which assumes that homologous compounds are likely to have similar properties. Therefore, the instantly claimed compound, which differs by hydrogen/alkyl, over a compound of prior art is unpatentable absent a showing of unexpected results. MPEP 2144.09 (VII) states “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).” In the instant case, Applicant has not established unexpected properties between the instantly claimed compound and the closest prior art homolog. In the instant case, a person having ordinary skill in the art at the time the invention was made would have been motivated to synthesize the instantly claimed homolog with the reasonable expectation that it would have the same utility as the closest structurally related compound taught by the prior and with the motivation of obtaining additional useful compounds.
The prior art teaches multiple compounds which are analogous to present formula (I) (compounds 65 and 83 of US ‘338) where R = H or C0 alkyl. Substitution of R = C0 alkyl of the compound 65 or 83 of the prior art for where R = C1 alkyl of the present invention are presumed to be obvious variants. One of ordinary skill in the art would have a reasonable expectation of success in arriving to the compounds of present claims based on compound 65 or compound 83 of the prior art as well as the ROCK inhibitory activity data disclosed for compounds of the prior art, especially for compound 65. Therefore, the compounds of US ‘338 are presumed to be obvious variants of the present compound of formula (I) and the present claims are prima facie obvious.
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 21-30 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16 and 18-19 of U.S. Patent No. 10,738,007. Although the claims at issue are not identical, they are not patentably distinct from each other because both directed to phenylpyrazole compounds of formula (I).
Claim 1 of the ‘007 Patent discloses a compound of formula (I). See present claim 21.
Claims 16 and 18 of the ‘007 Patent disclose various specific compounds of formula (I) of the ‘007 Patent, including compound 97 of present claims 31-32. Present claims 21-32 are embraced by the compound of claim 18 of the ‘007 Patent.
Claim 19 of the ‘007 Patent discloses a pharmaceutical composition comprising the compound of claim 1 of ‘007 Patent and a pharmaceutically acceptable carrier. See present claim 33.
Conclusion
Claims 21-30 and 33 are rejected.
Claims 34-41 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray 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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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626