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
Applicant’s election of Group I, drawn to a compound of Formula (I) and pharmaceutical composition, and a compound of Example 148 having the structure of:
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as the elected compound species of Formula (I) are maintained. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The Examiner noted that the elected compound species of Formula (I) (i.e., a compound of Example 148) above has a compound name of (1S,3R)-3-((1-((6-chloropyridin-3-yl) amino) isoquinolin-6-yl) oxy)-1-methylcyclohexan-1-ol according to page 71 of the instant specification.
Claims 8, 11 and 42 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner are necessitate by amendment, and the Examiner determined that the prior art at the time of the present invention was such that it did not anticipate or render obvious the elected compound species of Formula (I):
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. In light of this discovery, the search is expanded to the subject matter of the subgenus of the elected compound species, i.e., the compounds having the structure of:
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,
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(compound of Ex No. 197; “N-(6-chloropyridin-3-yl)-6-((tetrahydro-2H-pyran-4-yl)oxy)isoquinolin-1-amine” in claim 7),
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,
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(Compound of Ex No. 3, “N-(6-chloropyridin-3-yl)-6- m propoxyisoquinolin-1-amine” in claim 7), such that it does not encompass the full scope of the claims.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on June 10, 2026, wherein claims 1, 4, 7-8, 11, 41-42 are amended; and claims 2-3, 5-6, 9-10 and 12-40 are canceled.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 7-8, 11 and 41-42 are pending.
Claims 8, 11 and 42 are withdrawn.
Claims 1, 4, 7 and 41 are under examination in accordance with the elected species along with the expanded compound species set forth in the Expansion of Election of Species Requirement section above.
Priority
The instant application 18/330,100 filed on June 6, 2023 claims priority to, and the benefits of U.S. Provisional Application No. 63/350,180 filed on June 8, 2022.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/350,180, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the prior-filed application only discloses the compound of Example 1-35, and that does not include the elected compound species of Formula (I). Therefore, to the extent that the claims are drawn to a compound of Formula (I) that is not a compound of Example 1-35 recites in the prior-filed application, the claims are not entitled to the benefit of the prior-filed application and will receive an effective filing date of June 6, 2023, which is the filing date instant application.
Response to Arguments
Applicant's arguments filed on June 10, 2026 with respect to the disclosure of the prior-filed application fails to provide adequate support or enablement have been fully considered but they are not persuasive.
In Summary, applicant argues the Examiner does not raise any references made publicly
available between the filing date of the '180 Provisional and the filing date of the present Application; and therefore, applicant reserves the right to demonstrate that there is written description support in the prior-filed application.
In response, applicant’s argument is not found persuasive, because citing an intervening publication, published between the filing date of the ‘180 provisional and the filing date of the instant application, is not a requirement to demonstrate that the prior-filed application fails to provide written desorption support for the claimed invention. Given that the prior-filed application fails to explicitly disclose the elected species of compound of Formula (I), the claims drawn to the elected compound species and a pharmaceutical composition comprising the elected compound species are not entitled to the benefit of the prior-filed application for the same reason of record.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 10, 2026 was filed after the mailing date of the Non-Final Office Action on March 10, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Action Summary
All rejections pertaining to claim 3 are moot because the claim was canceled in view of the amendment to the claims filed on June 10, 2026.
Claims 1, 3-4, 7 and 41 rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives are withdrawn in view of the claim amendments.
Claim 7 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 are withdrawn in view of the claim amendments.
Claims 1, 3-4 and 41 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (WO 2007/071348 A1) are withdrawn in view of the claim amendments.
Claims 1, 3-4 and 41 rejected under 35 U.S.C. 102(a)(1) as being anticipated by García Collazo et al. (WO 2016/120808 A1), as evidenced by CAS Registry Number 1974273-18-1 (Entered STN Registry on August 17, 2016) are withdrawn in view of the claim amendments.
Claims 1, 3-4 and 41 rejected under 35 U.S.C. 103 as being unpatentable over García Collazo et al. (WO 2016/120808 A1) are withdrawn in view of the claim amendments; However, upon further consideration, the prior art has been revisited, modified, and reapplied as necessitate by amendment.
Claims 1, 3-4, 7 and 41 rejected under 35 U.S.C. 103 as being unpatentable over García Collazo et al. (WO 2016/120808 A1), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176), as evidenced by CAS Registry Number 1974273-18-1 (Entered STN Registry on August 17, 2016) are withdrawn in view of the claim amendments.
Claim Objections
The amendment to the claims filed on June 10, 2026 is object to under 37 CFR.1.121(c). Claim 1 has been amended by deleting “-N=S(O)(R7)R8” from the list of R3; However, the deleted subject matter was not properly indicated by strike-through as required by 37 CFR 1.121(c)(2). Applicant is required to submit a compliant amendment clearly identifying all additions and deletions to the claim(s). See MPEP 714 and 37 CFR 1.121 with respect to Manner of making amendments in application.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 7 and 41 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 (newly applied as necessitated by amendment).
Regarding claim 1, the recitation of “R7 and R8 are each independently alkyl, alkenyl, -R9-OR6, cycloalkyl, cycloalkylalkyl, heterocyclyl, heterocyclylalkyl, aryl or aralkyl” renders the claim indefinite, because there is no R7 and/or R8 group in the claimed compound of Formula (Ia); and therefore, it is not clear what these are. There is insufficient antecedent basis for this limitation in the claim. Accordingly, claims 4, 7 and 41 are rejected based on their dependency on a rejected base claim.
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.
Claim 7 is 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 (newly applied as necessitated by amendment).
Regarding claim 7, the claim recites numerous compound species that fail to further limit the compound of Formula (I) sets forth in claim 1. For instance, the recitation of the following compounds:
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fail to further limit the compound of Formula (I), because the R3 set forth in claim 1 cannot be “-N=S(O)(R7)R8”. While the Examiner has made every attempt to check the chemical names, Applicant is required to carefully check the entire claims for any, and all issues noted above.
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 § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Plettenburg et al. (US 2011/0245248 A1) (newly applied as necessitated by amendment).
Plettenburg et al. teaches a compound No. 167 having the structure of:
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(see e.g., p. 47, [0289], No. 167) is an exemplary compound of formula (I) or a pharmaceutically acceptable salt thereof having inhibitory effect on Rho-kinase and/or on Rho-kinase mediated phosphorylation of myosin light chain phosphatase (see e.g., [0005]). Plettenburg et al. further teaches the compound of formula (I):
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or a pharmaceutically acceptable salt or a physiologically functional derivative thereof (see e.g., [0011]; claim 1), wherein R1 is, inter alia, NH-R’ (see e.g., [0013]; claim 1); preferably, R6 is, inter alia, H, (C1-C4)alkylene-(C5-C10)heterocyclyl (see e.g., [0041]); R’ is, inter alia, (C3-C8)cycloalkyl, (C5-C10)heterocyclyl or (C6-C10)aryl (see e.g., [0033]-[0034]; claim 1). Plettenburg et al. further teaches examples of (C6-C10)aryl group includes, inter alia, phenyl (see e.g., [0071]); suitable (C5-C10)heterocyclyl group include, inter alia, pyridinyl, pyridyl, and pyrimidinyl; and pyridyl stands both for 2-, 3- and 4-pyridyl (see e.g., [0073]; [0075]). Plettenburg et al. further teaches a pharmaceutical composition, which contains an effective amount of at least one compound of the formula (I) and/or its physiologically acceptable salts and/or its prodrugs and a pharmaceutically acceptable carrier, i.e. one or more pharmaceutically acceptable carrier substances (or vehicles) and/or additives (orexcipients) (see e.g., [0083]).
In the present case, the difference between the compound No. 167 of Plettenburg et al. and the claimed compound is that the prior art compound contains phenyl ring rather than the 3-pyridyl ring instantly claimed as shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select Compound No. 167 of Plettenburg et al., and then modifying said compound by replacing the phenyl ring with 3-pyridyl ring to arrive at the claimed invention. One would have been motivated to do so, because Plettenburg et al. teaches a list of R’ (C6-C10)aryl, such as phenyl; and (C5-C10)heterocyclyl, such as 3- pyridyl, that is contemplated for use to arrive at a compound of formula (I) or a pharmaceutically acceptable salt thereof having inhibitory effect on Rho-kinase and/or on Rho-kinase mediated phosphorylation of myosin light chain phosphatase. One of ordinary skill in the art would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the Compound No. 167 of Plettenburg et al. modified in view of the Formula (I) taught by the prior art, by replacing the R’ of NH-R’ at R1 with another R’ group, i.e., replacing phenyl ring with 3-pyridyl ring, would have successfully arrive at the compound that exhibits the same or substantially similar inhibitory effect on Rho-kinase and/or on Rho-kinase mediated phosphorylation of myosin light chain phosphatase.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1, 4, 7 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Plettenburg et al. (US 2011/0245248 A1) as applied to claims 1, 4 and 41 above, and further in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176; cited in the previous Office Action) (newly applied as necessitated by amendment).
The teachings of Plettenburg et al. are set forth above and applied as before.
While Plettenburg et al. teaches (C6-C10)aryl and (C5-C10)heterocyclyl groups are unsubstituted or substituted one or more times by suitable groups independently selected from, inter alia, halogen (see e.g., [0076]); and halogen means, inter alia, chloro (see e.g., [0069]), Plettenburg et al. does not teach the expanded compound species of Formula (Ia) as claimed in claim 7, i.e.,
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(“N-(6-chloropyridin-3-yl)-6-((tetrahydro-2H-pyran-4-yl)oxy)isoquinolin-1-amine”).
Patani et al. bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches in the classical bioisosteres, the replacement of chlorine with isosteres from Grimm’s Hydride Displacement Law shown below:
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, results in analogues with similar biological activity (see e.g., p. 3153, left column, 3rd paragraph). Patani et al. further teaches classical isosteric substitutions when applied within ring systems result in different heterocyclic analogues which can be effective bioisosteres (see e.g., p. 3158, left column, “E. Ring Equivalents”, 1st paragraph); and further teaches isosteric divalent ring replacements as obtained from Grimm’s Hydride Displacement Law (see e.g., Table 2):
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resulted in retention of activity within a series of indane derivatives shown below (see e.g., p. 3158; right column, 1st paragraph):
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.
In the present case, the difference between the modified compound No. 167 of Plettenburg et al. set forth above and the claimed compound is that the prior art compound has a 6-membered heterocyclyl containing one nitrogen atom rather than one oxygen atom (i.e., contains piperidine rather than tetrahydropyran), and has unsubstituted 6-membered heteroaryl rather than substituted with a chlorine atom (i.e., contains 3-pyridyl ring rather than a 3-pyridyl ring substituted with a chlorine atom) as shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the modified compound 167 of Plettenburg et al. set forth above by replacing the nitrogen of the piperidine ring with an oxygen atom, and then replacing the hydrogen of the 3-pyridyl ring with a chlorine atom based on the bioisosteric replacement technique taught by Patani al. to arrive at the claimed invention. One would have been motivated to do so, because Patani et al. teaches the replacement of hydrogen with a chlorine atom, and the isosteric divalent ring replacement of -NH- with -O-, which are bioisosteric replacement techniques based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, can result in analogues with retention of biological activity. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by modifying the modified compound no. 167 of Plettenburg et al. set forth above in accordance with the bioisosteric replacement technique taught by Patani et al. would have successfully arrive at a compound that exerts the same or substantially similar inhibitory effect on Rho-kinase and/or on Rho-kinase mediated phosphorylation of myosin light chain phosphatase.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed.
Claims 1, 4, 7 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over García Collazo et al. (WO 2016/120808 A1; cited in the previous Office Action) (newly reapplied as necessitated by amendment).
García Collazo et al. teaches a compound of Example 37 having the structure of:
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is an exemplary compound of formula (IA) useful for treating or preventing a condition associated with the alteration of the activity of [Symbol font/0x62]-galactosidase in a patient (see e.g., p. 76, Example 37; abstract). García Collazo et al. further teaches a pharmaceutical composition, comprising the compound of formula (IA), or a pharmaceutically acceptable salt or solvate thereof, and at least one pharmaceutically acceptable excipient (see e.g., claim 20). García Collazo et al. further teaches the compound of formula (IA)
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, wherein each of A2 and A3 are independently selected from the group consisting of nitrogen, C(R3A) and C(NH2); each one of R3A is independently selected from, inter alia, hydrogen and halogen; and R11, R12, and R13 are each independently selected from the group consisting of, inter alia, hydrogen, halogen, -ORbA; each RbA is independently selected from, inter alia, -C1-4 alkyl and cycloalkyl-C3-10 (see e.g., claim 1). García Collazo et al. further teaches the terms “halogen” or “halo” refer to -F, -Cl, -Br or -I (see e.g., p. 26, line 11); and exemplary alkyl groups can be, inter alia, n-propyl (see e.g., p. 26, line 13-19).
The difference between the compound of Example 37 of García Collazo et al. and the claimed compound of Formula (I) lies on the position of nitrogen atom in the pyridine ring, and the R3A substituent at the A3 position of the pyridine (i.e., -NH2 rather than halogen, such as -Cl) shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select compound of Example 37 of García Collazo et al., and then modifying the position of nitrogen atom in the pyridine ring, and then replacing -NH2 with a halogen, such as -Cl, to arrive at the claimed invention. One would have been motivated to do so, because García Collazo et al. teaches each of A2 (
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) can be nitrogen or C(R3), wherein R3 includes a hydrogen; and further teaches that A3 can be C(NH2) or C(R3), and R3 can be halogen, including -Cl, and these are contemplated for use to arrive at a compound of formula (IA) useful for treating or preventing a condition associated with the alteration of the activity of [Symbol font/0x62]-galactosidase in a patient. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the compound of Example 37 of García Collazo et al. modified in view of the compound of formula (IA) taught by the prior art as noted above would have successfully arrive at the compound of formula (IA) useful for alternating the activity of [Symbol font/0x62]-galactosidase.
Regarding the expanded compound species of Formula (I) “N-(6-chloropyridin-3-yl)-6- m propoxyisoquinolin-1-amine” as claimed in claim 7, the difference between the modified compound of Example 37 of García Collazo et al. set forth above and the claimed compound is that the prior art compound contains -Cl at R13, rather than the propoxy group (CH3CH2CH2O-) at R11 instantly claimed as shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the modified compound of Example 37 of García Collazo et al. set forth above by changing the position of -Cl from R13 to R11, and then replacing said -Cl with -ORbA group, wherein RbA is n-propyl as the -C1-4 alkyl, to arrive at the claimed invention. One would have been motivated to do so, because García Collazo et al. teaches R11, R12, and R13 are each independently selected from the same list, including hydrogen, halogen and -ORbA; and RbA includes -C1-4 alkyl, such as n-propyl, that are contemplated for use to arrive at a compound of formula (IA) useful for treating or preventing a condition associated with the alteration of the activity of [Symbol font/0x62]-galactosidase in a patient. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound of Example 37 of García Collazo et al. set forth above further modified in view of the compound of formula (IA) taught by the prior art as noted above would have successfully arrive at the compound of formula (IA) useful for alternating the activity of [Symbol font/0x62]-galactosidase.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed.
Response to Arguments
Applicant’s arguments filed on June 10, 2026 have been fully considered. All rejections pertaining to claim 3 are moot because the claim was cancelled in view of the amendment to the claims filed on June 10, 2026.
Applicant's arguments filed on June 10, 2026 with respect to the rejection of claims 1, 3-4 and 41 under 35 U.S.C. 103 as being unpatentable over García Collazo et al. (WO 2016/120808 A1) have been fully considered.
Applicant's arguments filed on June 10, 2026 with respect to the rejection of claims 1, 3-4, 7 and 41 under 35 U.S.C. 103 as being unpatentable over García Collazo et al. (WO 2016/120808 A1), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176), as evidenced by CAS Registry Number 1974273-18-1 (Entered STN Registry on August 17, 2016) have been fully considered.
In short, Applicant amends independent claim 1 by deleting the recitation of “-R9-OR6, -R9-N(R6)2, -R9-C(O)R6, -R9-C(O)OR6, -R10-C(O)N(R6)2, alkenyl, alkynyl, haloalkenyl, cycloalkyl, cycloalkylalkyl, aryl, aralkyl, heterocyclyl, heterocyclylalkyl, heteroaryl or heteroarylalkyl” from the list of R2; deleting numerical value “0” from n; and adding the new limitation of “each instance of alkenyl, alkynyl, haloalkyl, haloalkenyl, cycloalkyl, cycloalkylalkyl, aryl, aralkyl, heterocyclyl, heterocyclylalkyl, heteroaryl or heteroarylalkyl is independently optionally substituted”. Applicant further amends dependent claim 7 by deleting the following species: “N-(6-chloropyridin-3-yl)isoquinolin-1-amine”, “N-(6-chloropyridin-3-yl)-3-methylisoquinolin-1-amine”, and “N-(6-chloropyridin-3-yl)-4,6-dimethoxyisoquinolin-1-amine”; and that removes the expanded compound species addressed in the previous rejection(s) of record. Each of these findings demonstrate that the claim amendment changes the scope of the claims and necessitated a modification of the rejection(s) of record, including prior arts.
In Summary, applicant argues the claim amendments overcome the rejection(s) of record by excluding -NH2 from R2. Applicant further argues that the examiner's conclusion of obviousness is based on improper hindsight reasoning, because the mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection. Specifically, applicant argues the Examiner fails to meet the burden in identifying a lead compound from García Collazo et al., because the compounds of García Collazo et al. are [Symbol font/0x62]-galactosidase modulator rather than voltage-gated potassium channel allosteric modulators; and therefore, there is no reason why one would have look into García Collazo et al. to provide the claimed compound with the claimed utility. Applicant further argues one would have no reason to select any particular compound from the numerous compounds disclosed in García Collazo et al. Applicant further argues Patani et al. does not remedy the deficiencies of Garcia Collazo et al.
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). In this case, applicant argues that García Collazo et al. fail to show certain features of the invention (i.e., “voltage-gated potassium channel allosteric modulators”); However, it is noted that the features of voltage-gated potassium channel allosteric modulators upon which applicant relies 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 other words, the obviousness-type rejection under 35 U.S.C. 103 does not require to meet the limitation(s) that are not positively recited. Rather, the rejection of record is formed on the basis that whether a person of ordinary skill in the art would modify the teachings of the prior art to produce the claimed invention, where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the rejection of record in form on the basis that García Collazo et al. teaches compound of Example 37 is an exemplary compound of Formula (IA) and a list of suitable substituent(s) (e.g., R11, R12, R13, A1, A2, A3) that are contemplated for use to arrive at a compound of Formula (IA). Specifically, García Collazo et al. clearly disclose a compound of Example 37 (see e.g., p. 76, Example 37; abstract), and its enzyme activity/β-qalactosidase activity in COS-7 cells bearing T420K human GLB1 are expressly disclosed in the working example (see e.g., p. 121, Example 37; p. 120, line 6-8). In other words, the compound of Example 37 taught by García Collazo et al. is clearly a preferred embodiment, and would reasonably be selected by one of ordinary skill in the art.
According to MPEP 2123, II, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”. In this case, the mere fact that García Collazo et al. teaches other compound species of Formula (IA) or other substituent(s) does not constitute a teaching away from modifying the compound of Example 37 in view of the Formula (IA) taught by García Collazo et al., because such disclosure does not criticize, discredit, or otherwise discourage that any compounds embraced by Formula (IA) cannot alternate the activity of [Symbol font/0x62]-galactosidase. According to MPEP 2141.02, VI, “[a] prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984)”. In other words, the fact that García Collazo et al. discloses the Formula (IA), including the list of A2 and A3, one would have reasonably expected that interchanging one A3 species for another A3 taught in the list would have successfully arrive at another compound of Formula (IA) with the same activity (alternating the activity of [Symbol font/0x62]-galactosidase), especially in the absence of evidence to the contrary.
In view of the foregoing, applicant’s arguments are not found persuasive; and therefore, upon further consideration, García Collazo et al. has been revisited, modified, and reapplied as necessitated by amendment for the reasons set forth above.
Conclusion
No claims are allowed.
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.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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