Detailed Action
The present office action is in response to the remarks filed 18 Jul 2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status
Claims 1-10 of the pending application have been examined on the merits. Claims 11-18 and 25 stand withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the cancellation of claims 19-24.
Priority
Applicants identify the instant application, Serial #: 17/920,794 filed 23 Oct 2022, as a National Stage Entry of International Patent Application #: PCT/US21/28136, filed 20 Apr 2021, which claims priority from U.S. Provisional Application #: 63/016,683, filed 28 Apr 2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 18 Jan 2023 and 16 May 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant's election with traverse of Group I, claims 1-10, with an additional election of species of Example 25 (below) and a secondary therapeutic agent useful in the treatment of Gaucher disease in the reply filed on 18 Jul 2025 is acknowledged. Prior art was returned after a search for the elected species.
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The traversal is for the following reasons: Applicant argues that Unity of Invention is evidenced by the International Search Report (pg. 2). Applicant argues that, “standards regarding unity of invention that apply to the International Searching Authority also apply to the U.S. Patent Office with respect to this application,” and therefore, “the unity of invention requirement is fulfilled and any reliance upon independence or distinctiveness of the invention is not relevant under the PCT” (pg. 2). Applicant further argues the “examiner has not provided proper reasons why each group lacks unity with each other group, specifically describing the unique special technical feature in each group as required in MPEP § 1893.03(d)” and that “examiner has considered the type of claims, i.e., compound/composition and method of use, without considering the special technical feature recited in, and common to, each claim” (pg. 2). Applicant argues that the office action mailed 22 May 2025 “fails to indicate whether Groups I-II are classified in different classes or subclasses” but that “the inventions are not independent because the compound/compositions set forth in claims 1-10 and the method of use in claims 11-18 and 25 are so closely related a search for the method claims would encompass a search for the compound/composition claims” (pgs. 2-3). Applicant finally argues that there is no evidence that a “search and examination directed to all claims would be a serious burden on the examiner” (pg. 3).
This is not found persuasive because: Examiner agrees that the Unity of Invention standard applies to the instant application as a National Stage Entry of International Application No. PCT/US21/28136 filed under 35 U.S.C. 371. As such, the "Independent and Distinct" standard for applications filed under 35 U.S.C. 111(a) does not apply and no analysis is required to determine the burden of search that would be required by examining both Groups I and II. Further, examiner may make a lack of unity requirement in a national stage application even if no such requirement was made by the International Search Authority or International Preliminary Examination Authority. See MPEP § 1893.03(d). In the office action mailed 22 May 2025 examiner provided a full explanation as to why the technical feature of Groups I and II is not considered special over the prior art. This explanation is restated below. Applicant argues that examiner did not give proper reasons for why groups lack unity with each other group, but fails to provide an alternative special technical feature shared by the groups. Therefore, the previous technical feature shared by Groups I and II presented by examiner in the previous office action stands and the restriction requirement is still deemed proper and made FINAL.
Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The compounds of Group I and II share the core structure of Formula (I) circled in black below:
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Wherein A is CH2 or O. While this core structure is shared among all the compounds, it is not special in view of WO 2016/126572 (provided in IDS 01/18/23), hereinafter ‘572. ‘572 teaches a compound with the same core structure (circled in black, below) as the instant compounds (pg. 28, Example 3):
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Where A is CH2. Therefore, the core, being the technical feature shared by the groups, is not a contribution over the art and thus the groups lack unity.
Claims 11-18 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 18 Jul 2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
During the search, additional art relevant to the claims addressing species where the phenyl ring is swapped for a pyridine ring is relevant to the claims was discovered. A rejection is set forth below with regards to this additionally discovered art.
Claim Objections
Claim 7 is objected to because of the following informalities: The resolution of the structures found in claim 7 is low. Examiner requests applicant reupload figures at a higher resolution in black and white. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claim 5 is 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 5 recites the limitation “wherein NR6R7 is…
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” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites that limitation that R6 and R7 may be taken together with the nitrogen atom to which they are attached to form a C4-C6 heterocycloalkyl optionally substituted with F or CH3. However, claim 1 does not allow for multiple substitutions of F or CH3. Applicant may overcome this rejection by amending to delete the above limitation from claim 5 or adding more context to the limitation of claim 1.
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.
Claims 1-10 is/are rejected under 35 U.S.C. 103 as being obvious over WO 2021/081141 (provided in IDS 01/18/23), hereinafter ‘141, further in view of WO 2015/042397 (provided in IDS 01/18/23), hereinafter ‘397, and Chang et al. (Bioorg Med Chem, 2017, 1:381-388), hereinafter Chang.
The applied reference has a common joint inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). ‘141 was published 29 Apr 2021 and claims priority to U.S. Provisional Application #: 62/294,959, filed 23 Oct 2019.
Applicants elected the following species in the reply filed 18 Jul 2025:
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and a second therapeutic agent useful for treating Gaucher disease. The elected species reads on instant claims 1-10.
‘141 teaches compounds of reference Formula (I) useful as glucosylceramide synthase inhibitors capable of treating diseases such as Gaucher disease (Abstract; paragraphs [0010]-[0011]; paragraph [0021]):
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and further teaches Example 1 (paragraph [0081]):
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‘141 teaches that Example 1 inhibits glucosylceramide synthase in MDCK cells with an IC50 of 1 nM (Table 1; and Table 2). ‘141 further teaches that replacing the Cl of Example 1 with a H increases the IC50 in MDCK cells to 6.5 nM. ‘141 teaches a composition comprising compounds of the reference, a second therapeutic agent useful in the treatment of Gaucher disease, and an excipient and/or pharmaceutically acceptable carrier (reference claims 14-15). However, Example 1 differs from the instantly elected invention in two ways. First, the reference compound has a phenyl moiety instead of 2-pyridyl as found on the instantly elected compound. Second, the Cl substituent is in the incorrect spot on the phenyl moiety.
‘397 teaches compounds useful as glucosylceramide synthase inhibitors with the same core structure, but having a pyridine ring in place of a phenyl ring as in ‘141, such as reference Compound 56 (paragraph [000539]):
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‘397 further teaches that Compound 56 has inhibits glucosylceramide synthase with an IC50 of ≤ 50 nM (paragraph [0001329]).
Chang teaches that aromatic rings are ubiquitous in pharmaceutical compounds and are often exchanged with another ring during the optimization process of drug discovery (Abstract). Chang further teaches a holistic, multiple endpoint optimization approach taking into account LogD lipophilicity, microsomal metabolism, P-gp efflux, and passive permeability (Abstract). Chang teaches that changing phenyl for 2-pyridyl creates significant changes for LogD lipophilicity, microsomal metabolism, and permeability, but no P-gp efflux (supplementary data).
MPEP § 2144.09(II) teaches, “compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2 groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.”
By following the teachings of ‘141, ‘397, and Chang, a person of ordinary skill in the art would modify reference Example 1, found in ‘141, by swapping the phenyl ring for a 2-pyridine ring, as taught by Chang, with a reasonable expectation of success that the pyridine ring would be active as a glucosylceramide synthase inhibitor, as taught by ‘397. The artisan would be motivated to perform this exchange to further optimize the drug and investigate the differences in LogD, permeability, microsomal metabolism, and P-gp efflux when a pyridine ring is exchanged for a phenyl ring in glucosylceramide synthase inhibitors. The artisan would further modify the ortho -Cl substituent to the other ortho position to facilitate a positional isomer which has a sufficiently close structural similarity that the artisan would have a presumed expectation of the compounds having similar properties. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active glucosylceramide synthase inhibitors) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compound in view of the compounds taught by ‘141.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
During the search, additional art relevant to the claims addressing species where the phenyl ring is swapped for a pyridine ring is relevant to the claims was discovered. A rejection is set forth below with regards to this additionally discovered art.
Claims 1-10 is/are rejected under 35 U.S.C. 103 as being obvious over WO 2016/126572 (provided in IDS 01/18/23), hereinafter ‘572, further in view of ‘397 and Chang.
‘572 teaches compounds useful as glucosylceramide synthase inhibitors taking the form of reference Formula (I) (paragraphs [0010]-[0011]):
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‘572 teaches multiple examples where R1 and m overlap with substituents of the instant claims, including Examples 2-4, 7, 9, and 12 (paragraphs [0079]-[0091]):
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These examples are further characterized by ‘572 in paragraph [0235], reproduced below:
Example
Broken Cell IC50 (nM)
WT-MDCK IC50 (nM)
MDR1-MDCKII IC50 (nM)
Mouse liver microsome t1/2 (min)
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‘572 further teaches a composition of a reference compound, a pharmaceutically acceptable carrier or vehicle, and a second therapeutic agent useful in the treatment of a disease or condition wherein inhibition of GCS provides a benefit, where that second therapeutic agent may be useful in the treatment of Gaucher disease (claims 10-11). However, ‘572 does not teach swapping the phenyl ring for a pyridine ring as in the instant claims.
‘397 teaches compounds useful as glucosylceramide synthase inhibitors with the same core structure, but having a pyridine ring in place of a phenyl ring as in ‘141, such as reference Compound 56 (paragraph [000539]):
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‘397 further teaches that Compound 56 has inhibits glucosylceramide synthase with an IC50 of ≤ 50 nM (paragraph [0001329]).
Chang teaches that aromatic rings are ubiquitous in pharmaceutical compounds and are often exchanged with another ring during the optimization process of drug discovery (Abstract). Chang further teaches a holistic, multiple endpoint optimization approach taking into account LogD lipophilicity, microsomal metabolism, P-gp efflux, and passive permeability (Abstract). Chang teaches that changing phenyl for 2-pyridyl creates significant changes for LogD lipophilicity, microsomal metabolism, and permeability, but no P-gp efflux (supplementary data).
By following the teachings of ‘572, ‘397, and Chang, a person of ordinary skill in the art would modify reference Examples 2-4, 7, 9, and 12, found in ‘572, by swapping the phenyl ring for a 2-pyridine ring, as taught by Chang, with a reasonable expectation of success that the pyridine ring would be active as a glucosylceramide synthase inhibitor, as taught by ‘397. The artisan would be motivated to perform this exchange to further optimize the drug and investigate the differences in LogD, permeability, microsomal metabolism, and P-gp efflux when a pyridine ring is exchanged for a phenyl ring in glucosylceramide synthase inhibitors.
The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active glucosylceramide synthase inhibitors) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compound in view of the compounds taught by ‘572.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-8 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,202,340 (provided in IDS 01/18/23), hereinafter ‘340, in view of ‘397 and Chang.
‘340 claims compounds having the following structure:
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Which overlaps with the instant claims when G is -CH2-; R3 is H or F; NR2R2’ is 1-pyrrolidinyl, 3-fluoro-1-pyrrolidinyl, or 1-azetidinyl; m is 1; and R1 is halo, OC1-3 alkyl optionally substituted with one to five fluoro atoms (claim 1). ‘340 further claims a pharmaceutical composition comprising compounds of the above structure and a pharmaceutically acceptable carrier or vehicle. However, ‘340 claims a phenyl group where the instant claims require a pyridine ring.
‘397 teaches compounds useful as glucosylceramide synthase inhibitors with the same core structure, but having a pyridine ring in place of a phenyl ring as in ‘141, such as reference Compound 56 (paragraph [000539]):
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‘397 further teaches that Compound 56 has inhibits glucosylceramide synthase with an IC50 of ≤ 50 nM (paragraph [0001329]).
Chang teaches that aromatic rings are ubiquitous in pharmaceutical compounds and are often exchanged with another ring during the optimization process of drug discovery (Abstract). Chang further teaches a holistic, multiple endpoint optimization approach taking into account LogD lipophilicity, microsomal metabolism, P-gp efflux, and passive permeability (Abstract). Chang teaches that changing phenyl for 2-pyridyl creates significant changes for LogD lipophilicity, microsomal metabolism, and permeability, but no P-gp efflux (supplementary data).
By following the teachings of ‘340, ‘397, and Chang, a person of ordinary skill in the art would modify the reference claims, found in ‘340, by swapping the phenyl ring for a 2-pyridine ring, as taught by Chang, with a reasonable expectation of success that the pyridine ring would be active as a glucosylceramide synthase inhibitor, as taught by ‘397. The artisan would be motivated to perform this exchange to further optimize the drug and investigate the differences in LogD, permeability, microsomal metabolism, and P-gp efflux when a pyridine ring is exchanged for a phenyl ring in glucosylceramide synthase inhibitors.
The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active glucosylceramide synthase inhibitors) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compound in view of the compounds taught by ‘340.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,220,479 (provided in IDS 01/18/23), hereinafter ‘479, in view of ‘397 and Chang.
‘479 teaches compounds of the following structure:
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which overlaps with compounds of the instant claims when R3 is H or F; R4 is H or CH3; G is CH2 or O; R6 is H, C1-3alkyl, C3-6cycloalkyl, or CD3; NR5R5’ is 1-pyrrolidinyl, 3-fluoro-1-pyrrolidinyl, or 1-azetidinyl; and R7, R8, R1, and R2 are H (claim 1). ‘479 further teaches a composition of a compound of the reference claims and a pharmaceutically acceptable carrier or vehicle (claim 13). However, ‘479 teaches a phenyl moiety where the instant claims teach a pyridine moiety.
‘397 teaches compounds useful as glucosylceramide synthase inhibitors with the same core structure, but having a pyridine ring in place of a phenyl ring as in ‘141, such as reference Compound 56 (paragraph [000539]):
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‘397 further teaches that Compound 56 has inhibits glucosylceramide synthase with an IC50 of ≤ 50 nM (paragraph [0001329]).
Chang teaches that aromatic rings are ubiquitous in pharmaceutical compounds and are often exchanged with another ring during the optimization process of drug discovery (Abstract). Chang further teaches a holistic, multiple endpoint optimization approach taking into account LogD lipophilicity, microsomal metabolism, P-gp efflux, and passive permeability (Abstract). Chang teaches that changing phenyl for 2-pyridyl creates significant changes for LogD lipophilicity, microsomal metabolism, and permeability, but no P-gp efflux (supplementary data).
By following the teachings of ‘479, ‘397, and Chang, a person of ordinary skill in the art would modify the reference claims, found in ‘479, by swapping the phenyl ring for a 2-pyridine ring, as taught by Chang, with a reasonable expectation of success that the pyridine ring would be active as a glucosylceramide synthase inhibitor, as taught by ‘397. The artisan would be motivated to perform this exchange to further optimize the drug and investigate the differences in LogD, permeability, microsomal metabolism, and P-gp efflux when a pyridine ring is exchanged for a phenyl ring in glucosylceramide synthase inhibitors.
The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active glucosylceramide synthase inhibitors) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compound in view of the compounds taught by ‘479.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625