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 .
Priority
This Application is a 371 of PCT/KR2022/006613, filed May 10, 2022 and claims foreign priority benefit of KR10-2021-0060942, filed May 11, 2021 in the Republic of Korea.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Nov. 7, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-15 are currently pending and subject to examination.
Claim Rejections – 35 USC § 112(d)
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 14 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. Claim 14 does not further limit the subject matter of claim 13 upon which it depends because it is merely directed towards an intended use of the composition of claim 13. The intended use does not impose any structural limitations on the composition. 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(s) 1-2, 4, 6-8, 10, and 13-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US 12,338,237 B2) .
The applied reference has common inventor(s) 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). This rejection under 35 U.S.C. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Claim 1 is directed towards a compound of formula 1:
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.
Kim teaches an overlapping genus:
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Kim, Specification, col. 4; subject matter of claim 1;
and species of compounds falling within the genus of formula 1. For example: (S)-quinuclidin-3-yl (6-(3-isopropoxyphenyl)-2,2-dimethyl-1,2,3,4-tetrahydronaphthalen-1-y1)carbamate (Kim, Specification, col. 10, lines 24-25; claim 20). This compound has the following structure falling within claimed formula 1:
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(drawn by examiner).
Therefore, claim 1 is anticipated.
Claims 2, 4, 6-8, 10 read on the above compound and are therefore also anticipated for the reasons given in the rejection of claim 1.
Claim 13 is directed towards a pharmaceutical composition comprising the compound as claimed in claim 1 as an active ingredient. Claim 14 is directed towards a pharmaceutical composition as in claim 13, for preventing or treating Gaucher disease, Fabry disease, Tay-Sachs disease or Parkinson’s disease.
Kim teaches a pharmaceutical composition comprising the compound as in claim 1 as an active ingredient, and the indications Gaucher disease, Fabry disease, Tay-Sachs disease or Parkinson’s disease:
[T]he present invention includes, within its scope, a pharmaceutical composition for inhibiting glucosylceramide synthase (GCS), comprising a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof as an active ingredient. In an embodiment, the present invention provides a pharmaceutical composition for preventing or treating the diseases associated with GCS, such as Gaucher disease, Fabry disease, Tay-Sachs disease, Parkinson's disease, etc., comprising a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof as an active ingredient.
Kim, Specification, col. 17, lines 56-67.
Therefore, claims 13-14 are anticipated.
Claim 15 is directed towards a method for inhibiting glucosylceramide synthase in a mammal, comprising administering a therapeutically effective amount of the compound of claim 1 to the mammal in need thereof.
Kim teaches a method for inhibiting glucosylceramide synthase in a mammal, comprising administering a therapeutically effective amount of the compound of claim 1 to the mammal in need thereof:
The present invention includes, within its scope, a method for inhibiting glucosylceramide synthase (GCS) in a mammal, comprising administering a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof to the mammal in need thereof.
Kim, Specification, col. 18, lines 50-54; subject matter of claim 23.
Therefore, claim 15 is anticipated.
Claim(s) 1-3, 6-9, and 12-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US 12,522,602 B2) .
The applied reference has common inventor(s) 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). This rejection under 35 U.S.C. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Claim 1 is directed towards a compound of formula 1:
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.
Kim teaches an overlapping genus:
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Kim, Specification, col. 4; subject matter of claim 1.
and species of compounds falling within the genus of formula 1. For example: (S)-quinuclidin-3-yl (5-(3-chloro-4-isopropoxyphenyl)-2,2- dimethyl-2,3-dihydro-1H-inden-1-yl)carbamate (Kim, Specification, col. 10, lines 28-29; claim 15). This compound has the following structure, falling within claim formula 1:
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(drawn by examiner).
Therefore, claim 1 is anticipated.
Claims 2-3, 6-9 and 12 read on this compound and are also anticipated for the reasons given in the rejection of claim 1.
Claim 13 is directed towards a pharmaceutical composition comprising the compound as claimed in claim 1 as an active ingredient. Claim 14 is directed towards a pharmaceutical composition as in claim 13, for preventing or treating Gaucher disease, Fabry disease, Tay-Sachs disease or Parkinson’s disease.
Kim teaches a pharmaceutical composition comprising the compound as in claim 1 as an active ingredient, and the indications Gaucher disease, Fabry disease, Tay-Sachs disease or Parkinson’s disease:
[T]he present invention includes, within its scope, a pharmaceutical composition for inhibiting glucosylceramide synthase (GCS), comprising a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof as an active ingredient. In an embodiment, the present invention provides a pharmaceutical composition for preventing or treating the diseases associated with GCS, such as Gaucher disease, Fabry disease, Tay-Sachs disease, Parkinson's disease, etc., comprising a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof as an active ingredient.
Kim, Specification, col. 22, lines 56-67; subject matter of claims 16-17.
Therefore, claims 13-14 are anticipated.
Claim 15 is directed towards a method for inhibiting glucosylceramide synthase in a mammal, comprising administering a therapeutically effective amount of the compound of claim 1 to the mammal in need thereof.
Kim teaches a method for inhibiting glucosylceramide synthase in a mammal, comprising administering a therapeutically effective amount of the compound of claim 1 to the mammal in need thereof:
The present invention includes, within its scope, a method for inhibiting glucosylceramide synthase (GCS) in a mammal, comprising administering a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof to the mammal in need thereof.
Kim, Specification, col. 23, lines 50-54; subject matter of claim 18.
Therefore, claim 15 is anticipated.
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.
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.
Claim(s) 1-2, 4, 6-8, 10, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 12,338,237 B2) as applied to claims 1-2, 4, 6-8, 10, and 13-15 above.
The rejection of claims 1-2, 4, 6-8, 10, and 13-15 above as anticipated by Kim is incorporated herein by reference. As such, these claims were prima facie obvious at the time of filing.
Claim 12 is directed towards specific species of compound of formula 1 as in claim 1. The naphthalenyl compounds of this claim are obvious over Kim. For example, claim 12 is directed towards the compound
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(claim 17, p. 19).
This compound has the following structure:
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(drawn by Examiner).
Kim teaches a highly similar compound, which differs by having propoxyphenyl instead of ethoxyphenyl: (S)-quinuclidin-3-yl (6-(3,5-dimethyl4-propoxyphenyl)-(7-fluoro-2,2-dimethyl-1,2,3,4-
tetrahydronaphthalen-1-yl)carbamate (Kim, Specification, col. 58, lines 62-64), which has the structure:
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(drawn by Examiner).
One of ordinary skill in the art would have a reasonable expectation of success to substitute ethoxyphenyl for propoxyphenyl because Kim teaches that the aryl is substituted with C1-6 alkoxy (Kim, Specification, col. 5, lines 21-25).
Therefore, claim 12 was prima facie obvious at the time of filing.
Claim(s) 1-2, 4-8, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 12,338,237 B2) as applied to claims 1-2, 4, 6-8, 10, and 12-15 above, and further in view of McCurdy & Cohen (“Bioisosterism”, Drug Design Org, Feb. 2007, p. 1-138).
The rejection of claims 1-2, 4, 6-8, 10 and 12-15 above is incorporated herein by reference.
Claims 5 and 9 are directed towards the compound of claim 1, wherein Y is O. As shown above, while Kim teaches compounds that are largely similar to the compounds of claims 5 and 9 except that Kim teaches that Y is CH2 and not O. One of ordinary skill in the art, however, would have a reasonable expectation of success to substitute CH2 for O because these groups are commonly known in the art to be bioisosteres with similar properties.
For example, McCurdy teaches that CH2 and O are divalent bioisosteres, which also behave similarly in ring systems:
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McCurdy, p. 12;
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McCurdy, p. 14.
Therefore, claims 5 and 9 were prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Nonstatutory 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.
Claim(s) 1-2, 4, 6-8, 10, and 12-15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,338,237 B2 (herein “the ‘237 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘237 patent claims an overlapping genus with the present claims and compounds falling within the genus of formula 1 as in claims 1-2, 4, 6-8 and 10. The ’237 patent also claims the same pharmaceutical compositions and methods of treatment. While the ‘237 patent does not claim identical species to the instantly claimed species, the instantly claimed species and the ‘237 patent claimed species are obvious over each other. The rejection of claims 1-2, 4, 6-8, 10, and 12-15 as unpatentable over U.S. 12,338,237 B2 is incorporated herein by reference. The ‘237 patent claims the cited subject matter described in the Specification.
Claim(s) 1-2, 4-8, and 10-15 is/are /are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,338,237 B2 (herein “the ‘237 patent”), as applied to claims 1-2, 4, 6-8, 10, and 12-15 above, in view of McCurdy & Cohen (“Bioisosterism”, Drug Design Org, Feb. 2007, p. 1-138).
Claims 5 and 9 are directed towards the compound of claim 1, wherein Y is O. As shown above, while Kim teaches compounds that are largely similar to the compounds of claims 5 and 9 except that Kim teaches that Y is CH2 and not O. One of ordinary skill in the art, however, would have a reasonable expectation of success to substitute CH2 for O because these groups are commonly known in the art to be bioisosteres with similar properties. For example, McCurdy teaches that CH2 and O are divalent bioisosteres, which also behave similarly in ring systems, see the Figures cited above in the 103 rejection, incorporated herein by reference.
Claim(s) 1-3, 6-9, 12 and 15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. US 12,522,602 B2 (herein “the ‘602 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘602 patent claims an overlapping genus with the present claims and compounds falling within the genus of formula 1 as in claims 1-3, 6-9 and 12. The ‘602 patent also claims the same methods of treatment. The rejection of claims 1-3, 6-9 and 12-15 as anticipated by the ‘602 patent is incorporated herein by reference. The ‘602 patent claims the cited subject matter described in its Specification.
Claim(s) 1-3, 6-9, and 12-15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. US 12,522,602 B2 (herein “the ‘602 patent”), as applied to claims 1-3, 6-9 and 15 above, and further in view of Borque et al. (WO 2012/129084 A2) (of record IDS cite no. 7).
As previously stated, the ‘602 patent claims an overlapping genus with the present claims and compounds falling within the genus of formula 1. The ‘602 patent also claims a method for inhibiting glucosylceramide synthase comprising administering the compound to a subject in need thereof. While the ‘602 patent does not claim a pharmaceutical composition comprising the compound of formula 1, one of ordinary skill in the art would have a reasonable expectation of success to formulate a pharmaceutical composition comprising the compound of formula 1, e.g. for the treatment of Fabry disease, because similar glucosylceramide synthase inhibitors are known to be included in compositions for the treatment of Fabry disease.
For example, Borque teaches glucosylceramide synthase inhibitors of formula I:
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Borque, Specification, p. 3;
and compositions comprising the same (id., p. 102), for the treatment of glucosylceramide synthase related conditions such as Fabry disease (id., p. 127).
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629