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 1 and 2 are pending in the application. Claims 1 and 2 are rejected.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on February 8th, 2024.
Priority
The instant claims are supported by U.S. Provisional Application No. 62/967,524 and therefore have an earliest effective filing date of January 29th, 2020. WO 2020/160192 A2 by Brucelle et al. (which claims priority to U.S. Provisional Application No. 62/881,163 filed July 31st, 2019) is cited below in double patenting rejections and is available under 35 USC 102(a)(2) until a disqualifying statement is made in the instant application.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 9) Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,851,445. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the patent as issued recites a compound of formula D2 as recited in instant claim 1. Regarding instant claim 2, a person having ordinary skill in the art would have been motivated to add a pharmaceutically acceptable excipient for ease of administration and where claims 4-6 of the patent recite pharmaceutical compositions for the analogous compound D1 of the patent.
(2 of 9) Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,851,445 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 1 of the patent recites compound D1 having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The patent provides the following definitions in column 12:
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Accordingly, even if claim 1 of the patent were subject to a certificate of correction to delete reference to compound D2, the claims of the patent would still be generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the patent) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare analogous compositions to those recited in claim 4 of the patent.
(3 of 9) Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,767,330 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 1 of the patent recites a citrate salt of a compound having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The patent provides the following definitions in column 111:
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Accordingly, the claims of the patent are generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the patent) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare analogous compositions to those recited in claims 2-10 of the patent.
(4 of 9) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/223,443 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of the copending case recites a citrate salt of a compound embraced by instant compound D2. Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare analogous compositions to those recited in claims 3-12 of the copending case.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(5 of 9) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-9, 11-15, 19, 20 and 25-29 of copending Application No. 18/292,426 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 1 of the copending case recites a method of using a compound having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The copending case provides the following definition on page 9:
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Accordingly, the claims of the copending case are generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the copending case) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare pharmaceutical compositions for ease of administration to a patient such as by intravenous administration in claim 29 of the copending case.
This is a provisional nonstatutory double patenting rejection.
(6 of 9) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11-18, 20, 24, 25, 40, 48-51, 62 and 69 of copending Application No. 18/292,508 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 48 of the copending case recites a method of using a compound having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The copending case provides the following definition on page 17:
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Accordingly, the claims of the copending case are generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the copending case) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility in the claims of the copending case would have been motivated to prepare pharmaceutical compositions for ease of administration to a patient to generate the subject contain a chiral glutarimide.
This is a provisional nonstatutory double patenting rejection.
(7 of 9) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11, 12, 14, 16, 17, 28-31, 33, 35, 45, 46, 49, 62, 83 and 84 of copending Application No. 18/856,340 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 14 of the copending case recites a method of using a compound having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The copending case provides the following definition on pages 11 and 12:
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Accordingly, the claims of the copending case are generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the copending case) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare pharmaceutical compositions for ease of administration to a patient.
This is a provisional nonstatutory double patenting rejection.
(8 of 9) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-92 of copending Application No. 19/500,457 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 83 of the copending case recites a method of using a compound having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The copending case provides the following definition on page 12:
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Accordingly, the claims of the copending case are generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the copending case) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare pharmaceutical compositions for ease of administration to a patient.
This is a provisional nonstatutory double patenting rejection.
(9 of 9) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-100 of copending Application No. 19/500,531 in view of WO 2020/160192 A1 by Brucelle et al. and in further view of Kaur et al. Global Journal of Pharmacy & Pharmaceutical Science, 2017, 1(4): GJPPS.MS.ID.555566. Claim 78 of the copending case recites a method of using a compound having the following structure:
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The compound has the same backbone structure as instant compound D2 except where the methoxy groups are deuterium enriched. The copending case provides the following definition on page 12:
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Accordingly, the claims of the copending case are generic to the compound D2 as instantly claimed. Furthermore, a person having ordinary skill in the art would have been familiar with permissible deuterium labeling at the analogous positions. Brucelle et al. teach compounds of the following general formula (page 1, support can be found in claim 1 of U.S. Provisional Application No. 62/881,163):
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where G can be the following structure on page 7 (support can be found in claim 25 of the provisional application):
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Brucelle et al. further teach the following definitions for RG1-RG5 on page 8 (support can be found in claim 27 of the provisional application):
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Brucelle et al. teach the use of both -OCH3 and -OC(2H)3. A person having ordinary skill in the art would have reasonably expected the instantly claimed compound to have similar utility as the non-enriched compound (as depicted in the claims of the copending case) and in view of the teachings of Brucelle et al. would have been motivated to prepare the instantly claimed deuterium labeled compound to test for any metabolic improvements. For instance, Kaur et al. teach in the abstract “Deuteration is an effective tool for the enhancement of drug’s metabolic profile.”
Regarding instant claim 2, a person having ordinary skill in the art in seeking to test the instantly claimed compound’s utility would have been motivated to prepare pharmaceutical compositions for ease of administration to a patient.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/MATTHEW P COUGHLIN/ Primary Examiner, Art Unit 1626