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 1-18 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6 and 7-14 in the reply filed on 07/22/2025 is acknowledged.
Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-6, 7-14 are examined herein on the merits.
Claim Rejections - 35 USC § 102
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 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.
1) Claims 1, 7, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barden et al. (Journal of Medicinal Chemistry (1994), 37(20), 3205-11, PTO-1449).
Barden et al. discloses compound 11 of structure below which is same as instant compound of formula as in instant claim 1, wherein R is C9H19. See Table 1, compound 11. Composition comprising compound in an excipient is taught. See page 3206, right hand column, under Biology. Agar dilution method using Muller-Hinton II agar is taught. See page 3206, right hand column, under Biology.
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Barden et al. anticipates instant claims.
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)(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.
2)Claims 1-5, 7-11, 13, 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lisanti et al. (WO 2020131696, PTO-892).
Lisanti et al. discloses instant compounds as in instant claims 1-6, and composition comprising instant compounds. See claim 6. Lisanti et al. teaches that the compounds therein may be used in the form of pharmaceutical composition prepared using diluents or excipients. See para [0060].
Lisanti et al. anticipates instant claims.
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.
3)Claim(s) 6, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lisanti et al. (WO 2020131696, PTO-892) as applied to claims 1-5, 7-11, 13, 14 above, and further in view of Legendre et al. (CrystEngComm. 2012, 14 (7): 2532–2540, PTO-892).
Lisanti et al. is applied as discussed above.
Lisanti et al. does not teach wherein the salt is one of monohydrate and hyclate.
Legendre et al. teaches that tetracycline compound doxycycline (DOX) is used against a wide variety of microbial pathogens. It is taught that different solid forms of a compound (e.g., polymorphs and solvates) may exhibit distinct properties like compressibility, density, solubility and dissolution rate. These differences can affect the drug bioavailability and are essential to ensure a reproducible behaviour of the drug in the organism, as well as its safety. Legendre et al. teaches that doxycycline monohydrate and doxycycline hyclate are known; and Legendre et al. teaches the solid state behaviour of monohydrate and doxycycline hyclate such as melting temperature, equilibrium solubility and dissolution rate were determined and correlated to structural features of both DOX crystal forms. See abstract; page 2533, left hand column; page 2539, left hand column, under Conclusion.
It would have been obvious to a person of ordinary skill in the art to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 because Legendre et al. teaches that monohydrate and doxycycline hyclate salts of tetracycline compound DOX are known; DOX and instant compounds are structurally similar. One of ordinary skill in the art would be motivated to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 which are structurally similar to DOX with the expectation of success of determining the bioavailability, solubility of said salts.
4)Claim(s) 6, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Barden et al. (Journal of Medicinal Chemistry (1994), 37(20), 3205-11, PTO-1449) as applied to claims 1, 7, 13 above, in view of Legendre et al. (CrystEngComm. 2012, 14 (7): 2532–2540, PTO-892).
Barden et al. is applied as discussed above.
Barden et al. does not teach wherein the salt is one of monohydrate and hyclate.
Legendre et al. teaches that tetracycline compound doxycycline (DOX) is used against a wide variety of microbial pathogens. It is taught that different solid forms of a compound (e.g., polymorphs and solvates) may exhibit distinct properties like compressibility, density, solubility and dissolution rate. These differences can affect the drug bioavailability and are essential to ensure a reproducible behaviour of the drug in the organism, as well as its safety. Legendre et al. teaches that doxycycline monohydrate and doxycycline hyclate are known; and Legendre et al. teaches the solid state behaviour of monohydrate and doxycycline hyclate such as melting temperature, equilibrium solubility and dissolution rate were determined and correlated to structural features of both DOX crystal forms. See abstract; page 2533, left hand column; page 2539, left hand column, under Conclusion.
It would have been obvious to a person of ordinary skill in the art to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 because Legendre et al. teaches that monohydrate and doxycycline hyclate salts of tetracycline compound DOX are known; DOX and instant compounds are structurally similar. One of ordinary skill in the art would be motivated to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 which are structurally similar to DOX with the expectation of success of determining the bioavailability, solubility of said salts.
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.
1)Claims 1-5, 6 7-11, 12, 13-14 rare ejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,672,810, and further in view of Legendre et al. (CrystEngComm. 2012, 14 (7): 2532–2540, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are drawn to a compound having formula as in instant claims 1-5 or a salt thereof; and a composition comprising a compound of formula as in instant claims 7-11.
Claims of ‘810 teach mitochondrial biogenesis inhibitor wherein the inhibitor comprises a compound having formula which is same as general formula as in instant claim 1. The compounds therein are used for treating endocrine therapy resistance cancer.
It would have been obvious to obtain instant compounds as in instant claims 1-2 because ‘810 teaches instant compounds of formula as in instant claim 1.
It would have been obvious to obtain instant compounds as in instant claims 3-5 because ‘810 teaches instant compounds of formula as in instant claim 1 which encompass instant compounds with particular R group as in instant claims 3-5.
Further, if would have been obvious to obtain a composition comprising instant compounds because ‘810 teaches instant compounds of formula as in instant claim 1; ‘810 teaches that the compounds therein are used for treating endocrine therapy resistance cancer. One of ordinary skill in the art would have been motivated to obtain a composition comprising instant compounds in an excipient or a carrier with reasonable expectation of success of using the composition for treating endocrine therapy resistance cancer.
‘810 does not teach wherein the salt is one of monohydrate and hyclate.
Legendre et al. teaches that tetracycline compound doxycycline (DOX) is used against a wide variety of microbial pathogens. It is taught that different solid forms of a compound (e.g., polymorphs and solvates) may exhibit distinct properties like compressibility, density, solubility and dissolution rate. These differences can affect the drug bioavailability and are essential to ensure a reproducible behaviour of the drug in the organism, as well as its safety. Legendre et al. teaches that doxycycline monohydrate and doxycycline hyclate are known; and Legendre et al. teaches the solid state behaviour of monohydrate and doxycycline hyclate such as melting temperature, equilibrium solubility and dissolution rate were determined and correlated to structural features of both DOX crystal forms. See abstract; page 2533, left hand column; page 2539, left hand column, under Conclusion.
It would have been obvious to a person of ordinary skill in the art to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 because Legendre et al. teaches that monohydrate and doxycycline hyclate salts of tetracycline compound DOX are known; DOX and instant compounds are structurally similar. One of ordinary skill in the art would be motivated to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 which are structurally similar to DOX with the expectation of success of determining the bioavailability, solubility of said salts.
2)Claims 1-5, 6 7-11, 12, 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 9, 11-17 of copending Application No. 17/414,842 (reference application), and further in view of Legendre et al. (CrystEngComm. 2012, 14 (7): 2532–2540, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are drawn to a compound having formula as in instant claims 1-5 or a salt thereof; and a composition comprising a compound of formula as in instant claims 7-11.
Claims of ‘842 are drawn to a composition comprising a combination of a first therapeutic agent that inhibits mitochondrial biogenesis and targets the large mitochondrial ribosome, a second therapeutic agent that inhibits mitochondrial biogenesis and targets the small mitochondrial ribosome, and a third therapeutic agent that induces mitochondrial oxidative stress; wherein: (a) the first therapeutic agent is a member of the erythromycin family or a conjugate of a member of the erythromycin family and a first fatty acid; (b) the second therapeutic agent is a member of the tetracycline family or a conjugate of a member of the tetracycline family and a second fatty acid; and (c) the third therapeutic agent is at least one of Vitamin C, ascorbyl palmitate; wherein the second therapeutic agent comprises one compound of structures as in claim 6 which are same as instant compounds as in instant claims 1-5; wherein the first therapeutic agent, the second therapeutic agent, and the third therapeutic agent are encapsulated in a liposomal drug delivery system.
It would have been obvious to obtain instant compounds and composition comprising instant compounds because ‘842 teaches instant compounds and teaches a composition comprising one compound of structures as in claim 6 therein which are same as instant compounds as in instant claims 1-5.
‘842 does not teach wherein the salt is one of monohydrate and hyclate.
Legendre et al. teaches that tetracycline compound doxycycline (DOX) is used against a wide variety of microbial pathogens. It is taught that different solid forms of a compound (e.g., polymorphs and solvates) may exhibit distinct properties like compressibility, density, solubility and dissolution rate. These differences can affect the drug bioavailability and are essential to ensure a reproducible behaviour of the drug in the organism, as well as its safety. Legendre et al. teaches that doxycycline monohydrate and doxycycline hyclate are known; and Legendre et al. teaches the solid state behaviour of monohydrate and doxycycline hyclate such as melting temperature, equilibrium solubility and dissolution rate were determined and correlated to structural features of both DOX crystal forms. See abstract; page 2533, left hand column; page 2539, left hand column, under Conclusion.
It would have been obvious to a person of ordinary skill in the art to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 because Legendre et al. teaches that monohydrate and doxycycline hyclate salts of tetracycline compound DOX are known; DOX and instant compounds are structurally similar. One of ordinary skill in the art would be motivated to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 which are structurally similar to DOX with the expectation of success of determining the bioavailability, solubility of said salts.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3)Claims 1-5, 6 7-11, 12, 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 9-17, 19-27, 46-48 of copending Application No. 18/425,427 (reference application), and further in view of Legendre et al. (CrystEngComm. 2012, 14 (7): 2532–2540, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are drawn to a compound having formula as in instant claims 1-5 or a salt thereof; and a composition comprising a compound of formula as in instant claims 7-11.
Claims of ‘427 are drawn to a composition comprising :a combination of a first therapeutic agent that inhibits mitochondrial biogenesis and targets the large mitochondrial ribosome, a second therapeutic agent that inhibits mitochondrial biogenesis and targets the small mitochondrial ribosome, and a third therapeutic agent that induces mitochondrial oxidative stress; wherein the second therapeutic agent comprises one compound of structures as in claim 6 which are same as instant compounds as in instant claims 1-5; wherein the first therapeutic agent, the second therapeutic agent, and the third therapeutic agent are encapsulated in a liposomal drug delivery system.
It would have been obvious to obtain instant compounds and composition comprising instant compounds because ‘427 teaches instant compounds and teaches a composition comprising one compound of structures as in claim 6 therein which are same as instant compounds as in instant claims 1-5.
‘427 does not teach wherein the salt is one of monohydrate and hyclate.
Legendre et al. teaches that tetracycline compound doxycycline (DOX) is used against a wide variety of microbial pathogens. It is taught that different solid forms of a compound (e.g., polymorphs and solvates) may exhibit distinct properties like compressibility, density, solubility and dissolution rate. These differences can affect the drug bioavailability and are essential to ensure a reproducible behaviour of the drug in the organism, as well as its safety. Legendre et al. teaches that doxycycline monohydrate and doxycycline hyclate are known; and Legendre et al. teaches the solid state behaviour of monohydrate and doxycycline hyclate such as melting temperature, equilibrium solubility and dissolution rate were determined and correlated to structural features of both DOX crystal forms. See abstract; page 2533, left hand column; page 2539, left hand column, under Conclusion.
It would have been obvious to a person of ordinary skill in the art to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 because Legendre et al. teaches that monohydrate and doxycycline hyclate salts of tetracycline compound DOX are known; DOX and instant compounds are structurally similar. One of ordinary skill in the art would be motivated to obtain monohydrate salt or to obtain hyclate salt of instant tetracycline compounds of formula as in instant claim 1 which are structurally similar to DOX with the expectation of success of determining the bioavailability, solubility of said salts.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art made of Record:
WO01/74761;
US 6165999;
WO 2018193114;
Wo 2018193113.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627
