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 of Claims
Claims 24-43 are pending as of the response and amendments filed on 2/4/26.
The 102(a)(1) rejection over Bascomb is withdrawn in consideration of the amendments.
The 103 rejections of record are withdrawn in view of the claim amendments.
Claims 24-43 were previously rejected for nonstatutory double patenting over the claims of US 10835501, US 11234944, US 11786482, and US 12115137. In response, Applicants have stated a terminal disclaimer is being filed to overcome these rejections. However, to date a terminal disclaimer is not of record. Therefore, the double patenting rejections of record are maintained, with modification to address the amended claims.
A new 103 rejection is made based on the amended claims, discussed below.
Claims 24-43 were examined and are rejected.
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) 24-28 and 34-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et. al., WO 2005102296 A2, publ. 11/3/2005.
Edwards teaches combinations for treating immunoproliferative skin disorders, such as psoriasis, wherein each component in the combination is present in a lower amount compared to pharmaceutical compositions containing the component as a single active agent (title & abstract; p. 1, 1st para). Edwards teaches agents from the following classes can be combined to effectively treat psoriasis (pp. 3-4, bridging para):
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. Edwards teaches the combinations allow for administration of a dose of active agent which would be sub-optimal or sub-therapeutic if administered alone (p. 4, 3rd para; p. 6, 2nd para). Edwards teaches cannabinoids and cannabinoid receptor agonists as inhibitors of keratinocyte proliferation and to include arachidonylethanolamide, delta-8 and delta-9 THC, hemp oil, as well as cannabidiol (CBD), with CBD and delta-9 THC taught as preferred (p. 7, 3rd-5th para). CBD and delta-9 THC are well-known in the art as phytocannabinoids. HMG-CoA reductase inhibitors are also taught as inhibitors of keratinocyte proliferation, and to include lovastatin, mevinolin, simvastatin, pravastatin, fluvastatin, or atorvastatin, with lovastatin or mevinolin especially preferred (p. 8, 4th para). Edwards teaches administering to a patient in need of treatment for an immunoproliferative skin disorder a combination as disclosed above in an appropriate amount (p. 12, 1st para). Edwards teaches the combination of MEV/THC (mevinolin/delta-9 THC) as one of the more potent combinations (p. 31, beginning with Ex. 9-p. 33, top 2 para).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated an immunoproliferative skin disorder in a subject in need thereof comprising administering to the subject the combination of a statin; and a phytocannabinoid such as CBD or delta-9 THC, in consideration of Edwards. As discussed above, Edwards teaches various combinations of agents for treating an immunoproliferative skin disorder, and exemplifies the combination of a cannabinoid and a statin, e.g., lovastatin and delta-9 THC. Cannabinoids and statins are both taught to inhibit keratinocyte proliferation, beneficial for the treatment of psoriasis. Edwards further teaches the combination allows for a lower dose of each agent compared to the dose required if each agent were administered alone. As such, it would have been prima facie obvious to a person of ordinary skill in the art to have administered the combination of a statin and a cannabinoid to a person who was already receiving a statin for the treatment of an immunoproliferative skin disease, wherein the dose of the statin administered in the combination therapy was lower than the dose of the statin administered previously in the absence of the combination, as Edwards teaches the combination therapy allows for administration of a lower dose of each active agent.
Claim Rejections-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.
Claims 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10835501 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a combination of atorvastatin and cannabidiol, and methods of treating a condition selected from hypercholesterolemia, atherosclerosis, myositis, and rhabdomyolysis by administering the combination (see instant claims 26, 28, and 29-33, and claims 1 and 13-15 of the US patent). The instant claims recite the limitations wherein the subject has previously received statin therapy, and the statin in the combination is administered at a lower dose than the dose of statin administered before. Although these limitations are not expressly recited in the patented claims, the patented claims do recite the dose of statin to be less in the combination compared to the dose of statin when taken alone. Therefore, it would have been prima facie obvious to have modified the patented claims by administering the combination of a statin and cannabidiol to a subject who had previously received statin therapy, wherein the dose of statin in the combination administered is less compared to the dose of statin administered alone. The instant and patented claims are therefore not patentably distinct.
Claims 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11234944 B2 in view of Bascomb et. al., US 20080033027 A1; and Merriam-Webster definition of “myopathy”, downloaded from internet 7/30/2025. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a combination of atorvastatin and cannabidiol, and methods of treating a lipid disorder, e.g., hypercholesterolemia and atherosclerosis by administering the combination (see instant claims 26, 28, and 29-33, and claims 6-7 and 9 of the US patent). While the patented claims don’t recite treating a myopathy as recited by instant claims, Bascomb discloses preparations, formulations, and kits comprising combination of active agents for improving disease symptoms involving inflammation, excessive sympathoneural drive, cachexia, anorexia, as well as stress or anxiety related thereto (title & abstract; para [0002], [0010]), and treatment of these disease states by administering a therapeutically effective amount of the combination (para [0026]). Bascomb further discloses the formulations with a pharmaceutical excipient (para [0017]). Bascomb further discloses the ingredient combination of valsartan, thalidomide, cannabidiol (30 mg), atorvastatin (60 mg.), and a vitamin mix (para [0271]). Bascomb teaches the combination therapy to be useful for treating and improving muscle atrophy or loss such as in cachexia (para [0173], [0184], [0285]), and to reduce inflammation (para [0346]). The broad definition of “myopathy” is a disease of the muscle (see Merriam-Webster). As Bascomb teaches the combination of atorvastatin and CBD to be useful for treating muscle atrophy and loss, and cachexia, it would have been prima facie obvious to have applied the method of the patented claims to treat myopathy. The instant claims recite the limitations wherein the subject has previously received statin therapy, and the statin in the combination is administered at a lower dose than the dose of statin administered before. Although these limitations are not expressly recited in the patented claims, the patented claims do recite the dose of statin to be less in the combination compared to the dose of statin when taken alone. Therefore, it would have been prima facie obvious to have modified the patented claims by administering the combination of a statin and cannabidiol to a subject who had previously received statin therapy, wherein the dose of statin in the combination administered is less compared to the dose of statin administered alone. The instant and patented claims are therefore not patentably distinct.
Claims 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11786482 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a combination of a statin and a phytocannabinoid. Patented claims 11-20 are drawn to improving the bioavailability of a statin by administering the combination of a statin and a phytocannabinoid. As the instant claims also recite administering the combination of a statin and a phytocannabinoid, it would have been prima facie obvious that the instantly claimed method would have provided the same effect as recited in the method of the patented claims, e.g., improved bioavailability of a statin. The instant claims recite the limitations wherein the subject has previously received statin therapy, and the statin in the combination is administered at a lower dose than the dose of statin administered before. Although these limitations are not expressly recited in the patented claims, the patented claims do recite the dose of statin to be less in the combination compared to the dose of statin when taken alone. Therefore, it would have been prima facie obvious to have modified the patented claims by administering the combination of a statin and cannabidiol to a subject who had previously received statin therapy, wherein the dose of statin in the combination administered is less compared to the dose of statin administered alone. The instant and patented claims are therefore not patentably distinct.
Claims 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12115137 B2 in view of Edwards et. al., WO 2005102296 A2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a combination of atorvastatin and cannabidiol, and methods of treating a condition selected from hypercholesterolemia, atherosclerosis, myositis, and rhabdomyolysis by administering the combination (see instant claims 26, 28, and 29-33, and claims 12-13 of the US patent). The instant claims recite the limitations wherein the subject has previously received statin therapy, and the statin in the combination is administered at a lower dose than the dose of statin administered before. Although these limitations are not expressly recited in the patented claims, such modification would have been prima facie obvious in view of Edwards. Edwards teaches combinations for treating immunoproliferative skin disorders, such as psoriasis, wherein each component in the combination is present in a lower amount compared to pharmaceutical compositions containing the component as a single active agent (title & abstract; p. 1, 1st para). Edwards teaches agents from the following classes can be combined to effectively treat psoriasis (pp. 3-4, bridging para):
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. Edwards teaches the combinations allow for administration of a dose of active agent which would be sub-optimal or sub-therapeutic if administered alone (p. 4, 3rd para; p. 6, 2nd para). Edwards teaches cannabinoids and cannabinoid receptor agonists as inhibitors of keratinocyte proliferation and to include arachidonylethanolamide, delta-8 and delta-9 THC, hemp oil, as well as cannabidiol (CBD), with CBD and delta-9 THC taught as preferred (p. 7, 3rd-5th para). CBD and delta-9 THC are well-known in the art as phytocannabinoids. HMG-CoA reductase inhibitors are also taught as inhibitors of keratinocyte proliferation, and to include lovastatin, mevinolin, simvastatin, pravastatin, fluvastatin, or atorvastatin, with lovastatin or mevinolin especially preferred (p. 8, 4th para). Edwards teaches administering to a patient in need of treatment for an immunoproliferative skin disorder a combination as disclosed above in an appropriate amount (p. 12, 1st para). Edwards teaches the combination of MEV/THC (mevinolin/delta-9 THC) as one of the more potent combinations (p. 31, beginning with Ex. 9-p. 33, top 2 para).
Therefore, it would have been prima facie obvious to have modified the patented claims by administering the combination of a statin and cannabidiol to a subject who had previously received statin therapy, wherein the dose of statin in the combination administered is less compared to the dose of statin administered alone. The instant and patented claims are therefore not patentably distinct.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627