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 .
Response to Arguments
Applicant's arguments filed 06/26/2026 have been fully considered but they are not persuasive.
With respect to the argument that Pham et al. does not characterize a mass ratio of TPM to active or even suggest that such a mass ratio is important for improving the bioavailability of active, "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01. A TPM mass ratio of 1:1 is implicitly taught: see “10 mg of CoQ10 was added to 100 mg Captex 355 as the base formulation before addition of other lipid excipients for all subsequent studies” (Results and Discussion, p. 403) and Table 1, Fig. 2 on p. 403 indicating the use of 10 mg CoQ10:10 mg TPM (1:1). This ratio lies within the claimed ratios. Furthermore, teaching cited at pp. 4-5 of Applicant arguments suggests that 10% w/w vitamin E analogs to MCT is chosen as the “base” formulation, implying that it may be routinely optimized. It is important to note that Pham et al. is generally concerned with the comparison of different vitamin E analogs on improving solubility of an active ingredient in MCTs, and therefore is not principally concerned with optimization of ratios of specific vitamin E analogs to MCTs or active ingredients. This however does not preclude said optimization, and Pham et al. in fact states at p. 405 “The mixing ratio of components comprising TPM could also play a role in bioavailability of formulated poorly water soluble drugs, and investigation of further refinement of this ratio is warranted to ultimately position the potential of this new excipient in the best way against established materials such as TPGS.” which suggests optimization of ratios components. With respect to the argument that “LifeSense focuses on the criticality of MCT, and in particular the MCT species,” "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). See MPEP 2145(IV). That the teachings of Pham et al. are applicable to those of LifeSense has been established, and therefore the combined teachings of LifeSense and Pham et al. support a conclusion of obviousness regardless of the teachings of LifeSense alone.
Applicant argues LifeSense and Pham et al. are at odds over the utility of MCT alone. Pham et al. merely generically states a potential disadvantage of MCTs. Note that LifeSense also teaches advantages of MCTs, for example “A practical advantage of solubilizing CBDs with MCTs are the very long shelf life of MCTs, with typical re-test dates being 3 years.” (p. 5). There are various advantages and disadvantages to both options, but this does not amount to a teaching away from using one or the other nor does it preclude the applicability of Pham et al. to LifeSense. LifeSense teaches the use of MCTs for solubilizing CBD, and Pham et al. teaches TPM as an additive to improve the efficacy of MCT in solubilizing poorly water-soluble drugs. Accordingly, to apply the teachings regarding improving MCT formulations of Pham et al. to those of LifeSense regarding MCT formulations would have been obvious.
Applicant also argues that CoQ10 and cannabinoids are both poorly water soluble yet different compounds and that the combination of references would have resulted in improved oral bioabailability merely because both compounds are poorly water soluble. Obviousness does not require absolute predictability, but at least some degree of predictability is required. See MPEP 2143.02. The MCT + TPM formulations taught by Pham et al. are clearly indicated as being relevant to formulating poorly water soluble drugs (see Title, Abstract), even if only CoQ10 was tested, and LifeSense is directed toward the poorly water soluble CBD. Structural similarity alone is not necessary to establish applicability of teachings of one compound to another. In the instant case, the physical property of solubility is relied upon and that both compounds are considered poorly water soluble drugs provides a sufficient nexus to apply the teachings of Pham et al. to LifeSense. Accordingly, there is a reasonable expectation of success in applying the teachings of the CoQ10 + MCT + TPM formulations taught by Pham et al. to the teachings of the CBD + MCT formulations taught by LifeSense. Accordingly, the rejection of claims 1-11 under 35 U.S.C. 103 as being unpatentable over LifeSense in view of Pham et al. is maintained.
Applicant argues that Izgelov teaches away from substituting MCTs for LCTs. That Izgelov suggests some degree of experimentation to determine the optimal drug delivery system between the two options does not amount to a teaching away from using one or the other. Accordingly, the nonstatutory double patenting rejection of claims 1-11 as being unpatentable over claims 1-20 of U.S. Patent No. 12,539,307 in view of Izgelov et al.; and the provisional nonstatutory double patenting rejection of claims 1-11 as being unpatentable over claims 1-20 of copending Application No. 12420850 in view of Izgelov et al. are maintained.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over LifeSense in view of Pham et al. (see 07/08/2024 IDS Ref. Des. C4 and C9, respectively).
LifeSense teaches that oral bioavailability of CBD is low due to limited aqueous solubility (p. 3) and that MCTs are useful for increasing solubility and oral bioavailability of CBDs (p. 8).
LifeSense does not teach the inclusion of a tocopheryl phosphate component comprising TP and T2P.
Pham et al. teaches the use of TPM (a mixture of TP and T2P, see Fig. 1) in combination with MCTs for improving solubility and bioavailability of poorly water-soluble drugs such as CoQ10 (see Abstract; whole document). Solutions comprising 100mg MCT, 10% w/w CoQ10 and 10 mg TPM were prepared (pp. 401-402). The TPM is a 2:1 w/w mixture of alpha-tocopheryl phosphate and di-alpha tocopheryl phosphate (p.401). Both Lifesense and Pham et al. are drawn toward methods of increasing solubility and oral bioavailability of poorly water-soluble drugs. Accordingly, would have been prima facie obvious to include TPM in the formulation taught by LifeSense as taught by Phan et al. with a reasonable expectation that doing so would improve solubility and oral bioavailability of CBD which is taught to be a poorly water-soluble drug. Claims 1-11 require specific ratios or amounts of specific components which either overlap with the amounts taught by Pham et al. or would be attained under the process of routine optimization. Additionally, claims 9 and 11 are drawn to routine oral dosage administration parameters/forms which are at once envisaged by a PHOSITA upon contemplation of oral delivery taught by both Lifesense and Pham et al. Accordingly, claims 1-11 are obvious.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,539,307 in view of Izgelov et al. (07/08/2024 Ref. Des. C2).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of U.S. Patent No. 12,539,307 are drawn to compositions and methods of use thereof comprising the same components of the instant claims but differ in that they require LCT instead of MCT. These are considered obvious variants in the art and therefore it would have been obvious to substitute LCT with MCT. See Izgelov et al. which teaches that MCT and LCT are both useful as carriers for cannabinoids (Title, Abstract). While properties may differ, they are nevertheless taught to be useful for the same purpose of drug delivery of cannabinoids and therefore claims 1-11 are obvious over claims 1-20 of U.S. Patent No. 12,539,307.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19420850 (reference application) in view of Izgelov et al. (07/08/2024 Ref. Des. C2).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of copending Application No. 19420850 are drawn to compositions and methods of use thereof comprising the same components of the instant claims but differ in that they require LCT instead of MCT. These are considered obvious variants in the art and therefore it would have been obvious to substitute LCT with MCT. See Izgelov et al. which teaches that MCT and LCT are both useful as carriers for cannabinoids (Title, Abstract). While properties may differ, they are nevertheless taught to be useful for the same purpose of drug delivery of cannabinoids and therefore claims 1-11 are obvious over claims 1-20 of copending Application No. 19420850.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-11 are rejected.
Claims 12-17 are withdrawn.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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