DETAILED ACTION
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
The instant application is the national stage entry of PCT/US2021/039755 filed 30 June 2021. Acknowledgment is made of the Applicant’s claim of domestic priority to provisional US applications 63/107,071 filed 29 October 2020 and 63/046,880 filed 1 July 2020.
Election/Restrictions
Applicant has previously elected, as the species of lipid matrix, a combination of wax, fatty alcohol, and fatty acid. Election was made without traverse in the reply filed on 29 August 2025.
Status of the Claims
Claims 1, 3-4, 6-22, and 24-25 are pending.
Claims 20-22 and 24-25 are withdrawn.
Claims 1, 3-4, and 6-19 are rejected.
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.
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, 3-4, 6-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Westphal et al. (WO 2015/160842) as evidenced by Western Washington University (https://ehs.wwu.edu/files/2022-01/Capsaicin.pdf).
Westphal teaches a composition formulated for oral administration comprising an effective amount of a capsaicinoid, capsinoid, or related analog or combination thereof (pg 2, ¶2). The capsaicinoid, which can be capsaicin, is present in amounts ranging from 0.001-10 wt% (pg 3, ¶2) wherein the capsaicinoid can be a liquid formulation (pg 4, ¶3) or a solid formulation (pg 6, ¶2). The overall composition can be a solid or liquid, but when a solid it can be a tablet or capsule (pg 4, ¶2). The capsaicinoid composition can further comprise excipients including surfactants, such as polysorbate 80 or polyoxyethylene hydrogenated castor oil, disintegrants (such as carmellose – sodium carboxymethyl cellulose), binding agents, emulsifiers, and other agents (pg 37, ¶5). In addition, the composition of Westphal can be formulated to further include polyglycolized glycerides (in soft or hard gelatin capsules) (pg 59, ¶1). It is noted that polyoxyethylene hydrogenated castor oil is a high flowpoint excipient, as identified in the instant specification at [0057], and polyglycolized glycerides are low flow point excipients [0052]. The additional components in Westphal can all be included in amounts ranging from 0.5-99 wt% (pg 53, ¶3). The composition can be an oil-based composition and thus comprise lipophilic additives such as waxes wherein the waxes can comprise fatty acids from 5-20 wt% (pg 56, ¶3-4). Specific examples of suitable wax agents include beeswax, candelilla wax, stearic acid, and mixtures thereof (pg 57, ¶1). In one example, the capsaicinoid can be formulated with a coating that releases the actives at neutral to alkaline pH (pg 60, ¶2). The capsaicinoid formulation can be formulated as a microparticle, which necessarily includes the size range of from 1-1000 microns (pg 61, ¶2-3).
It would have been prima facie obvious to prepare the orally administered composition of Westphal comprising an effective amount of capsaicin in an amount of from 0.001-10 wt% wherein the capsaicin can be a liquid or a solid and the composition can be in the form of a capsule or tablet, addressing instant claims 1, 4, 6, and 8-9. Western Washington University evidences that capsaicin is a waxy solid compound (pg 1). Thus, the inclusion of capsaicin in its wax form in addition to it as a liquid (solubilized) would have been obvious, since both solid and liquid forms are taught in the art, addressing instant claims 1 and 3. Claim 10 is addressed by Westphal teaching the composition can be microparticles. The relative amounts of wax or liquid forms of capsaicin are not taught by the art, however both solid forms and liquid forms are in the disclosure of Westphal. That being said and in lieu of objective evidence of unexpected results, the amounts of capsaicin wax and liquid can be viewed as variables which achieve the recognized result of an oral composition with a desired consistency. The optimum or workable range of wax and liquid can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
Regarding instant claim 7, Westphal teaches formulations with a coating that releases the actives at neutral to alkaline pH, which is “a pH of about 7 or greater.”
By selecting to include excipients polyoxyethylene hydrogenated castor oil and polyglycolized glycerides in 0.5-99 wt%, the skilled artisan would have addressed instant claims 11-12 and 17. Similarly, the skilled artisan could have selected polysorbate 80 as the surfactant, addressing instant claims 15-16. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of capsaicinoids and excipients from within Westphal, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Accordingly, claims 1, 3-4, 6-12, and 15-17 are rejected as obvious over the prior art.
Claims 1, 3-4, and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Westphal et al. (WO 2015/160842) in view of Talebian et al. (US 4,895,935) in view of Casillas et al. (US 2008/0318945) as evidenced by Western Washington University (https://ehs.wwu.edu/files/2022-01/Capsaicin.pdf).
Westphal and Western Washington University, as applied supra, are herein applied in their entirety for the teachings of an orally administered composition comprising capsaicin.
Westphal does not teach the composition further comprising a fatty alcohol such as stearyl alcohol.
Talebian teaches that in oral dosage forms, examples of excipients and carriers useful include waxes such as beeswax and stearyl alcohol.
Casillas teaches that in a solid oral dosage form such as a tablet or capsule, suitable disintegrants include sodium carboxymethyl cellulose and croscarmellose [0127].
It would have been prima facie obvious to prepare the orally administered composition comprising capsaicin of Westphal wherein the composition further comprises waxes such as candelilla wax, beeswax, and stearic acid and modify it to further include an additional wax suitable in oral dosage forms such as stearyl alcohol, as taught by Talebian. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07). In addition, it would have been obvious to include a disintegrant in the composition of Westphal in 0.5-99 wt%, which is taught in the art. Carmellose (sodium carboxymethyl cellulose) is listed as one suggestion, therefore it would have been obvious to use croscarmellose (cross-linked sodium carboxymethyl cellulose) as the disintegrant instead of carmellose, as required in instant claims 18-19.
The resulting composition renders obvious instant claims 1, 3-4, and 6-19.
Response to Arguments
Applicant's arguments filed 23 December 2025 have been fully considered but they are not persuasive. The Applicant argues, on page 6 of their remarks, that Westphal does not mention a mixture of capsaicin wax and capsaicin liquid. In addition, the applicant argues that the examples of Westphal teach to only utilize 0.075% of a capsaicin preparation.
In response, Westphal teaches that capsaicin can be used as a solid or a liquid composition and Western Washington University evidences that capsaicin is a waxy solid in its pure form. Therefore, a solid preparation is interpreted as meaning a wax. Since both solid and liquid are taught, it would have been obvious to use either form or both together in the same composition, as described above. Regarding the amount of capsaicin, the Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). The disclosure of Westphal teaches that capsaicin can be in amounts ranging from 0.001-10 wt%.
The Applicant argues, on pages 6-7 of their remarks, that the claimed composition offered a delayed release mechanism so that capsaicin is absorbed into the body through the small intestines to achieve effective appetite suppression, as shown in Fig. 2.
In response, Fig. 2 shows that a specific embodiment of the claimed invention has delayed release wherein the composition comprises candelilla wax. Candelilla wax is a known delayed-release agent for use in oral compositions, as taught by Zerangue et al. (US 2003/0158254) [0104]. As such, the results do not amount to unexpected results.
The Applicant argues, on page 8 of their remarks, that the claimed composition increases bioavailability of the capsaicin component as shown in Fig. 3.
In response, as a first matter, Fig. 3 is grainy and difficult to read and determine which line corresponds with which composition. That being said, it is unclear what compositions are formed that have greater bioavailability than the control group. Clarification is required.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613