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 .
Status of the Claims
Claims 14-19 and 22-25 are pending. Claim 23 is withdrawn. Claims 24-25 are withdrawn from consideration as being directed to a non-elected subject matter. Claims 20-21 and 26 are cancelled.
Claims 14-19 and 22 are currently under examination.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-19 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 does not end with a period and as such the claim is not definitively limited only to the limitations expressly recited in the claim. See MPEP 608.01(m).
Claims depending from rejected claims have also been rejected because they incorporate
all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness
concerns outlined above.
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.
Claims 14-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Faraci et al. (US20200037638A1, Published 02/06/2020) as evidenced by Krist (Vegetable Fats and Oils. Springer, Cham, Published 05/16/2020).
Applicant’s invention
Applicants’ claims are drawn to a solid pharmaceutical composition for oral use, comprising; ademetionine and cannabidiol and at least one pharmaceutically acceptable fatty matter.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 14, Faraci teaches formulations comprising a cannabinoid (i.e., at least one active ingredient) and a surfactant for improved absorption and oral bioavailability (abstract). Faraci further teaches the composition is a pharmaceutical composition, preferably an oral dosage form, more preferably a solid or semi-solid oral dosage form (paragraph [0017]). Faraci also teaches embodiments provide for the combination of active ingredients within any number of the categories described herein such as a cannabinoid and a nutraceutical (paragraph [0032]). Faraci further teaches the active ingredient is a nutraceutical such as ademetionine (paragraph [0058]). Faraci also teaches that the cannabinoid is selected form cannabidiol (paragraph [0165]). Faraci continues to teach that the composition comprises: at least one active ingredient; a surfactant; and a fatty acid, monoglyceride, diglyceride, triglyceride (i.e., fatty matter), or a combination thereof (paragraphs [0013-0015]).
Regarding claims 15-16, Faraci teaches the fatty acid, monoglyceride, diglyceride, triglyceride, or a combination can be an oil, such as nutmeg oil, beeswax, hydrogenated vegetable oil, soybean oil, etc. (paragraph [0094]). As evidenced by Krist, Nutmeg oil has a melting point of 45-51°C (i.e., higher than +30°C) (4.2 Physical Key Figures Table).
Regarding claims 17 and 18, Faraci teaches Table 1 comprises more than 10 wt% of one or more active ingredient (i.e., ademetionine) (paragraph [0117]). Faraci further teaches that the composition can comprise up to 50wt % of a cannabinoid (i.e., cannabidiol) (paragraph [0167]). Faraci also teaches the composition can comprise at least 35 wt% of exogenously added fat or oil (paragraph [0097]).
Regarding claim 19, Faraci teaches a composition comprising THC (tetrahydrocannabinol) in an amount selected from 0.25mg-75mg (paragraph [0120]).
Regarding claim 22, Faraci teaches the composition/pharmaceutical composition may be in the unit dose for oral administration (paragraph [0189]), wherein the unit dose may be in the form of tablets, capsules, etc. (paragraph [0190]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Faraci does not disclose a single embodiment or example where every limitation recited in the instant claims is taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art at the time of filing because Faraci teaches all of the claimed elements. It would have been prima facie obvious to one of ordinary skill to have a pharmaceutical composition for oral use, comprising; ademetionine and cannabidiol and at least one pharmaceutically acceptable fatty matter because Faraci teaches and contemplates all the elements required to make the pharmaceutical composition for oral use.
With regards to claims 17-19 , wherein ademetionine is present in an amount between 20% and 50% of the total weight of the composition; wherein the ratio of ademetionine to cannabidiol by weight is between 25:1 and 1:1; and wherein the tetrahydrocannabinol content is less than 0.5% of the total weight of the composition, it would have been obvious to one of ordinary skill to optimize the amounts of the ademetionine, cannabidiol, and tetrahydrocannabinol in the pharmaceutical composition for oral use to achieve desired results. One would have understood in view of Faraci that more than 10 wt% of one or more active ingredient (i.e., ademetionine) (paragraph [0117]); that the composition can comprise up to 50wt % of a cannabinoid (i.e., cannabidiol) (paragraph [0167]); and THC (tetrahydrocannabinol) in an amount selected from 0.25mg-75mg (paragraph [0120]). Therefore, it would have been obvious to one of ordinary skill in the art to use these amounts of ademetionine, cannabidiol, and tetrahydrocannabinol taught by Faraci as a starting point for routine optimization of dose for the desired results of the pharmaceutical composition. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
On pages 7-8 of Applicants remarks, Applicants argue that Faraci fails to teach or suggest Applicant’s claimed solid formulation comprising cannabidiol and ademetionine, as now expressly recited in amended claim 14, therefore there is no motivation of having solid formulation techniques. In particular, Applicant’s invention addresses the technical problem of combining two active ingredients with incompatible physiochemical properties, which is not contemplated or addressed by Faraci. Applicants also argue that there is no sufficient evidence of record for the required motivation to modify Faraci by incorporating Krist, because the record fails to provide the required evidence of motivation for a person of ordinary skill in the art to incorporate such fatty matter into Faraci’s formulation, which would be improper hindsight reconstruction.
These arguments are not persuasive. First, with regards to the argument wherein Applicants argue that Faraci does not provide motivation to have a solid formulation, Faraci teaches the composition is a pharmaceutical composition, preferably an oral dosage form, more preferably a solid or semi-solid oral dosage form (paragraph [0017]) and Faraci teaches the composition/pharmaceutical composition may be in the unit dose for oral administration (paragraph [0189]), wherein the unit dose may be in the form of tablets, capsules, etc. (paragraph [0190]), therefore, Faraci teaches having a solid formulation.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The Examiner points out that Krist was not applied to teach a missing limitation or to provide a limitation, as Faraci already teaches the presence of a fatty matter such as a fatty acid, monoglyceride, diglyceride, triglyceride, or a combination can be an oil, such as nutmeg oil, beeswax, hydrogenated vegetable oil, soybean oil, etc. (paragraph [0094]) and provides a motivation incorporating the limitation of a fatty matter. Krist was only provided to show that nutmeg oil (i.e., fatty matter) which is already taught in Faraci, inherently has a melting point equal to or higher than 30°C, therefore, Krist is only cited to provide evidence of an inherent property of nutmeg oil.
In response to applicant's argument that Applicant’s invention addresses the technical problem of combining two active ingredients with incompatible physiochemical properties, which is not contemplated or addressed by Faraci, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
No claims are allowed.
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 AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614