DETAILED ACTION
The receipt is acknowledged of applicants’ amendment filed 04/29/2026.
Claim 52-59, 61-66 and 72 previously presented, claim 53 is currently canceled.
Claims 52, 54-59, 61-66 and 72 are pending and subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Election/Restrictions
Applicant’s election without traverse of myrcene as species of terpenoids currently claimed by claim 55, and antioxidant as species of excipients currently claimed by claim 63, in the reply filed on 08/09/2021 is acknowledged. However, it is established that the examination of species will be extended to the extent necessary to determine patentability of the Markush-type claim, MPEP 803.02 [R-5].
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.
Claim 72 is 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.
The expression “less than about” does not set forth the metes and bounds of the claim. Recourse to the specification does not define the expression. The expression permits two contradicting interpretation of the claims. The term “less than" permits values equal to the value following the term and less than that value with no lower limit to the value, and the term “about” permits values below and above the claimed value, usually 10% unless otherwise defined in the specification. The boundaries of coverage is not imposed by the disclosure.
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.
Claims 52, 54-56, 58-59, and 61-66 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Verzura et al. (US 2016/0106705, IDS filed 04/22/2020) as evidenced by the article by Moselhy et al. (“In vitro and in vivo evaluation of antimicrobial and antioxidant potential of stevia extract”, previously provided), and Wendschuh et al. (US 2016/0250270, IDS filed 04/22/2020), and the combination further optionally evidenced by Kelly (US 2012/0295968, IDS filed 04/22/2020) as applied to claim 65.
Applicant Claims
Claim 52 is directed to a unit dose comprising:
(i) one or more carboxylated cannabinoids;
(ii) one or more-decarboxylated cannabinoids comprising a decarboxylated form of one of said carboxylated cannabinoids, and
(iii) terpenoid,
wherein a wt/wt ratio of decarboxylated cannabinoids to carboxylated cannabinoids is greater than 0.5,
wherein said unit dose comprises less than 10% of a degradation product of said terpenoid by weight of the unite dose, and said unit dosage form is formulated for oral, inhalation, intravenous, or intramuscular administration.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Verzura teaches composition comprising less than 35% one or more carboxylated cannabinoids and less than 1% one or more decarboxylated cannabinoids. Decarboxylated cannabinoids include ∆9 tetahydrocannabinoid (THC), and carboxylated cannabinoids include ∆9 tetahydrocannabinoid (TCHa) (¶¶ 0032-0035; 0056-0058, 0065-0066; claims 1-15). The composition further comprises one or more terpenes, e.g. myrcene, elected species of terpenoids, and comprises other terpenoids, e.g. terpinol (¶¶ 0005-006, 0013, 0066-0067; claims 6, 16). The total dose of cannabinoid ranges from 5 mg and more based on the condition to be treated, e.g. pain, cancer addition, etc. (¶¶ 0019-0025, 0083). The composition can be administered, orally, e.g. capsule or sublingually, or topically. The composition can be in a liquid form (¶ 0063). The oral dose, e.g. capsule, comprises 5 mg to 50 mg (¶ 0068; claim 17). The oral dose comprises excipients, e.g. sweetener which is stevia extract (¶ 0013, 0058, 0063; claim 19). Stevia extract is antioxidant as evidenced by the article by Moselhy (see the entire document). Stevia reads on the elected species of excipients: antioxidant. The composition may contain orange and lemon oils (claim 20) that are acidic in nature and have antioxidant effects.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Verzura teaches composition comprising terpenoids in the composition, the reference is silent regarding the terpenoid comprises less than 10% of degradation product as claimed by claim 52.
Wendschuh teaches composition comprising cannabinoids and purified terpenoid for treating pain. Terpene molecules found in plant produce smell and clues that a product has expired include rancid odor (abstract; ¶¶ 0019, 0255, 0373, 0379, 0424).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide composition comprising THC, THCa and terpenoids for treating pain as taught by Verzura, and use purified terpenoids taught by Wendschuh. One would have been motivated to do so because Wendschuh teaches terpene molecules found in plant produce smell. One would reasonably expect to formulate composition comprising THC, THCa and purified terpenoids that is expected to have pleasant odor. Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious. See MPEP 2144.01, VII. Therefore, it would have been obvious to have used the purer form of the terpenoids in the composition of Verzura motivated by the desire to use a product that has advantageous properties, e.g. odorless.
Regarding the ratio of decarboxylated to carboxylated cannabinoids of more than 0.5, i.e. 2:1, as claimed by claim 52, Verzura teaches less than 35% THCa and less than 1% THC that embrace the claimed ratios. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding terpenoids comprises less than 10% of degradation products of terpenoids as claimed by claim 52 and 56, Wendschuh teaches purified terpenoids that implies absence of degradation products. Note that Verzura does not teach any degradation product of terpenoids in the composition.
Regarding claim 54 that the decarboxylated cannabinoids comprises ∆9 THC, this is taught by Verzura.
Regarding terpenoids claimed by claim 55, both references teach the elected species myrcene, among other terpenoids that are claimed by claim 55.
Regarding second terpenoid as claimed by claim 56, Verzura teaches more than one terpenoids in the composition, e.g. myrcene, elected species of terpenoids, and terpinol.
Regarding excipients claimed by claims 58 and 59, Verzura teaches the elected species stevia, among other excipients, that reads on the elected species antioxidant.
Regarding the unit dose as claimed by claims 61-63, Verzura teaches liquid form as claimed by claim 61, and tablet and capsule that are solid form claimed by claims 62-63.
Regarding property as claimed by claim 64, the cited references in combination teaches the claimed ingredients of the composition in the claimed amounts, and it is expected to retain at least 80% of said carboxylated and decarboxylated cannabinoids after placement in a sealed container for 6 months at a temperature of about 25 °C and a relative humidity level of about 50% as claimed.
Regarding packaging the dosage form as claimed by claim 65, it is obvious that any medicine is packaged in an appropriate package, e.g. capsules are usually packages in a medicine bottle, and spray packaged in a spray container, etc., as evidenced by Kelly in claim 19.
Regarding kit supplemented with instruction as claimed by claim 66, kit is nothing but separate ingredients of a composition. The claimed kit does not precisely define present structural attributes of interrelated component parts of the claimed assembly/kit. Regarding the instruction, where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability….[T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the dose unit."
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 57 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Verzura, evidenced by Moselhy, and Wendschuh, and optionally evidenced by Kelly, as applied to claims 52-56, 58-59, 61-66 above, and further in view of Kelly (US 2012/0295968, IDS filed 04/22/2020).
Applicant Claims
Claims 57 and 72 further recite that the unit dose of claim 52 further comprises acid.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Verzura, evidenced by Moselhy, combined with Wendschuh, and optionally evidenced by Kelly, are previously discussed in this office action
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While the combination of the references suggests orange and lemon oils that are acidic, the references do not explicitly teach acids as claimed by claims 57 and 72.
Kelly teaches composition comprising a mixture of cannabinoids (e.g. a ∆9 tetrahydrocannabinol (THC), a pharmaceutically acceptable excipient, e.g. binder, and acid, e.g. orange and lemon oils, and citric acid and ascorbic acid, that are used by applicant to practice the present invention in paragraph [0014] of the current published application. Composition can be oral, e.g. tablet or capsule, injection, or an aerosol. The composition can be packaged within a container. The composition used for treating pain (see entire document, e.g. title, abstract, ¶¶ 0015, 0050-0052; and claims).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide composition for treating pain comprising THC, THCa, purified terpenoids and orange of lemon oils for treating pain as taught by Verzura, evidenced by Moselhy, and combined with Wendschuh, and use citric acid or ascorbic acid taught by Kelly instead of orange and lemon oils. One would have been motivated to do so because Kelly teaches equivalency between orange and lemon oils and citric and ascorbic acids in a composition comprising cannabinoids suitable for treating pain. One would reasonably expect formulating a composition comprising THC, THCa, purified terpenoids and citric or ascorbic acid that effectively treats pain in patient in need thereof.
Regarding the claim 72 that the composition comprises less than 10,000 ppm acid, one having ordinary skill in the art would have determined the required ppm based on the desired unit dose and intended use.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive.
35 U.S.C. § 112
Regarding claim 72, the examiner apologizes for the typographical error that indicated the claim recites “at least about” instead of “less than about”. The same rejection is applicable for the recited term “less than about”, as set forth above.
35 U.S.C. § 103
Applicant argues that Verzura does not disclose the claimed cannabinoid ratio. Verzura distinguishes decarboxylated cannabinoids from acid-form cannabinoids, explaining that THC, CBD, CBN, CBC, and related species refer to "decarboxylated forms," whereas THCa, CBDa, CBNa, CBCa, and related species refer to "acid forms" of cannabinoids. See Verzura at ¶ [0034]. The PRANA 2 formulation relied upon by the Examiner includes THCa less than or equal to 35%, CBDa greater than or equal to 60%, THC less than 1%, CBN less than 1%, and CBC less than 1%. See Verzura at ¶ [0065]. Thus, PRANA 2 includes at least 60% CBDa, an acid form, and less than 3% total THC, CBN, and CBC, which Verzura identifies as decarboxylated forms. PRANA 2 therefore does not meet the claimed weight ratio of decarboxylated cannabinoids to carboxylated cannabinoids. PRANA 3 likewise includes THCa greater than or equal to 40%, CBDa greater than or equal to 40%, THC less than 1%, CBN less than 1%, and CBC less than 1%, and likewise does not meet the claimed ratio. See Verzura at ¶ [0066]. PRANA 4 lists THC, CBD, CBN, and CBS, but does not disclose the claimed carboxylated cannabinoid together with a decarboxylated form of that carboxylated cannabinoid in the claimed unit dose. See Verzura at ¶ [0067].
In response to this argument, it is argued that, as applicant noted, the reference teaches formulation comprising more decarboxylated cannabinoids than carboxylated, and the decarboxylated cannabinoid is more than twice the carboxylated cannabinoids. That is to say the ratio of decarboxylated cannabinoids to the carboxylated is more that 0.5 as claimed. Note that more than 0.5 as claimed can be any ratio without upper limit as long as the decarboxylated cannabinoids are more than twice the carboxylated cannabinoids. The examiner believes the reference teaches the claimed ratio.
Applicant argues that none of the cited references teach or suggest the claimed amounts of degradation products (particularly in a unit dose). The Examiner acknowledges that Verzura is silent regarding whether the terpenoid is free of degradation product, and relies on Wendschuh's disclosure of "purified terpenoids" as allegedly implying an absence of degradation products. See OA at 8. However, Wendschuh defines "purified" as material isolated from a plant using chromatography, distillation, extraction, or a similar technique resulting in "greater than 60% purity," with certain embodiments having greater than 70%, 80%, or 90% purity. That disclosure does not teach or suggest the recited amount of degradation product of the terpenoid. To the contrary, Wendschuh's definition of "purified" expressly permits a substantial amount of material other than the purified terpene (e.g., up to 40%) and does not identify whether any such material is, or is not, a degradation product of the terpene. Nor does Wendschuh's general statement that terpene molecules found in plants "may produce smell" provide a reason to formulate the Verzura composition to contain the recited amount of terpenoid degradation product. Even if terpene molecules "may produce smell," there is no basis to connect that smell to terpenoid degradation products. If the Examiner is implying that odor-particularly rancid odor-is associated with degradation or expiration, an implication that is not supported by the references, then that implication also cuts against the rejection because rancid odor would, at most, indicate possible expiration or degradation, not the absence of degradation products.
In response to this argument, it is argued that Verzura does not teach any degradation products of terpenoids in the taught formulations. Wendschuh teaches undesirability to have terpenoid degradation products in pharmaceutical formulations comprising terpene because terpene molecules produce smell. Therefore, purified terpenes are used in the formulations comprising cannabinoids. One having ordinary skill in the art would have been motivated to use purified terpenes taught by Wendschuh to avoid bad odor and ensure stability of the pharmaceutical formulations. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
In any event, it has been held by the court that purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious. See MPEP 2144.01, VII.
Applicant argues that the present specification explains that terpenoid degradation products may be formed during manufacture or by heating, burning, or smoking a terpenoid-containing composition, and such degradation products may have little benefit, no effect, or harmful effects. See Specification at [0003], [0033]. The Examiner has at most identified a reference disclosing purified terpenes generally, not a teaching or reasoned basis that a unit dose prepared from Verzura and Wendschuh would contain the recited amount of degradation product of the claimed terpenoid.
In response to this argument, it is argued the recited amount of degradation product has no lower limit and can be absent, and reads on absence of any degradation product that are not taught by Verzura and excluded by purified form of Wendschuh.
Applicant argues that any contention that Wendschuh's purified terpenes inherently satisfy the claimed degradation-product limitation is unsupported, because a possible or assumed absence of degradation products is not sufficient to establish inherency, particularly in the context of obviousness. See, e.g., In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). The combination therefore does not teach or suggest the claimed unit dose and does not provide a reasonable expectation of achieving the recited degradation-product limitation.
In response to this argument, it is reiterated that Verzura does not teach any degradation products of terpenoids in the taught formulations. Wendschuh teaches undesirability to have terpenoid degradation products in pharmaceutical formulations comprising terpene because terpene molecules produce smell. This would suggested to one having ordinary skill in the art to use purified terpenes to avoid odorous formulation. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. The examiner believes the combination of the cited references suggests pure form of terpene that is expected to have no or traces of degradation products, i.e. less than 10%. Applicants failed to show any unexpected results obtained from having any specific amount of the degradation products of terpenoids.
Applicant argues that the Examiner also does not provide a reasoned motivation to combine Verzura and Wendschuh. Even if terpene molecules found in plants "may produce smell," odor profile is not the claimed limitation, nor is this alleged disclosure at all related to degradation products of terpenoids as claimed. Wendschuh's generalized odor disclosure does not teach that terpenoid degradation products control odor, does not identify a target amount of any terpenoid degradation product, and does not provide a reason to modify Verzura's cannabinoid formulations to achieve the claimed degradation-product limitation. At best, Wendschuh illustrates that "purified" terpenoids may have been known, but that is not an articulated reason with rational underpinning to arrive at the claimed unit dose. The combination therefore relies on knowledge gleaned from the present application rather than a teaching, suggestion, or reasoned explanation in the cited references. This is the essence of impermissible hindsight and the rejection is improper.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the references exists, as well as reasonable expectation to achieve the claimed product, as set forth in this office action. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references to achieve formulation comprising cannabinoid and pure terpenoid that comprises less than 10% of degradation products of terpenoid. Applicants failed to show any unexpected results obtained from having any specific amount of the degradation products of terpenoids.
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). In the instant case, the examiner relied on the cited references to construe rejection, motivation to combine the references exists, and reasonable expectation to achieve the present invention was presented, as set forth in this office action.
Applicant argues that Moselhy (cited for alleged disclosure of stevia) and Kelly (cited for alleged disclosure of acids) do not rectify the deficiencies of Verzura and Wendschuh. Accordingly, the rejection is deficient.
In response to this argument, it is argued that, as applicant notices, Moselhy cited for teaching of stevia and Kelly cited for teaching of acids. The references satisfy the purpose for which they are cited.
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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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