DETAILED ACTION
The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1611, examiner Isis Ghali.
The receipt is acknowledged of applicants’ amendment and request for RCE filed 08/04/2025.
Claim 52-59, 61-66 and 72 are pending and subject of this office 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2025 has been entered.
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 Objections
Claim 56 is objected to because of the following informalities: the claim recites “gradation products”, and the examiner assumes applicants meant “degradation products”, especially after careful review of the specification, only “degradation products” are disclosed. Appropriate correction is required.
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 52-59, 61-66 and 72 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.
Claims 52-59, 61-66 and 72 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: claim 52 recites the expressions “first carboxylated cannabinoid” and “first terpenoid” without reciting second “carboxylated cannabinoid” and second “terpenoid” in claim 52 or any of dependent claims.
Regarding claims 53 and 64, the expression “at least” without upper limit to the claimed values, renders the claims indefinite.
Regarding claim 72, the expression “at least 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 “at least" permits values equal to the value following the term and more than that value with no upper 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. Note: absence of upper limit to the claimed values, render the claims indefinite.
The term “substantially” in claims 52 and 56 is a relative term which renders the claim indefinite. The term “substantially free of (de)gradation products” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. How much degradation products can be present to consider the unit dose substantially free of degradation products?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 56 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim depends on claim 52 that recites “the unit dose is substantially free of all degradation products”, and claim 56 recites “the unit dose is substantially free of all gradation products”, that are the same limitation claimed by claim 52. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 52-56, 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”, currently 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 comprising a first carboxylated cannabinoid;
(ii) one or more-decarboxylated cannabinoids comprising a decarboxylated form of said first carboxylated cannabinoid, and
(iii) one or more terpenoids comprising a first terpenoid,
wherein a wt/wt ratio of decarboxylated cannabinoids to carboxylated cannabinoids is greater than 0.5,
wherein said unit dose of substantially free of a degradation product of said first terpenoid, 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 terpene, e.g. myrcene, elected species of terpenoids (¶¶ 0005-006, oo13, 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 is free 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 substantially free of degradation products of terpenoids as claimed by claim 52 and 56, Wendschuh teaches purified terpenoids that implies absence of degradation products.
Regarding the dose of at least 5 mg of decarboxylated cannabinoids as claimed by claim 53, Verzura teaches from 5 mg to 50 mg based on the intended condition to be treated.
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 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 1 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.
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./