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 .
Detailed Action
Filing Receipt and Priority
The filing receipt mailed 02/12/2024 states the instant application is a 371 of PCT/EP2022/0580003, filed 03/25/2022. The filing receipt also states that the instant application claims foreign benefit of EPO 21165056.9, filed 03/25/2021.
The certified copy of the foreign application submitted 09/22/2023 supports the instant claims. Therefore the effective filing date is 03/25/2021.
Information Disclosure Statement
The information disclosure statements submitted 09/22/2023 and 04/27/2026 have been considered.
Restriction/Species Election
Applicant’s election of Group I, claims 1, 4-7, and 11 is acknowledged.
In a phone call made 04/22/2026, Examiner contacted attorney Morrow about an election for one compound represented by Formula I, shown below.
Formula I in claim 1
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In a return phone call made 04/24/2026, applicant elected the following compound, cannabidiolic acid.
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Specification
The use of the term “CAS”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Objections
Claim 1 is inconsistent with its use of commas and semi-colons when separating species, specifically where claim 1 states “R2, R4, and R5 are each independently selected from the group consisting of H, OH; OCH3,…”
Claims 6 and 7 use the phrase “selected from the group consisting of” but lacks the conjunctions “and” or “or” at the end of their respective listings.
Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1, 4-7, and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 states “A method for (i) increasing resistance to age-related pathologies, (ii) improving physiological state or disorder related to cell ageing, (iii) improving a physiological state linked to metabolic fatigue in one or more cells, (iv) increasing mitochondrial energy in one or more cells, (v) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (v) improving mobility and/or (vii) improving healthspan and/or lifespan in an individual comprising administering…”.
The instant application discloses working examples starting on p. 42. Example 1 is drawn to measuring thermotolerance of C. elegans. Example 2 is drawn to increasing lifespan in an AMPK-dependent manner. Example 3 states that the percentage of highly active C. elegans increases after administration of CBDA. This is repeated in example 5. The last example, example 6 shows that autophagy is increased in zebrafish larva after administration of CBDA.
While the claimed methods in claim 1 are indefinite (See 112(b) rejection below), the specification discloses working examples of increasing the lifespan, increasing thermotolerance, and increasing mobility. However, no examples of the other terms (i, ii, iii, iv, v) have been shown within the specification. Because of the indefiniteness of the claim, it is not clear where “increasing thermotolerance” falls within the terms i-vii above.
One of ordinary skill in the art would not find the instant disclosure sufficient to indicate the applicant has possession of the full scope of claim 1.
Claim Rejections - 35 USC § 112(b)
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.
Indefiniteness
Claims 1, 4-7, and 11 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 1 states “A method for (i) increasing resistance to age-related pathologies, (ii) improving physiological state or disorder related to cell ageing, (iii) improving a physiological state linked to metabolic fatigue in one or more cells, (iv) increasing mitochondrial energy in one or more cells, (v) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (v) improving mobility and/or (vii) improving healthspan and/or lifespan in an individual comprising administering…”.
None of these terms and limitation are explicitly defined within the specification. For example, no “age-related pathologies” are contemplated within the claim or specification. The specification’s only consideration to age-related pathologies is on p. 1, l. 20-21 where it states “Furthermore, when energy supply is low, organisms sometime respond by slowing ageing and then increasing resistance to a diverse range of age-related pathologies.” There are also no exemplary listing of “age-related pathologies”. The terms “physiological state or disorder related to cell ageing”, “physiological state linked to metabolic fatigue” are also not explicitly defined and there are no listings in the claims or specification that indicate what “physiological state” or “disorder” are claimed.
Regarding the terms “increasing mitochondrial energy”, “increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function”, these terms are not explicitly defined and, additionally, the specification does not disclose methods to measure these effects or how they are typically measured within the art. Therefore, the claims are indefinite.
Claims 6 and 7 use “(substituted)” to describe the limitations “polyalkenyl chain” and “alkenyl chain”. It is not clear if applicant means “optionally substituted” or if applicant is claiming substituted alkenyl and/or polyalkenyl chains. Therefore the claims are indefinite.
Claims 1 and 4-7 state “and a derivative or analogue thereof, a OCH3 group can cyclize with a neighboring OH group to form a methylene dioxy bridge.” This follows a listing of potential species for R2, R4, and R5.
The term “derivative” is defined “as a compound that can be imagined to arise or is actually synthesized from a parent compound by replacement of one or more atoms with another atom or groups of atoms.” The term “analogue” is defined as “a compound having a structure similar to that of another one but differing from it in respect of a certain component.” However, it is not clear whether “derivative and analogue thereof” refers to the formula I in claim 1 or to the possible substituents. There is also no formula or structure with which one of ordinary skill in the art would be able to determine which compounds and/or substituents are derivatives or an analogue. Therefore one of ordinary skill in the art would not know the metes and bounds of the claims.
Missing Text
Claim 6 is missing text. See below, after “selected from the group consisting of”.
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Antecedent Basis
Claim 11 recites the limitation "wherein said compound of general formula I is cannabidiolic acid" in l. 2 of said claim. The structure of CBDA is shown above (compound 1). Claim 1 states “R2, R4, and R5 are each independently selected from the group consisting of H, OH;…substituted and branched C1 to C20 alkyl.” Compound 1 has a pentyl chain, which is neither substituted or branched. Therefore, there is insufficient antecedent basis for this limitation in the claim.
“Individual in need thereof”
Claim 1 states “an individual” without specifying that the individual is in need of the claimed methods. The specification defines “individual” to mean “any animal, including a human, that could benefit from one or more of the compounds, compositions or methods disclose herein.” This definition is broad and the specification does not indicate how to determine whether an individual could benefit from the claimed methods. The phrase “could benefit” is also ambiguous because the efficacy of claimed methods cannot be measured until after administration. One of ordinary skill could mistakenly practice the claimed methods because administration of the claimed compound to an individual may or may not lead to a positive outcome. The claim needs to specify that the individual is in need of such methods.
CAS RN
Claim 11 uses the term “CAS number 1244-58-2”. CAS Registry numbers act a unique identifiers for compounds with many possible systemic, generic, proprietary names. CAS RNs are used as an industry standard.
The CAS registry, and by extension CAS registry numbers such as the 1244-58-2 number, is a trademark of the American Chemical Society.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
Art Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-7, and 11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Korthout (WO 2012/144892).
Korthout on p. 2, l. 9-15 reports the use of a pharmaceutical composition comprising cannabidiol and cannabidiolic acid (CBDA) for use as an active pharmaceutical substance in the treatment of nausea, vomiting, emesis, and motion sickness. Korthout in reference claim 4-5 claims a composition comprising CBDA for use in “enhancing cellular resistance, for use in therapy of diabetes, for use in therapy of atherosclerosis, and to reduce the decline in stress response found in ageing.”
Claim(s) 1, 4-7, and 11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bolognini (British Journal of Pharmacology, 2013, 168, 1456-1470).
Bolognini on p. 1458 sec. In vivo procedures discloses administering CBDA to musk shrews where it states “After 15 min, [shrews] were injected with CBDA or [vehicle]. IN experiment A, they received an injection of either CBDA, at a dose of 0.05 mg*kg-1 (n=8), 0.1 mg*kg-1 (n=8), 0.5 mg*kg-1 (n=6), or 5 mg*kg-1 (n=8)…”. Bolognini in sec. Drugs and materials for in vivo experiments states “”CBDA was prepared in a vehicle (VEH) consisting of a 1:1:18 mixture of ethanol, Cremophor, and saline (SAL) and was administered i.p. in a volume of 2 mL*kg-1.”
The instant specification discloses that, in the working examples, only CBDA was administered. There is no data in the specification regarding compounds other than compound 1 (CBDA). The claimed effects can reasonably be seen as an effect of administering CBDA. Therefore, the disclosure of Bolognini embraces the claims.
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.
Co-pending application 18/251,759
Claims 1, 4-7, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 15-17, 21-22, and 27-28 of copending Application No. 18/251,759 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a method for activation of AMPK for curative treatment of non-alcoholic fatty liver disease in an individual having the non-alcoholic fatty liver disease, the method comprising administering to the individual a compound having the general formula I, below.
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Reference claim 13 specifies that the compound is CBDA.
For similar reasoning in the 102/103 rejection above, the reference claims embrace the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/862,421
Claims 1, 4-7, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 17, and 29-32 of copending Application No. 18/862,421 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1is drawn to a method for activation of AMPK comprising administering a composition comprising a first and second compound. The first compound is of the following formula.
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Claim 17 specifies that the first compound is cannabidiolic acid.
For similar reasoning in the 102/103 rejection above, the reference claims embrace the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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