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 Application
Claims 3-13 are pending in the application as of the second preliminary amendment submitted 09/14/2023. Claims 1-2 are cancelled. Claims 3-13 are examined herein.
Applicant’s remarks in the response dated 09/14/2023 regarding the second preliminary amendment is acknowledged. It is noted that compound IV represents cannabichromenic acid (CBCA) when R1 is H but is incorrectly referred to as tetrahydrocannabinolic acid (THCA). Rather, compound III represents tetrahydrocannabinolic acid (THCA), when R1 is H.
In view of the pending claims the following rejections are made, as discussed below.
Priority
This application is a 371 of PCT/EP2022/051402 filed 01/21/2022 and claims foreign priority to GREECE 20210100041 filed 01/22/2021.
It is noted that Applicants have not provided an English translation of the certified copy of the foreign priority application as required by 35 U.S.C. 119(b). Without the English translation, one cannot ascertain if the instant invention is supported in the Greece application. Therefore, art prior to the PCT date, but not before the date of the Greece application may be cited against the claims. Accordingly, claims 3-13 have been afforded an effective filing date of 01/21/2022, the filing date of the PCT application.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements submitted on 07/21/2023 (2) have been considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 1 the recitation of “A method for the preparation of cannabinoid acids” causes some confusion since the claim is directed to preparation of cannabinoid acid esters. It is suggested that Applicants amend claim 12 to recite “A method for the preparation of cannabinoid acid esters” to overcome this objection.
Additionally, the examiner suggests amending to remove the parentheses for the general formula and simply recite “having general formula I, II, III, IV,” OR recite “having general formula (I) or (II) or (III) or (IV)” to be consistent with the format in claim 13.
Appropriate correction is required.
Claim interpretation
The instant claims 4-6 have been interpreted as intended use claims drawn to a product, i.e., a pharmaceutical composition.
According to MPEP 2111.02(II), “The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
Therefore, the limitations following the preamble drawn to the intended use of the product - a pharmaceutical composition (as in claims 4-6), have not been not given patentable weight.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 3-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swisa et al. (WO 2021/034403 A1, 25 February 2021, hereinafter Swisa).
Regarding instant claims 13 and 3, Swisa teaches pharmaceutical compositions including a cannabinoid acid ester compound alone or in combination with one or more additional cannabinoid compounds (Abstract; Claim 1). Swisa teaches embodiments wherein the cannabinoid ester compound is a tetrahydrocannabinolic acid (THCA) ester of formula (Ia) (Abstract; Para. [0029]).
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Swisa teaches embodiments wherein the cannabinoid ester compound is a cannabigerolic (CBGA) acid ester of formula (II) (Abstract; Para. [0033]).
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Swisa teaches R1 and R2 are independently selected from C1-C10 alkyl, substituted C1-C10 alkyl, C2-C10 alkenyl, substituted C2-C10 alkenyl, C2-C10 alkynyl, and substituted C2-C10 alkynyl, or a pharmaceutically acceptable salt thereof (Para. [0029]; Para. [0033]). Swisa exemplifies R1 being methyl, ethyl, propyl, butyl, and pentyl (Claim 3). Swisa exemplifies R2 being pentyl in compounds of formula (Ic) and (IIa) (Para. [0031]; Para. [0034]; Claim 7).
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Swisa teaches embodiments wherein the one or more additional cannabinoid compounds can comprise cannabichromene (CBC) acid esters thereof (Paras. [0080]-[0081]; Paras. [00278]-[00279]; Claim 19).
According to MPEP 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
In the instant case, a cannabinoid acid ester of formula (II) (i.e., a cannabigerolic (CBGA) acid ester), formula (III) (i.e., a tetrahydrocannabinolic acid (THCA) ester) and formula (IV) (i.e., cannabichromenic acid (CBCA ester), wherein R1 is a linear or branched alkyl group, alkenyl group or alkynyl group having from 3 to 5 carbons as in instant claim 13 can be clearly envisaged from the disclosure of Swisa (Claim 1; Claim 3; Claim 7; Claim 8).
Although claim 13 recites “Cannabinoid acid esters having general formula (II) or (II) or (IV) individually or in any combination thereof, obtained directly by the method of claim 12”, claim 13 is a product-by-process type claim.
According to MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, "because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009).
In the instant case, as outlined above, Swisa anticipates the cannabinoid acid esters having general formula (II) or (III) or (IV) as in instant claim 13. Thus, the product-by-process claim, claim 13, is held unpatentable.
Regarding instant claims 7-9, Swisa anticipates the pharmaceutical composition as in claim 3. Swisa teaches the composition is formulated for administration orally, intravenously, intramuscularly, intraperitoneally (i.e., formulated for injection), transdermally (Para. [0128]; Para. [0153]; Claim 166). Swisa teaches the pharmaceutical composition is in the form of a liquid or solution (Para. [0129]).
Regarding instant claims 10-11, Swisa anticipates the pharmaceutical composition as in claim 3. Swisa teaches the pharmaceutical composition is in a form selected from tablet, pill, capsule, … and suppository (Para. [0129]; Claim 62).
Regarding instant claims 4-6 (see claim interpretation above), Swisa anticipates the pharmaceutical composition as in claim 3.
According to MPEP 2111.02(II), "[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.…Without such reliance, however, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." Consequently, "preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant."
Therefore, the intended use limitations in claims 4-6, “for use in the treatment of cancer; for use in the treatment of breast cancer; for use in the treatment of skin cancer, preferably melanoma”, are held unpatentable.
Alternately, according to MPEP 2112.01(II), “Products of identical chemical composition can not have mutually exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). Here, the pharmaceutical composition comprising cannabinoid esters, taught by Swisa, by virtue of its inherent property would be capable of exhibiting all intended use limitations recited by instant claims 4-6. Therefore, the disclosure of Swisa anticipates the limitations of instant claims 4-6.
Allowable Subject Matter
The method for the preparation of cannabinoid esters having general formula I, II, III, IV, as in claim 12, have been found to be free of prior art.
Miscellaneous
It is made of note that Swisa will be applicable as prior art under 35 U.S.C. 102(a)(2) with a PCT filing date of 19 June 2020, even if the foreign priority claim were perfected.
Conclusion
Claims 3-13 are rejected.
Claim 12 is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571) 272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.S.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627