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
Claims 1-9, 16-18, 22-23, 25, 28-29, and 36-42 are currently pending.
Response to Amendment
The amendment filed 10/16/2025 has been entered. Applicant’s amendments to the Claims have overcome rejection previously set forth in the Non-Final Office Action mailed 6/09/2025. Claims 3, 5, 7-9, 17-18, 22, 25, 36-38, and 40-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II or unelected species, there being no allowable generic or linking claim. New Claims 40-42 are not encompassed by applicant’s elected species which lacks double bond isomers. Thus, Claims 1-2, 4, 6, 16, 23, 28-29, and 39 are being examined on the merits herein.
The elected compound remains free of the art. The scope of search is limited to compounds comprising a “first linker” as follows:
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, and a therapeutic agent comprising the enumerated halides of option (4). (Although search and consideration is limited to the above first linker group, variables in the other linker groups, Re, Rf, and Rg at least, are undefined. It is suggested that applicant clarify the scope of such groups to avoid a 35 USC 112(b) rejection upon expansion of the scope of examination.)
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Regarding the term “metabolite”, applicant maintains the term is clear and that a metabolite is any “intermediate or end product of the metabolism of any of the recited cannabinoids”. Applicant’s argument is persuasive in view of the amendment to remove the term “active”.
Applicant argues the term “cannabidiol component” is clear in view of Para 164 of the Spec. Examiner withdraws the 35 USC 112(b) rejection over Claim 23 and asserts for clarity of record that “cannabinoid component” or any “[cannabinoid] component” is interpreted during examination to mean the component of the conjugate is in itself a complete cannabinoid rather than a chemical component/portion/piece which constitutes only a part of said cannabinoid.
The rejection over Korentur is withdrawn and examiner acknowledges that the group X halides excludes fluoride. A new rejection over a similar conjugate is issued hereinbelow, necessitating a second non-final rejection.
Claim Objections
Claim 42 should be punctuated with a period. Appropriate correction is required.
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.
Claims 1-2, 4, 6, 16, 28-29 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.
Applicant recites the term “cannabinoid” which encompasses several classes of cannabinoid, including endocannabinoids, phytocannabinoids, nonclassical synthetic cannabinoids and close structural derivatives thereof. Applicant does contemplate a vast array of phytocannabinoids and derivatives thereof (Para 164-177); however, applicant has not shown possession of the claimed invention with respect to cannabinoids which are endocannabinoids or synthetic cannabinoids. For example, endocannabinoid 2-Arachidonoylglycerol,
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, and JWH-018,
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, are art recognized cannabinoids which are encompassed by the claimed term “cannabinoid”, but are not contemplated in applicant’s disclosure at the time of filing. The latter of the two above examples is a nonclassical synthetic cannabinoid disclosed in Page 56, Fig 1 of Huffman (Life Sciences 97 (2014) 55–63), known at the time of the effective filing date. Although applicant states that the “cannabinoid component can be provided by any cannabinoid that contains a hydroxy group”, this description including the term “can” is not a limiting definition excluding endocannabinoids or synthetic cannabinoids. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014). See MPEP 2163 II(A)(3)(a)(ii). Cannabinoids are not a uniform and predictable superclass of drugs. Rather, Shevyrin (Russian Chemical Bulletin, International Edition, Vol. 64, No. 6, pp. 1249—1266, June, 2015) asserts that a survey of the literature reveals cannabinoids’ psychoactive properties present a barrier to pharmacological use. Their narcogenic potential varies with contrasting affinities for each of the two cannabinoid receptors. “[T]he preparation and study of new synthetic cannabinoids whose structural diversity cannot be systematized in terms of the traditional classification yet to be altered” (Page 1262, Conclusion). Therefore, the predictability of cannabinoids—across all subclasses—has not been established in the art or in applicant’s disclosure. Rather, the class is unpredictable pharmacologically speaking due to psychoactive effects, different receptor targets, and great structural diversity.
Claim Rejections - 35 USC § 112(d)
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 29 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.
Claim 29 recites “an isotopic variant of the conjugate molecule”. Claims 1 and 28, upon which 29 depends do not provide for isotopes within their claim scope. Therefore, Claim 29 improperly broadens the scope of the cited claims.
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.
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.
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.
Claims 1-2, 4, 6, 16, 23, 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rehman (Asian Journal of Chemistry; Vol. 25, No. 15 (2013), 8522-8526).
Rehman teaches THC derivative 3b diluted in phosphate buffer, a vehicle (Page 8523, Scheme I; Page 8524, Left Col.):
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in which the following definitions of the examined conjugate apply: the cannabinoid is a single (R,R) THC enantiomer; the linker is
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, wherein Y is C2 linear alkyl; and the therapeutic component is X, wherein X is a Br halide, which applicant classifies as encompassed by one of five therapeutic component groups.
Conclusion
No claim is allowable.
Claim 39 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney 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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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627