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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 April 2026 has been entered.
Claims 1, 3, 4, and 9-11 have been cancelled. Claims 2, 5, and 7 have undergone amendments. Thus, Claims 2, 5, 6, and 8, submitted on 6 April 2026, represent all claims currently under consideration.
Claim 7 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 July 2025.
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.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 9 March 2026, is acknowledged and has been considered.
Response to Amendment
The 35 U.S.C. § 102(a)(2) rejection of Claims 1, 5, 6, and 9-11 over McKinney is withdrawn. Applicant has cancelled Claim 1, rendering the rejection moot.
The 35 U.S.C. § 102(a)(2) rejection of Claims 1, 5, and 9-11 over Abdur-Rashid is withdrawn. Applicant has cancelled Claim 1, rendering the rejection moot.
The 35 U.S.C. § 103 rejection of Claims 1, 2, 5, 6, and 8-11 over McKinney in view of Kaur and May is withdrawn. Applicant has cancelled Claim 1, rendering that rejection moot. Applicant further argues that the secondary references do not provide motivation for the specific modifications which are found in the compounds of Claim 2, and there is no expectation that making these specific modifications would result in enhanced properties such as enhanced stability and/or potency. Applicant further argues that the inventors discovered that deuteration at the specific positions defined in examined Claim 2 leads to an unexpected increase in bioavailability and improved PK profile compared to CBD. Applicant points to data provided in the specification wherein Example 13 (ring-deuterated) had a 37% increase in bioavailability, which significantly exceeds the routine expectation of a 5-25% dose reduction mentioned by McKinney, with similar results obtained for Example 16 of the examined application. The Examiner finds these arguments to be persuasive. There is no specific motivation found in the prior art to deuterate cannabidiol at the specific locations which are claimed, and moreover, there would be no expectation that this modification would result in the significant improvements to its pharmacokinetics which were observed.
The 35 U.S.C. § 103 rejection of Claims 1, 2, 5, 6, and 8-11 over Abdur-Rashid in view of May is withdrawn. Applicant has cancelled Claim 1, rendering that rejection moot. The rejection of Claim 2 is withdrawn for the reasons stated previously.
The 35 U.S.C. § 103 rejection of Claims 1, 2, 5, 6, and 8-11 over Makriyannis in view of Ujvary, Kaur, and May is withdrawn. Applicant has cancelled Claim 1, rendering that rejection moot. The rejection of Claim 2 is withdrawn for the reasons stated previously.
The non-statutory patenting rejection of Claims 1, 2, 4-6, and 8 over co-pending Application No. 17/772,126 (now U.S. Patent No. 12,545,694) is maintained. Applicant argues that the compounds of Claim 1 of the ‘694 patent have a phosphoryl group present in the analogous variable R3 position, which is outside of the scope of what is claimed in the examined application. The Examiner does not find this argument to be persuasive. The phosphoryl group present in these compounds functions as a pro-drug moiety, and will be cleaved in vivo, resulting in the active parent compound (such as CBD or a derivative thereof) being released into the body. This is shown in the ‘694 patent specification (Page 32), where the pharmacokinetics of the compounds of the invention are shown and result in the release of the parent drug. As the compounds of ‘694 function as pro-drugs of the compounds of the examined application, including those of Claim 2, they are not patentably distinct from what is claimed.
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.
Claims 5, 6, and 8 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 5 has the limitation of “the compound according to Claim 2”. This is indefinite because there are several compounds claimed in Claim 2, causing confusion as to which specific compound is to be included in the composition. The Examiner suggests amending the claim to read “A compound according to Claim 2” to overcome this rejection. Claims 6 and 8 are similarly rejected as indefinite for depending upon Claim 5 without resolving the underlying issue of indefiniteness.
Claims 5, 6, and 8 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 5 recites the limitation "a stereoisomer, a solvate, a pharmaceutically acceptable salt, a cocrystal, or a prodrug thereof" in Line 3. There is insufficient antecedent basis for this limitation in the claim as Claim 2 does not recite that the compounds can be stereoisomers, solvates, salts, cocrystals, or prodrugs. Claims 6 and 8 are similarly rejected as indefinite for depending upon an indefinite claim without resolving the underlying issue of indefiniteness.
Claim 6 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. Claim 6 has the limitation of “or stereoisomers, hydrates, solvates, pharmaceutically acceptable salts and cocrystals of the other active ingredients” (emphasis added). It is unclear from the “and” if these formulations require each of these components (stereoisomers, hydrates, solvates, pharmaceutically acceptable salts, and cocrystals of the other active ingredients). The Examiner suggests amending to read “or crystals” to overcome this rejection.
Claim 8 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. Claim 8 claims the composition comprising at least one other active ingredient selected from several ginkgolides, and a combination of two or more thereof in any ratio (Emphasis added). It is unclear how the “and a combination of two or more thereof in any ratio” modifies the claim as the claim already states that the composition can have at least one other ingredient selected from the Markush list of ginkgolides. The Examiner suggests amending to read “or a combination of two or more thereof in any ratio” to overcome this rejection.
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 5 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 5 depends on Claim 2, and claims a composition comprising the compound or stereoisomer, solvate, salt, cocrystal, or prodrug thereof according to Claim 2. Claim 2 does not state that these compounds can be stereoisomers, solvates, salts, cocrystals, or prodrugs, causing Claim 5 to be broader than Claim 2, and therefore, not further limiting. 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 6 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 6 is dependent on Claim 5, which claims “optionally at least one other active ingredient”. Claim 6 then claims “stereoisomers, hydrates, solvates, pharmaceutically acceptable salts, and cocrystals of the other active ingredients”, which is broader than what is claimed in Claim 5, and thus does not further limit Claim 5. 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.
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.
Claims 2, 5, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, and 8 of U.S. Patent No. 12,545,694 (‘694).
Claim 1 of ‘694 is directed to a compound represented by general formula (I)
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wherein
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1019
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873
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491
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850
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514
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. Claim 2 of ‘694 is directed towards a compound of Claim 1 wherein the compound is represented by general formula (II)
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201
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784
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. Claim 4 of ‘694 is directed to specific compounds of Claim 1, including
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,
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,
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, and
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. Claim 5 claims a pharmaceutical composition comprising a compound of Claim 4, optionally one or more other active ingredients, and a pharmaceutically acceptable carrier and/or excipient. Claim 6 claims the composition according to claim 5 wherein the other active ingredient is one or more selected from the group consisting of ginkgolide, antineoplastic agent, anticoagulant, antiepileptic agent, antidepressant, anxiolytic, hypnotic, analgesic, or anesthetic. Claim 8 claims the composition according to claim 6 wherein the ginkgolide is one, two, or more selected from ginkgolide A, B, C, D, J, M, K, L, N, P, Q or bliobalide.
The claims are not identical but they are not patentably distinct because the compounds of ‘694 are prodrugs, and the resulting metabolites will meet the limitations of the compounds of the examined application. When the phosphate group is cleaved in the cited compounds of Claim 4, the resulting compound with have a hydroxyl group at the analogous variable R3 position. The resulting compounds meet the limitations of the claims of the examined application, and render several of the compounds of Claim 2 of the examined application obvious, differing only by the location of deuterium along the alkyl chain in the R position, or the length of the alkyl chain. The artisan would not expect these compounds to have significantly different properties due to the close chemical structure (See MPEP § 2144.09 I).
Conclusion
Claims 2, 5, 6, and 8 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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