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 Claims
The listing of claims filed 07 March 2024 has been examined. Claims 1-12 are pending. Claims 1-12 are amended. Claim 13 is cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 March 2024 is acknowledged and has been considered.
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 1-12 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.
The term “associated” in “associated with canine epilepsy” and “associated with epilepsy” in claims 1 and 2, respectively, is a relative term which renders the claim indefinite. The term “associated” 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 (MPEP 2173.05(b)). Claims 3-12 are also rejected because they incorporate the indefinite term by reference without resolving the issue.
The examiner recommends amending the claims to recite “treating seizures in a canine having epilepsy” or similar.
Claim 2 recites, “…the seizures associated with epilepsy are tonic, clonic, tonic-clonic, atonic, myoclonic, absence, focal seizures without impairment, focal seizures with impairment, and focal seizures with secondary generalization.” It is unclear whether the seizure could be placed into all these categories because, for example, “focal seizures with impairment” and “focal seizures without impairment” are mutually exclusive categories. The examiner suggests changing “and” to “or.”
For examination purposes, claim 2 will be interpreted as if “and” is “or” since the present recitation would require two mutually exclusive alternatives to be simultaneously present (seizures which cause impairment and do not cause impairment).
Claims 7 and 9 recite the limitation "the cannabinoids." There is insufficient antecedent basis for using definite article “the” because there is no preceding recitation of an indefinite article “a” or “an” in claim 1, upon which claims 7 and 9 depend.
Appropriate correction is required.
Claims 10-12 recite the limitation "the dose of CBDV." There is insufficient antecedent basis for using definite article “the” because there is no preceding recitation of indefinite article “a” or “an” in claim 1, upon which claims 10-12 depend.
Appropriate correction is required.
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.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guy (WO 2020/152438 A1).
Guy discloses a cannabidiol (CBD) composition used in treating comorbidities linked to epilepsy (p. 1, Paragraph [0001]) or treatment-resistant epilepsy including Dravet Syndrome (p. 6, Paragraphs [0052]-[0053]; Claim 13), wherein the composition comprises ≥ 98% CBD and ≤ 2% other cannabinoids like THC and CBDV (p. 5, Paragraph [0041]; p. 10, lines 10-11). Furthermore, Guy shows the seizures in subjects receiving a CBD composition were less severe (Fig. 3; p. 24, Paragraph [00143]). Guy discloses phytocannabinoids may be isolated from plants (p. 11, lines 18-27) or made synthetically (p. 8, Paragraph [0064]). Guy discloses the CBD dose is between 5-50 mg/kg/day (p. 6, Paragraph [0054]). Guy discloses the subject receiving the CBD composition as a treatment is an animal, and indicates the subject may be a dog (p. 7, Paragraph [0056]).
Regarding claim 1, Guy teaches a CBD composition which may contain ≤ 2% CBDV (Claim 1) to be administered to subjects having epilepsy, including dogs (p. 7, Paragraph [0056]).
Regarding claim 2, Guy teaches this CBD composition may be applied to patients with Dravet Syndrome (Claim 13) and these patients experience seizures such as clonic and tonic-clonic seizures, focal and generalized seizures, atypical absence seizures, myoclonic absence seizures, atonic seizures, and atonic seizures (p. 2, Paragraphs [0013]-[0014]). Furthermore, the composition may be administered to patients with Lennox-Gastaut Syndrome (LGS), which is associated with seizures such as tonic, atonic, atypical absence, and myoclonic (p. 3, Paragraphs [0021]-[0023]). Thus, Guy discloses a CBD composition containing CBDV may be administered to subjects experiencing these seizure types.
Regarding claim 5, Guy teaches administering a highly-purified CBD preparation containing 0.2-0.8% (w/w) CBDV to patients in addition to their regular anti-epileptic drug AED (p. 10, Table; p. 12, Paragraph [0087]; p. 20, Paragraph [00124]).
Regarding Claims 6-7, Guy teaches the cannabinoids present in the CBD composition containing CBDV may be isolated from cannabis plant material (p. 11, Paragraph [0081]).
Claim Rejections - 35 USC § 103
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.
Claims 3-4, 8-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Guy (WO 2020/152438 A1) in view of Whalley (US 10,799,467; IDS Cite No. 37).
Guy is discussed in the rejection above and that discussion is incorporated by reference for the purposes of the following rejections.
Whalley discloses using CBDV in treating epilepsy (Abstract), which can be in administered in combination with AEDs such as valproate (p. 32, Col. 5, lines 59-67 and Col. 6, lines 1-5; p. 34, Col. 9, lines 40-65) or other cannabinoids like tetrahydrocannabivarin (THCB) and CBD (p. 32, Col. 5, lines 42-55; p. 34, Col. 9, lines 32-36). Whalley discloses a CBDV preparation may be administered to reduce tonic-clonic seizures (p. 34, Col. 9, line 54) and partial seizures (Claim 1; p. 31, Col. 3, lines 16-25). Whalley discloses the CBDV may be an isolated cannabinoid (p. 32, Col. 5, lines 56-58), which is extracted from the cannabis plant (p. 32, Col. 6, lines 36-40), or it may be synthetic (p. 33, Col. 8, lines 65-67). Whalley discloses a CBDV dose between 50-200 mg/kg given to rats (p. 36, Col. 14, lines 12-17). Furthermore, Whalley discloses, “…CBDV shows great potential an anti-epileptic drug” (p. 37, Col. 16, lines 26-27).
Regarding claims 3-4, Guy teaches all of the elements of the claimed invention as stated above except a CBDV preparation comprising ≥ 95% (w/w) CBDV and ≤ 1.5% (w/w) THC (Instant Claim 3) or a CBDV preparation comprising ≥ 95% (w/w) CBDV and ≤ 5% (w/w) other cannabinoids wherein the other cannabinoid may be THC, CBD, tetrahydrocannabivarin (THCV), cannabidiol-C1 (CBD-C1), cannabidivarin acid (CBDVA), and cannabidiol-C4 (CBD-C4) (Instant Claim 4)
Whalley teaches a preparation comprising predominantly CBDV for use in treating epilepsy (p. 32, Col. 6, lines 6-28; p.34, Col. 10, lines 24-30; Table 4.2).
Whalley does not teach administering CBDV or any cannabinoid preparation to dogs or a CBDV preparation comprising ≥ 95% (w/w) CBDV.
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention and following the teachings of Guy to incorporate the teachings of Whalley to substitute CBD for CBDV in the amounts taught by Guy (MPEP 2143(I)(B)). Whalley discloses CBDV has shown improved anti-convulsant activity compared to CBD (p. 34, Col. 9, lines 17-18). Furthermore, Guy mentions there had been known to be advantages associated with including multiple cannabinoids within a pharmaceutical composition, as a botanically-derived CBD composition containing minor amounts of other cannabinoids, such as CBDV, had greater efficacy than a composition comprising synthetic CBD alone even when the CBD concentrations were identical (p.5, Paragraphs [0038]-[0039]). Thus, a PHOSITA would have been motivated to try substituting CBDV for CBD in the ≥ 98% CBD and ≤ 2% other cannabinoids composition disclosed by Guy (Claims 1-2, 5-7). In addition, Guy discloses the CBD composition may contain 0.02%-0.05% (w/w) THC (Claim 2), which is within the THC range required by the instant claims.
Regarding claims 8-9, Guy discloses phytocannabinoids may be isolated from plants (p. 11, lines 18-27) or made synthetically (p. 8, Paragraph [0064]).
Whalley teaches a CBDV preparation comprising synthetic CBDV (p. 33, Col. 8, lines 65-67).
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to combine the teachings of Guy and Whalley to treat canine epilepsy using synthetic CBDV or another synthetic cannabinoid within the composition. A PHOSITA would have understood a botanically-derived compound like CBDV, CBD, or other phytocannabinoids could also be prepared synthetically and could have predicted the isolated and synthetic variants would have similar pharmaceutical properties.
Regarding claim 12, Guy teaches all of the elements of the claimed invention as stated above except a 100 mg/kg/day CBDV dose.
Whalley teaches a 50, 100, and 200 mg/kg daily CBDV dose (Fig. 1-2, 7-8).
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to combine the teachings of Guy and Whalley to administer the 100 mg/kg CBDV dose described by Whalley to dogs impacted by epilepsy as taught by Guy. Further, Guy recites a formula by which the equivalent daily dose between humans and other animals, specifically rats, may be estimated (p. 36, Col. 13, lines 50-60). A PHOSITA would have known to adjust the cannabinoid dose according to the subject animal.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Guy (WO 2020/152438 A1) in view of Stott (WO 2015/198078 A1; IDS Cite No. 221).
Regarding claims 10-11, Guy teaches all of the elements of the claimed invention as stated in the rejections above except the ˃ 2.5 mg/kg/day and 10 mg/kg/day CBDV doses recited in the claims.
Guy teaches a CBD dose between 5-50 mg/kg/day (Claim 8; p. 6, Paragraph [0054]).
Stott discloses using 7-OH-cannabidivarin (7-OH-CBDV) in treating epilepsy. Stott states CBDV is 7-OH-CBDV’s parent compound (p. 12, Paragraph [0076]) and, as evidenced by Jiang, 7-OH-CBDV would have been a predictable CBDV metabolite as CBD was known to be metabolized to 7-OH-CBD (Jiang, Fig. 5). Furthermore, CBD and CBDV share very similar structures, with CBD having a side chain containing an additional two methylene bridges. Stott discloses the 7-OH-CBDV may be synthetic or isolated (p. 1, Abstract; Claims 1-2, 4-6), and it may be used in combination with 7-OH-cannabidiol (7-OH-CBD) or AEDs (Claims 7-8, 11; p. 5, Paragraph [0031] – p. 6, Paragraph [0036]). Stott discloses a 7-OH CBDV dose between 1-2000 mg/kg (Claim 9).
Stott does not teach administering CBDV to treat epilepsy in dogs or an example in which the specific CBDV doses recited in the instant claims were administered to animals.
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to combine the teachings of Guy and Stott to administer CBDV doses within the range disclosed by Stott to treat seizures in canines. Like Guy, Stott recites a formula by which the equivalent daily dose between humans and other animals may be estimated (p. 7, Paragraph [0051]). Thus, a PHOSITA could have used this equation to apply the CBDV dose amounts described by Stott to another animal, like a dog as disclosed by Guy, and have had a reasonable expectation of success. By combining the teachings of Guy and Stott, a PHOSITA would have known CBDV has an anti-convulsant effect in animals and could have optimized the CBDV dosage via routine optimization to achieve the desired seizure-reduction effect in canines (MPEP 2144.05(II)).
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 1-2 and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of Whalley (U.S. Patent No. US 10,799,467 B2).
Whalley claims a method for treating partial seizures by administering CBDV to the subject (Claim 1) alone or in combination with an AED including phenobarbital, ethosuximide, or valproate (Claims 3-6). Whalley does not limit the claimed “subject” to any particular animal.
Whalley’s claims do not recite administering CBDV to dogs.
A PHOSITA would have had a reasonable expectation of success in administering Whalley’s CBDV composition to dogs with epilepsy to reduce seizures. Animal models are used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in Whalley are not limited to a particular subject, they encompass any animal. Thus, an infringer of a patent granted from the instant claims would also be an infringer of the claims in Whalley.
Claims 1-2 and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 11,590,087 in view of Jiang (Jiang et al., Life Sciences, 2011, 89(5-6), 165-170) and Hill (Hill et al., British Journal of Pharmacology, 2012, 167(8), 1573-1752; IDS dated 18 March 2024, Cite No. 273).
‘087 claims a method in which 6-hydroxy cannabidivarin (6-OH CBDV) is used in treating epilepsy (Claim 1), wherein the 6-OH is synthetic or pure or isolated (Claims 2-3), and the administered dose may be 0-1,500 mg/kg/day (Claims 4-5, 9-16). In addition, ‘087 claims the recited method has an anti-convulsant effect or treats tonic and/or myoclonic seizures or reduces seizures in the subject receiving treatment (Claims 17-19) which may be a mammal or, more specifically, a human or a dog (Claims 6-8). ‘087 also claims the 6-OH CBDV is at least 96.7% pure.
‘087’s claims do not recite CBDV, administering CBDV to canines, a composition containing multiple cannabinoids or using cannabinoids in combination with AEDs.
CDBV is structurally similar to cannabidiol, but the side chain attached to the aromatic ring in CBD contains 5 carbon atoms as opposed to having only 3 carbon atoms in CBDV. Given the structural similarities between CBD and CBDV, a PHOSITA would have expected these compounds to have structurally similar metabolites. As evidenced by Jiang, CBD is metabolized to 6α-OH-CBD and 6β-OH-CBD by cytochrome P450 enzymes (Fig. 5). These CBD metabolites have a hydroxyl group at the same position as 6-OH CBDV. Furthermore, as evidenced by Hill, CBDV possesses anticonvulsant activity (p. 1629, Key Results), like CBD (p. 1630, Col. 1, Paragraph 2), and is suggested to have potential in treating epilepsy (p. 1629, Conclusions and Implications). Thus, a PHOSITA could have predicted substituting 6-OH CBDV for CBDV would also lead to a reduction in seizures.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘087 patent claims a CBDV metabolite which a skilled artisan would have predicted to demonstrate the same seizure-reduction effect as CBDV.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,633,369.
‘369 claims a method of treating seizures in a patient having Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, or Doose Syndrome by administering a CBD composition which may also contain ≤1.0% (w/w) CBDV (Claim 1) and the seizures may be atonic, tonic, clonic, tonic-clonic, absence, or myoclonic (Claims 9-11). ‘369 does not limit the claimed “patient” to any particular animal.
‘369’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of U.S. Patent No. 11,633,369 to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. Patent No. 11,633,369.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 21 of U.S. Patent No. 11,865,102 B2.
‘102 claims a method of treating epilepsy with a CBD preparation comprising about 0.1-0.15% (w/w) CBDV (Claim 1). Seizures are a symptom of epilepsy. ‘102 does not limit the claimed “subject” to any particular animal.
‘102’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of U.S. Patent No. 11,865,102 to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. Patent No. 11,865,102.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,064,399 B2.
‘399 claims a method in which 5-25 mg/kg/day cannabidiol (CBD) is administered in combination with up to 1% (w/w) CBDV in treating focal seizures associated with Lennox-Gastaut Syndrome or Tuberous Sclerosis Complex (Claim 7). ‘399 does not limit the claimed “subject” to any particular animal.
‘399’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of U.S. Patent No. 12,064,399 to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. Patent No. 12,064,399.
Claims 1-2 and 5-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 9-11, 13, and 19-21 of U.S. Patent No. US 11,147,776 B2 in view of Jiang (Jiang et al., Life Sciences, 2011, 89(5-6), 165-170) and Hill (Hill et al., British Journal of Pharmacology, 2012, 167(8), 1573-1752; IDS dated 18 March 2024, Cite No. 273).
‘776 claims a method in which 7-hydroxy cannabidivarin (7-OH CBDV) is used in treating seizures or epilepsy (Claim 3, 11, 13, and 19-21), wherein the administered dose may be 1-2,000 mg/kg/day (Claim 10). In addition, ‘776 claims the 7-OH-CBDV may be synthetic or isolated (Claim 9).
‘776’s claims do not recite CBDV or administering CBDV to canines.
CDBV is structurally similar to cannabidiol, but the side chain attached to the aromatic ring in CBD contains 5 carbon atoms as opposed to having only 3 carbon atoms in CBDV. Given the structural similarities between CBD and CBDV, a PHOSITA would have expected these compounds to have structurally similar metabolites. As evidenced by Jiang, CBD is metabolized to 7-OH-CBD (Fig. 5). These CBD metabolites have a hydroxyl group at the same position as 7-OH CBDV. Furthermore, as evidenced by Hill, CBDV possesses anticonvulsant activity (p. 1629, Key Results), like CBD (p. 1630, Col. 1, Paragraph 2), and is suggested to have potential in treating epilepsy (p. 1629, Conclusions and Implications). Thus, a PHOSITA would have predicted substituting 7-OH CBDV for CBDV would also lead to a reduction in seizures.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘776 patent claims a CBDV metabolite which could have been predicted to demonstrate the same seizure-reduction effect as CBDV.
Claims 1-2 and 5-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 9-11, and 19-21 of U.S. Patent No. US 11,793,770 B2 in view of Jiang (Jiang et al., Life Sciences, 2011, 89(5-6), 165-170) and Hill (Hill et al., British Journal of Pharmacology, 2012, 167(8), 1573-1752; IDS dated 18 March 2024, Cite No. 273).
‘770 claims a method in which 7-hydroxy cannabidivarin (7-OH CBDV) is used in treating seizures or epilepsy (Claims 3 and 11), wherein the administered dose may be 1-2,000 mg/kg/day (Claim 10). In addition, ‘770 claims the 7-OH-CBDV may be synthetic or isolated (Claim 9).
‘770’s claims do not recite CBDV or administering CBDV to canines.
CDBV is structurally similar to cannabidiol, but the side chain attached to the aromatic ring in CBD contains 5 carbon atoms as opposed to having only 3 carbon atoms in CBDV. Given the structural similarities between CBD and CBDV, a PHOSITA would have expected these compounds to have structurally similar metabolites. As evidenced by Jiang, CBD is metabolized to 7-OH-CBD (Fig. 5). These CBD metabolites have a hydroxyl group at the same position as 7-OH CBDV. Furthermore, as evidenced by Hill, CBDV possesses anticonvulsant activity (p. 1629, Key Results), like CBD (p. 1630, Col. 1, Paragraph 2), and is suggested to have potential in treating epilepsy (p. 1629, Conclusions and Implications). Thus, a PHOSITA could have predicted substituting 7-OH CBDV for CBDV would also lead to a reduction in seizures.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘770 patent claims a CBDV metabolite which could have been predicted to demonstrate the same seizure-reduction effect as CBDV.
Claims 1-2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,357,586 B2.
‘586 claims a method of using CBD in combination with CBDV and valproate in treating epilepsy (Claim 5). ‘586 does not limit the claimed “subject” to any particular animal.
‘399’s claims do not recite administering CBDV to dogs.
A PHOSITA would have had a reasonable expectation of success in administering ‘586’s CBD composition to dogs with epilepsy to reduce seizures. Animal models are used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘586 are not limited to a particular subject, they encompass any animal. Thus, an infringer of a patent granted from the instant claims would also be an infringer of the claims in ‘586.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 10,709,671 B2.
‘671 claims a method of using CBD in combination with CBDV in treating epilepsy (Claim 6). ‘671 does not limit the claimed “subject” to any particular animal.
‘671’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of U.S. Patent No. 10,709,671 to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. Patent No. 10,709,671.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,357,741 B2.
‘741 claims a method of using CBD in combination with CBDV in treating seizures (Claim 7). ‘741 does not limit the claimed “subject” to any particular animal.
‘741’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of U.S. Patent No. 13,357,741 to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. Patent No. 13,357,741.
Claims 1-2 and 5-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. U.S. 18/005,841.
‘419 claims a CBP preparation containing CBDV used in treating seizures associated with the BRAF mutation (Claim 4). ‘419 does not limit the claimed subject to any animal.
‘419’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of copending Application No. U.S. 18/005,841. to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. 18/005,841.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. US 18/912,442.
‘321 claims a method of using CBD and CBDV in treating epilepsy (Claim 9).
‘321’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of copending Application No. U.S. 18/912,442. to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. 18/912,442.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-12 of copending Application No. US 18/044,941.
‘809 claims a method of using CBDV in treating epilepsy (Claims 1-2), potentially in combination with other cannabinoids (Claim 4) or AEDs (Claims 5-6), where the CBDV or other cannabinoids may be synthetic or isolated from plant material (Claims 7-10) and the dose is greater than 2.5 mg/kg/day (Claims 11-12). The claims are not limited to any one animal.
‘809’s claims do not recite administering CBDV to dogs.
It would have been prima facie obvious to a PHOSITA following the recitations of copending Application No. U.S. 18/044,941 to administer the composition to epileptic dogs to reduce seizures with a reasonable expectation of success. Animal models are routinely used to study diseases impacting humans, so a PHOSITA would have expected a treatment method which is effective in some mammals to also be effective in other mammals, such as dogs. Moreover, because the claims in ‘369 are not limited to a particular patient population, they encompass any animal. Thus, the instant claims overlap in scope with the claims in U.S. 18/044,941.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/B.L.B./
Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623