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 .
Priority
This application is a 371 of PCT/CA2021/050801 (06/11/2021) and has PRO 63/038,532 (06/12/2020).
Status
Claims 1, 5-7, 10-16, 18-21, 23-25, 28 and 30 are pending.
Rejections not reiterated in this action are withdrawn.
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, 5-7, 10-14, 21, 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (US20160120874).
Simon teaches treating multiple myeloma using cannabinoids (claims 1-4) including specifically cannabidivarin (claim 11), cannabinol (claims 8 and 14), cannabichromene (claims 8 and 10). Thus, Simon teaches a method of treating multiple myeloma comprising administering cannabidivarin, cannabinol, and/or cannabichromene.
Regarding claim 21, Simon teaches the combination with anticancer agents including bortezomib/Velcade (claim 26, [0022]-[0024]).
Regarding claim 23, Simon teaches the treatment includes humans ([0084]).
Regarding claim 24, Simon teaches the cannabinoids in combination with a pharmaceutically acceptable carrier ([0024]).
Regarding claim 25, Simon teaches oral administration ([0080]).
Response to Remarks/Amendment - 35 USC § 102
Applicant amended the claims in a manner that adds a “proviso that the method does not comprise administering cannabidiol or tetrahydrocannabinol” and argues that Simon does not teach this limitation.
Simon specifically teaches treating multiple myeloma using cannabinoids (claims 1-4: use of a cannabinoid agent for the treatment of monoclonal gammopathy “where the monoclonal gammopathy is multiple myeloma”) including specifically cannabidivarin (claim 11: “where the cannabinoid agent of the cannabidiol (CBD) type is selected from the list consisting of: … (−)-cannabidivarin CBDV-C3”), cannabinol (claim 14: “where the cannabinoid agent of the cannabinol (CBN) type is selected from the list consisting of: cannabinol CBN-C5”), cannabichromene (claim 10: “where the cannabinoid agent of the type cannabichromene (CBC), is selected from the list consisting of: (±)-cannabichromene CBC-C5; (±)-cannabichromenic acid A CBCA-C5 A; (±)-cannabichromevarin CBCV-C3; (±)-cannabichromevarinic acid A CBCVA-C3 A, or any combinations thereof.”). Regarding the added proviso limitation, the prior art positively recites the elements as claimed and is silent regarding the proviso’ed compounds which need not state the absence of the limitation. Almirall, LLC v. Amneal Pharm., 28 F.4th 265, 273 (Fed. Cir. 2022) (“"[A] reference need not state a feature's absence in order to disclose a negative limitation." AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019).”). Therefore, the argument is not persuasive and the rejection maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-7, 10-14, 21, 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US20160120874) in view of Afrin et al. (Cancers 2020, 12, 1033, 27 pages).
Simon teaches treating multiple myeloma using cannabinoids (claims 1-4) including specifically cannabidivarin (claim 11), cannabinol (claims 8 and 14), cannabichromene (claims 8 and 10).
In an alternative claim interpretation where the claim language is considered as excluding phytocannabinoids CBD and THC, Simon does not specifically teach a composition that “does not comprise cannabidiol or tetrahydrocannabinol.”
Afrin teaches non-THC cannabinoids for the treatment of cancer and teaches the benefits of therapeutics which lack psychotropic side effects (p. 1, 19). Afrin also teaches that CBD has side effects including fatigue and hepatotoxicity (p. 3). One of ordinary skill in the art following the teaching of Simon to use cannabidivarin would have considered utilizing only cannabidivarin and avoid other cannabinoids which might possess undesirable effects such as identified by Afrin. Therefore, one of ordinary skill in the art would have considered using the cannabinoids taught by Simon including cannabidivarin, cannabinol, cannabichromene without THC or CBD in order to avoid side effects and arrive at the claimed invention with a reasonable expectation of success.
Regarding the claims to combinations of cannabinoids, with both being known in the art for treating MM their combination for the same purpose, is prima facie obvious. MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Claims 15-16, 18-20, 30 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US20160120874) in view of Afrin et al. (Cancers 2020, 12, 1033, 27 pages) as applied to 1, 3, 5-7, 10-14, 21, 23-25 above and further in view of Hameed et al. (Cancer Growth and Metastasis 2014:7 p. 33-42).
Claims 15-16 are to treating subjects with a phytocannabinoid for myeloma bone disease. Simon does not specifically teach myeloma bone disease.
Hameed teaches that myeloma bone disease (MBD) is common among patients suffering from MM with more than 80% having the condition (Abstract) and that treating MM with novel agents are promising in the treatment of MBD.
One of ordinary skill in the art would have considered applying the same therapy in the treatment of MM to patients having an associated condition of MBD with a reasonable expectation of success due to the nature of the cause of MBD and Hameed’s teaching that treatment of MM are promising in treatment of MBD. Similarly, as applied to claims 10-11, claims 18-20 are also obvious in combining the two cannabinoids for the same prupose.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Regarding new claim 30 depending from claim 16 and further specifying the subject is a human, Simon teaches the treatment is for humans ([0081]-[0084]) and as with claim 16 one of ordinary skill in the art would have considered applying the therapy to a human and arrive at the claimed invention with a reasonable expectation of success.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US20160120874) in view of Afrin et al. (Cancers 2020, 12, 1033, 27 pages) as applied to 1, 3, 5-7, 10-14, 21, 23-25 above and further in view of Russo (British Journal of Pharmacology (2011) 163, p. 1344–1364).
Regarding claim 28, Simon and Afrin do not specifically teach inhalation via vaporization. However, Russo teaches the well-known route of administration of inhalation including for cannabinoids and related compounds (Abstract, p. 1350-52). Thus, one of ordinary skill in the art would have known and had a reasonable expectation of success that administration via vapor inhalation would have been successful and arrive at the claimed invention.
Response to Remarks / Amendment - 35 USC § 103
Applicant amended the claims in a manner that adds a “proviso that the method does not comprise administering cannabidiol or tetrahydrocannabinol” and argues that Simon in view of Afrin does not render the claims obvious.
As with the 35 USC 102 rejection, Simon specifically teaches treating multiple myeloma using cannabinoids (claims 1-4: use of a cannabinoid agent for the treatment of monoclonal gammopathy “where the monoclonal gammopathy is multiple myeloma”) including specifically cannabidivarin (claim 11: “where the cannabinoid agent of the cannabidiol (CBD) type is selected from the list consisting of: … (−)-cannabidivarin CBDV-C3”), cannabinol (claim 14: “where the cannabinoid agent of the cannabinol (CBN) type is selected from the list consisting of: cannabinol CBN-C5”), cannabichromene (claim 10: “where the cannabinoid agent of the type cannabichromene (CBC), is selected from the list consisting of: (±)-cannabichromene CBC-C5; (±)-cannabichromenic acid A CBCA-C5 A; (±)-cannabichromevarin CBCV-C3; (±)-cannabichromevarinic acid A CBCVA-C3 A, or any combinations thereof.”). Regarding the added proviso limitation, the prior art positively recites the elements as claimed and is silent regarding the proviso’ed compounds which need not state the absence of the limitation. Almirall, LLC v. Amneal Pharm., 28 F.4th 265, 273 (Fed. Cir. 2022) (“"[A] reference need not state a feature's absence in order to disclose a negative limitation." AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019).”). Therefore, Simon strongly suggests the claimed invention.
Applicant argues that one of ordinary skill in the art would not be motivated to combine Simon with Afrin.
This argument is not persuasive as both are in the same field of endeavor of cannabinoid therapeutics, including both teaching cannabinoids as therapeutics for treating multiple myeloma. Thus, there was a substantial motivation for one of ordinary skill in the art to consider the combined teachings.
Applicant argues that Simon only disclosed the cannabinoid WIN 55,212-2 and thus would not consider other cannabinoids.
This argument is not persuasive as detailed above, Simon specifically claims the species in a method of treating MM. MPEP 2131.02 (“when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990)”).
Applicant argues that the teachings of Afrin could not necessarily be extended to the teachings of Simon.
This argument is not persuasive because Afrin teaches non-THC cannabinoids for the treatment of cancer and teaches the benefits of therapeutics which lack psychotropic side effects (p. 1, 19) as well as that CBD has side effects including fatigue and hepatotoxicity (p. 3). Furthermore, Afrin also teaches cannabinoids were useful in treating MM (p. 14). Thus, one of ordinary skill in the art following the combined teaching of the art would have had a reasonable expectation of success in using the single cannabinoids in treating MM and avoid cannabidiol and THC as suggested by Afrin and arrive at the claimed invention.
Conclusion
No claims allowed.
Any new grounds of rejection were necessitated by Applicant's amendment. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626