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 .
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guy et al (GB 2434312A; Guy).
Scope of prior art
On pages 13-14, Table 1, Guy teaches a CBD-containing plant extract which comprises:
CBD, Cannabigerol, Cannabichromene and Cannabidivarian. The components of the extract meet the limitations of herein rejected claims that are directed to components of the composition which is utilized in the method of treating Neurodegenerative disease.
In Table 1 Guy also teaches presence of non-cannabinoid components such as terpenes and on page 32, lines 6-25 teaches that the presence of non-cannabinoid components in the extract is responsible for improved efficacy of the plant extract.
On page 9, lines 10 – page 10 line 3, Guy teaches limitations directed to the dose of the composition. Unit dosage for the cannabinoid-containing extract in the range of 5mg -100mg of total cannabinoids (page 9 lines 28-31).
On page 9, lines 10-12 Guy teaches that the unit dose can be taken at any one time or within a specified time interval.
Various methods of administering the unit dose to a subject are taught on page 9, line33 – page 10, line 3. Said delivery methods include the instantly claimed sublingual, buccal, nasal, oral and pulmonary routs of drug administration.
On page 11, lines 1-7, Guy teaches that the cannabinoid containing plant extract are intended for use in treatment of neurodegenerative disease and Alzheimer’s disease (AD) (line 6) as one of the diseases that can be treated.
Ascertaining the difference
While Guy suggests treating AD by administering a cannabis plant extract which comprises CBD, Cannabigerol, Cannabichromene and Cannabidivarian, the reference lacks an actual example of AD being treated.
While Guy teaches broadly teaches terpenes in the plant extract, he fails to recite which specific terpenes are included.
Guy does not recite cannabinol being present in the extract.
Obviousness
One skilled in the art prior to the earliest effective filing date of the instant application would have found it obvious to administer a composition comprising CBD, Cannabigerol, Cannabichromene and Cannabidivarian to subject in need of treatment for PD. Guy suggests treating AD using whole plant extract as opposed to purified THC or CBD. On page 32, lines 6-25, Guy suggests that the improved effectiveness of the extract over pure cannabinoids is due to presence of minor cannabinoids and also due to the presence other components of the extract which constitute the non-cannabinoid fraction. Based on the above teaching one would select whole plant extract which comprises major cannabinoid, minor cannabinoid and non-cannabinoid components. Guy provides motivation to use cannabis plant extract by teaching that there is a need for an efficacious NMDA antagonist to treat neural degeneration and suggests use of the extract (page 3, lines 7-27). Guy also provides expectation of success via experimental results which indicate that administration of plant extract is particularly effective in prevention of neural degeneration.
Regarding presence of terpenes in the extract. Guy teaches that the extract was obtained from Cannabis Sativa L. and that the extract comprises various terpenes. While Guy does not identify the terpenes Examiner takes the position that the claimed terpenes are present in the extract as evidenced by Brousseau et al (Frontiers in Plant science, 2021, 12, 1-13). On page 5, second paragraph of the section titled “Terpenes” Brousseau discloses pinene and limonene to be the major terpenes found in Cannabis Sativa L. Brousseau therefore provides evidence that the terpenes recited by Guy include various pinenes and limonene. The terpenes are present because both Guy and Brousseau are directed to the same strain of cannabis, Cannabis Sativa L.
Regarding Cannabinol. While Guy does not recite cannabinol being present in the extract, Examiner’s position that cannabinol (CBN) is inherently present as evidenced by Brousseau et al. In figure 1 on page 4 Brousseau presents cannabinoid biosynthesis in Cannabis Sativa L (the same strain as used by Guy). Figure 1 shows that CBN is product of oxidation of THC and is produced by a biosynthetic pathway in Cannabis Sativa L. In addition, Whittle et al (GB 2391865A) teaches that CBN is produced from THC in the method of obtaining the plant extract (page 23, lines 2-9; page 26, Table 5). Whittle is referenced by Guy as the method by which plant extract is obtained. Since Guy relies on the method of Whittle to produce the plant extract and reports THC being presents in the CBD rich extract, it is inherent that some of the THC was converted into CBN.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 24-38 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,653,640. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the ‘640 patent are directed to a method of treating PD by administering the instantly claimed composition.
While claims of the ‘640 patent do not recite the unit dose and frequency of administration, one would have found it necessary to determine these parameters via routine experimentation in order to practice the claimed method. Claim 1 of the ‘640 patent recites administering an “effective amount” in order to administer said “effective amount” performing routine experimentation to determine the proper dose would be necessary.
Claims 21, 24-38 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,673,368. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims of the ‘368 patent are directed to treatment of PD comprising administration of a cannabis plant extract wherein the extract is obtained by supercritical or subcritical extraction. While claim 1 of the ’368 patent fails to recite the specific terpenes and cannabinoids other than THC and CBD, the extract is inherently the same as is instantly claimed. ‘368 extract was obtained from Cannabis Sativa L. and the extract comprises various terpenes. While ‘368 does not identify the terpenes Examiner takes the position that the claimed terpenes are present in the extract as evidenced by Brousseau et al (Frontiers in Plant science, 2021, 12, 1-13). On page 5, second paragraph of the section titled “Terpenes” Brousseau discloses pinene and limonene to be the major terpenes found in Cannabis Sativa L. Brousseau therefore provides evidence that the terpenes recited by ‘368 include various pinenes and limonene. The terpenes are present because both ‘368 and Brousseau are directed to the same strain of cannabis, Cannabis Sativa L.
Claims 21, 24-38 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 11980592. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims of the ‘592 patent are directed to a method of treating PD by administering the instantly claimed composition. PD meets the limitation “neurodegenerative disease”. The currently claimed amounts and administration schedule are found in claims of ‘592.
Claims 22, 23 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 11,980,592 in view of Guy et al (GB 2434312) Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims of the ‘592 patent are directed to a method of treating PD by administering the instantly claimed composition. PD meets the limitation “neurodegenerative disease”. The currently claimed amounts and administration schedule are found in claims of ‘592. Current claims are directed to treatment of AD while those of ‘592 are directed to treatment of PD. However, it would have been obvious to administer the composition of the ’592 patent to subjects in need of treatment of AD in view of Guy. Guy teaches composition comprising the components of the ‘592 composition and suggests its utility in treatment of neurodegenerative disease. Guy teaches that both AD and PD can be treated (page 11, lines 1-7). A skilled artisan would have found it obvious to treat AD instead of PD because Guy teaches that the cannabinoid composition has utility in treatment of both diseases.
Claims 22, 23 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 of U.S. Patent No. 10,653,640 in view of Guy et al (GB 2434312) Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims of the ‘640 patent are directed to a method of treating PD by administering the a composition comprising a composition comprising the minor cannabinoids cannabichrome, cannabigerol, and cannabidivarin; the currently claimed terpenes; and a major cannabinoid CBD (claim 2 and 3).. PD meets the limitation “neurodegenerative disease”. Current claims are directed to treatment of AD while those of ‘640 are directed to treatment of PD. However, it would have been obvious to administer the composition of the ’640 patent to subjects in need of treatment of AD in view of Guy. Guy teaches the composition of ’640 and suggests its utility in treatment of neurodegenerative disease. Guy teaches that both AD and PD can be treated (page 11, lines 1-7). A skilled artisan would have found it obvious to treat AD instead of PD because Guy teaches that the cannabinoid composition has utility in treatment of both diseases.
Conclusion
Claims 21-40 are pending
Claims 21-40 are rejected
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
