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 .
Application Status
The amendment filed on 10/28/2025 in response to the Non-Final office action of 7/02/2025 is acknowledged and has been entered.
Claims 1,3,6,7,10-12,16-20,26,27,30,32,34,42,44 and 45 are currently pending.
Claims 16-17 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 20 and 27 are withdrawn from consideration as being drawn to non-elected species.
Claims 1,3,6,7,10-12,18-19, 26,30,32,34,42,44 and 45 are under consideration.
Information Disclosure Statement
The information disclosure statement filed on 10/28/2025 has been considered except where lined through.
Objections/Rejections Withdrawn
The objection to claim 30 is withdrawn in view of applicants amendment.
The rejection of Claims 1,3,6,7,10-12,18-19, 26,30,32,34,42,44 and 45 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicants amendment to claims 1 and 10.
Rejections Maintained but amended in view of Applicants Amendments
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 3, 6, 7, 10-12, 18, 30, 32, 42 and 44 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shytle et al. (US2010/0267733A1, 2010-10-21).
Shytle et al. teach a method of modulating inflammatory response and/or treating a neurodegenerative disease in a patient by administering at least one cannabinoid and at least one nicotinic compound, wherein the cannabinoid is a cannabinoid-2 receptor agonist and includes, but is not limited to, JWH 015 and JWH 133 (paragraph 0013). With regards to the neurodegenerative disease, the PG Pub teaches that neurodegenerative diseases include, but are not limited to, Tay Sach’s disease (a type of lysosomal storage disease, lipidosis) and lysosomal storage diseases (paragraph 0013). Thus, while the prior art does not specifically teach inhibiting macrophage activation or the effect of administration of the cannabinoid-2 receptor agonist, e.g. decreasing the expression of the CB2 cannabinoid receptor in the subject, the claimed limitations appear to be met by administering the same compound to the same patient population. Applicants are reminded that the Office does not have the facilities or resources to determine whether such an effect occurs. The burden is on Applicants to prove that the prior art products do not necessarily possess the characteristics of the claimed products. See MPEP 2112.
Claim(s) 1, 3, 6, 7, 10-12, 18-19, 26, 30, 32 and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Galve-Roperh et al. (US2010/0004244A1, 2010-01-07).
Galve-Roperh et al. teach a method of promoting, inducing and enhancing neurogenesis, comprising administering to an individual in need thereof a therapeutically effective amount of a pharmaceutical composition comprising as an active ingredient a CB2 selective agonist (Claim 1 of the PG Pub). With regards to the CB2 selective agonist, the PG Pub teaches that selective CB2 agonist include, but are not limited to, HU-308 and uses this compound in many of the in vitro and in vivo examples (paragraph 0074 and examples). Moreover, the PG Pub teaches that the promotion of neurogenesis is used to treat neurological injuries, wherein the neurological injury is associated with a metabolic or nutritional disorder include, but not limited to, glycogen storage disorders and Farber’s disease (claim 11 and 18 of the PG Pub). Thus, while the prior art does not specifically teach inhibiting macrophage activation or the effect of administration of the cannabinoid-2 receptor agonist e.g. decreasing the expression of the CB2 cannabinoid receptor in the subject, the claimed limitations appear to be met by administering the same compound to the same patient population. Applicants are reminded that the Office does not have the facilities or resources to determine whether such an effect occurs. The burden is on Applicants to prove that the prior art products do not necessarily possess the characteristics of the claimed products. See MPEP 2112.
In response to the above rejections, Applicants contend that neither Shytle et al. nor Galve-Roperh et al. discloses a decreased expression of CB2 cannabinoid receptor as presently claimed.
Applicants response has been fully considered, but is not found persuasive.
As noted in the prior office action and above, the Examiner acknowledges that prior art does not specifically teach the effect of administration of the cannabinoid-2 receptor agonist e.g. decreasing the expression of the CB2 cannabinoid receptor in the subject, the claimed limitations appear to be met by administering the same compound to the same patient population. Applicants are reminded that the Office does not have the facilities or resources to determine whether such an effect occurs. The burden is on Applicants to prove that the prior art products do not necessarily possess the characteristics of the claimed products. See MPEP 2112.
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 (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.
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.
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.
Claim(s) 45 remains rejected under 35 U.S.C. 103 as being unpatentable over Shytle et al. (US2010/0267733A1, 2010-10-21), as applied above to claims 1, 3, 6, 7, 10-12, 18, 30, 32, 42 and 44, as evidenced by Pertwee (British Journal of Pharmacology (2008), 153, 199-215).
As described above, Shytle et al. teach a method of modulating inflammatory response and/or treating a neurodegenerative disease in a patient by administering at least one cannabinoid and at least one nicotinic compound, wherein the cannabinoid is a cannabinoid-2 receptor agonist and includes, but is not limited to, THC, JWH 015 and JWH 133 (paragraph 0013). With regards to the neurodegenerative disease, the PG Pub teaches that neurodegenerative diseases include, but are not limited to, Tay Sach’s disease (a type of lysosomal storage disease, lipidosis) and lysosomal storage diseases (paragraph 0013). While the prior art does not specifically teach that THC is a CB1 receptor agonist, as evidenced by Pertwee, TCH is a CB1 and CB2 receptor partial agonist (Abstract).
Shytle et al. does not teach that the composition comprises two cannabinoid agonist such as THC and JWH 133.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include THC in the method taught by Shytle et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Shytle et al. teach that THC is a cannabinoid that can be used in the method.
"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) (citations omitted)
Claim(s) 19 remains rejected under 35 U.S.C. 103 as being unpatentable over Shytle et al. (US2010/0267733A1, 2010-10-21), as applied above to claims 1, 3, 6, 7, 10-12, 18, 30, 32, 42 and 44, in view of Galve-Roperh et al. (US2010/0004244A1, 2010-01-07).
As described above, Shytle et al. teach a method of modulating inflammatory response and/or treating a neurodegenerative disease in a patient by administering at least one cannabinoid and at least one nicotinic compound, wherein the cannabinoid is a cannabinoid-2 receptor agonist and includes, but is not limited to, JWH 015 and JWH 133 (paragraph 0013). With regards to the neurodegenerative disease, the PG Pub teaches that neurodegenerative diseases include, but are not limited to, Tay Sach’s disease (a type of lysosomal storage disease, lipidosis) and lysosomal storage diseases (paragraph 0013).
Shytle et al. do not teach that the neurodegenerative disease is Farber’s disease.
Galve-Roperh et al. teach a method of promoting, inducing and enhancing neurogenesis, comprising administering to an individual in need thereof a therapeutically effective amount of a pharmaceutical composition comprising as an active ingredient a CB2 selective agonist (Claim 1 of the PG Pub). With regards to the CB2 selective agonist, the PG Pub teaches that selective CB2 agonist include, but are not limited to, HU-308 and uses this compound in many of the in vitro and in vivo examples (paragraph 0074 and examples). Moreover, the PG Pub teaches that the promotion of neurogenesis is used to treat neurological injuries, wherein the neurological injury is associated with a metabolic or nutritional disorder include, but not limited to, glycogen storage disorders and Farber’s disease (claim 11 and 18 of the PG Pub).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to treat a patient with Farber’s disease with the method taught by Shytle et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Galve-Roperh et al. teach that Farber’s disease can be treated with cannabinoid receptor agonists.
In response to these rejection, Applicants contend, as noted above in the 102 rejections above, none of the prior art references teach or suggest a decreased expression of the CB2 receptor as a result of the presently claimed methods.
These are arguments have been carefully considered, but are not found persuasive for the reasons set forth above.
New Rejections necessitated by Applicants amendment
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 (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.
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.
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.
Claim(s) 34 is rejected under 35 U.S.C. 103 as being unpatentable over Shytle et al. (US2010/0267733A1, 2010-10-21), as applied above to claims 1, 3, 6, 7, 10-12, 18, 30, 32, 42 and 44, in view of Utz et al. (Molecular Genetics and Metabolism 2015;114:274-280).
Shytle et al. teach a method of modulating inflammatory response and/or treating a neurodegenerative disease in a patient by administering at least one cannabinoid and at least one nicotinic compound, wherein the cannabinoid is a cannabinoid-2 receptor agonist and includes, but is not limited to, JWH 015 and JWH 133 (paragraph 0013). With regards to the neurodegenerative disease, the PG Pub teaches that neurodegenerative diseases include, but are not limited to, Tay Sach’s disease (a type of lysosomal storage disease, lipidosis) and lysosomal storage diseases (paragraph 0013).
Shytle et al et al. does not specifically teach a step of detecting levels of a cytokine or chemokine in a subject.
Utz et al. teach that the gangliosidoses diseases including Tay-Sachs disease are inherited and metabolic disease of lysosomal lipid catabolism in which the accumulation of ganglioside (Introduction). Specifically, Utz et al. teach that five markers of inflammation ENA-78 (a chemokine), MCP-1 (a cytokine), MIP-1alpha, MIP-1beta and TNFR2 were distinguished by their persistent elevation in the CSF of patients with infantile gangliosidosis phenotype, but not in the other patient groups (page 279, 2nd column, Inflamation). Moreover, Utz et al. teach that the observation of significant elevations of specific analytes associated with inflammation in CSF identifies these analytes as potential biomarkers of the underlying pathology and may help evaluate response to therapy (page 280, 1st column, Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Shytle et al. to include measuring the level of cytokines and chemokines in a subject in view of the teachings of Utz et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Utz et al. teach that the observation of significant elevations of specific analytes such as cytokines and chemokines associated with inflammation in CSF identifies these analytes as potential biomarkers of the underlying pathology and may help evaluate response to therapy.
Conclusion
Therefore, No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626