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 .
DETAILED ACTION
STATUS OF THE CLAIMS: Claims 43-62 are pending in this application.
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.
Claims 43-62 (including claims dependent thereon) are rejected under 35 U.S.C. 102 as being anticipated by Zhou Xibing et al. (CN113087599, which corresponds to US Pub. 20230059087).
Applicant claims a method for treating Prader Willi Syndrome (“PWS”) comprising the following:
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276
628
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wherein all the variables are defined in the claims.
This reference discloses methods for treating PWS comprising the compounds of formula (I) in paragraphs [0033], [0211] and [0225]. (See Abstract and entire document). These methods read on the instant claim. Since this reference teaches the exact methods, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 43-62 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhou Xibing et al. (CN113087599, which corresponds to US Pub. 20230059087).
Applicants claim a generic group of cannbidiolic acid ester compounds for treating PWS with the compounds of the following formula (I):
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136
176
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wherein:
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544
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Zhou discloses compounds of formula (I) and a generic group of cannabidiolic acid and ester compounds and compositions with a therapeutic utility for treating PWS, which embraces Applicant’s formula I and claimed compounds. (See Abstract and compounds).
Zhou does not teach treating PWS with compounds of formula (I) wherein R1 contains various C2-C15 alkyl, C2-C15 alkenyl and C2-C15alkynyl. Thus, Applicant claims differ from the reference by reciting specific species and a more limited genus than the reference by replacing methyl or ethyl of R1 with various C2-C15 alkyl, C2-C15 alkenyl and
C2-C15alkynyl.
It would have been obvious to one having ordinary skill in the art at the time of the invention to replace the R1 substituent of formula (I) or add various substituents to formula (I) as taught by the reference, because it is generally known to a person skilled in the art that it would easily obtain other cannabidiolic acid and ester compounds having excellent performance for treating PWS through the substitution or changing the R1 substituent with conventional alkyls, alkenyls or alkynyls groups. One of ordinary skill in the art would have been motivated to select the claimed compounds replacing R1 with various alkyls, alkenyls or alkynyls since such compounds would have been suggested by the reference as a whole for treating PWS. All the moieties are taught in the art. Further, a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. Thus, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 43-62 are rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (WO202113722) in view of Zhou Xibing et al. (CN113087599, which corresponds to US Pub. 20230059087).
Applicant claims a method for treating Prader Willi Syndrome (“PWS”) comprising the following:
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276
628
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wherein all the variables are defined in the claims.
Additionally, in dependent claims 45-62, Applicant claims the following:
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162
654
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798
644
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642
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Webb discloses various cannabidiolic acid ester compounds represented by formula (I) with various formulations and administrations to treat genetic disorders (e.g., muscular dystrophy or “MD”) caused by a variety of mutations in structural proteins that result in progressive degeneration and weakness of muscle due to muscle damage, inflammation or deposition of adipose and fibrotic tissues. (See pages 1 and 4, line 10 to page 6).
Webb does not explicitly disclose a method for treating the genetic disorder PWS with cannabidiolic acid ester compounds of formula (I).
Zhou discloses cannabidiolic acid ester compounds according to formula (I) to treat PWS, a genetic disorder caused by loss of function of specific genes on chromosome15, resulting in muscle weakness.
It would have been obvious to one having ordinary skill in the art at the time of the invention to combine the method of Webb with the method taught by Zhou for providing an alternative method for treating the PWS genetic disorder. Webb discloses various formulations and administration of cannabidiolic acid ester compounds of formula (I) to treat genetic disorders such as MD which causes muscle weakness due to muscle damage, inflammation or deposition of adipose and fibrotic tissues, and Zhou discloses methods for treating the PWS genetic disorder with symptoms of muscle weakness with cannabidiolic acid ester compounds of formula (I). All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, confronted with an alternative method for treating PWS, genetic disorder associated with muscle weakness, would combine the method of Webb and Zhou to generate a therapeutic effect for treating PWS and muscle weakness. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Webb and Zhou, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 43-62 are pending. Claims 43-62 are rejected. No claims are allowed.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622