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 Objections
Claims 1, 2, and 16-18 objected to because of the following informalities: while binomial Genus species names are italicized, their respective families are generally not italicized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 6, 8-20, 21, 22 and 24 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment a substance-use disorder (SUD) related to cocaine, using Ruminococcus gnavus, does not reasonably provide enablement for treatment of all substance-use disorders with any species of any genus of either of the families Ruminococcaceae and Rikenellaceae. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims. The claims are drawn to methods of treating any substance-use disorder with any species from the families Ruminococcaceae and Rikenellaceae. First, as many illicit substances provide for differing physiological effects, it is nearly impossible to suggest that a treatment for cocaine would necessarily be expected to be applied to function the same as a treatment for an amphetamine, or an opiate, as these all provide for different biochemical pathways of addition and abuse. For example, there is no reason to expect the pharmaceutical drug “Narcan” to mitigate an amphetamine overdose, since it is explicitly designed for opiates and opioids. As such, when just considering the broadest reasonable interpretation of the independent claim’s preamble, it would be unclear to the skilled artisan if the treatment for one SUD could be applied to another SUD in an entirely different drug classification. Second, the claims provide for any genus, and any species in either the Ruminococcaceae and Rikenellaceae families. That is to say, by claiming entire families, the Applicant is claiming approximately 50 separate genera with dozens of species, subspecies, and strains.
When looking at the instant specification, there is one applied example wherein the Applicants tested a member of the Ruminococcaceae family: Ruminococcus gnavus, on cocaine-dependent rats. There are no examples of other substances used for SUD testing, and there are no examples of the Applicants using other species or genera from the Ruminococcaceae family; additionally, although several species are listed in the specification, there appear to be no applied examples of members from the family Rikenellaceae. As such, the specification is only fully enabled for treating a cocaine-use disorder by providing R. gnavus; however, one could certainly argue, with reasonable evidence, that Ruminococcus species that possess similar properties as R. gnavus could be used to treat certain SUDs that provide for similar biochemical and/or neurological abuse/addition pathways as cocaine. Furthermore, since the objective affects of probiotics on a subject, especially on a subject’s behavior, can be highly unpredictable, there is no reasonable manner for the claims or specification to suggest that other bacterial species, could be predictably used to treat any other SUD.
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.
Claim 6 is 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 “severe” in claim 6 is a relative term which renders the claim indefinite. The term “severe” 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. It is unclear what criteria is used to determine a subject’s severity, with respect to SUD; since there is no clear scope of “severe” it is unclear how to fully consider the claimed subject pool.
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.
Claims 1-3, 5, 6, 8-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desai (PGPub 2019/0076491 [IDS Reference]). Desai teaches methods of treating SUD by administering R. gnavus. See paragraph [0001] [0036].
With respect to claims 1-3, and 5, Desai teaches administering R. gnavus to subjects with SUD. Additonally, Desai describes a consortium of bacterial species that include those of the Ruminococcaceae and Rikenellaceae families. See paragraph [0036].
With respect to claim 6, Desai places no limitations on the severity of a subject’s SUD, and as such, would necessarily include those with a “severe form of SUD.”
With respect to claims 8-11, Desai teaches stimulants, including cocaine. See paragraph [0005] [0006].
With respect to claim 12, Desai teaches dosages within the claimed range. See paragraph [0008].
With respect to claim 13, Desai teaches oral administration. See paragraph [0008].
With respect to claim 14, Desai teaches administration at least once a week. See paragraph [0009].
With respect to claims 15, Desai anticipates every step, and as such, must have reduced the subject’s cravings. See paragraph [00021].
With respect to claims 16 and 17, Desai anticipates all of the claimed steps, and explicitly describes the narrowest embodiment: the administration of R. gnavus for SUD. As such, all behaviors of the composition following administration are outside of the control of the artisan, and must necessarily be considered a behavior that would be inherent to the method. See MPEP 2112.
With respect to claim18, Desai suggests detecting the abundance of the subject’s microbiota. See paragraph [0048]. This analysis would provide the artisan with details about the prevalence of Ruminococcaceae and Rikenellaceae family members in the subject’s stool-sample.
With respect to claims 19 and 21, Desai suggests administering R. gnavus to a subject either orally or rectally. See paragraph [0058]. These administration methods would increase the amount of R. gnavus in a subject.
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.
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 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Desai (PGPub 2019/0076491 [IDS Reference]) and Ahdoot-Levi, et ai (Frontiers in Neuroscience, 15, 773197, 2021). See the discussion of Desai above. Desai neither teaches nor suggests further providing DHEA.
Ahdoot-Levi teaches methods of reducing cocaine-seeking behaviors by administering DHEA. See page 1, “Abstract” section. While there is no explicit suggestion to combine the two references, there ordinary artisan would find their combination obvious, wherein there would be a reasonable expectation a combination of SUD therapies would provide for additive improvements over each treatment individually.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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