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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Priority
This application claims benefit of priority to Provisional Application 62/975,807 filed 02/13/2020 and is also a Continuation in Part of PCT/IB2021/05113 filed 02/11/2021.
Election/Restrictions
Applicant’s election of species made 01/16/2025 electing sleep disorders as the specific condition, ‘thabine’ as the specific compound, serotonin reuptake modulators as the specific component and Bifidobacterium as the specific microorganism is reiterated. The specific combination requiring ‘thabine’ which Applicant argues is a misspelling for ‘thebaine’ (this argument is addressed below) and Bifidobacterium for the treatment of sleep disorders appears to be free of the prior art. However, this subject matter is not allowable as claim 1, specifically for the recitation of ‘thebaine,’ remains rejected under 35 USC 112a for being new matter. Even such, the Examiner moved on to other members of the Markush groups present in instant claim 1.
Amendments and Claim Status
In the reply filed 02/17/2026, Applicant amended claim 1 and canceled claims 2-4, 6-7 and 10-11. Applicant previously canceled claim 5. Claims 16-20 remain withdrawn as they are not encompassed by Applicant’s election made 01/16/2025.
Claims 1, 9 and 12-20 are currently pending.
Claims 16-20 remain withdrawn.
Claims 1, 9 and 12-15 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “dihydrocodeine” twice, once in line 12 and once in line 13. Additionally, some of the compounds listed in lines 11-14 are capitalized while others are not. All of the members of the Markush group of compounds are drugs and do not require capitalization. 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, 9 and 12-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to incorporate the limitations of previously pending claim 8. Claim 1 now recites “thebaine” in line 11. There is no express or implicit disclosure of ‘thebaine’ in the claims or the instant Specification. Applicant indicated in the arguments filed 02/17/2026 that the instant Specification has been amended to correct the spelling of “thebaine” from “thabine.” However, an amended Specification has not been filed. It is noted, if the Specification is amended in such a manner, the Specification will be objected to for new matter. It remains the Examiner’s position that the recitation of ‘thebaine’ is new matter.
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.
Claims 1, 9 and 12-15 are 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.
Claim 1 recites “wherein said condition is selected from the group consisting of autism spectrum disorder, depression … abuse, sleep disorders, …” in lines 2-4. It is unclear how ‘abuse’ is intended to limit ‘said condition’ because ‘abuse’ itself is not a condition. It is unclear what condition ‘abuse’ is intended to represent. It is unclear if a word is missing, for example, if ‘abuse’ supposed to be ‘substance abuse’ or something similar. Thus, one of ordinary skill in the art would not be reasonably apprised of what condition ‘abuse’ represents. Therefore, claim 1 and all claims dependent upon claim 1 are rendered indefinite.
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 and 12-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Desai et al. (WO 2017155861 A1, 09/14/2017.
Regarding claims 1 and 15, Desai et al. disclose compositions and methods for treating a subject for a substance-abuse related disease or disorder wherein the substance-abuse related disease or disorder can be alcohol-related or opioid-related (See entire document, Abstract). More specifically, Desai et al. disclose a method of treating a subject for substance-abuse related disease or disorder, comprising administering to the subject a microbiota transplant (Claim 1 of Desai et al.). The method of claim 1, further comprising administering a probiotic, therapeutic agent or a combination thereof to the subject (Claim 2 of Desai et al.) wherein the method includes administering a composition comprising at least one bacterial species including Bifidobacteria (Claim 3 of Desai et al.) and the therapeutic agent is naltrexone, disulfiram, methadone, buprenorphine and acamprosate (Claim 16 of Desai et al.). The combination of the probiotic and therapeutic agent reads on being provided as a kit.
Regarding claim 12, Desai et al. disclose the microbes can be enclosed in a gel matrix which provides protection for the cells, in some examples, the probiotic can be a foodstuff such as gels, jellies, yogurt and etc. (Page 9, Lines 30-32).
Regarding claim 13, Desai et al. disclose administering a combination of the probiotic and therapeutic agent (Claim 2 of Desai et al.). The combination reads on simultaneously administering the two.
Regarding claim 14, Desai et al. disclose the composition is administered once daily (Claim 11 of Desai et al.) for up to three weeks (Claim 12 of Desai et al.), reading on multiple administrations of the composition.
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.
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 1, 9 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al. (WO 2017155861 A1, 09/14/2017) in view of Sari et al. (Progress in Molecular Biology and Translation Science, 2011).
The teachings of Desai et al. are discussed above.
Regarding claim 9, Desai et al. further disclose various medications and behavioral therapy have been used to treat alcohol dependence. The neuronal targets of alcohol include many neurotransmitter systems and the molecules participating in or regulating the systems, including GABA, glutamate, DA, opioids and serotonin (Page 1, Lines 21-24).
Desai et al. do not disclose administering serotonin reuptake modulators.
However, Sari et al. disclose alcohol is an addictive drug that alters brain function through interactions with multiple neurotransmitter systems (See entire document, Abstract). Specifically, the serotonergic system is important in mediating alcohol reward, preference, dependence and craving (Abstract). Sari et al. further disclose studies have shown that selective serotonin reuptake inhibitors (SSRIs) effectively maintain the attenuation of alcohol intake achieved during treatment for at least 6 months after pharmacotherapy (Page 13, Paragraph 4). SSRIs read on serotonin reuptake modulators.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included an SSRI in the method of Desai et al. which is directed to treating alcohol abuse because SSRIs are a known and effective class of drugs for treating alcohol abuse as taught by Sari et al. Therefore, it would have to obvious to further administer an SSRI in addition to the probiotic and the therapeutic agent in the method of Desai et al. because all compositions are known to treat alcohol abuse/dependency motivated by the desire to effectively treat alcohol abuse/dependency as it amounts to combining compositions known to be useful for the same purpose. 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. The idea of combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Conclusion
Claims 1, 9 and 12-15 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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