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 preliminary amendment filed on 3/13/2024 is acknowledged. Claims 1-11 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 3/13/2024 and 3/17/2024 are acknowledged and have been considered except where lined through.
Claim Objections
Claim 5, 8 are objected to because of the following informalities:
-Claim 5 does not have any comma’s between the structure, nor does it end with a period.
-Claim 8 recites “etc” and “or the like”. It is suggested that these two phrases be deleted. Moreover, the structure of claim 8 is awkward since it contains multiple semicolons. It is suggested that Applicants amend claim 8 to recite following “a flavoring agent” the following: … wherein the pharmaceutical composition is for oral administration in the form of a tablet, pill, lozenge, dragee or a capsule (note: the examiner has removed “may be”). Alternatively, it is suggested that Applicants add additional claims for these limitations. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because both claims 9 and 11 recite the use of a compound without setting forth any method steps. As such, it is unclear whether applicants are attempting to claim a method or a compound with an intended use.
Claim Rejections - 35 USC § 112
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 3, 6 and 8-11 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.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 8, the phrase "such as" and “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites central nervous system disease such as “epilepsy” and also recites specific diseases within parenthesis such “refractory persistent epilepsy, rare genetic epilepsy (e.g. Dravet syndrome and Rett syndrome)) which is the narrower statement of the range/limitation. Additionally, claim 11 recites depression, particularly postpartum depression which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Moreover, Claims 9-11 are drawn to the use of the compound of formula I without reciting any method steps. In the instant case, claim 9 recites the use of the compound of formula I for a variety of treatments, while claim 11 recites the use of a compound of formula I for manufacturing of a medicament.
Conclusion
Therefore, Claims 1-11 are rejected. The compounds of claims 1-8 appear to be free of the prior art. The closest prior art is considered to be to Emory University (WO2009/108804A2, 2009-03-09) whom teach steroid analogues functionalized with polar substituents at the C3 and/or C20 positions of a steroid system that exhibit improved water solubility (abstract). Specifically, Emory teaches a compound having the structure
PNG
media_image1.png
122
210
media_image1.png
Greyscale
(claim 15 of Emory). The compound of Emory differs from the instantly claimed compound in that the compound is not deuterated as claimed. While the prior art discusses deuteration of steroids such as allopregnanolone, generically, see for example US20220289788A1 (2022-09-15), the prior art does not teach or suggest deuteration at the specific locations of the allopregnanolone derivative as claimed. In other words, there is not motivation to select one hydrogen vs. the other. As such, the compounds appear to be novel and unobvious.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pirali et al. (J. Med. Chem. 2019; 62:5276-5297).
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, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Prosecution Insights