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 . Claims 1-18 and 22-35 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I and a Pyridine species (wherein one of X1, X2 or X3 = N) in the reply filed on 02/27/2026 is acknowledged. Since the conditions for rejoinder are met, the invention of Groups I and II are rejoined.
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 1-4, 6, 8-16, 18 and 22-35 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. In claim 1, the triazine species wherein X1 = X2 = X3 = N was not described in the specification. There are no examples in the specification that disclose a triazine species. It is recommended that applicants amend claim 1 to exclude triazine (i.e. X1 = X2 = X3 = N) from claim 1.
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 22-27 and 31-35 are 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 of specific diseases mediated by α5-GABAARs in a subject as recited in claims 23-27 and 31-35, does not reasonably provide enablement: (1) for the prevention of any diseases recited in claims 23-27 and 31-35; and (2) for the treatment of any disease (other than diseases recited in claims 23-27 and 31-25) mediated by α5-GABAARs in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. It is recited in the claims, the prevention of diseases mediated by α5-GABAARs and also the treatment of any disease mediated by α5-GABAARs, but the specification is not enabled for such a scope.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
The instant claims recite “A method of preventing or treating a disease or medical disorder mediated by α5-GABAARs in a subject” wherein there is insufficient description in the specification regarding the treatment or prevention intended by the recitation.
The scope of the claims is not adequately enabled solely based on the activity
related to α5-GABAARs receptor activity provided in the specification. Test procedures of the compounds with respect to radioligand binding assay and in vitro α5-GABAARs relative efficacy assays are provided in the specification in Table 1 (pages 330-335), however, there is nothing in the disclosure regarding how this data correlates to the treatment or prevention of all the disorders embraced the instant claims. The disorders encompassed by the instant claims include treatment of any disease mediated by α5-GABAARs in a subject and the prevention of the diseases recited in the claims, some of which have been proven to be extremely difficult to treat. There is no reasonable basis for assuming that the myriads of compounds embraced by the claims will all share the same physiological properties since they are so structurally dissimilar as to be
chemically non-equivalent and there is no basis in the prior art for assuming the same. Note In re Surrey, 1 51 USPQ 724 regarding sufficiency of disclosure for a Markush group.
Thus, factors such as ‘sufficient working examples', ‘the level of skill in the art' and ‘predictability', etc. have been demonstrated to be sufficiently lacking in the use of the invention. ln view of the breadth of the claim, the chemical nature of the invention, the unpredictability of ligand-receptor interactions in general, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
In order to overcome this rejection, applicants have to delete “preventing” or “prevention” from claims 22 and 32 and also recite specific diseases mediated by α5-GABAARs in claim 22 as it was done in claim 23.
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.
Claim 22 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. Claim 22 is rejected because the phrase “medical disorder mediated by α5-GABAARs” is indefinite. What is covered ad what is not? It is recommended that applicants recite specific diseases or delete said phrase.
Objection
9. Claims 5, 7 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Information Disclosure Statement
10. Applicant’s Information Disclosure Statement, filed on 07/24/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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 MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624