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
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on October 14, 2025 is acknowledged. Applicant’s traversal is on the ground that Groups I-II are inter-related (part of one and the same invention), and thus, would not be unduly burdensome. This is not found persuasive because Groups I-II are separate and patentably distinct because there is no patentable co-action among them. Hence, Applicant’s inventions are distinct and have acquired a separate status in the art due to their recognized divergent subject matter and different classification. Additionally, because each group has different subclasses, it would constitute a burden on the Examiner to search all subclasses. Further, different fields of search would be required in the non-patent literature.
Thus, a search of the two groups would impose an undue burden upon the Examiner. Therefore, the restriction for examination purposes as indicated is proper. The requirement is still deemed proper and is therefore made FINAL.
Group II is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking.
Applicant is reminded that Group II will be rejoined if the compounds and compositions of Group I are allowed.
Applicant reserved the right to file a divisional application to the non-elected subject matter if rejoinder doesn’t apply.
An action on the merits of Group I (claims 1-13) is contained herein.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 1-13 (including claims dependent thereon and claims that relate back to independent claim 1) 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 pre-AIA the applicant regards as the invention.
Claims 1-2 as heteroaryl, heterocyclyl, and/or aryl. The terms are indefinite since the specification does not define the ring size, heteroatom, number and nature of substituents, and the exact point of contact with the atom(s) for the substituents. Correction is required.
Claim Rejections - 35 USC § 112, 1st paragraph
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 1-13 are (including claims dependent thereon and claims that relate back to or refer to independent claim 1) are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for some of the heteroaromatic system for A1-A8 and R substituents listed within the claims and specification of the current application, does not reasonably provide enablement for all of the A1-A8 and R substituents listed within the application. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPX 546 (BD. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
1. Amount of guidance provided by Applicant.
While the Applicant has demonstrated within the application a select number of the aryl rings, heterocyclic rings and tricyclo-heterocyclic rings, the generic claims according to formula (I) are massive, and only a small fraction of these compounds are disclosed, discussed, and/or their synthesis shown. In the claims and specification, applicants claim various variables for heteroaromatic system for A1-A8 and R substituents, which includes for tricyclo-heterocyclic rings as well as various “R” groups that are aryl, heteroaryl, and heterocycyl and etc. groups. However, the specification fails to teach all of these compounds, nor does the specification define the ring size, heteroatom, number and nature of substituents, and the exact point of contact with the atom(s) for the substituents.
2. Unpredictability in the art.
It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved”, and physiological activity is generally considered to be an unpredictable factor. (USPQ 18, 24 (CCPA 1970). See In re Fisher, 427 F.2d 833, 839, 166.
3. Number of working examples.
Applicants have provided working examples of the compounds (i.e., A1-A8 and R substituents are defined); however, these examples only read on a minute portion of the massive claims according to general formula I in the present application.
4. Scope of the claims.
The scope, of the claims, involves a plethora of compounds of general formula I:
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188
244
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wherein all the variables are defined in the claim. For example, in defining A1-A8 and some R substituents
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530
568
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756
562
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Thus, the scope of the claims is very broad.
5. Nature of the invention.
The nature of this invention relates generally to some tricyclo-heterocyclic ring (quinoxaline derivatives) compounds associated with treating pain and inflammation.
6. Level of skill in the art.
The artisan using Applicant’s invention would be a chemist with a Ph.D. degree, and having several years of bench experiences.
MPEP § 2164.01 (1) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d. 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” Thus, this conclusion is clearly justified here. Therefore, Applicant is not enabled for all of these compounds or compositions.
Conclusion
Claims 1-13 are pending. Claims 1-13 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622