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
STATUS OF THE CLAIMS: Claims 13-19 are pending in this application.
Claim Rejections - 35 USC § 112, 1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 14-15 (including claims dependent thereon) are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 14-15 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims are directed to compositions (e.g., pharmaceutical) comprising the claimed compounds. The claims are rejected for lack of enablement because there is an insufficient teaching of how to use the claimed compositions as claimed. The terms “composition” specify that at least some therapeutic benefit arise from some property of the composition. Intended use claims do not have patentability weight. A pill, for example is a pill no matter what it is used for, and thus, intended use are not consider patentable. Therefore, Applicant has not taught how to use the compounds of the invention to therapeutic effect for any condition.
Examiner suggests amending claim to delete the “use” of the composition.
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.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Horn et al. (J’nal Med. Chem’2014).
Applicant claims a compound having the following formula I:
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(I) ,
wherein all the variables are defined in the claim.
This reference discloses compounds that falls within the formula I on pages 3075-3090. (See Abstract, Tables 1-5 and Figures 1-2). These compounds read on the instant claims. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim 13 is rejected under 35 U.S.C. 103(a) as being unpatentable over Van Horn et al. (J’nal Med. Chem’2014).
Applicant claims compounds having the following formula I:
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(I) ,
wherein all the variables are defined in the claim.
This reference discloses a generic group of quinazoline compounds, which embraces Applicants’ claimed compounds. The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties, and thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. A prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. Thus, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 13-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rueger et al. (WO/97/20823).
Applicant claims compounds having the following formula I:
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(I) ,
wherein all the variables are defined as the following:
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.
This reference discloses a generic group of quinazoline compounds, composition and methods for treating sleep disorders with the compound of the following formula (I):
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which embrace Applicants’ claimed compounds. (See Abstract and compounds).
Rueger teaches the compounds of chemical formula (I): wherein alk1 and alk 2 can be selected as a single bond; R1 and R2 can be selected as H; X1 can be selected as C2 cycloalkylene; X2 can be selected as N(R4); and R3 and R4 can be selected as lower alkyl(CH3).
Roger does not teach compounds of formula (I) wherein R1 is N(CH3)2, R2 is NH-C3cyloalkyl and R3 is H. Thus, Applicant claims differ from the reference by reciting specific species and a more limited genus than the reference by R1 is N(CH3)2, R2 is NH-C3cyloalkyl and R3 is H.
It would have been obvious to one having ordinary skill in the art at the time of the invention to replace by R1 is N(CH3)2, R2 is NH-C3cyloalkyl and R3 is H substituent of formula (I) or add various substituents to formula (I) as taught by the reference, because it is generally known to a person skilled in the art that it would easily obtain other quinazoline compounds with excellent performance for treating sleep disorders through the substitution or changing the R1 and R2 substituents with conventional is N(CH3)2, NH-C3cyloalkyl and H groups. One of ordinary skill in the art would have been motivated to select the claimed compounds replacing R1 is N(CH3)2, R2 is NH-C3cyloalkyl and R3 is H would have been suggested by the reference as a whole for treating sleep disorders. All the moieties are taught in the art. Further, a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. Thus, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Additionally, the claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties, and thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. A prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. Thus, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 13-19 are pending. Claims 13-19 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.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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