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 .
Amended claims 1, 5, 7, 8-10, 12, 13-14, 16, and new claims 17, 18, 19-23 are pending.
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.
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Claims 1, 5, 7, 8-10, 12, 13-14, 16-18 are rejected under 35 U.S.C. 112, first paragraph, because the specification does not reasonably provide enablement large number of possibilities claimed for reasons of record. Amendments address part of the previous issues raised. Starting materials needed with respect to Q part of the possibilities remains partially unresolved. As pointed out previously at the bottom of page 3 onto page 4, the novelty of the claimed subject matter relies on the novelty of the Q part of the claimed formula, more specifically to the R4 of Q. (But for the R4 modification the instant compounds are close structural analogs of are claimed compounds of US12552766 and US12528788. Note that the said R4 modification is bioisosteric modification known in the art but no double patenting rejection is presented). There is no enabling disclosure with respect to how to make or use R4a wherein A2 is N and similarly, there is no enabling disclosure for R4b wherein A1 is CH.
Disclosed Scheme 7 relies on the chemistry (see XII in Scheme 6) using compounds of now deleted claim 15, which excluded the prior art compounds. The only instantly exemplified examples are based on these excluded compounds used in the instant Scheme 7 as intermediates and thus relates to the significance of the combination of the variables as to the ‘how to make’ requirement. There is no enabling disclosure with respect to how to make or use R4a wherein A2 is N and similarly, there is no enabling disclosure for R4b wherein A1 is CH. The specification is silent with regards to intermediates for as in claim 16 to make such as compounds. According to the U.S. Court of Customs and Patent Appeals in In re Argoudelis , De Boer, Eble, and Herr 168 USPQ 99 at 101, "[o]rdinarily no problem in this regard arises since the method of preparing almost all starting materials can be set forth in writing if the materials are not already known and available to the workers in the art, and when this is done the specification is enabling to the public". In re Argoudelis , De Boer, Eble, and Herr 168 USPQ 99 at 104, "it is essential that there be no question that, at the time an application for patent is filed, (emphasis in original) the invention claimed therein is fully capable of being reduced to practice (i.e., that no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remain in order to obtain an operative, useful embodiment)." . Organic chemistry is unpredictable and capricious as taught by Dorwald F. A. Side Reactions in Organic Synthesis, 2005, Wiley: VCH, Weinheim pg. IX of Preface pg. 1-15 which teaches that ” …as will be shown throughout this book, the outcome of organic reactions is highly dependent on all structural features of a given starting material, and unexpected products may readily be formed. [8]……...Even the most experienced chemist will not be able to foresee all potential pitfalls of a synthesis, especially so if multifunctional, structurally complex intermediates must be prepared.…..”
As to the use prong of the enablement requirement 35 USC § 112:
The data relating to potential use of the claimed compounds are found at pages 147-150. Many of the compounds tested are allegedly active as per Example B1; many of these compounds not in Examples B9 and B10 for different insect as being active. These lend support to the art-acknowledged concept that biological properties are unpredictable and ultimately tide to the chemical structure. See “Role of the Development Scientist in Compound Lead Selection and Optimization” by Venkatesh, J. Pharm. Sci. 89, 145-54 (2000) (p. 146, left column). Also see for example, according to Zhao, J. Agric. Food Chem. 2020, 68, 11282−11289, titled “Synthesis, Insecticidal Activities, and Structure−Activity Relationship of Phenylpyrazole Derivatives Containing a Fluoro Substituted Benzene Moiety”, substituents do make major difference in insecticidal property. See color coordination in Figures of Zhao and Table 1 and Table 3 at page 11284 and 11285. There is no structural guidance, such as structure-activity-relationships (SAR), ‘pharmacophore’ definition disclosed in the specification that would enable one of skill in the art to identify predictably embodiments of the instant formula (with combination all the variables as recited) without undue experimentation.
The claims are not commensurate in scope with the breadth of enablement in as much as the disclosure is limited to few combination of the invariable groups in the claimed formula. Sufficient examples are lacking. There is a substantial gap between what is taught in the specification and what is being claimed. For these reasons, one skilled in the art would be faced with undue amount of research. The specification lacks disclosure sufficient to make and use the invention commensurate with the scope of the claims.
MPEP 2164.01(a) states, “A conclusion of Iack 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. ln re Wright, 999 F.2d 1557,1562, 27 USPQ 2d 1510, 1513 (Fed. Cir. 1993).'' That conclusion is clearly justified here. Thus, undue experimentation would be required to make and use Applicants' invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Claim 19-23 are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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