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 .
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 1-10 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.
Claim 1 is directed to an alicyclic alcohol represented by General Formula (1). Claim 7 recites a fragrance composition comprising the alicyclic alcohol of claim 1. Claim 8 is directed to a method of obtaining an alicyclic alcohol represented by General Formula (6) by hydrogenating an aromatic aldehyde represented by General Formula (5). Claim 9 depends from claim 8 and further recites obtaining an alicyclic alcohol represented by General Formula (1) by hydrogenating an aromatic aldehyde represented by General Formula (7).
The disclosure does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the compounds encompassed by General Formulae (1) and (6), including embodiments in which two substituents are introduced on the same carbon atom of the cyclohexyl ring structure. The specification describes the invention generally as alicyclic alcohols useful as fragrance materials and identifies preferred compounds represented by Formulae (3) and (4). The working examples prepare and characterize the specific positional isomers corresponding to Formulae (3) and (4), and the figures and analytical data are directed to those compounds. The disclosure does not provide a representative number of species, structural identification data, synthesis examples, or other descriptive support showing possession of the broader compounds encompassed by General Formulae (1) and (6), including same-ring-carbon substitution embodiments.
The disclosure further teaches that the alicyclic alcohols are produced by hydrogenating dialkylbenzaldehyde starting materials represented by General Formulae (5) and (7). However, the specification does not describe how the disclosed hydrogenation route would provide the same-carbon-substituted cyclohexyl embodiments falling within the broad formulae, nor does it provide data showing that such embodiments were actually made, isolated, or characterized. The specification therefore supports the specifically disclosed Formula (3) and Formula (4) compounds and compositions containing them, but does not provide adequate written description for the full breadth of claims 1, 7, 8, and 9.
Claims 1-10 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) 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.
The specification does not enable one of ordinary skill in the art to make and use the full scope of the compounds and methods encompassed by General Formulae (1), (5), (6), and (7) without undue experimentation. The issue is not whether the specification enables the specific Formula (3) and Formula (4) compounds shown in the examples. Rather, the issue is whether the specification enables the full scope of the broader formula claims, including compounds in which two substituents are located on the same carbon atom of the cyclohexyl ring.
The Wands factors support a conclusion of nonenablement.
First, the quantity of experimentation necessary would be substantial because the skilled artisan would have to determine whether and how the disclosed hydrogenation of dialkylbenzaldehyde starting materials could produce the full range of claimed cyclohexyl substitution patterns, including same-carbon-substituted embodiments not shown in the examples.
Second, the amount of direction or guidance is limited because the specification provides general hydrogenation conditions and examples for the Formula (3) and Formula (4) compounds, but does not provide a synthesis route, reaction conditions, separation procedure, or analytical confirmation for the unsupported embodiments within the broader formulae.
Third, the working examples are limited to the specific disclosed positional isomers and mixtures thereof; there are no working examples for the same-carbon-substituted embodiments within General Formulae (1) and (6).
Fourth, the nature of the invention is chemical and structural, and small changes in substitution position on a cyclohexyl ring can materially affect the compound obtained, the feasibility of synthesis, isomer distribution, isolation, and fragrance properties.
Fifth, the state of the prior art may show that catalytic hydrogenation of substituted aromatic aldehydes was generally known, but that general knowledge does not cure the absence of guidance for obtaining the full scope of the claimed substitution patterns from the disclosed starting materials.
Sixth, the level of ordinary skill in the art would not eliminate the need for undue experimentation because the claims encompass structural embodiments that are not specifically exemplified, not analytically characterized, and not shown to be obtainable as main products by the disclosed process.
Seventh, although catalytic hydrogenation itself may be predictable in general, the particular product distribution and stereochemical/positional outcomes for the full genus of claimed substituted cyclohexyl alcohols are not adequately predicted or taught by the specification.
Eighth, the claims are broad relative to the disclosure because the claims encompass General Formulae (1) and (6), whereas the working disclosure is limited to Formulae (3) and (4) and compositions containing those two species.
Accordingly, the specification does not provide sufficient written description or enablement commensurate in scope with claims 1, 7, 8, and 9. The rejection could be overcome by amending the claims to correspond to the specifically disclosed and enabled Formula (3) and/or Formula (4) compounds, and by conforming the method and fragrance composition claims to the supported species or supported compositions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -6:30 pm).
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/DEBORAH D CARR/Primary Examiner, Art Unit 1691