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
Priority and Status of the Claims
1. Claims 1-19 are pending in the application.
Claim Rejections - 35 USC § 112
2. 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.
Claim 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112,
first paragraph (pre-AIA ), because the specification does not reasonably provide
enablement of the instant “butanolide” and “aldehyde” without limitation (i.e., no named
compounds or formula). 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 the claim.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is process of making butanolide, wherein “butanolide” and “aldehyde” is without limitation (i.e., no named compounds or formula), see claims 1-19.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Bohm et al. US 5,336,809. Bohm et al. ‘809 discloses
process of making a butanolide compound of formula (IV), see column 8.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is the exemplified a number of butanolide compounds, see pages 4-7 of the specification. There are no working examples present for “butanolide” and “aldehyde” without limitation (i.e., no named compounds or formula) found in the specification.
The breadth of the claims
The breadth of the claims is the instant “butanolide” and “aldehyde” without limitation (i.e., no named compounds or formula).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine what “butanolide” and “aldehyde” without limitation (i.e., no named compounds or formula) would be prepared by the instant processes in claim 1, if any.
The Ievel of the skill in the art
The Ievel of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physical characteristics to determine which “butanolide” are prepared. Thus, the specification fails to provide sufficient support of the broad scope of the compounds of the instant claims for the “butanolide”.
As a result necessitating one of skill to perform an exhaustive search for which “butanolide”, can be prepared of the instant claims in order to practice the claimed invention. 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 instantly claimed compounds. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compositions/compounds in regards to the “butanolide” without limitation, 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.
Genentech lnc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “ a
patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion'' and ''patent 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''.
Therefore, in view of the Wands factors and ln re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation, with no assurance of success. This rejection can be overcome by incorporation of the “butanolide” and “aldehyde” (i.e., formula (I) in claim 5 and the formula of aldehyde in claim 19) supported by specification into claim 1 would obviate the rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 29, 2026
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