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. This application is a 371 of PCT/CN2022/092097 09/28/2023, which claims benefit of the foreign application: CHINA CN202210284445.1 with a filing date 03/22/2022.
2. Claims 1-2, 5-6, 8, 10-11, 14, 17, 19 and 21-28 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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 24-25 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 “ lipid-lowing drug” without limitation (i.e., no named
compounds). 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 a compound “lipid-lowing drug”, wherein the “ lipid-lowing drug” is without limitation (i.e., no named compounds), see claims 24-25.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Lafrance et al. European Journal of Organic Chemistry (2007), (5), 811-825. It discloses a compound of formula (I).
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 “lipid-lowing drug” on pages 24-26 of the specification. There are no working examples present for “lipid-lowing drug” without limitation (i.e., no named compounds) found in the specification.
The breadth of the claims
The breadth of the claims is the instant “lipid-lowing drug” without limitation (i.e., no named compounds).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine what “lipid-lowing drug” without limitation (i.e., no named compounds) would be prepared by the instant 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 “lipid-lowing drug” are prepared. Thus, the specification fails to provide sufficient support of the broad scope of the compounds of the instant claims for the “lipid-lowing drug”.
As a result necessitating one of skill to perform an exhaustive search for which “lipid-lowing drug”, 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 “lipid-lowing drug” 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 “lipid-lowing drug” supported by specification into claim 24 would obviate the rejection.
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
5. 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 21 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Lafrance et al., European Journal of Organic Chemistry, 2007, 5: 811-825.
Applicant claim a compound of formula (VI-1), i.e.,
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174
244
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, wherein R1 is non-methyl aliphatic hydrocarbyl, acyl, or aromatic hydrocarbyl, see claim 21.
Lafrance et al. ‘169 discloses two compounds, see compound No. 5 and 6 on page 814. They clearly anticipate the instant compounds of formula (VI-1), wherein R1 is non-methyl aliphatic hydrocarbyl, acyl, or aromatic hydrocarbyl.
6. Claims 1-2, 5-6, 8, 10-11, 14, 17, 19 and 28 are neither anticipated nor rendered obvious over the record, and therefore are allowable.
Claim Objections
7. Claims 22-23 and 26-27 are objected to as being dependent on rejected claim 21.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
August 25, 2026
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