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 Claims
1. This application is a 371 of PCT/CN2022/077112 02/21/2022, which claims benefit of the foreign applications CHINA 202110204744.5 02/23/2021, CHINA 202110523923.5 05/13/2021, and CHINA 202210125821.2 02/10/2022
2. Claims 1-17 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.
Claims 16-17 are rejected under 35 U.S.C. 112(a) or 112 first paragraph (pre-AIA ), because the specification does not reasonably provide enablement of “a disease related to GnRH receptor” without limitation (i.e., no named disease), see claim 16. 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 these claims.
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 of claims 16-17 is drawn to intent methods of use for treating “a disease related to GnRH receptor” without limitation (i.e., no named disease).
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in
vitro and in vivo to determine which compound iloperidone exhibit the desired pharmacological activities (i.e., what compound iloperidone can treat which specific diseases by what mechanism). There is no absolute predictability even in view of the seemingly high Ievel of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face. The prior art is Miwa’s US 2019/ 0055261A1, it discloses a similar compound of the formula (II)for treating prostate cancer, see columns 2 and 8.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each
embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833,166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Applicants are claiming intent methods of use using the instant compound for
treating “a disease related to GnRH receptor” without limitation (i.e., no named disease). As such, the specification fails to enable the skilled artisan to use the instant compound for treating “a disease related to GnRH receptor” without limitation (i.e., no named disease). In addition, there is no established correlation between in vitro or in vivo activity and accomplishing “a disease related to GnRH receptor” without limitation (i.e., no named disease), and those skilled in the art would not accept allegations in the instant specification to be reliable predictors of success, and those skilled in the art would not be able to use the instant compounds since there is no description of an actual method “a disease related to GnRH receptor” without limitation (i.e., no named disease) in a host is treated.
Hence, one of skill in the art is unable to fully predict possible results from the administration of the instant compound due to the unpredictability of treating “a disease related to GnRH receptor” without limitation (i.e., no named disease). The “a disease related to GnRH receptor” without limitation (i.e., no named disease) is known to have many obstacles that would prevent one of ordinary skill in the art from accepting treating regimen on its face.
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 description of treating a number of disorders or diseases, see pages 1-3 of the
specification. There are no in vitro or in vivo working examples present for
“a disease related to GnRH receptor” without limitation (i.e., no named disease) by the
administration of the instant invention.
The breadth of the claims
The breadth of the claims is methods of use of the instant compounds for treating “a disease related to GnRH receptor” without limitation (i.e., no named
disease).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine how “a disease related to GnRH receptor” without limitation (i.e., no named disease) would be benefited (i.e., treated) by the administration of the instant invention and would furthermore then have to determine which of the claimed methods of use would provide “a disease related to GnRH receptor” without limitation (i.e., no named disease), 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 physiological activity by 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''.
in vitro and in vivo screening to determine which methods of use exhibit the desired pharmacological activity and which would benefit from this activity. Thus, the specification fails to provide sufficient support of the broad use of the pharmaceutical composition of the instant claims for the various diseases or disorders.
As a result necessitating one of skill to perform an exhaustive search for which metabolic-related disease s can be treated by what pharmaceutical compound 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 methods. 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 compound regards to the treatment of the many diseases, 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 named disease supported by the specification (i.e., claim 17) into claim 16 would obviate the rejection.
4. Claims 1-15 are neither anticipated nor rendered obvious over the record, and therefore are allowable.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 01, 2025