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 CON of PCT/US2022/040818 08/18/2022, which claims benefit of PRO 63/313,000 02/23/2022, PRO 63/295,007 12/30/2021, PRO 63/286,022 12/04/2021, and PRO 63/234,829 08/19/2021.
2. Amendment of claim 43, and cancelation of claims 1-42, 50-51 and 53-57 in the amendment filed on 5/4/2026 are acknowledged. Claims 43-49 and 52 are pending in the application.
Responses to Election/Restriction
3. Applicant’s election without traverse of Group III claims 43-57 (now are 43-49 and 52), in the reply filed on April 29, 2026 is acknowledged.
Claims 43-49 and 52 are pending in the application.
The scope of the invention of the elected subject matter is as follows.
Claims 43-49 and 52, are drawn to methods of use for treating cancer using a compound (2) thereof, and are prosecuted in the case.
The requirement is still deemed proper and therefore is made FINAL.
Claim Rejections - 35 USC § 112
4. 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 43-49 and 52 are rejected under 35 U.S.C. 112, first paragraph (pre-AIA ), because the specification does not reasonably provide enablement of treating” cancer” without limitation (i.e., no named cancer), see claim 43. 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 43-49 and 52 is drawn to intent methods of use for treating or preventing “cancer” without limitation (i.e., no named cancer).
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 Nomura et al. CAS: 173:252877, 2020, it discloses a similar compound for treating hypertenactivating autophagy.
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 for treating “cancer” without limitation (i.e., no named cancer). As such, the specification fails to enable the skilled artisan to treat “cancer” without limitation (i.e., no named cancer). In addition, there is no established correlation between in vitro or in vivo activity and treating “cancer” without limitation (i.e., no named cancer), 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 compound since there is no description of an actual method for treating “cancer” without limitation (i.e., no named cancer) 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 “cancer” without limitation (i.e., no named cancer). The “cancer” without limitation (i.e., no named cancer) is known to have many obstacles that would prevent one of ordinary skill in the art from accepting treating or preventing 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 cancers, see pages 4-7 of the specification. There are no in vitro or in vivo working examples present for treating “cancer” without limitation (i.e., no named cancer) 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 “cancer” without limitation (i.e., no named cancer).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine how “cancer” without limitation (i.e., no named cancer) 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 for treating “cancer” without limitation (i.e., no named cancer), 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 cancers or cancer supported by the specification (i.e., claims 45-46) into claim 43 would obviate the rejection.
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 52 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 52, line 2, recites the limitation “Table 2” without a chemical name is ambiguous and indefinite. It is unclear what the scope of the limitation “Table 2” is. Claims must stand alone to define invention, and incorporation into claims by express reference to specification is not permitted, are properly rejected under 35 U.S.C. 112 (b), see Ex parte Fressola, No. 93-0828. Incorporation of the limitation “Table 2” with a chemical name or structure into claim 52 respectively would obviate the rejection.
Claim Objections
6. Claim 52 is objected to as having a typographic error: a period is missing at the end of claim. Correction is required.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 15, 2026
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