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 CIP of 17235382 04/20/2021 PAT 12023341, which claims benefit of PRO 63/012,596 04/20/2020.
2. Claims 1-20 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 16-20 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 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 16-20 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 Bierbach et al. US 12,023,341, it discloses a similar compound for treating lung cancer.
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 supported by the specification (i.e., claim 20) into claim 16 would obviate the rejection.
Double Patenting
4. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-16 and 20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1, 8 and18 of Bierbach et al. US 12,023,341, over claim 1 of Bierbach et al. US 11,591,357, and over claim 1 of Bierbach et al. US 9,765,103 respectivle. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a compound/composition of formula (I), i.e.,
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, see claim 1. Dependent claims 2-15 further limit the scope of compounds, i.e., specific variables and compounds in claims 2-15.
Applicants claim a method of use for treating cancer in a subject, comprising:
determine expression of MATE1 in cancer tissue from the subject,
administer to the subject of a therapeutically effective amount of a compound of Formula (I’),
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, and the cancer is selected from non-small lung cell cancers, renal cell carcinoma or melanoma, see claim 16 and 20.
Bierbach et al. ‘341 claims a compound/composition of formula (I), i.e.,
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, and used for treating non-small lung cancer, see claims 1, 8 and 18 in columns 83-97.
Bierbach et al. ‘357 claims a compound of formula (I), i.e.,
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, see claim 1 in column 51.
Bierbach et al. ‘103 claims a compound of formula (I), i.e.,
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516
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, see claim 1 in column 38.
The difference between instant claims and Bierbach et al. ‘341, 357 and ‘103 is that the instant claims are embraced within the scope of Bierbach et al. ‘341, 357 and ‘103.
One having ordinary skill in the art would find the claims 1-16 and 20 prima facie obvious because one would be motivated to employ the compounds/compositions and methods of use of Bierbach et al. ‘341, 357 and ‘103 to obtain instant invention.
The motivation to make the claimed compositions derived from the known compound/compositions and methods of use of Bierbach et al. ‘341, 357 and ‘103 would possess similar activity to that which is claimed in the reference.
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
July 13, 2026
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