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 claims benefit of the provisional application 63583847 09/19/2023.
2. Claims 1-2, 85, 7-8, 23, 28, 31, 33, 38, 42-45, 47, 51, 53-54, 57 and 61 are pending int he 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 61 is rejected under 35 U.S.C. 112(a) or 112 first paragraph
(pre-AIA ), because the specification does not reasonably provide enablement of treating or preventing “disease” without limitation (i.e., no named disease), see claim 61. 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 28 and 52 is drawn to intent methods of use for treating or preventing “disease” 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 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 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 or preventing “disease” without limitation (i.e., no named disease). As such, the specification fails to enable the skilled artisan to use the instant compound for treating “disease” without limitation (i.e., no named disease).
In addition, there is no established correlation between in vitro or in vivo activity and accomplishing treating or preventing “disease” 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 for treating or preventing “disease” 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 or preventing “disease” without limitation (i.e., no named disease). The treating “disease” 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 9-10 of the
specification. There are no in vitro or in vivo working examples present for
treating or preventing “disease” 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 treating or preventing “disease” 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 “disease” without limitation (i.e., no named disease) would be benefited (i.e., treated or prevented ) by the administration of the instant invention and would furthermore then have to determine which of the claimed methods of use would provide treating “disease” 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 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 deletion the limitation “preventing” and incorporation of named diseases or disorders supported by the specification into claim 61 would obviate the rejection.
4. 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 51 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 51 recites the limitation “Table 1A, Table 1B and Table 2” without a chemical name is ambiguous and indefinite. It is unclear what the scope of the limitation “Table 1A, Table 1B and 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 1A, Table 1B and Table 2 with a chemical name or structure into claim51 respectively would obviate the rejection.
5. 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
6. 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 1 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Iino et al.
CAS: CAS: 121:300668, 1994.
Applicants claim a compound of formula (I), i.e.,
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, wherein X is -CH(R2)- or -NH-, R1-R2 and R4 is hydrogen or alkyl, R3 is carboxycycle, aryl or heteroaryl, and R5a and R5b is hydrogen, see claim 1.
Iino et al. ‘668 discloses ten compounds, see RN: 158982-27-5,
158982-29-7, 158982-30-0, 158982-31-1, 158982-32-2, 158982-33-3,
158982-34-4, 158982-35-5, 158982-36-6, and 158982-37-7. They clearly anticipate the instant compounds of formula (I), wherein X is -CH(R2)- or -NH-, R1-R2 and R4 is hydrogen or alkyl, R3 is carboxycycle, aryl or heteroaryl, and R5a and R5b is hydrogen.
Claim Rejections - 35 USC § 103
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2, 85, 7-8, 23, 28, 31, 33, 38, 42-45, 47, 53-54, 57 and 61 are rejected under 35 U.S.C. 103(a) as being obvious over Iino et al. US 5,463,078.
Applicants claim a compound/composition of formula (I), i.e.,
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, wherein X is -CH(R2)- or -NH-, R1-R2 and R4 is hydrogen or alkyl, R3 is carboxycycle, aryl or heteroaryl, and R5a and R5b is hydrogen, see claim 1. Dependent claims 2, 85, 7-8, 23, 28, 31, 33, 38, 42-45, 47, 53-54, 57 and 61 further limit the scope of compounds, i.e., specific variables, and methods of use for decreasing protein synthesis and treating diseases.
Determination of the scope and content of the prior art (MPEP §2141.01)
Iino et al. ‘078 disclose a compound/composition of formula (II), i.e.,
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, wherein X is -CONR1R2 or -CH2R3 and R1-R3
are hydrogen, alkyl or phenyl optional substituted with halogen, hydroxyl, carboxy
or alkoxy, and R is hydrogen. Iino et al. ‘078 compounds are used for treating
disease including infection or cancer (i.e., leukemia), see claims 1, 5, 7 and 8-15 in columns 16-18.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Iino et al. ‘078 is that the instant claims are embraced within the scope of Iino et al. ‘078.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-2, 85, 7-8, 23, 28, 31, 33, 38, 42-45, 47, 53-54, 57 and 61 prima facie obvious because one would be motivated to employ the compounds/compositions and methods of use of Iino et al. ‘078 to obtain instant invention.
The motivation to make the claimed compounds/compositions and methods of use derived from the known methods of use of Iino et al. ‘078 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.
Primary Examiner, Art Unit 1691
August 25, 2026
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