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/US2022/049171 11/07/2022, which claims benefit of the provisional application: 63290589 12/16/2021, and 63277122 11/08/2021.
2. Claims 1-22 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.
3.1 Claims 1-22 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 “Cb1-b inhibitor” 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 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 is a method of use using “Cb1-b inhibitor” without limitation (i.e., no named compounds), see claims 1 and 5.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Huestis et al. US 2023/0212153A1, it discloses a compound
of formula (I) as Cb1-B inhibitors for treating cancer, see columns 265-266.
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 a number of “Cb1-b inhibitor” on pages 22-23 of the specification. There is no data present in the instant specification for the “Cb1-b inhibitor” without limitation (i.e., no named compound).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “Cb1-b inhibitor” is without limitation (i.e., no named compound).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “Cb1-b inhibitor” without limitation. There is no guidance or working examples present for constitutional any “Cb1-b inhibitor” without limitation for the instant invention. Incorporation of the limitation of “Cb1-b inhibitor” supported by specification (i.e., claim 18) into claim 1 would overcome this rejection.
3.2 Claims 1-22 are rejected under 35 U.S.C. 112(a) or 112 first paragraph (pre-AIA ), because the specification does not reasonably provide enablement of “disease or condition” without limitation (i.e., no named disease), see claim 1. 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 is drawn to intent methods of use for treating “disease or condition” without limitation (i.e., no named disease), see claims 1 and 5.
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 prior art is Huestis et al. US 2023/0212153A1, it discloses a compound of formula (I) as Cb1-B inhibitors for treating cancer, see columns 265-266.
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 “disease or condition” 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 or condition” without limitation (i.e., no named disease). In addition, there is no established correlation between in vitro or in vivo activity and accomplishing “disease or condition” 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 “disease or condition” 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 “disease or condition” without limitation (i.e., no named disease). The “disease or condition” 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 1-6 of the
specification. There are no in vitro or in vivo working examples present for
“disease or condition” 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 “disease or condition” 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 or condition” 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 “disease or condition” 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 (i.e., claim 20) supported by the specification into claim 1 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 § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 non-obviousness.
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).
Claim 1, 4-5, 8, 18 and 22 are rejected under 35 U.S.C. 103(a) as being
obvious over Huestis et al. US 2023/0212153 A1 and Vicari et al. US 2009/0087440 A1.
It is noted that Huestis et al. ‘153 is a 102(a)(2) reference.
Applicants claim a method of treating or preventing a disease or condition in a subject in need thereof, comprising administering to the subject:(a) an effective amount of a Cb1-b inhibitor compound; and(b) one or more immunostimulatory sequences, wherein the Cb1-b inhibitor compound is the compounds of formula (I), the immunostimulatory sequences is TLR9 agonist and the disease is cancer, see claims 1, 4, 18 and 22.
Applicants claim a method of treating or preventing a disease or condition in a subject in need thereof, comprising administering to the subject:(a) an effective amount of a Cb1-b inhibitor compound; and(b) one or more TLR agonists, see claim 5, 18 and 22.
Determination of the scope and content of the prior art (MPEP §2141.01)
Huestis et al. ‘153 discloses a Cb1-B agonist of compounds of formula (I), i.e.,
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134
194
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Greyscale
, wherein the ring Q is heteroaryl including 1,2,4-
triazole. A number of Cb1-B agonists have been exemplified in Table 1 in columns 26-
34. Huestis et al. ‘153 compounds are used for treating cancer, see columns 264-
266.
Vicari et al. ‘440 discloses TRL agonists including TLR9 are used for treating
cancer, see columns 11-12.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Huestis et al. ‘153 and Vicari et al. ‘440 is that the instant claims are embraced within the scope of Huestis et al. ‘153 and Vicari et al. ‘440. It is noted that the instant claims are silent on the scope of Cbl1-b inhibitor compound and immunostimulatory sequences in claims 1 and 5, while Huestis et al. ‘153 represents a compound of formula (I) for Cb1-b inhibitor, and Vicari et al. ‘440 represents TLR9 as TRL agonist.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1, 4-5, 8, 18 and 22 prima facie obvious because one would be motivated to employ the methods of use of Huestis et al. ‘153 and Vicari et al. ‘440 to obtain instant invention.
It is prima facie obvious to combine teachings from Huestis et al. ‘153 and Vicari et
al. ‘440 which provide using a for Cb1-b inhibitor and TLR agonist each of which is taught
by the prior art to be useful for the same purpose, i.e., for treating cancer. Therefore idea
of combining them flows logically from theirs having been individually taught in the prior
art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), see
MPEP 2144.06.
The motivation to make the claimed methods of use derived from the known methods of use of Huestis et al. ‘153 and Vicari et al. ‘440 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
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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
June 01, 2026
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