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/US2023/018236 04/12/2023, which claims benefit of PRO 63/330,680 04/13/2022.
2. Claims 3-11, 22, 28, 30, 43, 45, 55, 70-71, 82-83 and 86 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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 3 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 3, line 2, recite the limitation “comprising” is ambiguous and indefinite. A compound or drug product claim cannot use open-ended language when defining the parameters of the gene or compound, see M.P.E.P. 2111.03. Replacement of the limitation “comprising” with a limitation “is” would overcome this rejection.
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.
4.1 Claims 3-11, 22, 28, 30, 43, 45, 55, 70-71, 82-83 and 86 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 “Triaryl phosphonium cation”, “pleuromutilin analog”, and “fluorophore” without limitation (i.e., no named chemical formula or moiety). 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 composition comprising “Triaryl phosphonium cation” and “pleuromutilin analog” and “fluorophore” without limitation (i.e., no chemical formula and named moiety), see claims 3 and 71.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Brown et al.US 2007/0167495 A1, it discloses a similar
compound of pleuromutilin or its derivative of formulae (IA) and (IB), see columns 13-
14.
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 “Triaryl phosphonium cation” on pages 3-5 of the specification. There is no data present in the instant specification for the “Triaryl phosphonium cation”, “pleuromutilin analog” and “fluorophore” without limitation (i.e., no named chemical formula and moiety).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “Triaryl phosphonium cation”, “pleuromutilin analog” and “fluorophore” are without limitation (i.e., no named chemical formula and moiety).
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 “Triaryl phosphonium cation”, “pleuromutilin analog” and “fluorophore” without limitation. There is no guidance or working examples present for constitutional any “Triaryl phosphonium cation”, “pleuromutilin analog” and “fluorophore” without limitation for the instant invention. Incorporation of the limitation of “Triaryl phosphonium cation” (i.e., formula (I)), “pleuromutilin analog” and “fluorophore” supported by specification into claim 3 and claim 71 respectively would overcome this rejection.
4.2 Claim 86 is 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 disorder” without limitation (i.e., no named disease), see claim 86. 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 “disease or disorder” without limitation (i.e., no named treated disease), see claim 86.
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 disorder” without limitation (i.e., no named treated disease). As such, the specification fails to enable the skilled artisan to use the instant compound for treating “disease or disorder” without limitation (i.e., no named treated disease). In addition, there is no established correlation between in vitro or in vivo activity and accomplishing “disease or disorder” without limitation (i.e., no named treated 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 “disease or disorder” without limitation (i.e., no named treated 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 “disease or disorder” without limitation (i.e., no named treated disease). The treating “disease or disorder” without limitation (i.e., no named treated 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 treated disease see pages 10-13 of the
specification. There are no in vitro or in vivo working examples present for
“disease or disorder” without limitation (i.e., no named treated 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 disorder” without limitation (i.e., no named treated
disease).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine “disease or disorder” without limitation (i.e., no named treated 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 disorder” without limitation (i.e., no named treated 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 treated disease supported by the specification into claim 86 would obviate the rejection.
Claim Objections
5. Claim 3 is objected to because of the following informalities: it is noted that claim 3 is drawn to a composition. Correction is required.
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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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 28, 2026
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