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 63633912 04/15/2024.
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.
3.1 Claims 1-20 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 “phosphodiesterase 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 “phosphodiesterase inhibitor” without limitation (i.e., no named compounds), see claim 1 and 15.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Hendrix et al. US 7,202,243, it discloses a
similar compound of formula (I) as a phosphodiesterase (PDE) inhibitor for treating
Parkinson’s disease, see columns 55-58.
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 “phosphodiesterase inhibitor” on pages 9-10 of the specification. There is no data present in the instant specification for the “phosphodiesterase 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 “phosphodiesterase 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 “phosphodiesterase inhibitor” without limitation. There is no guidance or working examples present for constitutional any “phosphodiesterase inhibitor” without limitation for the instant invention. Incorporation of the limitation of “phosphodiesterase inhibitor” supported by specification (i.e., claim 3 or 17) into claim 1 and 15 respectively would overcome this rejection.
3.2 Claims 1-14 and 19-20 are rejected under 35 U.S.C. 112(a) or 112 first paragraph (pre-AIA ), because the specification does not reasonably provide enablement of “neurodegenerative disease” 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 “neurodegenerative disease” without limitation (i.e., no named neurodegenerative disease), see claim 1.
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 neurodegenerative disease 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 Hendrix et al. US 7,202,243, it discloses a compound of formula (I) for treating Parkinson’s disease, see columns 55-58.
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 “neurodegenerative disease” without limitation (i.e., no named neurodegenerative disease). As such, the specification fails to enable the skilled artisan to use the instant compound for treating “neurodegenerative disease” without limitation (i.e., no named neurodegenerative disease). In addition, there is no established correlation between in vitro or in vivo activity and accomplishing “neurodegenerative disease” without limitation (i.e., no named neurodegenerative 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 “neurodegenerative disease” without limitation (i.e., no neurodegenerative 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 “neurodegenerative disease” without limitation (i.e., no named neurodegenerative disease). The “neurodegenerative disease” without limitation (i.e., no named neurodegenerative 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 neurodegenerative disease, see pages 5-9 of the
specification. There are no in vitro or in vivo working examples present for
“neurodegenerative disease” without limitation (i.e., no named neurodegenerative 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 “neurodegenerative disease” without limitation (i.e., no named
neurodegenerative 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 “neurodegenerative disease” without limitation (i.e., no named neurodegenerative 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 “neurodegenerative disease” without limitation (i.e., no named neurodegenerative 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 neurodegenerative disease 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 neurodegenerative disease, 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 neurodegenerative disease (i.e., claim 19 supported by the specification into claim 1 respectively 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 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 1-20 are rejected under 35 U.S.C. 103(a) as being obvious over Macceechini’s US 2012/0225922 A1 and Hendrix et al. US 7,202,243.
Applicants claim a method for treating a neurodegenerative disease comprising co-administration to a human in need thereof:
(1) am amount of a compound selected from the group consisting of Formula (I),
Formula (II), and Formula (III),
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, wherein X and Y are independently O, S, Or NR5, and R1-
R6 are hydrogen, alkyl, aryl or heteroaryl, and (2) an amount of a phosphodiesterase (PDE) inhibitor, see claim 1. Dependent claims 2-14 and 19-20 further limit the scope of methods, i.e., specific phosphodiesterase (PDE) inhibitor, administration strategy, and specific neurodegenerative diseases.
Applicants claim a pharmaceutical composition, comprising a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III),
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, wherein X and Y are independently O, S, Or NR5, and R1-
R6 are hydrogen, alkyl, aryl or heteroaryl, and (2) an amount of a phosphodiesterase (PDE) inhibitor, see claim 15. Dependent claims 16-18 further limit the scope of methods, i.e., specific phosphodiesterase (PDE) inhibitor, administration strategy.
Determination of the scope and content of the prior art (MPEP §2141.01)
Macceechini’s ‘922 discloses a compound/composition comprising
A compound of formula (I) (i.e., Posiphen), i.e.,
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. Macceechini’s ‘922 compound/composition is used for treating dementia is selected from the group consisting of Parkinson's disease, Huntington's disease, Prion's disease, Amyloid Lateral Sclerosis and a tauopathy, see columns 2-3.
Hendrix et al. ‘243 discloses compound/composition comprising
a phosphodiesterase inhibitor (PDE) compound of formula (I), i.e.,
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226
326
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. Hendrix et al. ‘243 compound/composition is used for treating Parkinson’s disease, see columns 2 and 55-58.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Macceechini’s ‘922 and Hendrix et al. ‘243 is that the instant claims are silent on the scope of phosphodiesterase inhibitor.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-20 prima facie obvious because one would be motivated to employ the composition and methods of use of Macceechini’s ‘922 and Hendrix et al. ‘243 to obtain instant invention.
It is prima facie obvious by the teachings taught by the prior art Macceechini’s ‘922 and Hendrix et al. ‘243 to be useful for the purpose, i.e., treating neurodegenerative diseases including Parkinson’s disease in a patient. The idea of combining them flows logically from their 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. Thus Yuen et al. ‘185, Alireza Latifi and Raymond render the instant invention.
The motivation to make the claimed methods of use derived from the known compositions and methods of use of Macceechini’s ‘922 and Hendrix et al. ‘243 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 1629
August 25, 2026
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