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/EP2023/000022 03/23/2023, which claims benefit of the foreign application: EPO EP22000080.6 03/25/2022.
2. Claims 16-30 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 16-30 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 “fumaric acid ester” 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 composition comprising “fumaric acid ester” without limitation (i.e., no named compounds), see claim 16 and 29.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Brysch et al. US 2019/0358227 A1, it discloses a
compound 5-amino-2,3-dihydro-1,4-phthalazinedione combined with dimethyl fumarate,
see column 16.
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 “fumaric acid ester” on pages 23-28 of the specification. There is no data present in the instant specification for the “fumaric acid ester” 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 “fumaric acid ester” 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 “fumaric acid ester” without limitation. There is no guidance or working examples present for constitutional any “fumaric acid ester” without limitation for the instant invention. Incorporation of the limitation of “fumaric acid ester” supported by specification (i.e., claim 21) into claim 16 and 29 respectively would overcome this rejection.
3.2 Claims 18-19, 23 and 30 are rejected under 35 U.S.C. 112(a) or 112 first paragraph (pre-AIA ), because the specification does not reasonably provide enablement of “pophylaxis (i.e., prevention) and “treatment” without limitation (i.e., no named disease), see claim 30. 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 “pophylaxis (i.e., prevention) abd “treatment” without limitation (i.e., no named disease), see claims 18-19, 23 and 30.
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 treatment 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 “treatment” without limitation (i.e., no named disease). As such, the specification fails to enable the skilled artisan to use the instant compound for prophylaxis or treating “treatment” without limitation (i.e., no named disease). In addition, there is no established correlation between in vitro or in vivo activity and accomplishing prophylaxis or “treatment” 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 prophylaxis or “treatment” 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 prophylaxis or “treatment” without limitation (i.e., no named disease). The “treatment” 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 treated disease, see pages 9-12 of the
specification. There are no in vitro or in vivo working examples present for
“treatment” 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 “treatment” 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 prophylaxis or “treatment” without limitation (i.e., no named treatment) 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 prophylaxis or “treatment” 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 treatment 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 treatment, 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 of “prophylaxis” from claims 18-19and 23 and incorporation of named diseases (i.e., claims 18) supported by the specification into claim 30 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).
Claims 16-30 are rejected under 35 U.S.C. 103(a) as being obvious over
Brysch et al. US 2019/0358227 A1.
Applicants claim a pharmaceutical combination of 5-amino-2,3-dihydro-1,4- phthalazinedione or one of its pharmaceutically acceptable salts, hydrates or solvates and at least one fumaric acid ester or a pharmaceutically acceptable salt thereof, see claim 16. Dependent claims 17-27 further limit compositions, i.e., specific fumaric acid ester compound, specific treated diseases, formulation, dose and administration strategy.
Determination of the scope and content of the prior art (MPEP §2141.01)
Brysch et al. ‘227 discloses a compound/composition comprising 5-amino-2,3-dihydro-1,4- phthalazinedione or one of its pharmaceutically acceptable salts, and an immunostimulatory agent selected from fumaric acid dimethyl esters, see section [0024] in column 3, section [0107] in column 10, and claims 1 and 6 in column 16. Brysch et al. ‘227 compound/composition is used for treating multiple sclerosis.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Brysch et al. ‘227 is that the instant claims are embraced within the scope of Brysch et al. ‘227.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 16-30 prima facie obvious because one would be motivated to employ compositions and methods of use of Brysch et al. ‘227 to obtain instant invention.
The motivation to make the claimed compositions derived from the known compositions and methods of use of Brysch et al. ‘227 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. 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).
Claim 16 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 and 6 of Brysch et al. US 11,007,192. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a pharmaceutical combination of 5-amino-2,3-dihydro-1,4- phthalazinedione or one of its pharmaceutically acceptable salts, hydrates or solvates and at least one fumaric acid ester or a pharmaceutically acceptable salt thereof, see claim 16.
Brysch et al. ‘192 claims a method of treating an individual having a chronic progressive form of multiple sclerosis by administering to such individual a pharmaceutically effective amount of 5-amino-2,3-dihydro-1,4-phthalazinedione, or one of its solvates, hydrates, crystalline polymorphs, tautomers, isotopically enriched forms, or one of their pharmaceutically acceptable salts, and dimethyl fumarate, see claims 1 and 6. Brysch et al. ‘192 disclose a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione, or one of its solvates, hydrates, crystalline polymorphs, tautomers and immunostimulatory selected from dimethyl fumarate, see columns 6-7 and 19.
The difference between instant claims and Brysch et al. ‘192 is that the instant claims are embraced within the scope of Brysch et al. ‘192.
One having ordinary skill in the art would find the claim 16 prima facie obvious because one would be motivated to employ the compounds/compositions and methods of use of Brysch et al. ‘192 to obtain instant invention.
The motivation to make the claimed compounds/compositions and methods of use derived from the known compounds/compositions and methods of use of Brysch et
al. ‘192 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
August 10, 2026
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