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 the Claims
1. This application is a CON of 17698189 03/18/2022 ABN, which is a CON of 16/876,911 05/18/2020 ABN, which is a CON of 14/774,938 09/11/2015 ABN, which is a 371 of PCT/US2014/IL2014/050261 03/13/2014, which claims benefit of the provisional application 61/779,357 with a filing date 03/13/2013.
2. Claims 1-17 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.
Claim 1-17 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 COMT 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 the claim.
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 methods of use using a composition comprising a catechol-O-methyl transferase (COMT) inhibitor, wherein the catechol-O-methyl transferase (COMT) inhibitor is without limitation (i.e., no named compounds), see claims 1-17.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Yacoby-Zeevi et al. US 2014/0051755 A1. Yacoby-Zeevi et al. ‘755 discloses that COMT inhibitors (i.e., entacapone or tolcapone) increase the half life of administered levodopa and substantially reducing the pulsatility of levodopa plasma levels to avoid low trough levels of plasma levodopa, see section [0035] in column 3.
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 exemplified a number of COMT inhibitors, see page 7 of the specification. There are no working examples present for “catechol-O-methyl transferase (COMT)” without limitation (i.e., no named compounds) found in the specification.
The breadth of the claims
The breadth of the claims is the instant “catechol-O-methyl transferase (COMT)” without limitation (i.e., no named compounds).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine what “catechol-O-methyl transferase (COMT)” without limitation (i.e., no named compounds) would be prepared by the instant claim 1, 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 physical characteristics to determine which “catechol-O-methyl transferase (COMT)” are prepared. Thus, the specification fails to provide sufficient support of the broad scope of the compounds of the instant claims for the “catechol-O-methyl transferase (COMT)”.
As a result necessitating one of skill to perform an exhaustive search for which “catechol-O-methyl transferase (COMT)”, can be prepared 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 compounds. 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 compositions/compounds in regards to the “catechol-O-methyl transferase (COMT)” without limitation, 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 the “catechol-O-methyl transferase (COMT)” (i.e., claim 13) supported by 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 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 1-17 are rejected under 35 U.S.C. 103(a) as being obvious over Yacoby-
Zeevi et al. US 2014/0051755 A1, Virkki et al. US 6,797,732, and Sirin et al. WO
2010/027340. It is noted that Yacoby-Zeevi et al. ‘755 is a 102 (a) (2) reference.
Applicants claim a method for treatment of Parkinson’s disease in an individual in need thereofcomprising parenterally administering a pharmaceutical composition comprising carbidopa and levopoda to said individual ; and orally administrating a catechol-O-methyl transferase (COMT)inhibitor, see claim 1. Dependent claims 2-17 further limit the scope of methods, i.e., the COMT is selected from entacapone or tolcapone in claims 13-17, comprising arginine in claim 5, administration dose or strategy in claims 2-4 and 6-12.
Determination of the scope and content of the prior art (MPEP §2141.01)
Yacoby-Zeevi et al. ‘755 discloses a method of treating a neurological or movement disorder (i.e., Parkinson’s disease) in a patient in need thereof, the method comprising the steps of: (a) substantially continuously administering to said patient a composition, wherein the composition is administered subcutaneously, intraduodenally or intravenously; and (b) orally administering levodopa and/or carbidopa and optionally entacapone or tolcapone, see claims 27 and 34 in column 17. The compositions comprise about 2.5 to about 7% by weight levodopa, about 0 to about 2% by weight carbidopa, about 5 to about 18% by weight arginine, and about 0.25% to about 3% by weight ascorbic acid or a pharmaceutically acceptable salt thereof, see claims 35 and 48 in column 17. It has been known that COMT inhibitors (i.e., entacapone or tolcapone) increase the half life of administered levodopa and substantially reducing the pulsatility of levodopa plasma levels to avoid low trough levels of plasma levodopa, see section [0035] in column 3.
Virkki et al. ‘732 discloses a stable oral solid composition comprising pharmacologically effective amounts of active agents consisting of entacapone, levodopa, and carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and comprising at least one pharmaceutically acceptable excipient other than microcrystalline cellulose, see column 12. Virkki et al. ‘732 compositions are used for treating Parkinson’s disease, see columns 5-11.
Sirin et al. ‘340 discloses a single hard oral composition including entacapone, levodopa and carbidopa or pharmaceutical acceptable salts of and at least one excipient; its feature is that it includes levopoda granule and mixture of carbidopa and entacapone granule, see page 9.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Yacoby-Zeevi et al. ‘755, Virkki et al. ‘732 and Sirin et al. ‘340 is that the instant claims are silent on the scope of COMT inhibitors.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-17 prima facie obvious because one would be motivated to employ the methods of use and compositions of Yacoby-Zeevi et al. ‘755, Virkki et al. ‘732 and Sirin et al. ‘340 to obtain instant invention.
The motivation to make the claimed methods of use compositions derived from the known methods of use and compositions of Yacoby-Zeevi et al. ‘755, Virkki et al. ‘732 and Sirin et al. ‘340 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).
Claims 1, 5 and 13 are rejected under the judicially created doctrine of
obviousness- type double patenting as being unpatentable over claim 1 of Yacoby-Zeevi
et al. US 9,040,578, and over claim 1 of Yacoby-Zeevi et al. US 9,993,451, over claim 1
of Yacoby-Zeevi et al. US 9,040,590, over claim 1 of Yacoby-Zeevi et al. US 8,193,243,
over claim 16 of Yacoby-Zeevi et al. US 9,040,577, and claim 1 of Yacoby-Zeevi et al. US
9,421,267 in view of Yacoby- Zeevi et al. US 2014/0051755 A1. Although the conflicting
claims are not identical, they are not patentably distinct from each other and reasons are
as follows.
Applicants claim a method for treatment of Parkinson’s disease in an individual in need thereofcomprising parenterally administering a pharmaceutical composition comprising carbidopa andlevopoda to said individual; and orally administering a catechol-O-methyl transferase (COMT)inhibitor selected from entacapone or tolcapone, and arginine, see claims 1, 5 and 13.
Yacoby-Zeevi et al. ‘578 claims pharmaceutically acceptable liquid composition comprising: (a) active components comprising: (i) about 5% to about 20% by weight levodopa; and (ii) carbidopa; and (b) about 20% to about 40% by weight arginine, meglumine, or a combination thereof; wherein said composition is at a pH of about 9.1 to about 9.8 at 25o C, see column 34. Yacoby-Zeevi et al. ‘578 compositions are used for treating Parkinson’s disease.
Yacoby-Zeevi et al. ‘451 claims a pharmaceutically acceptable liquid composition comprising levodopa, arginine, and about 0.5% to about 4% by weight carbidopa, wherein the pH of the liquid composition is about 8 to about 10 at 25o C. Yacoby-Zeevi et al. ‘451 compositions are used for treating Parkinson’s disease.
Yacoby-Zeevi et al. ‘590 claims a pharmaceutically acceptable liquid composition comprising levodopa, arginine, and about 2% to about 6% by weight carbidopa, wherein the pH of the liquid composition is 8 to 10 at 25o C, see column 20.
Yacoby-Zeevi et al. ‘590 compositions are used for treating Parkinson’s disease.
Yacoby-Zeevi et al. ‘243 claims pharmaceutically acceptable liquid composition comprising carbidopa, levodopa, and arginine, wherein the levodopa and the arginine have a molar ratio of about 1:1.5 to about 1:2.5, wherein the composition comprises about 2% by weight carbidopa, and wherein the pH of the liquid composition is about 8.5 to 9.5 at 25o C, see column 20. Yacoby-Zeevi et al. ‘243 compositions are used for treating Parkinson’s disease.
Yacoby-Zeevi et al. ‘577 claims a pharmaceutically acceptable liquid composition comprising: (a) about 4% to about 7% by weight levodopa; (b) about 0.5% to about 3% by weight carbidopa; and (c) about 9% to about 16% by weight arginine and/or meglumine, wherein said composition has a pH of about 9.1 to about 9.8 at 25o C, see column 32. Yacoby-Zeevi et al. ‘577 compositions are used for treating Parkinson’s disease.
Yacoby-Zeevi et al. ‘267 claims pharmaceutically acceptable liquid composition having a pH of about 9.1 to about 9.8 at 25o C, comprising: active components comprising carbidopa and about 10% to about 20% by weight levodopa; and arginine and optionally meglumine, wherein the molar ratio of active components to the
arginine is about 1:1.8 to about 1:3.5, see column 31. Yacoby-Zeevi et al. ‘267 compositions are used for treating Parkinson’s disease.
Yacoby-Zeevi et al. ‘755 discloses a method of treating a neurological or movement disorder (i.e., Parkinson’s disease) in a patient in need thereof, the method comprising the steps of: (a) substantially continuously administering to said patient a composition, wherein the composition is administered subcutaneously, intraduodenally or intravenously; and (b) orally administering levodopa and/or carbidopa and optionally entacapone or tolcapone, see claims 27 and 34 in column 17. It has been known that COMT inhibitors (i.e., entacapone or tolcapone) increase the half life of administered levodopa and substantially reducing the pulsatility of levodopa plasma levels to avoid low trough levels of plasma levodopa, see section [0035] in column 3.
The difference between instant claims and Yacoby-Zeevi et al. ‘578, ‘451, ‘590, ‘343, ‘577, ‘267 and ‘755 is that the instant claims are silent on the scope of COMT inhibitors.
One having ordinary skill in the art would find the claims 1, 5 and 13 prima facie obvious because one would be motivated to employ the methods of use and compositions of Yacoby-Zeevi et al. ‘578, ‘451, ‘590, ‘343, ‘577, ‘267 and ‘755 to obtain instant invention.
The motivation to make the claimed methods of use and compositions derived from the known methods of use of Yacoby-Zeevi et al. ‘578, ‘451, ‘590, ‘343, ‘577, ‘267 and ‘755 would possess similar activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 13, 2026
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