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
Claims 23-40 are pending in the application. Claims 23-40 are rejected.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on March 13th, 2025 and August 29th, 2024.
Claim Rejections - 35 USC § 112(a)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 23-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 23-40 were added by preliminary amendment on March 13th, 2025 and are not considered part of the original disclosure.
The instant claims are directed to methods of treating or controlling cytotoxic cerebral edema consequent to an ischemic stroke by administering 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate or a pharmaceutically acceptable salt thereof “wherein 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate or the pharmaceutically acceptable salt thereof is obtained from” either (in claim 23 and its dependent claims) a hydrate of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate or (in claim 33 and its dependent claims) a non-solvate non-hydrate crystalline form of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate.
In the remarks filed March 13th, 2025, Applicant refers to alleged support including pages 65-70, 70-73 and 78. The disclosure on pages 65-70 (Composition 1) is directed to pharmaceutical compositions comprising 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate in crystalline form whereas the instant claims are not required to contain 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate in crystalline form. The instant claims are drafted as product-by-process claims where 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate is “obtained from” a hydrate or crystalline form such that the actual material in the composition is not required to be a hydrate or in crystalline form.
The disclosure on pages 70-73 contains the following process:
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The section above entails obtaining a pharmaceutical composition from crystalline forms; however, the disclosure is limited to a mono or di-anion of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate whereas the instant claims are generic to non-salt forms and all salt forms. Furthermore, the instant claims are not required to have any particular form whereas the disclosure above entails a “pharmaceutically acceptable liquid”.
The specification contains the following disclosure on page 78:
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The method above, however, is limited to administration of a crystal comprising 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate where the instant claims are not required to contain any crystalline material.
The specification fails to generally disclose that the hydrate or non-solvate non-hydrate recited in the instant claims should generally be converted to any and all possible forms of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate including any and all pharmaceutically acceptable salts thereof. Even assuming that a person of ordinary skill in the art would extend the disclosure of page 70 to suggest that the pharmaceutical compositions can be used in treatment methods disclosed elsewhere in the specification, the scope of page 70 is limited to mono or di-anions and to compositions containing a pharmaceutically acceptable liquid. Similarly, while the specification discloses in paragraph [0003] that 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate generally is known to be useful in treating cerebral edema consequent to ischemic stroke, there is no disclosure suggesting that the hydrate or non-solvate non-hydrate instantly recited should be applied in obtaining any or all possible forms of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate or a pharmaceutically acceptable salt thereof.
Dependent claims are rejected as containing new matter for the same reasons as discussed above.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25-32 and 35-40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Parent claims 23 and 33 (from which each cited claim ultimately depends) recite a product-by-process nested in a method where dependent claims 25-32 and 35-40 define properties of a starting material in the product-by-process. Since the product is not limited by the method of preparation, dependent claims that limit the starting material in the product-by-process do not limit the scope of methods embraced by the parent claims, i.e. each of claims 25-32 and 35-40 is interpreted as covering identical scope to the claims from which they directly depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 23-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/169939 S2 by Pelletier et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches the following general method on page 67:
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As an example of a phenylbenzamide, the prior art teaches the following compound in claim 23:
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The compound above is a pharmaceutically acceptable salt of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate. The prior art further teaches the non-salt form in claim 21 on page 70. As examples of conditions, the prior art teaches the following on page 71:
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The prior art generally teaches treatment of cerebral edema including consequent to ischemic stroke. The prior art further teaches pharmaceutical compositions with a pharmaceutically acceptable diluent or carrier on page 72 (claim 34 of the prior art).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art generically encompasses methods instantly claimed but where the teachings above do not specifically refer to “cytotoxic” cerebral edema.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Regarding the limitation of “cytotoxic,” the prior art teaches on page 21, embodiment 1.55 that the edema can be cytotoxic cerebral edema. At least in the interest of determining which disclosed example would provide optimum results in the individual conditions of the prior art, a person having ordinary skill in the art would have been motivated to screen the exemplary compounds in the disclosed prior art utilities.
The instant claims 23 and 33 contain a product-by-process nested in a method. As noted in MPEP 2113(I): ‘"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)’. Absent an active method step, 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate prepared or obtained by any method is embraced by the instant claims. The same rationale applies to the properties recited in instant claims 25-32 and 35-40.
Regarding instant claims 24 and 34, the prior art teaches on page 23 (embodiment 1.76) that the compound can be administered intravenously. In the interest of determining an optimum method of delivery, a person having ordinary skill in the art would have been motivated to test the specific modes of administration taught by the prior art.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 12) Claims 23-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,117,909 in view of WO 2013/169939 S2 by Pelletier et al. The claims of the patent are generic to a hydrate of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate and where claim 16 of the patent recites a method of treating or controlling edema. A person having ordinary skill in the art in applying the material claimed in the patent would have been motivated to apply it in methods and compositions known to be useful with 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate including those discussed under 35 USC 103, which rationale is incorporated here by reference. The instantly recited product-by-process limitations are similarly met as discussed under 35 USC 103 including where the material recited in the claims of the patent is recited in instant claim 23 such that the material can be considered to be obtained from itself for claim 23.
(2 of 12) Claims 23-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,091,431 in view of WO 2013/169939 S2 by Pelletier et al. The claims of the patent are generic to an ethyl acetate solvate of 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate. A person having ordinary skill in the art in applying the material claimed in the patent would have been motivated to apply it in methods and compositions known to be useful with 2-{[3,5-bis(trifluoromethyl)phenyl]carbamoyl}-4-chlorophenyl dihydrogen phosphate including those discussed under 35 USC 103, which rationale is incorporated here by reference. The instantly recited product-by-process limitations are similarly met as discussed under 35 USC 103.
Claims 23-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over (3 of 12) claims 1-19 of U.S. Patent No. 9,573,885; (4 of 12) claims 1-40 of U.S. Patent No. 9,994,514; (5 of 12) claims 1-25 of U.S. Patent No. 11,873,266; (6 of 12) claims 1-6 of U.S. Patent No. 12,503,425; (7 of 12) claims 1-34 of U.S. Patent No. 10,894,055; (8 of 12) claims 1-15 of U.S. Patent No. 11,801,254; and (9 of 12) claims 1-16 of U.S. Patent No. 12,496,308; or provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (10 of 12) claims 1-80 of copending Application No. 19/428,761; (11 of 12) claims 1-87 of copending Application No. 19/419,243; and (12 of 12) claims 1-87 of copending Application No. 19/419,247; each in view of WO 2013/169939 S2 by Pelletier et al. Each of the conflicting patents or copending applications recites either the compound and/or overlapping method discussed under 35 USC 103, which rationale is incorporated here by reference. For the same reasons as discussed under 35 USC 103, the instantly claimed methods would have been obvious embodiments or utilities of the conflicting subject matter.
Rejections 10 of 12, 11 of 12 and 12 of 12 are provisional nonstatutory double patenting rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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