DETAILED ACTION
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 .
Priority
This application, filed 13 October, 2023, is a national stage application of PCT/EP2022/059857, filed 13 April, 2022, which claims foreign benefit of Application EP21168256.2, filed 14 April, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 November, 2023 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 13 October, 2023, in the matter of Application N° 18/286,809. Said documents have been entered on the record.
Claims 3-9, 11-13, 15, and 17-23 are amended. No new matter was introduced.
Thus, Claims 1-23 represent all claims currently under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-23 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to “Compounds of general formula (I),” which employs plural language and describes a class of compounds rather than distinctly claiming a singular invention, thereby rendering the scope of the claim unclear. Further, the claim recites “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same,” which introduces additional ambiguity as to the nature and boundaries of the claimed subject matter. In particular, certain listed variants are chemically incompatible or mutually exclusive and cannot meaningfully exist as a mixture. For example, a free base form of a compound and a salt thereof represent different protonation states that cannot coexist as a stable mixture under defined conditions, but instead interconvert to a single equilibrium form. Similarly, different solid-state forms such as a solvate and a non-solvated form, or different solvates of the same compound, generally do not stably coexist as a mixture and instead interconvert depending on environmental conditions. Accordingly, the “mixture of the same” renders the scope of Claim 1 unclear.
Claim 2 depends upon Claim 1 and fails to cure the deficiency above. Additionally, Claim 2 independently recites “Compounds according to claim 1 of general formula (la)” again employing plural language and “general formula” terminology that describes a class of compounds rather than distinctly claiming a singular invention. Claim 2 further independently recites “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same,” which raises the same scope ambiguity as discussed with respect to Claim 1.
Claims 3-16, which depend from Claim 1, equally fail to cure the plural language and “general formula” terminology that describes a class of compounds rather than distinctly claiming a singular invention, and also independently repeatedly recite “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same,” which raises the same scope ambiguity as discussed with respect to Claim 1.
Claim 6 also recites “phosphor,” which is not a recognized element name, rendering the identity of the referenced atom unclear.
Claim 15 additionally recites “wherein any substituent of claim 3 to 14 can be combined with any other substituent or substituents from one or more of claims 3 to 14,” which fails to provide clear structural boundaries as to which substituents may be combined, at which positions, and under what constraints. The claim does not specify whether such substituents are chemically compatible or mutually exclusive, nor does it limit the number or arrangement of substituents that may be simultaneously present, thereby rendering the scope of the claim indeterminate.
Claim 16 further recites a ~14 page list of species without any punctuation, or without an “and” or “or” connector preceding the final species. As written it is unclear whether the claim is intended to encompass one of the listed species, all of the listed species, or some undefined combination thereof. The absence of grammatical connectors renders the boundaries of the claimed subject matter indeterminate.
Claims 17-23, which rely upon Claim 1, also fail to cure the plural language and “general formula” terminology that describes a class of compounds rather than distinctly claiming a singular invention, as well as fail to cure the “or a mixture of same,” which raises the same scope ambiguities as discussed with respect to Claim 1.
Additionally, Claim 17 is directed to “ for use in the treatment or prophylaxis of a disease,” which does not clearly define a statutory category of invention under U.S. patent practice. The phrase “for use in the treatment or prophylaxis” merely recites an intended use and does not impose any structural limitation on the claimed compound, nor does the claim recite steps sufficient to define a method of treatment. Accordingly, it is unclear whether Claim 17 is intended to claim a compound or a method of treatment, rendering the scope of the claim indefinite.
Claim 19 beyond failing to cure the deficiencies of Claim 1 above, also fails to clearly define the nature and boundaries of the claimed “pharmaceutical combination,” including whether the recited active ingredients are co-formulated, co-administered, or optionally combined. The claim further recites an extensive list of “further active ingredients” without clear punctuation or conjunctions separating the listed items, rendering it unclear whether the claim is intended to encompass one listed ingredient, multiple listed ingredients, or combinations thereof. The inclusion of entries written as fixed combinations (e.g., “trifluride + tipiracil”) further introduces ambiguity as to whether such entries are intended to represent single active ingredients or combinations of multiple active ingredients. Accordingly, the scope of Claim 19 cannot be determined with reasonable certainty.
Claim 20 additionally is directed to the “use of a compound of general formula (I) according to claim 1 for the treatment or prophylaxis of a disease,” which does not clearly define a statutory category of invention under U.S. patent practice. The claim does not recite steps sufficient to define a method of treatment, nor does the phrase “use of” impose any structural limitation on the claimed compound. Accordingly, it is unclear whether Claim 20 is intended to claim a compound or a method of treatment, rendering the scope of the claim indeterminate.
Similarly, Claims 21 and 22 recite uses of but do not recite steps sufficient to define a method, nor impose any structural limitation on the claimed compound.
Claim 23 recites, “Method for controlling in humans and animals by administering an anti hyperproliferative effective amount of at least one compound as defined in Claim 1.” As written, the claim fails to specify what is being “controlled,” rendering the method incomplete and unclear. In addition, the terms “controlling” and “anti hyperproliferative effective amount” are functional and undefined, and the claim does not identify a disease, condition, or physiological state to which the method is directed. The phrase “in humans and animals” further introduces ambiguity as to whether the method must be applicable to both humans and animals or to either.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627