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 .
DETAIL ACTION
This office action is a response to a 371 application filed 8/22/2024, which is a national stage application of PCT/CZ2023/050008 filed 2/21/2023, which claims foreign priority to CZPV 2022-86 filed 2/23/2022.
As filed, claims 1-4 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/10/2024 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejection - 35 USC §§ 101 & 112
The following is a quotation of 35 U.S.C. § 101:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
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.
Although a claim should be interpreted in light of the specification disclosure, it is improper to read limitations contained in the specifi-cation into the claims. In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969); In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975).
A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See, e.g., Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966) (holding that the following claim was definite, but that it was not a proper process claim under 35 U.S.C. § 101: “The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sul-fonic acid.”); Ex parte Dunki, 153 USPQ 678 (B.P.A.I. 1967) (finding the following claim to be an improper definition of a process claim: “The use of a high carbon austen-itic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding fric-tion.”).
Claim 4 provides for the use of a compound of instant formula (I), but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Accordingly, claim 15 is rendered indefinite and rejected under 35 U.S.C. 112.
Claim 4 is also rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
The Examiner suggests that the “use" claim 4 be cancelled in light of the properly drafted product, process, and/or method claims presented in the instant application.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-4 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.
Regarding claim 1, the claim recites the structure of general formula (I), which has only one R group on each terminal heteroaromatic group, as shown by boxes below:
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At the same time, the claim, for instance, also recites “benzoquinoline”, etc. for both terminal heteroaromatic group of the methinium chain or “with one or more R groups” on both terminal heteroaromatic groups of the methinium salt or “CH=CH-CH=CH (i.e. a fused benzene nucleus)” for instant variable R. All of which includes multiple R groups.
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Accordingly, it is unclear to the Examiner whether the Applicant is intended to encompass one or more R groups or just one R group on both terminal heteroaromatic groups of the general formula (I). With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Regarding claim 1, the claim recites the phrase, “which may be further substituted by one or more of the same or different substituents R”. The use of the phrase, “may be”, introduced ambiguity into the scope of the claim, and it is unclear to the Examiner whether instant variable B is substituted or unsubstituted. Accordingly, the metes and bounds of this claim are unclear, which rendered the claim indefinite.
Regarding claim 3, the claim is dependent of claim 1, and claim 3 recites the phrase, “the treatment”, wherein the word, “the”, requires antecedent basis. It is unclear where applicant has defined “a” treatment in claim 1 or 3. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 4, the claim is dependent of claim 1, and claim 4 recites the phrase, “the production”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” production in claim 1 or 4. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 4, the claim is dependent of claim 1, and claim 4 recites the phrase, “the treatment”, wherein the word, “the”, requires antecedent basis. It is unclear where applicant has defined “a” treatment in claim 1 or 4. Without antecedent basis, the claim is rendered indefinite.
Regarding claims 2-4, the claims are dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered the claim indefinite.
Claim Interpretation
With regards to the intended use statements, such as “for the use as an inhibitor of dihydroorotate dehydrogenase”, in claim 1; “for use as an antimetastatic agent”, in claim 2; “for use in the treatment of metastases of solid tumors” in claim 3; and “for the production of a medicament for the treatment of metastatic oncological diseases” in claim 4, they have not been accorded patentable weight for prior art purpose because such statements failed to limit the structure of the compound of instant formula (I).
The Examiner finds that any prior art compound having the same structure as the compound of instant formula (I) would be capable of performing the intended use, according to the guidance in MPEP 2111.02(II).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Abstract Registry No. 17732-64-8, hereinafter CAS648.
Regarding claims 1-4, CAS648 teaches the following compound, which meets all the limitations of these claims.
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Wherein: instant variable R is H; one of instant variables X is CH=CH; the other instant variable X is S; instant variable B is unsubstituted phenyl; instant variable A is ethyl; and instant variable Y is perchlorate.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Pentamethinium salts suppress key metastatic processes by regulating mitochondrial function and inhibiting dihydroorotate dehydrogenase respiration”, hereinafter Fialova. See IDS filed 12/10/2024.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Regarding claims 1-4, Fialova, for instance, teaches the following compound as anti-cancer agent for inhibiting dihydroorotate dehydrogenase respiration, which meets all the limitations of these claims.
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(pg. 1, abstract)
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(pg. 5, Figure 1A, compounds 1 and 2)
Wherein: instant variable R is H; instant variables X are S or CR’2; instant variables R’ are methyl; instant variable B is unsubstituted pyridyl; instant variable A is ethyl; and instant variable Y is iodide.
Claim Objections
Claims 1-4 are objected to because of the following informalities:
Regarding claim 1, the claim recites the following phrase, which can be clarified by the following:
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Regarding claim 2, the claims recite the phrase, “The compound of general formula I, wherein the symbols A, B, X and Y have the meaning as defined in claim 1”.
Such expression can be clarified by reciting -- The compound of general formula I,
Regarding claim 3, the claim recites the phrase, “The compound of general formula I, wherein A, B, X and Y have the meaning as defined in claim 1”.
Such expression can be clarified by reciting -- The compound of general formula I,
Regarding claim 4, the claim recites the phrase, “the compound of the general formula I, where the symbols A, B, X and Y have the meaning as defined in claim 1”.
Such expression can be clarified by reciting -- the compound of the general formula I, --.
Appropriate correction is required.
Conclusion
Claims 1-4 are rejected.
Claims 1-4 are objected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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