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 .
Election/Restrictions
Applicant's election with traverse of a compound of mARC1 inhibitor in the reply filed on 9/4/2025 is acknowledged. The traversal is on the ground(s) that the compounds of structural formula I in claim 2 have a common structural feature (seen in claim 2) and share a common technical structure necessary for a common function (inhibiting mARC1). This is not found persuasive because Examiner asked for “an active compound/inhibitor of mARC1”, which was the language used in claim 1. Since the scope of claim 1 is larger and includes compounds that are not included in the structural formula I, this is not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
The elected species is
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. This species reads on claims 1-3, and 5-9. A search for this species did not find prior art. The search was extended to
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, which did find prior art.
The elected species and Markush search extends read on claims 1-3, and 5-9.
Priority
This application is a national stage entry of PCT/EP2021/066416 and claims foreign priority to DE102020003608.2.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
A review of the file wrapper indicates a foreign language priority document. However, since it is not in English, a judgement cannot be made as to whether it supports the instant claims, which is required to perfect foreign priority. The conditions of 35 U.S.C. § 119(a)-(d) or (f) are not met.
Therefore, the effective filing date for the instant claims is the international filing date of 6/17/2021.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 12/13/2022, 02/13/2023, and 02/13/2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: The phrase “linear, cyclic, or branched” in claim 2 is awkward because adjectives normally come before what they describe. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: It recites “the inhibitor” which clearly should be referring back to an inhibitor of mARC1 of claim 1. For parallelism, Examiner suggests changing “the inhibitor” in claim 9 to “an inhibitor of mARC1” so there is no doubt of indefiniteness. Appropriate correction is required.
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.
Claims 1-3, and 5-9 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation of elevated liver enzyme levels, and the claim also recites “(ALT, AST, ALP)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The phrase “in particular obesity” renders the scope of claim 1 non-distinct. It is not clear whether the scope of lipid metabolism disorders of claim 1 is limited to obesity or if obesity is merely exemplary. Therefore, the metes and bounds of claim 1 is unclear and thus indefinite.
Because the dependent claims 2-3 and 5-9 do not resolve the rationale underpinning this rejection, they are similarly rejected for the same reason.
Claims 2, and 7-9 recite the limitation "the active compound". Claim 1, which claims 2 and 7-9 depend on, no longer refers to an active compound. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation “or unsubstituted”. It is unclear whether the functional group in the second to last line is unsubstituted or if the list starting with C1- to C6- alkyl and ending with heterocycles can be unsubstituted. Therefore, the metes and bounds of claim 2 is unclear and thus indefinite.
Although claim 4 is not examined, Examiner notes about claim 4. The phrase “preferably phenyl” and “preferably a halogen… 3-chlorophenyl” renders the scope of claim 4 non-distinct. It is not clear whether the scope is limited to this narrower statement or whether the broader limitation of each “preferably” applies. See MPEP 2173.05(c)(I). Note, the list starting with “e.g.” is also the start of an exemplary list.
Although claim 4 is not examined, Examiner notes about claim 4. The phrase “in particular substituted in the meta …. 3-position” and “in particular 3-chlorophenyl” renders the scope of claim 4 non-distinct. It is not clear whether the scope of claim 4 is limited to these “in particular” limitations or if these limitations is merely exemplary. Therefore, the metes and bounds of claim 4 is unclear and thus indefinite.
The phrase “in particular 3-chlorophenyl” renders the scope of claim 5 non-distinct. It is not clear whether the scope of claim 5 is limited to this “in particular” limitation or if this limitation is merely exemplary. Therefore, the metes and bounds of claim 5 is unclear and thus indefinite.
Claim 7 recites the phrase “comprising or consisting of”. This phrase renders the metes and bounds of the claim unclear and thus indefinite. The word "consisting of" is closed language. The word " comprising" is open ended. Thus, the Examiner in unsure if the list “at least one hydroxamic acid, an amidoxime and/or a hydroxylamine” is a closed list or an open list of options.
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.
Claim(s) 1-3, 5, 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasuda (US 20130102570).
Yasuda anticipates a method for preventing or treating diabetes or obesity by administering to a subject in need thereof, an effective amount of a compound of formula I including “compound 1” .
Yasuda anticipates a compound with Cas#1220125-37-0 (table 2 Ref “compound 1”), depicted below,
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, which maps to Structure I wherein R1 is a substituted phenyl and R2 is a substituted C2 alkyl. R1 is substituted with a sulfonic acid. R2 is substituted by an amine group and carboxylic acid. This anticipates the method of claim 1 and a compound from claims 2-3 and 5.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, Compound 1 from Yasuda, and its properties, induces downregulation of reactions catalyzed by mARC1 and of protein-protein interactions mediated by mARC1 and induces the lowering of lipids in the blood of the patient, are inseparable. See MPEP 2112.01 (II). This anticipates claims 8-9.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 nonobviousness.
Claim(s) 1-3, 5, 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yasuda (US 20130102570) in view of NAGY (US 7763601)
Yasuda teaches claims 1-3, 5, and 8-9 above.
Yasuda does not teach an additional agent of claim 7.
NAGY teaches that O-(3-piperidino-2-hydroxypropyl)-nicotinic amidoxime (this is another pharmaceutical compound containing at least one amidoxime group) can be used for the prevention or reduction of excessive body weight or obesity in a patient (col. 3).
The artisan would have found it obvious to combine Yasuda’s compound 1, which is known to prevent and/or treat obesity, with O-(3-piperidino-2-hydroxypropyl)-nicotinic amidoxime, which is also known to prevent and/or treat obesity. It is prima facie obvious to combine one anti-obesity compound with another in order to form a composition to be used for the very same purpose (preventing and/or treating obesity). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claim 7.
Conclusion
No claims are allowed.
NILSSON (Nilsson et al., “Triazoloquinazolinediones as novel high affinity ligands for the benzodiazepine site of GABAA receptors”, Elsevier, 2011) is close art and discloses compound 10c, which is similar to the elected species of formula I, (page 113 Scheme 2). NILSSON does not teach compound 10c as a GABA receptor modulator (see tables 1 and 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625