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
The rejections of record have been maintained below.
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.
Response to Arguments
Applicants’ claim amendments and Remarks of 7/7/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the indefinite rejection, this rejection is withdrawn due to the claim amendments.
In regard to the anticipatory rejection, this rejection is maintained. Applicants submit that Yasuda does not disclose the method for inhibiting mARC1. Examiner disagrees; administering to a subject in need of treating or preventing diabetes or obesity is the same patient population as claim 1. Additionally, the compounds of structure 1 are mARC1 inhibitors, even if that was not appreciated at the time Yasuda was published. Additionally, Applicants submit that the present claim does not recite R1 derivatized with sulfonic acid.
Examiner disagrees. Yasuda’s compound, depicted below,
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, maps to Structure I wherein R1 is a substituted phenyl (which is a C6 aromatic—allowed by R1) and R2 is a substituted C2 alkyl. R1 is substituted with a sulfonic acid. R2 is substituted by an amine group and carboxylic acid.
In regard to the obviousness rejection, this rejection is maintained for the reasons stated above. Nagy is cited in order to combine another anti0obsetiy agent via Kerkhoven logic.
Response to Amendment
Claim Rejections - 35 USC § 112- New to amendments
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.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 2 recites the limitation in R2 that “or functional group or…”. This functional group is described by function without any structure and the functional is nebulous.
Dependent claims 3-6 are not included in this rejection for the following reasons: Claim 3 defines the functional group; Claims 4-6 define the structure of R2.
Claim Rejections - 35 USC § 102- Maintained
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, 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.
The structural limitations of claims 2-3 are met for the compound and the compound is used in the same method as claim 1. Applicant has not put any specific structure into what will give the compound the function of claims 8-9. Without limiting the scope of claim 1 and without guidance on how to select inhibitors of mARC1, and because the structure has been shown to be the same structure as instant claims 2-3 used in the same method of claim 1, it must necessarily function as claimed in claims 8-9. 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- Maintained
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, 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, 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 use the combination of anti-obesity compounds (described above) in a method of preventing and/or treating obesity (since they are known for the very same purpose). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I).
The artisan would expect that the combination would inhibitor mARC1 in a subject because at least Yasuda’s compound is a mARC1 inhibitor. Because everyone is at risk of developing all the conditions of claim 1, it would be obvious to administer this combination to any subject.
This teaches claim 7.
Conclusion
Claims 1-3, and 7-9 are rejected. Claims 5-6 are allowable except for depending on a rejected base claim.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
