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 .
This is a Final Office Action.
Claims 1, 4-14 and 16-19 are pending and under examination.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) (PROVISIONAL) or 119(a) (FOREIGN) or under 35 U.S.C. 120 (CONT/CIP), 121(DIV), or 365(c) (WO) is acknowledged. Applicant still has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) (PROVISIONAL) as follows: The later-filed application must be an application for a patent application (the parent for an invention which is also disclosed in the prior application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 63159338, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for claims 1, 4-7, 11, 12, 14 and 16-19 of this application. The present formula I is not found in the priority provisional document because the n, R1 and R2 variables are broader than what is disclosed in the provisional document. There may be other omissions as well. Thus, the effective filing date of the present claims 1, 4-7, 11, 12, 14 and 16-19 is the immediate filing date of March 9, 2022. The effective filing date of claims 8-10 and 13 is March 10, 2021.
Drawings
The objection to the drawings because some are too blurry and cannot be read, e.g. 2A, 6A and 6D, is withdrawn based on the amendments.
Claim Rejections - 35 USC § 112
The rejection of claims 1 and 8-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the treatment of diseases, is withdrawn based on amendments.
The rejection of claims 1 and 8-15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of hyperparathyroidism, osteoporosis or cancer cachexia, does not reasonably provide enablement for the prevention of hyperparathyroidism, osteoporosis or cancer cachexia, is withdrawn based on the amendments.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 15 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ren et al. (WO 2010053548, cited on the IDS), is withdrawn based on the amendments.
The rejection of claim(s) 1, 4-7, 11 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Sutkeviciute et al. ([WO 2010053548] Nature Chemical Biology, 18(3): 272-280 (corrected from previous office action), cited on the IDS with a December 21, 2021 published date) is withdrawn based on the 1.130 affidavit received by Dr. Jean-Pierre Vilardaga.
The rejection of claim(s) 1, 4-7, 12 and 15 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Feldman et al. (WO 9508534, cited on the IDS) is withdrawn based on the amendments.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 4-7 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Wright et al. (US 20030050248).
The present application claims 1) a method for inhibiting abnormally increased white adipose tissue browning; 2) a method for decreasing the risk of kidney stones; and 3) a method for modulating signaling and/or in vivo function of a parathryroid hormone (PTH) teyp 1 receptor (PTHR) comprising administering a compound of formula (I).
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Wright et al. teach the following species to inhibit the production of virulence factors:
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, see page 13 and 14, Tables 3 and 4, respectfully, compound 104.
The difference between the claimed and cited compound is the size of the nitrogen-containing ring, 4- versus Applicant’s 5-, 6-, and 7-membered ring. These compounds are homologues and considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Claims 4 and 5 are obvious based on result effective variables. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Claims 6-7 are drawn to a property that is inherent upon administration of the compound of formula (I). MPEP 2144.09 states, “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
Thus, claims 4-7 are rendered obvious.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624