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 .
Status of Claims
Claims 12-13, 31-32, 36-38, 40-54 are pending in the present application.
Claims 38 and 43-54 stand withdrawn from further consideration as being drawn to a nonelected invention/species.
Claims 12-13, 31- 32, 36-37, 40-42 will be examined according to MPEP § 803.02.
Response to Amendments
Applicant’s amendments to the claims of December 16th, 2024, in response to the Office Action of February 19th, 2025, are acknowledged.
All rejections cited in the previous Office Action not referred to herein has been withdrawn based on Applicant’s amendments.
Response to Arguments
Applicant traverses Examiner’s previous 35 U.S.C. 103 rejection over claims 12-13, 31-32, 36 and 37.
Applicant amended claim 12 to include the limitation “wherein the compound has a 50% effective virus-inhibitory concentration (EC50) of less than about 25 nM against at least one pseudotyped arenavirus in an Arenavirus glycoprotein pseudotype assay”. Examiner acknowledges that Sharma, et al. does not disclose or suggest this limitation, as the Applicant argues. However, as claim 12 and its dependent and examined claim 13 are drawn to products (compounds), any previously unappreciated characteristic of these compounds previously rendered obvious by Sharma, et al. are not patentable.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
As the Applicant’s claimed compound was rendered obvious over the prior art, any activity or characteristic of the compound was inherently present before the Applicant’s effective filing date.
Claims 31, 32, 36, and 37 additionally remain rejected for reasons set forth previously, as the amendment to claim 12 only applies to claims 12 and 13. For reasons stated, claims 12-13, 31-32, 36-37 remain rejected under 35 U.S.C. 103 over Sharma, et. Al.
Claim Rejections - 35 USC § 103 (Previous Rejection Maintained)
The rejection of claims 12, 13, 31, 32, 36 and 37 under 35 U.S.C. 103 over Sharma et al. (WO 2014/080241 cited by applicant on IDS submitted 6/21/2022) is
maintained.
Sharma et al. teaches compounds of:
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wherein X, Y, P, and Q are CR or N;
R, R1, R2, R3, R4, R5, and R7 are independently selected from hydrogen, (C1-C6)-alkyl, (C1-C6)-alkoxy, (C3-C12)-cycloalkyl, etc.;
R6 is selected from hydrogen, halogen, hydroxy, etc. and
R8 is hydrogen for use in treating diseases or disorders mediated by one or more proinflammatory cytokines (see the entire article, especially Abstract; page 5, line 13 - page 6, line 10; page 31, line 9 - page 32, line 27). The reference exemplifies compounds such as:
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etc.
The instant claims differ from the reference by reciting compounds not
exemplified therein.
However, the claimed compounds are encompassed by the generic definition of Formula 1 as defined by Sharma:
Claimed invention
Sharma et al.
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R1 is selected from (C6 to C10) aryl and 5-indolyl, wherein (C6 to C10) aryl is substituted with at least one R4a group;
R4a is independently selected from OH, (C1 to C6) alkyl, (C1 to C6) alkoxy, (C3 to C10) cycloalkyl, -C(O)R5, and -NR6aR6b, wherein
each of the said (C1 to C6) alkyl, (C1 to C6) alkoxy, and (C3 to C10) cycloalkyl is optionally substituted with at least one R7 group;
Each of R, R1 and R2 is hydroxy, substituted or unsubstituted (C1 to C6) alkyl, substituted or unsubstituted (C1 to C6) alkyoxy, (C3 to C12) cycloalkyl, heterocyclyl etc.;
Each of R3, R5 and R7 is hydrogen, substituted or unsubstituted (C1 to C6) alkyl, substituted or unsubstituted (C1 to C6) alkyoxy;
R6 is hydrogen, substituted or unsubstituted (C1 to C6) alkyl, ;
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R4b is selected from the group consisting of isopropoxy, cyclopropoxy, tert-butoxy, cyclopropylmethoxy, (2-hydroxypropan)-2-yl, (1-hydroxycyclopropan)-1-yl, (1-hydroxycyclobutan)-1-yl, difluoromethoxy, methoxyethoxy, difluoromethyl, cyclopropyl, and acetyl;
R3 is independently selected from hydrogen, (C1 to C6) alkyl, and (C1 to C6) alkoxy;
As noted by the Court, a reference is not limited to its working examples. It must be evaluated for what it teaches those of ordinary skill in the art. In re Boe, 355 F.2d 961, 148 USPQ 507 (CCPA 1966). In re Chapman, 357 F.2d 418, 148 USPQ 711 (CCPA 1966).
Based on the teachings of Sharma, modification of the exemplified compounds, such as,
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by replacing (i) CF3 with an unsubstituted (C1 to C6) alkyl (see definition of R6 of Sharma) and (ii) morpholinyl or SO2NH2 with substituted or unsubstituted (C1 to C6) alkoxy (see definition of R3 of Sharma) is rendered prima facie obvious. It is noted that the reference defines alkoxy as:
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(see page 7, lines 11-20).
The motivation to make said modification or to make any of the compounds of
the prior art genus is based on the teaching by the reference that the compounds
obtained would be useful in treating diseases or disorders mediated by one or more proinflammatory cytokines.
Claims 31, 36 and 37 further differ by reciting compounds wherein both R4a and R4b are isopropoxy and one of R3 is methyl:
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(applicant's elected compound).
However, as noted above, the prior art genus is inclusive of compounds wherein
R1, R3, and R7 are independently selected from (C1-C6)-alkyl and (C1-C6)-alkoxy (see definition on page 5, lines 25-28). Therefore, the selection of any of the species of the genus taught by the reference, including that of the instant claims, would have been obvious to the skilled artisan in the art at the time of the invention. The motivation is
based on the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as the genus as a whole.
Claim Rejections - 35 USC § 103 (New rejection over added claims)
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (WO 2014/080241 cited by applicant on IDS submitted 6/21/2022).
(All teachings of Sharma et al. previously set forth are applied herein).
Claims 40-42, newly added by Applicant, are drawn to the same compounds taught by Sharma, as previously set forth.
Claim 40 is drawn to the structure of formula (I), wherein R1 is a para-substituted phenyl with the R4a group, previously taught to encompass the structure taught by Sharma.
Claim 41 recites the previously rejected generic formula (I) in claim 12, with the added limitation “wherein the compound is a mammalian arenavirus cell entry inhibitor”.
Similarly, claim 42 recites the previously rejected generic formula (I) in claim 12, with the added limitation “wherein the compound is an arenavirus cell entry inhibitor that targets virus glycoprotein complex”.
In regards to claims 41 and 42, as recited previously in this Office Action, any previously unappreciated characteristic of these compounds previously rendered obvious by Sharma, et al. are not patentable.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
As the Applicant’s claimed compound was rendered obvious over the prior art, any activity or characteristic of the compound was inherently present before the Applicant’s effective filing date.
Conclusion
No Claims Allowed.
THIS ACTION IS MADE FINAL. 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 OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628