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 .
DETAILED ACTION
1. Applicant's amendment, filed 09/22/25 is acknowledged.
2. Claims 1-19 are pending.
Claims 1-19 read on a method for treating a viral infection comprising administering an effective amount of cortisol antagonist are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 09/22/25
3. 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.
4. Claim(s) 1-3, 5-7,9, 11,12,14 -17 are rejected under 35 U.S.C. 103 as been obvious over US Patent Application 20210299143 and US Patent Application 20200101087 in view of US Patent Application 20030190357
US Patent Application’087 teaches a method of treating and/or reducing the severity of wide range of viral infections including coronavirus, comprising administering to the subject an effective amount of cortisol antagonist ( glucocorticoid receptor antagonist). ( see entire document, Abstract and paragraphs 0002, 0008, 0022, 0030 ,0051 ,0325 and 0569 in particular)
It would be immediately obvious to one skill in the art that coronavirus infection includes SAR-Cov-2 because , as acknowledge by the instant specification SAR-Cov-2 is well known to be a coronavirus ( see paragraphs 0002 and 0005 in particular).
US Patent Application’143 teaches a method of treating and/or reducing the severity of coronavirus infections includingSARS-Cov-2, comprising administering to the subject an effective amount of glucocorticoid receptor antagonist. ( see entire document, Abstract and paragraphs 0006, 0035 in particular). It was well know to one skill in the art before the effective filing date of the claimed invention that cortisol antagonist is a glucocorticoid receptor antagonist. Thus, it is the Examiner’s position that it would be conventional and within the skill of the art to determine an optimal type of glucocorticoid receptor antagonist to be used for treating a viral infection.
It is noted that US Patent Application’087 and US Patent Application’143 do not explicitly teach the use of specific cortisol antagonist such as sodium valproate or enkephalin etc as recited in amended claims 1, 5, 9.
US Patent Application 20030190357 teaches the use of well known cortisol antagonist such as sodium valproate or enkephalin in treating various diseases ( see entire document, paragraphs 0007, 0011, 0017, 0072, and claim 2 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use cortisol antagonist such as sodium valproate or enkephalin in the method taught by US Patent Application’087 and US Patent Application’143 with a reasonable expectation of success because the prior art suggests that the use of cortisol antagonist such as sodium valproate or enkephalin in treating various diseases was well known and routinely used.
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
5. Claim(s) 1, 4, 8, 10, 13, 18, 19 are rejected under 35 U.S.C. 103 as been obvious over US Patent Application 20210299143 and US Patent Application 20200101087 , US Patent Application 20030190357 as applied to claims 1-3, 5-7,9-19 above and further in view of US Patent Application 20170291950 and US Paten Application 20230125415.
The teaching of US Patent Application 20210299143 and US Patent Application 20200101087 US Patent Application 20030190357 have been discussed supra.
US Patent Application 20210299143 and US Patent Application 20200101087 in view of US Patent Application 20030190357 do not explicitly teaches the use of IL-6 antagonist in treating viral infection.
US Patent Application ‘950 teaches a method of using IL-6 antagonist in treating viral infections ( see entire document, paragraphs 0038, 0052, 0081 in particular).
US Patent Application ‘415 teaches a method of using IL-6 antagonist in treating viral infections, including coronavirus ( see entire document, paragraphs 0004, 0014, 0114, 0115 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been obvious to one of the ordinary skill in the art at the time the invention was made to add Il-6 antagonist in the method of treating viral infection taught by US Patent Application 20210299143 and US Patent Application 20200101087 US Patent Application 20030190357 with a reasonable expectation of success because the prior art suggests that each of said antagonists can be used for treating viral infection.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Claims 18 and 19 are included because it would be conventional and within the skill of the art to identify the subjects suitable for treatment as acknowledge by the instant specification ( see paragraphs 0022 of the instant specification in particular). Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
6. No claim is allowed.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 extension fee 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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