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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
It appears that applicants failed to submit IDS for their claimed invention. It is a duty on all patent applicants to disclose prior art or background information that may be relevant to the patentability of the applicant's invention. For additional information, applicants may have to refer MPEP § 609.
Response to Restriction Requirement
Applicant's response to restriction requirement and election of group I, claims 1-10, inthe reply filed on 27th Feb 2026 is acknowledged. However, because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
With regard to election species, applicants simply say “Claims 2, 3 and 5 may be elected as the species for examination”, but fails to point out to a single species. The examiner chosen first species in the order, which AURONOFIN from claim 2, and examined the claims to the extent chosen elected species reads the claims, viz., claims 1-2, 6-8 and 10.
Claims 3-5, 9 and 11-19 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-2, 6-8 and 10 are examined on merits in this office action.
Claim objections
Claim 1 is objected to because of the following informalities: the recited “active gradient” should be changed to “active ingredient”. 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 7-8 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 pre-AIA the applicant regards as the invention.
Claims recite administration is through intraperitoneal injection or intramuscular-injection and nasal inhaling method, whereas independent claim limit the administration to oral. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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 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.
Claims 1-2, 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rothan (Virology, 2020, 547, 7-11; Available online on 19 May 2020) in view of Lee (Frontiers in Pharmacology, April 2019, vol.10, article 417, 1-10).
For claims 1-2 and 6:
Rothan teaches gold drug auranofin inhibits novel coronavirus, SARS-COV-2, replication and attenuates inflammation in human cells [see abstract and Fig.1-3].
The limitations in the claims, viz., ‘effective in treating Rheumatoid arthritis’ and ‘suppresses inflammation’ etc., are intended use and do not have weight. See MPEP 2111.02.
Differences between Rothan and instant claims are as follows:
(i) Rothan silent on treating coronavirus infection in an animal.
(ii) Rothan silent on the limitation, viz., gold atom forms a gold-S bond in the coronavirus protease active pocket.
(iii) Rothan silent on oral intake of the drug.
With regard to (i) of above, Rothan provided evidence of treating coronavirus in the human cell lines. In the drug discovery, first step is testing the drug in vitro, then in vivo and finally in the subject, such as mouse, monkey or human etc., which is a common practice in the art. Therefore, it is obvious to extrapolate the data from the human cell lines to the human subject.
With regard to (ii) of above, since the compound is identical and treating the same disease, and so, this limitation is expected, absent evidence to the contrary.
With regard to (iii) of above, auranofin is known in the art as an oral medication [see Introduction of Rothan, left paragraph in page 7].
For claims 7-8:
Rothan silent on administration through injection or nasal inhaling methods. However, mode of administration is result effective variable. For example, Lee teaches that auranofin is injected to a mice [see first paragraph in left column in page 8]. So, a skilled person in the art would determine suitable mode of administration through a routine experimentation, and so, these are obvious variants, absent evidence to the contrary. Please note that formulations for different mode of administrations require different conditions. In absence of such evidences, these limitations are obvious.
For claim 10:
Rothan teaches 0.1-10 micromolar concentrations of auranofin in their studies and also determined the EC50 value of 1.4 microM [see abstract, Methods and figures].
Generally, concentrations of components for a given process is considered as result effective variables, and the differences in their amounts will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such differences in result-effective variables are 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). 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.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants auranofin and its use in treating coronavirus, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to modify or combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Marzo et al., A Role for Metal-Based Drugs in Fighting COVID-19 Infection? The Case of Auranofin, ACS Med. Chem. Lett., 2020, 11, 1067-1068.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658