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 .
DETAIL ACTION
This office action is a response to a 371 application filed 10/6/2022, which is a national stage application of PCT/US2021/026304 filed 4/8/2021, which claims domestic priority to 63/062,608 filed 8/7/2020; and 63/008,547 filed 4/10/2020.
As filed, claims 1-20 are pending, wherein claims 1, 9, 13, and 17 are independent claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/24/2023 has been considered by the Examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claims 1, 2, 9, 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Foreign Patent Application Publication No. WO2021/176369, hereinafter Bezawada.
Regarding claims 1, 2, 9, 10, 13, and 14:
Determining the scope and contents of the prior art:
Bezawada, for instance, teaches the administration of the combination of N-((1S)-1-{(((1S)-3-hydroxy-2-oxo-1-{[(3S)-2-oxopyrrolidin-3-yl]methyl}propyl)amino]carbonyl}3-methylbutyl)-4-methoxy-1H-indole-2-carboxamide and remdesivir for treating COVID-19 in a patient. The abovementioned combination has shown to inhibit replication of the SARS-CoV-2 in a host cell.
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(pg. 106, lines 7-19)
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(pg. 107, lines 1-28)
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(pg. 118, claims 14 and 15)
Ascertaining of the difference between the prior art and the claim at issue:
Bezawada, for instance, did not explicitly teach the combination of N-((1S)-1-{(((1S)-3-hydroxy-2-oxo-1-{[(3S)-2-oxopyrrolidin-3-yl]methyl}propyl)amino]carbonyl}3-methylbutyl)-4-methoxy-1H-indole-2-carboxamide with dantrolene.
Finding of prima facie obviousness --- rationale and motivation:
With respect to this difference, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Based on the teachings of the MPEP and KSR above, by employing the rationale in (B) above, it would have been obvious for one of ordinary skill in the art to substitute one known element (i.e. remdesivir) in the abovementioned combination for another (i.e. dantrolene) to obtain predictable results (i.e. treating COVID-19).
In alternative, by employing the rationale in (E) above, it would have been obvious for one of ordinary skill in the art to try dantrolene from a finite number of identified, predictable solutions, with a reasonable expectation of success for treating COVID-19.
Lastly, a person of ordinary skill in the art is highly motivated to explore the obvious variants (e.g. combination made by the abovementioned preferred embodiments or blazemarks) in search for the combination that gives the best synergistic effect for treating COVID-19.
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(pg. 31, lines 21-34)
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(pg. 105, lines 12-22)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to a method of treating coronavirus infection via dantrolene, prodrug thereof, or pharmaceutically acceptable salt thereof.
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
17/995,602
1-24
Yes
In this instance, the analysis employed for the abovementioned nonstatutory obviousness-type double patenting rejection parallels the analysis for anticipation, wherein the instant method is anticipated by the method, as shown below, and such method is disclosed in the abovementioned conflicting claims of the abovementioned co-pending application.
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(claim 1 of the co-pending application)
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(claim 9 of the co-pending application)
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(claim 13 of the co-pending application)
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(claim 17 of the co-pending application)
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
17/995,604
1-24
Yes
In this instance, the analysis employed for the abovementioned nonstatutory obviousness-type double patenting rejection parallels the analysis for anticipation, wherein the instant method is anticipated by the method, as shown below, and such method is disclosed in the abovementioned conflicting claims of the abovementioned co-pending application.
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(claim 1 of the co-pending application)
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(claim 9 of the co-pending application)
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(claim 13 of the co-pending application)
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(claim 17 of the co-pending application)
Claim Objections
Claims 7, 8, and 17 are objected to because of the following informalities:
Regarding claims 7 and 8, the claims recite the phrase, “as compared to the amount of time of normalization”.
Such expression can be clarified by reciting -- as compared to the
Regarding claim 17, the claim recites the phrase, “reducing the infectivity of a coronavirus”.
Such expression can be clarified by reciting -- reducing --.
Appropriate correction is required.
Conclusion
Claims 1-20 are rejected.
Claims 7, 8, and 17 are objected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621