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 the Claims
Claims 1-20 are pending.
Claims 6 and 18 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/EP2021/066558, filed 6/18/2021; and further claims priority to foreign application EP20180838.3, filed 6/18/2020.
Information Disclosure Statement
All references from IDS(s) received 12/16/2022 and 03/15/2023 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of the following below without traverse in the reply filed on 11/14/2025 is acknowledged.
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Claims 6 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as not reading on the elected species.
Claims 1-5, 7-17 and 19-20 will be examined upon their merits.
Anticipatory art was found on elected specie 1, but not 2. The examiner expanded the disease to influenza viruses. See 102 analysis below for claims 1-2, 4-5, 7-17, and 19-20. A 103 analysis for the elected species, SARS-CoV-2, including claims 1-5, 7-17 and 19-20 can also be found below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7-12, 14-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Hwang, K. (WO1994003164A1; cited in IDS filed 3/15/2023; “Hwang”).
Hwang teaches calixarene compounds for the treatment of enveloped viruses. Hwang explicitly teaches an example of the elected specie (Table 1, Compound KY-1) also with a pharmaceutically acceptable carrier (page 70, line 9) and teaches the compounds for use in influenza A (Example D, Table 6), as required by instant claims 1, 2, 4, 5, 9, 10, 15, and 17.
Hwang also teaches the compounds for topical or inhalation administration (Page 9, line 31-33) in the form of liquid or tablet (Page 10, lines 10-14), as required by instant claims 8, 11, 12, 16, and 20.
Hwang also teaches the compound in combination with an additional antiviral compound (page 70, line 11-13), as required by instant claims 14 and 19.
Finally, Hwang teaches the dosage form to be a composition that is pharmaceutically effective, i.e. effective to inhibit viral infection of host cells (page 70, line 14-23), as required by claim 7.
Therefore, Hwang anticipates claims 1-2, 4-5, 7-12, 14-17, and 19-20.
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 (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.
Claims 1-5 and 7-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang, K. (WO1994003164A1; cited in IDS filed 3/15/2023; “Hwang”) as evidenced by the NIH National Library of Medicine (E envelope protein [ Severe acute respiratory syndrome coronavirus 2 ], Gene ID: 43740570; “NIH”).
Hwang teaches all the limitations of claims 1-2, 4-5, 7-12, 14-17, and 19-20, see 102 analysis above, and those teachings are incorporated herein.
With respect to claim 3, Hwang fails to explicitly teach the compounds for use in treating SARS-CoV-2. However, Hwang does teach the compound for other respiratory related enveloped viruses. Since SARS-CoV-2 is also a respiratory enveloped virus, as evidenced by the NIH, it would be obvious to a person skilled in the art at the time to also use the methods of Hwang and apply them to treating SARS-CoV-2.
With respect to claim 13, Hwang fails to explicitly teach administration of the antiviral of an amount of 1-100ug per nostril. However, Hwang does teach administration of the compound in a range of 0.1 ug to 100ug/mL and also teaches it can be done through inhalation administration. This is considered an overlapping range with instant claim 13. Therefore, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of 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.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the method of using a calixarene as an antiviral, as taught by Hwang, and substitute the viral infection for another enveloped virus, such as SARS-CoV-2, as evidenced by the NIH.
Therefore, claims 1-5, 7-17, and 19-20 would have been obvious to a person skilled in the art at the time.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-17, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 19-21, 24, 25, and 30 of copending Application No. 17/620,301 in view of Gola et al. (Frontiers in Clinical Drug Research-Anti-Infectives, 2017, 4, 93-141; “Gola”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are directed to treatment for a viral infection with a calixarene compound, where the reference application disclose a method of treating psoriasis, arthritis, asthma, or a condition treatable by steroids or heparan sulfate, with a calixarene compound and the secondary reference discloses use of steroids to treat viral infections.
The instant claims are directed to treatment of a viral infection with a calixarene compound, administered via composition by various routes (oral, injection, infusion etc.). The instant application also teaches an overlapping genus structure with the ‘301 application where the compound is calix[n]arene, or calixa[4]arene with four intrannular hydroxyl groups on the lower rim and four sulfonate groups on the upper rim as per elected species SCA-744. The instant application discloses treatment of a viral infection but does not explicitly recite treatment of a condition treatable by steroids.
However, the art recognizes that a viral infection is a condition treatable by steroids. Gola teaches the role of steroids in viral infections, where several natural and synthetic steroids have been reported as antiviral agents. Recent findings have demonstrated multiple physiological roles played by steroids during the course of different viral infections. These results encourage the assessment of novel steroids as antiviral and immunomodulatory entities (Abstract). It would have been prima facie obvious to a person skilled in the art to extract the compound taught by the ‘301 application and use it as an antiviral instead of a steroidal compound.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of using a calixarene as a steroid compound, as recited by the claims of the ’301 application, and use the compound as an antiviral instead. A person skilled in the art would be motivated to do so because where several natural and synthetic steroids have been reported as antiviral agents, as taught by Gola.
Therefore, claims 1-5, 7-17, and 19-20 would have been obvious to a person skilled in the art at the time.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-5, 7-17, and 19-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint 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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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621