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 .
Claims
Acknowledgement is made of the remarks/amendments 8/19/2025. Claims 1-15 were cancelled. Claims 16-27 were newly added.
Foreign Priority
Applicant’s claim for the benefit under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to EP 20000170.9 filed 4/27/2020 and EP 20000172.5 filed 4/28/2020 is acknowledged.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed foreign applications EP 20000170.9 and EP 20000172.5, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The EP Applications lack support for:
nose spray (claim 26) – the applications discuss sprays in general and nasal application generically, and discuss pharyngeal application via throat spray, but there is no support for a “nose spray”.
Consequently, the effective filing date of claims 26 is 4/26/2021. The remainder of the claims are afforded the effectively filed date of 4/27/2020.
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.
Claim 16-27 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 and 27 recite “A method for the prophylaxis or treatment of a SARS-CoV-2 infection…through administering to such an infected individual.” The claim is incongruent and as a result it is unclear who the claims’ patient population is. Prophylaxis requires administration to someone not yet infected. Yet this term is contradicted by the body of the claim which requires administering to an infected individual. It is unclear if the target patient must be infected with SARS-CoV-2 or not.
Claim 27 is made further indefinite by the phrase “as a monotherapy comprising at least one 6’-methoxycinchonan-9-ol.” Monotherapy is at odds with the limitation “at least one”. “At least one” implies that more than one active can be administered.
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)(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 16-17, 19-21, 23-24 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cohen et al. (WO 2021/216759, published 10/28/2021, effectively filed 4/21/2020 which predates the instant foreign priority claims).
Cohen et al. teach the treatment or prevention of SARS-CoV-2 infection with quinine, preferably quinine sulphate dihydrate, which is preferably delivered via a nasal delivery device, such as an inhaler, atomizer or nebulizer (claims 16-17, 19-21, 23-24), e.g. a vibrating mesh nebulizer (p. 21, I. 13 - p. 22, I. 27). No other actives are administered so Cohen et al. teaches quinine as monotherapy. The compositions can be in the form of a liquid and/or aerosol (p. 9, I. 20-24) or as a dry powder for oral drug delivery (p. 17, lines 26-27). It is shown that quinine is effective in reducing SARS-CoV-2 infection in sinonasal ALI (air-liquid interface) (p. 26, I. 15 - p. 27, I. 24). Nasal instillation of a 0.1 % (1 mg/ml) solution of quinine sulfate dihydrate in saline protects ferrets against SARS-CoV-2 infection (p. 28, I. 25 - p. 30, I. 15, which includes nose spray). The human clinical trial NCT04408183 is described (p. 30, I. 16 - p. 31, I. 5).
Regarding the claim limitation that treatment is by inhibiting the SARS-CoV-2 replication, Cohen et al. is silent on this effect. However, as Cohen et al. teaches administering quinine to treat and prevent SARS-CoV-2, which is the sole required active step of the claims, it only follows that the quinine would have the same effect claimed (i.e. inhibiting replication).
Claim Rejections - 35 USC § 103
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.
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 16-27 are rejected under 35 U.S.C. 103 as being unpatentable over Charous (WO 03/039546, IDS) in view of Peralta et al. (US 2020/0237689, filed 3/24/2020).
Charous teaches the treatment or prevention of viral respiratory infections, including human corona virus infection (Summary of the invention p. 7), by administering an anti-malarial compound in a targeted fashion to the organ that is infected, preferably quinine or quinidine among a number of derivatives (p.1 Field of the Invention, p. 13). The anti-malarials quinine and quinidine are both taught to have antiviral activity alone which reads on the claim limitation of monotherapy (note the 112b regarding monotherapy in claim 27). Administration can be via inhalation, e.g. in the form of aerosols, powders or mists, which can be administered by a vibrating ultrasonic nebulizer; in liquid particulate forms, as nasal spray, eye drops or oral pastes (page 18, lines 1-9; page 8, lines 17-19; page 13, lines 6-8; page 23, lines 9-23; page 24, lines 1-4; page 25, line 28 - page 26, paragraph 4; page 27, lines 3-17; page 29, line 27 - page 30, line 2; page 31, lines 15-18). Administration is to the nasopharynx and bronchial airway for respiratory viruses (p. 2 final paragraph, p. 7 Summary of the Invention). Charous also teaches that oral administration of anti-malarials is well known but that the concentration of the drug that reaches the infected organ is less (p. 9, lines 10-11). Targeted administration is preferred but oral is conventional and less effective (note Charous does not say oral is not effective at all (p. 11, lines 24-30). Charous teaches for prophylaxis the anti-malarial compounds are typically delivered in an amount of 2-5 mg/day (p. 25). Note the above 112(b) regarding whether or not prophylaxis patients are included or excluded from the claim scope. Either way, Charous teaches both treatment and prophylaxis.
The teachings of Charous differ from the instant claims in that Charous teaches administering quinine and quinidine for the treatment of viruses including human corona virus among others, but fails to teach the specific human corona virus which is SARS-CoV-2. Charous also teaches several forms of administration but does not teach sublingual (claim 22).
Peralta et al. teach that coronaviruses are a group of related viruses that cause respiratory tract infections – included in this family is SARS-CoV-2 and various other human coronaviruses ([0004], [0206]). Peralta et al. also teaches forms of topical delivery is sublingual, respiratory or nasal ([0252]).
It would have been prima facie obvious to one of ordinary skill in the art before the time of filing to have administered the antiviral quinine or quinidine compositions of Charous to treat SARS-CoV-2 with a reasonable expectation of success. One would have been motivated to do so as Charous teaches that quinine and quinidine are antiviral against human corona viruses – especially when delivery is targeted to the site of infection. SARS-CoV-2 falls under the family of human corona viruses and is known to cause respiratory tract infections – so there is motivation to target delivery to the respiratory system. Peralta et al. also teaches that sublingual, respiratory and nasal administration are all topical forms of administration so it would have been obvious to have used these forms of administration interchangeably.
Regarding the claim limitation that treatment is by inhibiting the SARS-CoV-2 replication, the teachings of Charous and Peralta et al. render obvious administering quinine and quinidine to treat and prevent SARS-CoV-2, which is the sole required active step of the claims. As a result on would be imbued with a reasonable expectation that the quinine and quinidine would individually have the same effect claimed (i.e. inhibiting replication).
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.
Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18717846 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to a pharmaceutical combination of 5- amino-2,3-dihydro-1,4-phthalazinedione or one of its pharmaceutically acceptable salts, hydrates or solvates and a 6'-methoxycinchonan-9-ol or a pharmaceutically acceptable salt thereof. Claims 7 and 8 specify that the 6'-methoxycinchonan-9-ol is quinine or one of its pharmaceutically acceptable salts. Claim 6 recites the intended use of this composition for the prophylaxis or treatment of a coronaviral infection including SARS-CoV-2. Subsequent dependent claims specify the specific salts of the phthalazinedione, the ratio of the two drugs and the mode of administration including nose spray, eye drops, pharyngeal (claims 14 and 15).
The 112b regarding monotherapy and administering at least one 6'-methoxycinchonan-9-ol is noted here. To the extent that claim 27 permits additional active ingredients, this rejection is applied.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments regarding the 102 rejections over Cohen and Carous have been fully considered but are moot in light of the new grounds of rejection necessitated by amendment.
The 102 rejection over the teachings of Cohen has been re-applied to a number of the new method claims. Applicant argues that Cohen fails to teach that the effect of the drug is by inhibiting the SARS-CoV-2 replication. The examiner acknowledges that Cohen et al. is silent on this effect. However, as Cohen et al. teaches administering quinine to treat and prevent SARS-CoV-2, which is the sole required active step of the claims, it only follows that the quinine would have the same effect claimed (i.e. inhibiting replication). It is inherent to the quinine being administered to the same patient population.
The rejection of Charous was converted into a 103 rejection. Charous fails to teach the treatment of SARS-CoV-2, but the examiner’s position (see above 103 rejection over the teachings of Carous in view of Peralta) is that such treatment and prophylaxis would have been obvious.
Applicant’s arguments regarding the NSDP rejection over copending 18717846 have been fully considered and are largely persuasive save for the ambiguity in claim 27 which calls into question whether or not combination therapy is permitted (i.e. “at least”).
Conclusion
Claims 16-27 are rejected. No claim is allowed.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kortney Klinkel, whose telephone number is (571)270-5239. The examiner can normally be reached on Monday-Friday 10 am to 7 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Michener can be reached on 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627