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
This application, filed 31 May, 2023, is a national stage application of PCT/EP2021/000150, filed 1 December, 2021, which claims foreign benefit of Application EP20000433.1, filed 2 December, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 16 June, 2026 is acknowledged and has been considered.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 June, 2026 has been entered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 16 June, 2026, in the matter of Application N° 18/255,262. Said documents have been entered on the record.
Claims 21, 24, 27-28, 30-31, 34-35 and 38-39 are amended. No new matter was introduced.
Thus, Claims 21-39 represent all claims currently under consideration.
Response to Amendments/Arguments
The objection to the drawings is withdrawn in view of Applicant’s submission of a replacement drawing sheet containing corrected Figure 1, which adequately addresses the deficiency previously identified by the Examiner.
The amendments to Claims 35 and 38-39 have overcome the objections based on minor informalities.
Applicant’s references to paragraphs [0047], [0049], etc. appear to correspond to paragraph numbering in U.S. Patent Application Publication No. US 2024/0075029 A1. The Examiner notes, however, that the specification submitted in the present application corresponds to the disclosure of WO 2022/117221 A1 and does not contain numbered paragraphs. Accordingly, for clarity of the prosecution record, references herein to the instant Specification are made to the page and paragraph locations of the Specification as actually submitted, rather than to paragraph numbers appearing in the subsequently published U.S. application.
Applicant’s amendment concerning the previously identified hyperlinks has been considered. As noted in the prior Office action, Applicant previously corrected the hyperlink appearing on page 7 of the Specification; however, two additional hyperlinks remained on page 8. The present amendment addresses the first link on Page 8, Para 1, but does not address the second hyperlink also specifically noted in the previous office action on the same page (Para 4). Accordingly, the objection to the Specification is maintained.
As Applicant identifies the corrected material by reference to paragraph [0049] of US 2024/0075029 A1, that paragraph numbering is not present in the Specification submitted in the instant Application, and has therefore not been entered. Any amendments to the instant Specification should identify and amend the corresponding location in the Specification of record (WO 2022/117221 A1).
The affidavit under 37 CFR 1.130(a) filed on 16 June, 2026 is sufficient to overcome the rejection of Claims 21-24 and 27 based on 35 U.S.C. 102(a)(1). The reference is subject to the exception of 35 U.S.C. 102(b)(1)(A). Accordingly, the rejection based on Schumann is withdrawn.
Applicant has amended independent Claim 21 to replace the recitation “a sequela of a SARS-CoV-2 infection” with “Long COVID.” Applicant explains that the terms are intended to be consistent with Para [0047] of US 2024/0075029 A1. The corresponding disclosure in the Specification of record appears on page 7, second to last paragraph, and defines a sequela as a disease, syndrome, symptom, or disability manifesting or persisting more than 28 days following SARS-CoV-2 infection and states that the term “Long COVID” is used synonymously.
Applicant’s arguments concerning the prior anticipation rejections have been considered. Applicant argues, principally, that Henry and Lynn and Brysch predate the emergence of SARS-CoV-2 and therefore do not disclose treatment of Long COVID, notwithstanding their teachings concerning treatment of chronic fatigue, inflammation, oxidative stress, or other conditions (Remarks, Pg 10). In view of the amended claim language and upon consideration of the cited art, the prior rejections under 35 U.S.C. 102 based upon Henry and Lynn and Brysch are withdrawn.
Applicant further argues that Henry and Lynn would not have rendered the claims obvious because Long COVID was unknown when Henry and Lynn was published; the etiology of Long COVID was not established at the effective filing date; and the presence of oxidative stress and inflammation in Long COVID would not, standing alone, have provided a reasonable expectation that an antioxidant or anti-inflammatory agent would successfully treat Long COVID. Applicant additionally points to later studies of various antioxidant and anti-inflammatory agents as evidence that activity against oxidative stress or inflammation does not necessarily establish therapeutic efficacy against Long COVID (Remarks, Pg 11-12).
These arguments have been considered. However, the presently applied rejection under 35 U.S.C. 103 does not rely upon Henry and Lynn alone, nor upon a general proposition that any antioxidant or anti-inflammatory compound would have been expected to treat Long COVID. Rather, as set forth in detail below, Marshall teaches the occurrence of persistent post SARS-CoV-2 symptoms, particularly severe fatigue, and expressly relates such persistent fatigue to chronic fatigue syndrome (CFS); Marshall further identifies persistent low-level inflammation, possibly triggered by infection, in connection with chronic fatigue syndrome and considers COVID-19 as such a potential trigger. Gerwyn and Maes independently teach that ME/CFS is associated with chronic oxidative/nitrosative stress and low-grade inflammation and that these processes may account for increased muscle fatigue and related dysfunction. Henry and Lynn, in turn, teach administration of 5-amino-2,3-dihydro-1,4-phthalazinedione, or a salt thereof, for treatment of acute or chronic fatigue and specifically investigate the compound for suppression of oxidative stress and inflammation.
Thus, the rejection does not depend upon a complete understanding of the etiology of Long COVID or upon an assumption that antioxidant or anti-inflammatory activity generally predicts efficacy against Long COVID. Rather, the cited references, considered together, provide a reasoned path from the persistent post-SARS-CoV-2 fatigue recognized in the art, through its recognized resemblance to ME/CFS and the pathological processes associated therewith to the use of a specific compound already taught for treatment of chronic fatigue and for modulation of those same processes. Accordingly, Applicant’s arguments do not overcome the new rejections under 35 U.S.C. 103 set forth below.
Applicant’s arguments concerning the nonstatutory double patenting (NSDP) rejections have been fully considered. In view of the amendment to the claims and upon reconsideration of the claims presently pending in the cited patents and copending applications, certain previously entered NSDP rejections have been withdrawn. The remaining NSDP rejections have been reconsidered and are maintained, as modified below. Additional grounds of NSDP have also been entered based upon presently pending claims and the prior art discussed therein.
Applicant principally argues that the cited patents and copending applications are directed to subject matter other than treatment of Long COVID and therefore do not render the presently claimed methods patentably indistinct (Remarks, Pg 13-17). However, the NSDP rejections presently entered do not rely merely upon the presence of 5-amino-2,3-dihydro-1,4-phthalazinedione in the respective claims. Rather, each rejection identifies the particular relationship between the claims of the reference patent or application and the instant claims and, where appropriate, relies on Marshall and Gerwyn and Maes to establish why the recited treatment of Long COVID would have constituted an obvious variation of the subject matter claimed in the reference patent or application. Accordingly, Applicant’s arguments do not overcome the NSDP rejections as presently formulated.
Specification (Maintained)
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
While one instance of an embedded link was corrected in the response filed 18 December, 2025, there are at least two additional instances found on Page 8 of the disclosure. Please review the Specification in its entirety for any additional occurrences.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 21-22, 24-28, 31, 33-36 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), in view of Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1), and further in view of Henry and Lynn (WO 2017/117586 A1, of previous record).
Regarding Claims 21-22 and 24, Marshall teaches that, months after infection with SAR-CoV-2, some individuals continued to experience severe fatigue and other persistent symptoms described as “long-COVID,” (Marshall, Nature, published Sept. 14, 2020, online article introductory summary) and identifies severe fatigue as one of the most insidious long-term effects of COVID-19. Marshall reports that individuals experienced fatigue approximately two months after onset of COVID-19 symptoms and further teaches that these persistent symptoms resemble chronic fatigue syndrome, also known as myalgic encephalomyelitis (ME/CFS). Marshall additionally discusses evidence from prior SARS coronavirus infection demonstrating long-term fatigue, including persistent fatigue, muscle pain, depression and disrupted sleep 13-36 months after infection, and reports that another study found chronic fatigue in 40% of individuals followed for four years after SARS infection (Marshall, Pg 341, §Chronic Fatigue).
Marshall further teaches that prior literature concerning chronic fatigue syndrome found persistent low-level inflammation, possibly triggered by infection, and expressly considers whether COVID-19 may similarly act as such a trigger, noting reports of previously healthy individuals whose energy levels had not returned to normal following infection and an expectation of new cases of chronic fatigue syndrome (Marshall, Pg 341, §Chronic Fatigue).
Gerwin and Maes teach that ME/CFS is associated with chronic oxidative and nitrosative stress (O&NS) and inflammation, and that chronic O&NS and low-grade inflammation may explain increased muscle fatigue, impaired muscle contractility and exercise intolerance in individuals with ME/CFS (Gerwin and Maes, §Abstract-Summary). Thus, the art had recognized chronic oxidative/nitrosative stress and low-grade inflammation as processes associated with the chronic fatigue syndrome to which Marshall compared the persistent fatigue observed following SARS-CoV-2 infection.
Henry and Lynn teach a method of treating a patient suffering from acute or chronic fatigue by administering a therapeutically effective amount of 5-amino-2,3-dihydro-1,4-phthalazinedione, or a salt thereof, including a monosodium salt (‘586, Pg. 2, Lines 2-3, Pg. 3, Line 7). Henry and Lynn further teach quantifying the efficacy of administration of the compound for “suppressing oxidative stress and inflammation” (‘586, Pg. 24, Lines 1-2).
Therefore, at the time of the invention, one of ordinary skill in the art confronted with individuals experiencing persistent fatigue and other symptoms of Long COVID as described by Marshall would have had reason to consider treatments known for chronic fatigue syndrome and for the pathological processes associated therewith. Marshall expressly directed attention to the resemblance between persistent post-SARS-CoV-2 fatigue and chronic fatigue syndrome and to persistent low-level inflammation as a possible infection-triggered process. Gerwyn and Maes further established that chronic fatigue syndrome was associated with chronic oxidative/nitrosative stress and low-grade inflammation. Henry and Lynn, in turn, taught administration of 5-amino-2,3-dihydro-1,4-phthalazinedione or a salt thereof for treatment of chronic fatigue and taught its use for suppressing oxidative stress and inflammation. Accordingly, it would have been obvious to administer a therapeutically effective amount of 5-amino-2,3-dihydro-1,4-phthalazinedione, or a salt thereof, to an individual experiencing Long COVID, with a reasonable expectation of providing therapeutic benefit.
Regarding Claims 25-26, Henry and Lynn teach pharmaceutical formulations can include the agent together with one or more pharmaceutically acceptable carriers or excipients and optionally other therapeutic agents (‘586, Pg. 16, Lines 21-22.)
Regarding Claims 27-28 and 35-36, Henry and Lynn teach a composition of the invention can be administered to the patient orally, topically, by inhalation, nasal delivery to the brain or by an injection (‘586, Pg. 10, Lines 18-21), and the composition can be formulated in the form of a pill, a capsule, a granule, a tablet, a pallet, a suspension, an injection, an infusion, a suppository, a continuous delivery system, a syrup, a tincture, an ointment, a cream, eye drops, eardrops, a flush, a lavage, a slow absorbing depot, a dressing, a lozenge, or any pharmaceutically acceptable application or as a nutritional supplement (‘586, Pg. 14, Lines 13-17.)
Regarding Claims 31 and 39, Henry and Lynn teach administration to the nasal passages, buccal mucosal and/or sublingual tissue may be preferred (‘586, Pg. 10, Lines 21-23.)
Regarding Claim 33, Henry and Lynn teach formulations can be stored in a freeze-dried (lyophilized) condition (‘586, Pg. 20, Line 29.)
Regarding Claim 34, Henry and Lynn teach an intravenous administration (‘586, Pg. 12, Lines 15-16.)
Claims 23, 30, 32 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), in view of Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1), and Henry and Lynn (WO 2017/117586 A1, of previous record), as applied to Claim 21 above, and further in view of Brysch (WO 2017/202496 A1, of previous record.)
Reference shares multiple inventors with instant application.
The teachings of Marshall, Gerwyn and Maes, and Henry and Lynn are set forth in the preceding rejection and are incorporated herein.
Regarding Claim 23, Brysch teaches a crystalline polymorph of 5-Amino-2,3,dihydro-1,4-phthalazinedione sodium salt selected from a group comprising Form I, Form II and Form III (‘496, Abstract and Pg. 26, Claim 2.)
Regarding Claims 30 and 38, Brysch teaches application can be carried out by means of liposomes (‘496, Pg. 22, Lines 20-22.)
Regarding Claim 32, Brysch further teaches administration of 5-Amino-2,3,dihydro-1,4-phthalazinedione can be applied orally, parenterally, intravenously, intraarterially, intramuscularly, topically, transdermally, subcutaneously, intradermally, sublingually, intravaginally, rectally or nasally (‘496, Pg. 21, Lines 33-35.)
It would have been prima facie obvious to one of ordinary skill in the art to employ the crystalline polymorphic forms and pharmaceutical administration/formulation embodiments taught by Brysch when administering 5-Amino-2,3,dihydro-1,4-phthalazinedione according the methods of Marshall, Gerwyn and Maes, and Henry and Lynn, because Brysch expressly teaches those forms and delivery embodiments as suitable means for administering the same active compound. One of ordinary skill would have had a reasonable expectation that such known forms and delivery means would likewise provide the compound for its intended therapeutic effect.
Claims 29 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), in view of Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1), and Henry and Lynn (WO 2017/117586 A1, of previous record), as applied to Claim 21 above, and further in view of Fleissner (WO 2017/140422 A1, of previous record.)
Reference shares multiple inventors with instant application.
The teachings of Marshall, Gerwyn and Maes, and Henry and Lynn are set forth in the preceding rejection and are incorporated herein. As discussed therein, Henry and Lynn teach administration of 5-Amino-2,3,dihydro-1,4-phthalazinedione by inhalation.
Fleissner further teaches a preferred embodiment is the formulation of luminol as an aerosol, which is administered to the patient by means of a nebulizer (‘422, Pg. 22, Lines 11 and 20.)
It would have been prima facie obvious to one of ordinary skill in the art to employ the nebulizer taught by Fleissner for inhalatory administration of 5-Amino-2,3,dihydro-1,4-phthalazinedione as taught by Henry and Lynn, as a known means of delivering the active compound by inhalation, with a reasonable expectation of successfully administering the compound to the respiratory tract.
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 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 3-6 of U.S. Patent No. 8,772,294 in view of Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), and Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 1 and 3-6 of the ‘294 patent are directed to crystalline polymorphic Forms I and II of 5-amino-2,3-dihydro-1,4-phthalazinedione sodium, and compositions thereof. In construing the scope of the claimed compounds and compositions, the specification of the ‘294 patent further identifies the compound as belonging to a class of compounds known to possess immunomodulatory, anti-inflammatory, antioxidative, and antitoxic properties (‘294, Col 2, Lines 25-26). See MPEP 804 (II)(B)(1), “In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”
The instant claims differ from the claims of the ‘294 patent principally in reciting the therapeutic use of the compound, or a salt thereof, for treating an individual having Long COVID. Instant Claim 23 further recites the crystalline polymorphs corresponding to Forms I and II claimed in the ‘294 patent.
Marshall teaches persistent post SARS-CoV-2 illness characterized by long-term symptoms, including severe and persistent fatigue, and recognizes similarities between post-COVID chronic fatigue and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Marshall further teaches that persistent low-level inflammation, potentially triggered by infection, had been implicated in chronic fatigue syndrome and identifies inflammation as a subject of investigation in patients experiencing prolonged effects following COVID-19.
Gerwyn and Maes teach that chronic oxidative and nitrosative and low-grade inflammation are present in many patients with ME/CFS and may contribute to increased muscle fatigue, impaired muscle contractability, and exercise intolerance.
Accordingly, at the time of the instant invention, one of ordinary skill in the art, seeking to treat the persistent fatigue and related manifestations recognized in individuals experiencing prolonged effects following SARS-CoV-2 infection, would have had reason to employ the therapeutically useful 5-amino-2,3-dihydro-1,4-phthalazinedione sodium, to include the crystalline polymorphic Forms I and II, and pharmaceutical compositions thereof claimed in the ‘294 patent, in view of Marshall’s recognition of the relationship between persistent post-COVID fatigue and CFS/ME and Gerwyn and Maes teaching that chronic oxidative/nitrosative stress and low-grade inflammation contribute to the fatigue associated with ME/CFS. A person of ordinary skill would therefore have had a reasonable expectation that administration of the claimed compound would provide therapeutic benefit by addressing fatigue and associated inflammatory and oxidative/nitrosative processes.
Thus, the recitation of treating an individual having Long COVID does not render the instant claims patentably distinct from Claims 1 and 3-6 of the ‘294 patent in view of Marshall and Gerwyn and Maes, and Claims 21-26 constitute an obvious variation of the invention claimed in the ‘294 patent.
Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2 and 8-9 of U.S. Patent No. 9,079,863, in view of Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), and Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1).
Although the claims at issue are not identical, they are not patentably distinct. Claims 1-2 and 8-9 of the ‘863 patent are directed to methods of treating inflammation in a subject by administering crystalline polymorphic forms of 5-amino-2,3-dihydro-1,4-phthalazinedione sodium salt. The instant claims differ principally in reciting administration to an individual having Long COVID.
The teachings of Marshall and Gerwyn and Maes are set forth in the preceding NSDP rejection and are incorporated herein. As discussed above, Marshall teaches persistent post-COVID fatigue and its relationship to CFS/ME and identifies persistent low-level inflammation as implicated in chronic fatigue syndrome, while Gerwyn and Maes teach chronic oxidative/nitrosative stress and low-grade inflammation in ME/CFS and their relationship to fatigue.
Accordingly, one of ordinary skill in the art would have had reason to employ the anti-inflammatory treatment claimed in the ‘863 patent in an individual experiencing Long COVID, particularly persistent fatigue associated with inflammatory and oxidative/nitrosative processes, with a reasonable expectation of therapeutic benefit. Thus, the recitation of Long COVID does not render instant Claims 21-23 patentably distinct from Claims 1-2 and 8-9 of the ‘863 patent in view of Marshall and Gerwyn and Maes.
Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 10,258,620 in view of Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), and Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1).
Although the claims at issue are not identical, they are not patentably distinct. Claim 1 of the ‘620 patent is directed to crystalline polymorphic Form III of 5-amino-2,3-dihydrophthalazine-1,4-dione sodium salt, which is expressly encompassed by instant Claim 23. The specification of the ‘620 patent further describes therapeutic uses of the claimed compound, including uses associated with its immunomodulatory and anti-inflammatory and antioxidative properties.
The teachings of Marshall and Gerwyn and Maes, and the rationale for employing the claimed compound in treating Long COVID, are set forth in the preceding NSDP rejections and are incorporated herein. For the same reasons, the recitation of treating an individual having Long COVID does not render instant Claims 21-23 patentably distinct from Claim 1 of the ‘620 patent in view of Marshall and Gerwyn and Maes.
Claims 21-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3, 6-14 and 16-27 of copending Application No. 17/913,687 and separately Claims 1-3 and 7-14 of copending Application No. 18/001,034, each in view of Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), and Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1).
The copending application ‘034 is directed to a method of treating or preventing a SARS-CoV-2 infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of 5-amino-2,3-dihydrophthalazine-1,4-dione or one of its pharmaceutically acceptable salts thereof. The copending application ‘687 is directed to a method of reducing or inhibiting replication of SARS-CoV-2 in an individual having acute lung injury caused by SARS-CoV-2 by administering 5-amino-2,3-dihydrophthalazine-1,4-dione or one of its pharmaceutically acceptable salts. Thus, each copending application claims therapeutic administration of the presently claimed compound in the SAR-CoV-2 disease context, whereas the instant claims recite administration thereof to an individual having Long COVID.
The teachings of Marshall and Gerwyn and Maes and the rationale concerning treatment of persistent post-COVID manifestations with the recited compound are set forth above and incorporated herein. In view of those teachings, one of ordinary skill in the art would have had reason to administer the same compound to an individual experiencing persistent manifestations following SARS-CoV-2 infection, with a reasonable expectation of therapeutic benefit. Accordingly, treatment of an individual having Long COVID represents an obvious variation of the therapeutic uses claimed in the copending applications.
This is a provisional nonstatutory double patenting rejection.
Claims 23, 25-26 and 32-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-6 and 9-16 of copending Application No. 17/913,687, in view of Marshall (Nature. Vol 585. 17 September 2020. PP 339-341), and Gerwyn and Maes (Curr Rheumatol Rep (2017) 19: 1).
Although the claims at issue are not identical, they are not patentably distinct. The claims of copending ‘846 are directed to pharmaceutical combinations comprising 5-amino-2,3-dihydrophthalazine-1,4-dione, or a salt thereof, in combination with 6'-methoxycinchonan-9-ol, including use of such combinations in the prophylaxis or treatment of coronavirus infection. The claims further expressly encompass SAR-CoV-2 infection and recite embodiments comprising the sodium salt, including crystalline polymorphic Forms I-III, as well as overlapping formulation (e.g., oral, sublingual, etc.) The instant claims differ principally in reciting administration to an individual having Long COVID rather than prophylaxis or treatment of the underlying coronavirus/SAR-CoV-2 infection.
The teachings of Marshall and Gerwyn and Maes and the rationale concerning treatment of persistent post-COVID manifestations with the recited compound are set forth above and incorporated herein. In view of those teachings, one of ordinary skill in the art would have had reason to employ the pharmaceutical combinations claimed in ‘846 to an individual experiencing persistent manifestations following SARS-CoV-2 infection, with a reasonable expectation of therapeutic benefit.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
Prosecution Insights