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.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 18 December, 2025, in the matter of Application N° 18/255,262. Said documents have been entered on the record.
Claims 1-20 are canceled. Claims 21-39 are new. No new matter was introduced.
Thus, Claims 21-39 represent all claims currently under consideration.
Response to Amendment
Claims 1-20 (all previous claims) have been canceled. Therefore, all previous rejections of claims under 35 U.S.C. 112(b), 102(a)(1), 103 and Double Patenting are moot.
Applicant’s arguments regarding the prior rejections under 35 U.S.C. 102(a)(1) are not persuasive, as they rely on the assertion that the cited references fail to disclose treatment of SAR-CoV-2 infection, whereas the presently pending claims recite prophylaxis or treatment of sequela of SAR-CoV-2 infection (Remarks, Pg. 8.) The claimed “sequela of SAR-CoV-2 infection” is interpreted, consistent with the Specification (instant Specification, Pg. 7-10), as encompassing inflammatory and oxidative and/or nitrosative stress conditions triggered by infection, irrespective of the particular symptom or diagnosis listed (e.g., chronic fatigue, mood swings, hair loss). The Specification attributes the purported therapeutic effect across all listed sequelae to common inflammatory and oxidative stress pathways, thereby collapsing the recited conditions into treatment or prevention of those underlying mechanisms.
Applicant’s arguments regarding the prior rejections under 35 U.S.C. 103 preemptively address rejections that have not been applied to the newly presented claims and are therefore not responsive.
Applicant’s remarks regarding the Double Patenting Rejections rely upon an “accompanying Terminal Disclaimers” (Remarks, Pg. 11), none of which have been received. Based on amendments, the non-statutory Double Patent Rejection directed to U.S. Patent 11,007,192 has been withdrawn. All other previously referenced rejections for non-statutory Double Patent Rejections related to Patents or Co-pending Applications have been updated/maintained below.
Additionally, below can be found new grounds of rejection necessitated by amendments.
Specification
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.
Drawings
After further review, the drawings are objected to because the bars found in Figure 1 are described as being Black, White, Dark Gray and Light Gray (instant Specification, Pg. 47), yet only Black and White are discernible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 35 and 38-39 are objected to because of the following informalities: typographical errors.
“aid” in the phrase “…wherein aid composition…”, is assumed to be “said.”
Appropriate correction is required.
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.
Claims 21-24 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schumann et al. (Int. J. Mol. Sci. 2020, 21, 8803; doi:10.3390/ijms21228803, of previous record), hereinafter Schumann.
Reference shares multiple inventors with instant application.
Regarding Claims 21-24, Schumann teaches MP1032, a phase-pure anhydrous polymorph of 5-amino-2,3-dihydro-1,4-phthalazinedione sodium which salt exerts immune-modulatory, self-regulated ROS scavenging, and SARS-CoV-2 antiviral properties. Schumann further teaches this pharmacodynamic profile, which simultaneously addresses several crucial pathophysiological processes of SARS-CoV-2 infection and COVID-19 renders MP1032 a promising candidate for the treatment and possibly prevention of COVID-19 (Schumann, Pg. 12, §5. Conclusions.)
Regarding Claim 27, Schumann teaches subjects received MP1032 during oral clinical development (Schumann, Pg. 8, §3. Discussion.)
Therefore, Schumann discloses a method of orally administering the same compound to treat SAR-CoV-2 infection, wherein the compound exhibits immune-modulatory and ROS scavenging activity. As SARS-CoV-2 infection inherently results in inflammatory and oxidative stress conditions, Schumann anticipates the claimed method of treating a sequela of SARS-CoV-2 infection, found in Claims 21-24 and 27.
Claims 21-22, 24-28, 31, 33-36, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henry and Lynn (WO 2017/117586 A1, of previous record.)
Regarding Claims 21-22, and 24, Henry and Lynn teach a method of treating a patient by administering a therapeutically effective amount of 5-amino-2,3-dihydro-1,4-phthalazinedione, or a salt thereof (e.g., a monosodium salt thereof) (‘586, Pg. 2, Lines 2-3), to treat a medical condition such as a mood disorder or dysfunction, a memory disorder or dysfunction, anxiety or stress-related condition, acute or chronic fatigue (‘586, Pg. 2, Lines 26-27, and Pg. 3, Lines 1-15.) Henry and Lynn further disclose they have quantified the efficacy of oral administration of different doses for suppressing oxidative stress and inflammation (‘586, Pg. 24, Lines 1-2.)
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.)
As such, Claims 21-22, 24-28, 31, 33-36, and 39 are anticipated by Henry and Lynn.
Claims 21-28, 30-32, 34-36 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brysch (WO 2017/202496 A1, of previous record.)
Reference shares multiple inventors with instant application.
Regarding Claims 21-22 and 24, Brysch teaches method of treatment for the prophylaxis and/or treatment of inflammatory and/or degenerative disorders (‘496, Pg. 22, Lines 26-28) using 5-Amino-2,3-dihydro-1,4-phthalazinedione, its complexes, solvates, hydrates, crystalline polymorphs, tautomers, isomers, isotopically enriched forms, prodrugs or their pharmaceutically acceptable salts (‘496, Abstract and Pg. 26, Claim 1.)
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 Claim 25, Brysch teaches a composition contains at least one of 5-amino-2,3-dihydro-1,4-phthalazinedione or any of aforementioned molecular variants of this compound, a carrier and at least one excipient (‘496, Pg. 11, Lines 12-14.)
Regarding Claim 26, Brysch teaches 5-amino-2,3-dihydro-1,4-phthalazinedione can be also combined at least one active agent selected from a group comprising steroidal and non-steroidal anti-inflammatory drugs; immunomodulators; immunostimulatory agents; immunosuppressive agents; antibiotics; anti-infective agents; antiviral agents; antifungal agents; antiprotozoal agents; anthelmintics; analgesics; local anesthetics; anticoagulants; antiplatelet drugs; muscle relaxants; tonic agents; and anabolic agents (‘496, Pg. 18, Lines 21-26.)
Regarding Claims 27-28, 31-32, and 34-36, Brysch teaches can be applied orally, parenterally, intravenously, intraarterially, intramuscularly, topically, transdermally, subcutaneously, intradermally, sublingually, intravaginally, rectally or nasally (‘496, Pg. 21, Lines 33-35.)
Regarding Claims 30 and 38, Brysch teaches application can be carried out by means of liposomes (‘496, Pg. 22, Lines 20-22.)
As such, Claims 21-28, 30-32, 34-36 and 38 are anticipated by Brysch.
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, 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.
Claim 29 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Henry and Lynn (WO 2017/117586 A1, of previous record) as applied to Claims 21-22, 24-28, 31, 33-36, and 39 above, and further in view of Fleissner (WO 2017/140422 A1, of previous record.)
Reference shares multiple inventors with instant application.
The teachings of Henry and Lynn are set forth in the above 35 U.S.C. 102 Rejections and are incorporated herein. Henry and Lynn teach a method of treating a patient with conditions such as a mood disorder or dysfunction, a memory disorder or dysfunction, anxiety or stress-related condition, acute or chronic fatigue, to suppress oxidative stress and inflammation, by administering a therapeutically effective amount of 5-amino-2,3-dihydro-1,4-phthalazinedione, or a salt thereof. 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 and can be administered to the patient orally, topically, by inhalation, nasal delivery to the brain or by an injection, 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 and further that administration to the nasal passages, buccal mucosal and/or sublingual tissue may be preferred.
Henry and Lynn fail to explicitly teach inhalatory administration can be carried out by means of a vibrating mesh nebulizer.
However, Fleissner 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.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to specifically administer 5-amino-2,3-dihydro-1,4-phthalazinedione (AKA luminol) to the patient by means of a nebulizer as taught by Fleissner, in the method of treatment comprising administration via inhalation of the same compound as taught by Henry and Lynn with a reasonable expectation of success.
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.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to crystalline polymorph form of a 5-amino-2,3-dihydrophthalazine-1,4-dione, and compositions thereof, the compound being known to possess anti-inflammatory and antioxidant properties.
Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2, 8-9 and 15 of U.S. Patent No. 9,079,863.
Although the claims at issue are not identical, they are not patentably distinct from each other because the compound was known for treating inflammation in various disease settings, it would have been obvious to apply it to inflammation resulting from the sequela of SAR-CoV-2 infection.
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.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to crystalline polymorph form of a 5-amino-2,3-dihydrophthalazine-1,4-dione, the compound being known to possess anti-inflammatory and antioxidant properties.
Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4 and 6 of U.S. Patent No. 11,111,218.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to crystalline polymorph form of a 5-amino-2,3-dihydrophthalazine-1,4-dione, and compositions thereof, the compound being known to possess anti-inflammatory and antioxidant properties.
Claims 21-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of copending Application No. 17795360, Claims 1-14 of copending Application No. 17913687, Claims 1-15 of copending Application No. 18717846, Claims 1-19 of copending Application No. 18726854, Claims 1-20 of copending Application No. 18726933, and Claims 16-30 of copending Application No. 18850379.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to the same compound/composition as the copending applications, and differ only by the recited intended use.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627