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 .
Status of Application, Amendments and/or Claims
Claims 1-6, 8, 9, 11, 12, 15-17, 21, 24, 26, 27, 38, 39, 45-47, 55, 56, 59, and 65 are pending.
Election/Restrictions
Applicant’s election without traverse of (i) an agent that is a RIPK1 inhibitor and/or RIPK3 inhibitor as the species of agent; and (ii) a TNF- or TNF/LT-alpha-inhibiting agent as the species of anti-inflammatory agent in the reply filed on 29 May 2026 is acknowledged.
Claims 2-6, 8, 11, 12, 17, 21, 24, 26, 27, 39, 46, 47, and 65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 May 2026.
Claims 1, 9, 15, 16, 38, 45, 55, 56, and 59 are under consideration in the instant application as they read upon the elected species.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06 May 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
1. The drawings are objected to because the instant drawings do not comply with 37 C.F.R. § 1.84(U)(1), which states that partial views of a drawing which are intended to form one complete view, whether contained on one or several sheets, must be identified by the same number followed by a capital letter.
• Figure 2A of the instant application, for example, is presented on 9 separate panels/pages. The nine total sheets of drawings for Figure 2A should be numbered ''Figures 2A-2I”.
• Figure 2B is presented on 9 separate panels/pages. The nine total sheets of drawings for Figure 2B should be numbered ''Figures 2J-2R”.
• Figure 2C is presented on 9 separate panels/pages. The nine total sheets of drawings for Figure 2C should be numbered ''Figures 2S-2AA”.
• Figure 2D is presented on 9 separate panels/pages. The nine total sheets of drawings for Figure 2D should be numbered ''Figures 2BB-2JJ”.
• Figure 2E is presented on 9 separate panels/pages. The nine total sheets of drawings for Figure 2E should be numbered ''Figures 2KK-2SS”.
• Figure 2F is presented on 9 separate panels/pages. The nine total sheets of drawings for Figure 2F should be numbered ''Figures 2TT-2BBB”.
• Figure 3 is presented on 5 separate panels/pages. The five total sheets of drawings for Figure 3 should be renumbered “Figures 3A-3E”.
• Figure 4 is presented on 2 separate panels/pages. The two total sheets of drawings for Figure 4 should be renumbered “Figures 4A-4B”.
• Figure 5 is presented on 2 separate pages. The two total sheets of drawings for Figure 5 should be renumbered “Figures 5A-5B”.
• Figure 7 is presented on 2 separate pages. The two total sheets of drawings for Figure 7 should be renumbered “Figures 7A-7B”.
• Figure 8 is presented on 4 separate pages. The four total sheets of drawings for Figure 8 should be renumbered “Figures 8A-8D”.
• Figure 9 is missing. (Based upon the description of the drawings in the specification, three of the pages labeled as “Figure 8” may have labeled incorrectly and should actually be Figure 9 (A-C).
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. Applicant is reminded that once the drawings are changed to meet the separate numbering requirement of 37 C.F.R. 1 1.84(U)(1), Applicant is required to file an amendment to change the Brief Description of the Drawings and the rest of the specification accordingly.
Specification
2. The disclosure is objected to because of the following informalities:
2a. The Brief Description of the Drawings does not refer to Figures 2A-2F.
2b. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 31, line 43 through page 32, lines 1-2; page 44, line 26 of the specification filed 16 November 2023). 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.
Appropriate correction is required.
Claim Objections
3. Claim 56 is objected to because of the following informalities:
3a. In claim 56, line 6, the word “and” or “or” should be inserted after the phrase “SARS-CoV2,”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
4. Claims 9 and 15 are 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.
4a. Claims 9 and 15 are indefinite because they recite “Table 1” and “Table 2”. The claims are reading limitations from the specification into the claims. MPEP § 2173.05(s) states that “[w]here possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claims. Incorporation by reference is a necessity doctrine, not for applicant's convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)." Please note that this issue could be overcome by amending the claims to refer to the specific ligands, targets, and inhibitors represented in Tables 1 and 2.
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.
5. Claims 1, 9, 15, 16, 38, 45, and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walczak et al. (WO 2019/141862; 25 July 2019; cited on the IDS 06 May 2025).
Walczak et al. teach a method of treating inflammatory disease in a subject, the method comprising administering to the subject a combination treatment of at least 3 agents, the combination comprising: (1) a first agent that neutralizes the receptor TNFR1 or a ligand thereof; and (2) a second agent that neutralizes either TRAIL-R (or a ligand thereof) or CD95 (or a ligand thereof); and a third agent that neutralizes (3d) RIPK1, meeting the limitations of instant claims 1, 9, 38, and 59 (page 5, lines 12-34; page 6, line 35). Walczak et al. disclose that the first agent neutralizes TNF and/or LT-α, meeting the limitations of instant claims 9, 15, and 16 (page 6, lines 5-6). Walczak et al. also provide a list of TNF, RIPK1, and RIPK3 inhibitors (pages 9-10, Table 2). Walczak et al. teach that “inflammatory disease” includes acute kidney injury; transplant rejection; ischemia reperfusion injury of solid organs; sepsis; muscular dystrophy; Parkinson’s Disease; Alzheimer’s Disease; and Huntington’s Disease, meeting the limitations of instant claims 1 and 45(iv) (page 15, lines 7-9; page 16, lines 13-18).
6. Claims 1, 9, 15, 16, 38, 45, and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hart et al. (US 2017/0362219; 21 December 2017).
Hart et al. teach that dysregulation of RIPK3-dependent signaling has been linking to inflammatory diseases (page 1, [0005]). Hart et al. teach the generation of a small molecule inhibitor of RIPK3 activity to block RIPK3-dependent pro-inflammatory signaling (to thereby provide a therapeutic benefit in inflammatory diseases characterized by increased and/or dysregulated RIPK3 kinase activity) (page 1, [0006-0013]). Hart et al. disclose that the specific disease or condition treated with the inventive compound is adult respiratory distress syndrome (ARDS) or transplant rejection, meeting the limitations of instant claims 1 and 45 (page 10, [0177-0178]; page 15, [0239]). Hart et al. disclose that the compounds of the invention can be used in combination with other therapeutic agents (page 1, [0014]; page 15, [0242]). Hart et al. state that the other therapeutic agents include TNF-α inhibitors, such as tenidap, anti-TNF antibodies, or soluble TNF, meeting the limitations of instant claims 1, 9, 15, 16, 38, and 59 (page 15, [0243]).
3. Claims 1, 9, 15, 16, 38, 45, 55, 56, and 59 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chaudhary, P. (US 2023/0130925 or WO 2021/188601). It is noted that US 2023/0130925 and WO 2021/188601 have the same disclosure. Thus, for brevity, relevant portions of US 2023/0130925 (‘925) will be cited below.
Chaudhary teaches a method of treating complications caused by a viral infection (i.e., SARS, SARS-cov2, MERS, influenza, COVID-19, etc.) by administration of an immune response modulating agent (IRMA), meeting the limitations of instant claims 1 and 56 (page 1, [0002-0004]). Chaudhary discloses that a number of viral infections are associated with complications, such as adult respiratory distress syndrome (ARDS) and kidney failure, meeting the limitations of instant claims 1, 45, 55, and 56 (page 1, [0003]; page 2, [0014]; pages 4-5, [0043-0044]). Chaudhary indicates that claimed method involves administration to a subject with a viral infection an IRMA that comprises ponatinib [RIPK1 inhibitor], meeting the limitations of instant claim 1 (page 1, [0004]; page 2, [0013]). Chaudhary discloses that the IRMA can be administered in combination with other agents or treatments (page 1, [0004]). Chaudhary teaches that the other treatment comprises an antagonist or inhibitor of TNF alpha, meeting the limitations of instant claims 1, 9, 15, 16, 38, and 59 (page 2, [0008]; pages 8-9, [0098]; page 11, [0135]).
Conclusion
No claims are allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bernard et al. Am J Respir Crit Care Med 149: 818-824, 1994 (teach that adult respiratory distress syndrome is also known as acute respiratory distress syndrome (page 819, column 2, 1st full paragraph)
Lambris et al. (US 2011/0142837 and WO 2009/014633; teach treating ARDS by administering a TNA-alpha inhibitor)
Pan et al. Biochem Biophys Res Comm 478: 1602-1608, 2016 (teach that necrostatin-1 (RIPK1 inhibitor) protects against oleic acid (OA)-induced ARDS in rats)
Shashaty et al. Crit Care 23: 235, 2019 (teach that the change in plasma RIPK3 from presentation to 48 hr is associated with ARDS in sepsis and trauma)
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BEB
Art Unit 1647
24 July 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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