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 .
DETAILED ACTION
Priority
This application is a continuation of U.S. Patent Application No. 17/233,141, filed April 16, 2021, which claims the benefit of priority to the following U.S. Provisional Application Nos.: 63/011,921, filed April 17, 2020, and 63/031,192, filed May 28, 2020, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 10/07/2024 is acknowledged. Claims 51-64 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/07/2024 and 11/03/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 10/07/2024 are acknowledged and accepted by the Examiner.
Specification
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 36). 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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 51-57 and 60-64 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wagner (WO2012/054584, IDS of record dated 10/07/2024).
The claims are directed to a method of treating cytokine release syndrome (CRS), the method comprising administering to a subject having CRS an effective amount of a peptide that alters or modulates the binding or interaction between CD40 complex and CD 154 proteins, wherein the peptide comprises SEQ ID NO: 4.
Regarding claims 51-53 and 63-64, Wagner discloses “methods and materials for treating and preventing autoimmune diseases. In particular, the present invention relates to the discovery that small peptides are capable of interacting with CD40, thereby interfering with the ability of CD40 to interact with CD 154, which is important in inflammation. The present invention also relates to the use of such peptides in reducing the inflammatory response, and in particular, the autoimmune inflammatory response. The present invention also relates to the use of such short peptides to prevent or reverse autoimmune disease, and particular, diabetes, in individuals suffering from such disease. It also relates to methods and materials for detecting T-cells that express CD40 (Th40 cells). Also provided are kits for reducing inflammation, treating autoimmune diseases, or detecting Th40 cells” (Abstract). Wagner discloses that the invention “provides a novel method for modulating inflammation, and in particular, inflammation that arises as a result of an autoimmune disease. The invention is based on the knowledge that interaction of CD40-ligand (CD154 protein) with CD40 protein expressed on T-cells (Th40 cells), is important in the development of autoimmune disease. The invention is also based on the elucidation of the critical residues in CD40 and CD 154 that are important for this interaction. The present invention relates to blocking the interaction between a CD40 protein and a CD 154 protein through the use of small peptides that interact with the CD40 protein at a site where the CD 154 protein would normally bind. The present invention also relates to using such peptides to reduce the level of Th40 cells, thereby reducing the severity of disease” (page 5 lines 28-34 to page 6 lines 1-2). Wagner discloses SEQ ID NO: 4 of the present invention (see Table 1 below, SEQ ID NOs.: 5, 7, 11-14, 20-21).
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With respect to the claims being directed to treating cytokine release syndrome (CRS), acute respiratory distress syndrome (ARDS) and acute lung injury (ALI), although the preamble refers to a different condition, the method’s compositions and steps are the same as the prior art, thus, it has not been given patentable weight because the recitation occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method of treating CRS given the knowledge of Wagner disclosing the method steps and peptides of the instant invention. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the fact that Wagner demonstrates the peptides successfully modulating the binding or interaction between CD40 complex and CD154 proteins comprising SEQ ID NO: 4. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 54, Wagner discloses SEQ ID NO: 7 of the present invention (see Table 1 above, SEQ ID NO: 9 and claim 10 of Wagner). Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method of treating CRS given the knowledge of Wagner disclosing the method steps and peptides of the instant invention. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the fact that Wagner demonstrates the peptides successfully modulating the binding or interaction between CD40 complex and CD154 proteins comprising SEQ ID NO: 7.
Regarding claim 55, Wagner discloses the peptide decreases an amount of inflammatory cytokines (page 10, lines 25-30; claim 9 of Wagner); whereby said peptide affects the interaction of CD40 with CD 154 in such a manner as alter the cytokine expression profile of a cell population treated with said peptide. Wagner does not explicitly state the recited cytokines; however, the peptides of Wagner comprise the peptide of SEQ ID NO: 4, thus would have the same functions of modulating inflammatory cytokines as listed in the instant claim. Moreover, Applicant is claiming a feature that is only determined after the method is performed and the assay results are analyzed. Therefore, the Office is interpreting the claims as being the same as claim 55.
Regarding claims 56 and 57, Wagner discloses the peptides can be modifies by pegylation, glycosylation and chemical modification (page 14, lines 31-33 to page 15, lines 1-2).
Regarding claim 60, Wagner discloses the peptide can be administered to the lungs of the subject (page 16, lines 11-21).
Regarding claim 61, Wagner discloses the peptide can be linked to an epitope tag polypeptide (page 14, lines 19-30).
Regarding claim 62, Wagner discloses the peptides can be modified by chemical means (page 15, lines 1-2).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 Langi, 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 51-53 and 55-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-14 of U.S. Patent No. 12048734. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The patented claims are directed to:
1. A method of treating COVID-19, the method comprising administering to a subject having COVID-19 an effective amount of a peptide that alters or modulates the binding or interaction between CD40 complex and CD 154 proteins, wherein the peptide comprises SEQ ID NO: 4 (instant claim 51).
2. The method of claim 1, wherein the peptide binds to CD40 complex (instant claim 52).
3. The method of claim 1, wherein the peptide disrupts or alters the interaction of CD40 complex with CD154 and reduces the number of Th40 cells in the subject (instant claim 53).
5. The method of claim 1, wherein administration of the peptide decreases an amount of inflammatory cytokine selected from the group of IL-2, IFNγ, IL-6, TNFα, TGF, and IL-17A, and/or increases an amount of IL-10 (instant claim 55).
6. The method of claim 1, wherein the peptide comprises a modification selected from phosphorylation, glycosylation, acetylation on the N-terminus and/or amidation on the C-terminus (instant claim 56).
7. The method of claim 1, wherein the peptide is linked to a polyethylene glycol (PEG) molecule (instant claim 57).
8. The method of claim 1, wherein the peptide is linked to one or more domains of an Fc region of human IgG immunoglobin (instant claim 58).
9. The method of claim 8, wherein the Fc region is human IgG hinge, CH2, CH3 region that is fused to at least one of the amino-terminus or carboxyl-terminus of the peptide (instant claim 59).
10. The method of claim 1, wherein the peptide is administered to the lungs of the subject (instant claim 60).
11. The method of claim 1, wherein the peptide is linked to an epitope tag polypeptide comprising between 6 and 50 amino acid residues (instant claim 61).
12. The method of claim 1, wherein the subject is experiencing cytokine release syndrome (CRS) and/or wherein the method treats or reduces the severity of CRS (instant claim 51).
13. The method of claim 1, wherein the subject is experiencing acute respiratory distress syndrome (ARDS) and/or wherein the method treats or reduces the severity of ARDS (instant claims 63-64).
14. The method of claim 1, wherein the peptide is constructed by chemical means (instant claim 62).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 12048734 discloses a method of treating cytokine release syndrome (CRS), the method comprising administering to a subject having CRS an effective amount of a peptide that alters or modulates the binding or interaction between CD40 complex and CD 154 proteins, wherein the peptide comprises SEQ ID NO: 4. Although the preamble refers to a different condition such as Covid-19 and acute lung injury, the method steps are the same as the patented claims, it has not been given patentable weight because the recitation occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Further, the MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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