Office Action 1: Non-Final Rejection (2024-09-28)

CLAIMS:
AMENDMENTS TO THE CLAIMS

This listing of the claims will replace all prior versions and listings of claims in the application.Please amend the claims as follows:

Application No. 18/329,069Attorney Docket No. 01118-0047-01US

1\. - 87. (Canceled)286

88\. (New) A method of treating pneumonia associated with COVID-19 comprising administering to a human subject in need thereof an effective amount of an anti-LIGHT antibody comprising a heavy chain and a light chain variable region comprising a CDR-H1 having the sequence of SEQ ID NO: 2, CDR-H2 having the sequence of SEQ ID NO: 3,CDR-H3 having the sequence of SEQ ID NO: 4, CDR-L1 having the sequence of SEQ ID NO: 5, CDR-L2 having the sequence of SEQ ID NO: 6, and CDR-L3 having the sequence of SEQ ID NO: 7.

89\. (New) The method of claim 88, wherein administration of the anti-LIGHT antibody reduces serum free-LIGHT levels in the subject.

90\. (New) The method of claim 88, wherein a single dose of about 16 mg/kg of the anti-LIGHT antibody is administered.

91\. (New) The method of claim 88, wherein the subject has received, or is currently receiving,an anti-COVID-19 therapy comprising a corticosteroid and/or remdesivir.

92\. (New) The method of claim 88, wherein administration of the anti-LIGHT antibody reduces the subject's risk of mortality by equal to or greater than 50% at 28 days and/or 60 days after administration.

93\. (New) The method of claim 88, where the subject is 60 years of age or older.

94\. (New) The method of claim 88, wherein administration of the anti-LIGHT antibody reduces the subject's risk of respiratory failure.

95\. (New) A method of treating respiratory failure associated with COVID-19 pneumonia comprising administering to a human subject in need thereof an effective amount of an anti- LIGHT antibody comprising a heavy chain and a light chain variable region comprising a CDR-H1 having the sequence of SEQ ID NO: 2, CDR-H2 having the sequence of SEQ ID NO: 3, CDR-H3 having the sequence of SEQ ID NO: 4, CDR-L1 having the sequence of SEQ ID NO: 5, CDR-L2 having the sequence of SEQ ID NO: 6, and CDR-L3 having the sequence of SEQ ID NO: 7.2

OFFICE ACTION:
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 .
1. Formal Matters
Claims 88-95 are pending and are the subject of this Office Action.
2. Specification
A.	If applicable, the first line of the specification should be updated to reflect the status (e.g. “now U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be found, any U.S. or Foreign Applications cited in the specification which have since issued should be updated with the corresponding Patent No.
B.	Though none could be found, any listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, the list may not be incorporated into the specification but must be submitted in a separate paper. Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
C.	Though no issues could be found, Applicant is advised that embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. The attempt to incorporate subject matter into the patent application by reference to a hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01(p), paragraph I regarding incorporation by reference. It is noted that the recitation of “www.” alone, as opposed to “http://www.”, is also active and should not be used.
D.	Though no issues could be found, trade names or marks used in commerce should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
E.	Though no issues could be found, when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and a sequence identifier (SEQ ID NO:X) must be used either in the drawing or in the Brief Description of the Drawings. See MPEP § 2422.02.
F.	Though no issues could be found, according to 37 CFR 1.821(d) (MPEP § 2422), where the description or claims of a patent application discuss a sequence listing that is set forth in the Sequence Listing in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
G.	The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Nonstatutory 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 88-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,708,406 (17/218,449). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment using the same LIGHT antibody.
The patent claims are drawn to treating ARDS and ACI, which are associated with COVID-19. ARDS and ACI are both caused by pneumonia. The instant claims are drawn to treating pneumonia, itself, as well as respiratory failure, associated with COVID-19. Since ARDS is considered a sign of respiratory failure, or is well-known to lead to failure, it would have been obvious at the time to have treated respiratory failure. Furthermore, paragraph [0228] of the specification defines the term “treat”, among other ways, to include prophylaxis/prevention. It can, therefore, be concluded that treating ARDS/ACI would prevent (i.e. treat) pneumonia/respiratory failure.
4. Conclusion
No claim is allowable.
Advisory information

APPLICANT REBUTTAL: 
REMARKS
Status of the Claims
Claims 88-95 are pending in the application. Claims 1-87 were previously canceled without prejudice or disclaimer.
Specification
The specification has been amended to change the application type from a divisional application to a continuation application. A corrected application data sheet is filed herewith reflecting this change. The amendments add no new matter.
Double Patenting
Claims 88-95 stand rejected on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-10 of U.S. Patent No. 11,708,406. Action at page 4.
Without conceding in the basis of rejection, and solely to expedite the prosecution of this application, Applicant submits herewith a terminal disclaimer over U.S. Patent No. 11,708,406. As such, Applicant respectfully requests that the double patenting rejection of claims 88-95 be withdrawn.
Conclusion

NEXT OFFICE ACTION: EXAMINER’S AMENDMENT
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 .
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
In the specification:
Amend the title to the following –
METHODS OF TREATING PNEUMONIA OR RESPIRATORY FAILURE ASSOCIATED WITH COVID-19 BY ADMINISTERING AN ANTI-LIGHT ANTIBODY
Advisory information

CITED REFERENCE SUMMARIES: Ref US11708406: Claims:
1. A method of treating acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) associated with COVID-19 comprising administering to a human subject in need thereof an effective amount of an anti-LIGHT antibody comprising a heavy chain and a light chain variable region comprising a CDR-H1 having the sequence of SEQ ID NO: 2, CDR-H2 having the sequence of SEQ ID NO: 3, CDR-H3 having the sequence of SEQ ID NO: 4, CDR-L1 having the sequence of SEQ ID NO: 5, CDR-L2 having the sequence of SEQ ID NO: 6, and CDR-L3 having the sequence of SEQ ID NO: 7.
2. The method of claim 1, wherein the subject has acute respiratory distress syndrome (ARDS).
3. The method of claim 1, wherein the subject has acute lung injury (ALI).
4. The method of claim 1, wherein the subject has pneumonia.
5. The method of claim 1, wherein administration of the anti-LIGHT antibody reduces serum free-LIGHT levels in the subject.
6. The method of claim 1, wherein a single dose of about 16 mg/kg of the anti-LIGHT antibody is administered.
7. The method of claim 1, wherein the subject has received, or is currently receiving, an anti-COVID-19 therapy comprising a corticosteroid, hydroxychloroquine, and/or remdesivir.
8. The method of claim 1 wherein administration of the anti-LIGHT antibody reduces the subject's risk of mortality by equal to or greater than 50% at 28 days and/or 60 days after administration.
9. The method of claim 8, where the subject is 60 years of age or older.
10. The method of claim 1, wherein administration of the anti-LIGHT antibody reduces the subject's risk of respiratory failure.