DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 7/22/26 has been entered in full. Claim 43 is amended. Claims 24 and 36-52 are pending.
Applicants’ election of Group II, currently all pending claims, was previously acknowledged and treated as an election without traverse. The election of “antibody-mediated transplant rejection” as the species of complement-mediated disease or disorder was also previously acknowledged. Claims 45 and 52 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 24, 36-44 and 46-51 are under consideration, as they read upon the elected species.
Information Disclosure Statement (IDS)
The Information Disclosure Statement filed on 7/22/26 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (1/22/26).
The objection to claim 43 at page 2 is withdrawn in view of the amendments to the claim.
The rejection of claims 24, 36-44 and 46-51 on the ground of nonstatutory obviousness-type double patenting at pages 3-6 as being unpatentable over claims 7-12, 14-20 and 24-32 of U.S. Patent 10,729,767, issued 8/4/20, is withdrawn in view of the terminal disclaimer naming the referenced patent or application filed by Applicants on 7/22/26 and approved by the USPTO.
Maintained Objections and/or Rejections
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24, 36-38, 40-41, 43 and 47-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,391,750, issued 8/19/25 (cited on a 11/20/25 IDS), and which shares the same applicant and inventors with the instant application.
This rejection was set forth at page 6 of the 1/22/26 Office action.
Claims 39 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,391,750 issued 8/19/25 (cited on a 11/20/25 IDS), and which shares the same applicant and inventors with the instant application, and further in view of Sandhu, 1992. Critical Reviews in Biotechnology, 12(5/6):437-462 (cited previously).
This rejection was set forth at pages 6-7 of the 1/22/26 Office action.
Claims 42 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,391,750 issued 8/19/25 (cited on a 11/20/25 IDS), and which shares the same applicant and inventors with the instant application, and further in view of U.S. Patent Application Publication 2014/0140933, published 5/22/14 (cited previously).
This rejection was set forth at pages 7-8 of the 1/22/26 Office action.
Applicants’ arguments (7/22/26; pages 9-11) as they pertain to the above rejections have been fully considered but are not deemed to be persuasive for the following reasons. Applicants’ arguments address the three rejections together and therefore are responded to together here.
Applicants argue that the rejections should be withdrawn because “the ‘750 patent does not qualify as a nonstatutory double patenting (NSDP) reference to the present application” (page 9), because a patent granting from the instant application “would not extend the term of the ‘750 patent”, in view of the terminal disclaimer filed over the ‘767 patent meaning that “a patent granting from the present application cannot expire any later than October 1, 2036” and “the ‘750 Patent has an expiration date of October 12, 2037” (page 10). Therefore, “a patent granting from the present application would not constitute an “unjustified extension of patent exclusivity” that the NSDP doctrine seeks to prevent” (page 10). In support, Applicants point to the facts in the instant case as being analogous to the decision of the PTAB in Ex Parte Baurin that was issued on 11/6/2024 (Appeal 2024-002920), “in which the Board held that the asserted references were not proper NSDP References and overturned the asserted NSDP rejections in view of these references” (page 10).
Applicants’ arguments have been fully considered but are not found persuasive. As set forth in the rejections of record, the instant claims are not patentably distinct from the claims of ‘750 (or the claims of ‘750 in view of a secondary reference), and ‘750 is a previously issued U.S. Patent sharing the same applicant and inventors. As such, the ‘750 patent is a proper NSDP reference with regard to the instant application, in accord with MPEP 804. The reasons why a terminal disclaimer are required to overcome such a NSDP rejection are outlined in MPEP 804.2.VI.
With respect to the Patent Board Appeal Decision in Ex Parte Baurin issued on 11/8/24 that is referenced by Applicants, the conclusion of this Appeal Decision has been reversed by a more recent Appeal Review Panel Decision. On 8/10/26, a “Decision On a Sua Sponte Rehearing” was issued, which reviewed the PTAB’s “reversal of Examiner’s rejections of claims 1-18 for nonstatutory double patenting” (pages 1-2), and reversed this decision. Per the conclusion on page 31, “For reasons discussed above, we reverse the Board’s Appeal Decision and Rehearing Decision. The Examiner’s rejections of record for obviousness-type double patenting, therefore, are affirmed”. And as outlined on page 33, the “Final Outcome of Appeal after Rehearing” is that each NSDP rejection is affirmed. As such, it is held that the current decision in Ex Parte Baurin supports that the ‘750 patent does qualify as NSDP reference with respect to the claims of the instant application.
Conclusion
Claims 44, 46 and 51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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