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 6/26/26 has been entered in full. The specification is amended. Claims 9, 12, 14 and 22 are amended. Claim 10 is canceled. New claim 26 is added. Claims 1-2, 4-9, 12-18, 20-22 and 25-26 are pending.
In an interview conducted on 8/7/26 (see the summary mailed 8/17/26), Applicants’ representative indicated that Applicants were considering abandoning the application. In a subsequent phone message left with the Examiner on 8/31/26, Applicants’ representative indicated that Applicants have not yet made a decision with regard to this. In the interview the Examiner had discussed mailing a Quayle Action to address objections to claim 26 if Applicants were not able to authorize an Examiner’s Amendment to amend the claim. On further consideration, the language of new claim 26 requires both an objection and a rejection for indefiniteness (see below). As such, a final Office action is herewith issued.
Information Disclosure Statement (IDS)
The Information Disclosure Statement filed on 8/4/26 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (4/1/26).
The objections to the specification at page 2 are withdrawn in view of the amendments to the specification.
All objections to, and/or rejections of, canceled claim 10 are moot.
The objection to claim 22 at pages 2-3 is withdrawn in view of the amendments to the claims.
The rejection of claims 9, 12 and 14-16 under 35 U.S.C. § 112(b) at pages 3-4 as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
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 1-2, 4-9, 12-18, 20-22 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of co-pending application 18/560,285, filed 11/10/23, and which shares the same applicant and inventors with the instant application.
This rejection was set forth at pages 4-7 of the 4/1/26 Office Action for claims 1-2, 4-9, 12-18, 20-22 and 25. New dependent claim 26 encompasses the same embodiment over which parent claim 9 is rejected, and as such is rejected on the same grounds.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the reasons set forth in the previous Office action.
Applicants’ arguments (6/26/26; page 10) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
In the response, Applicants argue that the instant application has an earlier filing date than the ‘285 application, and “consistent with MPEP 804 (see the section entitled “Application under examination has the earlier patent term filing date”) this rejection may be withdrawn if it is the only remaining rejection” (page 10).
Applicants’ arguments have been fully considered but are not found persuasive. New claim 26 requires a rejection under 35 U.S.C. 112(b) as being indefinite (see below), and therefore the provisional double patenting rejection is not the only remaining rejection and therefore must be maintained until it is the only remaining rejection.
New objections and/or rejections necessitated by Applicants’ amendment
Claim Objections
New claim 26 is objected to for the following informalities:
In claim 26, lines 1-2, “the human IgG constant domain a human IgG1 constant domain” should be “the human IgG constant domain is a human IgG1 constant domain” (underlining added to indicate the necessary correction).
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.
Claim 26 is 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 pre-AIA the applicant regards as the invention.
Claim 26 employs the term “including” in line 2. The transitional phrase “including” is generally interpreted as having the same meaning as “comprising”. See MPEP 21110.3.I, “COMPRISING” (“[t]he transitional term “comprising”, which is synonymous with “including”…). If interpreted as such in claim 26, lines 1-2 would read on a “a variant thereof comprising a variant comprising L234 and L235A substitutions, according to EU numbering”. In this case, the scope of the variants would be limited to only a variant having such mutations. However, it is unclear whether Applicants intend this meaning or instead intending for the claim to be directed to two alternatives: a variant in general or a specific variant. However, by joining these two alternatives with the word “including”, the claim is directed to a broad range (variant) together with a narrow range (specific variant) that falls within the broad range. This renders claim 26 indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims
If the former interpretation is intended, the claim could be rendered definite by amending it to recite, for example, “…a variant thereof comprising L234A and L235 substitutions…”. If the latter interpretation is intended, the claim could be rendered definite by amending it to recited, for example, “…a variant thereof or a variant thereof comprising L234A and L235A substitutions…”, or by limiting claim 26 to “a variant thereof” and adding a new dependent claim that narrow the variation to one comprising the L234A and L235 substitutions.
Conclusion
No claims are allowed.
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 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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Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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