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 .
Claim Status
Applicant’s amendments and remarks, filed 08/28/2026, are acknowledged.
Claims 12 and 21 are canceled.
Claims 1, 5-7, 10-11, 13, 16, 19-20, and 22 are amended.
Claims 1-11, 13-20, and 22-24 are pending.
It is noted that claims 12 and 21 are identified as “Canceled”, although there is text in the claims. 37 CFR 1.121(c) states that: “Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. Specifically, the MPEP states that “no claim text shall be presented for any claim in the claim listing with the status of ‘canceled’ or not entered’. MPEP 714 and 37 CFR 1.121(c)(4). For the interest of compact prosecution and customer service, Examiner has considered Applicant’s remarks and amendments filed 08/28/2026. Applicant is advised that failure to ensure claims are compliant in any future reply will be considered non-compliant and will result in a Notice of Non-Compliant Amendment.
As such, claims 1-11, 13-20, and 22-24 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The drawing objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the specification on 08/28/2026.
The specification objections are withdrawn. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 08/28/2026.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 08/28/2026.
Withdrawn Rejections
Applicant’s arguments, see pages 9 and 10, filed 08/28/2026, with respect to claims 1-24 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 12 and 21 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see pages 10 and 11, filed 08/28/2026, with respect to claims 11-13, 15, 20-22, and 24 rejected under 35 USC 112(a) as allegedly lacking written description have been fully considered and are persuasive. The issue regarding the specification failing to disclose Applicant’s possession of conjugates have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 12 and 21 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(a) is withdrawn.
New Objections and Rejections Necessitated by Amendment
Claim Objections
Claim 1 is objected to because of the following informalities:
“SEQ ID NO.” should read “SEQ ID NO:”.
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.
Claims 1-11, 13-20, and 22-24 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.
Claim 1 recites the limitation “as determined by IMGT®” and “as determined by Kabat”. This limitation incorporates a reference in the claim. MPEP2173.05(s) states:
Where possible, claims are to be complete in themselves. Incorporation by reference “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 claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Additionally, claim 1 contains the trademark/trade name “IMGT®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an amino acid residue numbering system and, accordingly, the identification/description is indefinite.
As such, claim 1 and its dependent claims are rejected.
Allowable Subject Matter
SEQ ID Nos: 112, 117, and 123 appear to be free of the art. The closest prior art is Babcook et al (US 2005/0049402 A1; publication date: 03/03/2005) which teach of antibodies directed to the antigen TNFα and uses of such antibodies (see Abstract). Specifically, Babcook et al disclose of SEQ ID NO: 262 which shares 86.8% identity to instant SEQ ID Nos: 117 and 123 (see alignment below).
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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 nonprovisional extension fee (37 CFR 1.17(a)) 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 DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (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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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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