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 06/30/2026, are acknowledged.
Claims 1-2, 4-7, 11-13, 15-19, 21-27, 29-34, 37-40, 43-49, 52, 54, and 56-57 are canceled.
Claims 3, 8-10, 14, 20, 28, 35, 36, 42, 51, 53, 55, 59, and 60 are amended.
Claims 63-67 are new.
Claims 3, 8-10, 14, 20, 28, 35, 36, 41, 42, 50, 51, 53, 55, and 58-67 are pending.
Claims 50, 53, 55, 58, 60-62, and 67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/16/2026.
As such, claims 3, 8-10, 14, 20, 28, 35, 36, 41, 42, 51, 55, 59, and 63-66 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/30/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
The drawing objections are withdrawn in part. Issues regarding minor informalities of Figure 19B have been sufficiently addressed through amendments to the specification on 06/30/2026.
The specification objections are withdrawn in part. Issues regarding sequence disclosures, minor informalities, and trademarks/names have been sufficiently addressed through amendments to the specification on 06/30/2026.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 06/30/2026.
Withdrawn Rejections
Applicant’s arguments, see page 11, filed 06/30/2026, with respect to claims 3, 5-10, 14, 17, 20, 28, 35-36, 41-42, 51, and 59 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 5-7 and 17 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see page 12, filed 06/30/2026, with respect to claims 3, 5-10, 14, 17, 20, 28, 35-36, 41-42, 51, and 59 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 the large genus of modified Fc regions has been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 5-7 and 17 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(a) is withdrawn.
Applicant’s remarks, see pages 12-15, filed on 06/30/2026, with respect to claims 3, 5, 8-10, 14, 28, 35, 41, 51, and 59 rejected under 35 USC 103 as allegedly being unpatentable over Durrant et al and further in view of Davis et al and Allan et al have been fully considered and are persuasive. Examiner acknowledges that claim 5 is canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claim 3 was amended to recite “wherein the modified Fc region comprises the amino acid sequence provided in SEQ ID NO: 1, or an amino acid sequence having at least 90% identity to SEQ ID NO: 1, and comprises all of the following modifications: N286T, K288W, K2900, A339P, Q342R, P343A, R344Q, E345T, L351I, S354P, D356E, E357Q, L358M, T359S, N361K, Q362K, K370T, G371N, Y373F, P374S, S375E, D376A, and A378S according to the IMGT system for numbering antibody sequences” which is not disclosed by the art. As such, the rejection under 35 USC 103 is withdrawn.
Applicant’s remarks, see pages 15-17, filed on 06/30/2026, with respect to claims 3, 5, and 6 rejected on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-4, 8-16, and 19-23 of US Patent No. 12,595,313; and, claims 3, 5, 8-10, 14, 28, 35, 41, 51, and 59 rejected on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-51 of US Patent No. 8,742,088 in view of Durrant, Davis, and Allan have been fully considered and are persuasive. Examiner acknowledges that claims 5 and 6 are canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claim 3 was amended to recite “wherein the modified Fc region comprises the amino acid sequence provided in SEQ ID NO: 1, or an amino acid sequence having at least 90% identity to SEQ ID NO: 1, and comprises all of the following modifications: N286T, K288W, K2900, A339P, Q342R, P343A, R344Q, E345T, L351I, S354P, D356E, E357Q, L358M, T359S, N361K, Q362K, K370T, G371N, Y373F, P374S, S375E, D376A, and A378S according to the IMGT system for numbering antibody sequences” which is not disclosed by the ‘313 patent, ‘088 patent, or the art. Further, the ‘313 patent is drawn to a structurally different product. As such, the double patenting rejections are withdrawn.
Maintained Objections
Drawings
The drawings are objected to because the title for Figure 37D recites “Nyeso119-143 frequency”, but the description recites “Nyeso1 119-143”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant’s Arguments
The drawings are objected to for alleged informalities. Office Action, page 5. Applicant submits herewith Replacement Sheet (1 sheet, Figure 37) to address the alleged informalities. Withdrawal of the objection is respectfully requested.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive. The replacement sheet comprises the same title and the description recites a different name. As such, the drawing objection for Figure 37D is maintained.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 8 and 60). 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.
Applicant’s Arguments
The specification is objected to for alleged informalities. Office Action, pages 8-11. Applicant submits herewith a Substitute Specification (clean and marked-up version) to address the alleged informalities. Withdrawal of the objection is respectfully requested.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive. Examiner acknowledges the substitute specification; however, the amendments to the specification do not overcome the hyperlink objection. Examiner suggests removing the “www.” from the hyperlinks to overcome the objection.
New Rejections Necessitated by Amendment
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 3, 8-10, 14, 20, 28, 35, 36, 41, 42, 51, 55, 59, and 63-66 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “wherein the modified Fc region comprises the amino acid sequence provided in SEQ ID NO: 1” and the claim also recites “an amino acid sequence having at least 90% identity to SEQ ID NO: 1, and comprises all of the following modifications: N286T, K288W, K2900, A339P, Q342R, P343A, R344Q, E345T, L351I, S354P, D356E, E357Q, L358M, T359S, N361K, Q362K, K370T, G371N, Y373F, P374S, S375E, D376A, and A378S” which is the narrower statement of the range/limitation. The claim(s) are considered 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.
Additionally, claim 3 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 a numbering system for antibody sequences and, accordingly, the identification/description is indefinite. As such, claim 3 and its dependent claims are rejected.
Claims 28 and 42 recite “any one of the preceding claims”. It is unclear if Applicant is referencing claim 3, or if Applicant is referencing all of the previous claims before claims 28 and 42 which would be improper. As such, claims 28, 42, and their dependent claims are rejected.
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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