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 .
Claim Status
Claims 1-10, 12-17, 23, 24, 27, and 28 were previously pending.
A non-final Office Action was mailed 14 November 2025.
In response to that Office Action, Applicant filed an Amendment/Request for Reconsideration on 16 January 2026.
On 16 January 2026, Applicant also filed a Terminal Disclaimer for co-pending application Nos: 18/017,167, 18/017,170, 18/017,173, 18/017,180, and 18/017,182. This Terminal Disclaimer has been reviewed, accepted, and recorded.
As a result of that Amendment, claim 1 was amended, claims 2-10, 12-17, 23, 24, 27, and 28 were cancelled, and claims 29-80 were added. Therefore, claims 1 and 29-80 are now pending and currently under examination.
Priority
Acknowledgment is made of applicant's claim for priority based on a parent application
filed on 23 July 2020.
The instant application filed on 20 January 2023 is a 371 of PCT/US2021/40998 filed
09 July 2021, which is a provisional of the following applications: 63/143,829 (filed 30 January 2021); 63/069,077 (filed 23 August 2020); and 63/055,777 (filed 23 July 2020) and which finds full support for the instant claims. Therefore, the effective filing date of the instant application is 23 July 2020 (the date 63/055,777 was filed).
Information Disclosure Statement (IDS)
The IDS (1) filed on 16 January 2026 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Withdrawn Claim Rejections
Previous rejection under 35 USC 112(a) – written description: Applicant has amended claim 1 and cancelled claims 2-10, 12-17, 23, 24, 27, and 28. Therefore, the previous rejection of claims 1, 3-5, 7-10, 12-17, 23, 24, 27, and 28 under 35 USC 112(a) for failing to comply with the written description requirement is moot and hereby withdrawn.
Previous rejection under 35 USC 112(b): Applicant has cancelled claim 17. Therefore, the previous rejection of claim 17 under 35 USC 112(b) is moot and hereby withdrawn.
Previous rejection under 35 USC 112(d): Applicant has cancelled claim 5. Therefore, the previous rejection of claim 5 under 35 USC 112(d) is moot and hereby withdrawn.
Previous provisional rejections on the ground of nonstatutory double patenting over copending application Nos: 18/017,167, 18/017,170, 18/017,173, 18/017,180, and 18/017,182: Applicant has filed a terminal disclaimer, received 16 January 2026, is sufficient to overcome the aforementioned provisional rejections.
New Claim Objections/Rejections
Applicant has amended claim 1 from an anti-TfR1 antibody comprising a VH of SEQ ID NO: 77 and a VL of SEQ ID NO: 78 to an anti-TfR1 antibody comprising a VH of SEQ ID NO: 76 and a VL of SEQ ID NO: 75, thereby changing the scope of claim 1. Applicant has further added claims 29-80. Therefore, the following new claim objections and rejections are necessitated by amendment.
New Claim Objections
Claims 38 and 76 are objected to for the following informalities: both claims recite the limitation “…wherein the exon is selected from exons 8, exon 23, exon 41…” It is assumed ‘exons’ is a typographical error and appropriate correction or clarification is required.
New Claim Rejections – 35 U.S.C. 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 34 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34 depends from claim 6, which has been cancelled. Therefore, there is lack of antecedent basis in this claim and therefore, claim 34 is indefinite.
Conclusion
Claim 34 is rejected. Claims 38 and 76 are objected to. Claims 1, 29-33, 35-37, 39-75, and 77-80 are allowable.
Closest Prior Art
Applicants claimed anti-trasnferrin receptor (TfR) antibody comprising a VH comprising the amino acid sequence of SEQ ID NO: 76 and a VL comprising the amino acid sequence of SEQ ID NO: 75. These sequences are free of prior art.
The closest prior art to the disclosed sequences is as follows:
Dennis (US 8,911,732 B2; date of patent: 16 December 2014) discloses anti-mesothelin antibodies and immunoconjugates. Dennis discloses an anti-mesothelin antibody comprised of a VL region represented by SEQ ID NO: 12 (col. 20, lines 58-62; col. 69). The disclosed SEQ ID NO: 12 in Dennis is 94.5% similar to SEQ ID NO: 75 as shown below:
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Didonato (US 11,939,397 B2; date of patent: 26 March 2024 with a prior effective filing date of 30 May 2018) discloses ENTPD2 antibodies comprised of a VH region represented by SEQ ID NO: 46 (col. 7, lines 61-65). The disclosed SEQ ID NO: 46 in Didonato is 84.5% similar to SEQ ID NO: 76 as shown below:
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955
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However, neither Dennis nor Didonato disclose the identical sequence to what is currently claimed in instant claim 1 nor a combination of SEQ ID NO: 75 and SEQ ID NO: 76 in an anti-transferrin receptor antibody.
Correspondence
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 Julia A Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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, Daniel E. Kolker can be reached at (571)272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1615
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645