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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/15/2026 has been entered.
Status of Claims
Claims 21-22 and 25-26 are pending and under examination.
Withdrawn Rejections
In light of the amendments, the 35 U.S.C. 112(a) rejection is hereby withdrawn.
In light of the amendments, the 35 U.S.C. 102(a)(1) rejection over Yamano et al. is hereby withdrawn.
In light of the amendments, the nonstatutory double patenting rejections over 9593165 and 18686256 are hereby withdrawn.
Claim Rejections - 35 USC § 112
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 21 and 25-26 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 21 recites a method of treating a patient with excess iron uptake, but the steps do not reflect how the administering of the claimed antibody would treat a patient with excessive iron uptake. Claims 25 and 26 are rejected because (1) they depend on claim 21 and (2) they do not provide any information on treating a patient with the antibody.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 recites that the antibody is an antibody fragment is broaden the scope of claim 21 because an antibody fragment does not contain all the information of an antibody structure. Therefore, the claim does not further limit the scope of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-22 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kurosawa et al. (US9593165B2, published 03/14/2017, see 892 dated 01/29/2025), as evidenced by Shen et al. (“Transferrin receptor 1 in cancer: a new sight for cancer therapy”, Am. J. Cancer Res. 2018;8(6): pgs. 916-931).
With respect to claims 21-22, Kurosawa teaches the present antibody specifically recognizes human TfR and inhibits the survival or growth of cancer cells that express TfR and when human antibody is administered to a human, the antigenicity of the antibody is significantly reduced (see co1. 10, lines 20-25). Kurosawa teaches that a transferrin receptor (TfR) was at first identified as a receptor that is present on a reticulocyte as a cell membrane structure for incorporating transferrin (Tf)-bound iron into a cell (see col., 1, lines 57-60). Kurosawa teaches that it has been reported that the transferrin receptor (TfR) is expressed at a high level for chronic lymphocytic leukemia (nonpatent literatures 37 and 38) and adult T-cell leukemia (nonpatent literature 40) (see col. 1, line 56 – col. 2, line 10). Kurosawa teaches antibodies are useful for the treatment of various cancers in which TfR is expressed at a high level (see col. 5, lines 15-18). Kurosawa teaches a pharmaceutical composition comprising the antibody of the present invention for treatment of cancers or diseases that caused by high expression of TfR wherein the cancer is leukemia or adult T-cell leukemia (see col. 18, lines 37-51). Kurosawa teaches that TfR436 antibodies did not only inhibit the growth of a tumor, but it also exhibited a significant tumor-reducing effect, at an amount of 10mg/kg (see col. 33, lines 4-7 and Example 8). Kurosawa further teaches antibodies on leukemia, TfR436 antibody significantly inhibited the growth of a tumor at even at a low amount of 1 mg/kg ( see col. 33, lines 55-59 and Fig. 9). Kurosawa teaches producing leukemia tumor in mice through transplantation and the mice were divided into some groups (n=5), using grouping software(EXSAS) and said TfR436 antibody was administered at an amount of 5mg/kg mouse into the caudal vein of each mouse and the administration was carried out twice a week in a total of five times (see col. 33, Example 9).
Noted that the instant specification has disclosed that TfR436 antibody, as having SEQ ID NO: 7 and SEQ ID NO:8, is published in WO2014/073641, which is the international publication of the Kurosawa (see paras. [0050]-[0053], as filed dated 05/19/2021). Thus, Kurosawa’s Tf436 antibody would contain the claimed sequences of SEQ ID NO: 7 and SEQ ID NO: 8, (also see Table 5 of Kurosawa). Because Kurosawa’s antibody reads on the structure of the claimed antibody, it would recognize the amino acids at positions 629 to 633 of the human transferrin receptor having SEQ ID NO:9 to the patient.
Meanwhile, the evidentiary teachings of Shen et al. indicate iron as the most important hematopoietic element plays a key role in leukemia and TfR1 was initially found as an important iron uptake receptor inducing the growth of leukemia cell lines (pg. 923, left col., para. 1). Shen also discloses high TfR1 expression positively correlated with Hgb concentration at diagnosis (pg. 923, left col., para. 1). Thus, Example 9 in Kurosawa of diagnosing and treating leukemia tumor with TfR436 antibody to inhibit TfR from transferrin would read on diagnosing a patient with excessive iron uptake in leukemia cells, as iron through TfR in cell induces leukemia cell growth.
With respect to claims 25-26, Kurosawa teaches human anti-TfR antibody (see col. 5, lines 5-7). Kurosawa teaches antibody fragment is scfv fragment (see col. 9, lines 33-37).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kurosawa et al. (US9593165B2, published 03/14/2017, see 892 dated 01/29/2025) in view of Taetle et al. (“Role of Transferrin, Fe, and Transferrin Receptors in Myeloid Leukemia Cell Growth”, J. Clin. Invest., volume 75, March 1985, 1061-1067).
Kurosawa has been discussed above. However, Kurosawa does not explicitly or directly teach diagnosing a patient with excessive iron uptake.
Taetle teaches anti-transferrin receptor antibody 42/6 and fresh leukemia cells were used to investigate the roles of Fe, transferrin receptors, and transferrin in leukemia cell growth, and mechanisms of 42/6 of inhibition and resistance (see abstract). Taetle also teaches that human leukemia cells require Fe for growth and that 42/6 inhibits transferrin-dependent cells by Fe deprivation there is a critical role of Fe in leukemia cell growth (see abstract).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have also correlated leukemia patients with excess iron uptake into cells because Kurosawa teaches transferrin receptor (TfR) incorporates transferrin (Tf)-bound iron into a cell and TfR436 antibody inhibits leukemia tumor growth by taking away TfR and transferrin affinity and Taetle teaches leukemia cell growth requires iron (Fe).
The person would reasonably expected success in diagnosing leukemia patients and excess iron uptake in leukemia cells because it has been well understood in the art that leukemia cell growth requires the presence of iron, and the level of iron, TfR, and leukemia are positively correlated.
With respect to claims 25-26, Kurosawa teaches human anti-TfR antibody (see col. 5, lines 5-7). Kurosawa teaches antibody fragment is scfv fragment (see col. 9, lines 33-37).
Double Patenting
The nonstatutory double 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 nonstatutory double patenting 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 in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting 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 terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer 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 terminal disclaimer 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 may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-22 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18030534 (see 892 dated 01/29/2025) in view of Kurosawa et al. (US9593165B2, published 03/14/2017, see 892 dated 01/29/2025) in view of Taetle et al. (“Role of Transferrin, Fe, and Transferrin Receptors in Myeloid Leukemia Cell Growth”, J. Clin. Invest., volume 75, March 1985, 1061-1067).
Application No. 18030534 recites a method for determining the medicinal effect or sensitivity of an anti-human transferrin receptor antibody having an action to inhibit the binding between human transferrin and a human transferrin receptor, wherein the method uses an intracellular iron content as an indicator. Claim 3 recites the medicinal effect or sensitivity of the antibody is determined based on the relative value to the iron content in a reference sample. Claim 8 recites the antibody is an antibody recognizing the amino acids at positions 629 to 633 of a human transferrin receptor. Claim 9 recites wherein the antibody is an antibody having a heavy chain first complementarity determining region (VH CDR1), a heavy chain second complementarity determining region (VH CDR2), and a heavy chain third complementarity determining region (VH CDR3), which are as set forth in SEQ ID NOs: 1, 2, and 3, respectively, and also having a light chain first complementarity determining region (VL CDR1), a light chain second complementarity determining region (VL CDR2), and a light chain third complementarity determining region (VL CDR3), which are as set forth in SEQ ID NOs: 4, 5, and 6, respectively. Claim 10 recites the antibody is an antibody having a heavy chain as set forth in SEQ ID NO: 7 and a light chain as set forth in SEQ ID NO: 8. However, the copending Application does not explicitly recite diagnosing and treating a patient with excessive iron uptake into cells.
Kurosawa and Taetle have been discussed in the above rejection. It would have been obvious at the time of filing to have used the antibody that inhibits TfR as recited in Application No. 18030534 to diagnose and treat the patient with excess iron uptake as taught by Kurosawa and Taetle and reasonably expected success because Kurosawa teaches transferrin receptor (TfR) incorporates transferrin (Tf)-bound iron into a cell and TfR436 antibody inhibits leukemia tumor growth by taking away TfR and transferrin affinity and Taetle teaches leukemia cell growth requires iron (Fe).
With respect to instant claim 26, the copending Applicant’s CDR would read on a peptide comprising CDR.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive over 35 U.S.C. 102(a)(1) rejection in view of Kurosawa.
Applicant argues on page 4 of the Remarks that diagnosing a patient with excess iron take would overcome the Kurosawa reference.
The argument is not found persuasive because the new evidentiary teachings of Shen et al. indicate iron as the most important hematopoietic element plays a key role in leukemia and TfR1 was initially found as an important iron uptake receptor inducing the growth of leukemia cell lines (pg. 923, left col., para. 1). Shen also discloses high TfR1 expression positively correlated with Hgb concentration at diagnosis (pg. 923, left col., para. 1). Thus, Example 9 in Kurosawa of diagnosing and treating leukemia tumor with TfR436 antibody to inhibit TfR from transferrin would read on diagnosing a patient with excessive iron uptake in leukemia cells, as iron through TfR in cell induces leukemia cell growth. Additionally, leukemia cell growth would possess excess iron uptake in leukemia cells.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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