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 .
Claims 1-20, filed 4/6/2023, are acknowledged. Claims 1-20 are pending and considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on 6/23/2023 and 11/22/2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Specification
The substitute specification filed 10/10/2023 has been entered.
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 1-20 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 "the medicinal effect". There is insufficient antecedent basis for this limitation in the claim. For examination purposes the examiner interprets that the claim reads “a medicinal effect”.
Claims 8, 18, 19, and 20 recite the limitation " a human transferrin receptor". It is unclear if this is the same or different from the “human transferrin receptor” or claim 1. For examination purposes the examiner interprets that the claims read “the human transferrin receptor”.
Dependent claims follow the same reasoning.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A, Prong 1: identify the abstract ideas. Regarding claim 1, the abstract idea is the determining step. “…determining the medicinal effect or sensitivity” is an evaluation, and the MPEP holds that both evaluations and mathematical calculations are abstract ideas (MPEP 2106.04(a)).
Step 2A, Prong 2: has the abstract idea been integrated into a particular practical application? There is nothing specific about the effect that is determined. Therefore the vague indication of method component to determine the effect is generically linking the use of the abstract idea to a field of endeavor.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? Elements of the claim beyond the abstract idea, include intracellular iron as an indicator, which is well known routine and conventional. Thus, this limitation does not provide “significantly more”.
Dependent claims only further refine the abstract idea.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurosawa et al. (US 9,593,165 B2).
Regarding claim 1, Kurosawa describes 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 (FIG. 11 shows the comparative results of the in vivo medicinal effects of modified anti-TfR006 antibodies and prior antibodies.),
wherein the method generally describes an intracellular iron (column 1 “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”
However Kurosawa is silent to specifically wherein the method uses an intracellular iron content as an indicator.
Kurosawa does describe “iron 59 (59Fe)… The binding of such a radioactive substance to the antibody can be carried out by a method known to a person skilled in the art… the binding level of cancer cells to the antibody is high.” (column 20) Additionally, Kurosawa describes “Human transferrin receptor (TfR) is a single-pass transmembrane protein (SEQ ID NO: 51) comprising 760 amino acids, and it is encoded by human chromosome 3. This protein has also been known as a CD71 antigen, and it is considered that this protein is associated with incorporation” (column 11) . This suggests motivation to particularly used an iron indicator, as it is good at being incorporated into a human transferrin receptor.
Therefore it would have been obvious for one skilled in the art at the time the invention was filled to incorporate an intracellular iron content as an indicator as suggested by Kurosawa as it is good at being incorporated into a human transferrin receptor.
Regarding claim 2, the combination described above describes the method according to claim 1, which is a method for determining the medicinal effect or sensitivity by utilizing the correlation of the intracellular iron content with the medicinal effect of the antibody (Kurosawa: column 1 “a labeled antibody is formed by linking a radioactive substance or a cytotoxic substance such as a toxin, an enzyme or a drug to an antibody, and the specificity of the antibody is utilized to deliver such a substance only to cancer tissues,” and column 11 “Examples of a means for examining reactivity include flow cytometry (FACS), enzyme-linked immunosorbent assay (ELISA), Western blotting, microfluorescence measuring technique (FMAT), surface plasmon resonance (Biacore ), immunostaining, and immunoprecipitation. The antibody used in flow cytometry may be either an antibody labeled with a fluorescent substance such as FITC or with biotin, or an unlabeled antibody.” And column 20 “iron 59 (59Fe)… The binding of such a radioactive substance to the antibody” Thus in combination with iron as the indicator, there would be a correlation between the intracellular iron content and the medicinal effect of the antibody.)
Regarding claim 3, the combination described above describes the method according to claim 1, wherein the medicinal effect or sensitivity of the antibody is determined based on the relative value to the iron content in a reference sample (Kurosawa: “Growth rate = antibody-added well value-blank( only culture media)/control value (antibody-not-added well)-blank(only culture media)x100%” In combination with iron as the indicator this equation would apply).
Regarding claim 4, the combination described above describes the method according to claim 1, wherein when the intracellular iron content is lower than the reference value, the medicinal effect or sensitivity of the antibody is determined to be high (Kurosawa: figure 2, column 10 “FIG. 2 shows the effects of each modified anti-TfR006 antibodies to inhibit the growth of K562 cells.” In combination, iron would follow the same pattern as presented in the graph with the intracellular iron content being lower than the reference value).
Regarding claim 5, the combination described above describes the method according to claim 1,wherein the medicinal effect or sensitivity of the antibody to cancer is determined (Kurosawa: figure 8 “Leukemia model”).
Regarding claim 6, the combination described above describes the method according to claim 5, wherein the cancer is blood cancer (Kurosawa: figure 8 “Leukemia model”).
Regarding claim 8, the combination described above describes the method according to claim 1, wherein the antibody is an antibody recognizing the amino acids at positions 629 to 633 of a human transferrin receptor (Kurosawa: column 32 “TfR436 antibodies”. See [0061] application specification, which describes that “the amino acids at positions 629 to 633 of TfR should be an epitope recognized by the TfR436 antibody.”).
Regarding claim 9, the combination described above describes the method according to claim 1, 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 (Kurosawa: column 95 claim 1 “(1) an antibody, in which the heavy chain first complementarity determining region (VH CDRl), the heavy chain second complementarity determining region (VH CDR2), and the heavy chain third complementarity 40 determining region (VH CDR3) are shown in SEQ ID NOs: 1, 2, and 7, respectively, and the light chain first complementarity determining region (VL CDRl), the light chain second complementarity determining region (VL CDR2), and the light chain third complementarity 45 determining region (VL CDR3) are shown in SEQ ID NOs: 4, 5, and 6, respectively;”).
Regarding claim 10, the combination described above describes the method according to claim 1, wherein 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 (Kurosawa: column 24 “The TfR006 anti- 10 body was mutated, such that the amino acid of Kabat No. 96 in the VH of a modified TfR402 antibody was changed from S to G (SEQ ID NO: 7), the amino acid of Kabat No. 97 in the VH of a TfR403 antibody was changed from N to A (SEQ ID NO: 8),”).
Regarding claim 11, the combination described above describes the method according to claim 2, wherein the medicinal effect or sensitivity of the antibody is determined based on the relative value to the iron content in a reference sample (Kurosawa: “Growth rate = antibody-added well value-blank( only culture media)/control value (antibody-not-added well)-blank(only culture media)x100%” In combination with iron as the indicator this equation would apply).
Regarding claim 12, the combination described above describes the method according to claim 2, wherein when the intracellular iron content is lower than the reference value, the medicinal effect or sensitivity of the antibody is determined to be high (Kurosawa: figure 2, column 10 “FIG. 2 shows the effects of each modified anti-TfR006 antibodies to inhibit the growth of K562 cells.” In combination, iron would follow the same pattern as presented in the graph with the intracellular iron content being lower than the reference value).
Regarding claim 13, the combination described above describes The method according to claim 3, wherein when the intracellular iron content is lower than the reference value, the medicinal effect or sensitivity of the antibody is determined to be high (Kurosawa: figure 2, column 10 “FIG. 2 shows the effects of each modified anti-TfR006 antibodies to inhibit the growth of K562 cells.” In combination, iron would follow the same pattern as presented in the graph with the intracellular iron content being lower than the reference value).
Regarding claim 14, the combination described above describes The method according to claim 2, wherein the medicinal effect or sensitivity of the antibody to cancer is determined (Kurosawa: column 100 “wherein the blood cancer is leukemia, lymphoma, or myeloma.”).
Regarding claim 15, the combination described above describes The method according to claim 3, wherein the medicinal effect or sensitivity of the antibody to cancer is determined (Kurosawa: column 100 “wherein the blood cancer is leukemia, lymphoma, or myeloma.”).
Regarding claim 16, the combination described above describes The method according to claim 4, wherein the medicinal effect or sensitivity of the antibody to cancer is determined (Kurosawa: column 100 “wherein the blood cancer is leukemia, lymphoma, or myeloma.”).
Regarding claim 18, the combination described above describes The method according to claim 2, wherein the antibody is an antibody recognizing the amino acids at positions 629 to 633 of a human transferrin receptor (Kurosawa: column 32 “TfR436 antibodies”. See [0061] application specification, which describes that “the amino acids at positions 629 to 633 of TfR should be an epitope recognized by the TfR436 antibody.”).
Regarding claim 19, the combination described above describes The method according to claim 3, wherein the antibody is an antibody recognizing the amino acids at positions 629 to 633 of a human transferrin receptor (Kurosawa: column 32 “TfR436 antibodies”. See [0061] application specification, which describes that “the amino acids at positions 629 to 633 of TfR should be an epitope recognized by the TfR436 antibody.”).
Regarding claim 20, the combination described above describes The method according to claim 4, wherein the antibody is an antibody recognizing the amino acids at positions 629 to 633 of a human transferrin receptor (Kurosawa: column 32 “TfR436 antibodies”. See [0061] application specification, which describes that “the amino acids at positions 629 to 633 of TfR should be an epitope recognized by the TfR436 antibody.”).
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurosawa et al. (US 9,593,165 B2) in view of Yeh et al. (Protides of the Biological Fluids, Volume 32, 1985, Pages 441-444).
Regarding claim 7, the combination described above describes the method according to claim 5, however is silent to wherein the cancer is acute myelogenous leukemia (AML).
Yeh describes determining the medicinal effect of an anti- human transferrin receptor antibody particularly with regard to acute myelogenous leukemia (abstract). Yeh further suggests motivation to focus on acute myelogenous leukemia within the scope of leukemia because it can be difficult to treat without also damaging normal bone marrow (page 442 “The results of this study show that Trf-Adr conjugate produced high degree of killing to AML cells, but had little effect to normal bone marrow cells.”)
Therefore it would have been obvious to one skilled in the art at the time the invention was filed to modify the cancer of the combination with acute myelogenous leukemia as suggested by Yeh because it is difficult to treat without also damaging normal bone marrow.
Regarding claim 17, the combination described above describes the method according to claim 6, however is silent to wherein the cancer is acute myelogenous leukemia (AML).
Yeh describes determining the medicinal effect of an anti- human transferrin receptor antibody particularly with regard to acute myelogenous leukemia (abstract). Yeh further suggests motivation to focus on acute myelogenous leukemia within the scope of leukemia because it can be difficult to treat without also damaging normal bone marrow (page 442 “The results of this study show that Trf-Adr conjugate produced high degree of killing to AML cells, but had little effect to normal bone marrow cells.”)
Therefore it would have been obvious to one skilled in the art at the time the invention was filed to modify the cancer of the combination with acute myelogenous leukemia as suggested by Yeh because it is difficult to treat without also damaging normal bone marrow.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY R. BERKELEY/
Examiner
Art Unit 1796
/ELIZABETH A ROBINSON/ Supervisory Patent Examiner, Art Unit 1796