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 .
Status of the Claims
Claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63 are currently pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record.
Claim Interpretation
The term “prevention” encompasses prophylactic treatment (see, e.g., instant specification at para. [0163]).
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.
Claim 8 is rejected under 35 U.S.C. 112(b) as failing to set forth the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8 is indefinite for reciting “wherein the TfR1-binding protein is a human or humanized anti-TfR1 antibody or a fragment thereof”, when the instant specification discloses that the claimed TfR1 binding proteins, ch128.1/IgG3 and ch128.1/IgG1, are chimeric and contain the variable regions of the murine monoclonal antibody 128.1 specific for human TfR1 (see instant specification, at paragraph [0005]). Therefore , it is unclear how the claimed TfR1 binding protein can be fully human.
Priority
The earliest effective U.S. filing date afforded the instantly claimed invention has been
determined to be 10 April 2019, the filing date of Provisional Application No. 62/993,530, to
which Int. Application No. PCT/US2021/023735 claims priority to.
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.
Claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Penichet1 in view of O’Reilly2.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Penichet discloses a method for preventing cancer3, including those listed in instant claim 14, comprising providing to the subject an effective amount of a transferrin receptor 1 (TfR1 )-binding protein, specifically an antibody or fragment thereof4 (reads on claims 1-2, 14, 29, and 43). Penichet further discloses: diagnosing EBV associated cancer5; wherein the TfR1-binding protein is a chimeric anti-TfR1 antibody or a fragment thereof (para (0023]: "In some embodiments, the anti-TfR1 antibody is a chimeric antibody such as a mouse-human chimeric antibody or a humanized antibody."; reads on claims 4 and 46); wherein the TfR1-binding protein is a ch128.1 antibody (para [0023]: "In some embodiments, the unconjugated anti-TfR1 antibody is ch128.1."; reads on claims 5 and 47); wherein the TfR 1-binding protein is ch128.1/lgG1 or ch128.1/lgG3 (para (0008]: "In some embodiments, the isotype of the unconjugated anti-TfR1 antibody is lgA, lgD, lgE, lgG or lgM, preferably lgG1 or lgG3." reads on claim 6-7 and 48-49); and wherein the TfR1-binding protein is a human or humanized anti-TfR1 antibody or a fragment thereof (para (0023]: "In some embodiments, the anti-TfR1 antibody is a mouse, rat or human antibody."; reads on claim 8); the method further comprising providing an additional therapeutic (para. [0008]: “In some embodiments, a secondary therapeutic agent is administered to the subject”; reads on claim 18 and 63).
The prior art of Penichet differs from the instantly claimed invention as follows: While Penichet discloses diagnosing EBV associated cancer, the reference does not expressly teach detecting an infectious agent in the subject.
O’Reilly remedies the deficiencies of Penichet by disclosing the following: detecting presence of an infectious agent in a subject to diagnose EBV associated cancer6 (reads on claims 1, 11, 29, 52-53, and 56).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: applying a known technique (e.g., the method of detecting an infectious agent, e.g. detection of EBV in a subject with lymphoma, as taught by O’Reilly) to a known method (e.g., the method of preventing cancer, e.g., prevention of an EBV-associated cancer such as lymphoma, as taught by Penichet) ready for improvement to yield predictable results, namely ensuring that the subject is positive for an infectious agent prior to administering the preventative treatment for a cancer that is associated with said infectious agent, e.g., EBV-associated cancer; and the simple substitution of one known element for another (e.g., one EBV-associated cancer, multiple myeloma, for another, lymphoma) to obtain predictable results (MPEP 2143(I)(B), (D), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to simply utilize known methods of detection prior to administering a treatment that targets the identified condition. Thus, a skilled artisan could have predictably and reasonably developed the claimed method.
Accordingly, claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63 are rejected.
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.
Patent No. 8,734,799
Claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of Patent No. 8,734,799 (reference patent) ) in view of O’Reilly (supra) and Penichet (supra).
The disclosures of O’Reilly and Penichet are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analyses.
Obviousness analysis: Regarding instant claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63, claims 104 and 108 of the reference patent explicitly claim a method of treating a B-cell malignancy, such as multiple myeloma, in a subject comprising providing the subject a therapeutically effective amount of a TfR1-binding protein, wherein the TfR1-binding protein is ch128.1/IgG1 or ch128.1/IgG3 (see reference claims 1-13). While the reference patent is directed to treatment rather than prevention, the term “prevention” encompasses prophylactic treatment, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in O’Reilly and Penichet by simply incorporating the step of detecting an infectious agent in the subject prior to administering treatment (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(B), (C), (D)).
Accordingly, instant claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63 are not patentably distinct relative to claims 1-13 of the reference patent.
Conclusion
Claims 1-2, 4-8, 11, 14, 18, 29, 43, 46-49, 52-53, 56, and 63 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Friday 9:00AM - 5PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 US20130028891A1; cited on the IDS and the Written Opinion of the ISA for Int. App. No. PCT/US2021/023735
2 WO2019178170A1; cited on the IDS and the Written Opinion of the ISA for Int. App. No. PCT/US2021/023735
3 See Penichet, e.g., at the abstract; para. [0031]: "A "prophylactic treatment" is a treatment administered to a subject who does not display signs or symptoms of a disease, pathology, or medical disorder, or displays only early signs or symptoms of a disease, pathology, or disorder, such that treatment is administered for the purpose of diminishing, preventing, or decreasing the risk of developing the disease, pathology, or medical disorder."; para. [0017]- "TfR1 (CD71) expression is increased on a wide variety of cancer cells, including hematopoietic cancers and in some cases, such as chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL), its expression can be correlated with tumor stage or prognosis."; para (0036): "In some embodiments, the cancer is one that expresses high levels of transferrin receptor 1 (CD71 ), such as malignant brain tumors, breast cancer, bladder cancer, gliomas, lung cancer, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, colorectal cancer, and hematopoietic malignancies. In some embodiments, the cancer is multiple (disseminated) myeloma, lymphoma, aggressive lymphoma")
4 See Penichet, e.g., at para. [0034]: "For example, a subject who has been diagnosed as having a cancer such as multiple myeloma may be administered a therapeutically useful amount one or more unconjugated anti-TfR1 antibodies according to the present invention.
5 See Penichet, e.g., at para. [0034]; note that multiple myeloma is associated with EBV infection
6 See O’Reilly, e.g., at para. [00138]: "In an aspect of the specific embodiment, the cancer is multiple myeloma or plasma cell leukemia."; para [00139]: "In another specific embodiment, the one or more antigens of the cancer are one or more antigens of EBV ... In another specific embodiment, the cancer is an EBV-positive gastric cancer and the one or more antigens are one or more antigens of EBV, such as, for example, EBNA 1, EBNA2, EBNA3A, EBNA3B, EBNA3C, LMP1, and/or LMP2. In another specific embodiment, the cancer is an EBV-positive leiomyosarcoma and the one or more antigens are one or more antigens of EBV, such as, for example, EBNA 1, EBNA2, EBNA3A, EBNA3B, EBNA3C, LMP1, and/or LMP2."; para [00176]: "In responding patients who had detectable EBV DNA levels in the blood prior to T- cell infusion, EBV DNA levels fell by 2 logio post infusion, and were a useful indication of response.").