DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 are pending and currently under examination a method of treating a myeloproliferative disorder comprising administering an anti-TMPRSS6 antibody.
Priority
The present application is a CIP. The present claims are directed to a method for treating a myeloproliferative disorder (e.g., polycythemia vera (PV)). However, the parent application USSN 17/916,008, does not appear to provide written description for any myeloproliferative disorder. Therefore, the priority date for claims 1-14 has been accorded the effective filing date of the present application, i.e., 11/25/2022.
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 1-14 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 and dependent claims thereof recite amino acid sequences that are three residues in length (e.g., RAN or WAF). However, these trimers do not have a corresponding SEQ ID NO in the sequence file. Therefore, the metes and bounds of the claims are indefinite.
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.
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 1-14 are rejected under 35 U.S.C. 103 as being obvious over Bennett et al. (WO2022229150; cited in IDS) in view of Du et al. (WO2021207072; cited in IDS; published 10/14/2021).
Du et al., though Applicant’s own work, was published more than one year before the priority date of the present claims (see Priority above) and therefore is applicable as prior art.
Bennett et al. taught a method of treating myeloproliferative disorder such as polycythemia vera (PV) comprising administering a TMPRSS6 inhibitor (see, e.g., Abstract and New treatment option: inhibiting Matriptase-2/TMPRSS6 page 3). In particular, Bennett taught that MT2 is the protein product of TMPRSS6 gene and that an inhibitor of MT2 can be used for treatment of PV (page 3, lines 15-20). Furthermore, Bennett taught that the MT2 inhibitor is a monoclonal antibody, which reads on an anti-TMPRSS6 antibody (page 8, line 20).
Bennett did not teach the specific anti-TMPRSS6 antibodies as recited in the present claims. However, it would have been obvious to one of ordinary skill in the art to use these antibodies as they were known in the art before the effective filing date of the claimed invention as taught by Du et al. (see Table 1, pages 33-34; Table 2, pages 37-39; Table 3, pages 40-47). Given that Du et al. is Applicant’s own work, the anti-TMPRSS6 antibodies would increase the activity of the hepcidin promoter, and have one of the recited effects. Furthermore, Du et al. taught monoclonal, chimeric, humanized antibody and pharmaceutical acceptable carriers (pages 19 and 21).
The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements (using a TMPRSS6 inhibitor antibody to treat a myeloproliferative disorder and the specific anti-TMPRSS6 antibodies as recited) were known in the prior art and one of skilled in the art would have arrived at the claimed invention by using known methods with no change in their respective function and the combination would have yielded nothing more than the predictable result of using the recited anti-TMPRSS6 antibodies for treating a myeloproliferative disorder.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,215,170 and claims 1-18 of U.S. Patent 11,866,513 in view of Bennett et al. (WO2022229150; cited in IDS).
The patent claims disclosed the same anti-TMPRSS6 antibodies. Even though the patent claims did not teach using the antibodies for treating a myeloproliferative disorder, it would have been obvious to one of ordinary skill in the art to use said antibodies for treating said disorder in view of the teachings by Bennett as discussed above (see 103). Therefore, the patent claims render obvious of the present claims in view of Bennett et al.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-46 of copending Application No. 19/042/342 and claims 1-21 of copending Application No. 19/472,577 in view of in view of Bennett et al. (WO2022229150; cited in IDS).
The co-pending claims disclosed the same anti-TMPRSS6 antibodies. Even though the co-pending claims did not teach using the antibodies for treating a myeloproliferative disorder, it would have been obvious to one of ordinary skill in the art to use said antibodies for treating said disorder in view of the teachings by Bennett as discussed above (see 103). Therefore, the co-pending claims render obvious of the present claims in view of Bennett et al.
This is a provisional nonstatutory double patenting rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641