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 Status
The preliminary amendments filed 09/06/2024 are acknowledged.
Claims 1, 3-4, 13, 16, 20-22, 26, 28-29, 41-42, and 56-61 are pending.
Claims 1, 3-4, 13, 16, 20-22, 26, 28-29, and 41-42 are amended.
Claims 2, 5-12, 14-15, 17-19, 23-25, 27, 30-40, and 43-55 are cancelled.
Claims 56-61 are new.
Claims 1, 3-4, 13, 16, 20-22, 26, 28-29, 41-42, and 56-61 are under examination.
Priority
The instant application claims priority to provisional application 63/504,357. Priority is given with the earliest effective filing date of 05/25/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Drawings
The drawings are objected to because Figures 1, 3G-3L, 4A-4I, 5A-5R, 7K-7P, 8A-8C are in color. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because of the following informalities: The specification lists SEQ ID NOs for skipped sequences, for example SEQ ID NO: 38 [see paragraphs 19, 33, 34, and Table 2]. Applicant is required to remove the SEQ ID NOs: for all skipped sequences and rely only upon the respective amino acid sequences. Appropriate correction is required.
Claim Objections
Claims 1, 57, and 58 are objected to because of the following informalities: Claims 1, 57, and 58 recite an acronym (i.e. JAK2/STAT5, TMPRSS6, JAK1, TfR1, MDM2, HDAC, PI3K, VH, and VL). The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
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.
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, 3-4, 13, 16, 20-22, 26, 28-29, 41-42, and 56-61 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 anti-TMPRSS6 antibody comprises: a heavy chain complementarity determining region 1 (HC CDR1) comprising the amino acid sequence of SEQ ID NO: 32, a HC CDR2 comprising the amino acid sequence of SEQ ID NO: 33, a HC CDR3 comprising the amino acid sequence of SEQ ID NO: 34, a light chain complementarity determining region 1 (LC CDR1) comprising the amino acid sequence of SEQ ID NO: 37, a LC CDR2 comprising the amino acid sequence of SEQ ID NO: 38, and a LC CDR3 comprising the amino acid sequence of SEQ ID NO: 39.” SEQ ID NO: 38 is a skipped sequence. While the specification does specify the three amino acid sequence for SEQ ID NO: 38 [see page 8, paragraph 19; page 65, Table 2], it is unclear if SEQ ID NO: 38 is referring to the respective three amino acid sequence as listed in the specification or is referring to a different sequence since the sequence listing does not list the specific three amino acid sequence. Therefore, the scope of this claim is indefinite.
Claims 3-4, 13, 16, 20-22, 26, 28-29, 41-42, and 56-61, which depend from claim 1, are therefore indefinite for the same reasons as set forth above.
Applicant can overcome this rejection by amending claim 1 to recite the specific amino acid sequence for SEQ ID NO: 38.
For purposes of examination, the Examiner will be interpreting SEQ ID NO: 38 to be the amino acid sequence “RAN” as set forth in the instant specification [see page 8, paragraph 19; page 65, Table 2].
Claim 57 recites limitations in parentheticals, for example, “(e.g., ropeginterferon a-2b-njft (Besremi), pegylated interferon). First, it is unclear, due to the presence of the parentheses, if the examples set forth are intended as limitations of the claims, or if they are merely exemplary. MPEP 2173.05(d) states, “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.” Second, “Besremi”, “Gleevec”, and “Givinostat” are trademarked. While not per se indefinite, the term must be analyzed to determine how the mark or name is used in the claim. Here, the trademark is used as a claim limitation to describe a particular material and thus the claim scope is uncertain since the mark or name cannot be used to properly identify any particular material or product but rather only identifies the source of the material. See MPEP 2173.05(U). The compounds should be claimed using the generic term. Additionally, the parentheticals following the name of the various drugs, for example “Bomedemstat (IMG-7298)”, makes it unclear if these are the same thing or two different things. Therefore, for all the reasons set forth above, the scope of this claim is 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.
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, 3-4, 16, 28-29, 41-42, and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US 20220411487; instant PTO-892) in view of Shen et al., 2010 (instant PTO-892) and Du (WO2021207072; 09/06/2024 IDS).
Regarding claims 1, 3, and 58, Chin teaches antibodies that specifically bind to the transmembrane serine protease 6 (TMPRSS6) protein [0008; claim 1] and teaches a method of treating a disease or disorder associated with iron overload, the method comprising administering a pharmaceutical composition comprising a therapeutically effective amount of the anti-TMPRSS6 antibody of the disclosure to a subject in need thereof [0039; claim 50], wherein the disease or disorder may be polycythemia vera (PV) [0040; claim 51].
However, Chin does not specifically teach that the PV is associated with overactivation of JAK2/STAT5 pathway or that the anti-TMPRSS6 antibody comprises HCDRs 1-3 comprising SEQ ID NOs: 32-34, respectively, and LCDRs 1-3 comprising SEQ ID NO: 37, the amino acid sequence RAN, and SEQ ID NO: 39, respectively.
Shen teaches that the JAK2V617F mutation was found in 65-97% patients with polycythemia vera (PV) [page 707, left column, first paragraph] and that the JAK2V617F mutation results in the continuous activation of the JAK2/STAT5 signaling pathway [page 709, right column, fourth-fifth paragraphs].
Du teaches an anti-TMPRSS6 antibody comprising an HC variable region of SEQ ID NO: 31 and an LC variable region of SEQ ID NO: 36 [page 7, lines 22-25; Table 2]. Du further teaches SEQ ID NOs: 32-34 for the sequences of the HCDRs 1-3, respectively, comprised within SEQ ID NO: 31 and SEQ ID NOs: 37-39 for the sequences of the LCDRs 1-3, respectively [page 37; Table 2].
SEQ ID NOs: 31 and 36 of Du have 100% sequence identity to SEQ ID NOs: 31 and 36, respectively, of instant claim 58. Further, SEQ ID NOs: 32-34 of Du have 100% sequence identity to SEQ ID NOs: 32-34, respectively, of instant claim 1 and SEQ ID NOs: 37-39 of Du have 100% sequence identity to SEQ ID NOs: 37, RAN, and 38, respectively, of instant claim 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the patient population of Shen with the method of treating PV as taught by Chin. One would have been motivated to have treated the patient population of Shen with the method of Chin because Shen teaches that a majority of PV patients have a JAK2V617F mutation which results in the continuous activation of the JAK2/STAT5 signaling pathway and Chin teaches a method of treating PV. Thus, there would be a reasonable expectation of success in treating the PV patients of Shen with the known method of treating PV as taught by Chin.
Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anti-TMPRSS6 antibody in the method of Chin to be the anti-TMPRSS6 antibody of Du. One would have been motivated to use these sequences for the anti-TMPRSS6 antibody because they are known sequences in the art for an anti-TMPRSS6 antibody, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Additionally, it is prima facie obvious to substitute equivalents known for the same purpose (see MPEP 2144.06 (II)).
Claim 4 is included in this rejection because Shen teaches PV patients that have a JAK2V617F mutation [page 707, left column, first paragraph].
Claim 16 is included in this rejection because Shen teaches PV patients that have a JAK2V617F mutation [page 707, left column, first paragraph] which results in the continuous activation of the JAK2/STAT5 signaling pathway [page 709, right column, fourth-fifth paragraphs]. As evidenced by Jamieson et al., 2006 (instant PTO-892), the JAK2V617F mutation occurs in hematopoietic stem cells and their progeny in PV [see Abstract]. Thus, the patients of Shen necessarily comprise a hematopoietic progenitor cell that comprises a mutation (i.e. JAK2V617F) that leads to JAK2/STAT5 overactivation.
Claims 28, 29, and 42 are included in this rejection because they merely recite effects or results of administering the anti-TMPRSS6 antibody. Since the antibody of Du is identical to that instantly claimed, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary.
Claim 59 is included in this rejection because Du teaches that the anti-TMPRSS6 antibody comprises a HC of SEQ ID NO: 73 and a LC of SEQ ID NO: 75 [page 8, lines 1-3].
SEQ ID NOs: 73 and 75 of Du have 100% sequence identity to SEQ ID NOs: 73 and 75, respectively, of the instant claim.
Claims 41, 60, and 61 are included in this rejection because since the antibody of Du is identical to that instantly claimed, the antibody must have the claimed properties since function flows from structure. See MPEP 2112.01(II).
Claims 1, 3-4, 13, 16, 28-29, 41-42, and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US 20220411487; instant PTO-892) in view of Shen et al., 2010 (instant PTO-892) and Du (WO2021207072; 09/06/2024 IDS), as applied to claims 1, 3-4, 16, 28-29, 41-42, and 58-61 above, and further in view of Regimbeau et al., 2022 (instant PTO-892).
The teachings of Chin, Shen, and Du are above.
However, Chin, Shen, and Du do not specifically teach that the subject has a non-JAK2 mutation.
Regarding claim 13, Regimbeau teaches that a small percentage of individuals with PV have mutations in addition to a JAK2 mutation that occur either in TET2, DNMT3a, or ASXL1 genes [page 2, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the patient population of Regimbeau with the method of treating PV as taught by Chin, Shen, and Du. One would have been motivated to have treated the patient population of Regimbeau with the method of Chin, Shen, and Du because Regimbeau teaches that a small percentage of individuals with PV have mutations in addition to a JAK2 mutation that occur either in TET2, DNMT3a, or ASXL1 genes and Chin, Shen, and Du teach a method of treating PV. Thus, there would be a reasonable expectation of success in treating the PV patients of Regimbeau with the known method of treating PV as taught by Chin, Shen, and Du.
Claims 1, 3-4, 16, 20-22, 26, 28-29, 41-42, and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US 20220411487; instant PTO-892) in view of Shen et al., 2010 (instant PTO-892) and Du (WO2021207072; 09/06/2024 IDS), as applied to claims 1, 3-4, 16, 28-29, 41-42, and 58-61 above, and further in view of Fox et al., 2021 (instant PTO-892).
The teachings of Chin, Shen, and Du are above.
However, Chin, Shen, and Du do not specifically teach that the subject presents with a phenotypic profile of PV, has increased hematocrit (HCT) and hemoglobin relative to a subject that does not have PV, and has erythrocytosis prior to the administration of the anti-TMPRSS6 antibody.
Regarding claims 20-22 and 26, Fox teaches that polycythemia vera is characterized by erythrocytosis (a phenotypic profile of PV), and that the World Health Organization’s major diagnostic criteria include an elevated hemoglobin or hematocrit level [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated subjects with a phenotypic profile of PV, increased hematocrit (HCT) and hemoglobin relative to a subject that does not have PV, and erythrocytosis prior to the administration of the anti-TMPRSS6 antibody, as taught by Fox, with the method of treating PV as taught by Chin, Shen, and Du. One would have been motivated to have treated the patient population of Fox with the method of Chin, Shen, and Du because Fox teaches polycythemia vera is characterized by erythrocytosis (a phenotypic profile of PV), and that the World Health Organization’s major diagnostic criteria include an elevated hemoglobin or hematocrit level, thereby confirming the subject has PV, and Chin, Shen, and Du teach a method of treating PV. Thus, there would be a reasonable expectation of success in treating the PV patients of Fox with the known method of treating PV as taught by Chin, Shen, and Du.
Claims 1, 3-4, 16, 28-29, 41-42, and 56-61 are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US 20220411487; instant PTO-892) in view of Shen et al., 2010 (instant PTO-892) and Du (WO2021207072; 09/06/2024 IDS), as applied to claims 1, 3-4, 16, 28-29, 41-42, and 58-61 above, and further in view of Vannucchi et al., 2015 (instant PTO-892).
The teachings of Chin, Shen, and Du are above.
However, Chin, Shen, and Du do not specifically teach that the subject is concurrently receiving an additional therapeutic for treating PV and wherein the additional therapeutic is Ruxolitinib.
Regarding claims 56-57, Vannucchi teaches that administration of Ruxolitinib had clinical benefit in patients with polycythemia vera (PV) and it was superior in improving symptoms associated with PV (i.e. treats PV) [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of treating PV as taught by Chin, Shen, and Du, to also administer the ruxolitinib of Vannucchi. One would have been motivated to have combined the anti-TMPRSS6 antibody in the method of Chin, Shen, and Du with the ruxolitinib of Vannucchi because both are known treatments for PV. This follows the logic of MPEP 2144.06 which states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the separate, known compositions for the same purpose of treating PV.
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, 3-4, 16, 28-29, 41-42, and 58-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-36, 41-42, and 44 of copending Application No. 19/042,342 and claim 22 of copending Application No. 19/472,577 in view of Chin (US 20220411487; instant PTO-892) and Shen et al., 2010 (instant PTO-892).
Regarding claims 1, 3, and 58-59 of the instant application, claims 34-36 and 41 of copending Application No. 19/042,342 teach an anti-TMPRSS6 comprising c) a HC CDR1, a HC CDR2, and a HC CDR3 of a VH that comprises the amino acid sequence of SEQ ID NO: 31, and a light chain complementarity determining region (LC CDR) 1 (LC CDR1), a LC CDR2, and a LC CDR3 of a VL that comprises the amino acid sequence of SEQ ID NO: 36, wherein the anti-TMPRSS6 antibody comprises: (c) a HC CDR1 comprising the amino acid of SEQ ID NO: 32, a HC CDR2 comprising the amino acid of SEQ ID NO: 33, a HC CDR3 comprising the amino acid of SEQ ID NO: 34, a LC CDR1 comprising the amino acid of SEQ ID NO: 37, a LC CDR2 comprising the amino acid of SEQ ID NO: 38, a LC CDR3 comprising the amino acid of SEQ ID NO: 39, (c) a VH comprising the amino acid sequence of SEQ ID NO: 31, and a VL comprising the amino acid sequence of SEQ ID NO: 36, and wherein (c) a HC comprising the amino acid sequence of SEQ ID NO: 73, and a LC comprising the amino acid sequence of SEQ ID NO: 75.
Claim 22 of copending Application No. 19/472,577 teaches a kit for treating an iron overload-associated condition in a subject in need thereof, the kit comprising:
(a) a container comprising a pharmaceutical composition comprising an anti-transmembrane serine protease 6 (TMPRSS6) antibody or an antigen-binding fragment thereof, wherein the anti-TMPRSS6 antibody comprises the HC CDR1, HC CDR2, HC CDR3, LC CDR1, LC CDR2, and LC CDR3 of any one of the antibodies set forth in Table 1; and (b) instructions for administering the pharmaceutical composition to the subject. Table 1 of the instant specification discloses an anti-TMPRSS6 antibody termed “A2” comprising SEQ ID NOs: 1, 2, and 35 for the HC CDRs 1-3, SEQ ID NOs: 36, RAN, and 6 for the LC CDRs 1-3, SEQ ID NO: 37 for the VH, SEQ ID NO: 38 for the VL, SEQ ID NO: 41 for the HC, and SEQ ID NO: 42 for the LC.
The sequences disclosed in copending Application Nos. 19/042,342 and 19/472,577 for the HC CDRs 1-3, LC CDRs 1-3, VH, VL, HC, and LC are 100% identical to those claimed in instant claims 1, 58, and 59.
However, copending Application Nos. 19/042,342 and 19/472,577 do not specifically teach a method of treating polycythemia vera (PV) in a subject, wherein the PV is associated with overactivation of JAK2/STAT5 pathway, the method
comprising administering an effective amount of an anti-TMPRSS6 antibody to the subject.
Chin teaches antibodies that specifically bind to the transmembrane serine protease 6 (TMPRSS6) protein [0008; claim 1] and teaches a method of treating a disease or disorder associated with iron overload, the method comprising administering a pharmaceutical composition comprising a therapeutically effective amount of the anti-TMPRSS6 antibody of the disclosure to a subject in need thereof [0039; claim 50], wherein the disease or disorder may be polycythemia vera (PV) [0040; claim 51].
Shen teaches that the JAK2V617F mutation was found in 65-97% patients with polycythemia vera (PV) [page 707, left column, first paragraph] and that the JAK2V617F mutation results in the continuous activation of the JAK2/STAT5 signaling pathway [page 709, right column, fourth-fifth paragraphs].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the anti-TMPRSS6 antibodies of the copending applications in the method of treating PV as taught by Chin. One would have been motivated to have modified the anti-TMPRSS6 antibody in the method of Chin to be the anti-TMPRSS6 antibodies of the copending application because they are known sequences for anti-TMPRSS6 antibodies, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Additionally, it is prima facie obvious to substitute equivalents known for the same purpose (see MPEP 2144.06 (II)).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the patient population of Shen with the method of treating PV as taught by Chin. One would have been motivated to have treated the patient population of Shen with the method of Chin because Shen teaches that a majority of PV patients have a JAK2V617F mutation which results in the continuous activation of the JAK2/STAT5 signaling pathway and Chin teaches a method of treating PV. Thus, there would be a reasonable expectation of success in treating the PV patients of Shen with the known method of treating PV as taught by Chin.
Claim 4 is included in this rejection because Shen teaches PV patients that have a JAK2V617F mutation [page 707, left column, first paragraph].
Claim 16 is included in this rejection because Shen teaches PV patients that have a JAK2V617F mutation [page 707, left column, first paragraph] which results in the continuous activation of the JAK2/STAT5 signaling pathway [page 709, right column, fourth-fifth paragraphs]. As evidenced by Jamieson et al., 2006 (instant PTO-892), the JAK2V617F mutation occurs in hematopoietic stem cells and their progeny in PV [see Abstract]. Thus, the patients of Shen necessarily comprise a hematopoietic progenitor cell that comprises a mutation (i.e. JAK2V617F) that leads to JAK2/STAT5 overactivation.
Claims 28, 29, and 42 are included in this rejection because they merely recite effects or results of administering the anti-TMPRSS6 antibody. Since the antibody of Du is identical to that instantly claimed, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary.
Claims 41, 60, and 61 are included in this rejection because since the antibody of Du is identical to that instantly claimed, the antibody must have the claimed properties since function flows from structure. See MPEP 2112.01(II).
Additionally, claim 42 of copending Application No. 19/042,342 teaches that the anti-TMPRSS6 antibody cross-reacts with at least one non-human TMPRSS6 and claim 44 of copending Application No. 19/042,342 teaches that the anti-TMPRSS6 antibody specifically binds to human TMPRSS6.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 13, 16, 28-29, 41-42, and 58-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-36, 41-42, and 44 of copending Application No. 19/042,342 and claim 22 of copending Application No. 19/472,577 in view of Chin (US 20220411487; instant PTO-892) and Shen et al., 2010 (instant PTO-892), as applied to claims 1, 3-4, 16, 28-29, 41-42, and 58-61 above, and further in view of Regimbeau et al., 2022 (instant PTO-892).
The teachings of copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen are above.
However, copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen do not specifically teach that the subject has a non-JAK2 mutation.
Regarding claim 13, Regimbeau teaches that a small percentage of individuals with PV have mutations in addition to a JAK2 mutation that occur either in TET2, DNMT3a, or ASXL1 genes [page 2, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the patient population of Regimbeau with the method of treating PV as taught by copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen. One would have been motivated to have treated the patient population of Regimbeau with the method of copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen because Regimbeau teaches that a small percentage of individuals with PV have mutations in addition to a JAK2 mutation that occur either in TET2, DNMT3a, or ASXL1 genes and copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen teach a method of treating PV. Thus, there would be a reasonable expectation of success in treating the PV patients of Regimbeau with the known method of treating PV as taught by copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 16, 20-22, 26, 28-29, 41-42, and 58-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-36, 41-42, and 44 of copending Application No. 19/042,342 and claim 22 of copending Application No. 19/472,577 in view of Chin (US 20220411487; instant PTO-892) and Shen et al., 2010 (instant PTO-892), as applied to claims 1, 3-4, 16, 28-29, 41-42, and 58-61 above, and further in view of Fox et al., 2021 (instant PTO-892).
The teachings of copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen are above.
However, copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen do not specifically teach that the subject presents with a phenotypic profile of PV, has increased hematocrit (HCT) and hemoglobin relative to a subject that does not have PV, and has erythrocytosis prior to the administration of the anti-TMPRSS6 antibody.
Regarding claims 20-22 and 26, Fox teaches that polycythemia vera is characterized by erythrocytosis (a phenotypic profile of PV), and that the World Health Organization’s major diagnostic criteria include an elevated hemoglobin or hematocrit level [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated subjects with a phenotypic profile of PV, increased hematocrit (HCT) and hemoglobin relative to a subject that does not have PV, and erythrocytosis prior to the administration of the anti-TMPRSS6 antibody, as taught by Fox, with the method of treating PV as taught by copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen. One would have been motivated to have treated the patient population of Fox with the method of copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen because Fox teaches polycythemia vera is characterized by erythrocytosis (a phenotypic profile of PV), and that the World Health Organization’s major diagnostic criteria include an elevated hemoglobin or hematocrit level, thereby confirming the subject has PV, and copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen teach a method of treating PV. Thus, there would be a reasonable expectation of success in treating the PV patients of Fox with the known method of treating PV as taught by copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 16, 28-29, 41-42, and 56-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-36, 41-42, and 44 of copending Application No. 19/042,342 and claim 22 of copending Application No. 19/472,577 in view of Chin (US 20220411487; instant PTO-892) and Shen et al., 2010 (instant PTO-892), as applied to claims 1, 3-4, 16, 28-29, 41-42, and 58-61 above, and further in view of Vannucchi et al., 2015 (instant PTO-892).
The teachings of copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen are above.
However, copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen do not specifically teach that the subject is concurrently receiving an additional therapeutic for treating PV and wherein the additional therapeutic is Ruxolitinib.
Regarding claims 56-57, Vannucchi teaches that administration of Ruxolitinib had clinical benefit in patients with polycythemia vera (PV) and it was superior in improving symptoms associated with PV (i.e. treats PV) [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of treating PV as taught by copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen, to also administer the ruxolitinib of Vannucchi. One would have been motivated to have combined the anti-TMPRSS6 antibody in the method of copending Application Nos. 19/042,342 and 19/472,577, Chin, and Shen with the ruxolitinib of Vannucchi because both are known treatments for PV. This follows the logic of MPEP 2144.06 which states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the separate, known compositions for the same purpose of treating PV.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
