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 .
Priority
This application is a CON of 17/314,581 05/07/2021 ABN. 17/314,581 is a CON of 16/212,497 filed 12/06/2018 now ABN. 16/212,497 has PRO 62/773,954 filed 11/30/2018. 16/212,497 has PRO 62/753,656 filed 10/31/2018. 16/212,497 is a CIP of 16/101,676 filed 08/13/2018 now ABN. 16/212,497 is a CIP of 62/596,056 filed 12/07/2017. 16/101,676 is a CON of 15/834,017 filed 12/06/2017 now PAT 10058573.
Information Disclosure Statement
It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicants duty to disclose all information known to be material to patentability.
Claim Status
Claims 168-187 are being examined on the merits in this office action.
Claim Rejections - 35 USC § 102
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 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 168-178, and 181-187 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bridger et al. (US20100178271A1 – hereinafter “Bridger”).
Regarding claim 168, Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. The disclosures anticipate claim 168.
Regarding claims 169-171, Bridger teaches that the compounds including CXCR2 agonist is administered at the range of 10 μg/kg-100 μg/kg [0075]. Examiner notes that the range encompasses the instant recited dose.
Regarding claims 172-173, Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072].
Regarding claims 174-176, Bridger teaches that the compounds including CXCR2 agonist is administered at about 240 μg/kg [0075]. Examiner notes that the dose is encompassed in the instant dose range.
Regarding claims 177, Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. Bridger teaches that the mice were administered AMD and 60 min alter were administered GROβ [0087]. The disclosures anticipate claims 177-178.
Regarding claims 181-185, Bridger teaches that the compounds including CXCR2 agonist is administered at the range of 10 μg/kg-100 μg/kg, or 1 μg/kg-300 μg/kg [0075]. Examiner notes that the range encompasses the instant recited dose.
Regarding claims 186-187, Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072].
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 179 and 180 are rejected under 35 U.S.C. 103 as being unpatentable over Bridger et al. (US20100178271A1 – hereinafter “Bridger”) as applied to claim 168 above, and further in view of Hoggart et al. (Methods in Molec. Biol., 2012, 49-67).
The teachings of Bridger are disclosed above and incorporated herein by reference.
Bridger does not explicitly teach the administration times of claim 179 and 180.
Examiner notes that Bridger teaches the instant method and teaches administering the antagonist 60 min prior to the agonist.
Additionally, Hoggart teaches a method of mobilizing hematopoietic stem cells from bone marrow comprising administering a combination of AMD3100 with GROβ, and that the GROβ is administered 45 min post administration of AMD3100 and that the time duration led to maximum mobilization (Page 53, 2nd paragraph, line 1-16). Hoggart teaches that mobilization assays should be conducted and that it is important to stagger the dosing of the mobilization agent such that the blood collection can be performed at peak mobilization time (Page 55, line 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Bridger and administer the antagonist between 30-180 or 70-130 minutes before the antagonist since both Bridger and Hoggart teach administering the antagonist at a certain time limit before the agonist and Hoggart teaches performing assays and staggering the dose to determine the peak mobilization. Examiner notes that one of ordinary skill in the art would have found it obvious through routine experimentation to vary the administration times to identify the optimal conditions for hematopoietic stem cells mobilization. Thus, one of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the administration times between the antagonist and agonist through routine experimentation since Hoggart suggests routine experimentation for optimal mobilization. Additionally, MPEP 2144.05 III A states that "[a] modification of a process parameter may be patentable if it 'produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." In this case, there is no evidence of a difference in kind or even degree when using the claimed doses and schedules. The disclosures render obvious claims 179-180.
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 168, 174-181 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 13-27 of copending Application No. 19/549,910. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a method that comprises mobilizing hematopoietic stem or progenitor cells into the peripheral blood using a CXCR2 agonist selected from the group consisting of GROβ, GROβ T, and variants thereof at a dose of from about 0.001 mg/kg to about 0.1 mg/kg or at a fixed dose of from about 1 mg to about 8 mg (claim 1, 13, 14, 15), wherein the method comprises administering a CXCR2 agonist and CXCR4 antagonist (claim 11, 16-27).
The instant claims recite a method for mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian subject into peripheral blood, the method comprising administering to the subject (i) a CXCR2 agonist, wherein the CXCR2 agonist is GROβ T, at a dose of from 50 µg/kg to 150 mg/kg and (ii) a CXCR4 antagonist (claim 168).
The claims of the copending application anticipate the instant claims.
Regarding claim 174-176, the claims of the copending application recite wherein the plerixafor was administered to the subject at a dose of about 240 µg/kg (claim 19).
Regarding claim 177-181, the claims of the copending application recite a method that comprises mobilizing hematopoietic stem or progenitor cells into the peripheral blood using a CXCR2 agonist selected from the group consisting of GROβ, GROβ T, and variants thereof at a dose of from about 0.001 mg/kg to about 0.1 mg/kg or at a fixed dose of from about 1 mg to about 8 mg (claim 1, 13, 14, 15), wherein the method comprises administering a CXCR2 agonist and CXCR4 antagonist, wherein the CXCR2 agonist was administered after the CXCR4 antagonist, wherein the CXCR2 agonist was administered within about 4 hours of administration of the CXCR4 antagonist, wherein the CXCR2 agonist was administered about 2 hours after the CXCR4 antagonist (claim 11, 16-27).
Claims 168-187 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/936,787 in view of Bridger et al. (US20100178271A1 – hereinafter “Bridger”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a method of mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian donor into peripheral blood, the method comprising administering to the donor (i) a CXCR2 agonist selected form the group consisting of GROβ, GROβ T, and variants thereof at a dose of from about 50 µg/kg to about 300 mg/kg and (ii) a CXCR4 antagonist (claim 1).
The instant claims recite a method for mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian subject into peripheral blood, the method comprising administering to the subject (i) a CXCR2 agonist, wherein the CXCR2 agonist is GROβ T, at a dose of from 50 µg/kg to 150 mg/kg and (ii) a CXCR4 antagonist (claim 168).
The copending claims do not teach that the agonists and antagonist are administered intravenously and subcutaneously are recited in claims172-173.
Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072].
The claims of the copending application render obvious the instant claims.
Regarding claims 169-171, the claims of the copending application recite a method of mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian donor into peripheral blood, the method comprising administering to the donor (i) a CXCR2 agonist selected form the group consisting of GROβ, GROβ T, and variants thereof at a dose of from about 50 µg/kg to about 300 mg/kg (claim 1).
Regarding claims 172-173, Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072]. It would have been obvious to modify the copending claims and administer the compounds as taught by Bridger to arrive to the instant claims.
Regarding claims 174-176, Bridger teaches that the compounds including CXCR2 agonist is administered at about 240 μg/kg [0075]. It would have been obvious to modify the copending claims and administer the compounds at the dose taught by Bridger to arrive to the instant claims.
Regarding claims 177-180, Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. Bridger teaches that the mice were administered AMD and 60 min alter were administered GROβ [0087]. It would have been obvious to modify the copending claims and administer the compounds as taught by Bridger to arrive to the instant claims.
Regarding claims 181-185, Bridger teaches that the compounds including CXCR2 agonist is administered at the range of 10 μg/kg-100 μg/kg, or 1 μg/kg-300 μg/kg [0075]. It would have been obvious to modify the copending claims and administer the compounds at the dose taught by Bridger to arrive to the instant claims.
Regarding claims 186-187, Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072]. It would have been obvious to modify the copending claims and administer the compounds as taught by Bridger to arrive to the instant claims.
Claims 168, 172-180, and 186-187 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 8-10, 12-13 of copending Application No. 17/773,422 in view of Bridger et al. (US20100178271A1 – hereinafter “Bridger”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a method of mobilizing a population of hematopoietic stem or progenitor cells from the bone marrow of a human subject into peripheral blood, the method comprising administering to the human subject a C-X-C chemokine receptor type 2 (CXCR2) agonist selected from the group consisting of growth-regulated protein β (GRO-β), truncated GROβ (GRO-β T) at a dose of about 0.03 mg/kg (claim 1-2), the method further comprising administering to the human subject a C-X-C chemokine receptor type 4 (CXCR4) antagonist, wherein the CXCR4 antagonist is plerixafor (claim 8-9).
The instant claims recite a method for mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian subject into peripheral blood, the method comprising administering to the subject (i) a CXCR2 agonist, wherein the CXCR2 agonist is GRO-β T, at a dose of from 50 µg/kg to 150 mg/kg and (ii) a CXCR4 antagonist (claim 168).
The copending claims do not teach that the agonists and antagonist are administered intravenously and subcutaneously are recited in claims 172-173.
Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072].
The claims of the copending application render obvious the instant claims.
Regarding claims 172-173, Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072]. It would have been obvious to modify the copending claims and administer the compounds as taught by Bridger to arrive to the instant claims.
Regarding claims 174-176, the copending claims recite CXCR2 antagonist is administered at about 240 μg/kg [0075]. It would have been obvious to modify the copending claims and administer the compounds at the dose taught by Bridger to arrive to the instant claims.
Regarding claims 177-180, the copending claims recite herein the CXCR2 agonist is administered after the CXCR4 antagonist (claim 12), wherein the CXCR2 agonist is administered within about 4 hours of administration of the CXCR4 antagonist (claim 13). Examiner notes that the copending recitation of within 4 hours, includes the times recited in the instant claims.
Regarding claims 186-187, Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072]. It would have been obvious to modify the copending claims and administer the compounds as taught by Bridger to arrive to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 168-187 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-10, 12-19, 22-23 of U.S. Patent No. 11260079. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a method which includes administering hematopoietic stem cell, wherein the hematopoietic stem cells were mobilized from bone marrow of a human donor into peripheral blood of the human donor by a method comprising administering to the donor (i) Gro-β T and (ii) plerixafor or a pharmaceutically acceptable salt thereof, wherein the Gro-β T is administered between 30-180 minutes after the plerixafor or the pharmaceutically acceptable salt thereof, wherein Gro-β T at a dose of from about 50 μg/kg to about 150 μg/kg (claim 1, 8-9, 18).
The instant claims recite a method for mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian subject into peripheral blood, the method comprising administering to the subject (i) a CXCR2 agonist, wherein the CXCR2 agonist is GROβ T, at a dose of from 50 µg/kg to 150 mg/kg and (ii) a CXCR4 antagonist (claim 168).
The claims of the patent anticipate the instant claims.
Regarding claims 169-171, the claims of the patent recite wherein Gro-β T at a dose of from about 50 μg/kg to about 150 μg/kg (claims 8-9).
Regarding claims 172-173, the claims of the patent recite wherein the plerixafor or a pharmaceutically acceptable salt thereof is administered subcutaneously to the donor and wherein the Gro-β T is administered intravenously (claims 2-3, 8-9, 18-19).
Regarding claims 174-176, the claims of the patent recite wherein the plerixafor or pharmaceutically acceptable salt thereof is administered to the donor at a dose of from about 50 μg/kg to about 500 μg/kg (claim 4), or at a dose of from about 200 μg/kg to about 300 μg/kg (claim 5), or at a dose of about 240 μg/kg (claim 6, 8-9, 17-18).
Regarding claims 177-180, the claims of the patent recite wherein the Gro-β T is administered between 30-180 minutes after the plerixafor (claim 1), or about 60 minutes after the plerixafor (claim 10), or 40-160 minutes after the plerixafor (claim 12), or between 50-150 minutes after the plerixafor (claim 13), or between 50-150 minutes after the plerixafor (claim 14), or between 60-140 minutes after the plerixafor (claim 15, 18), or about 120 minutes after the plerixafor (claim 16, 23) or between 70-130 minutes after the plerixafor (claim 22).
Regarding claims 181-185, the claims of the patent recite wherein Gro-β T at a dose of from about 50 μg/kg to about 150 μg/kg (claims 8-9).
Regarding claims 186-187, the claims of the patent recite wherein the plerixafor or a pharmaceutically acceptable salt thereof is administered subcutaneously to the donor and wherein the Gro-β T is administered intravenously (claims 2-3, 8-9, 18-19).
Claims 168, 172-181, and 185-187 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 9 of U.S. Patent No. 10058573, in view of Bridger et al. (US20100178271A1 – hereinafter “Bridger”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a method of mobilizing a population of hematopoietic stem cells from the bone marrow of a human donor into peripheral blood, the method comprising administering to the donor (i) Gro-β T at a dose of about 150 μg/kg, wherein the Gro-β T is administered intravenously to the donor and (ii) 240 μg/kg plerixafor or a pharmaceutically acceptable salt thereof, wherein the plerixafor or pharmaceutically acceptable salt thereof is administered subcutaneously to the donor (claim 1, 9).
The instant claims recite a method for mobilizing a population of hematopoietic stem cells from the bone marrow of a mammalian subject into peripheral blood, the method comprising administering to the subject (i) a CXCR2 agonist, wherein the CXCR2 agonist is GROβ T, at a dose of from 50 µg/kg to 150 mg/kg and (ii) a CXCR4 antagonist (claim 168).
The claims of the patent do not recite that the CXCR4 antagonist is administered prior to the CXCR2 agonist as recited in claim 177.
Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072]. Bridger teaches that the mice were administered AMD and 60 min alter were administered GROβ [0087].
The claims of the patent render obvious the instant claims.
Regarding claims 172-173, the claims of the patent recite wherein the Gro-β T is administered intravenously to the donor and wherein the plerixafor or pharmaceutically acceptable salt thereof is administered subcutaneously to the donor (claim 1, 9).
Regarding claims 174-176, the claims of the patent recite administering 240 μg/kg plerixafor or a pharmaceutically acceptable salt thereof (claim 1, 9).
Regarding claims 177-180, the claims of the patent recite a method of mobilizing a population of hematopoietic stem cells from the bone marrow of a human donor into peripheral blood, the method comprising administering to the donor (i) Gro-β T at a dose of about 150 μg/kg, wherein the Gro-β T is administered intravenously to the donor and (ii) 240 μg/kg plerixafor or a pharmaceutically acceptable salt thereof, wherein the plerixafor or pharmaceutically acceptable salt thereof is administered subcutaneously to the donor (claim 1, 9).
The claims of the patent do not recite that the CXCR4 antagonist is administered prior to the CXCR2 agonist as recited in claim 177.
However, Bridger teaches a method to mobilize progenitor and/or stem cells from the bone marrow into the peripheral blood of a subject comprising administering to the subject in combination an effective amount of at least one CXCR4 inhibitor or a pharmaceutically acceptable salt thereof, an effective amount of at least one CXCR2 agonist, wherein the CXCR4 inhibitor is AMD3100 or a pharmaceutically acceptable salt thereof, wherein the CXCR2 agonist is GROβ or a modified form thereof (claim 1-7; [0021-0022), that the subject includes animal subjects, in particular, veterinary and human subjects [0020]. Bridger teaches that CXCR2 agonists are GROβ and modified forms thereof, such as truncated forms [0036-0037]. Bridger teaches that the method comprises administering the CXCR4 inhibitor AMD3100 and the CXCR2 agonist GROβ rapidly mobilizes short- and long-term repopulating hematopoietic stem and that the GROβ is administered at a dose of 2.5 mg/kg [0087]. Bridger teaches that the compounds are administered by injection, such as by intravenous injection, but also by subcutaneous or intraperitoneal injection [0072]. Bridger teaches that the mice were administered AMD and 60 min alter were administered GROβ [0087]. It would have been obvious to modify the claims of the patent and through routine experimentation, to administer the compounds at the times taught by Bridger thus arriving to the instant claims.
Regarding claims 181 and 185, the claims of the patent recite that Gro-β T is administered at a dose of about 150 μg/kg (claim 1, 9).
Regarding claims 186-187, the claims of the patent recite wherein the Gro-β T is administered intravenously to the donor and wherein the plerixafor or pharmaceutically acceptable salt thereof is administered subcutaneously to the donor (claim 1, 9).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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