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 .
DETAILED ACTION
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 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.
Response to Amendments
Applicant’s amendments, corrected drawings, IDS, and response filed Sept. 3, 2025 have been received and entered into the case.
Status of the Claims
Claims 1-4, 8-13, 15, 17-18, and 23 are currently pending.
Claims 1, 2, 8 and 10 are amended.
Claims 5-7, 19-22 and 24-124 are cancelled.
Claims 1-4, 8-13, 15, 17-18, and 23 have been considered on the merits.
Drawing Objections
The drawing objections are withdrawn due to amendment.
Claim Objections
The claim objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ), written description are withdrawn due to amendment.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are withdrawn due to amendment.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are revised due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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 1-4, 8-13, 15, 17-18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Morrow et al. (10,058,573 B1) (ref. of record) as evidenced by NCBI BLASTp alignment (NBCI webpage for BLASTp, accessed Dec. 16, 2025), Bridger et al. (US 2010/0178271 A1) (ref. of record) and Hoggatt et al. (Stem Cell Mobilization: Methods and Protocols, 2012) (ref. of record).
With respect to claim 1, Morrow teaches a method of mobilizing hematopoietic stem cells from bone marrow into the peripheral blood of a human donor (abstract, Col. 1 lines 25-52). With respect to the claims 1 and 3, Morrow teaches the method where a CXCR2 agonist, Gro-β, a truncated Gro-β (Gro-β T) and variants thereof is administered (Col. 1 lines 25-52). Morrow teaches the method where the Gro-βT has sequence identity to the amino acid sequence of SEQ ID NO: 2 and the Gro-β has sequence identity to the amino acid sequence of SEQ ID NO: 1 (Col. 35 lines 4-9 and 30-35). SEQ ID NO. 1 shares 100% homology with instant SEQ ID NO. 1 and SEQ ID NO. 2 shares 100% homology with instant SEQ ID NO. 2 as evidenced by a BLAST alignment (see attached Blast alignments).
Although, Morrow teaches the dose can be 150 µg/kg (0.150 mg/kg) and the dose can be 50 µg/kg to 1 mg/kg (0.05 mg to 1 mg/ml) (Claim 1 and Col. 35 lines 55-58), Morrow does not teach the dose is from about 0.001 to less than 0.05 mg/kg (1 to 50 µg/kg) as recited in claim 1. Similarly, Morrow does not teach the dose is in the range of about 0.015 to less than 0.05 mg/kg as recited in claim 2, or the dose is about 0.03 mg/kg as recited in claim 4. Although Morrow does not teach the exact ranges or amounts recited in claims, one of ordinary skill in the art would recognize that the dosage of the CXCR2 agonist for the mobilizing of hematopoietic stem or progenitor cells from the bone marrow is a result effective variable and that the amount and dose would be matter of routine optimization as evidenced by Bridger. Bridger teaches suitable dosage ranges for the CXCR4 inhibitor and CXCR2 agonist will vary according to the size and weight of the patient, the condition that the patient is being treated for and other considerations, and that optimizing the protocols for administration to a particular patient is within the ordinary skill of the art (0075).
With respect to claims 8 and 9, Morrow teaches the method where the donor is administered a CXCR4 antagonist which is AMD3100 (plerixafor) (Col. 1 lines 25-52, Col. 39 lines 38-53, and claim 1). With respect to claim 10, Morrow teaches the method where AMD3100 (plerixafor) is administered to the donor at a dose of about 240 µg/kg (Col. 39 lines 38-53 and Col. 138 lines 48-67).
With respect to claim 11, Morrow teaches that CXCR4 antagonist and a CXCR2 agonist are administered simultaneously (Col. 154 lines 8-17). With respect to claim 12, Morrow teaches the method where the CXCR2 agonist is administered after the CXCR4 antagonist (Col. 154 lines 18-20). With respect to claim 13, Morrow teaches the method where the CXCR2 agonist is administered within about 4 hours of administration of the CXCR4 antagonist (Col. 154 lines 18-43).
Morrow does not teach the method where the CXCR2 agonist and the CXCR4 antagonist are administered on two consecutive days as recited in claim 15. Morrow does not teach the method where the CXCR2 agonist and the CXCR4 antagonist are each administered on two consecutive days and results in peak mobilization of at least 30 CD34+ cell/µL on the first day and peak mobilization of at least 20 CD34+ cell/µL on the second day as recited in claim 17. Even though Morrow does not teach administering the CXCR2 agonist and the CXCR4 antagonist on two consecutive days recited in claims 15 and 17, one of ordinary skill in the art would recognize that the dosage timing and number of doses of the hematopoietic stem and progenitor cell mobilizing agents, CXCR2 agonist and the CXCR4 antagonist, are result effective variables and that the timing and number of doses would be matter of routine optimization as evidenced by Hoggatt. Hoggatt teaches that when administrating a combination treatment of mobilization agents, different dosing regimens should be attempted to determine the possible synergistic activity and that the optimum kinetics of a mobilization agent on its own might not be the same when used in combination with other agents (pg. 53 para. 3 to pg. 54 para. 1).
Additionally, with respect to the intended results recited in claim 17, Morrow teaches that the method of administering to the donor a CXCR2 agonist and the CXCR4 antagonist results in a density of CD34+ cells of 38,000 to 100,000 cells/ml (38-100 cells/ cell/µL), 40,000 to 80,000 cells/ml (40-80 cells/ cell/µL), and 50,000 to 90,000 cells/ml (50-90 cells/ cell/µL) (Col. 4 line 57 to Col. 5 line 8).
Claims 17, 18 and 23 contain wherein clauses that recite the intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since these claims only recite the results of the steps, then art reading on claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. In other words, the claims are drawn to an invention employing the same process steps as taught by Morrow. In addition, it is noted with respect to claim 18, Morrow teaches that the method increases plasma MMP-9 (Fig. 11A and Col. 59 lines 8-14) and reports the method where there is an increase in the ratio of MMP-9 to tissue inhibitor of metalloproteinases 1 (TIMP-1) in the plasma (Fig. 11-13 and Col. 156 lines 57-67). Additionally, Morrow teaches the method where the CD34+CD90+CD45RA- cells frequency in the peripheral blood is increased by at least 3-fold and at least 8-fold after the administration of the CXCR2 agonist and the CXCR4 antagonist (Col. 33 line 51 to Col. 34 line 43). It is further noted that, Morrow does not test the donor for neutrophil activation and does not teach that the administration of the CXCR2 results in less than a 2.5 fold change in a neutrophil activation marker as recited in claim 18 or where the marker is CD11b, CD18, L-selectin or CD66 as recited in claim 23.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejections have been revised due to amendment.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 1-4, 8-13, 15, 17-18 and 23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 10,058,573 as evidenced by Bridger et al. (US 2010/0178271 A1) (ref. of record) and Hoggatt et al. (Stem Cell Mobilization: Methods and Protocols, 2012) (ref. of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim methods of mobilizing a population of hematopoietic stem cells from the bone marrow of mammalian donor into peripheral blood by administering to the donor a CXCR2 agonist.
Claims 1 and 9 of 10,058,573 recites a method of mobilizing a population of hematopoietic stem cells from the bone marrow of a human (mammalian) donor into peripheral blood by administering to the donor a CXCR2 agonist that is Gro-β T at a dose of 150 µg/kg (0.150 mg/kg) which reads in part on instant claim 1.
The claims of 10,058,573 do not recite the dose is from about 0.001 to less than 0.05 mg/kg (1 to 50 µg/kg) as recited in claim 1. Similarly, the claims of 10,058,573 do not recite the dose is in the range of about 0.015 to less than 0.05 mg/kg as recited in claim 2, or the dose is about 0.03 mg/kg as recited in claim 4. Although, the claims of 10,058,573 do not recite the exact ranges or amounts recited in claims, one of ordinary skill in the art would recognize that the dosage of the CXCR2 agonist for the mobilizing of hematopoietic stem or progenitor cells from the bone marrow is a result effective variable and that the amount and dose would be matter of routine optimization as evidenced by Bridger. Bridger teaches suitable dosage ranges for the CXCR4 inhibitor and CXCR2 agonist will vary according to the size and weight of the patient, the condition that the patient is being treated for and other considerations and that optimizing the protocols for administration to a particular patient is within the ordinary skill of the art (0075).
The limitation of the CXCR2 agonist is Gro-β T of instant claim 3 is recited by claim 1 and 9 of 10,058,573. The limitation of the method further comprising administering to the donor a CXCR4 antagonist of instant claim 8 is recited by claims 1 and 9 of 10,058,573. The limitation of the CXCR4 antagonist being plerixafor of instant claim 9 is recited by claims 1 and 9 of 10,058,573. The limitation of the administering a dose of plerixafor of 240 µg/kg of instant claim 10 is recited claims 1 and 9 of 10,058,573.
The claims of 10,058,573 do not recite the limitation of administering the CXCR2 agonist simultaneously with CXCR4 antagonist of instant claim 11. The claims of 10,058,573 do not recite the limitation of administering the CXCR2 agonist after the CXCR4 antagonist is of instant claim 12. The claims of 10,058,573 do not recite the limitation of administering the CXCR2 agonist within about 4 hours of administration of the CXCR4 antagonist is of instant claim 13. The claims of 10,058,573 do not recite the limitation of administering the CXCR2 agonist and the CXCR antagonist on two consecutive days of instant claims 15 and 17. Even though claims of 10,058,573 do not recite the various sequencing and timing of administering of the CXCR2 agonist and the CXCR4 antagonist as instantly claimed, one of ordinary skill in the art would recognize that the sequencing and dosage timing of the hematopoietic stem and progenitor cell mobilizing agents, CXCR2 agonist and the CXCR4 antagonist, are result effective variables and that the order, timing and number of doses would be matter of routine optimization as evidenced by Hoggatt. Hoggatt teaches that when doing combination treatment of mobilization agents, different dosing regimens should be attempted to determine the possible synergistic activity and that optimum kinetics of a mobilization agent on its own might not be the same when used in combination with other agents (pg. 53 para. 3 to pg. 54 para. 1).
Although the claims of 10,058,573 do not recited the limitations of claims 17, 18 and 23 these appear to be intended results of practicing the claimed method which is recited by 10,058,573.
Claims 1-4, 8-13, 15, 17-18 and 23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 6, 8-10, 12-16, and 18 of U.S. Patent No. 11,260,079 as evidenced by Bridger et al. (US 2010/0178271 A1) (ref. of record) and Hoggatt et al. (Stem Cell Mobilization: Methods and Protocols, 2012) (ref. of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim methods of mobilizing a population of hematopoietic stem cells from the bone marrow of mammalian donor into peripheral blood by administering to the donor a CXCR2 agonist.
Claims 1, 8, 9 and 18 of 11,260,079 recite a method used to mobilize a population of hematopoietic stem cells from the bone marrow of a human (mammalian) donor into peripheral blood by administering to the donor a CXCR2 agonist that is Gro-β T which reads in part on instant claims 1 and 3.
Claim 8 of 11,260,079 recites the Gro-β T at a dose of 50-150 µg/kg (0.05-0.150 mg/kg). The claims of 11,260,079 do not recite the dose is from about 0.001 to less than 0.05 mg/kg (1 to 50 µg/kg) as recited in claim 1. Similarly, the claims of 11,260,079 do not recite the dose is in the range of about 0.015 to less than 0.05 mg/kg as recited in claim 2, or the dose is about 0.03 mg/kg as recited in claim 4. Although, the claims of 11,260,079 do not recite the exact ranges or amounts recited in claims, one of ordinary skill in the art would recognize that the dosage of the CXCR2 agonist for the mobilizing of hematopoietic stem or progenitor cells from the bone marrow is a result effective variable and that the amount and dose would be matter of routine optimization as evidenced by Bridger. Bridger teaches suitable dosage ranges for the CXCR4 inhibitor and CXCR2 agonist will vary according to the size and weight of the patient, the condition that the patient is being treated for and other considerations, and that optimizing the protocols for administration to a particular patient is within the ordinary skill of the art (0075).
The limitation of the CXCR2 agonist is Gro-β T of instant claim 3 is recited by claims 1, 8, 9 and 18 of 11,260,079. The limitation of the method further comprising administering to the donor a CXCR4 antagonist of instant claim 8 is recited by claims 1, 8, 9 and 18 of 11,260,079. The limitation of the CXCR4 antagonist being plerixafor of instant claim 9 is recited by claims 1, 8, 9 and 18 of 11,260,079. The limitation of the administering a dose of plerixafor of 240 µg/kg of instant claim 10 is recited claims 6, 8, 9 and 18 of 11,260,079.
The limitation of administering the CXCR2 agonist after the CXCR4 antagonist is of instant claim 12 is recited by claims 1, 10, 12-16, and 18 of 11,260,079. The limitation of administering the CXCR2 agonist within about 4 hours of administration of the CXCR4 antagonist of instant claim 13 is recited by claims 1, 10, 12-16, and 18 of 11,260,079.
The claims of 11,260,079 do not recite the limitation of administering the CXCR2 agonist simultaneously with CXCR4 antagonist of instant claim 11. The claims of 11,260,079 do not recite the limitation of administering the CXCR2 agonist and the CXCR antagonist on two consecutive days of instant claims 15 and 17. Even though claims of 11,260,079 do not recite the various sequencing and timings of administering of the CXCR2 agonist and the CXCR4 antagonist as instantly claimed, one of ordinary skill in the art would recognize that the sequencing and dosage timings of the hematopoietic stem and progenitor cell mobilizing agents, CXCR2 agonist and the CXCR4 antagonist, are result effective variables and that the order, timing and number of doses would be matter of routine optimization as evidenced by Hoggatt. Hoggatt teaches that when doing combination treatment of mobilization agents, different dosing regimens should be attempted to determine the possible synergistic activity and that optimum kinetics of a mobilization agent on its own might not be the same when used in combination with other agents (pg. 53 para. 3 to pg. 54 para. 1).
Although the claims of 11,260,079 do not recited the limitations of claims 17, 18 and 23 these appear to be intended results of practicing the claimed method which is recited by the claims of 11,260,079.
Claims 1-4, 8-13, 15, 17-18 and 23 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 130-133, 135-137, 141-143, and 145 of copending Application No. 18/468506 in view of Morrow et al. (10,058,573 B1) (ref. of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim methods of mobilizing a population of hematopoietic stem cells from the bone marrow of mammalian donor into peripheral blood by administering to the donor a CXCR2 agonist.
Claim 130 of 18/468506 recites the limitations of instant claim 1, and recites a method of mobilizing a population of hematopoietic stem or progenitor cells from the bone marrow of a mammalian donor into peripheral blood by administering to the donor a CXCR2 agonist select from the group consisting of Gro-β, Gro-β T, and variants thereof at a dose of from about 0.001 mg/kg to about 0.1 mg/kg. The limitation of the range of 0.001 to less than 0.05 mg/kg of claim 1 is recited in the combination of claims 130 and 131 of 18/468506 which recites a range of 0.015 to 0.05 mg/kg.
The limitation of the range of 0.015 to less than 0.05 mg/kg of claim 2 is recited by claim 131 of 18/468506. The limitation of the CXCR2 agonist comprising Gro-β T and administered at a dose of about 0.03 mg/kg of instant claims 3 and 4 is recited by claims 132 and 133 of 18/468506.
The limitation of the method further comprising administering to the donor a CXCR4 antagonist of instant claim 8 is recited by claim 135 of 18/468506. The limitation of the CXCR4 antagonist being plerixafor of instant claim 9 is recited by claim 136 of 18/468506. The limitation of the administering a dose of plerixafor of 240 µg/kg of instant claim 10 is recited by claim 137 of 18/468506.
The limitation of administering the CXCR2 agonist simultaneously with CXCR4 antagonist of instant claim 11 is recited by claim 141 of 18/468506. The limitation of administering the CXCR2 agonist after the administration of the CXCR4 antagonist of instant claim 12 is recited by claim 142 of 18/468506. The limitation of administering the CXCR2 agonist within about 4 hours of administration of the CXCR4 antagonist is of instant claim 13 is recited by claim 143 of 18/468506. The limitation of administering the CXCR2 agonist and the CXCR antagonist on two consecutive days of instant claim 15 is recited by claim 145 of 18/468506.
Although the claims of 18/468506 do not recited the limitations of claims 17, 18 and 23 these appear to be intended results of practicing the claimed method which is recited by the claims of 18/468506.
The claims of 18/468506 do not recited that the subject is human as recited in the instant claims.
However, Morrow teaches a similar method of mobilizing hematopoietic stem cells from bone marrow into the peripheral blood of a human donor (abstract, Col. 1 lines 25-52). Morrow teaches the method where a CXCR2 agonist, Gro-β, a truncated Gro-β (Gro-β T) and variants thereof is administered (Col. 1 lines 25-52). Accordingly, one of ordinary skill in the art would have been motivated to modify the method of the claims of 18/468506 so that the mammalian subject is human for the benefit of being able to treat humans using the method as taught by Marrow. It would have been obvious to make such a substitution, since the claims of 18/468506 recite mammalian subjects and humans were known to be treated by such methods as taught be Morrow.
Response to Arguments
Applicant's arguments filed Sept. 3, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102, Applicant argues that Morrow teaches a dose range that is higher than the claimed (Remarks pg. 6-7 bridging para.). The Applicant’s amendments limiting the dose range from 0.001 mg/kg to less than 0.05 mg/kg necessitated the withdrawal of the rejection under 35 U.S.C. § 102. Applicant’s arguments are drawn to Morrow failing to teach this new limitation. However, this new limitation is addressed in the new rejections and it is maintained that the dose administered is a result effective variable and would optimized as evidenced by Bridger. Bridger teaches that suitable dosage ranges for the CXCR4 inhibitor and CXCR2 agonist will vary according to the size and weight of the patient, the condition that the patient is being treated for and other considerations, and that optimizing the protocols for administration to a particular patient is within the ordinary skill of the art (0075).
With respect to the rejections under 35 U.S.C. § 103, Applicant argues that Morrow teaches a dose range that is higher than the claimed and that Morrow discloses administration of higher doses of Gro-β T resulted in greater mobilization of hematopoietic stem cells in Figs. 7A, 8A and 9A (Remarks pg. 7 last para.). As stated above, it is maintained the dose administered is a result effective variable and would optimized. Additionally, Figs. 7A, 8A and 9A of Morrow do not clearly show that increasing the dose concentration results in greater mobilization of hematopoietic stem cells. For instance, the bottom graph of Fig. 6A shows at 4 hours after administration of Groβ T, a dose of 450 µg/kg had the highest mobilization of CD34+ cells followed by both 1.2 mg/kg and 50 µg/kg, and then 150 µg/kg with the lowest mobilization. The bottom graph of Fig. 7A shows at 4 hours after administration of Groβ T, a dose of 450 µg/kg had the highest mobilization of CD34+ cells followed by 50 µg/kg, then 150 µg/kg, and then 1.2 mg/kg. The bottom graph of Fig. 8A shows at 4 hours after administration of Groβ T, a dose of 450 µg/kg had the highest mobilization of CD34+CD90+CD45RA- cells followed by 1.2 mg/kg, then 50 µg/kg, and then 150 µg/kg. For instance, the bottom graph of Fig. 9A shows less mobilization with dose of 1.2 mg than doses of 150 or 50 µg/kg. The bottom graph of Fig. 9A shows at 4 hours after administration of Groβ T, a dose of 450 µg/kg had the highest mobilization of CD34+CD90+CD45RA- cells followed by 150 µg/kg, then 50 µg/kg, and then 1.2 mg/kg. Based on these figures, there appears to be no clear correlation with increasing the concentration of the dose and mobilization of the cells in Morrow.
Applicant argues that neither Bridger nor Hoggatt teach or suggest the claimed low dosage range and do not remedy the deficiencies of Morrow (Remarks pg. 7 last para.). Applicant is reminded that Bridger and Hoggatt are evidentiary references supporting the dose concentration is a result effective variable in the art and the timing and dosing of mobilization agents are result effective variables. Bridger and Hoggatt are not references supporting a rejection under U.S.C. §103, and thus is not being used to establish obviousness of a particular limitation.
Applicant argues that the instant invention is based in part on the discovery that a surprisingly low dose of a CXCR2 agonist, such as Gro-β or Gro-β T, can mobilize hematopoietic stem or progenitor cells (CD34+ cells and CD34+CD90+CD45R- cells) as demonstrated in Fig. 3 A and B and Fig. 4A and B of the instant application. Applicant argues the figures shows that 0.03 mg/kg dose achieved the highest peak concentration of (Remarks pg. 8 to pg. 9 para. 1). Applicant argues that surprisingly low dose from 0.001 mg/kg to 0.05 mg/kg of a CXCR2 agonist, such as Gro-β or Gro-β T, can mobilize hematopoietic stem or progenitor cells (Remarks pg. 9 para. 2). However, these arguments were not found to be persuasive, since even though the data clearly shows when a dose of 0.03 mg/kg is administered there is an increase in the mobilization of CD34+ and CD34+CD90+CD45R- cells, the data is not commensurate in scope with the claim invention. The claimed method is broader than the method for generating the data in the specification. Specifically, the method claimed can use other CXCR2 agonists, not just MGTA-145 (Gro-β T), and use a range of doses of CXCR2, from 0.0001 to less than 0.05 mg/kg. It is unclear if the same effects would be achieved under different conditions. Additionally, the data presented in Fig. 3 and 4 of the application appear to show that 0.03 mg/kg was the most effective and the other concentrations (i.e. 0.0075, 0.015, 0.075, 0.15, and 0.3 mg/kg) do not seem to be significantly different from each other.
With respect to the rejections under nonstatutory obviousness-type double patenting rejections, Applicant argues that the claims of Morrow (U.S. Patent No. 10,058,573) and U.S. Patent No. 11,260,079 do not read on instant claim 1 since they do not recite dose is from about 0.001 to 0.05 mg/kg (Remarks pg. 10 para. 1 and pg. 11 para. 2). Applicant argues since as explained in the rejections under 103, it was surprising that a low dose from 0.001 mg/kg to 0.05 mg/kg of a CXCR2 agonist, such as Gro-β or Gro-β T, can mobilize hematopoietic stem or progenitor cells, the claims as amended are patentably distinct over Marrow (Remarks pg. 10 para. 2 and pg. 11 para. 2). These argument were not found to be persuasive, for the same reasons stated for the similar arguments presented for the rejections under 35 U.S.C. § 103.
Applicant argues that U.S. Patent Appl. No. 18/468,506 should be withdrawn, since it has a later effective filing date (Remarks pg. 11 para. 5 to pg. 12 para. 1). However, the rejection has been maintained should appl. No. 18/468,506 issue before this one does and since the claims are still rejected under 35 U.S.C. §103.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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