DETAILED ACTION
This action is in response to papers filed 06/29/2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1, 3-5, and 7-22 are pending and examined on the merits herein.
Claims 1, 10, 14, and 21 are amended
Claims 2, 6, and 23-46 are cancelled.
Withdrawn Objections and Rejections
The objection to the drawings filed 11/29/2022, which contained color without an accompanying petition filed under 37 CFR 1.84(a)(2), is withdrawn in light of the replacement drawings in black and white submitted by Applicant on 06/29/2026.
The objections to claims 10 and 14 regarding informalities is withdrawn in light of the amendment to the claims.
The cancellation of claims 2 and 6 render any rejections thereof moot.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3, 5, 7-9, 11, 14-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), and Hernandez (WO2018197868A1; cited in IDS 04/12/2023).
Bernstein teaches a medium for culturing and expanding precursor cells, which may be human CD34+ hematopoietic stem cells, ex vivo (p 2, para 8; para 28; para 50). The medium comprises a Notch agonist, stem cell factor (SCF), and thrombopoietin (TPO) (p 2, para 8 – p 3, para 12) (claims 1, 3). Bernstein teaches that any Notch agonist known in the art, such as Jagged and Delta, can be used (para 79-81), including Delta-1 (DLL-1) (para 11) (claim 14). Bernstein teaches that precursor cells may be obtained from umbilical cord blood (claim 17) or bone marrow (claim 18). Bernstein teaches that the time in culture is a time sufficient to produce an expanded precursor cell population, and may be between 2 and 35 days, or at least 10, 15, or 16 days (para 104) (claim 19).
Bernstein does not teach the inclusion of 1) a TGFß agonist, 2) an antioxidant, 3) a bioactive phospholipid, 4) an aryl hydrocarbon receptor (AhR) agonist, or 5) a histone deacetylase (HDAC) inhibitor.
Regarding 1) a TGFß agonist: Zhao teaches that Activin A, a member of TGFß, promotes the expansion of primitive human umbilical cord CD34+ hematopoietic cells in a cell type-dependent manner (Abstract; Results, 3.1). Zhao teaches that in colony-forming unit (CFU) assays, the plating efficiencies and numbers of total colony forming units were significantly increased in the presence of Activin A for most cell types (Results, 3.1).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medium of Bernstein by adding Activin A, as taught in Zhao. One of ordinary skill in the art would have been motivated to make this modification because Zhao teaches that culturing CD34+ hematopoietic stem cells in the presence of Activin A significantly increases the plating efficiencies and numbers of total colony forming units for most cell types. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Zhao teaches that Activin A can be added to a medium for culturing CD34+ hematopoietic stem cells.
Regarding 2) an antioxidant: Lo teaches a serum-free culture medium for expanding hematopoietic stem cells, wherein the medium comprises vitamin C (ascorbic acid) or vitamin E (α-tocopherol) (Abstract; para 60-62) (claims 1, 7-8). Lo teaches that vitamin C, vitamin E, or a combination thereof, supports the expansion of CD34+ cells (para 95).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medium of Bernstein by adding vitamin C or vitamin E, as taught in Lo. One of ordinary skill in the art would have been motivated to make this modification because Lo teaches that culturing hematopoietic stem cells in the presence of vitamin C or vitamin E supports the expansion of CD34+ cells. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Lo teaches that vitamin C or vitamin E can be added to a medium for culturing hematopoietic stem cells.
Regarding 3) a bioactive phospholipid: Kostic teaches that lysophosphatidic acid (LPA) enhances survival of human CD34+ cells derived from umbilical cord blood in ischemic conditions (Abstract; Materials and Methods, para 1) (claims 1, 9).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medium of Bernstein by adding LPA, as taught in Kostic. One of ordinary skill in the art would have been motivated to make this modification because Kostic teaches that LPA enhances survival of human CD34+ cells in ischemic conditions. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Kostic teaches that LPA can be added to a medium for culturing hematopoietic stem cells.
Regarding 4) an aryl hydrocarbon receptor (AhR) agonist: Smith teaches that the addition of the AhR ligand FICZ to cultures resulted in exponential expansion of hematopoietic progenitor cells (Discussion, para 3) (claims 1, 11).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medium of Bernstein by adding FICZ, as taught in Smith. One of ordinary skill in the art would have been motivated to make this modification because Smith teaches the addition of the FICZ to cultures resulted in exponential expansion of hematopoietic progenitor cells. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Smith teaches that FICZ can be added to a medium for culturing hematopoietic stem cells.
Regarding 5) a histone deacetylase (HDAC) inhibitor: Hernandez teaches a method of expanding hematopoietic stem and progenitor cells (HSPCs) by culturing the HSPCs in the presence of a HDAC inhibitor and an aminothiol compound (claim 1). Hernandez teaches that this method produces expanded cells, wherein the number of total nucleated cells is increased (p 3, Summary of the Invention, para 1). Hernandez teaches that the HDAC inhibitor may be valproic acid (VPA) (claim 15), Scriptaid, Vorinostat, Tacedinaline, RG2833, RGFP966, Trichostatin A, LMK235, Tubastatin A, Quisinostat, or Sodium Phenylbutyrate (claim 16).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medium of Bernstein by adding an HDAC inhibitor, as taught in Hernandez. One of ordinary skill in the art would have been motivated to make this modification because Hernandez teaches that culturing HSCPs in the presence of an HDAC inhibitor increased the number of nucleated cells. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Hernandez teaches that an HDAC inhibitor can be added to a medium for culturing hematopoietic stem cells.
Claim(s) 4 remains rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), Hernandez (WO2018197868A1; cited in IDS 04/12/2023), and Sun (Stem Cell Research, 2012, 9(2): 77-86).
Bernstein, in view of Zhao, Lo, Kostic, Smith, and Hernandez, renders obvious claim 1.
Bernstein teaches the use of thrombopoietin (TPO) as a thrombopoietin receptor (TPOR) agonist. Bernstein does not teach the use of eltrombopag as the TPOR agonist.
Sun teaches that eltrombopag is a TPO receptor agonist, which enhances expansion of human umbilical cord hematopoietic stem cells in vitro (Abstract). Sun teaches that eltrombopag favors earlier HSC populations compared to recombinant human TPO.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medium of Bernstein by using eltrombopag as the TPOR agonist instead of TPO, as taught in Sun. One of ordinary skill in the art would have been motivated to make this modification when expansion of earlier HSC population is desired, because Sun teaches that eltrombopag favors earlier HSC populations compared to recombinant human TPO. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Sun teaches that eltrombopag enhances expansion of human umbilical cord hematopoietic stem cells in vitro.
Claim(s) 10 remains rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), Hernandez (WO2018197868A1; cited in IDS 04/12/2023), and Pebay (US7604990B2).
Bernstein, in view of Zhao, Lo, Kostic, Smith, and Hernandez, renders obvious claim 1.
Bernstein, in view of Kostic, teaches the use of lysophosphatidic acid (LPA) as the bioactive phospholipid in culture medium. Bernstein, in view of Kostic, does not teach the use of sphingosine-1-phosphate (S1P) as the bioactive phospholipid.
Pebay teaches that Sphingosine-1-phosphate (S1P) and lysophosphatidic acid (LPA) are two small bioactive lysophospholipids, which act on a wide range of cell types derived from the three developmental germ layers (col 2, para 1). Pebay teaches that most of the effects of these lysophospholipids seem to be mediated by specific lysophospholipid G-protein coupled receptors (LPL receptors) previously named endothelial differentiation gene (Edg) receptors (col 2, para 1).
Given the teachings of Pebay, there was a reasonable expectation that S1P would work equivalently as LPA as a bioactive lysophospholipid in culture media. Therefore, it would have been prima facie obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted LPA with S1P with predictable results. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Claim(s) 12 remains rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), Hernandez (WO2018197868A1; cited in IDS 04/12/2023), and Neavin (International Journal of Molecular Sciences, 2018, 19(12): 3851).
Bernstein, in view of Zhao, Lo, Kostic, Smith, and Hernandez, renders obvious claim 1.
Bernstein, in view of Smith, teaches the use of FICZ as the AhR agonist in culture medium. Smith teaches that two other AhR agonists, β-naphthoflavone and the prototypic environmental AhR ligand, 2,3,7,8-tetrachlorodibenzo[p]dioxin (TCDD), gave similar results to FICZ when used as the AhR agonist in culture medium (Results, “AhR mediates the expansion and specification of HPs,” para 1).
Bernstein, in view of Smith, does not teach the use of Norisoboldine as the AhR agonist.
Neavin teaches that FICZ, TCDD, and Norisoboldine are all AhR ligands that act through AhR (Table 1; Section 5, “AHR and Inflammatory Bowel Disease).
Given the teachings of Neavin and Smith, there was a reasonable expectation that FICZ, TCDD, and Norisoboldine would work equivalently as an AhR ligand in culture media. Therefore, it would have been prima facie obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted FICZ with Norisoboldine with predictable results. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Claim(s) 13 remains rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), Hernandez (WO2018197868A1; cited in IDS 04/12/2023), and Lu (Stem Cells, 2018, 36(8): 1273-1285; cited in IDS 08/15/2024).
Bernstein, in view of Zhao, Lo, Kostic, Smith, and Hernandez, renders obvious claim 1.
Bernstein teaches that any Notch agonist known in the art, such as Jagged and Delta, can be used in the culture medium (para 79-81). Bernstein does not specifically teach the use of Yhhu 3792 as a Notch agonist.
Lu teaches that Yhhu 3792 is a novel compound, which is an activator of the Notch signaling pathway (Abstract).
Given the teachings of Bernstein and Lu, there was a reasonable expectation that Yhhu 3792 would work equivalently as other Notch agonists, such as Jagged and Delta, as a Notch agonist in culture media. Therefore, it would have been prima facie obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the Notch agonists taught in Bernstein with Yhhu 3792 taught in Lu with predictable results. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Claim(s) 20 remains rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), Hernandez (WO2018197868A1; cited in IDS 04/12/2023), and Majeti (Cell Stem Cell, 2007, 1(6): 635-645).
Bernstein, in view of Zhao, Lo, Kostic, Smith, and Hernandez, renders obvious claim 1.
Bernstein does not teach CD34+ HSCs having a phenotype of Lin-CD34+CD38-CD45RA-CD90+.
Majeti teaches that a subpopulation of Lin-CD34+CD38-CD45RA-CD90+ cells from human cord blood fraction contains hematopoietic stem cells (HSCs) (Abstract).
Given the teachings of Bernstein and Majeti, there was a reasonable expectation that CD34+ HSCs with phenotype of Lin-CD34+CD38-CD45RA-CD90+ would work equivalently as other CD34+ HSCs as HSCs to be expanded or maintained in culture media. Therefore, it would have been prima facie obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the CD34+ HSCs in Bernstein with the Lin-CD34+CD38-CD45RA-CD90+ HSCs taught in Majeti with predictable results. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Claim(s) 21-22 remain rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (WO2015179633A1), in view of Zhao (Biomedicine & Pharmacotherapy, 2012, 66(8): 603-606), Lo (US20180163177A1), Kostic (Scientific Reports, 2015, 5: 16406), Smith (Hematopoiesis and Stem Cells, 2013, 122(3): 376-385), Hernandez (WO2018197868A1; cited in IDS 04/12/2023), and Lu (Stem Cells, 2018, 36(8): 1273-1285; cited in IDS 08/15/2024), as evidenced by Tocris (Yhhu 3792 SDS).
The teachings of Bernstein, Zhao, Lo, Kostic, Smith, and Hernandez are set forth above in the 35 U.S.C. 103 rejection for claim 1.
Regarding claim 21: Following the discussion of claim 1, Bernstein teaches a method of expanding or maintaining human CD34+ hematopoietic stem cells in a culture media comprising SCF, TPO, Activin A, Vitamin C, LPA, FICZ, a Notch agonist, and VPA.
Bernstein does not specifically teach the use of Yhhu 3792 as a Notch agonist.
Lu teaches that Yhhu 3792 is a novel compound, which is an activator of the Notch signaling pathway (Abstract).
Given the teachings of Bernstein and Lu, there was a reasonable expectation that Yhhu 3792 would work equivalently as other Notch agonists, such as Jagged and Delta, as a Notch agonist in culture media. Therefore, it would have been prima facie obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the Notch agonists taught in Bernstein with Yhhu 3792 taught in Lu with predictable results. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding claim 22:
Regarding SCF, TPO, Vitamin C, LPA, and Yhhu 3792:
Bernstein teaches using SCF at a concentration of 10-100 ng/mL and TPO at a concentration of 5-100 ng/mL (p 3, para 12).
Lo teaches using Vitamin C at a concentration of 50-375 μM (para 61).
Kostic teaches using LPA at a concentration of 100 μM (Materials and Methods: Cell survival analyses: effect of LPA concentration; Fig 1C; Materials and Methods: CD34+ cell proliferation analyses).
Bernstein teaches using a Notch agonist, which includes Yhhu 3792, at a concentration of between 0.025 to 5 μg/mL (claim 166). Yhhu 3792 has a molecular weight of 436.93 g/mol, as evidenced by Tocris, so 0.025 to 5 μg/mL of Yhhu 3792 is approximately 57.2 nM to 11,440 nM.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding Activin A, FICZ, and VPA:
Zhao teaches using Activin A at a concentration of 50 ng/mL (Materials and Methods, 2.2).
Smith teaches using FICZ at a concentration of 0.2 μM, which is 200 nM (Materials and Methods, para 2).
Hernandez teaches using VPA at concentration of between 0.01 μΜ to 50 μΜ (p 13, lines 9-10).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the concentrations of Activin A, FICZ, and VPA based on factors such as the conditions and duration of culture, to arrive at the claimed invention. See MPEP 2144.05(II)(A). As noted in In re Aller, 105 USPQ 233 at 235, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that changing the concentration of Activin A from 50 ng/mL as taught by Zhao to 20 ng/mL as claimed; changing the concentration of FICZ from 200 nM as taught by Smith to 500 nM as claimed; and changing the concentration of VPA from 50 μΜ as taught by Hernandez to 150 μM as claimed, was other than routine, that the concentrations resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art.
Response to Arguments
Re: Rejections under 35 U.S.C. § 103
Applicant argues: The Office acknowledges that Bernstein does not teach use of a TGFβ agonist, an antioxidant, a bioactive phospholipid, an aryl hydrocarbon receptor (AhR) agonist, or a histone deacetylase (HDAC) inhibitor (Office Action, p. 6, lines 11-12), yet alleges that Bernstein in combination with Zhao, Lo, Kostic, Smith, and Hernandez render the claimed method obvious.
The Office states (Office Action, p. 7, lines 12-18; emphasis added):
It would have been prima facie obvious for a person of ordinary skill in the art before the
effective filing date of the claimed invention to have modified the medium of Bernstein by adding
LPA, as taught in Kostic. One of ordinary skill in the art would have been motivated to make this
modification because Kostic teaches that LPA enhances survival of human CD34+ cells in
ischemic conditions.
Importantly, Kostic teaches use of LPA to enhance human CD34+ cells survival under hypoxic
conditions, specifically in 0.5% O2 (p. 14, para 2). Kostic fails to teach or suggest that LPA promotes expansion or maintenance of human CD34+ HSCs with standard oxygen levels e.g., normoxic culture conditions. Instead, Kostic states that "LPA is unable to maintain the undifferentiated state of CD34+ cells. Our results show that with or without LPA treatment, CD34+ cells spontaneously differentiate into mast cells and cells of myeloid lineage (essentially neutrophils and monocytes)." (Kostic, p. 11, para 2) This is in contrast to claim 1, which recites "[a] method of expanding or maintaining human CD34+ hematopoietic stem cells ... "
Furthermore, the skilled artisan would have recognized that cells exhibit distinct properties and
behaviors under hypoxic conditions rather than under standard oxygen conditions, as noted by Kostic (p. 11, para 2).
Accordingly, a person of skill in the art would not have been motivated to combine the teachings of Bernstein, Zhao, Lo, Kostic, Smith, and Hernandez to arrive at the claimed method.
In response: Applicant’s arguments have been fully considered, but are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the data from Kostic demonstrate the use of LPA to enhance human CD34+ cells survival under hypoxic conditions. For example, Kostic teaches that LPA enhances CD34+ cell survival in hypoxic conditions, comparable or exceeding survival of non-LPA-treated cells in normoxic conditions (e.g., Fig 1B, 1C). Importantly, Kostic does not teach or suggest that the treatment of CD34+ cells with LPA in normoxic conditions is detrimental; therefore, a person of skill in the art would have been motivated to apply the teachings of Kostic to cells under other conditions, including normoxic conditions.
Regarding the passage in p. 11, para 2 of Kostic cited by Applicant (“LPA is unable to maintain the undifferentiated state of CD34+ cells. Our results show that with or without LPA treatment, CD34+ cells spontaneously differentiate into mast cells and cells of myeloid lineage (essentially neutrophils and monocytes)”), the primary reference Bernstein teaches a medium for culturing and expanding precursor human CD34+ hematopoietic stem cells (p 2, para 8; para 28; para 50). Thus, the limitation regarding expanding or maintaining human CD34+ hematopoietic stem cells is taught in Bernstein. Kostic, nor the LPA taught therein, is solely relied upon for this limitation.
Moreover, Bernstein teaches culturing the CD34+ hematopoietic stem cells under both normoxic and hypoxic (5% O2) conditions (para 149). Therefore, the method taught in Bernstein encompasses hypoxic conditions. Thus, a person of ordinary skill would have been motivated to combine the teachings of Bernstein and Kostic to enhance survival of human CD34+ cells in hypoxic conditions, as set forth in the rejection above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632 /KARA D JOHNSON/Primary Examiner, Art Unit 1632
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