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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11-03-2025 has been entered.
Applicant's amendments to the claims and arguments filed on 11-03-2025 have been received and entered. Claims 1 has been amended. Claims 4-5, 8, 10-11, 16, 23 have been canceled. Claims 1-3, 6-7, 9, 12-15, 17-22 are pending in the instant application. Receipt is acknowledged of the 37 C.F.R. 1.132 declaration by Dr. Wang that was submitted on 11-03-2025. The declaration has been fully considered and is discussed below in the Response to Arguments section of this action.
Election/Restrictions
Applicant’s election of Group I (claims 1-7, 9-15, and 17-19) in the reply filed on 12-09-2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12-09-2024.
Claims 1-3, 6-7, 9, 12-15, and 17-19 are under consideration.
Priority
Instant application is a 371 of PCT/US2020/032433 filed on 05/12/2020 that claims priority from US provisional application 62/848,230 filed on 05/15/2019.
Withdrawn- Claim Rejections - 35 USC § 101
Claims 1-7, 9, 12-15, and 17-19 were rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. In view of applicant’s amendments and further consideration, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are
thereby rendered moot.
Withdrawn- Claim Rejections - 35 USC § 102
Claims 1-4, 6-7, 9, 12-15, and 17-19 were rejected under 35 U.S.C. 102 (a)(1) or (a)(2) as being anticipated by Motlagh et al. (Pub. No.: US 2013/0216495 Al, Pub. Date: Aug. 22, 2013) as evidenced by Pafumi et al (Clinics and Practice 2011; 1:e79 doi:10.4081/cp.2011.e79). In view of applicant’s amendments and further consideration, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot. The claims are however subject to new rejections over the prior art of record, as set forth below.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 5 was rejected under 35 U.S.C. 103 as being unpatentable over Motlagh et al. (Pub. No.: US 2013/0216495 Al, Pub. Date: Aug. 22, 2013) in view of Houze et al (Pub. No.: US 2015/0071886 A1, Pub. Date: Mar. 12, 2015). ). In view of applicant’s amendments and further consideration, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot. The claims are however subject to new rejections over the prior art of record, as set forth below
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-3, 6-7, 9, 12-15, and 17-19 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.
Regarding to claim 1, the phrase “wherein the pharmaceutically acceptable carrier solution preserves the cells at a high concentration” in lines 7-8 of base claim 1 is vague and render the claim indefinite because it is unclear if the phrase “a high concentration” refers back to the concentration of “1 x 107 to 1 x 109 cells/ml” recited in the item (i) of the base claim 1 or what concentration can be interpreted as “a high concentration”. The specification of the claim invention teaches that “For example, a therapeutic cell composition should have sufficiently high cell concentration (e.g., 1 x 107/ml, 1 x 108/ml).” (Page 5, lines 21-22). However, the specification of the claim invention only provides an example and does not provide definitive guidance for the lower limit for a ‘high concentration’ of umbilical cord blood cells following storage and/or freezing. For example, would 1 x 106 cells/ml satisfy the limitation of a ‘high concentration’ of preserved cells following storage and/or freezing in the claimed pharmaceutically acceptable carrier solution? With the claim currently written, it is unclear what is the lower limit for the phrase “a high concentration” regarding the preserved cells.
Claims 2-3, 6-7, 9, 12-15, and 17-19 are included in the rejection because they directly or indirectly depend from base claim. Appropriate correction is required.
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.
Claims 1-3, 6-7, 9, 12-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Motlagh et al. (Pub. No.: US 2013/0216495 Al, Pub. Date: Aug. 22, 2013) in view of Pasha et al (TRANSFUSION 2017;57;1744–1754, doi:10.1111/trf.14136) as evidenced by Houze et al (Pub. No.: US 2015/0071886 A1, Pub. Date: Mar. 12, 2015).
Claim interpretation:
The specification of the claimed invention teach that the therapeutic cells include umbilical cord blood cells, and the therapeutic composition or cells comprise CD34+ (Page 3, lines 9-12). Also, claim 12 of the claimed invention recite: The umbilical cord blood cells are CD34+ cells. Thus, the umbilical cord blood cells are interpreted as encompassing CD34+ cells.
The specification of the claimed invention teaches that “Such an electrolyte solution may for example be PLASMA-LYTE A or PLASMA-LYTE 148, which has an osmolarity of about 294 or 295 mOsmol/liter. PLASMALYTE A or PLASMA-LYTE 148 contains about 90 mM NaCl, about 5 mM KCl, about 1.5 mM MgCl2, about 27 mM Sodium Acetate Trihydrate, and about 23 mM Sodium Gluconate. While PLASMA-LYTE A has a pH of about 7.4, PLASMA-LYTE 148 has a pH of about 6.0.” (Page 11, lines 12-16). Thus, PLASMA-LYTE A or PLASMA-LYTE 148 is interpreted to have an osmolarity of about 294 or 295 mOsmol/liter and contains about 90 mM NaCl, about 5 mM KCl, about 1.5 mM MgCl2, about 27 mM Sodium Acetate Trihydrate, and about 23 mM Sodium Gluconate. PLASMA-LYTE A has a pH of about 7.4, and PLASMA-LYTE 148 has a pH of about 6.0.
It is also noted that PLASMA-LYTE is a registered trademark of Baxter International Inc. It is a brand name for a group of intravenous (IV) balanced crystalloid solutions, including Plasma-Lyte A and Plasma-Lyte 148, used for fluid and electrolyte replacement. The trademark has been registered and used by Baxter for decades, with the first filing dating back to 1959.
Regarding to claim 1, Motlagh et al teach that the invention relates to the field of treatment of ischemic conditions and diseases using a cell population comprising CD34+ cells (Abstract). The cell population is isolated from any adult, fetal or embryonic tissue comprising the desired cell population ([0060], page 6). The cell population is isolated from any biological sample suspected of containing CD34+cells ([0062], page 6). Motlagh et al teach that at least 95% or more of the cells of the cell population are viable cells after storage in the pharmaceutical composition for a period of time from about 1hour to about 5 days and/or at a temperature within the range of 1 to 30 degrees Celsius ([0107], page 11).
Motlagh et al teach in exemplary embodiments, the pharmaceutical compositions comprise at least about ….. at least about 108 cells ([0106], page 11). Additionally, Table 11 teaches average WBC counts x 107 cells/mL ([0330], page 28) (For the claimed: (i) about 1 x 107 to 1 x 109 /ml umbilical cord blood cells).
Motlagh et al also teach in exemplary aspects, the isotonic solution is or is substantially the same as any one of: Plasma-Lyte® A, Plasma-Lyte® 148, Plasma-Lyte® 56, Normosol®-R, Isolyte® P, Lactated Ringer's solution (also known as Hart- mann solution), Ringer's solution, and 5% Dextrose in water (D5W) ([0102], page 10) (Note: For element with charge of one, 1 mEq/L is equal to 1 mmol/L) (For the claimed: (ii) a pharmaceutically acceptable carrier solution that (a) contains about 25-30 mM acetate and about 20-25 mM gluconate).
Motlagh et al teach the isotonic solution of the pharmaceutical composition has an osmolality of about 240 mOsmol/L to about 350 mOsmol/L ([0011], page 1-2) (For the claimed: (ii) (b): “has an osmolality of about 270 to 320 mOsmol/L”).
Motlagh et al do not teach pharmaceutically acceptable carrier solution results in increased cell survival rate in umbilical cord blood cells. Pasha et al cure the deficiency.
Pasha et al teach development and testing of a stepwise thaw and dilute protocol for cryopreserved umbilical cord blood units (CBUs) (Title). Pasha et al stated that “It is clinically important to maintain high viability and potency of umbilical cord blood units (CBUs) for transplantation during thawing ……The developed thawing protocol recovers viable CD45+ and CD34+ cells above the standard thresholds and maintains CBU potency. PLASMA-LYTE A for thawing solution proved to be an efficient alternative to dextran 40” (Abstract) and “we confirm and extend results of Cloutier and colleagues on the use of PLASMA-LYTE A as an attractive alternative to dextran 40. We show that in the presence of HA, PLASMALYTE A effectively maintains viability of white blood cells (WBCs) and CD34+ cells above the thresholds set by regulatory bodies and preserves potency of thawed CBUs.” (Page 1745, left column, 3rd para.). Pasha et al teach “Consistent with the greater viability of UCB cells with PLASMA-LYTE A, the net number of viable CD45+ and CD34+ cells was generally greater with PLASMA-LYTE A (data not shown). In support of this, combined analysis of all time points revealed significant increase in the net number of viable CD45+(+6%, p = 0.0463) and CD34+ cells (+12%, p = 0.0026) with PLASMA-LYTE A (Page 1748, left column, last para.).
Pasha et al also teach CBUs used had a minimum volume of 50 mL and a total nucleated cell (TNC) count greater than 0.9 x 109 (Page 1745, left column, last para). Note: (0.9 x 109)/50 = 0.018 x109 = 1.8x107.
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the cell composition of Motlagh et al by using cell composition and method of Pasha et al to significant increase in the net number of viable umbilical cord blood units such as CD34+ cells as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Pasha et al teach that “PLASMA-LYTE A diluent provided superior viability of CD45+ and CD34+ cells than dextran 40 and recovered more colony-forming units” (Abstract), and “PLASMALYTE A effectively maintains viability of white blood cells (WBCs) and CD34+ cells above the thresholds set by regulatory bodies and preserves potency of thawed CBUs.” (Page 1745, left column, 3rd para.). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pasha et al were successful in increasing net number of viable CD45+ and CD34+ cells with PLASMA-LYTE A with detailed instructions and data.
As mentioned above in the claim interpretation, Applicant’s own disclosure provides evidences for PLASMA-LYTE A or PLASMA-LYTE 148 that encompasses the cited pharmaceutically acceptable carrier solution in the claim: an osmolarity of about 294 or 295 mOsmol/liter and contains about 90 mM NaCl, about 5 mM KCl, about 1.5 mM MgCl2, about 27 mM Sodium Acetate Trihydrate, and about 23 mM Sodium Gluconate. (see instant disclosure Page 11, lines 12-16). Additional evidence can be found in the Houze et al reference that PLASMA-LYTE A encompasses the cited pharmaceutically acceptable carrier solution in the claim: Houze et al teach progenitor cells of mesodermal lineage and their use in therapy (Abstract). One suitable carrier or diluents is Plasma-Lyte A. This is a sterile, nonpyrogenic isotonic solution for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2·3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2·6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0) ([0148], page 10).
Note: Given 100 mL:
Sodium Chloride (NaCl): 526 mg/100ml => 5.26g/l (NaCl: 58.44 g/mol)
Sodium Gluconate (C₆H₁₁NaO₇): 502 mg/100ml => 5.02g/l (C₆H₁₁NaO₇ : 218.14 g/mol)
Sodium Acetate Trihydrate (C₂H₃NaO₂·3H₂O): 368 mg/100ml => 3.68g/l (C₂H₃NaO₂·3H₂O: 136.08 g/mol)
Potassium Chloride (KCl): 37 mg/100ml => 0.37g/l (KCl: 74.55 g/mol)
Magnesium Chloride (MgCl₂·6H₂O): 30 mg/100ml => 0.3g/l (MgCl₂·6H₂O: 203.30 g/mol)
Concentrations in mM:
NaCl: 5.26/58.44 = 90.0 mM
Sodium Gluconate: 5.02/218.14 = 23.0 mM
Sodium Acetate Trihydrate: 3.68/136.08 = 27.0 mM
KCl: 0.37/74.55 = 5.0 mM
MgCl₂·6H₂O: (0.3/203.3 )= 1.48 mM
Motlagh et al do not teach/mention DMSO. Thus, a person of ordinary skill in the art would not look for and add DMSO in the composition. Additionally, Pasha et al teach “The most commonly used method of UCB preparation at transplant centers is the so-called thaw and dilute protocol that reduces the concentration of the cryoprotectant dimethyl sulfoxide (DMSO) to minimize its toxicity to grafts and side effects to patients.”. Thus, it is indicating that the concentration of DMSO in umbilical cord blood (UCB) preparation was recognized in the prior art to be a result-effective variable. A person of ordinary skill in the art would have been motivated to perform the reducing DMSO concentration into only a trace amount a plurality of times out of the course of routine optimization, in order to minimize its toxicity to grafts and side effects to patients (For the claimed: (ii) (b): “wherein the therapeutic composition is free of DMSO or contains a trace amount of DMSO”).
Regarding to claim 2, Motlagh et al teach the isotonic solution comprises electrolytes or ions at a concentration which is the same as that found in plasma, e.g., but without limitation to, human plasma. Plasma contains 145 mEq/L sodium (Na+), 110 mEq/L chloride (Cl-), 4-5 mEq/L potassium (K+), 2 mEq/L magnesium (Mg2+) ([0086], page 8). It is noted that:
145 mEq/L sodium (Na+) =145 mmol/L sodium (Na+) (charge of one)
110 mEq/L chloride (Cl-) = 110 mmol/L chloride (Cl-) (charge of one)
4-5 mEq/L potassium (K+) = 4-5 mmol/L potassium (K+) (charge of one)
2 mEq/L magnesium (Mg2+) = 1 mmol/L magnesium (Mg2+) (charge of two)
Regarding to claim 3, Motlagh et al teach that in exemplary aspects, the isotonic solution is calcium-free ([0011], page 2). In exemplary aspects, the isotonic solution is one which is free of lactate ([0101], page 10)
Regarding to claim 6, Motlagh et al also teach the isotonic solution is or is substantially the same as any one of: Plasma-Lyte® A, Plasma-Lyte® 148, and contents of Isotonic Solutions (mEq/L): Plasma-Lyte A: 140 mM Na+ (140 mEq/L) ([0102], page 10 and see the table below (also on page 10))
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Regarding to claim 7, Motlagh et al teach in certain aspects, the isotonic solution has a pH of about 5 to about 9 or a pH of about 7.0 ([0098], page 10).
Regarding to claim 9, Motlagh et al teach in exemplary embodiments, the pharmaceutical compositions comprise at least about at least about 108 cells ([0106], page 11). Additionally, Tables 11 teaches average WBC counts 11.9 x 107 cells/mL ([0330], page 28). Thus, one of ordinary skill in the art would be motivated and able to select about 1 x 108 cells/ml of therapeutic cells for generating a composition.
Regarding to claim 12, Motlagh et al teach a cell population comprising CD34+cells isolated from peripheral blood of a subject ([0002], page 1).
Regarding to claim 13-14, Motlagh et al teach the plasma protein in the pharmaceutical composition of the invention is serum albumin and in certain aspects, the serum albumin is human serum albumin. In some embodiments, human serum albumin is present in the pharmaceutical composition at a concentration ranging from about 0.5% (w/v) to about 10% (w/v) ([0076], page 8).
Regarding to claim 15, Motlagh et al teach the pharmaceutical composition of the invention provides a stable environment for the CD34+ cells, such that the CD34+ cells may be stably stored at a non-freezing temperature (e.g., but without limitation to 1 to 30 degrees Celsius or 2 to 8 degrees Celsius) ([0107], page 11).
Regarding to claim 17-18, Motlagh et al teach a pharmaceutical composition comprising (i) a cell population comprising CD34+ cells, (ii) a plasma protein, and (iii) an isotonic solution comprising at least one salt, said isotonic solution comprising acetate, gluconate, or both acetate and gluconate (Abstract). The pharmaceutical composition is packaged in a ready to use and/or non-reusable container, such as a syringe, vial or bag ([0014], page 2). Cells obtained through the methods described herein …. are optionally administered via a cell delivery matrix , and the cell delivery matrix in certain embodiments comprises any one or more of polymers and hydrogels comprising collagen, fibrin, chitosan, matrigel ([0135], page 14).
Regarding to claim 19, Motlagh et al teach the pharmaceutical composition described herein is formulated for parenteral administration …… ([0129], page 13). The parenteral formulations are in various aspects presented in unit-dose or multi-dose sealed containers, such as ampoules and vials, and can be stored in a freeze dried (lyophilized) condition ([0132], page 14).
Response to Arguments
Applicant's arguments and the Wang’s declaration filed on 11-03-2025 have been fully considered but they are not persuasive.
1. The Wang’s declaration on page 2 essentially argue that the therapeutic composition of claim 1 is unexpected in that it can be shipped under conditions such as room or ambient temperature at a high concentration over an extended period of time (e.g., 12 to 72 hours). As demonstrated in Examples 1 and 2 of the '241 Application, cells packed and stored in PLASMA-LYTE, as covered by claim 1, exhibited higher viability (by acridine orange/propidium iodide (AO/PI) stain), total CFU numbers, and total nucleated cells (TNC) recovery as compared to cells packed and stored in saline (Remarks, page 2)
Response to Arguments:
It is noted that PLASMA-LYTE is a registered trademark of Baxter International Inc. It is a brand name for a group of intravenous (IV) balanced crystalloid solutions, including Plasma-Lyte A and Plasma-Lyte 148, used for fluid and electrolyte replacement. The trademark has been registered and used by Baxter for decades, with the first filing dating back to 1959.
The use of Plasma-Lyte A with umbilical cord blood units also has been reported in the art such as in the reference of Pasha et al as described above. Specifically, Pasha et al stated that “PLASMA-LYTE A diluent provided superior viability of CD45+ and CD34+ cells than dextran 40 and recovered more colony-forming units” (Abstract) and “The superiority of PLASMA-LYTE A was also apparent by the increased potency of CBUs as shown by the greater number of CFUs at all time points” (Page 1749, left column, 1st para.). Additional, Motlagh et al also used Plasma-Lyte® A, Plasma-Lyte® 148 for their cell population composition ([0102], page 10), and Motlagh et al teach that at least 95% or more of the cells of the cell population are viable cells after storage in the pharmaceutical composition for a period of time from about 1hour to about 5 days and/or at a temperature within the range of 1 to 30 degrees Celsius ([0107], page 11). Thus, applicant’s argument regarding to unexpected results over prior art references are not persuasive.
2. The Wang’s declaration on page 2 essentially argue that the claimed therapeutic composition is non-obvious in that it addresses an unmet need by enabling packing and/or shipping of high concentrations of stem/pluripotent cells or preparations containing such cells at room or ambient temperature over an extended period of time. Conventional stem/pluripotent cells packaging and shipping do not allow one to ship cells at such high cell concentrations. To obtain therapeutic composition with such high cell concentrations, clinicians have to further process the cells to increase the cell numbers and/or concentrations (remarks, page 2).
Response to Arguments:
It is noted that Motlagh et al teach the pharmaceutical composition is packaged in a ready to use and/or non-reusable container, such as a syringe, vial or bag ([0014], page 2) and the pharmaceutical compositions comprise at least about 108 cells ([0106], page 11). The parenteral formulations are in various aspects presented in unit-dose or multi-dose sealed containers, such as ampoules and vials, and can be stored in a freeze dried (lyophilized) condition ([0132], page 14). The CD34+ cells in the various test solutions were then aspirated using a 16-gauge needle into BD 1 mL syringes with Luer-Lok™ Tip, Ref. 309628, capped with the original needle cap and stored in syringes for up to 3 days in temperature-controlled shipping containers at 1 to 10° C ([0346], page 29). Additionally, Table 14 provides estimates (Least Squares Means) of the high viability of CD34+ cells for product stored from day 0 through day 3 ([0354], page 30).
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Thus, the prior art reference Motlagh et al was enabling packing and/or shipping of high concentrations of CD34+ cells with high percentage of viability of CD34+ cells before the effective filing date of the claimed invention.
3. The applicants’ remarks on page 8-9 essentially argue that independent claim 1 has been amended to recite that the pharmaceutically acceptable carrier solution contains "about 90 mM Sodium Chloride (NaCl), about 5 mM Potassium Chloride (KCl), about 1.5 mM Magnesium Chloride (MgCl2•6H2O), about 27 mM Sodium Acetate Trihydrate (C2H3NaO2•3H2O), and about 23 mM Sodium Gluconate (C6H11NaO7)" and that "the pharmaceutically acceptable carrier solution preserves the cells at a high concentration and results in increased cell survival rate." The cited references either alone or in combination fail to disclose or suggest the therapeutic composition of amended claim 1 (Remarks, page 8-9).
Response to Arguments:
The description for prior art teachings necessitated by amendments are as described above and it will not be repeated here.
4. The applicants’ remarks on page 9 essentially argue that “As submitted in the previously filed response dated May 9, 2025, the therapeutic composition of claim 1 exhibits unexpected results, which underscores its patentability over the cited references” and “cells stored or shipped at PLASMA-LYTE A exhibit greater viability than those stored or shipped in saline at the same temperature. See FIG. IA and the Wang Declaration, paragraph 9. This finding further supports the non-obviousness of the therapeutic composition of claim 1. It follows that the therapeutic composition of claim I results in unexpected "satisfactory viabilities and development potentials for clinical uses." ” (remarks, page 9)
Response to Arguments:
As explained above , the therapeutic composition of claim 1 does not exhibit unexpected results: PLASMA-LYTE including Plasma-Lyte A and Plasma-Lyte 148 is a registered trademark of Baxter International Inc. The use of Plasma-Lyte A with umbilical cord blood units has been reported in the art: Pasha et al stated that “PLASMA-LYTE A diluent provided superior viability of CD45+ and CD34+ cells than dextran 40 and recovered more colony-forming units” (Abstract) and “The superiority of PLASMA-LYTE A was also apparent by the increased potency of CBUs as shown by the greater number of CFUs at all time points” (Page 1749, left column, 1st para.). Pasha et al stated that “In accordance with clinical practice, viability based on 7-AAD staining and CD34+ cell counts were obtained using a licensed kit and the ISHAGE single flow cytometry platform. Baseline post thaw viabilities (i.e., 30 min) for CD45+ (50 6 9%) and CD34+ (96 6 4%) cells for all CBUs were superior to the NetCord-FACT requirements of at least 40 and at least 70%, respectively” (Page 1750, left column, last para). Additional, Motlagh et al also used Plasma-Lyte® A, Plasma-Lyte® 148 for their cell population composition ([0102], page 10), and Motlagh et al teach that at least 95% or more of the cells of the cell population are viable cells after storage in the pharmaceutical composition for a period of time from about 1hour to about 5 days and/or at a temperature within the range of 1 to 30 degrees Celsius ([0107], page 11). Thus, applicant’s argument regarding to unexpected results over prior art references are not persuasive.
5. The applicants’ remarks on page 10 essentially argue that “The non-obviousness of the therapeutic composition of claim I is further evidenced by the fact that it addresses a long-felt unmet need. As described in the application, the claimed therapeutic composition addresses the unmet needs for "processes or methods of shipping stem cells at high concentration[s] and room/ambient temperatures." See Specification, page 2, lines 10- 14 (remarks, page 9)
Response to Arguments:
As mentioned above, the need for shipping and packaging for CD34+ cells have been addressed at least in the cited prior art reference: Motlagh et al teach the pharmaceutical composition is packaged in a ready to use and/or non-reusable container, such as a syringe, vial or bag ([0014], page 2) and the pharmaceutical compositions comprise at least about 108 cells ([0106], page 11). The CD34+ cells in the various test solutions were then aspirated using a 16-gauge needle into BD 1 mL syringes with Luer-Lok™ Tip, Ref. 309628, capped with the original needle cap and stored in syringes for up to 3 days in temperature-controlled shipping containers at 1 to 10° C ([0346], page 29). Additionally, Table 14 shows high percentage of viability of CD34+ cells for product stored from day 0 through day 3 (see table 14 of Motlagh et al above). Thus, at least the prior art reference Motlagh et al was enabling packing and/or shipping of high concentrations of CD34+ cells with high percentage of viability of CD34+ cells before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632