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
The instant application is a national stage entry under 35 U.S.C. § 371 of PCT/GB2022/052124 (filed 08/15/2022). Acknowledgement is made of Applicants’ claim for priority to foreign application GB 2111803.9 (filed 08/18/2021).
Election/Restrictions
Applicant’s election of Group I in the reply filed on 06/10/2026 in response to a Restriction requirement 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Claims 1-15 are pending in the application, with claims 14-15 withdrawn as directed to a nonelected invention.
Claims 1-13 read on the elected invention and are examined on the merits herein.
Duplicate Claim Warning
Applicant is advised that should claim 2 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3: The instant claim attempts to further limit the method of claim 2 by reciting the transporting or storing cells is at a temperature of more than 8°C; however, claim 2 depends from claim 1, which already requires this exact limitation. Thus, claim 3 is not effective to further limit the scope of claim 2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gay, et al. (US 2019/0030168).
Gay, et al. teaches clinical media that support viability, re-plating efficiency, and repopulation capacity of cells and tissues during storage (Abstract).
Regarding claims 1, 4-5: Gay, et al. teaches solutions for cell storage and transport (par. 0009); in an embodiment, the solution comprises a triblock copolymer comprising polyoxyethylene polyoxypropylene copolymer (par. 0079). Gay, et al. further discloses an embodiment wherein the cells are stored at about 25°C (par. 0116). This anticipates:
the method of transporting or storing cells, the method comprising transporting or storing cells in a composition comprising a block copolymer of polyoxypropylene and polyoxyethylene at a temperature of more than 8°C limitations recited in claim 1;
the wherein the temperature of more than 8°C is a temperature between 8°C and 35°C limitation recited in claim 4; and
the wherein the temperature of more than 8°C is a temperature between 10°C and 30°C limitation recited in claim 5.
Regarding claim 6: Following the above discussion, Gay, et al. teaches an embodiment wherein the storage temperature is at 16-22°C (par. 0116); this anticipates the wherein the temperature of more than 8°C is a temperature between 15°C and 25°C limitation recited in the instant claim.
Regarding claims 7-9: Following the above discussion, Gay, et al. teaches an embodiment wherein the cells are stored in the solution for 168 hours or more (par. 0060). This anticipates:
the wherein the cells are transported or stored for a period of up to at least 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, or up to at least 120 hours limitations recited in claim 7;
the wherein the cells are transported or stored for a period of up to at least 72 hours, 96 hours, or up to at least 120 hours limitations recited in claim 8; and
the wherein the cells are transported or stored for a period of up to at least 120 hours limitation recited in claim 9.
Regarding claim 10: Following the above discussion, Gay, et al. teaches an embodiment wherein the solution is contacted with a cell, a population of cells, or a tissue, with a volume of a solution provided herein to obtain a cell or tissue preparation that is suitable for clinical use (pars. 0112, 0115); this anticipates the contacting a cell, a population of cells, or a tissue, with a volume of the composition to obtain a cell or tissue preparation that is suitable for clinical use limitation recited in claim 10.
Regarding claims 11-12: Following the above discussion, Gay, et al. teaches an embodiment wherein the preparation is stored for at least 144 hours prior to administering the preparation to a subject (par. 0030); in an embodiment, the cells are stored at about 25°C (par. 0116). This anticipates:
the storing the cell, population of cells or tissue for a period of up to at least 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, or up to at least 120 hours, at a temperature of more than 8°C limitations recited in claim 11; and
the wherein the temperature of more than 8°C is a temperature between 8°C and 35°C limitation recited in claim 12.
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.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gay, et al. (US 2019/0030168) in view of Arduini, et al. (Transfusion. 1997).
The teachings of Gay, et al. are set forth above; claims 1 and 4-12 are anticipated by the same.
Arduini, et al. teaches the addition of L-carnitine to red blood cell preservative solution (Abstract).
Regarding claims 2-3, 13: Following the above discussion, Gay, et al. teaches the solution supports cell survival, as well as minimizes metabolic and physical stress, including shear stress, during transport (par. 0117); the disclosure does not teach the carnitine or glycerol limitations recited in the instant claims.
However, Arduini, et al. teaches L-carnitine (LC) has a beneficial effect in the maintenance of cellular integrity and viability in cells subjected to adverse conditions, and improves membrane stability of red blood cells subjected to high shear stress (Abstract; pg. 167, par. 2).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the solution of Gay, et al. by including L-carnitine, as taught by Arduini, et al. This conclusion of obviousness us based on the ‘combining known alternatives rationale’. One would be motivated to combine the solution of Gay, et al. with the L-carnitine of Arduini, et al. with the expectation of further minimizing shear stress experienced by the cells as well as further supporting cell survival and viability due to an additive effect. The combination of a solution which supports cell survival and minimizes shear stress and a compound which is beneficial for cell viability and improves membrane stability in cell subjected to shear stress (i.e., minimizes the effects of shear stress) is a predictable use of known alternatives thereof; further, as Arduini, et al. teaches the use of L-carnitine in a solution for the storage of red blood cells, the skilled artisan would have more than a reasonable expectation of success. This rationale aligns with the principle of combining known prior art elements according to known methods to yield predictable results; see MPEP 2143(I)(A). This modification renders obvious:
the method comprising transporting or storing cells in a composition comprising a block copolymer of polyoxypropylene and polyoxyethylene, and carnitine limitations recited in claim 2;
the wherein transporting or storing cells is at a temperature of more than 8°C limitation recited in claim 3; and
the wherein the composition further comprises carnitine limitation recited in claim 13.
Claims 1-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovic, et al. (WO 2016/154206).
Jovanovic, et al. teaches biopreservation mediums containing poloxamers and cryoprotectants useful for all phases of biopreservation including cryopreservation, thawing, and hypothermic (cold storage) of biological materials (Abstract).
Regarding claims 1-5, 13: Jovanovic, et al. teaches a composition comprising poloxamer 407 (pg.15; Table 2), wherein the poloxamer is a block copolymer comprising polyoxypropylene and polyoxyethylene (par. 00101). In an embodiment, the composition is for the hypothermic storage of cells (par. 0048), wherein the hypothermic conditions comprises temperatures from 0°C to 10°C (par. 0062). Jovanovic, et al. discloses an embodiment wherein the composition further comprises glycerin; i.e., glycerol (par. 00106). This renders obvious:
the method of storing cells, the method comprising storing cells in a composition comprising a block copolymer of polyoxypropylene and polyoxyethylene at a temperature of more than 8°C limitations recited in claim 1; noting that the prior art range of 0-10oC overlaps with the claimed range of more than 8oC. It has been held that where the prior art overlaps the claimed range, a prima facie case of obviousness exists. See MPEP 2144.05.
the storing cells in a composition comprising a block copolymer of polyoxypropylene and polyoxyethylene, and glycerol limitations recited in claim 2;
the wherein storing cells is at a temperature of more than 8°C limitation recited in claim 3;
the wherein the temperature of more than 8°C is a temperature between 8°C and 35°C limitation recited in claim 4; again noting the prior art overlaps the claimed range, thus a prima facie case of obviousness exists. See MPEP 2144.05.
the wherein the temperature of more than 8°C is a temperature between 10°C and 30°C limitation recited in claim 5; again noting the prior art overlaps the claimed range, thus a prima facie case of obviousness exists. See MPEP 2144.05, and
the wherein the composition further comprises glycerol limitation recited in claim 13.
Regarding claims 7-9: Following the above discussion, Jovanovic, et al. teaches an embodiment wherein the cells are stored for 5 weeks (par. 0007). This renders obvious:
the wherein the cells are transported or stored for a period of up to at least 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, or up to at least 120 hours limitations recited in claim 7;
the wherein the cells are transported or stored for a period of up to at least 72 hours, 96 hours, or up to at least 120 hours limitations recited in claim 8; and
the wherein the cells are transported or stored for a period of up to at least 120 hours limitation recited in claim 9.
Regarding claims 10-12: Following the above discussion, Jovanovic, et al. teaches an embodiment wherein the composition is used for the biopreservation of cell preparations for clinical use (par. 00111). This renders obvious:
the contacting a cell, a population of cells, or a tissue, with a volume of the composition to obtain a cell or tissue preparation that is suitable for clinical use limitation recited in claim 10;
the storing the cell, population of cells or tissue for a period of up to at least 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, or up to at least 120 hours, at a temperature of more than 8°C limitations recited in claim 11; and
the wherein the temperature of more than 8°C is a temperature between 8°C and 35°C limitation recited in claim 12, again noting the prior art overlaps the claimed range, thus a prima facie case of obviousness exists. See MPEP 2144.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA PRONZATI whose telephone number is (571)270-5725. The examiner can normally be reached Monday - Friday 9:00a - 5:00p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHRISTOPHER BABIC can be reached at (571)272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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