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
Amendments
In the reply filed on 06/18/2026, Applicant has amended claims 1, 3-4, 10, 27-28 and 31, newly canceled claims 2, 7, 30 and 32-33, and added new claims 43-47.
Claim Status
Claims 1, 3-6, 8-11, 27-29, 31, 34 and 41-47 are pending.
Claims 6, 8-9, 27-29, 31 and 34 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse on 04/12/2024.
Claims 1, 3-5, 10-11 and 41-47 are considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The corresponding signed and initialed PTO form 1449 has been mailed with this action.
Claim Objections
Claims 1, 4, 42 and 44 are objected to because of the following informalities:
Claims 1, 4, 42 and 44 recite abbreviations such as “CM-dextran”, “Q-dextran” and “dextran T10” and “dextran T70” (bolded by the examiner). An abbreviation should be preceded in its first occurrence by the specific identity of the entity which said abbreviation is intended to represent. Thereafter, the use of the abbreviation in the claims will be understood. For examination purpose, the terms “dextran T10” and “dextran T70” are examined as dextran having a molecular weight of about 10,000 daltons or about 70,000 daltons, respectively.
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 10-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reciting both “a saccharide” and “trehalose” is withdrawn in light of Applicant’s amendment to claim 10 to recite new limitation regarding distinct concentrations of a saccharide and trehalose, thus makes it clear that they are referring to distinct components in the composition.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection to claims 1 and 2 under 35 U.S.C. 102 (a)(1) as being anticipated by Pasley et al (Immunol. Lett. 2017 September; 192: 35-41. Cited in IDS 11/10/2025) is withdrawn in light of Applicant’s cancelation of claim 2 and amendment to claim 1 to recite limitations regarding selecting dextran from a list.
The prior rejection of claim 10 under 35 U.S.C. 102 (a)(1) as being anticipated by Bhagwat et al., (WO 2016/063208 A1. Prior art of record) is withdrawn in light of Applicant’s amendment to claim 10 to recite limitations regarding concentrations.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of claims 1, 2, 4, 5 and 10 under 35 U.S.C. 103 as being unpatentable over Bhagwat et al., (WO 2016/063208 A1. Prior art of record) in view of Andreasen et al., (WO 2015/150394 A1) is withdrawn in light of Applicant’s cancelation of claim 2 and amendments to claim 1 to recite limitations regarding ectoine and dextran being selected from a list, to claim 4 to remove dextran variants from the list, and to claim 10 to recite limitations regarding concentrations of the components.
The prior rejection of claims 2-3, 11 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagwat et al., in view of Andreasen et al., and further in view of Sun et al., (CryoLetters. 2012; 33(6): 485-493. Prior art of record) is withdrawn in light of Applicant’s cancelation of claim 2 and amendments to claim 1 to recite limitations regarding ectoine and dextran being selected from a list, and to claim 10 to recite limitations regarding concentrations of the components.
New 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.
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, 4-5, 10 and 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al., (J Tissue Eng Regen Med. 2017;11(10):2806-2815) in view of Jin et al., (CryoLetters. 2013; 34(4): 396-403) and Dumoulin et al., (Fertil Steril. 1994; 62(4): 793-798).
With respect to independent claims 1 and 10, Pollock teaches using differential evolution algorithm to determine DMSO-free cryopreservation solution formulations for different cell types (e.g., p. 2807, left col, last para), thus teaches the preamble a DMSO-free preservative or cryopreservative composition in claims 1 and 10.
Pollock teaches several cryopreservative compositions comprising ectoine and trehalose (see e.g., p. 2808, Table 1), thus teaches a DMSO-free cryopreservative composition comprising ectoine in claims 1 and 44, and trehalose in claim 5.
In regard to the concentrations being in an amount of about a percentage, it is noted that the instant specification has defined the term "about" means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, “particularly with respect to biological systems or processes, the term can mean within an order of magnitude, preferably within 5-fold, and also preferably within 2-fold, of a value” (specification, p. 5, para 1, underlined by examiner). Thus, the claimed concentrations being in an amount of about a percentage value encompass a range of within an order of magnitude of the claimed value.
Pollock teaches Level 4 and Level 5 compositions in Table 1 comprising ectoine in an amount of 0.5% and 1%, respectively (see e.g., p. 2808, Table 1). One of ordinary skill in the art would have immediately expected that this concentration form of ectoine is referring to 0.5% or 1% w/v (i.e., 0.5 g/100 mL or 1 g/100 mL), which is equivalent to 0.5% or 1% w/w (i.e., 0.5 g/100 g or 1 g/100 g) since the water-based cryopreservative solution has a density of about 1 g/mL. Pollock teaches the Level 4 composition in Table 1 comprising trehalose in an amount of 150 mM, which is equivalent to 5% w/w. Thus, Pollock teaches a DMSO-free cryopreservative composition comprising ectoine in an amount of about 5% w/w (encompassing 0.5% or 1% w/w as taught by Pollock) and trehalose in an amount of 5% w/w in claim 10 and claims 45-47.
However, although Pollock teaches to optimize DMSO-free cryopreservation solution formulations for different cell types (e.g., p. 2807, left col, last para), Pollock is silent on the composition comprising a polyamino acid being ε-poly-L-lysine and a saccharide being a dextran being a dextran T10 or a dextran T70 in claims 1, 4 and 43-44, or their concentrations in claims 10, 45 and 47.
In regard to a polyamino acid ε-poly-L-lysine in a cryopreservative composition, Jin tests the cryoprotection of carboxylated ε-poly-L-lysine (COOH-PLL) on fibroblasts and teaches COOH-PLL is not toxic to fibroblasts even at 25% (w/v) and the media containing 7.5% (w/v) COOH-PLL maintains cell morphology and significantly suppresses growth inhibition as well as cell detachment comparable to the media containing 10% (v/v) DMSO (e.g., abstract and Figs 3-4), thus teaches a polyamino acid being ε-poly-L-lysine (i.e., COOH-PLL) present in an amount of about 5% w/w (encompassing 7.5% w/w, i.e., 7.5% w/v taught by Jin) in claims 1, 10, 43-45 and 47. Jin teaches that COOH-PLL is a good cryoprotectant for mammalian cells against repeated freeze/thaw cycles, and may be used for cell preservation in fields of cell transplantation, tissue engineering and regenerative medicine (abstract).
In regard to a dextran T10 or a dextran T70 in a cryopreservative composition, Dumoulin tests the protective effects of dextran in the cryopreservation of human and mouse zonae pellucidae (ZP) and two-cell embryos (e.g., title and abstract). Dumoulin teaches 10% w/v dextran 10 and 10% w/v dextran 70 result in significantly less ZP damage and more intact embryos compared with the standard freezing procedure without dextran (p. 796, section “Effect of Polymers With Different MWs” and Table 3). Dumoulin also tests a dextran 300 in the amount of 1%, 5%, or 10% w/v and finds no significant differences between the tested dextran concentrations with regard to the incidence of ZP damage (p. 795, last section “Effect of Different Concentrations of Polymers”). Thus, Dumoulin teaches a saccharide being a dextran being a dextran T10 or a dextran T70 present in an amount of about 5% w/w (encompassing 10% w/w, i.e., 10% w/v taught by Dumoulin) in claims 1, 4, 10, 44-45 and 47.
Therefore, it would have also been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the DMSO-free cryopreservative composition of Pollock, by combining a polyamino acid ε-poly-L-lysine and a saccharide being a dextran of a dextran T10 or a dextran T70 at the claimed concentrations as suggested by Jin and Dumoulin with a reasonable expectation of success. Since Pollock aims to optimize DMSO-free cryopreservation solution formulations for different cell types (e.g., p. 2807, left col, last para), since Jin teaches that COOH-PLL is a good cryoprotectant for mammalian cells against repeated freeze/thaw cycles and may be used for cell preservation in fields of cell transplantation, tissue engineering and regenerative medicine (abstract), and since Dumoulin teaches dextran 10 and dextran 70 result in significantly less ZP (from oocytes) damage and more intact embryos compared with the standard freezing procedure without dextran (p. 796, section “Effect of Polymers With Different MWs” and Table 3), one of ordinary skill in the art would have had a reason to combine a COOH-PLL and a saccharide such as dextran T10 or dextran T70 as suggested by Jin and Dumoulin in the cryopreservative composition of Pollock in order to optimize cryopreservation solution compositions for multiple cell types (Pollock, abstract).
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments and prior art Sputtek and Pogozhykh filed on 06/18/2026 are acknowledged.
Applicant argues that the rejection under 35 U.S.C. § 103 over Bhagwat and Andersen is overcome (Remarks, p. 6-13).
As stated supra, the prior 103 rejection over Bhagwat and Andersen is withdrawn in light of Applicant’s amendments to claim 1 to recite limitations regarding ectoine or derivatives and dextran being selected from a list of variants, to claim 4 to remove dextran variants (to remove the one taught by Andersen) from the list, and to claim 10 to recite limitations regarding concentrations of the components, and the addition of new claims 43-47. However, as necessitated by amendments, a new ground of rejection has been made over Pollock in view of Jin and Dumoulin as discussed above.
Since the new ground of rejection does not rely on Bhagwat and Andersen for any teaching or matter specifically challenged in the argument, Applicant’s arguments become moot.
Claims 3, 11 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al., (J Tissue Eng Regen Med. 2017;11(10):2806-2815) in view of Jin et al., (CryoLetters. 2013; 34(4): 396-403) and Dumoulin et al., (Fertil Steril. 1994; 62(4): 793-798), as applied to claims 1 and 10 above, and further in view of Sun et al., (CryoLetters. 2012; 33(6): 485-493. Prior art of record).
As a first matter, with respect to claims 41-42 directed to the saccharide being dextran selected from dextran T10 or dextran T70, as stated supra, Pollock in view of Jin and Dumoulin make obvious a DMSO-free cryopreservative composition comprising dextran selected from dextran T10 or dextran T70.
However, Pollock, Jin and Dumoulin are silent on a derivative of ectoine comprising hydroxyectoine in claims 3, 11 and 41-42.
Sun teaches several cryopreservative compositions aiming to replace DMSO due to its toxicity to cells (e.g., p. 485, Introduction). Regarding ectoine or derivatives thereof, Sun teaches ectoine was shown to be able to protect skin cells against UV-radiation, immunosupression and membrane damage, and furthermore, studies on the stabilization of proteins as well as fluidization of membranes indicate that hydoxyectoine might be the most promising candidate for use as a cryoprotective agent (p. 486, para 1). Sun teaches addition of hydoxyectoine in the freezing medium improves the efficiency of recultivation compared to the freezing medium without hydoxyectoine (p. 490, para 2 and Fig 2), related to claims 3, 11 and 41-42.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the DMSO-free cryopreservative composition comprising ectoine suggested by Pollock in view of Jin and Dumoulin, by substituting ectoine with its derivative hydoxyectoine as suggested by Sun with a reasonable expectation of success. Since Sun suggests that studies on the stabilization of proteins as well as fluidization of membranes indicate that hydoxyectoine might be the most promising candidate for use as a cryoprotective agent (p. 486, para 1) and teaches addition of hydoxyectoine in the freezing medium improves the efficiency of recultivation (p. 490, para 2 and Fig 2), one of ordinary skill in the art would have had a reason to substitute with hydoxyectoine as suggested by Sun in the cryopreservative composition of Pollock in view of Jin and Dumoulin in order to enhance stabilization of proteins and to improve the efficiency of recultivation.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 06/18/2026 are acknowledged and have been discussed above.
Withdrawn Double Patenting Rejections
The prior rejection of claims 1-5, 10-11 and 41-42 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of US Patent No. 11,985,968 and claims 1-8 of US Patent No. 10,765,111 in view of Bhagwat et al., and Andreasen et al., is withdrawn in light of Applicant’s cancelation of claim 2 and amendments to claim 1 to recite limitations regarding ectoine and dextran being selected from a list, to claim 4 to remove dextran variants from the list, and to claim 10 to recite limitations regarding concentrations of the components.
New Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-5, 10-11 and 41-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of US Patent No. 11,985,968 in view of Pollock et al., (J Tissue Eng Regen Med. 2017;11(10):2806-2815), Jin et al., (CryoLetters. 2013; 34(4): 396-403) and Dumoulin et al., (Fertil Steril. 1994; 62(4): 793-798). Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims recite a cryopreservative composition comprising saccharides and organic amphoteric agents, exclusive of dimethyl sulfoxide (DMSO) (cited claim 1, related to instant claims 1 and 10), said organic amphoteric agent is ectoin and/or hydroxyectoine (cited claims 1 and 2, related to instant claims 3 and 10-11), the saccharide is α-D-glucopyranosyl-(1,1)-α-D-glucopyranoside (trehalose) and/or dextran-40 (cited claim 1, related to instant claims 5, 10 and 41).
However, the patented claims do not recite a polyamino acid being ε-poly-L-lysine and a dextran being a dextran T10 or a dextran T70 in claims 1, 4 and 42-44, or the concentrations of the components in claims 10 and 45-47.
Pollock teaches Level 4 and Level 5 compositions in Table 1 comprising ectoine in an amount of 0.5% and 1%, respectively (see e.g., p. 2808, Table 1). One of ordinary skill in the art would have immediately expected that this concentration form of ectoine is referring to 0.5% or 1% w/v (i.e., 0.5 g/100 mL or 1 g/100 mL), which is equivalent to 0.5% or 1% w/w (i.e., 0.5 g/100 g or 1 g/100 g) since the water-based cryopreservative solution has a density of about 1 g/mL. Pollock teaches the Level 4 composition in Table 1 comprising trehalose in an amount of 150 mM, which is equivalent to 5% w/w. Thus, Pollock teaches a DMSO-free cryopreservative composition comprising ectoine in an amount of about 5% w/w (encompassing 0.5% or 1% w/w as taught by Pollock) and trehalose in an amount of 5% w/w in instant claim 10 and claims 45-47.
Jin tests the cryoprotection of carboxylated ε-poly-L-lysine (COOH-PLL) on fibroblasts and teaches the media containing 7.5% (w/v) COOH-PLL maintains cell morphology and significantly suppresses growth inhibition as well as cell detachment comparable to the media containing 10% (v/v) DMSO (e.g., abstract and Figs 3-4), thus teaches a polyamino acid being ε-poly-L-lysine (i.e., COOH-PLL) present in an amount of about 5% w/w (encompassing 7.5% w/w, i.e., 7.5% w/v taught by Jin) in instant claims 1, 10, 43-45 and 47. Jin teaches that COOH-PLL is a good cryoprotectant for mammalian cells against repeated freeze/thaw cycles, and may be used for cell preservation in fields of cell transplantation, and regenerative medicine (abstract).
Dumoulin tests the protective effects of dextran in the cryopreservation of human and mouse zonae pellucidae (ZP) and two-cell embryos (e.g., title and abstract). Dumoulin teaches 10% w/v dextran 10 and 10% w/v dextran 70 result in significantly less ZP damage and more intact embryos compared with the standard freezing procedure without dextran (p. 796 and Table 3). Thus, Dumoulin teaches a saccharide being a dextran being a dextran T10 or a dextran T70 present in an amount of about 5% w/w (encompassing 10% w/w, i.e., 10% w/v taught by Dumoulin) in instant claims 1, 4, 10, 42, 44-45 and 47.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the DMSO-free cryopreservative composition comprising ectoine/hydroxyectoine, dextran-40 and trehalose recited in the patent claims, by combining a polyamino acid ε-poly-L-lysine and a dextran being a dextran T10 or a dextran T70 and choosing the claimed concentrations as suggested by Pollock, Jin and Dumoulin with a reasonable expectation of success. Since Pollock aims to optimize DMSO-free cryopreservation solution formulations for different cell types (e.g., p. 2807, left col, last para), since Jin teaches that COOH-PLL is a good cryoprotectant for mammalian cells against repeated freeze/thaw cycles and may be used for cell preservation in fields of cell transplantation, tissue engineering and regenerative medicine (abstract), and since Dumoulin teaches dextran 10 and dextran 70 result in significantly less ZP (from oocytes) damage and more intact embryos compared with the standard freezing procedure without dextran (p. 796, section “Effect of Polymers With Different MWs” and Table 3), one of ordinary skill in the art would have had a reason to combine a COOH-PLL and a dextran such as dextran T10 or dextran T70 as suggested by Jin and Dumoulin and to choose the claimed concentrations of the components as suggested by Pollock, Jin and Dumoulin in order to optimize cryopreservation solution compositions for multiple cell types (Pollock, abstract).
Since the instant application claims are obvious by cited patent claims, in view of Pollock, Jin and Dumoulin, said claims are not patentably distinct.
Claims 1, 3-5, 10-11 and 41-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US Patent No. 10,765,111 in view of Pollock et al., (J Tissue Eng Regen Med. 2017;11(10):2806-2815), Jin et al., (CryoLetters. 2013; 34(4): 396-403) and Dumoulin et al., (Fertil Steril. 1994; 62(4): 793-798). Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims recite a composition for cryopreservation consisting of: polyethylene glycol (PEG), a saccharide, and an organic amphoteric agent, wherein: said organic amphoteric agent is ectoin and/or hydroxyectoin; said saccharide is trehalose and/or dextran-40 (cited claim 1, related to instant claims 1, 3, 5, 10-11 and 41). Note that there is no DMSO in the cited composition.
However, the patented claims do not recite a polyamino acid being ε-poly-L-lysine and a dextran being a dextran T10 or a dextran T70 in claims 1, 4 and 42-44, or the concentrations of the components in claims 10 and 45-47.
Pollock teaches Level 4 and Level 5 compositions in Table 1 comprising ectoine in an amount of 0.5% and 1%, respectively (see e.g., p. 2808, Table 1). One of ordinary skill in the art would have immediately expected that this concentration form of ectoine is referring to 0.5% or 1% w/v (i.e., 0.5 g/100 mL or 1 g/100 mL), which is equivalent to 0.5% or 1% w/w (i.e., 0.5 g/100 g or 1 g/100 g) since the water-based cryopreservative solution has a density of about 1 g/mL. Pollock teaches the Level 4 composition in Table 1 comprising trehalose in an amount of 150 mM, which is equivalent to 5% w/w. Thus, Pollock teaches a DMSO-free cryopreservative composition comprising ectoine in an amount of about 5% w/w (encompassing 0.5% or 1% w/w as taught by Pollock) and trehalose in an amount of 5% w/w in instant claim 10 and claims 45-47.
Jin tests the cryoprotection of carboxylated ε-poly-L-lysine (COOH-PLL) on fibroblasts and teaches COOH-PLL is not toxic to fibroblasts even at 25% (w/v) and the media containing 7.5% (w/v) COOH-PLL maintains cell morphology and significantly suppresses growth inhibition as well as cell detachment comparable to the media containing 10% (v/v) DMSO (e.g., abstract and Figs 3-4), thus teaches a polyamino acid being ε-poly-L-lysine (i.e., COOH-PLL) present in an amount of about 5% w/w (encompassing 7.5% w/w, i.e., 7.5% w/v taught by Jin) in instant claims 1, 10, 43-45 and 47. Jin teaches that COOH-PLL is a good cryoprotectant for mammalian cells against repeated freeze/thaw cycles, and may be used for cell preservation in fields of cell transplantation, tissue engineering and regenerative medicine (abstract).
Dumoulin tests the protective effects of dextran in the cryopreservation of human and mouse zonae pellucidae (ZP) and two-cell embryos (e.g., title and abstract). Dumoulin teaches 10% w/v dextran 10 and 10% w/v dextran 70 result in significantly less ZP damage and more intact embryos compared with the standard freezing procedure without dextran (p. 796, section “Effect of Polymers With Different MWs” and Table 3). Thus, Dumoulin teaches a saccharide being a dextran being a dextran T10 or a dextran T70 present in an amount of about 5% w/w (encompassing 10% w/w, i.e., 10% w/v taught by Dumoulin) in instant claims 1, 4, 10, 42, 44-45 and 47.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the DMSO-free cryopreservative composition comprising ectoine/hydroxyectoine, dextran-40 and trehalose recited in the patent claims, by combining a polyamino acid ε-poly-L-lysine and a dextran being a dextran T10 or a dextran T70 and choosing the claimed concentrations as suggested by Pollock, Jin and Dumoulin with a reasonable expectation of success. Since Pollock aims to optimize DMSO-free cryopreservation solution formulations for different cell types (e.g., p. 2807, left col, last para), since Jin teaches that COOH-PLL is a good cryoprotectant for mammalian cells against repeated freeze/thaw cycles and may be used for cell preservation in fields of cell transplantation, tissue engineering and regenerative medicine (abstract), and since Dumoulin teaches dextran 10 and dextran 70 result in significantly less ZP (from oocytes) damage and more intact embryos compared with the standard freezing procedure without dextran (p. 796, section “Effect of Polymers With Different MWs” and Table 3), one of ordinary skill in the art would have had a reason to combine a COOH-PLL and a dextran such as dextran T10 or dextran T70 as suggested by Jin and Dumoulin and to choose the claimed concentrations of the components as suggested by Pollock, Jin and Dumoulin in order to optimize cryopreservation solution compositions for multiple cell types.
Since the instant application claims are obvious by cited patent claims, in view of Pollock, Jin and Dumoulin, said claims are not patentably distinct.
Response to Traversal:
Applicant’s arguments filed on 06/18/2026 are acknowledged.
Applicant indicates that a terminal disclaimer has been filed and requests to withdraw the rejections (Remarks, p. 13).
Applicant’s arguments have been fully considered but they are not persuasive because a terminal disclaimer was not found. As stated supra, the prior rejection is withdrawn in light of Applicant’s amendments to the claims. However, as necessitated by amendments, a new ground of rejection is made over the cited patent claims in view of Pollock, Jin and Dumoulin as discussed above.
Conclusion
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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