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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/15/2025 has been entered.
Applicant' s amendment and response filed on 09/15/2025 has been received and entered into the case.
Amendments
In the reply filed 09/15/2025, Applicant has amended claims 1, 4, 5 and 10, has newly canceled claims 18, 19, 24, 26 and 35, and has added new claims 41-42.
Claim Status
Claims 1-11, 27-34 and 41-42 are pending. Claims 6-9 and 27-34 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim.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 1-5, 10-11 and 41-42 are considered on the merits.
New Claim Objections
Claims 4 and 42 are objected to because of the following informalities:
Claims 4 and 42 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 term “CM-dextran” is examined as carboxymethyldextran.
Appropriate correction is required.
New 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.
Claims 10-11 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.
Claim 10 recites the broad recitation “a saccharide” and the claim also recites “trehalose” (a disaccharide) which is the narrower statement of the limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 11 is rejected as being dependent from claim 10 but not resolving the ambiguity.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection of claims 1-2, 4-5 and 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 1 to recite new limitation “wherein the saccharide is dextran” and to claim 10 to recite new limitation “trehalose and a saccharide”.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of claims 1-5 and 10-11 under 35 U.S.C. 103 as being unpatentable over Bhagwat et al., (WO 2016/063208 A1. Prior art of record) in view of Sun et al., (CryoLetters. 2012; 33(6): 485-493. Prior art of record) is withdrawn in light of Applicant’s amendment to claim 1 to recite new limitation “wherein the saccharide is dextran” and to claim 10 to recite new limitation “trehalose and a saccharide”.
New 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.
Claims 1 and 2 are rejected 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).
Pasley et al. appear to be Applicant’s own work. Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1) . Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
With respect to claims 1 and 2, Pasley teaches a combination of DMSO-free cryoprotectants comprising 7.5% PLL (Poly-L-lysine), 5% ectoine and 5% dextran for long-term preservation of NK cells (e.g., p. 37, right col, para 3.2, also Table 2). Thus, Pasley teaches a DMSO-free preservative or cryopreservative composition comprising a polyamino acid (i.e., Poly-L-lysine) in combination with an organic amphoteric agent (i.e., ectoine) and a saccharide wherein the saccharide is dextran in claims 1 and 2.
Accordingly, Pasley anticipates instant claims.
Claim 10 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Bhagwat et al., (WO 2016/063208 A1. Prior art of record).
Bhagwat teaches several cryopreservative compositions comprising a list of components (see p. 9, para 1, 2 and 6). Specifically, in page 9, para. 1, Bhagwat teaches a cryopreservative composition comprising “Ringer Lactate solution, Glycerol, Human Serum Albumin, Trehalose, Hydroxyethyl starch, GlutaMax, Poly-L-Lysine, Ectoine and PlasmaLyte A”. It is noted that there is no DMSO listed in this composition as well as two other compositions cited in page 9, paragraphs 1, 2 or 6, while DMSO is listed in compositions cited in page 9, paragraphs 3, 4, 5 and 7. Thus, Bhagwat teaches a DMSO-free preservative or cryopreservative composition comprising a polyamino acid (i.e., Poly-L-Lysine) in combination with ectoine, trehalose and a saccharide (i.e., Hydroxyethyl starch) in claim 10.
Accordingly, Bhagwat anticipates instant claim 10.
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, 2, 4, 5 and 10 are rejected 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).
With respect to independent claims 1 and 10, Bhagwat teaches several cryopreservative compositions comprising a list of components (see p. 9, para 1, 2 and 6). Specifically, in page 9, para. 1, Bhagwat teaches a cryopreservative composition comprising “Ringer Lactate solution, Glycerol, Human Serum Albumin, Trehalose, Hydroxyethyl starch, GlutaMax, Poly-L-Lysine, Ectoine and PlasmaLyte A”. It is noted that there is no DMSO listed in this composition as well as two other compositions cited in page 9, paragraphs 1, 2 or 6, while DMSO is listed in compositions cited in page 9, paragraphs 3, 4, 5 and 7. Thus, Bhagwat teaches a DMSO-free preservative or cryopreservative composition comprising a polyamino acid (i.e., Poly-L-Lysine) in combination with an organic amphoteric agent (i.e., ectoine), and saccharides such as trehalose and hydroxyethyl starch.
However, Bhagwat is silent on the saccharide being dextran in claim 1 and encompassed by claim 10, or the saccharide being selected from CM-dextran 4 and CM-dextran 150 in claim 4.
Andreasen teaches providing a cryoprotectant as a replacement for DMSO because DMSO is physiologically toxic and known to cause high blood pressure, nausea and vomiting if transfused to a recipient with the cells (p. 2, last para – p. 3, “Object of the invention”). Andreasen teaches a cryoprotective agent comprising a cryoprotectant selected from the group consisting of carboxyalkyldextran, such as carboxymethyldextran (i.e., the instantly recited “CM-dextran” in claim 4) (p. 3, “Summary of the invention”, and e.g., p. 10, lines 13-16, also see e.g., Examples 4-5 reciting “HCMD” (hydrogenated carboxymethyldextran) including HCMD 1, 2.5, 5 and 750). Andreasen teaches human iPS cells survive cryopreservation with HCMDs, ethylene glycol (EG) and Human Serum Albumin (HSA) as cryoprotectants that results in improved survival compared to DMSO (p. 48, last para.). Andreasen teaches the carboxyalkyldextran has a weight average molecular weight (MW) of between 300 and 900,000 Da (see reference claim 13, encompassing the instantly recited CM-dextran 4 and CM-dextran 150 in claim 4 which have MW of 4000 Da and 150,000 Da, respectively), and further comprises additional cryoprotectant such as glycerol, human serum albumin, trehalose and hydroxyethyl starch (see reference claims 17 and 20).
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 a polyamino acid, an organic amphoteric agent ectoine and a saccharide trehalose disclosed by Bhagwat, by combining a carboxymethyldextran having the claimed molecular weight as suggested by Andreasen with a reasonable expectation of success. Since Bhagwat teaches a DMSO-free cryopreservative composition comprising Glycerol, Human Serum Albumin, Trehalose, Hydroxyethyl starch, Poly-L-Lysine, and Ectoine (p. 9, para 1), and since Andreasen suggests carboxymethyldextran (CM-dextran) can be combined with Bhagwat’s cryoprotectants such as glycerol, human serum albumin, trehalose and hydroxyethyl starch (see reference claims 17 and 20) and human iPS cells survive cryopreservation with CM-dextran as cryoprotectant that results in improved survival compared to DMSO (p. 48, last para.), one of ordinary skill in the art would have had a reason to combine a CM-dextran as suggested by Andreasen in the DMSO-free cryopreservative composition of Bhagwat in order to improve survival of the cryopreserved cells.
Furthermore, regarding the claimed molecular weight in claim 4, notably, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See M.P.E.P. §2144.05. Thus, since the instantly claimed CM-dextran 4 and CM-dextran 150 in claim 4 lie inside ranges disclosed by the prior art Andreasen (see reference claim 13), it would have been obvious for one of ordinary skill in the art to have chosen the instantly claimed CM-dextran 4 or CM-dextran 150 with a reasonable expectation of success.
With respect to claim 2 directed to the organic amphoteric agent being ectoine, as stated supra, Bhagwat teaches the cryopreservative composition comprising ectoine (page 9, para. 1).
With respect to claim 5 directed to the composition further comprising trehalose, as stated supra, Bhagwat teaches the cryopreservative composition comprising trehalose (page 9, para. 1).
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 09/15/2025 are acknowledged.
Applicant argues that Bhagwat is silent on dextran thus cannot anticipate the composition recited in amended claim 1 (Remarks, p. 1-2).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejections have been withdrawn. However, a new ground of rejection is made over Bhagwat in view of Andreasen as discussed above. Specifically, Andreasen suggests combining dextran in Bhagwat’s cryopreservative composition.
Claims 2-3, 11 and 41-42 are rejected 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), 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).
With respect to claims 41-42 directed to the saccharide being dextran selected from CM-dextran 4 and CM-dextran 150, as stated supra, Bhagwat, in view of Andreasen, make obvious a DMSO-free cryopreservative composition comprising a polyamino acid in combination with ectoine, trehalose and a dextran selected from CM-dextran 4 and CM-dextran 150.
However, Bhagwat and Andreasen are silent on a derivative of ectoine comprising hydroxyectoine in claims 2-3, 11 and 41-42.
Nevertheless, Bhagwat teaches ectoine is an anti-aging agent which stabilizes proteins and other cellular structures (p. 8, Table 1).
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).
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 disclosed by Bhagwat in view of Andreasen, by substituting ectoine with its derivative hydoxyectoine as suggested by Sun with a reasonable expectation of success. Since Bhagwat includes ectoine because it is an anti-aging agent which stabilizes proteins and other cellular structures (p. 8, Table 1), and 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 Bhagwat in view of Andreasen in order to enhance stabilization of proteins and other cellular structures to improve the viability of cryopreserved cells (see Bhagwat, p. 25 for ectoine effect on viability of cells).
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 09/15/2025 are acknowledged and have been discussed above.
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 1-5, 10-11 and 41-42 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 Bhagwat et al., (WO 2016/063208 A1. Prior art of record) and Andreasen et al., (WO 2015/150394 A1). 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 2-3 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 1, 5, 10 and 41).
However, the patented claims do not recite a polyamino acid in the composition, nor recite the dextran being selected from CM-dextran 4 and CM-dextran 150.
Bhagwat teaches several cryopreservative compositions comprising poly-L-lysine in combination with an organic amphoteric agent ectoine and a saccharide trehalose (see page 9, para 1-2 and 6 for examples of compositions). Bhagwat teaches poly-L-lysine is an anti-aging component (p. 8, Table 1), which can be used in combination with ectoine (see Bhagwat, claim 6).
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 or saccaride recited in the patent, by combining a poly-L-lysine as taught by Bhagwat with a reasonable expectation of success. Since Bhagwat teaches poly-L-lysine is an anti-aging component (p. 8, Table 1), which can be used in combination with ectoine (see Bhagwat, claim 6), one of ordinary skill in the art would have had a reason to combine poly-L-lysine in the cited cryopreservative composition comprising ectoine in order to enhance the anti-aging effect as taught by Bhagwat.
Andreasen teaches providing a cryoprotectant as a replacement for DMSO (p. 3, “Object of the invention”), comprising a cryoprotectant selected from the group consisting of carboxyalkyldextran, such as carboxymethyldextran (i.e., the instantly recited “CM-dextran” in claim 4) (p. 3, “Summary of the invention”, and e.g., p. 10, lines 13-16, also see e.g., Examples 4-5 reciting hydrogenated carboxymethyldextran (“HCMD”) including HCMD 1, 2.5, 5 and 750). Andreasen teaches human iPS cells survive cryopreservation with HCMDs, ethylene glycol (EG) and Human Serum Albumin (HSA) as cryoprotectants that results in improved survival compared to DMSO alone (p. 48, last para.). Andreasen teaches the carboxyalkyldextran has a weight average molecular weight (MW) of between 300 and 900,000 Da (see reference claim 13, encompassing the instantly recited CM-dextran 4 and CM-dextran 150 in claim 4 which have MW of 4000 Da and 150,000 Da, respectively), and further comprises additional cryoprotectant such as trehalose (see reference claim 17).
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 dextran-40 recited in the patent, by substituting dextran-40 with carboxymethyldextran (CM-dextran) having claimed molecular weight as taught by Andreasen with a reasonable expectation of success. Since Andreasen has reduced to practice a CM-dextran having claimed molecular weight can be combined with trehalose and improves survival of cryopreserved cells (see above), one of ordinary skill in the art would have had a reason to substitute with CM-dextran having claimed molecular weight in order to improve survival of cryopreserved cells.
Since the instant application claims are obvious by cited patent claims, in view of Bhagwat and Andreasen, said claims are not patentably distinct.
Claims 1-5, 10-11 and 41-42 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 Bhagwat et al., (WO 2016/063208 A1. Prior art of record) and Andreasen et al., (WO 2015/150394 A1). 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, 2, 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 in the composition, nor recite the dextran being selected from CM-dextran 4 and CM-dextran 150.
Bhagwat teaches several cryopreservative compositions comprising poly-L-lysine in combination with an organic amphoteric agent ectoine and a saccharide trehalose (see page 9, para 1-2 and 6 for examples of compositions). Bhagwat teaches poly-L-lysine is an anti-aging component (p. 8, Table 1), which can be used in combination with ectoine (see Bhagwat, claim 6).
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 or saccaride recited in the patent, by combining a poly-L-lysine as taught by Bhagwat with a reasonable expectation of success. Since Bhagwat teaches poly-L-lysine is an anti-aging component (p. 8, Table 1), which can be used in combination with ectoine (see Bhagwat, claim 6), one of ordinary skill in the art would have had a reason to combine poly-L-lysine in the cited cryopreservative composition comprising ectoine in order to enhance the anti-aging effect as taught by Bhagwat.
Andreasen teaches providing a cryoprotectant as a replacement for DMSO (p. 3, “Object of the invention”), comprising a cryoprotectant selected from the group consisting of carboxyalkyldextran, such as carboxymethyldextran (i.e., the instantly recited “CM-dextran” in claim 4) (p. 3, “Summary of the invention”, and e.g., p. 10, lines 13-16, also see e.g., Examples 4-5 reciting hydrogenated carboxymethyldextran (“HCMD”) including HCMD 1, 2.5, 5 and 750). Andreasen teaches human iPS cells survive cryopreservation with HCMDs, ethylene glycol (EG) and Human Serum Albumin (HSA) as cryoprotectants that results in improved survival compared to DMSO alone (p. 48, last para.). Andreasen teaches the carboxyalkyldextran has a weight average molecular weight (MW) of between 300 and 900,000 Da (see reference claim 13, encompassing the instantly recited CM-dextran 4 and CM-dextran 150 in claim 4 which have MW of 4000 Da and 150,000 Da, respectively), and further comprises additional cryoprotectant such as trehalose (see reference claim 17).
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 dextran-40 recited in the patent, by substituting dextran-40 with carboxymethyldextran having claimed molecular weight as taught by Andreasen with a reasonable expectation of success. Since Andreasen has reduced to practice a carboxymethyldextran having claimed molecular weight can be combined with trehalose and improves survival of cryopreserved cells (see above), one of ordinary skill in the art would have had a reason to substitute with carboxymethyldextran having claimed molecular weight in order to improve survival of cryopreserved cells.
Since the instant application claims are obvious by cited patent claims, in view of Bhagwat and Andreasen, said claims are not patentably distinct.
Response to Traversal:
Applicant’s arguments filed on 09/15/2025 are acknowledged and have been fully considered.
In response to Applicant’s request that the double patenting rejections be held in abeyance until allowable subject matter is acknowledged (Remarks, p. 3), this is not found persuasive. Applicant is reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer. Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804.I.B.1. The double patenting rejections have been made over the prior cited patents in view of Bhagwat and Andreasen to address the amendment.
Conclusion
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Douglas (Doug) Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JIANJIAN ZHU/Examiner, Art Unit 1631