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 .
Response to Applicants Arguments
Applicants claim sheet dated April 18, 2025 with the subsequent examiner’s amendments were allowed June 17, 2025. On August 12, 2025, the Japanese Patent Office issued an office action on the Japanese version of this application. The Japanese office action, its English translation, and an IDS were provided to examiner August 25, 2025 by applicants. As a result of the Japanese office action provided by applicants, examiner reopened prosecution on September 17, 2025 to address issues of concern discussed in the Japanese office action. Applicants recently filed a new related application (Application 19/310,608). Therefore, an obviousness type double patenting rejection is made.
Claim Rejections - 35 USC § 112
Claims 1-10,12-20, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for preserving living large volume cellular material and/or cartilage comprising exposing the living large volume cellular material/cartilage to a solution of high concentration cryoprotectant formulation with iron metal nanoparticles (Fe mNPs); obtaining a cryopreserved cellular material/cartilage from the exposed cellular material/cartilage by subjecting the exposed cellular material/cartilage to a preservation protocol in which damage to the exposed cellular material/cartilage due to freezing does not occur; and nanowarming the cryopreserved cellular material/cartilage such that metabolic activity of the nanowarmed tissue is recovered to in a range of 70% to 100% of control values within two days of being rewarmed, the control values corresponding to metabolic activity of fresh cellular material/cartilage, which was not cryopreserved, in a growth media, wherein the total concentration of Fe mNPs in the high concentration cryoprotectant formation is in the range of from 2 mg/ml to 3 mg/ml, and wherein the high concentration cryoprotectant formulation comprises 4.65 mol/L dimethyl sulfoxide, 4.65 mol/L formamide, and 3.31 mol/L propylene glycol in 1xEuroCollins solution does not reasonably provide enablement for a method for preserving living large volume cellular material and/or cartilage tissue comprising exposing the living large volume cellular material/cartilage to a solution of high concentration cryoprotectant formulation; obtaining a cryopreserved cellular material/cartilage from the exposed cellular material by subjecting the exposed cellular material to a preservation protocol in which damage to the exposed cellular material/cartilage due to freezing does not occur; and nanowarming the cryopreserved cellular material/cartilage such that metabolic activity of the nanowarmed tissue is recovered to in a range of 70% to 100% of control values within two days of being rewarmed, the control values corresponding to metabolic activity of fresh cellular material/cartilage, which was not cryopreserved, in a growth media, wherein the total concentration of Fe mNPs in the high concentration cryoprotectant formation is in the range of from 2 mg/ml to 3 mg/ml, and wherein a cryoprotectant agent concentration in the high concentration cryoprotectant formulation is in a range of 75% to 83%. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Nature of the Invention:
Applicants last submitted set of claims dated April 18, 2025 encompassed a method for preserving large volume cellular material (Claim 1)/cartilage tissue (Claim 16) by exposing such material to a solution containing a high concentration of cryoprotectant formation. The preservation method in independent claims 1 and 16 recite exposing the living large volume cellular material/cartilage to a solution of high concentration cryoprotectant formulation containing Fe mNPs; obtaining a cryopreserved cellular material/cartilage from the exposed cellular material/cartilage by subjecting the exposed cellular material/cartilage to a preservation protocol in which damage to the exposed cellular material/cartilage due to freezing does not occur; and nanowarming the cryopreserved cellular material/cartilage such that the metabolic activity of the nanowarmed tissue is recovered to in a range of 70% to 100% of the control values within two days of being rewarmed, the control values corresponding to metabolic activity of fresh cellular material/cartilage, which was not cryopreserved, in a growth media, wherein a total concentration of Fe mNPs in the high concentration cryoprotectant formulation is in the range of from 2 mg/mL to 3 mg/mL, , and wherein a cryoprotectant agent concentration in the high concentration cryoprotectant formulation is in the range of 75% to 83%. On June 17, 2025, applicants offered amended claims that required the high concentration cryoprotectant formulation to comprise 4.65 mol/L dimethyl sulfoxide, 4.65 mol/L formamide, and 3.31 mol/L propylene glycol in 1xEuroCollins solution in the independent claims.
Breadth of the Claims:
The claims require that a cryoprotectant formulation is used in the process. The cryoprotectant formulation that has a cell recovery rate of 70 to 100% is VS83 (Figure 1). Applicants’ amendments required the presence of VS83 as the cryoprotectant formulation. VS83 requires the following components at the specific concentrations listed: 4.65 mol/L dimethyl sulfoxide, 4.65 mol/L formamide, and 3.31 mol/L propylene glycol in 1xEuroCollins solution. Applicants claim set dated April 18, 2025 and the claims allowed by applicant allow for the cryoprotectant agent concentration in the high concentration cryoprotectant formulation to be in the range of 75-83%. The claims do not clearly specify that the cryoprotectant formulation is the same as the cryoprotectant agent. The cryoprotectant formulation and the cryoprotectant agent can be the same entity or they can be different entities.
Applicants Specification/Guidance/Working Examples:
Figure 1 of applicants specification only shows that a metabolic activity for recovered cells of 70-100% after a freezing/thawing process is possible when VS83 is used. VS83 is a tradename. In the specification, VS83 has the following components: 4.65 mol/L dimethyl sulfoxide, 4.65 mol/L formamide, and 3.31 mol/L propylene glycol in 1x Euro Collins solution in combination with about 2mg/mL of Fe mNPs. Paragraph 61 of the specification states that this VS83 formulation has a molarity of 12.6 M. The components of VS83 are cryoprotectant agents, but is not clear in the claims if those components are the only cryoprotectant agents or there are other different cryoprotectant agents that are not part of the cryopreservation formulation.
Figure 1 shows that the following cryopreservation formulations VS55 and VS70 did not result in the high metabolic activity level recited in the claims. Figure 7 and Paragraph 131 teach that cryoprotectant formulations VS55 and DP7 (DMSO AND 1,2-propanediol with disaccharides) with cryoprotective agents (sucrose and/or trehalose) were unable to obtain a high metabolic level (70-100%) recited in the claim language. VS55 has the same components as VS83 but at a lower concentration, and VS55 cannot generate the metabolic activity level after thawing recited in the instant claims. Only Figure 1 shows that the VS83 formulation at its stated concentrations with the iron nanoparticles is able to provide cells with a high metabolic activity (70-100%) after thawing.
Conclusion: Because applicant has only demonstrated that a high metabolic activity (70-100%) after thawing is possible with just the VS83 solution and about 2 mg/mL Fe mNPs, applicant should only be entitled to that embodiment.
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 1-10,12-20, and 22 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. Both independent claims 1 and 16 are indefinite. The independent claims 1 and 16 state a large living volume cellular material/cartilage is exposed to a solution of high concentration cryoprotectant formulation. The high concentration cryoprotectant is a solution that comprises 4.65 mol/L dimethyl sulfoxide, 4.65 mol/L formamide, and 3.31 mol/L propylene glycol in 1xEuroCollins solution. Another limitation in claims 1 and 16 state that a ‘cryoprotectant agent concentration in the high concentration formulation is in the range of 75% to 83%.” It is not clear if the cryoprotectant agent includes just 4.65 mol/L dimethyl sulfoxide, 4.65 mol/L formamide, and 3.31 mol/L propylene glycol (the components of the VS83 cryoprotectant formulation) or if the cryoprotectant agents can include other different cryoprotectant agents such as sugars like trehalose. Because of the uncertainty, the metes and bounds cannot be ascertained.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-10,12-20, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 19/310,608. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of Application 19/310,608 have the same limitations with the exception that the concentrations of the dimethyl sulfoxide, formamide, and 1,2-propanediol are lower in the claims of 19,310,608. It would have been expected that a person of ordinary skill would have modified the amount of cryoprotectant formula to best preserve the living large volume of cellular material/cartilage. Instant claims 1 and 4 correspond to claim 1 of 19/310,608. Instant claim 2 corresponds to claim 2 of 19,310,608. Instant claim 3 corresponds to claim 3 of 19/310,608. Instant claim 5 corresponds to claim 4 of 19,310,608. Instant claim 6 corresponds to claim 5 of 19,310,608. Instant claim 7 corresponds to claim 6 of Application 19,310,608. Instant claim 8 corresponds to claim 7 of Application 19,310,608. Instant claim 9 corresponds to claim 8 of Application 19,310,608. Instant claim 10 corresponds to claim 9 of Application 19,310,608. Instant claim 12 corresponds to claim 10 of Application 19,310,608. Instant claim 13 corresponds to claim 11 of Application 19,310,608. Instant claim 14 corresponds to claim 12 of Application 19,310,608. Instant claim 15 corresponds to claim 13 of Application 19,310,608. Instant claim 16 corresponds to claims 14 and 18 of Application 19,310,608. Instant claim 17 corresponds to claim 15 of Application 19,310,608. Instant claim 19 corresponds to claim 16 of Application 19,310,608. Instant claim 20 corresponds to claim 17 of Application 19,310,608. Instant claim 22 corresponds to claim 18 of Application 19,310,608.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638