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 .
Status of the Claims
Claims 1-15 are pending.
Applicant’s election without traverse of group I claims 1-10 in the reply filed on 7/14/2026 is acknowledged. Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim Objections
Claims 1, 2, 5, and 6 are objected to because of the following informalities:
The claims appear to be a literal translation into English from a foreign document have some grammatical and idiomatic errors. For example, claim 1 includes the unit “ms/cm” as a unit of electrical conductivity of a solution. The correct unit was probably meant to be mS/cm (milliSiemens per centimeter). Also, “… a storage solution, comprising: an electrical conductivity of the storage solution being 3 ms/cm or more and 20 ms/cm or less” seems awkward. The Examiner suggests the following “…or an organic salt, wherein the electrical conductivity of the storage solution is from 3 mS/cm to 20 mS/cm.”
Claim 2 includes the term “having a molecular weight of 100 or less and being not frozen at 0°C.” The Examiner suggests instead “…compound (C), wherein the cell-membrane permeable compound (C) has a molecular weight of 100 g/mol or less, and does not freeze at 0°C”
Molecular weights are also limitations of claims 5 and 6, which appear without units. These were interpreted to be in terms of g/mol. The examiner Suggests including the g/mol unit in these claims as well.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Guangzhou
Claims 1-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
CN107271246A (Guangzhou) (Provided in IDS of 7/22/2025),
As evidenced by Hervas, F., et al. "Study of the extraction kinetic of glycosaminoglycans from raw sheepskin trimmings." Proceedings of International United of Environment Commission of IULTCS, Chengdu, China (2006): 14-16.
Regarding claim 1, Guangzhou teaches a preservation solution for cells liquid-based thin-layer cells. (Guangzhou claim 1). Guangzhou’s preservation solution comprises 2-3% paraformaldehyde, and NaCl at a concentration of 60-100 mmol/L. (Guangzhou claim 1).
Regarding the conductivity limitation, the conductivity of a solution comprising 60-100mmol/L would be roughly 8 mS/cm, which is within the claimed range. (see Hervas, Figure 2 for a rough calculation of the conductivity of a sodium chloride solution)
Regarding claims 2-4, Guangzhou teaches that their preservation solution comprises Glycerin at a concentration of 2- 10mmol/L. (Guangzhou claim 1).
Regarding claims 5-7, Guangzhou teaches that their preservation solution comprises Sucrose at 5-20mmol/L. (Guangzhou claim 1).
Regarding claim 9, NaCl at a concentration of 60-100 mmol/L. (Guangzhou claim 1).
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.
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.
Guangzhou, Van Dam, and Molin
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over:
CN107271246A (Guangzhou) (Provided in IDS of 7/22/2025),
As evidenced by Hervas, F., et al. "Study of the extraction kinetic of glycosaminoglycans from raw sheepskin trimmings." Proceedings of International United of Environment Commission of IULTCS, Chengdu, China (2006): 14-16, and
Van Dam, Andries J. "DMDM-hydantoin: The promising result of a search for an alternative in fluid preservation of biological specimens." Collection Forum. Vol. 18. No. 1-2. 2003, and
Molin DGM, Dam AJV. A Preservation Method Supporting Multipurpose Analysis of Long-stored Samples. Cell Preservation Technology. 2006;4(1):46-50
Claims 1-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guangzhou
Regarding claim 8, Guangzhou teaches the use of paraformaldehyde as the formaldehyde donor compound, not DMDM hydantonin, or 1-hydroxymethyl-5,5-dimethylhydantoin.
However, Van Dam reviewed several biocides for their suitability for the preservation of biological specimens, including formalin and DMDM hydantonin. (Van Dam, Abstract). Van Dam teaches that with respect to preservation quality, DMDM-hydantoin seems to have some great advantages over formalin, and that with respect to safety, there is a very important argument to be made for the use of DMDM-hydantoin as a substitute for formalin in fluid preservation (Van Dam, pg. 111, last two paragraphs). Van Dam admits that apart from this short-term experiment, DMDM-hydantoin had never been used for the purpose of preserving biological specimens. Van Dam recognized that at that time (2003), it was impossible to determine its long-term effects on biological tissues.
Molin, three years later, published an article teaching that DMDM-Hydantoin, in contrast to all other agents tested, has a potential to preserve tissue for multipurpose sample analysis that requires high quality mRNA, enzyme activity, or protein content. (Molin, Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use DMDM-Hydantoin as a preservative for biological samples, as taught by Van Dam and Molin, as the formaldehyde donor compound in the preservative solution taught by Guangzhou, in place of their formaldehyde donor compound, paraformaldehyde. One of ordinary skill in the art would have been motivated to do so, since this combination would be combining prior art elements according to known methods to yield predictable results. (MPEP 2143 (I)(A)). Van Dam and Molin teach that DMDM-Hydantoin can be used as a part of a preservative solution for biological samples, and gives a motivation to do so by pointing out certain advantages of DMDM-hydantoin (efficacy, safety) over other known formaldehyde donor compounds (formalin).
One of ordinary skill in the art would have had a reasonable expectation of success, since Van Dam and Molin teach that DMDM-Hydantoin can be used as a part of a preservative solution for biological samples.
Regarding Claim 10, Guangzhou does not teach that their preservation solution may be used to preserve blood. However, Van Dam and Molin teach that DMDM-Hydantoin can be used as a part of a preservative solution for biological samples generally, which reasonably would include any biological sample including blood or other biological fluids.
Conclusion
Claims 1-10 are rejected.
Claims 1-2 and 5-6 are objected to.
Claims 11-15 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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/THOMAS R. AMICK/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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