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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/07/2025 has been entered.
Claims 1 and 3 have been amended. Claim 16 has been newly added and no claims have been newly canceled.
Claims 1-5 and 7-16 are currently pending.
Claims 9-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2025.
Claims 1-5, 7-8, and 16 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Claims referring to “measured at 25˚C under atmospheric pressure” are interpreted to mean that the measurements are taken at ambient room temperature and ambient room atmospheric pressure. Any prior art teaching that does not indicate otherwise is interpreted as occurring at room temperature and room pressure.
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.
Claim(s) 1-5, 7-8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Qu et al (CN 109221086-A machine translation-from IDS filed 11/10/2023) in view of Katsuya (WO 2012/124206 A1-machine translation), Kamei, Ichiro (US 2017/0056438-from IDS filed 04/04/2022) and Takashi et al (JP 2002253270-machine translation, newly cited).
Regarding claims 1-2 and 7-8, Qu teach a composition used for cryoprotection of blood cells (animal cells) which includes a cryopreservation solution including polysaccharides (antifreezing agent), DMSO (antifreezing agent), DMEM, FBS (medium) and is combined with hydrogen (page 6 para 50-53, page 9 para 79, para 82, page 14 para 119-120, pages 16-17, claims 8, 9 and 10). Hydrogen is taught to have anti-oxidation, anti-inflammatory, anti-apoptosis and signal regulation properties (page 1 para 4).
While Qu do not specifically state that the hydrogen is dissolved, such as in hydrogen water, in their compositions, however the selection of hydrogen water with dissolved hydrogen would have been an obvious choice for the Qu compositions due to the motivation provided by the teaching of Katsuya. Katsuya teach that hydrogen-rich water has an anti-oxidant effect and protects cells (page 2). One of ordinary skill in the art would have had a reasonable expectation of success because Katsuya state that animal experiments and human experiments have demonstrated that hydrogen-rich water has anti-allergic, anti-inflammatory and anti-oxidant effects and are effective in various diseases (page 2).
Regarding claims 1, 3-5, Qu is silent with regard to the concentration of hydrogen, the redox potential of the composition and the pH of the composition.
Katsuya teaches a method of producing regenerated water (hydrogen-rich water) (abstract). Katsuya teaches that hydrogen-rich water has antioxidant effects and protects cells (page 2 of machine translation). Katsuya teaches that the pH of their solution is preferably 7 to 12 (which overlaps with the claimed range and thus renders it obvious), the redox potential is preferably -300 mV to -10 mV (which overlaps with the claimed range and thus renders it obvious) and the amount of dissolved hydrogen is preferably 0.1 to 1.2 ppm (which overlaps with the claimed range, thus rendering the claimed range obvious and qualifies as hydrogen rich water) (page 6 of machine translation).
One of ordinary skill in the art would have been motivated to include the claimed values for pH, redox potential and hydrogen concentration in the hydrogen-rich composition of Qu because Katsuya teach and suggest that these values are suitable and beneficial for a composition that is hydrogen-rich and intended for the protection of cells. One of ordinary skill in the art would have had a reasonable expectation of success because Katsuya state that animal experiments and human experiments have demonstrated that hydrogen-rich water has anti-allergic, anti-inflammatory and anti-oxidant effects and are effective in various diseases (page 2) and Qu is specifically using compositions enriched with hydrogen.
Regarding claims 1, 3 and 16, the combined teachings of Qu and Katsuya render obvious the claimed composition as described above, however they are silent with regard to the concentration of dissolved oxygen in the hydrogen-rich composition.
Kamei teaches a composition containing hydrogen and oxygen for use in a cell preservation or cryopreservation composition (abstract, page 1 para 9 and para 15, para 21). The concentration of hydrogen is disclosed as 0.1 to 3.0 ppm (which falls within the claimed range) and the concentration of oxygen is disclosed as 5 to 20 ppm (which overlaps with the claimed range of claim 1 and thus renders it obvious) (page 2 para 51).
One of ordinary skill in the art would have been motivated to optimize the oxygen concentration in the Qu hydrogen-rich composition to about 5 ppm because Kamei teach and suggest that this is a suitable oxygen concentration for a cell preservation composition containing hydrogen. The value of 3 ppm is only slightly lower than 5 ppm and thus obtainable through routine optimization and experimentation. One of ordinary skill in the art would have had a reasonable expectation of success because both Qu and Kamei are drawn to hydrogen rich compositions for cell preservation and Takashi teach and suggest that dissolved oxygen concentrations of 2 ppm are suitable and beneficial for cells in culture and cryopreservation (page 16, lines 4-10).
With regard to the concentrations of dissolved oxygen in the composition, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific oxygen concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viability of the cells being frozen would have been affected by these concentrations.
Therefore, the combined teachings of Qu et al, Katsuya, Kamei and Takashi et al render obvious Applicant's invention as claimed.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive. Applicant’s arguments have been addressed in so far as they relate to the rejections above.
Applicant argues that the Examiner’s reliance on Kamei’s disclosure is misinterpreted. Applicant asserts that Kamei fails to disclose the claimed concentration of dissolved oxygen for cryopreservation. Applicant asserts that Kamei discloses two different oxygen concentrations and that the higher oxygen concentration of 10-12.5 ppm disclosed at paragraph 50 and claim 1 is the only oxygen concentration intended for cryopreservation in the method of Kamei. Applicant asserts that an optional dissolved oxygen concentration of 5-20 ppm is disclosed at paragraph 51 and this concentration range is not linked to cryopreservation. Applicant asserts that the Examiner’s is in error stating that Kamei discloses a dissolved oxygen concentration of 5-20 ppm for cryopreservation.
This is not found persuasive. Kamei’s teaching at paragraph 51 indicates that a suitable concentration for dissolved oxygen in their invention of a hydrogen containing composition is 5 to 20 ppm. Paragraph 51 of Kamei is expanding on the teaching of paragraph 50 and is clearly intended to be relevant to those intended uses cited for their invention in paragraph 50.
Applicant argues that the combination of Kamei with Qu and Katsuya is technically unfeasible and constitutes impermissible picking and choosing. Applicant asserts that it would be technically difficult, if not impossible, to apply Kamei’s oxygen concentration while simultaneously maintaining the dissolved hydrogen concentration taught by Qu and Katsuya.
This is not found persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the current instance, Qu and Katsuya are silent with regard to the concentration of dissolved oxygen in a hydrogen-rich composition for use with cells. The person of ordinary skill in the art would be motivated to use a concentration for dissolved oxygen found elsewhere in the art of hydrogen-rich composition for use with cells as explained above.
Applicant argues that the present invention achieves unexpected results by evaluating the proliferative capacity of cells immediately after thawing, and that this is a more direct and accurate measure of cryopreservation efficiency than the method disclosed in Kamei. Applicant asserts that the evaluation criteria used in Kamei’s example 15 masks the initial damage to the entire cell population. Applicant argues that the present invention has a superior method of evaluating MTT activity of cell populations immediately after thawing. Applicant asserts that the enhancement of the proliferative capacity of the primary cell population immediately following cryopreservation is unexpected. Applicant asserts that the 132 Declaration previously submitted 07/10/2025 provides evidence of unexpected results.
This is not found persuasive. The claimed invention is drawn to a composition and thus the manner in which the composition is evaluated does not need to be special or superior in order to prove unexpected results.
In submitting evidence asserted to establish unobvious results, there is a burden on an applicant to indicate how the examples asserted to represent the claimed invention are considered to relate to the examples intended to represent the prior art and, particularly, to indicate how those latter examples do represent the closest prior art. See In re Borkowski, 595 F.2d 713, 184 USPQ 29 (CCPA 1974); In re Goodman, 339 F.2d 228, 144 USPQ 30 (CCPA 1964).
The evidence relied upon should also be reasonably commensurate in scope with the subject matter claimed and illustrate the claimed subject matter "as a class" relative to the prior art subject matter "as a class." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971 ); In re Hostettler, 429 F.2d 464, 166 USPQ 558 (CCPA 1970). See, also, In re Lindner, 457 F.2d 506, 173 USPQ 356 (CCPA 1972).
It should also be established that the differences in the results are in factunexpected and unobvious and of both statistical and practical significance. In reMerck, 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986); In re Longi, 759 F. 2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Klosak, 455 F2d 1077, 173 UAPQ 14 (CCPA 1972); In re D'Ancicco, 429 F.2d 1244, 169 USPQ 303 (CCPA 1971). Ex parte Gelles, 22 USPQ2d 1318 (BPAI 1992).
Hydrogen-rich water is expected to have low concentrations of dissolved oxygen and increased benefits over compositions not containing hydrogen-rich water. Applicant’s disclosure in their Specification also suggests that the concentration of dissolved oxygen may vary and do not suggest that there is anything unusual or unexpected about the concentration values lower than 10 ppm (see page 9 paragraphs 35-36, page 23 para 78, page 24 para 80).
Applicant argues that Kamei teaches away from the claimed invention.
This is not found persuasive. The fact that Kamei teaches some concentrations are preferred for their invention does not negate the fact that they also include a broader concentration range that is suitable for their invention and other similar hydrogen-rich compositions.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCРА 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ostojic, Sergei, “Serum Alkalinization and Hydrogen-Rich Water in Healthy Men”, https://www.mayoclinicproceedings.org/article/S0025-6196(12)00297-2/pdf , 2012, pp. 501-502.
Hidekazu et al., “Production of Physiological Active peptide and Productive Cell Therefor”, JP H0819397 A, machine translation, 1996, pp. 1-15.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631