CTFR 18/107,930 CTFR 80323 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Amendment Rejection of Claim(s) 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Serban et al. (RO 131368) has been modified in light of applicant’s amendments. Previously examined claims 1-6 have been cancelled and new claims 7-23 have been newly added. Claim Rejections - 35 USC § 112 07-30-02 AIA 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 7-23 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. Applicants recite “ in controlled manner ”, applicants fail to specify how it is being controlled and what defines it being in a “controlled manner”. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 7-23 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by RO (131368) . Regarding claim 7, placing a biological sample in an isochoric system; reducing the temperature of the isochoric system in controlled manner comprising (i) cooling the biological sample until a first temperature is reached; (ii) maintaining the biological sample at the first temperature for a certain period of time so that thermodynamic equilibrium for pressure is achieved at the first temperature; (iii) repeating steps (i) and (ii) at an X number of temperatures until a subfreezing temperature for the biological sample is achieved, wherein X is an integer of 2 or greater. (Refer to page 4) Ro discloses “Figure 5 illustrates how to operate an isochloric preservation process. In the first phase, the biological material is placed inside the isochloric chamber a nucleation site is then initiated. As the container is cooled, as the temperature decreases, the occurrence of ice increases the pressure in the isochloric chamber. The percentage of ice formed at about -22 C (Fig, 4) requires that the biological material subjected to cooling occupy only% of the volume of the isochloric chamber. Under these conditions, the biological material remains frozen, being in thermodynamic equilibrium with ice at temperatures around -22 C. This temperature is low enough to prevent the development of microorganisms during long-term storage. The additional advantage of the procedure is that the biological material subject to storage is found in the frozen state.” Ro further discloses “in a first step, the biological material is introduced into an isochoric chamber (1) at the ambient pressure, at higher temperature, close to freezing, said chamber being filled with an aqueous solution, while minimizing the gaseous phase between the aqueous solution and a cover (2) of the chamber (1), then the chamber is externally cooled, step during which the initiation of the crystallization and accumulation of ice inside the chamber (1) take place with the increase of the pressure and stabilization of the thermodynamic balance of phases between the ice and the aqueous solution inside the chamber (1), when the temperature decreases under the freezing point corresponding to the atmospheric pressure for the aqueous solution, after which, at a certain temperature between the freezing point at the atmospheric pressure and the temperature of the triple point between ice I, ice III and the aqueous solution within the phase diaphragm for the aqueous solution, a valve (3) is opened and puts in connection the content of chamber (1) with the ambient pressure, which creates, upon the drop of the chamber pressure, the conditions to reestablish the thermodynamical balance by the crystallization of small ice particles dispersed in the biological product, and finally, the frozen biological material having a fine structure of ice crystals in the intra and extracellular space of the treated volume is brought back to the atmospheric pressure, to the initial temperature close to the freezing point in atmospheric pressure conditions. The claimed device comprises an isochoric chamber (1), a cover (2) provided with a valve (3) which allows the pressure within the vessel to be equalized with the ambient pressure, the chamber (1) is introduced into an outer double-walled vessel (5) provided with a stirrer (9) with blades (10).” (Refer to Figures 5 and 6 and pages 1 and 7) Regarding claim 8, X is an integer of 4 to 1000. (Refer to Figures 4a, 5 and 6) Regarding claim 9, X is an integer of 6 to 1000. (Refer to Figures 4a, 5 and 6) Regarding claim 10, the biological sample is maintained at the temperature for a time period selected from about 10 seconds to about 1 hour. (Refer to Figure 1) Regarding claim 11, the biological sample is maintained at the temperature for about 30 seconds to 30 minutes. (Refer to Figure 1) Regarding claim 12, the subfreezing temperature of the biological sample is -20 °C or lower. (Refer to pages 1 and 7) Regarding claim 13, the subfreezing temperature of the biological sample is -80 °C or lower. (Refer to Figures 4a and 4b) Regarding claim 14, the subfreezing temperature of the biological sample is -135 °C or lower. (Refer to Figures 4a and 4b) Regarding claim 15, the subfreezing temperature of the biological sample is from -135 °C to -210 °C. (Refer to Figures 4a and 4b) Regarding claim 16, the cooling of (i) is a change of about 1 °C to about 10 °C from a prior temperature. (Refer to Figures 4a and 4b) Regarding claim 17, the biological sample is one or more biomolecules, one or more cell components, one or more cells, one or more viruses, one or more embryos, one or more tissues, one or more organs or a whole organism. (Refer to page 1, abstract) Regarding claim 18, the one or more biomolecules is selected from amino acids, oligopeptides, polypeptides, proteins, nucleobases, nucleotides, nucleosides, oligonucleotides, polynucleotides, nucleic acids, monosaccharides, oligosaccharides, polysaccharides, carbohydrates, fatty acids, waxes, sterols, monoglycerides, diglycerides, triglycerides, phospholipids, metabolites, vitamins, hormones, steroids, or any combination of the foregoing, wherein the one of more biomolecules can be naturally occurring biomolecules, made synthetically, or a combination thereof. (Refer to page 1, abstract) Regarding claim 20, the one or more cells are male or female reproductive cells. (Refer to page 1, abstract) Regarding claim 21, the whole organism is a prokaryotic organism. (Refer to page 1, abstract) Regarding claim 22, the whole organism is a eukaryotic organism. (Refer to page 1, abstract) Regarding claim 23, the biological sample further comprises one or more cryoprotectants. (Refer to page 7) Response to Arguments 07-37 AIA Applicant's arguments filed 3/27/2026 have been fully considered but they are not persuasive. Applicants argue that the process of Ro does not disclose “reducing the temperature of the isochoric system in a controlled manner ”. As discussed in the rejections above, applicants fail to specify how it is being controlled and what defines it being in a “controlled manner” and therefore Ro does teach reducing the temperature in a controlled manner by pulsatile freezing . Conclusion 07-39 AIA THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI NAGPAUL whose telephone number is (571)272-1273. The examiner can normally be reached M-F 9am to 5pm, EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JYOTI Mutreja/Primary Examiner, Art Unit 1798 Application/Control Number: 18/107,930 Page 2 Art Unit: 1798 Application/Control Number: 18/107,930 Page 3 Art Unit: 1798 Application/Control Number: 18/107,930 Page 4 Art Unit: 1798 Application/Control Number: 18/107,930 Page 5 Art Unit: 1798 Application/Control Number: 18/107,930 Page 6 Art Unit: 1798 Application/Control Number: 18/107,930 Page 7 Art Unit: 1798 Application/Control Number: 18/107,930 Page 8 Art Unit: 1798
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