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 claims
Claims 1, 4-6, 8-10 and 12 as amended on 10/07/2025 are currently pending.
Claims 1, 4-6, 9, 10, and 12 as amended on 10/07/2025 are under examination in the instant office action.
Claim 8 was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention by original presentation for prosecution on the merits (see office action mailed 10/04/2024; Group II, amended claim 8, drawn to a device for transport and preservation of a biological sample). See 37 CFR 1.142(b) and MPEP § 821.03.
In response to the office action, please, cancel non-elected, withdrawn and non-examined claim 8.
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.
Claims 1, 4-6, 9, 10 and 12 as amended are/remain rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0270293 (Chu), US 2008/0145919 (Franklin et al), US 5,066,578 (Wikmann-Coffekt), WO 2005/013799 (Bertuglia) and Yamashita et al (“Enhanced mass transfer in peritoneal dialysis with application of ultrasound”. Shonan Koka Daigaku Kiyo (2000), 34(1), 123-128; abstract accession number: 2001:624368 CAPLUS).
The cited document US 2012/0270293 (Chu) discloses a method for preservation of a biological sample, wherein the method comprises steps: (b) submerging and keeping a tissue specimen in a preservation or fixative solution under low temperature; and c) step of irradiating the tissue specimen with ultrasound under low temperature (par. 0016, lines 6-8; figure 1); wherein the low temperature for steps of submerging and irradiating with ultrasound is between 0°C and 15°C (par. 0060; par. 055) or 4°C - 10°C (figure 1), thus, overlapping the claimed temperature ranges. The specimen tissues include kidney, liver, pancreas (0075). Further, in the cited method there is no external oxygen supply as disclosed by the cited document.
Although the cited document US 2012/0270293 (Chu) does not explicitly describe protocol of blood removal (clamed step a), the harvest of tissue clearly results in removal of at least some blood. Thus, the step (a) of removing blood is inherently present in the cited method of US 2012/0270293 (Chu) within the broadest meaning of the claims. Moreover, this practice is routine and conventional for organ preservation before hypothermal storage and/or transport as intended for subsequent transplantation which is evidenced by US 5,066,578 (Wikmann-Coffekt); for example: see col. 2, lines 25-30; col. 3, lines 11-14). Thus, the practice of removing blood prior to preservation would be considered as obvious practice by one of skill in the art.
Therefore, the active steps as disclosed by the cited document of US 2012/0270293 (Chu) and as presently claimed are substantially the same.
With regard to limitation drawn to a design of a container system for preservation of biological sample, the cited document US 2012/0270293 (Chu) discloses that the biological sample is immersed into a preservation solution in an auxiliary container (see figure 1 “specimen container”) inside another container or a chamber equipped with a cooling system and an ultrasound systems. The bottom of the outer chamber is a tray support; and it is flat (see figure 1), thus, “sheet-like” within the broadest meaning of the claims. The chamber or a tray contains a fluid that is an “ultrasound medium” (figure 1). The chamber or a tray is expected to vibrate or to “freely” vibrate when ultrasound is applied as it is encompassed by the claims. Besides, the cited document US 2008/0145919 (Franklin et al) teaches agitating (and, thus, “vibrating”) the immersed organ intended for preservation by using ultrasonic means (par. 0031). Thus, the practice of agitating or “vibrating” the organ submerged into preservation solution though application of ultrasound means or ultrasound irradiation would be considered as obvious practice by one of skill in the art.
With regard to limitation drawn to ultrasound frequency the cited method of US 2012/0270293 (Chu) for preservation of a biological sample comprises application of ultrasound with high frequency range of 100 kHz to 5Mhz for organ preservation (0057) including organs such as kidney, liver, pancreas (0075). The ultrasound frequency range in the cited method of US 2012/0270293 (Chu) is outside of the presently claimed range 25-80 kHz.
However, the prior art teaches the use of low frequency ultrasound 28 kHz and 45 kHz over 100 kHz for enhancement of biological functions of a biological tissue immersed into physiologically acceptable solution. For example: see abstract of Yamashita. Thus, the prior art suggests the use of a low frequency ultrasound and below 100 kHz, which is applied in the cited method of US 2012/0270293 (Chu), for enhancement of biological functions of a biological tissue.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to apply low frequency ultrasound in the method for organ tissue of the cited method of US 2012/0270293 (Chu) as clearly taught/suggested by Yamashita with a reasonable expectation of success in enhancing biological functions of a biological tissue immersed into physiologically acceptable preservation solution.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further, as applied to claim 4: in the cited method of US 2012/0270293 (Chu) the ultrasound has intensity 0.1 to 100 watts respectively (par. 0057), thus, overlapping the claimed range. The average intensity level of ultrasound devices in medical field is 0.01-1 watts/cm2; for example: see WO 2005/013799 at page 6, lines 9-14.
As applied to claims 5-6 and 12: in the cited method of US 2012/0270293 (Chu) cold temperature ranges are between 0°C and 15°C (par. 0060) or 4°C - 10°C (figure 1), thus, overlapping the claimed temperature ranges.
As applied to claim 9: the auxiliary container as shown on figure 1 US 2012/0270293 (Chu) is closed or “closable” within the broadest meaning of the claims.
As applied to claim 10: in the cited method of US 2012/0270293 (Chu) the ultrasound is applied in a pulse manner (figures 7-8; claim 22).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments and contents of Declaration by Carmen Peralta filed on 10/07/2025 have been fully considered but they are not persuasive.
With regard to the claim rejection under 35 USC § 103 as being unpatentable over US 2012/0270293 (Chu), US 2008/0145919 (Franklin et al), US 5,066,578 (Wikmann-Coffekt), WO 2005/013799 (Bertuglia) and Yamashita et al (“Enhanced mass transfer in peritoneal dialysis with application of ultrasound”. Shonan Koka Daigaku Kiyo (2000), 34(1), 123-128; abstract accession number: 2001:624368 CAPLUS) Applicant argues the method for tissue preservation of Chu comprises the use of a fixative solution but not a preservation solution and that application of a fixative solution will not provide for an organ or tissue suitable for subsequent transplantation (see Declaration items 7-9; see response page 6, par. 2).
This argument is not found persuasive because claim-recited “preservation” solution is a generic solution and the solution contents as intended (see par. 0068 of published application) are not recited in the claims to delineate the intended differences, if any. The cited Chu acknowledges or recognizes fixative reagents as tissue “preservation reagents” in the solution (par. 0053). Moreover, fixative solutions with glutaraldehyde, for example, are commonly used to reduce immunogenicity of tissues before transplantation.
With regard to the cited US 2008/0145919 (Franklin et al) Applicant argues that Franklin employs ultrasound as vibration means in a chamber for tissue preservation which is different from the use of ultrasound in the claimed method. This argument is not found particular persuasive with regard to the claimed method which recites to vibration (or agitation) as result of ultrasound application.
With regard to the cited Yamashita Applicant argue that low US frequencies used by Yamashita are intended for a different application or a dialysis. Nevertheless, the cited reference clearly teaches and/or suggests that the low US frequencies in the range as recited in the pending claims allow for enhanced penetration of beneficial agent.
Some of the Applicant’s argument are directed to unexpected effects of the Applicants method for preservation of organs as based on synergistic combination of US frequencies with cold temperature.
However, the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim. It is well recognized that synergism is a highly unpredictable result that is very dependent on the specific materials used and specific treatment for each material. Thus, any combination for which synergism is not clearly established would be properly rejected because non-obviousness would not have been established.
No claims are allowed in the instant office action.
Conclusion
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.
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Vera Afremova
January 28, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653