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 Amendment
The amendment filed 10/29/2025 has been entered. Claims 1-11,13 & 15-17 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed X.
Response to Arguments
Applicant's arguments with respect to claims 1-11, 13 & 15-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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.
Claim 1-7, 11, 13 & 15-16 are rejected under 35 U.S.C 103 as being unpatentable over BESIRLI et al. (US 20160279350) herein referred to as Besirli in view of Eggers et al. (US 20070135880) herein referred to as Eggers.
Regarding Claim 1, Besirli discloses a thermoelectric cooling device for reducing temperature of a target tissue in a subject (Figure 1), the device comprising: a thermoelectric modulator (Figure 2, 34); a heat exchange system functionally coupled to the thermoelectric modulator (Figure 2, 36); and at least one thermally conductive probe functionally coupled to the thermoelectric modulator (Figure 2, 42); wherein activation of the thermoelectric modulator transfers heat from a target tissue to the heat exchange system (Paragraph [0045]; wherein the heat sink works with the Peltier modules to facilitate heat transfer), thereby reducing the temperature of the target tissue (Paragraph [0010]). However, Besirli does not explicitly disclose wherein an implantable thermoelectric cooling device wherein the heat exchange module comprises a magnetic or non-magnetic motor and wherein the device is fully implantable in the subject.
Eggers discloses an implantable thermoelectric cooling device (Figure 36) wherein the heat exchange module comprises a magnetic or non-magnetic motor (Figure 50; wherein assembly 710 includes an electric motor 712, the output shaft of which drives a magnet) and wherein the device is fully implantable in the subject (Paragraph [0125]; wherein the implant is implanted into the epidermis). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modified the thermoelectric device taught by Besirli to be fully implantable and include a magnetic motor. The motivation being to improved conduction heat transfer (Eggers, Paragraph [0044].
Regarding claim 2, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the thermoelectric modulator comprises a Peltier module (Paragraph [0043]; wherein one or more Peltier unit modules are disposed along, such as in an array, at least a portion of cooling power concentrator to provide thermoelectric cooling).
Regarding claim 3, Besirli in view of Eggers discloses the device according to claim 2. Besirli also discloses wherein the Peltier module comprises a Peltier cell coupled to the at least one thermally conductive probe (Figure 2, 34).
Regarding claim 4, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the thermoelectric modulator comprises a plurality of Peltier modules (Figure 2, 34), wherein each Peltier module comprises a Peltier cell coupled to the at least one thermally conductive probe (Figure 2).
Regarding claim 5, Besirli in view of Eggers discloses the device according to claim 2. Besirli also discloses wherein the Peltier module comprises a thermally conductive base plate positioned between the Peltier cell and the at least one thermally conductive probe (Figure 2, 32)
Regarding claim 6, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein activating the thermoelectric modulator comprises applying electrical power to the thermoelectric modulator to cause heat to be transferred from the target tissue to the heat exchange system (Paragraph [0043]; wherein the plurality of Peltier unit modules are operably coupled to power source and controller in such a way as to permit electrically parallel operation; Paragraph [0045]; wherein the heat sink works with the Peltier modules to facilitate heat transfer)
Regarding claim 7, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the heat exchange system comprises a fan to facilitate the transfer of heat from the target tissue (Figure 1, 52)
Regarding claim 11, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the thermoelectric modulator comprises a power source (Figure 1, 28)
Regarding claim 13, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the at least one thermally conductive probe is in direct contact with the target tissue (Paragraph [0042]; wherein the cold tip of the one thermally conductive probe defines the contact cooling region of cryoanesthesia device and provides a sterile surface for tissue contact)
Regarding claim 15, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the device further comprises a target tissue temperature monitoring device configured to be in direct contact with the target tissue (Paragraph [0039]; can comprise a temperature sensor operably coupled with at least one member of a thermal circuit comprising cold tip)
Regarding claim 16, Besirli in view of Eggers discloses the device according to claim 1. Besirli also discloses wherein the device further comprises a control system, wherein the control system is configured to modulate the temperature of the target tissue by adjusting or more device parameters to increase or decrease heat transfer from the target tissue (Paragraph [0039]; controller receives the temperature signal and is operable to control an operating temperature of Peltier unit modules via controlled current flow, controlled voltage, and/or pulse width modulation (PWM) of the DC battery source, thereby precisely regulating an operating temperature of cryoanesthesia device and controller can then compute temperature and/or heat flux)
Claims 8-10 & 17 is rejected under 35 U.S.C 103 as being unpatentable over Besirli and Eggers in view of Yee et al. (US 11076879) herein referred to as Yee.
Regarding Claim 8, Besirli in view of Eggers discloses the device according to claim 1. However, Besirli in view of Eggers does not explicitly disclose wherein the heat exchange system comprises a fluid block to facilitate the transfer of heat from the target tissue.
Yee discloses a thermoelectric cooling device (Figure 1) wherein the heat exchange system comprises a fluid block to facilitate the transfer of heat from the target tissue (Column 10, lines 56-60). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermoelectric cooling device taught by Besirli in view of Eggers to use a heat exchange system comprising a fluid block as taught by Yee. The motivation being it would be obvious to try different methods of heat exchange within the device to see which allowed for the best transfer of heat from target tissue (MPEP 2143 (E)).
Regarding Claim 9, Besirli and Eggers in view of Yee discloses the device according to claim 8. Yee also discloses wherein the fluid block comprises a piping system and a fluid (Column 10 lines 28-38), wherein the piping system is coupled to the thermoelectric modulator and wherein the fluid flows through the piping system, thereby facilitating the transfer of heat from the target tissue (Column 10 lines 28-38). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Besirli and Eggers in view of Yee to include the piping system as taught by Yee. The motivation being it would be obvious to try different methods of heat exchange within the device to see which allowed for the best transfer of heat from target tissue (MPEP 2143 (E)).
Regarding Claim 10, Besirli and Eggers in view of Yee discloses the device according to claim 8. Yee also discloses wherein the fluid comprises a biocompatible coolant (Column 10 lines 28-38; wherein water is biocompatible). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid as taught by Besirli in view of Yee to allow for a biocompatible fluid as taught by Yee. The motivation being it would be obvious to try different fluids within the device to see which allowed for the best transfer of heat from target tissue (MPEP 2143 (E)).
Regarding Claim 17, Besirli in view of Eggers discloses the device according to claim 1. However, Besirli in view of Eggers does not explicitly disclose wherein the temperature of the target tissue is reduced to about 20°C to about 35°C.
Yee discloses a thermoelectric cooling device (Figure 1) wherein the temperature of the target tissue is reduced to about 20°C to about 35°C (Column 6 lines 55-57). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Besirli and Eggers to allow for target tissue to be reduced to 20°C as taught by Yee. The motivation being to provide therapeutic effects and/or cosmetic procedures for cosmetically beneficial effects (Yee column 6, lines 40-42).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794