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 .
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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-7 and 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2021/0290430).
Regarding claim 1, Kim discloses a cryogenic device (see Figs. 1-5 and 10), comprising: a container including a fluid suitable to be used in skin cryotherapy (see reservoir 1100 containing liquefied nitrogen or carbon dioxide; [0171]-[0173], [0322], Fig. 5); a heat exchanger connected to an outlet of the container (see cooling element 3200 connected to the valve 2100 and nozzle 4100, [0223] and [0306], Fig. 10), wherein the fluid is cooled in the heat exchanger (see [0380]); a multi-stage thermoelectric cooler connected to the heat exchanger to cool the fluid in the heat exchanger (see thermoelectric cooling element 3220 and transfer unit 1200 as multiple sections/stages, [0381]-[0382], Fig. 10); a nozzle after the heat exchanger that discharges the cooled fluid (see nozzle 4100 and control valve 2100, [0306], Fig. 10); and a computer configured to open the nozzle when a temperature is reached (see control unit 5000 controlling the valve based on a confirmed temperature reached, [0397]).
Regarding claim 2, Kim further discloses wherein the fluid is a gas selected from carbon dioxide or nitrogen (see [0173]).
Regarding claim 3, Kim further discloses a temperature sensor measuring a temperature at the heat exchanger (see [0396]).
Regarding claim 6, Kim further discloses a heat sink connected to the multi-stage thermoelectric cooler (see heat dissipater 3230, [0381]-[0383], Fig. 10).
Regarding claim 7, Kim further discloses wherein the container is a refillable cartridge (see 1100 as a cartridge considered refillable due to its open end, [0322], Fig. 5).
Regarding claim 11, Kim further discloses one or more housing parts (see parts of housing shown in Fig. 10).
Regarding claim 12, Kim further discloses one or more housing enclosing the container, the heat exchanger, the multi-stage thermoelectric cooler, the nozzle, and the computer (see housing enclosing all elements, Figs. 5 and 10).
Regarding claim 13, Kim further discloses wherein the one or more housing is a heat sink for the multi-stage thermoelectric cooler (see heat dissipater 3230, [0381]-[0383], Fig. 10).
Regarding claim 14, Kim further discloses wherein the cryogenic device is configured to be a handheld device (the device is considered as a handheld device since it is useable by hand, see Figs. 3, 5, and 10).
Regarding claim 15, Kim further discloses a method of treating a skin lesion, comprising: with the device of claim 1, applying the cryogenic fluid onto a skin lesion (see use for skin lesions, [0153], Fig. 27).
Regarding claim 16, Kim further discloses wherein the skin lesion includes hyperpigmentation (see [0153]).
Regarding claim 17, Kim further discloses dispensing the fluid, wherein the device is positioned to dispense the fluid other than downwards from the device (see dispensing of the fluid to the side of the device, Fig. 27).
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.
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.
Claims 4-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 2021/0290430).
Regarding claims 4 and 5, Kim discloses the limitations of claim 3, however Kim fails to specifically disclose wherein the computer is configured to open the nozzle when the temperature is from -40 ⁰ C to 0 ⁰ C, or -30 ⁰ C to -10 ⁰ C.
However, Kim further discloses target cooling temperatures for the target region being −40° C and −15° C (see [0526]). Therefore, it would have been obvious to one having ordinary skill in the art before the time of filing to configure the computer to open the nozzle when the temperature is from -40 ⁰ C to 0 ⁰ C, or -30 ⁰ C to -10 ⁰ C in order to provide fluid cold enough to achieve the desired target temperature for the target region in light of Kim, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Regarding claim 8, Kim discloses the limitations of claim 7, however Kim fails to specifically disclose wherein the refillable cartridge is configured to hold from 12 g to 16 g of carbon dioxide. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the cartridge of Kim to be sized to hold from 12 g to 16 g of carbon dioxide since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the cartridge of Kim would not operate differently with the claimed capacity since the cartridge would still provide a supply of carbon dioxide to the heat exchanger as intended. Further, applicant places no criticality on the range claimed (specification pp. [0020] and [0042]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 2021/0290430) in view of Berger et al. (US 2018/0071007).
Regarding claims 9 and 10, Kim discloses the limitations of claim 1, however Kim fails to specifically disclose wherein the heat exchanger includes a coil heat exchanger or a plate heat exchanger.
Berger teaches a cryogenic device (see Fig. 3) comprising a thermoelectric heat exchanger including a coil heat sink (see [0106], Fig. 6) and an impingement plate in direct contact with the thermoelectric module hot side (see [0015]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat exchanger as disclosed by Kim to further include a coil heat exchanger or a plate heat exchanger in light of Berger, the motivation being to provide increase thermal contact with the outside environment in order to increase heat dissipation efficiency (see Berger [0015] and [0105]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 2021/0290430) in view of Cluzeau et al. (US 6,141,985).
Regarding claim 18, Kim discloses the limitations of claim 15, however Kim fails to specifically teach re-filling the container with the fluid after the container is emptied.
Cluzeau teaches a cryogenic device (see Fig. 1) comprising a removable cartridge for containing the cryogenic fluid (see cartridge of carbon dioxide 2, Fig. 1) and further teaches re-filling the cartridge after is emptied by the device (see col. 5, lines 57-65). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as disclosed by Kim to further include re-filling the container with the fluid after the container is emptied in light of Cluzeau, the motivation being to provide the additional advantage of being able to reuse the cartridge, thereby reducing medical waste.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794