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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
Response to Amendment
The amendment filed 11/20/2025 has been entered. Claims 1-23 remain pending in the application.
Response to Arguments
Applicant's arguments with respect to claims 1-23 have been considered but are not persuasive, see reasoning below.
Regarding claim 1, applicant argues that KO does not explicitly disclose “a heating element operationally coupled to said heating system which is adapted to provide heat to the applicator tip”. Examiner disagrees. While Examiner acknowledges that the RF energy taught by KO allows for the tissue to heat up, the claim language requires a heating systems, which is seen as the RF system generates heat and acts as a heating system which is disclosed in Paragraph [0004], which is operationally coupled to a heating element, which is seen as the RF transferring unit 310 shown in Figure 6, in which the RF energy is what is generating the heat which is disclosed in Paragraph [0033], therefore by is transferring energy to the applicator tip needles conductively. While examiner acknowledges the tissues resistance to the RF energy allows for the thermal energy to be created, the heating element provides the RF energy to the applicator tip which in turn allows the skin to heat up which will conductively heat up the applicator tip as well. With that being said, even if applicant does not agree with Examiner, Claim 1 is rejected in view of Ofir which clearly points towards “a heating element operationally coupled to said heating system which is adapted to provide heat to the applicator tip” such that Ofir discloses a heating element in the applicator tip shown in Figure 9d, 550, such that the heating element will provide direct heat to the applicator tip. Applicant also argues Ofir does not explicitly disclose the heating and cooling process as taught in claim 1. Applicant argues that the present invention does not have the cold base and heating element in the same component, the claim language does not specify this therefore, this argument is seen as mute and Examiner recommends amending the claims to better reflect this since examiner see collocated as arranged side by side which does not have to be separate components from each other. Such that as seen in Figure 9d, each needle contains either heating or cooling, side by side, in different areas since they are spaced apart, in which the heating and cooling can be simultaneously provided or switched on/off to operate each tip individually which is described in paragraph [0127]. Applicant also argues that the rejection of claim 1 is not obvious over KO in view of Ofir such that they would not work being put together. Examiner wants to points to the MPEP wherein the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those 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). Therefore, it does not matter that the applicator head of KO is not interchangeable with the applicator head of Ofir, the combined teachings would’ve been able to suggest to those of the ordinary art to incorporate the claim language. Therefore, Examiner stands by the rejection of claim 1 as taught above and in the Final rejection.
Regarding claims 2-23, Examiner sees claims 1 dependents as being unpatentable over KO in view of Ofir as taught by the Final action and in the reasonings above.
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 1-3, 6-7, 9-10, 13-20 & 22-23 are rejected under 35 U.S.C 103 as being unpatentable over KO et al. (US 20210251801) herein referred to as KO in view of Ofir et al. (US 20080051774) herein referred to as Ofir.
Regarding Claim 1, KO discloses a medical device (Figure 1), comprising: a cooling system (Paragraph [0010]; wherein a cooling channeling, cooling gas and cooling tank make up the cooling system); a heating system (Paragraph [0004]; wherein the RF system generates heat and acts as a heating system); and an applicator including a cold base operationally coupled to said cooling system, which is adapted for cooling a tip of the applicator (Figure 2, 202; wherein applicator head 202 comprises a tip with cooling channel 204 coupled to the cooling system which cools the applicator tip therefore acting as a cool base) and a heating element operationally coupled to said heating system (Figure 6, 310), which is adapted to provide heat to the applicator tip (Paragraph [0054]; wherein RF heating system is transferring heat energy to the applicator tip needles), and an applicator head collocated with said cold base and said heating element and adapted for applying a combination of heat and cold to a target area having a contact surface that includes areas of different shapes for cooling and heating (Figure 6; wherein heat transfer to the needles 320 which are different shape then flat applicator tip). However, KO does not explicitly disclose an applicator head adapted for applying a simultaneous combination of heat and cold to a target area so as to effect temperature gradient between cold and hot areas which further increases the efficacy as the gradient between the heat and cold is very effective in causing necrosis of tissue.
Ofir discloses a medical device (Figure 9d) comprising an applicator head adapted for applying a simultaneous combination of heat and cold to a target area so as to effect temperature gradient between cold and hot areas which further increases the efficacy as the gradient between the heat and cold is very effective in causing necrosis of tissue (Figure 9d, 510a&b; Paragraph [0127]; wherein the embodiment shown in Figure 9d allows for simultaneous heating and cooling to a target area that is meant to not reduce therefore efficacy is increased ). 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 medical device taught by KO to allow for simultaneous heating and cooling as taught by Ofir. The motivation being simple substitution of one known element, the applicator head taught by KO, for another known element, the applicator head taught by Ofir to obtain the predictable results of allowing for heating and cooling simultaneously (MPEP 2143 (B)).
Regarding claim 2, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said target area is a target tissue (Figure 6, T)
Regarding claim 3, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said cooling system is a vapor-compression refrigeration system (Paragraph [0033]; wherein a refrigerant tank (not illustrated) is provided in the main body and the refrigerant tank stores, in a pressurized gas state or liquid state, a cooling gas provided to a surface therefore is a vapor-compression refrigeration system).
Regarding claim 6, KO in view of Ofir discloses the device of claim 3. KO also discloses wherein said cold base and said heating element are in thermal contact with said applicator head (Figure 6, 205 & 310), and said cold base is in thermal contact with, and cooled by, tubing adapted to receive cold low-pressure fluid such that when said applicator head comes into contact with said target area, said target area is cryogenically cooled (Figure 6; Paragraph [0060]-[0061]; wherein cooling channel 205 is connected to tubing that is connected to the cooling gas which as taught in claim 3 can be a fluid/liquid wherein the cooling gas flows into the applicator head and is discharged through holes and cools the skin tissue); and wherein said heating element is actuated to provide location specific heat to said target area while said target area is being cooled (Paragraph [0061]; wherein cooling gas cools the skin tissue as the RF energy, which is applying heat, is being transfer through the needles).
Regarding claim 7, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein a disposable component is removably attached to said applicator head (Paragraph [0041]; wherein tip 203 is detachable from the applicator head 202), such that said disposable component is adapted to make contact with said target area (Figure 6, 203; wherein 203 is making contact with the tissue T).
Regarding claim 9, KO in view of Ofir discloses the device of claim 7. KO also discloses wherein said disposable component is populated with one or more sharp elements (Figure 6, 320), said one or more sharp elements adapted to convey heat and cold into said target area (Paragraph [0061]; wherein needles 320 are connected to the RF system therefore heating the tissue as well as the cooling gas is being directly applied to the needles therefore allowing for cold to be conveyed into the tissue area through the needle through holes).
Regarding claim 10, KO in view of Ofir discloses the device of claim 9. KO also discloses wherein said sharp elements are needles (Figure 6, 320).
Regarding claim 13, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said heating element is affixed to said applicator head via a slider arrangement (Paragraph [0056]; wherein heating element 310 is moved by output terminal 211 which moves linearly along the hole 303 therefore sliding the heating element up/down and is therefore a slider arrangement), said slider arrangement having a first position wherein said heating element is in contact with said applicator head (Figure 4) and a second position wherein said heating element is separated from said applicator head (Figure 6).
Regarding claim 14, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said heating element is disposed in a geometric shape (Figure 2; wherein heating element is not labeled but can be seen as the plate containing the needles in the cut-out portion of tip 203 and is disposed in cylinder shape therefore is considered a geometric shape).
Regarding claim 15, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said heating element includes more than one heating component (Figure 4, 310 & 320; wherein heating component 310 also comprises needles 320).
Regarding claim 16, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said applicator head is an interchangeable applicator head that is removably attached to said applicator (Paragraph [0041]; wherein tip 203 is detachable from the applicator head 202 and can be replaced after treatment).
Regarding claim 17, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said heating system and said cooling system are disposed in a main unit (Paragraph [0036]; wherein the RF generator which is a part of the heating system is in main unit 100 and refrigerant tank which is a part of the cooling system which is disposed in main unit 100) and said applicator is operationally coupled to said main unit via a connector (Figure 1, 100; wherein 100 is the main unit and is connected to the applicator through connection unit 300).
Regarding claim 18, KO in view of Ofir discloses the device of claim 1. KO also discloses wherein said heating system, said cooling system and said applicator are disposed in a single unit (Figure 1; wherein applicator 200 is a part of device 1 and cooling and heating systems are a part of main unit 100 as taught in Paragraph [0036], therefore all are disposed in device 1).
Regarding claim 19, KO in view of Ofir discloses the device of claim 9. KO also discloses wherein a plurality of said sharp elements are disposed in sufficient proximity to each other to support capillarity there-between (Figure 4, 320).
Regarding claim 20, KO in view of Ofir discloses the device of claim 1. KO also discloses further comprising a controller configured to provide instructions for controlling a temperature profile of said cooling and heating systems (Figure 3, 140; Paragraph [0050]; The control unit 140 may store information therefore instructions required for controlling the RF treatment device).
Regarding claim 22, KO in view of Ofir discloses the device of claim 1. KO also discloses further comprising a communications module adapted to connect to a network to retrieve data regarding methods for implementation of said application of said combination of heat and cold to said target area (Figure 3, 140; Paragraph [0050]; The control unit 140 may retrieve the data stored in the memory unit 130 and utilize the data for the control of the treatment device).
Regarding claim 23, KO in view of Ofir discloses the device of claim 1. KO also discloses further comprising a communications module adapted to connect to a network to update a database regarding instances of application of said combination of heat and cold to said target area (Figure 3, 260; Paragraph [0051]; wherein monitoring unit monitors condition information corresponding to the treatment occurring wherein the monitoring unit is connected to the control unit therefore connected to the memory unit allowing for data to be stored as seen in Figure 3).
Claim 4 is rejected under 35 U.S.C 103 as being unpatentable over KO and Ofir in further view of Buchbinder et. al (US 20120265188) herein referred to as Buchbinder.
Regarding claim 4, KO in view of Ofir disclose the device of claim 1, wherein said cooling system is a vapor-compression refrigeration system (Paragraph [0033]; wherein a refrigerant tank (not illustrated) is provided in the main body and the refrigerant tank stores, in a pressurized gas state or liquid state, a cooling gas provided to a surface therefore is a vapor-compression refrigeration system). However, KO in view of Ofir does not explicitly disclose wherein said cooling system is a cascade vapor-compression refrigeration system.
Buchbinder discloses a medical device (Figure 1) wherein a cooling system is a cascade
vapor- compression refrigeration system (Paragraph [0058]; wherein a common method of cooling is using a cascade compression refrigeration system and the refrigerant in use has is a vapor as discussed in Paragraph [0038] wherein the refrigerant is a liquid infused with gaseous bubbles therefore is a vapor). 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 cooling system taught by KO in view of Ofir to the cooling system taught by Buchbinder. The motivation being it’s a common method used in the art to achieve a required temperature (Buchbinder, Paragraph [0058]).
Claims 5, 8 & 21 are rejected under 35 U.S.C 103 as being unpatentable over KO and Ofir in further view of KIM (US 20190175396) herein referred to as KIM.
Regarding claim 5, KO in view of Ofir discloses the device of claim 1. However, KO in view of Ofir does not explicitly disclose wherein said cooling system includes one or more thermoelectric coolers (TEC).
KIM discloses a cooling medical device (Figure 1A) wherein said cooling system includes one or more thermoelectric coolers (Paragraph [0093]; wherein the cooling unit 113 supplies cooling energy through a thermoelectric element which is a thermoelectric cooler). 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 KO in view of Ofir to include the teachings of KIM’s cooling system. The motivation being by using a thermoelectric cooler it allows for the Peltier effect to occur to which a feedback control may be applied (KIM, Paragraph [0094]).
Regarding Claim 8, KO in view of Ofir discloses the device of claim 7. However, KO in view of Ofir does not explicitly disclose wherein alcohol is applied to a face of said disposable component that is adapted to come into contact with said target area.
KIM discloses a cooling medical device (Figure 1A) wherein alcohol is applied to a face of said disposable component that is adapted to come into contact with said target area (Figure 6B, 251; Paragraph [0234]-[0235]; wherein fluid 251 is isopropyl alcohol that comes out through a discharge portion of the face of disposable component that is adapted to come in contact with a target area therefore being applied to the face). 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 KO in view of Ofir to include alcohol being applied to the disposable component as taught by KIM. The motivation being to act as a disinfecting agent (KIM, Paragraph [0234]).
Regarding Claim 21, KO in view of Ofir discloses the device of claim 20. However, KO in view of Ofir does not explicitly disclose wherein said instructions include a number of times for applying said temperature profile.
KIM discloses a cooling medical device (Figure 1A) wherein instructions include a number of times for applying a temperature profile (Paragraph [0202]; wherein the control unit contains reuse preventing portion that provides instructions on reusing the cooling device therefore the number of times of applying the temperature profile). 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 controller taught by KO in view of Ofir to include the instructions taught by KIM. The motivation being to secure sterility and hygiene (KIM, Paragraph [0203]).
Claims 11-12 are rejected under 35 U.S.C 103 as being unpatentable over KO and Ofir in view of Berger et al. (US 9820795) herein referred to as Berger.
Regarding Claim 11, KO in view of Ofir discloses the device of claim 7. However, KO in view of Ofir does not explicitly disclose wherein thermal paste is applied between said applicator head and said disposable component.
Berger discloses a medical device (Figure 1) wherein thermal paste is applied between said applicator head and said disposable component (Figure 5; Column 11, lines 12-17; wherein applicator head employs a thermal paste to a component 133 which KO taught to be disposable).
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 KO in view of Ofir to include the thermal paste as taught by Berger. The motivation being to ensuring minimal temperature differences across adjacent components (Berger, Column 11, lines 10-12).
Regarding Claim 12, KO and Ofir in further view of Berger discloses the device of claim 11. Berger also discloses wherein said thermal paste is applied between said heating element and said disposable component (Figure 5; wherein thermal paste comes out of the tip of 132A, therefore is applied between heating element 138 and component 133 which KO taught to be disposable). 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 KO and Ofir in view of Berger to include the thermal paste as taught by Berger. The motivation being to ensuring minimal temperature differences across adjacent components (Berger, Column 11, lines 10-12).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794