DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/18/2025 has been entered.
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 .
Claim Status
Applicant’s amendments in the response filed on 8/14/2025 has been considered by the Examiner. Currently, claims 1-3, 6, 9, 11, 12, 15, 20, 21, 23, 29 31, 34, 36, and 54 are pending, claims 1, 6, 11, 15, and 20 have been amended, claims 4-5, 7-8, 10, 13-14, 16-19, 22, 24-28, 30, 32-33, 35, and 37-53 are canceled, and claim 54 is newly added. Applicant’s amendment to claim 6 has obviated the previously filed rejection of the claim under 35 U.S.C 112(b). A complete action on the merits of claims 1-3, 6, 9, 11, 12, 15, 20, 21, 23, 29 31, 34, 36, and 54 follows below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/18/2025 has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 3 recites the term “fixing means.” When referring to the specification “fixing means” is seen as a hook configured to receive a groove, or pins configured to receive holes, or clips.
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, 12, 20, 21, 23, 29, 31, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eberlein (2014/0219701) in view of Anderson (2015/0223975).
Regarding claim 1, Eberlein teaches a cooling device for cooling a subject’s tissue or organ surface ([0016] the application face of the applicator may transfer heat to or from the user's skin, thereby causing the user to feel a thermal sensation (warm or cool depending on the thermal energy in the applicator), the device comprising:
a handle (108);
a head comprising a housing (104) and
an electrical cooling element for cooling the subject’s tissue or organ surface disposed inside the housing (106 Peltier thermoelectric device), wherein at least a portion of the head is fabricated from a highly thermally conductive material to maximize thermal energy transfer from the cooling element to the subject’s tissue or organ surface which it is applied ([0018] applicator 102 can be made of stainless steel); and
a controller configured to
control the cooling element to generate a cooling temperature ([0019] electricity provided to the temperature modulating element (106) can be controlled, for example, via an electronic circuit [0022] temperature setting adjustment 132 [0023] device can apply cold).
Eberlein is silent about specifically teaching wherein the cooling element is configured to cool the subject’s tissue or organ surface, when activated, to a target temperature of below 0°C.
However, Anderson teaches a device within the same field on invention ([0008] cosmetic method and apparatus …[0009] for controlled cooling or freezing of skin tissue [0017]; a Peltier device [0017]) wherein the device is capable of applying temperatures below freezing ([0056]-[0062] -9°C for a contact time of 30 seconds).
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 controller and allow the device to cool to a temperature below 0°C since Anderson teaches moderate degrees of cooling or freezing can produce particular effects, such as affecting the expression of skin pigmentation [0003][0004][0007].
Regarding claim 12, Eberlein teaches the limitations of claim 1as previously rejected above. Eberlein does not teach a temperature sensor. However, Anderson teaches a temperature sensor for measuring the temperature of the subject’s tissue or organ surface ([0018] One or more temperature and/or optical sensors…can be provided to…detect the local temperature of contacted/cooled tissue).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a temperature sensor to detect the temperature of the point of contact and prevent undesired or excessive cooling.
Regarding claim 20, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Anderson teaches wherein the cooling element is configured to cool a subject’s tissue or organ surface , when activated to a target temperature of one of between -15°C and 0°C and between -10°C and -5°C ([0056]-[0062]).
Regarding claim 21, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein teaches wherein the cooling element comprises a thermoelectric device using the Peltier effect (106 Peltier thermoelectric device).
Regarding claim 23, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein teaches wherein at least one a of a lower surface of the head which is at least one of concave, convex, and a combination of concave and convex ([0018] the applicator 102 is of a generally convex, disk-shaped).
Regarding claim 29, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein teaches wherein the head comprises one of a disposable head and a removable sterile cover ([0020] the device 100 also includes a cap 112 that encapsulates the applicator 102 when the device is not in use).
Regarding claim 31, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein does not teach and wherein the control is configured to perform at least one of: turning off the cooling element when the target temperature is reached. However, Anderson teaches this limitation ([00117] the control arrangement 150 can transmit a signal or provide a mechanical configuration to turn the cooling arrangement 120 on or off, vary the rate of supplied cooling, etc. based on such signals). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller so it can shut off the device to prevent overcooling.
Regarding claim 36, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein wherein the handle comprises at least one of a power source (electrical source 110).
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 2, 3, 9, 11, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eberlein (2014/0219701) in view of Anderson (2015/0223975) and Caruso (WO2011/159317 A1).
Regarding claim 2, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected. Eberlein does not teach an interface for coupling the head to the handle. However, Caruso teaches a device within the same field of invention ([0031]) and teaches an interface for coupling the head to the handle (a stimulus head connector 101 which couples a head 100 to the distal end of the body 302).
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 head and the handle interface in Eberlein such that the head is separable since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179 (MPEP 2144.04 (V-C)).
Regarding claim 3, Eberlein in view of Anderson and Caruso teaches the limitations of claim 2. Eberlein does not teach a fixing means for removably attaching the head to the handle; the fixing means comprising a locking mechanism for fixing the angle of the head with respect to the handle such that applying pressure to the handle applies pressure to the head. However, Caruso teaches [0083] In an alternate embodiment, the neck of the handle 300 comprises a lockable hinge, allowing an adjustable alteration to the orientation of the vibration heads coupled to the device 1).
Regarding claim 9, Eberlein in view of Anderson teaches the limitations of claim 1. While Eberlein teaches a portion of the head to be rotatable with respect to the handle such that the head can contact the subject’s tissue or organ surface while the handle is held away from the subject’s tissue or organ surface ([0020] the applicator 102 may be articulatable (e.g. pivotable, rotatable, etc.) relative to the handle through an angle θ), it does not teach the head to be rotatable. However, Caruso teaches the limitation (see claim rejection 3). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a rotatable head since it has been held that the provision of adjustability, where needed, involves routine skill in the art . In re Stevens, 101 USPQ 284 (CCPA 1954) (MPEP 2144 (VD)
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 head in Eberlein to provide a locking mechanism for fixing the angle of the head since Caruso teaches it provides for adjustable alternation to the orientation of the head.
Regarding claim 11, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein is silent about specifically teaching wherein the controller is configured to determine a cooling time based on the initial temperature of the subject’s tissue or organ surface, the target temperature, and the cooling temperature.
However, Anderson teaches wherein the controller treatment time can optionally be determined relative to the initiation of freezing, e.g., as a duration of contact time between the cold object and the skin surface after local tissue freezing has begun. Temperature can be measured using contact sensors, non-contacting sensors, or both…A feedback signal can be generated and transmitted to the cooling device or the control arrangement, if present, such that undesired or excessive cooling or freezing can be avoided.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed limitation to provide to determine cooling time based on other parameters for the purposes oof facilitating a safe and effective treatment procedure for which no danger or risk results for the person undergoing the treatment [0018].
Regarding claim 15, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein in the embodiment in Fig. 3 generally provides for an annular head defining an aperture [0028] but does not teach through which a medical instrument can be passed.
However, Caruso teaches the limitation (Fig. 5B is u-shaped and annular as broadly as claimed. [0080] The heads will come in a variety of shapes and sizes to suit the gamut of surfaces of the human body. This will allow the device to be utilized wherever an injection or minor surgical procedure is to occur).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the shape of the head in the cooling device of Eberlein such that it is an annular head defining an aperture to allow for a medical instrument to pass since Eberlein teaches the applicator may be constructed in any other suitable shape and size and may have any suitable mass, surface finish, and/or surface treatment desired for a given application. Furthermore, it would have been obvious to modify the shape of the applicator/head for the purposes of providing a thermal therapy treatment in addition to another treatment as taught by Caruso.
Claims 6, 34, and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eberlein (2014/0219701) in view of Anderson (2015/0223975) and O’Neil (2015/0216816).
Regarding claim 6, Eberlein in view of Anderson teaches the limitations of claim 1. Eberlein teaches wherein the temperature controller is disposed in the handle ([0022] temperature setting adjustment 132 (e.g. a sliding switch, a rotating knob, or a push button).
Eberlein does not teach wherein the head further comprises a removable non-porous layer between the cooling element and the subject’s tissue.
However, O’Neil teaches a device within the same field of invention (cryotherapy device that enables tissue cooling [Abstract]) wherein the head comprises a removable non-porous layer between the cooling element and the subject’s tissue or organ surface (Fig. 5 release structure 502 can include an adhesive 504).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a non-porous layer between the cooling element and the subject’s tissue to allow to accurately position the applicator on the target site.
Regarding claim 34, Eberlein in view of Anderson teaches the limitations of claim 1 as previously rejected above. Eberlein does not teach comprising a user input for selecting a subject’s body part to be cooled, and the controller is configured to determine the cooling temperature based on the selected body part.
However, O’Neil teaches the controller 114 can receive data from an input device 118 (shown as a touch screen), transmit data to an output device 120, and/or exchange data with a control panel (not shown) [0099] and real-time collection and processing of such feedback data can be used in concert with treatment administration to ensure that the process parameters used to alter or reduce subcutaneous adipose tissue are administered correctly and efficaciously [0106].
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 provided a user input so that a user provides the appropriate cooling to the desired area.
Regarding claim 54, Eberlein in view of Anderson and O’Neil teaches the limitations of claim 6 as previously rejected above. O’Neil teaches wherein the non-porous layer comprises an adhesive (adhesive 504).
Response to Arguments
Applicant’s response filed on 8/14/2025 has been considered by the Examiner. Applicant’s amendments necessitate a new grounds of rejection over Eberlein (2014/0219701) in view of Anderson (2015/0223975) for claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794