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 examiner acknowledges that no new amendments have been entered. Claims 1, 3-16 remain pending in the application, with claims 2, 17-27 canceled in the present application.
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(s) 1, 3-6,11,13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costello (Patent No US 20160030205 A1) in view of Caruso (US patent No 20210106459 A1) and further in view of Vergara (Patent No Us 20190262169).
In regards to claim 1, Costello teaches a temperature regulating socket apparatus for selectively heating or cooling a residual limb of an amputee (a prosthetic limb heating apparatus for use with a prosthetic limb, para [0028]), the temperature regulating socket apparatus comprising: a socket having a brim (sleeve 10, para [0028]) a distal end and a continuous side wall (sleeve 20 includes a continuous side wall with upper end 22 and lower end 24, para [0030]) all defining an open interior area configured to receive the residual limb therein (Where lower end 22 is an open end configured to receive the limb portion, para [0030]) and a temperature regulating apparatus comprising: a) a heating element embedded within the socket side wall (conductive wire 30 in the sleeve, para 0032]).
Costello doesn’t teach wherein the heating element comprises a flexible heating element having a base member configured to be positioned at the distal end of the socket and a plurality of individually spaced apart heating units extending outwardly from the base member wherein each of the heating units is configured to extend along a length of the side wall toward the brim.
However, Vergara teaches the heating element comprises a flexible heating element (see in which Vergara discloses a plurality of heat exchange modules 104 which are flexible, [0091], seen as the analogous flexible heating element) having a base member (see the flexible skeleton 230 or base member, [0156]).
Vergara doesn’t teach configured to be positioned at the distal end of the socket and a plurality of individually spaced apart heating units extending outwardly from the base member wherein each of the heating units is configured to extend along a length of the side wall toward the brim.
However It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the base member to be positioned at the distal end of the socket and a plurality of individually spaced apart heating units extending outwardly from the base member wherein each of the heating units is configured to extend along a length of the side wall toward the brim, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Therefore, it would have been obvious for one skilled in the art to combine the socket apparatus of the combination with the thermal adjustment element disclosed by Vergara. This art is deemed analogous art as it is a therapeutic heating apparatus similar to the socket apparatus claimed by the combination. One of ordinary skill in the art would combine the two references to have the socket apparatus claimed by the combination using the heating adjustment apparatus as claimed by Vergara to provide a flexible heating element for temperature control of the skin, [0091].
Costello does not teach a temperature control unit operatively coupled to the heating element; and a power supply operatively coupled to the temperature control unit, wherein when the power supply is in its ON orientation the temperature control unit is powered whereby the temperature control unit regulates the temperature of the heating element to selectively heat the residual limb within the socket.
However, Caruso teaches an analogous temperature control unit (thermal control module 100, para [0030]) operatively coupled to the heating element; and a power supply (power supply 102, para [0034]) operatively coupled to the temperature control unit (thermal control module 100, para [0034]), wherein when the power supply is in its ON orientation the temperature control unit is powered whereby the temperature control unit regulates the temperature (controller 103, para [0034]) of the heating element (Peltier or other thermoelectric device 112, para [0034]) to selectively heat the residual limb within the socket.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the temperature regulating socket apparatus as disclosed by Costello with the temperature control unit disclosed by Caruso. The art provided by Caruso would be analogous art as it is used a therapeutic thermal control system similar to the socket apparatus being claimed. One of ordinary skill in the art would have been able to combine the temperature regulating socket apparatus with the temperature control unit in order to allow the user to control a setpoint temperature and other operational behavior of the module (Caruso para [0035]) as described by Caruso.
In regards to claim 3, the combination teaches the temperature regulating socket apparatus of claim 1 wherein the temperature control unit (Caruso, controller 103, para [0037]) adjustably supplies an electric current from the power supply (Caruso, power supply 102, para [0037]) to each of the heating units.
Regarding claim 4, the combination teaches the temperature regulating socket apparatus of claim 1 wherein the base member is dimensioned to encircle a mounting element located at the distal end (Costello, upper limb portion 104 nested in sleeve 20, para [0036]) of the socket wherein the mounting element is configured to couple a prosthetic device to the socket (Costello, upper limb 104 coupled to lower limb portion 106, para [0036]).
Regarding claim 5, the combination teaches the temperature regulating socket apparatus of claim 1 wherein the power supply is a battery (Caruso, power supply 102, which may be a battery, para [0035]), and wherein the battery and the temperature control unit are contained within a common housing (Caruso, battery housing 42, para [0035]).
Regarding claim 6, the combination teaches the temperature regulating socket apparatus of claim 5 wherein the socket includes a bracket configured to removably secure the housing to the socket (Costello, door or panel 44 that is moveable or completely removable, para [0035]).
Regarding claim 11, the combination teaches the temperature regulating socket apparatus of claim 3 wherein the power supply is a rechargeable battery (Caruso, rechargeable battery packs, para [0034]), and wherein the rechargeable battery and the temperature control unit are contained within a common battery pack housing (Costello, battery housing 42, para [0035])
In regards to claim 13, the combination teaches the temperature regulating socket apparatus of claim 3 wherein the battery pack housing includes a control board and an indicator, wherein the indicator is configured to display one or more of a remaining battery life, a recharging status and a wireless transmission status (Caruso, display shows current temperature, status of the battery and status of wireless connection, para [0066]).
Regarding claim 14, the combination teaches the temperature regulating socket apparatus of claim 3 wherein the socket includes a bracket configured to removably secure the battery pack housing to the socket (Costello, door or panel 44 that is moveable or completely removable, para [0035]).
Regarding claim 15, the combination teaches the temperature regulating socket apparatus of claim 3 wherein the socket includes a pack sleeve configured to removably secure the battery pack housing to the socket (Costello, door or panel 44 that is moveable or completely removable, para [0035]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costello (Patent No US 20160030205 A1) in view of Caruso (US patent No 20210106459 A1) and Vergara (Patent No Us 20190262169), further in view of Zsolesak (Patent No US 20150282556).
In regards to claim 9, the previous combination teaches the temperature regulating socket apparatus of claim 3.
The previous combination does not include that the heating element includes a wireless receiving coil wherein the temperature control unit includes a wireless charging transceiver, and wherein when said wireless charging transceiver is in an ON orientation a current is induced within the wireless receiving coil to supply each of the heating units .
However, using wireless induction as a method to power heating elements is well known in the art, see for example the analogous heating therapy sole disclosed by Zsolesak which does teach a wireless charging receiving coil (see the internal heating assembly 1003 which includes an inductive receiver coil, [0112]); the power supply or control unit includes a wireless charging transceiver (see the removeable assembly 1002 which contains the wireless transmitter inductive coil, [0112]); and when power is supplied to the wireless charging transceiver and the wireless charging transceiver is positioned proximate to the wireless charging receiving coil (wherein the external removeable assembly 1002 is found proximate the internal assembly 1003 which contains the receiver coil, see fig 33), a current is induced within the wireless charging receiving coil to supply power to the heating element (from [0112], see in which electromagnetic power is transferred to the internal heating element which emits heat for the device 1000).
Therefore, it would have been obvious for one skilled in the art to combine the temperature regulating device structure of Costello/Caruso/Vergara with the wireless coil and power induction transceiver system taught by Zsolesak in order to have wireless and efficient power transfer between the power supply and the heating source while also maintaining a modular temperature control device as disclosed by Zsolesak, [0111].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costello (Patent No US 20160030205 A1) in view of Caruso (US patent No 20210106459 A1) and Vergara (Patent No Us 20190262169), further in view of Baker et al. (Patent No US 20180214299 A1).
In regards to claim 16, the previous combination teaches the temperature regulating socket apparatus of claim 15.
The combination does not teach, wherein the pack sleeve and the battery pack housing include respective magnets of a magnet pair to removably secure the battery pack housing in the pack sleeve.
However, Baker teaches wherein the pack sleeve and the battery pack housing include respective magnets of a magnet pair to removably secure the battery pack housing in the pack sleeve (connect the housing and the socket using adhesives or magnets, para [0024]).
Therefore, it would have been obvious for one skilled in the art to combine the analogous art of the magnetic connect housing of Baker, with the temperature regulating socket apparatus taught by the combination. It would have been obvious for one skilled in the art to combine the magnetic connect housing to the temperature regulating socket apparatus as disclosed in order to couple and seal the components together as taught by Baker (para [0024]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costello (Patent No US 20160030205 A1) and Caruso (US patent No 20210106459 A1) and Vergara (Patent No Us 20190262169) in further view of Romkamp (Patent No US 20100204805 A1).
In regards to claim 7, the previous combination of Costello/Caruso/ Vergara teaches the temperature regulating socket apparatus of claim 1.
The combination does not teach wherein the socket is manufactured using casting or lamination.
However, Romkamp does teach wherein the socket is manufactured using casting or lamination (laminate 70, para [0017]).
Therefore, it would have been obvious for one skilled in the art to combine the socket apparatus taught by the combination with the laminate disclosed by Romkamp. This art is analogous as Romkamp discloses a socket device for use with pain elimination therapy. One skilled in the art would have combined the socket apparatus claimed form the combination with the laminate disclosed by Romkamp as to give excellent insulation and give a high heat tolerance as disclosed by Romkamp (para [0017]).
In regards to claim 8, the combination teaches the temperature regulating socket apparatus of claim 7 wherein the lamination uses carbon fiber or fiberglass. (Carbon fiberglass known laminates to one in the art, para [0017]).
Claim(s) 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costello (Patent No US 20160030205 A1) in view of Caruso (US patent No 20210106459 A1) and Vergara (Patent No Us 20190262169) in view of Haas et al. (Patent No Us 20040256381 A1).
In regards to claim 10, the combination teaches the temperature regulating socket of claim 3.
The combination does not teach wherein the wireless receiving coil is hermetically sealed within the socket side wall.
However, Haas does teach wherein the heating elements are hermetically sealed within the socket side wall (pouch 50 is hermetically sealed and contains the heating elements, para [0032]). The examiner realizes that the disclosure of Haas does not explicitly state that a wireless coil is hermetically sealed, however as the wireless coil is connected with and in operable communication with the heating element, it would have been obvious for one skilled in the art to have the wireless coil sealed within the hermetic pouch as well as to properly seal the device and prolong use, as taught by Haas, [0032].
Therefore, it would have been obvious for one skilled in the art to combine the temperature regulating socket of the combination with the hermetically sealed pouch. This art is analogous as it contains heating elements used for therapeutic purposes similar to that claimed of the socket. It would have been obvious for one skilled in the art to combine the temperature regulating socket of the combination with the hermetically sealed pouch of Haas as to provide protection and reuse for the heating elements (para [0032]) .
In regards to claim 12, the combination teaches the temperature regulating socket apparatus of claim 3 wherein the battery pack housing is hermetically sealed (pouch 50 is hermetically sealed and contains the battery elements, para [0032]).
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered and they are partially persuasive.
In regards to claim 1, in particular with respect to Caruso applicant argues that the examiner has failed to make a prima facie case as all the claim limitations must be taught or suggested by the prior art. Particularly applicant came to point out that “the Caruso reference no longer qualifies as prior art under 35 U.S.C. §§ 102(a) or 102(b). The present patent application (17/236,643) was filed April 21, 2021 and claims the benefit of U.S. Provisional Application No. 63/030,346 (the '346 Application) having a filing date of May 27, 2020. The subject matter of the claimed invention in the present patent application is fully supported by the '346 Application, thus providing an effective filing date of the present application as of May 27, 2020. Applicant notes that the Caruso reference includes a publication date of April 15, 2021, with a filing date of September 3, 2020 - both dates being later in time than the present effective filing date of May 27, 2020. It is further noted that the Caruso reference claims the benefit of U.S. Provisional Application No. 62/915,498 (the '498 Application) dated October 15, 2019. However, while the filing date of the '498 Application pre-dates May 27, 2020, the materials disclosed in the '498 Application are not applicable to claim 1 as amended herein. Namely, the '498 Application is wholly silent with regard to any heating as recited in amended claim 1. Accordingly, Applicant submits that the Caruso reference is no longer a valid prior art reference with respect thereto.”
Examiner acknowledges the previously presented amended claims 1-3, and 9 to change the “thermal adjustment element” to “heating element” which is supported by the disclosure of the applicant. Examiner also acknowledges and agree with applicant that based off of the filing of the provisional application No 63/030,346, with all the supported disclosure for the subject matter claimed, a priority date for the present application dates to May 27, 2020 which would render the Caruso reference as not qualifying prior art based on its filing date. However, as applicant pointed out the Caruso reference does claim priority benefit to provisional US application No 62/915,498 having a filing date of October 15, 2019 prior to the provisional filing of the current application. Applicant further goes on to say that the US application No 62/915,498 is wholly silent with regard to any heating as recited in amended claim 1. However, Examiner would like to draw the applicants’ attention to the Caruso Provisional application No 62/915,498 in the specification Detailed Description page 5, lines 25-26 where it is disclosed “A fan may be used to dissipate heat from the heatsink.” Furthermore in page 6 lines 9-12 in which it is disclosed “the fan speed can be controlled to properly control the heatsink temperature, or the current delivered to the Peltier device may be controlled to get the proper fluid output temperature, or the pump speed may be controlled to further help obtain the proper fluid output temperature” in which heating is not directly stated, however it would have been obvious for one skilled in the art to take controlling the output temperature of the fluid to include both heating and cooling of the fluid to achieve the desired temperature. Furthermore, as part of maintaining fluid output temperature, if the temperature drops below an ideal threshold, a warmer fluid would then ideally have to be pumped throughout the control device to achieve the desired temperature. By definition that includes a heat output relative to the previous temperature threshold, thereby effectively teaching the capability of heating to one skilled in the art. Therefore, the examiner is maintaining the rejection and maintains the view that the prior art of record Caruso contains enough disclosure to teach heating elements prior to the effective priority date of the current application.
Furthermore, upon further search and consideration, it was found that the prior art of record from Caruso is not providing the elements of a heating element, instead the prior art of Caruso is providing the structure of a thermal control unit which regulates the temperature of a Peltier or thermoelectric device found in paragraph [0034]. This support is found in the provisional application 62/915498 filed by Caruso on 10/15/2019 in which the temperature regulation control unit features can be found on the provisional specification on pages 6 and 7. The examiner would like to reemphasize the findings and teachings that the prior art of record Costello which was filed before the effective filing date of the present application is the source which teaches and discloses the heating elements which are found in this non-final rejection. The elements of the thermal control unit taught by Caruso are being used to regulate and modulate the treatment temperature of the thermoelectric elements. In which the prior art of record of Costello provides the disclosure that the thermoelectric elements are equated to the heating elements, [0032]. Therefore, as the prior art of record Caruso and the provisional application granting the earlier effective filing date both disclosing the thermal regulation control unit it would be obvious for one skilled in the art prior to the effective filing date to combine the control unit taught by Caruso with the prosthetic heating apparatus and heating elements which are disclosed and defined by Costello in paragraphs [0028]-[0032]. While examiner appreciates applicant argument to claim priority to a provisional application, the argument still does not overcome the art and therefore the provisional application provided by Caruso and the rejection of claim 1 as being anticipated by Costello in view of Caruso is maintained.
Furthermore, in regards to the new argument presented for the combination of the Caruso and Costello references in such that the provisional application ‘498 does not teach that thermal energy is added to the fluid and therefore does not teach heating components, has been considered but is ultimately unpersuasive. Examiner would like to remind applicant that the specific language of adding thermal energy to the fluid or Peltier device is not explicitly found or stated in the limitations of the present application. Therefore, based on the broadest reasonable interpretation of the present claim language, the prior art must define a heating element and not specifically an element which adds thermal energy to the fluid or treatment. Therefore, under the broadest reasonable interpretation, the examiner would like to bring applicant attention to what was already stated previously in the Caruso Provisional application No 62/915,498 in the specification Detailed Description page 5, lines 25-26 where it is disclosed “A fan may be used to dissipate heat from the heatsink.” Furthermore in page 6 lines 9-12 in which it is disclosed “the fan speed can be controlled to properly control the heatsink temperature, or the current delivered to the Peltier device may be controlled to get the proper fluid output temperature, or the pump speed may be controlled to further help obtain the proper fluid output temperature” in which heating is not directly stated, however it would have been obvious for one skilled in the art to take controlling the output temperature of the fluid to include both heating and cooling of the fluid to achieve the desired temperature. For example, if the fluid temperature runs too cold, in order to control or regulate the temperature it must be re-heated in order to successfully control the fluid output temperature. Therefore, the prior art of record contains enough disclosure to teach heating elements prior to the effective priority date of the current application.
Regarding the argument presented that the prior art of Macher used to reject claim 1 and relevant dependent claims does not teach the specific limitation that the heating elements are flexible, has been considered and ultimately found persuasive. Therefore, the previous prior art of record rejection of claim 1 in view of Macher has been removed. However, after further search and consideration, it has been found that the new prior art of record of Vergara does teach and suggest the use of flexible heating assemblies for use with the appendages as similarly claimed by the present application. Specifically, the prior art of Vergara teaches the heating element comprises a flexible heating element (see in which Vergara discloses a plurality of heat exchange modules 104 which are flexible, [0091], seen as the analogous flexible heating element) having a base member (see the flexible skeleton 230 or base member, [0156]). Therefore, as the limitation of flexible heating elements is taught by the prior art of record, the claim 1 and all relevant dependents remain rejected under the new prior art of record rejection of Costello in view of Caruso further in view of Vergara set forth in the present office action.
Applicant’s arguments with respect to the rejection(s) of claim(s) 9 under the Moreshead reference have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new prior art of record of Zsolesak. The new prior art of Zsolesak does teach a wireless charging receiving coil (see the internal heating assembly 1003 which includes an inductive receiver coil, [0112]); the power supply or control unit includes a wireless charging transceiver (see the removeable assembly 1002 which contains the wireless transmitter inductive coil, [0112]); and when power is supplied to the wireless charging transceiver and the wireless charging transceiver is positioned proximate to the wireless charging receiving coil (wherein the external removeable assembly 1002 is found proximate the internal assembly 1003 which contains the receiver coil, see fig 33), a current is induced within the wireless charging receiving coil to supply power to the heating element (from [0112], see in which electromagnetic power is transferred to the internal heating element which emits heat for the device 1000) as claimed in the present application. Therefore, as it has been done before by those skilled in the art, it would have been obvious to use the thermal energy transfer method involving wireless transceivers and coils taught by Zsolesak with the previous prior art of record rejection. Therefore, claim 9 remains rejected under the new prior art of record reference of Zsolesak set forth in the present office action.
With regards to the argument that the prior art of Haas in regards to claim 10 and 12 does not contain enough disclosure to teach that a wireless receiving coil is hermetically sealed, has been considered and found partially persuasive. The examiner agrees with the applicant that the prior rejection did not disclose enough information to fully teach that the wireless receiving coil is hermetically sealed. However, upon further consideration of the prior art of Haas, the rejection has been rewritten as presented in the current office action such that Haas does now teach wherein the heating elements are hermetically sealed within the socket side wall (pouch 50 is hermetically sealed and contains the heating elements, para [0032]). The examiner realizes that the disclosure of Haas does not explicitly state that a wireless coil is hermetically sealed, however as the wireless coil is connected with and in operable communication with the heating element, it would have been obvious for one skilled in the art to have the wireless coil sealed within the hermetic pouch as well as to properly seal the device and prolong use, as taught by Haas, [0032]. Therefore, as it would have been obvious for one skilled in the art to hermetically seal the wireless receiving coil in view of Haas, the claims 10 and 12 remain rejected under the newly considered prior art of record of Haas set forth in the present office action.
All other claims remain rejected by the prior art of record rejection set forth in the present office action as per their dependencies on the rejected independent claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/ Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794
Prosecution Insights