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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/27/2025 has been entered.
Claims Status
Claims 1-20 are currently pending and claims 1, 3, 13, 16 and 20 are currently amended.
Response to Arguments
Applicant’s arguments with respect to amended claim(s) 1, 16 and 20 have been considered but are moot because are moot in view of the new ground of rejection (please see new grounds of rejection below).
Applicant’s amendments of claims 1, 16 and 20 overcomes the previous rejection under 35 U.S.C. 112 (a), the rejections under 35 U.S.C. 112 (a) are withdrawn.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over KALLMYER et al. (US 2013/0106347 A1, hereinafter KALLMYER) in view of THOMPSON et al. (US 2014/0233184 A1, hereinafter THOMPSON) and in further view of STINAUER et al. (US 2024/0009472 A1, hereinafter STINAUER).
Regarding claim 1, KALLMYER discloses a charging device (See Fig.1, Item#22), comprising:
a coil configured to wirelessly transfer energy to an implantable medical device (See Fig.1, and Par.39, discloses a primary coil 26 for wireless transferring energy to implantable medical device 14 via secondary coil 16);
a phase change material that is disposed in contact with the coil, (See Pars.43 and 45, disclose a phase change material. Pars.48 and 77 disclose the phase change material is in contact with the charging coil);
a ground plane positionable on a first side of the phase change material such that at least a first portion of the phase change material is positioned between the ground plane and one or more surfaces of a target subject (See Pars.56 and 79 and Fig.8B, Item#130, disclose a conductive film placed on a first of the phase change material, the phase change material 132 is between the film and the patient’s skin [Par.65]).
However, KALLMYER does not disclose wherein the phase change material is removable from the charging device or a heat reduction assembly comprising a second material different from the phase change material that is disposed in contact with the coil and that absorbs at least a portion of heat generated by the coil.
THOMPSON discloses a charging device for an implantable medical device, the charging device comprising a phase change material that is removable from the charging device (See Pars.40-42 and 69 and Figs.1A-1F and 2 disclose a replaceable PCM heat accumulation structure 45).
KALLMYER and THOMPSON are analogous art since they both deal with chargers for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER with the teachings of THOMPSON by making the phase change material replaceable for the benefit of by reducing charging down time by allowing the user to replace the spent phase change material module with a fresh one (See THOMPSON, Par.42, discloses “Replacing a spent PCM heat accumulation structure 40a with a fresh PCM heat accumulation structure 40a will enable continued operation of the TET system by enabling the fresh PCM to absorb more heat before the temperature exceeds the desired limit”).
KALLMYER further discloses that the absorption ability of the phase change material is reduced when the phase changes from solid to liquid state (See Par.47).
However, KALLMYER and THOMPSON do not disclose a heat reduction assembly comprising a second material different from the phase change material that is disposed in contact with the coil and that absorbs at least a portion of heat generated by the coil.
STINAUER discloses a charger for an implantable medical device, a heat reduction assembly (See Fig.5B, Item#123 and Par.40, disclose a thermal diffuser which acts as a heat sink and provides heat transfer away from the charging coil 126) comprising a second material different from the phase change material that is disposed in contact with the coil (See KALLMYER, Par.50, discloses the phase change material is made of material such as wax. The material of heat sink 123 is made of soft plastic material [See Par.38]) and that absorbs at least a portion of heat generated by the coil (See Par.40, disclose a thermal diffuser which acts as a heat sink and provides heat transfer away from the charging coil 126).
KALLMYER, THOMPSON and STINAUER are analogous art since they all deal with charging devices for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by MYER and THOMPSON with the teachings of STINAUER by adding a heat sink to the charging device for the benefit of prolonging the availability of the charger before it reaches a temperature at which the phase change material is spent by absorbing a portion of the coil heat.
Regarding claim 2, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein:
the phase change material is incorporated in the charging device (See KALLMYER, Fig.8B, discloses the phase change material 132 incorporated in flexible housing 122); and
a flexibility of the charging device is associated with a state of the phase change material (See KALLMYER, Par.45, discloses the phase change material changes from solid to liquid, it is inherent that when the phase change material is solid, the flexibility is less than that when the phase change material is liquid).
Regarding claim 3, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1, wherein:
the phase change material absorbs at least a portion of heat generated by the coil (See KALLMYER Par.23, discloses the phase change material may absorb heat generated by the flexible coil).
Regarding claim 5, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein:
the charging device comprises at least one flexible portion (See KALLMYER, Fig.8B, discloses the phase change material 132 incorporated in flexible housing 122 and Par.97, discloses Containment structure 132 may be constructed of a thermally conductive or thermally insulative material that is also flexible); and
the phase change material is disposed within the at least one flexible portion (See KALLMYER Par.97, discloses Containment structure 132 may be constructed of a thermally conductive or thermally insulative material that is also flexible).
Regarding claim 6, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein the phase change material changes between a solid state and a fluid state at a temperature range of about 35 degrees Celsius to about 41 degrees Celsius (See KALLMYER, Par.45, discloses the phase change material may have a melting point between approximately 35 degrees Celsius and 43 degrees Celsius, the rang 35-41 is included in the range disclosed by KALLMYER).
Regarding claim 7, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein:
the phase change material is encapsulated in a housing, wherein the housing is insertable into the charging device (See THOMPSON, Pars.40 and 42, disclose the PCM heat accumulation unit comprising a housing that is replaceable within the charging device); and an external surface of the housing contacts at least one surface of the coil, at least one surface of the target subject, or both.
Regarding claim 8, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, further comprising:
a wearable element (See Fig.3 and 7A, and Pars.31 and 38 disclose a strap and harness for holding the charger to the patient body), wherein the charging device is insertable into a receptacle of the wearable element, coupled to the wearable element (See Figs.3 and 7A disclose charger 10 is coupled to the strap), or both, wherein the phase change material is comprised in the charging device (See THOMPSON, Fig.1B, discloses the phase changing material 45 inside the charging device 10).
Regarding claim 9, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein:
a first contact area between the charging device and the target subject under a first temperature condition is different from a second contact area between the charging device and the target subject under a second temperature condition (See Fig.1, discloses the charger head 26 in contact with the IMD area 16. As discussed in claim 1 rejection, e Pars.43 and 45, disclose a phase change material. Pars.48 and 77 disclose the phase change material is in contact with the charging coil. The temperature changes when the phase change material changes from solid to liquid state); the first temperature condition corresponds to a first state of the phase change material; and the second temperature condition corresponds to a second state of the phase change material (See KALLLMYER, Par.45, disclose the solid phase change material changes to liquid when it reaches a threshold temperature. KALLMYER further discloses in Par.47 that the temperature changes when the phase change material changes from slid to liquid as its temperature absorption ability decreases).
Regarding claim 11, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein an external surface of the heat reduction assembly contacts at least one surface of the coil (See STAUNER, See Fig.5B, Item#123 and Par.40, disclose a thermal diffuser which acts as a heat sink and provides heat transfer away from the charging coil 126, and in contact with the charging coil).
Regarding claim 12, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein at least a portion of the ground plane comprises a flexible material (See KALLMYER, Pars.56 and 79 and Fig.8B, Item#130, disclose a conductive film placed on a first of the phase change material. The film is flexible).
Regarding claim 13, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, wherein at least a portion of the ground plane comprises a thermal conductive material, and wherein the thermal conductive material facilitates heat transfer between the ground plane and at least one of the phase change material and the second material of the heat reduction assembly (See KALLMYER, Pars.56 and 79 and Fig.8B, Item#130, disclose a conductive film placed on a first of the phase change material).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over KALLMYER in view of THOMPSON and in further view of STINAUER and in further view of FORSBERG et al. (US 2005/0075696 A1, hereinafter FORSBERG).
Regarding claim 4, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, However, KALLMYER, THOMPSON and STINAUER do not disclose further comprising: a second coil associated with operations different from the wireless transfer of the energy to the implantable medical device, wherein at least a portion of the second coil is overlapped by the phase change material.
FORSBERG discloses a charging device for an implantable medical device, the charging device comprising a second coil associated with operations different from the wireless transfer of the energy to the implantable medical device (See Fig.3, Items#46 discloses a telemetry coil different from the wireless charging coil 54), wherein at least a portion of the second coil is overlapped by the phase change material (See Fig.3, Item#62, discloses phase change material adjacent to telemetry coil. KALLMYER discloses the phase change material 260 [Fig.14B, Item#260 and Par.144] extending across the entire charging surface [Fig.14B, Item#252 and Par.143]. The combination would result in the phase change material overlapping the telemetry coil).
KALLMYER, THOMPSON, STINAUER and FORSBERG are analogous art since they all deal with chargers for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER, THOMPSON and STINAUER with the teachings of FOSRBERG by adding the separate telemetry coil for the benefit of providing wireless data communication between the charging device and the implantable medical device.
Claim(s) 10 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over KALLMYER in view of THOMPSON and in further view of STINAUER and in further view of SCOTT et al. (US 2018/0126177 A1, hereinafter SCOTT).
Regarding claim 10, KALLMYER, THOMPSON and STINAUER disclose the charging device of claim 1 as discussed above, However, KALLMYER, THOMPSON and STINAUER do not disclose wherein the heat reduction assembly is removable from the charging device, and wherein the heat reduction assembly is positionable at least partially between the ground plane and the coil along a first direction.
SCOTT discloses a charging device for charging an implantable medical device comprising a detachable heat sink (See Par.98, discloses a heat sink chamber 122 may detachably couple to the housing using any of the mechanisms discussed herein, or heat sink chamber 122 may be configured to remain detached from heat sink chamber 122).
KALLMYER, THOMPSON, STINAUER and SCOTT are analogous art since they all deal with charging devices for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER, THOMPSON and STINAUER with the teachings of SCOTT by having a detachable heat sink allowing the user to replace the heat sink with a new heat sink for the benefit of allowing the continued operation of the charging device by replacing a damaged heat sink.
The examiner explains that the placement of the heat reduction assembly between the ground plane and the coil would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the benefit of further reducing the temperature of the charging coil.
Regarding claim 14, KALLMYER, THOMPSON, STINAUER and SCOTT disclose the charging device of claim 10 as discussed above, further comprising: a second ground plane conformable to the one or more surfaces of the target subject (See THOMPSON, Fig.1C, Item#48c discloses a plane conformable to the target surface 50).
It would have ben obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER, THOMPSON, STINAUER and SCOTT as applied to claim 10 with the further teachings of THOMPSON by adding the second plane for the benefit of providing additional protection for the charging coil.
Regarding claim 15, KALLMYER, THOMPSON, STINAUER and SCOTT disclose the charging device of claim 14 as discussed above, wherein the second ground plane is configured such that heat is transferred away from the second ground plane toward the ground plane (See THOMPSON, Pars.8 and 48, disclose portion 46c of enclosure 48c can instead be formed of a thermally conductive material, such that PCM heat accumulation structure 40c can be used to absorb heat both from ECA 10 and implanted medical device 80 and associated surrounding tissue, it is understood that the heat is then transferred away from the skin and towards the ground plane and the heat sink).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over KALLMYER in view of THOMPSON and in further view of STINAUER and in further view of CONG et al. (US 2013/0278226 A1, hereinafter CONG).
Regarding claims 16 and 20, KALLMYER discloses a system, comprising:
an implantable medical device (See Fig.1, Item#14);
a charging device (See Fig.1, Item#22) comprising:
a coil configured to wirelessly transfer energy to an implantable medical device (See Fig.1, and Par.39, discloses a primary coil 26 for wireless transferring energy to implantable medical device 14 via secondary coil 16);
a phase change material that is disposed in contact with the coil, (See Pars.43 and 45, disclose a phase change material. Pars.48 and 77 disclose the phase change material is in contact with the charging coil);
a ground plane positionable on a first side of the phase change material such that at least a first portion of the phase change material is positioned between the ground plane and one or more surfaces of a target subject (See Pars.56 and 79 and Fig.8B, Item#130, disclose a conductive film placed on a first of the phase change material, the phase change material 132 is between the film and the patient’s skin [Par.65]).
However, KALLMYER does not disclose wherein the phase change material is removable from the charging device, a heat reduction assembly comprising a second material different from the phase change material that is disposed in contact with the coil and that absorbs at least a portion of heat generated by the coil and electronic circuitry configured to control transferring of the energy to the implantable medical device based at least in part on a temperature of the charging device.
THOMPSON discloses a charging device for an implantable medical device, the charging device comprising a phase change material that is removable from the charging device (See Pars.40-42 and 69 and Figs.1A-1F and 2 disclose a replaceable PCM heat accumulation structure 45).
KALLMYER and THOMPSON are analogous art since they both deal with chargers for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER with the teachings of THOMPSON by making the phase change material replaceable for the benefit of by reducing charging down time by allowing the user to replace the spent phase change material module with a fresh one (See THOMPSON, Par.42, discloses “Replacing a spent PCM heat accumulation structure 40a with a fresh PCM heat accumulation structure 40a will enable continued operation of the TET system by enabling the fresh PCM to absorb more heat before the temperature exceeds the desired limit”).
KALLMYER further discloses that the absorption ability of the phase change material is reduced when the phase changes from solid to liquid state (See Par.47).
However, KALLMYER and THOMPSON do not disclose a heat reduction assembly comprising a second material different from the phase change material that is disposed in contact with the coil and that absorbs at least a portion of heat generated by the coil and electronic circuitry configured to control transferring of the energy to the implantable medical device based at least in part on a temperature of the charging device.
STINAUER discloses a charger for an implantable medical device, a heat reduction assembly (See Fig.5B, Item#123 and Par.40, disclose a thermal diffuser which acts as a heat sink and provides heat transfer away from the charging coil 126) comprising a second material different from the phase change material that is disposed in contact with the coil (See KALLMYER, Par.50, discloses the phase change material is made of material such as wax. The material of heat sink 123 is made of soft plastic material [See Par.38]) and that absorbs at least a portion of heat generated by the coil (See Par.40, disclose a thermal diffuser which acts as a heat sink and provides heat transfer away from the charging coil 126).
KALLMYER, THOMPSON and STINAUER are analogous art since they all deal with charging devices for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by MYER and THOMPSON with the teachings of STINAUER by adding a heat sink to the charging device for the benefit of prolonging the availability of the charger before it reaches a temperature at which the phase change material is spent by absorbing a portion of the coil heat.
However, KALLMYER, THOMPSON and STINAUER do not disclose electronic circuitry configured to control transferring of the energy to the implantable medical device based at least in part on a temperature of the charging device.
CONG discloses a charging device for an implantable medical device, the charging device comprising electronic circuitry (Claim 20 limitations, the electronic circuitry comprising a processor 50 and memory 52) configured to control transferring of the energy to the implantable medical device based at least in part on a temperature of the charging device (See Fig.3, disclose a charging module 58 and a processor 50, also see Fig.11 and Par.63, disclose the charging level is controlled based on the measured temperature [Fig.11,Steps#258,260,262]).
KALLMYER, THOMPSON, STINAUER and CONG are analogous art since they all deal with charging devices for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER, THOMPSON and STINAUER with the teachings of CONG by adding the electronic to control the of energy to the implantable medical device based on temperature of the charging device for the benefit of providing additional protecting to the user by using a lower power level that causes a slower rise to the charger temperature.
Regarding claim 17, KALLMYER, THOMPSON, STINAUER and CONG disclose the system of claim 16 as discussed above, wherein:
controlling the transferring of the energy to the implantable medical device is based at least in part on at least one of:
a temperature of a component within a threshold distance of the phase change material (See STINAUER Par.8, discloses the charger comprising a temperature sensor).
Regarding claim 18, KALLMYER, THOMPSON, STINAUER and CONG disclose the system of claim 17 as discussed above, wherein a flexibility of the charging device is associated with a state of the phase change material (See KALLMYER, Par.45, discloses the phase change material changes from solid to liquid, it is inherent that when the phase change material is solid, the flexibility is less than that when the phase change material is liquid).
Regarding claim 19, KALLMYER, THOMPSON, STINAUER and CONG disclose the system of claim 16 as discussed above, wherein: the charging device comprises a second ground plane conformable to the one or more surfaces of the target subject (See THOMPSON, Fig.1C, Item#48c discloses a plane conformable to the target surface 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by KALLMYER, THOMPSON, STINAUER and CONG as applied to claim 16 with the further teachings of THOMPSON by adding the second plane for the benefit of providing additional protection for the charging coil.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED H OMAR whose telephone number is (571)270-7165. The examiner can normally be reached 10:00 am -7:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Drew Dunn can be reached at 571-272-2312. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AHMED H OMAR/ Primary Examiner, Art Unit 2859
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