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 .
Priority
Claims 1-5, 7, 22, 24-27, and 29-42 are deemed to have an effective filing date of October 1, 2020.
Response to Amendment
This Action is in response to the Amendment filed December 18, 2025.
In view of the Amendment, most of the drawing objections, the objection to the specification, and the rejection of claims 7 and 30-35 under 35 USC 112, as set forth in the Office Action dated 09/15/2025, are withdrawn.
Claims 7 and 30 are amended.
Claims 39-42 are added.
Claims 6 and 23 are cancelled
Claims 1-5, 7, 22, 24-27, and 29-42 are pending.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
In response to Applicant’s assertion that claim 1 is not anticipated, the Examiner disagrees. The device of the claim includes a dedicated heat transfer arrangement that is capable of transferring away from the device heat. This is exactly what the heat transfer arrangement of Scott does: [0028]: a heat exchanger that removes heat from skin during recharging also removes heat away from the device so that recharging can occur for extended periods of time and also at higher power transfer rates. As shown in Fig. 1, the cited heat exchanger includes heat sink chamber 122 and tubing/path 124B/126 that moves heat away from the heat sink chamber 122 and the inductive charging unit 130 of the device. The heat is then removed at the heat exchanging unit 120 of heat exchanger 30. In addition, cited paragraph [0036] of Scott cycles coolant and removes heat from the primary coil 132 of the inductive charging unit of Scott. Thus, the device disclosed by Scott does transfer heat away from the device including an inductive power transmission apparatus.
In response to Applicant’s assertion that claim 22 is not anticipated, the Examiner disagrees. As set forth in the 09/15/2025 Office Action, paragraph [0036] of Scott discloses the cooling sub-system. In pertinent part, heat exchanger unit 30 includes a heat exchanging unit that cools the removed transferred heat via tubing 124B and provides coolant via tubing 124A to the heat sink chamber.
In response to Applicant’s assertion that claim 30 is not anticipated, the Examiner disagrees. As set forth in the 09/15/2025 Office Action, claim 30 comprises two elements: a battery charging apparatus and a cooling apparatus, which are met by Fig. 1 and paragraphs [0048] and [0035] Scott. Paragraphs [002]-[0003] of Scott disclose a dedicated prosthesis component charging device that can be used with IMDs [which have batteries as shown in Fig. 1]. Scott’s device is configured to recharge a power storage portion of the prosthesis while cooling an assembly of which the power storage portion is a part. The battery 112 of Fig. 1 is part of an assembly (shown in Fig. 1 of Scott) and is being cooled.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “104” has been used to designate both a tympanic membrane (Fig. 1) and a cable (Fig. 1A).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 is objected to because of the following informalities: Line 3 recites: “would occur as a result of normal convention to enhance heat transfer”. This sentence does not make sense. What is a normal convention? Is this a typographical error? Claim 5 does include the questioned phrase “normal convention”. The Examiner believes that this is a typographical error and should be “normal convection” in claim 5 and in the originally-filed specification (paragraph [00103]).
Claims 35 and 39 are objected because of the following informalities:
The recitation of “all things being equal” in line 6 of claim 35 and line 5 of claim 39 is narrative in form and does not conform to US practice of “distinctly pointing out and distinctly claiming the subject matter”. It is unclear to what “all things” refers. It is more of an idiomatic expression than defining the scope of the claim.
Appropriate correction is required.
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.
Claim 32 recites “a means for cooling the prosthesis component”.
The specification describes several different cooling embodiments: [0080]: Embodiments can include the utilization of heat pipes, and or small thermoelectric coolers (TEC) and miniature fans.
[0088]: in another exemplary embodiment, a heatsink can be placed in conductive heat transfer communication with the radiator and/or the radiator can be an expanded heat sink relative to the heat pipe. Any device, system, and/or method than can enhance heat extraction from the heat pipe/fluid path can be utilized in at least some exemplary embodiments.
Thus, most heat management systems would meet the requirements of a means for cooling.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 42 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The recitation of “by convection heat transfer directly from the prosthesis component” is not supported by the originally-filed specification (OFS). While Figs. 11-11B, 20 utilize “convection cooling” or “convection heat transfer”, it is unclear how those embodiments achieve heat transfer directly from the prothesis component that has a power storage portion. “Convection cooling” is described in paragraph [0095] of the OFS. “Convection heat transfer” is described in paragraph [00147] of the OFS. “Heat transfer radiation and/or convection” described in paragraph [0107] with respect to a cable extending between a BTE device and a headpiece (Fig. 4). However, none of these section provide support for “by convection heat transfer directly from the prosthesis component”. Claim 30 implies that “the prosthesis component” is being recharged and has a power source. While “heat can be transferred from the external component 2140, including from inside the external component, directly to the heatsink 2155 (e.g., paragraph [00150]), but, the external component does not have a battery that is being recharged. Accordingly, it is unclear if the inventor or a joint inventor had possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 40-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 40 depends from claim 22 and recites “the skin interface”. But, claim 22 recites “a skin interface surface”. It is unclear if the skin interface in line 5 of claim 40 refers back to the skin interface surface, or, if it is a new element.
Claim 41 recites “the prosthesis component” in line 2, but it does not appear to be referring back to the prosthesis component having a power storage portion of claim 30 as discussed above in the 35 USC 112(a) rejection. Accordingly, the scope of claim 41 is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 22, 24-26, 29-30, and 32-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2018/0126177 to Scott et al. (hereinafter referred to as “Scott”).
Regarding claim 1, Scott discloses a device (e.g., abstract: devices, system and techniques for cooling tissue during recharge of an implantable medical device battery), comprising: an inductive power transmission apparatus (e.g., Fig. 1 and paragraphs [0029] and [0036]: two or more of heat exchanger unit 30 that includes heat sink chamber 122 and tubing 124A, 124B, inductive charging unit 130, and external programmer 140 may be combined as a single unit) wherein the device includes a dedicated heat transfer arrangement configured to transfer away from the device heat that is generated when transferring power using the device (e.g., paragraph [0028]: the heat exchanger actively cools the skin of the patient during the recharging process so that the skin is cooled below its normal surface temperature and allows high rates of energy transfer, Fig. 1, 30), and the device is configured to transmit inductance power transcutaneous into a person (e.g., paragraphs [0028]: IMD of a patient receives power to recharge the IMD battery of the patient’s IMD and [0032]-[0033]: IMD battery may be wirelessly recharged by an inductive charger which generates heat in the patient as the patient’s IMD is recharged).
With respect to claim 2, Scott discloses the device of claim 1, wherein: the inductive power transmission apparatus includes a heat pipe that is part of a resonant tank of a closely coupled inductive link in a wireless power transmission system (e.g., the inductive power transmission apparatus of Scott (Fig. 1, 30, 124A, 124B, 130, 140) includes tubing 124A, 124B that efficiently transfer heat from a hot source to a colder area; and paragraph [0036]).
As to claim 3, Scott discloses the device of claim 1, wherein: the inductive power transmission apparatus includes an induction coil that is a heat pipe (e.g., paragraph [0032]: primary coil 132 is an inductor which conveys heats that can be absorbed by heat sink chamber 122 – see paragraph [0036]).
With respect to claim 4, Scott discloses the device of claim 1, wherein: the device is at least part of an external component of a prosthesis system that utilizes transcutaneous inductive power transfer to power an implanted component (e.g., paragraphs [0002]-[0003]: Scott discloses that its invention can be used with IMDs that replace a body part function of a patient (prosthesis system) and that those IMDs need recharging wirelessly).
As to claim 5, Scott discloses the device of claim 1, wherein: the device is configured to induce movement of air through the device beyond that which would occur as a result of normal convention to enhance heat transfer from the dedicated heat transfer arrangement (e.g., paragraph [0036]: the coolant is re-cooled by flowing air across the fluid, moving the heat into the surrounding air and surrounding description).
As to claim 7, Scott discloses the device of claim 1, wherein: the heat transfer arrangement includes a coupling to removably attach the device to a separate heat transfer device (e.g., paragraph [0091]: “heat sink chamber 122 and primary coil 132 may be removably affixed in order to allow the two elements to be attached and separated as needed”, and “the coupling may be hook and loop closures, interlocking indents and detects, a threaded connection, a sleeve or any other affixing mechanism”).
Referring to claim 22, Scott discloses a device (e.g., abstract: devices, system and techniques for cooling tissue during recharge of an implantable medical device battery), comprising: an inductive power transmission sub-system configured to transfer power to an implanted medical device (e.g., paragraphs [0028]: IMD of a patient receives power to recharge the IMD battery of the patient’s IMD and [0032]-[0033]: IMD battery may be wirelessly recharged by an inductive charger which generates heat in the patient as the patient’s IMD is recharged; Fig. 1, inductive charging unit 130, primary coil 132); a skin interface surface (e.g., Fig. 1, heat sink chamber surface 122 placed on skin 106 directly above the IMD 110; and paragraphs [0035]-[0036]); and a cooling sub-system configured to cool the skin interface surface (e.g., paragraph [0036]: heat exchanger unit 30 includes heat sink chamber 122 and tubing 124A, 124B where the heat sink absorbs heat from the primary coil 132 and skin 106 and the coolant/fluid moving in tubing 124A, 124B moves the heated coolant away so that the primary coil and skin decrease in temperature).
As to claim 24, Scott discloses the device of claim 22, wherein: the device is configured so that power can be transferred at a rate of at least twice that which would be the case in the absence of the system for cooling the skin interface surface while maintaining the same temperature thereof, all other things being equal (e.g., paragraph [0004]: system may actively cool the skin to allow for a higher recharge power and higher energy transfer rates that achieve faster recharge of the IMD battery – the device of Scott is capable of transferring power at a rate of twice that in the absence of its cooling system as it cools the skin similar to that discussed in the instant specification – see paragraphs [0040], [0043] and [0089]).
With respect to claim 25, Scott discloses the device of claim 22, wherein: the cooling sub-system is integrated with the inductive power transmission sub-system (e.g., paragraph [0091]-[0092]: The heat sink chamber 122 and primary coil may be separate elements or integrated within the same component).
As to claim 26, Scott discloses the device of claim 22, wherein: the device is configured to transfer heat with a part that also transmits power, thereby cooling the skin interface surface (e.g., paragraphs [0033], [0036], and [0048]: heat exchanger unit 30 includes heat sink chamber 122 and tubing 124A, 124B where the heat sink absorbs heat from the primary coil 132 of the charging device 20 and skin 106 and the coolant/fluid moving in tubing 124A, 124B moves the heated coolant away so that the primary coil and skin decrease in temperature).
With respect to claim 29, Scott discloses the device of claim 22, wherein: the inductive power transmission apparatus includes an induction coil that is a heat pipe (e.g., paragraph [0032]: primary coil 132 is an inductor which conveys heats that can be absorbed by heat sink chamber 122 – see paragraph [0036]).
Regarding claim 30, Scott discloses a device (e.g., abstract), comprising: a battery charging apparatus (e.g., Fig. 1, charging device 20 and paragraph [0048]: device 20 recharges rechargeable power source 18); and a cooling apparatus (e.g., Fig. 1, heat exchanger 30 and paragraph [0035]: heat exchanger 30 may operate according to a Peltier effect that is capable of cooling the surface of the skin of the patient below a desired threshold temperature), wherein the device is a dedicated prosthesis component charging device configured to recharge a power storage portion of the prosthesis component while cooling an assembly of which the power storage portion is a part (e.g., paragraphs [0002]-[0003]: Scott discloses that its invention can be used with IMDs that replace a body part function of a patient (prosthesis system) and that those IMDs need recharging wirelessly).
With respect to claim 32, Scott discloses the device of claim 30, wherein: the device includes a means for cooling the prosthesis component (e.g., paragraphs [0004] and [0036]: system for actively cooling tissue near an implantable medical device (IMD) to a temperature below body temperature would necessarily cool the IMD as well).
As to claim 33, Scott discloses the device of claim 30, wherein: the device is a fast charger (e.g., paragraph [0043]: a system according to the techniques of the disclosure allows for inductive heating at a rate much higher than other systems because the heat generated by fast rates of recharge is removed from the system before it can accumulate to undesirable levels) for an implant charger for a totally implantable cochlear implant (intended use).
With respect to claim 34, Scott discloses the device of claim 30, wherein: the device includes a compartment sized and dimensioned to receive the prosthesis component; and the device is configured to reduce an air temperature within the compartment by at least 5 degrees Celsius relative to an ambient air temperature of air in which the device is located (e.g., paragraph [0038]: heat exchanger unit 120 may cool the skin to a temperature range below the normal ambient surface temperature of the skin approximately 28 to 32 degrees Celsius where the skin is cooled to below 25 degree Celsius or below 22 degrees Celsius – a 6 degree Celsius difference).
As to claim 35, Scott discloses the device of claim 30, wherein: the prosthesis component is inductively coupled to the device; and the device is capable of fully recharging the prosthesis component from at least a 90% depleted battery state in a time period that is at least 30% shorter than that which would otherwise be the case in the absence of the availability of the functionality of the cooling device, all other things being equal, such that the skin interface component is not above 41 degrees Celsius at the end of the time period when an ambient air temperature of the device is at least 35 degrees Celsius in a shaded still air condition (e.g., paragraphs [0038] as above; [0107]: without an active cooling system, the battery of the IMD was only able to deliver 30% of the energy required to fully charge the battery before recharge was terminated); and [0108]: with the cooling system, the IMD battery was able to be fully charged – thus, the cooling system enabled charging to full state in at least 30% shorter time period than the non-cooling system since less than a third of the battery was charged).
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.
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.
Claims 27, 31 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Scott in view of US Patent Application Publication Nos. 2009/0096413 to Partovi et al. (hereinafter referred to as “Partovi”) and US 2022/0249844 to Alfsmann et al (hereinafter referred to as “Alfsmann”).
With respect to claim 27, Scott discloses the device of claim 22, wherein: the cooling sub-system is configured to transfer heat from the skin interface surface to a location on the device opposite the skin interface surface (e.g., Fig. 1 and paragraph [0036]: surface of heat sink chamber 122 adjacent skin 106 is cooled by the cooling sub-system 30 and is capable of transferring heat from the skin surface of the heat sink chamber 122 to a location opposite the skin surface as heat exchanging unit 120 is located opposite to the skin surface); but does not expressly disclose that the device is an off the ear charging device or an off the ear sound processor. However, Partovi, in a related art: systems and method for inductive charging of portable device, teaches that inductive power transfer can provide an ideal non-contact method for charging cochlear implants, hearing aids, or other monitoring devices that need periodic charging (e.g., paragraph [0164] of Partovi) where a cochlear implant is an off the ear device that needs power charging. Alfsmann further teaches that a cochlear implant employs a headpiece 206 that is communicatively coupled to a corresponding implantable antenna that is included within the cochlear implant 102 in order to wirelessly and transcutaneously transmit stimulation parameters and/or power signals (e.g., paragraph [0041] and Fig. 2 of Alfsmann). That is, Alfsmann teaches that the cochlear implant uses a headpiece (which is off the ear) to charge the cochlear implant. Accordingly, one of ordinary skill in the art would have recognized the benefits of providing power to an implanted cochlear implant using an off the ear charging device using an inductive power transmission sub-system in view of the teachings of Partovi and Alfsmann. Consequently, one of ordinary skill in the art would have modified the implantable medical device of Scott to be a cochlear implant and its inductive charging unit and heat exchanging unit to be located at the headpiece of the cochlear implant in view of the teachings of Partovi and Alfsmann, and because the combination would have yielded a predictable result.
As to claim 31, Scott discloses the device of claim 30, but does not expressly disclose that the device is a dedicated hearing prosthesis component charging device. However, as discussed above, Partovi and Alfsmann teach that a cochlear implant would have a dedicated charger located in the headpiece that to wirelessly and transcutaneously transmit power signals inductively. Consequently, one of ordinary skill in the art would have modified the implantable medical device of Scott to be a cochlear implant, a dedicated hearing prosthesis, and its inductive charging unit and heat exchanging unit, charging device, to be located at the headpiece of the cochlear implant in view of the teachings of Partovi and Alfsmann, and because the combination would have yielded a predictable result.
With respect to claim 40, Scott discloses the device of claim 22, but does not expressly disclose that the IMD is a behind-the-ear (BTE) device of an implantable hearing prosthesis configured to capture sound and generate an induction signal based on the captured sound to be transcutaneously transmitted by a headpiece of the BTE device to an implanted portion of the implantable hearing prosthesis and the skin interface is part of the headpiece of the BTE device. However, Partovi, in a related art: system and method for inductive charging of portable device, teaches that it was known in the medical arts to use inductive power transfer to charge cochlear implants (e.g., paragraph [0164]). And, Alfsmann, in a related art: cochlear implant system, teaches that a behind-the-ear device was known to those skilled in the art as housing the sound processor 22 and microphone 204 of the cochlear implant system 200 and includes a headpiece 206 to transmit transcutaneously signals to the cochlear implant 102 (e.g., paragraphs [0038]-[0039] and [0041]-[0042]). That is, Alfsmann teaches that the cochlear implant uses a headpiece (skin interface) to charge the cochlear implant. Accordingly, one of ordinary skill in the art would have recognized the benefits of providing power to an implanted cochlear implant using a headpiece using an inductive power transmission sub-system in view of the teachings of Partovi and Alfsmann. Consequently, one of ordinary skill in the art would have modified the implantable medical device of Scott to be a cochlear implant and its inductive charging unit and heat exchanging unit to be located at the headpiece of the cochlear implant in view of the teachings of Partovi and Alfsmann, and because the combination would have yielded a predictable result.
As to claim 41, Scott discloses the device of claim 30, wherein: the device is configured to directly contact a component during recharging of the power storage portion (e.g., paragraph [0004]: the system may cool a region of tissue and skin between the IMD and an external charger to a temperature below a normal surface skin temperature during wireless inductive coupling between the primary coil of the external charger and a secondary coil of the IMD where Fig. 1 show a component (heat sink chamber 122) directly contacts the primary coil 132 of the device, and paragraphs [0036] and [0090]-[0091] describing Figs. 6A-6B), but does not expressly disclose that the device (battery charger and cooling apparatus) is configured to directly contact a prosthesis component during recharging of the power storage portion. However, as discussed above, Partovi and Alfsmann, teach that when the implantable medical device of Scott is an implantable hearing prosthesis, a headpiece is used to inductively transfer energy to the implant. Accordingly, one of ordinary skill in the art would have recognized the benefits of adding a cooling apparatus to the headpiece that carries a primary coil to transfer energy to the cochlear implant in view of the teachings of Partovi and Alfsmann. Consequently, one of ordinary skill in the art would have modified the device of Scott so that the prosthetic component being recharged is a cochlear implant in view of the teachings of Partovi and Alfsmann that such was a well-known prosthetic in the medical arts, and because the combination would have yielded a predictable result.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Scott in view of legal precedent.
Scott discloses the device of claim 1, wherein, the device includes a skin interface surface (e.g., Fig. 1, heat sink chamber surface 122 placed on skin 106 directly above IMD 110; and paragraphs [0032]-[0036]), but does not expressly disclose that the device is configured so that power can be transferred at a rate of at least 1.5 times that which would be the case in the absence of the dedicated heat arrangement while maintaining a same temperature of the skin interface surface, all other things being equal. Scott does disclose that without its dedicated heat transfer arrangement the inductive charger transfer energy to the battery is at a slow rate to prevent the temperature of the IMD from exceeding a level harmful to the patient (e.g., paragraph [0003]) and that with the dedicated heat transfer arrangement, the system may actively cool the skin to allow for higher recharge power and higher energy transfer rates that achieve a faster recharge of the battery of the IMD by cooling a region of tissue and skin between the IMD and an external charger during wireless inductive coupling (e.g., paragraphs [0004], [0026], [0028]: heat transfer unit allows an inductive recharger to recharge at rates of at least 2800mW; and [0043]: inventive system allows for inductive charging of an IMD at a rate much higher than other systems because the heat generated by fast rates of recharge is removed from the system before it can accumulate to undesirable levels and risk harm to the patient). Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by Scott so that the power transfer rate is at least 1.5 times that of a system without the dedicated heat transfer arrangement, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the transfer rate of “at least 1.5 times”.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Scott in view of US Patent Application Publication No. 2015/0216 to Diller et al. (hereinafter referred to as Diller”).
Scott discloses the device of claim 30, but does not expressly disclose that the device is configured to cool the assembly by convection heat transfer directly from a component. Scott discloses a skin interface surface which is cooled by heat transfer (e.g., Fig. 1, heat sink chamber surface 122 placed on skin 106 directly above IMD 110; and paragraphs [0032]-[0036]). Diller, in a related art: devices, systems, and methods for thermoelectric heating and cooling of mammalian tissue, teaches that a heat sink may provide a cooling fan 804 to provide forced convection heat transfer (e.g., paragraph [0077] and Fig. 8B). Thus, one of ordinary skill in the art would have recognized the benefits of using convection heat transfer directly from a component, such as a heat sink, in view of the teachings of Diller. Consequently, one of ordinary skill in the art would have modified the device of Scott to include a fan to remove heat by forced heat transfer directly from the heat sink in view of the teachings of Diller, and because the combination would have yielded a predictable result.
It is the Office Action’s position that a component of the recharging and cooling device can be a prosthesis component, or a component used to charge the prosthesis.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792