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
This application is the national stage entry under 35 USC 371 of PCT/IB2022/050726 filed 27 January 2022 which claims the benefit of domestic priority from US Provisional Application no. 63/142,256 filed 27 January 2021.
Election/Restrictions
Applicant's election with traverse of Invention II, pertaining to claims 19-25 in the reply filed on 24 November 2025 is acknowledged.
Claims 1-7 and 34-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Inventions I and III, there being no allowable generic or linking claim.
The traversal is on the ground(s) that sub-section b of 36 CFR 1.475 was not addressed. This subsection is addressed below.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Group I. Claims 1-4 and 6-7, drawn to a method of operating a transcutaneous power transfer apparatus with active cooling.
Group II. Claims 19-25, drawn to a device/handpiece having a dedicated passive conduction thermal transfer apparatus.
Group III. Claims 34-40, drawn to a dedicated prosthesis charging device with integrated cooling.
According to sub-section b of 37 CFR 1.475: are the claims directed to a combination as in (1)? No, there is no process recited for manufacture of the product claim; A combination as in (2)? Group I and Group II are product and process, however the method of process (i.e., passive cooling structure) is different than product structure (i.e., active cooling), so no Group II is not a process of use of the product since there is a different technical feature recited by each product. Group II and Group III are product and product, and these products are distinct since they have different designs and special technical features. Group III relates to structure for charging a prosthesis and cooling the prosthesis for influencing the charging process. Group III is not limited to transcutaneous charging apparatus or components, does not require a passive thermal mass at the skin interface, nor is it clear from Group III if the cooling function is performed actively or passively. Thus, Group II and III are materially different in design and function, whereas Group III is an entirely different structural solution. Similarly, in contrast to Group I, Group III does not require transcutaneous energy transfer, may utilize passive cooling rather than active, and requires a compartment for charging and cooling the prosthesis, Group I is not considered a method of use of Group III. In view of this, neither of Groups I, II, or III can be said to have a relationship as in (2) of sub-section b of 37 CFR 1.475. Subsequently, in view of the considerations of (1) and (2) of sub-section b of 37 CFR 1.475, none of the other combinations of (3), (4), or (5) pertain.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The special technical feature of Group I is step for active cooling of an apparatus. The special technical feature of Group II is a passive cooling structure. The special technical feature of Group III includes the integration of a cooling device into a dedicated prosthesis component charging device requiring a compartment for placing the prosthesis in order to influence the charging process.
Groups I-III are deemed to lack unity of invention because even though the inventions of these groups require the technical feature of a transcutaneous power transmission system (i.e., a battery charging system) for transferring power to an implantable medical device through a skin interface and generic cooling feature, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Thompson et al. (US Publication no. 2014/0233184). Figures 1A-1B of Thompson et al. illustrate an external transcutaneous power transmission system 10 comprising a cooling element 45 and configured to transfer power to an implantable medical device 80.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
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 25 is 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. Line 3 recites “device” it is considered indefinite if this refers to the device of the preamble or the implanted device. Clarification is respectfully requested.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thompson et al. (US Publication no. 2014/0233184).
In regard to claim 19, Thompson et al. disclose an inductive power transmission system (para 12 and 36, transcutaneous energy transmission TET system comprising external charging accessory ECA 10) configured to transfer power to an implanted medical device 80 (para 36, ECA 10 is used to transfer energy to an implanted medical device);
a skin interface surface (para 36, ECA 10 includes a heat accumulation structure 40a that is thermally coupled to the patient's skin); and
a dedicated passive conduction thermal transfer apparatus (para 36, 39, and 40, heat accumulation structure 40 comprising phase change material 45) configured for temperature management of the device during the transfer of power (para 8-9, 38, a phase changing material PCM acts as a heat sink to absorb thermal energy generated through an energy transfer process; figures 1A-1G depict various configurations for orienting the heat accumulation structure 40 with respect to the ECA 10 housing and skin).
In regard to claim 20, the dedicated passive conduction thermal transfer apparatus is a dedicated thermal mass configured for thermal mass cooling of the device (para 36, 39, and 40, heat accumulation structure 40 comprises thermally phase change material 45; para 8-9, 38, PCM 45 acts as a heat sink to absorb thermal energy generated through an energy transfer process thereby allowing for self-cooling of the TET; para 40, thermally conductive material may include but are not limited to thermally conductive elastomers marketed under the trade name Cool Poly.TM., and thermally conductive co-polyester elastomers. The PCM acts as a heat sink, adsorbing thermal energy generated in the implanted medical device, effectively maintaining the adjacent tissue temperature below a threshold).
In regard to claim 21, the dedicated passive conduction thermal transfer apparatus 40 is thermally insulated from an ambient environment (para 44, PCM 45 is encased in portion 46 of enclosure 48, wherein the portion 46 is constructed of thermally insulating material to insulate PCM 45 from housing 10 and from the environment; insulating portion is considered illustrated in figures 1A-1G as the gap surrounding PCM 45).
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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.
Claim(s) 22, 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al. (US Publication no. 2014/0233184) in view of Single (US Publication no. 2005/0033382), further in view of Kallmyer et al. (WO 2013/062809).
In regard to claim 22, Thompson et al. describe the invention substantially as claimed however do not teach that the device is a headpiece for transcutaneous communication with an implantable hearing prosthesis inductance coil; and there are at least 15 grams of dedicated thermal mass material.
Thompson et al. does suggest that the TET may be useful for devices such as cochlear implants (para 2), however does not show the coil 30 and PCM 45 as part of headpiece for transcutaneous communication with an implantable hearing prosthesis inductance coil. Single depicts in figure 1 an implant recharging device 100 comprising a coil 104 for recharging an implant hearing prosthesis (para 21) and a thermal mass comprised of heat absorbing phase changing material 122 (para 27, 30, and 31).
Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the TET and ECA of Thompson et al. as a device to recharge a hearing prosthesis since it is suggested by Thompson et al. and is explicitly taught by Single.
Neither reference teaches that there are at least 15 grams of dedicated thermal mass material. Kallmyer et al. is directed to heat management for transcutaneous energy transfer recharge coils. To perform heat management, Kallmyer et al. uses heat sink 28 composed of a phase change material (page 13, lines 9-10) wherein the heat sink may include anywhere between 1.0 gram to 100 grams of phase change material (page 15 lines 28-30). The range taught by Kallmyer et al. is recognized to be broader than the claim’s “at least 15 grams” recitation (i.e., Kallmyer et al. includes amounts less than 15 grams) but the range of Kallmyer et al. also substantially overlaps the claimed requirement (i.e., any amount over 15 grams) which can be considered to provide sufficient specificity to satisfy the claimed limitation. Additionally, paragraph 172 of the present disclosure sets forth viable values for the amount of thermal mass material in the range of 10 grams to 75 or more. This teaching fails to set forth any criticality to the actual amount incorporated therein, nor sets forth a criticality as to the 15 gram bottom limit. In view of this, modification of the PCM of Thompson et al. to include at least 15 grams of thermal mass material is considered obvious to one of ordinary skill in the art since Kallmyer et al. teach the range with sufficient specificity that it would not require undue experimentation to discover the optimal amount. Moreover, as there is little on the record why the claimed amount is deemed critical, as the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation
In regard to claim 23, Thompson et al. describe the invention substantially as claimed however do not teach that the device is a headpiece for transcutaneous communication with an implantable hearing prosthesis inductance coil; and there are at least 30 grams of dedicated thermal mass material.
Thompson et al. does suggest that the TET may be useful for devices such as cochlear implants (para 2), however does not show the coil 30 and PCM 45 as part of headpiece for transcutaneous communication with an implantable hearing prosthesis inductance coil. Single depicts in figure 1 an implant recharging device 100 comprising a coil 104 for recharging an implant hearing prosthesis (para 21) and a thermal mass comprised of heat absorbing phase changing material 122 (para 27, 30, and 31).
Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the TET and ECA of Thompson et al. as a device to recharge a hearing prosthesis since it is suggested by Thompson et al. and is explicitly taught by Single.
Neither reference teaches that there are at least 30 grams of dedicated thermal mass material. Kallmyer et al. is directed to heat management for transcutaneous energy transfer recharge coils. To perform heat management, Kallmyer et al. uses heat sink 28 composed of a phase change material (page 13, lines 9-10) wherein the heat sink may include anywhere between 1.0 gram to 100 grams of phase change material (page 15 lines 28-30). The range taught by Kallmyer et al. is recognized to be broader than the claim’s “at least 30 grams” recitation (i.e., Kallmyer et al. includes amounts less than 30 grams) but the range of Kallmyer et al. also substantially overlaps the claimed requirement (i.e., any amount over 15 grams) which can be considered to provide sufficient specificity to satisfy the claimed limitation. Additionally, paragraph 172 of the present disclosure sets forth viable values for the amount of thermal mass material in the range of 10 grams to 75 or more. This teaching fails to set forth any criticality to the actual amount incorporated therein, nor sets forth a criticality as to the 30 gram bottom limit. In view of this, modification of the PCM of Thompson et al. to include at least 30 grams of thermal mass material is considered obvious to one of ordinary skill in the art since Kallmyer et al. teach the range with sufficient specificity that it would not require undue experimentation to discover the optimal amount. Moreover, as there is little on the record why the claimed amount is deemed critical, as the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
In regard to claim 25, Thompson et al. describe the invention as claimed, however do not teach that the dedicated passive conduction thermal transfer apparatus is configured to maintain, when the device is completely off and not being recharged, the mean skin interface surface surface temperature below 30 degrees C for at least 15 minutes in a completely dark ambient air environment of 40 degrees C with the thermal mass being at 5 degrees C at the beginning of the 15 minutes. The limitations here are construed to comprise material properties of the thermal mass as opposed to limitations limiting the structure of the device itself, wherein the thermal mass of the prior must be capable of possessing properties that allow it to perform as intended. In Thompson et al., the thermal mass comprising a phase change material is taught to have properties that permit absorption of various range of temperatures between -5o C to 190o C and to maintain a comfort range of a user in around 20o C to 40o C (Para 9). Thompson et al. also teach that a PCM with a melting point of 6oC may be suitable for use in the application disclosed (para 10). Additionally, Single discloses use of a phase change material that includes use of n-heneicosane (para 34) which is similar to the preferred material disclosed by the present invention. As n-heneicosane is disclosed of a preferred material, it is considered that this PCM necessarily incorporates and possess properties capable of performing as intended by the claim. Furthermore, there is no critical reasoning for the specific starting temperature nor the cooling time provided by the disclosure of the present invention. Therefore, selecting a thermal mass with a temperature of 5oC and cooling period of 15 minutes is considered to have been obvious to one of ordinary skill in the art at the time of the invention since it has been held that selection of a material on the basis of its suitability for the intended use has been held as a matter of routine skill and obvious design choice. Additionally, selection of a thermal mass with these material properties is considered obvious to one of ordinary skill in the art in order to optimize device cooling and patient comfort and safety.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al. (US Publication no. 2014/0233184) in view of Single (US Publication no. 2005/0033382).
In regard to claim 24, Thompson et al. describe the invention substantially as claimed however do not teach that the dedicated passive conduction thermal transfer apparatus includes a low temperature phase change material. Thompson et al. teaches use of thermally conductive materials under tradename Cool Poly.TM., and any other thermally conductive co-polyester elastomers (para 40). As much as this may be considered to comprise a “low temperature” phase change material, it is not explicit from the reference. Single teaches that the thermal mass used therein is comprised of heat absorbing phase changing material 122 (para 27, 30, and 31), wherein the phase changing material 122 is n-heneicosane (para 34). The disclosure of the present invention at paragraph 181 teaches n-heneicosane as an exemplary low temperature phase change material. Modification of the PCM 45 of Thompson et al. to be comprised of a low temperature phase change material is considered to have been obvious to one of ordinary skill since Single explicitly teach suitable materials known to have this property wherein the modification is considered to include the substitution of one known thermal absorbing material for a suitable alternative to yield a predictable result. Moreover, it has been held as obvious that selection of a material based on its suitability for an intended use only requires routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 13 February 2026