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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/23/2024 and 02/06/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-20 are objected to because of the following informalities: the phrase “the system” should be amended to recite “the external coil system” Appropriate correction is required.
Claims 1, 11, and 20 are objected to because of the following informalities: the phrase “and implantable blood pump” in line 2 should be amended to recite “an implantable blood pump” Appropriate correction is required.
Claims 2-10, and 12-19 are objected to because of the following informalities: the phrase “The system of Claim X” should be lowercase and amended to recite “The system of claim X” Appropriate correction is required.
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.
Claims 1-20 are 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(s) 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.
MPEP 2163.05, I, B “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) “
Claims 1, 11, and 20 recite the limitation, “thermally conductive plastic” which the disclosure fails to adequately describe an adequate representative number of species. The phrase “thermally conductive plastic” fails to have proper written description in the specification as the phrase occurs in [0032] which attempted to define the thermally conductive plastic as “thermoplastic elastomer” and “composed of polypropylene”. Although thermally conductive plastics such as Polyether Ether Ketone (PEEK), Nylon (PA6 and PA66), Polyphenylene Sulfide (PPS) are not uncommon in the art, thermoplastic elastomers and polypropylene are generally known as insulators and cannot be considered thermally conductive plastic due to its high electric resistance (see Thermtest Instruments, “Discovering the Thermal Conductivity of Polypropylene”, https://thermtest.com/application/thermal-conductivity-of-polypropylene, 03/17/2025). Furthermore, the recitation of “composed” of polypropylene indicates that polypropylene is mixed with another substance, which is not disclosed. The instant specification fails to disclose the thermally conductive plastic that is used for the instant invention. Therefore, the phrase “thermally conductive plastic” does not comply with the written description requirement of 35 USC 112(a).
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.
Claims 1-20 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.
Independent claims 1 and 11 recite in lines 2-3, "energy sufficient to power and implantable blood pump and controller". Similarly, claim 20 recites in lines 2-3, "energy sufficient to power and implantable blood pump". Claims 1 and 11 are indefinite because it is unclear whether the implantable blood pump and controller are being claimed in combination with the external coil system. Likewise, claim 20 is indefinite because it is unclear whether the implantable blood pump is being claimed in combination with the external coil system. For examination purposes, claims 1 and 11 are being interpreted as only claiming the external coil system being usable with an implantable blood pump and controller. Likewise, for examination purposes, claim 20 is being interpreted as only claiming the external coil system being usable with an implantable blood pump.
Claim 1 recites the limitation "the external coil" in lines 2, 4-5, and 7. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4, and 7 also recite the phrase "the external coil" which also have insufficient antecedent basis.
Claim 11 recites the limitation "the external coil" in lines 2, 4-5, and 7. There is insufficient antecedent basis for this limitation in the claim. Claims 12-14, and 17 also recite the phrase "the external coil" which also have insufficient antecedent basis.
Claim 11 recites the limitation "the foam" in lines 5. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests reciting “the foam base”.
Claim 16 recites the limitation "the thermal insulating base" in lines 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, it is unclear if the one temperature sensor is the same or different than the plurality of temperature sensors of claim 11.
Claim 18 recites the limitation "the base" in lines 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the external coil" in lines 2, 4-5, and 7. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4, 7, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett).
Regarding claim 1, Burnett teaches An external coil system for a transcutaneous energy transfer system (TETS), the external coil being configured to transfer energy sufficient to power and implantable blood pump and controller (Fig. 32-34), the system comprising:
a housing containing the external coil (Fig. 32-34(coil 302, housing 316)), the housing including:
a thermal insulating base, the external coil being partially disposed within the thermal insulating base (Fig. 32-34(interface base plate 318) Examiner notes that the coil is covered, and thereby disposed within, by the plate 318); and
a thermally conductive plastic, the external coil being partially disposed within the thermally conductive plastic ([0210] “thus avoiding contact between the patient interface plate 318 and the non-electrically conductive material 314, e.g., an epoxy.” Examiner notes that epoxy is a plastic that has a low conductance and is a thermal insulator. See the epoxy 314 that is covering the external coil 302.).
Regarding claim 2, Burnett teaches wherein the external coil is sandwiched between the thermal insulating base and the thermally conductive plastic (Fig. 34 shows interface base plate 318 and epoxy 314 enclosing and sandwiching the coil 302.).
Regarding claim 3, Burnett teaches wherein the external coil is enclosed within the thermal insulating base and the thermally conductive plastic (Fig. 34 shows interface base plate 318 and epoxy 314 enclosing the coil 302.).
Regarding claim 4, Burnett teaches wherein the thermal insulating base defines a first channel and the thermally conductive plastic defines a second channel, and wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the thermal insulating base and the thermally conductive plastic (Fig. 34 where first channel 320 of the insulating base and second channel 322 of the conductive plastic, where the coil is sized for the first and second channel.).
Regarding claim 7, Burnett teaches further including at least one temperature sensor disposed between the external coil and the thermally conductive plastic ([0025] “a temperature sensor may be provided to monitor the temperature of the patient interface plate 318. The sensor may be attached to the housing, conductive coil, or patient interface plate, or may be separate from the energy emitting device, but located in close proximity to the patient interface plate 318.”).
Regarding claim 9, Burnett teaches further including a garment alignment fabric layer coupled to the housing ([0119] “FIG. 9C illustrates a coil wrap shaped like a band 114, in which coils 116 are connected to a logic controller (not shown) by a connector 118. When this embodiment is employed, band 114 may be wrapped around a body portion (for example, an arm) and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114.”).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett).
Regarding claim 5, Brunett teaches the invention of claim 1. However, neither Brunett teach a first channel is deeper than the second channel. Although Brunett discloses the two different channels, the first channel being deeper than the second channel can also be used to allow the coil for a snuggle fit. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to first channel is deeper than the second channel, for the purpose of allowing the coil for a snuggle fit, since it has been held to be within the general skill of a worker in the art to select a known size on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett) in view of Bergin et al. (US 8758892)(Hereinafter Bergin).
Regarding claim 6, Brunett teaches the invention of claim 1. However, Brunett does not teach the coating being made of rubber. Bergin, in the same field of endeavor, teaches the heat dissipation of electronic devices (Abstract), and further teaches the thermally conductive plastic being coated with rubber (Col. 2 lines 18-23 “Such materials may contain one or more thermally-conductive particulate fillers dispersed within a polymeric binder, and may be provided in the form of cured sheets, tapes, pads, films and foams. Typical binder materials include silicones, urethanes, thermoplastic rubbers,” Col. 1 lines 19-23 “The thermally conductive foam interface product comprises a layer of a cured elastomeric material having air-filled voids passing at least partially through the interface, and a thermally-conductive particulate filler dispersed in the cured product.”) to provide a thermal pathway between the surfaces (Col. 13 lines 60-67). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett, with the foam base coated with rubber and defining a first channel of Bergin, because such a modification would allow to add mechanical stability to provide a thermal pathway between the surfaces.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett) in view of Holinski et al. (US 20200078596)(IDS)(Hereinafter Holinski).
Regarding claim 8, Brunett teaches the invention of claim 1. However, Brunett does not teach a foam base. Holinski, in the same field of endeavor, teaches a wirelenss interaction between an implantable device and an external device (Abstract), and further teaches wherein the thermal insulating base is composed of foam ([0168] “the dielectric member 1403 includes or comprises one or more of a polychloroprene rubber (e.g., neoprene), a urethane (e.g., PORON MSRS), a foam” [0162] “The external device can include an external inductive coil or midfield device.” See Fig. 14A and 17 where the external device is attached to, and thereby disposed within the foam 1403 (dielectric device).) to indicate proper location of the device for proper communication ([0009]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett, with the foam base of Holinski, because such a modification would allow to indicate proper location of the device for proper communication.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett) in view of Karst et al. (US 20110245892)(Hereinafter Karst).
Regarding claim 10, Brunett teaches the invention of claim 1. However, Brunett does not teach the garment alignment fabric layer is composed of polypropylene. Karst, in the same field of endeavor, teaches an implantable device with an external coil for transcutaneous recharging (Abstract), and further teaches wherein the garment alignment fabric layer is composed of polypropylene ([0162] “Many different insulating materials may be used to form spokes 210 (as well as the rest of the structure that comprises the antenna molding. Various types of polymers, including silicones, polypropylene”) to provide tough, water resistant, and flex resistant material ([0162]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett, with the garment alignment fabric layer is composed of polypropylene of Karst, because such a modification would allow to provide tough, water resistant, and flex resistant material.
Claim(s) 11-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett) in view of Holinski et al. (US 20200078596)(IDS)(Hereinafter Holinski) and Bergin et al. (US 8758892)(Hereinafter Bergin).
Regarding claim 11, Brunett teaches An external coil system for a transcutaneous energy transfer system (TETS), the external coil being configured to transfer energy sufficient to power and implantable blood pump and controller (Fig. 32-34), the system comprising:
a housing containing the external coil (Fig. 32-34(coil 302, housing 316)), the housing including:
a … base, the external coil being partially disposed within the … (Fig. 32-34(interface base plate 318)); and
a thermally conductive plastic, the external coil being partially disposed within the thermally conductive plastic (Fig. 32-34(interface base plate 318)).
However, Brunett does not teach a foam base and a plurality of temperature sensors in the housing. Holinski, in the same field of endeavor, teaches a wireless interaction between an implantable device and an external device (Abstract), and further teaches a foam base, the external coil being partially disposed within the foam ([0168] “the dielectric member 1403 includes or comprises one or more of a polychloroprene rubber (e.g., neoprene), a urethane (e.g., PORON MSRS), a foam” [0162] “The external device can include an external inductive coil or midfield device.” See Fig. 14A and 17 where the external device is attached to, and thereby disposed within the foam 1403 (dielectric device).); and a plurality of temperature sensors disposed within the housing ([0258] “temperature sensor components (e.g., one or more thermometer that detect ambient temperature),”) to indicate proper location of the device for proper communication ([0009]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett, with the foam base and a plurality of temperature sensors in the housing of Holinski, because such a modification would allow to indicate proper location of the device for proper communication.
However, Brunett in view of Holinski does not teach the coating being made of rubber. Bergin, in the same field of endeavor, teaches the heat dissipation of electronic devices (Abstract), and further teaches the thermally conductive plastic being coated with rubber (Col. 2 lines 18-23 “Such materials may contain one or more thermally-conductive particulate fillers dispersed within a polymeric binder, and may be provided in the form of cured sheets, tapes, pads, films and foams. Typical binder materials include silicones, urethanes, thermoplastic rubbers,” Col. 1 lines 19-23 “The thermally conductive foam interface product comprises a layer of a cured elastomeric material having air-filled voids passing at least partially through the interface, and a thermally-conductive particulate filler dispersed in the cured product.”) to provide a thermal pathway between the surfaces (Col. 13 lines 60-67). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett in view of Holinski, with the foam base coated with rubber and defining a first channel of Bergin, because such a modification would allow to add mechanical stability to provide a thermal pathway between the surfaces.
Regarding claim 12, Brunett teaches wherein the external coil is sandwiched between the foam base and the thermally conductive plastic (Fig. 34 shows interface base plate 318 and epoxy 314 enclosing and sandwiching the coil 302.).
Regarding claim 13, Brunett teaches wherein the external coil is enclosed within the foam base and the thermally conductive plastic (Fig. 34 shows interface base plate 318 and epoxy 314 enclosing the coil 302.).
Regarding claim 14, Brunett teaches wherein the foam base defines a first channel and the thermally conductive plastic defines a second channel, and wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the foam base and the thermally conductive plastic (Fig. 34 where first channel 320 of the insulating base and second channel 322 of the conductive plastic, where the coil is sized for the first and second channel.).
Regarding claim 15, Brunett in view of Holinski and teaches the invention of claim 1. However, neither Brunett teach a first channel is deeper than the second channel. Although Brunett discloses the two different channels, the first channel being deeper than the second channel can also be used to allow the coil for a snuggle fit. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to first channel is deeper than the second channel, for the purpose of allowing the coil for a snuggle fit, since it has been held to be within the general skill of a worker in the art to select a known size on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 16, Brunett teaches the invention of claim 1. However, Brunett does not teach the coating being made of rubber. Bergin, in the same field of endeavor, teaches the heat dissipation of electronic devices (Abstract), and further teaches the thermally conductive plastic being coated with rubber (Col. 2 lines 18-23 “Such materials may contain one or more thermally-conductive particulate fillers dispersed within a polymeric binder, and may be provided in the form of cured sheets, tapes, pads, films and foams. Typical binder materials include silicones, urethanes, thermoplastic rubbers,” Col. 1 lines 19-23 “The thermally conductive foam interface product comprises a layer of a cured elastomeric material having air-filled voids passing at least partially through the interface, and a thermally-conductive particulate filler dispersed in the cured product.”) to provide a thermal pathway between the surfaces (Col. 13 lines 60-67). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett, with the foam base coated with rubber and defining a first channel of Bergin, because such a modification would allow to add mechanical stability to provide a thermal pathway between the surfaces.
Regarding claim 17, Brunett teaches further including at least one temperature sensor disposed between the external coil and the thermally conductive plastic ([0025] “a temperature sensor may be provided to monitor the temperature of the patient interface plate 318. The sensor may be attached to the housing, conductive coil, or patient interface plate, or may be separate from the energy emitting device, but located in close proximity to the patient interface plate 318.”).
Regarding claim 18, Brunett teaches further including a garment alignment fabric layer coupled to the base, the garment alignment fabric layer being configured to couple the housing to a garment ([0119] “FIG. 9C illustrates a coil wrap shaped like a band 114, in which coils 116 are connected to a logic controller (not shown) by a connector 118. When this embodiment is employed, band 114 may be wrapped around a body portion (for example, an arm) and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric [garment] or other material in another portion of band 114.”).
Regarding claim 20, Brunett teaches An external coil system for a transcutaneous energy transfer system (TETS), the external coil being configured to transfer energy sufficient to power and implantable blood pump (Fig. 32-34), the system comprising:
a housing enclosing the external coil (Fig. 32-34(coil 302, housing 316)), the housing including:
a thermally conductive plastic defining a second channel, the external coil is sized to be received within the first channel and the second channel when sandwiched between the foam base and the thermally conductive plastic ([0210] “thus avoiding contact between the patient interface plate 318 and the non-electrically conductive material 314, e.g., an epoxy.” Examiner notes that epoxy is a plastic that has a low conductance and is a thermal insulator. Fig. 34 shows interface base plate 318 and epoxy 314 enclosing and sandwiching the coil 302.); and
a garment alignment fabric layer coupled to the housing ([0119] “FIG. 9C illustrates a coil wrap shaped like a band 114, in which coils 116 are connected to a logic controller (not shown) by a connector 118. When this embodiment is employed, band 114 may be wrapped around a body portion (for example, an arm) and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114.”).
However, Brunett does not teach a foam base and a plurality of temperature sensors in the housing. Holinski, in the same field of endeavor, teaches a wireless interaction between an implantable device and an external device (Abstract), and further teaches a foam base, the external coil being partially disposed within the foam ([0168] “the dielectric member 1403 includes or comprises one or more of a polychloroprene rubber (e.g., neoprene), a urethane (e.g., PORON MSRS), a foam” [0162] “The external device can include an external inductive coil or midfield device.” See Fig. 14A and 17 where the external device is attached to, and thereby disposed within the foam 1403 (dielectric device).); and a plurality of temperature sensors disposed within the housing on the surface of the external coil ([0258] “temperature sensor components (e.g., one or more thermometer that detect ambient temperature),”) to indicate proper location of the device for proper communication ([0009]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett, with the foam base and a plurality of temperature sensors in the housing of Holinski, because such a modification would allow to indicate proper location of the device for proper communication.
However, Brunett in view of Holinski does not teach the coating being made of rubber. Bergin, in the same field of endeavor, teaches the heat dissipation of electronic devices (Abstract), and further teaches a foam base coated with rubber and defining a first channel (Col. 2 lines 18-23 “Such materials may contain one or more thermally-conductive particulate fillers dispersed within a polymeric binder, and may be provided in the form of cured sheets, tapes, pads, films and foams. Typical binder materials include silicones, urethanes, thermoplastic rubbers,” Col. 1 lines 19-23 “The thermally conductive foam interface product comprises a layer of a cured elastomeric material having air-filled voids passing at least partially through the interface, and a thermally-conductive particulate filler dispersed in the cured product.”) to provide a thermal pathway between the surfaces (Col. 13 lines 60-67). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett in view of Holinski, with the foam base coated with rubber and defining a first channel of Bergin, because such a modification would allow to add mechanical stability to provide a thermal pathway between the surfaces.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. (US 20110021863)(IDS)(Hereinafter Burnett) in view of Holinski et al. (US 20200078596)(IDS)(Hereinafter Holinski), Bergin et al. (US 8758892)(Hereinafter Bergin), and Karst et al. (US 20110245892)(Hereinafter Karst).
Regarding claim 19, Brunett in view of Holinski and Bergin teach the invention of claim 1. However, Brunett in view of Holinski and Bergin does not teach the garment alignment fabric layer is composed of polypropylene. Karst, in the same field of endeavor, teaches an implantable device with an external coil for transcutaneous recharging (Abstract), and further teaches wherein the garment alignment fabric layer is composed of polypropylene ([0162] “Many different insulating materials may be used to form spokes 210 (as well as the rest of the structure that comprises the antenna molding. Various types of polymers, including silicones, polypropylene”) to provide tough, water resistant, and flex resistant material ([0162]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Brunett in view of Holinski and Bergin, with the garment alignment fabric layer is composed of polypropylene of Karst, because such a modification would allow to provide tough, water resistant, and flex resistant material.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 12138442 (Hereinafter ‘442). Although the claims at issue are not identical, they are not patentably distinct from each other because the systems of ‘442 requires the systems of 18/909328.
Regarding claim 1, ‘442 teaches An external coil system for a transcutaneous energy transfer system (TETS), the external coil being configured to transfer energy sufficient to power and implantable blood pump and controller (Claim 1 “An external coil system for a transcutaneous energy transfer system (TETS)… an external coil configured to transfer energy sufficient to power an implantable blood pump;”), the system comprising:
a housing containing the external coil (Claim 1 “a housing”), the housing including:
a thermal insulating base, the external coil being partially disposed within the thermal insulating base (Claim 1 “a thermal insulating base, the external coil being partially disposed within and contacting the thermal insulating base;”); and
a thermally conductive plastic, the external coil being partially disposed within the thermally conductive plastic (Claim 1 “a thermally conductive plastic, the external coil being partially disposed within and contacting the thermally conductive plastic.”).
Regarding claim 2, ‘442 teaches wherein the external coil is sandwiched between the thermal insulating base and the thermally conductive plastic (Claim 2 “wherein the external coil is sandwiched between the thermal insulating base and the thermally conductive plastic.”).
Regarding claim 3, ‘442 teaches wherein the external coil is enclosed within the thermal insulating base and the thermally conductive plastic (Claim 3 “wherein the external coil is enclosed within the thermal insulating base and the thermally conductive plastic.”).
Regarding claim 4, ‘442 teaches wherein the thermal insulating base defines a first channel and the thermally conductive plastic defines a second channel, and wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the thermal insulating base and the thermally conductive plastic (Claim 4 “wherein the thermal insulating base defines a first channel and the thermally conductive plastic defines a second channel, and wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the thermal insulating base and the thermally conductive plastic.”).
Regarding claim 5, ‘442 teaches wherein the first channel is deeper than the second channel (Claim 5 “wherein the first channel is deeper than the second channel.”).
Regarding claim 6, ‘442 teaches wherein the thermal insulating base is coated with rubber (Claim 6 “wherein the thermal insulating base is coated with rubber.”).
Regarding claim 7, ‘442 teaches further including at least one temperature sensor disposed between the external coil and the thermally conductive plastic (Claim 7 “further including at least one temperature sensor disposed between the external coil and the thermally conductive plastic.”).
Regarding claim 8, ‘442 teaches wherein the thermal insulating base is composed of foam (Claim 8 “wherein the thermal insulating base comprises foam.”).
Regarding claim 9, ‘442 teaches further including a garment alignment fabric layer coupled to the housing (Claim 9 “further including a garment alignment fabric layer coupled to the housing.”).
Regarding claim 10, ‘442 teaches wherein the garment alignment fabric layer is composed of polypropylene (Claim 10 “wherein the garment alignment fabric layer comprises polypropylene.”).
Regarding claim 11, ‘442 teaches An external coil system for a transcutaneous energy transfer system (TETS), the external coil being configured to transfer energy sufficient to power and implantable blood pump and controller (Claim 11 “An external coil system for a transcutaneous energy transfer system (TETS)… an external coil configured to transfer energy sufficient to power an implantable blood pump”), the system comprising:
a housing containing the external coil (Claim 11 “a housing comprising: a foam base, the external coil”), the housing including:
a foam base, the external coil being partially disposed within the foam (Claim 11 “a foam base, the external coil being partially disposed within the foam base;”); and
a thermally conductive plastic, the external coil being partially disposed within the thermally conductive plastic, the thermally conductive plastic being coated with rubber (Claim “a thermally conductive plastic, the external coil being partially disposed within the thermally conductive plastic, the thermally conductive plastic being coated with rubber;”); and
a plurality of temperature sensors disposed within the housing (Claim 11 “a plurality of temperature sensors disposed within the housing.”).
Regarding claim 12, ‘442 teaches wherein the external coil is sandwiched between the foam base and the thermally conductive plastic (Claim 12 “wherein the external coil is sandwiched between the foam base and the thermally conductive plastic.”).
Regarding claim 13, ‘442 teaches wherein the external coil is enclosed within the foam base and the thermally conductive plastic (Claim 13 “wherein the external coil is enclosed within the foam base and the thermally conductive plastic.”).
Regarding claim 14, ‘442 teaches wherein the foam base defines a first channel and the thermally conductive plastic defines a second channel, and wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the foam base and the thermally conductive plastic (Claim 14 “wherein the foam base defines a first channel and the thermally conductive plastic defines a second channel, and wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the foam base and the thermally conductive plastic.”).
Regarding claim 15, ‘442 teaches wherein the first channel is deeper than the second channel (Claim 15 “wherein the first channel is deeper than the second channel.”).
Regarding claim 16, ‘442 teaches wherein the thermal insulating base is coated with rubber (Claim 16 “wherein the foam base is coated with rubber.”).
Regarding claim 17, ‘442 teaches further including at least one temperature sensor disposed between the external coil and the thermally conductive plastic (Claim 17 “wherein at least one temperature sensor of the plurality of temperature sensors is disposed between the external coil and the thermally conductive plastic.”).
Regarding claim 18, ‘442 teaches further including a garment alignment fabric layer coupled to the base, the garment alignment fabric layer being configured to couple the housing to a garment (Claim 18 “further including a garment alignment fabric layer coupled to the foam base, the garment alignment fabric layer being configured to couple the housing to a garment.”).
Regarding claim 19, ‘442 teaches wherein the garment alignment fabric layer is composed of polypropylene (Claim 19 “wherein the garment alignment fabric layer comprises polypropylene.”).
Regarding claim 20, ‘442 teaches An external coil system for a transcutaneous energy transfer system (TETS), the external coil being configured to transfer energy sufficient to power and implantable blood pump (Claim 20 “An external coil system for a transcutaneous energy transfer system (TETS), the system comprising: an external coil configured to transfer energy sufficient to power an implantable blood pump;”), the system comprising:
a housing enclosing the external coil (Claim 20 “a housing comprising: a foam base coated with rubber and defining a first channel;”), the housing including:
a foam base coated with rubber and defining a first channel (Claim 20 “a housing comprising: a foam base coated with rubber and defining a first channel;”);
a thermally conductive plastic defining a second channel, the external coil is sized to be received within the first channel and the second channel when sandwiched between the foam base and the thermally conductive plastic (Claim 20 “a thermally conductive plastic defining a second channel, wherein the external coil is sized to be received within the first channel and the second channel when sandwiched between the foam base and the thermally conductive plastic;”); and
a plurality of temperature sensors disposed within the housing on the surface of the external coil (Claim 20 “a plurality of temperature sensors disposed within the housing on a surface of the external coil;”);
a garment alignment fabric layer coupled to the housing (Claim 20 “garment alignment fabric layer coupled to the housing.”).
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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