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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered. Claims 1-17 are currently pending and under examination.
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 8 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. Claim 8 recites “wherein the connection system is designed to transmit wireless a power of at least 2 W”, it is unclear what further structural limitations of the connection system applicant is attempting to encompass when reciting “designed to transmit wireless a power of at least 2 W”, clarification is required. Paragraph [0022] of the specification as filed recites “The connection system is generally designed to wirelessly transmit a power of at least 2W” which appears to recite almost verbatim what is within claim 8 but does not provide any further details regarding what further structural limitations applicant is attempting to encompass or what structure(s) or structural elements would be considered “designed to transmit wireless a power of at least 2 W”. For the purposes the examination it has been interpreted to include any connection system that is able to communicate wirelessly.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0030652 to Arndt et al. (Arndt) in view of US 2018/0311427 to Duhamel et al. (Duhamel) (both previously cited).
In reference to at least claim 1
Arndt discloses a connection system (e.g. cable connector 2 with connection elements 8-10 and cables 3,4 and 6) for transmitting energy and/or data to or from an implantable blood pump, the connection system (e.g. “Many such implants are provided with electrical devices, for example sensors or also motors or control devices, which, for example for the purpose of energy supply or communication, are to be connected by way of percutaneous cables to the region outside the patient's body, into which they are implanted (e.g. para. [0003]) comprising: a first connection unit connected to the blood pump (e.g. implantable cable 4 connected to connection element 8 is the “first connection unit” which is connected to blood pump 5, Figs. 1-2,5 para. [0053]); a second connection unit (e.g. implantable cable 3 containing cable connection 3a connected to connection element 10 is the “second connection unit” which is connected to a device outside the body, para. [0064]); wherein the first connection unit is wirelessly coupled to the second connection to permit wireless transmission of energy and/or data from the second connection unit to the first connection unit (e.g. electronic device 28 within cable connector 2 “serves for the wireless communication between implants which are connected to the cable connector, and a device outside..connected to the circuit board 26 via plug ins”, para. [0064]), further wherein the first connection unit and the second connection unit are implantable (e.g. implantable cable 4 and implantable cable 3 along with cable connector 2 are implanted, Fig. 1), so that both the first connection unit and the second connection unit are designed for use within a body of a patient (e.g. implantable cable 4 and implantable cable 3 along with cable connector 2 are implanted, Fig. 1). Regarding the second connection unit being connected to a control and/or energy unit, Arndt discloses “Many such implants are provided with electrical devices, for example sensors or also motors or control devices, which, for example for the purpose of energy supply or communication, are to be connected by way of percutaneous cables to the region outside the patient's body, into which they are implanted (e.g. para. [0003]), therefore it would have been obvious to one having ordinary skill in the art that the implantable cable 3 containing cable connection 3a is connected to a device outside the body such as a control and/or energy device. In the alternative, using a percutaneous lead such as cable 3 containing cable connection 3a to connect an implanted blood pump to an extracorporeal system control device and/or power sources was well-known in the art as evidence by Duhamel (e.g. connection 28 connects to system controller 20 and power sources 22, Fig. 1, para. [0038]-[0039]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the implantable cable 3 containing cable connection 3a to an extracorporeal system control device and/or power sources in order to provide control and/or power to the implanted pump.
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In reference to at least claim 2
Arndt discloses wherein the first connection unit has at least one coil and the second connection unit has at least one coil (e.g. electronic device 28 which is connected to connection elements 8 and 10 is provided with an antenna “coil”, para. [0064]), wherein the first connection unit and the second connection unit can be inductively coupled to each other via the coils for wireless transmission of energy and/or data (e.g. “An electronic device 28 which serves for the wireless communication between implants which are connected to the cable connector, para. [0064]).
In reference to at least claim 3
Arndt discloses wherein the first connection unit has a housing (e.g. implantable cable 4 connected to connection element 8 is the “first connection unit” includes a housing 19, Fig. 2, para. [0056]), and the second connection unit has a housing (e.g. implantable cable 3 containing cable connection 3a connected to connection element 10 is the “second connection unit” includes a housing 19, Fig. 2, para. [0056]), wherein the housing of the first connection unit and the housing of the second connection unit are liquid-tight and impervious to bodily fluids (e.g. “seals to the outside in a fluid-tight manner is provided in the plug housing 19”, para. [0055]-[0056]).
In reference to at least claim 4
Arndt discloses a mechanical connection means by which the first connection unit and the second connection unit can be releasably connected to each other (e.g. connection cable 4 and connection cable 3 are each releasably connected to cable connector 2 “by way of a union nut which can be screwed on the cable connector 2 or by way of a bayonet connection between the plug 17 and the metal cylinder 11”, para. [0033], [0057]).
In reference to at least claim 5
Arndt discloses wherein the mechanical connection means establishes a connection between the first connection unit and the second connection unit requiring an action of force of at least 10 N in order to be released (e.g. connection cable 4 and connection cable 3 are each releasably connected to cable connector 2 “by way of a union nut which can be screwed on the cable connector 2 or by way of a bayonet connection between the plug 17 and the metal cylinder 11”, para. [0033], [0057], which require a force of “at least 10 N in order to be released).
In reference to at least claim 6
Arndt discloses wherein the mechanical connection means is a screw closure, a bayonet closure, a detent closure, or a snap-action closure (e.g. connection cable 4 and connection cable 3 are each releasably connected to cable connector 2 “by way of a union nut which can be screwed on the cable connector 2 or by way of a bayonet connection between the plug 17 and the metal cylinder 11”, para. [0033], [0057]).
In reference to at least claim 7
Arndt discloses a mechanical orientation means, by which the first connection unit and the second connection unit can be oriented relative to each other so that the first connection unit and the second connection unit come to lie in a predefined orientation relative to each other (e.g. “the plug-in connection elements 8, 9, 10 are fixed in a manner such that their plug-in axes 8a, 9a, 10a run parallel to one another.”,para. [0058], [0061]).
In reference to at least claim 8
Arndt discloses wherein the connection system is designed to transmit wirelessly a power of at least 2 W (e.g. electronic device 28 within cable connector 2 “serves for the wireless communication between implants which are connected to the cable connector,”, para. [0064]).
In reference to at least claim 9
Arndt discloses wherein the first connection unit and the second connection unit have a flat design (e.g. “A flat form of the cable connector”, para. [0024]).
In reference to at least claim 10
Arndt discloses a system according to claim 1 but does not explicitly teach the first connection unit and the second connection unit have a total height of less than 20 mm when the connection units are in contact. It would have been an obvious matter of design choice to modify the Arndt reference, to have the first connection unit and the second connection unit have a total height of less than 20 mm, since applicant has not disclosed that having the first connection unit and the second connection unit have a total height of less than 20 mm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that the first connection unit and the second connection unit have a total height of less than 20 mm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 11
Arndt discloses a system according to claim 1 but does not explicitly teach the first connection unit and the second connection unit have a diameter of at most 40 mm. It would have been an obvious matter of design choice to modify the Arndt reference, to have the first connection unit and the second connection unit have a diameter of at most 40 mm, since applicant has not disclosed that having the first connection unit and the second connection unit have a diameter of at most 40 mm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that the first connection unit and the second connection unit have a diameter of at most 40 mm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 12
Arndt discloses wherein the first connection unit and the second connection unit have a rounded design for any components that are to be brought into connection with the body (e.g. “Such a cable connector designed in a largely rounded manner”, para. [0022], “A flat form of the cable connector.., wherein the corners can be rounded”, para. [0024]).
In reference to at least claim 13
Arndt discloses wherein the first connection unit and/or the second connection unit is deformable (e.g. implantable cable 4 which is part of the first connection unit and implantable cable 3 which is part of the second connection unit is deformable, Fig. 1).
In reference to at least claim 15
Arndt discloses “Many such implants are provided with electrical devices, for example sensors or also motors or control devices, which, for example for the purpose of energy supply or communication, are to be connected by way of percutaneous cables to the region outside the patient's body, into which they are implanted (e.g. para. [0003]), therefore it would have been obvious to one having ordinary skill in the art that the implantable cable 3 containing cable connection 3a is connected to a device outside the body such as a control and/or energy device. In the alternative, using a percutaneous lead such as cable 3 containing cable connection 3a to connect an implanted blood pump to an extracorporeal system control device and/or power sources was well-known in the art as evidence by Duhamel (e.g. connection 28 connects to system controller 20 and power sources 22, Fig. 1, para. [0038]-[0039]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the implantable cable 3 containing cable connection 3a to an extracorporeal system control device and/or power sources in order to provide control and/or power to the implanted pump.
In reference to at least claim 16
Arndt discloses a cardiac assist system (e.g. implantable pumps 5,7, Figs. 1) comprising: the connection system according to claim 1 (see rejection above); the blood pump (e.g. implantable pump 5). Regarding, the control and/or energy unit, Arndt discloses “Many such implants are provided with electrical devices, for example sensors or also motors or control devices, which, for example for the purpose of energy supply or communication, are to be connected by way of percutaneous cables to the region outside the patient's body, into which they are implanted (e.g. para. [0003]), therefore it would have been obvious to one having ordinary skill in the art that the implantable cable 3 containing cable connection 3a is connected to a device outside the body such as a control and/or energy device. In the alternative, using a percutaneous lead such as cable 3 containing cable connection 3a to connect an implanted blood pump to an extracorporeal system control device and/or power sources was well-known in the art as evidence by Duhamel (e.g. connection 28 connects to system controller 20 and power sources 22, Fig. 1, para. [0038]-[0039]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the implantable cable 3 containing cable connection 3a to an extracorporeal system control device and/or power sources in order to provide control and/or power to the implanted pump.
In reference to at least claim 17
Arndt discloses wherein the wireless coupling permits wireless transmission of energy and/or data from the first connection unit to the second connection unit (e.g. electronic device 28 within cable connector 2 “serves for the wireless communication between implants which are connected to the cable connector, and a device outside..connected to the circuit board 26 via plug ins”, para. [0064]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0030652 to Arndt et al. (Arndt) in view of US 2018/0311427 to Duhamel et al. (Duhamel) as applied to claim 13 further in view of US 2017/0151440 to Parramon et al. (Parramon) (previously cited).
In reference to at least claim 14
Arndt modified by Duhamel renders obvious a system according to claim 13. However, Arndt does not explicitly teach wherein the first connection unit and/or the second connection unit comprises silicone.
Parramon discloses an implantable generator which includes a housing (e.g. 212) and a silicone overmold (e.g. 250) that covers edges of the housing to provide soft surfaces for portion of the implanted device that might come into contact with patient tissue (e.g. “a silicone overmold..may be formed around the housing and the connector blocks”, para. [0047], [0057]).
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 first connection unit and/or the second connection unit of Arndt to include a silicone overmold, as taught by Parramon, in order to provide soft surfaces for portions of the implanted connection units that might come into contact with patient tissue (‘440, para. [0047]).
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
III. Claims Rejections 35 USC 112
Applicant argues “Applicant maintains that the claim language is sufficiently clear such that a person of ordinary skill in the art would understand the scope of claim 8 with reasonable certainty in the context of the application. (See Specification,² e.g. at " 22 and 48-49 (describing systems "designed to transmit wirelessly a power of at least 2 W"); see also June 20, 2025 Response to Office Action), see pg. 5-6 of response filed 11/26/2025, the examiner respectfully disagrees. Applicant points to paragraph [0022] and [0048]-[0049] however paragraph [0048] of the specification as filed do not recite anything related to wirelessly transmit a power of at least 2W. Paragraphs [0022] and [0049] of the specification as filed recites “The connection system is generally designed to wirelessly transmit a power of at least 2W” which appears to recite almost verbatim what is within claim 8 but does not provide any further details regarding what further structural limitations applicant is attempting to encompass when reciting “The connection system is generally designed to wirelessly transmit a power of at least 2W”, therefore it is still unclear what further structural limitations of the connection system applicant is attempting to encompass when reciting “designed to transmit wireless a power of at least 2 W”. Since the claim is unclear what further structural limitations applicant is attempting to encompass when reciting “The connection system is generally designed to wirelessly transmit a power of at least 2W” it is difficult to determine the metes and bounds of the claims and what structures applicant is attempting to encompass as being designed to wirelessly transmit a power of at least 2W. Further, applicant states that any connection system that is able to communicate wirelessly improperly interprets the claims to encompass systems that are not designed to transmit wirelessly a power of at least 2W, see pg. 6 of response filed 11/26/2025, but does not provide what structural limitations are lacking with such interpretation. It appears that applicant is attempting to provide a specific structural limitation when reciting “The connection system is generally designed to wirelessly transmit a power of at least 2W” since according to applicant not just any connection system that communicates wirelessly is “designed to wirelessly transmit a power of at least 2W” but does not disclose where within the specification such structure is provided so one of ordinary skill in the art when reading the claim understands the metes and bounds of the claim.
IV. Claims Rejections – 35 USC 103
Applicant argues “Neither Arndt nor Duhamel (nor Parramon) discloses a connection system as claimed…. Arndt’s implantable cable 4 (the alleged first connection unit) is not “wirelessly coupled to” implantable cable 3 (the alleged second connection unit), nor does Arndt disclose any coupling permitting wireless transmission of energy and/or data between cables 4 and 3. To the contrary, cables 4 and 3 of Arndt appear to establish a wired connection through cable connector 2 and there is no disclosure in Arndt of any wireless coupling permitting wireless transmission ‘from the second connection unit to the first connection unit’”, see pg. 6-7 of response filed 11/26/2025, the examiner respectfully disagrees. Arndt discloses electronic device 28, which is located within cable connector 2 and coupled with implantable cable 4 connected to connection element 8 which is the “first connection unit” and implantable cable 3 containing cable connection 3a connected to connection element 10 which is the “second connection unit” and “serves for the wireless communication between implants which are connected to the cable connector, and a device outside..connected to the circuit board 26 via plug ins”, see para. [0064]. Therefore the electronic device 28 does provide wireless coupling between implantable cable 3 containing cable connection 3a connected to connection element 10, i.e. the plug in connector coupled to cable 3 for connecting to an outside device, and implantable cable 4 connected to connection element 8, i.e. the plug in connector coupled to cable 4 for connecting to an implanted device, permitting wireless transmission between the connection units, see Fig. 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2022/0176088 to Salaheieh et al. which discloses an implantable relay device which communicates with an implanted sensor and external device.
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/JENNIFER L GHAND/ Examiner, Art Unit 3796