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 .
Claim Rejections - 35 USC § 112
Claim 6 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.
In claim 6, the term ’preferably’ renders the claim’s scope indefinite
Claim Rejections - 35 USC § 103
Claim(s) 1-4,6-8,10,11,13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson-Nauman et al (2014/0330327) and Chen et al (2012/0004708).
1. An implantable cardioverter defibrillator device (1), comprising:
a generator device (10) comprising a shock generation circuitry (103) for
producing an electrical shock pulse for performing a defibrillation therapy (Thompson teaches shock circuitry, see at least ¶21,51 which teaches capability of producing defibrillating shocks.)
communication circuitry (109) for establishing a communication connection (P) to an
external device (2) in a frequency range above 2 GHz; (Thompson teaches communication module 68, see at least figure 2, and an external device, see at least ¶53. Thompson is silent as to frequency over 2 GHZ. At least ¶38 of Chen teaches transmission at 1MHZ to 10 GHz. It would have been obvious to use frequencies over 2GHz since they allow for greater energy transmission and at longer distances, as taught in Chen)
at least one lead (11) comprising a shock electrode (115) for emitting said
electrical shock pulse; (figure 1b of Thompson teaches a lead 16, and electrode 24)
wherein the at least one lead (11) comprises at least one antenna (118)
operatively connected to the communication circuitry (109) for transmitting
communication signals to and/or receiving communication signals from the external
device (2) in said frequency range above 2 GHz. (Thompson is silent as to this. Chen at ¶35 teaches that the wire in the lead is used as an antenna, and figure 3 shows two way communication with external device 200. It would have been obvious to use the wire in the lead as antenna, as shown in Chen, for transmitting communication signal, with the device of Thompson, since it would allow for efficient transmission of the GHZ signals in a predictable manner)
2. The implantable cardioverter defibrillator device (1) according to claim 1,
characterized in that the implantable cardioverter defibrillator device (1) is a non-
transvenous implantable cardioverter defibrillator device. (see figure 1a of Thompson which shows ICD 14 outside the rib cage)
3. The implantable cardioverter defibrillator device (1) according to claim 1,
characterized in that the at least one antenna (118) is placed on an intermediate
portion of said at least one lead (11) in between a proximal end (111) of the at least
one lead (11) facing said generator device (10) and the shock electrode (115). (see at least figure 6 of Chen which shows antenna 150)
4. The implantable cardioverter defibrillator device (1) according to claim 3,
characterized in that the intermediate portion is configured, at implantation according
to a prescribed use, to be implanted at an implantation depth smaller than an
implantation depth of the generator device (10). (such is considered to be intended use. The intermediate portion of the lead of Thompson can be located as desired and based on what patient conditions dictate for the appropriate therapy)
6. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized in that the at least one antenna (118) is formed by a wire portion
having a length (L) in between 2 cm and 10 cm, preferably between 3 cm and 5 cm. (such is considered to be an obvious design choice yielding predictable results. The skilled artisan is expected to choose the size of the wire length depending upon transmission characteristics of the patient’s body and other factors.)
7. The implantable cardioverter defibrillator device (1) according to
Claim 1 characterized in that the communication circuitry (109) is configured to
establish a communication connection (P) to the external device (2) in a frequency
range between 2 GHz and 3 GHz and/or between 5 GHz and 6 GHz. (see at least ¶35,38 of Chen)
8. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized in that the communication circuitry (109) is configured to
establish a communication connection (P) to the external device (2) in a frequency
range between 2.4 GHz and 2.5 GHz. (see at least ¶35,38 of Chen)
10. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized in that the generator device (10) comprises a first connector
(106) and the at least one lead (11) comprises a second connector (116) connectable to
the first connector (106) for connecting the at least one lead (11) to the generator device
(10). (¶22 of Thompson teaches a ICD connector, and ¶23 of Thompson teaches a lead connector)
11. The implantable cardioverter defibrillator device (1) according to claim 10,
characterized in that the first connector (106) and the second connector (116) are
configured to establish an operative connection between the at least one antenna (118)
arranged on the at least one lead (11) and the communication circuitry (109) of the
generator device (10). (the connectors, as is known, connect the electrical components (wires) of the lead to the circuitry of the ICD so that signals can be sent from the ICD to the lead antenna)
13. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized by a sensing arrangement for sensing electrocardiogram
signals, wherein at least one electrode pole (113, 114) of said sensing arrangement is
arranged on said at least one lead (11). (at least ¶28 of Thompson teaches sensing electrodes on the lead)
14. The implantable cardioverter defibrillator device (1) according to claim 13,
characterized in that said sensing arrangement includes at least three electrode poles,
a processing circuitry (102) of the generator device (10) being configured to sense
electrocardiogram signals using different pairs of electrode poles of said at least three
electrode poles. (at least ¶28 of Thompson teaches sensing electrodes on the lead. The electrodes are connected to sensing module 62.)
15. A method for operating an implantable cardioverter defibrillator device (1), said
implantable cardioverter defibrillator device (1) comprising a generator device (10)
having a shock generation circuitry (103) for producing an electrical shock pulse for
performing a defibrillation therapy, (Thompson teaches shock circuitry, see at least ¶21,51 which teaches capability of producing defibrillating shocks.)
the method comprising:
establishing, using a communication circuitry (109) of the generator device
(10), a communication connection (P) to an external device (2) in a frequency range
above 2 GHz, (Thompson teaches communication module 68, see at least figure 2, and an external device, see at least ¶53. Thompson is silent as to frequency over 2 GHZ. At least ¶38 of Chen teaches transmission at 1MHZ to 10 GHz. It would have been obvious to use frequencies over 2GHz since they allow for greater energy transmission and at longer distances, as taught in Chen)
wherein communication signals are transmitted to and/or received from
the external device (2) in said frequency range above 2 GHz using at least one antenna
(118) operatively connected to the communication circuitry (109) and arranged on at
least one lead (11) connected to the generator device (10), (Thompson is silent as to this. Chen at ¶35 teaches that the wire in the lead is used as an antenna, and figure 3 shows two way communication with external device 200. It would have been obvious to use the wire in the lead as antenna, as shown in Chen, for transmitting communication signal, with the device of Thompson, since it would allow for efficient transmission of the GHZ signals in a predictable manner)
the at least one lead (11) comprising a shock electrode (115) for emitting said electrical shock pulse. (Thompson teaches shock electrode 24)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson-Nauman et al (2014/0330327) and Chen et al (2012/0004708), and further in view of Von Arx et al (2002/0065539).
5. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized in that the at least one antenna (118) is connected to a shielded
connection line (119) extending along the at least one lead (11) from the at least one
antenna (118) towards the generator device (10). (Thompson is silent as to shielding. Von Arx teaches shielding, see at least ¶20. It would have been obvious to use shielding with the device of Thompson since it would help reduce interference from other electromagnetic activity)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson-Nauman et al (2014/0330327) and Chen et al (2012/0004708), and further in view of Funderburk (2018/0369596).
9. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized in that the communication circuitry (109) is configured to
establish a communication connection (P) to the external device (2) using Bluetooth
or Bluetooth Low Energy. (Thompson is silent as to Bluetooth. Funderburk teaches Bluetooth technology, see ¶68. It would have been obvious to use Bluetooth since it is well known as an efficient manner of connecting disparate devices)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson-Nauman et al (2014/0330327) and Von Arx et al (2003/0114897).
12. The implantable cardioverter defibrillator device (1) according to
Claim 1, characterized in that the generator device (10) comprises a further, second
antenna (108) operatively connected to the communication circuitry (109) for
transmitting communication signals to and/or receiving communication signals from
the external device (2) in said frequency range above 2 GHz. (Thompsons silent as to a second antenna. Von Arx teaches two antennae, see at least figure 2 and ¶49. It would have been obvious to use two antennae since it would produce the predictable result of having a back-up in case one antenna was not working properly.)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792