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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “energy storage device”, “current limiting component” in claims 1 and 15, “controllable component” in claim 9, and “sensing arrangement” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 5 is objected to because of the following informalities: 1) In Claim 5, “H bridge” should be “H-bridge”. Appropriate correction is required.
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.
Claims 4, 7, and 11-14 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.
1) In Claim 4, “said fibrillation pulse” and “said defibrillation pulse” lack antecedent basis, as the claim depends on Claim 1, not Claim 3.
2) In Claim 7, the term “effective” (in “effective voltage level”) without further explanation is relevant and subjective. Effective to do what and compared to what?
2) Claim 11 is incomplete and unclear as the entirety of the body of the claim is “wherein a sensing arrangement for sensing electrocardiogram signals” with a verb or any other explanation. It’s unclear how this arrangement is related to the rest of the device of Claim 1.
3) In Claim 14, “said sensing arrangement” lacks antecedent basis, as the claim depends on Claim 1, not Claim 11.
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.
Claims 1-9, 11-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20120179218 by Moulder in view of US 20150306407 by Crutchfield.
Regarding Claim 1, Moulder teaches an implantable cardioverter defibrillator device (e.g. ¶17: ICD), comprising;
a generator device comprising a controlling circuitry and a shock generation circuitry (e.g. ¶¶ 17, 20-21, Fig. 1, 2 and 4: Class D electronic MOSFET and MUX amplifier 200 with HV capacitor 102, control unit 212 with Pulse Width Modulation, wherein input 3 is compared to desired waveform 4); and
a lead comprising a shock electrode for emitting an electrical output pulse (e.g. ¶ 3: lead with electrode);
wherein said shock generation circuitry comprises an energy supply arrangement containing an energy storage device for supplying energy to form an output pulse (e.g. ¶¶ 17, 21-23, and Fig. 1 and 2: shocking circuitry 100 with battery and HV capacitor 102 to supply energy for Truncated or Arbitrary pulse waveforms), an output circuit for outputting said output pulse to the shock electrode (e.g. ¶¶ 17, 21-23, Fig. 2: H-bridge 202), and a current limiting circuit arranged electrically in between the energy supply arrangement and the output circuit such that a current supplied from the energy supply arrangement flows through the current limiting circuit towards the output circuit (e.g. ¶¶ 17, 21-23, Fig. 2 and 4: Current Limited Switch 206 of Fig. 2, which as an example is a switch M2 in series with a current limiting resistance R2 of Fig. 4 and is electrically in between HV capacitor 102 and the H-bridge 202; Note that in Applicant’s disclosure, the “current limiting circuit” is for example a resistance and a switch, see 16:20-21);
wherein said current limiting circuit comprises a current limiting component (e.g. ¶¶ 17, 21-23, Fig. 2 and 4: Current Limited Switch 206 of Fig. 2, which as an example is a switch M2 in series with a current limiting resistance R2 of Fig. 4 and is electrically in between HV capacitor 102 and the H-bridge 202; Note that in Applicant’s disclosure, the “current limiting circuit” is for example a resistance and a switch, see 16:20-21), wherein the current limiting circuit is controllable by the controlling circuitry to modulate a current flowing through the current limiting circuit (e.g. ¶¶ 21-23: current limited switch 206 is controlled by PWM control circuit 212).
Moulder does not explicitly disclose that the controlling circuit comprises a processor, that does not disclose that the controlling circuitry is processing circuitry.
However, Crutchfield teaches an analogous ICD which includes a control unit having a processor to perform the control functions of the ICD (e.g. ¶¶ 42, 44, 47: control circuit 60 includes a processor). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a controlling processor in an ICD according to the teachings of Moulder, as taught by Crutchfield, as: a) this would predictably control the functionality of the ICD, and b) a processor would expand the capabilities of the ICD in terms of flexibility, speed, and enhancement of programming, processing and re-programming.
Regarding Claim 2, Moulder as modified in Claim 1 discloses the implantable cardioverter defibrillator device according to claim 1, yet does not disclose wherein the implantable cardioverter defibrillator device is a non-transvenous implantable cardioverter defibrillator device. However, Crutchfield teaches an analogous ICD which is a non-transvenous ICD (e.g. ¶¶ 3, 8: subcutaneous ICD). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to adapt the ICD according to the teachings of Moulder to be configured as a non-transvenous implantable cardioverter, as taught by Crutchfield, as: a) this would amount to an equivalent ICD to predictably provide defibrillation, and b) this would predictably provide “synchronous cardioversion shocks and/or asynchronous defibrillation shocks and subcutaneous pacemaker/cardioverter/defibrillator (SPCD) systems that provide additional staged therapies of anti-tachyarrhythmia pacing, synchronous cardioversion shocks and asynchronous defibrillation shocks” as suggested by Crutchfield (¶3), and c) SICDs lower the risk for vascular injuries and complications.
Regarding Claim 3, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, wherein said processing circuitry is configured to control the current limiting circuit to generate a fibrillation pulse for emission by said shock electrode in order to generate an defibrillation pulse for emission by said shock electrode in order to terminate a cardiac fibrillation state (e.g. ¶ 3: arresting fibrillation).
Regarding Claim 4, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, wherein said processing circuitry is configured to control the current limiting circuit to generate said defibrillation pulse for emission by said shock electrode according to a second modulation scheme (e.g. ¶ 3: arresting fibrillation).
Moulder does not explicitly disclose wherein said processing circuitry is configured to control the current limiting circuit to modulate said current flowing through the current limiting circuit to generate said fibrillation pulse according to a first modulation scheme different than the second modulation scheme. However, Moulder teaches generating arbitrary pulses through different modulation schemes via the PWM and the current limiter 206 to lower pain (e.g. abstract, ¶¶ 19,21). Crutchfield further teaches an analogous ICD, which uses different modulation schemes to produce threshold testing to induce fibrillation and to treat fibrillation (e.g. ¶¶ 4,47). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate programming to modulate the arbitrary output to produce fibrillation pulses that induce arrhythmia with a scheme different than the output pulses for arresting fibrillation in an ICD according to the teachings of Moulder, as taught by Crutchfield, in order to predictably perform the threshold testing that is “typically” performed to evaluate the effectiveness of an IMD (Crutchfield, ¶ 4).
Regarding Claim 5, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, wherein the output circuit is formed by an H bridge comprising switches to selectively form conduction paths for outputting said output pulse in a first polarity (e.g. ¶¶ 17, 21-23, Fig. 2: H-bridge 202).
Regarding Claim 6, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, wherein the energy supply arrangement comprises a multiplicity of energy storage devices functionally connected to a switching device, wherein the processing circuitry is configured to control the switching device to supply energy for generating said output pulse using a combination of some of said multiplicity of energy storage devices (e.g. abstract, ¶ 7, 15, 26: high voltage reservoir capacitor network C1-C3 with control by switches S1-S4).
Regarding Claim 7, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim1, wherein said processing circuitry is configured to control the current limiting circuit to set an effective voltage level of said output pulse using pulse width modulation (e.g. ¶ 19, 22: voltage control via current limiting circuit 206 and PWM 212).
Regarding Claim 8, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim1, herein the current limiting component comprises a resistance and a semiconductor component (e.g. Fig. 4: resistance R2 and semiconductor FET switch M2).
Regarding Claim 9, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, wherein the current limiting circuit comprises a controllable component which is controllable by the processing circuitry (as discussed in the modification of claim 2, all ICD functionality, including PWM switching is controlled by a processor).
Regarding Claim 11, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, wherein a sensing arrangement for sensing electrocardiogram signals (e.g. ¶3: electrodes for sensing heart electrical signals).
Regarding Claim 12, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 11, wherein an electrode pole of said sensing arrangement connected to said lead (e.g. ¶3: electrodes for sensing heart electrical signals arranged on the lead). Moulder does not explicitly disclose that the electrode is arranged on the lead. However, Crutchfield teaches an analogous ICD with a lead having electrodes arranged on the lead (e.g. ¶35, Fig. 2: electrodes 32/34). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place the electrodes on the lead in an ICD according to the teachings of Moulder, as taught by Crutchfield, in order to predictably contact the heart tissue when sensing and stimulating.
Regarding Claim 15, Moulder teaches a method for operating an implantable cardioverter defibrillator device (e.g. ¶17: ICD), said implantable cardioverter defibrillator device comprising a generator device and a lead having a shock electrode for emitting an electrical output pulse (as discussed in detail for Claim 1), the method comprising:
supplying, using an energy supply arrangement containing an energy storage device of a shock generation circuitry of the generator device, energy to form an output pulse and outputting, using an output circuit of said shock generation circuitry, said output pulse to the shock electrode (e.g. ¶¶ 17, 21-23, and Fig. 1 and 2: shocking circuitry 100 with battery and HV capacitor 102 to supply energy for outputting Truncated or Arbitrary pulse waveforms); and
controlling, using a controlling circuitry of the generator device, a current limiting circuit comprising a current limiting component to modulate a current flowing through the current limiting circuit, wherein the current limiting circuit is arranged electrically in between the energy supply arrangement and the output circuit such that a current supplied from the energy supply arrangement flows through the current limiting circuit towards the output circuit (e.g. ¶¶ 17, 21-23, Fig. 2 and 4: Current Limited Switch 206 of Fig. 2, which as an example is a switch M2 in series with a current limiting resistance R2 of Fig. 4 and is electrically in between HV capacitor 102 and the H-bridge 202; ¶¶ 21-23: current limited switch 206 is controlled by PWM control circuit 212).
Moulder does not explicitly disclose that the controlling circuit comprises a processor, that does not disclose that the controlling circuitry is processing circuitry.
However, Crutchfield teaches an analogous ICD which includes a control unit having a processor to perform the control functions of the ICD (e.g. ¶¶ 42, 44, 47: control circuit 60 includes a processor). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a controlling processor in an ICD according to the teachings of Moulder, as taught by Crutchfield, as: a) this would predictably control the functionality of the ICD, and b) a processor would expand the capabilities of the ICD in terms of flexibility, speed, and enhancement of programming, processing and re-programming.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Moulder/Crutchfield, as applied to Claims 1 and 11, and further in view of US 20120158097 by Weiss.
Regarding Claim 10, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 11, wherein the current limiting circuit comprises a switch (Fig. 4: switch M2 and resistance R2 are arranged in series), yet does not explicitly disclose wherein the current limiting component is arranged in a first path and the switch is arranged in a second path electrically in parallel to the first path. However, Weiss teaches an analogous ICD which utilizes two current limiting circuits arranged in parallel to one another, one of the two acting as a fail-safe mechanism (e.g. abstract, ¶15, 63, 66-67). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second current limiting circuit in parallel with the first current limiting circuit in an ICD according to the teachings of Moulder, as taught by Weiss, in order to provide a fail safe current limiting mechanism, as suggested by Weiss (¶66-67).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Moulder/Crutchfield, as applied to Claims 1 and 11, and further in view of US 20170157414 by Anderson.
Regarding Claim 13, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 11, yet does not explicitly disclose wherein an electrode pole of said sensing arrangement is formed by a housing of said generator device. However, Anderson teaches an analogous ICD device, wherein the housing of the ICD comprises a ground electrode (e.g. ¶ 55). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a ground electrode with the housing of an ICD according to the teachings of Moulder, as taught by Anderson, in order to predictably close the circuit formed by the sensing or stimulation electrodes with the body.
Regarding Claim 14, Moulder as modified in Claim 1, teaches the implantable cardioverter defibrillator device according to claim 1, yet does not explicitly disclose wherein said sensing arrangement includes three electrode poles, the processing circuitry being configured to sense electrocardiogram signals using different pairs of electrode poles of said three electrode poles. However, Anderson teaches an analogous ICD device, wherein the ICD comprises three sensing electrode poles which permit pair or combination thereof to form different sensing electrode vectors (e.g. ¶ 24-25, 46: sensing electrodes 24/28). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate sensing from pairs of three or more electrodes in an ICD according to the teachings of Moulder, as taught by Anderson, in order to predictably sense electrocardiograms from the body, and furthermore add a directional aspect to the sensing to enhance sensing accuracy and enable detection of wave propagation metrics, local activation times, origins of fibrillation and/or conduction blocks.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796