DETAILED ACTION
Response to Amendment
Claims 1-2, 4, 6, and 14 have been amended, and claim 10 has been cancelled. All other claims remain as originally or previously presented. Rejections of amended claims have been updated or addressed below.
Response to Arguments
Applicant’s arguments, see page 8, filed on 8/11/2026, with respect to the previous claim objections have been fully considered and are persuasive. The previous claim objections of claims 4 and 10 have been withdrawn.
Applicant's arguments, see pages 8-9, filed on 8/11/2026, with respect to the previous 35 U.S.C. 112(f) interpretation and 112(a)/(b) rejections have been fully considered but they are not persuasive. In their arguments, the Applicant points to Paragraph [0005] of the present application’s specification, which recites that “A housing of an ICD is typically made of tissue-compatible material” and “encapsulated inside are a microcomputer with electronic circuitry”. The Applicant argues that because a typical ICD includes a microcomputer and a computer program for receiving and evaluating signals, that one skilled in the art would understand this structure to be the recited “evaluation device”. The Examiner respectfully disagrees.
The specification does not provide any description of what structure makes up the
recited “evaluation device”. The specification describes that the “evaluation device” is part of the “controller”. The specification also does not explicitly say that the “controller” is synonymous with the previously described “microcomputer” that is pointed out by the Applicant. Therefore, the Examiner still ascertains that it would not be well known to one of ordinary skill in the art what structure the Applicant is referring to with the recited “evaluation device”, and thus the previous 112(f) interpretation and 112(a)/(b) rejections are maintained.
The Examiner notes that new 112(a) and 112(b) rejections are made as necessitated by the amendments added. Please see in further detail below.
Applicant's arguments, see pages 9-11, filed on 8/11/2026, with respect to the previous 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive. The Applicant argues that Min does not disclose “weighing signals based on a correlation of degree to which predetermined criteria are fulfilled”. Min, however, teaches an implantable medical system that measures a plurality of cardiac activity signals (Col. 19, lines 35-36), wherein the plurality of signals are combined in a weighted manner (Col. 19, lines 42-45). The Examiner notes that the limitation “that correlates with a degree to which predetermined criteria are fulfilled” is directed to further limiting the weighted manner in which the plural signals are combined, which is not positively recited. Therefore, this limitation fails to further define over prior art with a controller that combines plural signals in a weighted manner. Thus, it is understood that Greenhut in view of Min discloses “weighing signals based on a correlation of degree to which predetermined criteria are fulfilled”, and the previous 102/103 rejections are not withdrawn.
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 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 is: “the evaluation device configured for evaluating the amplified signals” in claim 7.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 to avoid it 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-9 and 11-14 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention. Claims 1 and 14 both recite “an evaluation of a combined signal in which the plural sensed signals are combined in a weighted manner that correlates with a degree to which predetermined criteria are fulfilled”. The specification does not provide any further description for how a degree to which predetermined criteria is fulfilled is determined, or how combining the plural sensed signals in a weighted manner would use said degree to which predetermined criteria are fulfilled.
Claim 7 is 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 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 inventors, at the time the application was filed, had possession of the claimed invention. The claim recites “an evaluation device”, however, the evaluation device is not described in any detail in the specification of what it is or how it evaluates the amplified signals.
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 1-9 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. The specification does not provide any description of how a degree to which predetermined criteria is fulfilled is determined, or what is meant by “a degree to which predetermined criteria is fulfilled”. Does the degree to which predetermined criteria is fulfilled correlate to whether or not the criteria is met? Or does it correlate to a numerical ratio of how strongly/weakly the criteria is met? The specification is silent to this, and therefore the scope of claims 1-9 and 11-14 is unclear.
Claim 7 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. The specification does not provide any description of what structure the recited “evaluation device” is, and therefore the scope of the instant claim is unclear. For examining purposes, the evaluation device is being interpreted as any device that evaluates sensed signals.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Greenhut et al. (U.S. Patent No. 7,904,153) (previously cited) in view of Min (U.S. Patent No. 11,147,980) (previously cited).
Regarding claim 1, Greenhut teaches a non-transvenous ICD system (Fig. 1, Col. 2, lines 36-37) comprising: a defibrillation generator (Fig. 1, Col. 2, line 53), a controller (Fig. 3, Col. 4, lines 22-29), an electrode line (Fig. 1-2, Col. 2, line 56), a shock electrode arranged at the electrode line (Fig. 2, Col. 3, line 38), at least three sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45, and 50-52) arranged at various positions within the ICD system (Fig. 2), wherein the defibrillation generator is configured for generating electric shocks (Col. 4, lines 30-33) and applying the electric shocks to cardiac tissue (Fig. 1, Col. 2, line 65) of a patient (Fig. 1, Col. 2, line 55) via the shock electrode (Col. 4, lines 32-34), wherein the controller is configured for (i) sensing plural signals indicating a cardiac activity (Col. 2, lines 37-38) by detecting an electric voltage (Col. 4, lines 60-61) along each of a plurality sensing vectors (Fig. 3, Col. 4, lines 63-64), wherein each sensing vector extends between two of the sensing electrodes (Col. 4, lines 62-65), (ii) automatically selecting (Col. 8, lines 11-13) plural sensed signals (Col. 2, lines 37-38) based on predetermined criteria being fulfilled (Col. 8, lines 11-13) and controlling the defibrillation generator for generating the electric shocks based on the selected plural signals (Col. 4, lines 5-8).
Greenhut does not teach that the controller is configured for automatically selecting plural sensed signals and controlling the defibrillation generator for generating the electric shocks based on an evaluation of a combined signal in which the plural sensed signals are combined in a weighted manner that correlates with a degree to which predetermined criteria are fulfilled.
Min, however, teaches an implantable medical system (Fig. 1, Col. 8, lines 53-55) that comprises one or more sub-cutaneous implantable cardioverter defibrillators (Fig. 1, Col. 9, lines 3-4), at least one lead (Fig. 1, Col. 9, line 21), and one or more sensing electrodes (Fig. 1, Col. 9, lines 24-25). Furthermore, Min teaches that the system may measure a plurality of cardiac activity signals (Col. 19, lines 35-36), wherein the plurality of signals are combined in a weighted manner (Col. 19, lines 42-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Greenhut to incorporate the teachings of Min to include a combined signal is determined by combining the plural signals in a weighted manner. Doing so would simulate cardiac activity signals sensed along a sensing vector associated with a lead (Col. 5, lines 1-2), as recognized by Min.
In regards to claim 1, the limitation “that correlates with a degree to which predetermined criteria are fulfilled” is directed to further limiting the weighted manner in which the plural signals are combined, which is not positively recited. Therefore, this limitation fails to further define over prior art with a controller that combines plural signals in a weighted manner.
Regarding claim 2, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the controller (Fig. 3, Col. 4, lines 22-29) is configured for automatically selecting at least one of the sensed signals (Col. 8, lines 11-13) based on an evaluation of characteristics indicated by the signal (Col. 8, lines 21-30), the characteristics including at least one of: a ratio of an R-wave amplitude and a T-wave amplitude (Col. 8, line 25); a signal-to-noise ratio (Col. 8, lines 22-23); time-dependent variations (Col. 8, lines 59-64) of the signal-to-noise ratio; time-dependent variations (Col. 8, lines 59-64) of amplitudes (Col. 8, lines 21-22); deviations of amplitudes from reference values (Col. 8, lines 28-29); time-dependent variations (Col. 8, lines 59-64) of morphologic variations (Col. 8, line 25); and deviations of morphologic variations from reference values (Col. 8, lines 28-30).
Regarding claim 3, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the controller (Fig. 3, Col. 4, lines 22-29) is configured for automatically evaluating the sensed signals (Col. 8, lines 21-30) based on at least one condition including: a body position of the patient (Col. 9, lines 12-13); an activity status of the patient (Col. 8, lines 65-67); a time of day (Col. 9, lines 2-5); and a therapy condition (Col. 15, lines 39-45).
Regarding claim 4, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the controller (Fig. 3, Col. 4, lines 22-29) is configured for automatically selecting at least one of the sensed signals (Col. 8, lines 11-13) based on a comparison of characteristics indicated by the signal with a predetermined limit value (Col. 8, lines 49-52).
Regarding claim 5, Greenhut in view of Min discloses the claimed invention of claim 4. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 4, wherein the signal is selected based on comparison results (Col. 8, lines 49-52) indicating at least one of: a ratio of an R-wave amplitude and a T-wave amplitude (Col. 8, line 25) being higher than a predetermined limit value (Col. 8, lines 49-52); a ratio of an R-wave amplitude and a T-wave amplitude (Col. 8, line 25) varying below a predetermined limit value (Col. 8, line 67 and Col. 9, lines 1-2 and 13-18) despite a change of a body position of the patient having occurred (Col. 9, lines 12-13); a signal-to-noise ratio (Col. 8, lines 22-23) being higher than a predetermined limit value (Col. 8, lines 49-52); time-dependent variations (Col. 8, lines 59-64) of the signal-to-noise ratio being below a predetermined limit value (Col. 8, line 67 and Col. 9, lines 1-2 and 13-18) despite at least one of a change of a body position (Col. 9, lines 12-13) and an activity of the patient having occurred (Col. 8, lines 65-67); at least one of signal amplitudes (Col. 8, lines 21-22) and morphologic metrics (Col. 8, line 25) varying below a predetermined limit value (Col. 8, line 67 and Col. 9, lines 1-2 and 13-18) despite at least one of a change of a body position (Col. 9, lines 12-13) and an activity of the patient having occurred (Col. 8, lines 65-67).
Regarding claim 6, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the controller (Fig. 3, Col. 4, lines 22-29) is configured for automatically selecting at least one of the sensed signals (Col. 8, lines 11-13) upon a shock having been generated by the defibrillation generator (Col. 4, lines 5-8).
Regarding claim 7, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the controller (Fig. 3, Col. 4, lines 22-29) comprises a switching device (Fig. 3, Col. 4, lines 66-67), and amplifier device (Fig. 3, Col. 4, line 59), and an evaluation device (Fig. 3, Col. 4, lines 59-60), wherein the switching device is configured for selectively connecting sensing electrodes associated to each one of the sensing vectors (Col. 4, lines 62-67) to the amplifier device (Col. 5, lines 2-4), wherein the amplifier device is configured for amplifying the signals (Fig. 4, Col. 7, lines 52-55), wherein the evaluation device is configured for evaluating the amplified signals (Col. 5, lines 4-5) for controlling the generating of the electric shocks based on the selected signals (Col. 4, lines 5-8).
Regarding claim 8, Greenhut in view of Min discloses the claimed invention of claim 7. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 7, wherein the switching device (Fig. 3, Col. 4, lines 66-67) is configured for selectively connecting to (Col. 4, lines 62-67) the amplifier device (Fig. 3, Col. 4, line 59) exclusively the sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45, and 50-52) associated to the one of the sensing vectors (Fig. 3, Col. 4, lines 63-64) for which the predetermined criteria are fulfilled (Col. 8, lines 11-13).
Regarding claim 9, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the switching device (Fig. 3, Col. 4, lines 66-67) is configured for connecting (Col. 4, lines 62-67) the sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45, and 50-52) associated to one of the sensing vectors (Fig. 3, Col. 4, lines 63-64) to the amplifier device (Fig. 3, Col. 4, line 59) sequentially for all of the sensing vectors (Col. 7, lines 65-67 and Col. 8, lines 1-3).
Regarding claim 13, Greenhut in view of Min discloses the claimed invention of claim 1. Greenhut further discloses the system (Fig. 1, Col. 2, lines 36-37) of claim 1, wherein the system comprises at least four sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45, and 50-52) being arranged such that pairs of sensing electrodes (Col. 4, lines 65-66) provide at least four sensing vectors (Fig. 3, Col. 4, lines 63-64) being non-parallel to each other (Fig. 1-2).
Regarding claim 14, Greenhut teaches a method for controlling generating of electric shocks (Col. 2, lines 36-38) in a non-transvenous ICD system (Fig. 1, Col. 2, lines 36-37), the non-transvenous ICD system comprising: a defibrillation generator (Fig. 1, Col. 2, line 53), a controller (Fig. 3, Col. 4, lines 22-29), an electrode line (Fig. 1-2, Col. 2, line 56), a shock electrode arranged at the electrode line (Fig. 2, Col. 3, line 38), at least three sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45, and 50-52) arranged at various positions within the ICD system (Fig. 2), wherein the defibrillation generator is configured for generating electric shocks (Col. 4, lines 30-33) and applying the electric shocks to cardiac tissue (Fig. 1, Col. 2, line 65) of a patient (Fig. 1, Col. 2, line 55) via the shock electrode (Col. 4, lines 32-34), wherein the method comprises: (i) sensing plural signals indicating a cardiac activity (Col. 2, lines 37-38) by detecting an electric voltage (Col. 4, lines 60-61) along each of a plurality sensing vectors (Fig. 3, Col. 4, lines 63-64), wherein each sensing vector extends between two of the sensing electrodes (Col. 4, lines 62-65), (ii) automatically selecting (Col. 8, lines 11-13) plural sensed signals (Col. 2, lines 37-38) based on predetermined criteria being fulfilled (Col. 8, lines 11-13) and controlling the defibrillation generator for generating the electric shocks based on the selected plural signals (Col. 4, lines 5-8).
Greenhut does not teach that the method comprises automatically selecting plural sensed signals and controlling the defibrillation generator for generating the electric shocks based on an evaluation of a combined signal in which the plural sensed signals are combined in a weighted manner that correlates with a degree to which predetermined criteria are fulfilled.
Min, however, teaches an implantable medical system (Fig. 1, Col. 8, lines 53-55) that comprises one or more sub-cutaneous implantable cardioverter defibrillators (Fig. 1, Col. 9, lines 3-4), at least one lead (Fig. 1, Col. 9, line 21), and one or more sensing electrodes (Fig. 1, Col. 9, lines 24-25). Furthermore, Min teaches that the system may measure a plurality of cardiac activity signals (Col. 19, lines 35-36), wherein the plurality of signals are combined in a weighted manner (Col. 19, lines 42-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Greenhut to incorporate the teachings of Min to include a combined signal is determined by combining the plural signals in a weighted manner. Doing so would simulate cardiac activity signals sensed along a sensing vector associated with a lead (Col. 5, lines 1-2), as recognized by Min.
In regards to claim 1, the limitation “that correlates with a degree to which predetermined criteria are fulfilled” is directed to further limiting the weighted manner in which the plural signals are combined, which is not positively recited. Therefore, this limitation fails to further define over prior art with a controller that combines plural signals in a weighted manner.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Greenhut in view of Min as applied to claim 1 above, and further in view of Zhang et al. (U.S. Patent No. 11,617,534) (previously cited).
Regarding claim 11, Greenhut teaches the system (Fig. 1, Col. 2, lines 36-37) of
claim 1 that comprises the at least three sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45,
and 50-52). Greenhut does not disclose that the at least three sensing electrodes are arranged at the electrode line.
Zhang, however, teaches a non-transvenous ICD system (Fig. 1A-1B, Col. 6, lines 58-59) that comprises a defibrillation generator (Fig. 1A-1B, Col. 6, line 64), a controller (Fig. 3, Col. 12, line 17), an electrode line (Fig. 1A-1B, Col. 6, line 65), a shock electrode (Col. 7, line 43), and at least three sensing electrodes (Fig. 1A-1B, Col. 7, lines 44 and 66-67). Furthermore, Zhang teaches that the at least three sensing electrodes are arranged at the electrode line (Fig. 1A-1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Greenhut to incorporate the teachings of Zhang to include that the at least three sensing electrodes are arranged at the electrode line. Doing so would allow a less-invasive implantation procedure to be used to implant said system (Col. 8, lines 42-61), as recognized by Zhang.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Greenhut in view of Min as applied to claim 1 above, and further in view of Lian et al. (U.S. PGPub No. 2012/0016249) (previously cited).
Regarding claim 12, Greenhut teaches the system (Fig. 1, Col. 2, lines 36-37) of claim 1 that includes the at least three sensing electrodes (Fig. 2, Col. 3, lines 39, 42-45, and 50-52) and a housing (Fig. 2, Col. 3, line 24) that accommodates the defibrillation generator and the controller (Fig. 1-2, Col. 3, lines 33-37). Greenhut does not teach that at least one sensing electrode is arranged at a header provided at the housing.
Lian, however, teaches an implantable device (Fig. 1, Paragraph 0069, lines 1-2) that includes a housing (Fig. 1, Paragraph 0069, lines 6-8). Furthermore, Lian teaches that the device includes at least one sensing electrode (Fig. 1, Paragraph 0069, line 11) that is arranged at (Paragraph 0071, lines 9-10) a header provided at the housing (Fig. 1, Paragraph 0069, lines 10-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Greenhut to incorporate the teachings of Lian to include that at least one sensing electrode is arranged at a header provided at the housing. Doing so would allow larger subcutaneous ECG amplitudes to be measured, which in turn provides more reliable sensing (Paragraph 0071), as recognized by Lian.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/H.A.H./Patent Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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