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.
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: “a parameter-determining device” in claim 18; “alert unit” in claim 27; “memory unit” in claim 32.
Published paragraph [0038] and claim 32 disclose the alert unit comprises a memory unit
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 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 18-34 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.
Claim limitation “a parameter-determining device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function but does not impart a particular . The disclosure recites the function but does not include the structure, material or acts necessary to perform the recited function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of taking parameter data from a probe to analyze and determine characteristics of the data representing the probe. This judicial exception is not integrated into a practical application because the parameter-determining probe is either an insignificant pre-solution activity of data gathering or is part of the processing unit used to analyze data which published paragraph [0073] discloses the processing unit is a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a parameter-determining device if it is a sensor is well-known, routine, and conventional. Zhang et al (US Publication 2007/0043394) discloses diagnosis of heart failure by detecting a variation of the intracardiac impedance at a constant heart rate; Van dam et al (US Publication 2009/0270747 analyzes the electrocardiogram (ECG) for changes in morphology to distinguish a cardiac condition from those of changes in position; and Gunderson et al (US Publication 2014/0350620) discloses using impedance to assist in identification of short circuits of the probe. If the parameter-determining device is part of a generic computing device similar to or a part of the processing unit which the disclosure indicates is a generic computer.
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) 18-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vincent et al (US Publication 2007/0270914).
Referring to Claim 18, Vincent et al teaches a device for monitoring operation of a probe of an implantable active cardiac device, in particular an implantable automatic defibrillator or a defibrillator for cardiac resynchronization (e.g. Paragraph [0001]), comprising: a parameter-determining device for determining values of a plurality of parameters characterizing the probe (e.g. Figure 3, Element 10 and Paragraphs [0041-0042]), and a processing unit configured to determine representative values that are representative of at least one parameter of the plurality of parameters characterizing the probe based on at least two different time scales (e.g. Paragraphs [0047] and [0054]), wherein the processing unit is further configured to compare an analysis value of the at least one parameter of the plurality of parameters characterizing the probe with the representative values of the at least one parameter (e.g. Paragraphs [0047] and [0054]).
Referring to Claim 19, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 18, wherein a first representative value is an average of a first predefined number of the representative values determined prior to the analysis value, wherein the analysis value and the average of the first predefined number of the representative values are compared by the processing unit (e.g. Paragraphs [0047-0055]).
Referring to Claim 20, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 19, wherein a second representative value is an average of a second predefined number of the representative values determined prior to the analysis value, wherein the analysis value and the average of the second predefined number of representative values are compared by the processing unit, and wherein the second predefined number is greater than the first predefined number (e.g. Paragraphs [0047-0055]).
Referring to Claim 21, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to at least one of claim 18, 19, or 20, wherein a third representative value is a rolling average based on an average of a third predetermined number of the representative values determined prior to the analysis value, wherein the analysis value and the rolling average of the third predetermined number of the representative values are compared by the processing unit, and wherein the rolling average and the third predetermined number of representative values corresponds to one of the plurality of parameters (e.g. Paragraphs [0047-0055]).
Referring to Claim 22, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 18, wherein the processing unit is configured during the determination of the representative values in such a way that one value, among the values of the plurality of parameters characterizing the probe that overruns a predefined limit value, is not taken into account (e.g. Paragraphs [0047-0055]).
Referring to Claim 23, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 18, wherein the processing unit is configured to compare the analysis value of the at least one parameter of the plurality of parameters characterizing the probe with the values that are representative of the at least one parameter, wherein a most recent value, with respect to the analysis value that is taken into account for the determination of the representative values, is within a first predetermined time interval (e.g. Paragraphs [0047-0055]).
Referring to Claim 24, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 23, wherein the processing unit is configured to compare the analysis value of the at least one parameter of the plurality of parameters characterizing the probe with the values that are representative of the at least one parameter, wherein the most recent value, with respect to the analysis value that is taken into account for the determination of the representative values, is within a second predetermined time interval (e.g. Paragraphs [0047-0055]).
Referring to Claim 25, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 18, wherein the at least one parameter is one of an amplitude of a detection signal, a continuity of the probe, a daily detection percentage, a number of non-sustained ventricular fibrillations, a number of untreated ventricular fibrillations, a number of treated ventricular fibrillations, a number of isolated extrasystoles, a number of total extrasystoles, an impedance of the probe, and a pacing threshold (e.g. Paragraphs [0047-0055]).
Referring to Claim 26, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 18, wherein the plurality of parameters characterizing the probe comprises at least two different parameters (e.g. Paragraphs [0047-0055]).
Referring to Claim 27, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 18, further comprising an alert unit for issuing an alert when the analysis value overruns in an increasing or decreasing manner a limit value of at least one representative value or/and a threshold limit of at least one parameter of the plurality of parameters (e.g. Figure 3, Element 26 and Paragraph [0056]).
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) 28-29, and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vincent et al (US Publication 2007/0270914) in view of Milpied et al (US Publication 2016/0303372).
Referring to Claim 28, Vincent et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 27, except wherein each parameter of the plurality of parameters respectively has a threshold limit, wherein the threshold limits are grouped into: a first group of threshold limits for which the alert unit is configured to issue an alert in the event that a threshold limit of a parameter is overrun, or a second group of threshold limits for which the alert unit is configured to issue an alert in the event that threshold limits of at least two parameters are overrun concomitantly. Milpied et al teaches that it is known to use each parameter of the plurality of parameters respectively has a threshold limit, wherein the threshold limits are grouped into: a first group of threshold limits for which the alert unit is configured to issue an alert in the event that a threshold limit of a parameter is overrun, or a second group of threshold limits for which the alert unit is configured to issue an alert in the event that threshold limits of at least two parameters are overrun concomitantly as set forth in Paragraphs [0122-0127] to provide identification of phenomena that reduce effectiveness of the applied therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with each parameter of the plurality of parameters respectively has a threshold limit, wherein the threshold limits are grouped into: a first group of threshold limits for which the alert unit is configured to issue an alert in the event that a threshold limit of a parameter is overrun, or a second group of threshold limits for which the alert unit is configured to issue an alert in the event that threshold limits of at least two parameters are overrun concomitantly as taught by Milpied et al, since such a modification would provide the predictable results of identification of phenomena that reduce effectiveness of the applied therapy.
Referring to Claim 29, Vincent et al in view of Milpied et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 28, except wherein a threshold limit of a parameter assigned to the second group is transferred to the first group if an overrunning of the threshold limit occurs a predetermined number of times, successively.
Milpied et al teaches that it is known to use wherein a threshold limit of a parameter assigned to the second group is transferred to the first group if an overrunning of the threshold limit occurs a predetermined number of times, successively as set forth in Paragraphs [0114-0116] to provide identification of phenomena that reduce effectiveness of the applied therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with wherein a threshold limit of a parameter assigned to the second group is transferred to the first group if an overrunning of the threshold limit occurs a predetermined number of times, successively as taught by Milpied et al, since such a modification would provide the predictable results of identification of phenomena that reduce effectiveness of the applied therapy.
Referring to Claim 31, Vincent et al in view of Milpied et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 28, except wherein a weighting value is assigned to each parameter of the second group and wherein the alert unit is configured to trigger an alert when a sum of the weighting values of the at least two parameters overruns a predetermined number (the examiner notes the claim does not requires a specific weight and includes a weight of 1).
Milpied et al teaches that it is known to use a weighting value is assigned to each parameter of the second group and wherein the alert unit is configured to trigger an alert when a sum of the weighting values of the at least two parameters overruns a predetermined number as set forth in Paragraphs [0122-0127] to provide identification of phenomena that reduce effectiveness of the applied therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with a weighting value is assigned to each parameter of the second group and wherein the alert unit is configured to trigger an alert when a sum of the weighting values of the at least two parameters overruns a predetermined number as taught by Milpied et al, since such a modification would provide the predictable results of identification of phenomena that reduce effectiveness of the applied therapy.
Referring to Claim 32, Vincent et al in view of Milpied et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 28, wherein the alert unit comprises a memory unit (e.g. Paragraph [0056]). However, Vincent et al does not explicitly disclose the memory unit is configured to save a threshold limit overrun for a specified period of time and wherein the memory unit is configured to delete the threshold limit after expiration of the specified period of time.
Milpied et al teaches that it is known to use a memory unit is configured to save a threshold limit overrun for a specified period of time and wherein the memory unit is configured to delete the threshold limit after expiration of the specified period of time as set forth in Paragraph [0109] to provide identification of phenomena that reduce effectiveness of the applied therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with memory unit is configured to save a threshold limit overrun for a specified period of time and wherein the memory unit is configured to delete the threshold limit after expiration of the specified period of time as taught by Milpied et al, since such a modification would provide the predictable results of identification of phenomena that reduce effectiveness of the applied therapy.
Referring to Claim 33, Vincent et al in view of Milpied et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 28, except wherein a parameter of the plurality of parameters comprises a first threshold limit and a second threshold limit, wherein the first threshold limit is part of the first group and the second threshold limit is part of the second group.
Milpied et al teaches that it is known to use wherein a parameter of the plurality of parameters comprises a first threshold limit and a second threshold limit, wherein the first threshold limit is part of the first group and the second threshold limit is part of the second group as set forth in Paragraphs [0122-0127] to provide identification of phenomena that reduce effectiveness of the applied therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with wherein a parameter of the plurality of parameters comprises a first threshold limit and a second threshold limit, wherein the first threshold limit is part of the first group and the second threshold limit is part of the second group as taught by Milpied et al, since such a modification would provide the predictable results of identification of phenomena that reduce effectiveness of the applied therapy.
Referring to Claim 34, Vincent et al in view of Milpied et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 28, except wherein a first set of the threshold limits among the threshold limits of the second group are linked to each other and a second set of threshold limits among the threshold limits of the second group are not linked to each other, wherein the alert unit is configured to trigger an alert in response to at least two overruns of threshold limits among the second set of threshold limits.
Milpied et al teaches that it is known to use a first set of the threshold limits among the threshold limits of the second group are linked to each other and a second set of threshold limits among the threshold limits of the second group are not linked to each other, wherein the alert unit is configured to trigger an alert in response to at least two overruns of threshold limits among the second set of threshold limits as set forth in Paragraphs [0122-0127] to provide identification of phenomena that reduce effectiveness of the applied therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with a first set of the threshold limits among the threshold limits of the second group are linked to each other and a second set of threshold limits among the threshold limits of the second group are not linked to each other, wherein the alert unit is configured to trigger an alert in response to at least two overruns of threshold limits among the second set of threshold limits as taught by Milpied et al, since such a modification would provide the predictable results of identification of phenomena that reduce effectiveness of the applied therapy.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vincent et al (US Publication 2007/0270914) in view of Milpied et al (US Publication 2016/0303372) as applied to claim 28 above, and further in view of Gunderson et al (US Publication 2014/0350620).
Referring to Claim 30, Vincent et al in view of Milpied et al teaches the device for monitoring operation of a probe of an implantable active cardiac device according to claim 28, except wherein: the first group of threshold limits relate to at least one of an impedance of the probe, a continuity of the probe, and a number of total extrasystoles, and the second group of threshold limits relate to an amplitude of a detection signal, a detection percentage, a pacing threshold, a number of isolated extrasystoles, a number of treated ventricular fibrillations, a number of sustained but untreated ventricular fibrillations, and a number of non-sustained ventricular fibrillations.
Gunderson et al teaches that it is known to use the first group of threshold limits relate to at least one of an impedance of the probe, a continuity of the probe, and a number of total extrasystoles, and the second group of threshold limits relate to an amplitude of a detection signal, a detection percentage, a pacing threshold, a number of isolated extrasystoles, a number of treated ventricular fibrillations, a number of sustained but untreated ventricular fibrillations, and a number of non-sustained ventricular fibrillations as set forth in Paragraphs [0036], [0054-0057] and [0072] to provide dentification of short circuits that reduce effectiveness of therapy while monitoring for anomalies in the electrocardiogram signal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Vincent et al, with the first group of threshold limits relate to at least one of an impedance of the probe, a continuity of the probe, and a number of total extrasystoles, and the second group of threshold limits relate to an amplitude of a detection signal, a detection percentage, a pacing threshold, a number of isolated extrasystoles, a number of treated ventricular fibrillations, a number of sustained but untreated ventricular fibrillations, and a number of non-sustained ventricular fibrillations as taught by Gunderson et al, since such a modification would provide the predictable results of identification of short circuits that reduce effectiveness of therapy while monitoring for anomalies in the electrocardiogram signal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/WILLIAM J LEVICKY/Primary Examiner, Art Unit 3796