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 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 1-20 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.
Regarding claim 1, the limitation “not delivering pulse stimulation to a stimulation electrode at the set myocardial position if it is determined that the sensing event is not an R-wave signal corresponding to the R-wave in the preset electrocardiogram” renders the claim unclear. Specifically, it is unclear if the method requires the step of not delivering pulse stimulation since the limitation is contingent on the determination of the sensing event. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04(II)). However, in order to further advance prosecution Examiner will be interpreting claim 1 as requiring the step of “not delivering pulse stimulation to a stimulation electrode at the set myocardial position if it is determined that the sensing event is not an R-wave signal corresponding to the R-wave in the preset electrocardiogram”. Examiner suggests amending the claim to recite when in place of if in order to help overcome the 112 rejection. Dependent claims inherit the same deficiencies.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of determining that a sensing event is not an R-wave signal) without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method/system for determining that a sensing event is not an R-wave signal.
Step 2A, Prong One
Regarding claims 1-20, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claim 1, the limitation of “not delivering pulse stimulation to a stimulation electrode at the set myocardial position if it is determined that the sensing event is not an R-wave signal corresponding to the R-wave in the preset electrocardiogram” is a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation. Examiner notes that no structure or stimulation is positively recited in the claim and not delivering stimulation amounts to doing nothing.
Step 2A, Prong Two
For claims 1-20, the judicial exception is not integrated into a practical application. For claims 19-20, the additional limitation of “a memory”, “a processor” and “a computer program” are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of “acquiring a first sensing time…” and “acquiring a second sensing time…” amount to nothing more than the pre-solution activity of data gathering (MPEP 2106.05(g)).
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations of “acquiring a first sensing time…” and “acquiring a second sensing time…” are directed to the pre-solution activity of mere data gathering, which does not amount to an inventive concept.
The recitation of the above-identified additional limitations of “a memory”, “a processor” and “a computer program” in claims 1-20 amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
Dependent claims 2-4 are further directed to insignificant extra-solution activities and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses (MPEP 2106.05(g)).
Dependent claims 5-18 are further directed to the abstract idea and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Claim 20 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory
categories of invention and thus fail as eligible subject matter. Claim 20 characterizes the invention
as a “A computer-readable storage medium”. A broadest reasonable interpretation of this language typically covers forms of non-transitory tangible media and transitory propagating signals per se, which are not patentable under 35 U.S.C. 101. Claims that cover both statutory and non-statutory embodiments under the broadest reasonable interpretation of the claims when read in light of the specification and in view of one skilled in the art, embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. The claims are considered to be broad enough to cover a transitory propagating signal that carries a programmed instruction set. The specification discloses a “computer-readable storage medium storing a computer program” in [0267]. This text does not exclude a transitory propagating signal. Furthermore, even when claims are directed to one of the four statutory categories of invention, the claims must not be wholly directed to subject matter encompassing a judicially recognized exception without a particular practical application. In the instant case, in addition to failing to fall within one of the four statutory categories of invention, the claims recite only instructions, i.e. an algorithm that is not limited to a particular practical application. It is suggested to add “non-transitory” to the claim body to distinguish over non-statutory subject matter.
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) 1-2, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rousso et al (US 2009/0099618) hereinafter Rousso.
Regarding claim 1, Rousso discloses a pulse stimulation control method (Fig. 6), comprising:
acquiring a first sensing time of an R-wave in a preset electrocardiogram ([0149] global electrocardiogram (ECG) signal recorded from a subject; [0171-0178] analyzing RR interval of global ECG signal);
acquiring a second sensing time corresponding to a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position ([0149] at least one locally sensed ventricular signal); and
not delivering pulse stimulation to a stimulation electrode at the set myocardial position if it is determined that the sensing event is not an R-wave signal corresponding to the R-wave in the preset electrocardiogram ([0150] if a suspected ectopic event other than paced ventricular induced electrical activity has been detected, inhibit the delivery of a CCM signal to the heart in at least the current cardiac beat cycle (step 86)),
wherein the pulse stimulation is cardiac contractility modulation (CCM) stimulation ([0150] inhibit delivery of a CCM signal).
Regarding claim 2, Rousso discloses determining the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the first sensing time ([0149] CCM delivery control is based on receiving at least one locally sensed ventricular signal and at least one global electrocardiogram (ECG) signal recorded from a subject (step 80)),
wherein the preset electrocardiogram is a surface electrocardiogram and/or an in vivo far-field myocardial electrocardiogram ([0138] one or more non-implanted external electrodes (not shown in FIG. 3) may be placed on the patient's skin and used to record a global ECG signal).
Regarding claim 17, Rousso discloses calculating the pulse delivery time corresponding to the stimulation electrode at the set myocardial position based on the second sensing time of the R-wave in the local myocardial electrocardiogram and a preset duration ([0232] curve 320 represents a schematically drawn pace channel recorded signal (which may in practice be any of the channels VS1, VS2, ECG1, ECG2; double headed arrow 330 represents a user programmable maximal pace time period which starts at the point 326).
Regarding claim 19, Rousso discloses an electronic device ([0131] device 30), comprising
a memory ([0330] programs embedded in the devices of the present invention may be implemented on any known type of memory or storage unit known in the art),
a processor ([0131] CPU 34), and
a computer program stored on the memory and executable on the processor ([0149] program implementing the method; [0330] programs embedded in the devices of the present invention may be implemented on any known type of memory or storage unit known in the art)
wherein the processor, when executing the computer program, implements the pulse stimulation control method according to claim 1 ([0135] performed by suitable programs operating on the CPU 34 (or embedded or stored therein); [0149] program implementing the method).
Regarding claim 20, Rousso discloses a computer-readable storage medium storing a computer program ([0330] programs embedded in the devices of the present invention may be implemented on any known type of memory or storage unit known in the art),
wherein the computer program, when executed by a processor, causes the processor to implement the pulse stimulation control method according to claim 1 ([0149] program implementing the method).
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) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Rousso (US 2009/0099618) in view of Jackson (US 2022/0161032).
Regarding claim 3, Rousso discloses the method of claim 2 as discussed above, but fails to disclose taking the first sensing time as a first time point, and taking a time point from a corresponding first set duration before the first time point as a time reference starting point; and acquiring the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference starting point.
However, Jackson discloses taking a first sensing time as a first time point ([0203] QRS onset in far-field electrogram 508; Fig. 10B), and
taking a time point from a corresponding first set duration before the first time point as a time reference starting point ([0203] 50 milliseconds propagation time from fiducial point 510 to the QRS onset in far-field electrogram 508); and
acquiring the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference starting point ([0203] fiducial point 504).
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 method as taught by Rousso with taking a first sensing time as a first time point, and taking a time point from a corresponding first set duration before the first time point as a time reference starting point; and acquiring the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference starting point as taught by Jackson. Such a modification would provide the predictable results of detecting corresponding far-field and local sense events by accounting for the propagation time between the two.
Regarding claim 4, the modified Rousso discloses the system of claim 3 as discussed above, but fails to disclose wherein a value of the first set duration ranges from 30 ms-200ms. However, Jackson discloses wherein a value of the first set duration ranges from 30 ms-200ms ([0203] approximately a 50 milliseconds propagation time from fiducial point 510 to the QRS onset in far-field electrogram 508). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Rousso with a value of the first set duration ranging from 30 ms-200ms as taught by Jackson. Such a modification would provide the predictable results of detecting corresponding far-field and local sense events by accounting for the propagation time between the two.
Claim(s) 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rousso (US 2009/0099618) in view of Gunderson et al (US 2006/0235476) hereinafter Gunderson.
Regarding claim 5, Rousso discloses the method of claim 1 as discussed above, but fails to disclose determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram when a first preset condition is not met, wherein the first preset condition is determined based on the first sensing time of the R-wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.
However, Gunderson discloses determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram when a first preset condition is not met ([0083] Mapping the two sets of detected R-waves may involve identifying a single VS-NF event that most closely corresponds in time to each VS-FF event; any VS-NF events not identified as being "mapped" VS-NF events are considered to be the result of an oversensing condition),
wherein the first preset condition is determined based on the first sensing time of the R-wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event ([0083] the nearest VS-NF event that occurs within plus or minus "M" msec, for example 100 msec, of each VS-FF event may be identified as being a "mapped" VS-NF event).
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 method as taught by Rousso with determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram when a first preset condition is not met, wherein the first preset condition is determined based on the first sensing time of the R-wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event as taught by Gunderson. Such a modification would provide the predictable results of determining if oversensing is present (Gunderson, [0084]).
Regarding claim 6, the modified Rousso discloses determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram, and then not delivering the pulse stimulation to the stimulation electrode at the set myocardial position ([0150] if a suspected ectopic event other than paced ventricular induced electrical activity has been detected, inhibit the delivery of a CCM signal to the heart in at least the current cardiac beat cycle (step 86)), but fails to disclose acquiring a sensing time window corresponding to the R-wave in the preset electrocardiogram based on the first sensing time; and if the second sensing time does not fall within the sensing time window, determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram.
However, Gunderson discloses acquiring a sensing time window (plus or minus “M” sec) corresponding to the R-wave in the preset electrocardiogram based on the first sensing time ([0083] plus or minus "M" msec, for example 100 msec, of each VS-FF event); and
if the second sensing time does not fall within the sensing time window ([0083] the nearest VS-NF event that occurs within plus or minus "M" msec, for example 100 msec, of each VS-FF event may be identified as being a "mapped" VS-NF event), determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram ([0083] any VS-NF events not identified as being "mapped" VS-NF events are considered to be the result of an oversensing condition).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Rousso with acquiring a sensing time window corresponding to the R-wave in the preset electrocardiogram based on the first sensing time; and if the second sensing time does not fall within the sensing time window, determining that the sensing event is not the R-wave signal corresponding to the R-wave in the preset electrocardiogram as taught by Gunderson. Such a modification would provide the predictable results of determining if oversensing is present (Gunderson, [0084]).
Regarding claim 7, the modified Rousso discloses the method of claim 6 as discussed above, but fails to disclose determining that the sensing event is the R-wave signal corresponding to the R-wave in the preset electrocardiogram if the second sensing time falls within the sensing time window. However, Gunderson discloses determining that the sensing event is the R-wave signal corresponding to the R-wave in the preset electrocardiogram if the second sensing time falls within the sensing time window ([0085] If the total number of VS-NF events (i.e., mapped plus unmapped VS-NF events) does not exceed the number of mapped VS-NF events by the preset multiple, then the method determines that no oversensing (or an insignificant amount of oversensing) exists and a true VS-NF event 601 has been determined).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Rousso with determining that the sensing event is the R-wave signal corresponding to the R-wave in the preset electrocardiogram if the second sensing time falls within the sensing time window as taught by Gunderson. Such a modification would provide the predictable results of determining if oversensing is present (Gunderson, [0084]).
Regarding claim 8, the modified Rousso discloses the method of claim 6 as discussed above, but fails to disclose a length of the sensing time window is determined based on the preset electrocardiogram or determined through programming control. However, Gunderson discloses a length of the sensing time window is determined based on the preset electrocardiogram or determined through programming control ([0083] plus or minus "M" msec, for example 100 msec, of each VS-FF event). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Rousso with a length of the sensing time window is determined based on the preset electrocardiogram or determined through programming control as taught by Gunderson. Such a modification would provide the predictable results of determining if oversensing is present (Gunderson, [0084]).
Regarding claim 9, the modified Rousso discloses the method of claim 8 as discussed above, but fails to disclose wherein for sinus rhythm, the length of the sensing time window is 30 ms-130ms; for ventricular ectopic excitation, the length of the sensing time window is 30 ms-250ms. However, Gunderson discloses a length of the sensing time window is 100ms ([0083] plus or minus "M" msec, for example 100 msec, of each VS-FF event). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Rousso with for sinus rhythm, the length of the sensing time window is 30 ms-130ms; for ventricular ectopic excitation, the length of the sensing time window is 30 ms-250ms as taught by Gunderson. Such a modification would provide the predictable results of determining if oversensing is present (Gunderson, [0084]).
Moreover, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Rousso with for sinus rhythm, the length of the sensing time window is 30 ms-130ms; for ventricular ectopic excitation, the length of the sensing time window is 30 ms-250ms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rousso (US 2009/0099618) in view of Olson (US 2015/0251012).
Regarding claim 10, Rousso discloses the method of claim 1 as discussed above, but fails to disclose determining, after the sensing event is determined as the R-wave signal corresponding to the R-wave in the preset electrocardiogram, a pulse delivery time corresponding to the stimulation electrode at the set myocardial position based on the second sensing time of the R-wave in the local myocardial electrocardiogram; and determining whether the pulse delivery time meets a second preset condition, and if yes, determining to deliver the pulse stimulation to the stimulation electrode at the set myocardial position; otherwise, not delivering the pulse stimulation to the stimulation electrode at the set myocardial position.
However Olson discloses determining, after the sensing event is determined an R-wave signal (R-wave sense signal), a pulse delivery time corresponding to the stimulation electrode at the set myocardial position (pacing escape interval) based on the sensing time of the R-wave in the local myocardial electrocardiogram ([0042] pacing escape interval is restarted upon an R-wave sense signal); and
determining whether the pulse delivery time meets a second preset condition (no sensed R-waves within the interval), and if yes, determining to deliver the pulse stimulation to the stimulation electrode at the set myocardial position ([0042] In response to the pacing escape interval expiring, a pace trigger signal is applied to the pace pulse generator 122 to generate a pacing pulse);
otherwise, not delivering the pulse stimulation to the stimulation electrode at the set myocardial position (Examiner notes that if an R-wave is sensed, and the preset condition is not met, the timer is restarted and the stimulation is not delivered [0042]).
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 method as taught by Rousso with determining, after the sensing event is determined as the R-wave signal corresponding to the R-wave in the preset electrocardiogram, a pulse delivery time corresponding to the stimulation electrode at the set myocardial position based on the second sensing time of the R-wave in the local myocardial electrocardiogram; and determining whether the pulse delivery time meets a second preset condition, and if yes, determining to deliver the pulse stimulation to the stimulation electrode at the set myocardial position; otherwise, not delivering the pulse stimulation to the stimulation electrode at the set myocardial position as taught by Olson. Such a modification would provide the predictable results of preventing unnecessary stimulation from being delivered to the patient and/or maintaining cardiac output after delivery of a shock that may cause the heart to slowly beat as it recovers back to normal function (Olson, [0042]).
Examiner’s Note
While claims 11-16 and 18 are rejected under 35 USC 112 and 101, Examiner notes that no prior art rejections have been made for these claims. Examiner has not found any prior art that teaches or suggests in combination the limitations recited in claim 11. Specifically, Examiner has not found any prior art that teaches “acquiring a deliverable pulse time window corresponding to the R-wave in the preset electrocardiogram, controlling the pulse stimulation to be delivered to the stimulation electrode at the set myocardial position in the pulse delivery time if the pulse delivery time falls within the deliverable pulse time window”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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