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 .
Response to Arguments
Allowable Subject Matter
Although previous Examiner indicated claims 2-16, 19 and 20 as including allowable subject matter, Examiner asserts that claims 2-16, 19 and 20 are now being rejected under 35 U.S.C. 102 or 35 U.S.C. 103 as indicated below (see section Claim Rejections 35 USC 102 and Claim Rejections 35 USC 103).
Claim Rejections 35 U.S.C § 101
Applicant’s arguments filed on 03/04/2026 have been fully considered but are either not persuasive or moot. To ensure compact prosecution, Examiner addresses the following arguments made by Applicant:
The steps “based on the first monitoring assessment information, adjusting a sensing parameter of a sensing amplifier of the medical device, and/or sending alarm information to a communication device, and/or storing relevant data corresponding to the first monitoring assessment in an adjustment module." cannot be realized in the mind, and are therefore not directed to mental processes.
The steps “based on the first monitoring assessment information, adjusting a sensing parameter of a sensing amplifier of the medical device, and/or sending alarm information to a communication device, and/or storing relevant data corresponding to the first monitoring assessment in an adjustment module”, provide an integration into practical application.
Applicant argues that the claims recite additional elements that in combination are not well understood, routine or conventional activities.
Regarding point (i), Examiner agrees with Applicant’s assertion that the steps “based on the first monitoring assessment information, adjusting a sensing parameter of a sensing amplifier of the medical device, and/or sending alarm information to a communication device, and/or storing relevant data corresponding to the first monitoring assessment in an adjustment module”, are not mental processes. As discussed in the section below (see Claim Rejections 101, STEP 2A, Prong 2), the steps are additional elements, more specifically, insignificant extra-solution activity.
Regarding point (ii), Examiner respectfully disagrees. As indicated in the section below (Claim Rejections 101, STEP 2A, Prong 2), the steps do not integrate the abstract idea as they are examples of insignificant extra solution activity or elements that are well understood, routine or conventional.
Regarding point (iii), Examiner respectfully disagrees. As discussed in the section below (see Claim Rejections 101, STEP 2B) the steps individually and in combination are directed to elements that are well understood routine and conventional, as evidenced by Gunderson (US 2016/0074666).
Claim Rejections 35 U.S.C § 102
Applicants’ arguments filed on 03/04/2026 have been fully considered but are moot in view of new grounds of rejection.
Claim Interpretation
While not necessarily unclear, it is conceivable that the following terms could be interpreted in ways other than the manner in which they are interpreted herein. Accordingly, Examiner seeks correction or confirmation of the following claim interpretations.
The limitation “adjustment label information” , based on Applicant’s specification [0091], is interpreted to mean any information related to sensing parameter adjustment.
The limitation “focus label information”, based on Applicant’s specification [0091], is interpreted to mean any information related to abnormality in the sensing parameter.
The limitation “maintain label information”, based on Applicant’s specification [0091], is interpreted to mean any information related to maintaining the sensing parameter (i.e., not performing an adjustment).
The limitation “threshold node” , based on Applicant’s specification [0119], is being interpreted to mean a value or criteria used to filter out unwanted signal information.
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 1-13, 15, and 17-22 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 1,
There is insufficient antecedent basis for the limitation “the medical device”. For examination purposes the first instance of “the medical device” will be interpreted as “a medical device”.
The limitation “wherein the first monitoring assessment information comprises whether the first monitoring wave being nearly to be sensed;” promotes a clarity concern. Specifically, it is unclear what applicant means by the phrase “nearly to be sensed”. For examination purposes, based on Applicant’s specification [0076] the limitation “nearly to be sensed” is being interpreted as referring to an oversensing event.
Examiner notes that dependent claims 2-6 inherit the same deficiencies.
In re claim 2,
There is insufficient antecedent basis for the limitation “the second monitoring wave”. For examination purposes, the limitation “the second monitoring wave” will be interpreted as “the second monitoring waves”
Regarding the limitation “nearly to be sensed”, see above (In re claim 1 (ii)).
In re claim 5, regarding the limitation “nearly to be sensed”, see above (In re claim 1 (ii)).
In re claim 7, see above (In re claim 1).
In re claim 11, regarding the limitation “nearly to be sensed”, see above (In re claim 1 (ii)).
In re claim 13,
Regarding the limitation “nearly to be sensed” see above (In re claim 1 (ii)).
The limitation raises a clarity concern when viewed in combination with Applicant’s specification specifically, FIG. 8 and FIG. 14. Examiner notes that claim 13 depends from claim 7 which requires “determining …second threshold value information”. Claim 13 further limits the method disclosed in claim 7 by requiring “determining…first threshold value information”. Examiner asserts that it is unclear how claim 7 and 13 coexist given that Applicants specification indicates “first threshold value” and “second threshold value” being synonyms for one another (see text on FIG. 8 and FIG. 14: “First threshold value information (a.k.a. second threshold value information)”) For examination purposes, given that the first threshold value information is also known as the second threshold value information, claim 13 will be treated as an Independent claim.
In re claim 15, regarding the limitation “nearly not to be sensed” see above (In re claim 1 (ii)). Examiner notes that “nearly not to be sensed” for similar reasons describe above ( In re claim 1 (ii)) is being interpreted as not determining an oversensing event or no oversensing event.
In re claim 21, regarding the limitation “nearly to be sensed”, see above (In re claim 1 (ii)).
In re claim 22, see above (In re claim 15).
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 1-13, 15, and 17-22 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Independent claims 1, 7, 17, 18, 19 and 20 are directed to a heart signal monitoring method (claims 1, 7), a non-transitory computer readable medium (claims 17, 19) and a medical electronic device (claims 18, 20). Thus, the claims are directed to statutory categories of invention. (Step 1: YES)
Step 2A, Prong 1
Independent claims 1, 7 and 17-20 recite the following limitations:
“determining, based on a first monitoring wave, first threshold value information corresponding to the first monitoring wave within a preset monitoring time interval” (mental process) (claim 1)
“wherein the first threshold value information is used for monitoring the first monitoring wave; and” (further limiting the abstract idea of “determining…first threshold value information”).
“determining, based on the first threshold value information, first monitoring assessment information corresponding to the first monitoring wave” (mental process) (claim 1)
“wherein the first monitoring assessment information comprises whether the first monitoring wave being nearly to be sensed” (further limiting the abstract idea of “determining…first monitoring assessment information”) (claim 1)
“wherein the determining, based on the first threshold value information, first monitoring assessment information corresponding to the first monitoring wave comprises: determining, based on second monitoring waves in the electrocardiogram corresponding to the first monitoring wave, a plurality of first periods corresponding to the first monitoring wave; determining peak information of the first monitoring wave corresponding to each of the plurality of first periods; and determining, based on the peak information of the first monitoring wave corresponding to each of the plurality of first periods and the first threshold value information, the first monitoring assessment information.” (further limiting the abstract idea of “determining…first monitoring assessment information”). (claim 1)
“determining, based on a second monitoring wave in an electrocardiogram corresponding to a first monitoring wave, a threshold node and second threshold value information corresponding to the second monitoring wave within a preset monitoring time interval” (mental process) (claim 7)
“wherein the threshold node and the second threshold value information are used for sensing the second monitoring wave, and the second threshold value information is used for avoiding sensing the first monitoring wave” (further limiting the abstract idea of “determining…a threshold node and second threshold value information”) (claim 7)
“determining, based on the threshold node and the second threshold value information, second monitoring assessment information corresponding to the second monitoring wave, wherein the second monitoring assessment information comprises whether the second monitoring wave being nearly not to be sensed;” (mental process) (claim 7)
Examiner notes that dependent claims 3, 4, 5, and 6 include limitations that further limit the abstract idea of “determining…first monitoring assessment information”.
Examiner notes that dependent claims 8, 9, 10 and 11 include limitations that further limit the abstract idea of “determining…second monitoring assessment information”.
Examiner notes that dependent claim 12 further limits the abstract idea of “determining…a threshold node and a second threshold value information”.
Examiner notes that dependent claim 13 recites the same limitations, directed mental processes, from claim 1 listed above.
Regarding the limitations directed to a mental process, the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper to be an abstract idea. Examples of mental processes include observation, judgement, evaluation and opinion. The limitations listed above are nothing more than a medical professional observing an electrocardiogram and identifying features that indicate issues with waveform sensing.
For the reasons above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea (Step 2A, Prong 1: Yes).
Step 2A, Prong 2
Claims 1, 7 and 17-20 recite the following additional elements:
“adjusting a sensing parameter of a sensing amplifier of the medical device, and/or” (insignificant extra solution activity that is well understood, routine and/or conventional see step 2B) (claim 1)
“sending alarm information to a communication device, and/or” (insignificant extra solution activity) (claim 1)
“storing relevant data corresponding to the first monitoring assessment in an adjustment module;” (insignificant extra solution activity) (claim 1)
“a non-transitory computer readable medium wherein a computer program is stored thereon” (generic computer component)(claim 17, claim 19)
“a medical electronic device” (generic computer component) (claim 18, claim 20)
“a processor” (generic computer component) (claim 18, claim 20)
“a memory for storing computer executable instructions of the processor” (generic computer component) (claim 18, claim 20).
The dependent claims recite the following additional elements:
“wherein based on the first monitoring assessment information, adjusting the sensing parameter of the sensing amplifier of the medical device comprises: when the first monitoring wave is nearly to be sensed, decreasing a sensing gain level of the sensing amplifier of the medical device” (insignificant extra solution activity) (claim 2)
“the sensing amplifier is a hardware component of the medical device and is configured to monitor heart signals” (generic computer component and further limitation of generic computer component) (claim 2, claim 15, claim 21)
“the medical device comprises any one of a pacemaker, an implantable cardioverter defibrillator, a cardiac resynchronization treatment defibrillator, a wearable cardioverter defibrillator, and
an extracorporeal defibrillator;” (generally linking to a field of use/technological environment) (claim 2, claim 15)
“adjusting a sensing parameter of a sensing amplifier of the medical device, and/or” (insignificant extra solution activity that is well understood, routine and/or conventional see analysis in Step 2B) (claim 7)
“sending alarm information to a communication device, and/or” (insignificant extra solution activity, example of data output) (claim 7)
“storing relevant data corresponding to the first monitoring assessment in an adjustment module;” (insignificant extra solution activity) (claim 7)
“increasing a sensing gain level of the sensing amplifier of the medical device” (insignificant extra solution activity, that is well understood, routine and/or conventional; see analysis in Step 2B) (claim 15, 22)
“wherein the medical electronic device is a medical device, and the medical device comprises a sensing amplifier” (generic computer component/generally linking to a field of use or technological environment) (claim 21, claim 22)
“decreasing a sensing gain level of the sensing amplifier of the medical device” (insignificant extra solution activity, that is well understood, routine and/or conventional; see analysis in Step 2B) (claim 21)
The limitations above fail to provide significantly more because they either amount to insignificant extra solution activity or generic computer components used to apply the abstract idea.
Step 2B
The claims do not include any additional elements that amount to significantly more than the judicial exception.
As discussed above, in Step 2A, Prong 2 the remaining additional elements amount to no more than applying the abstract idea using generic computer components and insignificant extra solution activity.
Regarding the limitations “adjusting a sensing parameter of a sensing amplifier of the medical device”, see Gunderson (US 2016/0074666) which discloses a system and method for determining T-wave oversensing (abstract; FIG. 3: 402; [0034]). Gunderson further discloses adjusting a parameter (406) of a sensing amplifier [0044-0051] if T-wave oversensing is detected (“Yes” coming out of diamond 402). Thus, the limitation “adjusting a sensing parameter of a sensing amplifier of the medical device” is well understood, routine and conventional (as evidenced by Gunderson).
Regarding the limitations “increasing a sensing gain level of the sensing amplifier of the medical device” and “decreasing a sensing gain level of the sensing amplifier of the medical device”, see Vonk (US 5, 913,800) which discloses a method (abstract) for automatic sensitivity adjustment (title) in an implantable cardiac device (abstract: “pacemaker”). Vonk discloses known approaches to adjusting sensitivity (col. 1, lines 12-14), one of which is to adjust a gain of a sense amplifier (i.e., increasing or decreasing gain) (col. 1, lines 35-45). Thus, the limitations ““increasing a sensing gain level of the sensing amplifier of the medical device” and “decreasing a sensing gain level of the sensing amplifier of the medical device” are well understood, routine and conventional (as evidenced by Vonk).
Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. (Step 2B: NO)
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 7-10, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunderson (US 2016/0074666).
In re claim 1, Gunderson discloses, a heart signal monitoring method (abstract; FIG. 3), comprising:
determining (occurs at 402; [0034]: “T-wave sensing”, process described in greater detail in incorporated reference Cao (US 7,831,304)), based on a first monitoring wave (Cao: FIG. 4: 264; col. 6, line 12: “T-wave”) in an electrocardiogram (Cao: 250), first threshold value information (Cao: 335, “second sensing threshold”) corresponding to the first monitoring wave (Cao: col. 7, lines 1-12) within a preset monitoring time interval (Cao: duration of time it takes to execute process shown in FIG. 5),
wherein the first threshold value information is used for monitoring the first monitoring wave (apparent as “secondary threshold” is used to identify “T-waves” as described in Cao: col. 7 lines 13-22); and
determining, based on the first threshold value information, first monitoring assessment information (Cao: information collected across 340, 343, 345, 350, 355, 360, 365 and 370) corresponding to the first monitoring wave (Cao: FIG. 5),
wherein the first monitoring assessment information comprises whether the first monitoring wave being nearly to be sensed (Cao: 370: “T-WAVE OVERSENSING”; Regarding the limitation “being nearly to be sensed” see above section Claim Rejection 112); and
based on the first monitoring assessment information,
adjusting a sensing parameter (406) of a sensing amplifier (204/200; [0022]) of the medical device (shown in FIG. 1), and/or
sending alarm information (Cao: col. 8, lines 56-62: “T-wave oversensing signal”) to a communication device (Cao: col. 8, lines 56-62) and/or
storing relevant data corresponding to the first monitoring assessment in an adjustment module (404)
wherein the determining, based on the first threshold value information, first monitoring assessment information corresponding to the first monitoring wave comprises:
determining, **based on second monitoring waves (Cao: col. 7, lines 4-7: “R-wave peaks”) in the electrocardiogram corresponding to the first monitoring wave, a plurality of first periods (Cao: 262, “Vs”) corresponding to the first monitoring wave (Cao: FIG. 4);
**It is apparent that “a plurality of first periods” are at least partially determined “based on second monitoring waves” given that the criteria (254) responsible for determining a V sense event (“Vs”) is adjusted in response to “R-wave peaks” as described in (Cao, col. 7, lines 1-12).
determining peak information (Cao: 360) of the first monitoring wave corresponding to each of the plurality of first periods (Cao: col. 8, lines 38-59); and
determining, based on the peak information of the first monitoring wave corresponding to each of the plurality of first periods and the first threshold value information, the first monitoring assessment information (Cao: FIG. 5).
In re claim 3, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7, 831, 304))
wherein the determining, based on the peak information of the first monitoring wave corresponding to each of the plurality of first periods and the first threshold value information, the first monitoring assessment information comprises:
determining, based on the peak information of the first monitoring wave corresponding to each of the plurality of first periods and the first threshold value information, first region label information (portion information collected across steps 340, 343, 354, 350, 355, 360, 365 and 370),
wherein the first region label information comprises
adjustment label information (370)
focus label information (343), and
maintaining label information (“NO” coming out of any one of 345, 350, 355, 360, 365) ; and
determining, based on the first region label information corresponding to each of the plurality of first periods, the first monitoring assessment information (apparent see previous bullets).
In re claim 4, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7, 831, 304))
wherein the determining, based on the peak information of the first monitoring wave corresponding to each of the plurality of first periods and the first threshold value information, first region label information of the first period corresponding to each of the plurality of first periods comprises:
performing calculation to obtain first difference value information (FIG. 6: 408) according to the peak information of the first monitoring wave corresponding to each of the plurality of first periods and the first threshold value information (col. 8, line 63 – col. 9 line 12) ;
performing calculation to obtain first ratio information (445: “R/T”) according to the first difference value information and the first threshold value information (apparent as 408 and 425 precede the “calculation to obtain first ratio information”); and
determining, based on the first ratio information, the first region label information (apparent, outcome of process shown in FIG. 6).
In re claim 7, Gunderson discloses, a heart signal monitoring method (abstract; FIG. 3) comprising:
determining (occurs at 402; [0034]: “T-wave sensing”, process described in greater detail in incorporated reference Cao (US 7,831,304)), based on a second monitoring wave (Cao: FIG. 4: 264; col. 6, line 12: “T-wave”) in an electrocardiogram (Cao: 250) corresponding to a first monitoring wave (FIG. 4: “R”), a threshold node (Cao: col. 7, lines 42-44: “criteria” for eliminating noise) and second threshold value information (Cao: combination of 254, and 355: “second sensing threshold”) corresponding to the second monitoring wave (Cao: col. 7, lines 1-12) within a preset monitoring time interval (Cao: duration of process in FIG. 5),
wherein
the threshold node and the second threshold value information are used for sensing the second monitoring wave (Cao: 335, 340, col. 7 lines 43-44), and
the second threshold value information is used for avoiding sensing the first monitoring wave (col. 7, lines 4-6, apparent that 254 partially limits sensing of R-wave as it is automatically adjusted in response to “R-wave” peaks on a beat-to-beat basis); and
determining, based on the threshold node and the second threshold value information (Cao: FIG. 5), second monitoring assessment information (Cao: information collected across 340, 343, 345, 350, 355, 360, 365 and 370) corresponding to the second monitoring wave (Cao, FIG. 5),
wherein
the second monitoring assessment information comprises whether the second monitoring wave being nearly not to be sensed (Cao: 370: “T-WAVE OVERSENSING”; Regarding the limitation “being nearly to be sensed” see above section Claim Rejection 112); and
based on the first monitoring assessment information,
adjusting a sensing parameter (406) of a sensing amplifier (204/200; [0022]) of the medical device (shown in FIG. 1), and/or
sending alarm information (Cao: col. 8, lines 56-62: “T-wave oversensing signal”) to a communication device (Cao: col. 8, lines 56-62) and/or
storing relevant data corresponding to the first monitoring assessment in an adjustment module (404).
In re claim 8, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7,831,304)), wherein the determining, based on the threshold node and the second threshold value information, second monitoring assessment information corresponding to the second monitoring wave comprises:
determining, based on the threshold node and the second threshold value information, a plurality of second periods (FIG. 4: “Vs” spanning “T-waves”) corresponding to the second monitoring wave,
wherein the second threshold value information is linear or exponential decay information (FIG. 4, specifically see shape of 254);
determining start point value information (FIG. 4: left most end of “Vs” spanning “T-waves”) and peak information (360) corresponding to each of the plurality of second periods (col. 8, lines 38-43); and
determining, based on the start point value information and the peak information corresponding to each of the plurality of second periods, the second monitoring assessment information (apparent as 335 precedes 340, 343, 345, 350, 355, 360, 365 and 370) .
In re claim 9, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7,831,304)), wherein the determining, based on the start point value information and the peak information corresponding to each of the plurality of second periods, the second monitoring assessment information comprises:
determining, based on the start point value information and the peak information corresponding to each of the plurality of second periods, second region label information (portion of information collected across 340, 343, 345, 350, 355, 360, 365 and 370) corresponding to each of the plurality of second periods,
wherein the second region label information comprises
adjustment label information (370),
focus label information (343), and
maintaining label information (“NO” coming out of any one of 345, 350, 355, 360, 365); and
determining, based on the second region label information corresponding to each of the plurality of second periods, the second monitoring assessment information (apparent see previous bullets).
In re claim 10, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7,831,304)), wherein the determining, based on the start point value information and the peak information corresponding to each of the plurality of second periods, second region label information corresponding to each of the plurality of second periods comprises:
performing calculation to obtain second difference value information (FIG. 6: 408) according to the peak information and the start point value information (col. 8, line 63 – col. 9 line 12);
performing calculation to obtain second ratio information (445: “R/T”) according to the second difference value information and the peak information (apparent as 408 and 425 precede the “calculation to obtain second ration information”; and
determining, based on the second ratio information, the second region label information (apparent, see above bullets).
In re claim 17, Gunderson discloses ([0034]; all mapping from now on directed to incorporated reference Cao (US 7,831,304))
a non-transitory computer readable storage medium (col. 6, lines 34-35 & 46-52),
wherein a computer program (col. 6, lines 46-52: “instructions”) is stored thereon for performing the heart signal monitoring method according to claim 1 (col. 6, lines 34-35 & 46-52; additionally see above In re claim 1).
In re claim 18, Gunderson discloses, a medical device (FIG. 1; FIG. 2; [0014]: “implantable cardioverter defibrillator”) comprising:
a processor (224); and
a memory [0030] for storing executable instructions of the processor [0030],
wherein the processor is used for implementing the heart signal monitoring method according to claim 1 ([0034]; Cao: col. 6, lines 34-35 & 46-52)
In re claim 19, Gunderson discloses (all mapping from now on directed to incorporated reference Cao (US 7,831,304)),
a non-transitory computer readable storage medium (col. 6, lines 34-35 & 46-52),
wherein a computer program (col. 6, lines 46-52: “instructions”) is stored thereon for performing the heart signal monitoring method according to claim 7 (col. 6, lines 34-35 & 46-52; additionally see above In re claim 7).
In re claim 20, Gunderson discloses, a medical electronic device (FIG. 1; FIG. 2; [0014]: “implantable cardioverter defibrillator”) comprising:
a processor (224); and
a memory [0030] for storing executable instructions of the processor [0030],
wherein the processor is used for implementing the heart signal monitoring method according to claim 7 ([0034]; see incorporated reference Cao (US 7,831,304): col. 6, lines 34-35 & 46-52; see above In re claim 7)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 13, 15 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2016/0074666), in view of Vonk (US 5,913,880).
In re claim 2, Gunderson discloses,
wherein based on the first monitoring assessment information, adjusting the sensing parameter of the sensing amplifier of the medical device comprises:
when the first monitoring wave is nearly to be sensed (“Yes” coming out of diamond 402), decreasing a sensing parameter (406; [0022]: “reducing sensitivity”) of the sensing amplifier of the medical device
wherein
the sensing amplifier is a hardware component of the medical device (see FIG. 2; [0022]) and is configured to monitor heart signals [0022]
the medical device comprises any one of
a pacemaker,
an implantable cardioverter defibrillator [0014],
a cardiac resynchronization treatment defibrillator,
a wearable cardioverter defibrillator, and
an extracorporeal defibrillator;
wherein
the first monitoring wave is a T wave and the second monitoring wave is an R wave (see above In re claim 1); and/or
the first monitoring wave is a far-field R (FFR) wave, and the second monitoring wave is a P wave (optional).
Gunderson does not disclose the sensing parameter of the sensing amplifier being a sensing gain level and thus lacks: decreasing a sensing gain level of the sensing amplifier of the medical device.
Vonk summarizes several well-known methods (col. 1, lines 12-14) for adjusting a sensitivity of a sense amplifier (col. 1, lines 35-36), one of which involves adjusting the sense amplifiers sensing gain level (col. 1, lines 39-45). As disclosed by Vonk, the sensing gain level can be increased to better detect low amplitude waveforms and decreased in response to higher amplitude waveforms (col. 1, lines 39-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing parameter of the sensing amplifier of Gunderson to be a sensing gain level, given that adjusting gain is a known way to alter sensitivity of a sense amplifier, as taught by Vonk. Moreover, one of ordinary skill in the art would have the ability to choose a sensing parameter that would best meet their needs.
In re claim 13, see above (In re claim 1 and In re claim 2). Additionally, see above section Claim Rejections 35 USC 112b (In re claim 13).
In re claim 15, Gunderson discloses, further comprising:
when the second monitoring wave is nearly not to be sensed (“No” coming out of diamond 402),
wherein
the sensing amplifier is a hardware component of the medical device (see FIG. 2; [0022]) and is configured to monitor heart signals [0022]
the medical device comprises any one of
a pacemaker,
an implantable cardioverter defibrillator [0014],
a cardiac resynchronization treatment defibrillator,
a wearable cardioverter defibrillator, and
an extracorporeal defibrillator;
Gunderson does not disclose
when the second monitoring wave is nearly not to be sensed, increasing a sensing gain level of the sensing amplifier of the medical device
As discussed above, Vonk describes several ways to adjust a sensitivity of a sense amplifier (col. 1, lines 35-36). As disclosed by Vonk, increasing sense amplifier gain is a known technique to improve the sense amplifiers sensitivity to lower voltage signals large (col. 1, lines 39-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson to increase a sensing gain level of the sensing amplifier of the medical device when the second monitoring wave is nearly not to be sensed, as suggested by Vonk. One would be motivated to make this modification because increasing a sensing gain level of a sense amplifier is a known technique to improve detection of lower-amplitude signals, as evidenced by Vonk. One would be further motivated to increase a sensing gain level of the sensing amplifier given that the medical device has already determined that there is no risk of oversensing (i.e., “nearly not to be sensed”).
In re claim 21, see above (In re claim 2).
In re claim 22, see above (In re claim 15).
The proposed combination also yields (all mapping directed to Gunderson)
wherein the medical electronic device is a medical device (apparent) and the medical device comprises the sensing amplifier (see FIG. 2; [0022])
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2016/0074666).
In re claim 5, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7,831,304)), wherein the determining, based on the first ratio information, the first region label information comprises:
when the first ratio information is less than a first preset value (445, “< 75% R/T(DIFF)”), determining the first region label information to be the adjustment label information (see “Y” coming out of box 445 which contributes to detection of “T-WAVE OVERSENSING” at 455); and/or
when the first ratio information is greater than or equal to the first preset value and less than a second preset value, determining the first region label information to be the focus label information, wherein the second preset value is greater than or equal to 15%, and less than or equal to 30% (optional);
wherein the determining, based on the first region label information corresponding to each of the plurality of first periods, the first monitoring assessment information comprises:
when the first region label information corresponding to each of a plurality of consecutive first periods is the adjustment label information, determining that the first monitoring wave is nearly to be sensed (apparent as “adjustment label” is 370, “T-Wave Oversensing”),
wherein the plurality of consecutive first periods comprise two or more than two first periods (FIG. 4; col. 7, lines 3-4: “multiple (N) V sense events”).
Gunderson does not explicitly disclose
wherein the first preset value is greater than or equal to 5%, and less than or equal to 15%;
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first preset value to be greater than or equal to 5% and less than or equal to 15%, 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. MPEP 2144.05-II-A.
In re claim 11, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7,831,304)),wherein the determining, based on the second ratio information, the second region label information comprises:
when the second ratio information is less than a third preset value (445, “< 75% R/T(DIFF)”), determining the second region label information to be the adjustment label information (see “Y” coming out of box 445 which contributes to detection of “T-WAVE OVERSENSING” at 455) ; and/or
when the second ratio information is greater than or equal to the third preset value and less than a fourth preset value, determining the second region label information to be the focus label information, wherein the fourth preset value is greater than or equal to 15%, and less than or equal to 30% (optional);
wherein the determining the second monitoring assessment information based on the second region label information corresponding to each of the plurality of second periods comprises:
when the second region label information corresponding to each of a plurality of consecutive first periods is the adjustment label information, determining that the second monitoring wave is nearly not to be sensed (apparent as “adjustment label” is 370, “T-Wave Oversensing”),
wherein the plurality of consecutive second periods comprise two or more than two second periods (FIG. 4; col. 7, lines 3-4: “multiple (N) V sense events”).
Gunderson does not disclose
wherein the third preset value is greater than or equal to 5%, and less than or equal to 15%;
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the third preset value to be greater than or equal to 5% and less than or equal to 15%, 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. MPEP 2144.05-II-A.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2016/0074666), in view of McClure et al. (US 6,650,931).
In re claim 6, Gunderson discloses (all mapping directed to incorporated reference Cao ((US 7,831,304) wherein the determining, based on second monitoring waves in the electrocardiogram corresponding to the first monitoring wave, a plurality of first periods corresponding to the first monitoring wave comprises:
determining occurrence period information corresponding to the second monitoring waves (FIG. 4; col. 7, lines 13-18; Examiner notes that the term “occurrence period information” is broad and can be interpreted as any information related to the occurrence of the “second monitoring waves”);
determining a plurality of first monitoring nodes (FIG. 4: left most portion of rectangle, “Vs” associated with “R” waves) of the second monitoring waves;
determining a node (FIG. 4: left most portion of rectangle “VS” associated with “T-waves”) as a start time node of the first period corresponding to the first monitoring node,
wherein the plurality of first periods and the plurality of first monitoring nodes have a one-to-one correspondence (see FIG. 4, specifically first 6 “Vs” events) ;
determining, an end time node (FIG.4: right most portion of rectangle “VS” associated with “T-waves”) of the first period corresponding to the first monitoring node (FIG. 4); and
determining, based on a preset percentage of the occurrence period information, an end time node (FIG. 4: left most portion of rectangle, “Vs” associated with “R” waves) of the first period corresponding to the first monitoring node (apparent that determination of end time node is at least based on some portion of the information related to the occurrence of the “second monitoring wave”); and
determining, based on the start time node and the end time node, the first period corresponding to the first monitoring node (apparent see steps above).
Gunderson does not disclose
determining a node after a preset period starting from each of the plurality of first monitoring nodes as a start time node of the first period corresponding to the first monitoring node,
McClure discloses a heart signal monitoring method focused on identifying start and end point of a T-wave in an electrocardiogram (abstract). As disclosed by McClure, in one embodiment a start time of a T-wave is identified by using a programmed time delay that begins at the end of a most recent R-wave (col. 17, lines 49-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a start time node of the T-wave using a preset period from the R-wave, as taught by McClure. One would have been motivated to make this modification because it is a known way to identify a start of a T-wave, as evidenced by McClure. Moreover, Examiner asserts that one of ordinary skill in the art would have the ability to choose a method of identifying T-waves that would best meet their needs.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2016/0074666), in view of Cao et al. (US 10,799,710; herein referred to as Cao II).
In re claim 12, Gunderson discloses (all mapping directed to incorporated reference Cao (US 7,831,304)) wherein the determining, based on the threshold node and the second threshold value information, a plurality of second periods corresponding to the second monitoring wave comprises:
determining, based on the threshold nodes, a plurality of second monitoring nodes of the second monitoring wave (FIG. 4: left most portion of rectangles “VS” associated with “T-waves”); and
determining a second period (FIG. 4: right most portion of rectangles “VS” associated with “T-waves”) corresponding to the second monitoring node.
Gunderson does not disclose,
determining a preset period after each of the plurality of second monitoring nodes as the second period corresponding to the second monitoring node.
Cao II discloses a heart signal monitoring method (col. 1, lines 7-10) that uses a preset time duration to identify an end of a T-wave (col. 31, lines 4-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson to determine an end of a T-wave using a preset period, as taught by Cao II. One would have been motivated to make this modification because it is a known way to determine T-wave duration as evidenced by Cao II. Moreover, Examiner asserts that one of ordinary skill in the art would have the ability to choose a method of identifying T-waves that would best meet their needs. Accordingly, such a modification would yield “determining a preset period after each of the plurality of second monitoring nodes as the second period corresponding to the second monitoring node”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lybarger et al. (US 2021/0052895) discloses a system and method for detecting oversensing and adjusting sensitivity parameters accordingly (abstract). 11
Conclusion
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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