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 Status: Claims 1-20 are pending.
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 abstract idea without significantly more. The claim(s) recite(s) a system.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 1 is directed towards a system.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “to determine, based on the impedance data, one or more impedance state electrodes from the plurality of electrodes that have an impedance state”.
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites “a processor” which can be interpreted as a generic processor. The processing device and the programmable processor do not integrate the judicial exception into a practical application, because it is merely using a generic processor as a tool to perform an abstract idea (see MPEP 2106.05(f)).
The claim recites additional elements “a medical device having a plurality of electrodes, the medical device being configured to measure impedance for each of the plurality of electrodes and generate impedance data”, “wherein the medical device is configured to communicate the generated impedance data to the at least one eternal device”, “a display”, and “wherein the processor is configured to provide on the display a plurality of electrode icons corresponding to the plurality of electrodes, and wherein the processor is configured to provide on the display an impedance status representation for one or more of the plurality of electrode icons corresponding to the one or more impedance state electrodes”. However, these additional elements do not integrate the judicial exception into a practical application, because gathering data, communicating data, and displaying results amounts to insignificant extra-solution activity.
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “a medical device having a plurality of electrodes, the medical device being configured to measure impedance for each of the plurality of electrodes and generate impedance data”, “wherein the medical device is configured to communicate the generated impedance data to the at least one eternal device”, “a display”, and “wherein the processor is configured to provide on the display a plurality of electrode icons corresponding to the plurality of electrodes, and wherein the processor is configured to provide on the display an impedance status representation for one or more of the plurality of electrode icons corresponding to the one or more impedance state electrodes”.
The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)).
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). See MPEP 2106.05(d)II.
The courts have recognized electronic recordkeeping as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log). See MPEP 2106.05(d)II.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 2-20, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-9, 11-14, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goetz et al. (US 20110307032).
Re Claim 1, Goetz discloses a system, comprising:
a medical device (para. [0043], therapy system 2 includes implantable stimulator 4) having a plurality of electrodes (fig. 1, para. [0043], [0044], Lead segments 12A and 12B each include a set of electrodes forming part of the array of electrodes 11), the medical device being configured to measure impedance for each of the plurality of electrodes and generate impedance data (para. [0221], In FIG. 28, a system integrity feature, shown generally at 400, graphically displays the results of an impedance measurement performed on the electrodes of two implanted leads, namely Lead 1 and Lead 2.); and
at least one external device, the at least one eternal device including a display (para. [0163], fig. 28, user interface 59 of programmer 40) and a processor (para. [0162], Processor 53 of programmer 40), wherein the medical device is configured to communicate the generated impedance data to the at least one eternal device (fig. 28, user interface 59, para. [0220], various programmer screens that graphically display the results of impedance measurements. Connectivity between the implanted device and each electrode of a lead may be continuously tested in real-time),
wherein the processor is configured to provide on the display a plurality of electrode icons corresponding to the plurality of electrodes (fig. 28, para. [0221], graphically displays the results of an impedance measurement performed on the electrodes of two implanted leads, namely Lead 1 and Lead 2.),
wherein the processor is configured to determine, based on the impedance data, one or more impedance state electrodes from the plurality of electrodes that have an impedance state (para. [0221], fig. 28, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test. The representation of electrode 14 of FIG. 28 is colored yellow to indicate that there may be a problem with the electrode based on a higher-than-normal impedance measurement, e.g., between about 3,000 ohms and about 40,000 ohms, but it is likely still functioning. The representation of electrode 15 of FIG. 28 is colored red to indicate that the impedance of electrode 15 was high enough to be considered an open circuit condition based on a very high impedance measurement, e.g., above about 40,000 ohms, thus it is likely not functioning.), and
wherein the processor is configured to provide on the display an impedance status representation for one or more of the plurality of electrode icons corresponding to the one or more impedance state electrodes (para. [0221], fig. 28, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test. The representation of electrode 14 of FIG. 28 is colored yellow to indicate that there may be a problem with the electrode based on a higher-than-normal impedance measurement, e.g., between about 3,000 ohms and about 40,000 ohms, but it is likely still functioning. The representation of electrode 15 of FIG. 28 is colored red to indicate that the impedance of electrode 15 was high enough to be considered an open circuit condition based on a very high impedance measurement, e.g., above about 40,000 ohms, thus it is likely not functioning.).
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Re Claim 2, Goetz discloses that the processor is configured to provide on the display a therapy programming display screen, and receive user input via the therapy programming display screen to program an electrical therapy including to select active ones of the plurality of electrodes for use to deliver the electrical therapy (para. [0218], the method includes receiving user input via the programmer that graphically defines the target stimulation zone. In such an example, the user input may graphically manipulate, e.g., stretch or shrink, at least one of a shape and a location of the initial stimulation zone in order to define the target stimulation zone; para. [0211], Then, programmer 40 receives input from a user to transition stimulation from the initial stimulation zone of FIG. 23 to one of the target stimulation zones shown in FIG. 23.), wherein the impedance status representation is on the therapy display screen used to program the electrical therapy (para. [0221], fig. 28, The display shown at 400 in FIG. 28 provides a simplified, color-coded, graphical indication of impedance measurements to the user).
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Re Claim 3, Goetz discloses that the impedance status representation includes an "X" on or near the one or more of the plurality of icons corresponding to the one or more impedance state electrodes (fig. 28, para. [0226], electrode 15 is flagged as failing electrodes with an “X”).
Re Claim 4, Goetz discloses that the impedance status representation on the display does not include an impedance measurement (para. [0222], a user may “check” one or more of the electrode representations, as seen at 403, and programmer 40 will not display the actual impedance measurements).
Re Claim 5, Goetz discloses that the one or more impedance state electrodes have an out-of-bounds impedance (para. [0221], The representation of electrode 15 of FIG. 28 is colored red to indicate that the impedance of electrode 15 was high enough to be considered an open circuit condition based on a very high impedance measurement, e.g., above about 40,000 ohms, thus it is likely not functioning).
Re Claim 6, Goetz discloses that the one or more impedance state electrodes have a valid impedance (para. [0221], fig. 28, programmer 40, for example, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test).
Re Claim 7, Goetz discloses that the plurality of electrodes is on a lead, and wherein the processor is configured to provide on the display a representation of the lead with the plurality of electrode icons (para. [0221], In FIG. 28, a system integrity feature, shown generally at 400, graphically displays the results of an impedance measurement performed on the electrodes of two implanted leads, namely Lead 1 and Lead 2.).
Re Claim 8, Goetz discloses that each of the electrode icons is labeled with a corresponding electrode number (para. [0221], fig. 28, the graphical representation of electrodes 0-7 and 8-15).
Re Claim 9, Goetz discloses that the impedance status representation includes a color identifying the one or more impedance state electrodes (para. [0221], fig. 28, colored the graphical representation of electrodes 0-7 and 8-15: green for “passed”, yellow for still functioning; red for an open circuit condition/likely not functioning).
Re Claim 11, Goetz discloses that the impedance status representation includes an "X" on or near the one or more of the plurality of icons corresponding to the one or more impedance state electrodes (fig. 28, para. [0226], electrode 15 is flagged as failing electrodes with an “X”).
Re Claim 12, Goetz discloses that
the impedance status representation is a first impedance status representation (fig. 28, para. [0221], programmer 40, for example, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test.);
the processor is configured to determine, based on the impedance data, one or more second impedance state electrodes from the plurality of electrodes (fig. 28, para. [0221], The representation of electrode 14 of FIG. 28 is colored yellow to indicate that there may be a problem with the electrode based on a higher-than-normal impedance measurement, e.g., between about 3,000 ohms and about 40,000 ohms, but it is likely still functioning.), and
the processor is configured to provide on the display a second impedance status representation for one or more of the plurality of electrode icons corresponding to the one or more second impedance state electrodes (fig. 28, para. [0221], The representation of electrode 14 of FIG. 28 is colored yellow to indicate that there may be a problem with the electrode based on a higher-than-normal impedance measurement, e.g., between about 3,000 ohms and about 40,000 ohms, but it is likely still functioning.).
Re Claim 13, Goetz discloses that the medical device is configured deliver electrical stimulation using the plurality of electrodes (para. [0047], Some of the stimulation electrodes may be coupled to function as stimulation electrodes and sense electrodes on a selective basis).
Re Claim 14, Goetz discloses that the medical device is configured to sense electrical signals using the plurality of electrodes (para. [0047], Some of the stimulation electrodes may be coupled to function as stimulation electrodes and sense electrodes on a selective basis).
Re Claim 17, Goetz discloses that
the plurality of electrodes is on a lead (fig. 1, para. [0043], [0044], Lead segments 12A and 12B each include a set of electrodes forming part of the array of electrodes 11);
the processor is configured to provide on the display a representation of the lead with the plurality of electrode icons (para. [0221], In FIG. 28, a system integrity feature, shown generally at 400, graphically displays the results of an impedance measurement performed on the electrodes of two implanted leads, namely Lead 1 and Lead 2.);
each of the electrode icons are labeled with a corresponding electrode number (para. [0221], fig. 28, the graphical representation of electrodes 0-7 and 8-15); and
the impedance status representation for the one or more of the plurality of icons includes at least one of:
a line segment under the one or more of the plurality of icons corresponding to the one or more impedance state electrodes;
an "X" on or near the one or more of the plurality of icons corresponding to the one or more impedance state electrodes (fig. 28, para. [0226], electrode 15 is flagged as failing electrodes with an “X”); or
a color associated with the one or more of the plurality of icons corresponding to the one or more impedance state electrodes (para. [0221], fig. 28, colored the graphical representation of electrodes 0-7 and 8-15: green for “passed”, yellow for still functioning; red for an open circuit condition/likely not functioning).
Re Claim 18, Goetz discloses that the one or more impedance state electrodes have an out-of-bounds impedance, and the impedance status representation for the one or more of the plurality of icons indicates that the corresponding one or more impedance electrodes have the out-of-bounds impedance (para. [0221], The representation of electrode 15 of FIG. 28 is colored red to indicate that the impedance of electrode 15 was high enough to be considered an open circuit condition based on a very high impedance measurement, e.g., above about 40,000 ohms, thus it is likely not functioning).
Re Claim 19, Goetz discloses that the one or more impedance state electrodes have a valid impedance, and the impedance status representation for the one or more of the plurality of icons indicates that the corresponding one or more impedance electrodes has the valid impedance (para. [0221], fig. 28, programmer 40, for example, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test).
Re Claim 20, Goetz discloses that
the one or more impedance state electrodes include one or more first impedance state electrodes having an out-of-bounds impedance (para. [0221], The representation of electrode 15 of FIG. 28 is colored red to indicate that the impedance of electrode 15 was high enough to be considered an open circuit condition based on a very high impedance measurement, e.g., above about 40,000 ohms, thus it is likely not functioning) and one or more second impedance state electrodes having a valid impedance (para. [0221], fig. 28, programmer 40, for example, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test); and
the impedance status representation includes a first impedance status representation indicating that the corresponding one or more first impedance state electrodes have the out-of-bounds impedance (para. [0221], The representation of electrode 15 of FIG. 28 is colored red to indicate that the impedance of electrode 15 was high enough to be considered an open circuit condition based on a very high impedance measurement, e.g., above about 40,000 ohms, thus it is likely not functioning), and a second impedance status representation indicating that the corresponding one or more of the second impedance state electrodes have the valid impedance (para. [0221], fig. 28, programmer 40, for example, colored the graphical representation of electrodes 0-7 and 8-13 green to indicate that the impedance of these electrodes were within a predetermined range of values, e.g., between 0 and about 3,000 ohms, and thus “passed” the impedance test).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (US 20110307032)
Re Claim 10, Goetz discloses the claimed invention substantially as set forth in claim 1.
Goetz discloses that the impedance status representation includes an "X" on or near the one or more of the plurality of icons (fig. 28, para. [0226], electrode 15 is flagged as failing electrodes with an “X”) or a color associated with the one or more of the plurality of icons (para. [0221], fig. 28, colored the graphical representation of electrodes 0-7 and 8-15: green for “passed”, yellow for still functioning; red for an open circuit condition/likely not functioning) corresponding to the one or more impedance state electrodes.
Goetz is silent regarding the impedance status representation includes a line segment under the one or more of the plurality of icons corresponding to the one or more impedance state electrodes
The appearance of the impedance status representation is non-functional descriptive material that does not amount to a patentable difference; therefore, the appearance is design choice.
It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the impedance status representation as taught by Goetz with a line segment under the one or more of the plurality of icons corresponding to the one or more impedance state electrodes, because Applicant has not disclosed that a line segment provides an advantage over other choices of appearance. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with colored graphical representation or "X" on or near the one or more of the plurality of icons as taught by Goetz, because it provides the function of indicating the impedance status and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Goetz.Therefore, it would have been an obvious matter of design choice to modify Goetz to obtain the invention as specified in the claim(s).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (US 20110307032) in view of Panescu et al. (US 20180078170).
Re Claim 15, Goetz discloses the claimed invention substantially as set forth in claim 1.
Goetz further discloses that the processor is configured to provide on the display an impedance detail icon, and to respond to selection of the impedance detail icon by displaying the measured impedances for the plurality of electrodes (para. [0222], a user may “check” one or more of the electrode representations and programmer 40 will display the actual impedance measurement.).
Goetz is silent regarding the measured impedance being displayed in a separate window.
However, Panescu discloses methods of determining catheter orientation (abstract) and teaches in respond to selection of the impedance detail icon by displaying the measured impedances for electrode (para. [0588], fig. 37A, the data and other information provided to the user (e.g., in a pop-up or other separate window 8300) by hovering over or otherwise selecting an ablation 8202 can include, among other things, information (e.g., graphical, textual, etc.) regarding the electrode's orientation relative to targeted tissue 8310, contact information 8320 (e.g., a qualitative or quantitative output relating to the level of contact between the electrode and tissue as described in further detail herein), a graph or waveform illustrating impedance measurements).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Goetz, by configuring the processor, in respond to selection of the impedance detail icon, to display in a separate window the measured impedances for the plurality of electrodes, as taught by Panescu, for the purpose of displaying the impedance information when needed.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (US 20110307032) as modified by Panescu et al. (US 20180078170), and further in view of Johnson (US 20230390484).
Re Claim 16, Goetz as modified by Panescu discloses the claimed invention substantially as set forth in claim 15.
Goetz further discloses that the processor is configured to provide on the display a date when the impedance was measured (fig. 28 shows the date of measurement; para. [0220], FIGS. 28 and 29, described below, depict various programmer screens that graphically display the results of impedance measurements).
Goetz is silent regarding the processor is configured to provide on the display a time when the impedance was measured.
However, Johnson discloses implantable insulin pump (abstract) and teaches the processor is configured to provide on the display a date and time when the impedance was measured (para. [0055], The processor of the smartphone, in executing the app, can be configured to display, for example, impedance measurements made by the system, corresponding blood glucose values, or both, dosages of medication dispensed by the reservoir, and the time and date of each measurement and delivery of the medication.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Goetz as modified by Panescu, by configuring the processor to provide on the display a date and time when the impedance was measured, as taught by Johnson, for the purpose of diagnostics of the electrodes (para. [0055]) and proper delivery of stimulation therapy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, January 9, 2026Examiner, Art Unit 3792