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.
Response to Arguments
Applicant's arguments filed on May 6, 2026 have been fully considered but they are not persuasive.
Regarding 102 rejection, Applicant made an argument that Applicant is unable to find in Goetz a disclosure of providing the impedance status representation on the same therapy programming display screen used to select active electrodes for therapy delivery. Rather, Goetz describes these as separate features accessed through different screens.
These arguments have been considered but are not persuasive.
As previously presented in claim mapping, screen used to receive user input is shown in fig. 23 and screen showing impedance status representation is shown in fig. 28. Both fig. 23 and fig. 28 are indicated with same user interface 59 and same program RestoreSensor2. Therefore, the same therapy programming display screen is used to display both functions. They may be presented as different features in the same program displayed on the same screen. However, the claim limitation doesn’t recite that both features have to be overlaid or presented simultaneously. Therefore, Goetz’s disclosure still reads on the amended limitation.
Regarding 101 rejection, Step 2A, Prong One, Applicant disagreed that the limitation “to determine, based on the impedance data, one or more impedance state electrodes from the plurality of electrodes that have an impedance state” is a mental process with an argument that determination of impedance state is based on impedance data generated by a medical device and that impedance measurements cannot be practically performed in the human mind, as they require physical hardware.
This argument has been fully considered but is not persuasive.
The above limitation doesn’t require measuring step of impedance. It merely recites determining, based on the impedance data, one or more impedance state electrodes, which can be performed in the human mind.
Regarding Step 2A, Prong Two, Applicant made an argument that the specific manner of displaying information in the claim is analogous to Example 37, Claim 1 of January 2019 Eligibility Examples, which recited automatically displaying icons on a GUI in a specific manner. Applicant stated that the present claim provide a specific improvement over prior systems by integrating impedance status information with the therapy programming display screen, thereby eliminating the need to toggle between separate screen. Applicant further stated that the claims are analogous to those found patent-eligible in Core Wireless Licensing S.A.R.L. v. LG Elecs., Inc., 880 F.3d 1356, 1362-63 (Fed. Cir. 2018), where the Federal Circuit held that claims reciting a specific GUI improvement were “directed to an improvement in the functioning of computers”.
These arguments have been fully considered but are not persuasive.
Example 37, Claim 1 of January 2019 Eligibility Examples recite a method of rearranging icons on a graphical user interface where most used icons are automatically moved to a position on the GUI closest to the start icon of the computer system based on the determined amount of use.
Examiner disagrees that instant claim 1 is analogous to Example 37, Claim 1. Instant Claim 1 recites simply receiving input of information and outputting the information via display whereas Example 37, Claim 1 recites automatic arrangement of icons that provides direct practical use rather than simply displaying information.
Regarding the court decision for case, Core Wireless Licensing S.A.R.L. v. LG Elecs., Inc., pages 9 and 10 state the following:
“Claim 1 of the ‘476 patent requires ‘an application summary that can be reached directly from the menu,’ specifying a particular manner by which the summary window must be accessed. The claim further requires the application summary window list a limited set of data, ‘each of the data in the list being selectable to launch the respective application and enable the selected data to be seen within the respective application.’ This claim limitation restrains the type of data that can be displayed in the summary window. Finally, the claim recites that the summary window ‘is displayed while the one or more applications are in an un-launched state,’ a requirement that the device applications exist in a particular state.”
Claim 1 of ‘476 patent in above case provides direct practical use by providing an application summary at a specific location and configuring the data of interest in the application summary to be selectable to launch the respective application and to be seen within the respective application.
Instant Claim 1 does not seem to be analogous to Claim 1 of ‘476 patent.
Additionally, as currently claimed, claim 1 does not require “eliminating the need to toggle between separate screen”.
Regarding Step 2B, Applicant made an argument that the ordered combination of elements (physical impedance measurement via an implantable medical device having a plurality of electrodes, communication of generated impedance data to an external device, determination of impedance state electrodes, and specific display of an impedance status representation coupled to electrode icons on a therapy programming display screen) amounts to significantly more than alleged abstract idea.
This argument has been fully considered but is not persuasive.
The additional elements are 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)), as evidenced by section 101 rejection below.
Besides the limitations directed to mental process, the claim recites mere data gathering, receiving/transmitting data, and displaying results, which are insignificant extra-solution activity and do not show non-conventional or non-generic arrangement of known, conventional pieces.
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”, “at least one external device including a display”, “wherein the processor is configured to provide on the display a therapy programming display screen, and to 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,” “wherein the processor is configured to provide on the therapy programming display screen a plurality of electrode icons corresponding to the plurality of electrodes,” and “wherein the processor is configured to provide on the therapy programming display screen 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”, “at least one external device including a display”, “wherein the processor is configured to provide on the display a therapy programming display screen, and to 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,” “wherein the processor is configured to provide on the therapy programming display screen a plurality of electrode icons corresponding to the plurality of electrodes,” and “wherein the processor is configured to provide on the therapy programming display screen 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)) and Berkheimer Memo.
Ruals (US 20110202112 A1) discloses that a medical device configured to measure the impedance for each of a plurality of electrodes and generate impedance data is well-known and conventional (para. [0022], Conventional neurostimulation systems provide the functionality to measure the impedance associated with various electrode combinations. As currently performed, the impedance measurements only permit persistent electrical breaks and shorts to be identified. For example, if an internal wire within the lead body of the stimulation lead becomes broken, conventional neurostimulation leads are capable of detecting the high impedance associated with the break.).
Heinke (US 20200261024 A1) discloses that a medical device configured to measure the impedance for each of a plurality of electrodes and generate impedance data is well-known and conventional (para. [0017], The individual electrodes can be conventional electrodes for impedance measurement and/or neurostimulation.).
Below are examples of activities that the courts have found to be insignificant extra-solution activity (See MPEP 2106.05(g)):
Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)
A more recent example of a limitation that does no more than generally link a judicial exception to a particular technological environment is Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 120 USPQ2d 1201 (Fed. Cir. 2016). In Affinity Labs, the claim recited a broadcast system in which a cellular telephone located outside the range of a regional broadcaster (1) requests and receives network-based content from the broadcaster via a streaming signal, (2) is configured to wirelessly download an application for performing those functions, and (3) contains a display that allows the user to select particular content. 838 F.3d at 1255-56, 120 USPQ2d at 1202. The court identified the claimed concept of providing out-of-region access to regional broadcast content as an abstract idea, and noted that the additional elements limited the wireless delivery of regional broadcast content to cellular telephones (as opposed to any and all electronic devices such as televisions, cable boxes, computers, or the like). 838 F.3d at 1258-59, 120 USPQ2d at 1204. Although the additional elements did limit the use of the abstract idea, the court explained that this type of limitation merely confines the use of the abstract idea to a particular technological environment (cellular telephones) and thus fails to add an inventive concept to the claims. 838 F.3d at 1259, 120 USPQ2d at 1204. See MPEP 2106.05(h).
Example that the courts have indicated may not be sufficient to show an improvement in computer-functionality (See MPEP 2106.05(a)):
Instructions to display two sets of information on a computer display in a non-interfering manner, without any limitations specifying how to achieve the desired result, Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45, 127 USPQ2d 1553, 1559-60 (Fed. Cir. 2018).
Example that the courts have indicated may not be sufficient to show an improvement to technology include (See MPEP 2106.05(a)):
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
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 external 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 external 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 therapy programming display screen (figs. 23-26), and to 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 (figs. 23-26, para. [0054], clinician programmer 20 and/or patient programmer 22 may be used to receive user input indicating a target stimulation zone; para. [0211], [0117], [0147], [0218], [0126], In response to receiving user input, processor determines electrodes that should be recruited to generate target stimulation zone),
wherein the processor is configured to provide on the therapy programming display screen 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 therapy programming display screen 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 one or more impedance state electrodes include at least one active electrode selected for use to deliver the electrical therapy (fig. 28, para. [0185] discloses selected electrodes from 0 to 15 based on stimulation zones) and having an out-of-bounds impedance, and wherein the impedance status representation identifies the at least one active electrode having the out-of-bounds impedance (fig. 28, para. [0221], [0222], As shown at 402, programmer 40 may also display an indication, via text, with respect to electrodes that are suspect or that fail the impedance test. The text may indicate that unusually high impedances were detected and for which electrodes the high impedance was detected.).
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lyons (US 11116585 B2) discloses generating a graphical representation including electrode icons corresponding to a plurality of electrodes of the ablation catheter for displaying via the GUI, wherein the plurality of electrodes are configured to sense electrical impedance, generating electrical impedance plots based on sensed electrical impedance, the electrical impedance plots to be displayed within at least some of the electrode icons on the GUI, wherein each of the electrical impedance plots comprises a time-variation sequence of electrical impedances, receiving input, via the graphical representation, selecting at least some of the electrode icons, and causing the RF generator to transmit RF energy to the plurality of electrodes of the ablation catheter corresponding to the selected electrode icons (fig. 11, claim 1)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792 /JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, August 13, 2026Examiner, Art Unit 3792
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