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
Rejections under 35 USC 102/103
Applicant’s arguments and amended claims, see page 8 of the Remarks filed 04/28/2026, with respect to the rejection of claim 1 and its dependents under 35 USC 102/103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection over Steinke in view of Riahi as detailed below.
Rejections under 35 USC 101
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
On pages 8-9 of the Remarks dated 04/28/2026, Applicant argues that the claimed invention, when considered holistically, recites at least one inventive concept which is directed to more than an abstract idea/mental process because the act of measuring an impedance value cannot be performed in the human mind. Examiner previously identified the step of measuring impedance as extra-solution activity of data gathering. Applicant further argues in view of BASCOM that the claimed steps go beyond insignificant pre-solution activity, relying upon the assertion by BASCOM that an inventive concept can be found in the ordered combination of claim limitations that transform the abstract idea of filtering content into a particular, practical application of that abstract idea.
Examiner appreciates Applicant’s arguments, but respectfully disagrees with the assertion that the claimed steps integrate the abstract idea into practical application. Examiner maintains the characterization of the step of measuring impedance values as extra-solution activity. The act of data gathering is not enough to integrate the abstract idea into practical application or amount to significantly more than the abstract idea itself. When considered holistically, Examiner maintains that the claimed invention is merely a computer implementation of a mental process, wherein data is gathered, compared to a threshold/expected value, and then a determination is made based on the comparison. At its core, these acts may be practically performed in the human mind, because a human is capable of comparing a measured impedance value to an expected/threshold value, and making a determination based on the comparison.
With this in consideration, the rejection under 35 USC 101 is maintained.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 02/12/2024 has been considered by the Examiner.
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.
Claim 8 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “said comparison” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1, 11, 16, and 19 recite a method, claim 12 recites a machine, and claim 15 recites a non-statutory computer program.
Step 2A, Prong 1
Claims 1, 16, and 19 recite the limitations of checking whether the electrical links between electrodes and connections within a port of a medical device are correctly established based upon determined pre-conditioned impedance values and/or measured impedance values of the selected pairs of connections. These steps, given their broadest reasonable interpretation, can be practically performed in the human mind and are thereby considered to be directed to an abstract idea/mental process. A person of ordinary skill in the art could check the connections between electrodes and a medical device port by observing measured impedances between connection pairs and determining the connections are not correctly established if the measured values are outside of an anticipated range/do not follow anticipated patterns relative to the other measured impedances. Claim 11 recites a method of operating a medical device using the method according to claim 1. Claim 12 recites a medical device which carries out the method according to claim 1. Claim 15 recites a computer program to perform the method according to claim 1.
Step 2A, Prong 2
Claims 1, 11, 12, 15, 16, and 19 do not include any additional elements that integrate the abstract idea into a practical application.
Claim 1 includes the additional elements of a medical device comprising at least two electrode groups on at least one lead body, a pulse generator having at least one port wherein the port has a number of connections equal to or greater than the number of electrodes present, where the electrodes are connected to the port via at least one lead connector; and the method comprising determining connection pairs and measuring the impedance between the selected pairs.
The medical device is claimed such that it amounts to generally linking the use of a judicial exception to a particular technological environment or field of use. The limitations of determining connection pairs and measuring the impedance between the selected pairs is pre-solution activity of date collection in the form of performing clinical tests to obtain input for an equation, in this case gathering impedance values between connection pairs to determine if the electrode connections are established correctly. See MPEP 2106.05(g), In re Grams, 888 F.2d 835.
Claims 11, 12, 16, and 19 include the same additional elements as described above regarding claim 1.
Claim 15 includes the additional elements of claim 1 and a computer program product and processer. These additional elements introduced in claim 15 are claimed generically and merely amount to computational implementation of the abstract idea. See MPEP 2106.04(d).
Therefore, the additional elements do not amount to integrating the abstract idea into practical application.
Step 2B
Claims 1, 11, 12, 15, 16, and 19 do not include any additional elements that amount to significantly more than the abstract idea.
See analysis of the identified additional elements above in Step 2A, Prong 2, including limitations to the method comprising determining connection pairs and measuring the impedance between the selected pairs. The additional elements of the claimed medical device comprising at least two electrode groups on at least one lead body, a pulse generator having at least one port wherein the port has a number of connections equal to or greater than the number of electrodes present, where the electrodes are connected to the port via at least one lead connector can be held to be well-understood, routine, and conventional in the art, and they are recited with a high level of generality which does not amount to significantly more than the abstract idea itself.
Claims 2-6 and 10 further limit the extra-solution activity of data gathering.
Claims 7-9, 17, 18, and 20 further define the abstract idea.
Claims 13 and 14 further limit the apparatus/system to amount to linking the invention to a technological environment or field of use.
Claim 15 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a transitory signal.
MPEP 2106.03(I) states ‘a transitory signal, while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine, is not a tangible article or commodity under the definition of a manufacture (even though it is man-made and physical in that it exists in the real world and has tangible causes and effects), and is not composed of matter such that it would qualify as a composition of matter. Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03.’
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.
(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 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinke et al (US 20190076659 A1).
Regarding claim 16, Steinke teaches a method to check a medical device (see Fig. 1 illustrating a DBS system), wherein said medical device comprises
at least two electrode groups (see Fig.1 which pictures multiple electrode groups on leads 18) and
a pulse generator (10),
wherein each electrode group (electrodes 16 found on leads 18) comprises at least two electrodes (see Figs. 5A-D illustrating groups of electrodes 16 each comprising four electrodes labeled E1-E8, Fig. 1 illustrating at least two electrodes 16 on each of leads 18),
wherein the at least two electrode groups are arranged on a surface of at least one lead body (see Fig. 1 which pictures multiple leads 18 and Figs. 5A-D illustrating various lead bodies 18A-D),
wherein the pulse generator (10) comprises at least one port (8),
wherein a number of connections (contacts of connector block 22) of the at least one port (8) is equal to or greater than a number of electrodes (16) of all electrode groups (see [0004]; each connector block 22 includes 8 contacts and thus supports 8 electrodes 16), and
form connection groups (connector blocks 22 and lead connector 20) corresponding to the electrode groups (see [0004]; contacts in the connector block 22 make direct contact with corresponding contacts on the lead connector),
wherein the electrodes (16) are electrically linked using at least one lead connector (20) to the at least one port (8) of the pulse generator (10, see [0004]; port 8 and its associated connector block 22 form a device connector with which lead connector 20 is connected), and
wherein the method comprises the steps of:
(a) selecting pre-defined pairs of connections, wherein the connections of each pair are assigned to different connection groups (see Figs. 6-7, [0016]; a user may select the implanted leads 18 and associate the lead connectors 20 with the port 8 in which they are positioned),
wherein at least one connection is varied in one pre-defined pair with regard to any other selected pair (Fig. 6);
(b) measuring an impedance value between the connections of each of the selected pairs of connections (see [0039]; identifying the types of leads 18 connected to each port 8 to verify port connections by relying upon the measurement and evaluation of impedance and induced field potential data from the connected electrodes); and
(c) determining whether a connection of the number of connections has been installed backwards into the at least one port, wherein the determination is based on the measured impedance values (see Fig. 7, [0038-0039]; where the leads in ports B and C are connected backwards and the system uses a means of identifying the types of leads 18 connected to each port 8 to verify port connections by relying upon the measurement and evaluation of impedance and induced field potential data from the connected electrodes, Figs. 18-19, [0068]; the process 300 may shift the data to accommodate the incorrect insertion, i.e., shift the contact 2 data to contact 1, etc. in order to attempt to identify or verify the type of known electrode group that is improperly connected).
Regarding claims 17 and 18, Steinke teaches the method of claim 16, wherein the determination is based on the measured impedance being lower or higher than a pre-determined impedance value (see Figs. 18-19, [0066-0068]; process 300 associates data indicative of each lead type with measured impedance values to identify patterns in the data that are associated with different physical arrangements of electrodes for the different known electrode groups, anomalies in the data wherein the measured impedance is higher or lower than an expected value may indicate an improper connection of the lead connector 20 with a device port 8, process 300 may shift the data to accommodate the incorrect insertion, i.e., shift the contact 2 data to contact 1, etc. in order to attempt to identify or verify the type of known electrode group that is improperly connected).
Regarding claim 19, Steinke teaches a method to check a medical device (see Fig. 1 illustrating a DBS system), wherein said medical device comprises
at least two electrode groups (see Fig.1 which pictures multiple electrode groups on leads 18) and
a pulse generator (10),
wherein each electrode group (electrodes 16 found on leads 18) comprises at least two electrodes (see Figs. 5A-D illustrating groups of electrodes 16 each comprising four electrodes labeled E1-E8, Fig. 1 illustrating at least two electrodes 16 on each of leads 18),
wherein the at least two electrode groups are arranged on a surface of at least one lead body (see Fig. 1 which pictures multiple leads 18 and Figs. 5A-D illustrating various lead bodies 18A-D),
wherein the pulse generator (10) comprises at least one port (8),
wherein a number of connections (contacts of connector block 22) of the at least one port (8) is equal to or greater than a number of electrodes (16) of all electrode groups (see [0004]; each connector block 22 includes 8 contacts and thus supports 8 electrodes 16), and
form connection groups (connector blocks 22 and lead connector 20) corresponding to the electrode groups (see [0004]; contacts in the connector block 22 make direct contact with corresponding contacts on the lead connector),
wherein the electrodes (16) are electrically linked using at least two lead connectors (20, see Fig. 1 wherein each electrode group has their own respective lead connector 20) to the at least one port (8) of the pulse generator (10, see [0004]; port 8 and its associated connector block 22 form a device connector with which lead connector 20 is connected), and
wherein the method comprises the steps of:
(a) selecting pre-defined pairs of connections, wherein the connections of each pair are assigned to different connection groups (see Figs. 6-7, [0016]; a user may select the implanted leads 18 and associate the lead connectors 20 with the port 8 in which they are positioned),
wherein at least one connection is varied in one pre-defined pair with regard to any other selected pair (Fig. 6);
(b) measuring an impedance value between the connections of each of the selected pairs of connections (see [0039]; identifying the types of leads 18 connected to each port 8 to verify port connections by relying upon the measurement and evaluation of impedance and induced field potential data from the connected electrodes); and
(c) determining that a lead connector of the two lead connectors is installed incorrectly based on the measured impedance value being lower than a pre-determined value (see Figs. 18-19, [0065-0066]; process 300 to determine lead/port connections uses connected electrode data, including monopolar impedance, bipolar impedance, and induced field potential data, to associate connected groups of electrodes with one of the known electrode groups based on properties in the data that are indicative of different physical arrangements of electrodes in known electrode groups; it can be appreciated that if the measured impedance value was lower than the expected impedance for the expected electrode group, then the classifier would determine the lead connection is installed incorrectly).
Regarding claim 20, Steinke teaches the method of claim 19, further comprising:
(a) measuring the impedance value between the connection of each of the selected pairs of connections for a second time (see Figs. 18-19, [0066-0067]; all or some portion of the data may be collected by the IPG only upon request, in which case the process 300 may wait while the data is collected by the IPG 10); and
(b) determining that the lead connector of the two lead connectors is installed correctly based on the measured impedance value being higher than the pre- determined value (see Figs. 18-19, [0065-0066]; process 300 to determine lead/port connections uses connected electrode data, including monopolar impedance, bipolar impedance, and induced field potential data, to associate connected groups of electrodes with one of the known electrode groups based on properties in the data that are indicative of different physical arrangements of electrodes in known electrode groups; it can be appreciated that if the measured impedance value was above a threshold associated with an electrode group type, for example a segmented electrode, then the connection would be determined to be correct).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Steinke et al (US 20190076659 A1) in view of Riahi et al (US 20200132434 A1).
Regarding claim 1, Steinke teaches a method to check a medical device (see Fig. 1 illustrating a DBS system), wherein said medical device comprises
at least two electrode groups (see Figs. 5A-D illustrating various electrode configurations where the groups are considered to be comprised of electrodes 16 labeled E1-E4 and E5-E8) and
a pulse generator (10),
wherein each electrode group (E1-E4 and E5-E8) comprises at least two electrodes (see Figs. 5A-D illustrating groups of electrodes 16 each comprising four electrodes labeled E1-E8),
wherein the at least two electrode groups (E1-E4 and E5-E8) are arranged on a surface of at least one lead body (see Figs. 5A-D illustrating various lead bodies 18A-D),
wherein the pulse generator (10) comprises at least one port (8),
wherein a number of connections (contacts of connector block 22) of the at least one port (8) is equal to or greater than a number of electrodes (16) of all electrode groups (see [0004]; each connector block 22 includes 8 contacts and thus supports 8 electrodes 16), and
form connection groups (connector blocks 22 and lead connector 20) corresponding to the electrode groups (see [0004]; contacts in the connector block 22 make direct contact with corresponding contacts on the lead connector),
wherein the electrodes (16) are electrically linked using at least one lead connector (20) to the at least one port (8) of the pulse generator (10, see [0004]; port 8 and its associated connector block 22 form a device connector with which lead connector 20 is connected), and
wherein the method comprises the steps of:
(a) selecting pre-defined pairs of connections, wherein the connections of each pair are assigned to different connection groups (see Figs. 13 and 14 illustrating measured bipolar impedance between electrodes, it can be appreciated that electrodes E1-E4 are considered a first group and E5-E8 are considered a second group so bipolar impedance measured between pairs such as E1 and E5 comprises a pair assigned to different connection groups),
wherein at least one connection is varied in one pre-defined pair with regard to any other selected pair (see Fig. 13 illustrating varied pre-defined pairs, for example, E1 and E6);
(b) measuring an impedance value between the connections of each of the selected pairs of connections (see Figs. 13 and 14 illustrating bipolar impedance measured between pairs); and
(c) checking whether the electrical links of the electrodes (16) and the connections are correctly established (see [0002]; identification of the types of leads connected to an IMD based on different physical electrode arrangements of different types of leads, Fig. 18; process 300) based on both of:
(i) normalized impedance values (see [0068]; the data may be pre-processes to normalize the data, remove anomalies, etc.), and
(ii) the measured impedance values of the selected pairs of connections (see Fig. 18, [0065-0067]; in one embodiment a classifier is manually configured to identify patterns or characteristics in the connected electrode data that are indicative of known electrode groups, where the connected electrode data may be bipolar impedance).
Steinke is silent regarding both a pre-conditioned impedance value and the measured impedance value of the selected pair of connections being used to determine whether the electrical links of the electrodes and the connections are correctly established,
wherein the pre-conditioned impedance value is determined for each of the selected pairs of connections such that is provides a pre-conditioning of the respective measured impedance value for attenuating unwanted noise.
Riahi teaches a method for estimating the configuration of a first and second group of electrodes by measuring the impedance between electrode pairs where each pair is comprised of an electrode belonging to the first group and an electrode belonging to the second group (Riahi, Abstract), and checking whether the electrical links of the electrodes and the connections are correctly established based on both of:
(i) determined pre-conditioned impedance values (see Riahi [0022]; pre-conditioning the measured impedances between selected electrodes), and
(ii) the measured impedance values of the selected pairs of connections (see Riahi [0021]; measuring the impedance between a selected pair of electrodes),
wherein the pre-conditioned impedance value is determined for each of the selected pairs of connections such that it provides a pre-conditioning of the respective measured impedance value for attenuating unwanted noise (see Riahi [0021-0025]; pre-conditioning the measured impedances to attenuate unwanted noise, e.g. electrode-tissue interface impedance contributions to the measured impedances).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Steinke’s method for determining electrode connection using normalized impedance data with Riahi’s pre-conditioning method. One of ordinary skill in the art would have been motivated to make this modification in order to use the distribution of measurements to subtract estimations of electrode-specific characteristics and extract the characteristic profile that represents electrode-to-electrode distances in order to determine connections between electrode pairs (Riahi [0030]).
Regarding claim 2, Steinke in view of Riahi teaches the method according to claim 1, wherein the method further comprises the step of labeling the connections (contacts of connector 22) of the at least one port (8),
wherein the connections of one connection group are entirely labeled in a pre-defined way (see [0016]; known connection between the electrode nodes and the contacts in the connector blocks 22, [0068]; the contacts are labeled in such a manner as contact 1, contact 2, etc. as described in a situation where the system identifies an incorrect connection, it can be appreciated that each of the contacts are labeled numerically to designate them from one another),
wherein the labeling of all connections is provided such that it reflects the distance of each electrode of one electrode group to each electrode of a different electrode group if each electrode is correctly electrically linked to the respective connection (see [0070]; max increase between any pair of consecutive data points in an ordered set of monopolar impedance data associated with a particular electrode group provides an indication about the connections between electrode pairs including the type of electrode, i.e. circumferential or segmented, and location of said electrode pairs).
Regarding claim 3, Steinke in view of Riahi teaches the method of claim 2. Steinke is silent regarding the method further comprising the step of assigning one or both of:
(i) each measured impedance value, or
(ii) pre-conditioned impedance value of one pair of labeled connections,
to one category of a pre-defined set of categories, and
wherein the category of one pair of labeled connections is determined from the two labels of the one pair of connections.
Riahi teaches a method for estimating the configuration of a first and second group of electrodes by measuring the impedance between electrode pairs where each pair is comprised of an electrode belonging to the first group and an electrode belonging to the second group (Riahi, Abstract), wherein the method comprises the step of assigning one or both of:
(i) each measured impedance value (see Riahi [0021]; measuring the impedances between the electrodes (i), (j), of each selected electrode pair (i,j)), or
(ii) pre-conditioned impedance value of one pair of labeled connections (see Riahi [0022]; pre-conditioning the measured impedances to attenuate the unwanted noise),
to one category (offset x) of a pre-defined set of categories (see Riahi [0043]; determining the lead offset using pre-conditioned impedances comprises calculating an average impedance value corresponding to an average of the pre-conditioned impedance values for each considered electrode offset x between an electrode belonging to the first group and an electrode belonging to the second group)
wherein the category of one pair of labeled connections is determined from the two labels of the one pair of connections (see [0036]; electrode offsets are determined using the electrode connection labels, for example where the first group is labeled 1-8 and the second group is labeled 9-16 where electrodes 1 and 9 are aligned, the electrode pair (1,16) has an offset of -7 and the electrode pair (8,9) has an offset of 7, see Table 1).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Steinke’s method for checking a medical device using measured impedances between electrode pairs with the categories as determined by the electrode offset between electrodes in a connected pair as taught by Riahi. One of ordinary skill in the art would have been motivated to make this modification in order to characterize the relationship between electrodes in a connection pair and group connection pairs having the same relative offset together to compare their impedances (Riahi Table 1, [0061-0062]).
Regarding claim 4, Steinke and Riahi teach the method of claim 3. Steinke is silent regarding wherein the pairs of connections are selected such that one or both of:
(i) at least one measured impedance value, or
(ii)determined pre-conditioned impedance value,
is assigned to each category.
Riahi teaches wherein the pairs of connections (i,j) are selected such that one or both of:
(i) at least one measured impedance value (Zi,j), or
(ii)determined pre-conditioned impedance value (Zi,j”),
is assigned to each category (see Riahi [0062]; forming a pre-conditioned impedance profile comprising averages of pre-conditioned impedance values for each electrode offset x).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Steinke’s method for checking a medical device using measured impedances between electrode pairs with at least one pair belonging to each of the categories as determined by the electrode offset between electrodes in a connected pair as taught by Riahi. One of ordinary skill in the art would have been motivated to make this modification in order to represent all of the expected impedance values for the possible electrode offsets without having to measure every possible pairing.
Regarding claim 5, Steinke and Riahi teach the method according to claim 3. Steinke is silent regarding calculating an average value from one or both of:
(i) all measured impedance values, or
(ii)determined pre-conditioned impedance values of the respective category.
Riahi teaches calculating an average value from one or both of:
(i) all measured impedance value (Zi,j), or
(ii)determined pre-conditioned impedance value (Zi,j”) of the respective category (see Riahi [0062]; forming a pre-conditioned impedance profile comprising averages of pre-conditioned impedance values for each electrode offset x).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Steinke’s method for checking a medical device using measured impedances between electrode pairs with calculating an average impedance value for each of the categories as determined by the electrode offset between electrodes in a connected pair as taught by Riahi. One of ordinary skill in the art would have been motivated to make this modification in order to determine a normalized baseline to represent the expected impedances for each electrode offset (Riahi [00620).
Regarding claim 6, Steinke and Riahi teach the method according to claim 5. Steinke is silent regarding plotting said one or more of:
i) determined average measured impedance values,
(ii)average pre-conditioned impedance values or the measured impedance value, or
(iii) the determined pre-conditioned impedance values,
over the respective category in a diagram and analyzing a profile of a graph formed by said values over all categories in said diagram.
Riahi teaches plotting (Fig. 4A-D) said one or more of:
(ii)average pre-conditioned impedance values (see Figs. 4A-4D, [0130-0140]; the template is determined by averaging a large number of pre-conditioned impedance values at each electrode offset x), or
(iii) the determined pre-conditioned impedance values (see Fig. 4A-4D, [0130-0141]; subject impedance data is graphed at each electrode offset x),
over the respective category in a diagram and analyzing a profile of a graph formed by said values over all categories in said diagram (see Figs. 4A-4D, [0130-0141]; subject impedance data is plotted against a determined template to characterize the impedance value at each electrode offset x to determine the lead offset).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Steinke’s method for checking a medical device using measured impedances between electrode pairs by plotting impedance values over each of the categories as determined by the electrode offset between electrodes in a connected pair as taught by Riahi. One of ordinary skill in the art would have been motivated to make this modification in order to visually represent the measured data in relation to the expected impedance at each electrode offset, where a large deviation from the expected indicative of an error would be visible.
Regarding claim 7, Steinke in view of Riahi teaches the method according to claim 3, wherein the method further comprises the step of comparing each measured impedance value to a respective pre-defined target value for the respective pair of connections. See [0052], Fig. 14 illustrating the bipolar impedance measurements for lead 18A where the impedance measurements for the electrode E5 group increase linearly from electrodes E4-E1. The graph of Fig. 14 demonstrates an idealized version of the relationship between connected pairs.
Regarding claim 8, Steinke and Riahi teach the method of claim 6. Steinke further teaches wherein a type of the lead body (18) is identified based on said comparison and/or on said profile of the graph in said diagram (see [0054]; the full set of bipolar impedance data for a set of eight electrodes includes clearly identifiable trends that enable the differentiation of different types of leads).
Regarding claim 9, Steinke in view of Riahi teaches the method according to claim 7, wherein the method further comprises the step of determining the one connection of the respective connection group (E1-E4 and E5-E8) electrically linked to the most distal electrode (4) of the respective electrode group (5) based on said comparison and/or on said profile of the graph in said diagram (Fig. 14). See paragraphs [0051-0053], Fig. 14 illustrating the measured bipolar impedance between electrode combinations on a lead, for example lead 18D, where the electrode connection groups are labeled by their most proximal electrode E1 and E5, and the most distal electrode from the opposite electrode group can be identified by having the largest bipolar impedance, E8 for the first connection group labeled E1 and E4 for the second connection group labeled E5.
Regarding claim 10, Steinke teaches the method of claim 1. Steinke further teaches wherein the selected pre-defined pairs of connections are a subset of the possible pairs of connections (Steinke [0065]). Steinke is silent regarding the subset comprising at most half of all possible pairs of connections. However, it can be appreciated that Steinke discloses the general conditions of the claim, being that the pre-defines pairs of connections comprise only a part of all of the possible pairs. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A), In re Aller, 105 USPQ 233.
Regarding claim 11, Steinke teaches a method of operating a medical device, wherein the method (300) comprises the steps of the checking method according to claim 1, and
wherein the method further comprises the step of selecting an operation mode of the pulse generator (10) based on the checking method, based on the identified type of lead body (10) and then operates according to the selected operation mode (see [0066]; the connected electrode data is evaluated using a classifier to associate connected groups of electrodes with one of the known electrode groups, i.e. the lead groups that are programmed into the software, based on the properties in the data that are indicative of different physical arrangements of electrodes in known electrode groups). See Fig. 20.
Regarding claim 12, Steinke teaches a medical device (see Fig. 1 illustrating a DBS system),
wherein said medical device comprises
at least two electrode groups (see Figs. 5A-D illustrating various electrode configurations where the groups are considered to be comprised of electrodes 16 labeled E1-E4 and E5-E8) and
a pulse generator (10),
wherein each electrode group (E1-E4 and E5-E8) comprises at least two electrodes (see Figs. 5A-D illustrating groups of electrodes 16 each comprising four electrodes labeled E1-E8),
wherein the at least two electrode groups (E1-E4 and E5-E8) are arranged on a surface of at least one lead body (see Figs. 5A-D illustrating various lead bodies 18A-D),
wherein the pulse generator (10) comprises at least one port (8),
wherein the number of connections (contacts of connector block 22) of the at least one port (8) is equal to or greater than the number of electrodes (16) of all electrode groups (see [0004]; each connector block 22 includes 8 contacts and thus supports 8 electrodes 16), and
form connection groups (connector blocks 22 and lead connector 20) corresponding to the electrode groups (see [0004]; contacts in the connector block 22 make direct contact with corresponding contacts on the lead connector),
wherein the electrodes (16) are electrically linked using at least one lead connector (20) to the at least one port (8) of the pulse generator (10, see [0004]; port 8 and its associated connector block 22 form a device connector with which lead connector 20 is connected),
wherein the medical device is configured to execute the method steps of claim 1 (see above rejection of claim 1 as being unpatentable over Steinke in view of Riahi).
Regarding claim 13, Steinke teaches the medical device according to claim 12, wherein the lead body (18) comprises a surgical lead or a percutaneous lead (see [0010]; the leads 18 and IPG 10 are implanted).
Regarding claim 14, Steinke teaches a system comprising the medical device of claim 12 and a remote computer (202), wherein the remote computer is at least temporarily connected to the medical device via a communication link (92), and wherein the remote computer is configured to execute a part of the method steps instead of the medical device (see [0010]; the configuration process is typically performed using a clinician’s programmer system comprising a computer 202).
Regarding claim 15, Steinke teaches a computer program product comprising instructions which, when executed, cause a processor (222) to perform the steps of the methods according to claim 1 (see [0010]; the configuration process is typically performed using a clinician’s programmer system comprising a computer 202).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights