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
Applicant’s arguments, filed 05/12/2026, with respect to independent claims 1 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Additionally, since the amendments to independent claims 1 and 20 change the scope of claims 1-10 and 20 and do not merely incorporate limitations from previous dependent claims, a new grounds of rejection is made in view of previously applied references as explained in further detail below.
Applicant contends that Gabriela fails to disclose, teach or suggest the claimed feature, where “claim 1 has been amended to clarify that ‘wherein at least one pair of recording electrodes defines a transverse axis and comprises electrodes arranged in a stacked configuration at a common longitudinal position along the single lead and wherein at least one pair of stimulating electrodes defines a longitudinal axis and comprises electrodes arranged sequentially along a length of the single lead, the transverse axis being perpendicular to the longitudinal axis’ … claim 20 has been amended to recite ‘wherein the at least one recording electrode comprises two recording electrodes, the two recording electrodes including a first recording electrode disposed proximate to a first longitudinal end region of the single lead and a second recording electrode disposed proximate a second longitudinal end of the single lead’ and ‘wherein the at least one stimulating electrode comprises a plurality of stimulating electrodes arranged in a serial configuration along a central region of the single lead between the first recording electrode and the second recording electrode.’” These arguments are moot in light of the new scope of the claims.
Applicant's arguments, filed 05/12/2026, with respect to claims 11-19 have been fully considered but they are not persuasive.
Applicant contends that “[w]hen addressing the features of previously presented claim 11, the Office Action at pages 21 and 22 alleges that Gabriela's description at paragraph [0154] teaches ‘wherein the at least one recording electrode includes a recording electrode oriented towards the anatomical element and a recording electrode oriented away from the anatomical element.’ As discussed during the April 22, 2026 interview, Gabriela fails to disclose, teach or suggest this claimed feature. Thus, this feature is a distinction over the cited references.” Examiner respectfully disagrees.
In response to Applicant’s argument that “Gabriela fails to disclose, teach or suggest this claimed feature. Thus, this feature is a distinction over the cited references,” Examiner takes the position that Gabriela teaches the claimed feature of “wherein the at least one recording electrode includes a recording electrode oriented towards the anatomical element and a recording electrode oriented away from the anatomical element” because ¶[0154] of Gabriela teaches “When utilized as sense electrodes, segmented electrodes 102A-102C are configured to sense in a specific direction less than 360 degrees relative to lead body 100, rather than in all directions away from lead body 100. Sense electrodes that extend around a portion of the circumference of lead body 100 (or along one side of a paddle lead) may be useful for providing more localized sensing of a physiological signal at a particular tissue site in brain 28, such as within a particular anatomical structure of brain 28. This may help sensing module 46 generate a more robust physiological signal that provides a better indication of a patient condition than, for example, a physiological signal sensed within a larger volume of tissue by sense electrodes that are not as localized as the segmented sense electrodes,” where Examiner interprets that at least one sense electrode is oriented towards the anatomical element and another sense electrode is oriented away from the anatomical element since the electrodes are configured to sense in specific directions, of which includes both towards and away from the anatomical element. Furthermore, regarding the Examiner Interview dated 04/22/2026, Examiner noted that “Applicant and Examiner also discussed independent claim 11 and Examiner's interpretation of Gabriela in relation to Applicant's claim language. Based on Examiner's understanding of the proposed amendments, Examiner disclosed that the proposed amendments will be unlikely to overcome the previously applied references from the Non-Final Office Action dated 02/25/2026.”
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 1-4, 7, 10, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gabriela et al. (hereinafter “Gabriela”) (U.S. Pub. No. 2012/0053658 A1).
Regarding claim 1, Gabriela teaches a system for controlling a therapeutic procedure (¶[0030], where “FIG. 1 is a conceptual diagram illustrating an example therapy system 10 that delivers therapy to manage a patient condition. In the example of FIG. 1, therapy system 10 is a deep brain stimulation (DBS) system”) comprising:
a pulse generator configured to generate an electrical signal (¶[0033], where “the stimulation generator of IMD 16 is configured to generate and deliver electrical pulses to patient 12 via electrodes of a selected stimulation electrode combination ... the stimulation generator of IMD 16 may be configured to generate and deliver a continuous wave signal, e.g., a sine wave or triangle wave. In either case, a signal generator within IMD 16 may generate the electrical stimulation therapy for DBS according to a therapy program that is selected at that given time in therapy”);
a single lead in communication with the pulse generator and configured to transmit the electrical signal to a plurality of electrodes (¶[0059], where “implanted lead extension 18 is coupled to IMD 16 via connector 30 (also referred to as a connector block or a header of IMD 16) … leads 20 are implanted within the right and left hemispheres, respectively, of patient 12 in order to deliver electrical stimulation to one or more regions of brain 28, which may be selected based on the patient condition or disorder controlled by therapy system 10 … leads 20 may be implanted within the same hemisphere of brain 28 or IMD 16 may be coupled to a single lead”); and
the plurality of electrodes being physically connected to the same lead (¶[0064], where “a housing of IMD 16 may include one or more stimulation and/or sensing electrodes …leads 20 may be … any other type of shape effective in treating patient 12 and/or minimizing invasiveness of leads 20,” ¶[0206], where “FIG. 17 illustrates a schematic plan view of an example paddle lead 151,” ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns. In the example of paddle lead 151 shown in FIGS. 17 and 18, some or all of the electrodes 154 are configured to both sense bioelectrical brain signals and deliver electrical stimulation to brain 28. In these examples, a processor of therapy system 10 (e.g., processor 60 of programmer 14, processor 40 of IMD 16 or another computing device) can selectively activate one or more electrodes 154 as stimulation electrodes and a different subset of two or more electrodes 154 as sense electrodes”) and configured to be implanted near a stimulation target (¶[0059], where “implanted lead extension 18 is coupled to IMD 16 via connector 30 (also referred to as a connector block or a header of IMD 16) … leads 20 are implanted within the right and left hemispheres, respectively, of patient 12 in order to deliver electrical stimulation to one or more regions of brain 28, which may be selected based on the patient condition or disorder controlled by therapy system 10 … leads 20 may be implanted within the same hemisphere of brain 28 or IMD 16 may be coupled to a single lead”),
the plurality of electrodes comprising at least one stimulating electrode and at least one recording electrode (¶[0210], where “some or all of the electrodes 154 are configured to both sense bioelectrical brain signals and deliver electrical stimulation to brain 28. In these examples, a processor of therapy system 10 (e.g., processor 60 of programmer 14, processor 40 of IMD 16 or another computing device) can selectively activate one or more electrodes 154 as stimulation electrodes and a different subset of two or more electrodes 154 as sense electrodes,” ¶[0211], where “processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode”), the at least one stimulating electrode configured to stimulate an anatomical element based on the electrical signal and the at least one recording electrode configured to record a physiological response (¶[0044], where “IMD 16 senses a physiological signal at substantially the same time (e.g., within about one second or less) that stimulation is delivered to patient 12,” ¶[0046], where “IMD 16 may sense a physiological signal via electrodes of leads 20 at substantially the same time that IMD 16 delivers electrical stimulation to patient 12 via electrodes of leads 20 or after IMD 16 delivers electrical stimulation to patient 12, e.g., when the effects of the stimulation are still observed within tissue of brain 28”),
wherein at least one pair of recording electrodes defines a transverse axis and comprises electrodes arranged in a stacked configuration at a common longitudinal position along the single lead, and wherein at least one pair of stimulating electrodes defines a longitudinal axis and comprises electrodes arranged sequentially along a length of the single lead, the transverse axis being perpendicular to the longitudinal axis (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, as shown in the annotated figure below, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the electrodes parallel to stimulation electrode 154C along longitudinal axis 162 function as stimulation electrodes and that the electrodes parallel to sense electrodes 154A and 154B function as recording or sense electrodes. As shown in the annotated Figure 18 below, at least one pair of recording electrodes defines a transverse axis and comprises electrodes arranged in a stacked configuration at a common longitudinal position along the single lead, and wherein at least one pair of stimulating electrodes defines a longitudinal axis and comprises electrodes arranged sequentially along a length of the single lead, the transverse axis being perpendicular to the longitudinal axis.).
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Regarding claim 2, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela teaches that the at least one recording electrode is proximal to the at least one stimulating electrode (Figure 18, sense electrode 154B, stimulation electrode 154C, where Examiner takes the position that since sense electrode 154B is below stimulation electrode 154C, that the sensing electrode, equivalent to a recording electrode, is proximal to the stimulating electrode).
Regarding claim 3, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela teaches that the at least one recording electrode is distal to the at least one stimulating electrode (Figure 18, sense electrode 154A, stimulation electrode 154C, where Examiner takes the position that since sense electrode 154A is above stimulation electrode 154C, that the sensing electrode, equivalent to a recording electrode, is distal to the stimulating electrode).
Regarding claim 4, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela teaches that a first recording electrode of the at least one recording electrode is proximal to the at least one stimulating electrode (Figure 18, sense electrode 154B, stimulation electrode 154C, where Examiner takes the position that since sense electrode 154B is below stimulation electrode 154C, that the sensing electrode, equivalent to a recording electrode, is proximal to the stimulating electrode) and a second recording electrode of the at least one recording electrode is distal to the at least one stimulating electrode (Figure 18, sense electrode 154A, stimulation electrode 154C, where Examiner takes the position that since sense electrode 154A is above stimulation electrode 154C, that the sensing electrode, equivalent to a recording electrode, is distal to the stimulating electrode).
Regarding claim 7, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela teaches that each stimulating electrode of the at least one pair of stimulating electrodes is spaced apart from one another at a first distance and the at least one pair of stimulating electrodes are positioned at a second distance from the at least one recording electrode (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the electrodes parallel to stimulation electrode 154C along longitudinal axis 162 function as stimulation electrodes, such that there is at least one pair of stimulating electrodes, and that the electrodes parallel to sense electrodes 154A and 154B function as recording or sense electrodes, where each stimulation electrode is inherently a first distance from one another and the stimulation electrodes are inherently a second distance from at least one of the sense, or recording, electrodes 154A.).
Regarding claim 10, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela teaches a processor (¶[0088], where “Processor 40 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or discrete logic circuitry,” ¶[0210], where “a processor of therapy system 10 (e.g., processor 60 of programmer 14, processor 40 of IMD 16 or another computing device) can selectively activate one or more electrodes 154 as stimulation electrodes and a different subset of two or more electrodes 154 as sense electrodes”); and
a memory storing data for processing by the processor (¶[0088], where “Processor 40 controls stimulation generator 44 according to therapy programs 54 stored in memory 42”), the data, when processed, causes the processor to:
generate an electrical signal using the pulse generator (¶[0088], where “Processor 40 controls stimulation generator 44 according to therapy programs 54 stored in memory 42 to apply particular stimulation parameter values specified by one or more of programs, such as amplitude, pulse width, and pulse rate”);
stimulate the anatomical element based on the electrical signal (¶[0088], where “Processor 40 controls stimulation generator 44 according to therapy programs 54 stored in memory 42 to apply particular stimulation parameter values specified by one or more of programs, such as amplitude, pulse width, and pulse rate”);
record the physiological response from the stimulation (¶[0092], where “Processor 40 may receive the output of sensing module 46,” ¶[0093], where “IMD 16 senses a physiological signal of patient 12 via a subset of electrodes that are electrically coupled to sensing module 46”); and
adjust the electrical signal based on the recorded physiological response (¶[0092], where “Processor 40 may receive the output of sensing module 46. Processor 40 may apply additional processing to the signal received from sensing module 46, e.g., convert the output to digital values for processing and/or amplify the signal”).
Regarding claim 20, Gabriela teaches a single lead for stimulation of a target (¶[0030], where “FIG. 1 is a conceptual diagram illustrating an example therapy system 10 that delivers therapy to manage a patient condition. In the example of FIG. 1, therapy system 10 is a deep brain stimulation (DBS) system,” ¶[0059], where “implanted lead extension 18 is coupled to IMD 16 via connector 30 (also referred to as a connector block or a header of IMD 16) … leads 20 are implanted within the right and left hemispheres, respectively, of patient 12 in order to deliver electrical stimulation to one or more regions of brain 28, which may be selected based on the patient condition or disorder controlled by therapy system 10 … leads 20 may be implanted within the same hemisphere of brain 28 or IMD 16 may be coupled to a single lead”) comprising:
a plurality of electrodes physically connected to and positioned on the single lead (¶[0064], where “a housing of IMD 16 may include one or more stimulation and/or sensing electrodes …leads 20 may be … any other type of shape effective in treating patient 12 and/or minimizing invasiveness of leads 20,” ¶[0206], where “FIG. 17 illustrates a schematic plan view of an example paddle lead 151,” ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns. In the example of paddle lead 151 shown in FIGS. 17 and 18, some or all of the electrodes 154 are configured to both sense bioelectrical brain signals and deliver electrical stimulation to brain 28. In these examples, a processor of therapy system 10 (e.g., processor 60 of programmer 14, processor 40 of IMD 16 or another computing device) can selectively activate one or more electrodes 154 as stimulation electrodes and a different subset of two or more electrodes 154 as sense electrodes”) and configured to be implanted near an anatomical element (¶[0059], where “implanted lead extension 18 is coupled to IMD 16 via connector 30 (also referred to as a connector block or a header of IMD 16) … leads 20 are implanted within the right and left hemispheres, respectively, of patient 12 in order to deliver electrical stimulation to one or more regions of brain 28, which may be selected based on the patient condition or disorder controlled by therapy system 10 … leads 20 may be implanted within the same hemisphere of brain 28 or IMD 16 may be coupled to a single lead”), the plurality of electrodes comprising at least one stimulating electrode and at least one recording electrode (¶[0210], where “some or all of the electrodes 154 are configured to both sense bioelectrical brain signals and deliver electrical stimulation to brain 28. In these examples, a processor of therapy system 10 (e.g., processor 60 of programmer 14, processor 40 of IMD 16 or another computing device) can selectively activate one or more electrodes 154 as stimulation electrodes and a different subset of two or more electrodes 154 as sense electrodes,” ¶[0211], where “processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode”), the at least one stimulating electrode configured to stimulate a stimulating target and the at least one recording electrode configured to record a physiological response resulting from the stimulation (¶[0044], where “IMD 16 senses a physiological signal at substantially the same time (e.g., within about one second or less) that stimulation is delivered to patient 12,” ¶[0046], where “IMD 16 may sense a physiological signal via electrodes of leads 20 at substantially the same time that IMD 16 delivers electrical stimulation to patient 12 via electrodes of leads 20 or after IMD 16 delivers electrical stimulation to patient 12, e.g., when the effects of the stimulation are still observed within tissue of brain 28”),
wherein the at least one recording electrode comprises two recording electrodes (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, where Examiner interprets that the electrodes parallel to sense electrodes 154A and 154B function as recording or sense electrodes such that there are two recording electrodes), the two recording electrodes including a first recording electrode disposed proximate to a first longitudinal end region of the single lead and a second recording electrode disposed proximate a second longitudinal end of the single lead (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, where the annotated Figure 18 as shown below shows the two recording electrodes where each is on a respective longitudinal end of the single lead, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.”),
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wherein the at least one stimulating electrode comprises a plurality of stimulating electrodes arranged in a serial configuration along a central region of the single lead between the first recording electrode and the second recording electrode (Figure 18, sense electrode 154B, stimulation electrode 154C, where as shown in the annotated Figure 18 below, the stimulation electrodes are along a central region of the single lead between the first and second recording electrodes.), and
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wherein the plurality of stimulating electrodes comprises at least one pair of stimulating electrodes (Figure 18, electrodes 154, stimulation electrode 154C, longitudinal axis 162, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the electrodes parallel to stimulation electrode 154C along longitudinal axis 162 function as stimulation electrodes such that there is a pair of stimulating electrodes.), each stimulating electrode of the at least one pair of stimulating electrodes is spaced apart from each other at a first distance and the at least one pair of stimulating electrodes is positioned at a second distance from the first recording electrode and at a third distance from the second recording electrode (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the electrodes parallel to stimulation electrode 154C along longitudinal axis 162 function as stimulation electrodes and that the electrodes parallel to sense electrodes 154A and 154B function as recording or sense electrodes, where each stimulation electrode is inherently a first distance from one another and the stimulation electrodes are inherently a second distance from the first sense, or recording, electrode 154A, and a third distance from the second sense, or recording, electrode 154B.).
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.
Claims 8, 9, 11, 14-15, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gabriela as modified.
Regarding claim 8, Gabriela teaches all limitations of claim 1 as described in the rejection above.
The above-described embodiment of Gabriela does not teach that the single lead comprises a cylindrical lead having segments and the at least one recording electrode comprises at least a half segment.
A second embodiment of Gabriela teaches that the single lead comprises a cylindrical lead having segments (¶[0205], where “the examples described with respect to FIGS. 1-16B are directed to symmetrical sensing with electrodes on one or more cylindrical leads”) and the at least one recording electrode comprises at least a half segment (Figure 14A, sense electrodes 120, 122, 124, 126, and 128, where the sense electrodes shown are at least a half segment, ¶[0062], where “Each partial ring or segmented electrode may extend around less than the entire outer perimeter of a lead,” ¶[0063], where “Another example of a lead including a complex electrode array geometry is shown and described with reference to FIGS. 14A and 14B … if a lead includes a plurality of levels of stimulation electrodes, where each level includes a plurality of segmented or partial ring stimulation electrodes, the lead may also include a plurality of levels of sense electrodes, where each level of sense electrodes includes a similar arrangement of segmented or partial ring sense electrodes”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Gabriela, which teaches that the single lead comprises a cylindrical lead having segments and the at least one recording electrode comprises at least a half segment, with the invention of Gabriela so that electrical stimulation may be directed in a specific direction from the lead to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue (Gabriela ¶[0061]).
Regarding claim 9, Gabriela teaches all limitations of claim 1 as described in the rejection above.
The above-described embodiment of Gabriela does not teach that the at least one recording electrode has a surface area larger than the at least one stimulating electrode.
A second embodiment of Gabriela teaches that the at least one recording electrode has a surface area larger than the at least one stimulating electrode (¶[0175], where “sense electrodes may be … substantially greater in surface area than one or more of stimulation electrodes 112A-112C, 114A-114C, 116A-116C, and 118A-118C”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Gabriela, which teaches that the at least one recording electrode has a surface area larger than the at least one stimulating electrode, with the invention of Gabriela so that the sensing electrodes have a suitable surface area, or a conductive surface area, for the IMD to sense a signal (Gabriela ¶[0175]).
Regarding claim 11, Gabriela teaches a system for controlling a therapeutic procedure (¶[0030], where “FIG. 1 is a conceptual diagram illustrating an example therapy system 10 that delivers therapy to manage a patient condition. In the example of FIG. 1, therapy system 10 is a deep brain stimulation (DBS) system”) comprising:
a pulse generator configured to generate an electrical signal (¶[0033], where “the stimulation generator of IMD 16 is configured to generate and deliver electrical pulses to patient 12 via electrodes of a selected stimulation electrode combination ... the stimulation generator of IMD 16 may be configured to generate and deliver a continuous wave signal, e.g., a sine wave or triangle wave. In either case, a signal generator within IMD 16 may generate the electrical stimulation therapy for DBS according to a therapy program that is selected at that given time in therapy”).
The above-described embodiment of Gabriela does not explicitly teach a first lead in communication with the pulse generator and configured to transmit the electrical signal to at least one electrode; at least one stimulating electrode positioned on the first lead and configured to stimulate an anatomical element based on the electrical signal, the at least one stimulating electrode to be implanted at a first position near the anatomical element; a second lead; and at least one recording electrode positioned on the second lead and configured to record a physiological response to the stimulation, the at least one recording electrode to be implanted at a second position near the at least one stimulating electrode, wherein the at least one recording electrode records the physiological response after a predetermined time period has expired after the at least one stimulating electrode stimulates the anatomical element, and wherein the at least one recording electrode includes a recording electrode oriented towards the anatomical element and a recording electrode oriented away from the anatomical element.
A third embodiment of Gabriela teaches a first lead in communication with the pulse generator and configured to transmit the electrical signal to at least one electrode (Figure 1, IMD 16, lead extension 18, lead 20A, ¶[0031], where “In the example of FIG. 1, therapy system 10 includes medical device programmer 14, implantable medical device (IMD) 16, lead extension 18, and leads 20A and 20B with respective sets of electrodes 24, 26”);
at least one stimulating electrode positioned on the first lead and configured to stimulate an anatomical element based on the electrical signal (¶[0031], where “electrodes 24, 26 of leads 20A, 20B (collectively referred to as "leads 20"), respectively, are positioned to deliver electrical stimulation to a tissue site within brain 28,” ¶[0108], where “Processor 40 selects a first subset of electrodes 24 as stimulation electrodes (76). The subset can include one electrode or a plurality of electrodes, but typically includes less than all of electrodes 24 of lead 20A”), the at least one stimulating electrode to be implanted at a first position near the anatomical element (¶[0059], where “leads 20 are implanted within the right and left hemispheres, respectively, of patient 12 in order to deliver electrical stimulation to one or more regions of brain 28”);
a second lead (Figure 1, IMD 16, lead extension 18, lead 20B, ¶[0031], where “In the example of FIG. 1, therapy system 10 includes medical device programmer 14, implantable medical device (IMD) 16, lead extension 18, and leads 20A and 20B with respective sets of electrodes 24, 26”); and
at least one recording electrode positioned on the second lead and configured to record a physiological response to the stimulation (¶[0107], where “the technique shown in FIG. 4 can be implemented to select sense electrodes from electrodes 26 of lead 20B or another lead that includes a plurality of electrodes that can function as sense or stimulation electrodes”), the at least one recording electrode to be implanted at a second position near the at least one stimulating electrode (¶[0059], where “leads 20 are implanted within the right and left hemispheres, respectively, of patient 12 in order to deliver electrical stimulation to one or more regions of brain 28”),
wherein the at least one recording electrode records the physiological response after a predetermined time period has expired after the at least one stimulating electrode stimulates the anatomical element (¶[0047], where “In another example of closed loop therapy, IMD 16 may deliver stimulation therapy to patient 12 for a period of time (e.g., on the order of seconds, minutes, or longer, which may or may not be predetermined) and after the period of time, IMD 16 may sense the physiological signals for a set period of time (e.g., on the order of seconds, minutes, or longer, which may or may not be predetermined). In this case, IMD 16 may sense the physiological signal with at least one of the same electrodes that was used to deliver stimulation to patient 12, or with a different set of electrodes that does not have any common electrodes with the stimulation electrodes.” Examiner takes the position that the physiological signal is being sensed after expiration of a predetermined time, which here is the stimulation therapy to a patient for a predetermined period of time, since the IMD senses the physiological signals after stimulation therapy to a patient for a predetermined period of time).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a third embodiment of Gabriela, which teaches a first lead in communication with the pulse generator and configured to transmit the electrical signal to at least one electrode; at least one stimulating electrode positioned on the first lead and configured to stimulate an anatomical element based on the electrical signal, the at least one stimulating electrode to be implanted at a first position near the anatomical element; a second lead; and at least one recording electrode positioned on the second lead and configured to record a physiological response to the stimulation, the at least one recording electrode to be implanted at a second position near the at least one stimulating electrode, wherein the at least one recording electrode records the physiological response after a predetermined time period has expired after the at least one stimulating electrode stimulates the anatomical element, with the invention of Gabriela in order to deliver electrical stimulation to one or more regions of brain (Gabriela ¶[0059]) and to indicate the effects of the stimulation being delivered to the patient since a sensed bioelectrical brain signal may provide feedback to control the timing, intensity, and/or other parameters of therapy delivery (Gabriela ¶[0046]).
None of the above-described embodiments of Gabriela teaches that the at least one recording electrode includes a recording electrode oriented towards the anatomical element and a recording electrode oriented away from the anatomical element.
A fourth embodiment of Gabriela teaches that the at least one recording electrode includes a recording electrode oriented towards the anatomical element and a recording electrode oriented away from the anatomical element (¶[0154], where “When utilized as sense electrodes, segmented electrodes 102A-102C are configured to sense in a specific direction less than 360 degrees relative to lead body 100, rather than in all directions away from lead body 100. Sense electrodes that extend around a portion of the circumference of lead body 100 (or along one side of a paddle lead) may be useful for providing more localized sensing of a physiological signal at a particular tissue site in brain 28, such as within a particular anatomical structure of brain 28. This may help sensing module 46 generate a more robust physiological signal that provides a better indication of a patient condition than, for example, a physiological signal sensed within a larger volume of tissue by sense electrodes that are not as localized as the segmented sense electrodes.” Examiner interprets that at least one sense electrode is oriented towards the anatomical element and another sense electrode is oriented away from the anatomical element since the electrodes are configured to sense in specific directions, of which includes both towards and away from the anatomical element.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a fourth embodiment of Gabriela, which teaches that the at least one recording electrode includes a recording electrode oriented towards the anatomical element and a recording electrode oriented away from the anatomical element, with the modified invention of Gabriela in order to provide more localized sensing of a physiological signal at a particular tissue site in the brain, and to generate a more robust physiological signal that provides a better indication of a patient condition than, for example, a physiological signal sensed within a larger volume of tissue by sense electrodes that are not as localized as the segmented sense electrodes (Gabriela ¶[0154]).
Regarding claim 14, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above.
Gabriela teaches that the at least one stimulating electrode comprises a pair of stimulating electrodes (Figure 18, electrodes 154, stimulation electrode 154C, longitudinal axis 162, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the electrodes parallel to stimulation electrode 154C along longitudinal axis 162 function as stimulation electrodes such that there is a pair of stimulating electrodes.), each stimulating electrode of the at least one stimulating electrode is spaced apart from each other at a first distance and the at least one pair of stimulating electrodes are positioned at a second distance from the at least one recording electrode (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the electrodes parallel to stimulation electrode 154C along longitudinal axis 162 function as stimulation electrodes and that the electrodes parallel to sense electrodes 154A and 154B function as recording or sense electrodes, where each stimulation electrode is inherently a first distance from one another and the stimulation electrodes are inherently a second distance from the sense, or recording, electrodes.).
Regarding claim 15, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above.
Gabriela teaches that the at least one recording electrode is perpendicular to the at least one stimulating electrode (Figure 18, electrodes 154, sense electrodes 154A and 154B, stimulation electrode 154C, longitudinal axis 162, ¶[0210], where “FIG. 18 illustrates a schematic paddle lead surface 158 that includes more than one column of electrodes. Paddle lead 151 may include any suitable number of electrode columns,” ¶[0211], where “For example, if processor 40 of IMD 16 selects electrodes 154A, 154B as sense electrodes and electrode 154C as a stimulation electrode, a line or plane of symmetry for sense electrodes 154A, 154B may substantially bisect stimulation electrode 154C,” ¶[0212], where “if processor 40 selects multiples stimulation electrodes and respective symmetrical sense electrodes for each of the sense electrode groups, the lines or planes of symmetry for of the symmetrical sense electrode groups may have substantially the same angle A relative to longitudinal axis 162 of lead body 152.” Examiner interprets that the sense electrode pair of sense electrodes 154A and 154B are perpendicular to stimulation electrode 154C.).
Regarding claim 18, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above.
The above-described embodiment of Gabriela does not teach that the at least one recording electrode has a surface area larger than the at least one stimulating electrode.
A second embodiment of Gabriela teaches that the at least one recording electrode has a surface area larger than the at least one stimulating electrode (¶[0175], where “sense electrodes may be … substantially greater in surface area than one or more of stimulation electrodes 112A-112C, 114A-114C, 116A-116C, and 118A-118C”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Gabriela, which teaches that the at least one recording electrode has a surface area larger than the at least one stimulating electrode, with the modified invention of Gabriela so that the sensing electrodes have a suitable surface area, or a conductive surface area, for the IMD to sense a signal (Gabriela ¶[0175]).
Regarding claim 19, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above. Furthermore, regarding claim 19, see the rejection of claim 10 above.
Claims 5-6 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gabriela and Gabriela as modified as applied to claims 1 and 11 above, respectively, and further in view of Esteller et al. (hereinafter “Esteller”) (U.S. Pub. No. 2019/0366094 A1).
Regarding claim 5, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela does not teach that the single lead comprises a directional lead and wherein the at least one stimulating electrode directs the stimulation in a target direction.
Esteller teaches methods and systems configured to sense an evoked neural response and use the evoked neural response as feedback for providing neuromodulation therapy (Abstract), and further teaches that the single lead comprises a directional lead (¶[0077], where “The electrode/channel configuration 1000 includes a lead 14 having a plurality of electrodes 16 … the electrodes may be configured using multiple leads, for example multiple … directional leads ... Generally, any of the electrodes may be usable for stimulating and/or for sensing”) and wherein the at least one stimulating electrode directs the stimulation in a target direction (¶[0077], which teaches a directional lead for a stimulating electrode. Examiner takes the position that a directional lead inherently teaches directing stimulation in a target direction since directional leads are designed to direct stimulation towards specific targets.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Esteller, which teaches that the single lead comprises a directional lead and wherein the at least one stimulating electrode directs the stimulation in a target direction, with the invention of Gabriela in order to direct the stimulation to a desired location.
Regarding claim 6, Gabriela teaches all limitations of claim 1 as described in the rejection above.
Gabriela does not teach that the single lead comprises a directional lead and wherein the at least one recording electrode records the physiological response in a target direction.
Esteller teaches that the single lead comprises a directional lead (¶[0077], where “The electrode/channel configuration 1000 includes a lead 14 having a plurality of electrodes 16 … the electrodes may be configured using multiple leads, for example multiple … directional leads ... Generally, any of the electrodes may be usable for stimulating and/or for sensing”) and wherein the at least one recording electrode records the physiological response in a target direction (¶[0077], which teaches a directional lead for a sensing or recording electrode. Examiner takes the position that a directional lead inherently teaches directing recording in a target direction since directional leads are designed to direct the recording of activity.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Esteller, which teaches that the single lead comprises a directional lead and wherein the at least one recording electrode records the physiological response in a target direction, with the invention of Gabriela in order to direct the recording to a desired location.
Regarding claim 16, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above.
Gabriela as modified does not teach that the first lead comprises a directional lead wherein the at least one stimulating electrode directs the stimulation in a target direction.
Esteller teaches that the first lead comprises a directional lead (¶[0077], where “The electrode/channel configuration 1000 includes a lead 14 having a plurality of electrodes 16 … the electrodes may be configured using multiple leads, for example multiple … directional leads ... Generally, any of the electrodes may be usable for stimulating and/or for sensing”) wherein the at least one stimulating electrode directs the stimulation in a target direction (¶[0077], which teaches a directional lead for a stimulating electrode. Examiner takes the position that a directional lead inherently teaches directing stimulation in a target direction since directional leads are designed to direct stimulation towards specific targets.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Esteller, which teaches that the first lead comprises a directional lead and wherein the at least one stimulating electrode directs the stimulation in a target direction, with the modified invention of Gabriela in order to direct the stimulation to a desired location.
Regarding claim 17, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above.
Gabriela as modified does not teach that the second lead comprises a directional lead wherein the at least one recording electrode records the physiological response in a target direction.
Esteller teaches that the second lead comprises a directional lead (¶[0077], where “The electrode/channel configuration 1000 includes a lead 14 having a plurality of electrodes 16 … the electrodes may be configured using multiple leads, for example multiple … directional leads ... Generally, any of the electrodes may be usable for stimulating and/or for sensing.” Examiner takes the position that since the directional lead can apply to multiple leads and since a first and second lead are taught by Gabriela as modified, that the directional lead applies to a second lead.) wherein the at least one recording electrode records the physiological response in a target direction (¶[0077], which teaches a directional lead for a sensing or recording electrode. Examiner takes the position that a directional lead inherently teaches directing recording in a target direction since directional leads are designed to direct the recording of activity.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Esteller, which teaches that the second lead comprises a directional lead wherein the at least one recording electrode records the physiological response in a target direction, with the modified invention of Gabriela as modified in order to direct the recording to a desired location.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gabriela as modified as applied to the rejection of claim 11 above, and further in view of Osorio (U.S. Pub. No. 2006/0173522 A1).
Regarding claim 12, Gabriela as modified teaches all limitations of claim 11 as described in the rejection above.
Gabriela as modified does not teach that the at least one recording electrode is at least one of implanted epidurally or implanted intrathecally.
Osorio teaches a method and implantable medical device system capable of being anchored in a head or spinal cord of a patient (Abstract) where the at least one recording electrode is at least one of implanted epidurally (¶[0032], where “The invention may be embodied in any implantable medical device system wherein a component of the system is to be implanted epidurally … the same principles may be applied to implant a medical device component either epidurally … relative to dura of the spinal cord. The medical device component may be any component of a medical device system including … a monitoring element to sense a neurological condition (recording electrode, sensor, etc.)”) or implanted intrathecally.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Osorio, which teaches that the at least one recording electrode is at least one of implanted epidurally, with the modified invention of Gabriela in order to anchor the medical device component in a fixed position relative to the dura and the brain (Osorio ¶[0048]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gabriela as modified and Osorio as applied to the rejection of claim 12 above, and further in view of Li et al. (hereinafter “Li”) (CN 215653026 U).
Regarding claim 13, Gabriela as modified in combination with Osorio teaches all limitations of claim 12 as described in the rejection above.
Neither Gabriela as modified nor Osorio teaches that the at least one recording electrode is disposed on a pump catheter.
Li teaches that the at least one recording electrode is disposed on a pump catheter (Page 1, ¶ 10, where “A catheter, comprising a tube body and a first electrode, the tube body is used to be arranged on a predetermined object and used to deliver medicinal liquid to a target area; the first electrode is arranged at the distal end of the tube body and used for sensing the electrical signal of the target area.” Examiner takes the position that since the catheter delivers medicine to a target area that it is equivalent to a pump catheter.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Li, which teaches that the at least one recording electrode is disposed on a pump catheter, with the modified invention of Gabriela in order to sense the signal in the target area and adjust medicine delivery parameters according to the signal, improving the accuracy of medication delivery and treatment effectiveness (Li Page 5, ¶ 4).
Conclusion
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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/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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