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 .
Election/Restrictions
Applicant's election with traverse of Group 1 in the reply filed on December 2, 2025 is acknowledged. The traversal is on the grounds that “a thorough search and examination of the claims of Group II would be relevant to the search and examination of the claims of Group I because each group of claims overlap in scope” and “search and examination of the claims of Group II would include a search for prior art that includes an IMD for sensing biosignals including sensing circuitry, as recited in claim 19, and would therefore be relevant to the search and examination of the claims of Group I”. However, this is not found persuasive because claim 19 of Group 2 requires an implantable sensing element for a biosignal (diagnostic with sensing only), yet claim 1 of Group 1 an implantable pulse generator for providing stimulation pulses and a sensing circuit for sensing biosignals associated with neural tissue (treatment with stimulation and sensing). Therefore, the subject matter is in fact divergent and would require additional search and consideration.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 9,955,289 B1) in view of Haefner et al. (US 5,699,014 A).
As to claim 1, Liu et al. discloses an implantable pulse generator (IPG) for generating electrical pulses to stimulate a neural tissue of a patient (implantable medical device, depicted as 100 in Figure 1; Figures 1 and 3), comprising: one or more battery components for powering the IPG (col. 3, lines 29-40); pulse generating circuitry for generating electrical pulses (col. 3, lines 41-64); a header structure with a plurality of electrical connections adapted to contact one or more terminals of one or more stimulation leads or one or more lead extensions coupled to respective ones of the one or more stimulation leads (Figure 1 and 3), wherein the one or more stimulation leads each include a plurality of electrodes (Figure 1-2); and sensing circuitry for sensing one or more biosignals associated with the neural tissue (Figures 1-2), wherein the sensing circuitry comprises an amplifier for amplifying the one or more biosignals (Figure 2).
Liu et al. discloses the invention substantially as claimed but does not explicitly disclose the “amplifier including a noise- optimized input stage coupled to a power-optimized output stage”. Haefner et al. discloses “a low-power, low-noise amplifier with well-controlled and linear voltage gain, high input-impedance, and wide dynamic range, suitable as a preamplifier to a signal processing system, such as a switched-capacitor filter. One application for which the present invention is particularly well suited is for amplification of the electrical signals in the heart produced by atrial depolarization” (col. 4, lines 29-37). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the amplifier of Liu et al. with amplifier of Haefner et al. to provide an amplifier with the noise- optimized input stage coupled to a power-optimized output stage to ensure optimized power consumption while collecting biosignal data to provide the predictable results optimizing device function and performance.
As to claim 2, the modified Liu et al. discloses the noise-optimized input stage comprises one or more bipolar junction transistors (BJTs) formed on a first semiconductor die (Liu et al, col. 12, lines 4-20; Haefner et al., col. 10, line 10 to col. 11, lines 34) and the power-optimized output stage comprises one or more complementary metal-oxide-semiconductor (CMOS) field effect transistors (FETs) formed on a second semiconductor die (Haefner et al., Abstract).
As to claim 3, the modified Liu et al. discloses the one or more BJTs comprise BJTs having a forward gain greater than a predetermined value (Haefner et al., col. 10, line 10 to col. 11, lines 34).
As to claim 3, the modified Liu et al. discloses the one or more CMOS FETs are configured to operate as a bias current source for providing a bias current to the input stage (Haefner et al., Abstract and col. 4, lines 30-65).
As to claim 5, the modified Liu et al. discloses the bias current source is configured as a variable current source operable to control a gain associated with the input stage (Haefner et al., col. 4, lines 37-65).
As to claim 6, the modified Liu et al. discloses the one or more CMOS FETs are configured to operate as a load with respect to the input stage (Haefner et al., Abstract and col. 4, lines 37-65).
As to claim 7, the modified Liu et al. discloses the load comprises a variable load operable to compensate for production variation in the one or more BJTs forming the input stage (Haefner et al., col. 10, line 10 to col. 11, lines 34) or in the one or more CMOS FETs forming the output stage of the amplifier (Haefner et al., Abstract and col. 4, lines 37-65).
As to claim 8, the modified Liu et al. discloses the one or more CMOS FETs are configured to amplify one or more signals generated by the input stage responsive to the one or more biosignals driving the input stage (cardiac signals are biosignals; Liu et al., Figure 2; Haefner et al., col. 4, lines 30-37).
As to claim 9, the modified Liu et al. discloses the invention substantially as claimed with one or more biosignals (cardiac signals) and an evoked response detection window (Liu et al., Figure 2; col. 5, line 65 to col. 6, line 10) for the determination of evoked responses in response to receiving one or more stimulation pulses but does not explicitly disclose the evoked response is an evoked compound action potential (ECAP) signal generated by the nerve tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the evoked response sensed by the modified Liu et al. with an evoked compound action potential (ECAP) signal generated by nerve tissue in order to provide the predictable results of ensuring the stimulation is meeting specific patient therapeutic needs and requirements.
As to claim 10, the modified Liu et al. discloses the one or more biosignals (cardiac signals, Liu et al., Figure 2; Haefner et al., col. 4, lines 30-37) comprise at least local field potential signal associated with the nerve tissue (electrical cardiac signals are local field potential signals that are associate with nerve tissue).
As to claim 11, the modified Liu et al. discloses the pulse generating circuitry is operable to be configured responsive to a control signal generated by a diagnostic circuit driven by the one or more biosignals sensed by the sensing circuitry (Liu et al., col. 6, line 53 to col. 7, line 11).
As to claim 12, the modified Liu et al. discloses switching circuitry (Liu et al., Figure 2) for selectively outputting generated stimulation pulses to one or more electrical connections and for selectively connecting one or more electrical connections to the sensing circuitry to sense the one or more biosignals using one or more electrodes of the one or more stimulation leads (Liu et al, Figure 2; col. 6, lines 19 to col. 7, line 34).
As to claim 13, the modified Liu et al. discloses the power-optimized output stage is configured to drive a pair of differential output nodes coupled to an analog-to-digital converter (ADC) having a differential input (Liu et al., Figure 2).
As to claim 14, the modified Liu et al. discloses the noise-optimized input stage is configured as a differential input stage operable to connect to a select pair of electrodes of the one or more stimulation leads (Liu et al., Figures 1-2).
As to claim 15, the modified Liu et al. discloses the differential input stage includes a first input node and a second input node, the first input node coupled to a first high pass filter disposed between the first input node and a corresponding first electrode, the second input node coupled to a second high pass filter disposed between the second input node and a corresponding second electrode, the first and second high pass filters driven by a reference voltage (Liu et al., Figure 2).
As to claim 16, the modified Liu et al. discloses the first and second high pass filters are each operated by a respective switch configured to facilitate charging or discharging of a corresponding capacitive element of the first and second high pass filters within a predetermined time window (Liu et al., Figure 2; col. 5, line 65 to col. 6, line 10).
As to claim 17, the modified Liu et al. discloses the invention substantially as claimed with power optimization, but does not explicitly disclose the “power-optimized output stage is configured for operating the amplifier with a current less than around 100 pA to 150 pA”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the current of the amplifier, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of optimizing performance to meet specific patient therapeutic needs and requirements.
As to claim 18, the modified Liu et al. discloses the invention substantially as claimed with noise-optimized, but does not explicitly disclose the “noise-optimized input stage is configured for operating the amplifier with a root mean square (RMS) equivalent input noise level of less than around 1.0 pV RMS to 1.5 pV RMS”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to noise level of the amplifier, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of optimizing performance to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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