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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/02/2025 is being considered by the examiner.
Status of Claims
Claims 15-32 are currently pending. Claims 1-14 and 29-32 are directed to non-elected inventions. Claims 1-14 are canceled. Claims 15-28 are under examination.
Response to Arguments
Applicant’s arguments, see Remarks pages 9-11 (35 USC § 112(b) Rejections), filed 09/02/25 with respect to the 35 U.S.C. § 112(b) rejections of claims 23-24 have been fully considered. Applicant’s argument regarding “about” as a tolerance (as presented in the Specification) is persuasive and the rejections of claims 23-24 are withdrawn.
Applicant’s arguments, see Remarks pages 11-35 (35 USC. § 103 Claim Rejection), filed 09/02/25 with respect to the 35 U.S.C. § 103 rejections of claims 15-28 have been fully considered. Regarding Claim 15, Applicant argues:
First, the Office Action cites the same disclosure from Wolf A (e.g., Fig. 12F, [0148], [0165]) to account for multiple distinct limitations in claim 15. Claim 15 requires a first die stack including a first and second perpendicularly oriented laser, each surrounded by its own photodiode and coupled to two separate parabolic redirectors, and a second die stack that includes a third and fourth laser-photodiode pair likewise coupled to two additional parabolic redirectors. Wolf A does not disclose or suggest the four laser photodiode pairs. Rather, the Office Action simply repeats the same single description of emitters and detectors "in the optical pathway" to disclose these separate limitations. This single description does not disclose where all the claimed components are found simultaneously in the prior art with sufficient clarity to support a prima facie case.
More particularly, the Office Action's reliance on a single disclosure in Wolf A to satisfy multiple different claim elements effectively treats the disclosure of a single part by the reference as a disclosure of four distinct and separate laser-photodiode pairs and two distinct die stacks. The Federal Circuit has made clear that inherency and element mapping cannot be established by using the same structure to satisfy multiple distinct claim limitations where the reference itself does not disclose them. (09/02/25 Remarks, page 16)
This argument summary is overall persuasive. Applicant refers to these arguments in greater detail in the following sections, where the Examiner more specifically provides comments.
Regarding Claim 15, Applicant additionally argues:
The Office Action cites Wolf A, paragraph [0135], as disclosing this requirement of the claim. Wolf A states that "the optoelectronic device 816 is also perpendicular to the optical axis of the lead channels." However, the manner in which Wolf A uses the term "perpendicular" is not the same as the claimed "perpendicularly oriented" lasers and one of skill in the art would not understand it to be so. Wolf A describes the device package as being positioned with the emitter directed straight into the end face of the optical fiber - that is - parallel to the longitudinal axis of the lead. A person of ordinary skill in the art, reading Wolf A in context, would therefore understand Wolf A's use of "perpendicular" to mean pointing the emitter parallel with the fiber end, not mounting the emitter to fire vertically upward into the side of the lead. In contrast, one of skill in the art would understand the Applicants specification to disclose "perpendicularly oriented" to mean that each VCSEL is mounted to emit vertically, i.e., perpendicular to the fiber's longitudinal axis, and the redirector then bends that vertical emission into alignment with the fiber. See, e.g., VCSELs 850 and 852. Any broader interpretation of the term "perpendicularly oriented" - such as covering "parallel oriented" arrangements as disclosed by Wolf A - would be inconsistent with the Applicants disclosure and thus not reasonable under the BRI standard.
Accordingly, Wolf A's disclosure of a device package oriented at a right angle to a lead channel is a different geometric relationship than the claimed configuration of a laser's emission axis perpendicular to the lead axis and coupled via a parabolic redirector. Absent the teaching of Applicant's Specification, one of ordinary skill in the art would not interpret Wolf A as disclosing or suggesting the claimed perpendicular arrangement. To arrive at that conclusion requires importing Applicant's definition into the prior art, which constitutes impermissible hindsight. (09/02/25 Remarks, pages 17-18)
This argument is not persuasive. The argument uses an understanding of the term “perpendicularly” which depends on the Specification (see MPEP 2111.01 - “It Is Improper to Import Claim Limitations from the Specification”). The claim language itself is unclear what the laser is perpendicular with (see new 112(b) rejection). The use of a VSCEL would create a vertical orientation with respect to the stack in Kuhn.
Regarding Claim 15, Applicant additionally argues:
In addition, the Office Action appears to rely on paragraph [0148] of Wolf A, referencing the Analog Devices ADPD144RI module, as disclosing the claimed "die stack" and the claimed relationship that the photodiode "surround" the emitter. That reliance is misplaced. The
ADPD144RI is an integrated optical sensor module designed for photoplethysmography applications. The module includes two integrated LED emitters and a four-segment photodiode array. As shown in Figure 11 of its datasheet (shown below), the four photodiode quadrants are clustered together in a rectangular block positioned at best adjacent to, but certainly not around, the LEDs.
Rather, the LEDs are at one end of the package and the photodiode array is at the other end of the package. While this arrangement may constitute a single package with both emitters and detectors, it does not disclose a laser surrounded by a photodiode as required by the claim. Instead, the arrangement presents a side-by-side geometry in which the emitters and detectors occupy separate adjacent regions. The distinction is significant: the claimed configuration requires the photodiode elements to be disposed around and encircle the emitter. Accordingly, Wolf A does not teach or suggest the claimed die stack or the "surrounding" relationship.
Wolf A in fact teaches away from, the claimed "surrounding" relationship. Figures 12AC and 12G-I, together with paragraphs [0144] and [0162], expressly describe and illustrate that Wolf A 's emitters and detectors are separated by a PVC baffle. The function of this baffle is to optically isolate the detector from the emitter in order to minimize direct signal interference. Thus, rather than showing photodiodes that surround an emitter, Wolf A discloses the opposite arrangement-detectors deliberately spaced apart and partitioned from the emitter by a physical barrier. This disclosure teaches away from a surrounding configuration, because the reference emphasizes separation and isolation as a design feature, not encirclement. Accordingly, Wolf A not only fails to provide the claimed geometry, but affirmatively teaches against it. (09/02/25 Remarks, pages 18-20)
This argument is persuasive. Based on the evidence presented in Applicant arguments, neither Wolf A nor Kuhn teach a photodiode surrounding a laser. Therefore, the rejection of claim 15 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Johnson (US PG Pub 2019/0221997 A1), see “Claim Rejections - 35 USC § 103” section. Reading Wolf A [0144], the baffle appears to be used to prevent cross-contamination between the quadrants aligning with the optical leads.
Regarding Claim 15, Applicant additionally argues:
The Office Action asserts that "while not explicitly using two header bays, the single header bay with four lead channels in Wolf A appears to serve the same functions as the two header bays each with two lead channels in the instant application, prompting the difference to be interpreted as a design choice." The Office Action cites MPEP § 2144.04(VI)(C), which addresses situations involving a mere rearrangement of parts. This rationale does not establish a prima facie case of obviousness here. A proper reliance on MPEP § 2144.04(VI)(C) requires that the rearrangement be nothing more than a cosmetic change, without any functional difference or new result. 25 That standard is not met. The two diametrically opposed header bays of the claimed invention do not merely rearrange the four lead channels of Wolf A. Instead, they perform materially different functions and achieve distinct results. The opposed header bays disperse heat from the VCSELs across separate physical regions of the case, improving thermal management and reducing localized heating. 26 They also provide improved optical alignment by isolating optical folding assemblies within separate header structures, thereby reducing signal cross-talk and Fresnel reflection interference. 27 In addition, the opposed headers allow for balanced anchoring to fascia during implantation, reducing lead strain and migration risk. 28 These functional improvements are not present in Wolf A's single header design. Hence, there is certainly more than a cosmetic difference between the prior art and the claimed invention and so the claimed invention cannot be mere design choice.
Furthermore, design choice rejections are only proper when the modification would have been straightforward and without risk of impairing the prior art's intended purpose. 29 Wolf A 's intended purpose is to achieve compactness and simplicity by concentrating all leads within a single header aligned to a common optical window and daughterboard. Modifying that structure to include two diametrically opposed headers would defeat this purpose by requiring a larger case, multiple optical windows, and additional surgical access points. Such a modification would increase surgical complexity, enlarge the package size, and risk optical misalignment and higher signal losses. Accordingly, there would not have been a reasonable expectation of success in making this modification without undermining the operation and intended advantages of Wolf A. (09/02/25 Remarks, pages 20-21)
This argument is persuasive. In the Specification, Applicant discloses an unexpected result, benefit, or criticality to the two header bay feature, such as the headers being placed apart from each other in order to improve the dispersion of heat generated by the lasers ([0048]). Therefore, the rejection of claim 15 is withdrawn as neither Wolf A or Kuhn teach a rationale for separating leads into two header bays. However, upon further consideration, a new ground(s) of rejection is made in view of
Scott (US PG Pub 2019/0060656 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 16-18 and 21-22, Applicant argues claims 16-18 (09/02/25 Remarks, page 22) and claims 21-22 (09/02/25 Remarks, page 24) inherit the arguments from claim 15 and should be similarly withdrawn. This argument is persuasive because the rejection of claim 15 was withdrawn over Wolf A in view of Kuhn. However, upon further consideration, a new ground(s) of rejection is made in view of Chung (US 6,975,465 B1), Johnson (US PG Pub 2019/0221997 A1), and Scott (US PG Pub 2019/0060656 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 19, Applicant argues:
At page 13, the Office Action likens the "supply current to the photodiode" of the claim to the "received optical signal current" described in the Specification (see, e.g., [0024]). This interpretation is incorrect. As set forth in the specification and supported by the identified Hamamatsu S5980-09(ESI) photodiode in paragraph [0079], an electrical engineer of ordinary skill in the art would understand that a photodiode operates with two distinct currents: (1) a bias or supply current that establishes the detector's operating point, and (2) a photocurrent generated in response to incident optical energy. The variable Iy described in paragraph [0024] of the Specification refers to the photocurrent signal output of the photodiode, not its supply or bias current. By contrast, the normalization routine of Figure 15 expressly teaches adjusting the photodiode supply current to trim detector responsivity until channels are equalized. One of skill in the art would therefore not conflate photocurrent with supply current, and the Office Action's interpretation does not align with the disclosure or with the ordinary operation of biased photodiodes.
More importantly, paragraph [0151] of Wolf A does not disclose the normalization function of the signal generator recited in claim 19. Wolf A teaches compensating for long-term emitter degradation by increasing the drive current to emitter 1204, thereby maintaining constant fiber output. This is fundamentally different from the claimed invention, which normalizes channel response by adjusting the supply currents to photodiodes. Wolf A's disclosure is emitter side compensation, not detector-side normalization. A person of ordinary skill in the art would not equate emitter drive adjustments with photodiode bias current adjustment (normalization). (09/02/25 Remarks, pages 22-23)
This argument is persuasive. The emitter current is being adjusted based on the detector in the previous rejection where claim 19 states “normalize a first supply current to the first photodiode and a second supply current to the second photodiode.” Therefore, the rejection of claim 19 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Beatty (US PG Pub 2016/0170284 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 20, Applicant argues:
As set out above, one of ordinary skill in the art would understand from Applicant's disclosure that the photodiodes employed in the present system are biased and operate with a supply or drive current. The specification expressly supports that the photodiodes in the present system are biased devices that operate with a supply current. Paragraph [0079] identifies photodiode package 914 as Part No. S5980-09(ESI) from Hamamatsu Photonics. As described in the manufacturer's datasheet, this device is specified in terms of dark current at a reverse bias voltage, confirming that it is intended to be operated with a bias supply. A person of ordinary skill in the art would therefore understand that the photodiodes disclosed in the application are not passive, unbiased elements, but are reverse-biased detectors whose operating point is established by a supply or drive current.
The Specification further explains the normalization routine of Figure 15 in concrete detail. The processor retrieves readouts for two detector channels (for example, a first photodiode adjacent VCSEL 850 and a second photodiode adjacent VCSEL 852). It compares the channel outputs, computes the difference, and then reduces the supply current of the higher output photodiode by that difference (see steps 1513 and 1516). The routine then returns "normalized power levels" for the two photodiodes, with the specification noting that the differences are applied to the photodiode supply current to normalize the source of emission, i.e., to normalize what the system measures as source emission across channels. Thus, Figure 15 is not merely "balancing emitter outputs." It is equalizing detector channel response by trimming each photodiode's supply current until their reported optical power matches a common baseline. In practical terms, the specification treats "normalizing source emission" as achieving consistent, channel-to-channel measured source power by tuning detector bias and sensitivity, rather than altering the laser drive current. This process corresponds exactly to claim 20, which recites reducing the first supply current if it is greater than the second, and reducing the second supply current if it is greater than the first, thereby yielding normalized detector response.
The Office Action equates the "supply current to the photodiode" with the "received optical signal current" (see, e.g., citing [0024]). This interpretation is incorrect. As set forth in the specification and supported by the identified Hamamatsu S5980-09(ESI) photodiode ([0079]), a person of ordinary skill in the art would understand that a photodiode operates with two distinct currents: (1) a bias or supply current that establishes the detector's operating point, and (2) a photocurrent generated in response to incident optical energy. The variable Iy described in paragraph [0024] refers to the photocurrent signal output of the photodiode, not its supply or bias current. By contrast, the normalization routine of Figure 15 expressly teaches adjusting the photodiode supply current to trim detector responsivity until channels are equalized. One of skill in the art would therefore not conflate photocurrent with supply current, and the Office Action's interpretation does not align with the disclosure or with the ordinary operation of biased photodiodes. (09/02/25 Remarks, pages 26-29)
This argument is persuasive. The emitter current in Wolf A is being adjusted based on the detector in the previous rejection where claim 19 states “normalize a first supply current to the first photodiode and a second supply current to the second photodiode.” Additionally, Wolf B does not discuss normalizing the supply current. Therefore, the rejection of claim 20 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Beatty (US PG Pub 2016/0170284 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 20, Applicant additionally argues:
With respect to claim 20, the Office Action asserts that Wolf B discloses the step of "reducing the first supply current if the first supply current is greater than the second supply current; and reducing the second supply current if the second supply current is greater than the first supply current." The Office Action equates the output signal currents generated by Wolf B's detectors with the claimed photodiode supply currents. This is incorrect.
Wolf B describes detectors that generate photocurrents in response to reflected light beams, and the differences between those photocurrents are used as positional signals for closed loop control. These photocurrents are output signal currents produced by the photodiodes, not input supply currents applied to the photodiodes to establish their bias point. As explained in the present specification in connection with Figure 15, the claimed invention normalizes detector response by trimming the supply current (bias) to the higher-output photodiode, thereby reducing its responsivity until the channels are equalized. A person of ordinary skill in the art would understand that Wolf B does not disclose or suggest this technique; rather, it relies on the natural differences in photocurrent as its feedback signal. (09/02/25 Remarks, page 29)
This argument is persuasive. The emitter current in Wolf A is being adjusted based on the detector in the previous rejection where claim 19 states “normalize a first supply current to the first photodiode and a second supply current to the second photodiode.” Additionally, Wolf B does not discuss normalizing the supply current. Therefore, the rejection of claim 20 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Beatty (US PG Pub 2016/0170284 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding claims 23-24, Applicant argues:
The reliance by the Office Action on an "obvious to try" rationale under 35 U.S.C. § 103 does not establish a prima facie case of obviousness as to these claims. Under MPEP § 2143(I)(E) and the Supreme Court's guidance in KSR International Co. , the obvious to try rationale is limited to situations where a skilled artisan faces a recognized problem, where there are only a finite number of identified and predictable solutions, and where there is a reasonable expectation of success in trying those solutions. The Federal Circuit has consistently emphasized that there must be "articulated reasoning with some rational underpinning" to connect the recognized problem to the cited solution. 31 Although the prior art need not have identified the exact same problem as the applicant, the proposed solution must nevertheless be reasonably related to the problem the skilled artisan faced.
In the present case, the Office Action asserts that because Crowe discloses the use of green or blue light in photoplethysmography to assess blood volume, it would have been obvious for a skilled artisan to substitute those wavelengths into Wolf A's dual-wavelength reflectometry system to address the recognized problem of optical signal degradation. This reasoning is flawed for several reasons. First, the problem identified in the present application is not assessing tissue properties, but rather isolating Fresnel reflections and optical degradation in the fiber optic system from reflections attributable to spinal cord movement. As described in paragraphs [0121]-[0122] of the Specification, the second wavelength (e.g., blue or green light) is used precisely because it is absorbed by surrounding tissue and hemoglobin, leaving only the Fresnel reflections. These reflections provide a measurement of optical system signal loss and noise, which is then used to compensate the stimulation current and maintain signal fidelity.
By contrast, Crowe teaches the use of green and blue light in reflectance photoplethysmography to enhance the detection of pulsatile blood volume because those wavelengths are more strongly absorbed by blood. That teaching addresses a different problem altogether-improving signal-to-noise ratio in measuring blood flow-and provides no suggestion that green or blue light should be used to eliminate blood-related signals in order to isolate system-level Fresnel reflections. Indeed, Crowe uses a single wavelength to obtain a single physiological measurement (blood volume), and does not disclose or suggest the dual wavelength architecture recited in claims 17, 18, and 23. (09/02/25 Remarks, pages 30-32)
This argument is not persuasive. Wolf A discloses “the wavelengths of the emitters may range from visible red to infrared, or approximately 620-1700 nanometers. The emitter(s) may be either single wavelength or multiple wavelengths” ([0148]) when implementing the interpretation of optical data to compensate for position as mapped in claim 18. Based on the difference in signal detail during reflectometry between blue or green and red or infrared wavelengths as discussed in Crowe, it would be obvious to try blue or green waveforms. A limited number of wavelength categories for reflectometry are possible in Crowe ([0014-0015] – deficiencies of only using red and infrared; [0066-0067] – blue/green used). The BRI of claim 18 does not specify the specific type of compensation in line with the arguments above (e.g. Fresnel reflections and optical degradation) and would constitute an improper importation of limitations from the specification (see MPEP 2111.01 - “It Is Improper to Import Claim Limitations from the Specification”). Therefore, the rejections of claims 23 and 24 are maintained.
Regarding claims 23-24, Applicant additionally argues:
Moreover, the Office Action has failed to show that there is a finite number of predictable solutions to the recognized problem. The art of plethysmography recognizes an almost infinite number of possible wavelengths and optical configurations, but there is no teaching that a skilled artisan seeking to measure system degradation would have reasonably expected success by borrowing Crowe 's use of green or blue light for blood absorption. To the contrary, Applicant's Specification teaches that the claimed system uniquely combines two wavelengths with distinct functional roles: red or near-infrared light to detect spinal cord movement, and green or blue light to detect Fresnel reflections and system degradation, both feeding into the same stimulation signal for compensation. This dual-frequency isolation and correction mechanism is not taught or suggested in the prior art.
Accordingly, even if Crowe disclosed green or blue light as an alternative to red or infrared for assessing blood properties, that disclosure is unrelated to the recognized problem of system degradation addressed in the present application. Without a rational connection between the recognized problem and the proposed prior art solution, the "obvious to try" rationale fails. The Office Action therefore does not establish a prima facie case of obviousness for claim 23.
With respect to claim 24, Applicant respectfully refers to the arguments set forth above in connection with claim 23. The same deficiencies in the Office Action's "obvious to try" rationale apply equally here, as claim 24 merely specifies a narrower range of wavelengths for the second signal. Accordingly, for the reasons discussed above with respect to claim 23, a primafacie case of obviousness has not been established for claim 24. (09/02/25 Remarks, pages 32-33)
This argument is not persuasive. Wolf A discloses “the wavelengths of the emitters may range from visible red to infrared, or approximately 620-1700 nanometers. The emitter(s) may be either single wavelength or multiple wavelengths” ([0148]) when implementing the interpretation of optical data to compensate for position as mapped in claim 18. Based on the difference in signal detail during reflectometry between blue or green and red or infrared wavelengths as discussed in Crowe, it would be obvious to try blue or green waveforms. A limited number of wavelength groupings for reflectometry are possible in Crowe ([0014-0015] – deficiencies of only using red and infrared; [0066-0067] – blue/green used). Therefore, the rejections of claims 23 and 24 are maintained.
Regarding claims 25-26, Applicant argues:
Claim 25 requires that "the first parabolic redirector further comprises: a collimating lens centered on the first optical axis ... ". The Office Action relies on Wolf A for a "convex lens positioned at the proximal end of the optical fiber to focus light into and out of the optical fiber", and then combines Wolf A with Wolf C, which allegedly teaches a collimating lens at the proximal end of the optical fiber in an optical sensing/reflectometry system. The Office Action concludes that it would have been obvious to modify Wolf A's proximal-end lens with the collimating lens from Wolf C.
The combination suggested by the Office Action fails to disclose this element claim 25. The claim does not merely recite a lens located at the proximal end of a fiber. Rather, it requires that the collimating lens be part of the first parabolic redirector and centered on the first optical axis - the lens is structurally integrated into the parabolic redirector. Neither Wolf A nor Wolf C discloses or suggests such an arrangement. Wolf A's lens is not described as part of a parabolic redirector structure. Similarly, Wolf C describes collimating lenses in the context of aligning light for reflectometry, but not as an element integrated into a parabolic redirector as expressly required by claim 25. (09/02/25 Remarks, pages 33-34)
This argument is persuasive. The parabolic redirector and right-angle prism in the embodiments in Figures 16C and 17B are not placed within the stimulator casing and instead describe embodiments near the distal paddle electrodes. Therefore, the rejections of claim 25-26 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding claims 25-26, Applicant additionally argues:
The Office Action cites Wolf A, paragraph [0209], as allegedly disclosing a structure that performs the claimed function. However, the structure of Wolf A does not perform the identical function required by the claim. As explained in Applicant's specification, the claimed parabolic surface is configured to reflect a transmit ray from the emitter toward the lead and to reflect a receive ray from the lead toward the photodiode detector. What Wolf A discloses is very different. Wolf A at paragraph [0209] discloses only parabolic reflectors that redirect light emitted from optical fiber segments (the transmit ray) outward away from the lead, and direct reflected light (the receive ray) from the windows toward the detector lead. In other words, the transmit ray moves away from the lead, not toward it -- and the receive ray moves toward the optical window, not toward the photodiode - which is not the function required by claim 25.
Because Wolf A fails to disclose a parabolic surface that performs the identical function required the Office Action does not establish that the prior art teaches the claimed means-plus function limitation. Absent disclosure of the required function, the Office Action fails to make a primafacie case of obviousness for claim 25. The rejection of claim 1 under 35 U.S.C. § 103 is improper because Wolf A fails to disclose, either expressly or inherently, every element of the claimed invention arranged as required by the claim.
First, Wolf A does not teach or suggest the claim element of a parabolic redirector and a right-angle prism arranged in such a way that a second interface surface of the redirector is immediately adjacent a third interface surface of the prism as required by the claim. The composite reflector 1710 described in paragraph [0220] and shown in Figure 16C of Wolf A is a completely separate embodiment that is not disclosed or suggested to be used in combination with the right-angle prism 1808 described in paragraph [0223] and illustrated in Figure 17B. These embodiments are mutually exclusive system configurations and are never disclosed as being used in conjunction with one another, and in fact cannot be used together (as will be discussed more fully later). The Office Action fails to identify which surfaces of the composite reflector are the first and second interface surfaces. The Office Action fails to identify which surfaces of the right angle prism are the third and fourth interface surfaces. The Office Action also fails to identify any surfaces of either the composite reflector or the right angle prism are immediately adjacent each other. (09/02/25 Remarks, pages 34-35)
This argument is similarly persuasive. The parabolic redirector and right-angle prism in the embodiments in Figures 16C and 17B are not placed within the stimulator casing and instead describe embodiments near the distal paddle electrodes. Therefore, the rejections of claim 25-26 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 27, Applicant argues:
First, at page 16, the Office Action cites paragraph [0168] of Wolf A, referring to "transmission window 1409" as a transparent cover plate that "overlaps the emitter." However, as shown in Figure 13A and described at [0168], the transmission window 1409 is located at the distal end of the percutaneous lead, enclosing a diffuser cavity 1430. It is not at the proximal end near the daughterboard, where the emitters and detectors are housed. Because the transmission window is at the opposite end of the lead, it cannot plausibly be "between the emitter and the die stack," nor does it overlap the emitter. The Office Action's characterization is inconsistent with Wolf A 's disclosure.
Second, the Office Action again equates the Analog Devices ADPD144RI module with the claimed "die stack." As explained in connection with claim 15, that reliance is misplaced. The ADPD144RI is an integrated optical sensor package for photoplethysmography, with two LED emitters and a side-by-side photodiode block. The photodiodes are not arranged to surround the emitters, and the module does not disclose the structural relationship of multiple perpendicularly oriented lasers each surrounded by photodiodes and coupled to parabolic redirectors. Treating the ADPD l 44RI as the claimed die stack overlooks this critical distinction.
Third, and most importantly, claim 27 requires a structural relationship in which the light emitter is positioned adjacent the parabolic redirector. The Office Action cites paragraph [0209] of Wolf A, which states that "the emitter is oriented toward the parabolic redirector." But "oriented toward" is not equivalent to "adjacent." Wolf A's reflectors 1550, 1551, 1552, and 1553 (see Figs. 14B and l 4C) are located at the distal end of a paddle lead, far from the proximal end where the emitter resides. These reflectors are as remote from the emitter as possible, and thus not "adjacent" in any sense. The claimed adjacency between emitter and redirector is a concrete structural relationship not disclosed or suggested in Wolf A.
Furthermore, for a person of ordinary skill in the art, Wolf A teaches precisely the opposite to what the claim requires, namely that the emitters are positioned at the proximal end to inject light directly into the lead fibers, and reflectors or windows are positioned at the distal end. To modify Wolf A into the claimed configuration-placing a transparent cover plate between a die stack and a perpendicularly oriented laser so as to position the emitter adjacent a parabolic redirector-would require re-engineering the device in a manner that undermines Wolf A's intended structure and operation. Absent the teaching of Applicant's Specification, there is no basis for such a modification, and arriving at the claimed configuration requires impermissible hindsight.
Accordingly, Wolf A fails to disclose or suggest the transparent cover plate positioned between the emitter and die stack, and fails to disclose or suggest the structural adjacency between the emitter and parabolic redirector required by claim 27. The Office Action therefore does not establish a primafacie case of obviousness under 35 U.S.C. § 103. (09/02/25 Remarks, pages 24-26)
This argument is persuasive.
(1) Neither Wolf A nor Kuhn disclose a transmission window situated between the emitter and die stack. Therefore, the rejection of claim 27 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Johnson (US PG Pub 2019/0221997 A1), see “Claim Rejections - 35 USC § 103” section.
(2) Based on the evidence presented in Applicant’s arguments, neither Wolf A nor Kuhn teach a photodiode surrounding a laser. Therefore, the rejection of claim 15 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Johnson (US PG Pub 2019/0221997 A1), see “Claim Rejections - 35 USC § 103” section.
(3) The parabolic redirector and right-angle prism in the embodiments in Figures 16C and 17B are not placed within the stimulator casing and instead describe embodiments near the distal paddle electrodes. Therefore, the rejection of claim 27 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section
Summary: The 35 U.S.C. § 103 rejections of claims 15-28 are withdrawn. New 35 U.S.C. § 103 rejections of claims 15-28 newly in view of Scott (US PG Pub 2019/0060656 A1), Chung (US 6,975,465 B1), Johnson (US PG Pub 2019/0221997 A1), and Beatty (US PG Pub 2016/0170284 A1) are added (see Claim Rejections - 35 USC § 103).
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.
Claims 15-28 are 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 15 (which carry as terms into claims 17-18 and 27-28): The use of “perpendicularly oriented laser” in “a first die stack, having a first perpendicularly oriented laser, surrounded by a first photodiode, optically coupled to the first parabolic redirector; the first die stack, having a second perpendicularly oriented laser, surrounded by a second photodiode, optically coupled to the second parabolic redirector; a second die stack, having a third perpendicularly oriented laser, surrounded by a third photodiode, optically coupled to the third parabolic redirector; and the second die stack, having a fourth perpendicularly oriented laser, surrounded by a fourth photodiode, optically coupled to the fourth parabolic redirector” is indefinite because it is unclear what the laser is perpendicular to in the claim language. The clarity of the claim would be enhanced by specifying the element to which the laser is perpendicular.
Claims 16 and 19-26 are rejected for being dependent on rejected claims
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 15-18, 21-22, and 25-28 are rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001130 A1, see previously cited), to be referred to as Wolf A, in view of Chung (US 6,975,465 B1, see “Notice of References Cited”), Johnson (US PG Pub 2019/0221997 A1, see “Notice of References Cited”), and Scott (US PG Pub 2019/0060656 A1, see “Notice of References Cited”).
Regarding Claim 15, Wolf A teaches an implantable pulse generator system ([0002], [0165]) comprising:
• a case ([0087] – nonmetallic case 507);
• a first header bay, formed in the case (Figure 6F, [0114-0115]);
•a first header assembly, fixed in the first header bay, having a first lead retainer channel and a second lead retainer channel (Figure 6F, [0117] - pairs of lead channels placed in the header bay: “The header body includes a plurality of generally latitudinal and parallel lead channels, such as lead channel 702. In a preferred embodiment, the header body includes four lead channels. Alternatively, it may have two lead channels”);
•a first electro-optical lead, having a first optical axis, positioned in the first lead retainer channel (Figure 6F – four leads are depicted; [0117] – each of four leads placed inside a lead channel);
•a second electro-optical lead, having a second optical axis, positioned in the second lead retainer channel (Figure 6F – four leads are depicted; [0117] – each of four leads placed inside a lead channel);
•a first optical connection, centered on the first optical axis, optically coupled to the first electro-optical lead (Figure 6F – lead optically connects through the optical window 618);
•a second optical connection, centered on the second optical axis, optically coupled to the second electro-optical lead (Figure 6F – lead optically connects through the optical window 618);
• a first die stack, having a first light emitter, a first light detector, optically coupled to the first electro-optical lead (Fig 12F, [0165] – emitters and detectors are positioned in the optical pathway for each lead: “a preferred embodiment of a coupling arrangement between optical leads and optical emitters in a surgical lead will be described. Emitter 1293 is optically coupled to central fiber 1225 of signal lead 1221. Detector 1291 is optically coupled to lead 1223 of signal lead 1221. Emitter 1295 is optically coupled to central fiber 1227 and detector 1297 is connected to lead 1229”; [0148] – the emitter and detector are placed in a shared circuit: “Alternatively, an emitter and detector may be integrated into a single ASIC such as with the ADPD144RI from Analog Devices, Inc. of Norwood, Mass”);
• the first die stack, having a second light emitter, a second light detector, optically coupled to the second electro-optical lead (Fig 12F, [0165] – emitters and detectors are positioned in the optical pathway for each lead; [0148] – the emitters and detectors are placed in a shared circuit);
Wolf A does not disclose:
(1) a first parabolic redirector, centered on the first optical axis, optically coupled to the first electro-optical lead and a second parabolic redirector, centered on the second optical axis, optically coupled to the second electro-optical lead;
(2) a first die stack, having a first light emitter, surrounded by a first light detector, optically coupled to the first parabolic redirector and the first die stack, having a second light emitter, surrounded by a second light detector, optically coupled to the second parabolic redirector; and
(3) a second header bay, diametrically disposed to the first header bay, formed in the case; where the second header bay contains:
•a second header assembly, fixed in the first header bay, having a third lead retainer channel and a fourth lead retainer channel;
• a third electro-optical lead, having a third optical axis, positioned in the third lead retainer channel;
• a fourth electro-optical lead, having a fourth optical axis, positioned in the fourth lead retainer channel;
• a third parabolic redirector, centered on the third optical axis, optically coupled to the third electro-optical lead;
• a fourth parabolic redirector, centered on the fourth optical axis, optically coupled to the fourth electro-optical lead;
• a second die stack, having a third light emitter, surrounded by a third light detector, optically coupled to the third parabolic redirector; and
• the second die stack, having a fourth light emitter, surrounded by a fourth light detector, optically coupled to the fourth parabolic redirector;
Chung, in the same field of endeavor of optical coupling between a laser source and an optical fiber (col 1, lines 43-61), teaches control prisms, which can have a variety of curved shapes (col 1, lines 55-61), such as the parabolic shape in the curved prism displayed in Fig. 5 which redirects and collimates the laser emitted from 3 (col 6, lines 42-66).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s optical emitter in a dual reflectometry system by incorporating the parabolic curved redirector prism in Chung. This would have been obvious because both Wolf A and Chung discuss optical coupling optical elements and Chung provides a solution/improvement for allowing a laser and optical fiber in different axes to be optically coupled and providing greater flexibility with the positioning of the emitter within Wolf A’s case. The parabolic curve shape can reduce aberrations as the light signal passes through the prism. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the parabolic curved redirector prism in Chung.
Johnson, in the same field of endeavor of a laser emitter and photodetector ([0002]), teaches a VCSEL laser surrounded by a photodetector or photodiode (Fig. 2, [0013] – “An example of a VCSEL packaged in a TO header and can is illustrated in FIG. 2. A stack can be created consisting of a photodiode 202 mounted on the metal TO header 204, and a VC:SET, 206, which is smaller than the photodiode active area, mounted on a metal pad on then photodetector. To isolate the photodiode 202 from the header 204, it could optionally be mounted on a ceramic submount patterned with metal located between the header and the photodiode. The various VCSEL and PD contacts are wire bonded to the pins of the header or package for electrical contact […] Light reflected at a sufficiently
high angle will reach the area of the photodetector 202 not covered by the VCSEL chip and can be used to monitor the output power”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s optical emitter in a dual reflectometry system by incorporating the laser as an optical emitter and photoreceiver in Johnson. This would have been obvious because both Wolf A and Johnson discuss laser emitters and photodetectors and Johnson provides a solution/improvement by using a laser with a surrounding photodiode for monitoring reflected light and adjusting VCSEL output based on the reading. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the laser as an optical emitter and photoreceiver in Johnson.
Scott, in the same field of endeavor on implantable pulse generator with lead connection ports ([0005]), teaches two headers diametrically opposed on opposite sides of the stimulator casing (Figs. 10-12, [0096]) where the separate headers can supply different properties of stimulation signals along attached leads as a benefit ([0096-0097]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s optical emitter in a dual reflectometry system with one header bay by incorporating the diametrically opposed dual header bay design in Scott. This would have been obvious because both Wolf A and Scott discuss nerve stimulation with leads attached to a header bay in a stimulator casing and Scott provides a solution/improvement by using two structurally equivalent header bays on opposite ends of the casing in order to tailor stimulation properties for leads attached to each separate header. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating a second header bay with the same structure as the first header bay such as taught in Scott.
Therefore, Claim 15 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 16, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 15, as indicated hereinabove. Wolf A further discloses the first electro-optical lead further comprises:
• an optical fiber, positioned coaxially with the first optical axis (Figure 13E, [0182-0183] – optical fiber assembly containing optical fiber formed in the percutaneous lead);
• a set of electrical contacts (1408a, 1408b, 1408c, 1408d, 1408e, 1408f, 1408g, 1408h), fixed on a proximal surface of the first electro-optical lead ([0170] – electrical contacts on the proximal exterior surface of the lead); and
• a set of electrodes (1406a, 1406b, 1406c, 1406d, 1406e, 1406, 1406g, 1406h), fixed on a distal surface of the first electro-optical lead ([0171] – distal stimulation electrodes), electrically connected to the set of electrical contacts ([0137] – stimulation pulses from the generator are sent to the electrodes via the fixed contacts).
Therefore, Claim 16 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 17, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 16, as indicated hereinabove. Wolf A further discloses the first header bay further comprises:
• a set of fixed contacts (1408a, 1408b, 1408c, 1408d, 1408e, 1408f, 1408g, 1408h), rigidly positioned in the first lead retainer channel ([0170] – positioned to connect with the lead in the retainer channel, as seen in Figure 7A) and operatively connected to an electro-optical signal generator ([0137] – stimulation pulses from the generator are sent to the electrodes via the fixed contacts);
• wherein the electro-optical signal generator is programmed ([0144] – “Processor 1208 draws
power from the battery and is supplied with an onboard memory that contains instructions for its operation”) to:
send a first transmit ray, of a first wavelength, from the first light emitter ([0148]) into the first optical pathway and the optical fiber ([0149-0151]);
receive a first return signal from the first light detector, based on a first receive ray;
generate a stimulation signal based on the first return signal ([0137] – electrical signal generated by main circuit board via signals interpreted by the light detectors); and
send the stimulation signal to the set of fixed contacts, for transmission to the set of electrodes ([0137] – stimulation signal sent to the lead contacts to transmit to electrodes)
Wolf A does not disclose a perpendicularly oriented laser (emitter), photodiode (detector), and first parabolic redirector (optical pathway).
The perpendicularly oriented laser and photodiode are taught by Johnson, as explained in Claim 15. The first parabolic redirector as part of the optical pathway istaught by Chung, as explained in Claim 15.
Therefore, Claim 17 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 18, the implantable pulse generator system is obvious over Wolf A in view of in view of Chung, Johnson, and Scott according to Claim 17, as indicated hereinabove. Wolf A further discloses the electro-optical signal generator is further programmed to:
• send a second transmit ray, of a second wavelength ([0148] – multiple wavelengths, or even the same wavelength, can be used), from the first light emitter into the optical pathway and the first electro-optical lead ([0149-0151]);
• receive a second receive ray at the first light detector ([0013-0015]; [0137] – electrical signal generated by main circuit board via signals interpreted by the light detectors);
• generate a compensation value from the second receive ray ([0013-0015]; [0137] – the new optical reading is used to adjust the electrical stimulation to compensate for changes in position identified by the optical sensor); and
• modify the stimulation signal based on the compensation value ([0013-0015]; [0137] – new stimulation signal sent to the lead contacts to transmit to electrodes).
Wolf A does not disclose a perpendicularly oriented laser (emitter), photodiode (detector), and first parabolic redirector (optical pathway).
The perpendicularly oriented laser and photodiode are taught by Johnson, as explained in Claim 15. The first parabolic redirector as part of the optical pathway is taught by Chung, as explained in Claim 15.
Therefore, Claim 18 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 21, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 19, as indicated hereinabove. Wolf A further discloses the electro-optical signal generator is further programmed to:
• correct for a time based variation in the first supply current ([0151] – “It can be seen that the light output of fiber 1215 degrades over time due to microfractures in the fiber and other degradation of optical components in the surgical lead. The decrease in optical performance of fiber 1215 is monitored over time by processor 1208 by reading the voltage signal from detector 1296, which receives light from fiber 1215 reflected by the spinal cord. Processor 1208 is programmed to compensate for the degradation in light output by increasing the current to emitter 1204 according to curve ‘b’”). Note the term “supply current” is not used in the instant Specification for clear identification, although the idea appears to line up with the “drive current” presented in [0135] and [0138].
Therefore, Claim 21 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 22, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 21, as indicated hereinabove. Wolf A further discloses the step of correcting further comprises:
• deriving a difference between an initial supply current to the first light detector and the first supply current ([0152-0161] – details the process of adjusting the current over time, which requires comparison of a previous current setting and the required increase in current).
Note the term “supply current” is not used in the instant Specification for clear identification, although the idea appears to line up with the “drive current” presented in [0135] and [0138]. Wolf A does not disclose a photodiode (detector).
The photodiodes are taught by Johnson, as previously explained in Claim 15.
Therefore, Claim 22 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 25, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 18, as indicated hereinabove. Wolf A discloses further comprises:
• a convex lens positioned at the proximal end of the optical fiber to focus light into and out of the optical fiber ([0181])
• a surface, for reflecting a transmit ray toward the first electro-optical lead and a receive ray toward the first light detector ([0149-0151]);
Wolf A does not disclose a photodiode (detector) and first parabolic surface in the parabolic redirector (optical pathway).
The photodiode is taught by Johnson, as explained in Claim 15. The first parabolic redirector as part of the optical pathway is taught by Chung, as explained in Claim 15. Additionally, Wolf A’s lens is not explicitly identified as a collimating lens.
Chung, in the same field of endeavor of optical coupling between a laser source and an optical fiber (col 1, lines 43-61), teaches control prisms, which can have a variety of curved shapes (col 1, lines 55-61), such as the parabolic shape in the curved prism displayed in Fig. 5 which redirects and collimates the laser emitted from 3 (col 6, lines 42-66). Chung further teaches the curve surface of the prism acts as a collimator (col 1, lines 43-60 – “The subject invention can utilize a beam control prism placed next to a diode laser bar. The subject beam control prism can have, for example, a curved surface and/or a high reflective coated surface for a diode laser wavelength. The curved surface can collimate the fast axis divergence and the so mirror surface can change the beam direction”)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s optical emitter in a dual reflectometry system by incorporating the parabolic curved redirector prism in Chung. This would have been obvious because both Wolf A and Chung discuss optical coupling optical elements and Chung provides a solution/improvement for allowing a laser and optical fiber in different axes to be optically coupled and providing greater flexibility with the positioning of the emitter within Wolf A’s case. The parabolic curve shape can reduce aberrations as the light signal passes through the prism. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the parabolic curved redirector prism in Chung.
Therefore, Claim 25 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 26, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, Scott, and Wolf C according to Claim 25, as indicated hereinabove. Wolf A does not teach a first parabolic surface in the parabolic redirector (optical pathway). Regarding the parabolic redirector in Chung, Chung further teaches the parabolic surface includes a reflective coating (col 7, lines 8-10 – “The reflective surface of prisms 2 shown in FIGS. 5, 6, and 8 can be coated with a dielectric or metallic high reflectivity coating”).
Therefore, Claim 26 is obvious over Wolf A is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 27, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 15, as indicated hereinabove. Wolf A does not disclose
a transparent cover plate, between the first perpendicularly oriented laser and the first die stack, positioning the first perpendicularly oriented laser adjacent the first parabolic redirector.
Regarding the VCSEL and photodiode in Johnson, Johnson further teaches that a bottom mirror layer between the VCSEL AND photodiode transmits light to the photodiode ([0049] – “For example, FIG. 7 shows a photodiode arranged 718 between the bottom metal layer 712 and a submount 720. The light emitted via the bottom mirror 708 through the bottom of the VCSEL, through the opening in the metal layer 714, is detected by the silicon photodiode 718”). The VCSEL resting on the bottom mirror is lined up under an optical window which the emitter passes light through toward an optical axis (Fig. 2, [0013]).
Regarding the parabolic redirector in Chung, Chung further teaches the redirector accepts light from the laser emitter and bends light to line up with the optical axis in the output end (Fig. 5, col 6, lines 42-66).
Therefore, Claim 27 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Regarding Claim 28, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 27, as indicated hereinabove. Wolf A discloses a window, sealed to the case ([0115] – “Optical window 618 is preferably a crystal insert in a wall of the header bay that is hermetically sealed in the IPG casing, as will be further described”). However, Wolf A does not disclose a window between the first perpendicularly oriented laser and the first parabolic redirector.
Regarding the VCSEL and photodiode unit in Johnson, Johnson further teaches a lid or cap with a window for transmitting the light (Fig. 2, [0013] – “A lid or cap 208 is provided on top of the package. In the case of the TO header 204, this is usually a tall metal can, with a window 210 in the top surface. The window 210 preferably does not have an AR coating, or has a controlled coating to determine the amount of light that will be reflected at the two surfaces of the window”), which would be considered the equivalent of the optical window which the emitter passes light through toward an optical axis.
Regarding the parabolic redirector in Chung, Chung further teaches the redirector accepts light from the laser emitter and bends light to line up with the optical axis in the output end (Fig. 5, col 6, lines 42-66).
Therefore, Claim 28 is obvious over Wolf A in view of Chung, Johnson, and Scott.
Claims 19-20 are rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001130 A1, see previously cited), to be referred to as Wolf A, in view of Chung (US 6,975,465 B1, see “Notice of References Cited”), Johnson (US PG Pub 2019/0221997 A1, see “Notice of References Cited”), Scott (US PG Pub 2019/0060656 A1, see “Notice of References Cited”), and Beatty (US PG Pub 2016/0170284 A1, see “Notice of References Cited”).
Regarding Claim 19, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 17, as indicated hereinabove. Wolf A discloses wherein:
• the first die stack further comprises a second light detector ([0146-0149] – multiple detectors);
Wolf A does not disclose a photodiode (detector) or the electro-optical signal generator is further programmed to: normalize a first supply current to the first photodiode and a second supply current to the second photodiode.
The photodiodes are taught by Johnson, as previously explained in Claim 15.
Beatty, in the same field of endeavor of controlling an electrooptical device ([0001-0002]), teaches the bias current can be adjusted between arms, each arm containing a photodiode, in order to balance components on each arm such as the photodiodes ([0043-0044]). Additionally, differences between the first and second photodiode currents are noted when a bias current is applied to a particular arm containing its respective photodiode in order to apply a correction factor to equalize the photodiode outputs ([0058] – “For example, both arms 314 and 316 may be driven with a bias current one at a time, maximum current values pertaining to each photodiodes (e.g., MAX IPD1 and MAX IPD2) may be determined, and a correction factor MAX IPD2/MAX IPD1 may be derived. This correction factor may be applied to subsequent photodiode measurements to correct for the error pertaining to the fabrication mismatch”). Note the term “supply current” is not used in the instant Specification for clear identification, although the idea appears to line up with the “drive current” presented in [0135] and [0138].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s dual reflectometry system with multiple detectors by incorporating the correction factor in biasing currents between arms containing photodiodes in Beatty. This would have been obvious because both Wolf A and Beatty discuss the control of electrooptical devices and Beatty provides a solution/improvement to correct phase and current differences between photodiode signals arising due to different properties of the photodiodes. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the correction factor in biasing currents between arms containing photodiodes in Beatty.
Therefore, Claim 19 is obvious over Wolf A in view of Chung, Johnson, Scott, and Beatty.
Regarding Claim 20, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, Scott, and Beatty according to Claim 19, as indicated hereinabove. Wolf A does not disclose the step of normalizing further comprises: reducing the first supply current if the first supply current is greater than the second supply current; and reducing the second supply current if the second supply current is greater than the first supply current.
Beatty, in the same field of endeavor of controlling an electrooptical device ([0001-0002]), teaches the bias current can be adjusted between arms, each arm containing a photodiode, in order to balance components on each arm such as the photodiodes ([0043-0044]). Additionally, differences between the first and second photodiode currents are noted when a bias current is applied to a particular arm containing its respective photodiode in order to apply a correction factor to equalize the photodiode outputs ([0058] – “For example, both arms 314 and 316 may be driven with a bias current one at a time, maximum current values pertaining to each photodiodes (e.g., MAX IPD1 and MAX IPD2) may be determined, and a correction factor MAX IPD2/MAX IPD1 may be derived. This correction factor may be applied to subsequent photodiode measurements to correct for the error pertaining to the fabrication mismatch”). Note the term “supply current” is not used in the instant Specification for clear identification, although the idea appears to line up with the “drive current” presented in [0135] and [0138].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s dual reflectometry system with multiple detectors by incorporating the correction factor in biasing currents between arms containing photodiodes in Beatty. This would have been obvious because both Wolf A and Beatty discuss the control of electrooptical devices and Beatty provides a solution/improvement to correct phase and current differences between photodiode signals arising due to different properties of the photodiodes. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the correction factor in biasing currents between arms containing photodiodes in Beatty.
Therefore, Claim 20 is obvious over Wolf A in view of Chung, Johnson, Scott, and Beatty.
Claims 23-24 are rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001130 A1, see “Notice of References Cited”), to be referred to as Wolf A, in view of Chung (US 6,975,465 B1, see “Notice of References Cited”), Johnson (US PG Pub 2019/0221997 A1, see “Notice of References Cited”), Scott (US PG Pub 2019/0060656 A1, see “Notice of References Cited”), and Crowe (US PG Pub 2009/0306487 A1, see previously cited).
Regarding Claim 23, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, and Scott according to Claim 18, as indicated hereinabove. Wolf A discloses:
• the first wavelength is between about 700 nanometer and about 800 nanometers ([0148] – “The wavelengths of the emitters may range from visible red to infrared, or approximately 620-1700 nanometers”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
Wolf A does not disclose a second wavelength is between about 400 nanometers and about 500 nanometers.
Crowe, in the same field of optical reflectometry with emitters and photodetectors (Abstract), teaches the use of blue or green light ([0066] – “When used in reflectance mode, light in the blue and/or green portion of the optical spectrum is used which gives a larger pulsatile signal and improved signal to noise ratio”). Crowe further teaches: “In addition, the choice of light in the blue/green portion of the optical spectrum (i.e. wavelengths of between 400 nm and 600 nm) gives improved reliability through the reduction of noise and the increase in AC component signal amplitude, when the photoplethysmograph device is used in reflection mode” ([0067]). Crowe designates the use of blue and green light to counteract the deficiencies of red and infrared light when reflecting off tissue ([0014]). With respect to the 400-600 nm range in Crowe, MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s optical elements in a dual reflectometry system using red and infrared light by incorporating the use of blue and green light reflectometry in Crowe. At the time, there would have been a recognized problem with reflection signal degradation with more common red and infrared emitters. Given the limited wavelengths on the visible spectrum, it would have been obvious for a person of ordinary skill in the art to try green and blue as alternative wavelengths to assess tissue properties. A person of ordinary skill in the art would have a reasonable expectation of successfully discerning tissue properties with either blue or green light.
Therefore, Claim 23 is obvious over Wolf A in view of Chung, Johnson, Scott, and Crowe.
Regarding Claim 24, the implantable pulse generator system is obvious over Wolf A in view of Chung, Johnson, Scott, and Crowe according to Claim 18, as indicated hereinabove. Wolf A further discloses:
• the first wavelength is between about 700 nanometer and about 800 nanometers ([0148] – “The wavelengths of the emitters may range from visible red to infrared, or approximately 620-1700 nanometers”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
Wolf A does not disclose the second wavelength is between about 520 nanometers and about 532 nanometers.
Crowe, in the same field of optical reflectometry with emitters and photodetectors (Abstract), teaches the use of blue or green light ([0066] – “When used in reflectance mode, light in the blue and/or green portion of the optical spectrum is used which gives a larger pulsatile signal and improved signal to noise ratio”). Crowe further teaches: “In addition, the choice of light in the blue/green portion of the optical spectrum (i.e. wavelengths of between 400 nm and 600 nm) gives improved reliability through the reduction of noise and the increase in AC component signal amplitude, when the photoplethysmograph device is used in reflection mode” ([0067]). Crowe designates the use of blue and green light to counteract the deficiencies of red and infrared light when reflecting off tissue ([0014]). With respect to the 400-600 nm range in Crowe, MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf A’s optical emitter in a dual reflectometry system using red and infrared light by incorporating the use of blue and green light reflectometry in Crowe. At the time, there would have been a recognized problem with reflection signal degradation with more common red and infrared emitters. Given the limited wavelengths on the visible spectrum, it would have been obvious for a person of ordinary skill in the art to try green and blue as alternative wavelengths to assess tissue properties. A person of ordinary skill in the art would have a reasonable expectation of successfully discerning tissue properties with either blue or green light.
Therefore, Claim 24 is obvious over Wolf A in view in view of Chung, Johnson, Scott, and Crowe.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796