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 .
Status of Claims
Claims 1-26 are currently pending. Claims 11-26 are directed to non-elected inventions. Claims 11-26 are canceled. Claims 1-10 are under examination.
Response to Arguments
Applicant’s arguments, see Remarks pages 5-23 (35 USC § 103 Claim Rejection), filed 07/28/25 with respect to the 35 U.S.C. § 103 rejections of claims 1-10 have been fully considered. Regarding Claim 1, Applicant argues:
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. (07/28/25 Remarks, pages 10-11)
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 Therefore, the rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
Second, the Office Action fails to address the claim element requiring a photoreceiver to be positioned parallel to the fourth interface surface of the prism. This limitation is recited expressly in claim 1 but is entirely omitted from the Office Actions analysis. In Wolf A, the optical components shown in Figures 16A through 16C (the reflector embodiment) and Figures 17 A and 17B (the prism embodiment) are located at the distal end of the surgical lead and are connected to the pulse generator header via multi-duct leads labeled 1718, 1720, and 1722 in Figure 16, and 1814, 1816, and 1818 in Figure 17. Wolf A explicitly states that these multi-duct leads are flexible, consistent with the lead architecture illustrated in Figure 13A. The light detectors 1205, 1206 and 1207 shown in Figure 12A are shown mounted on daughterboard 814 in Figure 8, and are positioned at the proximal end of the multi-duct lead, entirely remote from the optical components at the distal end of the lead. There is no disclosure or suggestion in Wolf A that a photo receiver is positioned parallel to the any surface of the prism, nor could it be, given the long distance between the distal end of the lead and the proximal end of the lead and the flexible nature of the lead itself Moreover, one of skill would not expect these two components to be parallel because of how they are surgically implanted at different positions in the body. Rather, one of ordinary skill in the art would understand that since the leads are flexible to allow for body movement without dislocating the surgical lead, then the multi-duct leads could not be rigidly aligned to allow the photoreceiver to be parallel to the prism in the manner required by the claim, and the reference contains no teaching or suggestion to do so. (07/28/25 Remarks, pages 11-12)
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 rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
Third, at page 6, the Office Action relies on inherency of unidentified "angled surfaces" in reflector 1710 and prism 1808 to establish the first interface surface, the second interface surface, the third interface surface, the fourth interface surface, and the relative positions of these surfaces relative to the parabolic redirector, the right angle prism, and each other as required by the claim. However, inherency may not be used to supply a missing limitation unless the allegedly inherent features necessarily flow from the teachings of the prior art. 29 Here, Wolf A provides no teaching nor any technical rationale, showing where the claimed interface surfaces are or how the claimed interface surfaces would be arranged to meet the structural requirements of the claim. Further, the references provide no teaching or suggestion that the claimed interface surfaces and their relative positioning would be an inevitable result of the simple composite reflector or the right angle prism disclosed. To the contrary, Wolf A discloses only that these structures are used entirely separately to accomplish the same task. The Office Action's assertion that the presence and arrangement of the interface surfaces are "inherent" is therefore legally unsupported, as it rests on mere possibility or speculation rather than necessary following from the teachings of the references. (07/28/25 Remarks, page 12)
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 rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
Fourth, at page 5, the Office Action suggests that the claim requires only "optical contact" between elements. But this mischaracterizes the plain language of the claim and so cannot be used to support a prima facie case. Claim 1 unambiguously recites that "the second interface surface [is] immediately adjacent the third interface surface," which is a structural limitation-not a functional one. The claim does not merely require that light pass between elements, but instead defines a specific physical relationship between the surfaces that is neither taught nor suggested by the prior art. The absence of this structural feature from the prior art precludes a prima facie case of obviousness. (07/28/25 Remarks, pages 12-13)
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 rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
Fifth, even if one were to attempt to combine the reflector embodiment and the prism embodiment of Wolf A, doing so would render the Wolf A system inoperable. The reflector embodiment requires reflective cap mounted to the optical fiber that provides complete reflection of light and terminates axial propagation of light down the fiber, as described in paragraph [0220]. The right-angle prism embodiment of paragraph [0223 ], by contrast, absolutely requires that light enter and leave the prism through the fiber axially. Hence, the reflective cap necessarily prevents axial transmission of light out of, or into, the fiber in a way that would prevent use of the prism. These two embodiments are therefore mutually incompatible unless the fiber termination is substantively altered-a modification that is neither taught nor suggested by Wolf A and that cannot reasonably be attributed to the skill of an ordinary artisan without impermissible hindsight. (07/28/25 Remarks, pages 12-13)
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 rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
At page 5, the Office Action asserts that the combination of the reflector embodiment and the prism embodiment would be merely "design choice." However, the parabolic redirector of the claim yields advantages and serves a technical purpose not disclosed by the prior art and so the combination identified by the Office Action cannot be mere design choice - nor can it be mere substitution.
The claimed parabolic redirector-required by the claim to have specific surfaces in specific positions immediately adjacent the right-angle prism-serves a unique technical purpose by providing a precise three-dimensional folding of the optical path, turning the optical axis first 90 degrees horizontally and then 90 degrees vertically downward to focus light on the die stack.
This takes place in the limited confines of the IPG header - not in the paddle lead. Hence, the claimed parabolic redirector provides a distinct advantage of compact geometry required by the limited space in the IPG header. Additionally, the claimed parabolic redirector separates the transmit and receive light paths by directing each through distinct angles and surfaces within a single optical assembly. This claimed configuration eliminates the need for a circulator or other bulky optical switching mechanism, which the Application expressly identifies as impractical due to excessive signal loss and spatial constraints. The parabolic redirector thus provides a technical purpose and an advantage neither of which is taught or suggested by the prior art. The prior art specifically teaches that the reflector embodiment and the prism embodiment serve technical purposes different than the claimed invention. (07/28/25 Remarks, pages 13-14)
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, where the redirector/prism components would have different functions than those described in the instant application. Therefore, the rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
The motivation to make the combination suggested by the Office Action is also insufficient to support a prima facie case of obviousness. Under controlling law, an obviousness rejection must be supported by articulated reasoning with some rational underpinning that explains why a person of ordinary skill in the art would have been motivated to make the proposed modification in the manner claimed, with a reasonable expectation of success. But here, conclusory statements that two components "serve the same function and positioning" or "individually fulfill the same role as those elements in combination" or "could be combined [somehow] in series to further focus light" does not satisfy this requirement, particularly where the proposed combination requires substantial redesign of optical components that have mutually exclusive structures and functions. Because each different embodiment relies on different and conflicting configurations of the optical fiber they cannot be combined without changing the designs that allow them to function. (07/28/25 Remarks, pages 15-16)
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, where a substantial redesign would need to occur to incorporate those distal components into the proximal header. Therefore, the rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 1, Applicant additionally argues:
The Office Action offers no explanation as to how the suggested combination could be constructed to satisfy the claim elements, how light would be routed or redirected between the two components, or how the resulting configuration would function within the surgical lead or the IPG header. The Office Action thus fails to articulate a clear or workable path from the prior art to the claimed invention, as required to support a prima facie case.
At page 5, the Office Action states "the parabolic [reflector] and the right angle prism "could be combined in series to further focus light ... ". However, under the law, merely showing that a person of ordinary skill in the art could adapt a piece of prior art to perform a recited function is inadequate to show that a person of skill would adapt that teaching. A combination is not obvious simply because it could have been made -- the proper focus is what a skilled artesian would have been motivated to do at the time of the invention rather than what a skilled artesian would have been able to do.
Here, neither the prior art nor the Office Action provides any suggestion as to how to
position the disparate structures described in Wolf A so as to accomplish the structure and
function of the claimed parabolic redirector. The reflector embodiment depends on a modified
fiber with an end reflector while the prism embodiment requires uninterrupted axial light
propagation-optical conditions that are fundamentally incompatible. There is no workable
design described in the Office Action that accounts for this fundamental incompatibility.
Further, there is no workable design described in the Office Action that accounts for the
positions of the interface surfaces. The possibility that these embodiments could be combined in a way described by the claim arises only because of Applicant's own specification, which
discloses a parabolic redirector capable of dual-axis folding, collimation, and collection of both
transmitted and reflected signals. Without that disclosure, there is no apparent reason or path
identified by the Office to attempt the combination. Put more simply, the incomplete rationale of the Office Action rests not on the teachings of the prior art, but on an impermissible hindsight reconstruction of Applicant's invention. Such reasoning is not sufficient to support a rejection
under 35 U.S.C. § 103. (07/28/25 Remarks, pages 16-17)
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, where a substantial redesign would need to occur to incorporate those distal components into the proximal header. Therefore, the rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claims 3 and 5-9, Applicant argues
Claims 3 and 5-9 depend directly or indirectly from claim 1. Therefore, for the reasons
set out above, the§ 103 rejections of claims 3 and 5-9 should also be withdrawn. (07/28/25 Remarks, page 17)
This argument is persuasive. The rejection of claim 1 over Wolf A in view of Kuhn was withdrawn, so the corresponding rejections of claims 3 and 5-9 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1), Chung (US 6,975,465 B1), and Johnson (US PG Pub 2019/0221997 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 10 , Applicant argues
The rejection of claim 10 under 35 U.S.C. § 103 is improper because the prior art fails to disclose, either expressly or inherently, every element of the claimed invention arranged as required by the claim. Claim 10 requires that a transmit ray be sent through both a right-angle prism and a parabolic redirector to the first optical axis, and that a reflected ray from the optical fiber likewise be received through the parabolic redirector and the prism, incident on the photoreceiver. The Office Action fails to identify any passage in Wolf A or Kuhn disclosing or suggesting the claimed single transmission path and single reception path, and instead asserts that the elements are in "optical contact" and that the surfaces of the components are "inherent." Those arguments are insufficient to support a prima facie case. (07/28/25 Remarks, page 19)
Applicant then recapitulates the arguments related to claim 1 (07/28/25 Remarks, pages 19-21).
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. There is no teaching to suggest these components could be combined along an optical pathway in the proximal stimulator. Therefore, the rejection of claim 10 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 2 , Applicant argues:
The rejection of claim 2 under 35 U.S.C. § 103 is improper because the cited references, Wolf A, Wolf B and Kuhn, separately or combined, fail to disclose or suggest the claimed configuration, and the Office Action fails to articulate a legally sufficient rationale for combining them. Claim 2 expressly requires that "the parabolic redirector incorporates a collimating lens, adjacent the first interface surface, focused on the first optical axis." This is a structural limitation that specifies the location and optical function of the collimating lens with respect to the parabolic redirector, and it is not met by the proposed combination.
First, the Office Action does not identify any structure in Wolf A that corresponds to the "first interface surface" of the parabolic redirector, nor does it show that a collimating lens is incorporated into the parabolic redirector at a location adjacent that surface. The rejection relies on composite reflector 1710 as the parabolic redirector, but fails to analyze where the claimed first interface surface would be on that structure, and fails to demonstrate how a collimating lens would be placed adjacent to it. Instead, the Office Action relies on a general statement that Wolf A discloses a convex lens at the proximal end of the optical fiber (paragraph [0181]), without establishing any structural relationship to the redirector or identifying how that convex lens could satisfy the specific spatial and functional requirements of claim 2. This omission alone precludes a prima facie case of obviousness, as the proposed combination lacks a critical claimed element arranged as required. (07/28/25 Remarks, pages 21-22)
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. There is no teaching to suggest these components could be combined along an optical pathway in the proximal stimulator. Therefore, the rejection of claim 2 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Regarding Claim 2, Applicant argues:
Second, the proposed rationale for combining Wolf A with Wolf B ignores important structural and functional limitations of the systems disclosed by those references. For example, in both of the relevant embodiments in Wolf A, whether involving the composite reflector of paragraph [0220] or the prism of paragraph [0223], these optical components are located at the distal end of the lead, far from the pulse generator housing. In contrast, the collimating lens disclosed in Wolf B is situated at the proximal end of the lead, near the pulse generator housing. 35
The Office Action makes no attempt to reconcile this fundamental problem, nor does it explain how or why a collimating lens designed for proximal-end alignment in Wolf B could be structurally or functionally incorporated into the reflector or prism located at the distal tip of the lead in Wolf A - or vice versa. The Office Action likewise fails to explain how or why to
eliminate the flexible lead between the proximal and distal ends. Indeed, doing so would require
a substantial and unexplained redesign of the reflector, the prism, or the lens, the lead, or all four. There is no teaching or suggestion in the prior art that would motivate such a redesign, and no reasoning in the Office Action that would render it obvious without relying on impermissible
hindsight. (07/28/25 Remarks, pages 21-22)
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. There is no teaching to suggest these components could be combined with a collimator along an optical pathway in the proximal stimulator. Therefore, the rejection of claim 2 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Park (US PG Pub 2013/0258469 A1) and Chung (US 6,975,465 B1), see “Claim Rejections - 35 USC § 103” section.
Summary: The 35 U.S.C. § 103 rejections of claims 1-10 are withdrawn. New 35 U.S.C. § 103 rejections of claims 1-10 newly in view of Park (US PG Pub 2013/0258469 A1), Chung (US 6,975,465 B1), and Johnson (US PG Pub 2019/0221997 A1) are added (see Claim Rejections - 35 USC § 103).
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 1-3 and 5-10 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 Park (US PG Pub 2013/0258469 A1, see “Notice of References Cited”), Chung (US 6,975,465 B1, see “Notice of References Cited”), and Johnson (US PG Pub 2019/0221997 A1, see “Notice of References Cited”).
Regarding Claim 1, Wolf A discloses an external pulse generator system ([0002]) comprising:
• a case ([0087] – nonmetallic case 507);
• a lead retainer hole, positioned in the case, having a first optical axis ([0119]);
• a light emitter ([0148]);
• a photoreceiver ([0148] – “Alternatively, an emitter and detector may be integrated into a single ASIC such as with the ADPD144RI from Analog Devices, Inc. of Norwood, Mass”); and
• a processor circuit, having a memory, operatively connected to the light emitter and the photoreceiver ([0137] – daughterboard controls both electrical and optical pathways while connected to main circuit board with multiple emitters and detectors as described in [0144-0147]; [0138] – the main circuit board is connected to processors where processors have memory as seen in [0307]).
Wolf A does not disclose:
• a parabolic redirector, having a first interface surface, perpendicular to a second interface surface, connected by a parabolic surface, focused on the first optical axis;
• a right angle prism, having a third interface surface perpendicular to a fourth interface surface connected by an angled surface, adjacent the parabolic redirector;
• the second interface surface immediately adjacent the third interface surface;
• a laser, directed toward the fourth interface surface
• a photoreceiver, surrounding the laser, positioned parallel to the fourth interface surface;
Park, in the same field of endeavor of optical coupling between a laser source and an optical fiber ([0003], [0005]), teaches two right angle prism are used to direct light from an entering beam in one axis to an exiting beam along another axis ([0047] – “In this example, the functional aspects of the "cube" 305 and first right angle prism 310 are a single component 405, and the second right angle prism 315 is a second component 410. A beam with spatial beam profile 415 entering component 405 is reflected, via TIR, off a back surface 417 (first reflecting surface) of the component 405. The reflected beam then is then reflected, via TIR, a second time off the hypotenuse 419 (second reflecting surface) of the component 410 before exiting the prism 400, at an exit plane 420, along the negative Z direction with a spatial beam profile 425. The spatial beam profile 425 of the beam is rotated 90 degrees with respect to the spatial beam profile 415. In alternate, embodiments, the component 410 may be rotated such that the beam exits the prism, via the exit plane 420, along the positive Z direction, or some other direction”), where the two right angle prisms are attached along adjacent surfaces of the prisms allow entering and exiting of the beam (Fig. 4).
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 prism redirectors in Park. This would have been obvious because both Wolf A and Park discuss optical coupling between a laser source and an optical fiber and Park provides a solution/improvement for allowing a laser and optical fiber in different axes to be optically coupled, thereby providing greater flexibility with the positioning of the emitter within Wolf A’s case. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the prism redirectors in Park.
Chung, in the same field of endeavor of optical coupling between a laser source and a distal component (col 1, lines 43-61), teaches control prisms can have a variety of curved shapes (col 1, lines 55-61 – reduces aberrations in the light beam; and col 6, lines 42-66), such as the parabolic shape in the curved prism displayed in Fig. 5.
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, thereby providing flexibility with the positioning of the emitter within Wolf A’s case. The parabolic curve shape can reduce aberrations and collimate light 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/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”; Fig. 7, [0047-0049]).
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 photodiode as a photodetector in Johnson. This would have been obvious because both Wolf A and Johnson discuss 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 photodiode as a photodetector in Johnson.
Therefore, Claim 1 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 2, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 1, as indicated hereinabove. Wolf A does not teach a parabolic redirector focused on the first optical axis. Regarding the redirector prisms in Park and the teaching that redirectors can come in a variety of surface shapes (such as parabolic curves)as established in Chung, Park further teaches the redirector incorporates a collimating lens, adjacent the first interface surface, focused on the first optical axis (Fig. 1, [0032] – collimators focus light at both ends of the redirector, corresponding to input collimators 115a-115d and output collimator 125).
Therefore, Claim 2 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 3, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 1, as indicated hereinabove. Wolf A does not disclose wherein the laser is fixed on the photoreceiver by a transmission window. 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”).
Therefore, Claim 3 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 5, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 1, as indicated hereinabove. Wolf A does not teach a parabolic redirector focused on the first optical axis. Regarding the redirector prisms in Park and the teaching that redirectors can come in a variety of surface shapes (such as parabolic curves) as established in Chung, Park further teaches redirector prisms have a first reflective coating ([0043] – “Additionally or alternatively, in some embodiments, the surfaces may be coated with materials to maximize reflection of the beam”).
Therefore, Claim 5 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 6, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 5, as indicated hereinabove. Wolf A does not teach a right-angled prism focused on the first optical axis. Regarding the redirector prisms in Park, Park further teaches the angled surface has a second reflective coating ([0043] – “Additionally or alternatively, in some embodiments, the surfaces may be coated with materials to maximize reflection of the beam”).
Therefore, Claim 6 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 7, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 1, as indicated hereinabove. Wolf A further discloses comprising:
• a percutaneous lead, fixed in the lead retainer hole ([0119] – threaded hole in header for accepting lead), having a second optical axis coaxial with the first optical axis ([0165] - dual optical reflectometry channels in the lead);
• an optical fiber, axially positioned along the second optical axis, integrally formed in the percutaneous lead (Figure 13E, [0182-0183] – optical fiber assembly containing optical fiber formed in the percutaneous lead);
• a set of electrical contacts, proximally fixed on an exterior surface of the percutaneous lead ([0170] – electrical contacts on the proximal exterior surface of the lead), electrically connected to the processor circuit ([0144] – the processor controls the electrical signal which travels through the contacts); and
• a set of stimulation electrodes, distally fixed on the exterior surface of the percutaneous lead ([0171] – distal stimulation electrodes), electrically connected to the set of electrical contacts, by a set of flexible conductors (conductors positioned across the length of a lead in [0172], which is described as flexible in [0168], meaning the conductors must be flexible to move with the lead), integrally formed in the percutaneous lead ([0171] – distal stimulation electrodes, as part of the percutaneous leads, are connected to the lead contacts on the distal end).
Regarding Claim 8, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 7, as indicated hereinabove. Wolf A further discloses wherein the percutaneous lead further comprises: a stylet lumen, disposed adjacent and parallel to the optical fiber (Figure 13E, [0182] – the stylet channel 1405 receives the optical fiber subassembly 1419: “optical fiber subassembly 1419 is positioned in stylet channel 1405. The outer diameter of ferrule 1412 is less than the outer diameter of lead body 1402 but greater than the diameter of stylet channel 1405, such that the lead body acts as a stop for the ferrule”). The optical fiber 1418 is positioned in the optical fiber subassembly 1419 so as to be adjacent and parallel (in the same longitudinal direction) to the stylet channel 1405 (Figures 13D and 13F, [0176, 0178]).
Therefore, Claim 8 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 9, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 8, as indicated hereinabove. Wolf A further discloses wherein the percutaneous lead further comprises: a transparent optical transmission tip optically fused with the optical fiber ([0181] – polished optical tip placed at the end of the optical fiber with a convex lens to transmit light into and out of the optical fiber).
Therefore, Claim 9 is obvious over Wolf A in view of Park, Chung, and Johnson.
Regarding Claim 10, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 9, as indicated hereinabove. Wolf A further discloses further comprising: a set of instructions, resident in the memory ([0144] – “Processor 1208 draws power from the battery and is supplied with an onboard memory that contains instructions for its operation”), that when executed cause the external pulse generator system to:
• generate a transmit ray from the emitter ([0148]);
• send the transmit ray to the first optical axis ([0119]);
• receive a reflected ray from the optical fiber incident on the photoreceiver ([0149]);
• generate a variation variable based on the reflected ray ([0151] – “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”, [0137] – main circuit board receives light signals back from the spine);
• generate an electrical stimulation signal, modulated by the variation variable ([0137] – electrical signal generated by main circuit board via signals interpreted by the light detectors); and
• send the electrical stimulation signal to the set of electrical contacts ([0136] – the main circuit board is connected to the electrical leads via the contacts) to create a modulated electrical field at the set of stimulation electrodes ([0137] – these electrical signals are translated into stimulation signals).
Wolf A does not disclose (1) a parabolic redirector and a right-angle prism interfacing together to pass light to the first optical axis and (2) a laser emitter.
Park, in the same field of endeavor of optical coupling between a laser source and an optical fiber ([0003], [0005]), teaches two right angle prism are used to direct light from an entering beam in one axis to an exiting beam along another axis ([0047]), where the two right angle prisms are attached along adjacent surfaces of the prisms allow entering and exiting of the laser beam (Fig. 4, [0006] – laser diodes).
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 prism redirectors in Park. This would have been obvious because both Wolf A and Park discuss optical coupling between a laser source and an optical fiber and Park provides a solution/improvement for allowing a laser and optical fiber in different axes to be optically coupled, thereby providing greater flexibility with the positioning of the emitter within Wolf A’s case. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wolf A by incorporating the prism redirectors in Park.
Chung, in the same field of endeavor of optical coupling between a laser source and a distal component (col 1, lines 43-61), teaches control prisms can have a variety of curved shapes (col 1, lines 55-61 – reduces aberrations in the light beam; and col 6, lines 42-66), such as the parabolic shape in the curved prism displayed in Fig. 5.
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, thereby providing flexibility with the positioning of the emitter within Wolf A’s case. The parabolic curve shape can reduce aberrations and collimate light 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 10 is obvious over Wolf A in view of Park, Chung, and Johnson.
Claim 4 is 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 Park (US PG Pub 2013/0258469 A1, see “Notice of References Cited”), Chung (US 6,975,465 B1, see “Notice of References Cited”), Johnson (US PG Pub 2019/0221997 A1, see “Notice of References Cited”), and Fayram (US PG Pub 2018/0085593 A1, see IDS filed on 06/29/2023).
Regarding Claim 4, the external pulse generator system is obvious over Wolf A in view of Park, Chung, and Johnson according to Claim 3, as indicated hereinabove. Wolf A discloses the emitter on the daughterboard is electrically connected to the processor circuit ([0135]). Wolf A does not disclose wherein the laser is electrically connected to the processor circuit by a metallic trace on the transmission window.
The laser as an emitter is taught by Johnson, as previously explained in Claim 1. Regarding the transmission window in Johnson, as previously explained in claim 3, Johnson further teaches a powering arrangement for the VCSEL’s ([0044] – “A VCSEL package may facilitate the electrical and optical interfaces to a chip. VCSELs are diodes and hence may have a contact to the anode and a contact to the cathode to operate. Since the substrate of the VCSEL is often conducting, this may be accomplished by attaching the VCSEL into the package using a conductive epoxy or solder between the VCSEL substrate and the package. The other contact can be formed by a wire bond to the metal bond pad areas on the top side of the chip”).
Fayram, in the same field of endeavor of optical sensing and reflectometry ([0017]), teaches an optical source and detector connected to a controller ([0018]), where the circuit elements are connected with a metallic trace ([0453] – “Control hardware can include electronics components (passive components (e.g., diodes, transistors, resistors, capacitors, inductors, or the like), discrete integrated circuits, logic components (e.g., logic gates, multiplexers, or the like), application specific integrated circuits (ASICs) as well as metallic traces which connect signal and power pads for each of the components”). The transmission window could be used as a conduit to connect circuit elements near the transmission window using a metallic trace (where the metallic trace would be useful due to size constraints of wiring and removing wiring which could block optical signals).
It would have been obvious to one having 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 a material made of a trace metal to connect the emitter and processor in Fayram. This would have been obvious because both Wolf A and Fayram discuss optical sensing/reflectometry and Fayram provides a solution/improvement by using a metallic trace to connect circuit elements so as not to block optical elements with wire connections. Therefore, one of ordinary skill would be motivated to improve the system of Wolf A by incorporating a material made of a trace metal to connect the emitter and processor in Fayram.
Therefore, Claim 4 is obvious over Wolf A in view of Park, Chung, Johnson, and Fayram.
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
Prosecution Insights