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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8, 12-13, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170225007 A1 to Orinski in view of US 20110295347 A1 to Wells et al (hereinafter “Wells”).
Regarding claim 1. Orinski discloses an optical stimulation lead (abstract, para 0005 “optical stimulation lead”), comprising: a lead body comprising a distal end, a distal portion, and a proximal portion (para 0005); and an optical assembly attached to the distal end of the lead body (para 0005 “an optical assembly attached to the distal end of the lead body”), wherein the optical assembly comprises: a metal enclosure (para 0005, fig 3, metal tube 470); a light emitter (para 0005 “a light emitter “) disposed within the metal enclosure (fig. 3, para 0051, para 0055, etc.); an electrical feedthrough pin electrically coupled to the light emitter (para 0005 “at least one feedthrough pin”); a first substrate disposed within the metal enclosure and coupled to the light emitter (para 0055 “insulator disc 569”); and an emitter cover disposed opposite the lead body and configured to transmit light from the light emitter, wherein the emitter cover is coupled to the metal enclosure (para 0005 “emitter cover disposed over the light emitter and coupled to the metal tube”). Orinski fails to disclose wherein the first substrate comprises aluminum nitride, wherein the first substrate is arranged within the metal enclosure with the aluminum nitride in a thermal conductive path that conducts heat from the light emitter to the metal enclosure.
Wells, from a similar field of endeavor, teaches the housing to include a layer of very high thermal conductive material (such as aluminum nitride) that readily absorbs short heat spikes (para 0121). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Orinski with the teachings of Wells to provide the predictable result of reducing heat.
Regarding claim 2. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the metal enclosure comprises titanium (para 0034, 0048, 0050, 0056-0057 “titanium”).
Regarding claim 3. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the light emitter comprises a laser diode (para 0045).
Regarding claim 4. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the optical assembly forms a hermetically sealed housing for the light emitter (para 0052).
Regarding claim 5. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, further comprising a plurality of terminals disposed along the proximal portion of the lead body (para 0042) and a plurality of conductors extending along the lead body (para 0037), wherein at least one of the conductors of the plurality of conductors electrically couples the electrical feedthrough pin to at least one of the terminals of the plurality of terminals of the lead (para 0005, 0042-0043, etc.).
Regarding claim 6. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the emitter cover comprises at least one of an optical diffuser or a lens (para 0047).
Regarding claim 8. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the optical assembly further comprises a second substrate different from the first substrate, wherein the light emitter is attached to the second substrate and the second substrate is disposed between the first substrate and the light emitter (para 0055 “connector plate 567”; the claim does not provide any details regarding what the second substrate is. Under its BRI, any component provided between the LED and the first substrate would read over the claimed imitation).
Regarding claim 12. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the optical assembly further comprises: a non-conductive block, wherein the feedthrough pin extends through the non-conductive block; and a metal base disposed around the non-conductive block (para 0037; para 0048 “Ceramic block” – ceramic is non-conductive).
Regarding claim 13. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 12, wherein the first substrate is in contact with the metal base (para 0037; para 0048 “Ceramic block”, fig. 3B).
Regarding claim 16. Orinski as modified by Wells renders obvious the optical stimulation system, comprising: the optical stimulation lead of claim 1; and a control module coupleable to the optical stimulation lead (para 0011), the control module comprising a housing (para 0011), and an electronic subassembly disposed in the housing and configured and arranged to provide electrical signals to the light emitter of the optical stimulation lead (para 0011).
Regarding claim 17. Orinski as modified by Wells renders obvious the optical stimulation system of claim 16, wherein the optical stimulation lead further comprises a plurality of terminals disposed along the proximal portion of the lead body (para 0036), the optical stimulation system further comprising a connector for receiving the proximal portion of the lead body (para 0036), the connector having a proximal end, a distal end, and a longitudinal length (para 0036), the connector comprising: a connector housing defining a port at the distal end of the connector (para 0039, 0042), the port configured and arranged for receiving the proximal portion of the lead body of the optical stimulation lead, and a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminals disposed along the proximal portion of the lead body of the optical stimulation lead (para 0042).
Regarding claim 18. Orinski as modified by Wells renders obvious the electrical stimulation system of claim 17, wherein the connector is part of the control module (para 0039, 0042).
Regarding claim 19. Orinski as modified by Wells renders obvious the electrical stimulation system of claim 17, further comprising a lead extension coupleable to both the electrical stimulation lead and the control module, wherein the connector is part of the lead extension (para 0036, 0038, 0041-0042, etc.).
Regarding claim 20. Orinski as modified by Wells renders obvious a method of stimulating patient tissue, the method comprising: implanting the optical stimulation lead of claim 1 into the patient tissue; and emitting light from the light emitter of the optical stimulation lead to stimulate the patient tissue (para 0014).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orinski as modified by Wells as applied to claims 1-6, 8, 12-13, 16-20 above, and further in view of US 20170000419 A1 to Schouenborg.
Regarding claim 7. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, but fails to disclose wherein the optical assembly further comprises a non-permeable gel disposed within the metal enclosure
Schouenborg from a similar field of endeavor teaches providing a transparent gel filling the space provided in the light emitting device (abstract, para 0020, 0025, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Orinski as modified by Wells with the teachings of Schouenborg to provide the predictable result of filling the space in the device to increase stiffness (para 0048).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orinski as modified by Wells as applied to claims 1-6, 8, 12-13, 16-20 above, and further in view of US 20080065181 to Stevenson.
Regarding claim 9. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, but fails to disclose wherein the optical assembly further comprises a getter disposed within the metal enclosure, wherein the getter comprises a desiccant.
Stevenson from a similar field of endeavor shows that it is known to provide a desiccant, known as a moisture getter, to be disposed within a housing to provide a biocompatible and hermetically sealed container (para 0016, 0081). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Orinski as modified by Wells with the teachings of Stevenson to provide the predictable result of a biocompatible and hermetically sealed container.
Regarding claim 10. Orinski as modified by Wells and Stevenson renders obvious the optical stimulation lead of claim 9, wherein the first substrate is disposed between the light emitter and the getter (see rejection of claim 9; rearrangement of parts, without any evidence of criticality is being held to be an obvious matter of design choice. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Regarding claim 11. Orinski as modified by Wells and Stevenson renders obvious the optical stimulation lead of claim 9, wherein the getter is disposed on the metal enclosure around the light emitter (see rejection of claim 9; rearrangement of parts, without any evidence of criticality is being held to be an obvious matter of design choice. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orinski as modified by Wells as applied to claims 1-6, 8, 12-13, 16-20 above, and further in view of US 20150005680 to Lipani.
Regarding claim 14. Orinski as modified by Wells renders obvious the optical stimulation lead of claim 1, wherein the optical assembly further comprises an adhesive (para 0048-0051), wherein the first substrate is disposed between the light emitter and the adhesive (para 0048-0051) but fails to disclose where the adhesive comprises boron nitride.
Lipani from a similar field of endeavor shows that it is known using boron nitride because it is a good thermal conductive (para 0159). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Orinski as modified by Wells with the known teachings of Lipani to provide the predictable result of increasing heat conductivity.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orinski as modified by Wells and Lipani as applied to claim 14 above, and further in view of US Stevenson (US 20080065181).
Regarding claim 15. Orinski as modified by Wells and Lipani renders obvious the optical stimulation lead of claim 14, but fails to disclose wherein the optical assembly further comprises a getter disposed within the metal enclosure, wherein the getter comprises a desiccant, the first substrate is disposed between the light emitter and the getter, and the getter at least partially surrounds the adhesive.
Stevenson from a similar field of endeavor shows that it is known to provide a desiccant, known as a moisture getter, to be disposed within a housing to provide a biocompatible and hermetically sealed container (para 0016, 0081). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Orinski as modified by Wells with the teachings of Stevenson to provide the predictable result of a biocompatible and hermetically sealed container.
It is noted that rearrangement of parts, without any evidence of criticality is being held to be an obvious matter of design choice. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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