DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claims 1-2 and 4-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 9-16, 18 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinberg (US 5,856,915).
As to claim 1, Weinberg discloses modular implant device configured for stimulation of at least one nerve or muscle in a body of a subject (col. 2, lines 8-13) comprising: a housing (cover, depicted as 56 in Figure 4-6; col. 4, lines 30-41); and at least one electrical lead and/or at least one stimulation electrode (wire bond, depicted as 62 in Figure 5 and 98 in Figure 6; col. 5, lines 11-30); wherein the at least one electrical lead is partly attached to the housing (Figures 5-6; col. 5, lines 11-30), the housing comprises at least two modular elements (substrate, depicted as 30 in Figure 2 and substrate, depicted as 40 in Figure 2), the modular elements being arranged in a stack (Figures 2-6), each modular element comprises a frame (col. 3, lines 11-47; Figures 2 and 4-6) and the frames of the modular elements are stacked on top of one another (col. 3, lines 11-47; Figures 2 and 4-6).
As to claim 2, Weinberg discloses the stack comprises at least two modular elements which are hermetically sealed and attached to each other (Figures 1 and 4; col. 2, lines 30-47).
As to claim 4, Weinberg discloses the frame of each modular element is four sided, and each side has a width (Figures 2-6).
As to claim 6, Weinberg discloses at least one modular element is a strain relief module (slot, depicted as 60 in Figures 3 and 5-6; col. 3, lines 48- col. 4, line 30), the strain relief module comprises a cavity enclosed by the frame (Figures 3 and 5-6; col. 3, lines 48- col. 4, line 30) and wherein the frame is configured as a strain relief ring (examiner considers the slot, depicted as 60 in Figure 3, to be a “ring”; “Although the substrate 40 is shown with a single rectangular slot 60, it can be appreciated that various aperture shapes and sizes positioned at various locations of the substrate 40 can be used to achieve multi-level connectivity. The size and number of particular slots used for connectivity purposes will be dictated by particular design constraints of the entire module 12” (col. 4, lines 22-30)).
As to claim 7, Weinberg discloses the cavity is backfilled with an insulating material (col. 3, lines 42-47).
As to claim 9, Weinberg et al. discloses the at least one electrical lead comprises an electrical contact tip on at least one of its ends (contacts, depicted as 64 and 66 in Figure 5 and 104 and 106 in Figure 6; col. 5, lines 11-30).
As to claim 10, Weinberg discloses at least one modular element is a strain relief module (slot, depicted as 60 in Figures 3 and 5-6; col. 3, lines 48- col. 4, line 30), the strain relief module comprises a cavity enclosed by the frame and the frame is configured as a strain relief ring (examiner considers the slot, depicted as 60 in Figure 3, to be a “ring”; “Although the substrate 40 is shown with a single rectangular slot 60, it can be appreciated that various aperture shapes and sizes positioned at various locations of the substrate 40 can be used to achieve multi-level connectivity. The size and number of particular slots used for connectivity purposes will be dictated by particular design constraints of the entire module 12” (col. 4, lines 22-30), and the electrical contact tip is disposed on the housing (Figures 5-6; col. 5, lines 11-30), wherein the electrical contact tip is in particular disposed in the cavity of one of the strain relief module (Figures 5-6; col. 5, lines 11-30).
As to claim 11, Weinberg discloses the frame has four sides (Figures 2-6) and the electrical lead passes through a lead exit disposed in one of the sides of the strain relief ring of the strain relief module (Figures 5-6; col. 5, lines 11-30).
As to claim 12, Weinberg discloses the width of a side of the strain relief ring having a lead exit is bigger than the width of a side of the frame having no lead exit (Figures 3 and 5-6).
As to claim 13, Weinberg. discloses the electrical lead forms a double bend when passing through the lead exit of the strain relief ring (Figures 5-6).
As to claim 14, Weinberg discloses at least one of the electrical leads is a connection lead configured for electrically connecting the modular device to another electrical device (wire bond, depicted as 62 in Figure 5 and 98 in Figure 6; col. 5, lines 11-30; Figures 5-6).
As to claim 15, Weinberg discloses pacing leads connected to the head of the pacemaker in Figure 1. As such, Weinberg discloses “at least one stimulation electrode” (via the medical lead in Figure 1) “is disposed on an outer surface of a housing side” (via the header of the pacemaker in Figure 1) of the modular device” (see Figure 1).
As to claim 16, Weinberg discloses a plurality of stimulation electrodes (at least two via the two medical leads in Figure 1).
As to claim 18, Weinberg discloses at least one modular element is a circuit module, wherein the circuit module comprises a circuit board enclosed by the frame (Abstract; Figures 2-6).
As to claim 21, Weinberg discloses the circuit board comprises at least one electrical contact (contacts, depicted as 64 and 66 in Figure 5 and 104 and 106 in Figure 6; col. 5, lines 11-30).
As to claim 22, Weinberg discloses at least one modular element is a strain relief module (slot, depicted as 60 in Figures 3 and 5-6; col. 3, lines 48- col. 4, line 30), the strain relief module comprises a cavity enclosed by the frame and the frame is configured as a strain relief ring (examiner considers the slot, depicted as 60 in Figure 3, to be a “ring”; “Although the substrate 40 is shown with a single rectangular slot 60, it can be appreciated that various aperture shapes and sizes positioned at various locations of the substrate 40 can be used to achieve multi-level connectivity. The size and number of particular slots used for connectivity purposes will be dictated by particular design constraints of the entire module 12” (col. 4, lines 22-30), the at least one electrical lead (wire bond, depicted as 62 in Figure 5 and 98 in Figure 6; col. 5, lines 11-30) comprises an electrical contact tip on at least one of its ends (contacts, depicted 66 in Figure 5 and 106 in Figure 6; col. 5, lines 11-30), and the at least one feedthrough (depicted as 64 in Figures 3 and 5) each circuit module is configured for electrical connection with the electrical contact tip of at least one electrical lead disposed in the cavity of the strain relief module stacked just over or just beneath said circuit module (Figures 3-6).
As to claim 23, Weinberg. discloses a network of at least two modular devices (Figures 2-6) configured for implantation inside a body of a subject (Figure 1; col. 2, lines 8-13) wherein each modular device is electrically connected to at least one other modular device through electrical leads (wire bond, depicted as 62 in Figure 5 and 98 in Figure 6; col. 5, lines 11-30), and wherein each of the at least two module devices comprises a housing (cover, depicted as 56 in Figure 4-6; col. 4, lines 30-41); and at least one electrical lead, and/or at least one stimulation electrode (wire bond, depicted as 62 in Figure 5 and 98 in Figure 6; col. 5, lines 11-30); and wherein the at least one electrical lead is partly attached to the housing (Figures 5-6; col. 5, lines 11-30), the housing comprises at least two modular elements (substrate, depicted as 30 in Figure 2 and substrate, depicted as 40 in Figure 2), the modular elements being arranged in a stack (Figures 2-6), each modular element comprises a frame (col. 3, lines 11-47; Figures 2 and 4-6) and the frames of the modular elements are stacked on top of one another (col. 3, lines 11-47; Figures 2 and 4-6).
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:
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.
Claims 5, 8, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg (US 5,856,915).
As to claim 5, Weinberg discloses the substrate frame materials does not explicitly disclose the employment of titanium in the frame. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the materials of the frame to “at least partly made from a material comprising titanium” in order to provide the predictable results of such a modification would provide the predictable results adding additional support to the otherwise insulative structure. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416 (See MPEP 2144.07). As such, modifying the material(s) employed in the frame would have the predictable results of optimizing cost and performance of the medical device.
As to claim 8, Weinberg the invention substantially as claimed but does not explicitly disclose employing silicone as the insulating material. Silicone is an extremely well-known insulating material in electronics and electrical stimulation art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the insulating material for silicone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416 (See MPEP 2144.07). Furthermore, such a modification would provide the predictable results of modifying the device construction to optimize cost and performance.
As to claim 17, Weinberg discloses the device substantially as claimed with a plurality of stimulation electrodes (at least 2 electrodes, one per lead for the two medical leads in Figure 1) but does not explicitly disclose a plurality of stimulation electrodes arranged in an array. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the medical leads and/or stimulation electrodes of Weinberg to be an array formation is electrode arrays, such as paddle leads, are extremely well known in the electrical stimulation art. Furthermore, employing an electrode array would provide the predictable results of optimizing the stimulation area and electrode formation to meet specific patient therapeutic needs and requirements.
As to claim 19, Weinberg discloses the device substantially as claimed with a circuit board and fame but does not explicitly brazed the circuit board to frame. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the adhesive means of Weinberg to include brazening since brazing and soldering (col. 1, lines 48-58) are extremely well-known processes for attaching electrical components in the electronic art and electrical stimulation art. Furthermore, modifying Weinberg to brazen the circuit board to the frame would provide the predictable results of optimizing the construction and manufacturing.
As to claim 20, Weinberg discloses the invention substantially as claimed with a circuit board comprising ceramic material, but does not explicitly disclose the circuit board is printed. Printed circuit boards are extremely well known in electronics. As such, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the circuit board construction of Weinberg to be printed in order to provide the predictable results of modifying manufacturing and construction to optimize cost and performance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796