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 § 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.
1. Claim 5 is 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.
In regards to claim 5, “the conductive members” lack antecedent basis since they have yet to be claimed. It appears this claim was meant to depend from claim 4 rather than claim 1. Correction is needed.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2. Claim(s) 1-4, 7-9, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rawat (US 20110134013 A1)
In regards to claim 1, Rawat discloses an implantable medical device (Abstract), comprising:
an electronics housing; circuitry within the electronics housing (Par. 0028 discloses electronic circuitry that has a metallic shielded compartment, i.e, housing); and
a header assembly secured to the electronics housing (Fig 1A-1D show the electronics hosuing [150] connected to a header [100A]) and including
a hollow header body defining an internal volume, a header assembly connector located within the internal volume, operably connected to the circuitry, defining an interior configured to receive a lead connector and an exterior (Fig 5 shows the header [500] having a hollow opening filled with the connector elements [560] that has electric lead connector pins see also Par. 0054),
a hard fill within the internal volume (Par. 0055 discloses a bore within the header is filled with silicone, i.e. a hard fill), and
a seal between the exterior of the header assembly connector and the hard fill (Par. 0044 teaches there is an encapsulating material on the exterior of the header).
In regards to claim 2, Rawat discloses the implantable medical device claimed in claim 1, wherein the electronics housing includes a container and a cover (Par. 0028 discloses electronic circuitry that has a metallic shielded compartment); and
the header assembly connector is connected to the circuitry within the electronics housing by a plurality of feedthrough leads that extend through the cover (Fig 5 shows the header having the connector elements [555] with electric lead connectors [550], see also Par. 0054).
In regards to claim 3, Rawat discloses the implantable medical device claimed in claim 1, wherein the circuitry comprises stimulation circuitry (Par. 0028 discloses stimulation circuitry).
In regards to claim 4, Rawat discloses the implantable medical device claimed in claim 1, wherein, the header assembly connector includes a plurality of conductive members and a plurality of non-conductive members (Par. 0035 teaches there being a plurality of conductive and non-conductive members/materials).
In regards to claim 7, Rawat discloses the implantable medical device claimed in claim 1, wherein the hollow header body is formed from a polymer (Par. 0043 teaches the header being a polymer).
In regards to claim 8, Rawat discloses the implantable medical device claimed in claim 1, wherein the header assembly include a connector block located within the header body; and the header assembly connector is mounted on the connector block (Par. 0054 and Fig 5 show the connector block [555] sitting on the header assembly connector [560]).
In regards to claim 9, Rawat discloses the implantable medical device claimed in claim 1, wherein the seal is formed from seal material; and the hard fill is formed from hard fill material that is different than the seal material (Par. 0055 teaches the fill being silicone and Par. 0044 teaches the encapsulating seal can be silicone or it can be any other suitable material, i.e. different)
In regards to claim 13, Rawat discloses the implantable medical device claimed in claim 1, further comprising: an electrode lead including an elongate lead body having a proximal end
and a distal end, a plurality of electrically conductive contacts associated with the distal
end of the lead body (Par. 0060 teaches there being more than one electrode terminal and electrode leads), and a lead connector associated with proximal end of the lead body and having a non-conductive member and a plurality of spaced electrically conductive contacts on the non-conductive member (Par. 0035).
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.
3. Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rawat in view of Sjostedt (US 20080246231 A1).
In regards to claim 5 and 6, Rawat discloses the implantable medical device claimed in claim 1, except for wherein the conductive members include an annular main body and an annular coil spring, wherein adjacent conductive members and non-conductive members are secured to one another with an interference fit.
However, in the same field of endeavor, Sjostedt discloses a connector assembly for implantable medical devices (Abstract) wherein the connector contains a conductive body and spring elements (Par. 0041) and wherein there is an interference fit with the springs (Par. 0043) in order to pass electrical signals as well as facilitate assembly of the various components (Par. 0041-0043).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rawat and modified them by having the device comprise a body, springs, and an interference fit, as taught and suggested by Sjostedt, in order to pass electrical signals as well as facilitate assembly of the various components (Par. 0041-0043 of Sjostedt)
4. Claim(s) 10-12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rawat in view of Tidemand (US 20040122481 A1)
In regards to claims 10-12, Rawat discloses the implantable medical device claimed in claim 9, except for wherein the seal material defines a liquid state viscosity; and the hard fill material defines a liquid state viscosity that is less than the seal material liquid state viscosity, wherein the seal material defines a cured state modulus; and the hard fill material defines a cured state modulus that is greater than the seal material cured state modulus, wherein the hard fill material comprises epoxy; and the seal material comprises silicone adhesive.
However, in the same field of endeavor, Tidemand teaches a header connector for implantable medical devices (Abstract) wherein there is a liquid fill material for the header which is made of epoxy (Par. 0018-0019) and wherein there is a silicone adhesion, i.e. seal (Par. 0019 – since the seal and the fill is made of the same materials as the applicants, it would meet the claim limitations about the viscosity and cured modulus), in order to maintain a rigid and stable body (Par. 0019).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rawat and modified them by having the header filled with liquid epoxy and the seal made of silicone, as taught and suggested by Tidemand, in order to maintain a rigid and stable body (Par. 0019 of Tidemand).
In regards to claim 15, Rawat discloses a method, comprising the steps of:
sealing the exterior of a header assembly connector that includes a plurality of conductive members and a plurality of non-conductive members (Par. 0044 teaches there is an encapsulating material such as silicone to seal the exterior of the header ;
positioning the header assembly connector with the sealed exterior within an interior volume of an implantable medical device header body (Fig 1 shows the header assembly [100A] connected to/placed on an implantable medical device, see also Par. 0035) and
While Rawat teaches there being a fill material in the header (see Par. 0055), they do not explicitly teach there being a liquid state fill material being transferred into the header body. However, in the same field of endeavor, Tidemand teaches a header connector for implantable medical devices (Abstract) wherein the header is filled with liquid epoxy (Par. 0018-0019) in order to maintain a rigid and stable body (Par. 0019).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rawat and modified them by having the header filled with liquid epoxy, as taught and suggested by Tidemand, in order to maintain a rigid and stable body (Par. 0019 of Tidemand).
In regards to claim 16, the combined teachings of Rawat and Tidemand as applied to claim 15 discloses the method of claim 15, further comprising the step of: securing leads to the connector prior to applying the seal (Par. 0043 of Rawat).
In regards to claims 17-20, the combined teachings of Rawat and Tidemand as applied to claim 15 discloses the method of claim 15, wherein the hard fill material comprises epoxy (Par. 0018-0019 of Tidemand, see claim 15 rejection). The combination as applied to claim 15 does not disclose wherein sealing comprises applying seal material, which is different than the hard fill material, to the exterior of the header assembly connector and allowing the seal material to cure, wherein the seal material defines a liquid state viscosity; and the hard fill material defines a liquid state viscosity that is less than the seal material liquid state viscosity, wherein the seal material defines a cured state modulus; and the hard fill material defines a cured state modulus that is greater than the seal material cured state modulus; and the seal material comprises silicone adhesive.
However, Tidemand does go on to disclose wherein there is a silicone adhesion, i.e. seal (Par. 0019 – since the seal and the fill is made of the same materials as the applicants, it would meet the claim limitations about the viscosity and cured modulus), in order to maintain a rigid and stable body (Par. 0019).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rawat and Tidemand and modified them by having the header filled with liquid epoxy and the seal made of silicone, as taught and suggested by Tidemand, in order to maintain a rigid and stable body (Par. 0019 of Tidemand).
5. Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rawat in view of McCabe (US 20080021504 A1).
In regards to claim 14, Rawat discloses the implantable medical device claimed in claim 13, except for wherein the electrode lead includes a nerve cuff and the electrically conductive contacts are part of the nerve cuff.
However, in the same field of endeavor, McCabe teaches an IMD with a header connector assembly (Par. 0060-0062) wherein there are leads extending from the header that can be connected to a nerve cuff (Fig 17 and Par. 0092) in order to stimulate the targeted nerve (Par. 0092).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rawat and modified them by having the leads connect to a nerve cuff, as taught and suggested by McCabe, in order to stimulate the targeted nerve (Par. 0092 of McCabe).
Conclusion
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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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