DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 102
3. 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.
4. Claims 1, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee U.S. 6,496,715 (herein referred to as “Lee”).
5. Regarding Claim 1, Lee teaches an implantable device (Figs. 4a-4c), comprising:
a. a tubular body (Fig. 4c, ref num 40) with at least one open end that defines an inner space (Fig. 4b, see inner space within ref num 40);
b. a cap closing the at least one open end and having an inner surface on one side and an outer surface on the other side, the inner surface facing the inner space (Fig. 4a, ref num 44 has an outer surface and an inner surface); and
c. a circuit board disposed in the inner space along an axial direction passing from the at least one open end to another end (Figs. 4a and 4b, ref num 41), and having an active surface along the axial direction (see Fig. 4a, ref num 41 has active surface as shown), a board electrode disposed on the active surface (Fig. 4a, ref num 46), and a wireless communication circuit configured to communicate biological information obtained via the board electrode (Fig. 4a, ref num 45; Col. 7, lines 37-44, “An integrated circuit 46 houses circuitry and intelligence required for the function and the memory M is packaged on the other side of the circuit board. In this preferred form, the invention uses a communications circuit 45 having a telemetry antenna both to indicate from outside the body that a read out is requested of the device, and for communicating data out from said device”; Col. 2, lines 19-22, “Monitoring can be done using implantable pulse generators such as pacemakers and other heart stimulating devices or devices with leads in the heart for capturing physiologic parameters, including the ECG”);
d. wherein a protrusion is disposed on the inner surface of the cap (Figs. 4a and 4b, ref num 42 is a protrusion Col. 7, lines 33-35, “The metal electrode 42 is connected via a feedthrough 43 which is itself electrically connected to the circuit board 41”) and contacts the active surface (Col. 7, lines 33-35);
e. wherein an inner electrode is disposed on the protrusion (Fig. 4a, ref num 42 is the protrusion at which the electrode is disposed on) and is electrically connected to the board electrode (Col. 7, lines 25-52), wherein an outer electrode is disposed on the outer surface of the cap and is electrically connected to the inner electrode (Figs. 4a-4c, ref num 49 is provided over the entirety of ref num 40 which is electrically connected to ref num 42),
f. wherein the implantable device further comprises a connection member that connects the inner electrode and the board electrode (Fig. 4A, ref num 43; Col. 7, lines 33-35),
g. wherein the protrusion has on one side a first surface contacting the active surface and on another side a second surface facing a direction that intersects the axial direction (Figs. 4a-4c, ref num 43 first side is the side connected with ref num 41 and second side is connected to ref num 42, i.e., the electrode), and
h. wherein the inner electrode is disposed on the second surface of the protrusion (see Fig. 4A, ref num 42 is on the second surface of ref num 43), and the connection member is electrically conductive (Col. 7, lines 33-35 describe the electrical connection of ref num 43, i.e., being electrically conductive).
6. Regarding Claim 10, Lee teaches the outer electrode has a larger surface area than the inner electrode (Figs. 4a-4c, ref num 49 is provided over the entirety of ref num 40, which would have a larger surface area than ref num 42).
7. Regarding Claim 11, Lee teaches the cap comprises a ceramic material and a metal material (Col. 7, lines 27-28, “an outer titanium shell 40, in a plastic cap means 44, which together form the exterior of the device”; Col. 9, lines 25-30, “One can construct the device 50 as a solid container having out of body compatible materials. For examples, titanium or other metal or alloy, coated with compatible insulator but exposed for at electrode areas or fitted with conductive electrodes, ceramic having conductive areas thereon”).
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee.
10. Regarding Claim 2, Lee fails to teach the cap has an outer diameter that is less than an inner diameter of the tubular body.
However, since the cap and tubular body have the same width (see Figs. 4A-4C), then it would have been an obvious matter of design choice to have the outer diameter of the cap be smaller than the inner diameter of the tubular body, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
11. Regarding Claim 12, Lee teaches the second surface approaches the active surface (see Figs. 4a-4C), but fails to teach the second surface is tilted. However, it would have been an obvious matter of design choice to make the different portions of the second surface of the protrusion to be tilted, such that the protrusion is whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
12. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and in view of Lund U.S. 9,362,570 (herein referred to as “Lund”).
13. Regarding Claim 3, Lee teaches the at least one open end is a first open end, the cap is a first cap (see Figs. 4a-4c, the open end defined by ref num 40 is the first open end, and ref num 44 is the first cap).
Lee fails to teach the tubular body has a second open end that is opposite the first open end, wherein the implantable device further comprises a second cap that closes the second open end, and wherein the first cap and the second cap each have an outer diameter that is less than an inner diameter of the tubular body.
Lund teaches an implantable device of analogous art (Fig. 16), wherein the device comprises a tubular body (Figs. 16 and 17, ref num 34) and a first cap closing at least one open end of the tubular body (Fig. 16, ref num 35; see Fig. 17, ref num 35 closes an open end of ref num 34). The device further comprises a second cap (Fig. 16, ref num 42) configured to close a second open end opposite of the first open end (Fig. 17, ref num 42 closes an open end opposite to ref num 35). This further contains the circuit board within the device (Col. 8, lines 9-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to have a second cap to close a second opening to ensure that the circuit board is contained with the device.
While Lee as modified by Lund fails to teach the first and second caps have outer diameters that are less than an inner diameter of the tubular body, it would have been an obvious matter of design choice to have the outer diameters of the first and second caps be smaller than the inner diameter of the tubular body, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
14. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and in view of Lim U.S. 2019/0232066 (herein referred to as “Lim”).
15. Regarding Claim 4, Lee fails to teach the cap comprises a feed-through conductor that penetrates the cap and that electrically connects the outer electrode and the inner electrode, and wherein the feed-through conductor is tilted with regards to a thickness direction of the cap.
Lim teaches an implantable device of analogous art (Figs. 1a, 2a-2b, 3, 4a-4b), the device comprises a cap (Fig. 2, ref num 122), an inner electrode (Fig. 4B, ref num 142), and an outer electrode (Fig. 2, ref num 126). The device also comprises a feedthrough conductor that penetrates the cap (Fig. 4B, ref num 148) and electrically connects the outer electrode and the inner electrode (Fig. 4B, ref num 148 connects ref num 126 to ref num 142; para 0074). This ultimately facilitates the connection of the outer electrode to the circuit/electronics module (para 0065). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to include a feedthrough conductor that penetrates the cap in order to connect the outer electrode to the inner electrode and facilitate electrical connection of the circuit board to the electrodes.
While Lee as modified fails to teach the feedthrough conductor is tilted, it would have been an obvious matter of design choice to make the different portions of the conductor to be tilted with regards to the direction of the cap, such that the conductor is whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
16. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and in view of Landherr U.S. 2017/0065207 (herein referred to as “Landherr”).
17. Regarding Claim 5, Lee teaches the protrusion is a first protrusion (see Figs. 4a-4c, ref num 42 is the first protrusion).
Lee fails to teach a second protrusion disposed on the inner surface of the cap, and wherein the circuit board is disposed between the first protrusion and the second protrusion.
Landherr teaches a device of analogous art (Fig. 1, 2, 3a-3b), wherein the device comprises a first and second protrusion on the inner surface of the cap (Fig. 3a, ref num 314, 318) such that the circuit board is disposed between the first and second protrusions (Fig. 3a, ref num 316; para 0072, “the intermediate portion 316 of the scaffold assembly 304 may be configured to support and position a circuit component”). This ensures that the circuit board resists movement when implanted into the body (para 0076). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to have a second protrusion, such that the circuit board is disposed between the first and second protrusion, in order to ensure that the circuit board does not move once implanted in the body.
18. Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee and Landherr, and further in view of Bobgan U.S. 2017/0303424 (herein referred to as “Bobgan”).
19. Regarding Claims 6 and 7, Lee fails to teach a recess is formed between the first protrusion and the second protrusion and wherein the circuit board is disposed in the recess and the recess is defined by an inner wall having a first inner wall and a second inner wall facing each other.
Bobgan teaches a device of analogous art (Figs. 2A-2C), such that the cap (Fig. 3C, ref num 230) comprises a first and second protrusion (Fig. 2C, ref num 274, 266) that defines a recess (Fig. 2C, recess defined between 304 and 306). A circuit board is disposed in said recess (Fig. 2A and 2C, ref num 216; para 0079, “the flanges 244, 266 and 252, 274 to enclose the core circuitry assembly 216”). The recess is defined by an inner wall having a first inner wall and a second inner wall facing each other (see Fig. 2C, ref num 274, 266 has first and second inner walls, ref num 258, 260 to define recess). These protrusions protect the circuit board from applied energy to weld the housing around the circuit board (para 0075). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to dispose the circuit board within a recess in order to enclose the circuit board within the device.
20. Regarding Claims 8 and 9, Lee fails to teach the circuit board contacts at least one of the first inner wall or the second inner wall, further that the circuit board contacts both the first inner wall and the second inner wall.
Bobgan teaches the circuit board contacts the first and second inner walls (Fig. 2C, ref num 216 has interface surfaces 292 and 294, para 0081, such that ref nums 258, 260 contact ref nums 292, 294; para 0082, “the circuit board contacts both the first inner wall and the second inner wall”). This ensures that the circuit board is enclosed within the device (para 0082). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to have the circuit board contact the first and second inner walls in order to enclose the circuit board within the device.
Conclusion
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794