DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1, 3-10, 13-14, 16, 18-24, 26 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b), or 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.
Claim(s) 1, 4, 15, 24 is/are 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.
With respect to claim 1, an “assembly, including a functional component” is taken to be indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
With respect to claim 4, 24, a “lead assembly” is taken to be indefinite in that it fails to point out what is included or excluded by the claim language. For example, it was not found in the specification where the leads are essential or any way connected to the lead assembly. This claim is an omnibus type claim.
With respect to claim 15, a “support assembly” is taken to be indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
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.
Claim(s) 1, 4, 21, 23, 24, 26, 28, 32 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Bardy (US Publication No. 20100331868)
Regarding claim 1, Bardy teaches an implant, comprising: an assembly (28, 228, 288, implant; para. 0004, implantable monitors, sensors, chips), including a functional component (para 0004; Bluetooth transmit and receive) supported by a support structure (28, 228, 288, implant body), wherein the assembly is configured to be placed in soft tissue of a human recipient (para. 0008, recipient subcutaneous tissue).
Regarding claim 4, Brady teaches the implant of claim 1, further comprising: a lead assembly (20, 220, implant instrument), extending from the assembly, wherein the lead assembly is a malleable (as shown Fig. 2A, 2B).
Regarding claim 21, Bardy teaches the implant of claim 1, wherein: the assembly is intracutaneously implanted in a mammal (para. 0008, recipient).
Regarding claim 23, Bardy teaches the implant (28, 228, 288, implant) of claim 1, wherein: there is a thickness of skin above the functional component and a layer of skin below the functional component; and the functional component is an antenna (as shown in figs. 3, 4A, 28C).
Regarding claim 24, Bardy teaches the method of claim 9, wherein: a lead assembly (20, 220, implant instrument) extends from the assembly, wherein the lead assembly is a malleable (as shown by figures 2A, 2B).
Regarding claim 26, Bardy teaches the implant of claim 1, wherein: the assembly (implant) is in a pocket in skin of a mammal (para. 0008, recipient).
Regarding claim 28, Bardy teaches a device, comprising: a means (implantation instrument) for positioning in soft tissue; means for functioning (para. 0004, monitors, sensors, chips) of a medical device.
Regarding claim 32, Bardy teaches the device of claim 28, wherein the means for functioning is a means for receiving an RF signal (0004, Bluetooth technology).
Regarding claim 33, Bardy teaches the device of claim 28, wherein: the means for positioning in soft tissue (implant instrument) and the means for functioning (para. 0004, monitors, sensors, chips) of a medical device are part of an assembly that also includes a means for positioning an external component (para 0004, anticipates using a Bluetooth short range external receiver) relative to the assembly.
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.
Claim(s) 2-3, 5, 12, 14-15, 20, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady.
Regarding claim 2, although Bardy does not specifically teach the implant of claim 1, wherein: the functional component is an antenna, Bardy does teach transmitting and receiving via Bluetooth technology (para. 0004).
The Examiner takes Official Notice that it is extremely well-known for an antenna to be used with transceiver (transmitting and receiving) for communication.
One of ordinary skill in the art before the effective filing date of the claimed invention could have applied an antenna in the well-known manner and the result would have been predictable.
Regarding claim 3, .Brady fails to teach the implant of claim 1, wherein the assembly includes holes extending all the way therethrough from an upper surface to a lower surface.
However, the Examiner takes Official Notice that placing holes in an assembly is well known in the art for positioning items within the assembly or venting the assembly.
It would have been an obvious matter of design choice to place holes since applicant has not disclosed that holes solves any state problem or is for any particular purpose and appears that the invention would perform equally well with Brady.
Regarding claim 5, Brady teaches the assembly has skin on above and below the structure.
However, Brady does not teach the depth range between about 2 mm and about 5 mm of skin above the assembly and at least about 1 mm of skin below the assembly.
It would have been an obvious matter of design choice to position the assembly at any depth since applicant has not disclosed that the specified depth solves any state problem or is for any particular purpose and appears that the invention would perform equally well with position disclosed by Bardy (para. 0066 denoted by the length measurement of the instrument).
Regarding claim 12, Bardy fails to specifically teach the implant of claim 1, wherein: the functional component is an electrically conductive inductance circuit (claim 12), such as an inductance coil (claim 13).
However, the Examiner takes Official Notice that it is known to use an antenna in an implant of which may include an induction coil for radio frequency communications (para. 0004).
One of ordinary skill in the art before the effective filing date of the claimed invention could have applied an inductance circuit, such as an antenna/coil in the well-known manner and the result would have been predictable.
Regarding claim 14, Bardy teaches an apparatus capable of performing a method, comprising: generating a radio frequency signal (para. 0004, Bluetooth technology short range) external to a recipient (para. 0008, recipient); and receiving the radio frequency signal via an implanted antenna implanted in the recipient, wherein a layer of skin is located between the antenna and bone of a recipient in which the antenna is implanted (figs. 3, 4B, 28C, assembly located in the subcutaneous tissue).
Although Bardy does not specifically teach an antenna, Bardy does teach transmitting and receiving via radio frequency (para. 0004, Bluetooth technology).
The Examiner takes Official Notice that it is extremely well-known for an antenna to be used with transceiver for radio frequency signals (transmitting and receiving) for communication.
One of ordinary skill in the art before the effective filing date of the claimed invention could have applied an antenna in the well-known manner and the result would have been predictable.
Regarding claim 15, Brady teaches he method of claim 14, wherein: the antenna is supported by an antenna support assembly (implant body) that is completely away from the bone of the recipient (subcutaneously implanted).
Regarding claim 20, Brady fails to teach an apparatus capable of performing the method of claim 14, wherein: the antenna is an inductance coil; and the bone is a skull bone.
However, the Examiner takes Official Notice that it is known to use an antenna in an implant of which may include an induction coil for radio frequency communications (para. 0004).
One of ordinary skill in the art before the effective filing date of the claimed invention could have applied an inductance circuit, such as an antenna/coil in the well-known manner and the result would have been predictable.
Furthermore, Brady teaches the implant instrument being able to insert an implantable device below the skin of a recipients body. Since skin is on top of bone, then Brady anticipates inserting the device in the skin above the skull bone.
In particular, It would have been an obvious matter of design choice to include skin on top of the skull bone as a potential site since applicant has not disclosed that any particular placement solves any state problem or is for any particular purpose and appears that the invention would perform equally well with Brady’s implantation concept.
Regarding claim 25, Bardy teaches the implant of claim 1, wherein: there is a thickness of skin above the functional component (28, 228, 288, part of implant) and a layer of skin below the functional component (as shown by figures. 2, 4A, 28C).
Although Bardy does not specifically teach an antenna, Bardy does teach transmitting and receiving via radio frequency (para. 0004, Bluetooth technology).
The Examiner takes Official Notice that it is extremely well-known for an antenna to be used with transceiver for radio frequency signals (transmitting and receiving) for communication.
One of ordinary skill in the art before the effective filing date of the claimed invention could have applied an antenna in the well known manner and the result would have been predictable.
Allowable Subject Matter
Claim(s) 6-11, 16-19, 22, 27, 29-31 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Examiner’s Note
The referenced citations made in the rejection(s) above are intended to exemplify areas in the prior art document(s) in which the examiner believed are the most relevant to the claimed subject matter. However, it is incumbent upon the applicant to analyze the prior art document(s) in its/their entirety since other areas of the document(s) may be relied upon at a later time to substantiate examiner’s rationale of record. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984). However, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHYLESHA DABNEY whose telephone number is (571)272-7494. The examiner can normally be reached Monday - Wednesday and Friday 10:30-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fan Tsang can be reached at 5712727547. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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April 4, 2026
/PHYLESHA DABNEY/Patent Examiner, Art Unit 2694