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. Also see paragraphs 0007-0011).
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 solve 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 the 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).
Response to Arguments
Applicant's arguments filed, have been fully considered but they are not persuasive.
With respect to the Applicant’s arguments pertaining to 35 USC § 112 related to claims 1, 4, 15, 24 that these claims are not omnibus, the Examiner disagrees.
For example, claim 1 states “an assembly including a functional component…” Based on the specification, the Examiner was unable to find any passage that supports what is included or excluded by this recitation. Furthermore, upon the Examiner reviewing the Applicant’s subsequent response, the Examiner notes that the Applicant was unable to explain what was meant by the recitation. Therefore, the Examiner contends that the rejection is maintained.
Claims 4, 15, and 24 rejection is maintained for similar reasons.
In addition, 35 U.S.C 112 pertaining to inclusion or exclusion (MPEP ¶7.35), an omnibus type claim rejection does not require further explanation.
With respect to the Applicant’s arguments pertaining 35 USC § 102 related to claims 1, 4, 21, 23, 24, 26, 28, 32 that Brady fails to teach the claimed language, the Examiner disagrees.
The Applicant argument on page 11 referencing whether the claim is understood. An omnibus type claim is indefinite because the Applicant claim(s) fail(s) to point out what is included or excluded such that the bounds of their invention is taught by the claims or disclosure. This type of rejection does not address the understanding of the claim terms.
With respect to the Applicant’s arguments page 11, the Applicant argues that invention does not include the subject matter suggested by Brady (see claim 1 rejection above). The Examiner contends that the claims do not include or exclude any interpretation of the claims so much so that Brady clearly supports the subject matter claimed. Therefore, the rejection is maintained.
With respect to the Applicant’s arguments page 13, the “support structure” is met by the implant body (28, 228, 288) of Brady.
With respect to the Applicant’s arguments page 14, the “subcutaneous tissue” is the placement area found in paragraphs 0007-0011. In particular, paragraph 0008 discusses a tool used for placement of the implant.
With respect to the Applicant’s arguments pages 14 and 16, Brady 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. In particular paragraphs 0007-0011 teaches an implantation instrument for positioning.
With respect to the Applicant’s arguments page 15, Brady teaches a surgical procedure to implant a device intracutaneously, i.e. within the skin, of a patient/recipient (paragraph 0001-0011).
With respect to the Applicant’s arguments page 15, claim 24 was rejected as an omnibus type claim for the reasons stated as related to the “lead assembly”. The Applicant failed to point out in a subsequent response how the “lead assembly” was defined by the disclosure. Further, the Examiner did not find in the Applicant’s specification the definition. 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).
With respect to the Applicant’s arguments page 16, Brady teaches a “short range” external receiver which anticipates means for position or arranging at a short range location or state.
With respect to the Applicant' s argument that pertaining to officially noticed facts (pages 17-21), the Examiner disagrees.
Firstly, to adequately traverse a finding of official notice, an Applicant must specifically point out the supposed errors in the examiner' s action, which would include stating “why” the noticed fact is not considered to be common knowledge or well-known in the art. See 37 CFR 1.111(b). See also Chevenard, 139 F.2d at 713, 60 USPQ at 241. A general allegation that the claims define a patentable invention without any reference to the examiner' s assertion of official notice would be inadequate (MPEP 2144.03C).
Since the Applicant' s reference to the Examiner' s assertion was inadequate for the reasoning stated above, the Examiner' s common knowledge or well-known in the art statements are taken to be Admitted Prior Art because Applicant either failed to traverse the examiner' s assertion of official notice or that the traverse was inadequate (MPEP 2144.03).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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September 18, 2026
/PHYLESHA DABNEY/Patent Examiner, Art Unit 2694
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