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 filed 12/30/2025 have been fully considered but they are not persuasive. Edvardsson teaches a dielectric filler and a metallic boundary that holds and surrounds the dielectric filler, the metallic boundary having a slot portion that is shaped and sized to be received by the slot of the enclosure, and an upper flange that is configured to be hermetically coupled with the outer wall (Para. 0080, “The slot antenna of the invention is made in the wall of the compartment or housing, or in the metallized surface portion, and is connected as in any of the preferred embodiments above. The complete compartment or housing is then covered by a dielectric material, preferably a thin layer of the dielectric material, to obtain a medical device having an outer surface suitable to be implanted in a human being, and optionally to hermetically seal the medical device”, the Examiner notes the upper flange is the thin outer layer of the dielectric material hermetically sealing the lower dielectric filler and slot antenna). For this reason the rejections are maintained, but are updated to cite the newly amended claim language.
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, 5-14, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20050222633 awarded to Edvardsson, hereinafter Edvardsson.
Regarding Claim 1, Edvardsson teaches an implantable medical device (IMD) configured for implant in a body (abstract), the IMD comprising: an enclosure formed of an electrically conductive material and comprising an outer wall (Para. 0009, “Firstly, a header made of dielectric material is disposed between the two conductive halves, thereby allowing external interfering radiation to enter the implantable device and interfere with signals transmitted within any of the two conductive halves or with signals transmitted across the dielectric header”) and a slot extending through the outer wall (Para. 0022, “If the housing is an electrically conductive housing, the entire housing with the slot can be tailored to operate as an antenna for the radio frequency telemetry signals without any requirement of an insulating separation”); a slot antenna comprising the enclosure (Para. 0080); a dielectric filler and a metallic boundary that holds and surrounds the dielectric filler, the metallic boundary having a slot portion that is shaped and sized to be received by the slot of the enclosure, and an upper flange that is configured to be hermetically coupled with the outer wall (Para. 0080, “The slot antenna of the invention is made in the wall of the compartment or housing, or in the metallized surface portion, and is connected as in any of the preferred embodiments above. The complete compartment or housing is then covered by a dielectric material, preferably a thin layer of the dielectric material, to obtain a medical device having an outer surface suitable to be implanted in a human being, and optionally to hermetically seal the medical device”, the Examiner notes the upper flange is the thin outer layer of the dielectric material hermetically sealing the lower dielectric filler and slot antenna); and communication circuitry within the enclosure and electrically coupled with the slot antenna (Para. 0022, “If the housing is an electrically conductive housing, the entire housing with the slot can be tailored to operate as an antenna for the radio frequency telemetry signals without any requirement of an insulating separation”).
Regarding Claim 5, Edvardsson teaches the IMD of claim 1, wherein the dielectric element is formed of a non- metallic, biocompatible material and has a thickness in a range of a 20 mil to 100 mil (~ 0.5 mm to 2.5 mm) (Para. 0042, “0.39 cm”).
Regarding Claim 6, Edvardsson teaches the IMD of claim 1, wherein the dielectric element is configured to extend to at least partially through a thickness of the slot (Para. 0044, “One of the feed conductors 13 is therefore provided with a hermetic feed-through 19 in the electrically conductive housing 1 so that the feed conductor 13 can protrude from one of the edges 15 of the electrically conductive housing 1, and extend across the slot 10 to be connected at the opposite edge 17 of the slot 10 to create an electric field within the slot 10 by flowing a feeding current in the feed conductor 13.”).
Regarding Claim 9, Edvardsson teaches the IMD of claim 1, wherein the metallic boundary is formed of electrically conductive material and is electrically coupled with the outer wall (Figs. 2a-2b, electrically conductive housing 1).
Regarding Claim 10, Edvardsson teaches the IMD of claim 1, wherein the metallic boundary is configured to extend at least partially through a thickness of the slot (Figs. 2a-2b, Para. 0054, “Further, the slot 10 is filled with a dielectric material 31, particularly a plastic, a glass or a ceramic material. This provides a well-defined dielectric constant of the material 31 in the slot, as well as providing good support for the therapy lines 25”).
Regarding Claim 11, Edvardsson teaches the IMD of claim 10, wherein the dielectric element further comprises a plurality of connection pins that extend from the metallic boundary into the enclosure (Figs. 2a-2b, output therapy lines 25).
Regarding Claim 12, Edvardsson teaches the IMD of claim 1, wherein the outer wall of the enclosure in a region of the slot is characterized by an enclosure profile (housing 110, Fig. 10), the upper flange comprises a lower surface (lower surface is the side of the thin dielectric layer facing the internal structures of the device) and the lower-surface is characterized by a lower-surface profile that matches the enclosure profile (Para. 0080).
Regarding Claim 13, Edvardsson teaches the IMD of claim 12, wherein the enclosure profile is non-linear with a first curvature and the lower surface profile is non-linear with a second curvature that matches the first curvature (Fig. 10, Para. 0080).
Regarding Claim 14, Edvardsson teaches the IMD of claim 12, wherein the enclosure profile is flat and the lower-surface profile is flat (Fig. 11).
Regarding Claim 16, Edvardsson teaches the IMD of claim 1, further comprising a transmission line electrically coupled at an enclosure end to the outer wall at each of a first connection point and a second connection point on opposite sides of the slot (Fig. 2a, output therapy lines 25), and at a circuitry end to the communication circuitry (Fig. 2a, operating circuitry 3).
Regarding Claim 17, Edvardsson teaches the IMD of claim 16, wherein the transmission line comprises: a signal conductor having an enclosure end electrically coupled to the first connection point (conductor 13, Figs. 2a/2b and 9), and a circuitry end electrically coupled to a signal terminal of the communication circuitry (Fig. 2a/2b); and a ground conductor having an enclosure end electrically coupled to the second connection point (ground 11’, Fig. 9), and a circuitry end electrically coupled to a ground terminal of the communication circuitry (Fig. 2a/2b).
Regarding Claim 18, Edvardsson teaches the IMD of claim 17, wherein: the ground conductor comprises an upper layer of electrically conductive material (layer attached to the RF circuitry) and a lower layer of electrically conductive material (layer in gap 30), and the upper layer is electrically coupled to the lower layer by electrically conductive vias (ground 11’ is continuous, Para. 0063, “A ground connector 11' or similar of the printed circuit board 43 is conveniently connected to the metallized portion of the ceramic-filled cavity 41"), the signal conductor comprises an internal layer of electrically conductive material positioned between the upper layer and the lower layer (conductor 13 is continuous through the layers), and the transmission line further comprises a dielectric material that separates the upper layer, the internal layer, and the lower layer (dielectric material 31/41’).
Regarding Claim 19, Edvardsson teaches the IMD of claim 18, wherein the ground conductor, the signal conductor, and the dielectric material are configured so the transmission line is impedance matched to a signal path between the communication circuitry and the slot of the slot antenna (Para. 0046, “The feed of the antenna may be implemented in any manner known in the art, e.g. using balanced feed or unbalanced feed, and using any kind of antenna tuning circuit or impedance matching network (not illustrated), which loads the antenna with a variable amount of inductance or capacitance to thereby adjust the effective electrical length of the antenna and match the antenna impedance to the impedance of the transmitter/receiver”).
Claim Rejections - 35 USC § 103
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 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 2, 4, 15, and 20-22 rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20050222633 awarded to Edvardsson, hereinafter Edvardsson.
Regarding Claims 2, Edvardsson teaches the IMD of Claim 1, wherein the antenna operates in a frequency band of 2.4-2.5 GHz (Para. 0042). Edvardsson does not teach wherein the slot antenna has a peak radiation gain in a range of -8 dBi to -13dBi. The instant specification does not disclose any criticality associated with this claimed range.
However, Edvardsson teaches that the radiation gain can be adjusted to the particular needs of the device (Para. 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edvardsson, i.e. by using a radiation gain in a range a range of -8 dBi to -13dBi, as Edvardsson teaches that it is an obvious design choice employed in the creation of an antenna system.
Regarding Claim 4, Regarding Claims 2, Edvardsson teaches the IMD of Claim 1, wherein the dielectric constant is 1 and adjustable based on the need of the device (Para. 0042-0043) and the antenna operates in a frequency band of 2.4-2.5 GHz (Para. 0042). Edvardsson does not teach wherein the dielectric constant is in a range of 2 to 20. The instant specification does not disclose any criticality associated with this claimed range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edvardsson, i.e. by using a range of 2-20 for the dielectric constant, since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding Claims 15 and 20-22, Edvardsson teaches the IMD of Claims 1 and 19. Edvardsson does not teach the wherein: the upper layer and the lower layer of the ground conductor have a cross-section width between 1 mm to 10 mm; the internal layer has a cross-section width between 50 microns to 500 microns; and the dielectric material has a dielectric constant between 2 and 20 and a thickness between 10 mil and 30 mil, wherein: the enclosure has a length El in a range of 20 mm to 75 mm, a width E, in a range of 20 mm to 75 mm, and a height Eh in a range of 3 mm to 20 mm; and the slot has a length Si in a range of 10 mm to 40 mm and a width SW in a range of 0.5 mm to 5 mm, or wherein: an interior volume of the enclosure is in a range of 1200 mm3 to 112,500 mm3, and the slot has an area in a range of 5 mm2 to 200 mm2. However, Edvardsson does teach the adjustment of sizing parameters based on the needs of the device in Paras. 0042-0043 and 0047. The instant specification does not disclose any criticality associated with these claimed ranges.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edvardsson, i.e. by sizing the components of Edvardsson’s device to the parameters specified above, as the ranges lack criticality and general sizing is an obvious design choice made by one of ordinary skill in the creation of the device (MPEP 2144.04(IV)(A), “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20050222633 awarded to Edvardsson, hereinafter Edvardsson, in view of U.S. Patent Publication 20090248112 Mumbru et al, hereinafter Mumbru.
Regarding Claim 3, Edvardsson teaches IMD of claim 1, wherein radiation gain can be adjusted to a desirable level (Para. 0047). Edvardsson does not teach wherein the slot antenna has a peak radiation gain in a range of -5 dBi to -15 dBi when implanted under skin and operating in a frequency band of 5.15 GHz to 5.85 GHz. The instant specification does not disclose any criticality associated with these claimed ranges.
However, in the art of implantable devices Mumbru teaches a frequency of 5.7 GHz (Para. 0124) and that radiation gain can be adjusted to the acceptable limits of the device (Para. 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edvardsson by Mumbru, i.e. by operating at a frequency of 5.7 GHz, for the predictable purpose of simply substituting one known frequency range for another. Further, it would have been obvious to have the radiation gain in a range of -5 to -15 dBi, as both Edvardsson and Mumbru teaches adjusting the radiation gain to the acceptable range needed by the device for a given purpose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 9265958 awarded to Joshi, specifically Fig. 11-12 and Col. 12, Lines 28-47, (“Positioning the antenna 1108 within the conductive housing 1102, as opposed to external to the conductive housing 1102, enables elimination of connective elements to connect the antenna 1108 to the communication circuitry 1126. Such connective elements tend to be bulky, failure prone and difficult to work with during manufacturing of an IMD. The conductive housing 1102 may reduce performance of the antenna 1108 when the antenna 1108 is positioned within the conductive housing 1102. Providing the opening 1104 that is hermetically sealed with the dielectric material 1106 reduces or eliminates interference of the conductive housing 1102 with communications via the antenna 1108. The header block 1202 protects the dielectric material 1106 from damage and protects the patient from pieces of the dielectric material 1106 in the event of catastrophic failure of the dielectric material 1106. Thus, effective communications may be provided safely, at low manufacturing cost, and in a relatively small form factor IMD 1000 by positioning the antenna 1108 within the conductive housing 1102 beneath the dielectric material 1106 and the header block 1202”).
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 Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung, can be reached at (571)-272-8506. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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