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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/2/2026 has been entered.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23, line 25 recites “batter”, this should read “battery”. Appropriate correction is required.
Response to Arguments
The drawing rejections have been withdrawn based on the amendments received on 6/2/2026.
Applicant’s arguments, see Applicant’s Response, filed 6/2/2026, with respect to the rejections of claims 23, 20-21 and 16 under Alexander et al. US 7,515,964 in view of Sell et al. US 2021/0275823 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Parker et al. US 10,918,866.
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.
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.
Claims 23, 20-21 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Alexander et al. US 7,515,964 previously cited in view of Sell et al. US 2021/0275823 previously cited and further in view of Parker et al. US 10,918,866.
Regarding claims 23 and 20-21: Alexander discloses an implantable pulse generator (“pacemaker”, column 4, lines 9-10 and column 1, lines 15-20) comprising:
a housing body 136 (“casing”) for housing electronic circuitry (“electronic circuitry”, column 5, line 19), the housing hermetically seals the electronic circuitry (column 1, lines 9 and line 41 and column 4, line 17) this hermetically sealing is considered to separate the electronic circuitry from biological contamination;
an upper header 116 (figure 6) connected with the housing body 136 (figure 6) which includes a first receptacle 108 (figure 6), second receptacle 112 (figure 6), third receptacle 110 (figure 6) and forth receptacle 114 (figure 6), each receptacle 108/110/112/114 includes an electrical contact (column 5, line 18), each receptacle 108/110/112/114 receives a proximal end of a conductor (“lead”) to deliver electrical signals from the electrical circuitry to each electrical contact (“electrode”, column 5, lines 11-39);
wherein the first 108 (figure 6) and second receptacles 112 (figure 6) are aligned along a first upper axis and are spaced apart radially from each other via the header material considered to be a separator (figure 6, column 5, lines 40-55, “encapsulating”, column 5, lines 34-39);
wherein the third 110 (figure 6) and forth receptacles 114 (figure 6) are aligned along a second upper axis and are spaced apart radially from each other via the header material considered to be a separator (figure 6, column 5, lines 40-55, “encapsulating”, column 5, lines 34-39);
wherein the first and second receptacles extend in opposite directions along the first upper axis away from the separator spacing the first and second receptacles apart (figure 6); and
wherein the third and fourth receptacles extend in opposite directions along the second upper axis away from the separator spacing the first and second receptacles apart (figure 6).
However Alexander does not disclose that the receptacles include four electrical contacts (claim 23 limitation) and the volume of the pulse generator is between 5-12 cc’s (claims 20-21 limitations). Sell however teaches of one or more connectors 118 (figure 3C) four are shown 118A/118B/118C/118D (figure 3C). Sell further teaches that the volume of the implanted device ranges from 5-14 cc’s (paragraph 0053).
It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Alexander to include four electrical connectors within the receptacle as well as an implanted volume between 5-14 cc’s, as taught by Sell, in order to stimulate tissue.
Alexander/Sell discloses the claimed invention, Alexander further disclose a battery 14 figure 2, that powers the circuit (column 1, line 39) which is considered to be in communication with the electrical contacts. However, Alexander/Sell does not disclose a recharge antenna to receive RF energy from an external system, with the antenna extending around a perimeter of the upper header and in communication with the rechargeable battery. Note that it is considered customary and inherent that an implanted device, such as the devices of Alexander and Sell, would necessarily include a rechargeable battery as opposed to a battery that does not have the capability of recharging.
Parker teaches of a medical device which includes a header and signal generator which are implantable (abstract). With specific reference to figure 2, Parker teaches of a charging and communicating assembly 214 which includes a support element 220. The support element 220 carries the communication antenna 222 and the charging coil 224 (paragraph 0025). The charging coil charges the medical device (paragraph 0002) using RF induction (paragraph 0021) and is operably attached to a rechargeable battery 230 (paragraph 0026, “The battery 230 can be recharged”). The support element 220 matches the rectangular shape of the header (paragraph 0030) with the communication antenna 222 and the charging coil 224 coupled to the electrical components within the can 204. The support element 220 is considered to be extending around an interior perimeter of the header, as is shown in figure 2. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Alexander/Sell to include the support element of Parker which includes both the charging coil and the telemetry antenna extending around an interior parameter of the header assembly and operably attached to the rechargeable battery and circuit components, as taught by Parker, in order to enable both telemetry data communication and inductive power transfer.
Regarding claim 5: Alexander/Sell/Parker discloses the claimed invention. Parker further teaches of a communication antenna 222 (figure 2)
Claims 5-6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alexander et al. US 7,515,964 previously cited in view of Sell et al. US 2021/0275823 previously cited and further in view of Parker et al. US 10,918,866 and further in view of Kishawi et al. US 2010/0137936 previously recited.
Regarding claims 5-6 and 19: Alexander/Sell/Parker discloses the claimed invention. Parker further teaches of a communication antenna 222 (figure 2), however Alexander/Sell/Parker does not disclose that the communication antenna receives programming signals from an external programmer and delivering the signal to the electrical circuitry and delivering therapy to electrodes near a distal end of the lead based on the programmed signal. Kishawi however, teaches of an antenna 132 (figure 9) within the IPG 102 (figure 9), the clinical programmer 200 (figure 15A) includes antenna 204 (figure 15A), the antenna's provide wireless communication (paragraph 0113) between the implant and the external clinical programmer. The clinical programmer generates desired stimulation pulses and programs for therapy which are used to program the implant device via RF links and telemetry (paragraphs 0077-78 and 0084), the pulse generator then applies signals to the electrodes for the delivery of therapy (paragraphs 0094, 0096 and 0107-0108). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Alexander/Sell to include an antenna within the implant which communicates with an external programmer which also includes an antenna to wirelessly communicate stimulation programs to the implant from the external device, as taught by Kishawi, in order to update and change stimulation parameters.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Alexander et al. US 7,515,964 previously cited in view of Sell et al. US 2021/0275823 previously cited and further in view of Parker et al. US 10,918,866 and further in view of Kishawi et al. US 2010/0137936 previously recited and further in view of Kast et al. 2009/0112282 previously recited.
Regarding claim 22: Alexander/Sell/ Parker/Kishawi discloses the claimed invention however Alexander/Sell/ Parker/Kishawi does not disclose the use of Bluetooth. Kast however teaches of the use of Bluetooth to communicate between the clinical and patient programmer (paragraph 0035). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Alexander/Sell/Parker/Kishawi to include the use of Bluetooth to communicate between the patient and clinical programmer, as taught by Kast, in order to utilized standard or proprietary telemetry protocols.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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