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, see Applicants Response, filed 1/20/2026, with respect to the rejections under Kishawi et al. US 2010/0137938 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Alexander et al. US 7,515,964 in view of Sell et al. US 2021/0275823. All previous objections and rejections are withdrawn in light of the claim amendments received and in response to the arguments presented.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first upper axis, separator(s) and the second upper axis (all in claim 23) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New claim 23 includes the limitation “a separator” in lines 14 and 16. Claim 23 appears to be specific to figure 3C which has lower and upper leads within a header. Although the leads are separate, there is no specific “separator” labeled in any of the drawings nor is there a “separator” discussed in the specification. This could be a specific component however it appears to be a typical header design where the material of the header encases the separate lead connector blocks.
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 in view of Sell et al. US 2021/0275823.
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 the3 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 and the volume of the pulse generator is between 5-12 cc’s. 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.
Regarding claim 16: Alexander discloses a battery (column 1, lines 39-40) these batteries are customarily rechargeable however Sell also teaches of a rechargeable battery (paragraphs 0006). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was field to modify Alexander’s battery to be a rechargeable battery, as taught by Sell, utilize a smaller battery.
Claims 5-6 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Alexander et al. US 7,515,964 in view of Sell et al. US 2021/0275823 and further in view of Kishawi et al. US 2010/0137936 previously recited.
Regarding claims 5-6 and 19: Alexander/Sell discloses the claimed invention however Alexander/Well does not disclose an antenna for wirelessly receiving 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.
Regarding claims 17-18: Alexander/Sell discloses the claimed invention however Alexander/Well does not disclose an antenna which communicates via RF coupling with the rechargeable battery for recharging the internal battery via a control circuit. Kishawi however teaches of rechargeable battery (paragraphs 0073 and 0079) which is rechargeable via the clinical or patient programmer (paragraph 0134) the charging as well as the programming of the IPG is occurring via the telemetry and recharge circuit which includes antennas from both the external and internal devices, RF transmission is further disclosed (paragraph 0074). 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 which communicates via RF coupling with the rechargeable battery for recharging the internal battery via a control circuit, as taught by Kishawi, in order to charge the device from an external location using RF coupling.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Alexander et al. US 7,515,964 in view of Sell et al. US 2021/0275823 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/ Kishawi discloses the claimed invention however Alexander/Sell/ 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/ 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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796