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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/4/2024 has been entered.
Response to Arguments
Applicant’s arguments with respect to the claim rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
All objections and rejections have been withdrawn in favor of the below rejections.
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 1, 4-5 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2006/0241717 in view of FUKAMACHI et al. US 2012/00221072.
Regarding claim 1: Whitehurst discloses an implantable neurostimulator 130 (figure 2) comprising:
an implanted coil receiving power and data from an external coil 222 (figure 5) and providing power and data to an electronic circuit 170 (“electronic circuitry”, figure 2 and paragraph 0040) within a hermetic package (paragraphs 0014-05, 0018, 0054);
the electronic circuitry operably connected to an electrode lead 150 (figure 2, considered to be a supply cable) operably connected to a plurality of electrodes 152 (figure 2);
an electrode array (paragraphs 0009, 0011 and 0052-53 ) which covers a motor cortex of a brain (“motor cortex”, paragraphs 0022 and 0036), as is known in the art electrodes that can stimulate cortical tissue are inherently capable of contacting any portion of the cortex, and
the electrode array and supply cable (considered to be the electrode array 152 and the lead 150 in figure 2) are a single body (figure 2, the lead and electrodes are considered to be a single body as is shown in figure 2) and the hermetic package 130 (figure 2) includes the implanted coil, the SCU 130 is implanted within the skull (paragraphs 0010 and 0018) and the lead is tunneled through a burr hole to place the electrode array into the proper location for stimulation (paragraph 0011).
Whitehurst therefore discloses the claimed invention, however even though Whitehurst discloses stimulation of the cortex (abstract and paragraph 0002) he does not distinctly disclose a plurality of stimulation drivers with each driver connected to an electrode. Fukamachi however teaches of neuromodulation via a neuromodulation controller 150 (figure 8) which includes output drivers 80 that activate selected electrodes (paragraph 0031). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst to include multiple stimulation output drivers connected to electrodes, as taught by Fukamachi, in order to activate selected electrodes.
Specifically regarding the language in the preamble “to support stroke rehabilitation”. The preamble of the claim has not been given patentable weight because the recitation “to support stroke rehabilitation” occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 4-5 and 9-12: the claims each recite that the electrode array is adapted to cover an upper extremity region of the motor cortex, more than the motor cortex, cover a prefrontal cortex, auditory cortex, eloquent cortex or speech cortex. Whitehurst discloses that the stimulation can occur motor cortex, premotor cortex and adjacent to the motor cortex including stimulation which produces movement in an upper arm (paragraph 0035). This is considered to be disclosure as to the electrode array spanning these areas. Further, this is considered to be functional and/or intended use language. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises electrodes used for cortical stimulation including the motor cortex and spanning multiple cortical regions.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2006/0241717 in view of FUKAMACHI et al. US 2012/00221072 and further in view of Lozano US 2008/0045775 previously cited.
Regarding claims 2-3: Whitehurst/FUKAMACHI discloses the claimed invention including receiving power and data from an external component (Whitehurst paragraph 0043) however Whitehurst/FUKAMACHI does not specifically disclose using either visual observations of a muscle twitch or a detected motor evoked potential as feedback to deliver stimulation. Lozano however discloses both closed-loop and open-loop stimulation (paragraph 0053). The open-loop stimulation can be based on visual observation of a motor response (paragraphs 0053-0054) and the closed-loop stimulation is based on neural discharges and/or electrophysiological signals related to signals input (paragraph 0052). The feedback signals are disclosed as being EEG signals, ECoG signals, single unit or multiunit neuronal activity as detected with microelectrode recording techniques, EMG signals, coherence signals, chemical signals, thermal signals, and/or accelerometer signals (paragraph 0051). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst/FUKAMACHI to include both open and closed feedback stimulation, where the open loop stimulation relies on visual observation and the closed loop stimulation relies on EMG signals from muscles, as taught by Lozano, in order to selectively inhibiting or driving the amplitude and/or frequency of neural discharges in, from, and/or associated with a specific target neural population and/or brain area of a mammal (paragraph 0046, Lozano).
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2006/0241717 in view of FUKAMACHI et al. US 2012/00221072 and further in view of Rapoport et al. US 2021/0213279.
Regarding claims 6 and 13: Whitehurst/FUKAMACHI discloses the claimed invention however Whitehurst/FUKAMACHI does not disclose a flexible circuit with a supply cable and electrode array. Rapoport, figure 10 teaches of an electrode array 100 with electrodes 1002 and traces 1006. This array is thin-film polymer based and is considered to be a flexible circuit (paragraphs 0147, “flexible electrode arrays”). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst/FUKAMACHI to include a flexible circuit with electrodes and traces (considered to be supply cables), as taught by Rapoport, in order to have arrays which can conform to the tissue.
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