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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/01/2025 has been entered.
Response to Amendment
The amendment filed 12/01/2025 has been entered. Claims 1-5, 9, 11, 13-15, 17-18, 21, 25, 29-31 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 09/05/2025.
Response to Arguments
Applicant's arguments with respect to claims 1-5, 9, 11, 13-15, 17-18, 21, 25, 29-31 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. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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 1, 4-5, 14 is rejected under 35 U.S.C 103 as being unpatentable over Anikeeva et al. (US 20140371564) herein referred to as Anikeeva, in view of Vardiman (US 20160228693) herein referred to as Vardiman.
Regarding claim 1, Anikeeva discloses A spatially expandable probe for simultaneous interfacing across distant regions of a brain of a subject in need thereof (Figure 1, 200), the spatially expandable probe comprising:(i) a scaffold (Figure 2B, 230) configured to receive a plurality of flexible probes (Figure 2B, 212), the scaffold comprising a first end insertable within the brain of the subject (Figure 2B, 242; Paragraph [0060]; wherein tip 242 is inserted into brain tissue) and a plurality of enclosed, helically-oriented channels formed within and extending internally from the first end along a length of the scaffold (Figure 2A, 214; Figure 2B; wherein as shown in figure 2A, channels 214 are enclosed in scaffold 230 which is shown to be in a helical orientation in Figure 2B); and (ii) a plurality of flexible probes (Figure 2A, 212), each of the flexible probes in the plurality of flexible probes slidably engaged within an enclosed, helically-oriented channel in the plurality of enclosed, helically-oriented channels and having a probe end extendable from the first end of the scaffold (Figure 2B, 260; Paragraph [0067]; wherein drive slides moving the elements in the probe up or down); wherein sliding each of the flexible probes within the enclosed, helically-oriented channel in a first direction with respect to the scaffold causes the probe end to extend from the first end of the scaffold (Figure 7E); wherein sliding each of the flexible probes within the enclosed, helically-oriented channel in a second direction opposite the first direction causes the probe end to withdraw closer to the first end of the scaffold (Figure 7B); and wherein each of the enclosed, helically-oriented channels in the plurality of enclosed, helically-oriented channels is oriented such that, when the probe end of each of the flexible probes is extended from the first end of the scaffold, the probe ends extend in different directions to access the distant regions of the brain of the subject (Figure 4B). However, Anikeeva does not explicitly disclose wherein the probe ends extend in different direction as controlled by the enclosed, helically-oriented channels.
Vardiman discloses spatially expandable probe (Figure 3) wherein the probe ends extend in different direction as controlled by the enclosed, helically-oriented channels (Figure 3B; wherein the enclosed helically oriented channels control the probes to extend out different openings in different directions). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the channels taught by Anikeev to allow for them to control the probes sticking out in different direction as taught by Vardiman. The motivation being to allow for mulit-directional selectively deployable deep brain stimulation (Vardiman, Paragraph [0018]).
Regarding claim 4, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. Anikeeva also discloses wherein the flexible probes are jointly slidable within the enclosed, helically-oriented channel such that sliding the plurality of flexible probes in the first direction causes an equidistant extension of the probe (Figure 7E).
Regarding claim 5, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. Anikeeva also discloses wherein each of the enclosed, helically-oriented channels in the plurality of enclosed, helically-oriented channels is oriented at a different angle with respect to a normal of the scaffold at the first end such that, when the probe ends are extended from the first end, the probe ends extend in different directions to create a three- dimensional spatially expanded probe for extending across the distant regions of the brain of the subject (Figure 4B; wherein probes are not shown as expanded but when expanded would extend in different directions).
Regarding claim 9, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. Anikeeva also discloses wherein one or more of the flexible probes comprise cylindrical, rectangular, square, strip, linear, irregular neural probes, neural probes made of metal or polymer electrodes embedded in a polymer, or a combination thereof (Figure 2A, 212; wherein probes 212 are cylindrical).
Regarding claim 14, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. Anikeeva also discloses wherein the plurality of enclosed, helically-oriented channels comprise a number of channels from about 2 to about 100 channels (Figure 3B, 314, wherein there is 4 channels).
Claims 2-3, 21 & 25 are rejected under 35 U.S.C 103 as being unpatentable over Anikeeva and Vardiman in further view of WEBER et al. (US 20130165920) herein referred to as WEBER.
Regarding Claim 2, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1, wherein one or more of the flexible probes comprises a multifunctional fiber probe (Anikeeva, Paragraph [0065]; wherein flexible probe comprises an optical fiber that supports propagation of one or more transverse modes at wavelengths in the ultraviolet, visible, and/or infrared portions of the electromagnetic spectrum therefore is seen as multifunctional) comprising: (i) an elongated probe body having a probe end for insertion into the brain region of the subject and a proximal end opposite the probe end (Anikeeva, Figure 2A; Paragraph [0060]; wherein tip 242 is inserted into brain tissue). However, Anikeeva in view of Vardiman does not explicitly disclose (ii) a plurality of interfacing elements extending within the elongated probe body from the proximal end to the probe end; and (iii) one or more sites on an exterior surface of the elongated probe body operably coupled to an interfacing element in the plurality of interfacing elements to interface with brain tissue, the one or more sites along the length of the multifunctional probe at a distance from the probe end to allow for the interfacing with the brain tissue to occur along the length of the multifunctional fiber probe.
Weber discloses a spatially expandable probe for simultaneous interfacing across distant regions of the brain of a subject in need thereof (Figure 10B; Paragraph [0004]-[0005]; wherein the probe is to be used for stimulating renal nerves and those brain tissue includes renal nerves) comprising (ii) a plurality of interfacing elements extending within the elongated probe body from the proximal end to the probe end (Paragraph [0062]; wherein flexible probes 22 & 68 are configured as an electrode), and (iii) one or more sites on an exterior surface of the elongated fiber body operably coupled to an interfacing element in the plurality of interfacing elements to interface with the tissue (Paragraph [0062]; wherein flexible probe is configured as an electrode; Paragraph [0006]; wherein the system is moved to a desired location in a body vessel and the scaffold is retracted, allowing the flexible probes to expand radially such that the electrode can contact the wall of the vessel), the one or more sites along the length of the probe at a distance from the probe end to allow for the interfacing with the brain tissue to occur along the length of the probe (Paragraph [0062]; wherein flexible probe is configured as an electrode; Paragraph [0006]; wherein the system is moved to a desired location in a body vessel and the scaffold is retracted, allowing the flexible probes to expand radially such that the electrode can contact the wall of the vessel). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the probes taught by Anikeeva in view of Vardiman to include the interfacing elements as taught by Weber. The motivation being to allow for use radio-frequency ablation or modulation procedures (Weber, Paragraph [0009]).
Regarding Claim 3, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. However, Anikeeva in view of Vardiman does not explicitly disclose wherein each of the flexible probes is independently slidable within the enclosed, helically-oriented channel such that, for each of the probe ends, a distance of the probe end from the first end of the scaffold can be independently controlled.
Weber discloses a spatially expandable probe for simultaneous interfacing across distant regions of the brain of a subject in need thereof (Figure 10B; Paragraph [0004]-[0005]; wherein the probe is to be used for stimulating renal nerves and those brain tissue includes renal nerves) wherein each of the flexible probes is independently slidable within the enclosed, helically-oriented channel such that (Figure 10; wherein flexible probe 22 is independently slidable with channel 26 and flexible prove 68 is independently slidable in channel 66), for each of the probe ends, a distance of the probe end from the first end of the scaffold can be independently controlled (Paragraph [0006]; wherein the flexible probe may be pulled proximally relative to the shaft and the electrode is activated intermittently or continuously. As the carrying element is pulled, the electrode is moved longitudinally and radially to provide a desired pattern, therefore is independently controlled since the probes can be moved to a desired patterned both longitudinally and radially). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the probes taught by Anikeeva in view of Vardiman to be independently controlled as taught by Weber. The motivation being to allow the probes to be moved to a desired patterned both longitudinally and radially (Weber, Paragraph [0006]).
Regarding claim 21, Anikeeva and Vardiman in view of Weber discloses the spatially expandable probe according to claim 2. Anikeeva and Vardiman in view of Weber also discloses wherein one or more interfacing elements in the plurality of interfacing elements comprise an electrode (Weber, Paragraph [0062]; wherein flexible probe is configured as an electrode). Vardiman also discloses wherein an electrode having openings on the exterior surface of the fiber probe at sites along the length of the fiber probe (Figure 9B, 512; wherein there is an opening on the electrode on the exterior surface); and wherein the interfacing comprises one or both of applying an electrical signal to the tissue at or near the sites (Figure 3G; wherein E is the electrical field being applied to the tissue and T is the tissue) and measuring an electrical signal from the tissue at or near the sites (Figure 3G; wherein the electrical field is measured if it’s able to be shown in a figure). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible probe taught by Anikeeva in view of Weber to include the teachings of Vardimann. The motivation being the electrode provides therapeutic valve to a patient (Vardimann, Paragraph [0106]).
Regarding claim 25, Anikeeva and Vardiman in view of Weber discloses the spatially expandable probe according to claim 2. Vardiman also discloses wherein one or more interfacing elements in the plurality of interfacing elements comprise an optical waveguide having openings on the exterior surface of the fiber probe at sites along the length of the fiber probe (Paragraph [0108]; wherein flexible probes can include a brainwave reader, not shown, which is an optical waveguide); and wherein the interfacing comprises one or both of emitting an optical signal to stimulate the tissue at or near the sites and measuring an optical signal from the tissue at or near the sites (Paragraph [0109]; wherein one or more brainwave monitors could detect the pattern of neural activity and energize one or more electrodes on one or more probes in order to counteract the undesirable neural activity patterns). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible probe taught by Anikeeva in view of Weber to include the teachings of Vardimann. The motivation being to counteract the undesirable neural activity patterns (Vardimann, Paragraph [0109]).
Claims 11 is rejected under 35 U.S.C 103 as being unpatentable over Anikeeva and Vardiman in further view of ROGERS et al. (US 20190090801) herein referred to as ROGERS.
Regarding Claim 11, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. However, Anikeeva in view of Vardiman does not explicitly disclose wherein one or more of the flexible probes has a bending stiffness of about 10 N/m to about 60 N/m when measured at a frequency between 0.01Hz and 10 Hz using the Stiffness Measurement Test.
ROGERS discloses microfluidic probe (Figure 83) disclose wherein one or more of the flexible probes has a bending stiffness of about 10 N/m to about 60 N/m when measured at a frequency between 0.01Hz and 10 Hz using the Stiffness Measurement Test (Figure 91). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible probe taught by Anikeeva in view of Vardiman to include the bending stiffness taught by ROGERS. The motivation being this level of bending stiffness facilitates adaptation to the micromotions associated with movement, respiration, and blood flow (ROGER, Paragraph [0709]).
Claims 13 are rejected under 35 U.S.C 103 as being unpatentable over Anikeeva and Vardiman in further view of Brinkmann et al. (US 20160361120) herein referred to as Brinkmann.
Regarding Claim 13, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. However, Anikeeva in view of Vardiman does not explicitly disclose wherein one or more of the flexible probes has a diameter of about 2000 pm or less.
Brinkmann discloses a probe device (Figure 4) wherein one or more of the flexible probes has a diameter of about 2000 pm or less (Paragraph [0147]; wherein probe fiber has a diameter of 200 pm which is less than 2000 pm). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible probe taught by Anikeeva in view of Vardiman to include the dimensions taught by Brinkmann. The motivation being it would be obvious to try different probe diameters to see which diameter produced the best result of contacting brain tissue (MPEP 2143 (E)).
Claims 15 are rejected under 35 U.S.C 103 as being unpatentable over Anikeeva and Vardiman in view of CHU (US 20190380776) herein referred to as CHU.
Regarding Claim 15, Anikeeva in view of Vardiman discloses the spatially expandable probe according to claim 1. However, Anikeeva in view of Vardiman does not explicitly disclose wherein one or more of the channels in the plurality of helical channels has a pitch of about 0.1 mm to about 25 mm.
CHU discloses a probe with helical element (Figure 2A) wherein one or more of the channels in the plurality of helical channels has a pitch of about 0.1 mm to about 25 mm (Paragraph [0075]; wherein the pitch of a helical element may range between 0.3 mm and 20 mm). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the helical channels taught by in view of Vardiman to include the pitch dimensions taught by CHU. The motivation being it would be obvious to try different pitch dimensions to see which pitch size produced the best result of contacting brain tissue (MPEP 2143 (E)).
Claims 18 is rejected under 35 U.S.C 103 as being unpatentable over Anikeeva, Vardiman and Weber in further view of ROGERS.
Regarding Claim 18, Anikeeva and Vardiman in view of Weber discloses the spatially expandable probe according to claim 2. However, Anikeeva and Vardiman in view of Weber does not explicitly disclose wherein one or more interfacing elements in the plurality of interfacing elements comprise a microfluidic channel having openings on the exterior surface of the fiber probe at sites along the length of the fiber probe; and wherein the interfacing comprises one or both of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue at or near the sites and sampling the tissue at or near the sites.
ROGERS discloses microfluidic probe (Figure 83) disclose wherein one or more interfacing elements in the plurality of interfacing elements comprise a microfluidic channel having openings on the exterior surface of the fiber probe at sites along the length of the fiber probe (Figure 83G); and wherein the interfacing comprises one or both of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue at or near the sites and sampling the tissue at or near the sites (Paragraph [0708]; wherein the probe allows for tandem pharmacological and optogenetic manipulation of neural circuitry, wherein drug delivery is considered prophylactic since it is meant for treatment). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to to have modified the flexible probe taught by Anikeeva, Vardiman and Weber to include the microfluidic channel discloses by ROGERS. The motivation being drug delivery into the tissue (ROGERS, Paragraph [0708]).
Claims 29, 30 & 31 are rejected under 35 U.S.C 103 as being unpatentable over Anikeeva, Varidman and Weber in further view of Mercanzini et al. (US 20130085361) herein referred to as Mercanzini.
Regarding Claim 29, Anikeeva and Vardiman in view of Weber discloses the spatially expandable probe according to claim 2. However, Anikeeva and Vardiman in view of Weber does not explicitly disclose wherein the plurality of interfacing elements comprises at least two, at least three, or at least four interfacing elements, and wherein interfacing the tissue comprises two or more of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue; optical stimulation of the tissue, electrical stimulation of the tissue, and electrical sensing of the tissue at or near the sites.
Mercanzini discloses a microelectrode probe (Figure 4A) wherein the plurality of interfacing elements comprises at least three, interfacing elements (Figure 4A, 265Ma-MC), and wherein interfacing the tissue comprises two or more of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue; optical stimulation of the tissue, electrical stimulation of the tissue, and electrical sensing of the tissue at or near the sites (Paragraph [0132]; wherein microelectrode elements can electrically stimulate the tissue as well as electrical sense the region of tissue that’s of interest). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the interfacing elements taught by Anikeevaand Vardiman in view of Weber to include the interfacing elements taught by Mercanzini. The motivation being to detect and map out the region of interest prior to providing electrical stimulation (Mercanzini, Paragraph [0132]).
Regarding Claim 30, Anikeeva and Vardiman in view of Weber discloses the spatially expandable probe according to claim 2. However, Anikeeva and Vardiman in view of Weber does not explicitly disclose wherein the plurality of interfacing elements comprises at least two, at least three, or at least four interfacing elements, and wherein interfacing the tissue comprises one or more of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue at two sites; optical stimulation of the tissue at two sites, electrical stimulation of the tissue at two sites, and electrical sensing of the tissue at or near two of the sites.
Mercanzini discloses a microelectrode probe (Figure 4A) wherein the plurality of interfacing elements comprises at least three interfacing elements (Figure 4A, 265Ma-MC), and wherein interfacing the tissue comprises one or more of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue at two sites; optical stimulation of the tissue at two sites, electrical stimulation of the tissue at two sites, and electrical sensing of the tissue at or near two of the sites (Paragraph [0132]; wherein microelectrode elements can electrically stimulate the tissue as well as electrical sense the region of tissue that’s of interest at each of the three microelectrode sites). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the interfacing elements taught by Anikeeva and Vardiman in view of Weber to include the interfacing elements taught by Mercanzini. The motivation being to detect and map out the region of interest prior to providing electrical stimulation (Mercanzini, Paragraph [0132]).
Regarding Claim 31, Anikeeva and Vardiman in view of Weber discloses the spatially expandable probe according to claim 2. However, Anikeeva and Vardiman in view of Weber does not explicitly disclose wherein the interfacing elements are sealed at the probe end of the elongated fiber such that the sites are only along the length of the fiber.
Mercanzini discloses a microelectrode probe (Figure 3) wherein the interfacing elements are sealed at the probe end of the elongated fiber such that the sites are only along the length of the fiber (Figure 3, 145Ma-Mc; Paragraph [0153]; wherein Any implanted elements of the stimulation source are preferably fabricated and/or contained with a hermetically sealed, bio-compatible envelope). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the interfacing elements taught by Anikeeva and Vardiman in view of Weber to include the interfacing elements taught by Mercanzini. The motivation being such bio-compatible packaging of signal sources is well known in the art (Mercanzini, Paragraph [0153]).
Conclusion
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794