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 .
Election/Restrictions
Applicant’s election of Invention I, Claims 1-16 and 19-20 in the reply filed on 5/14/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-7, 9, 11, 12 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 2, Claim 2 recites “wherein each group of light emitting diode pixels comprises one of the first light emitting diode and one of the second light emitting diode.” However, both “the first light emitting diode” and “the second light emitting diode” are recited in Claim 1 as a single component. It is thus grammatically unclear whether the “the first light emitting diode” and the “the second light emitting diode” that each group of light emitting diode pixels comprises is the same (e.g., the groups overlap via their inclusion of the same LED) or different (e.g., each group has a different light emitting diode but each is structurally the same) than “the first light emitting diode” and “the second light emitting diode” of Claim 1.
For purposes of this Office Action, “the first light emitting diode” and “the second light emitting diode” are being interpreted as different light emitting diodes that are each structurally the same as those of Claim 1.
Regarding Claim 3, Claim 3 recites “wherein each group of light emitting diode pixels comprises two of the first light emitting diode and two of the second light emitting diode.” This limitation is indefinite for the same reasons as explained above with respect to the similar limitation of Claim 2, and is being interpreted similarly.
Regarding Claim 4, Claim 4 recites “the first light emitting diode pixels” and “the second light emitting diode pixels.” There is insufficient antecedent basis for these limitations. Claim 1 recites “a first plurality of light emitting diode pixels,” “a first light emitting diode” and “a second light emitting diode,” but does not recite either “first light emitting diode pixels” or “second light emitting diode pixels.” It is unclear from the phrasing of Claim 4 which Claim 1 elements are further limited.
For purposes of this Office Action, Claim 4 is being interpreted to mean that individual pixels of the “a first plurality of light emitting diode pixels” recited by Claim 1 are arranged in a grid pattern. Although no “second” such plurality is recited by Claim 1, Claim 4 is being further interpreted to mean that an additional “plurality of light emitting diode pixels” that is different from the “first plurality of light emitting diode pixels” are also arranged in a grid pattern.
Regarding Claim 5, Claim 5 recites “wherein the recording electrodes are positioned adjacent to the plurality of light emitting diode pixels.”
There is insufficient antecedent basis for the term “the plurality of light emitting diode pixels.”
For purposes of this Office Action, the term “the plurality of light emitting diode pixels” is being interpreted to reference “the first plurality of light emitting diode pixels” of Claim 1.
It is grammatically unclear whether individual recording electrodes are contemplated as being adjacent to individual pixels of the plurality of light emitting diode pixels, or whether the entire plurality of light emitting diode pixels as a whole is adjacent such recording electrodes.
For purposes of this Office Action, the latter interpretation is being used.
Regarding Claim 6, Claim 6 recites “wherein the first light emitting diode pixel is a red light emitting diode pixel.”
There is insufficient antecedent basis for the term “the first light emitting diode pixel.”
It is unclear which element of Claim 1 is intended to be modified such that it is “a red light emitting diode pixel.”
For purposes of this Office Action, the term “wherein the first light emitting diode pixel is a red light emitting diode pixel” is being interpreted to mean that a pixel of the “the first plurality of light emitting diode pixels” of Claim 1 is red.
Regarding Claim 7, Claim 7 recites “wherein the second light emitting diode pixel is a blue light emitting diode pixel.”
There is insufficient antecedent basis for the term “the second light emitting diode pixel.”
It is unclear which element of Claim 1 is intended to be modified such that it is “a blue light emitting diode pixel.”
For purposes of this Office Action, the term “wherein the second light emitting diode pixel is a blue light emitting diode pixel” is being interpreted to mean that a pixel of the “the first plurality of light emitting diode pixels” of Claim 1 is blue.
Regarding Claim 9, Claim 9 recites “wherein the first plurality of light emitting diode pixels span a distance of 300 to 1500 micrometers at the probe tip.” It is grammatically unclear in what sense the phrase “at the probe tip” limits the claim. For example, “at the probe tip” might mean that the distance spanned is measured from the probe tip, that the first plurality of light emitting diode pixels are “at the probe tip” and “span a distance of 300 to 1500 micrometers” thereupon, or something else.
For purposes of this Office Action, Claim 9 is being interpreted to mean that the distance spanned is measured from the probe tip.
Regarding Claim 11, Claim 11 recites “wherein the second plurality of light emitting diode pixels comprises a first light emitting diode and a second light emitting diode.” It is unclear whether the “a first light emitting diode and a second light emitting diode” of Claim 11 are the same as or different from the “a first light emitting diode and a second light emitting diode” of Claim 1.
For purposes of this Office Action, the “a first light emitting diode and a second light emitting diode” of Claim 11 are being interpreted as different than the “a first light emitting diode and a second light emitting diode” of Claim 1.
Regarding Claim 12, Claim 12 recites “wherein the second plurality of light emitting diode pixels span a distance of 300 to 1500 micrometers at the probe tip.” This limitation is indefinite for the same reasons as explained above with respect to the similar limitation of Claim 9, and is being interpreted similarly.
Regarding Claim 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0106204 A1 to Segev et al. (“Segev”) in view of Mao, D. et al., "Single-Cell Optogenetic Control of Calcium Signaling with a High-Density Micro-LED Array" iScience. 2019; 21:403-412 (“Mao”) and Li ET AL., "Colocalized, bidirectional optogenic modulations in freely behaving mice with a wireless dual-color optoelectronic probe" Nature Communications, Vol. 13, 2022, page 1-141 (“Li”).
Regarding Independent Claim 1, Segev teaches:
An optical neural probe comprising (Abstract, “A neural probe for light stimulation of a tissue is provided.”);
a probe body; (Fig. 5; see Annotated Fig. 5, below);
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a shank extending from the probe body to a tip; (Fig. 5; see Annotated Fig. 5, above);
wherein the tip comprises a first plurality of light emitting diode pixels (Para. [0058], “An alternative approach involves the integration of microscale light emitting diodes (μLEDs) directly onto the probe shanks17-19.” Fig. 5; see Annotated Fig. 5, above);
and a first plurality of recording electrodes, (Para. [0028], “FIG. 8 is a panel showing in vivo photoactivation of hippocampal CA3 pyramidal neurons in a mouse with concomitant electrophysiological recording. (8 a) Schematic depicting the relative configuration of a recording electrode tip, the photonic probe, and light that is emitted from one E-pixel.” (emphasis added));
and wherein each group of light emitting diode pixels has a center-to-center distance of 30 to 150 micrometers. (Para. [0048], “The pitch of the E-pixels of a probe can be adjusted by changing either or both the shank-to-shank spacing in an array, and the spacing of E-pixels on a shank. In some embodiments, the pitch can be in the range of about 200 μm to about 50 μm, or less than or equal to about 50 μm;” Para. [0062], “E-pixels arrays (FIG. 5b ) can be placed at any location along the implantable shanks; in the first prototypes reported here, we include nine E-pixels, spaced on a 200 μm pitch. It is straightforward to achieve ≦50 μm spacing between adjacent E-pixels without changing our fabrication protocols29 (Appendix A);” Para. [0081], “As stated in the main text, the E-pixels on our initial prototype probes are spaced 200 μm apart. This spacing is being reduced to 100 μm in our current design, and will be further reduced to about 50 μm, without any requisite changes in the design or fabrication methodology.”).
Segev does not fairly disclose such an arrangement in groups as claimed. This deficiency is addressed below. However, Segev describes “groups of 1,” which “groups of 1” Segev describes as being spaced apart “in the range of about 200 μm to about 50 μm.” Segev thus teaches such spacing as claimed.
Segev’s range of “about 200 μm to about 50 μm” overlaps the claimed range of “30 to 150 micrometers.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Although Segev does not disclose the precise range of “30 to 150 micrometers,” it would have been obvious for a person of ordinary skill in the art to select from Segev’s disclosed range of “about 200 μm to about 50 μm” any suitable range, including a range of “30 to 150 micrometers” as claimed. So-doing would entail only routine optimization, and is likely based on Segev’s disclosure to result in success.
Segev does not disclose:
wherein the first plurality of light emitting diode pixels comprises a first light emitting diode and a second light emitting diode, wherein the first light emitting diode and the second light emitting diode emit a different color of light;
wherein the first plurality of light emitting diode pixels are arranged in groups,
wherein each light emitting diode pixel in a group has a center-to-center distance of 10 to 50 micrometers;
Mao describes “Single-Cell Optogenetic Control of Calcium Signaling with a High-Density Micro-LED Array” (Title). Mao is analogous art.
Mao teaches:
wherein the first plurality of light emitting diode pixels comprises a first light emitting diode and a second light emitting diode, (Pg. 405, First Paragraph, “On the hardware side, we fabricated a GaN-based, 4-by-4 micro-LED array that can output 462/19 nm light to activate ChR2 (Figure S2);” Pg. 404, Figure 1);
Each micro-LED of Mao’s “4-by-4 micro-LED array” is such a “light emitting diode” as claimed, and Mao’s array contains 16 such light emitting diodes. Mao thus teaches such “a first light emitting diode and a second light emitting diode” as claimed.
wherein the first plurality of light emitting diode pixels are arranged in groups, (Pg. 405, First Paragraph, “On the hardware side, we fabricated a GaN-based, 4-by-4 micro-LED array that can output 462/19 nm light to activate ChR2 (Figure S2);” Pg. 404, Figure 1B);
Mao’s “4-by-4 micro-LED array” is such a group as claimed.
wherein each light emitting diode pixel in a group has a center-to-center distance of 10 to 50 micrometers; (Pg. 405, First Paragraph, “Using reactive-ion etching steps, a total of 16 LED pixels, each 6.5 μm-by-6.5 μm in size, were patterned in a cross-bar structure with a 16-μm pitch (Figure 1B);” Pg. 404, Figure 1B).
Mao’s “16-μm pitch” is such “a center-to-center distance of 10 to 50 micrometers” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Segev with the teachings of Mao (i.e., to expand upon Segev’s approach of Segev Para. [0058] where Segev’s pixels comprise microscale light emitting diodes integrated directly into the Sergey’s probe by using for each of Segev’s microscale LEDs such a high-density “4-by-4 micro-LED array” as taught by Mao) in order to “optogenetically address individual cells that are sub-10 μm apart in densely packed cell populations” (Mao at Pg. 403, Summary Section).
The Examiner notes that pursuant to such modification, the device of combined Segev and Mao would comprise a first light emitting diode and a second light emitting diode as the first plurality of light emitting diode pixels in the manner claimed, and would result in the first plurality of light emitting diode pixels being arranged in groups in the manner claimed. Keeping with Mao’s “16-μm pitch,” each light emitting diode pixel in the group would thus have “a center-to-center distance of 10 to 50 micrometers” as claimed.
The combination of Segev and Mao does not disclose:
wherein the first light emitting diode and the second light emitting diode emit a different color of light;
Li describes “Colocalized, bidirectional optogenetic modulations in freely behaving mice with a wireless dual-color optoelectronic probe” (Title). Li is analogous art.
Li teaches:
wherein the first light emitting diode and the second light emitting diode emit a different color of light; (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
Li teaches a particular configuration for a dual-color LED probe configured to emit blue and red light. The Examiner notes that Li is used for its more general teaching of the benefit of such a dual-color LED probe configured to emit blue and red light rather than for any particular configuration (e.g., Li’s “vertically stacked” configuration or the more typical “laterally arranged” configuration).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Segev and Mao with the teachings of Li (i.e., to use a first light emitting diode and a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) in order to facilitate “perform[ance of] dual-color neural activation and inhibition” (Li at Pg. 3, Fig. 1 Caption).
Regarding Claim 2, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Li additionally teaches:
wherein each group of light emitting diode pixels comprises one of the first light emitting diode and one of the second light emitting diode (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Segev, Mao and Li with the teachings of Li (i.e., to use for each of Segev as modified by Mao’s groups a first light emitting diode and a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) in order to facilitate “perform[ance of] dual-color neural activation and inhibition” (Li at Pg. 3, Fig. 1 Caption).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Segev, Mao and Li with the teachings of Li (i.e., to use for each of Segev as modified by Mao’s groups a first light emitting diode and a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) because such a modification entails mere duplication of parts, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. See MPEP 2144.04(VI)(B).
Regarding Claim 3, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Li additionally teaches:
wherein each group of light emitting diode pixels comprises two of the first light emitting diode and two of the second light emitting diode (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Segev, Mao and Li with the teachings of Li (i.e., to use for each of Segev as modified by Mao’s groups a first light emitting diode and a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) in order to facilitate “perform[ance of] dual-color neural activation and inhibition” (Li at Pg. 3, Fig. 1 Caption).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Segev, Mao and Li with the teachings of Li (i.e., to use for each of Segev as modified by Mao’s groups two of a first light emitting diode and two of a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) because such a modification entails mere duplication of parts, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. See MPEP 2144.04(VI)(B).
Regarding Claim 4, the combination of Segev, Mao and Li renders obvious the entirety of Claim 3 as explained above.
Segev additionally teaches:
wherein the first light emitting diode pixels and the second light emitting diode pixels are arranged in a grid pattern (Para. [0062], “E-pixels arrays (FIG. 5b ) can be placed at any location along the implantable shanks; in the first prototypes reported here, we include nine E-pixels, spaced on a 200 μm pitch. It is straightforward to achieve ≦50 μm spacing between adjacent E-pixels without changing our fabrication protocols29 (Appendix A);” Paras. [0046] through [0050], describing arrayed shanks).
Segev arranges pixels on each of Segev’s shanks in an array, and additionally arranges Segev’s shanks themselves in an array. The combined “pixel-on-shank” plus “multiple shank” arrays form such a “grid pattern” of pixels as claimed. The pixels on the first of Segev’s such shanks corresponds to “the first light emitting diode pixels,” and the pixels on the second of Segev’s such shanks corresponds to “the second light emitting diode pixels.”
Regarding Claim 5, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
wherein the recording electrodes are positioned adjacent to the plurality of light emitting diode pixels (Para. [0028], “FIG. 8 is a panel showing in vivo photoactivation of hippocampal CA3 pyramidal neurons in a mouse with concomitant electrophysiological recording. (8 a) Schematic depicting the relative configuration of a recording electrode tip, the photonic probe, and light that is emitted from one E-pixel.” (emphasis added)).
Segev’s recording electrodes are positioned adjacent to the plurality of light emitting diode pixels in that Segev’s recording electrodes are positioned on the tip of Segev’s shank, which tip is beyond when Segev’s pixels end.
Regarding Claim 6, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Li additionally teaches:
wherein the first light emitting diode pixel is a red light emitting diode pixel (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
As explained above, the term “wherein the first light emitting diode pixel is a red light emitting diode pixel” is being interpreted to mean that a pixel of the “the first plurality of light emitting diode pixels” of Claim 1 is red.
Regarding Claim 7, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Li additionally teaches:
wherein the second light emitting diode pixel is a blue light emitting diode pixel (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
As explained above, the term “wherein the second light emitting diode pixel is a blue light emitting diode pixel” is being interpreted to mean that a pixel of the “the first plurality of light emitting diode pixels” of Claim 1 is blue.
Regarding Claim 8, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
wherein the shank is configured to locate the tip at a probing depth to target a neuron. (Para. [0025]; Para. [0046]).
Regarding Claim 9, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
wherein the first plurality of light emitting diode pixels span a distance of 300 to 1500 micrometers at the probe tip. (Para. [0026], “In this image, blue light (473 nm) is emitted from an E-pixel located approximately 250 μm away from the tip of the shank. This light stimulates the green photoluminescence visible in the image. (Inset, top) Optical micrograph showing another E-pixel (here, approximately 100 μm from the shank tip) emitting blue light;” Para. [0062], “E-pixels arrays (FIG. 5b ) can be placed at any location along the implantable shanks; in the first prototypes reported here, we include nine E-pixels, spaced on a 200 μm pitch. It is straightforward to achieve ≦50 μm spacing between adjacent E-pixels without changing our fabrication protocols29 (Appendix A);” Fig. 5b).
Per Segev Para. [0026], Segev’s shank includes pixels that are “located approximately 250 μm away from the tip of the shank.” Per Segev Para. [0062], Segev’s pixels are “spaced on a 200 μm pitch,” and nine such pixels are present. Segev’s “first plurality of light emitting diode pixels” thus “span a distance of 300 to 1500 micrometers at the probe tip” in the manner claimed.
Regarding Claim 10, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
wherein the shank has a thickness of less than 100 micrometers; a width of 100 to 250 micrometers; and a length of 3 to 12 millimeters (Para. [0046], “Elongated microsized shanks can be of an arbitrary length to reach any region within the tissue. In some embodiments, a shank can have a length of about 1 mm or more, about 2 mm or more, about 3 mm, about 4 mm or more, or about 5 mm or more. A shank can be sized to minimize damage to the tissue. For example, a shank can be sufficiently narrow so as to circumvent immune responses, scarring and gliosis after implantation into brain or other nervous tissue. In some embodiments, the width of the shank can be about 500 μm or less, about 400 μm or less, about 300 μm or less, about 200 μm or less, about 100 μm or less, about 50 μm or less, or about 25 μm or less, and the thickness of the shank can be about 100 μm or less, about 75 μm or less, about 50 μm or less, about 25 μm or less, about 20 μm or less, or about 15 μm or less.” (emphasis added)).
Segev’s “thickness of … about 100 μm or less…” is such “a thickness of less than 100 micrometers” as claimed.
Segev’s “width of … about 300 μm or less” overlaps the claimed range of “a width of 100 to 250 micrometers.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Although Segev does not disclose the precise range of “a width of 100 to 250 micrometers,” it would have been obvious for a person of ordinary skill in the art to select from Segev’s disclosed range of “a width of … about 300 μm or less” any suitable range, including a range of “a width of 100 to 250 micrometers” as claimed. So-doing would entail only routine optimization, and is likely based on Segev’s disclosure to result in success.
Segev’s “length of … about 3 mm, about 4 mm or more, or about 5 mm or more” overlaps the claimed range of “a length of 3 to 12 millimeters.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Although Segev does not disclose the precise range of “a length of 3 to 12 millimeters,” it would have been obvious for a person of ordinary skill in the art to select from Segev’s disclosed range of “a length of … about 3 mm, about 4 mm or more, or about 5 mm or more” any suitable range, including a range of “a length of 3 to 12 millimeters” as claimed. So-doing would entail only routine optimization, and is likely based on Segev’s disclosure to result in success.
Regarding Claim 11, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
further comprising a second plurality of light emitting diode pixels and a second plurality of recording electrodes, (Para. [0058]; Para. [0048]; Fig. 5; see Annotated Fig. 5, above at Claim 1; Abstract, “The probe includes a base that has light supplying circuitry, and one or more elongated microsized shanks extending from the base. Each shank has a longitudinal axis and includes one or more waveguides extending along the shank's length, with the waveguides being optically connected to the light supplying circuitry;” Para. [0046]’ Para. [0047]);
Segev teaches multiple shanks each having the configuration of that explained above with respect to Claim 1. Claim 11 broadly recites that the optical neural probe of Claim 1 further comprises such a second plurality of light emitting diodes as claimed, without mention of any particular component on which the second plurality is positioned. A second shank of Segev’s multiple shanks thus reads on Claim 11. The foregoing rejection of Claim 11 is based on this interpretation.
wherein each group of light emitting diode pixels has a center-to-center distance of 30 to 70 micrometers; (Abstract; Para. [0048], “The pitch of the E-pixels of a probe can be adjusted by changing either or both the shank-to-shank spacing in an array, and the spacing of E-pixels on a shank. In some embodiments, the pitch can be in the range of about 200 μm to about 50 μm, or less than or equal to about 50 μm.”);
Segev’s disclosed range of “200 μm to about 50 μm, or less than or equal to about 50 μm” overlaps the claimed range of “30 to 70 micrometers.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Although Segev does not disclose the precise range of “30 to 70 micrometers,” it would have been obvious for a person of ordinary skill in the art to select from Segev’s disclosed range of “200 μm to about 50 μm, or less than or equal to about 50 μm” any suitable range, including a range of “30 to 70 micrometers” as claimed. So-doing would entail only routine optimization, and is likely based on Segev’s disclosure to result in success.
and wherein the second plurality of light emitting diode pixels and the second plurality of recording electrodes are positioned 1 to 2 millimeters away from the first plurality of light emitting diode pixels and the first plurality of recording electrodes. (Para. [0048], “The pitch of the E-pixels of a probe can be adjusted by changing either or both the shank-to-shank spacing in an array, and the spacing of E-pixels on a shank. In some embodiments, the pitch can be in the range of about 200 μm to about 50 μm, or less than or equal to about 50 μm.”).
Segev does not disclose a distance of 1 to 2 millimeters between Segev’s first and second plurality of light emitting diodes. However, Segev teaches that such distance is easily manipulable via alteration to shank spacing, and provides “about 200 μm to about 50 μm” as an example spacing. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Segev’s shank spacing such that it results in a pitch of “1 to 2 millimeters” because such a modification entails a mere change in size/proportion, which is a common practices court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. Segev’s shanks are amenable to any spacing, and such a change in spacing entails only routine optimization that is likely to result in success per Segev’s disclosure.
Mao teaches:
wherein the second plurality of light emitting diode pixels comprises a first light emitting diode and a second light emitting diode (Pg. 405, First Paragraph, “On the hardware side, we fabricated a GaN-based, 4-by-4 micro-LED array that can output 462/19 nm light to activate ChR2 (Figure S2);” Pg. 404, Figure 1);
Each micro-LED of Mao’s “4-by-4 micro-LED array” is such a “light emitting diode” as claimed, and Mao’s array contains 16 such light emitting diodes. Mao thus teaches such “a first light emitting diode and a second light emitting diode” as claimed.
wherein the second plurality of light emitting diode pixels are arranged in groups, (Pg. 405, First Paragraph, “On the hardware side, we fabricated a GaN-based, 4-by-4 micro-LED array that can output 462/19 nm light to activate ChR2 (Figure S2);” Pg. 404, Figure 1B);
Mao’s “4-by-4 micro-LED array” is such a group as claimed.
wherein each light emitting diode pixel in a group has a center-to-center distance of 10 to 30 micrometers; (Pg. 405, First Paragraph, “Using reactive-ion etching steps, a total of 16 LED pixels, each 6.5 μm-by-6.5 μm in size, were patterned in a cross-bar structure with a 16-μm pitch (Figure 1B);” Pg. 404, Figure 1B).
Mao’s “16-μm pitch” is such “a center-to-center distance of 10 to 50 micrometers” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Segev with the teachings of Mao (i.e., with respect to a second of Segev’s shanks, to expand upon Segev’s approach of Segev Para. [0058] where Segev’s pixels comprise microscale light emitting diodes integrated directly into the Sergey’s probe by using for each of Segev’s microscale LEDs such a high-density “4-by-4 micro-LED array” as taught by Mao) in order to “optogenetically address individual cells that are sub-10 μm apart in densely packed cell populations” (Mao at Pg. 403, Summary Section).
Li additionally teaches:
wherein the first light emitting diode and the second light emitting diode emit a different color of light; (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Segev and Mao with the teachings of Li (i.e., with respect to a second of Segev’s shanks, to use a first light emitting diode and a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) in order to facilitate “perform[ance of] dual-color neural activation and inhibition” (Li at Pg. 3, Fig. 1 Caption).
Regarding Claim 12, the combination of Segev, Mao and Li renders obvious the entirety of Claim 11 as explained above.
wherein the second plurality of light emitting diode pixels span a distance of 300 to 1500 micrometers at the probe tip (Para. [0026], “In this image, blue light (473 nm) is emitted from an E-pixel located approximately 250 μm away from the tip of the shank. This light stimulates the green photoluminescence visible in the image. (Inset, top) Optical micrograph showing another E-pixel (here, approximately 100 μm from the shank tip) emitting blue light;” Para. [0062], “E-pixels arrays (FIG. 5b ) can be placed at any location along the implantable shanks; in the first prototypes reported here, we include nine E-pixels, spaced on a 200 μm pitch. It is straightforward to achieve ≦50 μm spacing between adjacent E-pixels without changing our fabrication protocols29 (Appendix A);” Fig. 5b).
Per Segev Para. [0026], Segev’s shank includes pixels that are “located approximately 250 μm away from the tip of the shank.” Per Segev Para. [0062], Segev’s pixels are “spaced on a 200 μm pitch,” and nine such pixels are present. Segev’s “first plurality of light emitting diode pixels” thus “span a distance of 300 to 1500 micrometers at the probe tip” in the manner claimed.
The Examiner notes that Claim 12 is being interpreted under the same “second shank” interpretation as explained above with respect to Claim 11, with the subject distance being judged relative to the same “the probe tip” of Claim 1, which “the probe tip” serves as a basis for absolute measure.
Regarding Claim 13, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Mao additionally teaches:
wherein the probe body comprises electrical connections for electrical communication with a printed circuit board. (Pg. 404, Figure 1 Caption, “(A) One micro-LED array wired bonded onto a printed circuit board (PCB) under an upright fluorescence microscope configured for cell imaging.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Segev, Mao and Li with the teachings of Mao (i.e., to employ such a printed circuit board as taught by Mao and its associated connections) because such a modification entails only a simple substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., that of combined Segev, embodiment of Para. [0058], Mao and Li) which differed from the claimed device by the substitution of some components (i.e., Segev’s unspecified means of electronic control) with other components (i.e., a printed circuit board and its associated electrical connections).
The substituted components and their functions were known in the art. For example, Mao teaches such a printed circuit board and its associated electrical connections at Pg. 404, Figure 1 Caption.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Regarding Claim 14, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Mao additionally teaches:
wherein the optical neural probe further comprises a printed circuit board bound to the probe body (Pg. 404, Figure 1 Caption, “(A) One micro-LED array wired bonded onto a printed circuit board (PCB) under an upright fluorescence microscope configured for cell imaging.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Segev, Mao and Li with the teachings of Mao (i.e., to employ such a printed circuit board as taught by Mao and its associated connections) because such a modification entails only a simple substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., that of combined Segev, embodiment of Para. [0058], Mao and Li) which differed from the claimed device by the substitution of some components (i.e., Segev’s unspecified means of electronic control) with other components (i.e., a printed circuit board and its associated electrical connections).
The substituted components and their functions were known in the art. For example, Mao teaches such a printed circuit board and its associated electrical connections at Pg. 404, Figure 1 Caption.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Regarding Claim 15, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
further comprising a second shank extending from the probe body to a second tip, (Para. [0058]; Para. [0048]; Fig. 5; see Annotated Fig. 5, above at Claim 1; Abstract, “The probe includes a base that has light supplying circuitry, and one or more elongated microsized shanks extending from the base. Each shank has a longitudinal axis and includes one or more waveguides extending along the shank's length, with the waveguides being optically connected to the light supplying circuitry;” Para. [0046]; Para. [0047]);
Segev teaches multiple shanks each having the configuration of that explained above with respect to Claim 1. A second shank of Segev’s multiple shanks thus reads on Claim 15.
wherein the second tip comprises a third plurality of light emitting diode pixels and a third plurality of recording electrodes, (Para. [0058]; Para. [0048]; Fig. 5; see Annotated Fig. 5, above at Claim 1);
wherein each group of light emitting diode pixels has a center-to-center distance of 30 to 150 micrometers(Para. [0048], “The pitch of the E-pixels of a probe can be adjusted by changing either or both the shank-to-shank spacing in an array, and the spacing of E-pixels on a shank. In some embodiments, the pitch can be in the range of about 200 μm to about 50 μm, or less than or equal to about 50 μm;” Para. [0062], “E-pixels arrays (FIG. 5b ) can be placed at any location along the implantable shanks; in the first prototypes reported here, we include nine E-pixels, spaced on a 200 μm pitch. It is straightforward to achieve ≦50 μm spacing between adjacent E-pixels without changing our fabrication protocols29 (Appendix A);” Para. [0081], “As stated in the main text, the E-pixels on our initial prototype probes are spaced 200 μm apart. This spacing is being reduced to 100 μm in our current design, and will be further reduced to about 50 μm, without any requisite changes in the design or fabrication methodology.”).
Segev does not fairly disclose such an arrangement in groups as claimed. This deficiency is addressed below. However, Segev describes “groups of 1,” which “groups of 1” Segev describes as being spaced apart “in the range of about 200 μm to about 50 μm.” Segev thus teaches such spacing as claimed.
Segev’s range of “about 200 μm to about 50 μm” overlaps the claimed range of “30 to 150 micrometers.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Although Segev does not disclose the precise range of “30 to 150 micrometers,” it would have been obvious for a person of ordinary skill in the art to select from Segev’s disclosed range of “about 200 μm to about 50 μm” any suitable range, including a range of “30 to 150 micrometers” as claimed. So-doing would entail only routine optimization, and is likely based on Segev’s disclosure to result in success.
Mao additionally teaches:
wherein the third plurality of light emitting diode pixels comprises a third light emitting diode and a fourth light emitting diode, (Pg. 405, First Paragraph, “On the hardware side, we fabricated a GaN-based, 4-by-4 micro-LED array that can output 462/19 nm light to activate ChR2 (Figure S2);” Pg. 404, Figure 1);
Each micro-LED of Mao’s “4-by-4 micro-LED array” is such a “light emitting diode” as claimed, and Mao’s array contains 16 such light emitting diodes. Mao thus teaches such “a first light emitting diode and a second light emitting diode” as claimed.
wherein each light emitting diode pixel within the third plurality of light emitting diode pixels has a center-to-center distance of 10 to 50 micrometers; (Pg. 405, First Paragraph, “Using reactive-ion etching steps, a total of 16 LED pixels, each 6.5 μm-by-6.5 μm in size, were patterned in a cross-bar structure with a 16-μm pitch (Figure 1B);” Pg. 404, Figure 1B).
Mao’s “16-μm pitch” is such “a center-to-center distance of 10 to 50 micrometers” as claimed.
and wherein the third plurality of light emitting diode pixels are arranged in groups, (Pg. 405, First Paragraph, “On the hardware side, we fabricated a GaN-based, 4-by-4 micro-LED array that can output 462/19 nm light to activate ChR2 (Figure S2);” Pg. 404, Figure 1);
Each micro-LED of Mao’s “4-by-4 micro-LED array” is such a “light emitting diode” as claimed, and Mao’s array contains 16 such light emitting diodes. Mao thus teaches such “a first light emitting diode and a second light emitting diode” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Segev with the teachings of Mao (i.e., with respect to a second of Segev’s shanks, to expand upon Segev’s approach of Segev Para. [0058] where Segev’s pixels comprise microscale light emitting diodes integrated directly into the Sergey’s probe by using for each of Segev’s microscale LEDs such a high-density “4-by-4 micro-LED array” as taught by Mao) in order to “optogenetically address individual cells that are sub-10 μm apart in densely packed cell populations” (Mao at Pg. 403, Summary Section).
Li additionally teaches:
wherein the third light emitting diode and the fourth light emitting diode emit a different color of light; (Pg. 2, Right Column, First Paragraph, “…the probe structure comprises of a copper (Cu)-coated polyimide (PI) thin film substrate, an indium gallium phosphide (InGaP) red LED, a silicon oxide (SiO2)/titanium oxide (TiO2)-based dielectric filter, and an indium gallium nitride (InGaN) blue LED;” Pg. 2, Right Column, Second Paragraph, “Separate metallization and electrical insulation ensure that red and blue micro-LEDs can be independently lighted up and display spectrally varied illuminations (red, blue, or combined) in the same location (Fig. le and Supplementary Movie Sl);” Pg. 3, Fig. 1 Caption).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Segev and Mao with the teachings of Li (i.e., with respect to a second of Segev’s shanks, to use a first light emitting diode and a second light emitting diode that emit a different color of light in accordance with the benefit of such a dual-color LED probe configured to emit blue and red light rather taught by Li) in order to facilitate “perform[ance of] dual-color neural activation and inhibition” (Li at Pg. 3, Fig. 1 Caption).
Regarding Claim 16, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
wherein the shank comprises silicon or an alloy thereof. (Paras. [0021] through [0022]; Para. [0025]).
Regarding Claim 19, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
A method of stimulating target neurons expressing light responsive proteins in a tissue, the method comprising: (Para. [0017], “In another aspect, a method of illuminating a tissue is provided;” Para. [0028], “FIG. 8 is a panel showing in vivo photoactivation of hippocampal CA3 pyramidal neurons in a mouse with concomitant electrophysiological recording.”);
inserting an optical neural probe into the tissue, (Para. [0017], “ The method includes inserting one or more elongated microsized shanks into the tissue….”);
wherein the optical neural probe is according to claim 1; (see Rejection of Claim 1, above);
activating the optical neural probe to deliver light to stimulate the target neurons; (Para. [0017], “In another aspect, a method of illuminating a tissue is provided;” Para. [0028], “FIG. 8 is a panel showing in vivo photoactivation of hippocampal CA3 pyramidal neurons in a mouse with concomitant electrophysiological recording.”);
and measuring neuronal activity with the recording electrodes in response to stimulating the target neurons. (Para. [0028], “FIG. 8 is a panel showing in vivo photoactivation of hippocampal CA3 pyramidal neurons in a mouse with concomitant electrophysiological recording.”).
Regarding Claim 20, the combination of Segev, Mao and Li renders obvious the entirety of Claim 1 as explained above.
Segev additionally teaches:
wherein the tissue is of a living test subject such as an animal or human, or wherein the tissue is an organoid. (Para. [0028], “FIG. 8 is a panel showing in vivo photoactivation of hippocampal CA3 pyramidal neurons in a mouse with concomitant electrophysiological recording.”).
Art Made of Record but Not Relied Upon
The Examiner notes as relevant the following art, which is made of record although not relied upon in the foregoing rejection:
US 2023/0101125 A1 to Wang et al. (“Wang”) describes “Systems And Method For Optogenetically Controlling Insulin Secretion For Treating Type 1 Diabetes” (Title) and discloses at Fig. 2a and Para. [0022] “four individually addressable microscale light emitting diode (μLEDs) 220” arranged in a grid pattern.
US 2020/0073100 A1 to Gibson et al. (“Gibson”) describes “optical interfaces and methods for rapid volumetric neural sensing and modulation” (Para. [0003]) in the context of optogenetics (Para. [0004]) and discloses a “…micro-patterned LED array at 488 nm in a grid pattern consisting of hundreds of individually addressable pixels” (Para. [0078]; see also Paras. [0085] through [0088]).
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 Li ET AL., "Colocalized, bidirectional optogenic modulations in freely behaving mice with a wireless dual-color
optoelectronic probe" Nature Communications, Vol. 13, 2022, page 1-14 was disclosed by Applicant in the IDS dated 10/8/2024.
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