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 . Claims 1-4 and 7-18 are currently pending, with claims 14-18 being withdrawn as per the Election (08/21/2026).
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 08/21/2026 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 non-obviousness.
Claims 1-4, 7-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ji et al. “Flexible polyimide-based hybrid optoelectric neural interface with 16 channels of micro-LEDs and electrodes” Microsystems & Nanoengineering (2018) 4:27 (hereinafter Ji) in view of Rogers et al. US Publication 2016/0066789 (hereinafter Rogers).
Regarding claim 1, Ji discloses a probe assembly (Figure 1a), comprising a recording probe (Figure 2b and Fabrication of the microelectrode array section) having one or more recording traces (Figure 2b which shows the layers including a trace wires of gold (Au) where there are 16 traces connected to the 16 electrodes, see the Materials and Methods section); and a stimulating probe having one or more stimulating traces (Figure 2a which shows gold traces connected to gold wires and silver paste; see also Fabrication of the micro-LED array section), the stimulating probe being stacked against the recording probe (Figure 2C, Results as well as Back-to-Back alignment assembly sections); and a plurality of polymer layers including a top surface polymer layer on a top surface of the recording probe (Figure 2b which includes layers of polyimide above and below the gold traces), a recording probe interface polymer layer on a bottom surface of the recording probe (Figure 2b which includes layers of polyimide above and below the gold traces), a stimulating probe interface polymer layer on a top surface of the stimulating probe (Figure 2a which includes layers of polyimide above and below the gold traces), and a bottom surface polymer layer on a bottom surface of the stimulating probe (Figure 2a which includes layers of polyimide above and below the gold traces), wherein the top surface polymer layer and the recording probe interface polymer layer sandwich the one or more recording traces (Figure 2b), and the stimulating probe interface polymer layer and the bottom surface polymer layer sandwich the one or more stimulating traces (Figure 2a) such that the plurality of polymer layers, the one or more recording traces, and the one or more stimulating traces are configured to conform around an anatomical structure (Figure 2c which shows the final structure, where given the material choice the device is identical to the Applicant’s, the device is fully capable of conforming around an anatomical structure; additionally, Figure 1e appears to show such contact over a rats cerebral cortex).
Ji teaches more of a planar design, and while “probe shank” does not inherently include structure, Ji could still meet the above language given that the probe shank’s special definition is simply the remainder of the claim. So, if the rest of the limitations are met, they collectively are considered a probe shank based on the structure of the claim. In the alternate, Rogers teaches an implantable neural device that can be in the form of a probe shank (Figures 1b-c, e). It would have been obvious to the skilled artisan before the effective filing date to utilize the shaping as taught by Rogers with the device of Ji as a matter of design choice. Further the designs of the planar substrate (shown in Ji) is an art recognized equivalent to a shank type substrate (of Rogers) as both can accomplish similar tasks depending on the exact anatomy to be addressed (see teaching reference Ricket et al. US 2009/0221896 at Figures 1b-2).
Regarding claim 2, Ji discloses that the plurality of polymer layers are made from a polyimide-based material (abstract, Figure 2 which details polyimide).
Regarding claim 3, Ji is silent on the other material options as claimed. Rogers details that the plurality of polymer layers is made from a parylene-based material, a PDMS-based material, or a silicone-based material (which details both polyimide as well as silicones). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the materials of Rogers in lieu of the polyimide of Ji as they are art recognized equivalents.
Regarding claim 4, the resultant combination of Ji and Rogers above is fully capable of bending the overall polymer layers into one of a plurality of hills and valleys (see also Rogers Figure 1e showing a base curvature and [0071] which details anatomical structures within the brain that require extreme amounts of curving and flexibility).
Regarding claim 7, Ji discloses that the recording probe includes an optical window configured to at least partially expose a light source on the stimulating probe (Figure 2c which shows the opening near the transparent UV adhesive for the LED to shine through to the recording probe from the stimulating probe).
Regarding claim 8, Ji discloses that the light source on the stimulating probe is an inorganic light emitting device (ILED), an organic light emitting device (OLED), a quantum dot (QD), or an electroluminescent device (the Design of the opto-electric neural interface section, paragraph three includes the exact make/model of the LEDs used which are bare micro-LED chips (C460TR2227-0328, Cree Inc., USA) and they are inorganic LEDs).
Regarding claim 11, Ji is silent on the additional subassemblies. Rogers teaches various functional subassemblies being stacked together (Figure 1B), the various functional assemblies including one or more temperature sensors, one or more neurotransmitter sensors, and/or one or more microfluidic layers or channels ([0019] and at layer #4 of Figure 1B). It would have been obvious to the skilled artisan before the effective filing date to utilize the additional functional subassemblies/layers are taught by Rogers with the device of Ji in order to aid in monitoring temperature of both the surrounding tissue and the device itself (see Rogers [0019]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ji in view of Rogers, as applied to claim 7, and in further view of Deligianni et al. US Publication 2019/0232083 (hereinafter Deligianni).
Regarding claim 9, Ji discloses a plurality of light sources (abstract which details 16 of the light sources, I-LEDs), but is silent on the multiple colors or wavelengths. Deligianni teaches a neural probe that includes stimulating via light sources that includes utilizing different colors having different wavelengths ([0026]). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the different colors/wavelength as taught by Deligianni with the LEDs of Ji to express different optogenetic opsins (as mentioned by Ji in paragraph four of “Design of the opto-electric neural interface” section).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ji in view of Rogers, and in further view of Guo et al. “A Polyimide-Based Flexible Optoelectrodes for Low-Noise Neural Recording” IEEE Electron Device Letters, Vol. 40, No. 7, July 2019 (hereinafter Guo).
Regarding claim 10, Ji is silent on the shielding. Guo teaches a near identical device that additionally includes a metal shielding layer is placed between the recording probe and the stimulating probe (the metal shielding as per Figure 2a). It would have been obvious to the skilled artisan to utilize the shielding as taught by Guo with the device of Ji in order to improve the quality of the recorded signals (see Guo II Electrode Design which provides more detail).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ji in view of Rogers and in further view of Decre et al. US Publication 2016/0144166 (hereinafter Decre).
Regarding claims 12-13, Ji is silent on the interposer. Decre teaches a neural sensing and stimulating device that an interposer (111) that is connected between a cable (220) and the recording probe and the stimulating probe (130) to minimize micromotion of a headstage (not positively claimed and by extension given the structure is identical it would have been fully capable without any additional structural modification), wherein a circuit chip is hybrid-integrated in the interposer to change the signal-to-noise ratio of recorded signals and reduce a number of traces by digitally multiplexing stimulation signals and the recording signals (502/504 which is a multiplexing switch and associated processing circuitry/circuit chip; hybrid integrated appears to be a product by process type limitations, see MPEP 2113). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the interposer and chipset as taught by Decre with the device of Ji in order to all for a reduction in traces.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Brian M Antiskay whose telephone number is (571)270-
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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