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 .
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claims 1-2, 4-6, 10-11, 13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kolaya et al. (“Deep brain stimulation: Challenges at the tissue-electrode interface and current solutions”, 37:5, May 30, 2021) in view of Spencer et al. (“Characterization of Mechanically Matched Hydrogel Coatings to Improve the Biocompatibility of Neural Implants”, Scientific Reports volume 7, Article number: 1952 (2017)).
Regarding claims 1-2, 4-6, 10-11, 13, Kolaya et al. teaches a neural interface and method of making a neural interface [Abstract] with the method comprising at least partially coating a fiber (carbon fiber which is multifunctional in that it is electrical, structural and thermally stable) with in a layer of polyurethane-polyethylene glycol hydrogel [Table 1] and drying the solution of PU-PEG (synthetic polymer) on the fiber to form a PU-PEG on the fiber. Kolaya et al. are silent regarding the claimed carbon fiber being a bundle carbon fiber. However, it would have been obvious to one of ordinary skill in the art to arrive at a carbon fiber bundle for the carbon fibers given the limited number of choices (bundle or not) and in order to increase surface area and signal robustness. Kolaya et al. are silent regarding the claimed coating being by dipping. However, it would have been obvious to one of ordinary skill in the art to use dipping given the limited number of options and dipping is well known in the art and thus withdrawing the fiber from the PU-PEG solution.
Kolaya et al. is silent regarding the claimed (additional layer of hydrogel. However, Spencer et al. teaches multiple layers of hydrogel and thickness of hydrogel coating (the additional layer or coating of hydrogel is considered to be the claimed hydrogel layer) formed by dipping in a bath after forming the layer of PU-PEG on the fiber bundle in order to accommodate the elastic deformation associated forces applied to the coating from brain micromotion. [0076, Fig. 3A]. Therefore, the hydrogel would be synthetic polymer. It would have been obvious to one of ordinary skill in the art to use the hydrogel layer of Spencer et al. in Kolaya et al. in order to accommodate the elastic deformation associated forces applied to the coating from brain micromotion and arrive at the claimed invention.
Regarding claims 18-19, Kolaya et al. teaches a method of making a neural interface [Abstract] with the method comprising coating a fiber (carbon fiber which is multifunctional in that it is electrical, structural and thermally stable) with a solution of polyurethane-polyethylene glycol [Table 1] and drying the solution of PU-PEG on the fiber to form a PU-PEG on the fiber. Kolaya et al. are silent regarding the claimed coating being by dipping. However, it would have been obvious to one of ordinary skill in the art to use dipping given the limited number of options and dipping is well known in the art and thus withdrawing the fiber from the PU-PEG solution.
Regarding claim 20, Kolaya et al. is silent regarding the claimed (additional layer of hydrogel. However, Spencer et al. teaches multiple layers of hydrogel and thickness of hydrogel coating (the additional layer or coating of hydrogel is considered to be the claimed hydrogel layer) formed by dipping in a bath after forming the layer of PU-PEG on the fiber bundle in order to accommodate the elastic deformation associated forces applied to the coating from brain micromotion. [0076, Fig. 3A]. Therefore, the hydrogel would be synthetic polymer. It would have been obvious to one of ordinary skill in the art to use the hydrogel layer of Spencer et al. in Kolaya et al. in order to accommodate the elastic deformation associated forces applied to the coating from brain micromotion and arrive at the claimed invention.
Claims 7-9 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kolaya et al. (“Deep brain stimulation: Challenges at the tissue-electrode interface and current solutions”, 37:5, May 30, 2021) in view of Spencer et al. (“Characterization of Mechanically Matched Hydrogel Coatings to Improve the Biocompatibility of Neural Implants”, Scientific Reports volume 7, Article number: 1952 (2017)) in view of Pallavi et al. (“Hydrogel systems and their role in neural tissue engineering”, J R Soc Interface (2020) 17 (162), Jan 8, 2020.).
Regarding claims 7-9 and 15-17, the previous combination is silent regarding the claimed molecules and cells. However, Pallavi et al. teaches incorporation (loading of hydrogels) of cells (which contain proteins) in the human brain been obvious to one of ordinary skill in the art for cell therapy and healing to use the cells and proteins of Pallavi et al. in the previous combination for cell therapy and healing.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kolaya et al. (“Deep brain stimulation: Challenges at the tissue-electrode interface and current solutions”, 37:5, May 30, 2021) in view of Spencer et al. (“Characterization of Mechanically Matched Hydrogel Coatings to Improve the Biocompatibility of Neural Implants”, Scientific Reports volume 7, Article number: 1952 (2017)) in view of Jia et al. (WO 2021067905).
Regarding claim 3 and 12, the previous combination is silent regarding the claimed multifunctional fiber. However, Jia et al. teaches multifunctional fiber that can be used in electrodes and probes comprising electrical, optical and microfluidic fiber for improved sensing and modulating of neural activity. It would have been obvious to one of ordinary skill in the art to use the multifunctional fiber comprising electrical, optical and microfluidic fiber Jia et al. in the previous combination for improved sensing and modulating of neural activity.
Prior Art Not Used but Relevant
PG Pub. 2013/0063438 teaches a hydrogel coated implant.
Conclusion
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/Shawn Mckinnon/Examiner, Art Unit 1789