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 .
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 21-22 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.
Claim 21 recites the limitation "the optical fiber" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the electrical fiber" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the microfluidic fiber" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the optical fiber" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the electrical fiber" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the microfluidic fiber" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 10, 18 are 20 are allowed.
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 and 13 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 Hendricks et al. (PG Pub. 2011/0257504).
Regarding claims 1-2, 4-6 and 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.
The previous combination is silent regarding the claimed fiber being polymer. However, Hendricks et al. teaches using polymer fiber because they can be created several ways from a diversity of substrates and materials and are highly adaptable and can be readily tailored for specific, diverse applications and can be prepared to contain or release bioactive agents which can facilitate electrode (or device) function and communication/integration at the interface between the electrode and electrolyte. Therefore, it would have been obvious to use the polymer fiber of Hendricks et al. in the previous combination because they can be created several ways from a diversity of substrates and materials and are highly adaptable and can be readily tailored for specific, diverse applications and can be prepared to contain or release bioactive agents which can facilitate electrode (or device) function and communication/integration at the interface between the electrode and electrolyte 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 Hendricks et al. (PG Pub. 2011/0257504) 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 21-23 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 Hendricks et al. (PG Pub. 2011/0257504) in view of Jia et al. (WO 2021067905).
Regarding claim 3 and 21-23, 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 that is twisted together (helixed) including polymer fibers to form the fiber bundle with improved strength and affixed with epoxy. 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 and strength.
Prior Art Not Used but Relevant
PG Pub. 2013/0063438 teaches a hydrogel coated implant.
Response to Arguments
Claim 10, 18 and 20 are found to be allowable. Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive in regard to the remaining claims.
Applicant argues bundling Kolaya’s fiber would have decreased surface area reduced signal robustness. Creating a bundle of carbon fibers can increase surface area compared to a singular fiber because each fiber has its own outer surface area. A single fiber surface area = 2πrL and the bundle of N fibers surface area = N(2πrL). Signal robustness can also improve with a bundle over a single fiber by providing more redundancy, lower impedence and more recording activity.
Applicant argues Kolaya does not teach the newly claimed polymer fiber. However, Hendricks et al. teaches using polymer fiber because they can be created several ways from a diversity of substrates and materials and are highly adaptable and can be readily tailored for specific, diverse applications and can be prepared to contain or release bioactive agents which can facilitate electrode (or device) function and communication/integration at the interface between the electrode and electrolyte. Therefore, it would have been obvious to use the polymer fiber of Hendricks et al. in the previous combination because they can be created several ways from a diversity of substrates and materials and are highly adaptable and can be readily tailored for specific, diverse applications and can be prepared to contain or release bioactive agents which can facilitate electrode (or device) function and communication/integration at the interface between the electrode and electrolyte and arrive at the claimed invention.
Applicant argues bundling Jia’s multifunctional fiber with Kolaya’s carbon fiber would limit access to exposed microfluidic sites and electrical interfacing sites and therefore the two cannot be combined. Jia teaches carbon nanotube incorporated in the multifunctional fiber and therefore Jia can be combined with Kolaya. The entire multifunctional fiber of Jia would replace the carbon fiber of Kolaya.
Applicant is invited to amend the claims over the cited art
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN MCKINNON whose telephone number is (571)272-6116. The examiner can normally be reached Monday thru Friday generally 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marla McConnell can be reached at 571-270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Shawn Mckinnon/Examiner, Art Unit 1789
Prosecution Insights