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 without traverse of group I, claims 1 – 2, 4 – 5, 7, 9 – 12 and 15 in the reply filed on December 8, 2025 is acknowledged.
Claims 1 – 2, 4 – 5, 7, 9 – 12, 15, 18 – 20, 22 – 25, 38, 41 – 42, 45 – 47 are pending; claims 18 – 20, 22 – 25, 38, 41 – 42, 45 – 47 are withdrawn as being drawn to non-elected subject matter; claims 1 – 2, 4 – 5, 7, 9 – 12 and 15 have been considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 9, 2024 and April 22, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 5 and 7 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.
Claims 5 and7 are drawn to a biocompatible gel, however are rendered indefinite for reciting “the plurality of cells encapsulated” as the phrase lacks proper antecedent basis.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 2, 4 – 5, 7, 9 – 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Farina et al. (WO 2019/079384, cited by US 2021/0187260) in view of Golway et al. (US 10392595)
Regarding claim 1, Farina teaches devices made from gel matrix (0044) comprising microchannels and nanochannels (0004 – 0005, claims) wherein the microchannels have a diameter of 100 – 300 microns (0005) and nanochannels have a diameter of 2.5 – 1000 nm (0004); and cells (0005 – 0006, claims) adjacent thereto in micro-reservoirs having a diameter of 50 micron (0005, figures 1, 2, 0049), indicating the cells are within 50 microns of at least on microchannel or nanochannel.
Farina does not teach the microchannels and nanochannels are not patterned. However, Golway teaches a gel matrix comprising a microvasculature of microchannels (abstract, col.15 line 12 - 38) wherein the microvessels (microchannels) spontaneously grow as a neovasculature (col.5 line 42 – 60) (are not patterned microchannels); and a plurality of cells (abstract, col.5 line 60 – 65); wherein the microchannels have an average diameter of 200 μm (col.15) (within the claimed range of 5 – 500 microns or μm). Golway teaches advantages of the neovasculature (non-patterned channels) include adaptability in response to physiological environment and making it more stable in biological applications (col.5 line 1 – 21); while the goal of Farina is to stimulate neovascularization in vivo (0095). In this regard, at the time the claims were filed, one of ordinary skill in the art would have been motivated to form the microchannels and nanochannels in Farina as a neovasculature (or without a pattern) for the known advantages of adaptability and stability in physiological environments.
Regarding claim 2, Farina teaches the gel matrix may be composed of agarose, collagen, alginate, cellulose, polyethylene, polycaprolactone or gelatin (0044); while Golway teaches collagen (col.9 line 64 – col.10 line 9).
Regarding claim 4, Farina teaches the gel may be cylindrical, spherical (0038).
Regarding claims 5 and 7, Farina teaches 75 – 100% of cells are viable and functional at 24 hours and 48 hours (figure 10, 0052, 0093, 0095, 0098).
Regarding claims 9 – 12 and 15, Farina teaches the cells are insulin producing cells, human embryonic stem cells (hESCs) and pluripotent stem cells (iPSCs) differentiated to obtain insulin producing cells (stem cell derived cells), pancreatic islet cells, insulin producing cell aggregates (stem cell derived enriched beta-clusters) (0005, claim 11).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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