DETAILED ACTION
Claims 1-14 are currently pending.
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
Applicants’ election without traverse of Invention Group I (claims 1-12) in the reply filed on 6/8/2026 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
Priority
Acknowledgment is made of applicants' claim for foreign priority to KR application 10-2020-0125837, filed 9/30/2022 and KR application 10-2023-0106268, filed 8/14/2023. Certified copies of the foreign priority documents are present in the application file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/1/2025 and 9/29/2023 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 10-11 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 10 and 11 recites the limitation "the hydrogel". There is insufficient antecedent basis for these limitations in claims 10 and 11 since claim 9, from which claims 10 and 11 depend, recites the phrase “a hydrogel block”. Thus, it is unclear if the phrase “the hydrogel” in claims 10 and 11 are referring to the hydrogel block, or an additional hydrogel component.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al., (Nature communications 13.1: 1261, 2022. (pp.1-11 and 18 pages of Supplementary Information); see IDS 12/1/2025) (“Kang”).
Kang is directed to methods for preparing a three-dimensional (3D) polymorphic artificial cell membrane array since block copolymer-based membranes provide a platform for a variety of biotechnological applications such as artificial cells, cell-mimetic biosensors and bioreactors (Abstract).
Kang’s Fig. 1 illustrates the electric-field-assisted self-assembly method for
the scalable fabrication of the 3D block copolymer artificial cell membranes (3DBCPMs) with diverse shapes/sizes, high stability, and biofunctionality on silicon (Si) microwell template using a diblock copolymer, namely polybutadiene-b-polyethyleneoxide (PBd-PEO).
Regarding claim 1, Kang teaches preparing microwell arrays comprising multiple microwells formed on a silicon template (substrate) (page 9 at Fabrication of microwell array on silicon template; Fig. 1a).
Kang’s Fig. 2a(iv) shows the inside of the microwells are coated with the diblock copolymer (i.e., an artificial biological membrane material), and thereafter a buffer solution comprising 10mM sucrose was injected via a syringe pump for hydration, and an electric field was subsequently applied (page 9 at Formation of 3D block copolymer artificial cell membrane by electric field; Fig. 2a).
Kang further teaches that hydrogels were injected immediately after the formation of the 3DBCPMs by exchanging the 10 mM sucrose solution with a 10 mM sucrose solution mixed with 7% PEGDMA (polyethylene glycol dimethacrylate) (i.e., generating pressure by injecting a hydrogel block) (page 9 at Formation of 3D block copolymer artificial cell membrane by electric field).
Thus, Kang’s teaching anticipates claim 1.
Regarding claims 2 and 3, Fig. 2a of Kang illustrates the microwells have a diameter and depth of approximately 5 µm (scale bar: 5 µm), thus anticipating claims 2 and 3.
Regarding claim 4, Kang teaches the artificial cell membrane material is block copolymer PBd-PEO (Fig. 2a), thus anticipating claim 4.
Regarding claim 7, Kang teaches the electric field is a sinusoidal alternating current (AC) electric field, thus anticipating claim 7.
Regarding claims 8-10, Kang teaches pressure is applied by injection of a hydrogel block, wherein the hydrogel comprises PEGDMA (Mn 1000) (page 9, left col, first paragraph and at Formation of hydrogel-supported 3DBCPMs), thus anticipating claims 8-10.
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 nonobviousness.
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.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kang, as applied to claims 1-4 and 7-10 above, and further in view of Han et al., (Biosensors and Bioelectronics 141 (2019) 111404, 11 pages; see PTO-892) (“Han”).
The teaching of Kang is set forth above and anticipates claims 1-4 and 7-10.
Regarding claims 5 and 6, it is noted that Kang teaches the buffer solution is 10 mM sucrose. Kang does not further comment on the buffer is a physiological solution (claim 5), or those specifically recited in claim 6.
However, Han is directed to 3D free-standing lipid bilayers (3DFLBs) as olfactory cell biosensory mimics that mimic artificial cell membrane structures (Abstract and Introduction, left col, last paragraph to right col, first paragraph). Han teaches formation of the 3DFLBs using an electroforming method that applies alternating current after microwell hydration. Han teaches using buffers B and C which include HEPES, in addition to the sucrose solution.
Thus, Han established it was well-known that HEPES is suitable for inclusion with the sucrose buffer for conducting electroformation. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute Han’s HEPES/sucrose solution for Kang’s sucrose containing buffer since both buffers are known to be suitable for conduction electroformation methods. Therefore, one of ordinary skill in the art would recognize this as simply substituting one type of electroformation buffer for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Kang and Han because each of these teachings are directed at preparing 3D biological membranes using electroformation methods.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, as applied to claims 1-4 and 7-10 above.
The teaching of Kang is set forth above and anticipates claims 1-4 and 7-10.
Regarding claim 11, it is noted that Kang teaches PEGDMA (Mn 1000) (page 9, left col, first paragraph and at Formation of hydrogel-supported 3DBCPMs). Kang does not further comment on the hydrogel being a mixture of PEGDMA 1000 and PEGDMA 3400. However, it would have been obvious to one having ordinary skill in the art at the time of filing to include additional formulations of PEGDMA, specifically PEGDMA having an increased molecular weight of 3400, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. As such, the instant claim is rendered obvious.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, as applied to claims 1-4 and 7-10 above, and as further evidenced by Kim et al., (Nature Communications| (2024) 15:4524, 12 pages; see PTO-892) (“Kim 2024”).
The teaching of Kang is set forth above and anticipates claims 1-4 and 7-10.
Regarding claim 12, Kang teaches the electric field is applied with a specific frequency of 10 Hz to 1 MHz (claimed range overlaps the prior art range) (page 9 at Formation of 3D block copolymer artificial cell membrane by electric field) and the injection was conducted at a flow rate of 20 µL/hour and once solution exchange was completed, the flow rate was set to zero (page 9 at Formation of hydrogel-supported 3DBCPMs). Kang does not further comment on the pressure associated with a flow rate of 20 µL/hour, specifically that the pressure is 300 kPa or less. However, Kim 2024 is directed to methods of artificial membrane fusion using electroformation and hydraulic pressure (Abstract). Kim evidences that a flow rate of 40 µL/hour correlates to a hydraulic pressure of 1.57 kPa (page 10, left col).
Therefore, given that Kang’s flow rate is 20 µL/hour, it is reasonable to consider that Kang’s pressure is less than 1.57 kPa, thus meeting the limitation of claim 12.
Conclusion
No claim is allowed.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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