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 .
DETAILED ACTION
Applicant’s arguments, filed 4/9/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burden (Mechanically Enhancing Planar Lipid Bilayers with a Minimal Actin Cortex, Langmuir, 2018, 34, 10847-10855; IDS filed 9/10/2024). Burden is directed to preparation of Minimal Actin Cortex comprising a thin, 2D layer of actin filaments that mechanically enhances artificial lipid bilayers, increasing their elastic modulus while preserving lateral fluidity, electrical resistance, and molecular access for biosensing and nanopore applications (abstract; Introduction). The MAC is formed by linking actin to the lipid membrane via a biotin-streptavidin-biotin bridge, creating a robust, biomimetic structure that significantly improves bilayer stability against stress without hindering function (Results and Discussion). The study used different types of lipids, including zwitterionic (net charge of 0), anionic (net charge of -1), and cationic (net charge of +1) lipids to create bilayers with varying charge properties (Experimental Section). This is a device comprising a lipid bilayer that is linked to multiple (at least two layers) of interconnected polymer filaments, wherein the lipid bilayer is attached to a substrate, wherein each of the at least two layers of interconnected polymer filaments has a thickness, wherein each of the at least two layers of interconnected polymer filaments bears a net positive electrostatic charge, a net negative electrostatic charge, or no electrostatic charge (Abstract; Results and Discussion).
Applicant arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Burden defines “single layers” and “multiple layers,” the examiner’s response is that a multiple layer qualifies as “at least two layers.” Regarding applicant’s argument that Burden describes its bilayer as a “single layer” for the purposes of its invention does not make the bilayer a single layer. By contrast, Burden teaches that there are two layers with filament-to-filament cross-linking. The artisan would understand this to be a bilayer, even if the filament-to-filament crosslinking were rare. Regarding applicant’s argument that “multiple stacked layers” is not part of the disclosure as it uses the term “can be imagined,” this is a teaching of multiple stacked layers and the artisan would understand it as such. Regarding applicant’s arguments directed to claim 3, the claimed invention encompasses any electrostatic charge or no electrostatic charge, as evidenced by the limitation “bears a net positive electrostatic charge, a net negative electrostatic charge, or no electrostatic charge.” It is therefore deemed that the electrostatic charge in the prior art reference falls under the scope of the claim.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Burden (Mechanically Enhancing Planar Lipid Bilayers with a Minimal Actin Cortex, Langmuir, 2018, 34, 10847-10855; IDS filed 9/10/2024). The relevant portions of Burden are given above. In addition, Burden teaches that the membrane thickness may be about 5 nm (Results and Discussion).
Burden fails to teach the present range of from about 8 to about 16 nanometers (nm).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the thickness to improve the efficacy of the device for ion-channel and nanopore sensing applications. In this way, one would find the present range of about 8 to about 16 nanometers through routine experimentation. The prior art provides sufficient guidance to this end as about 5 nm disclosed by Burden nearly touches the present range of about 8 to about 16 nm.
Applicant arguments have been fully considered but are not found persuasive. Regarding applicant’s remarks regarding claim 1, these have been addressed above. Regarding applicant’s argument that the tension between mechanical enhancement and access restriction demonstrates that the outcome of creating multiple interconnected layers is far from predictable, the examiner’s response is that the lipid bilayer art is a well established art, and modifications and adjustments to lipid bilayers is routine in the art. The examiner recognized that Burden fails to teach the present range of from about 8 to about 16 nanometers (nm), but it would have been obvious to one of ordinary skill in the art to optimize the thickness to improve the efficacy of the device for ion-channel and nanopore sensing applications. In this way, one would find the present range of about 8 to about 16 nanometers through routine experimentation. The prior art provides sufficient guidance to this end as about 5 nm disclosed by Burden nearly touches the present range of about 8 to about 16 nm.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
8/12/2026
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