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 1-9, in the reply filed on 08/03/2026 is acknowledged.
Claims 24 and 26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/03/2026.
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 1-9 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.
Regarding claims 1 and 4, the term “about” in claims 1 and 4 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2-9 are rejected by virtue of their dependency on claim 1.
Claim Rejections - 35 USC § 102
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 1-3, 5, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lopez (DEL AGUA LOPEZ, Isabel, "Conducting polymer materials for bioelectronics applications Thesis Advisors," Thesis, 153 pages, University of Basque County UPV/EHU, Spain (January 2018); cited in the IDS filed 07/22/2024).
Regarding claim 1, Lopez teaches a porous scaffold membrane (section 5.2.3 and Figs. 5.4, 5.5b, 5.5c teaches porous scaffolds, i.e. porous scaffold membrane) configured for use in a well plate insert (interpreted as an intended use, the scaffolds shown in Figs. 5.4, 5.5b, 5.5c are capable of being used in a well plate insert) comprising a conducting polymer (section 5.2.3 teaches porous scaffolds including PEDOT:xanthan gum and PEDOT:PSS scaffolds, wherein at least PEDOT is a conducting polymer) wherein the porous scaffold membrane comprises a porosity of at least about 30% (Figs. 5.5b, 5.5c teaches the porosity is at least 30%) and an average pore diameter from about 10 um to about 150 um (page 108, first paragraph and Figs. 5.5b, 5.5c teach the pore size in the range of 10-150 um).
Regarding claim 2, Lopez further teaches wherein the conducting polymer comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) (section 5.2.3 and Fig. 5.4 teaches porous scaffolds including PEDOT:PSS).
Regarding claim 3, Lopez further teaches wherein the porous scaffold membrane is configured to allow gas and nutrient permeation (interpreted as a functional limitation, see MPEP 2114; Lopez teaches the porous scaffold membrane as claimed, see above claim 1, and is identical to the presently claimed structure and therefore, would have the ability to perform the function recited in the claim; See MPEP 2112.01 (I); page 109, first paragraph teaches the scaffolds with pores facilitates cell nutrient percolation, therefore is configured to allow gas and nutrient permeation).
Regarding claim 5, Lopez further teaches wherein the porous scaffold membrane comprises a conductivity from 5 to 100 S/cm (see above claim 1, Lopez teaches an identical porous scaffold membrane as claimed and therefore must have the same claimed properties, i.e. conductivity from 5 to 100 S/cm; see MPEP 2112.01(I)-(II)).
Regarding claim 7, Lopez further teaches wherein the porous scaffold membrane comprises a macroporous morphology (page 108, first paragraph and Figs. 5.5b, 5.5c teach the pore size in the range of 10-150 um, i.e. macroporous; note that the instant specification, [00127] defines macroporous structures as having pores in the range of 10-1000um).
Regarding claim 8, Lopez further teaches wherein the porous scaffold membrane comprises a continuous structure (section 5.2.3 and Figs. 5.4, 5.5b, 5.5c teaches the PEDOT scaffold is a continuous structure or a single body of material), optionally wherein the porous scaffold membrane comprises a disc shape (Fig. 5.4 shows a disc shaped PEDOT scaffold).
Regarding claim 9, Lopez further teaches wherein the porous scaffold membrane further comprises at least one additional agent selected from one or more of:
a. at least one cryoprotectant (interpreted as not required due to the phrase “one or more of”);
b. at least one oligosaccharide (interpreted as not required due to the phrase “one or more of”);
c. at least one polymer (section 5.2.3 and Figs. 5.4, 5.5b, 5.5c teaches, in the instance of interpreting the porous scaffold membrane as PEDOT, the scaffold additionally includes xanthan gum or PSS, i.e. polymer);
d. at least one conductivity enhancing agent (interpreted as not required due to the phrase “one or more of”);
e. at least one biopolymer (section 5.2.3 and Figs. 5.4, 5.5b, 5.5c teaches, in the instance of interpreting the porous scaffold membrane as PEDOT, the scaffold additionally includes xanthan gum, i.e. biopolymer); and/or
f. at least one crosslinking agent (section 5.2.1 teaches the PEDOT scaffolds includes crosslinker DVS to stabilize the scaffold structure).
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.
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 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez as applied to claim 1 above.
Regarding claim 4, Lopez fails to explicitly teach: wherein the porous scaffold membrane (section 5.2.3 and Figs. 5.4, 5.5b, 5.5c) comprises a thickness from about 100 um to 1000 um.
Lopez teaches fabrication and characterization of PEDOT:PSS films (section 2.2.1; Fig. 2.1), wherein the thickness of the film is 0.5 mm, i.e. 500 um (Fig. 2.2). Lopez teaches cyclic voltammetry tests were performed on films having a thickness of 0.5mm, i.e. 500um (page 48, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the porous scaffold membrane to incorporate Lopez’s teachings of fabrication and characterization of porous scaffold membrane with a thickness of 500um (Fig. 2.2; page 48, first paragraph) to provide: wherein the porous scaffold membrane comprises a thickness from about 100 um to 1000 um. Doing so would have a reasonable expectation of successfully utilizing known membrane thicknesses for improved fabrication and characterization of the porous scaffold membrane as taught by Lopez.
Regarding claim 6, Lopez further teaches wherein the porous scaffold membrane comprises an impedance in the presence of phosphate buffered saline of between 1 and 500 Ohm at 1kHZ (see above claim 1, Lopez teaches an identical porous scaffold membrane as claimed and therefore must have the same claimed properties, i.e. an impedance in the presence of phosphate buffered saline of between 1 and 500 Ohm at 1kHZ; see MPEP 2112.01(I)-(II)).
Lopez fails to explicitly teach: the porous scaffold membrane (section 5.2.3 and Figs. 5.4, 5.5b, 5.5c) comprises a membrane thickness of 500 um.
Lopez teaches fabrication and characterization of PEDOT:PSS films (section 2.2.1; Fig. 2.1), wherein the thickness of the film is 0.5 mm, i.e. 500 um (Fig. 2.2). Lopez teaches cyclic voltammetry tests were performed on films having a thickness of 0.5mm, i.e. 500um (page 48, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the porous scaffold membrane to incorporate Lopez’s teachings of fabrication and characterization of porous scaffold membrane with a thickness of 500um (Fig. 2.2; page 48, first paragraph) to provide: the porous scaffold membrane comprises a membrane thickness of 500 um. Doing so would have a reasonable expectation of successfully utilizing known membrane thicknesses for improved fabrication and characterization of the porous scaffold membrane as taught by Lopez.
In an alternative interpretation, claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez as applied to claim 1 above, and further in view of Zhang et al. (Zhang et al., “Solvent-induced changes in PEDOT:PSS films for organic electrochemical transistors”, APL Mater. 3, 014911 (2015)). In this alternative interpretation, Lopez is interpreted as failing to teach: wherein the porous scaffold membrane comprises a conductivity from 5 to 100 S/cm.
Regarding claim 5, Lopez fails to teach wherein the porous scaffold membrane comprises a conductivity from 5 to 100 S/cm.
Lopez teaches processes to enhance the conductivities of conductive polymers, which find numerous applications in sensors and biosensors (page 4, first paragraph). Lopez teaches to increase the conductivity, enhancement agents that improve the conductivity of the dispersion are being intensively studied and applied (page 6, first paragraph; section 1.1.2). Lopez teaches by addition of dopants, PEDOT:PSS can exhibit a wide range of electrical conductivities, from 10-2 to 4600 S/cm (page 8, lines 1-3). Lopez teaches conductivity of films between 10-1 to 10 S/cm (page 16, first paragraph).
Zhang teaches organic electrochemical transistors based on conducting polymer films doped with PEDOT:PSS for bioelectronic applications (abstract). Zhang teaches conductivity of PEDOT:PSS films modified with various concentrations of conductivity enhancing agents, the films having conductivities from about 0-650 S/cm (Fig. 1). Zhang teaches films are mixed with chemical compounds to increase film electrical conductivity from pristine PEDOT:PSS suspensions that have conductivity as low as 1 S/cm (page 3, second paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous scaffold membrane of Lopez to incorporate Lopez’s teachings of improving conductivity of polymers and addition of dopants can cause the polymer to exhibit conductivity from 10-2 to 4600 S/cm (page 4, first paragraph; page 6, first paragraph; section 1.1.2; page 8, lines 1-3) and conductivity of films between 10-1 to 10 S/cm (page 16, first paragraph) and Zhang’s teachings of varying PEDOT:PSS films with conductivity enhancing agents to have conductivities from around 0-650 S/cm (abstract; Fig. 1) to provide: wherein the porous scaffold membrane comprises a conductivity from 5 to 100 S/cm. Doing so would have a reasonable expectation of improving and optimizing the conductivity of the membrane for desired applications.
Additionally, since Lopez teaches a conductivity range of 10-2 to 4600 S/cm (page 8, lines 1-3) and 10-1 to 10 S/cm (page 16, first paragraph) and Zhang teaches a conductivity range of 0-650 S/cm (Fig. 1), wherein the ranges overlaps with the claimed range of 5-100 S/cm, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous scaffold membrane of Lopez to provide wherein the porous scaffold membrane comprises a conductivity from 5 to 100 S/cm. I.e., it would have been prima facia obvious to have selected the overlapping portion of the range (i.e. 5-100 S/cm) from the taught ranges (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05 (I)).
In an alternative interpretation, claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez as applied to claim 1 above. In this alternative interpretation, Lopez is interpreted as failing to teach: the porous scaffold membrane comprises an impedance in the presence of phosphate buffered saline of between 1 and 500 Ohm at 1kHZ.
Regarding claim 6, Lopez fails to explicitly teach wherein the porous scaffold membrane comprises an impedance in the presence of phosphate buffered saline of between 1 and 500 Ohm at 1kHZ and a membrane thickness of 500 um.
Lopez teaches fabrication and characterization of PEDOT:PSS films (section 2.2.1; Fig. 2.1), wherein the thickness of the film is 0.5 mm, i.e. 500 um (Fig. 2.2). Lopez teaches cyclic voltammetry tests were performed on films having a thickness of 0.5mm, i.e. 500um (page 48, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the porous scaffold membrane to incorporate Lopez’s teachings of fabrication and characterization of porous scaffold membrane with a thickness of 500um (Fig. 2.2; page 48, first paragraph) to provide: the porous scaffold membrane comprises a membrane thickness of 500 um. Doing so would have a reasonable expectation of successfully utilizing known membrane thicknesses for improved fabrication and characterization of the porous scaffold membrane as taught by Lopez.
Modified Lopez fails to explicitly teach: wherein the porous scaffold membrane comprises an impedance in the presence of phosphate buffered saline of between 1 and 500 Ohm at 1kHZ.
Lopez teaches PEDOT:xanthan gum scaffold and impedance measurements with and without cells (page 113, Fig. 5.8), wherein the impedance of the scaffold is between 100 and 1000 Ohm at 1kHZ (Fig. 5.8d; note that it is unclear of the specific value of impedance at 1kHZ). Lopez teaches commonly, aqueous electrolytes, such as phosphate buffered saline solution, are used to operate organic electrochemical transistors (page 13, first paragraph; page 56, last paragraph).
Since Lopez teaches an impedance in the range of 100-1000 Ohm at 1kHZ, wherein the ranges overlaps with the claimed range of between 1 and 500 Ohm at 1kHZ, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous scaffold membrane of Lopez to wherein the porous scaffold membrane comprises an impedance in the presence of phosphate buffered saline of between 1 and 500 Ohm at 1kHZ. I.e., it would have been prima facia obvious to have selected the overlapping portion of the range from the taught range to optimize the electrical properties of the scaffold for use in common aqueous electrolytes such as phosphate buffered saline (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05 (I)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Charalampos et al. (FR 3071359 A1; cited in the IDS filed 07/22/2024; see machine translation) teaches an organic electrochemical transistor comprising a 3-dimensional biocompatible polymer matric (abstract) comprising PEDOT:PSS (claims 2,4). Charalampos teaches PEDOT:PSS is preferred as it exhibits good stability in liquid medium (page 5, second full paragraph). Charalampos teaches the pore diameter is between 50 and 100 µm (page 3, last paragraph).
Ferro (FERRO, M., "Development of conducting polymer devices for the monitoring of in vitro barrier tissue models," HAL Open Science, 153 pages, Universite de Lyon, France (June 2020); cited in the IDS filed 07/22/2024) teaches an organic electrochemical transistor comprising PEDOT:PSS that has shown great efficiency to quantify electrical properties of tissues (page iv, first full paragraph). Ferro teaches an electrical resistance monitoring platform using a transwell insert (Figs. 2.7, 3.1) and PEDOT:PSS flexible gate membrane (Fig. 2.7, 3.1).
Lynn et al. (US 20100248368 A1) teaches a composite biomaterial comprising a porous surface portion (abstract). Lynn teaches the materials contain macropores with pores greater than 10 microns ([0034]), wherein macropore size ranges include 1-1000 microns, more preferably 200-600 microns ([0263]). Lynn teaches porosity is preferably from 50-99.99 vol%, more preferably 70-98 vol% ([0268]).
Vermaas et al. (US 20160101420 A1) teaches a porous membrane (abstract). Vermaas teaches an electrode includes a conductive material ([0069]), wherein the electrically conducting organic polymer that is deposited onto a plastic substrate may be poly(3,4-ethylenedioxythiophene) poly(styrenesulfonate) (PEDOT:PSS) ([0073]). Vermaas teaches the porous membrane may have a porosity between 20-85%, such as 50-65% ([0127]) and may have an average pore size of between 1 and 100 um ([0128]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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