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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/22/2026 has been entered.
Status of Claims
Claims 1-7 and 10-13 are pending.
Claims 1-7 and 10-13 are rejected.
Claim 9 is cancelled. Note: Applicant’s response states claim 9 is cancelled, however, the submitted claim set does not indicate this. Examiner requests an amended claim set with the correct claim identifier indicating claim 9 is cancelled.
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 1-7 and 10-13 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 Claim 1, line 18 states “plate shape”. It is unclear what shape this limitation is referring to as plates can be of varying shapes. Further clarification and correction is required. For examination purposes, it is interpreted as a flat plate extending from the first region.
Claims 2-7 and 10-13 are further rejected as they depend from Claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-7, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US20170321176A1) in view of Naoki et al. (JP2012120452A).
Regarding Claim 1, Kim teaches the following:
A cell sheet manufacturing device (a cell culture vessel) comprising a support layer (base substrate) and a graphene layer (one deposited graphene layer)(para 12)
A state of cell growth and proliferation can be checked in real time from an electric signal obtained through the electrode (see electrodes in Fig. 1a, below). In one embodiment of the present invention, impedance can be obtained by an alternating current that flows through the culture medium between two electrodes spaced apart from each other, and conductance can be obtained by a direct current (para 16). In order for a current to flow through, there must be an input terminal which sends that current through the electrode that is coupled to it (at least one electrostimulation input terminal coupled to a working electrode).
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Kim further teaches cell growth and proliferation can be checked in real time from an electric signal obtained through the electrode and impedance can be obtained by an alternating current that flows through the culture medium between two electrodes spaced apart from each other (para 16)(the working electrode transmitting electrical stimuli to the deposited graphene layer and a counter electrode electrically opposite to the working electrode)
Kim does not teach a culture substrate case comprising a case bottom on which the culture substrate is placed, an outer wall surrounding an edge of the case bottom; a culture substrate case cover covering an upper opening of the culture substrate case, wherein the culture substrate case cover comprises at least one electrode insertion hole through which at least one of the working electrode or the counter electrode passes, wherein a portion of the counter electrode passes the electrode insertion hole and extends in a direction of the culture substrate, and is located in a first region corresponding to a center of the culture substrate, and wherein another portion of the counter electrode has a plate shape extending from the first region, and is configured to uniformly apply electrical stimuli to the entire region of the culture substrate.
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Naoki teaches a cell testing vessel having a substrate, an electrode on the bottom surface, a counter electrode, and a cell adhesion region (para 13). Naoki further teaches a culture substrate case where the culture substrate is placed on the bottom and an outer wall surrounding the edge of the case bottom (Fig. 1a, below)(Note: the bottom half of item 2 in Fig. 1a is being considered the case bottom while the upper half is the substrate).
Naoki further teaches a case cover which covers an upper opening of the culture substrate case and has an electrode insertion hole through which the counter electrode passes (Fig. 1a, above)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kim and put it within a case as taught by Naoki. One would have been motivated to make this modification so experiments could be carried out under constant conditions (para 16).
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Naoki further teaches a lead 33 which is oriented perpendicularly to the substrate (a portion of the counter electrode passes the electrode insertion hole and extends in a direction of the culture substrate) and a wire like counter electrode 30 which extends from the first portion and extends parallel to the culture substrate 22 (portion of the counter electrode has a plate shape extending from the first region )(Fig. 1a, below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kim and used the counter electrode as taught by Naoki. One would have been motivated to make this modification as it would allow voltage to be applied without causing unevenness which allows cell testing to be performed with high precision and good reproducibility (para 16).
Naoki does not teach the portion of the counter electrode which passes through the electrode insertion hole and extends in a direction of the culture substrate is located in a first region corresponding to a center of the culture substrate. However, it would have been obvious to one of ordinary skill in the art to locate the insertion hole in the center of the cover locating the electrode in a first region corresponding to the center of the culture substrate as, absent evidence to the contrary, a rearrangement of parts has been held prima facie obvious. See MPEP 2144.04(VI)(C).
Further, the device configured to uniformly apply electrical stimuli to the entire region of the culture substrate is an intended use of the device. . A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The device of Kim in view of Naoki would be capable of applying electrical stimuli to the entire culture substrate and therefore meets the claim.
Regarding Claim 2, Kim in view of Naoki teaches all of the limitations of Claim 1 (see above). Kim further teaches the graphene layer to be place directly on top of the electrodes and input terminals (Fig. 1a, above)(the electrostimulation input terminal is directly coupled to the graphene layer).
Regarding Claim 3, Kim in view of Naoki teaches all of the limitations of Claim 2 (see above). Kim further teaches a plurality of electrostimulation input terminal are disposed on an edge of the graphene layer (see Fig 1a, above).
Regarding Claim 5, Kim in view of Naoki teaches all of the limitations of Claim 1 (see above). Kim further teaches a patterned electrode (conductive metal layer) adjacent to the support layer (para 12) and the electrode may be selected from a group of Al, Cu, Pt, and Cr/Au (para 14)(the conductive metal layer comprises at least one of indium tin oxide, Ag, Au, or Cu).
Regarding Claim 6, Kim in view of Naoki teaches all of the limitations of Claim 5 (see above). Kim further teaches the graphene layer is disposed on the base substrate and the electrostimulation input is also directly coupled to the base substrate (see Fig. 1c, above).
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Regarding Claim 7, Kim teaches all of the limitations of Claim 1 (see above). Naoki further teaches the counter electrode 30 to be spaced apart from the culture substrate 22 (Fig. 1a, below).
Regarding Claim 10, Kim in view of Naoki teach all of the limitations of Claim 1 (see above). Naoki further teaches the counter electrode 33 and electrode 21 are configured so that power can be supplied via lead 33 (para 37)(the working electrode and the counter electrode are connected to a power supply).
Regarding Claim 11, Kim in view of Naoki teaches all of the limitations of Claim 1 (see above). Naoki further teaches the materials constituting the electrodes include silver, gold, copper, etc. (para 31)(at least one of the working electrode or the counter electrode comprises at least one of Pt, Au, Ag, Ti, or stainless steel).
Regarding Claim 12, Kim in view of Naoki teaches all of the limitations of Claim 1 (see above). Kim further teaches a graphene layer (graphene layer is a single layer)(para 12).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US20170321176A1) in view of Naoki et al. (JP2012120452A) and further in view of Min Ah (KR20110134720A).
Kim in view of Naoki teaches all of the limitations of Claim 1 (see above). Kim further teaches the support layer may be formed of silicon rubber, glass, PET film or wafer (para 13). Kim in view of Naoki does not teach the base to comprise polystyrene.
Min Ah teaches a cell stimulator with a graphene electrode installed on a flexible polymer substrate such as PET, PI, PS (polystyrene), PDMS, etc. (para 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the PET in the support layer of Kim with polystyrene as taught by Min Ah. One would have been motivated to make this substitution as Min Ah teaches polystyrene to be a suitable material for graphene to be attached to and it would have resulted in an effective cell stimulation device.
Further, it is obvious to substitute an equivalent in the art known for the same purpose. See MPEP 2144.06(II).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US20170321176A1) in view of Naoki et al. (JP2012120452A) and further in view of Kim et al. (US20160017268A1).
Kim (‘176) in view of Naoki teaches all of the limitation of Claim 1 (see above). Kim (‘176) in view of Naoki does not teach an oxygen functional group formed on a surface of the graphene layer.
Kim (‘268) teaches a microelectrode array with a cell culturing surface (para 6). Kim (‘268) further teaches the cell surface can be coated with materials such as graphene, graphene oxide (oxygen functional group formed on a surface of the graphene layer), etc. (para 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the graphene layer of Kim (‘176) with the graphene oxide layer as taught by Kim (‘268). One would have been motivated to make this substitution as Kim (‘268) teaches graphene oxide to be an effective coating that promotes electroconductivity (para 28).
Response to Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are directed towards newly amended claims and have been addressed in the rejection above.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The amendments to address the 112(b) rejections from the 01/28/2026 Office Action have been accepted and the 112(b) rejections from the 01/28/2026 Office Action have been withdrawn, however, new 112(b) rejections have been made (see above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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