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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, it appears applicant states Figure 5(b) shows parallel and intersecting portions of the counter electrode for the new limitations added to claim 1, however, they are described as alternatives in the Specification on pages 20-21 of the Specification as filed. Further, while the plane of the upright portion of Figure 5(b) would intersect the culture substrate, that portion itself is not shown to intersect the culture substrate. So neither the Specification nor the Figure provide written description of the newly claimed feature.
Dependent claims 2-7 and 9-13 also fail to comply with the written description requirement and are rejected based on their dependency on claim 1.
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 9-13 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.
Claim 1, line 10, states “a first portion intersecting the culture substrate”. It is unclear how the first portion of the electrode can intersect the substrate when there is also a second portion extending from the first portion which is parallel to the substrate. The first portion would be stopped once the second portion contacted the substrate and not intersect the substrate. Further clarification is requested. For examination purposes, it is interpreted as an extension of the plane of the first portion would intersect the culture substrate.
Claims 2-7 and 9-13 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 9-12 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 the counter electrode to include a first portion intersecting the culture substrate and a second portion extending from the first portion and having a plate shape parallel to 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 lead 33 (first portion) which is oriented perpendicularly to the substrate and a wire like counter electrode 30 (second portion) which extends from the first portion and has a plate shape parallel to the culture substrate 22 (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).
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 9, Kim in view of Naoki teach all of the limitations of Claim 1 (see above). Kim does not teach a culture substrate case with a bottom, an outer wall, a case cover and an electrode insertion hole in the case cover through which one of the working electrode of the counter electrode passes.
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Naoki 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).
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 11/21/2025 have been fully considered but they are not persuasive. Applicant’s arguments were directed towards newly amended claims and have been addressed in the rejection above.
Naoki has been reinterpreted to meet the new claim language with the first portion of the counter electrode (labeled above) being included as part of the counter electrode.
The amendments to address the Claim Objections from the 08/29/2025 Office Action have been accepted and the Claim Objections from the 08/29/2025 Office Action have been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796