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 .
Status of the Claims
Claims 1, 4-5, 8, and 12 have been amended. Claim 7 has been canceled. Claims 15-20 have been previously withdrawn. Claims 1-6 and 8-14 are currently examined herein.
Status of the Rejection
All claim objections from the previous office action are withdrawn in view of the amendments.
All 35 § U.S.C 103 are essentially maintained and modified only in view of the Applicant’s amendments.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Axion (MEA Plate Brochure, 2018) in view of Paradox (Para-dox Photoredox Catalysis & Parallel Synthesis Reaction Blocks, 2022).
Regarding Claim 1, Axion teaches a device for electrochemical experimentation (Axion MEA Plates [page 1]) comprising:
a reaction well holder (as illustrated in the MEA plate on page 1, reaction well holder is clear rectangular piece with numerous reaction wells) having a top surface (top surface corresponds to the openings of the reaction wells [page 1]) and a bottom surface opposite the top surface (bottom of plate in MEA plate photo on page 1), the reaction well holder comprising:
a plurality of reaction wells (reaction holder can be 6-, 24-, 48-, or 96- well formats [Axion MEA plates, page 1]), each reaction well having an opening in the top surface of the reaction well holder (as illustrated in MEA plate photo on page 1, reaction wells are open on the top) and a bottom surface between the top surface and the bottom surface of the reaction well holder (as illustrated in photo on page 1, bottom of reaction wells end on a surface with electrodes, which corresponds to a bottom surface between the top surface and the bottom surface of the reaction well holder);
a plurality of electrodes in the plurality of reaction wells (as illustrated in photo on page 1 as well as MEA layouts on page 4, multiple electrodes are located in the reaction wells), each reaction well comprising two or more of the plurality of electrodes located on an interior side of the bottom surface of each reaction well (multiple electrodes can be located on sides of the bottom of the reaction well [cytoview MEA and biocircuit MEA tables on page 4]); and
a plurality of electrical contacts located on the bottom surface of the reaction holder (as illustrated in photo on page 3, electrical contacts of the reaction well holder are connected to the electrodes in the reaction well), wherein, for each reaction well, two or more of the plurality of electrical contacts are in electrical communication with the two or more of the plurality of electrodes of the reaction well (as illustrated in photo on page 3, multiple electrical contacts of the reaction well holder are connected to the electrodes in the reaction well).
Axion is silent on a gasket positioned on the top surface of the reaction well holder and covering the openings of the plurality of reaction wells; and
a top plate positioned on top of the gasket and fastened to the reaction well holder to create an airtight seal for the plurality of reaction wells, wherein the top plate is a stainless steel plate comprising a plurality of through holes aligned with the openings of the plurality of reaction wells.
Paradox teaches a gasket (Top rubber mat of HTe Chem Assembly [expanded view page 13]; which can be silicone rubber [bottom left Cat. No. 24282, page 12]) positioned on the top surface of the reaction well holder and covering the openings of the reaction wells (as illustrated in the expanded view of the HTe Chem Assembly on page 13, rubber gasket covers the reaction wells); and
a top plate (top cover, page 5, which can be stainless steel, see top cover with wider holes for 96-well reaction block aligned with the reaction wells [bottom right, page 5]) positioned on top of the gasket and fastened to the reaction well holder (as illustrated on pages 5 and 12-13, top cover is positioned on top of the silicon gasket and fastened to the reaction well holder via screws) to create an airtight seal for the reaction wells (as seen, for example, in reaction block assembly on the top of page 7 and bottom left of page 12, gasket creates an air tight seal);
wherein the top plate is a stainless steel plate (top cover may be stainless steel [bottom right, page 5]) comprising a plurality of through holes aligned with the openings of the plurality of reaction wells (top cover, page 5, which can be stainless steel, see top cover with wider holes for 96-well reaction block aligned with the reaction wells [bottom right, page 5]).
Axion and Paradox are considered analogous art to the claimed inventions because they are in the same field of reaction well plates. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the reaction well holder of Axion to include a gasket positioned on the top surface of the reaction well holder and covering the openings of the plurality of reaction wells; and a top plate positioned on top of the gasket and fastened to the reaction well holder to create an airtight seal for the plurality of reaction wells, wherein the top plate is a stainless steel plate comprising a plurality of through holes aligned with the openings of the plurality of reaction wells, as taught by Paradox, as a reaction well holder with a gasket and top plate allows for broad range of electrochemical reaction studies, such as electrosynthesis and electrophotochemistry (Paradox, [first para. col. 2, page 13]).
Regarding Claim 2, modified Axion teaches the device of claim 1.
Axion teaches wherein the plurality of reaction wells includes 6, 24, 48, or 96 reaction wells (reaction holder can be 6-, 24-, 48-, or 96- well formats [Axion MEA plates, page 1]).
Regarding Claim 3, modified Axion teaches the device of claim 1.
Axion is silent on wherein each reaction well has a volume of at least 0.2 milliliters to at most 5.0 milliliters.
Paradox teaches wherein each reaction well has a volume of 2.0 milliliters (for example, 48 vial tray uses 2 mL vials [48-Well Vial Tray, page 8]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the reaction wells of modified Axion to have a volume of 2.0 milliliters, as taught by Paradox, as a reaction well volume of this amount is suitable for electrochemical measurements (Paradox, [first para. col. 2, page 13]).
Regarding Claim 4, modified Axion teaches the device of claim 1;
the limitation “the plurality of electrodes are screen-printed electrodes” is considered a product-by-process limitation). The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Regarding Claim 5, modified Axion teaches the device of claim 1.
Axion teaches wherein, for each reaction well, three of the plurality of electrical contacts are in electrical communication with three of the electrodes of the corresponding reaction well (multiple electrodes, at least three, are in contact with electrical contacts on bottom of plate, as illustrated in first picture of BioCircuit MEA 24 plate on page 1).
Regarding Claim 6, modified Axion teaches the device of claim 1, and teaches wherein the gasket is a silicone rubber gasket (as outlined in the claim 1 rejection above, Paradox teaches gaskets used are made of silicon, see for example high-temp silicone/rubber cover Cat. No. 24282 [bottom left, page 12] in Paradox).
Claims 8-9 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Axion and Paradox, as applied to claim 1 above, and in view of Wohlstadter (US 2004/0022677 A1).
Regarding Claim 8, modified Axion teaches the device of claim 1.
Axion is silent on wherein the reaction holder further comprises:
an upper portion having a top surface and a bottom surface opposite the top surface, the top surface of the upper portion being the top surface of the reaction well holder, the upper portion comprising a plurality of through holes corresponding to the openings and interior walls of the plurality of reaction wells; and
a lower portion having a top surface and a bottom surface opposite the top surface of the lower portion, the bottom surface of the lower portion being the bottom surface of the reaction well holder, the top surface of the lower portion comprising the plurality of electrodes of the plurality of reaction wells, the plurality of electrodes being a plurality of screen printed electrodes.
Wohlstadter teaches a multi-well plate for conducting assays (abstract), and teaches an upper portion (upper portion is plate top 804 [para. 0405]; illustrated in Fig. 8A) having a top surface (top surface is top of 804 in Fig. 8B) and a bottom surface opposite the top surface (bottom surface is bottom of 804 containing the reaction wells in Fig. 8B), the top surface of the upper portion being the top surface of the reaction well holder (top surface of 804 is the top of the reaction well holder), the upper portion comprising a plurality of through holes corresponding to the openings and interior walls of the plurality of reaction wells (as illustrated in Fig. 8B, upper portion has openings and interior walls of the reaction wells); and
a lower portion (lower portion corresponds to conductive layer 820 [para. 0405]; illustrated in Fig. 8A) having a top surface and a bottom surface opposite the top surface of the lower potion, the bottom surface of the lower portion being the bottom surface of the reaction well holder (as illustrated in Fig. 8A, bottom surface of conductive layer 820 is the bottom of the reaction well holder), the top surface of the lower portion comprising the plurality of electrodes of the plurality of reaction wells (top surface of conductive layer 820 can be for reaction well electrodes [paras. 0402, 0406]), the plurality of electrodes being a plurality of screen printed electrodes (electrodes can be screen-printed [para. 0156]).
Modified Axion and Wohlstadter are considered analogous art to the claimed inventions because they are in the same field of reaction well plates. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the reaction well holder of modified Axion to have an upper portion having a top surface and a bottom surface opposite the top surface, the top surface of the upper portion being the top surface of the reaction well holder, the upper portion comprising a plurality of through holes corresponding to the openings and interior walls of the plurality of reaction wells; and a lower portion having a top surface and a bottom surface opposite the top surface of the lower portion, the bottom surface of the lower portion being the bottom surface of the reaction well holder, the top surface of the lower portion comprising the plurality of electrodes of the reaction wells, the plurality of electrodes being a plurality of screen printed electrodes, as taught by Wohlstadter, as a reaction well holder with this setup allows for assay measurements that require electrodes to be located at the bottom of the reaction well (Wohlstadter, [para. 0018]).
Regarding Claim 9, modified Axion teaches the device of claim 8.
Axion is silent on wherein the reaction well holder further comprises: a plurality of alignment indicators to align the upper portion and the lower portion.
Wohlstadter further teaches wherein the reaction well holder further comprises: a plurality of alignment indicators (plate holder [para. 0475] and alignment holes [para. 0876]) to align the upper portion and the lower portion (alignment holes made to align the plate bottom with the plate top [para. 0876]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the reaction well holder of modified Axion to have a plurality of alignment indicators to align the upper portion and the lower portion, as taught by Wohlstadter, as a reaction well holder with this setup allows alignment and function of the screen-printed electrodes in the reaction wells (Wohlstadter, [0876]).
Regarding Claim 13, modified Axion teaches the device of claim 1.
Axion is silent on wherein the device is configured to be mounted on a potentiostat such that the plurality of electrical contacts of the device are aligned with a corresponding plurality of electrical contacts of the potentiostat.
Wohlstadter teaches wherein the device is configured to be mounted on a potentiostat (well plate can be mounted to a potentiostat [para. 0186]) such that the plurality of electrical contacts of the device are aligned with a corresponding plurality of electrical contacts of the potentiostat (plate holder is adapted to keep electrical contacts in place [para. 0475]).
Modified Axion and Wohlstadter are considered analogous art to the claimed inventions because they are in the same field of reaction well plates. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the reaction well holder of modified Axion configured to be mounted on a potentiostat such that the plurality of electrical contacts of the device are aligned with a corresponding plurality of electrical contacts of the potentiostat, as taught by Wohlstadter, as a reaction well holder with this setup allows for interfacing with a potentiostat for specialized applications (Wohlstadter, [para. 0186]).
Regarding Claim 14, modified Axion teaches a system for electrochemical analysis comprising: the device for electrochemical experimentation of claim 13 (as outlined in the claim 13 rejection above, modified Axion teaches the device of claim 13); and
the potentiostat (as outlined in the claim 13 rejection above, Wohlstadter teaches the reaction well plate can be mounted to a potentiostat [para. 0186] in Wohlstadter).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Axion, and Paradox, as applied to claim 1 above, and in view of Collection Plate (Collection Plates & Accessories, 2022) and Wohlstadter (US 2004/0022677 A1).
Regarding Claim 10, modified Axion teaches the device of claim 1.
Axion is silent on further comprising: an alignment member to hold the device in place for alignment of the plurality of electrical contacts of the device located on the bottom surface of the reaction well holder with a corresponding plurality of electrical contacts of a potentiostat.
Collection Plate teaches well plate systems (generally on pages 1 and 2), and teaches an alignment member (as seen in left side of photo on page 2, Flexi-Tier collection system includes an open area alignment member) to hold the device in place for alignment (as seen in photo on page 2, alignment member is a rectangular ring with an open area designed to attach to the perimeter of the well plate system).
It would be obvious to one of ordinary skill in the art prior to the effective filing date to modify the reaction well holder of modified Axion to include an alignment member to hold the device in place, as taught by Collection Plate, as adding an alignment member allows for securing of the reaction wells depending on the well plate system (Collection Plate, [page 2]).
Modified Axion is silent on the alignment member holds the device in place for alignment of the plurality of electrical contacts of the device located on the bottom surface of the reaction well holder with a corresponding plurality of electrical contacts of a potentiostat.
Wohlstadter teaches a potentiostat (a potentiostat may be connected [para. 0186]).
Modified Axion and Wohlstadter are considered analogous art to the claimed inventions because they are in the same field of reaction well plates. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the reaction well holder of modified Axion to include a potentiostat, as taught by Wohlstadter, as a reaction well holder with this setup allows for assay measurements that require electrodes (Wohlstadter, [para. 0018]); the limitation the alignment member is configured to “hold the device in place for alignment of the plurality of electrical contacts of the device located on the bottom surface of the reaction well holder with a corresponding plurality of electrical contacts of a potentiostat” is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. In the instant case, Collection Plate teaches an alignment member (see photo on page 2 of Collection Plate), that secures the reaction wells of the well plate in place, which would aid in alignment of the plurality of electrical contacts of the device located on the bottom surface of the reaction well holder with a corresponding plurality of electrical contacts of a potentiostat of modified Axion. Thus, the alignment member of modified Axion is capable of performing the claimed function above.
Regarding Claim 11, modified Axion teaches the device of claim 10, and teaches wherein the alignment member is an alignment ring configured to snugly fit around a perimeter of the reaction well holder (as taught in the claim 10 rejection above, Collection Plate teaches alignment member is a rectangular ring configured to fit around the reaction wells [see photo on page 2 of Collection Plate]).
Regarding Claim 12, modified Axion teaches the device of claim 10, and teaches wherein the alignment member has an open interior to receive the reaction well holder (as taught in the claim 10 rejection above, Collection Plate teaches the alignment member is a rectangular ring with an open center [see photo on page 2 of Collection Plate]).
Axion is silent on the open interior has an area at least 50 cm2 and at most 200 cm2.
Wohlstadter teaches the reaction well holder has an open interior has an area of 109 cm2 (as the skirt 112 surrounds the base of a plate 100 with dimensions 3.365 inches by 5.030 inches [para. 0009], which corresponds to 3.365 inches x 2.54 cm/1 inch = 8.55 cm by 5.030 inches x 2.54 cm/1 inch = 12.8 cm, which gives an area of 8.55 cm x 12.8 cm = 109 cm2; the alignment member of modified Axion would have approximately the same open interior area as the alignment member fits around the reaction well holder).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment member of modified Axion to have an open interior to receive the reaction well holder, and the open interior has an area at least 109 cm2, as taught by Wohlstadter, as a well plate with this setup and area allows for incorporation into assay machines (Wohlstadter, [para. 0466]).
Response to Arguments
Applicant’s arguments, see Remarks pgs. 2-7, filed 07/08/2026, with respect to the 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant's Argument #1:
Applicant argues on pages 3-4 that Axion, the primary reference in the Office Action, would be rendered inoperable as Axion is directed to microelectrode arrays for use in cellular arrays. By adding the teachings of Paradox to include a silicone/rubber cover and top cover to arrive at the presently claimed invention, the airtight seal created would render Axion inoperable as cellular based assays cannot be conducted under anaerobic conditions.
Examiner's Answer #1:
Applicant's arguments have been considered but are not persuasive. Although using the teachings of Paradox of adding a silicone/rubber cover and top cover to arrive at the presently claimed invention would create an airtight environment, certain cellular measurements can still be performed under anaerobic conditions, such as cellular studies using only anaerobic cells. Thus, the apparatus of Axion would not be rendered inoperable using the applied teachings of Paradox.
Applicant's Argument #2:
Applicant argues on pages 4-5 that Axion and Paradox do not disclose or suggest “a gasket positioned on the top surface of the reaction well holder and covering the openings of the plurality of reaction wells” and “wherein the top plate is a stainless steel plate comprising a plurality of through holes aligned with the openings of the plurality of reaction wells”, as the depiction of page 13 of Paradox has the top portion of the HTe- Chem Assembly does not have openings that align with the reaction wells, but rather is a housing for the electrochemical assembly.
Examiner's Answer #2:
Applicant's arguments have been considered but are not persuasive. As the gasket depicted on page 13 of Paradox for the HTe- assembly does have holes aligned with the reaction wells (Paradox, blown out view of HTe- Assembly on page 13), and Paradox offers top covers composed of stainless steel (Paradox, bottom right of page 5), Axion in view of Paradox teaches a gasket positioned on the top surface of the reaction well holder and covering the openings of the plurality of reaction wells” and “wherein the top plate is a stainless steel plate comprising a plurality of through holes aligned with the openings of the plurality of reaction wells”. Examiner notes that other embodiments of Paradox, such as the Aluminum Reaction Block on the bottom left of page 12 and the Parallel Synthesis Reaction Blocks on page 7 also teach the top plate with a plurality of through holes aligned with the openings of the plurality of reaction wells.
Applicant's Argument #3:
Applicant argues on pages 5-6 that Axion and Paradox do not disclose or suggest “wherein the top plate is a stainless steel plate comprising a plurality of through holes aligned with the openings of the plurality of reaction wells”, as the reaction well block on page 5 of Paradox is merely a high-throughput reaction plate. As there are no electrodes, electrical contacts, or any indication as to how the reaction well block on page 5 of Paradox could be modified to be an electrochemical experimentation device while maintaining the through holes aligned with the openings of the plurality of reaction wells.
Examiner's Answer #3:
Applicant's arguments have been considered but are not persuasive. As the stainless steel plate taught on page 5 of Paradox is a stainless steel plate for a high throughput reaction well, and both Paradox and Axion teach electrochemical assemblies with electrodes (HTe- Chemical Assembly on page 13 in Paradox; BioCircuit MEA 96 plate on page 2 in Axion), it would be obvious to one of ordinary skill to modify the top plate of modified Axion to comprise stainless steel, as stainless steel would be considered an option for high throughput reaction blocks (Paradox, pages 2-3 and 5); the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art [MPEP § 2144.07].
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795