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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/14/2024 has been considered by the examiner.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 1-14, drawn to a device for electrochemical experimentation, classified in G01N27/403.
Group II. Claims 15-20, drawn to a method for electrochemical experimentation, classified in G01N27/283.
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process. For example, device of Group 1 can be used for polymerase chain reaction (PCR) for biological samples including DNA, RNA, or PNA.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
A telephone call was made to Attorney Todd Farnsworth (Reg # 65,432) on 02/26/2026 to request an oral election, and a provisional election without traverse to prosecute Group I, Claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 1, 4-5, 7-8, and 12 are objected to because of the following informalities:
Claim 1, please amend “the reaction wells” to “the plurality of reaction wells”; “the electrodes” to “the plurality of electrodes”; “the electrical contacts” to “the plurality of electrical contacts”.
Claim 4, please amend “the electrodes” to “the plurality of electrodes”.
Claim 5, please amend “the electrical contacts” to “the plurality of electrical contacts”, “the reaction well” to “the corresponding reaction well”.
Claims 7-8, please amend “the reaction wells” to “the plurality of reaction wells”.
Claim 8, please amend “a lower portion having a top surface and a bottom surface opposite the top surface” to “a lower portion having a top surface and a bottom surface opposite the top surface of the lower portion”.
Claim 12, please amend “the open interior and has an area” to “the open interior .
Appropriate correction is required.
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 1-7 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 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 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 electrical contacts are in electrical communication with the two or more of the 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 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 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 page 5, 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, gasket creates an air tight seal).
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 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 reaction wells, as taught by Paradox, as a reaction well holder with a gasket and top plate allows for broad electrochemical reaction use (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 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 electrical contacts are in electrical communication with three of the electrodes of the 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).
Regarding Claim 7, modified Axion teaches the device of claim 1, and teaches wherein the top plate is a stainless steel plate comprising a plurality of through holes aligned with the openings of the reaction wells (as outlined in the claim 1 rejection above, Paradox teaches top plates can be stainless steel, see top cover with wider holes for 96-well reaction block aligned with the reaction well openings [bottom right, page 5] 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 reaction wells; and
a lower portion having a top surface and a bottom surface opposite the top surface, 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.
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 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, 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 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 reaction wells; and a lower portion having a top surface and a bottom surface opposite the top surface, 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 requires electrodes 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 (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 in assay machines (Wohlstadter, [para. 0466]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL LEE GAMBLE JR whose telephone number is (703)756-5492. The examiner can normally be reached Mon - Fri 10:00-6:00 EST.
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
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