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
The Amendment filed July 6, 2026 has been entered. Claims 1-3, 4(w), 5-9, 11-12 have been amended; claims 14-21 are new; claim 13 is cancelled; and claims 4 and 14-21 have been withdrawn. Claims 1-3, and 5-12 are currently examined herein.
Status of the Rejection
The non-compliant amendment is withdrawn in view of the amendment.
New ground of restriction is necessitated by the amendment as outlined below.
Applicant’s amendments to the Claims have overcome each objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed March 11, 2026.
New grounds of claim objection are necessitated by the amendment as outlined below.
All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12, drawn to a diagnostic apparatus, classified in B01L2300/0645.
II. Claims 14-21, drawn to a method for manufacturing a diagnostic apparatus, classified in B29C45/16.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process as claimed can be used to make another and materially different product since the diagnostic apparatus made by the process does not require the plurality of electrodes disposed in a plurality of through holes of the insulator, which is required in the apparatus of invention I.
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 separate statuses in the art in view of their different statutory categories;
the inventions have acquired separate statuses in the art due to their recognized divergent subject matter;
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;
the prior art applicable to one invention would likely not be applicable to another invention; and/or
the inventions are likely to raise different non-prior art issues (i.e., under 35 U.S.C. § 101 and/or 112).
MPEP § 819 states "The general policy of the Office is that applicants are not permitted to shift to claim another invention after an election is made and an Office action on the merits is made on the elected invention. See MPEP § 706.07(h), subsection VI.(B). Therefore, Claims 14-21 of the invention II are withdrawn; and claim 4 drawn to the unelected species B of the invention I (Applicant's election of Species A, Claims 1-3 and 5-13, without traverse in the reply filed on 12/04/2025) is also withdrawn.
Claim Objection
Claim 3 is objected to because of the following informalities:
Claim 3: please amend “at least one of the plurality of electrodes” in Ln 1-2 to – the at least one of the plurality of electrodes--.
Appropriate correction is required.
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 1-2, 5, 7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (US20220395832A1), and in view of Pavesi et al. (How to embed three-dimensional flexible electrodes in microfluidic devices for cell culture applications, Lab on a chip, 2011, 11, 1593).
Regarding claim 1, Fan teaches a diagnostic apparatus (a microfluidic device [claims 22-23, Figs.1 and 9]) comprising:
a base plate including an insulator (substrate 100 including an insulating layer 112 as shown in Figs. 1B and 9 [para. 0055, 0088]); and
a plurality of electrodes disposed in a plurality of through holes of the insulator (a plurality of electrodes 103 and 102 disposed in a plurality of through holes of the insulator 112 as shown in Figs. 1B and 9; each electrode 103 and its lead 102 together is deemed as an electrode, and Figs. 1B and 9 shows the lead 102 of each electrode is disposed in a through hole 110 of the insulating layer 112), wherein the plurality of electrodes are spaced apart on a surface of the base plate (Figs. 1B and 9 show the plurality of electrodes are spaced apart on a top surface of the insulating layer 112 of the base plate) and configured to cause a fluid located on the surface to be moved based on applied voltage (By applying a corresponding potential to each driving electrode 103, under the dielectric wetting effect, the three-phase contact angle of the droplet becomes smaller, resulting in asymmetrical deformation of the droplet and an internal pressure difference, thereby driving the droplet to move [para. 0062], thus the plurality of electrodes are configured to perform the claimed function),
wherein the insulator corresponds to a first portion of the base plate (see Figs. 1B and 9).
Fan is silent to wherein the plurality of electrodes are formed of conductive plastic.
Pavesi teaches one or more electrodes formed by penetrating through a base plate including an insulator (Fig. 1a-1d shows a conductive material injected into the lateral channels of a PDMS device to form electrodes, wherein the conductive material is a mixture of PDMS and MWCNT [the 2nd paragraph in Col. 1 on page 1594]. The PDMS device is deemed as the base plate including an insulator since PDMS is an insulator, and the conductive material is conductive plastic due to the presence of PDMS which is a type of plastic).
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 electrode material of the plurality of electrodes in Fan with the electrode material of conductive plastic comprising a mixture of PDMS and MWCNT, as taught by Pavesi, since Pavesi teaches a conductive nanocomposite material of PDMS and MWCNT as a suitable alternative electrode material for microfluidic applications (the 2nd paragraph in Col. 1 on page 1594 in Pavesi). Furthermore, 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].
Regarding claim 2, modified Fan teaches the diagnostic apparatus of claim 1, and Fan teaches an upper width of at least one of the plurality of electrodes (width of each electrode 103 disposed above the insulator 112 in Figs. 1B and 9) is larger than a middle width of the at least one of the plurality of electrodes (width of each lead 102 located inside each through hole 110 as shown in Figs. 1B and 9) by a first reference size, and a lower width of at least one of the plurality of electrodes (width of the lead 102 disposed at the bottom of the insulator 112 and on the first base substrate 101 as shown in Figs. 1B and 9) is larger than the middle width of at least one of the plurality of electrodes by a second reference size (see Figs. 1B and 9), and the first reference size is larger than the second reference size (as shown in Figs.1B and 9, the width of the electrode 103 disposed above the insulator 112 [upper width] is larger than the width of the lead 102 disposed at interface of the first base substrate 101 and the insulator 112 [lower width], which is larger than the width of the lead 102 located in the middle of the through hole [middle with], and Figs. 1B and 9 show the first reference size is larger than the second reference size).
Regarding claim 5, modified Fan teaches the diagnostic apparatus of claim 1, wherein the conductive plastic comprises carbon nanotubes (MWCNTs [the 2nd paragraph in Col. 1 on page 1594 in Pavesi]).
Regarding claim 7, modified Fan teaches the diagnostic apparatus of claim 1, and Fan teaches wherein an upper width of an electrode gap formed by two or more electrodes is smaller than a lower width of the electrode gap (Figs. 1B and 9 show that an upper width of an electrode gap formed by two or more electrodes 103 is smaller than a lower width of the electrode gap since the width of the leads 102 of the two or more electrodes are smaller than the width of each electrode 103).
Regarding claim 9, modified Fan teaches the diagnostic apparatus of claim 7, and the limitation “wherein the base plate of the electrode gap is formed by injecting the insulator into a lower portion of the electrode gap” is a product by process limitation. The determination of patentability is based upon the product or apparatus structure itself. Patentability 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). In the instant case, as outlined in the rejection for claim 7 above, modified Fan teaches the electrode gap between adjacent electrodes with the insulator 112 disposed at a lower portion of the electrode gap, as shown in Figs.1B and 9 in Fan. Thus, the disclosed product is the same as the claimed one. There is no evidence the step of the recited process of forming the base plate of the electrode gap imparts any additional structure on the apparatus that is not already present or substantially similar to that of modified Fan.
Regarding claim 10, modified Fan teaches the diagnostic apparatus of claim 1, and Fan teaches further comprising a reservoir ( In the driving electrode 103, the third region 117 is usually used as a liquid reservoir to store the fluid to be processed. The droplets separated from the liquid reservoir generally move in an expected path on the driving electrodes 103 of the first region 115 and the second region 116 in accordance with the applied voltage [para. 0092]). The limitation “for dispensing the fluid contained in a housing” 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, Fan teaches a liquid reservoir to store the fluid to be processed. The droplets separated from the liquid reservoir generally move in an expected path on the driving electrodes 103 of the first region 115 and the second region 116 in accordance with the applied voltage [para. 0092]. Thus, the disclosed reservoir is configured for dispensing the fluid contained in a housing (a housing of the reservoir).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Fan and Pavesi, as applied to claims 2 and 7 above, and further in view of Jayaraman et al. (Defect-free metallization of through-glass vias with engineered geometry in additive-free electrolyte, Electrochemistry Communications, 2020, 120, 106823).
Regarding claim 3, modified Fan teaches the diagnostic apparatus of claim 2, and is silent to wherein the width of the at least one of the plurality of electrodes is tapered from an upper portion of the at least one of the plurality of electrodes to a middle portion of the at least one of the plurality of electrodes and tapered from a lower portion of the at least one of the plurality of electrodes to the middle portion of the at least one of the plurality of electrodes.
Jayaraman teaches a via tapered from an upper portion of the electrode to a middle portion and tapered from a lower portion of the electrode to the middle portion, as shown in Figs. 5d and 6e. Fig.2 shows R1 and R2 are the radii at the top and middle of the via, respectively (see caption of Fig.2). If the cross-section of the via is uniform ( i.e., Rav=R1=R2), conformal plating alone does not guarantee seamless filling (the first paragraph in Col. 2 on page 3).
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 shape of each via (the middle part of the electrode disposed in each through hole) in modified Fan to conical cross-section in the middle such that a width of the electrode is tapered from an upper portion of the electrode to a middle portion and tapered from a lower portion of the electrode to the middle portion, as taught by Jayaraman, since it would ensure void-free filling (abstract and the first paragraph in Col. 2 on page 3 in Jayaraman). Furthermore, the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1976) (see MPEP § 2144.04).
Regarding claim 8, modified Fan teaches the diagnostic apparatus of claim 7, and Figs. 1B and 9 in Fan show the width of a lower portion of the electrode gap (electrode gap between two leads 102 located at the interface of the insulator 112 and the first base substrate 101) is smaller than the width of the middle portion of the electrode gap (electrode gap between two leads 102 located in the middle of the through holes 110 of the insulator 112).
Fan is silent to wherein a width of the electrode gap is tapered from a middle portion of the electrode gap toward an upper portion of the electrode gap and tapered from the middle portion of the electrode gap toward a lower portion of the electrode gap.
Jayaraman teaches a via tapered from an upper portion of the electrode to a middle portion and tapered from a lower portion of the electrode to the middle portion, as shown in Figs. 5d and 6e. Fig.2 shows R1 and R2 are the radii at the top and middle of the via, respectively (see caption of Fig.2). If the cross-section of the via is uniform ( i.e., Rav=R1=R2), conformal plating alone does not guarantee seamless filling (the first paragraph in Col. 2 on page 3). Figs. 5d and 6e also show that a width of the electrode gap between two adjacent electrodes tapered from a middle portion of the electrode gap toward an upper portion and tapered from the middle portion of the electrode gap toward a lower portion.
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 shape of each via (the middle part of each electrode embedded within the insulator) in modified Fan to conical cross-section in the middle such that a width of the electrode inside each through hole is tapered from an upper portion of the electrode to a middle portion of the electrode and tapered from a lower portion of the electrode to the middle portion of the electrode, and a width of the electrode gap between two adjacent electrodes is tapered from a middle portion of the electrode gap toward an upper portion of the electrode gap and tapered from the middle portion of the electrode gap toward a lower portion of the electrode gap, as taught by Jayaraman, since it would ensure void-free filling (abstract and the first paragraph in Col. 2 on page 3 in Jayaraman). Furthermore, the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1976) (see MPEP § 2144.04).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fan and Pavesi, as applied to claim 1 above, and further in view of Gach et al. (US20190126279A1).
Regarding claim 6, modified Fan teaches the diagnostic apparatus of claim 1, and is silent to wherein the insulator comprises at least one of polycarbonate (PC), poly methyl methacrylate (PMMA), cyclic olefin polymer (COP), cyclic olefin copolymer (COC), polyethylene terephthalate (PET), polyimide (PI), polyethylene (PE), acrylic, acrylonitrile butadienestyrene (ABS), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), polystyrene (PS), polypropylene (PP), or polyvinyl chrloride (PVC).
Gach teaches digital microfluidic systems and methods for droplet manipulation based on EWOD (title and [para. 0004]). Figs.4F and 4H show the EWOD device comprises one or more electrodes (combined electrode 440, via 430, and the interconnection at the bottom of the via 430 is deemed as an electrode [para. 0046], and Figs. 4F and 4H show a plurality of electrodes) formed by penetrating through a base plate including an insulator (substrate 425, which may be glass, organic or inorganic polymers (e.g., liquid crystal polymers or polyimide), printed circuit boards, paper, etc. [para. 0043]).
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 material of the insulator in modified Fan with polyimide, as taught by Gach, since Gach teaches polyimide as a suitable material for the insulator for EWOD [para. 0043]. Furthermore, 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].
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fan and Pavesi, as applied to claim 10 above, and further in view of Srinivasan et al. (US20100120130A1).
Regarding claim 11, modified Fan teaches the diagnostic apparatus of claim 10, and Fan teaches wherein one or more adjacent electrodes of the plurality of electrodes that are formed adjacent to the reservoir in the base plate ( In the driving electrode 103, the third region 117 is usually used as a liquid reservoir to store the fluid to be processed. The droplets separated from the liquid reservoir generally move in an expected path on the driving electrodes 103 of the first region 115 and the second region 116 in accordance with the applied voltage).
Fan is silent to wherein the one or more adjacent electrodes have an upper width larger than an upper width of other electrodes, of the plurality of electrodes, formed in the base plate.
Srinivasan teaches an EWOD as shown in Fig.4c, comprising adjacent electrode 422 of the plurality of electrodes (electrodes 416 and 422 in Fig.4c), wherein the adjacent electrode 422 is formed adjacent to the reservoir 434, has an upper width larger than an upper width of the other electrode 416 ([para. 0064]; Fig.4c). Reservoir electrode 422 is illustrated as being larger than droplet operations electrodes 416 [para. 0064].
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 size of the one or more adjacent electrodes that are formed adjacent to the reservoir to have an upper width larger than an upper width of other electrodes, as taught by Srinivasan, since Srinivasan teaches the reservoir electrode (corresponding to the one or more adjacent electrodes) formed adjacent to the reservoir and is larger than the droplet operation electrodes (corresponding to other electrodes) for dispensing droplets [para. 0064].
Regarding claim 12, modified Fan teaches the diagnostic apparatus of claim 11, and Fan is silent to wherein a quantity of the one or more adjacent electrodes corresponds to a size of the reservoir.
Srinivasan further teach wherein Fig.4C shows the opening of the reservoir is substantially aligned with the reservoir electrode 422, and one reservoir electrode is arranged below the reservoir since the size of the reservoir electrode is a little bit larger than that the size of the reservoir [para. 0064]. Thus, Srinivasan teaches a quantity of the one or more adjacent electrodes corresponds to a size of the reservoir.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a quantity of the one or more adjacent electrodes corresponds to a size of the reservoir, which would allow to arrange the adjacent electrodes aligned with the upper reservoir [para. 0064 and Fig.4C in Srinivasan].
Response to Arguments
Applicant's arguments, see Remarks Pgs. 7-10, filed 7/6/2026, with respect to the 35 U.S.C. § 103 rejections have been fully considered, and the previous 103 rejections have been withdrawn.
Applicant’s Argument #1:
Applicant argues at pages 7-10 that the cited prior art fails to teach “a plurality of electrodes disposed in a plurality of through holes of the insulator” in the amended claim 1.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for claim 1 above.
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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
Prosecution Insights