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 August 11th, 2025 has been entered. Claims 2 and 8 have been amended. Claim 28 has been added. Claim 3, 6-7, 9, 12, 19, and 23 have been previously canceled. Claims 16-18, 20-22, and 24-27 have been previously withdrawn. Claims 1-2, 4-5, 8, 10-11, 13-15, and 28 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome each 112(b) rejections previously set forth in the Non-Final Office Action mailed March 10th, 2025.
All 35 U.S.C. § 103 rejections from the previous office action are essentially maintained and modified only in response to the amendments to the claims.
New grounds of rejection under 35 § U.S.C 103 are necessitated by the Applicant’s amendments for new claim 28.
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, 4-5, 8, 10-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Petralia et al. (A miniaturized silicon based device for nucleic acids electrochemical detection, Sensing and Biosensing Research. 2015; 6, pages 90-94, provided in IDS dated 08/15/2023) in view of Santoruvo (US 2003/0116552 A1).
Regarding Claim 1, Petralia teaches a device (a silicon electrochemical device [first para. of section 2.2, page 91; illustrated in Fig. 1 and Fig. 2a-c]; the limitation “for detecting a substance in a solution” is an intended use limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. An intended use limitation 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, the silicon electrochemical device is used to detect nucleic acids based on electrochemical detection in a PCR chamber with a total solution volume of 20 µL [second para. col. 1, page 91]. Thus, the silicon electrochemical device is capable of performing the intended use above; the device comprising:
a substrate comprising silicon (6’’ silicon substrate [first para. section 2.2, page 91; illustrated in Fig. 1]);
a first electrode (platinum working electrode [last para. col. 1, page 91]; illustrated in Fig. 1) and coupled to the substate (working electrode is coupled to silicon substrate as illustrated in Fig. 1, page 91); the limitation “for use as a working electrode in an electrochemical cell” is a functional recitation. 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, platinum working electrode of Petralia is utilized in an electrochemical cell (last para. col. 1, page 91) and serves as the working electrode for either real time PCR experiments (section 2.3, page 91) or functionalized with an immobilized capture probe (section 2.4, page 91). Thus, the platinum working electrode is capable of performing the functional limitation above.
Petralia is silent on Ohmic contacts coupled to the substrate and configured to pass a current through the substrate when connected to a power source.
Santoruvo teaches an integrated heater as a field effect transistor for semiconductor substrates (abstract), and teaches Ohmic contacts (source 14 and drain 16 in Fig. 1 [para. 0030]) coupled to the substrate (source 14 and drain 16 are coupled to wafer 11 as illustrated in Fig. 1). As the source 14 and drain 16 provide a resistance (current) that produces heat indicated by arrows 22 in Fig. 1 [para. 0030], Santoruvo teaches the Ohmic contacts positioned on the opposite end of the chamber 30 where, for example, detection of DNA takes place [para. 0002].
Santoruvo and Petralia are considered analogous art to the claimed inventions because they are in the same field of miniaturized silicon devices for DNA detection. 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 bottom side of the silicon substrate of Petralia to include Ohmic contacts coupled to the substrate, as taught by Santoruvo, as Ohmic contacts would provide current that generates heat in the silicon substrate for target objects (Santoruvo, [para. 0019]; Fig. 1). The limitation “configured to pass a current though the substrate when connected to a power source” is a functional recitation. 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, when the source 14 and drain 16 of Santoruvo are connected to a power source, a current pass through the substrate generating heat (Santoruvo, [para. 0030]). Thus, the source 14 and drain 16 are capable of performing the claimed function above.
Regarding Claim 2, modified Petralia teaches the device of claim 1.
Petralia teaches, wherein the substrate comprises: a) one or more bulk silicon layers (6’’ silicon substrate [first para. of section 2.2, page 91]), and optionally one or more silicon dioxide layers (silicon oxide layer [first para. of section 2.2, page 91; Fig. 1).
Regarding Claim 4, modified Petralia teaches the device of claim 1.
Petralia teaches wherein the first electrode: a) comprises a noble metal (working electrode is composed of platinum [last para. col. 1, page 91]).
Regarding Claim 5, modified Petralia teaches the device of claim 1.
Petralia teaches further comprising: a) a second electrode for use as a counter electrode in the electrochemical cell (gold counter electrode [last para. col. 1, page 91]). wherein the second electrode is coupled to the silicon comprising substrate via a first insulating layer (silicon oxide is first deposited on silicon substrate to electrically isolate electrodes [first para. of section 2.2, page 91; illustrated in Fig. 1).
b) optionally a third electrode for use as a reference electrode in the electrochemical cell (gold reference electrode [last para. col. 1, page 91]).
Regarding Claim 8, modified Petralia teaches the device of claim 1, wherein the Ohmic contacts are coupled to a second surface of the substrate (as outlined in the claim 1 rejection, Ohmic contacts are added to the bottom silicon substrate of modified Petralia).
Regarding Claim 10, modified Petralia teaches the device of claim 8, wherein the Ohmic contacts and the first electrode are on opposite sides of the substrate (as outlined in the claim 1 rejection, Ohmic contacts are added to the bottom side of the silicon substrate, opposite of the working electrode, of modified Petralia).
Regarding Claim 11, modified Petralia teaches the device of claim 8.
Petralia teaches wherein the first electrode is electrically insulated from the Ohmic contacts (a silicon dioxide layer electrically isolates working electrode [first para. section 2.2, page 91]), and wherein the substrate optionally comprises an electrically insulating layer optionally comprising silicon dioxide (a silicon dioxide layer [first para. section 2.2, page 91]; Figure 1, page 91).
Regarding Claim 13, modified Petralia teaches the device of claim 1.
Petralia teaches wherein the first electrode is in electrical and thermal contact with the substrate (as illustrated in Fig. 1, the working electrode is in electrical contact with the substrate, with measurements from the working electrode recorded using a potentiostat, [first para. section 2.5, page 91]; temperature of the working electrode can be adjusted using integrated heaters below the silicon substrate [second para. section 2.2, page 91]).
Regarding Claim 14, modified Petralia teaches the device of claim 1.
Petralia teaches further comprising a chamber (polycarbonate PCR chamber [second para. col. 1, page 91; as illustrated in Fig. 1, the chamber is above the working electrode for holding solution, page 91]), wherein the first electrode is positioned within the chamber (working electrode [WE] is positioned in the chamber as illustrated in Fig. 1 [page 91]).
The limitation “for retaining the solution” 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, liquid solution is added to the chamber above the working electrode and square wave curves are recorded for detection [entire section of 2.4, page 91; Fig. 1, page 91 in Petralia]). Thus, the chamber of Petralia is capable of performing the functional limitation above.
Regarding Claim 15, Petralia teaches a system (a system comprising a silicon electrochemical device [first para. section 2.2, page 91] and a potentiostat [entire section 2.5, pages 91-92]); the limitation “for detecting a substance in a solution” is an intended use limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. An intended use limitation 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, the system is used for nucleic acid detection based on the electrochemical monitoring of an unspecific DNA intercalating probe [second para. col. 1, page 91]. Thus, the system is capable of performing the intended use; the system comprising:
A device (a silicon electrochemical device [first para. section 2.2, page 91; illustrated in Fig. 1]) comprising a substrate comprising silicon (silicon substrate in Fig.1 [page 91]) and a first electrode for use as a working electrode (Pt working electrode [third para. section 2.2, page 91; illustrated in Fig. 1]) in an electrochemical cell and coupled to the substrate (as illustrated in Fig. 1, working electrode is in an electrochemical cell and coupled to silicon substrate, page 91]), and
a potentiostat (Parstat 2273 [first para. section 2.5, page 91]); the limitation “configured to control an electrochemical potential of the first electrode” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. An intended use limitation 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, the Parstat 2273 records square wave voltammetry measurements using the working electrode [entire section 2.5, pages 91-92; square wave curves illustrated in Figs 4-6].
Petralia is silent to where in the device further comprising Ohmic contacts coupled to the substrate and configured to pass a current through the substrate when connected to a power source.
As outlined in the rejection of claim 1 above, Petralia as modified by Santoruvo teaches the device according to claim 1.
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 system of Petralia with the device according to claim 1, as taught by modified Petralia, as the device taught by modified Petralia would provide current that generates heat in the silicon substrate for target objects (Santoruvo, [para. 0019]; Fig. 1).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Petralia and Santoruvo, as applied to claim 1 above, and in view of Rahimi (Optimization of Porous Silicon Conditions for DNA-based Biosensing via Reflectometric Interference Spectroscopy. Cell J 2019; 20(4), 584-591).
Regarding Claim 28, modified Petralia teaches the device of claim 1.
Petralia is silent on wherein the substrate comprises one or more porous silicon layers.
Rahimi teaches fabrication of biosensors to detect nucleic acids (abstract), and teaches wherein the substrate comprises one or more porous silicon layers (silicon substrate was etched to create porous silicon [entire Section Preparation of porous silicon, page 585]).
Modified Petralia and Rahimi are considered analogous art to the claimed inventions because they are in the same field of miniaturized silicon devices for DNA detection. 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 substrate of modified Petralia by adding a porous silicon layer, as taught by Rahimi, as a porous silicon layer has been commonly used in biosensor applications as a suitable transducer in combination with a variety of detection methods including those based on electrical, electrochemical, optical and thermal methods (Rahimi, [col. 1 para. 1, page 584]).
Response to Arguments
Applicant's arguments, see Remarks pgs. 9-11, filed 08/11/2025, 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 9-11 that the device according to claim 1 would not be predicted from Petralia and Santoruvo, as Examples 3 and 4 of the present application improve the electroanalytical performance of the reporter molecules when detected using the device of claim 1. Inclusion of Ohmic contacts passing current through the substrate allows the device of claim 1 to achieve significantly greater sensitivity compared to measurements at ambient temperatures. In addition, Petralia and Santoruvo both do not recognize any effects of heating on sensor performance or use of heaters during detection.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. First, Petralia in view of Santoruvo teach all apparatus limitations of claim 1. As the disclosed device is essentially the same as the instant claim 1, the disclosed Ohmic contacts are capable of performing the same functions.
Applicant’s Argument #2:
Applicant argues on page 10 that Petralia and Santoruvo each require cleanroom-based fabrication techniques, while the sensor of claim 1 does not require such intensive fabrication techniques.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive, as the process to fabricate the sensor is considered product-by-process. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Applicant’s Argument #3:
Applicant argues on page 11 that new claim 28 depends on claim 1 and is patentable for at least the same reasons as claim 1. In addition, new claim 28 additionally recites that the substrate comprises one or more porous silicon layers, which is not taught by the cited prior art.
Examiner’s Response #3:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for claim 28.
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.
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
/ALEXANDER W KEELING/Primary Examiner, Art Unit 1795