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 May 13th, 2026 has been entered. Claims 1-2 have been amended. Claim 28 has been canceled. Claims 16-18, 20-22, and 24-27 have been previously withdrawn. Claims 1-2, 4-5, 8, 10-11, and 13-15 are currently examined herein.
Status of the Rejection
New grounds of claim objection are necessitated by the amendment.
New grounds of 35 U.S.C § 112b rejections are necessitated by Applicant’s amendments.
All 35 U.S.C. § 103 rejections from the previous office action are essentially maintained and modified only in response to Applicant’s amendments.
Claim Objections
Claims 5 and 15 are objected to because of the following informalities:
Claim 5, please amend “substrate” to “the substrate” (two places).
Claim 15, please amend “a device according to claim to” to “[[a]] the device according to claim 1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 8, 10-11, and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “the surface” lacks antecedent basis. Claims 2, 4-5, 8, 10-11, and 13-15 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite Claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 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) and Rahimi (Optimization of Porous Silicon Conditions for DNA-based Biosensing via Reflectometric Interference Spectroscopy. Cell J 2019; 20(4), 584-591).
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; wherein the substrate comprises one or more porous silicon layers; and wherein the Ohmic contacts are coupled to the surface of the substrate.
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), a power source (a voltage is applied to the gate electrode 26 to cause conduction in channel region 20 between source and drain regions 14 and 16, in a manner conventional with MOSFETs [para. 0034]), and wherein the Ohmic contacts are coupled to the surface of the substrate (source 14 and drain 16 are coupled to surface of 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 and a power source, wherein the Ohmic contacts are coupled to the surface of the substrate, as taught by Santoruvo, as Ohmic contacts would provide current that generates heat in the silicon substrate for target objects for temperature control (Santoruvo, [paras. 0019 and 0041]; 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, as outlined in the rejection above, when the Ohmic contacts are connected to a power source, the Ohmic contacts are configured to pass a current through the substrate to generate heat (Santoruvo, [para. 0030]). Thus, the Ohmic contacts and power source of modified Petralia are capable of performing the claimed function above.
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]).
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, modified Petralia teaches a system (a system comprising a silicon electrochemical device [first para. section 2.2, page 91 in Petralia]; 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 in Petralia]. Thus, the system is capable of performing the intended use; the system comprising:
the device according to claim 1 (as outlined in the claim 1 rejection above, modified Petralia teaches the device according to claim 1).
Petralia teaches 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 in Petralia].
Response to Arguments
Applicant's arguments, see Remarks pgs. 7-12, filed 05/13/2026, 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 7-12 that MPEP 2114 has been misapplied regarding intended use for the limitation “configured to pass a current through the substrate when connected to a power source”, as MPEP 2114 cannot be used when the prior art is silent on the structural element. The current inquiry under 35 U.S.C 103 is whether there is an objective reason for a person to add “Ohmic contacts coupled to the substrate…connected to a power source” to the device of Petralia. In addition, Examiner’s motivation for combining Petralia and Santoruvo is a conclusory statement and does not address why one of ordinary skill in the art working with electrochemical detection would have wanted to add a heating capability to the device.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. As the prior art of Petralia, Santoruvo, and Rahimi teaches all structural limitations of independent claim 1; the limitation “configured to pass a current through the substrate when connected to a power source” is considered a functional limitation. Thus, MPEP 2114(II) can be used and if the prior art structure is capable of performing the intended use, then it meets the claim. In addition, adding the Ohmic contacts to the apparatus of Petralia helps with temperature control (see Santoruvo [para. 0041] which states that good temperature control is needed). Thus, one of ordinary skill in the art would be motivated to add Ohmic contacts for temperature control.
Applicant’s Argument #2:
Applicant argues on page 9 that Rahimi, which is used to reject the limitation “wherein the substrate comprises one or more porous silicon layers”; however, Rahimi is directed to fabrication of a biosensor based on reflectometric interference spectroscopy, and not electrochemical detection. Thus, one of ordinary skill would not be motivated to combine Rahimi with the proposed combination of Petralia and Santoruvo.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive. As Rahimi is directed towards a DNA-based biosensor (abstract), and also teaches that porous silicon is a nanostructure of silicon material that can be used as a suitable transducer in a variety of detection methods including electrochemical methods (col. 1, first para. page 584 in Rahimi), Rahimi is considered an analogous reference and one of ordinary skill in the art would consider utilizing porous silicon for electrochemical biosensors.
Applicant’s Argument #3:
Applicant argues on pages 9-10 that even if one would combine the three references, the combination would not yield “wherein the Ohmic contacts are coupled to the surface of the substrate”, as Santoruvo teaches Ohmic contacts formed within the body and thus not coupled to the surface of the substrate.
Examiner’s Response #3:
Applicant’s arguments have been fully considered, but are not persuasive. As claim 1 currently recites “wherein the Ohmic contacts are coupled to the surface of the substrate”, the Ohmic contacts taught by Santoruvo (source 14 and drain 16 in Fig. 1 [para. 0030]) are coupled to the surface (surface of wafer 11 in Fig. 1) even if source 14 and drain 16 are located in wafer 11. Examiner recommends clarifying that the location of the Ohmic contacts on the surface (such as on top surface of the substrate as opposed to only coupled to the surface) to further differentiate from the prior art.
Applicant’s Argument #4:
Applicant argues on pages 10-12 that Applicant renews the argument presented in response filed August 11th, 2025 of unexpected results of increased sensitivity, which is not taught by the prior art of record.
Examiner’s Response #4:
Applicant’s arguments have been fully considered, but are not persuasive. As varying temperature is considered an important parameter for biological analysis (see Santoruvo [para. 0041] which states that good temperature control is needed for biological analysis), sensitivity changing with temperature in a biosensor would not be considered an unexpected result for biosensors.
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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