DETAILED ACTION
Status of the Claims
1. Claims 1, 4-5, 10, 12, 15, 19, 21, 24, 26, 36, 53-54 are pending.
Status of the Rejections
2. Rejection of claim(s) 1, 4-5,19, 21, 26, 36 and 53-54 in view of Weiss et al. (WO 2019/200164) are being modified in view of applicant’s amendments.
Objection to the Priority
3. Objection to claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) is being withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-5,19, 21, 26, 36 and 53-54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiss et al. (WO 2019/200164).
Claim 1. Weiss et al. teach sensor for detecting a nucleic acid (biosensor device to detect target nucleic acid [0035] and [0053], comprising:
a substrate (substrate 245 made from silicon wafer; [0053]);
a pair of terminal electrodes disposed on the substrate in mutually spaced apart and opposing relation (source and drain electrodes 114, 116 disposed on the substrate and mutually space apart in opposing relation; see Fig 8A); and
a sensing element, between and in electrical contact with the pair of terminal electrodes (semiconduction channel, 243 in contact with source and drain electrodes; [0053], wherein the sensing element comprises:
(i) a semiconducting portion of the substrate, wherein a conduction path between the terminal electrodes passes through the semiconducting portion (substrate is made up of silicon forms conduction path between the source and drain electrodes; [0053][0062]); and
(ii) an oligonucleotide on a surface of the semiconducting portion, the oligonucleotide being complementary to the nucleic acid to be detected, wherein hybridisation of the nucleic acid with the oligonucleotide leads to a change in resistance of the sensor (immobilize nucleic acid onto the semiconductor surface; [0059] and hybridization of nucleic acid with immobilized nucleic acid lead to change in transconductance (reciprocal of resistance) [0062]);
wherein the semiconducting portion has a resistivity of greater than 100 ohm.cm (the semiconductor substrate is made up of silicon [0053] which inherently has resistivity in the range of 1000 to 10000 ohm.cm as evidenced by applicant disclosure [0020][0017]and thus meet claim limitation of a resistivity of greater than 100 ohm.cm).
Claim 4. Weiss et al. teach the semiconducting portion has a resistivity of in the range of 1000 to 10000 ohm.cm (the semiconductor substrate is made up of silicon [0053] which inherently has resistivity in the range of 1000 to 10000 ohm.cm as evidenced by applicant disclosure [0020][0017]and thus meet claim limitation of a resistivity of greater than 100 ohm.cm).
Claim 5. Weiss et al. teach the semiconducting portion comprises a high-resistivity non-oxide semiconductor (the semiconductor substrate is made up of silicon [0053] which is high-resistivity non-oxide semiconductor).
Claim 19. Weiss et al. teach the oligonucleotide is chemically bonded to the semiconducting portion by a process comprising: (i) silanization of the semiconducting portion with a silanizing agent having a terminal functionality selected from the group consisting a carboxy group (ii) reacting an oligonucleotide with the terminal functionality (indium oxide surface silanized with PTMS have MBS as terminal functionality to immobilize nucleic acid; [0062]).
Claim 21. Weiss et al. teach the oligonucleotide is complementary to a nucleic acid having a single point mutation to a native DNA sequence (detecting SNP i.e. single mismatched nucleotide associated with disease such as Cancer [0086][0003]).
Claim 26. Weiss et al. teach a method for detecting a nucleic acid detect target nucleic acid [0035][0053], the method comprising the steps of:
a) contacting a sensing element of a sensor of claim 1 with a substance possibly containing the nucleic acid (contacting sample containing target nucleic acid with the biosensor [0068]);
b) measuring an electrochemical parameter of the sensor corresponding to a resistance of the sensor (measuring change in transconductance (reciprocal of resistance) [0062]); and
c) detecting the presence or absence of the nucleic acid on the sensing element based on electrochemical parameter measured in step (b) (detecting presence of DNA based on change in transconductance during hybridization; [0063]).
Claim 36. Weiss et al. teach a method of fabricating a sensor for detecting a nucleic acid (method of making biosensor for detecting DNA; [0053] and Figs 8A-8B) the method comprising the steps of:
a. providing a substrate comprising a semiconducting portion (substrate 245 made from silicon wafer; [0053]);
b. producing a pair of terminal electrodes on the substrate in mutually spaced apart and opposing relation, wherein the semiconducting portion of the substrate is positioned between and in electrical contact with the terminal electrodes and wherein a conduction path between the terminal electrodes passes through the semiconducting portion (source and drain electrodes 114, 116 disposed on the substrate and mutually space apart in opposing relation and semiconduction channel, 243 in contact with source and drain electrodes wherein the substrate is made up of silicon forms conduction path between the source and drain electrodes [0053][0062] and see Fig 8A); and
c. immobilizing an oligonucleotide on a surface of the semiconducting portion, the oligonucleotide being complementary to the nucleic acid to be detected, thereby producing a sensing element comprising (i) the semiconducting portion and (ii) the oligonucleotide (immobilize nucleic acid onto the semiconductor surface; [0059] and hybridization of nucleic acid with immobilized nucleic acid lead to change in transconductance (reciprocal of resistance) [0062]);
wherein the semiconducting portion has a resistivity of greater than 100 ohm.cm (the semiconductor substrate is made up of silicon [0053] which inherently has resistivity in the range of 1000 to 10000 ohm.cm as evidenced by applicant disclosure [0020][0017]and thus meet claim limitation of a resistivity of greater than 100 ohm.cm).
Claims 53 and 54. Weiss et al. teach oligonucleotide is chemically bonded to the semiconducting portion by a process comprising: (i) silanization of the semiconducting portion with a silanizing agent having a terminal functionality selected from the group consisting of an epoxy group, a thiol an amino group, a carboxy group and a hydroxy group, and (ii) reacting an oligonucleotide with the terminal functionality (indium oxide surface silanized with PTMS and have MBS as terminal functionality to immobilize nucleic acid; [0062]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (WO 2019/200164).
Claim 15. Weiss et al. teach the semiconducting portion comprises an oxygen deficient metal oxide (semiconductor substrate comprises channel 243 comprised of indium oxide (oxygen deficient metal oxide); [0053]. Weiss et al. do not teach the oxygen-deficient metal oxide is selected from the group consisting of zinc oxide (ZnO), strontium titanium oxide (STO), tin oxide (SnO2), and titanium dioxide (TiO2). However, it is well known ZnO and TiO2 are well known oxygen deficient metal oxide used in semiconductor based sensing device and thus substituting indium oxide with ZnO2 or TiO2 would yield predictable results with reasonable expectation.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. as applied to claim 1 above, and further in view of Tsao et al. (US 2018/0201983).
Claim 24. Weiss et al. teach cancer patient DNA is detected [0083] but do not explicitly teach the oligonucleotide is the BRAF oligonucleotide. However, Tsao et al. teach colon-cancer is associated with BRAF DNA mutations [0013][0012]. Therefore, it would have been obvious Weiss et al. device would be capable for detecting BRAF DNA as it is mutation in DNA from a cancer patient.
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. as applied to claim 1 above, and further in view of Ong et al. (US 2010/0015008).
Claims 10 and 12. Weiss et al. teach substrate is comprised of silicon [0053] but do not teach semiconductor the non-oxide semiconductor is an intrinsic silicon semiconductor and the silicon semiconductor is a float-zone silicon semiconductor.
However, Ong et al. teach device of analyzing biological entity such as DNA comprised of disposing DNA onto substrate comprised of silicon wafer obtained from float-zone (reads on intrinsic silicon wafer) [0127][0056].
Therefore, it would have been obvious before the effective filing date of the invention in view of Ong et al. teaching to use float-zone silicon wafer as choice of material for semiconductor substrate in Weiss et al. biosensor because 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. (see MPEP § 2144.07)
Response to Arguments
Applicant's arguments filed on 4/21/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 of remarks regarding claim 1 that Weiss uses 3-electrode system whereas claim of present invention has 2 electrodes.
In response, claim 1 states “a sensor…. comprising,” the phrase comprising is inclusive or open-ended and does not exclude additional, unrecited elements and furthermore the phrase comprising transitioning from the preamble of the body signals that the entire claim is open-ended (see MPEP 2111.03), therefore claim allows for additional elements and thus gate electrode or third electrode of Weiss et al. is allowed. Therefore, Weiss et al. biosensor device meets the claim limitations.
Applicant argues on page 8 of remarks that biosensor of the present invention does not include insulating layer between the conduction path and the source of the bias.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., insulating layer not included between the conduction path and the source of the bias) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, claim 1 states “a sensor…. comprising,” the phrase comprising is inclusive or open-ended and does not exclude additional, unrecited elements and furthermore the phrase comprising transitioning from the preamble of the body signals that the entire claim is open-ended (see MPEP 2111.03), therefore claim allows for additional elements and thus insulating layer of Weiss et al. is allowed. Therefore, Weiss et al. biosensor device meets the claim limitations.
Applicant argues on pages 8-9 of remarks that Weiss’s FET biosensor operates by sweeping voltage applied at the gate electrode and thin layers of SiO2 and In2O3 are required prior to the electrode fabrication.
In response, claim 1 states “a sensor…. comprising,” the phrase comprising is inclusive or open-ended and does not exclude additional, unrecited elements and furthermore the phrase comprising transitioning from the preamble of the body signals that the entire claim is open-ended (see MPEP 2111.03), therefore claim allows for additional elements and thus applying sweeping voltage and thin layers of SiO2 and In2O3 of Weiss et al. is allowed. Therefore, Weiss et al. biosensor device meets the claim limitations.
Applicant argues on pages 10-11 of remarks that data collection and sensor performance evaluation is different from Weiss, electrical measurements are taken in dried condition. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., data collection and sensor performance evaluation and electrical measurements are taken in dried condition) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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