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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2023 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, Claims 1-4, 6, 8-9, 11-12, 14-18 and 20, without traverse in the reply filed on 10/15/2025 is acknowledged.
Claim Objection
Claims 1-4, 12 and 16-18 are objected to because of the following informalities:
Claim 1: please amend “binding of a bioanalyte” to -- binding of [[a]] the bioanalyte--.
Claim 2: please amend “ohm.cm” to – ohm[[.]] · cm--.
Claim 3: please amend “ohm.cm” to – ohm[[.]] · cm--; “the range of” to – [[the]] a range of--.
Claim 4: please amend “an electrical resistance in the range of” to – [[an]] the electrical resistance in [[the]] a range of--.
Claim 12: please amend “the semiconducting layer” to -- the semiconducting [[layer]] portion--.
Claim 16: please amend “and/or” to –[[and/]] or--.
Claim 17: please amend “wherein the biomolecule is a capture protein, and wherein the capture protein is a protein-binding scaffold, a T-cell receptor, a binding-fragment of a TCR, a variable lymphocyte receptor, an antibody and/or a binding-fragment of an antibody” to –wherein the biomolecule is [[a]] the capture protein, and wherein the capture protein is [[a]] the protein-binding scaffold, [[a]] the T-cell receptor, [[a]] the binding-fragment of a TCR, [[a]] the variable lymphocyte receptor, [[an]] the antibody, [[and/]] or [[a]] the binding-fragment of an antibody--. Note that claim 17 depends upon claim 16 and the limitations of claim 17 are identical to those of claim 16 (see rejection of claim 17 under 35 USC § 112d in the following).
Claim 18: please amend “and/or Nanofitins” to – [[and/]] or Nanofitins--.
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, 4, 6, 8-9, 11-12, 14-18 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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, claim 1 recites “a high-resistivity”, and the term “high” is a relative term which also renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instant claim, it is unclear what is the requirement of the resistivity of the non-oxide semiconductor be considered as a high-resistivity. Claims 4,6, 8-9, 11-12, 14-18 and 20 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1. Note that claims 2-3 cure the deficiencies of the indefinite claim 1 because each of claims 2-3 recites the resistivity range.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-18 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In the instant case, the limitations of claim 17 are identical to those of claim 16, and claim 17 depends upon claim 16. Claim 18 is further rejected by virtue of its dependence upon claim 17. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4,6, 9, 11-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Byrne et al. (US20210116412A1).
Regarding claim 1, Byrne teaches a sensor (a FET sensor 200 in Fig.2 [para. 0041]) for detecting a bioanalyte (for the detection of analytes including Salmonella [abstract]; the analyte of interest can be present in a biological sample [para. 0079]; thus the disclosed sensor is specifically configured to perform the intended use of detecting a bioanalyte), comprising:
a substrate (substrate 202 and channel 204 in Fig.2 [para. 0041]);
a pair of terminal electrodes (source electrode 206 and drain electrode 208 in Fig.2 [para.0041]) disposed on the substrate in mutually spaced apart and opposing relation (see Fig.2); and
a sensing element (channel 204 and recognition elements 210 in Fig.2 [para. 0041 ]), between and in electrical contact with the pair of terminal electrodes (see Fig.2), wherein the sensing element comprises:
(i) a semiconducting portion of the substrate (channel 204 in Fig.2 wherein the channel can be formed from a semiconductor materials such as silicon [para. 0050]; note that silicon is also used in this instant application as evidenced by instant claim 6), wherein the semiconducting portion comprises a high-resistivity non-oxide semiconductor (silicon inherently has a high resistivity. Since the disclosed non-oxide semiconductor of silicon is the same as that used in this instant application, it is contended that the silicon of the prior art inherently has the same high resistivity as the silicon used in this instant application. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. high-resistivity), is necessarily present in the prior art material. The courts have held that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II)) and wherein a conduction path between the terminal electrodes passes through the semiconducting portion (the channel 204 forms a path for current flow between the source electrode and the drain electrode [para. 0041]); and
(ii) a bioanalyte binding site (recognition elements 201 in Fig.2 [para. 0041]) on a surface of the semiconducting portion (recognition elements 210 for an analyte of interest immobilized on the surface of the channel 204 via a linking group 212 in Fig.2 [para. 0041]), and “wherein binding of the bioanalyte to the bioanalyte binding site causes a change in electrical resistance of the sensor” 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, Byrne teaches the sensor for rapid detection of analytes based on the binding of analytes to recognition elements [para. 0106]. The sensor can include electronic circuitry configured to measure a change in current flow [para. 0072]. The active sensors can be used to detect an analyte of interest by contacting the analyte of interest with the sensor, and measuring a change in an electrical property of the sensor channel. The change in electrical property can be, for example, a change in current flow [para. 0076]. Fig.10 shows the change in a measured sensor electrical property (current versus threshold voltage) in response to exposure of the sensor towards PBS and a sample contaminated with Salmonella [para. 0023]. The difference in current values for PBS and the sample with the analyte of Salmonella shows binding of the bioanalyte (Salmonella) to the bioanalyte binding site (recognition elements) causes a change in electrical resistance of the sensor. Thus, the disclosed sensor is configured to perform the claimed functions.
Regarding claim 2, Byrne teaches the sensor according to claim 1, wherein the non-oxide semiconductor has a resistivity of greater than 100 ohm·cm (as outlined in the rejection of claim 1 above, the non-oxide semiconductor of silicon inherently has the same resistivity as the silicon used in this instant application. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. a resistivity of greater than 100 ohm·cm), is necessarily present in the prior art material. The courts have held that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II)).
Regarding claim 3, Byrne teaches the sensor according to claim 1, wherein the non-oxide semiconductor has a resistivity in the range of about 500 ohm·cm to about 50,000 ohm·cm (as outlined in the rejection of claim 1 above, the non-oxide semiconductor of silicon inherently has the same resistivity as the silicon used in this instant application. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. a resistivity in the range of about 500 ohm·cm to about 50,000 ohm·cm), is necessarily present in the prior art material. The courts have held that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II)).
Regarding claim 4, Byrne teaches the sensor according to claim 1, wherein the sensor has an electrical resistance in the range of about 10 kiloohms to about 10000 kiloohms (the electrical resistance of the sensor is found to be an inherent characteristic of the sensor comprising all the claimed elements. Since the prior art does disclose the sensor comprising substantially the same elements or components as those of the instant application, it is contended that the sensor of the prior art inherently has the electrical resistance in the range of about 10 kiloohms to about 10000 kiloohms).
Regarding claim 6, Byrne teaches the sensor according to claim 1, wherein the non-oxide semiconductor is an intrinsic silicon semiconductor (the channel can be formed from a semiconductor such as silicon [para. 0050]. Since Byrne does not teach that the silicon is doped, thus, the disclosed silicon is an intrinsic silicon semiconductor).
Regarding claim 9, Byrne teaches the sensor according to claim 1, wherein the substrate comprises the semiconducting portion as an integral portion thereof (Fig.2 shows the substrate comprises the semiconducting portion as an integral portion thereof).
Regarding claim 11, Byrne teaches the sensor according to claim 1, wherein the bioanalyte binding site is chemically bonded to the semiconducting portion (recognition elements can be immobilized on the channel surface via a linking group [para. 0055]; the linking group comprises a polyvalent linking group; For example, the polyvalent linking group can be derived from a small molecule linker that forms two or more covalent bonds with the channel surface and a covalent bond with the recognition element [para. 0056]. Since a covalent bond is a chemical bond, thus the bioanalyte binding site is chemically bonded to the semiconducting portion).
Regarding claim 12, Byrne teaches the sensor according to claim 11, and the limitation “wherein the bioanalyte binding site is chemically bonded to the semiconducting layer by a process comprising: (i) silanization of the non-oxide semiconductor with a silanizing agent having a terminal functionality selected from the group consisting of an epoxy group, a thiol group, an amino group, a carboxy group and a hydroxy group, and (ii) reacting a precursor comprising the bioanalyte binding site with the terminal functionality” 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, Byrne teaches wherein the bioanalyte binding site is chemically bonded to the semiconducting layer by using polyvalent linking group such as (3-glycidyloxypropyl)trimethoxysilane [para. 0057], which comprises an epoxy group. Thus, the product obtained by the process is the same as the disclosed product.
Regarding claim 14, Byrne teaches the sensor according to claim 1, wherein the bioanalyte binding site is present on a biomolecule (Suitable recognition element include antibodies, antibody fragments, antibody mimetics, peptides, proteins, oligonucleotides, DNA, RNA, aptamers, and organic small molecules [para. 0061]).
Regarding claim 15, Byrne teaches the sensor according to claim 1, wherein the bioanalyte binding site is present on a biomolecule selected from the group consisting of a protein and a peptide (Suitable recognition element includes antibodies, antibody fragments, antibody mimetics, peptides and proteins [para. 0061]).
Regarding claim 16, Byrne teaches the sensor according to claim 15, wherein the biomolecule is a capture protein (since the recognition element 210 for an analyte of interest is immobilized on the surface of the channel 204 [para. 0041], and the suitable recognition element includes antibodies, antibody fragments, antibody mimetics, and proteins [para. 0061], the biomolecule of the recognition element is a capture protein), and wherein the capture protein is a protein-binding scaffold (antibody mimetics [e.g., engineered affinity ligands such as AFFIBODY® affinity ligands] [para. 0061]; AFFIBODY® affinity ligands are protein-binding scaffolds), an antibody or a binding-fragment of an antibody (the suitable recognition element includes antibodies, antibody fragments, and antibody mimetics [para. 0061]).
Regarding claim 17, Byrne teaches the sensor according to claim 16, wherein the biomolecule is a capture protein (since the recognition element 210 for an analyte of interest is immobilized on the surface of the channel 204 [para. 0041], and the suitable recognition element includes antibodies, antibody fragments, antibody mimetics, and proteins [para. 0061]; the biomolecule of the recognition element is a capture protein), and wherein the capture protein is a protein-binding scaffold (antibody mimetics [e.g., engineered affinity ligands such as AFFIBODY® affinity ligands] [para. 0061]; AFFIBODY® affinity ligands are protein-binding scaffolds), an antibody or a binding-fragment of an antibody (the suitable recognition element includes antibodies, antibody fragments, and antibody mimetics [para. 0061]).
Regarding claim 18, Byrne teaches the sensor according to claim 17, wherein the protein-binding scaffold is selected from the group consisting of Affibodies (AFFIBODY affinity ligands [para. 0061]), and wherein the binding-fragment of an antibody comprises a Fab, (Fab′)2, single-chain variable fragment (scFv), or single domain antibodies (sdAb) (this limitation depends on an optional limitation of a binding-fragment of an antibody recited in claim 17, thus it is optional. Furthermore, Byrne teaches the recognition element comprises an antibody selectively binds to a target antigen, and the antibody includes single chain antibodies, Fab fragments, F(ab′)2 fragments, scFv (single-chain variable), and single-domain antibody (sdAb) fragments) [para. 0064]).
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 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Byrne, as applied to claim 6 above, and in view of Hirler et al. (US20170263720A1).
Regarding claim 8, Byrne teaches the sensor according to claim 6, and is silent to wherein the silicon semiconductor is a float-zone silicon semiconductor.
Hirler teaches method of forming a semiconductor device such as a FET sensor 201 by using a semiconductor substrate/wafer. As a typical base material for manufacturing a variety of such semiconductor devices, silicon wafers grown by the Czochralski (CZ) method, e.g. by the standard CZ method or by the magnetic CZ (MCZ) method or by the Continuous CZ (CCZ) method may be used. FZ (Float-Zone) silicon wafers may also be used (title, [para. 0035, 0104]).
Byrne and Hirler are considered analogous art to the claimed invention because they are in the same field of semiconductor device such as FET comprising a semiconductor substrate made of a silicon wafer. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute silicon of the semiconductor portion of the substrate in Byrne with a float zone silicon as the semiconducting portion of the substrate, as taught by Hirler, since Hirler teaches FZ silicon is a suitable alternative silicon base material for manufacturing a variety of such semiconductor devices [para. 0035]. The simple substitution of one known element for another (i.e., a FZ silicon for another silicon) is likely to be obvious when predictable results are achieved (i.e., providing a silicon substrate of the FET sensor) [MPEP § 2143(I) (B)]. 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].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Byrne, as applied to claim 1 above, and in view of Sohn et al. (Field-effect-transistor type C-creative protein sensor using cysteine-tagged protein G, Electronics Letters, 2008, 44(16), 955-956. DOI:10.1049/el:20080720)
Regarding claim 20, Byrne teaches the sensor according to claim 1, and further teaches wherein the bioanalyte binding site selectively binds the analyte of interest for the detection of the analyte [para. 0062], and the analyte of interest can comprise a protein [para. 0086-0087].
Byrne does not explicitly teach wherein the proteins of the analyte of interest include interleukin-6 (IL-6), C-reactive protein (CRP), or a viral protein, thus is silent to wherein the bioanalyte binding site binds interleukin-6 (IL-6), C-reactive protein (CRP), or a viral protein.
Sohn teaches a FET type CRP sensor (title and Fig.2), wherein the recognition element immobilized on a surface of the channel of the FET is anti-CRP antibody, which binds to the analyte of interest of CRP (Fig.2, and the first paragraph in Results and discussion).
Byrne and Sohn are considered analogous art to the claimed invention because they are in the same field of bioFET comprising a recognition element immobilized on a surface of the channel of the FET to selectively bind the analyte of interest. 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 antibody of the recognition element in Byrne with anti-CRP antibody, as taught by Sohn, since it would allow to selectively detect CRP (abstract in Sohn). The simple substitution of one known element for another (i.e., anti-CRP antibody for another antibody) is likely to be obvious when predictable results are achieved (i.e., selectively binds to the analyte of interest of CRP for the detection of CRP) [MPEP § 2143(I) (B)]. 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]. With the above modification, the modified bioanalyte binding site of anti-CRP antibody binds C-reactive protein (CRP) of the analyte of interest.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 6 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over respective claims 5, 5, 10, and 12 of
co-pending Application No. 18/572,665 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of ‘665. Although the claims are not identical, they are not patentably distinct from each other because claim 5 of ‘665 discloses all limitations recited in instant claim 1 wherein an oligonucleotidea being complementary to the nucleic acid to be detected recited in claim 1 of ‘665 corresponds to a bioanalyte binding site binding to the bioanalyte in instant claim 1.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of ‘665. Although the claims are not identical, they are not patentably distinct from each other because claim 5 of ‘665 discloses all limitations recited in instant claim 2.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of ‘665. Although the claims are not identical, they are not patentably distinct from each other because claim 10 of ‘665 discloses all limitations recited in instant claim 6.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of ‘665. Although the claims are not identical, they are not patentably distinct from each other because claim 12 of ‘665 discloses all limitations recited in instant claim 8.
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Liu et al. (US20160334362A1) teaches a bioFET as shown in Fig.1A wherein channel regions 127 are formed in semiconductor active layer 155. Liu et al. (US20200072789A1) teaches a bioFET sensor fabricated on a SOI substrate. Huang et al. (US20230080531A1) teaches a bioFET wherein the channel layer is formed of doped silicon. Huang et al. (US20190033252A1) teaches a bioFET in Fig.15 wherein the semiconductor substrate may be a silicon substrate.
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/SHIZHI QIAN/Examiner, Art Unit 1795