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 .
Claim Status
Claims 1-8 and 10-21 are pending and examined. Claim 9 is canceled.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) received on 6/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3 and 18 are objected to because of the following informalities:
Regarding claim 3, Ln. 2 recites, “silane groups(s)”, which is grammatically incorrect. It appears the above limitation should recite “silane group(s)” to be grammatically correct.
Regarding claim 18, Lns. 2-3 recite, “or is still be part of a cell, cell membrane, virus coat, in which the target analyte, is normally found in situ”, which is grammatically incorrect. It appears that the above limitation needs to be amended to recite, “or is still a part of a cell, cell membrane, or virus coat, in which the target analyte is normally found in situ” to be grammatically correct.
Examiner’s Note: the term “normally” is rejected under 112(b) as shown below in the Claim Rejections-35 USC 112 section of this instant Office Action, and should also be addressed in order to overcome the 112(b) rejection.
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 3-8, 11-12, and 14-21 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 3, Ln. 2 recites, “wherein the reactive sulphur group(s) is/are a thiol or silane groups(s)”. However, a silane group does not contain sulphur, by definition. Therefore, it is unclear how a silane group can be a reactive sulphur group. Further, claim 3 depends on claim 1, which recites only a single reactive sulphur or silicon group. Therefore, it is unclear how additional reactive sulphur group(s) are present, and if they are associated with the SAM, or another part of the biosensor. Further clarification is needed.
Regarding claim 4, Ln. 2 recites, “wherein the fluorocarbon molecule is a linear fluoro alkane thiol, or fluoro alkanesilane”. However, it is unclear if the recited fluoro alkanesilane is intended to be linear or not. Further clarification is needed.
Claims 5-6 are rejected at least for depending on claim 4, a rejected claim.
Regarding claim 5, Lns. 1-2 recite, “wherein the linear fluoro alkanethiol, or fluoro alkanesilane is selected…”. However, it is unclear if the recited fluoro alkanesilane is intended to be linear or not. Further clarification is needed.
Regarding claim 7, Lns. 2-3 recite, “wherein the electrode surface is formed from a glassy carbon…or noble metal including gold, ruthenium, rhodium, palladium, platinum and silver”. However, it is unclear if all of these noble metals must be present in the electrode surface to satisfy the claim, or if only one of the noble metals must be present to satisfy the claim. Further clarification is needed.
Claim 8 is rejected at least for depending on claim 7, a rejected claim.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
Claim 12 is rejected at least for depending on claim 11, a rejected claim.
Regarding claim 11, the claim recites that the electrochemical biosensor is made by forming a SAM on a surface of at least one detection electrode. However, the claimed electrochemical biosensor additionally includes a biological agent captured by the SAM, and it is unclear how the biological agent is captured by the SAM, based only on the method steps recited in claim 11. Further clarification is needed.
Examiner’s Note: if claim 11 is amended to incorporate the limitations of claim 12, it would provide clarity for how the biological agent is captured by the SAM, and overcome this particular 112(b) rejection for claim 11.
Regarding claim 14, Ln. 2 recites, “wherein the electrodes are provided on a substrate”. However, claim 1 previously recites that at least one detection electrode is recited. Therefore, it is unclear if the electrodes recited in claim 14 are the same as or different from the at least one detection electrode recited in claim 14. Further clarification is needed.
Claim 15 is rejected at least for depending on claim 14, a rejected claim.
Regarding claim 15, Ln. 2 recites, “provided in the form of…on a printed circuit board; or on FETS/OFETS”. However, it is unclear if the printed circuit board or FETS/OFETS are positively recited or not, i.e. if the printed circuit board or FETS/OFETS need to be present in order to satisfy the claim. Further clarification is needed.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “capable of binding”, and the claim also recites “typically specifically binding”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Further, the term “typically” in claim 16 is a relative term which renders the claim indefinite. The term “typically” 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. It is unclear what frequency the target analyte must be capable of specifically binding to the biological agent in order to be considered “typically”.
Further regarding claim 16, the claim states that it is a method of detecting a target analyte, but does not positively recite an actual step where the target analyte is bound to the biological agent. Rather, the claim merely recites, “the target analyte is capable of binding, typically specifically binding, to the biological agent”. Therefore, it is unclear how the target analyte interacts with the biosensor, such that the biosensor is capable of detecting the target analyte. Further clarification is needed.
Claims 17-21 are rejected at least for depending on claim 16, a rejected claim.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 18, Ln. 3 recites, “is normally found in situ”. The term “normally” is a relative term which renders the claim indefinite. The term “normally” 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. It is unclear what frequency the target analyte must be found within the cell, cell membrane, or virus coat in situ, in order to be considered to be normally found in situ.
Claim 19 is rejected at least for depending on claim 18, a rejected claim.
Regarding claim 20, Lns. 1-2 recite, “the biological macromolecule”. There is insufficient antecedent basis for this limitation in the claim, as a biological macromolecule has not been recited previously. However, a biological agent has been recited previously. For purposes of compact prosecution, the above limitation has been examined as, “the biological agent”.
Claim 21 is rejected at least for depending on claim 20, a rejected claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-8 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US Pub. No. 2016/0025634; hereinafter Chou) in view of Park et al. (US Pub. No. 2019/0331605; hereinafter Park).
Regarding claim 1, Chou discloses an electrochemical biosensor for use in detecting a target analyte ([0013], [[0078]). The biosensor comprises:
at least one detection electrode comprising a surface coated with a self-assembled monolayer (SAM), wherein the SAM comprises, consists essentially of, or consists of a molecule bound to the surface of the electrode through a reactive sulphur or silicon group present on the molecule ([0102], gold is an electrode, and is therefore capable of functioning as a detection electrode, [0142]-[0151]).
A biological agent captured by the SAM ([0039], [0142]-[0151]).
Chou fails to explicitly disclose that the molecule is a hydrofluorocarbon or fluorocarbon molecule.
Park is in the field of forming self-assembled monolayers on substrates (Park [0091]), and is therefore reasonably pertinent to the problem faced by the inventor. Park teaches a hydrofluorocarbon or fluorocarbon molecule having a reactive thiol group, where the fluorocarbon or hydrofluorocarbon molecule is 1H,1H,2H,2H-Perfluorodecanethiol (Park; [0091], [0095]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of Chou with the teachings of Park so that the molecule is a hydrofluorocarbon or fluorocarbon molecule, where the fluorocarbon or hydrofluorocarbon molecule is 1H,1H,2H,2H-Perfluorodecanethiol, as Park teaches that 1H,1H,2H,2H-Perfluorodecanethiol can be used to form a self-assembled monolayer on a gold surface (Park; [0091], [0095]), and Chou is concerned with formed self-assembled monolayers on a gold surface (Chou; [0102], [0142]-[0151]). Further, hydrofluorocarbons/fluorocarbons such as 1H,1H,2H,2H-Perfluorodecanethiol are hydrophobic, and Chou teaches that a self-assembled monolayer may have a hydrophobic surface (Chou [0150]), such that using the 1H,1H,2H,2H-Perfluorodecanethiol as in Park may be desirably advantageous.
Note: with regards to the biosensor being an electrochemical biosensor for use in detecting a target analyte, see MPEP 2111.02, which states that, “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Regarding claim 2, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the hydrofluorocarbon or fluorocarbon molecule is a linear, branched or cyclic alkane, alkene or alkyne molecule having a single or multiple reactive sulphur or silicon groups (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 3, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the reactive sulphur group(s) is/are a thiol or silane groups(s) (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 4, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the fluorocarbon molecule is a linear fluoro alkanethiol, or fluoro alkanesilane (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 5, modified Chou discloses the electrochemical biosensor according to claim 4, wherein the linear fluoro alkanethiol, or fluoro alkanesilane is 1H,1H,2H,2H-Perfluorodecanethiol (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 6, modified Chou discloses the electrochemical biosensor according to claim 4, wherein the linear fluoro alkanethiol is 1H,1H,2H,2H-Perfluorodecanethiol (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 7, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the electrode surface is formed from a glassy carbon; metal oxide; conducting polymer; or noble metal including gold, ruthenium, rhodium, palladium, platinum and silver (Chou [0102]).
Regarding claim 8, modified Chou discloses the electrochemical biosensor according to claim 7. Modified Chou further discloses that the electrode surface is gold (Chou [0102]).
Regarding claim 16, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses a method of detecting a target analyte, the method comprising capturing a biological agent with the electrochemical biosensor (Chou; [0039], [0142]-[0151]), The target analyte is capable of binding, typically specifically binding, to the biological agent (Chou; [0039], [0142]-[0151]. As previously stated in the Claim Rejections-35 USC 112 section of this instant Office Action, no step of actually detecting a target analyte is positively recited. However, Chou teaches detecting a target analyte in [0084]).
Regarding claim 17, modified Chou discloses the method according to claim 16. Modified Chou further discloses that the target analyte is a chemical (such as a hormone, narcotic or pollutant) or biological molecule (such as, a peptide, protein, glycoprotein, enzyme, glycolipid, cell surface receptor, cytokine, antibody, or nucleic acid) (as previously stated in the Claim Rejections-35 USC 112 section of this instant Office Action, no step of actually detecting a target analyte is positively recited. However, Chou teaches detecting a biological molecule in [0084]).
Regarding claim 18, modified Chou discloses the method according to claim 16. Modified Chou further discloses that the target analyte is free within the sample being analyzed, or is still a part of a cell, cell membrane or virus coat, in which the target analyte is normally found in situ (as previously stated in the Claim Rejections-35 USC 112 section of this instant Office Action, no step of actually detecting a target analyte is positively recited. The method of modified Chou is capable of detecting a target analyte in this fashion).
Regarding claim 19, modified Chou discloses the method according to claim 18. Modified Chou further discloses that the target analyte is a virus coat protein (as previously stated in the Claim Rejections-35 USC 112 section of this instant Office Action, no step of actually detecting a target analyte is positively recited. The method of modified Chou is capable of detecting a virus coat protein).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8 and 16-19 above, and further in view of Budach et al. (US Pat. No. 6,707,561; hereinafter Budach).
Regarding claim 10, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose that the biological agent is captured by physisorption to the SAM layer.
Budach is in the analogous field of sensors (Budach Col. 1 Lns. 5-14). Budach teaches a biological agent that captured by physisorption to a SAM layer (Budach; Col. 13 Lns. 21-48, specifically Lns. 30-33, Col. 13 Ln. 60-Col. 14 Ln. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the electrochemical biosensor of modified Chou with the teachings of Budach so that the biological agent is captured by physisorption to the SAM layer, as Budach teaches that antibodies can be attached by physisorption to a SAM (Budach; Col. 13 Lns. 21-48, specifically Lns. 30-33, Col. 13 Ln. 60-Col. 14 Ln. 2), and Chou suggests that antibodies can be used as capture agents (Chou [0039]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8 and 16-19 above, and further in view of Hanson (US Pub. No. 2009/0324834).
Regarding claim 11, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose a method of making the electrochemical biosensor, the method comprising:
forming a SAM on a surface of at least one detection electrode, by contacting the surface of the at least one detection electrode with a solution comprising an organic solvent and a hydrofluorocarbon or fluorocarbon molecule as described hereinabove, and allowing the solvent to evaporate and the SAM to form on the surface of the at least one detection electrode.
Hanson is in the field of forming coatings on metallic substrates (Hanson [0002]), and is therefore reasonably pertinent to the problem faced by the inventor. Hanson teaches a method comprising: forming a SAM on a surface of at least one substrate, by contacting the surface of the at least one substrate with a solution comprising an organic solvent and a hydrofluorocarbon or fluorocarbon, and allowing the solvent to evaporate and the SAM to form on the surface of the at least one substrate (Hanson; [0004]-[0009], [0038]-[0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of modified Chou with the teachings of Hanson to include a method of making the electrochemical biosensor, the method comprising: forming a SAM on a surface of at least one detection electrode, by contacting the surface of the at least one detection electrode with a solution comprising an organic solvent and a hydrofluorocarbon or fluorocarbon molecule as described hereinabove, and allowing the solvent to evaporate and the SAM to form on the surface of the at least one detection electrode. The motivation would have been to be able to form a substantially continuous coating of SAM on the detection electrode (Hanson; [0004]-[0009], [0038]-[0039]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park and Hanson as applied to claim 11 above, and further in view of Budach.
Regarding claim 12, modified Chou discloses the method according to claim 11.
Modified Chou fails to explicitly disclose contacting the SAM coated electrode with a solution comprising the biological agent and allowing the biological agent to be captured by the SAM layer coated on the electrode.
Budach is in the analogous field of sensors (Budach Col. 1 Lns. 5-14). Budach teaches contacting a SAM coated substrate with a solution comprising a biological agent and allowing the biological agent to be captured by the SAM layer coated on the substrate (Budach Col. 24 Ln. 37-Col. 25 Ln. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Chou with the teachings of Budach so that the method includes contacting the SAM coated electrode with a solution comprising the biological agent and allowing the biological agent to be captured by the SAM layer coated on the electrode, as Budach teaches that this method can be used to immobilize an antibody to a SAM (Budach Col. 24 Ln. 37-Col. 25 Ln. 10), and Chou suggests that antibodies can be used as capture agents (Chou [0039]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8 and 16-19 above, and further in view of Bhansali et al. (US Pub. No. 2017/0059561; hereinafter Bhansali).
Regarding claim 13, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose at least one reference and/or counter electrode electrically coupled to said at least one detection electrode.
Bhansali is in the analogous field of electrochemical sensors (Bhansali [0009]). Bhansali teaches at least one reference and/or counter electrode electrically coupled to a detection electrode (Bhansali [0011]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of modified Chou with the teachings of Bhansali to include at least one reference and/or counter electrode electrically coupled to said at least one detection electrode, as Bhansali teaches that such an arrangement can be used to create an electrochemical immunosensing substrate (Bhansali [0011]), particularly as Chou establishes that its device can be used to detect substances using electrochemiluminescence (Chou [0084]).
Regarding claim 14, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose that the electrodes are provided on a substrate.
Bhansali teaches that electrodes are provided on a substrate (Bhansali [0011]). The biosensor is in the form of microelectrodes (Bhansali; [0011], [0095]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of modified Chou with the teachings of Bhansali so that the electrodes are provided on a substrate, and the sensor is provided in the form of microelectrodes, as Bhansali teaches that such an arrangement can be used to create an electrochemical immunosensing substrate (Bhansali; [0011], [0095]), particularly as Chou establishes that its device can be used to detect substances using electrochemiluminescence (Chou [0084]).
Regarding claim 15, modified Chou discloses the electrochemical biosensor according to claim 14. Modified Chou further discloses that the biosensor is provided in form of microelectrodes (see Claim 14 above at Bhansali teaching the biosensor in the form of microelectrodes in [0011], [0095]).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8 and 16-19 above, and further in view of Kim et al. (US Pub. No. 2023/0160895; hereinafter Kim).
Regarding claim 20, modified Chou discloses the method according to claim 16. Modified Chou further discloses that the target analyte is SARS-CoV-2 or a coat protein thereof (as previously stated in the Claim Rejections-35 USC 112 section of this instant Office Action, no step of actually detecting a target analyte is positively recited. The method of modified Chou is capable of detecting the claimed target analyte).
Modified Chou fails to explicitly disclose that the biological agent, which is captured by the electrochemical biosensor is ACE-2.
Kim is in the analogous field of biological detection kits (Kim [0001]). Kim teaches ACE-2 as a biological agent that is captured by a sensor (Kim; [0052]-[0053], [0094], see Fig. 1b). The motivation would have been that ACE-2 is a protein that can be used to detect SARS-CoV-2 (Kim; [0052]-[0053], see Fig. 1b), and Chou has previously established that proteins are suitable capture agents for target analyte detection (Chou [0039]).
Regarding claim 21, modified Chou discloses the method according to claim 20, wherein the SARS-CoV-2 is COVID-19 (as previously stated in the Claim Rejections-35 USC 112 section of this instant Office Action, no step of actually detecting a target analyte is positively recited. The method of modified Chou is capable of detecting COVID-19).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN MCGUIRK/Examiner, Art Unit 1798