DETAILED ACTION
Status of the Claims
1. Claims 1-57 are pending.
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.
2. Claims 6, 26 and 27 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 6, 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).
Claim 26 recites the limitation "the blocking layer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the blocking layer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 3-13, 17, 18, 28-30, 33-37,39, 46-48, 50 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gooding et al. (US 2014/0174949).
Claim 1. Gooding et al. teach a device for detecting the presence of, or measuring the concentration or amount of, at least one analyte in a sample fluid (electrochemical sensor for detecting presence of analyte; [0090]), the device comprising:
at least one electrode (electrode; see Fig 1a);
a plurality of affinity-based probes, at least one of the affinity-based probes being capable of binding to an analyte (large number of binding moieties has affinity to bind to analyte; [0065][0081];
a plurality of redox molecules, wherein one or more affinity-based probes of the plurality of affinity-based probes each have at least one redox molecule associated therewith (large number of redox probe is attached to the binding moiety; [0061][0081]); and
a non-monolayer blocking layer associated with a surface of the at least one electrode (protective layer on the electrode surface; [0082] wherein the protective layer comprises a layer; [0047][0048]).
Claim 3. Gooding et al. teach the plurality of affinity-based probes are attached to the at least one electrode (binding moieties are attached to electrode; see fig 1a).
Claim 4. Gooding et al. teach the plurality of affinity-based probes are attached to the non-monolayer blocking layer (binding moieties are attached to protecting layer via redox probe; [0062][0046]).
Claim 5. Gooding et al. teach the redox molecules of the plurality of redox molecules include ferrocene [0062].
Claim 6. Gooding et al. teach the electrode includes a material chosen from gold, platinum, nickel, aluminum, silicon, conductive liquid infused materials such as ionic liquids, PEDOT:PSS, conductive oxides, carbon, boron-doped diamond, nanotubes or nanowire meshes, and other suitable electrically conducting materials [0039].
Claim 7. Gooding et al. teach the non-monolayer blocking layer includes a plurality of molecules that are attached both to the electrode and to at least one other molecule of the plurality of molecules (the protecting layer is a layer comprised of polymer comprising functional groups [0045][0047], thus polymer layer includes plurality of molecules that are attached both to electrode and to each other.
Claim 8. Gooding et al. teach non-monolayer blocking layer includes at least in part material selected from the group of a metal oxide, a semiconductor oxide, a thin polymer film, acrylic, polyamide, an inorganic dielectric, a hydrogel, a fluoropolymer, parylene C, parylene HT, PVDF, silicon dioxide, silicon nitride, titatinum dioxide, and barium titanate [0048].
Claim 9. Gooding et al. teach non-monolayer blocking layer includes a material that is an inorganic dielectric, and wherein the inorganic dielectric of a metal oxide or a semiconductor oxide [0048].
Claim 10. Gooding et al. teach the non-monolayer blocking layer includes a material that is a hydrogel, and wherein the hydrogel is chosen from poly(hydroxyethyl methacrylate) and poly(ethylene glycol) [0045].
Claim 11. Gooding et al. teach the non-monolayer blocking layer is a homogeneous layer (layer of polyphenol reads on homogenous layer; [0045]).
Claim 12. Gooding et al. teach the non-monolayer blocking layer is a heterogeneous layer (layer of oligoethylene glycol and 4-aminophenyl reads on heterogeneous layer; [0047]).
Claim 13. Gooding et al. teach the non-monolayer blocking layer includes a material that is resistant to fouling (PEG layer are blocking agent; [0045] thus inherently is resistant to fouling).
Claim 17. Gooding et al. teach the non-monolayer blocking layer includes a hydrophilic and/or charged surface (protective layer includes polyphenol which is hydrophilic; [0045]).
Claim 18. Gooding et al. teach the hydrophilic surface is positioned on the device to be adjacent to fluid when the device is exposed to fluid (protective layer come is in contact with sample fluid; [0079].
Claim 28. Gooding et al. teach the non-monolayer blocking layer has an electrical capacitance measured at less than 1 kHz (the protective layer is formed silicon dioxide; [0048] which inherently has electrical capacitance measured at less than 1 kHz as indicated in applicant’s disclosure [0044]) .
Claim 29. Gooding et al. teach the non-monolayer blocking layer has an electrical capacitance selected from the group consisting of less than 200 µF/cm2, less than 20 µF/cm2, less than 10 µF/cm2, less than 5 µF/cm2, and less than 3 µF/cm2 (the protective layer is formed silicon dioxide; [0048] which inherently has electrical capacitance within the claimed range as indicated in applicant’s disclosure [0044]).
Claim 30. Gooding et al. et al. teach the non-monolayer blocking layer has a thickness that is on average a value selected from the group consisting of at least >0.2, >0.5, >1, and >2 nm thick (protective layer is comprises a layer or monolayer; [0048], thus a layer has thickness of greater than 1 nm).
Claim 33. Gooding et al. teach protective layer is comprised of silicon oxide which is of same material as applicant (see paragraph [0043]). Thus, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.).
Therefore, the non-monolayer blocking layer (protective layer) limits the electrical background current as measured by square wave voltammetry and has a redox peak current that is a value selected from the group consisting of at least 2, 5, and l0X greater than this background current.
Claim 34. Gooding et al. teach the protective layer is comprised of silicon oxide which is of same material as applicant (see paragraph [0043]). Thus, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.).
Therefore, the non-monolayer blocking layer inherently has an electrical breakdown field, and during measurements the applied electric field is below said breakdown field, and the applied electric field can periodically be applied above the breakdown field to reduce or remove fouling of the surface of the non-monolayer blocking layer.
Claim 35 is/are considered product-by-process claim. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. 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 MPEP § 2113).
Claim 36. Gooding et al. teach method of preparing a device for detecting the presence of, or measuring the concentration or amount of, at least one analyte in a sample fluid (method of formation of electrochemical sensor for detecting presence of analyte; [0086] [0090]), the method comprising: coating an electrode with a layer that includes at least a plurality of affinity-based probes (glycosylated pentapeptide disposed on electrode which is analog to HbA1c) and a non-monolayer blocking layer (protective layer of oligoethylene; [0086]-[0087]).
Claim 37. Gooding et al. teach forming the non-monolayer blocking layer occurs via deposition of a material (protective layer is deposited onto the electrode; [0086]).
Claim 39. Gooding et al. teach coating of affinity-based probes occurs after coating of a non-monolayer blocking layer (glycosylated pentapeptide is disposed after the protective layer is formed; [0086][0087]).
Claim 46. Gooding et al. teach the non-monolayer blocking layer is comprised at least in part of a metal oxide or semiconductor oxide [0048].
Claim 47. Gooding et al. teach method of preparing a device for detecting the presence of, or measuring the concentration or amount of, at least one analyte in a sample fluid (method of formation of electrochemical sensor for detecting presence of analyte; [0086] [0090]), the method comprising: forming a non-monolayer blocking layer adjacent to an electrode (protective layer of oligoethylene; [0086]-[0087]); and forming a plurality of affinity-based probes adjacent to an electrode (glycosylated pentapeptide disposed on electrode which is analog to HbA1c).
Claim 48. Gooding et al. teach forming the non-monolayer blocking layer occurs via deposition of a material (protective layer is deposited onto the electrode; [0086]).
Claim 50. Gooding et al. teach coating of affinity-based probes occurs after coating of a non-monolayer blocking layer (glycosylated pentapeptide is disposed after the protective layer is formed; [0086][0087]).
Claim 57. Gooding et al. teach the non-monolayer blocking layer is comprised at least in part of a metal oxide or semiconductor oxide [0048].
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) 2, 19-25, 30-32, 42, 43, 53 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gooding et al. as applied to claims 1, 36 and 47 above, and further in view of Mathew et al. (WO 2020/178408).
Claims 2, 42 and 53. Gooding et al. teach affinity-based probe is antibody for antigen analyte [0010] but do not teach each affinity-based probe of at least a subset of the plurality of affinity-based probes is an aptamer. However, Mathew et al. teach sensor for particle detection comprised of substrate, electrode and disposing recognition element such as antibody or aptamer specific for the predetermined particle 9 on electrode surface (see Fig 1 and page 30, ll. 5-26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Mathew et al. teaching a biological sensor could be configured with either antibody or aptamer specific for the analyte to be detected.
Claims 19, 43 and 54. Gooding et al. teach electrode is layered with protective membrane [0082] but do not teach further comprising at least one anti-fouling layer. However, Mathew et al. teach sensor for particle detection comprised of electrode layered with passivation layer 125 and anti-fouling layer 113 and disposing recognition element such as antibody or aptamer specific for the predetermined particle 9 on electrode surface (see Fig 1 and page 30, ll. 5-26 and page 31, ll. 3-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Mathew et al. teaching to add anti-fouling layer onto the protective layer of Goodling et al. because anti-fouling layer would reduce or prevent fouling of the electrode surface.
Claim 20. Mathew et al. teach the antifouling layer is an endogenous antifouling layer (coating is comprised of protein or recognition elements; page 13, ll, 19-35).
Claim 21-23. Mathew et al. teach the antifouling layer is an exogenous (PEG or zwitterionic) antifouling layer (page 35, ll. 2-7).
Claim 24. Mathew et al. teach antifouling layer is comprised of a plurality of molecules that have a molecular structure of R1-(CH2)n-R2, wherein R2 is chemically attached to blocking layer (polyethylene glycol (page 35, ll. 2-7) reads on claimed molecular structure wherein R2 is functional group OH attached to passivation layer).
Claim 25. Mathew et al. teach the antifouling layer comprises charged molecules (zwitterionic; page 35, ll. 2-7).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gooding et al. as applied to claim 1 above, and further in view of Zhang et al. (CN 105806913, examiner is using English machine translation as provided).
Claims 14-15. Gooding et al. teach the protective layer is comprised of semiconductor material such as SiO2 [0048] but do not teach the non-monolayer blocking layer includes a wide bandgap semiconductor, the wide bandgap semiconductor includes an alloy chosen from AlGaN, InAlGaN, or mixtures thereof.
However, Zhang et al. teach GaN biosensor comprising AlGaN as barrier layer disposed on GaN based electrode comprised of antibody (see pages 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention in view of Zhang et al. teaching to use AlGaN as material of choice for protective layer 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).
Claim 16. Gooding et al. in view of Zhang et al. teach at least one feature to remove surface fouling during use (use of AlGaN as protective layer allows to remove surface fouling during use as evidence by applicant’s disclosure [0055]).
Allowable Subject Matter
Claims 26-27, 31-32, 38, 40, 41, 44-45 49, 51-52 and 55-56 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
Prosecution Insights