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 .
Election/Restrictions
Applicant’s election of Group I - drawn to a continuous sensor device (claims 1-15), and Species B - Fig. 1C, in the reply filed on 09/29/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2, 6, and 15-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/29/2025.
Status of Claims
Claims 1, 3-5, and 7-14 are hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/29/2023 and 03/04/2024 are being considered by the examiner.
Claim Objections
Claims 1, 3-5, 7-9, and 11-14 are objected to because of the following informalities:
Regarding claim 1, line 9 recites “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 1, line 9 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 3, line 1 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 3, lines 1-2 recite “the electrode”, however it appears it should read --the at least one electrode-- (emphasis added).
Regarding claim 4, line 1 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 4, line 2 recites “that provides at least”, however it appears it should read --that provides the at least-- (emphasis added).
Regarding claim 4, line 2 recites “a resistance”, however it appears it should read --the resistance-- (emphasis added).
Regarding claim 4, lines 2-3 recite “a pressure”, however it appears it should read --the pressure-- (emphasis added).
Regarding claim 4, line 3 recites “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 4, line 3 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 5, line 1 recites “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 7, line 2 recites “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 8, line 2 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 8, line 2 recites “that provides at least”, however it appears it should read --that provides the at least-- (emphasis added).
Regarding claim 8, lines 2-3 recite “a resistance”, however it appears it should read --the resistance-- (emphasis added).
Regarding claim 8, line 3 recites “a pressure”, however it appears it should read --the pressure-- (emphasis added).
Regarding claim 8, line 3 recites “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 8, lines 3-4 recite “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 9, line 1 recites “the sensing monolayer”, however it appears it should read --the aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 9, line 2 recites “the electrode”, however it appears it should read --the at least one electrode-- (emphasis added).
Regarding claim 9, line 3 recites “the least one”, however it appears it should read --the at least one-- (emphasis added).
Regarding claim 9, lines 3-4 recite “the electrode”, however it appears it should read --the at least one electrode-- (emphasis added).
Regarding claim 9, line 4 recites “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 11, lines 1-2 recite “the sensing monolayer”, however it appears it should read --the aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 12, line 1 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 12, line 2 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 12, line 4 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 12, lines 4-5 recite “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 13, line 1 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 13, line 2 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 13, line 4 recites “the feature”, however it appears it should read --the at least one feature-- (emphasis added).
Regarding claim 13, lines 4-5 recite “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Regarding claim 13, lines 6-7 recite “less than <3X, <10X, …”, however it appears “less than” should be deleted.
Regarding claim 14, lines 1-2 recite “aptamer sensing monolayer”, however it appears it should read --aptamer sensing monolayer layer-- (emphasis added) to maintain consistent claim language.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: The claim limitation “at least one feature configured to be inserted into a body … configured to provide at least one of a resistance to abrasion effect or a pressure effect” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “feature” coupled with functional language “configured to be inserted into a body … configured to provide at least one of a resistance to abrasion effect or a pressure effect” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “feature”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“features include microneedles … single indwelling needle … a flexible circuit … a protective membrane applied to protect the sensor from abrasion or pressure effects”, or equivalents thereof, as described in para. [0024] and [0027] of the disclosure filed on 03/21/2023.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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)(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, 3, 4, 7, and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kendall et al. (US 20210338158 A1), hereinafter referred to as Kendall.
The claims are generally directed towards a continuous sensing device for measuring at least one analyte in interstitial fluid, the device comprising: at least one feature configured to be inserted into a body, the at least one feature configured to be inserted into a skin of the body, the at least one feature at least partially coated with at least one electrode functionalized with an aptamer sensing monolayer layer, the aptamer sensing monolayer layer comprising an aptamer with attached redox couples and passivating material, wherein the at least one feature is configured to provide at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer when the feature is placed into the body.
Regarding claim 1, Kendall discloses a continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 1, para. [0057], para. [0233], para. [0243]), the device comprising:
at least one feature (Fig. 1, element 112, “microstructure”, para. [0243], para. [0309]) configured to be inserted into a body, the at least one feature configured to be inserted into a skin of the body (Fig. 1, para. [0243], “microstructures are configured to breach the stratum corneum … entering at least the viable epidermis …”), the at least one feature at least partially coated with at least one electrode functionalized with an aptamer sensing monolayer layer, the aptamer sensing monolayer layer comprising an aptamer with attached redox couples and passivating material (para. [0309-0310], “microstructures include an electrode … one or more microstructure electrodes interact with one or more analytes …”, para. [0320], para. [0323-0326], “aptamer is a coating on the microstructure … aptamer has a first conformation in the absence of analyte binding and a second conformation upon analyte binding … change … may then be detected using, for example, a labelling moiety such as a redox moiety or fluorescent label attached to or close to the relevant portion of the aptamer …”, para. [0340-0342], “aptamer comprises … redox moiety … methylene blue …”, para. [0724], “methylene blue and the thiol group were covalently attached … aptamer … 6-mercaptohexanol … solution”),
wherein the at least one feature is configured to provide at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer when the feature is placed into the body (para. [0432-0433], “microstructures could contain a material, or include a coating, such as polyethylene glycol (PEG), which generally repels substances from the surface of the microstructure … cellulose membrane …” - the instant specification describes the feature including a membrane, which includes cellulose membranes. see para. [0029]).
Regarding claim 3, Kendall discloses the device of claim 1, wherein the feature comprises a membrane covering the electrode (para. [0309-0310], “microstructures include an electrode … one or more microstructure electrodes interact with one or more analytes …”, para. [0432-0433], “microstructures could contain a material, or include a coating, such as polyethylene glycol (PEG), which generally repels substances from the surface of the microstructure … cellulose membrane …”).
Regarding claim 4, Kendall discloses the device of claim 1, wherein at least one material is added onto the feature to provide the configuration that provides at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer when the feature is placed into the body (para. [0432-0433], “microstructures could contain a material, or include a coating, such as polyethylene glycol (PEG), which generally repels substances from the surface of the microstructure … cellulose membrane …” - the instant specification describes the feature including a membrane, which includes cellulose membranes. see para. [0029]).
Regarding claim 7, Kendall discloses the device of claim 1, further comprising at least one biocompatible dissolvable material applied to the aptamer sensing monolayer (para. [0424-0428], “outer coating … dissolves once in-situ, allowing an underlying functional coating to be exposed, for example to allow analytes to be detected …”).
Regarding claim 8, Kendall discloses the device of claim 4, wherein a biocompatible dissolvable material is the at least one material added onto the feature to provide the configuration that provides at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer when the feature is placed into the body (para. [0427], “selectively dissolvable coating … exposing … functional feature, so that analytes are only detected once the coating has dissolved …”, para. [0430], “coating can also be used to … repel … at least one substance …”, para. [0433], “cellulose membrane”, para. [0661], “methyl cellulose/sucrose formulation … coating was dissolving off the electrode …”).
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.
Claims 5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall et al. (US 20210338158 A1), hereinafter referred to as Kendall as applied to claims 1 and 3 above, and further in view of Gottlieb et al. (US 20100030045 A1), hereinafter referred to as Gottlieb.
Regarding claim 5, Kendall discloses the device of claim 3.
However, Kendall does not explicitly disclose wherein the membrane and the aptamer sensing monolayer are physically separated.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]) and a membrane covering the electrode (Fig. 2, para. [0061-0066]). Gottlieb further teaches the membrane and the sensing monolayer are physically separated (para. [0065], “sensing layer is coated and or disposed next to one or more additional layers … adhesion promoting layer …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally have the membrane and the aptamer sensing monolayer are physically separated, as taught by Gottlieb. This is because Gottlieb teaches multiple layers can be disposed over the analyte sensing layer, such as an adhesion promoting layer, which facilitates the adhesion of the one or more membrane and the sensing layer (para. [0066]).
Regarding claim 9, Kendall discloses the device of claim 1, wherein exposed portions of the electrode are coated with at least one material different from the aptamer sensing monolayer (para. [0724], “aptamers were immobilized to the gold electrode … electrode was washed … process was repeated with … 6-mercaptohexanol …”).
However, Kendall does not explicitly disclose wherein the sensing monolayer is not exposed to tissue or cellular content in the body, and the electrode coats both exposed and non-exposed portions of the at least one feature inserted into the skin.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]). Gottlieb further teaches the sensing monolayer is not exposed to tissue or cellular content in the body (para. [0062], “insulating cover layer … disposed on portions of the sensor …”), and the electrode coats both exposed and non-exposed portions of the at least one feature inserted into the skin (Fig. 2, element 102, 104, 110, para. [0061-0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally have the sensing monolayer not exposed to tissue or cellular content in the body, and the electrode coat both exposed and non-exposed portions of the at least one feature inserted into the skin, as taught by Gottlieb. This is because Gottlieb teaches an insulating material coating the device allows for one or more exposed regions to be created to allow a target analyte to reach the electrode at certain locations, while also providing protection (para. [0062]).
Regarding claim 10, modified Kendall discloses the device of claim 9, wherein the exposed portions of the at least one feature inserted into the skin are configured to absorb at least one endogenous solute found in the body (para. [0335], “suitable aptamer …”, para. [0386], “the analyte is a protein …”).
Regarding claim 11, modified Kendall discloses the device of claim 9, wherein the at least one material different from the sensing monolayer comprises an exogeneous passivating material (para. [0724], “aptamers were immobilized to the gold electrode … electrode was washed … process was repeated with … 6-mercaptohexanol …” - see para. [0031] of the instant specification).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall et al. (US 20210338158 A1), hereinafter referred to as Kendall as applied to claim 1 above, and further in view of Gottlieb et al. (US 20100030045 A1), hereinafter referred to as Gottlieb, in view of Negi et al. (US 20170007813 A1), hereinafter referred to as Negi.
Regarding claim 12, Kendall discloses the device of claim 1.
However, Kendall does not explicitly disclose wherein the feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the feature is inserted into the body, and which carriers the aptamer sensing monolayer.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]). Gottlieb further teaches the feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the feature is inserted into the body (Fig. 2, element 108, para. [0062], “one or more exposed regions or apertures … allow an analyte such as glucose to permeate the layers of the sensor and be sensed by the sensing elements …”), and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the feature is inserted into the body, and which carriers the sensing monolayer (Fig. 2, element 106, para. [0062], “insulating cover layer … disposed on portions of the sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally include an exposed area configured to be exposed to tissue or cellular content in the body after the feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the feature is inserted into the body, and which carriers the aptamer sensing monolayer, as taught by Gottlieb. This is because Gottlieb teaches an insulating material coating the device allows for one or more exposed regions to be created to allow a target analyte to reach the electrode at certain locations, while also providing protection (para. [0062]).
However, modified Kendall does not explicitly disclose wherein a ratio of the unexposed to the exposed area is configured to be at least one of >1.3X, >3X, >10X, >30X, >100X.
Negi teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 1, Fig. 2, para. [0006]). Negi further teaches the feature includes exposed and unexposed areas (Fig. 2, para. [0044]) and the number of exposed areas and the distance between the areas can vary (para. [0056-0058]). Because Negi clearly teaches that variability of the dimensions and dimensional relationships of the components, it suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Negi as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 13, Kendall discloses the device of claim 1.
However, Kendall does not explicitly disclose wherein the feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the feature is inserted into the body, and which carriers the aptamer sensing monolayer.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]). Gottlieb further teaches the feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the feature is inserted into the body (Fig. 2, element 108, para. [0062], “one or more exposed regions or apertures … allow an analyte such as glucose to permeate the layers of the sensor and be sensed by the sensing elements …”), and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the feature is inserted into the body, and which carriers the aptamer sensing monolayer (Fig. 2, element 106, para. [0062], “insulating cover layer … disposed on portions of the sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally include an exposed area configured to be exposed to tissue or cellular content in the body after the feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the feature is inserted into the body, and which carriers the aptamer sensing monolayer, as taught by Gottlieb. This is because Gottlieb teaches an insulating material coating the device allows for one or more exposed regions to be created to allow a target analyte to reach the electrode at certain locations, while also providing protection (para. [0062]).
However, modified Kendall does not explicitly disclose wherein the ratio of the unexposed to the exposed area is at least one of less than <3X, <10X, <30X, <100X, <300X.
Negi teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 1, Fig. 2, para. [0006]). Negi further teaches the feature includes exposed and unexposed areas (Fig. 2, para. [0044]) and the number of exposed areas and the distance between the areas can vary (para. [0056-0058]). Because Negi clearly teaches that variability of the dimensions and dimensional relationships of the components, it suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Negi as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 14, modified Kendall discloses the device of claim 13, wherein a coverage density of aptamer across the aptamer sensing monolayer will vary by at least one of <30%, <100%, <300%, <1000% (para. [0354], “number of aptamers and/or aptamer density in the coating will depend on the analyte … aptamer density in the coating should be a density which results in a measurable response upon analyte binding … density in the coating is in the range of from …”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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, Jason M Sims can be reached at (571)272-7540. 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.
/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791