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 .
Claim Interpretation
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 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:
“a means to establish fluid communication between the at least one aptamer sensor and the sample fluid” in claims 1 and 18
“a means for correcting a measurement error due to said temperature-dependent response” in claim 1
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 means for correcting a measurement error due to said temperature-dependent response” is described as “software via look-up tables, or approximated predictive equations or algorithms, or into analog electronics, or other suitable techniques” in paragraph [0056] of the provided specification.
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 § 112
112(a)The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, the claim limitation “a means to establish fluid communication between the at least one aptamer sensor and the sample fluid”, However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Paragraph [0012] merely restates the claim and does not clearly link a structure that establishes fluid communication. The same issue is present in claim 18. As the claim has invoked 35 USC 112(f) interpretation, the lack of corresponding structure for the mean plus function recitation in the specification amounts to a lack of written description as the applicant’s disclosure has failed to exhibit that the applicant had possession of the claimed invention at the time of filing. See MPEP 2163, II, 3(a).
Claim 1-39 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.
In regards to claim 1, the claim limitation “a means to establish fluid communication between the at least one aptamer sensor and the sample fluid” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Paragraph [0012] merely restates the claim and does not clearly link a structure that establishes fluid communication. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The same issue is present in claim 18.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 3 recites the limitation "at least one temperature sensor". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same temperature sensor as in the claim 1 or a separate sensor. It is recommended the claim be amended to say “the at least one temperature sensor”.
The term “about” in claim 8 is a relative term which renders the claim indefinite. The term “about 3 mm” 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 how much the distance varies from 3mm. The same issue is present in claims 9-11 and 25-28.
The term “adequate” in claim 12 is a relative term which renders the claim indefinite. The term “adequate” 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 makes a prediction adequate. The same issue is present in claims 29 and 39
Claims not explicitly rejected above are rejected because they depend from claims rejected above as indefinite.
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.
(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.
Claim(s) 1-2, 4-6,13, 17-19, 23, and 33-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larson (US 20210140956 A1 – cited by applicant).
In regards to claim 1 Larson teaches a device for measuring one or more analytes in a sample fluid, the device comprising ([0037] “With reference to FIG. 1B, the aptamer 140 is selected to interact with a target analyte”):
at least one aptamer sensor comprising a plurality of aptamers, wherein the sensor provides a measurement of at least one of said analytes and wherein the measurement is affected by changes in temperature (“a temperature-dependent response”) ([0038] “With reference to FIG. 1C, an MCAS sensor that incorporates both active aptamer sensing elements 110 and reference aptamer sensing elements 105”, [0048] Another variable affecting EAB sensor error or drift is temperature”);
a means to establish fluid communication between the at least one aptamer sensor and the sample fluid ([0054] “The device 400 includes a water-impermeable substrate 410, a protective covering 412, a microfluidic channel 480, an inlet 482 and a sweat collector (not shown) to introduce a sweat sample into the device”);
at least one temperature sensor ([0048] “A temperature sensor may be used to measure the ambient temperature in the vicinity of the aptamer”);
and a means for correcting a measurement error due to said temperature-dependent response ([0048] “A temperature sensor may be used to measure the ambient temperature in the vicinity of the aptamer, and provide a benchmark that may be used with a look up table to calibrate sensor response at a given temperature”, “This temperature reference sensor would provide a temperature hysteresis correction factor for the active sensor”).
In regards to claim 2 Larson teaches the device of claim 1 wherein the sample fluid is selected from the group consisting of interstitial fluid, blood and combinations thereof ([0015-0016] “As used herein, “biofluid” may mean any human biofluid, including, without limitation, sweat, interstitial fluid, blood, plasma, serum, tears, and saliva”).
In regards to claim 4 Larson teaches the device of claim 1 wherein the aptamer sensor is capable of being placed subcutaneously. The apparatus is not explicitly placed subcutaneously, however it is capable of being placed subcutaneously.
In regards to claim 5 Larson teaches the device of claim 4 wherein the temperature sensor is capable of being placed subcutaneously. The apparatus is not explicitly placed subcutaneously, however it is capable of being placed subcutaneously.
In regards to claim 6 Larson teaches the device of claim 4 wherein the temperature sensor is capable of being placed outside the skin (0030] “As a further example, many embodiments of the disclosed invention could benefit from mechanical or other means known to those skilled in wearable devices, patches, bandages, and other technologies or materials affixed to skin, to keep the devices or sub-components of the skin firmly affixed to skin or with pressure favoring constant contact with skin or conformal contact with even ridges or grooves in skin, and are included within the scope of the disclosed invention”).
In regards to claim 13 Larson teaches the device of claim 1 further comprising at least one component which is capable of containing a record or prediction of a temperature dependence of the aptamer sensor ([0048] “temperature sensor may be used to measure the ambient temperature in the vicinity of the aptamer, and provide a benchmark that may be used with a look up table to calibrate sensor response at a given temperature”).
In regards to claim 17 Larson teaches the device of claim 1 wherein the aptamer sensor is optical and carries at least one fluorescent tag on each of the plurality of aptamers ([0051] “In addition to the proactive reference sensors and sensor elements described, some embodiments may be configured as passive reference sensors. One such passive reference sensor uses fluorescent tags that can be read to determine the amount of sensor dissociation over time. For example, an EAB sensor includes a plurality of reference aptamer sensing elements that have a fluorescent tag affixed to their redox moieties, to their docking structures, or elsewhere”).
In regards to claim 18 Larson teaches a method for measuring one or more analytes in a sample fluid, comprising:
a. exposing a sample fluid comprising one or more analytes to at least one aptamer sensor ([0038] “With reference to FIG. 1C, an MCAS sensor that incorporates both active aptamer sensing elements 110 and reference aptamer sensing elements 105”, [0048] Another variable affecting EAB sensor error or drift is temperature”); the aptamer sensor comprising:
i. a means to establish fluid communication between the at least one aptamer sensor and the sample fluid ([0054] “The device 400 includes a water-impermeable substrate 410, a protective covering 412, a microfluidic channel 480, an inlet 482 and a sweat collector (not shown) to introduce a sweat sample into the device”); and
ii. at least one temperature sensor([0048] “A temperature sensor may be used to measure the ambient temperature in the vicinity of the aptamer”); and
b. detecting a concentration of said one or more analytes in the sample using the sensor ([0021] “EAB sensor” means an electrochemical aptamer-based biosensor that is configured with a plurality of aptamer sensing elements that, in the presence of a target analyte in a fluid sample, produce a signal indicating analyte capture, and which signal can be added to the signals of other such sensing elements, so that a signal threshold may be reached that indicates the presence or concentration of the target analyte);
wherein the temperature sensor takes at least one measurement and the measurement is a referenced record or prediction of a temperature dependence of the aptamer sensor that predicts change in aptamer sensor response to change in temperature ([0048] “A temperature sensor may be used to measure the ambient temperature in the vicinity of the aptamer, and provide a benchmark that may be used with a look up table to calibrate sensor response at a given temperature”, “This temperature reference sensor would provide a temperature hysteresis correction factor for the active sensor”); and
further, the signal measured by the aptamer sensor is adjusted by using the measurement of the temperature sensor and the record or prediction such that the signal from the aptamer sensor accurately represents analyte concentration ([0048] Another variable affecting EAB sensor error or drift is temperature. As a first order consideration, temperature affects aptamer conformation response to analyte capture. A temperature sensor may be used to measure the ambient temperature in the vicinity of the aptamer, and provide a benchmark that may be used with a look up table to calibrate sensor response at a given temperature).
In regards to claim 19 Larson teaches the method of claim 18 wherein the sample fluid is selected from the group consisting of interstitial fluid, blood and combinations thereof ([0015-0016] “As used herein, “biofluid” may mean any human biofluid, including, without limitation, sweat, interstitial fluid, blood, plasma, serum, tears, and saliva”).
In regards to claim 23 Larson teaches the method of claim 18 wherein the temperature sensor is placed outside the skin (0030] “As a further example, many embodiments of the disclosed invention could benefit from mechanical or other means known to those skilled in wearable devices, patches, bandages, and other technologies or materials affixed to skin, to keep the devices or sub-components of the skin firmly affixed to skin or with pressure favoring constant contact with skin or conformal contact with even ridges or grooves in skin, and are included within the scope of the disclosed invention”).
In regards to claim 33 Larson teaches the method of claim 18 wherein the aptamer sensor is optical and carries at least one fluorescent tag on each of the plurality of aptamers ([0051] “In addition to the proactive reference sensors and sensor elements described, some embodiments may be configured as passive reference sensors. One such passive reference sensor uses fluorescent tags that can be read to determine the amount of sensor dissociation over time. For example, an EAB sensor includes a plurality of reference aptamer sensing elements that have a fluorescent tag affixed to their redox moieties, to their docking structures, or elsewhere”).
In regards to claim 34 Larson teaches the method of claim 18 wherein the measurement of the temperature sensor is a direct measure of the temperature at the aptamer sensor [0048] temperature sensor measures the direct temperature of aptamer sensor)
In regards to claim 35 Larson teaches the method of claim 18 wherein the measurement of the temperature sensor is an indirect measure of the temperature at the aptamer sensor ([0048] "For example, the electrode surface may be affixed with a SAM, molecule, or polymer with known temperature-induced decay rates, or an aptamer sensing element, or dummy element, may be attached to redox moiety having a known temperature-induced dissociation profile". Sensor indirectly measures temperature through the decay rates).
In regards to claim 36 Larson teaches the method of claim 18 wherein the electrochemical aptamer sensor is attached to a user by placing at least a portion of the sensor in the user's skin (0030] “As a further example, many embodiments of the disclosed invention could benefit from mechanical or other means known to those skilled in wearable devices, patches, bandages, and other technologies or materials affixed to skin, to keep the devices or sub-components of the skin firmly affixed to skin or with pressure favoring constant contact with skin or conformal contact with even ridges or grooves in skin, and are included within the scope of the disclosed invention”).
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.
Claim(s) 8-11, 16-16, 25-28, and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20210140956 A1 – cited by applicant).
In regards to claim 8 Larson teaches the device of claim 1. Larson does not explicitly teach that the temperature sensor is located no more than about 3 mm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 9 Larson teaches the device of claim 1. Larson does not explicitly teach that the temperature sensor is located no more than about 1 mm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 10 Larson teaches the device of claim 1. Larson does not explicitly teach that the temperature sensor is located no more than about 300 μm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 11 Larson teaches the device of claim 1. Larson does not explicitly teach that the temperature sensor is located no more than about 100 μm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 15 Larson teaches the device of claim 13 wherein the aptamer sensor is an electrochemical aptamer sensor with a redox tag attached to each of the plurality of aptamers ([0023] such functionalization may include tagging the aptamer with a redox moiety, or attaching thiol binding molecules, docking structures, or other components to the aptamer. Multiple aptamer sensing elements functionalized on an electrode comprise an EAB sensor) and determining an analyte concentration response of the aptamer ([0032] “A contemporaneous comparison of the reference EAB's signal to that of the active sensor can therefore reveal the number of functional sensor elements at the time of sensor use, so that signal strength can be more accurately correlated with analyte concentration”). Larson doesn’t explicitly teach what values are in the look up table. However, It would have been obvious to include analyte concentration values for signal strengths at various temperatures in the look up table.
In regards to claim 16 Larson teaches the device of claim 13 wherein the aptamer sensor is an electrochemical aptamer sensor with a redox tag attached to each of the plurality of aptamers ([0023] such functionalization may include tagging the aptamer with a redox moiety, or attaching thiol binding molecules, docking structures, or other components to the aptamer. Multiple aptamer sensing elements functionalized on an electrode comprise an EAB sensor) and a change in sensor response of use of the sensor over time ([0051] “One such passive reference sensor uses fluorescent tags that can be read to determine the amount of sensor dissociation over time. For example, an EAB sensor includes a plurality of reference aptamer sensing elements that have a fluorescent tag affixed to their redox moieties, to their docking structures, or elsewhere. As the EAB sensor degrades over time, the amount of fluorescence remaining on the EAB sensor is measured, e.g., with an optical sensor such as a photodiode, and the degree of dissociation determined”). Larson doesn’t explicitly trach multiple hours, but it would be obvious to use the sensor multiple times over multiple hours/days to obtain measurements for a user over a period of time and to include these sensor response changes in the look up table..
In regards to claim 25 Larson teaches the method of claim 18. Larson does not explicitly teach that the temperature sensor is located no more than about 3 mm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 26 Larson teaches the method of claim 18. Larson does not explicitly teach that the temperature sensor is located no more than about 1 mm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 27 Larson teaches the method of claim 18. Larson does not explicitly teach that the temperature sensor is located no more than about 300 μm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 28 Larson teaches the method of claim 18. Larson does not explicitly teach that the temperature sensor is located no more than about 100 μm from at least one electrochemical aptamer sensor. It is noted that Applicant has not disclosed in the specification that the claimed distance between the temperature sensor and aptamer sensor provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine an optimum distance between the temperature sensor and aptamer sensor of Larson. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 31 Larson teaches the method of claim 18 wherein the aptamer sensor is an electrochemical aptamer sensor with a redox tag attached to each of the plurality of aptamers ([0023] such functionalization may include tagging the aptamer with a redox moiety, or attaching thiol binding molecules, docking structures, or other components to the aptamer. Multiple aptamer sensing elements functionalized on an electrode comprise an EAB sensor) and determining an analyte concentration response of the aptamer ([0032] “A contemporaneous comparison of the reference EAB's signal to that of the active sensor can therefore reveal the number of functional sensor elements at the time of sensor use, so that signal strength can be more accurately correlated with analyte concentration”). Larson doesn’t explicitly teach what values are in the look up table. However, It would have been obvious to include analyte concentration values for signal strengths at various temperatures in the look up table.
In regards to claim 32 Larson teaches method of claim 18 wherein the aptamer sensor is an electrochemical aptamer sensor with a redox tag attached to each of the plurality of aptamers ([0023] such functionalization may include tagging the aptamer with a redox moiety, or attaching thiol binding molecules, docking structures, or other components to the aptamer. Multiple aptamer sensing elements functionalized on an electrode comprise an EAB sensor) and a change in sensor response of use of the sensor over time ([0051] “One such passive reference sensor uses fluorescent tags that can be read to determine the amount of sensor dissociation over time. For example, an EAB sensor includes a plurality of reference aptamer sensing elements that have a fluorescent tag affixed to their redox moieties, to their docking structures, or elsewhere. As the EAB sensor degrades over time, the amount of fluorescence remaining on the EAB sensor is measured, e.g., with an optical sensor such as a photodiode, and the degree of dissociation determined”). Larson doesn’t explicitly trach multiple hours, but it would be obvious to use the sensor multiple times over multiple hours/days to obtain measurements for a user over a period of time and to include these sensor response changes in the look up table.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20210140956 A1 – cited by applicant) as applied to claim 1, in view of Peeters (US 20160178622 A1 – cited by applicant).
In regards to claim 3 Larson teaches the device of claim 1. Larson fails to teach a device further comprising a reader component with at least one temperature sensor. Peeters teaches reader component with at least one temperature sensor ([0062] “The biosensor device 10 furthermore comprises a signal processing unit 16”; “This signal processing unit 16 is adapted for, e.g. programmed for, calculating at least one heat transfer resistivity value based on temperature values obtained from the first temperature sensing element 14 and the second temperature sensing element”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device of Larson to include a signal processing unit like the device of Peeters in order to process the signals from the temperature sensor.
Claim(s) 7, 12, 29, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20210140956 A1 – cited by applicant) as applied to claims 1, 4, and 18 in view of Heikenfeld ‘398 (US 20190183398 A1 – cited by applicant).
In regards to claim 7 Larson teaches the device of claim 4 including a temperature sensor that is capable of being placed inside or outside the skin (See arguments for claims 4 and 5 above). Larson fails to teach a first and second temperature sensor. Heikenfeld ‘398 teaches multiple temperature sensors ([0022] Multiple temperature sensors, or higher resolution sensors, could be used in the disclosed embodiments to increase accuracy). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device of Larson to include multiple temperature sensors like the device of Heikenfeld ‘398 in order to increase accuracy. These sensors are both capable of being placed inside or outside the skin.
In regards to claim 12 Larson teaches the device of claim 1. Larson fails to teach thermal insulation on the device such that the temperature sensor provides adequate prediction of the temperature of at least one electrochemical aptamer sensor. Heikenfeld ‘398 teaches thermal insulation ([0024] The device 100 also includes a passive thermal component comprising one or more layers of a low thermal conductivity material or insulator, as indicated at 170 and 172). would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device of Larson to include the insulation of Heikenfeld ‘398 in order to decrease the temperature variability of the sensors (Heikenfeld [0024] “The thermal isolation decreases the temperature variability of the sensors 120, 122, 124, 126, enabling the sensors to operate at a consistent, controlled temperature”).
In regards to claim 29 Larson teaches the method of claim 18. Larson fails to teach thermal insulation on the device such that the temperature sensor provides adequate prediction of the temperature of at least one electrochemical aptamer sensor. Heikenfeld ‘398 teaches thermal insulation ([0024] The device 100 also includes a passive thermal component comprising one or more layers of a low thermal conductivity material or insulator, as indicated at 170 and 172). would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device used in the method of Larson to include the insulation of Heikenfeld ‘398 in order to decrease the temperature variability of the sensors (Heikenfeld ‘398 [0024] “The thermal isolation decreases the temperature variability of the sensors 120, 122, 124, 126, enabling the sensors to operate at a consistent, controlled temperature”).
In regards to claim 39 Larson teaches the method of claim 18. Larson fails to teach thermal insulation such that the temperature sensor provides adequate prediction of the temperature of the aptamer sensor. Heikenfeld ‘398 teaches thermal insulation ([0024] The device 100 also includes a passive thermal component comprising one or more layers of a low thermal conductivity material or insulator, as indicated at 170 and 172). would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device used in the method of Larson to include the insulation of Heikenfeld ‘398 in order to decrease the temperature variability of the sensors (Heikenfeld ‘398 [0024] “The thermal isolation decreases the temperature variability of the sensors 120, 122, 124, 126, enabling the sensors to operate at a consistent, controlled temperature”).
Claim(s) 14 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson and (US 20210140956 A1 – cited by applicant) as applied to claims 13 and 18 in view of Wu (An Electrochemical Aptamer-Based Sensor for Real-Time Monitoring of Insulin)
In regards to claim 14 Larson teaches the device of claim 13 wherein the aptamer sensor is an electrochemical aptamer sensor with a redox tag attached to each of the plurality of aptamers ([0023] such functionalization may include tagging the aptamer with a redox moiety, or attaching thiol binding molecules, docking structures, or other components to the aptamer. Multiple aptamer sensing elements functionalized on an electrode comprise an EAB sensor). Larson fails to teach wherein record or prediction additionally comprises a frequency response of the aptamer. Wu teaches that for the electrochemical sensors employed with a redox moiety the applied frequency is significant to the sensor response (Page 6 “When using sensors fabricated with the Insulin-End aptamer, this threshold frequency is observed to be ~200 Hz. In the presence of insulin, the increase in the MB current was observed from 5 Hz with current plateauing at 75 Hz, and the declining frequencies >200 Hz. As can be seen, insulin binding induced significant signal suppression across ACV frequencies, nevertheless, ACV profiles for the absence and presence of insulin are similar, which indicates the proposed binding-induced steric hindrance mechanism”. It would have been prima facie obvious to include frequency responses like the ones of Wu in the lookup table for various temperatures and analyte concentrations of Larson. Doing so would allow the device to associate the frequency response of the aptamer sensor with the detected temperature.
In regards to claim 30 Larson teaches the method of claim 18 wherein the aptamer sensor is an electrochemical aptamer sensor with a redox tag attached to each of the plurality of aptamers ([0023] such functionalization may include tagging the aptamer with a redox moiety, or attaching thiol binding molecules, docking structures, or other components to the aptamer. Multiple aptamer sensing elements functionalized on an electrode comprise an EAB sensor). Larson fails to teach wherein record or prediction additionally comprises a frequency response of the aptamer. Wu teaches that for the electrochemical sensors employed with a redox moiety the applied frequency is significant to the sensor response (Page 6 “When using sensors fabricated with the Insulin-End aptamer, this threshold frequency is observed to be ~200 Hz. In the presence of insulin, the increase in the MB current was observed from 5 Hz with current plateauing at 75 Hz, and the declining frequencies >200 Hz. As can be seen, insulin binding induced significant signal suppression across ACV frequencies, nevertheless, ACV profiles for the absence and presence of insulin are similar, which indicates the proposed binding-induced steric hindrance mechanism”. It would have been prima facie obvious to include frequency responses like the ones of Wu in the lookup table for various temperatures and analyte concentrations of Larson. Doing so would allow the device to associate the frequency response of the aptamer sensor with the detected temperature.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20210140956 A1 – cited by applicant) as applied to claim 18, in view of Peeters (US 20160178622 A1 – cited by applicant) in view of Heikenfeld ‘579 (US 20190254579 A1 – cited by applicant).
In regards to claim 20 Larson teaches the method of claim 18. Larson fails to teach further comprising a reader component with at least one temperature sensor. Peeters teaches reader component with at least one temperature sensor ([0062] “The biosensor device 10 furthermore comprises a signal processing unit 16”; “This signal processing unit 16 is adapted for, e.g. programmed for, calculating at least one heat transfer resistivity value based on temperature values obtained from the first temperature sensing element 14 and the second temperature sensing element”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device of Larson to include a signal processing unit like the device of Peeters in order to process the signals from the temperature sensor. Larson/Peeters fails to teach a device wherein the aptamer sensor is disposable.
Heikenfeld ‘579 teaches a disposable aptamer sensor (Claim 25). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the device of Larson/Peeters to be disposable like the device of Heikenfeld ‘579 in order to allow the device to be thrown out in order to minimize risk of contamination between patients.
Claim(s) 21-22, 24 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20210140956 A1 – cited by applicant) as applied to claim 18, in view of Lin (US 20170350882 A1).
In regards to claim 21 Larson teaches the method of claim 18. Larson fails to teach a method wherein the aptamer sensor is placed subcutaneously. Lin teaches placing an aptamer sensor device subcutaneously ([0013] “technology can enable innovative subcutaneously implanted sensors to measure concentrations of certain molecules, such as glucose, in interstitial fluid (ISF)”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to implant the aptamer sensor of Larson subcutaneously in order to measure analytes in the interstitial fluid of a user like the method of Lin.
In regards to claim 22 Larson teaches the method of claim 18. Larson fails to teach a method wherein the temperature sensor is placed subcutaneously. Lin teaches placing an aptamer sensor device with a temperature sensor subcutaneously ([0013] “technology can enable innovative subcutaneously implanted sensors to measure concentrations of certain molecules, such as glucose, in interstitial fluid (ISF)”, [0036] “a temperature sensor located below the first and second plates”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to implant the aptamer device including the temperature sensor of Larson subcutaneously in order to measure analytes in the interstitial fluid of a user like the method of Lin.
In regards to claim 24 Larson teaches the method of claim 18, including a temperature sensor that is placed outside the skin ([0030] device is affixed to the skin in order to analyze sweat, [0048] temperature sensor). Larson fails to teach a first temperature sensor that is placed subcutaneously. Lin teaches placing an aptamer sensor device with a temperature sensor subcutaneously ([0013] “technology can enable innovative subcutaneously implanted sensors to measure concentrations of certain molecules, such as glucose, in interstitial fluid (ISF)”, [0036] “a temperature sensor located below the first and second plates”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the method of Larson to use one skin affixed aptamer and temperature device to measure analytes in sweat and another second implanted aptamer and temperature device to measure analytes in the interstitial fluid of a user like the method of Lin. Doing so would allow the device to analyze analytes in both sweat and interstitial fluid.
In regards to claim 37 Larson teaches the method of claim 18. Larson fails to teach a temperature sensor is inserted at least 100 μm into a user's skin. Lin teaches placing an aptamer sensor device with a temperature sensor subcutaneously which is inherently at least 100 μm into a user’s skin ([0013] “technology can enable innovative subcutaneously implanted sensors to measure concentrations of certain molecules, such as glucose, in interstitial fluid (ISF)”, [0036] “a temperature sensor located below the first and second plates”, To be subcutaneous the device must be in the fat under the skin with is inherently more than 100 μm). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to implant the aptamer device including the temperature sensor of Larson subcutaneously in order to measure analytes in the interstitial fluid of a user like the method of Lin.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20210140956 A1 – cited by applicant) as applied to claim 18, in view of Lin (US 20170350882 A1) in view of Braganza (US 20210228160 A1).
In regards to claim 38 Larson teaches the method of claim 18. Larson fails to teach a method wherein at least two temperature sensors are placed at different depths into or distances from a user's skin to measure a temperature gradient that predicts temperature of the aptamer sensor. Lin teaches placing an aptamer sensor device with a temperature sensor subcutaneously ([0013] “technology can enable innovative subcutaneously implanted sensors to measure concentrations of certain molecules, such as glucose, in interstitial fluid (ISF)”, [0036] “a temperature sensor located below the first and second plates”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to implant the aptamer device including the temperature sensor of Larson subcutaneously in order to measure analytes in the interstitial fluid of a user like the method of Lin.
Larson/Lin fails to teach a method wherein at least two temperature sensors are placed at different depths into or distances from a user's skin to measure a temperature gradient that predicts temperature of the aptamer sensor. Braganza teaches temperature sensors that are placed at different depths into or distances from a user's skin to measure a temperature gradient that indicates a temperature at an implanted device ([0151] “By implanting IMD 10 to have a body side sensor positioned inside IMD 10 on the flat side of IMD 10 and a skin side sensor on the curved side of IMD 10, processing circuitry 50 may utilize temperature values received from at least the two separately located sensors in order to identify temperature gradients at IMD 10”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the temperature sensors of Larson/Lin to include two temperature sensors to measure a temperature gradient of the aptamer like the device of Braganza. Doing so would merely be substituting one temperature determination method for another.
Conclusion
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791