Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 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 1, line 6, “the other side of the flat part” lacks antecedent basis.
Claim Rejections - 35 USC § 101
Claims 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to an abstract idea without significantly more.
With Respect to claims 13 the claims recite the following limitation(s):
Claim 13: A continuous glucose measurement method comprising the steps of:
(S1) inserting the glucose sensor of claim 1 into a skin to collect tissue fluid;
(S2) storing charge generated by oxidation of glucose contained in the tissue fluid in the supercapacitor;
(S3) quantifying a glucose level by measuring a voltage change of the supercapacitor; and
(S4) transmitting the glucose level to an external device.
Step 1- Claim 13 is directed to a method for glucose measurement.
Step 2a Prong 1 – The claimed invention is directed to non-statutory subject matter. The above limitations, under their broadest reasonable interpretation, fall within the "methods of organizing human activity and mental processes” grouping of abstract ideas, enumerated in MPEP
2106.04(a)(2)(II), in that they recite steps involving managing personal behavior and mental steps which involve obtaining a measurement by using the device and storing a charge and quantifying a glucose level and transmitting the result. When given their BRI, the limitations are considered an abstract idea of being certain methods of organizing human activity and mental processes.
With respect to claim 13, The method sets forth inserting the glucose sensor and storing a charge which is merely a use of the device set forth in claim 1 as a way for collection of data to enable quantifying the glucose level and then transmitting the result .
Step 2a Prong 2 - The recitation of the additional elements of the device of claim 1merely invokes such additional element(s) as a tool to perform the abstract idea. MPEP 2106.05(f).
Further, the recitation of these additional element(s) in the claim generally links the use of the abstract idea to a particular technological environment or field of use, i.e., a computerized environment. MPEP 2106.05(h).
As such, under Prong 2 of Step 2A, when considered both individually and as a whole, the limitations of claim 13 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d)
With respect to claim 13, There do not appear to be any additional elements provided and the abstract idea is not integrated into a practical application of utilizing any system components and actually doing anything with the glucose measurement once it is transmitted.
As such, these additional elements do not integrate the abstract idea into a practical application and therefore the claim is directed to the judicial exception.
Step 2B - The recitation of the additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. These additional elements do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Even when considered as an ordered combination, the additional elements of claim 13 do not add anything that is not already present when they are considered individually. Therefore, under Step 2B, there are no meaningful limitations in claim 13 that transform the judicial exception into a patent eligible application such that the claim amounts to significantly more than the judicial exception itself (Step 2B: NO). MPEP 2106.05.
Accordingly, under the Subject Matter Eligibility test, claim 13 is ineligible.
Furthermore, the dependent claim 14 does not add significantly more to the
abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pakr et al.(KR20220050350) hereinafter Pakr et al. in view of Kim et al(KR20200113997) hereinafter Kim et al.
Pakr et al. teaches a blood glucose sensor, and more particularly, to a patch-type blood glucose sensor capable of sensing blood glucose by self-charging without an external power source, and capable of continuously measuring blood glucose without blood collection. A blood glucose sensor according to the present invention includes a capacitor; and a conductive microneedle array positioned on one side of the capacitor, an enzyme layer coated on the microneedle array and containing a glucose oxidase, and a porous membrane coated on the enzyme layer.
Regarding claims 1, 12 - 14, Pakr et al. teaches a microneedle array including a flat part and a plurality of microneedles located on one surface of the flat part;
an enzyme layer located on a surface of the plurality of microneedles and including glucose oxidase;
a supercapacitor located on the other side of the flat part.
Note fig. 1, “the microneedle unit includes a conductive microneedle array located on one side of the capacitor, an enzyme layer coated on the microneedle array and containing glucose oxidase, and a porous membrane coated on the enzyme layer, through the skin of the blood glucose measurement target. The part in contact with the tissue fluid. Accordingly, glucose in the tissue fluid passes through the porous membrane and moves to the enzyme layer, and may be oxidized by glucose oxidase. Charges generated as glucose is oxidized may be transferred to and stored in a capacitor through a conductive microneedle array. That is, glucose can be directly supplied from the tissue fluid in the epidermis and oxidized without the need for blood sampling, and the charge generated by the oxidation reaction is stored in the capacitor, and the blood sugar of the blood glucose measurement target can be detected through the charge stored in the capacitor.”
Pakr et al. does not specifically teach a wireless communication module electrically connected to the supercapacitor.
Kim et al. teaches in the same field of endeavor a real-time blood glucose monitoring device including a microneedle array having an enzyme coating and a porous coating on top of the enzyme coating, a supercapacitor to power the device, and wireless communication module where the signal measured from the measurement unit may be transmitted to the notification unit through a communication unit, and the notification unit may be, for example, a mobile phone or a smartphone. In addition, a separate communication module for ZigBee communication and Bluetooth communication is embedded in the terminal and the measurement unit as a pair, so that data can be transmitted/received wirelessly, and a separate communication module is installed outside the terminal.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Pakr et al. a wireless communication module to wirelessly transmit the real-time glucose measurements to an external device such as a smart phone a user can more conveniently check a change in the concentration of the sugar in real time as taught by Kim et al.
Regarding claim 2, Pakr et al. teaches wherein the microneedle array is electrically connected to one electrode of the supercapacitor. Note fig. 1, “The capacitor is one electrode electrically connected to the microneedle array, and may store electric charges transferred through the microneedle array.
In one embodiment of the present invention, the capacitor has one electrode electrically connected to the microneedle array, and any conventional capacitor structure capable of storing electric charges transferred from the microneedle array is applicable. Preferably as a supercapacitor, comprising a first current collector, a first electrode including a first active layer positioned on the first current collector, and a second current collector and a second active layer positioned on the second current collector It may have a structure in which the second electrodes are positioned to face each other, a separator is positioned between the first electrode and the second electrode, and an electrolyte is supported between each electrode and the separator. Such a supercapacitor can be easily charged and discharged by electric charge, and has a high charge sensitivity, enabling more rapid blood glucose sensing.”.
Regarding claim 3, Pakr et al. teaches wherein a charge generated by oxidation of glucose in the enzyme layer is stored in the supercapacitor. Note fig. 1 and the corresponding description.
Regarding claim 4, Pakr et al. teaches wherein the glucose sensor operates without separate external power. Note fig. 1 and the corresponding description. “the blood glucose sensor of the present invention is fixed to the skin of a blood glucose measurement target by a microneedle unit including an enzyme layer, and can continuously oxidize the glucose of the blood glucose measurement target to generate an electric charge, and transfer the generated charge to the capacitor. By storing it, it is possible to measure blood sugar without an external power source. Such a blood sugar sensor enables continuous measurement of blood sugar in real time..”.
Regarding claim 5, Pakr et al. teaches wherein the microneedle array includes a conductive polymer. Note fig. 1 and corresponding description, “the microneedle array is a conductive material and may have a structure in which a conductive polymer and a metal are laminated. Specifically, the microneedle array may have a structure in which a metal is coated on the surface of the microneedle array made of a conductive polymer and stacked.”.
Regarding claims 6-9, Pakr et al. teaches a porous membrane located on the enzyme layer wherein the porous membrane includes a PVDF-based polymer , wherein an average pore size of the porous membrane is 200 to 500 nm, wherein an average porosity of the porous membrane is 50 to 60%.
Note fig. 1 and corresponding description, “The porous membrane is coated on the enzyme layer, and serves to protect the enzyme layer from the outside. Specifically, when the enzyme layer is directly inserted into the human body, the enzyme layer is exposed to the tissue fluid, and the enzyme layer may collapse. Accordingly, there is a problem that the enzyme is released into the body, and an inaccurate value may be measured during long-term measurement. The porous membrane prevents the enzyme layer from directly contacting the tissue fluid, thereby preventing the enzyme layer from collapsing, and preventing the enzyme from being altered by the external environment. In addition, since the oxidation of glucose is possible without the breakdown of the enzyme layer in the tissue fluid, it is possible to accurately measure blood glucose for a long time. Such a porous membrane is uniformly coated on the enzyme layer, so that the shape formed by the microneedle can be maintained as it is. As an example, the microneedles are provided in a cone shape as shown in FIG. 1, and as the enzyme layer is uniformly formed on the surface of the microneedles, the microneedles with the enzyme layer are also provided in a cone shape, and the porous membrane is also provided in a cone shape. can In this case, the thickness ratio of the enzyme layer: the porous membrane may be, but not limited to, 1:1 to 1:10, specifically 1:2 to 1:5. may migrate to the enzyme layer. The average pore size of the porous membrane may be 100 nm to 1 μm, specifically 200 nm to 500 nm, but is not limited thereto. However, the porous membrane having an average pore size within the above range can selectively supply only the glucose component to the enzyme layer excluding other components of the tissue fluid, thereby enabling more precise blood glucose sensing. The average porosity of the porous membrane may be 30% to 80%, specifically 50% to 60%, but is not limited thereto. However, the porous membrane having an average porosity within the above range allows an appropriate amount of glucose in the tissue fluid to flow in, thereby preventing a decrease in the linearity of sensing.”, “Such a porous membrane can be applied to any biocompatible material, specifically, may be a hydrophobic fluorine-based polymer, specifically, may contain a PVDF-based polymer, and in one embodiment, the porous membrane may be made of PVDF (Polyvinylidene fluorid).”.
Regarding claims 10 and 11, Pakr et al. teaches wherein the supercapacitor includes:
a first electrode located on one surface of a first current collector; a second electrode located on one surface of a second current collector and spaced apart from the first electrode; and an electrolyte located between the first electrode and the second electrode and teaches wherein the electrolyte includes a gel polymer electrolyte.
Note fig. 1 and the corresponding description, “The capacitor is one electrode electrically connected to the microneedle array, and may store electric charges transferred through the microneedle array. In one embodiment of the present invention, the capacitor has one electrode electrically connected to the microneedle array, and any conventional capacitor structure capable of storing electric charges transferred from the microneedle array is applicable. Preferably as a supercapacitor, comprising a first current collector, a first electrode including a first active layer positioned on the first current collector, and a second current collector and a second active layer positioned on the second current collector It may have a structure in which the second electrodes are positioned to face each other, a separator is positioned between the first electrode and the second electrode, and an electrolyte is supported between each electrode and the separator. Such a supercapacitor can be easily charged and discharged by electric charge, and has a high charge sensitivity, enabling more rapid blood glucose sensing.”. And the electrolyte is also not limited as long as it is an electrolyte commonly used in the art, and may be phosphoric acid in one embodiment, but is not limited thereto.”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kil et al., ACS Appl. Mater. Interfaces January 13, 2022, 14,3838-3848, A self-charging supercapacitor for a patch-type Glucose Sensor. Teaches a microneedle array including a flat part and a plurality of microneedles located on one surface of the flat part; an enzyme layer located on a surface of the plurality of microneedles and including glucose oxidase; a supercapacitor located on the other side of the flat part.
FANG (110044986) teaches a glucose monitoring probe, comprising: a base layer, a glucose enzyme sensing layer formed on the base layer and having a glucose enzyme capable of chemical reaction with glucose, semipermeable membrane, the formed on the glucose-enzyme sensing layer, control the rate of glucose molecules, and a biocompatible film, which is formed on the semi-transparent film, wherein, between the substrate layer and the glucose enzyme sensing layer, a nanometer particle layer with catalyzing glucose to react and is porous. and the glucose enzyme nano particle layer. According to the present disclosure, it can decrease the working electrode working voltage, reduce interference and prolong the service life of the glucose monitoring probe, and improve the reaction sensitivity of the glucose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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/BRIAN L CASLER/ Primary Examiner, Art Unit 3791