DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of group I, claims 1-32 in the reply filed on 5/18/2026 is acknowledged.
Claims 33-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/18/2026.
Claim Rejections - 35 USC § 103
3. 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.
4. Claim(s) 1, 8-9, 14-15, 23, 29-30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (US 2018/0353748 A1) (hereinafter “Heikenfeld (‘748)”) in view of Thomas et al. (US 2021/0161437 A1) (hereinafter “Thomas”).
Regarding claim 1, Heikenfeld (‘748) teaches a method of measuring analytes in a subject in vivo for a period of time comprising (para [0021] - "In one embodiment, a sensor device for sensing on the skin Includes one or more analyte-specific sensors and a volume-reducing component that provides a volume-reduced pathway for biofluid between the one or more sensors and pre-existing pathways in said skin when said device is positioned on said skin"; para [0077] - "For example, a first sensor (e.g., sensor 122) could measure a first cytokine and a second sensor (e.g., sensor 124) could measure a second cytokine that has similar dilution in the biofluid as the first cytokine (e.g., due to size, charge, lipophilicity, etc.), and the ratios of these two analytes may be compared at one time point or over multiple time points to provide meaningful information"; para [0083] - "For example, with the reverse iontophoresis electrode 150 electrically grounded, the counter electrode 152 could have a positive voltage for 5 minutes. Next, a 25 minute rest period of no voltage could occur"): a device comprising:
at least one sensor comprising an aptamer material (para [0075] - "As interstitial fluid moves through the wicking collector 136, the wicking couplers 130, 132, 134 allow the sensors 120, 122, 124, respectively, to sense the interstitial fluid. In an exemplary embodiment, the sensor 120 may comprise an ion-selective electrode for sodium and a reference electrode, the sensor 122 is an amperometric sensor for urea, and the sensor 124 is an electrochemical aptamer sensor for vasopressin"); at least one feature for coupling said sensor to an analyte in the subject in vivo (para [0093] - "The device 200 also includes a reverse iontophoresis electrode 250, which is carried by a substrate 210, a counter electrode 252, and a controller 160. When the wicking collector 236 is transporting biofluid towards the sensors 220, 222, 224, electrical current for the reverse iontophoresis could flow through the membrane 270, while the membrane 270 would significantly reduce or block the passive diffusion or advective flow of generated pH (acid or base) or of buffering agent or buffering byproducts"; para [0075]); c) using the feature to couple the sensor to an analyte in the subject (para [0093]).
Heikenfeld (‘748) does not explicitly teach the method comprising a) storing the device, said device further comprising at least one sterile packaging material enabling a storage state; wherein
the at least one sensor is contained in the sterile packaging material, and further, wherein the at least one sensor and the at least one feature are sterile; or the method further comprising (prior to step (c)): b) removing the sterile packaging material from the device.
Thomas teaches a method of analyte monitoring comprising storing a sensor device and device components for monitoring analytes in a sterile packaging material, and removing the device and components from sterile packaging materials prior to use (abstract; para [0009] - "FIG. 1 is a conceptual diagram depicting an example analyte monitoring system that may incorporate one or more embodiments of the present disclosure"; para [0913] - "the sensor 110 and the associated electrical components included in the sensor control device 104 are provided to the user in multiple (two) packages, and the user must open the packaging"; para [0456]-[0458] - "The applicator cap 210 may
also create a dust-free environment during shipping and storage").
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed, to apply the sterile storage taught by Thomas to the method of analyte detection taught by Heikenfeld (‘748), in order to prevent contamination of the sensor and feature prior to use.
Regarding claim 8, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, and Thomas further teaches the method further comprising sterilizing the device by sterilizing the device components and then assembling the device components in a sterile environment (para [0168] "If the sensor control device 302 is assembled in a controlled environment, there may be no need to terminally sterilize the internal electrical components").
Regarding claim 9, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, and Thomas further teaches the method further comprising sterilizing the device by separately sterilizing the device and the device components and integrating the device and device components in a sterile environment (para [0162]-[0163] - "For the two-piece architecture system, the sensor tray 202 (FIG. 2A) and the sensor applicator 102 (FIG. 2B) are provided to the user as separate packages, thus requiring the user to open each package and finally assemble the system. In some applications, the discrete, sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized in separate sterilization processes unique to the contents of each package and otherwise incompatible with the contents of the other"; para [0168]).
Regarding claim 14, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, and Thomas further teaches wherein the device is sealed in a pouch made of ethylene oxide porous Tyvek (para [0198] - "The first layer may be made of a synthetic material (e.g., a flash-spun high-density polyethylene fiber), such as Tyvek available from DuPont®. Tyvek is highly durable and puncture resistant and allows the permeation of vapors. The Tyvek® layer can be applied before or after the radiation sterilization 612, and following the radiation sterilization 612"; para [0585] - "Example chemicals that may be used for the gaseous chemical sterilization 4704 include, but are not
limited to, ethylene oxide, vaporized hydrogen peroxide, nitrogen oxide (e.g., nitrous oxide, nitrogen dioxide, etc.), and steam").
Regarding claim 15, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, and Thomas further teaches wherein the sensor is sterilized with a sterilant while it is sealed in the sterile packaging material, and further, wherein the sterile packaging material is porous
to the sterilant (para [0198]).
Regarding claim 23, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, and Thomas further teaches wherein the device is sterilized using a method selected from the group consisting of gamma irradiation, Xray irradiation, E-beam dosing, UV irradiation and combinations thereof (para [0188] - "While positioned within the sensor applicator 102, the fully assembled sensor control device 302 may be subjected to radiation sterilization 612. The radiation sterilization 612 may comprise, for example, e-beam irradiation, but other methods of sterilization may alternatively be used including, but not limited to, low energy X-ray irradiation").
Regarding claim 29, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the device is sterilized using a solvent. It would have been obvious, at the time the invention was filed, to one during the course of ordinary experimentation to apply a solvent to sterilize the device as this was a common method to sterilize devices in the art of medicine at the time.
Regarding claim 30, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the device is sterilized using a solvent selected from the group consisting of ethanol, isopropanol, propanol, and other alcohols. It would have been obvious, at the time the invention was filed, to one during the course of routine experimentation to apply an alcohol to sterilize the device as this is a common method to sterilize devices in the art of medicine at the time.
Regarding claim 32, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, and Thomas further teaches the method further comprising sterilizing the device using conditions comprising an inert environment (para [0168]).
5. Claim(s) 2-7, 12-13, 16, 18, 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748) in view of Thomas and further in view of Heikenfeld (‘779).
Regarding claim 2, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1 but does not explicitly teach wherein the device further comprises at least one aptamer storage material.
Heikenfeld (‘779) teaches a sensor for analyte detection comprising an aptamer, and an aptamer storage material (para [0004] - "Further, the sensor includes at least one substrate-adjacent aptamer. In addition, the sensor includes at least one storage material, which reduces or prevents significant degradation during the storage state such that the sensor can then be used in the sensing state after the storage state"; para [0031] "As used herein, "storage material" refers to at least one chemical, fluid, material, or combination thereof, which stabilizes substrate-bound aptamers, and/or substrate-adjacent molecules, such that the sensor can be stored without significant degradation prior to use").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the aptamer storage material taught by Heikenfeld (‘779) to the method made obvious by Heikenfeld (‘748) in view of Thomas to better store the aptamer.
Regarding claim 3, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the at least one sensor is capable of producing a signal when exposed to the analyte; and further, wherein the signal has an initial level of strength
prior to storage of the sensor in sterile packaging material. Heikenfeld (‘779) teaches a sensor capable of producing a signal when exposed to the analyte; and further, wherein the signal has an Initial
level of strength prior to storage of the sensor in sterile packaging material (para [0005] "In one embodiment, after the sensor has been in a sensing state, it has an initial electrochemical signal gain that is within 10 percent of the signal gain in the pre-storage state"). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to apply the sensor taught by Heikenfeld (‘779) to the method made obvious by Heikenfeld (‘748) in view of Thomas to maintain the shelf-life of the device.
Regarding claim 4, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the sensor has a second level of strength after storage of the sensor in sterile packaging material, and said second level of strength differs from the initial level of strength such that the analyte is still measurable in-vivo. Heikenfeld (‘779) teaches a sensor that has a second level of strength after storage of the sensor in sterile packaging material, and said second level of strength differs from the initial level of strength such that the analyte is still measurable in-vivo (para [0005]; para [0011] - "In another embodiment of the present invention, a method of detecting at least one analyte in a sample solution is disclosed. The method
involves obtaining a sensor in a pre-storage state, wherein the sensor comprises at least one substrate-adjacent aptamer and at least one first material which reduces or prevents significant degradation during a storage state. Then, the sensor is stored in a storage state, then placed in a sensing state"; para [0038] "As used herein, "sensing state" refers to a state of the sensor after the time of storage and during use for sensing an analyte in a sensor solution. In addition, the "sensing state" refers to normal operation of the sensor once it is ready for accurate measurement of at least one analyte"). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the sensor taught by Heikenfeld (‘779) to the method made obvious by Heikenfeld (‘748) in view of Thomas to ensure the sensor was operable following storage.
Regarding claim 5, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfield ('779) makes obvious the method of claim 4, and Heikenfeld (‘779) further teaches wherein the second level of strength is lower than the initial level of strength by an amount selected from the group consisting of less than 80%, less than 40%, less than 20%, less than 10%, and less than 5% (para [0056] "Various aptamer sensors and aptamers can give varying results of storage stability, and therefore may be stored for at least one of 1 week, 1 month, 6 months, 1 year, and provide a reduction in signal gain that is less than at least one of 2%, 5%, 10%, 20%, 30%, 40%, or 80% of the signal gain before storage").
Regarding claim 6, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the device remains sterile and shelf stable for a period of time selected from the group consisting of at least 2 weeks, at least 2 months, and at least 6
months. Heikenfeld (‘779) teaches a sensor that remains shelf-stable after storage of at least 6 months (para [0056]). It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the sensor taught by Heikenfield ('779) to the method made obvious by Heikenfeld (‘748) in view of Thomas to prolong the shelf life of the device.
Regarding claim 7, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfield ('779) makes obvious the method of claim 1, and Heikenfeld (‘748) further teaches wherein the device comprises a plurality of device components (para [0065] "Certain embodiments of the disclosed invention show sub-components of what would be sensing devices with more sub-components needed for use of the device in various applications, which are obvious (such as a battery)").
Regarding claim 12, Heikenfeld (‘748) in view of Thomas; further in view of Heikenfeld (‘779) makes obvious the method of claim 2, and Thomas further teaches the method further comprising sterilizing the device wherein the sterilization comprises sterilizing the sensor and the (aptamer) storage material together with a packaging material that is stable during sterilization (para [0225] "In embodiments that include the cap 812, the cap 812 may be made of a material that permits propagation of the radiation 814 there through to facilitate radiation sterilization of the part 806. Suitable materials for the cap 812 include, but are not limited to, a non-magnetic metal (e.g., aluminum, copper, gold, silver, etc.), a thermoplastic, ceramic, rubber (e.g., ebonite), a composite material (e.g., fiberglass, carbon fiber reinforced polymer, etc.), an epoxy, or any combination thereof. In some embodiments, the cap 812 may be transparent or translucent, but can otherwise be opaque, without departing from the scope of the disclosure").
Regarding claim 13, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 2, but does not explicitly teach wherein the aptamer storage material has a thickness selected from the group consisting of at least <500 nm, at least <100 nm, and at least < 20 nm. Heikenfeld (‘779) teaches the removal of the aptamer storage material prior to use after storage (para [0031] "As used herein, "storage material" refers to at least one chemical, fluid, material, or combination thereof. which stabilizes substrate-bound aptamers, and/or substrate-adjacent molecules, such that the sensor can be stored without significant degradation prior to use, and the
storage material removed prior to use of the sensor by means such as evaporation, dissolution, or other suitable mechanism"). It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply a thin aptamer storage material (<500 nm) to the sensor to facilitate the rapid removal of the aptamer storage material prior to use of the sensor.
Regarding claim 16, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 15 but does not explicitly teach wherein the device remains sterile and shelf stable for a period of time selected from the group consisting of at least 2 weeks, at least 2 months, and at least 6 months.
Heikenfeld (‘779) teaches a sensor that remains shelf-stable after storage of at least 6 months (para [0056]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply the sensor taught by Heikenfeld (‘779) to the method made obvious by Heikenfeld (‘748) in view of Thomas to prolong the shelf life of the device.
Regarding claim 18, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 2, and Heikenfeld (‘779) further teaches wherein the aptamer storage material comprises a composition selected from the group consisting of thin trehalose, dried serum, polyethylene glycol, polyvinyl alcohol, a dried salt layer, other polymers, dextran, and mixtures thereof (para [0057]- "With reference to Figures 3A and 3B, an identical device was fabricated and initially tested, the device was then coated with trehalose as a storage material").
Regarding claim 27, Heikenfeld (‘748), in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 2, but does not explicitly teach wherein the aptamer storage material has a thickness that is less than the size of spores. Heikenfeld (‘779) teaches the use of
aptamer storage material to prevent microbial contamination of the sensor (para [0050] "In an embodiment of the disclosed invention, the storage material is in total or in part an inert gas such as argon, nitrogen, carbon-dioxide, or other non-reactive gas or a gas that is antimicrobial in nature"). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply an aptamer storage material with a thickness less than the size of spores to prevent the encapsulation of microbial spores within the aptamer storage material.
Regarding claim 31, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 2, and Heikenfeld (‘779) further teaches wherein the sensor is coated with an aptamer storage material selected from the group consisting of glucose, trehalose, and other sugars (para [0057]), but does not explicitly teach wherein the aptamer storage material is then exposed to a solvent selected from the group consisting of isopropanol, propanol, and other sterilizing organic solvents; wherein the sugar or other aptamer storage material is poorly soluble in the solvent. Heikenfeld (‘779) teaches the dissolution of the storage material after the storage state to prepare the sensor (para [0039] - "As used herein, "recovery material" refers to a material that a sensor is placed in after the storage state to prepare the sensor for the sensing state. in one embodiment, a recovery material is a non-aqueous solvent that dissolves the storage material"). It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply a sterilizing organic solvent that the aptamer storage material demonstrates poor solubility in to prevent the dissolution of the aptamer storage material and contamination of the sensor during storage.
6. Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748), in view of Thomas, further in view of Addison (US 2014/0266695 A1).
Regarding claim 10, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach the method further comprising sterilizing the device using conditions comprising dry heat in an inert environment.
Addison teaches a method of sterilizing a sensing device, comprising dry heat (abstract; para [0056] - "Additionally, in certain embodiments, the disinfecting gas device 200 may also be configured for dry heat sterilization. For example, the disinfecting gas device200 may include a heat source 230 to provide heat to the disinfecting gas device 200. Additionally, in one embodiment, the disinfecting gas
device 200 may be configured to utilize air, rather than a disinfecting gas, in combination with the heat source 230 to implement a dry heat sterilization process. In certain embodiments, the minimum predetermined temperature threshold may be between approximately 10 degrees Celsius and 300 degrees Celsius, 50 degrees Celsius and 250 degrees Celsius, 100 degrees Celsius and 200 degrees Celsius, or 150 degrees Celsius and 180 degrees Celsius, or any other temperature range. Additionally, the minimum predetermined time threshold for exposure to the disinfecting gas and/or the heat may be between approximately 30 minutes and 3 hours, 45 minutes and 2.5 hours, 1 hour and 2 hour, or any other time range").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the dry heat sterilization taught by Addison to the device made obvious by Heikenfeld (‘748) in view of Thomas, in order to sterilize the device.
Regarding claim 11, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the device is sterilized using conditions comprising an inert environment at greater than or equal to 120 Celsius for more than 1 hour. Addison teaches a method of sterilization comprising dry heat at greater than or equal to 120 Celsius for more than 1 hour (para [0056]).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the dry heat sterilization taught by Addison to the device made obvious by Heikenfeld (‘748) in view of Thomas to sterilize the device.
7. Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748) in view of Thomas, and further in view of McKinlay (US 021/0189450 A1).
Regarding claim 21, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein an ethylene oxide protectant is immobilized inside the device such that it does not harm or irritate the body. McKinlay teaches a biosensor device comprising an ethylene oxide protectant used for sterilization, that is immobilized inside the device (para [0034] - "FIG. 7 is a simplified diagrammatic representation of an ethylene oxide (ETO) sterilization process 40 for a biosensor having a binding mechanism to an absorption layer for glucose oxidase. More particularly, ethylene oxide (ETO) sterilization Step 42 precedes Step 44 where ETO binds to an absorption layer 12 (see FIG. 1). Step 44 depicts ETO 22 (see FIG. 1) bound to sterilization absorption layer 22").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the ethylene oxide immobilization taught by McKinlay to the method made obvious by Heikenfeld (‘748) in view of Thomas to prevent irritation by ethylene oxide.
Regarding claim 22, Heikenfeld ('748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein an ethylene oxide protectant is held inside the device by a size selective membrane covering the sensor. McKinlay teaches a biosensor device comprising an ethylene oxide protectant used for sterilization, that is held inside the device by a selectively permeable membrane covering a sensor (para [0034]; para [0003] "further improvements are needed to increase accuracy and longevity of inserted sensors when measuring constituents and physical membrane lamination and permeability issues can negatively affect performance").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the selectively permeable membrane taught by McKinlay to the method made obvious by Heikenfeld ('748) in view of Thomas to contain ethylene oxide within the sensor.
8. Claim(s) 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748), in view of Thomas, further in view of Taylor (WO 2020/214839 A1).
Regarding claim 24, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the device is sterilized using gamma irradiation at a range from about 25 to about 40 kGy. Taylor teaches sterilizing a medical device using gamma irradiation at a range from about 25 to about 40 kGy (abstract; para [0057] "In various embodiments, a degradable polymer may be exposed to ionizing energy such as E-beam irradiation or gamma radiation, for example, in a dosage of from about 1 kGy to about 100 kGy, or from about 30 kGy to about 60 kGy, or from about 35 kGy to about 45 kGy, from about 20 kGy to about 70 kGy and all ranges and amounts therein between"; para [0087] - "After formation of the structurally stable nasal splint, the nasal splint, still contained within the force-applying and/or shape-maintaining container was exposed to ionizing radiation
of from about 30 kGy to about 60 kGy to enhance degradation of the polymeric material").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the gamma irradiation sterilization taught by Taylor to the method made obvious by Heikenfeld (‘748) in view of Thomas to sterilize the device.
Regarding claim 26, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1 wherein the device is sterilized using E-beam dosing at a range from about 25 to about 40 kGy.
Taylor teaches sterilizing a device using e-beam irradiation at a range from about 25 to about 40 kGy (para [0057]; para [0087]).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the e-beam irradiation sterilization taught by Taylor to the method made obvious by Heikenfeld (‘748) in view of Thomas to sterilize the device.
9. Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748), in view of Thomas, further in view of Suppiger (US 2020/0390690 A1).
Regarding claim 25, Heikenfeld (‘748) in view of Thomas makes obvious the method of claim 1, but does not explicitly teach wherein the device is sterilized using Xray irradiation at a range from about 10 to about 500 Gy. Suppiger teaches a method of sterilizing a device wherein the device is sterilized using Xray irradiation at a range from about 10 to about500 Gy (para [0073] "The invention thus concerns an injectable aqueous implant formulation which has been sterilized by gamma-ray or
X-ray irradiation"; para [0097] - "Generally, sterilization by gamma-ray or X-ray irradiation is performed at 25-33 Gy").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the X-ray sterilization taught by Suppiger to the method made obvious by Heikenfeld ('748) in
view of Thomas to sterilize the device.
10. Claim(s) 17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748), in view of Thomas, further in view of Heikenfeld (‘779), further in view of McKinlay.
Regarding claim 17, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 2, but does not explicitly teach wherein the aptamer storage material comprises an ethylene oxide protectant. McKinlay teaches an aptamer storage material comprising an ethylene oxide protectant (para [0006] - "In one aspect, an analyte biosensor is provided having an analyte biosensing layer and an ethylene oxide absorption layer. The ethylene oxide absorption layer is provided over the analyte biosensing layer").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the ethylene oxide layer taught by McKinlay to the aptamer-based sensor made obvious by Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) to prevent contamination of the aptamer.
Regarding claim 19, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 18, but does not explicitly teach wherein the aptamer storage material further comprises an ethylene oxide protectant. McKinlay teaches an aptamer storage material comprising an ethylene oxide protectant (para [0006]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply the ethylene oxide layer taught by McKinlay to the aptamer-based sensor made obvious by
Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) to prevent contamination of the aptamer.
Regarding claim 20, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779), further in view of McKinlay makes obvious the method of claim 19, but does not explicitly teach wherein the ethylene oxide protectant is comprised in a layer having a thickness selected from the group consisting of >20 nm, >200 nm, and >1 m. McKinlay teaches the thickness of the sterilization layer controlling the rate of transmission between the analyte and the analyte sensor (para [0025] "Finally, such sterilization absorption layer can be provided with a thickness that provides a metering layer configured to control rate of transmission of analyte to the analyte biosensing layer").
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply an ethylene oxide protectant with a thickness >1 m to prevent the transmission of contaminants or analytes to the analyte sensor during the storage state.
11. Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (‘748), in view of Thomas, further in view of Heikenfeld (‘779), further in view of Van Antwerp (US 6,413,393 B1).
Regarding claim 28, Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) makes obvious the method of claim 2, but does not explicitly teach wherein the aptamer storage material comprises a biocompatible UV-absorber.
Van Antwerp teaches a sensor comprising a biocompatible UV-absorber (col 4, In 57-61 - "Preferred embodiments of the inventive sensor and method for its production employ UV-absorbing polymers that are biocompatible, i.e., polymers that are characterized by low cytotoxicity. Such polymers are particularly useful in fabricating sensors, in particular biosensors such as glucose sensors").
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to apply the biocompatible UV-absorber taught by Van Antwerp to the method made obvious by Heikenfeld (‘748) in view of Thomas, further in view of Heikenfeld (‘779) to protect the aptamer sensor from radiation damage.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E CONLEY whose telephone number is (571)272-8414. The examiner can normally be reached on M-F, 8:30am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SEAN E CONLEY/Primary Examiner, Art Unit 1799
Prosecution Insights