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 Objections
Claims 1, 8, and 19 are objected to because of the following informalities:
Claim 1 – “pursuing a. a first” should be “pursuing [[a. ]]a first” and “2-5, sensors” should be “2-5[[,]] sensors”.
Claim 4 – “effecting” should be “a[[e]]ffecting”
Claim 8 – dependent from another dependent claim that does not chronologically precede it (see more below)
Claim 19 – “sheet 1s stationary” should be “sheet i[[1]]s stationary”
Appropriate correction is required.
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
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 and 3-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “2 or more sensors,” and the claim also recites “2-5, sensors, 2-10 sensors, 2-100 sensors, and 2-1000 sensors” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. By virtue of dependency, claims 3-27 are also rejected.
Regarding claims 4, 7, 13-15, 17 and 27, the phrases "optionally” and “preferably " render the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d). By virtue of dependency, claims 9-11 are also rejected.
Claim 8 recites the limitation "the base strip.” There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 3-16, and 18-27 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Vaddiraju (US 20180325430 A1).
Regarding claim 1, Vaddiraju teaches a method for production of a continuous glucose monitoring device (CGM device) sensor ([0028] “FIG. 4 is a schematic view of a system and method for fabricating an analyte sensor”), comprising providing an extended length of base matrix sheet ([0038] “analyte sensor 10 include a planar flexible polymeric base layer 12, such as a polyester film or substrate”), or individual pieces of base matrix sheet ([0070] “remaining polyester substrate 185 (including the singulated analyte sensors in the form of ribbons)”), and pursuing:
a.a first process comprising displacing the extended length of base sheet through a plurality of production stations (Fig. 4), wherein: at each station, the base sheet undergoes at least one production process, the at least one production process at least including: deposition of an enzyme layer ([0058] “ the electrochemical sensing stack 50 includes an analyte sensing layer, such as an enzyme layer, for example a glucose oxidase layer"), screen printing of dielectric layer on at least one side of the base sheet ([0046] “An insulating dielectric layer 30 that is impermeable to electrochemically active constituents in the analyte containing fluid can be applied and patterned to define the electrode's electrochemically active surface area. Methods of applying and patterning the dielectric layer include screen printing”), and at least one of folding and cutting the extended length into individual sensors ([0069] “The polyester substrate 175 is then fed to a punching stage 180. At the punching stage 180, the polyester substrate is punched, or otherwise cut, to form partially singulated ribbons for forming singulated analyte sensors;” [0073] “At the singulation stage 230, the individual analyte sensors, in the form of ribbons connected to the polyester substrate web, may be singulated through complete separation from the polyester substrate web.”);
or a second process comprising processing the individual pieces of the base sheet, one at a time, to produce a single or a plurality of sensors, wherein: the plurality of sensors is selected from the group consisting of: 2 or more sensors, 2-5, sensors, 2-10 sensors, 2-100 sensors, and 2-1000 sensors (Fig. 5; [0076] “The gaps 80 between adjacent analyte sensors 72 are formed during the punching out process by removal of portions of the polyester substrate, such as the punched out or scrap portion 181 in FIG. 4.”), and processing of the individual pieces includes at least deposition of an enzyme layer, and screen printing of dielectric layer, on at least one side of the piece of base sheet ([0070] “The remaining polyester substrate 185 (including the singulated analyte sensors in the form of ribbons) is fed to an enzyme deposition stage 190. At the enzyme deposition stage 190, an enzyme, such as glucose oxidase, is deposited over the working electrodes. For example, the enzyme may be screen printed or rotary printed onto the polyester substrate. Alternatively, the enzyme may be deposited by an aerosol-based drop on demand technology. In addition to the enzyme, other materials for forming an electrochemical sensing stack may be deposited over the polyester substrate at the enzyme deposition stage 190.” [0048] “the insulating dielectric layer 30 is formed by screen printing”).
Regarding claim 3, Vaddiraju teaches the method of claim 1, wherein the at least one production process is performed on a first side and a second side of the base sheet ([0063] “As shown, the glucose limiting membrane 60 may be formed around the entire end 18 of the analyte sensor 10, i.e., over both the first side 14 and the second side 16 of the base layer 12, including over reference electrodes and counter electrodes;” [0065] “the reference electrode 24 is formed by a silver/silver chloride ink layer 40 deposited over the second side 16 of the base layer 12. The silver/silver chloride ink may be selectively deposited onto the second side 16 of the base layer 12 by screen printing or rotary printing. In such embodiments, the entire second side 16 could be overprinted or overloaded with silver/silver chloride ink to allow more loading of silver chloride. Further, such an embodiment eliminates positional registration process capability to reduce overall fabrication process error. As shown in FIG. 3, the glucose limiting membrane 60 completely covers the reference electrode 24 formed by the silver/silver chloride ink layer 40 on the second side 16 of the base layer 12.”).
Regarding claim 4, Vaddiraju teaches the method of claim 1, further comprising effecting at least one and preferably a plurality of fiducial markings for use in at least one of alignment of specific deposition areas/points/spots and markings for coding and/or tacking of the CGM device, on one or two sides of the base sheet ([0020] “depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.” [0046] “The electrode signal is proportional to the surface area that is exposed to the analyte containing fluid. An insulating dielectric layer 30 that is impermeable to electrochemically active constituents in the analyte containing fluid can be applied and patterned to define the electrode's electrochemically active surface area.”).
Regarding claim 5, Vaddiraju teaches the method of claim 1, wherein the at least one production process is performed on a first side, then a second side ([0063] “As shown, the glucose limiting membrane 60 may be formed around the entire end 18 of the analyte sensor 10, i.e., over both the first side 14 and the second side 16 of the base layer 12, including over reference electrodes and counter electrodes.” [0065] “In FIG. 3, the reference electrode 24 is not formed from the platinum layer 20 on the first side 14 of the base layer 12. Rather, the reference electrode 24 is formed on the second side 16 of the base layer 12. Specifically, the reference electrode 24 is formed by a silver/silver chloride ink layer 40 deposited over the second side 16 of the base layer 12. The silver/silver chloride ink may be selectively deposited onto the second side 16 of the base layer 12 by screen printing or rotary printing.”).
Regarding claim 6, Vaddiraju teaches the method of claim 1, wherein the first side or bottom side is configured as a counter electrode side for including the counter electrode, and the second side to upper side is configured as a working electrode side for including the working electrode, the second side being opposite the first side ([0065] “In FIG. 3, the reference electrode 24 is not formed from the platinum layer 20 on the first side 14 of the base layer 12. Rather, the reference electrode 24 is formed on the second side 16 of the base layer 12. Specifically, the reference electrode 24 is formed by a silver/silver chloride ink layer 40 deposited over the second side 16 of the base layer 12. The silver/silver chloride ink may be selectively deposited onto the second side 16 of the base layer 12 by screen printing or rotary printing.” working electrode 22).
Regarding claim 7, Vaddiraju teaches the method of claim 1, further comprising covering at least one portion of the base sheet on at least one and preferably both of the first and second sides ([0040] Further, a platinum layer 20 is formed on the first side 14 of the base layer 12. In exemplary embodiments, the platinum layer 20 is formed by sputtering platinum onto the first side 14 of the base layer 12.”).
Regarding claim 8, Vaddiraju teaches the method of claim 18, wherein the at least one portion of the base sheet comprises a strip of the base strip bordered by an edge thereof ([0066] “As shown, the system 100 fabricates analyte sensors in a roll-to-roll process by processing a roll 101 of a flexible substrate, such a polyester film, that includes a layer of sputtered platinum;” base layer 12).
Regarding claim 9, Vaddiraju teaches the method of claim 7, wherein the covering comprises a metal ([0040] Further, a platinum layer 20 is formed on the first side 14 of the base layer 12. In exemplary embodiments, the platinum layer 20 is formed by sputtering platinum onto the first side 14 of the base layer 12.”).
Regarding claim 10, Vaddiraju teaches the method of claim 9, wherein the metal comprises at least one of gold and platinum ([0040] Further, a platinum layer 20 is formed on the first side 14 of the base layer 12. In exemplary embodiments, the platinum layer 20 is formed by sputtering platinum onto the first side 14 of the base layer 12.”).
Regarding claim 11, Vaddiraju teaches the method of claim 9, wherein the metal is a sputtered metal ([0040] Further, a platinum layer 20 is formed on the first side 14 of the base layer 12. In exemplary embodiments, the platinum layer 20 is formed by sputtering platinum onto the first side 14 of the base layer 12.”).
Regarding claim 12, Vaddiraju teaches the method of claim 1, further comprising providing a liner material configured to protect at least one edge area of the base sheet ([0054] “the analyte sensor 10 may be provided with a protection layer 45 over the first side 14 of the base layer 12 for protecting the platinum from biofouling and other immune response degradation.”).
Regarding claim 13, Vaddiraju teaches the method of claim 1, wherein, for the counter electrode side, the method includes, at one and/or another of the production stations, depositing, at predetermined locations, at least one of and preferably a plurality of, and more preferably all of an Ag/AgCl layer, a dielectric layer and a biocompatible layer ([0021] “The method includes providing a polyester base layer with a first side sputtered with a layer of platinum and with a second side opposite the first side. The method includes patterning the layer of platinum to form working electrodes. Also, the method includes forming an insulating dielectric layer over the first side of the base layer, wherein the insulating dielectric layer is formed with openings exposing portions of the working electrodes. The method further includes printing silver/silver chloride ink over the second side of the base layer. The method also includes partially singulating individual sensors from the base layer, wherein each individual sensor is connected to the base layer by a tab. The method includes depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.”).
Regarding claim 14, Vaddiraju teaches the method of claim 1, wherein, for the working electrode side, the process includes at least one of, and preferably a plurality of, and more preferably all of deposition of an enzyme layer, a dielectric layer and a biocompatible layer, an interface conductive layer, a glucose limiting layer, and an anti-interference layer ([0020] “The method further includes depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.” [0021] “the method includes forming an insulating dielectric layer over the first side of the base layer, wherein the insulating dielectric layer is formed with openings exposing portions of the working electrodes.” [0054] “the analyte sensor 10 may be provided with a protection layer 45 over the first side 14 of the base layer 12 for protecting the platinum from biofouling and other immune response degradation. An exemplary protection layer 45 may be a hydrophilic hydrogel layer and can be made from a wide variety of materials known to be suitable for such purposes, e.g., polyvinyl alcohol, poly (N-isopropylacrylamide), poly (N-vinylpyrrolidone), polyethylene glycol, polyurethane, poly acrylic acid, cellulose acetates, Nafion, polyester sulfonic acids hydrogels or any other suitable hydrophilic membranes known to those skilled in the art;” [0055] “As shown in FIG. 2, the protection layer 45 covers the entire top side 14 of the base layer 12 and completely encapsulates the platinum layers of the electrodes 22 and 24.” [0060] “In certain embodiments, the electrochemical sensing stack 50 may include an adhesion promoter layer disposed over the analyte sensing or enzyme layer in order to facilitate contact and/or adhesion between the analyte sensing layer and another overlying layer … In alternative embodiments, protein or like molecules in the analyte sensing layer can be sufficiently crosslinked or otherwise prepared to allow the analyte modulating membrane layer to be disposed in direct contact with the analyte sensing layer in the absence of an adhesion promoter layer. In certain embodiments, additional layers such as an interference rejection layer may be included in the electrochemical sensing stack 50.”).
Regarding claim 15, Vaddiraju teaches the method of claim 14, wherein the biocompatible layer is deposited on top of one or more other layers, and/or at both sides through one or more bilateral slots provided in the base sheet, wherein optionally, the deposition of the biocompatible layer from the top and sides is configured to cover a circumference of the sensor circumference ([0054] “the analyte sensor 10 may be provided with a protection layer 45 over the first side 14 of the base layer 12 for protecting the platinum from biofouling and other immune response degradation. An exemplary protection layer 45 may be a hydrophilic hydrogel layer;” [0055] “As shown in FIG. 2, the protection layer 45 covers the entire top side 14 of the base layer 12 and completely encapsulates the platinum layers of the electrodes 22 and 24.” [0071] “Then, the polyester substrate 195 is fed to an enzyme curing stage 200. At the enzyme curing stage 200, the enzyme (and other deposited materials) is cured, such as by an ultraviolet light photo-initiated curing process. During curing, the enzyme crosslinks and becomes immobilized. The polyester substrate 205 may then be fed to a membrane formation stage 210. At the membrane formation stage 210, the end of each ribbon may be coated with a glucose limiting membrane and other desired membranes. For example, the end of each ribbon may be dip coated or slot coated to form the desired membranes.”).
Regarding claim 16, Vaddiraju teaches the method of claim 1, further comprising cutting the base sheet into one or more planar portions/configurations ([0069] The polyester substrate 175 is then fed to a punching stage 180. At the punching stage 180, the polyester substrate is punched, or otherwise cut, to form partially singulated ribbons for forming singulated analyte sensors; Fig. 5).
Regarding claim 18, Vaddiraju teaches the method of claim 1, wherein the base sheet includes a plurality of pre-specified areas or points/spots for the deposition of materials one or two sides thereof ([0020] “depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.” [0046] “The electrode signal is proportional to the surface area that is exposed to the analyte containing fluid. An insulating dielectric layer 30 that is impermeable to electrochemically active constituents in the analyte containing fluid can be applied and patterned to define the electrode's electrochemically active surface area.”).
Regarding claim 19, Vaddiraju teaches the method of claim 1, wherein during the second process, each piece of base sheet 1s stationary (Fig. 4, enzyme deposition stage 190; [0070] “The remaining polyester substrate 185 (including the singulated analyte sensors in the form of ribbons) is fed to an enzyme deposition stage 190. At the enzyme deposition stage 190, an enzyme, such as glucose oxidase, is deposited over the working electrodes. For example, the enzyme may be screen printed or rotary printed onto the polyester substrate. Alternatively, the enzyme may be deposited by an aerosol-based drop on demand technology. In addition to the enzyme, other materials for forming an electrochemical sensing stack may be deposited over the polyester substrate at the enzyme deposition stage 190.”).
Regarding claim 20, Vaddiraju teaches the method of claim 19, wherein stationary comprises processing each piece of base matrix at a single location (Fig. 4, enzyme deposition stage 190; [0070] “The remaining polyester substrate 185 (including the singulated analyte sensors in the form of ribbons) is fed to an enzyme deposition stage 190. At the enzyme deposition stage 190, an enzyme, such as glucose oxidase, is deposited over the working electrodes. For example, the enzyme may be screen printed or rotary printed onto the polyester substrate. Alternatively, the enzyme may be deposited by an aerosol-based drop on demand technology. In addition to the enzyme, other materials for forming an electrochemical sensing stack may be deposited over the polyester substrate at the enzyme deposition stage 190.”).
Regarding claim 21, Vaddiraju teaches the method of claim 19, wherein for the second process, material deposition is conducted by displacement of a material injector to a plurality of areas/points/spots over the piece of base sheet ([0022] “The method includes depositing an enzyme layer over the working electrodes. The method feeds the remaining polyester substrate to an enzyme curing stage. The method includes curing the enzyme layer. The method feeds the remaining polyester substrate to a membrane formation stage. The method includes coating the working electrodes with a glucose limiting membrane.” [0071] “At the membrane formation stage 210, the end of each ribbon may be coated with a glucose limiting membrane and other desired membranes. For example, the end of each ribbon may be dip coated or slot coated to form the desired membranes.” Fig. 4).
Regarding claim 22, Vaddiraju teaches the method of claim 1, further comprising calibrating each sensor ([0014] “yield a factory calibrated analyte sensor without need for further external calibrations.” [0072] “Specifically, the individual analyte sensors on polyester substrate 215 may be processed through a functionality check stage 220. At the functionality check stage 220, each analyte sensor is exposed to a buffer solution containing glucose, and the sensor's signal-time profile is recorded and evaluated.”).
Regarding claim 23, Vaddiraju teaches the method of claim 1, further comprising curing during and/or after deposition of one or more layers on one or both sides of the base sheet ([0067] “The polyester substrate 125 is then fed from the insulation stage 120 to an insulation curing stage 130 where the insulating dielectric material is cured to form the insulating dielectric layer.” [0068] “The protection material may be deposited by screen printing or by rotary printing. The polyester substrate 165 is then fed to the curing stage 170 where the protection material is cured to form a protection layer.” [0071] “Then, the polyester substrate 195 is fed to an enzyme curing stage 200. At the enzyme curing stage 200, the enzyme (and other deposited materials) is cured, such as by an ultraviolet light photo-initiated curing process.”).
Regarding claim 24, Vaddiraju teaches the method of claim 1, wherein the base sheet thickness is between 25 - 75um ([0038] “the base layer 12 includes a first side 14 and an opposite second side 16 and an end 18. An exemplary base layer 12 has a thickness of from about 25 micrometers (μm) (about 1 mil) to about 381 μm (about 15 mil)”).
Regarding claim 25, Vaddiraju teaches the method of claim 1, wherein the/a conductive layer includes a thickness of between 50 - 200nm ([0040] “Further, a platinum layer 20 is formed on the first side 14 of the base layer 12. In exemplary embodiments, the platinum layer 20 is formed by sputtering platinum onto the first side 14 of the base layer 12. An exemplary platinum layer 20 may have a thickness of from about 5 to about 120 nm, such as from about 10 to about 50 nm.”).
Regarding claim 26, Vaddiraju teaches the method of claim 1, further comprising covering one or both sides of the base sheet with a protective liner ([0054] “the analyte sensor 10 may be provided with a protection layer 45 over the first side 14 of the base layer 12 for protecting the platinum from biofouling and other immune response degradation.”).
Regarding claim 27, Vaddiraju teaches the method of claim 1, further comprising depositing at least one additional layer selected from the group consisting of: enzymes, mediators, cross linkers, adhesives, and any polymer that can be used for controlling diffusion of glucose and oxygen and/or for controlling the diffusion of various interfering compounds, including, optionally, acetaminophen, and ascorbic acid ([0060] “In certain embodiments, the electrochemical sensing stack 50 may include an adhesion promoter layer disposed over the analyte sensing or enzyme layer in order to facilitate contact and/or adhesion between the analyte sensing layer and another overlying layer … In alternative embodiments, protein or like molecules in the analyte sensing layer can be sufficiently crosslinked or otherwise prepared to allow the analyte modulating membrane layer to be disposed in direct contact with the analyte sensing layer in the absence of an adhesion promoter layer. In certain embodiments, additional layers such as an interference rejection layer may be included in the electrochemical sensing stack 50.”).
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) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaddiraju (US 20180325430 A1) in view of Moein (US 20120323098 A1).
Regarding claim 17, Vaddiraju teaches the method of claim 1, wherein the base sheet further includes electrical contacts in electrical communication with each electrode ([0035] “sensor accuracy must be maintained during the lifetime of a continuous glucose monitoring device… Continuous glucose monitoring sensors provide the ability to continuously track glucose levels in a patient, and to correlate them to his or her physical activity and diet, thereby providing for therapy decisions as well as for adjustments, as necessary.” [0046] “The electrode signal is proportional to the surface area that is exposed to the analyte containing fluid. An insulating dielectric layer 30 that is impermeable to electrochemically active constituents in the analyte containing fluid can be applied and patterned to define the electrode's electrochemically active surface area.” [0072] “Specifically, the individual analyte sensors on polyester substrate 215 may be processed through a functionality check stage 220. At the functionality check stage 220, each analyte sensor is exposed to a buffer solution containing glucose, and the sensor's signal-time profile is recorded and evaluated.”). However, Vaddiraju fails to disclose folding the base sheet 90°, coupling with an introducer, or coupling the electrical contacts with a printed circuit board assembly of a skin adhered control unit.
Moein teaches methods of making analyte sensor connectors and systems that include analyte sensor connectors. Moein discloses and wherein the method further comprises at least one of, and preferably a plurality of, and more preferably, all of folding the base sheet at approximately 90°, coupling the base sheet with an introducer, and coupling the electrical contacts with a printed circuit board assembly of a skin adhered control unit ([0185]” FIG. 22 shows analyte sensor 913 in a bent configuration such that the distal end of the analyte sensor, which includes the analyte sensing region, is positioned at approximately a 90.degree. angle relative to the plane of the PCB assembly 906… to slideably engage needle 902 of the sensor insertion device 901.” [0162] “The data processing unit 102 may include a fixation element, such as an adhesive or the like, to secure it to the user's body. A mount (not shown) attachable to the user and mateable with the data processing unit 102 may be used. For example, a mount may include an adhesive surface.” Fig. 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vaddiraju to include folding the base sheet 90°, coupling with an introducer, and coupling the electrical contacts with a printed circuit board assembly of a skin adhered control unit as disclosed in Moein to allow the distal end of the analyte sensor to slideably engage the needle of the sensor insertion device while the proximal end of the analyte sensor, including the electrode contacts, may fit parallel to the PCB assembly, enabling periodic sampling of the analyte level of the user (Moein [0162, 0185]).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791