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 .
Response to Amendment
The amendment filed on May 04, 2026 was considered by the examiner. Claims 1 and 3-27 are pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “base strip bordered by an edge thereof” must be shown or the feature canceled from the claim 8. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 3: “pursuing a:” should be “pursuing:”.
Appropriate correction is required.
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 4 and 8 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 4, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites “a base strip bordered by an edge thereof” in line 2; but it is not clear if this recitation is the same as, related to, or different from the recitation “base sheet” in claim 1, line 4. The indefinite article “a” suggests that they are different, but the similar phraseology suggests that they are the same. If the recitations are the same, the present recitation should be “the base sheet”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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 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: 2-5 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 providing 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 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.”; see also [0063] 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).
Regarding claim 8, Vaddiraju teaches the method of claim 7, wherein the at least one portion of the base sheet comprises a 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.”; note that the claim does not require the same covering to be on both sides).
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, a plurality 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 a plurality 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 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 is 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, 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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 a plurality 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]).
Response to Arguments
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 6, filed May 04, 2026, with respect to the objections of claims 1, 8, and 19 have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, new objections are made that were necessitated by Applicant’s amendment filed on May 04, 2026.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 6, filed May 04, 2026, with respect to the rejections of claims 1 and 3-27 under 35 U.S.C. § 112(b) have been fully considered and are persuasive; except the “optionally” rejection to claim 4, which was not addressed by argument or amendment. Therefore, the rejections have been withdrawn, except the “optionally” rejection to claim 4, which is maintained.
Applicant’s arguments, prior art
Applicant’s arguments, see pg. 6-8, filed May 04, 2026, with respect to the rejections of claims 1 and 3-27 under 35 U.S.C. § 102(a)(1), § 102(a)(2), and § 103 have been fully considered and are NOT persuasive. Applicant argues that Vaddiraju does not teach the second process that comprises processing the individual pieces of the base sheet, one at a time. The examiner respectfully disagrees. The claim requires either one of the first process or the second process. As Vaddiraju teaches the first process, even if Applicant’s arguments were persuasive with regard to the second process, the claims would still be rejected in view of Vaddiraju. Furthermore, Applicant argues that the ribbons may be connected via a tab. However, Vaddiraju also discloses “Complete singulation and separation of the individual analyte sensors 72 may occur by severing at each tab at end 76.” (see [0076]). Therefore, Applicant’s arguments are not persuasive and the rejections to the claims are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
