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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-15 in the reply filed on 09/16/2026 is acknowledged.
Drawings
The drawings are objected to because Figs. 1 and 13 are fuzzy and should be resubmitted. 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 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.
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.
Claims 1-2, 4-6, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al (US 20080029390 A1, cited in applicant’s IDS, hereinafter Roche) in view of the Non-Patent Literature (NPL) to Park et al (“Biopsy needle integrated with multi-modal physical/chemical sensor array”, hereinafter Park).
Regarding Claim 1, Roche discloses a glucose sensor (Element 11, Fig. 1) configured to be wrapped around a surface of an injection needle (“the biosensor 11 may be installed within a probe or catheter for intravenous insertion into a patient, for example, via a CVC”, [0027]) or cannula (As this limitation is claimed in the alternative, it does not have to be disclosed by the reference in order for the claim as a whole to be anticipated), the glucose sensor comprising:
a flexible substrate (Element 13, Fig. 1; “The biosensor or sensor 11 may be formed on a substrate 13 (e.g., a flex substrate)”, [0018]);
at least two electrodes (Element 15, 17, and/or 19, Fig. 1) disposed on a surface of the flexible substrate (See Fig. 1; “One or more electrodes 15, 17 and 19 may be attached or bonded to a surface of the substrate 13”, [0018]);
a glucose-responsive hydrogel (Element 23, Fig. 2) at least partially disposed on a first electrode of the at least two electrodes (“The magnified side view of FIG. 2 shows an illustration of a hydrogel layer 23 formed on the working electrode 19”, [0028]; “The hydrogel layer 23 includes at least one reactive agent that may be added to the chitosan. In one embodiment, the reactive agent may be an enzyme such as an oxidase enzyme. In an embodiment for a glucose biosensor, the reactive agent may be glucose oxidase, such as may be derived from Aspergillus niger (EC 1.1.3.4), type II or type VII”, [0031]); and
a membrane permeable to glucose (“The linear response exhibited in FIGS. 5 and 6 indicates that a hydrogel according to the invention may also function as a rate-limiting layer 25 between blood plasma and glucose oxidase”, [0049]);
wherein:
the membrane is disposed on the glucose-responsive hydrogel (“The linear response exhibited in FIGS. 5 and 6 indicates that a hydrogel according to the invention may also function as a rate-limiting layer 25 between blood plasma and glucose oxidase”, [0049]); and
Modified Roche discloses the claimed invention except for expressly disclosing wherein a total thickness of the glucose sensor is less than 10 µm. However, Park, which also discloses a glucose sensor (“In this paper, we report a biopsy needle integrated with a novel multi-modal physical/chemical sensor array for electrical conductivity, pH, and glucose concentration measurement as shown in Fig. 1(c)”, Section 1) configured to be wrapped around a surface of an injection needle (See Fig. 1(b)), teaches wherein a total thickness of the glucose sensor is less than 20 µm (“a glucose sensor was fabricated on a flexible polyimide substrate with thickness less than 20 μm”, Abstract), which overlaps the claimed range of less than 10 µm. It has been held by the courts that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I)). In addition, Park teaches the advantage of reducing the thickness of the glucose sensor (“Because the sensor is ultra-thin, the increase of the diameter of the biopsy needle and tissue damage during needle insertion can be minimized”, Section 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glucose sensor configured to be wrapped around an injection needle of Roche to be less than 10 µm, because Park teaches an advantage to sensors less than 20 µm in thickness, and reducing the total thickness to 10 µm would have merely required optimization within prior art conditions and routine experimentation.
Regarding Claim 2, modified Roche discloses the glucose sensor of claim 1, wherein the glucose sensor is configured to measure a glucose concentration up to about 26 mM (“After soaking each test sensor from these groups for 15.5 hours in a saline solution, each sensor was exposed to known glucose concentrations, with the working electrode excited to a potential of about 650 mV. For each sensor, the electrical current resulting in the electrode was measured at glucose concentrations of 50, 100, and 150 mg/dL”, [0046]).
Regarding Claim 4, modified Roche discloses the glucose sensor of claim 1, wherein the glucose-responsive hydrogel (Element 23, Fig. 2) comprises:
a polymer permeable to glucose (“The hydrogel layer 23 may be composed of chitosan, at least one reactive agent, and at least one cross-linking agent”, [0029]);
an oxidoreductase enzyme that catalyzes oxidation of glucose (“The hydrogel layer 23 includes at least one reactive agent that may be added to the chitosan. In one embodiment, the reactive agent may be an enzyme such as an oxidase enzyme. In an embodiment for a glucose biosensor, the reactive agent may be glucose oxidase, such as may be derived from Aspergillus niger (EC 1.1.3.4), type II or type VII”, [0031]); and
a redox mediator (“Chitosan by itself, however, may be insufficient to provide an adequate robustness needed to contain the reactive agent. Therefore, a cross-linking agent such as genipin may be added to the chitosan to form a matrix with sufficient mechanical strength and immobilizing properties”, [0032]).
Regarding Claim 5, modified Roche glucose sensor of claim 4, wherein the polymer comprises at least one of chitosan (“The hydrogel layer 23 may be composed of chitosan, at least one reactive agent, and at least one cross-linking agent”, [0029]), polyvinyl alcohol, or Nafion.
Regarding Claim 6, modified Roche discloses the glucose sensor of claim 4, wherein the oxidoreductase enzyme comprises at least one of glucose oxidase (“The hydrogel layer 23 includes at least one reactive agent that may be added to the chitosan. In one embodiment, the reactive agent may be an enzyme such as an oxidase enzyme. In an embodiment for a glucose biosensor, the reactive agent may be glucose oxidase, such as may be derived from Aspergillus niger (EC 1.1.3.4), type II or type VII”, [0031]) or a derivative or mutant thereof.
Regarding Claim 10, modified Roche discloses the glucose sensor of claim 1, wherein the at least two electrodes comprise a noble metal (“the reference electrode 15 may be a silver/silver chloride type deposited or formed on the substrate 13”, [0024]; “The counter electrode 17 may be constructed from conductive materials such as platinum”, [0025]; “The working electrode 19 may be formed using platinum/graphite materials similar to those used for forming the counter electrode 17”, [0026]).
Regarding Claim 12, modified Roche discloses the glucose sensor of claim 1, wherein the flexible substrate comprises at least one of polydimethylsiloxane or polyimide (“In one embodiment, the substrate 13 may be a polyimide material”, [0022]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Park, and further in view of Du et al (US 20200405200 A1, hereinafter Du).
Regarding Claim 3, modified Roche discloses the glucose sensor of claim 2, wherein the glucose sensor is capable of measuring a glucose concentration of a patient after the injection needle or cannula is inserted into the patient (See Fig. 6; “The graph of FIG. 6 shows the results of the glucose assay on the same sensors as a function of current output over time. The time period shown covers the three step changes in glucose concentration that correspond to the 50, 100, and 150 mg/dL concentrations. After an initial transient spike in the current signal coincident with each step change, the response at each concentration quickly levels off to a steady state response.”, [0048]) Modified Roche discloses the claimed invention except for expressly disclosing wherein the glucose sensor is capable of measuring a glucose concentration of a patient in less than 40 seconds. However, Du, which also discloses a glucose sensor (“The sensor of any of the preceding embodiments, wherein the enzyme is glucose oxidase and the biomarker is glucose”, [0020]; see [0050]-[0054]), teaches wherein the glucose sensor is capable of measuring a glucose concentration of a patient in less than 40 seconds (“In one embodiment of the biosensor made according to the present technology, tetrabutylammonium bromide was used as the bio-linker and glutaraldehyde crosslinked glucose oxidase as the as the enzyme for detection of glucose. The biosensor was observed to be highly accurate within the range of 5 to 500 μM, possess a good sensitivity of 4.82 mA.Math.s/M, a low detection limit of 5 μM, and a response time of 30 seconds. See FIG. 4”, [0054]). It has been held that "[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references." Id. at 1368, 80 USPQ2d at 1651. See MPEP 2143(G). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Roche such that the glucose sensor is capable of measuring a glucose concentration of a patient when the injection needle or cannula is inserted into the patient in less than 40 seconds after the injection needle or cannula is inserted, as suggested by Du, because this would make the glucose sensing process faster.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Park, and further in view of Pei et al (US 20210219876 A1, hereinafter Pei).
Regarding Claim 7, modified Roche discloses the glucose sensor of claim 4. Modified Roche discloses the claimed invention except for expressly disclosing wherein the redox mediator comprises at least one of an iron salt complex, an osmium salt complex, or a ruthenium salt complex. However, Pei, which also discloses a glucose sensor ([0080]), teaches wherein the redox mediator comprises at least one of an iron salt complex, an osmium salt complex, or a ruthenium salt complex (“In one embodiment, the oxidized form of the redox mediator includes at least one of potassium ferricyanide, sodium ferricyanide, ferrocene and its derivatives, ruthenium compounds such as hexaammineruthenium(III) chloride and its derivatives, osmium complexes...”, [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Roche wherein the redox mediator is at least one of an iron salt complex, an osmium salt complex, or a ruthenium salt complex listed by Pei, because these oxidized forms of redox mediators can increase the shelf life of the biosensor ([0007]-[0008]), while increasing the efficiency and strength of the redox reaction.
Regarding Claim 8, modified Roche discloses the glucose sensor of claim 7. Modified Roche discloses the claimed invention except for expressly disclosing wherein the iron salt complex comprises potassium ferricyanide. However, Pei, which also discloses a glucose sensor ([0080]), teaches wherein the redox mediator comprises wherein the iron salt complex comprises potassium ferricyanide (“In one embodiment, the oxidized form of the redox mediator includes at least one of potassium ferricyanide”, [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Roche wherein the iron salt complex comprises potassium ferricyanide, because this oxidized form of a redox mediator can increase the shelf life of the biosensor ([0007]-[0008]), while increasing the efficiency and strength of the redox reaction.
Regarding Claim 9, modified Roche discloses the glucose sensor of claim 7. Modified Roche discloses the claimed invention except for expressly disclosing wherein the ruthenium salt complex comprises hexamine ruthenium. However, Pei, which also discloses a glucose sensor ([0080]), teaches wherein the ruthenium salt complex comprises hexamine ruthenium (“In one embodiment, the oxidized form of the redox mediator includes at least one of potassium ferricyanide, sodium ferricyanide, ferrocene and its derivatives, ruthenium compounds such as hexaammineruthenium(III) chloride and its derivatives...”, [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Roche wherein the ruthenium salt complex comprises hexamine ruthenium, because this oxidized form of a redox mediator can increase the shelf life of the biosensor ([0007]-[0008]), while increasing the efficiency and strength of the redox reaction
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Park, and further in view of the Non-Patent Literature (NPL) to Chuang et al (“Flexible thick-film glucose biosensor: Influence of mechanical bending on the performance”, hereinafter Chuang).
Regarding Claim 11, modified Roche discloses the glucose sensor of claim 1. Modified Roche discloses the claimed invention except for expressly disclosing wherein the membrane comprises Nafion. However, Chuang, which also discloses a glucose biosensor configured to be wrapped (See Figs. 1(A)-1(B), Section 2.2; a bendable sensor can also be wrapped around external objects), teaches wherein the membrane comprises Nafion (“Subsequently, a 2 μL droplet of 1% Nafion® (diluted in 95% alcohol) was cast onto the enzyme-coated electrode surface and was allowed to dry”, Section 2.2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Nafion to the membrane of modified Roche, because this leads to enhanced sensitivity in bendable glucose sensors (See Abstract; “In summary, we have examined the influence of mechanical bending upon the sensing performance of the flexible Nafion/GOx/carbon SPEs. Bending the SPEs over wide range of curvatures does not cause any adverse effect on the current response, but actually leads to an enhanced sensitivity”, Section 4).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Park, and further in view of Wang et al (US 20200337641 A1, hereinafter Wang)
Regarding Claim 13, modified Roche discloses the glucose sensor of claim 1, wherein the flexible substrate is a first flexible substrate (“The biosensor or sensor 11 may be formed on a substrate 13 (e.g., a flex substrate)”, [0018]). Modified Roche discloses the claimed invention except for expressly disclosing the glucose sensor further comprising:
a second flexible substrate disposed on at least a portion of the first flexible substrate, the second flexible substrate having voids where the at least two electrodes are located.
However, Wang, which also discloses a glucose sensor ([0005]), teaches the glucose sensor further comprising:
a second flexible substrate disposed on at least a portion of the first flexible substrate (“a device for epidermal electrochemical sensing includes...a second flexible substrate coupled to the first flexible substrate”, [0041]), the second flexible substrate having voids where the at least two electrodes are located (“wherein the second substrates is structured to include (i) a channel, (ii) a first set of one or more holes that connect to a first end of the channel and provide one or more inlets, (iii) a reservoir intersecting the channel and (iv) a second set of one or more holes that connect to a second end of the channel and provide one or more outlets, wherein the two or more electrodes on the first flexible substrate are aligned with the reservoir of the second flexible substrate”, [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Roche as taught by Wang, because this allows the electrodes to be electrically insulated from all side, as taught by Wang ([0043], [0050])
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Park, and further in view of the Non-Patent Literature (NPL) to Yoon et al (“Semi-implantable polyimide/PTFE needle-shaped biosensor for continuous glucose monitoring”, cited in Applicant’s IDS, hereinafter Yoon).
Regarding Claim 14, modified Roche discloses the glucose sensor of claim 1. Modified Roche discloses the claimed invention except for expressly disclosing the sensor further comprising the injection needle, wherein the flexible substrate is disposed on a shaft of the injection needle. However, Yoon, which also discloses a glucose sensor (“In this paper, semi-implantable and highly miniaturized needle-shaped biosensor was newly developed for painless and continuous glucose monitoring”, Abstract) configured to be wrapped around the surface of an injection needle (See Fig. 2; “the needle-shaped sensor was attached and rolled up on medical PTFE catheter by using biocompatible silicone adhesive”, Experimental: Fabrication), teaches wherein the flexible substrate is disposed on a shaft of the injection needle (See Fig. 2; “the needle-shaped sensor was attached and rolled up on medical PTFE catheter by using biocompatible silicone adhesive”, Experimental: Fabrication). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the injection needle of Yoon to the glucose sensor configured to be wrapped around the surface of an injection needle of modified Roche, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Park, and further in view of Kim et al (US 20200238016 A1, hereinafter Kim).
Regarding Claim 15, modified Roche discloses the glucose sensor of Claim 14. Modified Roche discloses the claimed invention except for expressly disclosing an all-in-one insulin pen comprising the glucose sensor of claim 14. However, Kim, which also discloses a glucose sensor (Element 314, Fig. 3), teaches all-in-one insulin pen (Element 100, Fig. 1; “An aspect of the present disclosure provides a medicine injection device that may measure a blood glucose level and inject insulin simultaneously”, [0006]) comprising the glucose sensor (See Fig. 3; “The medicine injection device 100 collects a body fluid sample of a living body through a needle 110, and senses an amount of a target analyte”, [0047]; “FIGS. 3 and 4 are diagrams illustrating examples of a configuration of a needle”, [0065]). It would have been obvious to add the all-in-one insulin pen of Kim to the glucose sensor of modified Roche, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Chen et al (US 20190290170 A1), relevant to Claim 3 ([0079])
Du also discloses wherein the membrane comprises Nafion ([0020]).
See Shin et al (US 20240158426 A1), which discloses wherein the redox mediator comprises an osmium salt complex ([0065]-[0067]).
See Wang et al (US 20080026473 A1), which discloses advantages to making a glucose sensor configured to be attached to a needle ([0161]) thin ([0074]).
The Non-Patent Literature to Huang et al (“An automated all-in-one system for carbohydrate tracking, glucose monitoring, and insulin delivery”, cited in applicant’s IDS), also teaches the subject matter of Claim 14.
See the Non-Patent Literature (NPL) to Uehara et al (“Size-Selective Diffusion in Nanoporous but Flexible Membranes for Glucose Sensors”).
See the Non-Patent Literature (NPL) to Xuan et al (“A wearable electrochemical glucose sensor based on simple and low-cost fabrication supported micro-patterned reduced graphene oxide nanocomposite electrode on flexible substrate”).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
