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 .
This Office Action is responsive to the Amendment and Response Under 37 CFR 1.111 filed February 23, 2026. The Examiner acknowledges the amendments to claims 1, 11, 13 and 14, as well as the cancellation of claims 10, 12, 15-16 and 23-35. Claims 1-9, 11, 13-14, 17-22 and 36 are pending.
Response to Arguments
Applicant’s arguments, see remarks, filed February 23, 2026, with respect to the previous rejection of claims 11 and 13-14 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of claims 11 and 13-14 under 35 USC 112(b) has been withdrawn.
Applicant's arguments, filed February, 23, 2026, have been fully considered but they are not fully persuasive. Applicant argues that the device of Ward ‘839’ teaches a sensing device in figure 8 that cannot deliver insulin or any liquid when flat, and moreover is unsuitable for subcutaneous implantation unless made tubular and somehow inserted through the skin, and further, is not implantable but topical and requires a separate tubular cannula to deliver a drug. Applicant further argues that the previously cited references fail to suggest a rectangular design having an inner lumen for drug delivery with a sufficient thickness to be subcutaneously implanted. Additionally, Applicant argues the previously used Pollack reference has nothing to do with the presently claimed sensing cannula because it pertains to a specific cannula for fixing leaking walls in the eye with perfluorocarbon fluid, and that the devices of Pollack and the Ward references are too dissimilar as the fields of art are too divergent for a practitioner of one to look to the other. Applicant also argues the structure of the Pollack device simply could not be modified with the sensing system of Applicant’s sensing cannula and the resulting device would not be operable for the purpose of Pollack.
In response to Applicant’s argument that the device of Ward ‘839’ teaches a sensing device in figure 8 that cannot deliver insulin or any liquid when flat, and moreover is unsuitable for subcutaneous implantation unless made tubular and somehow inserted through the skin, and further, is not implantable but topical and requires a separate tubular cannula to deliver a drug, this argument is found to be unpersuasive because the device of figure 8 in Ward ‘839’ was not relied upon to teach a sensing device that delivers insulin and determines glucose concentrations. Instead, figures 1 and 7 of Ward ‘839’ were relied upon for such teachings, thus Ward ‘839’ does teach a sensing device that delivers insulin and can be subcutaneously implanted to determine analyte (i.e., glucose) concentrations (see Ward ‘839’, par 0027-0032, 0034-0037, 0040-0041, 0043, 0045-0048, 0055, 0061, 0075, 0077, fig. 1, 7 & 9).
In response to applicant's argument that the previously used Pollack reference is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Pollack reference is reasonably pertinent to the particular problem with which the inventor was concerned as Pollack teaches devices and method for targeted delivery of a substance, wherein the distal tip of a cannula can optionally be circular, ovular, square, or rectangular (see Pollack, par 0132, figs. 11 & 12). Therefore, as the instant application pertains to a sensing cannula for delivering a drug and determining glucose concentration when subcutaneously implanted, and the Ward references similarly pertain to sensing cannulas/catheters, the Pollack reference is reasonably pertinent to the Ward references and the instant application. As the Ward '839', Ward '542', and Pollack references teach sensing cannulas, it would have been obvious to one of ordinary skill in the art to modify the system of Ward ‘839’ as modified by Ward ‘542’ such that the planar top face, the planar bottom face, and the thickness in combination provide a rectangular cross-section to the sensing cannula because that would merely be the simple substitution of one cross-sectional shape of the sensing cannula (i.e., rectangular as in Pollack) for another (i.e. circular/ovular, as in Ward ‘839’ as modified by Ward ‘542’).
In response to applicant's argument that the structure of the Pollack device simply could not be modified with the sensing system of Applicant’s sensing cannula and the resulting device would not be operable for the purpose of Pollack, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Moreover, regarding Applicant’s argument that the cited references fail to suggest a rectangular design having an inner lumen for drug delivery with a sufficient thickness to be subcutaneously implanted, this argument is moot in view of the new grounds of rejection, because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See 35 USC 103 rejections below.
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.
Claim(s) 1-5, 8, 11, 13-14, 18-22 & 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2006/0263839 --as previously cited--, hereinafter referenced as "Ward '839'" in view of US Patent Application Publication 2016/0354542 --as previously cited--, hereinafter referenced as “Ward ‘542’”, in further view of US Patent Application Publication 2020/0022691 –as previously cited--, hereinafter referenced as “Pollack”.
With respect to claim 1, Ward ‘839’ teaches a sensing cannula for delivering a drug and determining glucose concentration when subcutaneously implanted (see Ward ‘839’, par 0027-0032, 0034-0037, 0040-0041, 0043, 0045-0048, 0055, 0061, 0075, 0077, fig. 1, 7 & 9), the sensing cannula comprising:
a proximal end and a distal end (i.e., a proximal end comprising a plurality of sensing zones (i.e., electrodes) and a distal end from which a hollow metal structure can extend distally) comprising (see Ward ‘839’, par 0032-0033, 0046-0047 & 0061-0062, figs. 1 & 7);
a planar top face comprising an electrode (i.e., the top surface of the flat sensing device) (see Ward ‘839’, par 0061-0062, fig. 7, wherein the flat sensing device has a top surface comprising a plurality of sensing zones (i.e., electrodes)),
where the electrode comprises an electrical contact on the planar top face at the proximal end,
where the electrical contact is in electrical communication with the electrode (i.e., a sensor module is connected to an indicating electrode and a reference electrode) (see Ward ‘839’, par 0059),
where a thin permselective membrane 112 is on the electrode, where the thin permselective membrane contacts an enzyme (see Ward ‘839’, par 0043, 0050, 0052, 0063, 0087, 0089, fig. 1 & 8, claim 26);
a planar bottom face (i.e., the bottom surface of the flat sensing device) (see Ward ‘839’, par 0061-0062, fig. 7, wherein the flat sensing device has a bottom surface opposite the top surface);
and a thickness between the planar top face and the planar bottom face comprising an inner lumen (i.e., there is a thickness between the top surface and the bottom surface, and the planar surfaces can be wrapped into a hollow structure that comprises a lumen therein) (see Ward ‘839’, par 0046, 0055, 0061-0062, 0075 & 0077, fig. 7),
and where the inner lumen provides fluid communication from the proximal end to the distal end of the cannula (i.e., the lumen provides one or more passages through which drugs can be passed, therefore the lumen provides fluid communication from a proximal end of the device containing the drug to the distal end wherein the lumen interfaces with the skin of a patient to administer the drug) (see Ward ‘839’, par 0055, 0075, 0077, fig. 9),
where the inner lumen is formed from a polymeric tube (i.e., structure 102 that is a tube that comprises an inner lumen and is formed from polymers) (see Ward ‘839’, par 0032, fig. 1),
and where the polymeric tube has a melting temperature that is higher than the glass transition temperature of a surrounding polymer, where the surrounding polymer contacts the polymeric tube and contributes to the thickness between the planar top face and the planar bottom face of the cannula (i.e., multiple extrusions are used to form the wall of a tube and the multiple extrusions contain materials of different melting temperatures and mechanical properties such that the materials can be extruded immediately subsequent to one another without melting the extrudate of the first extrusion such that wires can be imbedded in the wall of the tube) (see Ward ‘839’, par 0057).
Ward ‘839’ fails to teach the permselective membrane contacts both an enzyme and a redox mediator.
Ward ‘542’ teaches an insulin delivery catheter that is configured to measure glucose, comprising an osmium and pyridine or imidazole ligand complex, or in other words, a redox mediator on the surface of an indicating electrode (see Ward ‘542’, par 0035, 0058, 0088). The use of the redox mediator permits the transference of electrons from glucose to an indicating electrode without interference from any preservatives that may be present in insulin (see Ward ‘542’, par 0017).
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 system of Ward ‘839’ such that it comprises a permselective membrane contacts both an enzyme and a redox mediator because a redox mediator permits the transference of electrons from glucose to an indicating electrode without interference from any preservatives that may be present in insulin (see Ward ‘542’, par 0017).
Ward ‘839’ as modified by Ward ‘542’ fails to teach the planar top face, the planar bottom face, and the thickness in combination provide a rectangular cross-section to the sensing cannula.
Pollack teaches devices and method for targeted delivery of a substance, wherein the distal tip of a cannula can optionally be circular, ovular, square, or rectangular (see Pollack, par 0132, figs. 11 & 12).
It would have been obvious to one of ordinary skill in the art to modify the system of Ward ‘839’ as modified by Ward ‘542’ such that the planar top face, the planar bottom face, and the thickness in combination provide a rectangular cross-section to the sensing cannula because that would merely be the simple substitution of one cross-sectional shape of the sensing cannula (i.e., rectangular as in Pollack) for another (i.e. circular/ovular, as in Ward ‘839’ as modified by Ward ‘542’).
Ward ‘839’ as modified by Ward ‘542’ and Pollack fails to teach the thickness between the planar top face and the planar bottom face comprising the inner lumen is from 0.25 mm to 0.5 mm.
However, Ward ‘839’ as modified by Ward ‘542’ and Pollack teaches a thickness between the planar top face and the planar bottom face comprising an inner lumen that can have a variety of sizes (i.e., there is a thickness between the top surface and the bottom surface, and the planar surfaces can be wrapped into a hollow structure that comprises a lumen therein, wherein the lumen and its thickness/width can have a variety of sizes) (see Ward ‘839’, par 0045-0046, 0055, 0061-0062, 0075 & 0077, fig. 7). 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 system of Ward ‘839’ as modified by Ward ‘542’ and Pollack such that the thickness between the planar top face and the planar bottom face comprising the inner lumen is from 0.25 mm to 0.5 mm because Ward ‘839’ as modified by Ward ‘542’ and Pollack teaches a thickness between the planar top face and the planar bottom face comprising an inner lumen that can have a variety of sizes. Therefore, it would merely be a matter of routine optimization to arrive at a thickness between the planar top face and the planar bottom face comprising the inner lumen is from 0.25 mm to 0.5 mm, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 2, Ward ‘839’ further teaches the electrode of the planar top face is a working electrode and the planar bottom face comprises a pseudo-reference electrode (i.e., on one side of the flat rectangular sensing cannula is the indicating electrode, and on the other side is the reference electrode) (see Ward ‘839’, par 0034-0035, 0037-0040).
With respect to claim 3, Ward ‘839’ further teaches the electrode of the planar top face is a working electrode and the planar bottom face comprises a counter electrode and a reference electrode (i.e., on one side of the flat rectangular sensing cannula is the indicating electrode, and on the other side is the reference electrode and counter electrode) (see Ward ‘839’, par 0034-0035, 0037-0041).
With respect to claim 4, Ward ‘839’ further teaches the electrode of the planar top face comprises a working electrode and a pseudo-reference electrode (i.e., the indicating electrode and the reference electrode are concentric to one another) (see Ward ‘839’, par 0034-0035, 0037-0040).
With respect to claim 5, Ward ‘839’ further teaches the electrode of the planar top face comprises a working electrode, a counter electrode, and a reference electrode (i.e., the indicating electrode and the reference electrode are concentric to one another and the counter electrode is used as an additional electrode wherein current flows through the counter electrode rather than through the reference electrode) (see Ward ‘839’, par 0034-0035, 0037-0041).
With respect to claim 8, Ward ‘839’ further teaches the inner lumen is in fluid communication with a source of a drug, the source of the drug chosen from a drug delivery pump, a syringe, and a gravity-fed source (i.e., the lumen is in fluid communication with drug delivery mechanisms such as a pump, syringe, or a drug reservoir) (see Ward ‘839’, par 0060, 0063, 0077-0078, figs. 6 & 8-9).
With respect to claim 11, Ward ‘839’ further teaches the polymeric tube comprises a polymer chosen from polytetrafluoroethylene, polyurethane, polyolefin, polyimide, polyether ether ketone, silicone, epoxy, urea formaldehyde, phenolics, unsaturated polyester resins, and combinations thereof (i.e., the tube is made from fluoropolymers, such as polytetrafluoroethylene) (see Ward ‘839’, par 0032, fig. 1).
With respect to claim 13, Ward ‘839’ further teaches the surrounding polymer is a thermoplastic polymer chosen from poly-ether imide, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polybenzimidazole, acrylic, nylon, fluoropolymers, and combinations thereof (i.e., the first extrudate that acts as the surrounding polymer that surrounds the tube is formed of polytetrafluoroethylene, a fluoropolymer) (see Ward ‘839’, par 0032, 0057).
With respect to claim 14, Ward ‘839’ further teaches the surrounding polymer comprises fibers chosen from carbon fiber, glass fiber, and combinations thereof (i.e., the surrounding polymer that surrounds the tube structure 102 is a carbon material such as glassy carbon or carbon fibers) (see Ward ‘839’, par 0034).
With respect to claim 18, Ward ‘839’ further teaches at least one port establishing fluid communication between the inner lumen and at least one of the planar top face, the planar bottom face, and the thickness (i.e., a port establishes fluid communication through a planar top face for delivering a drug when the device is in use) (see Ward ‘839’, par 0051, 0054-0056, 0059, figs. 2-5).
With respect to claim 19, Ward ‘839’ further teaches the inner lumen lacks fluid communication with the distal end (i.e., the distal end is used for analyte sensing rather than drug delivery thus fluid communication is not needed at the distal end) (see Ward ‘839’, par 0079).
With respect to claim 20, Ward ‘839’ further teaches a trocar contacting at least one of the planar top face and the planar bottom face (i.e., the trocar is located at the planar bottom face) (see Ward ‘839’, par 0075-0076, fig. 9).
With respect to claim 21, Ward ‘839’ further teaches the distal end is tapered to a point (i.e., the lumen of the device contains a stylet with a sharpened tip) (see Ward ‘839’, par 0075).
With respect to claim 22, Ward ‘839’ further teaches a distal end of the inner lumen is in fluid communication with a metal tube extending beyond the distal end of the cannula (i.e., the lumen of the device is in fluid communication with a metal tube structure 102 that extends from an end of the sensing device distally) (see Ward ‘839’, par 0032-0033, fig. 1).
With respect to claim 36, Ward ‘839’ further teaches the thin permselective membrane comprises a polymer chosen from poly vinyl pyridine, polyurethane, and sulfonated tetrafluoroethylene-based fluoropolymers (i.e., the permselective membrane is made of polyurethane) (see Ward ‘839’, par 0043).
Claim(s) 6-7, 9 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward '839' in view of Ward '542' and Pollack as applied to claim 1 above.
With respect to claim 6, Ward ‘839’ in view of Ward ‘542’ and Pollack fails to explicitly teach that the width of the planar top face and the planar bottom face is from 0.2 mm to 1.0 mm.
Nonetheless, 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 sensing cannula of Ward ‘839’ in view of Ward ‘542’ and Pollack such that the width of the planar top face and the planar bottom face is from 0.2 mm to 1.0 mm because Ward ‘839’ in view of Ward ‘542’ and Pollack teaches that the planar structures of the sensing device are configured to be wrapped into a hollow structure, such as around a mandrel to form one or more lumens through which a drug is delivered into a mammalian body, therefore the planar top face and the planar bottom face of the planar structures has a small width such that it can be wrapped around a mandrel to form a drug delivering lumen (see Ward ‘839’, par 0031, 0046, 0048, 0055 & 0061, fig. 7). Therefore, it would merely be a matter of routine optimization to arrive at the width range of 0.2 mm to 1.0 mm of the planar top face and the planar bottom, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 7, Ward ‘839’ in view of Ward ‘542’ and Pollack teaches the sensing cannula of claim 6, wherein it would have been obvious to one of ordinary skill to make the width of the planar top face and the planar bottom face 0.2 mm to 1.0 mm. Ward ‘839’ further teaches that a length of the cannula defined by the inner lumen is seven to thirty times the width (i.e., the length of the sensing or drug delivery tube (i.e., cannula) is 1-2 inches or longer) (see Ward ‘839’, par 0045).
With respect to claim 9, Ward ‘839’ in view of Ward ‘542’ and Pollack does not explicitly teach that the inner lumen constitutes from 50% to 90% of a cross-sectional area of the distal end of the cannula.
Nonetheless, 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 sensing cannula of Ward ‘839’ in view of Ward ‘542’ and Pollack such that the inner lumen constitutes from 50% to 90% of a cross-sectional area of the distal end of the cannula because Ward ‘839’ in view of Ward ‘542’ and Pollack teaches that the inner lumen has a cross-sectional area that is comparable to that of the distal end of the cannula (see Ward ‘839’, fig. 1, wherein the inner lumen constitutes a similar cross-sectional area to that of the distal end of the structure 102). Therefore, it would merely be a matter of routine optimization to arrive at a cross-sectional area of the inner lumen that constitutes from 50% to 90% of the cross-sectional area of the distal end of the cannula, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 17, Ward ‘839’ in view of Ward ‘542’ and Pollack does not explicitly teach the working electrode has a surface area that is not more than 20% to 25% of the surface area of a pseudo-reference electrode.
Nonetheless, 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 sensing cannula of Ward ‘839’ in view of Ward ‘542’ and Pollack such that the working electrode has a surface area that is not more than 20% to 25% of the surface area of a pseudo-reference electrode because Ward ‘839’ teaches that the reference electrode has an exposed area that is at least 3, 4, or 5 times greater than the exposed area of the indicating electrode (see Ward ‘839’, par 0040). Therefore, it would merely be a matter of routine optimization to arrive at a working electrode has a surface area that is not more than 20% to 25% of the surface area of a pseudo-reference electrode, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
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 Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./ Examiner, Art Unit 3791
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