DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 January 2026 has been entered.
Status of Claims
Claim 1 is currently amended. Claims 7 and 16-18 have been canceled. Claims 1-6, 8-15 and 19-25 are pending.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 1-6, 9-10, 14-15 and 19-25 is/are rejected under 35 U.S.C. 103 as being un-patentable over US 2014/0213866 A1 (previously cited, Simpson) in view of US 2012/0027810 A1 (previously cited, Chen); or alternatively, over Simpson in view of Chen and US 2013/0281802 A1 (Matsumoto).
Regarding claims 1-6, 15 and 19-20, Simpson teaches and/or suggests an analyte sensor system comprising:
an analyte sensor configured for in vivo use, the analyte sensor comprising:
an elongated core (¶ [0331] sensor body and/or support member 112; e.g., Figs. 11-12, core wire 1002; Figs. 13-14, layer 1028), wherein the elongated core comprises an elongated polymer core (¶ [0402] nonconductive core wire 1002, ¶ [0406] nonconductive layer 1028, etc.; ¶ [0402] where nonconductive materials include polymers), the elongated core comprising a layer of conductive material covering at least a portion thereof (¶ [0331] support member 112 including one or more electrodes; ¶ [0213] at least one conductive trace extending along the core wire and/or at least one electrode over the core wire, e.g., ¶ [0403] conductive trace 1012 and/or electrode 1008, 1010; ¶ [0406] conductive traces 1030, 1032, 1034 and/or electrodes 1022, 1024, 1026 provided over the nonconductive layer 1028; etc.);
a working electrode disposed on the elongated core (¶ [0008] electrode, e.g., ¶ [0403] one of the electrodes 1008 or 1010 serves as a working electrode; ¶ [0406] electrode 1026 serves as a working electrode; etc.); and
a membrane covering at least a portion of the working electrode (¶ [0331] membrane 114 disposed over at least a portion of the support member 112; ¶ [0008] membrane covering at least a portion of the at least one electrode; etc.), wherein the membrane comprises an enzyme layer (e.g., ¶ [0394]; ¶ [0129] of US 2009/0247856 A1, which Simpson incorporates by reference in ¶ [0473]; etc.), wherein the analyte sensor is configured to transform from a freestanding sensor to a non-freestanding sensor responsive to in vivo hydration of the analyte sensor (e.g., ¶¶ [0395]-[0399] in any disclosed embodiment, the sensor body may be a stimulus-responsive material(s), which are materials that change at least one property, such as hardness, elastic modulus, etc. responsive to a stimulus, such as hydration); and
an insertion sheath (e.g., ¶¶ [0413]-[0416] sheath 1072; ¶ [0419] protective sheath 1104) having a lumen in which the analyte sensor is disposed (e.g., ¶ [0414] "intraluminal surface of the sheath," indicating the sheath includes a lumen into which the analyte sensor is disposed, e.g., Fig. 18), wherein the analyte sensor is configured to be at least partially inserted into skin of a host via the insertion sheath (e.g., ¶¶ [0413]-[0416], ¶ [0419], etc. the sheath protects the membrane during the insertion procedure, and may provide additional column strength for increased resistance to buckling), and wherein the insertion sheath is withdrawn from the skin of the host after the in vivo insertion of the analyte sensor (¶ [0415], ¶ [0419] sheath 1104 is retracted partially or fully to expose the sensor 1102 and/or the sensor tip 1106).
Simpson further teaches/suggests the analyte sensor has a Young's modulus of less than 500 MPa after in vivo insertion (i.e., in the non-freestanding state) (¶ [0397] where the tensile modulus of the sensor while implanted may be between about 0.5-10 kPa to reduce the injury and foreign body response), and the analyte sensor has a Young's modulus significantly/sufficiently greater than in the non-freestanding state Young's modulus before the in vivo insertion (i.e., in the free-standing state) to facilitate insertion of the analyte sensor without buckling (¶ [0399] elastic modulus of the sensor body is 10x higher/greater before in vivo insertion). Simpson, however, neither expressly discloses the analyte sensor, or elongated core thereof, has a Young's modulus of between 500 MPa and 147 GPa, less than 5 GPa, or less than 2 GPa before in vivo insertion (i.e., in the freestanding state).
However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the analyte sensor of Simpson with analyte sensor (e.g., a stimulus-responsive elongated core and/or protective outer layer thereof) having a Young's modulus between 500 MPa and 147 GPa, less than 5 GPa, or less than 2 GPa while freestanding and/or before in vivo insertion because Applicant has not disclosed the claimed Young's modulus ranges provide an advantage, are used for a particular purpose, or solve a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the Young's modulus values disclosed by Simpson (e.g., 10x the disclosed tensile/elastic modulus of tissue) because either arrangement facilitates insertion of the analyte sensor without buckling, while providing comfort for the patient, reducing injury and foreign body response, etc. during sensor wear.
Alternatively/Additionally, Chen discloses a device configured for in vivo insertion into the skin without buckling (e.g., ¶ [0289]), said device having a Young's modulus between 500 MPa and 147 GPa, less than 5 GPa, or less than 2 GPa before in vivo insertion (e.g., ¶ [0281] Young's modulus of the projections is 1 GPa). 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 analyte sensor of Simpson with the analyte sensor (e.g., a stimulus-responsive elongated core thereof), having a Young's modulus between 500 MPa and 147 GPa, less than 5 GPa, or less than 2 GPa before the in vivo insertion as taught and/or suggested by Chen (e.g., 1 GPa) in order to provide the analyte sensor with sufficient rigidity/stiffness to successfully penetrate skin (Chen, ¶ [0289]).
Simpson as modified does not expressly disclose the analyte sensor has a buckling force of greater than 0.25 N before the in vivo insertion and a buckling force of less than 0.25 N after in vivo insertion. However, Simpson and/or Chen disclose buckling force is a function of at least Young's modulus (e.g., Simpson, ¶ [0428] increased hardness/stiffness increases column strength and resistance to buckling during insertion; Chen, ¶¶ [0282]-[0289]; etc.), such that Simpson as modified teaches/suggests there is an inherent buckling force associated with the Young's modulus of Simpson as modified, wherein the buckling force is greater before in vivo insertion and at least sufficient to successfully penetrate skin (Simpson, ¶ [0428]; Chen, ¶ [0289]), and less after in vivo insertion given the reduced Young's modulus. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the analyte sensor of Simpson with analyte sensor (e.g., a stimulus-responsive elongated core thereof) having a buckling force of greater than 0.25 N before the in vivo insertion and a buckling force of less than 0.25 N, less than less 0.02 N, less than 0.01 N, or less than 0.001 N after in vivo insertion because Applicant has not disclosed the claimed buckling force ranges provide an advantage, are used for a particular purpose, or solve a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the buckling forces otherwise yielded by the Young's modulus values of Simpson as modified above because either arrangement facilitates insertion of the analyte sensor, while providing comfort for the patient, reducing injury and foreign body response, etc. during sensor wear.
Alternatively/Additionally, as discussed above, buckling force is a function of at least Young's modulus, which provides a quality that can be optimized. Since the Young's modulus values, and therefore the buckling forces yielded thereby, provide a quality which can be optimized (e.g., ability of the free-standing sensor to penetrate the skin, user comfort and/or reduced trauma of the non-freestanding sensor), the specific claimed ranges of buckling forces before and after in vivo insertion of the sensor would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Simpson as modified does not expressly disclose the insertion sheath comprises/is a "needle" having a sharpened distal tip configured to pierce the skin of a host. However, Simpson discloses the sheath may be longer than the analyte sensor, thereby suggesting said sheath may cover the sensor tip (¶ [0416], ¶ [0419], etc.). Simpson discloses the sensor body itself may have a blunt tip (e.g., ¶ [0008]) and discloses the introducer sheath may be utilized during insertion of analyte sensors lacking a piercing element (e.g., ¶ [0416]). Simpson further discloses providing a sharpened leading edge facilitates skin penetration (e.g., ¶ [0336]). Accordingly, 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 Simpson, particularly for analyte sensors having a blunt tip (i.e., lacking a tissue-piercing element), with the sheath being longer than the sensor and having a sharpened distal tip configured to pierce the skin of a host in order to better facilitate skin penetration (¶ [0336]); reduce/further reduce the risk of buckling of the analyte sensor and damaging the membrane during sensor insertion (¶¶ [0413]-[0416]); enable surrounding tissue to move toward the sensor (¶ [0419]); etc. While Simpson does not expressly describe the sheath as a "needle," one of ordinary skill in the art would readily appreciate the sheath of Simpson as modified above is a sharply pointed instrument for puncturing tissue, and therefore falls within the broadest reasonable interpretation of the term "needle" (see previously-cited OED definition).
Alternatively/Additionally, Matsumoto discloses/suggests an inserter needle (guide needle 220) having a lumen in which an analyte sensor (sensor 120) is disposed (e.g., Fig. 8(B)), and a sharpened distal tip configured to pierce skin of a host (needle portion 225 formed in a sharp tip shape to smoothly perform a puncturing operation to insert the guide needle 220 in the living body), wherein the analyte sensor is configured to be at least partially inserted into the skin of the host from the lumen of the inserter needle (Fig. 17; ¶ [0092]; etc.), and wherein the inserter needle is withdrawn from the skin of the host after the in vivo insertion of the analyte sensor (Fig. 18; ¶ [0095]; etc.). Further, Matsumoto expressly discloses the inserter needle is designed/configured (e.g., having slit 228) to enable the electrical connection between the sensor and sensor electronics to be maintained before and after insertion with the guide needle (e.g., ¶ [0064]; ¶ [0095]), i.e., the problem with insertion needles alleged by Simpson (e.g., ¶ [0044]). 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 Simpson, particularly for analyte sensors having a blunt tip (i.e., lacking a tissue-piercing element), with the sheath functioning as an insertion needle as taught/suggested by Matsumoto, e.g., having a lumen in which the analyte sensor is disposed, a sharpened distal tip configured to pierce skin of a host, etc. in order to better facilitate skin penetration (¶ [0336]); reduce/further reduce the risk of buckling of the analyte sensor and damaging the membrane during sensor insertion (¶¶ [0413]-[0416]); enable surrounding tissue to move toward the sensor (¶ [0419]); etc. without adding the complexity of needing to electrically connect the sensor to sensor electronics after insertion (Simpson, ¶ [0044]; Matsumoto, ¶ [0064]; ¶ [0095]; etc.).
Regarding claim 9, Simpson as modified teaches/suggests the elongated core comprises at least one material selected from the group consisting of copper, gold, magnesium, silver, tin, titanium, a titanium alloy, zinc, and combinations thereof (e.g., ¶¶ [0397]-[0398] the sensor body comprises a stimulus-responsive material(s), which may include nickel-titanium). Alternatively and/or additionally, Simpson discloses at least one other analyte sensor embodiment comprising an elongated core (core 1276) including copper, gold, magnesium, silver, tin, titanium, a titanium alloy, zinc, or a combination(s) thereof (¶ [0472]). 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 analyte sensor of Simpson with an elongated core including copper, gold, magnesium, silver, tin, titanium, a titanium alloy, zinc, or a combination(s) thereof in order to configure/further adapt the analyte sensor to resist buckling during insertion (¶ [0471]).
Regarding claim 10, Simpson as modified teaches/suggests the conductive material selected from the group consisting of carbon, conductive polymer, platinum, platinum-iridium, gold, palladium, iridium, and combinations thereof (e.g., ¶ [0402] electrodes 1008, 1010 may be platinum, platinum-iridium, carbon, etc.).
Regarding claim 14, Simpson as modified teaches/suggests the analyte sensor is further configured to transform from a freestanding sensor to a non-freestanding sensor responsive to a temperature change across a transition temperature, as discussed with respect to claim 1 above. The only exemplary transition temperature disclosed by Simpson is 37° C, or 98.6° F (¶ [0398], ¶ [0399], etc.). Accordingly, Simpson does not disclose the transition temperature is between 78-98° F. However, it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). Accordingly, since the disclosed transition temperature is less than a degree from the claimed range, at least the upper end of said range would have been obvious because the transition temperatures are so close that one of ordinary skill in the art would expect the analyte sensor disclosed by Simpson and the claimed analyte sensor to provide the same result (e.g., transforming to the analyte sensor to a flexible, non-freestanding state after insertion in vivo).
Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the analyte sensor of Simpson with the transition temperature being between 78-98° F because Applicant has not disclosed the claimed temperature range provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses a larger transition temperature range of 78-100° F is suitable (e.g., ¶ [0165]). As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the transition temperature disclosed by Simpson because either arrangement enables direct insertion of the analyte sensor (i.e., without a separate applicator), while providing comfort for the patient, reducing injury and foreign body response, etc. during sensor wear.
Regarding claim 21, Simpson as modified teaches/suggests the layer of conductive material is a conductive trace that runs along a length of the elongated polymer core or the elongated fiber core, wherein a portion of the conductive trace comprises the working electrode (e.g., Figs. 11-12, conductive trace 1012 and/or electrode 1008, 1010, one of which serves as a working electrode; Figs. 13-14, conductive traces 1030, 1032, 1034 and/or electrodes 1022, 1024, 1026 provided over the nonconductive layer 1028, wherein electrode 1026 serves as a working electrode; etc.).
Regarding claim 22, Simpson as modified teaches/suggests the limitations of claim 15, as discussed above, but does not expressly disclose the elongated polymer core (e.g., nonconductive core wire 1002, ¶ [0406] nonconductive layer 1028, etc.) comprises an elongated elliptical polymer core. However, Simpson teaches/suggests at least one embodiment in which an elongated polymer core comprises an elongated elliptical polymer core, wherein at least one conductive trace runs along the elongated elliptical polymer core (¶ [0418] sensor body may be any of a variety of cross-sectional shapes, such as an ellipse). 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 analyte sensor of Simpson with an elongated elliptical polymer core, wherein at least one conductive trace runs along the elongated elliptical polymer core, as a simple substitution of one suitable elongated core cross-sectional shape for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 23-25, Simpson as modified teaches/suggests the limitations of claim 15, as discussed above. Since none of claims 15 and 23-25 require the analyte sensor to comprise an elongated fiber core, Simpson as modified further meets the limitations of claims 23-25.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Chen (or Simpson in view of Chen and Matsumoto) as applied to claim(s) 1 above, and further in view of WO 2017/004531 A1 (previously cited, Rogers).
Regarding claim 8, Simpson as modified teaches/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the elongated core has a flexural modulus of between 0.1 and 300 kPa after the in vivo insertion. However, as discussed above, Simpson discloses the sensor may be designed to focus on softness and flexibility to provide better comfort to the patient while inserted (¶ [0413]). Rogers discloses an implantable device may be considered "soft" when bulk properties such as Young's modulus and bending modulus are tailored to minimize the transmission of undue physical stresses and forces on surrounding tissue (¶ [0006]), disclosing the bulk properties may be matched to soft tissue, such as between 0.1 and 300 kPa (e.g., ¶ [0022], ¶ [0024], etc.). Accordingly, similar to the disclosure of Simpson with respect to Young's modulus, Rogers discloses the bending (flexural) modulus of an in vivo device while in the body similarly provides a quality which can be optimized (i.e., reducing stress and/or force on surrounding tissue). 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 analyte sensor of Simpson with a hydration-responsive elongated core having a flexural modulus between 0.1 kPa and 300 kPa after in vivo insertion as taught/suggested by Rogers in order to reduce/further reduce stress/force on surrounding tissue (Rogers, ¶ [0006]) and/or because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(11).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Chen (or Simpson in view of Chen and Matsumoto) as applied to claim(s) 1 above, and further in view of US 2013/0245412 A1 (previously cited, Rong).
Regarding claims 11-12, Simpson as modified teaches/suggests the limitations of claim 1, as discussed above, and further discloses a layer of insulating material covering at least a portion of the layer of conductive material (e.g., Fig. 12, electrically-insulating layer 1014 overlying conductive trace 1012), but does not expressly disclose the working electrode is formed in part by a window in the layer of insulating material that exposes an electrode portion of the layer of conductive material.
Rong teaches/suggests an analyte sensor (Fig. 1) comprising an elongated core (core 11) comprising a layer of conductive material covering at least a portion of the elongated core (first layer 112 formed of a conductive material); a layer of insulating material covering at least a portion of the layer of conductive material (second layer 104 formed of an insulating material), wherein a working electrode is formed in part by a window in the layer of insulating material that exposes an electrode portion of the layer of conductive material (¶ [0152] working electrode is exposed via window 106, e.g., Fig. 1C); and an additional conductive layer covering at least a portion of the layer of insulating material (third layer 114 comprising a conductive material), the additional conductive layer comprising a reference electrode (¶ [0153] third layer may comprise a reference electrode).
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 analyte sensor of Simpson with a layer of insulating material covering at least a portion of the layer of conductive material, wherein the working electrode is formed in part by a window in the layer of insulating material that exposes an electrode portion of the layer of conductive material, and an additional conductive layer covering at least a portion of the layer of insulating material, the additional conductive layer comprising a reference electrode as taught/suggested by Rong in order to enable providing an analyte sensor having a symmetrical design without a preferred bend radius (Rong, ¶ [0188]) and/or as a simple substitution of one known means/method for arranging a working and reference electrode on an elongated core of an analyte sensor for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Chen (or Simpson in view of Chen and Matsumoto) as applied to claim(s) 1 above, and further in view of US 2011/0073475 A1 (previously cited, Kastanos).
Regarding claim 13, Simpson as modified teaches/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the analyte sensor is formed from a plurality of substantially planar layers comprising the elongated core.
Kastanos teaches/suggests an analyte sensor formed from a plurality of substantially planar layers (e.g., Fig. 2B), the plurality of planar layers including an elongated core (substrate 204); and a layer of conductive material covering at least a portion of the elongated core (first conducting layer 201 disposed on at least a portion of substrate layer 204), such that a working electrode is disposed on the elongated core (e.g., ¶ [0045] first conducting layer 201 comprises the working electrode), wherein the analyte sensor is configured to transform from a freestanding sensor to a non-freestanding sensor responsive to in vivo hydration of the analyte sensor (e.g., ¶ [0014]).
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 analyte sensor of Simpson with the analyte sensor being formed from a plurality of substantially planar layers comprising the elongated core as taught and/or suggested by Kastanos in order to provide an analyte sensor with fewer manufacturing, e.g., printing, challenges (Simpson, ¶ [0401]) and/or as a simple substitution of one suitable analyte sensor configuration (e.g., coaxial layers vs stacked planar layers) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Chen (or Simpson in view of Chen and Matsumoto) as applied to claim(s) 15 above, and further in view of US 2014/0194701 A1 (previously cited, Drinan).
Regarding claims 23-25, as discussed above, Simpson as modified teaches/suggests the limitations of claim 15, as discussed above. Since none of claims 15 and 23-25 require the analyte sensor to comprise an elongated fiber core, Simpson as modified further meets the limitations of claims 23-25, as noted above.
Alternatively/Additionally, Simpson discloses the analyte sensor comprises a sensor body may comprise an elongated insulating body substantially surrounding an elongated core (non-conductive outer layer or jacket 1004 over core wire 1002); and at least one conductive coating on the elongated core, wherein the conductive coating comprises a trace that runs along the elongated insulating body (e.g., Figs. 11-12, conductive trace 1012 and/or electrode 1008, 1010 on/along jacket 1004 and therefore indirectly on the core wire 1002), wherein a portion of the elongated core having the conductive coating forms the working electrode (¶ [0403] one of the electrodes 1008 or 1010 serves as a working electrode). However, Simpson does not disclose the elongated core is/comprises an elongated fiber core comprising one or more para-aramid fibers.
Drinan discloses an in vivo device comprising an elongated fiber core including one or more para-aramid fibers and an elongated insulating body substantially surrounding the elongated fiber core (¶ [0081] an interior comprised of nylon or high strength fiber mesh, such as KEVLAR; and outside polymer wall or polymeric coatings thereon). Drinan discloses the elongated fiber core adds strength while maintaining a required flexibility (¶ [0081]).
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 analyte sensor of Simpson with the elongated core being and/or comprising an elongated fiber core comprising a para-aramid fiber(s) as taught/suggested by Drinan in order to provide the analyte sensor, or at least the elongated core thereof, with additional mechanical strength while maintaining a desired flexibility (Drinan, ¶ [0081]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant contends Simpson and Chen, either alone or in combination, fail(s) to teach or suggest the claimed analyte sensor system, particularly the inserter needle limitation thereof (Remarks, pg. 7). With respect to Simpson, Applicant asserts the disclosure that the introducer sheath may be longer than the length of the sensor body does not mean that the sheath extends beyond the tip of the analyte sensor and is sharpened such that it pierces the skin of the host, noting Fig. 18 shows a blunted end of the introducer sheath ending proximal to the distal tip of the tissue piercing element of the sensor. Applicant further notes Fig. 23 also shows an introducer sheath having a blunt edge (Remarks, pg. 7).
The examiner does not contend that Simpson expressly discloses and/or illustrates the introducer sheath extending beyond the distal tip of the sensor body or having a sharpened distal end. However, the test for obviousness 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). The embodiment(s) illustrated in Figs. 18 and 23 is/are not the only configurations disclosed/suggested by Simpson. Rather, as noted in the rejection of record above, Simpson expressly discloses, as an alternative to the embodiment illustrated in Fig. 18, the introducer sheath may be longer than the analyte sensor, thereby at least suggesting said sheath may cover the sensor tip (¶ [0416], ¶ [0419], etc.). Simpson discloses the introducer sheath may be utilized during insertion of analyte sensors lacking a piercing element (e.g., ¶ [0416]) and the sensor body itself may have a blunt tip (e.g., ¶ [0008]). Simpson further discloses providing a sharpened leading edge facilitates skin penetration (e.g., ¶ [0336]). Accordingly, 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 Simpson, particularly for analyte sensors having a blunt tip (i.e., lacking a tissue-piercing element), with the introducer sheath extending distally past the sensor and having a sharpened distal tip configured to pierce the skin of a host, thereby additionally functioning as an insertion needle, in order to better facilitate skin penetration (¶ [0336]); reduce/further reduce the risk of buckling of the analyte sensor and damaging the membrane during sensor insertion (¶¶ [0413]-[0416]); enable surrounding tissue to move toward the sensor (¶ [0419]); etc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791