DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 9-12, and 16-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574) in view of Stafford (US 2008/0097246), and further in view of VESA Mini DisplayPort Connector Standard (hereinafter “VESA”)
As to claim 2, Curry teaches a glucose sensor subassembly (123) for assembly with an on-body device (1100), wherein the on-body device is configured to be worn on a subject’s body and monitor an in vivo glucose level ([0005]), and wherein the glucose sensor subassembly comprises a sensor subassembly housing (130) comprising an aperture (168); a plurality of electrical connectors coupled with the sensor subassembly housing ([0119] – as the sensor recites contacts for connecting, there is inherently a plurality of electrical connectors); a glucose sensor (14) comprising a proximal section electrically coupled with the plurality of electrical connectors (32; [0119]), a distal section configured to be positioned under a skin surface and in contact with a bodily fluid of the subject (30); and a sharp comprising a sharp hub (124) and a distal tip (160), wherein a portion of the glucose sensor and a portion of the sharp extend through the aperture of the sensor subassembly housing (Fig. 13), and wherein the on-body device, when assembled with the glucose sensor subassembly, is configured to wirelessly transmit data indicative of the monitored in vivo glucose level of the subject in response to a request from a reader device ([0101].
Curry fails to teach a needle guard, said needle guard forming a sealed enclosure with the sensor subassembly, and wherein the distal section of the glucose sensor and the distal tip of the sharp are disposed in the sealed enclosure. Stafford teaches an in vivo analyte sensor system in which a needle guard (104) encloses a lower portion of the sharp as well as the sensor ([0022]) and keep a sterile environment. It would have been obvious to modify Curry with Stafford to enable the use of a needle guard and maintain a sterile environment for the sensor and prevent any changes to the sensor chemistry which may lead to infection or inaccurate measurements.
The above combination fails to teach that a lengthwise portion of a proximal section of the glucose sensor bisects each electrical connector of the plurality of electrical connectors. VESA teaches an electrical cable/connector combination in which a device with a plurality of electrical contacts (Fig. 2-17 - central tongue portion of the connector) bisects each electrical connector (Fig. 2-15). While the mini-display port is meant for reversible connections, one of ordinary skill in the art would recognize that this connector arrangement could also be utilized in a permanently assembled system, as the arrangement does not require reversibility to function.
As to claim 9, Curry teaches the on-body device comprises a printed circuit board ([0139]).
As to claim 10, Curry teaches each electrical connector of the plurality of electrical connectors comprises a conductive portion configured to electrically couple with the printed circuit board of the on-body device (inherent as the circuit board must connect with the sensor via the electrical connectors).
As to claim 11, Curry teaches the distal tip of the sharp is configured to guide the distal section of the glucose sensor through the skin surface and into contact with the bodily fluid of the subject ([0120]; Fig. 17).
As to claim 12, Curry teaches the distal section of the glucose sensor is supported within the distal tip of the sharp ([0121]).
As to claim 16, as Curry teaches three conductive contacts ([0119]), in such a configuration there must inherently also be three connectors.
As to claim 17, Curry teaches the sharp hub comprises a conical or semi-conical geometry (Fig. 46 – 2408).
As to claim 18, Curry teaches the distal section of the glucose sensor is substantially perpendicular to the proximal section of the glucose sensor (Fig. 3).
As to claim 19, Stafford teaches the needle guard is configured to disengage from a distally facing surface of the sensor subassembly housing ([0023]).
Claim 4 and 24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574), Stafford (US 2008/0097246), and VESA Mini DisplayPort Connector Standard (hereinafter “VESA”), and further in view of Slomski et al. (US 2009/0234212).
As to claims 4 and 24, the above combination does not necessarily teach the sensor subassembly housing comprises a plurality of openings, and wherein the each electrical connector of the plurality of electrical connectors is configured to engage with a corresponding opening of the plurality of openings. However, Slomski teaches an analyte sensor with a housing (716) with openings (750) configured to permit passage of contacts (712) on sensor subassembly (704). As such, it would have been obvious to modify the above combination with Slomski to utilize a housing comprising a plurality of openings, each opening configured to engaged with an electrical connector, to provide rigid stability and protection for the sensor device while allowing for electrical connections for functionality.
Claims 5, 6, 20-23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574), Stafford (US 2008/0097246), and VESA Mini DisplayPort Connector Standard (hereinafter “VESA”), and further in view of Hoss et al. (US 2011/0021889).
As to claims 5 and 20, the above combination does not teach that each electrical connector comprises a flexible material. Hoss teaches an in vivo analyte monitoring device with a connector that is made non-rigid or flexible ([0129]) to increase comfort ([0063]). It would have been obvious to modify the above combination with Hoss to create a more comfortable device.
As to claim 6, the above combination fails to teach the use of a carbon-doped silicone material for electrical connectors. Hoss teaches an in vivo analyte monitoring device with a connector made of a conductive polymeric material such as carbon-doped silicone ([0129]). It would have been obvious to modify the above combination with Hoss to utilize a material known to be usable as an electrical connector as it would be obvious to try.
As to claim 21, Curry teaches the distal section of the glucose sensor is substantially perpendicular to the proximal section of the glucose sensor (Fig. 3).
As to claim 22, Curry teaches the distal tip of the sharp is configured to guide the distal section of the glucose sensor through the skin surface and into contact with the bodily fluid of the subject ([0120]; Fig. 17).
As to claim 23, Curry teaches the distal section of the glucose sensor is supported within the distal tip of the sharp ([0121]).
Claims 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574), Stafford (US 2008/0097246), and VESA Mini DisplayPort Connector Standard (hereinafter “VESA”), and further in view of Peterson (US 2002/0161338).
As to claim 7, the above combination fails to teach that the needle guard comprises polypropylene. Peterson teaches a catheter device with a needle guard that is made of polypropylene ([0031]). It would have been obvious to modify the above combination with Peter to utilize a material known to be usable as a needle guard as it would be obvious to try.
Claims 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574), Stafford (US 2008/0097246), and VESA Mini DisplayPort Connector Standard (hereinafter “VESA”), and further in view of Odell et al. (US 2001/0044608).
As to claim 8, the above combination fails to teach that the needle guard includes thermoplastic elastomer inserts configured to releasably secure the sharp. Odell teaches a needle sheath (24) made of a thermoplastic elastomer ([0031]) which is capable of holding the needle (46) in place (Fig. 2). It would have been obvious to modify the above combination with Odell to utilize a thermoplastic portion to secure the sharp so that it be secure against sudden movement and/or forces to prevent damage.
Claims 13 and 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574), Stafford (US 2008/0097246), and VESA Mini DisplayPort Connector Standard (hereinafter “VESA”), and further in view of Santini, JR et al. (US 2005/0096587).
As to claims 13 and 15, the above combination does not teach the sealed enclosure includes an epoxy or a dielectric material. However, Curry does teach that the wholly implantable assembly can be provided in a sealed housing (e.g. hermatically sealed biocompatible housing)([0085]) and that the device can be provided with a seal to preserve the sterility of the device ([0092]). Santini teaches a glucose sensing device and notes that such microelectronic device packages are typically made of dielectric material and epoxies to allow components to be placed in close proximity and to facilitate the interconnection of components while protecting the electronics from the environment ([0102]). It would have been obvious to modify the above combination with Santini, to utilize specific materials to create the sealed enclosures within the subassembly, as it would allow for the benefits taught by Santini.
Claims 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Curry et al. (US 2011/0288574), Stafford (US 2008/0097246), and VESA Mini DisplayPort Connector Standard (hereinafter “VESA”), and further in view of Santini, JR et al. (US 2005/0096587) and Trippel et al. (US 2008/0133059).
As to claim 14, the above combination does not teach the sealed enclosure includes a UV cure. However, Curry does teach that the wholly implantable assembly can be provided in a sealed housing (e.g. hermatically sealed biocompatible housing)([0085]) and that the device can be provided with a seal to preserve the sterility of the device ([0092]). Santini teaches a glucose sensing device and notes that such microelectronic device packages are typically made of dielectric material and epoxies to allow components to be placed in close proximity and to facilitate the interconnection of components while protecting the electronics from the environment ([0102]). Trippel teaches a dielectric layer that can be comprised of UV-cured acrylate ([0035]). It would have been obvious to modify the above combination with Santini and Trippel, to utilize specific materials to create the sealed enclosures within the subassembly, as it would allow for the benefits taught by Santini.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot 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.
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.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 1/14/26