DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claims 2 and 17, the claims recite “a skin surface” twice. It is unclear whether the same surface is intended; the second should read “the skin surface”.
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 2-4, 6, 8, 10-15, 17-19, 21, 23, and 25-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoss et al. (US 2007/0203407) in view of Say et al. (USP #6,175,752) and Gregg (USP #5,262,035).
As to claim 2, Hoss teaches a glucose monitoring system ([0015]) comprising: a glucose sensor having a proximal portion ([0035] - sensor segment provided in housing 410) and a distal portion (402), the distal portion configured to be inserted through a skin surface (Fig. 4A) and in contact with an interstitial fluid to generate electrical signals indicative of levels of glucose in the interstitial fluid ([0001]), a sensor substrate including a first side having a first surface area and defining a first side of the glucose sensor, and a second side having a second surface area and defining a second side of the glucose sensor ([0041] – Fig. 7 describes a two-sided analyte sensor), a first conductive layer disposed on the first side, wherein the first conductive layer substantially covers the first surface area, a second conductive layer disposed on the second side, wherein the second conductive layer substantially covers the second surface area ([0041] – two sided sensor system with substrate 701 with a working electrode 702 on a first side and a reference electrode 703 on a second side, the sides being opposite sides of the substrate; Fig. 7 – electrodes 702 and 703 covering most of the substrate 701), a data processing unit configured to be mounted on a skin surface and including: one or more processors electrically coupled to the proximal portion of the glucose sensor via a connector having: a first part disposed on the first side of the glucose sensor and engaging the first conductive layer, and a second part disposed on the second side of the glucose sensor and engaging the second conductive layer ([0043] – transmitter unit 102 is electrically coupled to the sensor on both sides of the substrate to establish electrical connection to both electrodes; [0022] – transmitter unit comprising a processor), a battery coupled to the one or more processors ([0024] – power supply 207), an RF transmitter/receiver (206) coupled to the one or more processors ([0024]), and one or more memories coupled with the one or more processors ([0026]), and that the one or more memories store instructions which, when executed by the one or more processors determine a glucose level based on the electrical signals generated by the glucose sensor ([0026]).
Hoss fails to expressly teach a sensing layer disposed on at least a portion of the first conductive layer and extending across a width of the first conductive layer, the sensing layer including a glucose-responsive enzyme bonded to a polymer disposed on at least a portion of the first conductive layer;
Say teaches an analyte monitoring device with an electrochemical sensor (Abstract) and teaches the sensing layer disposed on the working electrodes (col. 7 lines 40-64), the sensing layer including a glucose-responsive enzyme (col. 16 lines 53-62), and extending across a width of the conductive layer (col. 16 lines 41-52 – sensing layer may extend beyond the conductive material 56 of the electrode). Gregg teaches enzyme electrodes for electrochemical sensing (Abstract) in which the enzyme is bonded to a polymer (col. 8 lines 3-9 – electrode is coated with a crosslinked redox polymer film with an enzyme bound to it). It would have been obvious to modify Hoss with Say and Gregg to utilize known arrangements as it would have been obvious to try.
As to claim 3, Hoss fails to expressly teach that the sensor substrate comprises a non-conducting material. Say teaches the use of non-conducting materials to make the substrate (col. 7 line 66 to col. 8 line 4). Moreover, while not explicitly stated by Hoss, should the substrate be conductive, the device would not properly function, as the electrodes on opposing sides of the substrate would fail to work independently. As such, it would have been obvious to further modify the above combination with Say to utilize a non-conductive material for the substrate to allow the device to properly function.
As to claim 4, Hoss fails to expressly teach that the sensor substrate comprises a flexible substrate. Say teaches a flexible substrate (col. 8 line 5). It would have been obvious to further modify the above combination with Say to reduce pain to the patient and damage to the tissue cased by the implantation of the device, as state by Say (col. 8 lines 5-10).
As to claim 6, Say teaches the sensing layer defines a sensor active area (col. 15 line 66 to col. 16 line 4).
As to claim 8, Hoss fails to expressly teach that the second conductive layer comprises silver/silver chloride. Say teaches electrodes that are made of silver/silver chloride (col. 12 lines 48-60). It would have been obvious to modify the above combination further with Say to utilize electrode materials that are known to be usable for in vivo detection of analyte, as it would be obvious to try.
As to claims 10-14, Hoss fails to teach the provision of an alarm when a glucose condition is detected based at least in part on the determined glucose level, said glucose condition being hypoglycemia or hyperglycemia, or impending hypoglycemia or hyperglycemia. Say teaches the analyte monitoring system providing an alarm to alert the patient to a hypoglycemic or hyperglycemic glucose level, or impending hypoglycemia or hyperglycemia (col. 7 lines 2-12).
As to claim 15, Hoss teaches the proximal portion has a planar configuration (Fig. 6-7) and wherein the first part of the connector is mechanically and electrically coupled to the first side of the glucose sensor and the second part of the connector is mechanically and electrically coupled to the second side of the glucose sensor ([0042] – contacts on both sides of the substrate; [0043] – electrically coupled on both sides of the substrate to establish electrical connection).
As to claim 17, the above combination teaches the features of claim 2, which claim 17 also recites identically except for the sensing layer including a “mediator bonded to a polymer” in place of “a glucose-responsive enzyme bonded to a polymer”. In addition, Say teaches the use of electron transfer agents including redox species bound to a polymer (col. 19 lines 10-32). It would have been obvious to modify the above combination further with Say to utilize a mediator to lower the operating potential, lowering the probability of measuring interferents, as well as boosting sensitivity of the device.
As to claims 18-19, 21, 23, and 25-30, these claims recite limitations identical to claims 3, 4, 6, 8, 10-15 respectively and are rejected for the same reasons.
Claims 5, 7, 9, 20, 22, 24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoss et al. (US 2007/0203407), Say et al. (USP #6,175,752), and Gregg (USP#5,262,035), and further in view of Kotzan et al. (US 2009/0156920).
As to claims 5 and 20, Say teaches the sensing layer comprises a strip of material which extends beyond the conductive material of the electrodes (col. 16 lines 41-52). However, the combination does not expressly teach the material extending orthogonal to a first side edge and a second side edge of the sensor substrate.
Kotzan teaches an implantable analyte sensor (Abstract) in which the electrode contact layers extend substantially over the entire width of the carrier substrate ([0022]), which would have to be orthogonal to the edge of the substrate. It would have been obvious to modify the above combination with Kotzan to allow the smallest possible dimensions for the invasive portion of the sensor, thereby reducing the amount of discomfort to the user.
As to claims 7 and 22, the above combination does not expressly teach that the sensor active area defines a rectilinear polygon. Kotzan teaches that the electrode areas are defined solely by the cutting and lamination processes ([0054]) and that the substrate has specific dimensions ([0068]) which reflect a rectilinear polygon (Fig. 1). It would have been obvious to modify the above combination with Kotzan to utilize a shape that is known to be usable in in vivo analyte sensing as it would be obvious to try.
As to claims 9 and 24, the above combination does not expressly teach a first insulation layer disposed on the first side of the glucose sensor over at least a portion of the first conductive layer and a second insulation layer disposed on the second side of the glucose sensor over at least a portion of the second conductive layer. Kotzan teaches this feature ([0023]). It would have been obvious to modify the above combination with Kotzan to prevent undesirable electrochemical reactions, as taught by Kotzan ([0023]).
Claims 16 and 31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoss et al. (US 2007/0203407), Say et al. (USP #6,175,752), and Gregg (USP#5,262,035), and further in view of Mazza et al. (US 2009/0102678).
As to claims 16 and 31, the above combination fails to expressly teach an alignment pin extending through the proximal portion of the glucose sensor. Mazza teaches an analyte sensor alignment and retention mechanism (Abstract) which makes use of alignment pins on the sensor ([0031], [0046]), to allow accurate positioning and alignment of the sensor with respect to the transmitter unit ([0029]). Accordingly, it would have been obvious to modify the above combination with Mazza to allow for better positioning between the contacting elements so that electrical connection can be better achieved.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/26/26
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