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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 2, 2025 has been entered.
This Office action is responsive to an amendment filed September 2, 2025. Claims 1-13 & 15-22 are pending. Claims 1, 12 and 20 have been amended. New claim 22 has been added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-5, 9, 12 & 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (WO 2010/045247) (“Potts” hereinafter) in view of Peyser et al. (US 2006/0004271) (“Peyser” hereinafter).
In regards to claim 1, Potts discloses a method of manufacturing a biochemical sensor 100, the method comprising:
forming a fluid region 116 in a microfluidic layer 104 (i.e., container layer is configured to hold a microliter or less of sweat, see par 0068) (see at least fig. 1b and par 0049, 0058 & 0092);
forming a reference electrode (not shown) within the fluid region 116 on a planar surface of an electrode layer (i.e., hydrophilic material coating when layers 102, 104 are hydrophobic, see par 0072 & 0089) (i.e., electrodes may be applied to channel layer 102 or vent layer 106, see par 0077-0078) (see at least par 0015, 0019, 0079 & 0089-0090);
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forming a biochemical sensor electrode (122, 124) adjacent to the reference electrode (not shown) and within the fluid region 116 on the planar surface, wherein the reference electrode (not shown) and the biochemical sensor electrode (122, 124) are configured to form an electrode array for measuring a response current (see at least fig. 1b and par 0015, 0019, 0077-0079 & 0089);
forming a selective membrane (i.e., sweat permeable membrane to collect only sweat excreted by the sweat pores and prevent collecting glucose from other sources) (see at least par 0055);
forming an enzymatic material 120 including a biochemical sensing material (i.e., glucose oxidase and/or glucose dehydrogenase) (see at least par 0073-0074 & 0077);
bonding the electrode layer (i.e., hydrophilic material coating when layers 102, 104 are hydrophobic, see par 0072 & 0089) directly to the microfluidic layer 104 such that the fluid region 116 is encompassed on a top side thereof by the electrode layer (i.e., hydrophilic material coating when layers 102, 104 are hydrophobic, see par 0072 & 0089) and on sides thereof by the microfluidic layer 104 (see at least par 0092);
forming a barrier layer 102 on the microfluidic layer 104, wherein the barrier layer 102 has a first planar surface that is in contact with and further encompasses the fluid region 116 on a bottom side thereof and wherein the barrier layer 102 includes an opening 114 that is configured to draw fluid into the fluid region 116 when a second planar surface of the barrier layer 102 opposite the first planar surface is in contact with human or animal skin, and wherein the enzymatic material 120 is configured to be exposed to the fluid drawn into the fluid region 116 by the opening 114 (see at least fig. 1b and par 0049, 0052, 0065 & 0067);;
configuring terminals 118 of the electrode array to receive a constant current from a power supply (i.e., a battery within the patch itself, see par 0096) (see at least fig. 1a and par 0062-0064, 0079, 0086 & 0090-0091); and
configuring the terminals 118 of the electrode array to receive the response current corresponding to the constant current from the power supply (i.e., a battery within the patch itself, see par 0096) (see at least par 0083-0084 & 0096).
Potts discloses a method, as described above, that fails to explicitly teach a method comprising forming a selective membrane on the biochemical sensor electrode; forming an enzymatic material including a biochemical sensing material on the selective membrane; wherein the selective membrane is configured permit passage of an electroactive material corresponding to the sensed biochemical from the enzymatic material for detection by the biochemical sensor electrode while rejecting electroactive interferents.
However, Peyser teaches that it is known to provide a method comprising forming a selective membrane (i.e., charge-selective membrane) on the biochemical sensor electrode; wherein the selective membrane (i.e., charge-selective membrane) is configured permit passage of an electroactive material (i.e., hydrogen peroxide) corresponding to the sensed biochemical from the enzymatic material for detection by the biochemical sensor electrode while rejecting electroactive interferents (i.e., ascorbate, urate and other material) (see at least par 0080-0083).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts comprising forming a selective membrane on the biochemical sensor electrode as taught by Peyser; forming the enzymatic material including a biochemical sensing material as taught by Potts, on the selective membrane as taught by Peyser; wherein the selective membrane is configured permit passage of an electroactive material corresponding to the sensed biochemical from the enzymatic material for detection by the biochemical sensor electrode while rejecting electroactive interferents as taught by Peyser since such a modification would amount to applying a known technique (i.e., adding a charge-selective membrane as taught by Peyser) to a known device (i.e., as taught by Potts) ready for improvement to achieve a predictable result such as increasing the sensitivity of the device by allowing passage of hydrogen peroxide, for example, while excluding ascorbate, urate and other material, which can react directly with the sensor to produce a spurious signal (see at least par 0082-0083 of Peyser)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 4, Potts discloses the method of claim 1, wherein the forming the fluid region 116 comprises removing a portion of the microfluidic layer 104 to form a sensor chamber (i.e., container layer is configured to hold a microliter or less of sweat, see par 0068) (see at least fig. 1b and par 0049, 0058 & 0092).
In regards to claim 5, Potts discloses the method of claim 1, wherein the forming the biochemical sensor electrode (122, 124) comprises depositing a gold electrode material (see at least par 0075) on the electrode layer (i.e., hydrophilic material coating when layers 102, 104 are hydrophobic, see par 0072 & 0089).
In regards to claim 9, Potts discloses the method of claim 1, wherein the biochemical sensing material (i.e., glucose oxidase and/or glucose dehydrogenase) comprises a glucose sensing material (see at least par 0073-0074 & 0077).
In regards to claim 12, Potts discloses a device comprising:
a reference electrode (not shown) disposed on a planar surface of an electrode layer (i.e., hydrophilic material coating when layers 102, 104 are hydrophobic, see par 0072 & 0089) (see at least fig. 1b and par 0015, 0019, 0079 & 0089-0090);
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a biochemical sensor electrode (122, 124) disposed adjacent to the reference electrode (not shown) on the planar surface, the biochemical sensor electrode (122, 124) and reference electrode (not shown) being commonly disposed in a fluid region 116 that is encompassed on sides thereof by a microfluidic layer 104 disposed on the planar surface, wherein the reference electrode (not shown) and the biochemical sensor electrode (122, 124) are configured to form an electrode array for measuring a response current (see at least fig. 1b and par 0015, 0019, 0079 & 0089-0090);
a barrier layer 102 on the microfluidic layer 104, wherein the barrier layer 102 has a first planar surface that is in contact with and further encompasses the fluid region 116 on a bottom side thereof, and wherein the barrier layer 102 includes an opening 114 that is configured to draw fluid into the fluid region 116 when a second planar surface of the barrier layer 102 opposite the first planar surface is in contact with human or animal skin (see at least fig. 1b and par 0049, 0052, 0065 & 0067);
a selective membrane (i.e., sweat permeable membrane to collect only sweat excreted by the sweat pores and prevent collecting glucose from other sources) impermeable to at least one biochemical interferent (i.e., glucose from other sources such as via desquamation or diffusion) (see at least par 0055);
an enzymatic layer 120 electrically responsive to a biochemical, wherein the enzymatic material 120 is configured to be exposed to the fluid drawn into the fluid region 116 by the opening 114 (see at least par 0073-0074 & 0077); and
terminals 118 of the electrode array (see at least fig. 1a and par 0062-0064, 0079, 0086 & 0090-0091) that are configured to receive a constant current from a power supply (i.e., a battery within the patch itself, see par 0096), wherein the terminals 118 of the electrode array are further configured to receive the response current corresponding to the constant current from the power supply (i.e., a battery within the patch itself, see par 0096).
Potts discloses a device, as described above, that fails to explicitly teach a device comprising a selective membrane disposed on the biochemical sensor electrode; an enzymatic layer disposed on the selective membrane; wherein the selective membrane is configured permit passage of an electroactive material corresponding to the sensed biochemical from the enzymatic material for detection by the biochemical sensor electrode while rejecting electroactive interferents.
However, Peyser teaches that it is known to provide a device comprising a selective membrane (i.e., charge-selective membrane) disposed on the biochemical sensor electrode; wherein the selective membrane (i.e., charge-selective membrane) is configured permit passage of an electroactive material (i.e., hydrogen peroxide) corresponding to the sensed biochemical from the enzymatic material for detection by the biochemical sensor electrode while rejecting electroactive interferents (i.e., ascorbate, urate and other material) (see at least par 0080-0083).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Potts comprising a selective membrane disposed on the biochemical sensor electrode as taught by Peyser; the enzymatic layer as taught by Potts, disposed on the selective membrane as taught by Peyser; wherein the selective membrane is configured permit passage of an electroactive material corresponding to the sensed biochemical from the enzymatic material for detection by the biochemical sensor electrode while rejecting electroactive interferents as taught by Peyser since such a modification would amount to applying a known technique (i.e., adding a charge-selective membrane as taught by Peyser) to a known device (i.e., as taught by Potts) ready for improvement to achieve a predictable result such as increasing the sensitivity of the device by allowing passage of hydrogen peroxide, for example, while excluding ascorbate, urate and other material, which can react directly with the sensor to produce a spurious signal (see at least par 0082-0083 of Peyser)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 19, Potts discloses the device of claim 12, further comprising: the microfluidic layer 104 disposed on the electrode layer (i.e., hydrophilic material coating when layers 102, 104 are hydrophobic, see par 0072 & 0089) and comprising a sensor chamber region 116 disposed at least partially surrounding at least one of the reference electrode (not shown) and the biochemical sensor electrode (122, 124) (i.e., container layer 104 is configured to hold a microliter or less of sweat, see par 0068) (see at least fig. 1b and par 0049, 0058 & 0092).
In regards to claim 20, Potts discloses a method of electrically detecting a biochemical, the method comprising:
contacting a first planar surface of a barrier layer 102 of a biochemical sensor 100 to a biological surface (i.e., skin) (see at least abstract, fig. 1b and par 0015 & 0017-0018);
configuring the barrier layer 102 with an opening 114 to into a microfluidic chamber of the biochemical sensor 100 in contact with and encompassed on a bottom side thereof by a second planar surface of the barrier layer 102 opposite the first planar surface, wherein the opening 114 is configured to draw biofluid from the biological surface (i.e., skin) into the microfluidic chamber when the barrier layer 102 is in contact with the biological surface (i.e., skin) (see at least fig. 1b and par 0065 & 0067);
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contacting the biofluid drawn from the biological surface (i.e., skin) at a biochemical sensor electrode (122, 124) of the biochemical sensor 100, wherein the biochemical sensor electrode (122, 124) and a reference electrode (not shown) are commonly disposed in the microfluidic chamber that is encompassed on sides thereof by a microfluidic layer 104, wherein the reference electrode (not shown) and the biochemical sensor electrode (122, 124) are configured to form an electrode array for measuring a response current (see at least fig. 1b and par 0015, 0019, 0077-0079 & 0089);
filtering an interferent (i.e., glucose from other sources such as via desquamation or diffusion, see par 0055) at a selective membrane (i.e., sweat permeable membrane to collect only sweat excreted by the sweat pores and prevent collecting glucose from other sources) (see at least par 0015);
applying a constant current from a power supply (i.e., a battery within the patch itself, see par 0096) to a first electrode terminal of the electrode array (see at least fig. 1a and par 0062-0064, 0079, 0086 & 0090-0091);
obtaining the response current associated with the biofluid at the biochemical sensor electrode (122, 124) at a second electrode terminal of the electrode array, wherein the response current corresponds to the constant current applied from the power supply (i.e., a battery within the patch itself, see par 0096) (see at least fig. 1b and par 0015, 0019, 0077-0079 & 0089); and
generating a quantitative biochemical response based at least partially on the response current (see at least fig. 1b and par 0015, 0019, 0077-0079 & 0089).
Potts discloses a method, as described above, that fails to explicitly teach a method comprising filtering an interferent at a selective membrane disposed between the biochemical sensor electrode and the biological surface, wherein the selective membrane is configured permit passage of an electroactive material corresponding to the sensed biochemical while rejecting the interferents.
However, Peyser teaches that it is known to provide a method comprising filtering an interferent at a selective membrane disposed between the biochemical sensor electrode and the biological surface, wherein the selective membrane is configured permit passage of an electroactive material (i.e., hydrogen peroxide) corresponding to the sensed biochemical while rejecting the interferents (i.e., ascorbate, urate and other material) (see at least par 0080-0083).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts comprising filtering an interferent at a selective membrane disposed between the biochemical sensor electrode and the biological surface, wherein the selective membrane is configured permit passage of an electroactive material corresponding to the sensed biochemical while rejecting the interferents as taught by Peyser since such a modification would amount to applying a known technique (i.e., adding a charge-selective membrane as taught by Peyser) to a known device (i.e., as taught by Potts) ready for improvement to achieve a predictable result such as increasing the sensitivity of the device by allowing passage of hydrogen peroxide, for example, while excluding ascorbate, urate and other material, which can react directly with the sensor to produce a spurious signal (see at least par 0082-0083 of Peyser)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 21, Potts discloses the method of claim 20, further comprising applying an iontophoresis current to the biological surface (i.e., skin) to stimulate release of the biofluid from the biological surface (i.e., skin) (see at least par 0054).
In regards to claim 22, Potts discloses the method of claim 1, as described above, that fails to explicitly teach a method wherein the electroactive material comprises hydrogen peroxide. However, Peyser teaches that it is known to provide a method wherein the electroactive material comprises hydrogen peroxide (see at least par 0080-0083). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts wherein the electroactive material comprises hydrogen peroxide. However, Peyser teaches that it is known to provide a method wherein the electroactive material comprises hydrogen peroxide as taught by Peyser since such a modification would amount to applying a known technique (i.e., adding a charge-selective membrane as taught by Peyser) to a known device (i.e., as taught by Potts) ready for improvement to achieve a predictable result such as increasing the sensitivity of the device by allowing passage of hydrogen peroxide, for example, while excluding ascorbate, urate and other material, which can react directly with the sensor to produce a spurious signal (see at least par 0082-0083 of Peyser)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 2-3, 16 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (WO 2010/045247) (“Potts” hereinafter) in view of Peyser et al. (US 2006/0004271) (“Peyser” hereinafter) further in view of Li et al. (US 2014/0012115) (“Li” hereinafter).
In regards to claim 2, Potts as modified by Peyser discloses the method of claim 1, that fails to explicitly teach a method further comprising: mixing the biochemical sensing material with a stabilizer solution to form the enzymatic material including the biochemical sensing material. However, Li teaches that it is known to provide a method further comprising: mixing the biochemical sensing material (i.e., glucose oxidase) with a stabilizer solution (i.e., albumin) to form the enzymatic material including the biochemical sensing material (see at least par 0044 & 0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser further comprising: mixing the biochemical sensing material with a stabilizer solution to form the enzymatic material including the biochemical sensing material as taught by Li since such a modification would amount to applying a known technique (i.e. as taught by Li) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as modulating factors such as the retained biological activity of the enzyme, its mechanical and/or operational stability--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Potts as modified by Peyser discloses the method of claim 1, that fails to explicitly teach a method wherein the stabilizer solution comprises a bovine serum albumin stabilizer solution. However, Li teaches that it is known to provide a method wherein the stabilizer solution comprises a bovine serum albumin stabilizer solution (see at least par 0044 & 0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser wherein the stabilizer solution comprises a bovine serum albumin stabilizer solution as taught by Li since such a modification would amount to applying a known technique (i.e. as taught by Li) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as modulating factors such as the retained biological activity of the enzyme, its mechanical and/or operational stability--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 16, Potts as modified by Peyser discloses the device of claim 12, that fails to explicitly teach a device wherein the enzymatic layer includes glucose oxide and a stabilizer material, and is electrically responsive to contact with glucose. However, Li teaches that it is known to provide a device wherein the enzymatic layer includes glucose oxide and a stabilizer material (i.e., albumin), and is electrically responsive to contact with glucose (see at least par 0044 & 0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser wherein the enzymatic layer includes glucose oxide and a stabilizer material, and is electrically responsive to contact with glucose as taught by Li since such a modification would amount to applying a known technique (i.e. as taught by Li) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as modulating factors such as the retained biological activity of the enzyme, its mechanical and/or operational stability--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 18, Potts as modified by Peyser discloses the device of claim 12, wherein the enzymatic layer includes lactate oxide and a stabilizer material, and is electrically responsive to contact with lactate. However, Li teaches that it is known to provide a device wherein the enzymatic layer includes lactate oxide and a stabilizer material (i.e., albumin), and is electrically responsive to contact with lactate (see at least par 0044 & 0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser wherein the enzymatic layer includes glucose oxide and a stabilizer material, and is electrically responsive to contact with glucose as taught by Li since such a modification would amount to applying a known technique (i.e. as taught by Li) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as modulating factors such as the retained biological activity of the enzyme, its mechanical and/or operational stability--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 6-8, 13 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (WO 2010/045247) (“Potts” hereinafter) in view of Peyser et al. (US 2006/0004271) (“Peyser” hereinafter) further in view of Zhang et al. (US 2014/0197042) (“Zhang” hereinafter).
In regards to claim 6, Potts as modified by Peyser discloses the method of claim 5, that fails to explicitly teach a method wherein the forming the biochemical sensor electrode further comprises depositing a carbon nanotube electrode material on the gold electrode material. However, Zhang teaches that it is known to provide a method wherein the forming the biochemical sensor electrode further comprises depositing a carbon nanotube electrode material on the gold electrode material (see at least abstract and par 0009, 0012, 0019, 0021, 0037 & 0039). Therefore, since Potts discloses a method wherein the one more electrodes are made from more than one conductive material including gold, platinum and carbon (see at least par 0075 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Potts as modified by Peyser wherein the forming the biochemical sensor electrode further comprises depositing a carbon nanotube electrode material on the gold electrode material as taught by Zhang since such a modification would amount to applying a known technique (i.e. as taught by Zhang) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as rendering the results more accurate and reliable without requiring any additional chemical reactions or optical detection means to detect the reaction products (see at least par 0037 & 0039 of Zhang)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 7, Potts as modified by Peyser discloses the method of claim 6, wherein the forming the biochemical sensor electrode further comprises depositing a platinum electrode material on the carbon nanotube electrode material. However, Zhang teaches that it is known to provide a method wherein the forming the biochemical sensor electrode further comprises depositing a platinum electrode material on the carbon nanotube electrode material (see at least abstract and par 0009, 0012, 0019, 0021, 0037 & 0039). Therefore, since Potts discloses a method wherein the one more electrodes are made from more than one conductive material including gold, platinum and carbon (see at least par 0075 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Potts as modified by Peyser wherein the forming the biochemical sensor electrode further comprises depositing a platinum electrode material on the carbon nanotube electrode material as taught by Zhang since such a modification would amount to applying a known technique (i.e. as taught by Zhang) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as rendering the results more accurate and reliable without requiring any additional chemical reactions or optical detection means to detect the reaction products (see at least par 0037 & 0039 of Zhang)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 8, Potts as modified by Peyser discloses the method of claim 1, wherein the forming the reference electrode further comprises depositing a gold electrode material on the electrode layer, and depositing a silver chloride electrode material on the gold electrode material. However, Zhang teaches that it is known to provide a method wherein the forming the reference electrode further comprises depositing a gold electrode material on the electrode layer, and depositing a silver chloride electrode material on the gold electrode material (see at least abstract and par 0009, 0012, 0019, 0021, 0037 & 0039). Therefore, since Potts discloses a method wherein the one more electrodes are made from more than one conductive material including gold, platinum, silver and carbon (see at least par 0075 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Potts as taught by Peyser wherein the forming the reference electrode further comprises depositing a gold electrode material on the electrode layer, and depositing a silver chloride electrode material on the gold electrode material as taught by Zhang since Zhang teaches that a combination of gold and silver chloride would be suitable for a working electrode (see at least par 0019 thereof).
In regards to claim 13, Potts as modified by Peyser discloses the device of claim 12, that fails to explicitly teach a device further comprising: a carbon nanotube electrode material disposed on the biochemical sensor electrode; and a platinum electrode material disposed on the carbon nanotube electrode material. However, Zhang teaches that it is known to provide a device further comprising: a carbon nanotube (SWNT) electrode material disposed on the biochemical sensor electrode (see at least abstract and par 0009, 0012, 0019, 0021, 0037 & 0039); and a platinum electrode material disposed on the carbon nanotube electrode material (see at least abstract and par 0009, 0012, 0019, 0021, 0037 & 0039). Therefore, since Potts discloses a method wherein the one more electrodes are made from more than one conductive material including gold, platinum, silver and carbon (see at least par 0075 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Potts as modified by Peyser further comprising: a carbon nanotube electrode material disposed on the biochemical sensor electrode; and a platinum electrode material disposed on the carbon nanotube electrode material as taught by Zhang since such a modification would amount to applying a known technique (i.e. as taught by Zhang) to a known device (i.e. as taught by Potts) ready for improvement to achieve a predictable result such as rendering the results more accurate and reliable without requiring any additional chemical reactions or optical detection means to detect the reaction products (see at least par 0037 & 0039 of Zhang)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Potts discloses the device of claim 13, further comprising: the selective membrane (i.e., sweat permeable membrane to collect only sweat excreted by the sweat pores and prevent collecting glucose from other sources, see par 0055) disposed on the platinum electrode (i.e., electrode may be made from one or more of carbon and platinum, see par 0075).
Claim(s) 10 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (WO 2010/045247) (“Potts” hereinafter) in view of Peyser et al. (US 2006/0004271) (“Peyser” hereinafter) further in view of Collier et al. (US 2009/0159442) (“Collier” hereinafter).
In regards to claim 10, Potts as modified by Peyser discloses the method of claim 1, that fails to explicitly teach a method wherein the biochemical sensing material comprises a choline sensing material. However, Collier teaches that it is known to provide wherein the biochemical sensing material comprises a choline sensing material (see at least par 0024 & 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser wherein the biochemical sensing material comprises a choline sensing material as taught by Collier in order to detect choline oxidase-based biological conditions.
In regards to claim 17, Potts as modified by Peyser discloses the device of claim 12, that fails to explicitly teach a device wherein the enzymatic layer includes choline oxide and a stabilizer material, and is electrically responsive to contact with choline. However, Collier teaches that it is known to provide a device wherein the enzymatic layer includes choline oxide (see at least par 0024 & 0049) and a stabilizer material (i.e., albumin), and is electrically responsive to contact with choline (see at least par 0025, 0055 & 0064). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser wherein the biochemical sensing material comprises a choline sensing material as taught by Collier in order to modulate factors such as the retained biological activity of the enzyme, its mechanical and/or operational stability.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (WO 2010/045247) (“Potts” hereinafter) in view of Peyser et al. (US 2006/0004271) (“Peyser” hereinafter) further in view of Moser et al. (US 2005/0205422) (“Moser” hereinafter).
Potts as modified by Peyser discloses the method of claim 1, wherein the biochemical sensing material comprises a lactate sensing material.
However, Moser teaches that it is known to provide a method wherein the biochemical sensing material comprises a lactate sensing material (see at least par 0018, 0025, 0030-0032 & 0037).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Potts as modified by Peyser wherein the biochemical sensing material comprises a lactate sensing material as taught by Moser since such a modification would amount to a simple substitution of one known element (i.e., the biochemical sensing material as taught by Potts) for another (i.e., the biochemical sensing material as taught by Moser) to obtain predictable results such as detecting a current indicative of lactate as an analyte--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13 & 15-22 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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