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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-2, 4-9, 13-16, and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauks (US 7,767,068) in view of Satou (JPH08225626), and further in view of Murray (U.S. 4,653,499).
Regarding claims 1, 7-9, 13-14, and 16, Lauks teaches a potentiometric reference sensor (Fig. 2A; col. 26, ll. 20-22: planar potentiometric dissolved carbon dioxide sensor) having a multi-layer reagent matrix comprising:
a first layer (Fig. 2A; col. 26, ll. 31-32: hydrophilic matrix layers 87 and 88) comprising: a salt (col. 26, ll. 32-33: containing chloride and bicarbonate salts); and
a second layer (Fig. 2A; col. 26, l. 38: outer membrane 89) disposed over the first layer, wherein the second layer has water vapor permeability (col. 26, l. 7: gas permeable membranes; ll. 11-12: permit rapid water vapor permeation) and ion permeability (col. 7, ll. 42-43: the gas permeable over-layer is rendered appropriately ion conducting).
Lauks does not disclose the first layer having an amorphous structure comprising at least one amorphous polymer (claim 1) or wherein the at least one amorphous polymer comprises an amorphous polysaccharide (claim 7) or wherein the amorphous polysaccharide comprises at least one of pullulan, dextran, and amylose (claim 8) or wherein the amorphous polysaccharide is pullulan (claim 9).
However, Satou teaches an ion conductive polymer solid electrolyte used as an electrochemical material (¶1). In order to ensure high ionic conductivity at room temperature, it is important to have many amorphous regions in the matrix polymer where the ionic conductor can easily move, and to lower the glass transition temperature of the polymer (¶16). For example, the polymer is intertwined with the polymer chain of the hydroxyalkyl polysaccharide or hydroxyalkyl polysaccharide derivative to form a strong semi-IPN three-dimensional network structure, but the crystal structure is not formed and the matrix is amorphous (¶75). Examples of polysaccharides include pullulan, amylose, dextran, and the like (¶34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lauks by substituting its hydrophilic matrix layers with the amorphous one comprising an amorphous polymer as taught by Satou because amorphous polymer is a suitable electrochemical material forming the polymer matrix where the ionic conductor can easily move to ensure high ionic conductivity at room temperature ([0016] lines 1-3).
Lauks does not disclose wherein the second layer is hydrophobic (claim 13) or wherein the second layer is configured as a semipermeable cover membrane (claim 14) or wherein the second layer comprises a cellulose acetate butyrate polymer (claim 16).
However, Murray teaches a reference electrode with membranes applied to the outer surface (col. 3, ll. 26-28). As shown in Fig. 1, a first salt layer and a second salt layer 14 are applied to the outer surface of the conductive element (Fig. 1; col. 4, ll. 35-46). For being used as a reference electrode, a hydrophobic outer layer 16 is formed upon layer 14 (col. 5, ll. 26-27), which is a membrane not selective with respect to ion transport by a particular ion, thus allowing the structure to operate as a reference electrode (col. 5, ll. 27-31). In the preferred embodiment, the substance used as the membrane is cellulose acetate butyrate (col. 5, ll. 31-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lauks by substituting the outer membrane with the hydrophobic one made of cellulose acetate butyrate as taught by Murray because cellulose acetate butyrate is a suitable outer layer material for reference electrode which is not selective with respect to ion transport by a particular ion and thus allowing the structure to operate as a reference electrode (Col. 5, lines 27-31). The suggestion for doing so would have been that cellulose acetate butyrate is a suitable material for being outer layer of a reference electrode and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Further, since the material of the outer membrane, cellulose acetate butyrate, is the same material disclosed in the specification, it must have the same property of being semipermeable having water vapor permeability and ion permeability (PGpub ¶¶19-20). MPEP 2112.01(I).
Regarding claim 2, Lauks teaches wherein the first layer is hydrophilic (col. 26, ll. 31-32: hydrophilic matrix layers 87 and 88).
Regarding claim 4, the designation “wherein the at least one amorphous polymer is characterized such that, when oversaturated with the salt, the at least one amorphous polymer and the salt do not separate when the first layer is formed” is deemed to be inherent to the amorphous polysaccharides because the same material with the same structure must have the same property. MPEP 2112.01(I). Here, Lauks in view of Satou and Murray teaches a salt layer (Lauks, Fig. 2A; col. 26, ll. 31-32: hydrophilic matrix layers 87 and 88 containing chloride and bicarbonate salts) including an amorphous polymer matrix (Satou, ¶12; e.g., ¶23: polysaccharide) containing ion-conductive metal salts (¶11), and thus when the amorphous polysaccharides are oversaturated with the salt, they are not separate when the first layer is formed.
Regarding claims 5-6, Lauks, Satou, and Murray disclose all limitations of claim 1. Lauks and Murray do not teach wherein the at least one amorphous polymer comprises only one amorphous polymer (claim 5) or wherein the at least one amorphous polymer comprises a plurality of different amorphous polymers (claim 6).
However, Satou teaches a diester compound containing a polyoxyalkylene component and a monoester compound containing a polymethoxyoxyalkylene component are polymerized to form a three-dimensional network structure, the hydroxyalkyl polysaccharide molecule (¶25). Thus, the three-dimensional network structure is one amorphous polymer as a whole and it comprises a plurality of different polymers due to the different polymerizable components.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lauks by using one amorphous polymer (i.e., the three-dimensional network structure) or a plurality different amorphous polymers (i.e., the polymer made of polyoxyalkylene and polymethoxyoxyalkylene components) as taught by Satou because it is known in the prior art that an amorphous three-dimensional network structure of polysaccharide(s) containing ion conductive metal salt is suitable material for being the ion conductive polymer solid electrolyte (¶24). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Regarding claim 15, Lauks teaches wherein the second layer physically contacts the first layer (Fig. 2A)
Regarding claim 19, Lauks teaches further comprising a reference electrode (Fig. 2A; col. 26, ll. 25-27: silver rod element 83A with silver chloride over-layer 84A is the internal reference electrode), wherein the first layer is disposed over the reference electrode (Fig. 2A).
Regarding claim 20, Lauks teaches wherein the first layer physically contacts the reference electrode (Fig. 2A).
Regarding claim 21, Lauks teaches wherein the reference electrode is configured as a silver-silver chloride electrode (col. 26, ll. 25-27: silver rod element 83A with silver chloride over-layer 84A is the internal reference electrode).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauks in view of Satou and Murray, and further in view of Chih-hui (US 2002/0003087).
Regarding claim 3, Lauks, Satou, and Murray teaches all limitations of claim 1, but fail to teach wherein the first layer has a polymer concentration in a range of about 0.02% (w/w) to about 7.0% (w/w).
However, Chih-hui teaches an electrochemical electrode test strip (¶3) comprising conductive films 302 (Fig. 3B-C; ¶31) including a reference electrode 309 and a working electrode 310 (¶31), and a reactive film 303 disposed thereon the conductive films 302 (Fig. 3C; ¶30). The reagent solution of the reactive film 303 contains an active species and a mixed solution, which contains a polymer, an electron medium, a nonionic surfactant and a buffer solution (¶33). The polymer can be chosen from PVP, PEG, gelatin, dextran, PVA, methylcellulose, carboxymethyl cellulose, albumin, chitin or a combination thereof (¶34; here, gelatin, dextran, methylcellulose, carboxymethyl cellulose, and chitin are all polysaccharides). About 1-4 wt% of polymer contributes to the reagent solution of the reactive film 303 (¶34), which overlaps the claimed range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lauks, Satou, and Murray by adjusting the polysaccharide concentration within the claimed range because it is a suitable range for polysaccharide, i.e., polymer matrix, to contribute to the reagent layer, the reactive film. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauks in view of Satou and Murray, and further in view of Marett (US 2008/0149482).
Regarding claims 10-12, Lauks, Satou, and Murray disclose all limitations of claim 1, but fail to teach wherein the salt is characterized as having equi-mobility cations and anions (claim 10) or wherein the salt comprises at least one of potassium chloride, potassium nitrate, ammonium chloride, and lithium acetate (claim 11) or wherein the salt is potassium chloride (claim 12).
However, Marett teaches reference electrodes for potentiometric measurement of ion concentration using silver/silver chloride element combined with a saturated solution of potassium chloride (KCl) for the development of a stable potential with respect to a sensing electrode ([Abstract] lines 1-5). The salt KCl is preferred because of it is almost equitransferent and thus minimizes the diffusion potential set up between the reference solution and the solution being tested ([Abstract] lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chih-hui by substituting the salt, potassium ferricyanide, with potassium chloride KCl as taught by Marett because KCl is almost equitransferent, i.e., having equi-mobility cations and anions, and thus minimizes the diffusion potential during the potentiometric measurement of ion concentration ([Abstract] lines 1-8) for the development of a stable potential with respect to a sensing electrode ([Abstract] lines 1-5).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauks in view of Satou and Murray, and further in view of Kulhanek (WO 1989/006855).
Regarding claim 22, Lauks, Satou, and Murray disclose all limitations of claim 19, but fail to teach further comprising an electrically insulating substate, wherein the reference electrode is disposed over the electrically insulating substrate.
However, Kulhanek teaches an electrode including an insulating base-plate or sheet 1; a layer 2 of electrically conductive metal; a layer 7 of an insoluble salt of the metal of the layer 2; a layer 8 of reference electrolyte; and finally a mask 4 made of a hydrophobic insulative material (Fig. 1; p. 9, last para.). Thus, Kulhanek teaches a reference electrode (Fig. 1: 2 and 7; p. 11, p. 2: to coat a silver layer with an insoluble silver salt, e.g., AgCl) disposed over the electrically insulating substrate (Fig. 1: insulating base-plate or sheet 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lauks, Satou, and Murray by disposing the reference electrode over the electrically insulating substrate as taught by Kulhanek because it is known as a suitable electrode configuration in the prior art. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 23, Lauks teaches further comprising at least one electrically conductive layer (Fig. 2A; col. 26, l. 24: conductor element 82A) disposed over the electrically insulating substrate (Examiner notes the term “over” depends on the orientation of the device) and in electrical connection with the reference electrode (Fig. 2A: indicating the conductor elements 82A in electrical connection with the reference electrode 83A/84A).
Allowable Subject Matter
Claim(s) 17-18 and 24-25 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose nor render obvious all of the cumulative limitations of claims 17-18 and 22-24 with particular attention to the limitations:
wherein the second layer is chlorosulfonated polyethylene (claim 17) or the second layer is chlorosulfonated polyethylene (claim 18);
wherein the first layer and the second layer are at least partially disposed within the well opening (claim 24).
Here, Lauks teaches a potentiometric reference sensor (Fig. 2A: potentiometric dissolved carbon dioxide sensor) having a multi-layer reagent matrix comprising: a first layer (Fig. 2A: hydrophilic matrix layers 87 and 88) comprising: a salt (col. 26, ll. 32-33: containing chloride and bicarbonate salts); and a second layer (Fig. 2A: outer membrane 89) disposed over the first layer, wherein the second layer has water vapor permeability (col. 26, ll. 7, 11-12) and ion permeability (col. 7, ll. 42-43). However, Lauks does not teach the outer layer is chlorosulfonated polyethylene. Kulhanek teaches a laminated reference electrode (Fig. 1: layers 2 and 7, Ag/AgCl) disposed on an electrically insulating substrate (Fig. 1: the insulating base-plate or sheet 1), and at least one electrically insulating layer (Fig. 1: mask 4 made of a hydrophobic insulative material) disposed over the electrically insulating substrate and having a well opening (Fig. 1: hole/window 4a) formed therein (Fig. 1). However, neither Lauks nor Kulhanek teaches both the first layer and the second layer are at least partially disposed within the well opening.
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795
