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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/29/2023 is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
p. 13, line 1, “0.117” should read “0.1117” (p.12, line 15);
p. 7, line 3, “NH+” should read “NH4+”;
p 12, lns 1 and 3, “Kread“ should read “K+read“.
Appropriate correction is required.
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 7 -10 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.
Claim 7 recites “wherein said correction algorithm is: NH4 corr = (NH4 read+/ - A * K+ read +/ - B) / C; where A, B C are constants” in lines 2-3. It is unclear what the variables are (e.g. is “NH4 read+” or “NH4 read” a variable? is “K+ read” or “K+ read+” a variable), and consequently, it is unclear if “+”, “/” and “-“ are part of a variable, individual operators, a negative sign, or are they meant to be read together as a plus-or-minus sign. In addition, it is also unclear what the variables represent, and the constants A, B and C are without units. It also appears the equation is inconsistent with what is described in the specification “corrected NH4+ is given by NH4+read – (A* Kread + B)” on p. 13 lines 1-3. Clarification is requested.
Claim 8 recites the limitation “wherein said A is equal to 0.1117, B is equal to 1.293 and C is 0” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, if the applicant intends for the claim to be dependent on claim 7, having C = 0 would render the equation recites in claim 7 undefined.
Claims 9-10 are indefinite because their dependence on claim 8.
Claim Rejections - 35 USC § 103
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Amemiya et al. (US 5580441 A) in view of Longoni et al. (EP2510877A1)(provided in the Applicant’s IDS of 06/29/2023) in view of Burchette et al. (US 6398931 B1) in view of Jenny et al. (Determination of K+ in diluted and undiluted urine with ion-selective electrodes. Mikrochim Acta 74, 309–315 (1980)) and further in view of Walberg (US 3896994 A) as evidenced by Kecskes et al. (HU 199994 B).
Regarding claim 1, Amemiya teaches an analysis device of urine adapted to analyse a sample of untreated urine and to determine the value of the physio-chemical characteristics of said urine sample;
said analysis device (the device in Fig. 4 but with the flow-cell configuration of Fig. 7 specifically with a NH4+ ion selective electrode and a K+ ion selective electrode; it comprises 9, 11, 13, 7A, 7B, 21, 23A, 23B, 25, 27 and sample and standard solution inlets)(col. 10, lns. 1-4) comprising a sampler inlet (the sample inlet in Fig. 7); and
an analysis station (9, 11, 13, 7A, 7B, 21, 23A, 23B, 25, 27)(Figs. 4 and 7) placed in fluid passage connection with said sampler inlet (Fig. 7), suitable for carrying out said analysis of at least part of said portion of fluid to be analysed (col. 10, lns. 1-12) and comprising a plurality of ion-selective electrodes including at least:
an ion-selective electrode K+ for potassium ions (K+)(ISE 23B) comprising an iono-phore (col. 12, lines 20-24), and
an NH4+ ion-selective electrode (ISE 23A);
said analysis station (9, 11, 13, 7A, 7B, 21, 23A, 23B, 25 and 27) being configured to correct the measurements of said NH4+ ion-selective electrode by means of a predetermined correction algorithm (equations 9 and 10) in such a way as to replicate the precision of said ion-selective electrode K+ on said NH4+ ion-selective electrode exclusively through computational calculations (col. 12, lines 20-28 and Figs. 5 and 6. See also columns 10-12).
said ionophore being valinomycin (col. 12, lines 20-24).
Amemiya teaches an ion concentration measuring apparatus for measuring ion concentration in biological samples (col. 1, lns. 8-9). Amemiya teaches the apparatus includes an sample inlet (Fig. 7) but fails to teach the inlet (the sample inlet in Fig. 7) is adapted to be put in a fluid passage connection with a patient and to dose a portion of fluid to be analysed.
However, Longoni teaches a analysis device for measuring ion concentrations in untreated urine. Longoni further teaches the analysis device comprises an sampler 60a (sample inlet) adapted to be put in a fluid passage connection with a patient and to dose a portion of fluid to be analysed (para. 0026). Longoni further teaches the sampler enable urine to reach the device exactly as it comes out of the patient through a catheter (para. 0070).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample inlet taught by Amemiya with the sampler 60a taught by Longoni in order to enable urine sample to reach the measuring apparatus exactly as it comes out of the patient through a catheter with a reasonable expectation of success (Longoni, para. 0070) (MPEP 2143)(I)(G).
In addition Amemiya teaches the ion-selective electrode K+ (ISE 23B) comprise valinomycin as a sensitive material (col. 12, lines 20-24), but does not provide other structural details of the electrode and thus fails to teach the ion-selective electrode K+ for potassium comprising a support body, a first internal reference electrode, a reference solution and a selective element comprising a substrate and a membrane including a silicone polymer and an ionophore polymer.
However, Burchette teaches a ion-selective electrode (Fig. 1). Burchette further teaches the electrode comprising a support body (2), a first internal reference electrode (4), a reference solution (electrolyte solution in compartment 7) and a selective element comprising a substrate (cap 20)(substrate is interpreted as a base that provide structural support) and a membrane (24). Burchette further teaches the electrode allows for the membrane to be removed and replaced (abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the K+ ion-selective electrode (ISE 23B) taught by Amemiya with the ion-selective electrode comprising a support body (Burchette, 2), a first internal reference electrode (Burchette, 4), a reference solution (Burchette, electrolyte solution in compartment 7) and a selective element comprising a substrate (Burchette, cap 20) and a membrane (Burchette, 24) taught Burchette but still comprising valinomycin in order to have the structure details of the ion-selective electrode as well as having an electrode that has a mechanism for membrane to be removed and replaced with a reasonable expectation of success (Burchette, abstract) (MPEP 2143)(I)(G).
In addition, modified Amemiya teaches the electrode has valinomycin as a sensitive material does not explicitly teach structure of the membrane and thus fails to teach the membrane including a silicone polymer and ionophore polymer, and said silicone polymer
However, Jenny teaches an ion-selective electrode based on valinomycin for detecting potassium. Jenny teaches the membrane of the ion-selective electrode comprise silicone polymer (silicone rubber Silopren K-10000)(pp. 309-310, Materials and Methods) and ionophore polymer (valinomycin encapsulated in silicone polymer). In addition Jenny teaches silicone polymer is PDMS (Silopren K1000 is a PDMS, Kecskes teaches “The cross-linked dimethylpolysiloxane can be prepared, inter alia, by crosslinking the silicone monomer SILOPREN K-1000 from the Swiss company FLUKA” on p. 3, 4th paragraph). Jenny further teaches the ion-selective electrode comprising silicone rubber and valinomycin eliminated anion interference (Jenny, p. 314).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane of the selective member of the ion-selective electrode for potassium taught by modified Amemiya with the membrane including a silicone polymer (Jenny, silicone rubber Silopren K-10000) and ionophore polymer (Jenny, valinomycin encapsulated in silicone polymer), and said silicone polymer being polydimethylsiloxane (Silopren K1000 is PDMS, Kecskes, p. 3) as taught by Jenny in order to prepare a ion-selective electrode to determine K+ concentration without anion interference with a reasonable expectation of success (Jenny, p. 314) (MPEP 2143)(I)(G).
In addition, modified Amemiya teaches the substrate (cap 20 of Burchette) is made of epoxy or Delrin and thus fails teach said substrate being a PVC structural support.
However, Amemiya teaches electrode 55A, a solid state ion selective electrode, has a base body (case) made of polyvinyl chloride (col. 16, lns. 44-45). Furthermore, Walberg teaches an electrode tip cap (10)(col. 8, lns. 16-17) that is made material such as polyvinylchloride or Delrin (Walberg, col. 8, lns. 10-16).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of cap 20 of Burchette (substrate) taught by modified Amemiya with polyvinyl chloride because one of ordinary skill in the art would accordingly have recognized whether Delrin or polyvinylchloride would result in the predictable result of providing a suitable material for the cap 20 of Burchette.
The teachings of modified Amemiya would yield said substrate (cap 20) being a PVC structural support (cap 20 is made with PVC in modified Amemiya).
Regarding claim 2, modified Amemiya teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Amemiya further teaches wherein said silicone polymer is polydimethylsiloxane cured at room temperature (Jenny, p. 310, “solvent is allowed to slowly evaporate.” If it is found that Jenny does not teach PDMS cured at room temperature, then the examiner put for the following rejection. Jenny teaches the PDMS is cured as the solvent methyl chloride, which has a boiling point of ~40 oC, is being slowly evaporated. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the temperature of the curing process taught by Jenny to room temperature in order for the solvent to evaporate slowly (Jenny, p. 310) with a reasonable expectation of success (MPEP 2143)(I)(G).)
Regarding claim 3, modified Amemiya teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Amemiya teaches wherein said membrane comprises a percentage by weight of said silicone polymer comprised between 97.5% and 98% (Jenny, p. 310, Silopren and Siloprenvernetzer crosslinkers adds up to be 97.5%).
Regarding claim 4, modified Amemiya teaches all of the elements of the current invention as stated above with respect to claim 1, wherein said membrane comprises a percentage by weight of said ionophore comprised between 2% and 2.5% (Jenny, p. 310, wt. 2.5%).
Regarding claim 5, modified Amemiya teaches all of the elements of the current invention as stated above with respect to claim teaches all of the elements of the current invention as stated above with respect to claim 1, Modified Amemiya further teaches wherein said membrane comprises, internally, a structural support (the network cavities of the crosslinked PDMS provides a structural support to the ionophore).
Regarding claim 6, modified Amemiya teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Amemiya teaches the membrane is 100 mm (Jenny, p. 310, 2nd para.) and thus fails to teach wherein said membrane has a thickness of between 250 and 300 micrometres.
However, Amemiya teaches wherein the membrane thickness is a result-effective variable. Specifically, Amemiya teaches that membrane thickness influences selectivity against interference ions (col. 19, lns. 31-35). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the membrane thickness to between 250 and 300 micrometres to obtain desirable selectivity because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Prior Art
Claim 7 -10 are not being treated with prior art. MPEP 2173.06(II) states, "where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In reSteele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims." This is the case here and the examiner points to the rejection of claims 7-10 under 112(b) supra. The examiner notes that claims 9 and 10 contain, besides the limitation of claim 8, the same limitations as claims 2 and 3, respectively, and the limitations of claim 2 and 3 are treated with prior art as discussed above.
Conclusion
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758