DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specifications
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification [0006] is contrary to the disclosure of claim 11 which reads, “The method of claim 10 wherein the pH independent polycationic compound is a quaternary ammonium-based polymer or a polyamine.” Because the amendment to the claim is not supported by the specifications and the amendment was on the day of filing.
Appropriate correction is required
Claim Rejections - 35 USC § 112
Claims 1, 15, 21 and 28 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 1 recites the limitation "the material" in line 4 it is unclear what is encompassed by the terminology “the material” since in step (a) there is both a fluid and a polycationic compound or mixture thereof. There is insufficient antecedent basis for this limitation in the claim. Claims 2-8, 10-11, 13, 15, 17-19,21-22, and 25 are rejected because of their dependency on claim 1.
Claim 15 recites the limitation “at least 0.1% of the total fluid volume are added to the fluid” in line 2 is unclear what is reference regarding the HBDr; whether it refers to an amount of HDBr orthe solution of HDBr. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "a known quantity of the polycationic compound" in line 3 it is unclear if a known quantity of the polycationic compound is the same that is recited in claim 1. There is insufficient antecedent basis for this limitation in the claim. If it is the same the claim needs to be amended to end line 2 with the wording, “…comprising the known quantity of the polycationic compound.”
Claim 28 recites the limitation "the material" in line 8 it is unclear what it is referenced by the terminology in step (a) there is a fluid and indicator compound. There is insufficient antecedent basis for this limitation in the claim.
Rejections
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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. 102 which forms the basis for all obviousness rejections set forth in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, 10 and 13, 17-19, 25, 28-29, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wassmer (Characterization and Detection of polyanions by Direct Polyelectrolyte Titration, Karl-Heinz Wassmer et al.,1991, pp. 556-558.)
Regarding parts claim 1, (Wassmer et.al., abstract p.553) teaches a novel technique for investigation of polyanions by direct polyelectrolyte titration.
Regarding part (a) of claim 1, (Wassmer, paragraph 1, p.557) teaches the basis of the determination of polyanions is the formation of a polysalt by reaction of the polyanion with a polycation against which it is titrated. The polysalt reaction meets the condition for a titrimetric determination: it proceeds essentially quantitatively and is very rapid. Paragraph 6 discloses that the titrating agents used are usually KPVS as polyanion and N-methylglycolchitosa(MGC) and poly dimethlyammonium chloride(poly-DADMAC) as polycations. Therefore, the limitation of part (a) is met.
Regarding part (b) of claim 1, (Wassmer, abstract p.553) teaches a phototitrator allows for an extremely high sensitivity can be reached using 3,6-ionene bromide as cationic titrant and eriochrome black T as metachromatic indicator for end-point detection. (Wassmer, paragraph 6, p.558) teaches in the case of direct polyanion determination, there are in principle two possibilities for photometric detection, if the polyanion to be determined is chromotropic… a cationic metachromatic dye can be used as the indicator, it is bound to polyanion matrix at the start of the titration. On adding the polycation a displacement of the dye from the polyanion by titrant take place at the equivalence point and the strength of the color reaction depends on the chromotropic properties of the polyanion. On the other hand, when a metachromatic anionic dye is used, the chromotropy of the polyanion not necessary, the dye is initially present in the solution in free form. After complete neutralization of the polyanion, the indicator reaction between excess chromotropic polycation and the dye occurs. Therefore, the limitation of part (b) is meet.
Regarding part (c) of claim 1, (Wassmer, abstract, p.553) teaches the use of a phototitrator that allows the determination of charge densities for polymer characterization and the detection of polymers in aqueous solution to trace concentration of 10µg/L. (Wassmer paragraph 1, p556) teaches the use of phototitrator that works with two light emitting diodes(LED Siemens) as light sources with a photodiode(BPX91B) as the detector; the measuring feature is illustrated in (Fig 1, p.556). The transmission changes owe to the changes in the absorption and/or turbidity in the measuring cuvette lead to changes in the intensity of the light impinging on the photodiode and the photocurrent is amplified in a phase sensitive manner and the differences in the intensities is output as the measuring signal. (Wassmer paragraph 2, p. 556) teaches
the titrations are controlled by a microprocessor and the measurement of curves, evaluation, and documentation is performed the BASIC program FTMTT. The features of the phototitrator allows for the continuous monitoring of a polyelectrolyte titrations, a signal measurement therefore the limitations c is meet
Regarding part (d) of claim 1, (Wassmer, paragraph 2, p.563) teaches in the presence of larger amounts of monovalent salts….the titration curves in the range of the endpoint reaction for the ECBT/IB system are flatter and have a less pronounced break-point(see fig 8.). Moreover, (Wassmer) discloses this is indicative of the weakening of the dye/polycation binding by screening of the electrostatic interactions and the equilibrium constant and thus the slope of titration curves decreases. Therefore, the limitation of part (d) is meet.
Regarding claim 2 (Wassmer, paragraph 1, p. 556) teaches the use of o-TB and ECBT as indictors that are used with it phototitrator. Furthermore, in paragraph 6, p.555 in is owing to the pH sensitivity of ECBT, 1mmol/L of buffer (NH3/NH4+ at pH 10 and 1 or tris HCl at pH 7 and 8). Since MES buffer is a non-interfering zwitterion buffer system, having a pH range of 5.5-7.0, and readily forms coordination complexes, and is structurally similar to the buffer components (NH3/NH4+ at pH 10 and 11 or tris HCl at pH 7 and 8). Therefore, the limitations of claim 2 are met.
Regarding claim 3, (Wassmer, paragraph 2, p.559) solutions investigated by polyelectrolyte titration are usually dilute, this is necessary for the determination of charge densities in order to prevent precipitation of the polyelectrolyte complex, and to determine absorption low concentrations must be used and the indicator must also be present in high dilutions, otherwise the titration result would be falsified by the indicator reaction. Moreover, (Wassmer, paragraph 2, p.559) the teaches the formation of the ECBT/IB complex as shown in (Fig 4) for various ECBT/IB concentration ratios. EBCT being pH dependent is required to be in a buffer therefore to assess its use would require different concentrations of a buffering compound.
Regarding claim 6 (Wassmer paragraph 1, p. 554) in principle turbidimetric, potentiometric, conductometric or streaming potential measurements can be used instead of optical measurements for end point detection, but the optical measurements have the advantage of being simpler, this the limitations of claim 6 is met.
Regarding claim 7(Wassmer, paragraph 1, p.556) teaches photometric detection. The photitrator used was improved version of an apparatus already described before and can be employed universally as a phototitrator. Moreover, it has two light emitting diodes having emission maxima at 635nm and 565nm (see Fig. 1). Therefore, the limitations of claim 7 is met.
Regarding Claim 8, (Wassmer, paragraph 2, p.555) teaches the use of Poly (potassium vinylsulfonate (KPVS) as a polyanionase inhibitor, thus the limitations of claim 8 have been met.
Regarding claim 10, (Wassmer, paragraph 6, p.554) teaches in paragraph 8 the use of 3,6-Ionene Bromide(polybrene). Hexadimethrine bromide (polybrene or 3,6-Ionne bromide) is a pH-independent polycation. Therefore, the limitation of claim 10 is meet
Regarding claim 11 (Wassmer paragraph 1, p.559) Moreover, in paragraph teaches other anionic dyes such as ….and the cationic polyelectrolyte’s poly (diallyldimethlyammonium chloride) (poly-DADMAC) and N-methlyglycochitosan (MGC) were also tested in the titration. Therefore, the limitations of claim 11 is met.
Regarding claim 13 (Wassmer paragraph 1, p.559) teaches other anionic dyes such as eriochrome blue SE, arsenazo 111, murexide and tetramethylmurexide, and the cationic polyelectrolytes poly(dially1dimethylammonium chloride) (poly-DADMAC) and Nmethylglycolchitosan (MGC) were also tested in the titration. Therefore, the limitations of claim 13 is met.
Regarding claim 17, (Wassmer, paragraph 1, p.559), teaches the combination ECBT/ione bromide(IB) proved to be the best indicator with respect to sensitively for the direct titration of polyanions, especially polycarboxylates. ECBT is an anion dye thus the limitation of claim 17 is met.
Regarding claim 18,(Wassmer, paragraph 4, p555), teaches using Eriochrome Black T (ECBT). Eriochrome Black T (ECBT) is an azo dye, thus the limitation of claim 18 is met.
Regarding claim 19, (Wassmer, paragraph 3, p.559), teaches the metachromatic bad shift on the formation of ECBT/IB complex as shown in (Fig 4). Moreover, other dyes such as Eriochrome blue SE, arsenazoIII, murexide and tertramethlymurexide….were also tested in the titration. Eriochrome Black T (ECBT) is an azo dye and anrsenazoIII is a a sulfonazo dye. AnrsenazoIII It is a type of azo dye that contains sulfonate groups., thus the limitations of claim 19 is met.
Regarding claim 25 (Wassmer, paragraph 2, p. 561), teaches the equivalence consumption of ionene bromide (see Fig 6) expressed in µeq/L is plotted against the poly(acrylic acid) concentration in µeq/L and the straight line drawn result from the linear regression. The linear relationship between the equivalence consumption and the concentration indicates the condition…reaction is fulfilled, thus the limitation of claim 25 has been met.
Regarding claim 28 part (a) (Wassmer et. al., paragraph 6, p.558-559) teaches in the case of direct polyanion determination there are two possibilities for photometric detection, if the polyanion to be determined is… a cationic metachromatic dye can be used as the indicator, it is bound to polyanion matrix at the start of the titration. On adding the polycation a displacement of the dye from the polyanion by titrant take place at the equivalence point and the strength of the color reaction depends on the chromotropic properties of the polyanion. On the other hand, when a metachromatic anionic dye is used, the chromotropy of the polyanion not necessary, the dye is initially present in the solution in free form. After complete neutralization of the polyanion, the indicator reaction between excess chromotropic polycation and the dye occurs.
Regarding claim 28 part (b), (Wassmer et. al., paragraph 1, p.557) teaches the basis of the determination of polyanions is the formation of a polysalt by reaction of the polyanion with a polycation against which it is titrated. The polysalt reaction meets the condition for a titrimetric determination: it proceeds essentially quantitatively and is very rapid. Paragraph 6 discloses that the titrating agents used are usually KPVS as polyanion and N-methylglycolchitosa(MGC) and poly dimethlyammonium chloride(poly-DADMAC) as polycations.
Regarding claim 28 part (c) (Wassmer et. al., 1991, abstract) teaches direct polyelectrolyte titration using a specially developed phototitrator, with a high sensitivity for 3,6-ionene bromide as cationic titrant and Eriochrome black T as metachromatic indicator for endpoint detection. (Wassmer et. al., paragraph 1, p 556) the phototitrator has an emission maxima at 635nm and 565nm, uses photodiode (BPX91B), and other light emitting diodes with...different wavelengths are available for other indicators (see Fig. 1). (Wassmer , paragraph 3 p. 559-560) teaches absorption spectra for various ECBT/IB concentration ratios, a red shift occurs on binding to the polymer, and the ECBT absorption is shifted to higher wavelengths with increasing ionene bromide concentration (see Fig. 4).
Regarding claim 28 part (d) (Wassmer et. at., paragraph 2, p 560) teaches that titrations curves of polyacrylic acid were carried out using the phototitrator(see Fig. 5). The voltage signal resulting from the absorption change in the indicator reaction is plotted against the volume of 3,6-ionen bromide metered. The decrease of voltage end value with increasing polyanion concentration is due to increasing turbidity in the solution.
Regarding claim 29, The limitation of claim 29 is meet by (Wassmer, paragraph 6, p.555) teaches owing to the pH sensitivity of ECBT (Eriochrome Black T), 1mmol/L of buffer (NH3/NH4+ at pH 10 and 11 or tris HCl at pH 7 and 8) was added to the titration solution. Therefore, the limitations of 29 is met.
Regarding claim 31 (Wassmer, paragraph 3, p.556), teaches the use of Dosimat 665 from Metrohm as a motorized burette, for titrations ranging from 0.01 to 0.1 mg/L, a Hamilton microliter syringe was mounted on the Metrohm exchange unit via self-developed adapters. The metering steps were 10 or 20 microliters. The time interval between the steps is 1 or 4 second depending on the concentration range. Therefore, the limitation of claim 31 is met.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 4 is rejected under 35 U.S.C. 103 rejection over (Characterization and Detection of polyanions by Direct Polyelectrolyte Titration Karl-Heinz Wassmer et. al., 1991) in view of (SEC assay for Polyvinylsulfonic acid impurities in 2-(N-Morpholion) ethanesulfonic Acid Using a Charged Aerosol Detector, Taylor Zang et. al., 2010.
Regarding claim 4 (Wassmer, abstract, p.553) teaches detection as low as 10g/L of polymer in aqueous solution. (Wassmer) does not teach a detection of PVS at 1.5 ppm or 0.25ppm of buffering solution nor 0.16µg/mL of buffering solution.
(Zhang et.al. abstract, 2010) teach a method for measuring polyvinyl sulfonic acid (PVS) in MES and other Good’s buffers. (Zhang et. al., paragraph 4, p. 148) teaches the precision of the method at different PVS levels (see table 2, p.149). The limit of the detection (LOD) and limit of quantification (LOQ) …yields 0.5 and 1.4µg/mL respectively. Zhang also teaches that PVS is a known impurity in buffers that can interfere with enzyme activity and cause protein precipitation (page 145, paragraph 1) and the ability to monitor the PVS concentration in various buffers (page 149, paragraph 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum limit of detection to a range of 0.16µg/mL which would allow the ability to monitor the PVS concentration is various buffers (page 149, paragraph 1) (MPEP § 2144.05 (II)).
Claims 22 and 30 are rejected under 35 U.S.C. 103 rejection over (Characterization and Detection of polyanions by Direct Polyelectrolyte Titration Karl-Heinz Wassmer et. al., 1991) in view of Jaracz (US Pat. App. 20160178527)
Regarding claim 22 (Wassmer, paragraph 4, p.555) teaches using a buffer to accommodate for the sensitivity of dye, Eriochrome black T. (Wassmer) does not teach or mention the use of a specific buffer such as a Good’s buffer.
(Jaracz) in paragraph [0039] teaches a titration method which utilized HEPES as a buffer because it is useful in solutions having a pH of approximately 7.
Therefore, it would be obvious for a person of ordinary skill in the art before the effective filing date of the claim invention to use a Good’s buffer for performing complexometric titrations using a Good’s buffer because Jaracz teaches that HEPES (Good’s buffer) is useful in solutions having a pH of approximately 7.
Regarding claim 30, (Wassmer, paragraph 4, p. 555) teaches using a buffer to accommodate for the sensitivity of Eriochrome black T, 1mmol/L of buffer (NH3/NH4+ at pH 10 and 11 or tris HCl at pH 7 and 8) was added to the titration solution. (Wassmer,) does not disclose the use of a Good’s buffer.
(Jaracz) in paragraph [0039] teaches a titration method which utilized HEPES as a buffer because it is useful in solutions having a pH of approximately 7.
Therefore, it would be obvious for a person of ordinary skill in the art before the effective filing date of the claim invention to use a Good’s buffer for performing complexometric titrations using an indicator dye because Jaracz teaches that HEPES (Good’s buffer) is useful in solutions having a pH of approximately 7.
Claims 5 are rejected under 35 U.S.C. 103 rejection over (Characterization and Detection of polyanions by Direct Polyelectrolyte Titration Karl-Heinz Wassmer et. al., 1991) in view of (Spectrophotometric detection of the endpoint in metachromatic titration of polydiallyidimethylammonium chloride in water B. Gumbi et. al. 2013).
Regarding claim 5 (Wassmer, paragraph 2, p.560) teaches a voltage signal result in an absorbance change in the indicator reaction is plotted against the volume of 3,6-ionene bromide (see fig. 5). In (Wassmer paragraph 1, p.561), the detection of ECBT/ionene bromide (IB) compound equivalence volume is due to the break point in the two straight lines drawn minus the blank value determined in a corresponding manner, here the “breakpoint method” is more accurate than the “point of inflection method”. Moreover, (Wassmer, paragraph 1, p 554) detection of indicator can be performed by, “turbidimeric11-12, potentiometric13-16…can be used instead of optical measurements for end point detection. (Wassmer) in does not explicitly state the titration endpoint is where the sample absorbance is halfway between the initial sample absorbance and steady state absorbance or is a local maximum of the first derivative of the sample absorbance.
(Gumbi, paragraph 7, p. 119) teaches a colloidal titration of polyDAMAC with PVSK and the endpoint is determined when the indicator has a color change. (Gumbi, paragraph 4, p.121) teaches with respect to curve at 634nm there are two potential endpoints on titration curves, the upper and lower break point, the upper break…obtained from deducting the blank and the lower break corresponds to color change … and the lower break corresponds to the colour change observed when doing a visual titration. Similarly, description applies to curve at 510nm. (see. Fig 5, p121). (Gambi paragraph 4, p. 121) teaches other authors in the literature were unable to obtain a distinct titration curve at 510 nm; specifically, no lower and upper plateau region with a sigmoidal curve, attributed to a spectrometer set to capture 100 full scans per second with a dip probe.
Therefore, it would be obvious for a person of ordinary skill in the art before the effective filing date of the claim invention to choose titration endpoint where the sample absorbance is halfway between the initial sample absorbance and steady state absorbance or is a local maximum of the first derivative of the sample absorbance, because (Gambi paragraph 4, p.121) teaches obtaining a titration endpoint by two potential endpoints on titration curves, the upper and lower break point, the upper break and the lower break corresponds to the colour change observed when doing a visual titration.
Claim 15 is rejected under 35 U.S.C. 103 over Characterization and Detection of polyanions by Direct Polyelectrolyte Titration Karl-Heinz Wassmer et. al., 1991) in view of Titration General Chemistry Lab News Mary Jane Smith https://sites.middlebury.edu/chem103lab/2016/09/02/bureting/
(Wassmer et. al., paragraph 6, pp.554-555) teaches using polybrene and its concentration of the titration solutions was 100 or 30 mg/L depending on the sample concentration. (Wassmer paragraph 2, p. 560) teaches the signal resulting from the absorption change in the indicator plotted against the volume of 3,6-ione bromide metered in. (Wassmer), does not teach the use of plurality of HDBR aliquots totaling at least with 0.1% of total volume added to a fluid.
(Smith, paragraph 1) A titration is the gradual addition of a known volume of one reagent (the titrant) to another reactant until the observed completion of a chemical reaction.(Smith paragraph 2) teaches the 50.0 mL Class A buret used in the laboratory has been certified to deliver volumes to a tolerance of 0.1% of the total volume or in our case ±0.05 mL. Moreover, (Smith paragraph 6) teaches to deliver volume increments smaller than a normal drop (±0.03 mL) allows a partial drop to form and then rinse the partial drop into the titration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum amount of HDBr to be added to at least 0.1% of a total fluid volume which would allow for the observed completion of the chemical reaction (MPEP § 2144.05 (II)).
Claim 21 are rejected under 35 U.S.C. 103 as being obvious over (Characterization and Detection of polyanions by Direct Polyelectrolyte Titration Karl-Heniz Wassmer et. al., 1991) in view of Non-extraction flow injection determination of cationic surfactants using eriochrome black -T, Ali A. Ensafi et. at., 2009).
(Wassmer, paragraph 4, p. 555), teaches using Eriochrome Black T and the concentration of the indicator in the titration was 1*10-6 mol/L, however it does not teach using a range of its concentration as 0.8-1.7 µg/ml EBT to be added per mL of the fluid comprising a known quantity of polycationic compound. (Wassmer, Fig 4, p.560), discloses the Eriochrome black T of 6.0 µM in different polycationic concentration is plotted with corresponding absorbances.
(Ensafi, paragraph 3, p. 794) discloses the simple methods of choice for the determination of cationic and nonionic surfactants could be methods based on the formation of an ion-association complex between the cationic surfactant and anionic dyes. (Ensafi paragraph 3, p.794) teaches a spectrophotometric procedure for the determination of CSs….as cationic surfactant without liquid–liquid extraction based on the color reaction of CS with eriochrome black-T (EBT) as a new chromogenic reagent.
(Ensafi, paragraph 4, p.795), teaches EBT solution 1.35*10-3mol/L was prepared daily by dissolving 0.0623 g of EBT in distilled water. (Ensafi, paragraph 10, p 795), teaches 5mL of universal buffer (pH 9.0, 0.04 mol/L) plus 1.0 mL of 9.0*10-5mol/L EBT was pipetted. The influence of EBT concentration on absorbance sensitivity was investigated (see Fig. 5). Results showed that absorbance reached its maximum value at 1.35*10-4 therefore 1.35*10-4 of EBT was selected as the optimal concentration for further study.
Therefore, it would be obvious for a person of ordinary skill in the art before the effective filing date of the claim invention to determine, through routine experimentation the optimum concentration of ECBT to be added be 0.8-1.7 µg/mL which would allow for the optimal concentration of ECBT for further study in monitoring PVS in a fluid.
Conclusion
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/R.T.J./ Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796