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 Objections
Claim 23 objected to because of the following informalities: 0.5 is missing a unit. The claim sentence lacks a period at the end. Appropriate correction is required.
Claim Interpretation
For the rejection to claim 6, the examiner under broadest reasonable interpretation (BRI), has interpreted the term “rinse solution” to mean wash from the cleaning solution.
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.
Claim 16 is 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.
The terms “trace” and “residual” in claim 16 is a relative term, which renders the claim indefinite. The terms “trace” and “residual” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree to convey what is considered trace or residual, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The oxidizing substances as cited in the instant claim are rendered indefinite by the use of this term. It is unclear whether the terms “trace” or “residual” has an upper limit as described in the specification, only citing a lower limit of 0.25 ng/25 cm2 or 0.05 ng/mL.
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 1-3, 10, 13-15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weatherspoon et al (US PG-Pub US 20200390869 A1).
Regarding claim 1, Weatherspoon et al teaches an analytical method for detecting the presence of oxidizing substances by peptide degradation (see [0414]-[0415], an oxidatively unstable rusalatide acetate peptide, suspectable to degradation, for example. In the presence of oxygen and certain transition metals. See also [0485]-[0486], disclosing that if impurities, contaminants or degradation products are detected during the process of preparing a rusalatide acetate formulation, steps can be taken to identify the impurities, contaminants, or degradation products, with examples of product-related impurities including oxidation.), the method comprising: mixing a peptide with a sample to create a test preparation (see [0355], disclosing the use of degassed or deoxygenated solvents and solutions to enhance stability of rusalatide acetate, and to minimize or avoid any undesired oxidation of rusalatide acetate.); and detecting impurities of the peptide in the test preparation, wherein detected impurities indicate the presence of oxidizing substances in the sample (see [0414]-[0415], an oxidatively unstable rusalatide acetate peptide, suspectable to degradation, for example. In the presence of oxygen and certain transition metals. See also [0485]-[0486], disclosing that if impurities, contaminants or degradation products are detected during the process of preparing a rusalatide acetate formulation, steps can be taken to identify the impurities, contaminants, or degradation products, with examples of product-related impurities including oxidation.).
Regarding claim 2, Weatherspoon et al teaches the method of claim 1, further comprising identifying the detected impurities of the peptide in the test preparation (see [0485], disclosing that if impurities, contaminants or degradation products are detected during the process of preparing a rusalatide acetate formulation, steps can be taken to identify the impurities, contaminants, or degradation products.).
Regarding claim 3, Weatherspoon et al teaches the method of claim 1, further comprising measuring the amount of the detected impurities (see [0485], disclosing suitable methods that can be used for identification, quantitation, and analysis if there are co-eluting peaks while using two-dimensional LC-MS in facilitating the identification of impurities.).
Regarding claim 10, Weatherspoon et al teaches the method of claim 1, wherein detecting impurities of the peptide in the test preparation comprises analyzing the test preparation using high performance liquid chromatography or ultra- high performance liquid chromatography (see [0455], disclosing using high-performance liquid chromatograph to analyze samples of rusalatide acetate for degradant formation, (e.g., formation of degradation products). See also [0483], discussing analytical methods used to analyze and characterize rusalatide acetate, including but not limited to, high performance liquid chromatography (HPLC) and ultra-high-performance liquid chromatography (UHPLC).).
Regarding claim 13, Weatherspoon et al teaches the method of claim 1, wherein presence of oxidizing substances in the sample causes degradation of the peptide (see [0414]-[0415], disclosing an oxidatively unstable rusalatide acetate peptide, susceptible to degradation, for example, in the presence of oxygen and certain transition metals.).
Regarding claim 14, Weatherspoon et al teaches an analytical method for detecting the presence of oxidizing substances by peptide degradation (see [0414]-[0415], an oxidatively unstable rusalatide acetate peptide, susceptible to degradation, for example. In the presence of oxygen and certain transition metals. See also [0485]-[0486], disclosing that if impurities, contaminants or degradation products are detected during the process of preparing a rusalatide acetate formulation, steps can be taken to identify the impurities, contaminants, or degradation products, with examples of product-related impurities including oxidation.), the method comprising: preparing a test preparation comprising a peptide and a sample, wherein the peptide degrades in the presence of oxidizing substances (see [0355], disclosing the use of degassed or deoxygenated solvents and solutions to enhance stability of rusalatide acetate, and to minimize or avoid any undesired oxidation of rusalatide acetate. See also [0414]-[0415], an oxidatively unstable rusalatide acetate peptide, susceptible to degradation, for example. In the presence of oxygen and certain transition metals.); and detecting impurities of the peptide in the test preparation, wherein detected impurities indicate the presence of oxidizing substances in the sample (see [0414]-[0415], an oxidatively unstable rusalatide acetate peptide, susceptible to degradation, for example. In the presence of oxygen and certain transition metals. See also [0485]-[0486], disclosing that if impurities, contaminants or degradation products are detected during the process of preparing a rusalatide acetate formulation, steps can be taken to identify the impurities, contaminants, or degradation products, with examples of product-related impurities including oxidation.).
Regarding claim 15, Weatherspoon et al teaches the method of claim 14, further comprising identifying the detected impurities of the peptide in the test preparation and measuring the amount of each detected impurity (see [0485], disclosing that if impurities, contaminants or degradation products are detected during the process of preparing a rusalatide acetate formulation, steps can be taken to identify the impurities, contaminants, or degradation products. Suitable methods can be used for identification, quantitation, and analysis if there are co-eluting peaks while using two-dimensional LC-MS in facilitating the identification of impurities.).
Regarding claim 20, Weatherspoon et al teaches the method of claim 14, wherein the detecting impurities of the peptide in the test preparation comprises analyzing the test preparation using high performance liquid chromatography or ultra-high performance liquid chromatography (see [0455], disclosing using high-performance liquid chromatograph to analyze samples of rusalatide acetate for degradant formation, (e.g., formation of degradation products). See also [0483], discussing analytical methods used to analyze and characterize rusalatide acetate, including but not limited to, high performance liquid chromatography (HPLC) and ultra-high-performance liquid chromatography (UHPLC).).
Claim Rejections - 35 USC § 103
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 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Weatherspoon et al, in view of Kenney et al (US PAT 11135265 B2).
Regarding claim 4, Weatherspoon et al teaches a peptide, rusalatide acetate and its compositions, formulations, and dosages (see Weatherspoon et al, [0003]).
Weatherspoon et al fails to teach the method of claim 1, wherein the peptide comprises vasopressin.
However, in the analogous art of vasopressin formulations for use in treatment of hypotension, Kenney et al teaches vasopressin, a peptide hormone, where the invention seeks to provide polymers to act as stabilizing agents to decrease the degradation of the vasopressin (see Kenney et al, Abstract, Col. 5, lines 4-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide of Weatherspoon et al to incorporate the vasopressin (as taught by Kenney et at), for the benefit of using vasopressin clinically in the treatment of sepsis and cardiac conditions, and in the elevation of patient's suffering from low blood pressure (see Kenney et al, Col.1, Lines 21-27).
Regarding claim 17, Weatherspoon et al fails to teach the method of claim 14, wherein the peptide comprises vasopressin. However, Kenney et al teaches vasopressin, a peptide hormone, where the invention seeks to provide polymers to act as stabilizing agents to decrease the degradation of the vasopressin (see Kenny et al, Abstract, Col. 5, lines 4-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide of Weatherspoon et al to incorporate the vasopressin (as taught by Kenney et at), for the benefit of using vasopressin clinically in the treatment of sepsis and cardiac conditions, and in the elevation of patient's suffering from low blood pressure (see Kenney et al, Col.1, Lines 21-27).
Claims 5, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weatherspoon et al, in view of Armbruster et al (US PG-Pub 20210404920 A1).
Regarding claim 5, Weatherspoon et al teaches the use of degassed or deoxygenated solvents and solutions to enhance stability of rusalatide acetate, and to minimize or avoid any undesired oxidation of rusalatide acetate (see Weatherspoon et al, [0335]).
Weatherspoon et al fails to teach the method of claim 1, wherein the sample comprises a rinse solution.
However, in the analogous art of sorbent composition for pre-analytical treatment of samples, Armbruster et al teaches washing a column, followed by eluted buffer containing 0.1% trifluoracetic acid. Flow-through, wash fractions (equilibrating buffer and water) as well as eluate of the column were then collected separately, and analyzed (see Armbruster et al, [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the solutions of Weatherspoon et al to incorporate the washing and collection of wash (as taught by Armbruster et al), for the benefit of determining methods to perform enzymatic reactions on the surface and within microcapsules without the need of washing steps (see Armbruster et al, [0027]).
Regarding claim 11, Weatherspoon et al fails to teach the methods of claim 1, further comprising collecting the sample from equipment previously exposed to a cleaning solution.
However, Armbruster et al teaches washing a column, followed by eluted buffer containing 0.1% trifluoracetic acid, where then flow-through, wash fractions (equilibrating buffer and water) as well as eluate of the column were then collected separately, and analyzed (see Armbruster et al, [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analytical methods of Weatherspoon et al to incorporate the washing and collection of wash (as taught by Armbruster et al), for the benefit of determining methods to perform enzymatic reactions on the surface and within microcapsules without the need of washing steps (see Armbruster et al, [0027]).
Regarding claim 18, Weatherspoon et al fails to teach the method of claim 14, wherein the sample comprises a rinse solution or a swab sample.
However, Armbruster et al teaches washing a column, followed by eluted buffer containing 0.1% trifluoracetic acid, where then flow-through, wash fractions (equilibrating buffer and water) as well as eluate of the column were then collected separately, and analyzed (see Armbruster et al, [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analytical methods of Weatherspoon et al to incorporate the washing and collection of wash (as taught by Armbruster et al), for the benefit of determining methods to perform enzymatic reactions on the surface and within microcapsules without the need of washing steps (see Armbruster et al, [0027]).
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weatherspoon et al as applied to claims 1 and 14 above, and in further view of Wang (CN 201476980 U).
Regarding claim 6, Weatherspoon et al fails to teach the method of claim 1, wherein the sample comprises a swab sample.
However, in the analogous art of device for collecting and testing samples, Wang teaches reagent solutions reaching 17 swab sampler, where after wetting the swab, the solution goes into reaction tube 2, and then the reactor 1 and a reaction pipe 2 separately, for collecting the wetted swab sample of microorganism or dishware surface for rapid detection of ATP principle of firefly luciferase, an oxidative enzyme (see Wang, [0028] Fig 1.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analytical methods of Weatherspoon et al to incorporate the swab sampler (as taught by Wang), for the benefit of performing field testing with immediate test results on-site (see Wang, Abstract).
Regarding claim 18, Weatherspoon et al teaches the use of degassed or deoxygenated solvents and solutions to enhance stability of rusalatide acetate, and to minimize or avoid any undesired oxidation of rusalatide acetate (see Weatherspoon et al, [0335]).
Weatherspoon et al fails to teach the method of claim 14, wherein the sample comprises a rinse solution or a swab sample.
However, Wang teaches reagent solution reaching 17 swab sampler, where after wetting the swab, the solution goes into reaction tube 2, and then the reactor 1 and a reaction pipe 2 separately, for collecting the wetted swab sample of microorganism or dishware surface for rapid detection of ATP principle of firefly luciferase, an oxidative enzyme (see Wang, [0028] Fig 1.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analytical methods of Weatherspoon et al to incorporate the swab sampler (as taught by Wang), for the benefit of performing field testing with immediate test results on-site (see Wang, Abstract).
Claims 7-9, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Weatherspoon et al, in view of Lee et al (US 20180118906 A1).
Regarding claim 7, Weatherspoon et al teaches oxygen and certain transition metals degrading the oxidatively unstable rusalatide acetate peptide while in its presence (see Weatherspoon et al, [0414]-[0415]).
Weatherspoon et al fail to teach the method of claim 1, wherein the oxidizing substances comprise a chlorine-containing or bromine-containing compound.
However, in the analogous art of water-soluble film with low coefficient of friction, Lee et al teaches water-treatment agents, including cleaning and detergent compositions as aggressive oxidizing chemicals. For example, sanitizing agents can include hypochlorite salts such as sodium hypochlorite and calcium hypochlorite. Salts and hydrates of the sanitizing compounds are also contemplated, where dichloroisocyanuric acid may be provided as sodium dichloroisocyanurate. Bromine containing sanitizing agents may also be suitable for use in unit dose packaging applications, including 1-bromo-3-chloro-5,5-dimethylhydrantoin (see Lee et al, [0144], [0146]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substances of Weatherspoon et al to incorporate the aggressive oxidizing chemicals (as taught by Lee et al), for the benefit of creating composition held in a water-soluble pouched that removes the need for consumers to measure the product and reduce mess associated with dispensing the cleaning product (See Lee et al, [0003]-[0005]).
Regarding claim 8, Weatherspoon et al fail to teach the method of claim 7, wherein the chlorine-containing compound is selected from the group consisting of sodium hypochlorite, calcium hypochlorite, and sodium dichloroisocyanurate.
However, Lee et al teaches water-treatment agents, including cleaning and detergent compositions as aggressive oxidizing chemicals. For example, sanitizing agents can include hypochlorite salts such as sodium hypochlorite and calcium hypochlorite. Salts and hydrates of the sanitizing compounds are also contemplated, where dichloroisocyanuric acid may be provided as sodium dichloroisocyanurate (see Lee et al, [0144], [0146]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substances of Weatherspoon et al to incorporate the sanitizing agents, salts, and hydrates (as taught by Lee et al), for the benefit of creating composition held in a water-soluble pouched that removes the need for consumers to measure the product and reduce mess associated with dispensing the cleaning product (See Lee et al, [0003]-[0005]).
Regarding claim 9, Weatherspoon et al fails to teach the method of claim 7, wherein the bromine-containing compound is 1-bromo-3-chloro-5,5-dimethylhydantoin (BCDMH).
However, Lee et al teaches water-treatment agents, including cleaning and detergent compositions as aggressive oxidizing chemicals. For example, bromine containing sanitizing agents may be suitable for use in unit dose packaging applications, including 1-bromo-3-chloro-5,5-dimethylhydrantoin (see Lee et al, [0144], [0146]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substances of Weatherspoon et al to incorporate the bromine containing sanitizing agent (as taught by Lee et al), for the benefit of creating composition held in a water-soluble pouched that removes the need for consumers to measure the product and reduce mess associated with dispensing the cleaning product (See Lee et al, [0003]-[0005]).
Regarding claim 12, Weatherspoon et al fails to teach the method of claim 11, wherein the cleaning solution comprises a chlorine-containing or bromine-containing compound.
However, Lee et al teaches water-treatment agents, including cleaning and detergent compositions as aggressive oxidizing chemicals. For example, sanitizing agents can include hypochlorite salts such as sodium hypochlorite and calcium hypochlorite. Salts and hydrates of the sanitizing compounds are also contemplated, where dichloroisocyanuric acid may be provided as sodium dichloroisocyanurate. Bromine containing sanitizing agents may also be suitable for use in unit dose packaging applications, including 1-bromo-3-chloro-5,5-dimethylhydrantoin (see Lee et al, [0144], [0146]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substances of Weatherspoon et al to incorporate the sanitizing agents (as taught by Lee et al), for the benefit of creating composition held in a water-soluble pouched that removes the need for consumers to measure the product and reduce mess associated with dispensing the cleaning product.
Regarding claim 19, Weatherspoon et al fail to teach the method of claim 14, wherein the oxidizing substances comprise a chlorine-containing or bromine-containing compound.
However, in the analogous art of water-soluble film with low coefficient of friction, Lee et al teaches water-treatment agents, including cleaning and detergent compositions as aggressive oxidizing chemicals. For example, sanitizing agents can include hypochlorite salts such as sodium hypochlorite and calcium hypochlorite. Salts and hydrates of the sanitizing compounds are also contemplated, where dichloroisocyanuric acid may be provided as sodium dichloroisocyanurate. Bromine containing sanitizing agents may also be suitable for use in unit dose packaging applications, including 1-bromo-3-chloro-5,5-dimethylhydrantoin (see Lee et al, [0144], [0146]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substances of Weatherspoon et al to incorporate the aggressive oxidizing chemicals (as taught by Lee et al), for the benefit of creating composition held in a water-soluble pouched that removes the need for consumers to measure the product and reduce mess associated with dispensing the cleaning product (See Lee et al, [0003]-[0005]).
Claims 16 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Weathersppon et al as applied to claim 1 above, and in further view of Holvoet et al (US PAT 6309888 B1).
Regarding claim 16, Weatherspoon et al teaches oxygen and certain transition metals degrading the oxidatively unstable rusalatide acetate peptide while in its presence (see Weatherspoon et al, [0414]-[0415]).
Weatherspoon et al fails to teach the method of claim 14, wherein the oxidizing substances comprise trace or residual amounts.
However, in the analogous art of detection and determination of the stages of coronary artery disease, Holvoet et al teaches a competitive assay using monoclonal antibody mAb-4E6, based on the inhibition by copper-oxidized low-density lipoprotein. Equal volumes of diluted purified mAb-eE6 solution and of either diluted standard solution of diluted plasma solutions, with copper-oxixidied low-density lipoprotein added as competing ligand at a final concentration ranged from 50 to 500 ng/mL, which are then mixed and prepared (see Holvoet et al, Col. 14, lines 31-56). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of oxidizing substances of Weatherspoon et al to incorporate the ranges of 50 to 500 ng/mL (as taught by Holvoet et al), with the benefit of being able to predict coronary artery diseases by detecting the level of oxidized low-density lipoprotein species in a patient sample (see Holvoet et al, Col. 3, lines 53-63).
Regarding claim 21, Weatherspoon et al fails to teach the method of claim 1, wherein the amount of oxidizing substances present in the sample is from about 0.05 ng/mL to about 100 ng/mL.
However, Holvoet et al teaches a competitive assay using monoclonal antibody mAb-4E6, based on the inhibition by copper-oxidized low-density lipoprotein. Equal volumes of diluted purified mAb-eE6 solution and of either diluted standard solution of diluted plasma solutions, with copper-oxidized low-density lipoprotein added as competing ligand at a final concentration ranged from 50 to 500 ng/mL, which are then mixed and prepared (see Holvoet et al, Col. 14, lines 31-56).
While the combined teachings of Weatherspoon et al and Holvoet et al does not explicitly teach the method of claim 1, wherein the amount of oxidizing substances present in the sample is from about 0.05 ng/mL to about 100 ng/mL, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Weatherspoon et al and Holvoet et al to utilized the specified ranges of about 0.05 ng/mL to about 100 ng/mL, as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Regarding claim 22, Weatherspoon et al fails to teach the method of claim 1, wherein the amount of oxidizing substances present in the sample is from about 0.125 ng/mL to about 50 ng/mL.
However, Holvoet et al teaches a competitive assay using monoclonal antibody mAb-4E6, based on the inhibition by copper-oxidized low-density lipoprotein. Equal volumes of diluted purified mAb-eE6 solution and of either diluted standard solution of diluted plasma solutions, with copper-oxidized low-density lipoprotein added as competing ligand at a final concentration ranged from 50 to 500 ng/mL, which are then mixed and prepared (see Holvoet et al, Col. 14, lines 31-56).
While the combined teachings of Weatherspoon et al and Holvoet et al does not explicitly teach the method of claim 1, wherein the amount of oxidizing substances present in the sample is from about 0.125 ng/mL to about 50 ng/mL, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Weatherspoon et al and Holvoet et al to utilized the specified ranges of about 0.125 ng/mL to about 50 ng/mL, as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Regarding claim 23, Weatherspoon et al fails to teach the method of claim 1, wherein the amount of oxidizing substances present in the sample is from about 0.5 to about 25 ng/mL.
However, Holvoet et al teaches a competitive assay using monoclonal antibody mAb-4E6, based on the inhibition by copper-oxidized low-density lipoprotein. Equal volumes of diluted purified mAb-eE6 solution and of either diluted standard solution of diluted plasma solutions, with copper-oxidized low-density lipoprotein added as competing ligand at a final concentration ranged from 50 to 500 ng/mL, which are then mixed and prepared (see Holvoet et al, Col. 14, lines 31-56).
While the combined teachings of Weatherspoon et al and Holvoet et al does not explicitly teach the method of claim 1, wherein the amount of oxidizing substances present in the sample is from about 0.5 to about 25 ng/mL, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Weatherspoon et al and Holvoet et al to utilized the specified ranges of about 0.5 ng/mL to about 25 ng/mL, as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797