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 .
Election/Restrictions
Applicant’s election without traverse of Group I, consisting of claims 1-7 in the reply filed on February 13, 2026 is acknowledged.
Claims 8-9 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method for controlling a measurement accuracy of an analyzer that measures a particle number concentration of calcium oxalate dihydrate crystals in a sample, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 13, 2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 24, 2023 and November 07, 2023 are being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Füredi-Milhofer et al. (The influence of surfactants on the crystallization of calcium oxalate hydrates).
Regarding claim 1, Füredi-Milhofer teaches a method comprising preserving the calcium oxalate hydrate crystals in solutions containing anionic and non-ionic surfactants (pg. [707]/199, abstract). Wherein the surfactants affect crystal morphology and hydrate formation (pg. [709]/201, “DDACl promoted the formation of rhomb-like CM crystals, while SDS induced needle-like crystal growth.””…it became apparent that while strongly inhibiting crystal growth of COM, SDS promoted nucleation and/or growth of COD.”).
Regarding claim 6, Füredi-Milhofer teaches the anionic surfactant is a dodecyl sulfate salt/SDS (pg. [709]/201, The influence of ionic surfactants).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Füredi-Milhofer et al. (The influence of surfactants on the crystallization of calcium oxalate hydrates) in view of Manissorn et al. (Systematic evaluation for effects of urine pH on calcium oxalate crystallization, crystal-cell adhesion and internalization into renal tubular cells).
Regarding claim 2, Füredi-Milhofer teaches calcium oxalate hydrate crystals in surfactant containing aqueous systems.
Füredi-Milhofer does not teach the pH of the surfactant containing solutions.
Manissorn teaches that calcium oxalate crystallization is affected by urine pH and evaluate calcium oxalate crystallization under near neutral pH conditions, including pH values within the claimed range (pg. 2, Results, Effect of urine pH on CaOx crystallization).
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 pH of 7.0 to 7.8 in the surfactant containing calcium oxalate system of Füredi-Milhofer which would allow for the desired structure and behavior of the calcium oxalate dihydrate crystals (Manissorn, pg. 2, Results, Effect of urine pH on CaOx crystallization)(MPEP § 2144.05 (II)).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Füredi-Milhofer et al. (The influence of surfactants on the crystallization of calcium oxalate hydrates) in view of Gardner (Effect of Pyrophosphate and Phosphate Anions on the Crystal Growth Kinetics of Calcium Oxalate Hydrates).
Regarding claim 3, Füredi-Milhofer does not teach the solution further comprises a phosphoric salt.
Gardner teaches the effect of pyrophosphate and phosphate on the crystallization of calcium oxalate hydrates. The phosphoric salt, sodium pyrophosphate inhibits calcium oxalate monohydrate crystal grown and has no effect on calcium oxalate dihydrate (pg. 864, “Sodium pyrophosphate decreases the nucleation kinetics of calcium oxalate monohydrate…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a phosphoric salt in the surfactant containing solution of Füredi-Milhofer because Gardner teaches that sodium pyrophosphate inhibits calcium oxalate monohydrate while the kinetics of calcium oxalate dihydrate are unaffected. The inclusion of a phosphoric salt in the known aqueous calcium oxalate crystallization system would have been a predictable modification for controlling crystal environment conditions and crystal stability.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Füredi-Milhofer et al. (The influence of surfactants on the crystallization of calcium oxalate hydrates) in view of Füredi-Milhofer et al. (Füredi-Milhofer II) (Induction of crystallization of calcium oxalate dihydrate in micellar solutions of anionic surfactants).
Regarding claim 4, Füredi-Milhofer teaches calcium oxalate hydrate crystallization in aqueous systems containing surfactants.
Füredi-Milhofer does not teach the anionic or the non-ionic surfactant has a final concentration of from 0.01 to 1 w/v%.
Füredi-Milhofer II teaches micellar solutions of anionic surfactants affecting calcium oxalate dihydrate crystallization (pg. 1062, Control of crystallization of calcium oxalate phases(s) by synthetic organic molecules, “investigated a series of synthetic anionic polymers (carboxylates and sulphonates) and found that the type of precipitating crystal hydrate depended on the concentration of the polymer”.
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 concentration within the claimed range of 0.01 to 1 w/v% of the solution comprising surfactant which would allow for the desired crystallization of calcium oxalate dihydrate (Füredi-Milhofer II, pg. 1062, Crystallization from high ionic strength solutions) (MPEP § 2144.05 (II)).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Füredi-Milhofer et al. (The influence of surfactants on the crystallization of calcium oxalate hydrates) in view of Tully (Sulfonic Acids).
Regarding claim 5, Füredi-Milhofer does not teach that the anionic surfactant is an alkane sulfonate salt.
Tully teaches that sulfonic acid derivatives derived from alkanes are widely used as surfactants on an industrial scale (pg. 1, Sulfonic Acids).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an alkane sulfonate salt as the anionic surfactant in the system of Füredi-Milhofer because alkane sulfonates were a known species of anionic surfactants (pg. 11, Uses, Surfactants and Detergent Uses). Substitution of one known anionic surfactant for another (an alkane sulfonate salt) would have been a predictable variation yielding expected results.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Füredi-Milhofer et al. (Füredi-Milhofer I)(The influence of surfactants on the crystallization of calcium oxalate hydrates) in view of Füredi-Milhofer (Füredi-Milhofer III) (The Formation and Transformation of Crystalline Dispersions as Studied by Thermal Analysis).
Regarding claim 7, Füredi-Milhofer I does not teach that the non-ionic surfactant is a polyoxyethylene sorbitan fatty acid ester.
Füredi-Milhofer III teaches crystalline dispersion systems and the role of surfactants in stabilizing and controlling dispersion properties and crystal phase behavior (pg. 434, Crystallization in confined spaces: emulsions and microemulsions). The use of polyoxyethylene (20) sorbitan mono-dodecanoate (Tween-20) as an emulsifier to induce crystallization is also taught (pg. 436, “using polyoxyethylene (20) sorbitan mono-dodecanoate…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a polyoxyethylene sorbitan fatty acid ester as the non-ionic surfactant in the surfactant containing calcium oxalate system of Füredi-Milhofer I because such surfactants were well known nonionic surfactants commonly used in micellar and dispersion systems to control interfacial properties and stabilize dispersed crystalline phases. The selection of a known nonionic surfactant from a finite number of predictable alternatives would have been routine optimization yielding predictable results.
Conclusion
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/B.K.S./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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