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
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.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Svoboda et al (CS 217802) in view of Lin et al (CN 109813666).
Svoboda teaches a preparation and use of polymeric strips for determination of trypsin (see Examples 1 and 2).
The preparation comprises the following procedure:
A 40 mm wide filter paper is impregnated with the following mixture of solutions:
phosphate buffer, pH = 7.0, 0.2 mol / l sodium chloride 0.2 mol / 1 g% TRITON X-100 ethanol solution cholic acid solution g% agar solution and 0.5 g sodium alginate solution. Then the paper is dried at a temperature of about 60 °C.
At the same time, an equally wide strip of 0.2 mm thick white PVC foil is adhered to one adhesive side of double-sided self-adhesive tape of 20 mm width. A 10 mm wide strip of finely divided, powdered substrate is applied to the other adhesive side of the self-adhesive tape and fixed by pressing so that 5 mm wide strips of free adhesive area remain on both sides of the strip; by means of these adhesive surfaces, a self-adhesive tape with a PVC foil and a colored substrate applied is adhered longitudinally to a strip of impregnated paper 6 mm from its one longitudinal edge. Then, on the other side of the impregnated paper, a 34 mm wide PVC foil is glued again with a double-sided self-adhesive tape so that the foil is 6 mm from the edge of the paper as well as the substrate tape. Finally, the paper - 6 mm from the foil with the substrate- glues 48 mm wide PVC foil holder. The entire strip is then cut transversely into strips of 6 mm width.
When potato starch with covalently bound remazol brilliant blue is used as a substrate in the preparation of these strips, diagnostic strips suitable for determining amylase activity in, for example, human urine are obtained.
Regarding claims 14-16, the determination is performed by dipping the protruding portion of the paper into the urine to be examined for 4 to 5 seconds and placing the strip in a microtube. After incubation for 10 minutes, the strip is removed and briefly soaked - again by the protruding portion of the paper - to a developing liquid composed of 0.4 mol / l NaOH to which 0.5% cetylpyridinium bromide was added. The paper is then returned to the tube and after 5 to 2 minutes developing, the blue color of the indicator portion of the strips is evaluated either visually by comparison with the scale or photometrically. The intensity of this staining is directly proportional to the activity of alpha-amylase in the urine examined in the range of 500 to 10,000 U / l (see Example).
The substrate used is so-called OBR-collagen, i.e. collagen with covalently bound ostazine brilliant red. Determination of trypsin, respectively. its activity is performed in the same manner as the alpha-amylase assay described in the previous example. The indicator portion of the strip becomes pink to deep crimson red, the intensity of which is proportional to the trypsin activity in the range of 100 to 500 units of BAEE / ml in the sample to be examined (see Example 2).
Svoboda fails to teach dyes listed in instant claim 1.
Lin discloses a method for detecting trypsin based on UV measurement of changing 3,3',5,5'-tetramethylbenzidine absorbance.
The linear range of detection is 0.06-0.6 mu g/ml and detection limit is 0.03 mu g/ml were achieved (see Abstract and claims).
Therefore, it would have been obvious to a person of ordinary skills in the art to use Lin’s dye in Svoboda’s method, since it allows to achieve very low trypsin detection limit.
Svoboda does not teach a method of making a trypsin detection film.
However, both modified Svoboda and Applicant prepared a polymer film used for the same purpose of trypsin detection.
Claims 13-16 represents product-by-process Claim. Since modified Svoboda 's and Application’s film used for the same purpose of trypsin detection, the process of claim 1 does not convey any patentable distinct features to the product.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process" In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See Also In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974), In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Therefore, it would have been obvious to a person of ordinary skills in the art to expect the same properties from modified Svoboda’s and Applicant’s compositions, since they use the same dye indicator and the same photometric method of trypsin determination.
Allowable Subject Matter
Claims1-12 allowed.
Search for prior art does not result in a reference covering the subject matter of independent claim 1 and dependent claims 2-12.
The closest prior art found is represented by Svoboda et al (see rejection above).
Svoboda fails to teach the following process steps:
“providing a base plate assembly comprising a base plate and a first lubricant disposed on the base plate; placing a film-forming solution of the polymer film substrate on the base plate assembly, and putting a cover plate with a second lubricant on the film-forming solution, wherein the film- forming solution is in contact with the first lubricant and the second lubricant, respectively; and separating the polymer film substrate from the base plate assembly and the cover plate after a polymerization reaction of various raw materials in the film-forming solution to obtain the polymer film substrate”.
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GL
/GREGORY LISTVOYB/Primary Examiner, Art Unit 1765