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 .
Examiner’s Note
The claims should be on a separate page from the abstract
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.
Claims 1, 3, 5-6, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Dawes et al. (US 2005/0077222, hereinafter “Dawes”).
In regard to claims 1, 3, 5-6, 8, and 11, Dawes discloses a liquid chromatography system that includes a separation column having an internal bore and an end fitting assembly (abstract). The separation column is preferably a micro capillary or nano liquid chromatography column ([0026]), also a metal frit and a metal sheath (i.e. liquid chromatography system; having a passageway; wherein the at least one coated passageway comprises a column)([0017]-[0018]). The separation column is preferably made of glass lined metal tubing (i.e. a liquid chromatography system having a coated passageway coated with a silicon-based coating; coating includes a material selected from SiO2)([0026]).
Dawes discloses that liquid chromatography systems force a liquid phase through the separation column with a sample to be analyzed and the effluent of the column are carried to a detection system used to measure and quantitate the separated components (i.e. a method of analyzing a sample comprising directing a sample through at least one coated passageway, the coated passageway comprising an interior surface coated with a silicon-based coating, directing the sample through the fluid passageway and measuring an amount of sample remaining following travel through the coated passageway)([0003]).
It would have been obvious to one of ordinary skill in the art to choose any material disclosed for the separation column, including glass lined metal tubing and to use the separation column for its intended purpose to provide a liquid chromatography process for analyzing samples and thereby arrive at the claimed invention.
While there is no specific disclosure that the glass is substantially uniform in thickness, it is the examiner’s position that it would have been obvious to use a glass lining that is substantially uniform in thickness so that the liquid chromatography column would have a steady and even flow of the sample therethrough.
Regarding claim 5, given that the glass liner is the same composition throughout and does not vary in composition, it is intrinsically uniform in composition along the length of the lumen.
Regarding claim 6, given that glass is generally considered to be an amorphous material, it is the examiner’s position that the coating is amorphous.
Regarding claim 8, it is the examiner’s position that it would have been obvious to use two layers of glass on the column because this would merely amount to duplicating parts. It is noted that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dawes et al. (US 2005/0077222), as applied to claim 1 above, in view of Spacek et al. (US 4,968,421 A).
Regarding claim 2, Dawes discloses all of the claim limitations as set forth above. Dawes does not specifically disclose that the sample is sensitive to metals.
Spacek discloses that sensitive biologically active compounds that are commonly used in liquid chromatography may be irreversibly changed by contact with a metal (i.e. sample is sensitive to metal)(C1/L35-50).
Dawes and Spacek are analogous art because they both teach about liquid chromatography. It would have been obvious to use a sensitive biologically active compound as disclosed by Spacek as the sample in the analysis method of modified Dawes because these materials are well known to be used as samples in liquid chromatography analysis. Doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
Claims 1, and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dawes et al. (US 2005/0077222, hereinafter “Dawes”) in view of Smith et al. (US 2012/0251797, hereinafter “Smith”).
In regard to claims 1, and 3-11, Dawes discloses a liquid chromatography system that includes a separation column having an internal bore and an end fitting assembly (abstract). The separation column is preferably a micro capillary or nano liquid chromatography column ([0026]), also a metal frit and a metal sheath (i.e. liquid chromatography system; having a fluid passageway; wherein the at least one passageway comprises a column)([0017]-[0018]). The separation column is preferably made of glass lined metal tubing (i.e. a passageway; wherein the passageway comprises a column)([0026]).
Dawes discloses that liquid chromatography systems force a liquid phase through the separation column with a sample to be analyzed and the effluent of the column are carried to a detection system used to measure and quantitate the separated components (i.e. a method of analyzing a sample comprising providing a liquid chromatography system having a coated passageway coated with a silicon-based coating, directing the sample through the fluid passageway and measuring an amount of the sample remaining following travel through the passageway)([0003]).
It would have been obvious to one of ordinary skill in the art to use the separation column for its intended purpose to provide a liquid chromatography process for analyzing samples and thereby arrive at the claimed invention.
Dawes is silent with regard to the passageway having a coating comprising a silicon species including a material selected from the group consisting of SiO2, SiC, Si3N4, SiOxCy, SiOxNy, SiCxHy or mixtures thereof.
Smith discloses a chemical vapor deposition coating that is inert (abstract, [0033]). The method includes thermal decomposition of dimethylsilane to achieve desired surface properties ([abstract]). The coating layer can be a functionalized layer, in which the amorphous carbosilane is oxidized to form an oxidized layer of amorphous carboxysilane (i.e. silicon-based coating; SiC, SiOxCy, SiCxHy)([0047]). It is noted that there is additionally a diffusion layer 108 and a functionalized layer 110 ([0038]-[0039]). The coating is formed on any suitable substrate ([0035]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the functionalized coating layer of an amorphous carboxysilane of Smith on the metal tubing of Dawes before the application of glass motivated by the expectation of forming a separation column that has improved chemical resistance, improved inertness, and improved adhesion over non-diffusion coatings ([Smith 0037]). Alternatively, it is noted that the coating could be applied to the glass layer. Alternatively, it is the examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the functionalized coating layer of an amorphous carboxysilane of Smith on the entirety of the metal sheath of Dawes motivated by the expectation of forming a sheath that has improved chemical resistance, improved inertness, and improved adhesion over non-diffusion coatings ([Smith 0037]).
It is the examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the functionalized coating layer of an amorphous carboxysilane of Smith on the metal sheath of Dawes motivated by the expectation of forming a sheath that has improved chemical resistance, improved inertness, and improved adhesion over non-diffusion coatings ([Smith 0037]).
While there is no specific disclosure that the coating is substantially uniform in thickness, it is the examiner’s position that it would have been obvious to use a coating that is substantially uniform in thickness so that the liquid chromatography column would have a steady and even flow of the sample therethrough. Further, it would have been obvious to coat the coating uniformly in structure and composition along the length of the column to provide the desirable properties of improved chemical resistance, improved inertness, and improved adhesion evenly over the entire column.
Regarding claims 3-4, The coating layer can be a functionalized layer, in which the amorphous carbosilane is oxidized to form an oxidized layer of amorphous carboxysilane (i.e. SiOxCy)(Smith [0047]).
Regarding claim 5, given that the coating is the same composition vapor deposited on the surface and not formed by different compositions in different positions on the surface, it is the examiner’s position that it would be uniform in composition and also it would have been obvious to coat the coating uniformly in structure and composition along the length of the column to provide the desirable properties of improved chemical resistance, improved inertness, and improved adhesion evenly over the entire column.
Regarding claim 6, the coating is amorphous (Smith [0038],[0047]).
Regarding claim 7, the coating comprises an amorphous array of Si-C bonds (Smith [0038]).
Regarding claim 8-9, the glass layer could be considered the second layer comprising a silicon based species. Alternatively, the functionalized surface layer and the layer beneath the functionalized layer could be considered the two layers comprising a silicon based species (i.e. two or more layers each comprising a silicon-based species; different silicon species).
Regarding claim 10, modified Dawes discloses that the coating has thickness of between about 0.1 micrometers to about 3.0 micrometers (i.e. overlapping about 10 nm to about 5 µm)([Smith 0038]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dawes et al. (US 2005/0077222) and Smith et al. (US 2012/0251797), as applied to claim 1 above, in view of Spacek et al. (US 4,968,421 A).
Regarding claim 2, modified Dawes discloses all of the claim limitations as set forth above. Modified Dawes does not specifically disclose that the sample is sensitive to metals.
Spacek discloses that sensitive biologically active compounds that are commonly used in liquid chromatography may be irreversibly changed by contact with a metal (i.e. sample is sensitive to metal)(C1/L35-50).
Dawes and Spacek are analogous art because they both teach about liquid chromatography. It would have been obvious to use a sensitive biologically active compound as disclosed by Spacek as the sample in the analysis method of modified Dawes because these materials are well known to be used as samples in liquid chromatography analysis. Doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
Claims 1, and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (US 2002/0176800 A1) in view of Dawes et al. (US 2005/0077222) and Smith et al. (US 2012/0251797, hereinafter “Smith”).
In regard to claims 1, and 3-11, Henry discloses a liquid chromatography system that includes a separation column having an internal bore and an end fitting assemblies, wherein the liquid chromatography column comprises metal, stainless steel and end-fittings containing frits that may be stainless steel (i.e. at least one passageway; comprises a column) (abstract, [0022], claim 6, [0057]).
Henry does not specifically disclose analyzing a sample by directing a sample through the fluid passageway and measuring an amount of the sample remaining following travel through the coated passageway.
Dawes discloses that liquid chromatography systems force a liquid phase through the separation column with a sample to be analyzed and the effluent of the column are carried to a detection system used to measure and quantitate the separated components (i.e. a method of analyzing a sample comprising providing a liquid chromatography system having a fluid passageway, directing the sample through the fluid passageway and measuring an amount of the sample remaining following travel through the coated passageway)([0003]).
Henry and Dawes are analogous art because they both teach about chromatography systems, It would have been obvious to one of ordinary skill in the art to use the liquid chromatography system of Henry for its intended purpose as taught by Dawes to provide a liquid chromatography process for analyzing samples and thereby arrive at the claimed invention.
Henry is silent with regard to the fluid passageway having a silicon-based coating, the coating including a material selected from the group consisting of SiO2, SiC, Si3N4, SiOxCy, SiOxNy, SiCxHy or mixtures thereof.
Smith discloses a chemical vapor deposition coating that is inert (abstract, [0033]). The method includes thermal decomposition of dimethylsilane to achieve desired surface properties ([abstract]). The coating layer can be a functionalized layer, in which the amorphous carbosilane is oxidized to form an oxidized layer of amorphous carboxysilane (i.e. SiC, SiOxCy, SiCxHy)([0047]). It is noted that there is additionally a diffusion layer 108 and a functionalized layer 110 ([0038]-[0039]). The coating is formed on any suitable substrate ([0035]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the functionalized coating layer of an amorphous carboxysilane of Smith on the entirety of metal tubing (including the inner lumen) of Henry motivated by the expectation of forming a separation column that has improved chemical resistance, improved inertness, and improved adhesion over non-diffusion coatings ([Smith 0037]).
While there is no specific disclosure that the coating is substantially uniform in thickness, it is the examiner’s position that it would have been obvious to use a coating that is substantially uniform in thickness so that the liquid chromatography column would have a steady and even flow of the sample therethrough. Also, it would have been obvious to coat the coating uniformly in structure and composition along the length of the column to provide the desirable properties of improved chemical resistance, improved inertness, and improved adhesion evenly over the entire column.
Regarding claims 3-4, The coating layer can be a functionalized layer, in which the amorphous carbosilane is oxidized to form an oxidized layer of amorphous carboxysilane (i.e. SiOxCy)(Smith [0047]).
Regarding claim 5, given that the coating is the same composition vapor deposited on the surface and not formed by different compositions in different positions on the surface, it is the examiner’s position that it would be uniform in composition and also it would have been obvious to coat the coating uniformly in structure and composition along the length of the column to provide the desirable properties of improved chemical resistance, improved inertness, and improved adhesion evenly over the entire column.
Regarding claim 6, the coating is amorphous (Smith [0038],[0047]).
Regarding claim 7, the coating comprises an amorphous array of Si-C bonds (Smith [0038]).
Regarding claims 8-9, the functionalized surface layer and the layer beneath the functionalized layer could be considered the two layers comprising a silicon based species (i.e. two or more layers each comprising a silicon-based species; different silicon species).
Regarding claim 10, modified Henry discloses that the coating has thickness of between about 0.1 micrometers to about 3.0 micrometers (i.e. overlapping about 10 nm to about 5 µm)([Smith 0038]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (US 2002/0176800 A1), Dawes et al. (US 2005/0077222) and Smith et al. (US 2012/0251797), as applied to claim 1 above, in view of Spacek et al. (US 4,968,421 A).
Regarding claim 2, modified Henry discloses all of the claim limitations as set forth above. Modified Henry does not specifically disclose that the sample is sensitive to metals.
Spacek discloses that sensitive biologically active compounds that are commonly used in liquid chromatography may be irreversibly changed by contact with a metal (i.e. sample is sensitive to metal)(C1/L35-50).
Henry and Spacek are analogous art because they both teach about liquid chromatography. It would have been obvious to use a sensitive biologically active compound as disclosed by Spacek as the sample in the analysis method of modified Henry because these materials are well known to be used as samples in liquid chromatography analysis. Doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES C YAGER whose telephone number is (571)270-3880. The examiner can normally be reached 9-6 EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES C YAGER/Primary Examiner, Art Unit 1782
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