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.
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.
Claims 1, 3-4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions” Oct. 2009 – cited on Applicant’s 07/29/2025 IDS), and further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination" – Feb 24, 2017; available at: https://www.silcotek.com/blog/how-to-stop-hplc-corrosion-protein-fouling-and-contamination).
Regarding claim 1, Carr discloses (Fig. 1) a liquid chromatography technique (see par. [0002]), comprising:
providing a liquid chromatography system (see pars. [0002] and [0024]) having a coated stainless steel fluid- contacting element 100 (i.e. the column: [0036]); and
transporting a fluid (which can have biological components: see Abstract, par. [0007]) in contact with [0034] the coated stainless steel fluid-contacting element 100 (see pars. [0002], [0026], [0036]);
wherein the coated stainless steel fluid-contacting element 100 has a coating 140 [0035]-[0036], the coating including carbon, silicon, oxygen, and hydrogen (see par. [0035]; note: “mixtures thereof” which, for example, could be a mixture of SiCxHy and one of the oxides), and a decomposition (see pars. [0019] and [0026]), and an oxidation (i.e. the coating can include an oxide: [0021]/[0035]); and
the liquid chromatography system having a frit [0034].
Carr does not disclose the fluid includes adenosine triphosphate.
Zhao discloses the fluid includes adenosine triphosphate (Abstract: ATP detecting; in HPLC with column: see Preferred Embodiment section).
Since the art recognizes that Carr’s chromatography system is suitable for analyzing bioanalytical separations (see Carr: Abstract, and par. [0007]), and Zhao’s fluid includes biological material (i.e. ATP: see Abstract), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the fluid includes adenosine triphosphate, as taught by Zhao-1. See MPEP 2144.07.
Carr also does not disclose the coating includes a functionalization.
Smith discloses the coating includes a functionalization (see pages/slides 9-13).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Carr’s LC technique so that the coating includes a functionalization, as taught by Smith.
Such a modification would be a use of a known technique (Smith’s coating) to improve similar devices (Carr’s) in the same way – see MPEP(I)(C); and would improve the inertness of the coating (see Smith, page/slide 13).
Finally, Carr does not disclose that the coated stainless steel fluid-contacting permits anti-stiction transport of the fluid.
SilcoTek (see the article cited above) discloses that a coated stainless steel fluid-contacting permits anti-stiction transport of the fluid (i.e. “proteins don’t stick to Dursan” – that is, the coating on the HPLC parts – see bottom p. 3, top of p.4).
Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Carr’s LC technique so that the coated stainless steel fluid-contacting permits anti-stiction transport of the fluid, as taught by SilcoTek.
Such a modification would prevent protein carryover and fouling (see SilcoTek: bottom p. 3, top of p.4).
Regarding claims 3-4, Carr is applied as above and discloses each of the fitting and the pump head have the coating [0023].
Regarding claim 6, Carr discloses (Fig. 1) the liquid chromatography system has a stationary phase (see pars. [0002] and [0034]), the stationary phase having particles having a size of less than 6 micrometers (necessarily so, when the coating thickness is less than 6μm: [0032]).
Regarding claim 9, Carr discloses (Fig. 1) the liquid technique is high performance liquid chromatography (see pars. [0040] and [0044]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions”), further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination"), and further in view of Van Alstine et al. (WO 2004/082801).
Regarding claim 7, Carr’s modified device is applied as above, and further discloses the liquid chromatography system has a stationary phase (see pars. [0002] and [0034]).
Carr does not disclose the stationary phase having particles being hydrophobic.
Van Alstine discloses the stationary phase having particles being hydrophobic (Van Alstine: Background, p. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the stationary phase has particles that are hydrophobic, as taught by Van Alstine.
Such a modification would stabilize and control the analyte interactions with the target and medium (Van Alstine: Background, p. 2).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions”), further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination"), further in view of Gjerde et al. (U.S. Patent 5,997,742), further in view of Kitagawa (U.S. Pub. 2007/0144977), and further in view of Casey et al. (WO 2011/161481).
Regarding claim 8, Carr’s modified device is applied as above, and further discloses the liquid chromatography system includes a coated metallic column [0034].
Carr does not disclose the liquid chromatography system includes a solvent reservoir, a solvent degasser, a gradient valve, a mixing vessel, a high-pressure pump, switching valves, a sample injection loop, a pre-column portion, a detector, a data acquisition system, and a waste collector.
Gjerde discloses (Figs. 1-7) the liquid chromatography system includes a solvent reservoir 12 (col. 16, lines 11-12), a solvent degasser (col. 12, lines 54-58), a sample injection loop 18/22 (col. 16, lines 16-18), a pre-column portion (anything before column 26, such as guard disc 24: see Fig. 7), a detector 28 (col. 16, line 21), and a data acquisition system (which records tha chromatograms shown in Figs. 1-5).
Kitagawa discloses (Fig. 1) the liquid chromatography system includes a gradient valve [0024], a mixing vessel (mixer: [0017]), a high-pressure pump [0005], and switching valves [0066].
Casey discloses the liquid chromatography system includes a waste collector [0055].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the liquid chromatography system includes a solvent reservoir, a solvent degasser, a gradient valve, a mixing vessel, a high-pressure pump, switching valves, a sample injection loop, a pre-column portion, a detector, a data acquisition system, and a waste collector, as taught by Gjerde, Kitagawa, and Casey.
Such a modification would be merely a combination of prior art elements according to known methods to yield predictable results: see MPEP 2143(I)(A).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions”), further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination"), further in view of Von Doehren et al. (EP 2597460).
Regarding claims 10-12, Carr’s modified device is applied as above, but does not disclose the liquid technique is ultra high performance liquid chromatography; the liquid technique is partitioned high performance liquid chromatography; and the liquid technique is partitioned ultra high performance liquid chromatography.
Von Doehren discloses the liquid technique is ultra high performance liquid chromatography [0009]; the liquid technique is partitioned high performance liquid chromatography (the HLPC/UHLPC technique can be done with a partition: [0002]); and the liquid technique is partitioned ultra high performance liquid chromatography (the HLPC/UHLPC technique can be done with a partition: [0002]/[0009]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the liquid technique is ultra high performance liquid chromatography; the liquid technique is partitioned high performance liquid chromatography; and the liquid technique is partitioned ultra high performance liquid chromatography, as taught by Von Doehren.
Such a modification would be merely the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results: see MPEP 2143(I)(D).
Claims 13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions”), further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination"), and further in view of Stout et al. (U.S. Patent 4,902,413).
Regarding claims 13 and 15-17, Carr’s modified device is applied as above, but does not disclose the liquid technique is normal-phase chromatography, reversed-phase chromatography, size exclusion chromatography, or ion-exchange chromatography.
Stout discloses the liquid technique can be normal-phase chromatography, reversed-phase chromatography, size exclusion chromatography, or ion-exchange chromatography (see col. 1, lines 24-31; and col. 5, lines 26-31).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the liquid technique is normal-phase chromatography, reversed-phase chromatography, size exclusion chromatography, or ion-exchange chromatography, as taught by Stout.
Such a modification would be merely the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results: see MPEP 2143(I)(D).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions”), further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination"), further in view of Gjerde et al. (U.S. Pub. 2016/0223441).
Regarding claim 14, Carr’s modified device is applied as above, but does not disclose the liquid technique is displacement chromatography.
Gjerde discloses the liquid technique can be displacement chromatography (see pars. [0121] and [0123]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the liquid technique is displacement chromatography, as taught by Gjerde.
Such a modification would be merely the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results: see MPEP 2143(I)(D).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (U.S. Pub. 2015/0024152) in view of Zhao et al (CN 105699507), further in view of Bouvier et al (WO 2010/009311), further in view of Smith et al. (“The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions” Oct. 2009 – cited on Applicant’s 07/29/2025 IDS), and further in view of SilcoTek ("How To Stop HPLC Corrosion, Protein Fouling, And Contamination" – Feb 24, 2017; available at: https://www.silcotek.com/blog/how-to-stop-hplc-corrosion-protein-fouling-and-contamination).
Regarding claims 5 and 18, Carr discloses (Fig. 1) a liquid chromatography technique (see par. [0002]), comprising:
providing a liquid chromatography system (see pars. [0002] and [0024]) having a coated stainless steel fluid- contacting element 100 (i.e. the column: [0036]); and
transporting a fluid (which can have biological components: see Abstract, par. [0007]) in contact with [0034] the coated stainless steel fluid-contacting element 100 (see pars. [0002], [0026], [0036]);
wherein the coated stainless steel fluid-contacting element 100 has a coating 140 [0035]-[0036], the coating including carbon, silicon, oxygen, and hydrogen (see par. [0035]; note: “mixtures thereof” which, for example, could be a mixture of SiCxHy and one of the oxides), and a decomposition (see pars. [0019] and [0026]), and an oxidation (i.e. the coating can include an oxide: [0021]/[0035]); and
the liquid chromatography system having a frit [0034], a fitting [0023], and a pump head [0023], and wherein each of the frit, the fitting, and the pump head have a coating (see pars. [0023] and [0034]).
Carr does not disclose the fluid includes adenosine triphosphate.
Zhao discloses the fluid includes adenosine triphosphate (Abstract: ATP detecting; in HPLC with column: see Preferred Embodiment section).
Since the art recognizes that Carr’s chromatography system is suitable for analyzing bioanalytical separations (see Carr: Abstract, and par. [0007]), and Zhao’s fluid includes biological material (i.e. ATP: see Abstract), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Carr’s LC technique so that the fluid includes adenosine triphosphate, as taught by Zhao-1. See MPEP 2144.07.
Carr also does not disclose the coating includes a functionalization.
Smith discloses the coating includes a functionalization (see pages/slides 9-13).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Carr’s LC technique so that the coating includes a functionalization, as taught by Smith.
Such a modification would be a use of a known technique (Smith’s coating) to improve similar devices (Carr’s) in the same way – see MPEP(I)(C); and would improve the inertness of the coating (see Smith, page/slide 13).
Carr also does not disclose the liquid chromatography system has a valve; and wherein the valve has a coating.
Bouvier discloses the liquid chromatography system has a valve (Summary of the Invention: p. 2), and wherein the valve, has a coating (Summary of the Invention: p. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Carr’s LC technique so that the liquid chromatography system has a valve, and wherein the valve has a coating, as taught by Bouvier.
Such a modification would protect the various components of the LC system (see Background section, p. 2).
Finally, Carr does not disclose that the coated stainless steel fluid-contacting permits anti-stiction transport of the fluid.
SilcoTek (see the article cited above) discloses that a coated stainless steel fluid-contacting permits anti-stiction transport of the fluid (i.e. “proteins don’t stick to Dursan” – that is, the coating on the HPLC parts – see bottom p. 3, top of p.4).
Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Carr’s LC technique so that the coated stainless steel fluid-contacting permits anti-stiction transport of the fluid, as taught by SilcoTek.
Such a modification would prevent protein carryover and fouling (see SilcoTek: bottom p. 3, top of p.4).
Response to Arguments
Applicant's arguments filed 05/27/2025 have been fully considered but they are not persuasive. Applicant argues that the “SilcoTek” reference should be disqualified as prior art under the 102(b)(2)(C) exception, however, this exception only applies to references that are based on a filing date of a patent or a patent application. In the case of the “SilcoTek” reference, this reference is not a patent or patent application and the rejection is based on the publication date/date available to the public (“SilcoTek” is a publication available on the internet at the listed date); see MPEP 2152 and 2152.02(e). Thus, the “SilcoTek” reference cannot be excepted under the 102(b)(2)(C) exception.
The examiner also notes that the “Smith” reference (i.e. “The Deposition and Functionalization of Silicon-Based Materials to Prevent Surface Corrosion, Adsorption, Contamination and Catalytic Interactions” Oct. 2009 – cited on Applicant’s 07/29/2025 IDS) discloses an anti-stiction property of a silicon-based coating (see slide 2). In addition, another reference to “SiloTek” (i.e. “Inert Dursan Prevent Protein & Biomolecule Sticking & Carryover – cited on Applicant’s 07/29/2025 IDS) also teaches an anti-stiction property of a coating for LC equipment (see pp. 1-2).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Benjamin Schmitt, whose telephone number is (571) 270-7930. The examiner can normally be reached M-F | 8:30-5:00.
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/BENJAMIN R SCHMITT/Primary Examiner, Art Unit 2852