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
Claims 5 and 13 are objected to because of the following informalities:
Regarding claim 5, the claim refers back to specific compositions introduced in claim 4. As such, it should be dependent on claim 4 instead of claim 3.
Regarding claim 13, the claim refers back to specific compositions introduced in claim 12. As such, it should be dependent on claim 12 instead of claim 11.
Appropriate correction is required.
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.
Claims 4-5 and 12-13 are 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.
Regarding claim 4, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. It is unclear as to which exact limitations are optional. See MPEP § 2173.05(d).
Regarding claim 4, the phrase "in an embodiment" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5, the phrase "in an embodiment" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 12, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. It is unclear as to which exact limitations are optional. See MPEP § 2173.05(d).
Regarding claim 13, it is dependent on claim 12 (see claim objection above).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, 9, and 14 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Stewart et al. (US 2006/0169030 A1) (hereinafter Stewart).
Regarding claim 1, Stewart teaches an analytical system [IPMS system] (see Abstract) comprising:
a mass spectrometer [mass spectrometer] (Para [0008]) and an ionization source coupled to the mass spectrometer [ionizing sample before processing through mass spectrometer; electrospray to ionize spiked sample; other ionization sources may be used] (Para [0006, 0038]),
an analytical fluidic system (see Figs. 1-4) connectable to the ionization source [electrospray probes 130a, 130b] via a downstream valve [selection valves 116, 301, 425, 430] for infusing samples into the mass spectrometer via the ionization source [sample mix module 300 to MDM(+)/MDM(-)], wherein the downstream valve is located downstream with respect to the analytical fluidic system in a normal direction of flow through a fluidic stream towards the ionization source (Para [0024-0028, 0037], see Figs. 1-4),
a downstream pump fluidically connectable to the ionization source via the downstream valve [each selection valve may select particular ones of syringe pumps 405a-405e], wherein the downstream pump is fluidically connected to a plurality of fluid containers comprising respective fluids [pumps 405a-405e fluidically connected to spike dilution modules through sample mix modules] (Para [0037], see Figs. 1-4), the fluids comprising at least one concentrated composition for calibrating the mass spectrometer and at least one diluent for diluting the at least one concentrated composition [spike dilution module where concentrated spike may be diluted; dilution of spikes with a diluent source] (Para [0019], see Fig. 1),
a controller [processor] configured to control the downstream pump in order to obtain at least one diluted composition by automatically mixing at least one concentrated composition with at least one diluent with a predetermined dilution factor, to infuse the at least one diluted composition into the ionization source, to obtain a mass spectrum of the at least one diluted composition and to execute a calibration of the mass spectrometer based on an assessment of the mass spectrum [processor controls automatic sampling of the solution of interest, spiking the sample with a calibration standard, ionizing the spiked sample, processing the ionized spiked sample through the mass spectrometer] (Para [0006, 0008]).
Regarding claim 7, Stewart as applied to claim 1 above teaches the claimed invention, in addition to wherein the analytical fluid system comprises a plurality of fluidic streams, wherein at least one fluid container comprises a wash liquid, and wherein the controller is further configured to control the downstream pump and the downstream valve to connect to the ionization source between two consecutive fluidic streams in order to wash liquid from a previous fluidic stream out of a conduit between the downstream valve and the ionization source with the wash liquid before liquid from a subsequent fluidic stream enters the conduit [sample mix module; cleaning solution] (Para [0023-0027], see Fig. 3).
Regarding claim 9, Stewart teaches an automated analytical method use of a mass spectrometer [IPMS system; mass spectrometer] (Para [0008], see Abstract), the method comprising:
connecting a downstream pump [pumps 405a-405e] to an ionization source [electrospray probes 130] coupled to the mass spectrometer via a downstream valve [selection valves 116, 301, 425, 430] arranged downstream of an analytical fluidic system (see Figs. 1-4), wherein the downstream valve is located downstream with respect to the analytical fluidic system in a normal direction of flow through a fluidic stream towards the ionization source (Para [0024-0028, 0037], see Figs. 1-4), wherein the downstream pump is fluidically connected to a plurality of fluid containers comprising respective fluids [pumps 405a-405e fluidically connected to spike dilution modules through sample mix modules] (Para [0037], see Figs. 1-4), the fluids comprising at least one concentrated composition for calibrating the mass spectrometer and at least one diluent for diluting the at least one concentrated composition [spike dilution module where concentrated spike may be diluted; dilution of spikes with a diluent source] (Para [0019], see Fig. 1),
controlling the downstream pump in order to obtain at least one diluted composition by automatically mixing at least one concentrated composition with at least one diluent with a predetermined dilution factor, infusing the at least one diluted composition into the ionization source, obtaining a mass spectrum of the at least one diluted composition, executing a calibration of the mass spectrometer based on an assessment of the mass spectrum [processor controls automatic sampling of the solution of interest, spiking the sample with a calibration standard, ionizing the spiked sample, processing the ionized spiked sample through the mass spectrometer] (Para [0006, 0008]).
Regarding claim 14, Stewart as applied to claim 9 above teaches the claimed invention, in addition to further comprising controlling the downstream pump and the downstream valve to connect to the ionization source between two consecutive fluidic streams of the analytical fluidic system in order to wash liquid from a previous fluidic stream out of a conduit between the downstream valve and the ionization source with the wash liquid before liquid from a subsequent fluidic stream enters the conduit [sample mix module; cleaning solution] (Para [0023-0027], see Fig. 3).
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.
Claims 2-3 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart as applied to claims 1 and 9 above, and further in view of Fischer et al. (US 5,703,360) (hereinafter Fischer).
Regarding claims 2 and 10, Stewart as applied to claims 1 and 9 above teaches the claimed invention, except for wherein the calibration includes a mass axis check and/or a mass axis adjustment. Fischer teaches an analytical spectrometry system and method wherein calibration of the system comprises a mass axis check (Col 5, line 57 - Col 6, line 7). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Stewart with Fischer such that the calibration includes a mass axis check and/or a mass axis adjustment, in order to accurately calibrate the system.
Regarding claims 3 and 11, Stewart in view of Fischer as applied to claims 2 and 109 above teaches the claimed invention, except for wherein in case of failure or anticipation of failure of the mass axis check and/or mass axis adjustment, based on the assessment of the mass spectrum of the at least one diluted composition, the controller may be further configured to execute any one or more actions selected form adapting the dilution factor of the at least one concentrated composition, adjusting one or more mass spec acquisition parameters, executing a maintenance procedure, before repeating the mass axis check and/or mass axis adjustment. Fischer additionally teaches wherein one or more mass spectrometer acquisition parameters are adjusted in response to the calibration results (Fischer Col 5, line 57 - Col 6, line 7). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Stewart in view of Fischer such that wherein in case of failure or anticipation of failure of the mass axis check and/or mass axis adjustment, based on the assessment of the mass spectrum of the at least one diluted composition, the controller may be further configured to execute any one or more actions selected form adapting the dilution factor of the at least one concentrated composition, adjusting one or more mass spec acquisition parameters, executing a maintenance procedure, before repeating the mass axis check and/or mass axis adjustment, in order to adjust the system based on calibration results.
Claims 4-6 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart as applied to claims 1 and 9 above, and further in view of Zhou et al. (Surface-Induced Dissociation of Ion Mobility-Separated Noncovalent Complexes in a Quadrupole/Time-of-Flight Mass Spectrometer, 2012) (hereinafter Zhou).
As best understood regarding claims 4, 6 and 12, Stewart as applied to claims 1 and 9 above teaches the claimed invention, except for wherein the at least one concentrated composition comprises cesium iodide, optionally ethylamine and/or formic acid, a polar solvent, methanol, and/or water, and optionally cyclosoporine A and/or 5-(4-hydroxyphenyl)-phenylhydantoin and/or ammonium formate and wherein the at least one diluent is any of methanol, acetonitrile, ethanol, propanol, isopropanol, or a combination of any ones thereof. Zhou teaches concentrated compositions used in mass spectrometry comprising cesium iodide with a diluent comprising acetonitrile (Pg. 6018, Materials and Methods section). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Stewart with Zhou such that the at least one concentrated composition comprises cesium iodide, optionally ethylamine and/or formic acid, a polar solvent, methanol, and/or water, and optionally cyclosoporine A and/or 5-(4-hydroxyphenyl)-phenylhydantoin and/or ammonium formate and wherein the at least one diluent is any of methanol, acetonitrile, ethanol, propanol, isopropanol, or a combination of any ones thereof, for the predictable result of calibrating a mass spectrometry system.
As best understood regarding claims 5 and 13, Stewart in view of Zhou as applied to claims 4 and 12 above teaches the claimed invention, except for wherein in the at least one concentration composition, cesium iodide has a concentration from 0.1 ug/mL to 100 mg/mL; ethylamine, if present, has a concentration from 0.01 ug/mL to 1 mg/mL, and formic acid, if present, has a concentration from 0.001% (v/v) to 10% (v/v); cyclosporine A, if present, has a concentration from 0.01 ug/mL to 1000 ug/mL, 5-(4-hydroxyphenyl)-phenylhydantoin, if present, has a concentration from 0.01 ug/mL to 1000 ug/mL, ammonium formate, if present, has a concentration from 0.01 mM to 1 M; a polar solvent, methanol, water, or a mixture thereof is added to 100%. Zhou additionally teaches wherein the concentration composition comprises cesium iodide dissolved in acetonitrile:water:formic acid in a 50:50:0.1 solution (Pg. 6018). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Stewart in view of Zhou such that at least one concentration composition, cesium iodide has a concentration from 0.1 ug/mL to 100 mg/mL; ethylamine, if present, has a concentration from 0.01 ug/mL to 1 mg/mL, and formic acid, if present, has a concentration from 0.001% (v/v) to 10% (v/v); cyclosporine A, if present, has a concentration from 0.01 ug/mL to 1000 ug/mL, 5-(4-hydroxyphenyl)-phenylhydantoin, if present, has a concentration from 0.01 ug/mL to 1000 ug/mL, ammonium formate, if present, has a concentration from 0.01 mM to 1 M; a polar solvent, methanol, water, or a mixture thereof is added to 100%, for the predictable result of calibrating a mass spectrometry system. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart as applied to claims 1 and 9 above, and further in view of Ozbal et al. (US 2005/0123970 A1) (hereinafter Ozbal).
Regarding claims 8 and 15, Stewart as applied to claims 1 and 9 above teaches the claimed invention, in addition to wherein at least one fluid container comprises a wash liquid [cleaning solution] (Para [0023-0027]). Stewart fails to teach wherein the analytical fluidic system comprises at least one fluidic stream comprising an HPLC column, and wherein the controller is further configured to control the downstream pump and the downstream valve to connect to the at least one fluidic stream in order to backflush and thereby clean the at least one HPLC column with the was liquid. Ozbal teaches an analytical spectrometry system and method comprising an HPLC column wherein wash liquid is backflushed into the column while the eluent from another column is being sent to the mass analyzer (Para [0021]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Stewart with Ozbal such that the analytical fluidic system comprises at least one fluidic stream comprising an HPLC column, and wherein the controller is further configured to control the downstream pump and the downstream valve to connect to the at least one fluidic stream in order to backflush and thereby clean the at least one HPLC column with the was liquid, in order to prevent contamination between samples.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID Z HUANG whose telephone number is (571)270-5360. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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/DAVID Z HUANG/ Primary Examiner, Art Unit 2855