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 .
Claims Status
Claims 1 and 6-14 are rejected.
Claims 2-5 are objected.
Claim Objections
Claim 11 objected to because of the following informalities:
Claim 11: “a chromatography system” in line 2 should be replaced with --the chromatography system--.
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.
Claim 9 is 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.
Claim 9: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “less than 100µV”, and the claim also recites “or less than 30µV” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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, 7 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berger et al. (US 2002/0070169) [hereinafter Berger].
With respect to claim 1, Berger discloses a chromatography system, as shown in Fig. 1, having: one or more pumps 202, 206 (mobile phase pumps), as shown in Fig. 1; an injector valve 212 (sample injector) fluidically coupled through a flow path to the one or more mobile phase pumps 202, 206, as shown in Fig. 1; a dampener 208 positioned in the flow path between the one or more mobile phase pumps 202, 206, and the sample injection device 212, as shown in Fig .1; a chromatographic column 214 comprising an inlet and an outlet, wherein the inlet of the chromatographic column 214 is fluidically coupled to the sample injection device 212, as shown in Fig. 1; and a detector 216 coupled to the outlet of the chromatographic column 214, as shown in Fig. 1.
With respect to claim 7, Berger discloses wherein the one or more packed bed columns 214 comprise a first packed bed column and a second packed bed column connected in series, as shown in Fig. 1.
With respect to claim 10, Berger discloses a heater 16, 18, in thermal communication with the chromatographic column 214, as shown in Fig. 1.
With respect to claim 11, Berger discloses a method of performing chromatography on a sample, the method comprising passing the sample through a chromatography system, as shown in Fig. 1.
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.
Claim(s) 6 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Berger (US 2002/0070169) in view of Vilenchik et al. (US 5,190,658) [hereinafter Vilenchik].
With respect to claim 6, Berger lacks wherein the chromatographic column comprises a size exclusion chromatography (SEC) sorbent.
Vilenchik discloses an apparatus and method for size exclusion chromatography. Vilenchik discloses that in size exclusion chromatography, the separation of components is a function of their molecular size and the stationary phase typically does not attract the components, and separation depends on the amount of time that the substances spend in the porous stationary phase as compared to time in the fluid (see col. 1, lines 41-46). Vilenchik also teaches that the stationary phase may be polymer-based sorbents or inorganic sorbents (see col. 2, lines 8-33). Vilenchik further teaches that size exclusion chromatography is widely utilized in a variety of scientific fields, for example, in the biological sciences, size exclusion chromatography is used for the isolation and purification of biological molecules, such as peptides, hormones or DNA, and size exclusion chromatography is used in the polymer chemistry field to determine molecular weight distribution of polymers and to isolate or resolve polymers of a particular size from a mixture of variously sized polymers (see col. 1, lines 60-68). It would have been obvious to one of ordinary skill in the art to provide the column disclosed by Berger with a size exclusion chromatography (SEC) sorbent, as taught by Vilenchik, in order to separate components as a function of their molecular size (see col. 1, lines 41-46) and since one of ordinary skill would choose a desired sorbent according to a desired application (see col. 1, lines 41-46; and col. 2, lines 8-33).
With respect to claims 12-13, Berger lacks wherein the sample comprises macromolecules; and wherein the sample comprises a biological polymer. Vilenchik teaches that size exclusion chromatography is widely utilized in a variety of scientific fields (see col. 1, lines 60-61). In the biological sciences, size exclusion chromatography is used for the isolation and purification of biological molecules, such as peptides, hormones or DNA (see col. 1, lines 61-64). Size exclusion chromatography is used in the polymer chemistry field to determine molecular weight distribution of polymers and to isolate or resolve polymers of a particular size from a mixture of variously sized polymers (see col. 1, lines 64-68). Vilenchik teaches a method for separating macromolecules in a composition by molecular size that utilize a stationary phase support that is suitable for use with chromatographic systems (see col. 3, lines 43-50). It would have been obvious to use a sample having a macromolecule or a biological polymer as taught by Vilenchik in the system disclosed by Berger, in order to separate components in the samples, and since one ordinary skill would recognize to choose a desired type of sample according to a desired application.
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Berger (US 2002/0070169) in view of Some (US 2023/0022034).
With respect to claim 8, Berger lacks wherein the detector is a multi-angle light scattering (MALS) detector.
Some discloses a system for controlling the purification of a macromolecule solution via real-time multi-angle light scattering (MALS), as shown in Fig. 1A, including a chromatography pump and system, a chromatography column, and a MALS detector, as shown in Fig. 1A. The MALS detector is used for determining both the absolute molar mass and the average size of molecules in solution, by detecting how they scatter light (see paragraph 0027). It would have been obvious to one of ordinary skill in the art to replace with detector used by Berger with a MALS detector as taught by Some in order to determine both the absolute molar mass and the average size of molecules in solution, by detecting how they scatter light (see paragraph 0027) and since one of ordinary skill would recognize to choose a desired type of detector according to a desired application.
With respect to claim 9: Berger as modified by Some lacks wherein the dampener is configured to reduce RMS baseline noise of the mobile phase to less than 100 μV or less than 30 μV in the MALS detector. However, this would have been obvious to one of ordinary skill in the art since one of ordinary skill would recognize to configure the dampener to configure the dampener according to a desired application.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Berger (US 2002/0070169) in view of Vilenchik (US 5,190,658) and Some (US 2023/0022034).
With respect to claim 14, Berger lacks wherein the sample is passed through a size exclusion chromatographic column to a multi-angle light scattering detector.
Vilenchik teaches a method for size exclusion chromatography. Vilenchik discloses that in size exclusion chromatography, the separation of components is a function of their molecular size and the stationary phase typically does not attract the components, and separation depends on the amount of time that the substances spend in the porous stationary phase as compared to time in the fluid (see col. 1, lines 41-46). Some discloses a system for controlling the purification of a macromolecule solution via real-time multi-angle light scattering (MALS), as shown in Fig. 1A, including a chromatography pump and system, a chromatography column, and a MALS detector, as shown in Fig. 1A. The MALS detector is used for determining both the absolute molar mass and the average size of molecules in solution, by detecting how they scatter light (see paragraph 0027). It would have been obvious to one of ordinary skill in the art to pass the sample disclosed by Berger through a size exclusion chromatographic column to a multi-angle light scattering detector, as taught by Vilenchik and Some, in order to separate components as a function of their molecular size (see col. 1, lines 41-46 of Vilenchik) and to determine both the absolute molar mass and the average size of molecules in solution, by detecting how they scatter light (see paragraph 0027 of Some) and since Berger already suggests the use of a chromatographic column and detector and one of ordinary skill would recognize to choose a specific type of column and detector according to a desired application.
Allowable Subject Matter
Claims 2-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 2 would be allowed because the prior art of record does not show or suggest wherein the dampener comprises one or more particle bed columns comprising packed particles, in combination with the remaining limitations in the claim. Berger lacks this limitation and it would have not been obvious to modify because there is no reason or suggestion to do so and the system would not operate as intended.
Claims 3-5 would be allowed due to their dependency on claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Davankov et al. (US 2007/0000837) teaches a method of separating electrolytes by size exclusion chromatography. Wikfors et al. (US 7,670,487) teaches a chromatography system including a dampener.
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/MADELINE GONZALEZ/Primary Examiner, Art Unit 1773
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