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 Status
Claims 1-20 are pending. Claims 1-13, 18, and 20 are withdrawn.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/313543, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Accordingly, claims 14-17 and 19 are not entitled to the benefit of the prior application. The prior application does not provide support for at least “high-duty-cycle”, “pumping, by an isocratic pump, a mobile phase A solvent through a column to a waste area”, and “once the first mobile phase gradient and the first sample are entirely pumped into the first gradient storage chamber, moving the valve to couple the column with the first gradient storage chamber”.
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 20 recites the limitation "the mobile phase gradient”. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to “first mobile phase gradient” or “second mobile phase gradient”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Strategic Combination of Isocratic and Gradient Elution for Simultaneous Separation of Polar Compounds in Traditional Chinese Medicines by HPLC by Zhang et al. (Zhang), as evidenced by Thermo Scientific Dionex UltiMate 3000 Pumps The Benchmark in LC Solvent Delivery by Thermo Scientific (Thermo Scientific), and further in view of U.S. Patent No. 2021/0300965 by Nguyen et al. (Nguyen).
In regard to claim 14, Zhang teaches a method of using a high-duty-cycle liquid chromatography system (abstract). Zhang teaches obtaining a first and second sample (2.2 Instrumentation and HPLC Parameters, autosampler; 2.3 Sample and Standard Preparation). Zhang teaches performing mobile phase gradient elution (2.2 Instrumentation and HPLC Parameters, step (ii) and (iii)). Zhang teaches an Ultimate 3000 pump (2.2 Instrumentation and HPLC Parameters). Zhang teaches an isocratic elution with a mobile phase solvent (2.2 Instrumentation and HPLC Parameters, step (vi)). Zhang teaches a column with a detector (2.2 Instrumentation and HPLC Parameters, column). Zhang teaches analyzing the sample by the detector (2.2 Instrumentation and HPLC Parameters, diode array detector).
Zhang does not explicitly teach moving a valve to couple the mobile phase gradient delivery pump and a gradient storage chamber. Zhang does not explicitly teach pumping by an isocratic pump a mobile phase solvent to a waste. However, Zhang teaches an Ultimate 3000 pump (2.2 Instrumentation and HPLC Parameters). The citations from Thermo Scientific show that these are features of the pump.
Thermo Scientific teaches a UltiMate 3000 pump (page 1). Thermo Scientific teaches switching valves (page 5, Nano/Cap Pumps; page 7, Figure 14). Thermo Scientific teaches moving a valve to couple a mobile phase gradient delivery pump and a gradient storage chamber (page 7, Figure 14, LPG, proportioning valve, pump head, purge valve, mixer). Thermo Scientific teaches pumping, by the mobile phase gradient delivery pump, a mobile phase gradient and the sample to the gradient storage chamber via the valve (page 7, Figure 14, LPG, pump head, purge valve, mixer). Thermo Scientific teaches pumping, by an isocratic pump, a mobile phase A solvent through a column to a waste area (page 7, Figure 14, ISO, pump outlet). Zhang teaches once the mobile phase gradient and the same are entirely pumped into the gradient storage chamber, moving the valve to couple the column with the gradient storage chamber (page 7, Figure 14, LPG, proportioning valve, pump head, purge valve, mixer; page 3, The Art of Mixing). Zhang teaches pushing the mobile phase gradient and the same through the column by pumping, by an isocratic pump, the mobile phase A solvent through the column to the detector, and analyzing the sample by the detector (page 7, Figure 14, ISO, pump outlet).
Zhang does not teach pumping, by the mobile phase gradient delivery pump, a second mobile phase gradient and the second sample to a second gradient storage chamber via the valve, while the first mobile phase gradient and first sample are being pushed through the column and analyzed by the detector.
Zhang does not teach applying a voltage to the column. Thermo Scientific teaches measuring current (page 5, Figure 13). Thermo Scientific teaches electrochemical detection (page 2).
Nguyen teaches liquid chromatography ([0003]). Nguyen teaches isocratic and gradient separations ([0053]). Nguyen teaches applying a voltage to the column configured to couple the column to a detector ([0056]). Nguyen teaches mass spectrometry utilizes a voltage to quantify species ([0056]). Nguyen teaches pumping, by the mobile phase gradient delivery pump, a second mobile phase gradient and the second sample to a second gradient storage chamber via the valve, while the first mobile phase gradient and first sample are being pushed through the column and analyzed by the detector (claim 10; [0060]; [0053]-[0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate a voltage, as taught by Nguyen, in the method of Zhang as applying a voltage is a known way in which to activate separation quantification in mass spectrometry. It is known in the art to utilize a voltage when applying mass spectrometry. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate an additional second mobile phase gradient, as taught by Nguyen, in the method of Zhang, as it is a known separation method and can improve resolution.
In regard to claim 16, Zhang does not explicitly teach the unique species comprise at least one of proteins or fragments thereof, lipids, or metabolites. However, Zhang teaches in the references section that multidimensional column separations are used for protein quantification (1. Introduction, biological and/or pharmacological; References, [13] protein quantification). It would have been obvious to one of ordinary skill in the art before the effective filing date to separate proteins utilizing the method of the claims since it is known in the art to utilize chromatography for protein separations.
In regard to claim 17, Zhang does not explicitly teach the detector is a mass spectrometer. ThermoScientific teaches coupling mass spectrometry into UltiMate 3000 (page 8).
Furthermore, Zhang teaches in the references section that mass spectrometry is a known method of detection in liquid chromatography systems (References, [6] mass spectrometry; References, [8] mass spectrometry). It would have been obvious to one of ordinary skill in the art before the effective filing date to utilize mass spectrometry in the method of Zhang as it is a known detector in the art of chromatography.
In regard to claim 19, Zhang does not explicitly teach the sample is a biological sample that includes at least one of tissues, biopsies, cell homogenates, cell fractions, cultured cells, non-cultured cells, whole blood, plasma, biological fluids, or single cells. However, Zhang teaches in the reference section that plasma is a known source of pharmacokinetic matrerials and separated in liquid chromatography (References, [6] dog’s plasma). It would have been obvious to one of ordinary skill in the art before the effective filing date to utilize plasma in the method of Zhang as it is a known source of pharmacokinetic materials.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Strategic Combination of Isocratic and Gradient Elution for Simultaneous Separation of Polar Compounds in Traditional Chinese Medicines by HPLC by Zhang et al. (Zhang), as evidenced by Thermo Scientific Dionex UltiMate 3000 Pumps The Benchmark in LC Solvent Delivery by Thermo Scientific (Thermo Scientific), and further in view of U.S. Patent No. 2021/0300965 by Nguyen et al. (Nguyen), as noted above, further in view of English Translation of CN105929069 by Wang et al. (Wang).
In regard to claim 15, modified Zhang teaches the limitations as noted above. Further, Zhang teaches traditional Chinese medicines (abstract). Modified Zhang does not teach analyzing identifies at least 1,000 unique species.
Wang teaches chromatography and mass spectrometry (abstract). Wang teahces gradient and isocratic elution (page 6-7). Wang teaches traditional Chinese medicines contain thousands of compounds (page 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date that the sample of Zhang contains thousands of species for separation as it is known in the art that Chinese medicines contain thousands of compounds.
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
In regard to the Applicant’s argument regarding the priority, the Examiner does not find this persuasive.
The Applicant argues with a high level of generality that the provisional application provides support. There are no specific citations referenced to show which limitations are covered by which specific portions of the provisional application.
In regard to the Applicant’s argument regarding the new limitations, the Examiner does not find this persuasive and notes the rejection is updated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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