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
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.
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.
Claim(s) 1-2, 4-5, 9-15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quint et al. (EP3896443A1) in view of Quinn et al. (WO97/26532).
Re claim 1, Quint et al. teach a method of washing an element (i. e. chromatography system) by providing a first washing liquid towards the element, and providing a second washing liquid towards the element, wherein the second composition is different from the first washing liquid. Applicant is directed to paragraph 29, which teaches different wash liquids to wash out residual samples in the valve to detector conduit. Paragraph 46 teaches a controller for controlling the wash pump connection time while pumping the wash liquid. Paragraph 67 teaches that the fluid streams may be different. In particular, the method may be adapted to switch between any two or more or all of the plurality of fluidic streams and in any sequence. Paragraph 57 teaches the wash pump 40 connected to 4 wash liquid containers containing different washing liquids (paragraph 29). Applicant is also directed to Fig. 4 which teaches two washing times t-W. It is also noted that applicant’s claim reads broadly on a binary mixture having two components (i.e., the first liquid and the second liquid) which are directed to the element.
Re claims 1 and 17, Quint et al. do not specifically teach the limitations of a first liquid directly proximal to a second liquid. However, Quint et al. teach that washings could be performed in any sequence. Therefore, in the absence of a showing of criticality and/or unexpected results, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to adjust the processing parameters and sequence of the washing fluids to order to achieve the desired level of cleanliness. Re claims 1 and 17, Quint et al. do not teach liquid plugs, specifically a first plug of a first washing liquid and a second plug of a second washing liquid. Quinn et al. teach an HPLC apparatus and method wherein injections are made in a manner to minimize the amount of eluant required. Page 5 teaches fluid injections form closely bunched but separated fluid plugs, which are injected sequentially. Page 5 teaches a sample mixture and one or more eluant fluid or fluids are introduced into the column as fluid plugs. Page 6 further teaches that the plug is understood to mean a mass or volume of fluid that is injected into a flow stream in a chromatographic column so as to form a discrete mass, which enhances the rate of mass transfer, thus increasing the throughput/productivity of the column by reducing dramatically the time required to effect separations (pages 4-5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Quint et al. to include sequential liquid plugs, as taught by Quinn et al., for purposes of enhances the rate of mass transfer, thus increasing the throughput/productivity of the column by reducing dramatically the time required to effect separations. In reference to the limitations of the liquid plugs defining a wash volume, Quinn et al. teach that each plug is understood to mean a mass or volume of fluid. It is noted that applicant’s claim is not restricted as to the dimensions/volume of the liquid plug. In reference to the element, paragraph 18 taches that the LC system comprises at last one LC column, wherein the column can include trap column or an HPLC column which can retain and elute analytes of interest.
Re claim 2, the limitations are broadly interpreted such that the liquid storage section of the chromatography system reads on the tubing (Fig. 1A). Specifically, the washing liquid is picked up by the wash pump 40 into the liquid storage section (i.e. conduit along flow rate 45). Additionally, the claim does not further define the pickup cycle, and therefore the wash liquid being pumped at intervals (paragraph 71) would read on a washing liquid pick up cycle, refer to Fig. 4). Re claim 4, applicant is directed to Fig. 4, wherein teach t-W is considered a cycle. Re claim 5, the claim is broadly interpreted to read on a chemical mixture comprising two components, the first component (i.e. first composition) having at least 70% and the second component having at most 30%. Specifically, the claim reads on a binary mixture. Paragraph 72 teaches an acetonitrile: water solution of 5:95, wherein the first component is water, having a concentration of at least 70 percent, and the second component is acetonitrile having a concentration of at most 30 percent. Re claim 9, refer to paragraphs 24 and 28. Re claim 10, Quint et al. teach a wash pump waste port 24’ leading to the waste 50 and further teaches washing before and after subsequent fluidic streams which inherently results in the draining of the fluidic streams prior to a washing step. Paragraph 61 teaches the fluidic streams 11, 12, 13 are directed to waste 50 via waste ports 21’, 22’, 23’ respectively. Re claims 11-12, refer to paragraph 27, which teaches a positive pressure wash pump, also refer to paragraphs 27 and 56-57. Re claim 13, Quint et al. do not specifically teach increasing the pressure of the first and second washing liquids before the rinse step, wherein the first and second washing liquids are in a section of the chromatography system not fluidly connected to the element. The skilled artisan would reasonably expect the pressurization to increase as a result of pumping the washing liquid by the wash pump 40 since paragraph 23 teaches that the wash pumps are positive pressure pumps. Additionally, in view of Fig. 1A, the first and second washing liquids are in a section of the chromatography system not fluidly connected to the element. Specifically, the first and second washing liquids are in a section (i.e. above the wash pump 40), not fluidly connected to the chromatography system, unless the pump is activated to inject the washing liquids. Furthermore, the liquids are pressurized prior to the washing step, since the liquids are being pumped prior to preforming the washing step. Re claim 14, the prior art of Quint et al. fails to teach the claimed pressures. Absent of a showing of criticality and/or unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of Quint et al. to include adjusting the pressures of the wash pump in order to actively pump a wash liquid at higher flow rates from the wash liquid source to the chromatography system to effectively remove trace sample residue. Re claim 15, refer to paragraph 27, which teaches a positive pressure wash pump, also refer to paragraphs 27 and 56-57. Re claim 18, refer to Fig. 4 of Quint et al., wherein t-W reads on “liquid plugs”, wherein the liquids can be a plurality of different liquids (paragraphs 29 and 72) in any sequence. Also refer to page 5 of Quinn et al.
Claims 3 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quint et al. (EP3896443A1) in view of Quinn et al. (WO97/26532) and further in view of Cormier et al. (US2019/0366325).
Quint et al. in view of Quinn et al. teach the invention substantially as claimed with the exception of the system comprising a pick-up needle and a wash port, wherein the needle is located in the wash port through the washing liquid pickup routine. Cormier et al. teach an online sample manager for a liquid chromatography system which include a needle 316, for injecting a sample and/or washing solution into the chromatography system. Paragraphs 45-47, 50-51, and 57 teach that the fluidic components in the system may be cleaned by pushing wash solution and diluent through needles. In reference to the wash port, applicant is directed to Fig. 3 with the needle 316 positioned in the wash tower 320. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified method of Quint et al. to include a pick-up needle and wash port for injecting and introducing washing solutions into the chromatography system. Re claim 21, in reference to user input, the skilled artisan would reasonably expect the limitations to be met since Quint et al. teach a controller configured to control the analytical system (paragraph 43). Quint et al. further teaches the processor may communicate and/or cooperate with the scheduler and/or data manager to schedule and/or execute operations.
Response to Arguments
Applicant continues to maintain the argument that Quint teaches washing a valve to detector conduit and does not teach washing a trap column and/or separation column. The examiner agrees with applicant’s assertion that Quint teaches washing a valve to detector conduit. However, Applicant’s arguments are unpersuasive as the LC system of Quint includes an LC column (paragraph 18) and further teaches using a wash liquid comprising solvents to remove traces of samples, which would include analytes present in the column. It is noted that applicant’s wash liquid is not limited to any type of composition, and therefore any solvent to remove residual in the LC system reads on applicant’s wash liquid. Additionally, paragraph 11 of Quint is directed to cleaning LC systems and therefore, the examiner maintains the position that cleaning an LC system by ejecting various solvents into the system is neither novel and/or unobvious to one of ordinary skill in the art. Specifically, the examiner maintains the rejections for the reasons set forth above. Additionally, as stated the LC system teaches a plurality of columns, and further teaches using different eluents (fluid streams) to remove traces of samples, which reads on a washing step. Furthermore, applicant’s claim language is broadly interpreted that washing includes the application of a first and second liquid towards the element. Paragraph 40 of Quint ‘443 teaches the liquid from the fluidic stream includes LC eluates and wash liquid in between the fluidic streams. Applicant’s claim is broadly interpreted as injecting two different liquids into a column. Quint teaches a plurality of solvents (fluid streams 11, 12, 13) for elution of residual sample from the column, which reads on a rinsing step. In summary, Quint teaches that different solvents may be used. Quint teaches that the solvents may be mixed but this is not required (paragraph 29) and further teaches that any sequence of the washing liquids can be provided. Applicant’s claim is open ended such that the first and the second washing liquid is not limited to a single ingredient. Furthermore, applicant has not limited the claim to a specific chemical for either the first and/or the second washing liquids.
In the event the claims were amended, Quint et al. clearly teaches that different liquids and/or combinations of liquids can be used in any sequence. Paragraph 67 of Quint et al. 443 clearly teaches switching between 2 or more of the fluidic streams. Since the LC columns are part of the LC system and the fluidic streams, switching between 2 or more fluidic streams would result in various contaminants being eluted from the column. The examiner argues that 2 or more fluidic streams washes both the column (i.e. elution of trace sample) as well as washing of the detector conduit 30, as the elution of trace samples flow to the detector conduit 30 and to a mass spectrometer (paragraph 72). Fig. 5 of Quint clearly shows liquid flow of the first fluidic stream followed directly by liquid flow from the second fluidic stream. Furthermore, applicant has not defined the dimensions/volume of a liquid plug, and broadly interpreted injecting a first liquid followed by injection of a second liquid, would read on two liquid plugs.
In summary, the prior art teaches a) washing both column and detector with a plurality of solvents in any sequence to remove contaminants, b) replacing a first liquid directly by a second liquid (Fig. 5 of Quint ‘443), and c) the introduction of eluant fluids as fluid plugs in a column. The claims, as presented are not allowable, as the claims are broadly interpreted as cleaning a column with a plurality of solvents, as liquid plugs of different solvents, such that the claims are not limited to any specific liquid and/or composition. The concept of cleaning a column with a plurality of different solvents, wherein a first solvent is replaced by a second solvent, for elution of trace contaminants, is neither novel nor unobvious in view of the teachings of the prior art.
7. Applicant’s arguments directed to reduction of column carryover while maintaining sample throughput is not persuasive because it is not commensurate in scope with the instantly claimed invention and it is unclear what the skilled artisan would consider as a “reduction” of the column carryover.
8. Re claims 3 and 20-21 directed to rendering the system more complex and prone to errors are not persuasive as it not based on any factual evidence provided. Using a needle and wash port for injecting and introducing washing solutions into the chromatography system is not considered patentable subject matter as it is considered as an equivalent conventional means for sample introduction into a chromatography system.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharidan Carrillo whose telephone number is (571)272-1297. The examiner can normally be reached M-F, 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Barr can be reached on 571-272-1414. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Sharidan Carrillo
Primary Examiner
Art Unit 1711
/Sharidan Carrillo/Primary Examiner, Art Unit 1711 bsc