DETAILED CORRESPONDENCE
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 .
Remarks
The examiner appreciates applicants reaching out to inquire about a potential typo in the previous Office Action. This is a corrected Office Action to correct the patent number used in the previous double patenting rejection in the Office Action mailed on 6/1/26. Specifically, the double patenting rejection in paragraph 50 of the previous Office Action has been corrected from U.S. Patent No. 10439402 to U.S. Patent No. 10989728.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/21/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The examiner notes that Citation #14 under the Non-Patent Literature section has been struck through because the document is not submitted as a high-quality image such that it is legible. Thus, the Citation #14 under the Non-Patent Literature fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Status
Claims 1-20 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected based on the following analysis:
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract idea of “selecting” a flow path and “processing the data” to “determine” a quality of the path, which are mental processes.
Although not recited as being performed by a computer, even if these were performed by a computer, MPEP 2106.04(a)(2)III is clear that using a computer/controller to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Once the determination has been made, then no action is taken. Therefore, there is no particular practical application.
The claim also recites implementing a protocol by actuating a pump to flow reagent through a flow path, discharging fluid through a discharge flow path, and measuring flow rate at the discharge flow path. However, this is just using the generic pump, flow paths and measurement to gather data to be used in the abstract idea of determining. Data gathering to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Additionally, the generic pump, flow paths and measurement are not used outside their normal capacity and are recited at such a high level of generality that it amounts to just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
Although not recited as being performed by a computer, even if these were performed by a computer, performing the abstract idea on a general-purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.05(b)I.).
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of a implementing a protocol by actuating a pump to flow reagent through a flow path, discharging fluid through a discharge flow path, and measuring flow rate at the discharge flow path. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record). Nelson discloses implementing a protocol by actuating a pump to flow reagent through a flow path, discharging fluid through a discharge flow path, and measuring flow rate at the discharge flow path (Nelson teaches using a pump to pump reagents through a flow path and to a waste discharge flow path, where the flow rate is measured at the waste discharge flow path using a flow meter; Fig. 1-3, pages 11, 12, 15, 18, 19. See also claims 28, 34, 37, 52, 73. Nelson teaches that multiple reagents are used which means that there are multiple reagent flow paths, one for each reagent that is used and selected; Fig. 1-3, pages 8, 14, 15, 26, 31).
The dependent claims 2-20 undergo a similar analysis and do not appear to resolve any of the above issues, and are therefore similarly rejected. Claims 2 and 17 just repeats the steps and are rejected similarly to claim 1 above. Claim 3 recites the abstract ideas of determining volumes, and does not have a particular practical application because producing a notification does not integrate the exception into a practical application because notifying is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook (see MPEP 2106.04(d) and 2106.05(g)). Claims 4-8, 18 describe manipulation of data which is either a mental process and/or math. Claims 9 and 16 recites details of the abstract idea. Claims 10-15, 19, 20 recite details of a flow cell system, which under step 2B are WURC (see prior art rejection below).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 6-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 has been amended to recite that “(c) comprises low-pass filtering of the data” where (c) in claim 1 is the physical process of discharging fluid through a discharge flow path. Support for the newly added limitation of the instant claims was not found by the examiner in the original disclosure, as no mention of step (c) comprises low-pass filtering of the data exists in the disclosure. It is unclear how the physical process of discharging in step (c) can involve or include low-pass filtering, which is an abstract process of filtering signals. The examiner notes that [23] of the instant PGPub does discuss that step (e) comprises low-pass filtering. Thus, the limitation “(c) comprises low-pass filtering of the data” is considered new matter. Claims 6-8 are similarly rejected as they each recite similar limitations where step (c) is further described as a mathematical manipulation for the determination step, which is an abstract process, that is not supported in the instant specification as a physical process related to the discharging step as recited in step (c). Support is not found for claims 6-8 occurring during step (c) in the existing disclosure.
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, 6-8 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 pre-AIA the applicant regards as the invention.
As to claim 4, it is unclear how the physical process of discharging in step (c) can involve or include low-pass filtering of data, which is an abstract process of filtering signals. Claims 6-8 are similarly unclear as they each recite similar limitations where step (c) is further described as a mathematical manipulation for the determination step, which is an abstract process, that seems unclear how the abstract process occurs during the physical process of discharging as recited in step (c). Do applicants intend for the processing of data in step (e) to include the low-pass filtering of the data? The examiner notes that [23] of the instant PGPub does discuss that step (e) comprises low-pass filtering and the examiner will interpret the claims as such for purposes of examination. Appropriate correction and/or clarification is required.
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 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 1-3, 5, 9, 16 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record).
As to claim 1, Nelson teaches a method (Nelson; Title) comprising: implementing a stored test protocol for performing one or more reagent displacement tests, wherein each reagent displacement test includes: a) selecting a reagent flow path from a plurality of reagent flow paths; b) actuating a pump to draw a predetermined amount of fluid through the selected reagent flow path in accordance with the stored test protocol; c) discharging the drawn fluid from the pump and through a discharge flow path; d) measuring flow rates of any liquid discharged through the discharge flow path during (c) and generating data representative of the flow rates; and e) processing the data to determine a quality of the selected reagent flow path (Nelson teaches using a pump to pump reagents through a flow path and to a waste discharge flow path, where the flow rate is measured at the waste discharge flow path using a flow meter; Fig. 1-3, pages 11, 12, 15, 18, 19. See also claims 28, 34, 37, 52, 73. Nelson teaches selecting protocols; page 16. Nelson teaches that the process takes place within a controller and is automated, which means that the protocol has been stored; pages 11, 19. Nelson teaches that multiple reagents are used which means that there are multiple reagent flow paths, one for each reagent that is used and selected; Fig. 1-3, pages 8, 14, 15, 26, 31. Nelson further teaches that the flow rate is then used to determine the volume, where this is used to verify system performance and also validate accuracy; pages 15, 18, 19).
As to claim 2, Nelson teaches the method of claim 1, wherein (a) through (e) are repeated for different reagent flow paths (Nelson teaches the process can be repeated; pages 15, 18. Nelson teaches that multiple reagents are used which means that there are multiple reagent flow paths, one for each reagent that is used and selected; Fig. 1-3, pages 8, 14, 15, 26, 31).
As to claim 3, Nelson teaches the method of claim 1, wherein (e) further includes: f) determining, during (e), a total volume of the liquid flowed through the discharge flow path during (c) using the data; g) determining that the volume of the liquid flow through the discharge path during (c) is outside of a first threshold amount from the predetermined amount of fluid and, based at least in part thereupon, that the selected reagent flow path of (a) thereby has a fault; and h) responsive to (g), producing a notification regarding the fault (Nelson teaches providing feedback to a user, where the flow volume is gathered by a user and can be indicative of a fail/fault that is within a user defined percentage threshold; pages 11, 18. Nelson also teaches viewing assay results; claims 21, 55).
As to claim 5, Nelson teaches the method of claim 3, wherein (f) comprises integrating the data to obtain the volume of the liquid flowed through the discharge flow path during (c) (Nelson teaches using the flow meter information to determine the flow volume; pages 11, 15, 18, 19. When a flow meter detects flow rate, the only way to use that data to determine volume is to take the integral of the flow rate with respect to time, which gives the volume).
As to claim 9, Nelson teaches the method of claim 3, wherein determining in (g) that the fault exists is based, at least in part, on the selected reagent whether the fault condition exists responsive to the data and based, at least in part, upon the selected reagent (Nelson teaches that multiple reagents are used which means that there are multiple reagent flow paths, one for each reagent that is used and selected; Fig. 1-3, pages 8, 14, 15, 26, 31. Nelson further teaches that the flow rate is then used to determine the volume, where this is used to verify system performance and also validate accuracy; pages 15, 18, 19. Nelson teaches providing feedback to a user, where the flow volume is gathered by a user and can be indicative of a fail/fault that is within a user defined percentage threshold; pages 11, 18).
As to claim 16, Nelson teaches the method of claim 3, wherein (g) further comprises determining a volumetric flow rate of the liquid flow through the discharge path based on the volume determined in (g) and determining that the selected reagent flow path of (a) thereby has the fault based on the volumetric flow rate (Nelson teaches that multiple reagents are used which means that there are multiple reagent flow paths, one for each reagent that is used and selected; Fig. 1-3, pages 8, 14, 15, 26, 31. Nelson further teaches that the flow rate is then used to determine the volume, where this is used to verify system performance and also validate accuracy; pages 15, 18, 19. Nelson teaches providing feedback to a user, where the flow volume is gathered by a user and can be indicative of a fail/fault that is within a user defined percentage threshold; pages 11, 18).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 5-8, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record).
As to claim 5, Nelson teaches the method of claim 3 (see above). If it is determined that Nelson does not teach integrating the data to obtain the volume of the liquid flowed through the discharge flow path during (c), then it would have been obvious to one of ordinary skill in the art when determining the fault condition exists by evaluating the flow rate and volumes of Nelson to have integrated the flow rate data to obtain the volume because integrating the flow rate would provide a predictable result of obtaining the volume.
As to claim 6, Nelson teaches the method of claim 3, with processing the data representative of the measured liquid flow, and determining a fault condition based on the measured flow (see above).
Nelson does not specifically teach performing a cutoff to remove spikes in the data. However, it would have been obvious to one of ordinary skill in the art when determining the fault condition exists by evaluating the flow rate of Nelson to have removed spikes in the data because spikes could be considered outliers and may be anomalies and should be filtered out of the data since they may not provide a true representation of the measured data.
As to claim 7, Nelson teaches the method of claim 3, with processing the data representative of the measured liquid flow, and determining a fault condition based on the measured flow (see above).
Nelson does not specifically teach truncating data, where the data is a rise trace. However, it would have been obvious to one of ordinary skill in the art when determining the fault condition exists by evaluating the flow rate of Nelson to have truncated and removed sudden rises in the data because sudden rises in the data could be considered an anomaly and should be filtered out of the data.
As to claim 8, Nelson teaches the method of claim 3, with processing the data representative of the measured liquid flow, and determining a fault condition based on the measured flow (see above).
Nelson does not specifically teach truncating data, where the data is a fall trace. However, it would have been obvious to one of ordinary skill in the art when determining the fault condition exists by evaluating the flow rate of Nelson to have truncated and removed sudden falls in the data because sudden falls in the data could be considered an anomaly and should be filtered out of the data.
As to claim 18, Nelson teaches the method of claim 1, with processing the data representative of the measured liquid flow, and determining a fault condition based on the measured flow (see above).
Nelson does not specifically teach using averaging the data. However, it would have been obvious to one of ordinary skill in the art when determining the fault condition exists by evaluating the flow rate of Nelson to have averaged the data because averaging provides a good indication of the data across time points in order to ensure that the measurements of the data are accurate.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record) in view of Brown et al (US 20150346149; hereinafter “Brown”; already of record).
As to claim 4, Nelson teaches the method of claim 3, where the data is analyzed to determine faults (see above).
Nelson does not teach low-pass filtering of the data. However, Brown teaches the analogous art of analysis methods (Brown; abstract) with low-pass filtering of the data (Brown teaches a low pass filter for the detected data; [165]). It would have been obvious to one of ordinary skill in the art to have modified the data analysis of Nelson to include low-pass filtering as in Brown because Brown teaches that low pass-filter helps to produce a sampled signal (Brown; [165]) and also because this would select signals by a frequency relative to a cut off frequency.
Claims 10-13, 15, 17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record) in view of Buermann et al (US 20130260372; hereinafter “Buermann”; already of record).
As to claim 10, Nelson teaches the method of claim 1, wherein: the pump is part of a system, and the selected reagent flow path for at least one stored test protocol passes through a flow cell that is removable from the system (Nelson teaches the cartridge as a flow cell which is removed into the system; Fig. 1-3, pages 11-13, 19, claim 2).
Although Nelson teaches the system is used for the evaluation of genes and DNA (Nelson; pages 6, 7, 9, 12), Nelson does not teach that the system is a sequencing system. However, Buermann teaches the analogous art of a method of analysis using a flow cell where the system is a sequencing system (Buermann teaches using reagents within a flow cell where the analysis is used for sequencing; Fig. 16, [2, 3, 4, 5, 29, 30, 91, 111, 112,113]). It would have been obvious to one of ordinary skill in the art to have modified the system detecting DNA and genes in the flow cell of Nelson to have analyzed the sequencing as in Buermann because Buermann teaches that sequencing helps to provide important data to identify various diseases, drug responses, clinically relevant characteristics, and also help doctors evaluate health, lifestyle and treatment (Buermann; [3, 4, 5]).
As to claims 11-13, Nelson teaches the method of claim 10, a system that flows fluid through a flow cell and includes input flow paths and a discharge flow path (see above).
Nelson does not specifically teach prior to (c), a used reagent selector valve to cause the discharge flow path to be selected from a plurality of discharge flow paths; wherein the selected reagent flow path for the at least one stored test protocol passes through a reagent selector valve and a common line selector valve of the sequencing system; wherein: the flow cell includes at least a first flow lane and a second flow lane that both extend through a portion of the flow cell, in at least a first reagent displacement test of the one or more reagent displacement tests, the common line selector valve is configured to cause the drawn fluid to flow through the first flow lane, and in at least a second reagent displacement test of the one or more reagent displacement tests, the common line selector valve is configured to cause the drawn fluid to flow through the second flow lane. However, Buermann teaches the analogous art of a method of analysis using a flow cell where the system is a sequencing system (Buermann teaches using reagents within a flow cell where the analysis is used for sequencing; Fig. 16, [2, 3, 4, 5, 29, 30, 91, 111, 112,113]) with prior to (c), a used reagent selector valve to cause the discharge flow path to be selected from a plurality of discharge flow paths (Buermann teaches used reagent valve 2045 that connects to various flow paths to create multiple different discharge flow paths; Fig 16, [113]); wherein the selected reagent flow path for the at least one stored test protocol passes through a reagent selector valve and a common line selector valve of the sequencing system (Buermann teaches a reagent selector valve 2042/2043 and a common valve 2043/2044; Fig. 16, [112]); wherein: the flow cell includes at least a first flow lane and a second flow lane that both extend through a portion of the flow cell, in at least a first reagent displacement test of the one or more reagent displacement tests, the common line selector valve is configured to cause the drawn fluid to flow through the first flow lane, and in at least a second reagent displacement test of the one or more reagent displacement tests, the common line selector valve is configured to cause the drawn fluid to flow through the second flow lane (Nelson teaches the flow cells with various lanes. However, Buermann also teaches the flow cell includes several lanes where the reagents are moved to the lanes from 2036 and through the valves to one of the lanes in flow cell 2020 and where reagents are moved to another of the lanes from 2036 through the valves and to the other lane where the different lanes create different flow paths; [112], Fig. 16). See also Buermann Fig. 16, [112-116]. It would have been obvious to one of ordinary skill in the art to have modified the system that flows fluid through the flow cell of Nelson to have included the selector valves and common valves followed by the flow cell and used discharge valve as in Buermann because Buermann teaches that it is known to fluidically control fluids through a flow cell with multiple lanes using the various valves (Buermann; [112-116], Fig. 16).
As to claim 15, Nelson teaches the method of claim 10, wherein: the sequencing system comprises a stage with a plurality of ports configured to interface with corresponding ports on the flow cell, and the method further comprises installing the flow cell into the stage and interfacing the ports on the flow cell with the ports on the stage (Nelson teaches an interface to attach the cartridge flow cell to the system, and there would be ports in the interface to allow fluid flow; page 15, Fig. 1-3. The system of Nelson being modified to be a sequencing system as in Buermann has already been discussed above in claim 10).
As to claim 17, Nelson teaches the method of claim 1, wherein (a) through (e) are repeated for every reagent flow path in a system (Nelson teaches the process can be repeated; pages 15, 18. Nelson teaches that multiple reagents are used which means that there are multiple reagent flow paths, one for each reagent that is used and selected; Fig. 1-3, pages 8, 14, 15, 26, 31).
Although Nelson teaches the system is used for the evaluation of genes and DNA (Nelson; pages 6, 7, 9, 12), Nelson does not teach that the system is a sequencing system. However, Buermann teaches the analogous art of a method of analysis using a flow cell where the system is a sequencing system (Buermann teaches using reagents within a flow cell where the analysis is used for sequencing; Fig. 16, [2, 3, 4, 5, 29, 30, 91, 111, 112,113]). It would have been obvious to one of ordinary skill in the art to have modified the system detecting DNA and genes in the flow cell of Nelson to have analyzed the sequencing as in Buermann because Buermann teaches that sequencing helps to provide important data to identify various diseases, drug responses, clinically relevant characteristics, and also help doctors evaluate health, lifestyle and treatment (Buermann; [3, 4, 5]).
As to claim 20, Nelson teaches the method of claim 1, with the pump (See above).
Nelson does not teach the pump is a syringe pump. However, Buermann teaches the analogous art of a method of analysis using a flow cell where the system uses syringe pumps to drive fluids (Buermann; [114, 115], Fig. 16). It would have been obvious to one of ordinary skill in the art to have modified the pump for moving fluids of Nelson to be a syringe pump as in Buermann because Buermann teaches that syringe pumps are obvious variants of pumps to move fluids (Buermann; [114-115]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record) in view of Buermann et al (US 20130260372; hereinafter “Buermann”; already of record) in view of Banerjee et al (US 20100111768; hereinafter “Banerjee”; already of record)
As to claim 14, Nelson teaches the method of claim 13, wherein: the flow cell is fluidically interposed between the common line selector valve and the pump at least when the common line selector valve is configured to cause the drawn fluid to flow through either the first lane or the second lane of the flow cell (Nelson teaches the pump can be anywhere; page 8. The modification of the flow cell, valve and pump system of Nelson to be configured for multiple lanes of a flow cell as in Buermann has been discussed in claims 10-13 above. Buermann teaches the flow cell 2020 between the common valve 2043/2044 and the pump 2051-2058).
Modified Nelson does not teach the sequencing system includes a bypass line that fluidically connects the common line selection valve with the pump, thereby bypassing the flow cell, and in at least a third reagent displacement test of the one or more reagent displacement tests, the common line selector valve is configured to cause the drawn fluid to flow through the bypass line. However, Banerjee teaches the analogous art of analysis through a flow cell and a bypass line that fluidically connects the common line selection valve with the pump, thereby bypassing the flow cell, and in at least a third reagent displacement test of the one or more reagent displacement tests, the common line selector valve is configured to cause the drawn fluid to flow through the bypass line (Banerjee teaches bypass line 725 which connects flow cell 724 with common selector valve 720; [88], Fig. 7C). It would have been obvious to one of ordinary skill in the art to have modified the reagents flowing through the flow cell of Nelson to have included a bypass line as in Banerjee because Banerjee teaches that the bypass line provides another path for fluid to be discarded directly to the pump (Banerjee; [88]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al (WO 2014150853; hereinafter “Nelson”; already of record) in view of Banerjee et al (US 20100111768; hereinafter “Banerjee”; already of record).
As to claim 19, Nelson teaches the method of claim 1, with the reagent flow paths with a plurality of reagents (see above).
Nelson does not specifically teach interfacing the reagent flow paths with a plurality of reagent recipients prior to (a), wherein at least some of the reagent recipients contain distilled water. However, Banerjee teaches the analogous art of analysis through a flow cell where water is mixed with other reagents prior to introduction to the flow cell (Banerjee; [86]). It would have been obvious to one of ordinary skill in the art to have modified the reagents flowing through the flow cell of Nelson to be formed by mixing water and solutions prior to flow through the flow cell as in Banerjee because Banerjee teaches that it is known to mix solutions using water prior to flow through the flow cell (Banerjee; [86]). When mixing various reagents, it would be obvious to one of ordinary skill in the art to use distilled water as the water source because distilled water is purified such that there are no unknown contaminants or impurities, thereby ensuring high accuracy and preventing unwanted interference during laboratory experiments.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11841376. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘376 disclose a method (claim 8 of ‘376 describes a method) comprising: implementing a stored test protocol for performing one or more reagent displacement tests (claim 8 of ‘376 describes a prescribed test protocol for reagents), wherein each reagent displacement test includes: a) selecting a reagent flow path from a plurality of reagent flow paths (claim 8 of ‘376 describe a controller which selects a flow path); b) actuating a pump to draw a predetermined amount of fluid through the selected reagent flow path in accordance with the stored test protocol (claim 8 of ‘376 describes actuating a pump); c) discharging the drawn fluid from the pump and through a discharge flow path (claim 8 of ‘376 describes discharging fluid through a discharge flow path); d) measuring flow rates of any liquid discharged through the discharge flow path during (c) and generating data representative of the flow rates (claim 8 of ‘376 describes measuring flow rates); and e) processing the data to determine a quality of the selected reagent flow path (claim 8 of ‘376 describe identifying a fault/quality issue).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12 of U.S. Patent No. 10989728. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘728 disclose a method (claim 1 of ‘728 describes a control process, and claim 12 describes a method) comprising: implementing a stored test protocol for performing one or more reagent displacement tests (claims 1 and 12 of ‘728 describes a prescribed test protocol for reagents), wherein each reagent displacement test includes: a) selecting a reagent flow path from a plurality of reagent flow paths (claims 1 and 12 of ‘728 describe selecting a flow path); b) actuating a pump to draw a predetermined amount of fluid through the selected reagent flow path in accordance with the stored test protocol (claim 12 of ‘728 describes actuating a pump and claim 1 of ‘728 describes using a controller/processor to control a pump to pump reagent through a flow path); c) discharging the drawn fluid from the pump and through a discharge flow path (claim 12 of ‘728 describes discharging fluid through a discharge flow path and claim 1 of ‘728 describes using a controller/processor to control a pump to discharge reagent through a discharge flow path); d) measuring flow rates of any liquid discharged through the discharge flow path during (c) and generating data representative of the flow rates (claim 12 of ‘728 describes measuring flow rates and claim 1 of ‘728 describes using a flow meter to obtain date on the flow rate); and e) processing the data to determine a quality of the selected reagent flow path (claims 1 and 12 of ‘728 describe identifying a fault/quality issue).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Allington, R. (US 5354440; hereinafter “Allington”; already of record) teaches the volume of fluid flow is proportional to the time integral of the flow rate (Allington; col 14, lines 51-53).
Kahlon et al. (US 20140177378; hereinafter “Kahlon”; already of record) teaches the flow meter after the flow cell; Fig. 2A.
Conclusion
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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