DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 12 and 18 – 30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/19/2026. Applicant canceled claims 13 – 17.
Response to Arguments
Applicant’s arguments, filed 9/4/2026, with respect to the rejection(s) of claims 1 – 5, 7 and 8 under pre-AIA 35 U.S.C. 102(a)/(b)/(e) as being anticipated by Joyce et al. (US 2005/0227239 A1), have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. The subsequent dependent prior art rejections have been withdrawn as well. However, upon further consideration, a new ground(s) of rejection is made in view of Knapp et al. (WO 2005/113148 A1).
The previous objection of claims 1 and 2 have been withdrawn.
The previous rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 – 5, 7, 8, 31, 32, 34 and 35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Joyce et al. (US 2005/0227239 A1; hereinafter “Joyce”) in view of Knapp et al. (WO 2005/113148 A1; hereinafter “Knapp”).
Regarding claim 1, Joyce teaches a method of controlling a fluidics system to perform the biochemical analysis of successive samples sequentially, the method comprising:
controlling the fluidics system (the disclosed apparatus comprising the nanopore system 120 and the instrument that the chip is placed into implicitly comprise a controller utilizing software; paragraphs 72, 75 and 76) to supply a sample from a well to a nanopore sensor device comprising a plurality of nanopores (the array 112 may comprise a microarray comprising a well or channel 118; paragraphs 48 and 50);
performing biochemical analysis of the sample (via the detector of the nanopore system 120; paragraphs 75);
flushing the sensor device to clear the sample (via a flushing and/or washing protocol; paragraphs 73, 74, 78 and 79); and
controlling the fluidics system (the disclosed apparatus comprising the nanopore system 120 and the instrument that the chip is placed into implicitly comprise a controller utilizing software; paragraphs 72, 75 and 76) to supply a second sample to the nanopore sensor device (the apparatus comprises supply channels comprising a sipper which projects sample into channel 118 (paragraph 72); the apparatus comprising the nanopore system 120 implicitly comprise inlet pumps to regulate the sample flow through the apparatus; paragraphs 53, 72 and 75).
Joyce does not specifically teach the step of controlling the fluidics system configured to:
select a second sample from a plurality of samples;
position a fluidics system component at an outlet corresponding to the second sample; and supply the second sample to the nanopore sensor device.
Joyce does teach that a sample is introduced into the apparatus by any number of methods including injection and manual application (paragraph 72). As indicated above, Joyce also does teach the use of a sipper for acquiring sample fluid and introducing the sample fluid the chip (paragraph 72).
Knapp teaches a microfluidic system comprising a pipettor channel 620 (sipper) for accessing microwell plate 622, which includes samples or reagents (page 56, line 7 – page 58, line 4; figures 6 and 7). The computer 626 or computer controller 726 can control movement of tray 622 or array 725, and/or microfluidic device 601 or 701 to permit the relevant pipettor channel to process samples or other materials on the array or in the wells of the tray (page 58, lines 1 – 4; figure 6). Consequently, as evidenced by Knapp, the use of a fluidics system component, such as a pipettor or sipper apparatus, or functionally equivalent fluidic component, for selecting a sample from a plurality of samples, would have been considered to be suitable and predictable to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the step of controlling the fluidics system configured to: select a second sample from a plurality of samples; position a fluidics system component at an outlet corresponding to the second sample; and supply the second sample to the nanopore sensor device.
Regarding claim 2, Joyce teaches the method of claim 1, comprising controlling, using a controller (the disclosed apparatus comprising the nanopore system 120 and the instrument that the chip is placed into implicitly comprise a controller utilizing software; paragraphs 72, 75 and 76), the fluidics system to supply the sample from the well (the array 112 may comprise a microarray comprising a well or channel 118; paragraphs 48 and 50) to the nanopore sensor device (nanopore system 120; paragraph 47) (the apparatus comprises supply channels comprising a sipper which projects sample into channel 118 (paragraph 72); the apparatus comprising the nanopore system 120 implicitly comprise inlet pumps to regulate the sample flow through the apparatus; paragraphs 72 and 75).
Regarding claim 3, Joyce teaches the method of claim 2, wherein the controller is controlled by a control module that is implemented in an embedded computer by software executed thereon (the disclosed apparatus comprising the nanopore system 120 and the instrument that the chip is placed into implicitly comprise a controller utilizing software; paragraphs 72, 75 and 76).
Regarding claim 4, Joyce teaches the method of claim 1, wherein the fluidics system comprises supply channels and inlet pumps configured for pumping fluids from reservoirs to the sensor device (the apparatus comprises supply channels comprising a sipper which projects sample into channel 118 (paragraph 72); the apparatus comprising the nanopore system 120 implicitly comprise inlet pumps to regulate the sample flow through the apparatus; paragraphs 72 and 75).
Regarding claim 5, Joyce teaches the method of claim 4, wherein the fluidics system comprises an output pump configured for pumping fluids out of the sensor device through an outlet channel connected to a waste reservoir configured for disposal of the fluids (e.g., paragraphs 78 and 79).
Regarding claim 7, Joyce teaches the method of claim 1, wherein performing biochemical analysis of the sample comprises classifying an analyte in the sample on the basis of a modulated electrical signal (paragraphs 14, 67 – 69 and 75; claims 1, 21, 30, 35 and 37).
Regarding claim 8, Joyce teaches the method of claim 1, wherein the sample comprises an analyte selected from the group consisting of DNA, RNA, polynucleotides, protein, polymers, and small molecule (e.g., proteins, peptides, nucleotides, DNA and RNA; paragraphs 2 and 52).
Regarding claims 31 and 32, as indicated above, Knapp teaches that the sipper can be utilized to acquire samples from various wells of the tray if this configuration is utilized. The computer 626 or computer controller 726 can control movement of tray 622 or array 725, and/or microfluidic device 601 or 701 to permit the relevant pipettor channel to process samples or other materials on the array or in the wells of the tray (page 58, lines 1 – 4; figure 6). Therefore, Knapp implicitly teaches sampling a second sample from a second well. Furthermore, there would be a reasonable expectation for success in sampling a second sample from a second well. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to providing wherein the second sample is supplied from the well or wherein the second sample is supplied from a second well.
Regarding claim 34, modified Joyce does not specifically teach the method of claim 1, wherein the fluidics system is configured to add more sample if the apparatus is making insufficient measurements. However, it would be logical to a person of ordinary skill in the art to add more sample to the apparatus if the apparatus is making insufficient measurements in order to make measurements that are accurate. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, there would be a reasonable expectation for success in adding more sample to the apparatus if the apparatus is making insufficient measurements since there would be more sample fluid available for taking measurements. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the fluidics system is configured to add more sample if the apparatus is making insufficient measurements.
Regarding claim 35, modified Joyce does not specifically teach the method of claim 1, wherein the fluidics system is configured to add a different sample if the measurement requirements for one sample have been met. However, it would be logical to a person of ordinary skill in the art to add a different sample to the apparatus if the measurement requirements for one sample have been met in order to take measurements on more samples for analysis. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, there would be a reasonable expectation for success in adding a different sample if the measurement requirements for one sample have been met. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the fluidics system is configured to add a different sample if the measurement requirements for one sample have been met.
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Joyce et al. (US 2005/0227239 A1; hereinafter “Joyce”) and Knapp et al. (WO 2005/113148 A1; hereinafter “Knapp”), and further in view of Ludwig et al. (US 2008/0069739 A1; hereinafter “Ludwig”).
Regarding claim 6, modified Joyce does not specifically teach the method of claim 5, wherein the fluidics system comprises a selector valve disposed in supply channels between the inlet pumps connected to the reservoirs and the output pump, wherein the selector valve is configured to selectively connect the sensor device to the reservoirs or to the waste reservoir.
Joyce does teach valve-controlled fluidic lines to each of the openings in the chip comprising the microarray (paragraph 76). Joyce further teaches the use of a flushing and/or washing protocol with an associated waste container or reservoir (paragraphs 74, 78 and 79).
However, the use of multiple-port selector valves with microfluidic chemical process systems is well known in the art as evidenced by Ludwig (e.g., paragraphs 137 and 462). Consequently, as evidenced by Ludwig, the use of a selector valve with a microfluidic system would have had a reasonable expectation for success. Disposing the selector valve within various supply channels between the inlet pumps connected to the reservoirs and an output pump would have been within the ambit of a person of ordinary skill in the art in order to facilitate effective fluid flow control within the fluidics system. The Supreme Court decided that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art (see MPEP § 2143, E.). Furthermore, the combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the fluidics system comprises a selector valve disposed in supply channels between the inlet pumps connected to the reservoirs and the output pump, wherein the selector valve is configured to selectively connect the sensor device to the reservoirs or to the waste reservoir in order to facilitate effective flushing and washing of the system.
Claim 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Joyce et al. (US 2005/0227239 A1; hereinafter “Joyce”) and Knapp et al. (WO 2005/113148 A1; hereinafter “Knapp”), and further in view of Kang et al. (WO 2007/127327 A2; hereinafter “Kang”).
Regarding claim 9, modified Joyce does not teach the method of claim 1, wherein the sensor device comprises a sensor device body in which there is formed a plurality of recesses, each recess having an electrode arranged therein, wherein an amphiphilic membrane is formed across each recess and each of the plurality of nanopores is inserted into the amphiphilic membrane across a corresponding recess.
Joyce does teach a recess containing a nanopore (nanopore 3; figure 7A; paragraph 55) and an electrode therein (electrodes 7 and 9; figure 7A; paragraph 55).
Kang further teaches a nanopore sensor system comprising an amphiphilic membrane comprising a lipid bilayer film having a nanopore (e.g., page 1, lines 24 – 33). The nanopore sensor configuration is well known in the art as evidenced by Kang. The use of the amphiphilic membrane further comprising a nanopore would have been considered to be suitable and predictable to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, using a plurality of recesses, each comprising an electrode therein and an associated nanopore and amphiphilic membrane would have been obvious to a person of ordinary skill in the art. Joyce does teach that multiple electrodes and/or substrates can be used (paragraph 55). The mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.04). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the sensor device comprises a sensor device body in which there is formed a plurality of recesses, each recess having an electrode arranged therein, wherein an amphiphilic membrane is formed across each recess and each of the plurality of nanopores is inserted into the amphiphilic membrane across a corresponding recess.
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Joyce et al. (US 2005/0227239 A1; hereinafter “Joyce”), Knapp et al. (WO 2005/113148 A1; hereinafter “Knapp”) and Kang et al. (WO 2007/127327 A2; hereinafter “Kang”), and further in view of Edel (WO 2009/022152 A1; hereinafter “Edel”).
Regarding claim 10, modified Joyce does not specifically teach the method of claim 9, wherein the sensor device body is covered by a cover that extends over the sensor device body and is hollow to define a chamber into which each recess opens, wherein a common electrode is disposed within the chamber outside of the recesses.
Edel teaches in figure 2 a pertinent nanoporous device body 8 covered by a cover (upper cover 28 comprising glass layer 28a that extends over the sensor body 8 and is hollow to define a chamber (the volume defined by the glass layer 28a and spacer layer 28b containing the arrow indicating where the analyte solution is introduced) into which each recess (the volume defined by spacer layer 22 positioned beneath spacer layer 28b) opens, wherein a common electrode (e.g., electrode 38) is disposed within the chamber and outside of the recess (see page 9, line 17 – page 10, line 13; figure 2). This same sensor configuration as taught by Edel would have been considered to be suitable and predictable to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, using a plurality of recesses, each comprising an electrode therein and an associated nanopore and amphiphilic membrane would have been obvious to a person of ordinary skill in the art. Joyce does teach that multiple electrodes and/or substrates can be used (paragraph 55). The mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.04). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the sensor device body is covered by a cover that extends over the sensor device body and is hollow to define a chamber into which each recess opens, wherein a common electrode is disposed within the chamber outside of the recesses.
Claim 33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Joyce et al. (US 2005/0227239 A1; hereinafter “Joyce”) and Knapp et al. (WO 2005/113148 A1; hereinafter “Knapp”), and further in view of Cox et al. (US 2007/0068573 A1; hereinafter “Cox”).
Regarding claim 33, modified Joyce does not specifically teach the method of claim 32, wherein supplying the second sample from the second well comprises rotating a rotor of a rotary valve to align with an inlet port in communication with the second well.
Cox teaches a pertinent microfluidic system comprising the use of a rotary valve which aligns with various channels or conduits, ducts or inlet ports and tubes within the system (paragraphs 28, 138 and 141 – 144). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein supplying the second sample from the second well comprises rotating a rotor of a rotary valve to align with an inlet port in communication with the second well.
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 BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
