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
Applicant’s election without traverse of group I comprising claims 1 – 10 in the reply filed on 5/19/2026 is acknowledged. Claim 11 was canceled by applicant.
Claims 12 – 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy (GB 1016614.8) has been filed in parent Application No. 13/512,937, filed on 10/1/2010. The certified copy (GB 0922743.0) has been filed in parent Application No. 18/587,733, filed on 12/31/2009.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 3, the term “configured” should be inserted prior to the phrase “to supply” to positively recite the functionality of the fluidics system (i.e., claim 1 should read: “… controlling the fluidics system configured to supply a sample … .” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in line 7, the term “configured” should be inserted prior to the phrase “to supply” to positively recite the functionality of the fluidics system (i.e., claim 1 should read: “… controlling the fluidics system configured to supply a second sample … .” Appropriate correction is required.
Claim 2 is objected to because of the following informalities: in line 2, the term “configured” should be inserted prior to the phrase “to supply” to positively recite the functionality of the fluidics system (i.e., claim 2 should read: “… the fluidics system configured to supply the sample … .” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the reservoirs" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
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 § 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 (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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1 – 5, 7 and 8 is/are rejected under pre-AIA 35 U.S.C. 102(a)/(b)/(e) as being anticipated by Joyce et al. (US 2005/0227239 A1; hereinafter “Joyce”).
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).
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).
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).
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”) in view of Ludwig et al. (US 2008/0069739 A1; hereinafter “Ludwig”).
Regarding claim 6, 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 selector valves with chemical process systems is well known in the art as evidenced by Ludwig (e.g., paragraph 137). 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”) in view of Kang et al. (WO 2007/127327 A2; hereinafter “Kang”).
Regarding claim 9, 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”) 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).
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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.
Conclusion
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.
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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.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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