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 § 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.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is considered a "Use" claims that does not purport to claim a process, machine, manufacture, or composition of matter and thus fails to comply with 35 U.S.C. 101.
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 1, 11, 13, 15, and 21 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. Claims 2-10, 12, 14, and 15-20 are rejected as being dependent on the claims above.
Regarding claim 1, the terms “relatively loosely” and “relatively densely” are relative term which renders the claim indefinite. The term does not provide what the “uneven portion” are relating the “loosely” and “densely” limitations. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For prosecution, the interpretation is the terms are relative to the first and second uneven portions, that the "relatively loosely" means it is less dense than the "relatively densely" uneven portion.
Regarding claim 11, the claim recites the limitation "the protrusion is provided as a cone" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the metes and bounds of the claim because the previous claim recites “a plurality of protrusions” and the claim recites “the protrusion”.
Regarding claim 13, the claim recites the limitation "the electrode portion is formed on the protrusion of the fine uneven structure" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the metes and bounds of the claim because the previous claim recites “a plurality of protrusions” and the claim recites “the protrusion”.
Regarding claim 15, the claim recites the limitation "the electrode portion….one the protrusion of the fine uneven structure" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the metes and bounds of the claim because the previous claim recites “a plurality of protrusions” and the claim recites “the protrusion”.
Regarding claim 21, the claim attempts to claim a process without setting forth any steps in the process and is therefore indefinite.
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.
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.
Claim(s) 1-5, 7-12, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman (US 20050042766).
Regarding claim 1, Ohman teach a detection device comprising: a flow channel (Abstract: microfluidic with a flow paths) provided on a substrate formed of resin (Para. 0086: PMMA) and transporting a liquid sample from one end side to the other end side (Fig. 13: from one end side A to other end side D); a solid-phase part provided on the other end side of the flow channel, in which an antibody is set to a solid-phase (Claim 13; para.0041, 0075: biological affinity (antibodies) attached to the microposts); a detection unit provided with an electrode portion to detect a reaction of the liquid sample with respect to the antibody (Claim 21: electrode) ; and a fine uneven structure having a plurality of protrusions formed integrally with the flow channel, wherein the fine uneven structure has a first uneven portion in which the plurality of protrusions are provided relatively loosely (Para. 0067; Fig. 13: microstructure group A, see 112 rejection for interpretation of "relatively loosely", the term "fine" is interpreted as a thin such as "micropost") , and a second uneven portion in which the plurality of protrusions are provided relatively densely (Para. 0067; Fig. 13: microstructure group D see 112 rejection for interpretation of "relatively densely") , and the first uneven portion and second uneven portion are provided further toward the one end side of the flow channel than the solid-phase part (Para. 0044, claim 1: flow path to form patterns to transport liquid samples to, through and from functional means such as electrodes). Ohman is silent to the electrode taught in a single embodiment of the first uneven portion and second uneven portion are provided further toward the one end side of the flow channel than the solid-phase part. As taught by Ohman, it is advantageous to detect liquid samples based "to" the functional means to detect the analytes that pass through the micropost, thus providing a way to detect the analyte by size exclusion (para. 0067; Fig. 13). Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the first uneven portion and second uneven portion are provided further toward the one end side of the flow channel than the solid-phase part to provide the above advantage of detecting the analytes that pass through the micropost, thus providing a way to detect the analyte by size exclusion.
Regarding claim 2, Ohman teach detection device for detecting a substance to be detected in a liquid sample, the detection device comprising: a flow channel for transporting the liquid sample from one end side to the other end side (Fig. 13: from one end side A to other end side D); a solid-phase part provided on the other end side of the flow channel, in which an antibody is set to a solid-phase (Claim 13; para.0041, 0075: biological affinity (antibodies) attached to the microposts); a detection unit which detects a reaction of the liquid sample with respect to the antibody (Claim 21: electrode); and a fine uneven structure having a plurality of protrusions formed integrally with the flow channel, wherein the fine uneven structure has a first uneven portion in which the plurality of protrusions are provided relatively loosely (Para. 0067; Fig. 13: microstructure group A, see 112 rejection for interpretation of "relatively loosely", the term "fine" is interpreted as a thin such as "micropost") ,, and a second uneven portion in which the plurality of protrusions are provided relatively densely (Para. 0067; Fig. 13: microstructure group D, see 112 rejection for interpretation of "relatively densely") , and the first uneven portion and second uneven portion are provided further toward the one end side of the flow channel than the solid-phase part (Para. 0044, claim 1: flow path to form patterns to transport liquid samples to, through and from functional means such as electrodes). Ohman is silent to the electrode taught in a single embodiment of the first uneven portion and second uneven portion are provided further toward the one end side of the flow channel than the solid-phase part. As taught by Ohman, it is advantageous to detect liquid samples based "to" the functional means to detect the analytes that pass through the micropost, thus providing a way to detect the analyte by size exclusion (para. 0067; Fig. 13). Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the first uneven portion and second uneven portion are provided further toward the one end side of the flow channel than the solid-phase part to provide the above advantage of detecting the analytes that pass through the micropost, thus providing a way to detect the analyte by size exclusion.
Regarding claim 3, Ohman teach wherein the detection unit is provided further toward the other end side of the flow channel than the solid-phase part. (Para. 0067, Fig. 13: detect liquid samples based "to" the functional means to detect the analytes that pass through the micropost, where the solid-phase part is located with the antibody).
Regarding claim 4, Ohman teach the uneven portion is provided further toward the one end side of the flow channel than the second uneven portion. (Fig. 13: the first portion group A is provided further toward the one end side than the second portion group D)
Regarding claim 5, Ohman teach the detection device has a buffer region in which no protrusion is provided at a boundary of the first uneven portion and the second uneven portion (Fig. 13: spaces between regions A, B, C, and D) .
Regarding claim 7, Ohman teach the detection device has a recess region in which a recess is provided at a boundary between the first uneven portion and the second uneven portion (Fig. 13: space between the regions is considered a recess where the micro posts are not present)
Regarding claim 8, Ohman teach the detection device has a region in which the protrusions are provided in a diamond-shaped lattice (Fig. 5).
Regarding claim 9, Ohman teach the detection device has a region in which the protrusions are provided in a regular lattice pattern.
Regarding claim 10, Ohman teach the first uneven portion and the second uneven portion are adjacent, a ratio (P1/P2) of a pitch (P1) between the protrusions in the first uneven portion and a pitch (P2) between the protrusions in the second uneven portion is 1.1 or more and 5 or less. (Para. 0058: different column height)
Regarding claim 11, Ohman teach the protrusion is provided as a cone. (Fig. 11: larger protrusion 16)
Regarding claim 12, Ohman teach an introduction portion for introducing the liquid sample into the flow channel, wherein the liquid sample is formed of a plurality of types of solutions, and the introduction portion is provided at a plurality of locations according to the plurality of types of solutions. (Fig. 9: apertures or holes 7 and 8)
Regarding claim 21, Ohman teach detecting a reaction of a liquid sample with respect to an antibody using the detection device according to claim1 (Claim 13; para.0041, 0075: biological affinity (antibodies) attached to the micropost; see 101/112 rejection of the use claim above).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman in view of Bergman (US 20070266777).
Regarding claim 6, Ohman teach the detection device, but is silent to a step or an incline is provided at a boundary between the first uneven portion and the second uneven portion, and a region on a first uneven portion side of the step or the incline is higher than a region on a second uneven portion side.
Bergman teach first projections 36 provided at a higher than region on a second projections 38 with a step to provide a filter and not allowing passing of particulate substances (Para. 0022). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the step at the boundary of the first and second projections of Bergman to provide the above advantage of filtering particulate substances.
Claim(s) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman in view of Numthuam et al, “Synergistic effects of micro/nano modifications on electrodes for microfluidic electrochemical ELISA” Volume 156, Issue 2, August 2011, Pages 637-644.
Regarding claims 13-14, Ohman teach electrodes, but is silent to the electrode portion is formed on the protrusion of the fine uneven structure, a maximum peak height Rp of a roughness curve of the electrode portion is 0.005 pm or more and 10 pm or less, and an average length RSm of a roughness curve element is 0.01 pm or more and 15 pm or less; the electrode portion has a conductor film layer formed of a conductor substance on the protrusion of the fine uneven structure by at least one type of sputtering, vacuum evaporation, laser ablation, or CVD. .
Numthuam et al teach electrode portion is formed on the protrusion of the fine micropillars by sputter deposition of metals (p. 639 para. 2.3: sputter-deposition; p.642 col. 1 para. 1: fine structure of micropillar formed). It is advantageous to provide fine structure micropillars as the electrodes because they increase the output current with the modification (p. 642 col. 1 para. 1). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the electrode of Numthuam for the electrode of Ohman to provide the above advantage of increasing the output current with the modification .
Ohman/Numthuam teach the fine micropillar electrode and the shape, material and properties of the columns are selected to create a capillary flow (Ohman: Para. 0054), but do not explicitly teach a maximum peak height Rp of a roughness curve of the electrode portion is 0.005 pm or more and 10 pm or less, and an average length RSm of a roughness curve element is 0.01 pm or more and 15 pm or less. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a roughness is a result effective variable that gives the well known and expected results of changing the shape and affecting the capillary flow. In the absence of a showing of unexpected results, the Office maintains the choice of the maximum peak height Rp of a roughness curve of the electrode portion is 0.005 pm or more and 10 pm or less, and an average length RSm of a roughness curve element is 0.01 pm or more and 15 pm or less would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 15, Ohman/Numthuam teach the electrode portion has a printed layer of paste including conductor particles on the protrusion of the fine uneven structure (Numthuam p. 642 col. 1 para. 1: colloidal gold particles).
Regarding claim 16, Ohman/Numthuam teach the electrode portion has a working electrode and a counter electrode separated from the working electrode, and the working electrode is provided at the same position as the counter electrode or on an upstream side from the counter electrode in a flow channel direction (Numthuam: Fig. 1: WE micropillars separated and upstream of the AE (auxiliary electrode) in a flow channel direction).
Regarding claims 17-18, Ohman/Numthuam teach the counter electrode and working electrodes are provided over an entire width direction of the flow channel. (Numthuam: Fig. 1a and 1b)
Regarding claim 19, Ohman/Numthuam teach the working electrode is configured as a comb-shaped electrode (Numthuam: Fig. 1b, micropillars array is a comb-shape)
Regarding claim 20, Ohman/Numthuam teach the electrode portion further has a reference electrode (Numthuam: Fig. 1: RE, reference electrode).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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, Maris R. Kessel can be reached at (571) 270-7698. 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.
/Dennis White/Primary Examiner, Art Unit 1758