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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/22/2025 is acknowledged. Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 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.
Claim(s) 1-12, 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2005/0042137, hereinafter Peterson.
Regarding claim 1, Peterson teaches a test container (figure 11) comprising: an inlet (item 64) into which a specimen solution is to be put (paragraph [0048]); an attachable and detachable lid part (item 30) that covers the inlet (figure 3); a first storage portion (item 65) that is provided such that the inlet is an end surface of an opening (figure 3) and that stores a specimen solution added dropwise from the inlet (intended use MPEP § 2114 (II)); a second storage portion (items 40 and 80) that is capable of storing liquid and causes the specimen solution and a reagent to react with each other (intended use MPEP § 2114 (II)); a first flow channel (items 106, 109, 110 and 117) that connects the first storage portion to the second storage portion (figure 9); a first cylinder (paragraphs [0046] and [0102], syringe pump, the tube of the syringe pump connected to item 105) of which one end is connected to the first storage portion via a second flow channel (paragraph [0094], item 182) and the other end is open to an outside (paragraph [0102]); a second cylinder (paragraphs [0046] and [0102], syringe pump, the tube of the syringe pump connected to item 125) of which one end is connected to the second storage portion via a third flow channel (paragraph [0094], item 182) and the other end is open to an outside (paragraph [0102]); a first plug (paragraphs [0046] and [0102], syringe pump, the plunger of the syringe pump) that is provided to be movable in the first cylinder (paragraph [0102]); and a second plug (paragraphs [0046] and [0102], syringe pump, the plunger of the syringe pump) that is provided to be movable in the second cylinder (paragraph [0102]), wherein an internal space including the first storage portion, the second storage portion, the first flow channel, the second flow channel, and the third flow channel is capable of being pressurized in a case where the first plug and the second plug are pressed and moved from the outside (intended use MPEP § 2114 (II)).
Regarding claim 2, Peterson teaches wherein the internal space is hermetically sealed by the first plug and the second plug (paragraphs [0094] and [0102]), and the second plug is moved from the internal space to the outside in the second cylinder while being interlocked with movement of the first plug in a case where the first plug is pressed from the outside and moved toward the internal space in the first cylinder (intended use MPEP § 2114 (II)).
Regarding claim 3, Peterson teaches wherein an air vent (the back opening of the syringe barrel) is provided at a part of the second cylinder and the internal space is capable of being pressurized in a case where the second plug is moved closer to the internal space than the air vent (intended use MPEP § 2114 (II)).
Regarding claim 4, Peterson teaches a purification chamber (item 86) that is provided in a middle of the first flow channel and removes impurities in the specimen solution (paragraph [0055]).
Regarding claim 5, Peterson teaches wherein the reagent is stored in the second storage portion (paragraph [0048], the point at which the master mix is added to item 40).
Regarding claim 6, Peterson teaches a third storage portion (item 71) that is provided in a middle of the first flow channel and stores the reagent (paragraph [0048]).
Regarding claim 7, Peterson teaches a purification chamber (item 86) that is provided in a middle of the first flow channel and removes impurities in the specimen solution (paragraph [0055]), wherein the third storage portion (item 71) is provided between the purification chamber and the second storage portion in the middle of the first flow channel (figure 9).
Regarding claim 8, Peterson teaches a stirring flow channel (item 122) that is provided between the third storage portion and the second storage portion (figure 9) and facilitates mixture of the specimen solution and the reagent (intended use MPEP § 2114 (II)).
Regarding claim 9, Peterson teaches wherein a bottom surface of the second storage portion is formed of a film (item 48).
Regarding claim 10, the reagent is not positively claimed and therefore any limitation on the reagent has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Peterson. Further Peterson teaches this limitation in paragraph [0048].
Regarding claim 11, Peterson teaches a test device (figure 11) comprising: the test container according to claim 1 (see supra); and a pressing machine (paragraph [0102]) including a first pressing unit that presses the first plug positioned in the first cylinder of the test container from the outside and a second pressing unit that presses the second plug positioned in the second cylinder from the outside (the portion of the syringe pump which presses the syringe down), wherein in a case where the first plug is pressed and moved toward the internal space by the first pressing unit, the specimen solution stored in the first storage portion of the test container is fed to the second storage portion (intended use MPEP § 2114 (II)).
Regarding claim 12, Peterson teaches a first heating unit (items 190A and 190B) that is provided at a position allowing the first heating unit to be in contact with a bottom surface of the second storage portion of the test container (figure 23) and heats liquid stored in the second storage portion (paragraph [0068]).
Regarding claim 14, Peterson teaches a detection unit (item 218) that detects whether or not an object to be detected is included in the specimen solution in the second storage portion (paragraph [0112]).
Regarding claim 15, Peterson teaches the detection unit includes an excitation light source (paragraph [0112]) that irradiates liquid stored in the second storage portion with excitation light for exciting the fluorescent probe, and a photodetector that detects fluorescence emitted from the fluorescent probe excited by irradiation with the excitation light (paragraph [0112]).
The reagent is not positively claimed and therefore any limitation on the reagent has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Peterson. Further Peterson teaches this limitation in paragraph [0048].
Claim Rejections - 35 USC § 103
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) 3 is/are additionally rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of United States Patent No. 5,328,462, hereinafter Fischer.
Regarding claim 3, if it is determined that Peterson fails to teach wherein an air vent is provided at a part of the second cylinder, then Peterson would fail to teach this limitation.
Fischer teaches a syringe tube which has a vent hole in the side of the cylinder of the syringe so that air can be vented into the syringe after use (Fischer, column 3, lines 52-55).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added an air vent in the second cylinder because it would allow for air to be vented into the syringe after use (Fischer, column 3, lines 52-55).
Regarding the limitation that the internal space is capable of being pressurized in a case where the second plug is moved closer to the internal space than the air vent, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Peterson and Fischer and the apparatus of modified Peterson is capable of pressurizing as described. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Peterson (see MPEP §2114).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of United States Application Publication No. 2010/0173394, hereinafter Colston.
Regarding claim 13, Peterson a heater at the bottom surface of the reaction chamber (figure 23). However, Peterson fails to teach a second heating unit that is provided at a position allowing the second heating unit to be in contact with a bottom surface of the first storage portion of the test container and heats liquid stored in the first storage portion.
Colston teaches a device in which the sample is preheated as this would provide a hot-start temperature for the PCR (Colson, paragraph [0708]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a second heating element in contact with the bottom surface of the first storage portion because it would allow for the sample to be preheated which would provide a hot-start temperature for the PCR (Colson, paragraph [0708]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796