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 .
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 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.
Claim(s) 1 – 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura et al. (US 2005/0101028 A1; hereinafter “Kawamura”) in view of Knobel (US 5,482,863; hereinafter “Knobel”).
Regarding claim 1, Kawamura teaches throughout the publication a mixing method for mixing a biological sample and a reagent in a reaction tank (Abstract; paragraphs 46 – 48), comprising entering a first reagent (e.g., via injection port 2; paragraphs 52 and 54; figures 1 and 2) into the reaction tank (sample cell 1; figures 1 and 2; paragraphs 51 – 62) to form a swirling flow (e.g., via the stirring effect; paragraph 60).
Kawamura does not specifically teach the steps of:
moving a sampler with a biological sample into a reaction tank;
dispensing a suspended part of the biological sample to a tip of the sampler such that the suspended part comes into contact with air;
entering a first reagent into the reaction tank to form a swirling flow; and
making the swirling flow contact with the tip of the sampler to mix with the suspended part of the biological sample.
Knobel teaches an apparatus and method for suspending particles (Abstract; figures 2 – 7; col. 2, line 45 – col. 3, line 67; col. 4, lines 7 – 64). Knobel teaches the steps of:
moving a sampler (pipetting needle 18) with a biological sample into a reaction tank (reagent container 8);
dispensing a suspended part of the biological sample to a tip of the sampler such that the suspended part comes into contact with air (the pipetting needle 18 can be positioned above the liquid level when dispensing fluid, therefore permitting the discharged sample fluid or suspended part come into contact with air; figures 3 and 4);
making the swirling flow contact with the tip of the sampler to mix with the suspended part of the biological sample (e.g., the discharged sample fluid is then mixed via the resulting vortex 24 and 25; col. 3, lines 14 – 67; col. 4, lines 32 – 40; figures 3 and 4).
Consequently, as evidenced by Knobel, the use of a sampler for adding sample or reagent fluid to a reaction tank and to facilitate effective mixing would have been considered to be suitable and predictable to a person of ordinary skill in the art. It would have been obvious to a person of ordinary skill in the art to combine the teachings of Knobel of the sampler with the reaction tank configuration of Kawamura to effectively add sample and reagent fluids to a reaction tank and facilitate effective mixing when performing a biochemical test requiring thorough mixing. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” 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 further steps of: moving a sampler with a biological sample into a reaction tank; dispensing a suspended part of the biological sample to a tip of the sampler such that the suspended part comes into contact with air; entering a first reagent into the reaction tank to form a swirling flow; and making the swirling flow contact with the tip of the sampler to mix with the suspended part of the biological sample. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 2, Knobel teaches the mixing method of claim 1, further comprising: dispensing a flushing part of the biological sample into the swirling flow such that the swirling flow directly mixes in the flushing part (e.g., Knobel teaches that multiple reagent injections can be employed, thereby functioning as a flushing part; col. 3, lines 18 – 67).
Regarding claim 3, Knobel teaches the mixing method of claim 1, further comprising: the sampler continuously dispenses the suspended part and the flushing part (e.g., Knobel teaches that multiple reagent injections can be employed, thereby functioning as a flushing part; col. 3, lines 18 – 67).
Regarding claim 4, Knobel teaches the mixing method of claim 3, wherein a position of the sampler after entering the reaction tank is misaligned with a direction in which the first reagent enters into the reaction tank (e.g., the pipetting device with a conveying means for moving the pipetting needle can be in three directions at right angles to one another, thereby permitting different positions or angles to be used with the pipetting needle in order to ensure effective sample fluid and reagent mixing; col. 2, lines 49 – 51).
Regarding claim 5, Kawamura teaches the mixing method of claim 1, the flow rate of the first reagent entering the reaction tank comprises a first flow rate and a second flow rate, and the second flow rate is different from the first flow rate (Kawamura teaches a pump 6 for injection port 2 is controlled by computer 7 (figure 17; paragraphs 54, 83 and 131), thereby permitting different flow rates to be used for each reagent to ensure effective sample fluid mixing).
Regarding claim 6, Kawamura teaches the mixing method of claim 5, the flow rate of the first reagent entering the reaction tank changes from the first flow rate to the second flow rate, and the second flow rate is greater than the first flow rate (Kawamura teaches a pump 6 for injection port 2 is controlled by computer 7 (figure 17; paragraphs 54, 83 and 131), thereby permitting different flow rates to be used for each reagent to ensure effective sample fluid mixing).
Regarding claim 7, Kawamura teaches the mixing method of claim 1, wherein the process of entering the first reagent into the reaction tank comprises a first stage and a second stage, and a flow rate of the first stage is less than a flow rate of the second stage (Kawamura teaches a pump 6 for injection port 2 is controlled by computer 7 (figure 17; paragraphs 54, 83 and 131), thereby permitting different flow rates to be used for each reagent to ensure effective sample fluid mixing).
Regarding claim 8, Knobel teaches the mixing method of claim 7, wherein the swirling flow makes contact with the tip of the sampler in the first stage (implicit in figures 3 and 4 when additional sample or reagent fluid is added to the reaction vessel 8).
Regarding claim 9, Knobel teaches the mixing method of claim 1, wherein after the swirling flow comes into contact with the suspended part, the sampler moves in the reaction tank to cause the biological sample to be attached to an outer wall surface of the sampler to detach from the sampler (implicit in figures 3 and 4 when additional sample or reagent fluid is added to the reaction vessel 8; and col. 3, lines 14 – 67).
Regarding claim 10, Knobel teaches the mixing method of claims 1, further comprising entering a second reagent into the reaction tank after the first reagent forms the swirling flow (implicit in figures 3 and 4 when additional sample or reagent fluid is added to the reaction vessel 8; and col. 3, lines 14 – 67).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura et al. (US 2005/0101028 A1; hereinafter “Kawamura”) and Knobel (US 5,482,863; hereinafter “Knobel”), and further in view of Masuda et al. (US 2017/0074863 A1; hereinafter “Masuda”).
Regarding claim 11, modified Kawamura teaches the mixing method of claim 10, wherein the first reagent comprises at least a diluent and the second reagent comprises at least a hemolytic agent.
Regarding claim 12, modified Kawamura teaches the mixing method of claim 10, the first reagent comprises at least a hemolytic agent and the second reagent comprises at least a dye.
However, Masuda teaches the use of reagents comprising hemolytic and dye reagents for use in a blood analyzer (Abstract). The use of diluents or buffer reagents are well known in the art. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). Consequently, the incorporation of each of these reagents would have been considered to be suitable and predictable to a person of ordinary skill in the art. 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 first reagent comprises at least a diluent and the second reagent comprises at least a hemolytic agent, or wherein the first reagent comprises at least a hemolytic agent and the second reagent comprises at least a dye.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yi et al. (US 2020/0225257 A1) is the published application of parent application no. 16/727,810, which was abandoned.
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
Prosecution Insights