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 Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of structural elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that a installation part, transport mechanism, magnetic separation device, and evaporation concentration device are not defined by any specific structures in the claims.
It is noted that the term “when” recited throughout the claims is directed to conditions not requirements.
It is noted that the term “or” is directed to alternatives not requirements.
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.
Claims 1-9 are 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.
As to claim 1, it is unclear how the analyzer is considered as being “automatic” because the analyzer is not defined as comprising any element that can provide for any automation, such as a computer, controller, etc. The phrase “the steps of” is unnecessary. The claim should read as “the control method comprising:”
Claims 2-9 are rejected via dependency upon a rejected claim.
In claims 2-9, it is presumed that claims are referring to same method of claim 1. There for the claims should read as “The control method.
As to claim 5, it is unclear if it required for the analyzer to comprise a reaction disc because the “when” clause is directed to a condition that is never required to occur. There is no step recited that requires reacting the sample with anything. Furthermore, it is unclear what is meant by “mounting the first container of the second container” because it is unclear if this means that the first and second container previously recited as containing the liquid is now also required to contain the sample of the reaction vessel previously recited.
As to claim 6, it is unclear what is nexus of “a liquid in a container” to the liquid in the first and second containers recited in claim 1 because the claim does not recite such.
As to claim 9, it is unclear how the claim further limits the method of claim 1 because the claim does not provide for any additional step nor further limits any prior steps. The claim is directed to an automatic analyzer. However, it is unclear what is structurally considered as defining the automatic analyzer because there is no transitional phrase and list of structural elements provided in the claim.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/002431 (HITACHI D1) also published as US 2022/0268798, EBIHARA; Daisuke et al..
D1 discloses for example in (figures 1, 6, 7 and corresponding descriptive text) a control method for controlling an automatic analyzer that analyzes a sample, wherein:
the automatic analyzer has
a nozzle (133) that aspirates or discharges a liquid, (see also dispensing mechanisms 113, 123 that can dispensing and aspirate liquids),
a first installation part (302, left side) where a first container {116) for storing the liquid is installed, (See also disks, 120 and 121),
a second installation part (302, middle or right side) where a second container for storing the liquid is installed, (See also disks, 120 and 121), and
a transport mechanism (132) for transporting the first container and the second container; (See also 112, 118, 125 that move the vessels/containers throughout the analyzer)
both the nozzle (133) and the transport mechanism (132) are accessible to each of the first container installed at the first installation part and the second container installed at the second installation part;
the first installation part and the second installation part are respectively placed at positions where the transport mechanism and the nozzle are in contact with each other when the nozzle accesses the first container installed at the first installation part while the transport mechanism accesses the second container installed at the second installation part (see fig. 7); and
the control method includes the steps of:
aspirating the liquid by the nozzle from the first container installed at the first installation part;
installing the second container at the second installation part by the transport mechanism after the nozzle aspirates the liquid from the first container; and discharging the liquid by the nozzle to the second container.
The analyzer also comprises a processor for implementing software, interpreting and executing a program for implementing respective functions (automation); analysis unit 103 and control unit 104. (claim 9).
D1 does not specify installing the second container at the second installation part by the transport mechanism after the nozzle aspirates the liquid from the first container; and discharging the liquid by the nozzle to the second container.
The Applicant is advised that the Supreme Court recently clarified 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. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that the order of the steps may be automated as desired by employing an analyzer as that of D1 that comprises the same structural elements or equivalents as claimed such that the transport mechanism can be operated simultaneously or separately as such does not require any special skills nor knowledge beyond that of one of ordinary skill in the art.
Claims 2-4 are directed a sequence of operations, which are also obvious for the same reasons applicable to claim 1.
As to claim 5, see the reaction vessel disk 120 and reagent disk 122 in fig. 1.
As to claims 6-8, the analyzer comprises an evaporation concentration device 131, fig. 1 and 302 employed for evaporation of liquid, and a magnetic separation mechanism 124, magnet 201 employed for magnetic separation of magnetic particles from liquids in a container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. HASHIMOTO; Shozo; SAKAIRI; Susumu et al.; SATO; Naoto; and Clark; Frederick L. et al. disclose automated analyzers and methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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