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 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”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that although the claims mention a specimen (not specified as being anything specific in the claim), clinical department (not structurally defined), doctor (presumptive a human being), hemoglobin in the specimen, solvent not specified as being anything specific in the claim), and a target component (not specified as being anything specific in the claim), none of the prior are positively claimed as structural elements of the apparatus (system). All of such are considered as materials and/or articles (and a person) that are intended be, can be used with, or worked upon by the apparatus. None of such structurally define the claimed invention. There is no requirement for the “system” nor any elements of such to be used to perform anything in any method at all, including in any method as may be intended by applicant. The claims are directed to an apparatus not a process of use. Process steps and recitations of intended/possible use are not structural elements. No process steps (switching, measuring, selecting, testing, requesting, setting, comparing, eluting, detecting, etc. nor any other acts) are ever required to be performed by anyone and/or anything (positively claimed structures that define the invention).
It is noted that the system (apparatus) of claim 1 is defined by two, broad structurally undefined elements…(1) an analyzer (not defined as comprising any specific structures) that is presumed to be the analysis apparatus 30 disclosed in the specification; and (2) a management unit ((not defined as comprising any specific structures) that is presumed to be the management apparatus 80. If so, it suggest that applicant employ consistent terminology in the claims with that in the specification because the terms “analyzer” and “management unit” are not found in the specification as being referenced by any reference numerals provided for in the drawings.
It is noted that although the specification discloses that both of the analysis apparatus 30 and the management apparatus 80 are defined by a number of structural elements, such elements are not provided for in the claims. Instead, claim 1 is includes “configured to…” clauses that do not provide for any structural elements of the analyzer and management unit, but such clauses are directed to intended possible uses relative to the unclaimed specimen, information, clinical department, doctor, etc. and/or process steps. It is noted that employing the phrase “configured to…” prior to each and every possible use of a structural element does not provide for any further structure of a structural element.
It is further noted that phrase “the analyzer being switchable between a first measurement mode and a second measurement mode…” does not provide for any further structure of the analyzer. Measurement modes that presumed to mean operational modes (directed to what the analyzer can be possible employed to perform…process steps that are intended to define such modes, but such steps are not provided for in the claim) are not structures. There is no structural element claimed (as a structural element of the analyzer) that can physically perform any “switching” of any “modes”. Furthermore, “a measurement item” is not structure and not a structural element of the analyzer.
The same is applicable to the “measurement unit” that is not defined in the claim by any specific structures.
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 1-7 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 what is structurally required to define an analyzer and a management unit because the claims do not provide for such. Instead, each are defined relative to “configured to…” clauses. See Claim Interpretation. It is unclear what is meant by and further structurally required by the portion of the claim directed the broad, unspecified “information” on a clinical department that has requested a test to be set for the specimen” because the claim does not provide for such. See also Claim interpretations. Although not structure, it is unclear what is “information on a clinical department” (and what is structurally required to be a clinical department) because the claim does not provide for such. It is further noted that there is no requirement for anyone nor anything to ever make any request for a test to be “set” for any unclaimed specimen. However, it is unclear what is required to be done by who/what to be considered as “to be set” because the claim does not provide for such. No “setting” of any unspecified test is ever required to be done.
Claims 2-7 are rejected via dependency upon a rejected claim.
It is unclear what is further structurally required by claims 2-7 because the claims do not provide for any additional structural elements nor further structure of the analyzer or management unit. The claims are directed to further intended/possible use and/or process steps relative to further unclaimed articles and/or materials.
As to claim 2, although information is not structure, it is noted that the claim does not provide for what is such information. It is unclear how any broad, unspecified information on an unclaimed, undefined clinical department and broad, unspecified “information on a doctor belonging to the clinical department”. See Claim Interpretations. Although no information structurally defines the invention, it is unclear what is required of information to be considered as “associated with” information on a doctor belonging to the clinical department because the claim does not provide for such. However, it is noted that any “information” can be subjectively considered as being “associated with” any further information or anything else that one so desires.
It is unclear what is further structurally required by claim 4 because of that as stated above and the claim is directed to hemoglobin and measurement modes that are not structural elements of the claimed invention. There is no requirement for the invention to be used to measure anything including any hemoglobin that may be present in any unclaimed, unspecified specimen. See Claim Interpretations.
It is unclear what is further structurally required by claims 5-7 because of that as stated above and the claims are directed to a solvent and measurement modes that are not structural elements of the invention. There is no requirement for any solvent to be present, eluting of anything to performed, nor any solvent to fed from anything to anything at any “feeding speed” that is “increased” relative to anything.
As to claim 5-7, as noted above, measurement modes are not structure and are not clearly defined in the claims and no eluting of anything is required to be performed in/by any “mode”. However, it is unclear what is structurally meant by and what is “higher eluting power” and “feeding speed” of a solvent because such are not defined in the claims.
As to claims 5 and 7, although no solvent is claimed as a structural element of the invention and no eluting of anything is required to be performed using any solvent, it is unclear what is considered as “eluting power” and what such eluting power is required to be higher than because the claim does not provide for such. There is no relative comparison of any eluting power of any solvent to anything else provided for in the claim.
As to claim 6, although no feeding of any solvent from anywhere/anything (structure) to any structure, it is unclear what is meant by “increased” because no definitive comparison of, relative to any “feeding speed” of anything else is provided for in the claim so as to determined what is considered as “increased”.
As to claim 7, in addition to the above applicable remarks and rejections, it is unclear what is structurally meant/required by the phrase “in a case in which a target component is detected, …” because the claim does not provide for such. No such “case” is ever required to occur. No (unspecified, undefined) target component is claimed as an element of the invention and no detecting of any target component is ever required to occur. However, it is unclear what is the structural nexus of such “target component” to anything previously recited in the claims because the claim does not provide for such.
Furthermore, although no detecting of anything by anyone nor anything and no switching of any solvent is required to be performed, it is unclear what is required to be done by who/what to be considered as detecting a target component and switching a solvent (not claimed as a structural element of the invention).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sezaki; Akira et al., US 10,527,594.
Sezaki discloses a liquid chromatography measurement instrument (system) employed to perform a liquid chromatography measurement method includes: switching between a first measurement mode using a liquid chromatography method in which hemoglobin A1c and a hemoglobin variant are measured in a measurement sample by sequentially delivering a first component-separating eluent, a second component-separating eluent and a wash eluent to an analytical column (analyzer), and a second measurement mode using the liquid chromatography method in which the hemoglobin A1c is measured by sequentially delivering the first component-separating eluent and the wash eluent to the analytical column; delivering the wash eluent in the first measurement mode prior to an influence from the second component-separating eluent disappearing such that a first retention time of the hemoglobin A1c in the first measurement mode and a second retention time of the hemoglobin A1c in the second measurement mode are substantially the same as each other; and delivering the first component-separating eluent after the wash eluent. (Abstract; Figures and descriptions of such).
The system includes a switching unit (management unit) that is configured to switch between a first measurement mode using a liquid chromatography method in which hemoglobin A1c and a hemoglobin variant are measured in a measurement sample by sequentially delivering a first component-separating eluent, a second component-separating eluent and a wash eluent to an analytical column, and a second measurement mode using the liquid chromatography method in which the hemoglobin A1c is measured by sequentially delivering the first component-separating eluent and the wash eluent to the analytical column. (column 3, lines 15-35).
The fourth aspect of the present disclosure is a non-transitory storage medium storing a program that causes a computer (management unit) to execute liquid chromatography measurement processing, the liquid chromatography measurement processing including: switching between a first measurement mode using a liquid chromatography method in which hemoglobin A1c and a hemoglobin variant are measured in a measurement sample by sequentially delivering a first component-separating eluent, a second component-separating eluent and a wash eluent to an analytical column, and a second measurement mode using the liquid chromatography method in which the hemoglobin A1c is measured by sequentially delivering the first component-separating eluent and the wash eluent to the analytical column; delivering the wash eluent in the first measurement mode prior to an influence from the second component-separating eluent disappearing such that a first retention time of the hemoglobin A1c in the first measurement mode and a second retention time of the hemoglobin A1c in the second measurement mode are substantially the same as each other; and delivering the first component-separating eluent after the wash eluent. (column 4, lines 16-37).
The instrument body 2 includes a sample preparation unit 5, an analyzer unit 6, and a photometer unit 7.
The photometer unit 7 is for optically detecting hemoglobin contained in the solution desorbed from the analytical column 60. (column 5, lines 27-28).
At step S10, determination is made as to whether the blood sample 13 to be measured is to be measured in the variant mode or to be measured in the fast mode (also referred to as normal mode). Processing transitions to step S12 for the fast mode measurement, and processing transitions to step S26 for the variant mode measurement. Note that the variant mode (first measurement mode) is a measurement mode that uses a liquid chromatography method to measure HbA1c and hemoglobin variants in the blood sample 13 by successively delivering plural types of eluent, described later, to the analytical column 60 in a predetermined sequence. Further, the fast mode (second measurement mode) is a measurement mode that, among plural types of eluent, successively delivers a plural common eluents common to the eluents used in the variant mode to the analytical column 60 in a predetermined sequence, to measure HbA1c.
Whether to use the variant mode or the fast mode as the measurement mode for measuring each blood sample 13 is, for example, preset by a user. For example, the measurement mode may be identified and set by reading bar code information affixed to the blood collection tube 11, by receiving an instruction signal from a host computer, or by input from the operation section. This enables compatibility even in situations in which blood collection tubes 11 to be measured by the fast mode and by the variant mode are housed together in the rack. (management unit; column 6, line 55 – column 7, line 4).
By adopting such an approach, the present exemplary embodiment is able to switch measuring between the fast mode and the variant mode using a single instrument. (column 9, lines 38-40).
See also controller 100 (management unit) and claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. LIU; Hai et al.; ONUMA; Naotsugu et al.; NAKAYAMA; Yusuke; Scolari; Caroline et al.; Sezaki; Akira et al.; Shuford; Christopher Michael et al.; Yotani; Takuya et al.; Ishikawa; Kazuki et al.; Oishi; Kazuyuki; Williams; Jonathan Paul et al.; Satake; Seiji et al.; Taira; Hiroaki et al.; YOSHIDA; Suguru et al.; Sakai; Toshikatsu et al.; Sugiyama; Koji et al.; Firminger; Shawn P. et al.; Sugiyama; Koji et al.; Setoguchi; Yuji et al.; Sugiyama; Koji et al.; Mizuno; Masako et al.; and Mizuno; Masako et al. disclose analytical devices and methods using the devices.
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..
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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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