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 .
Preliminary Amendment
Receipt is acknowledged of the preliminary amendment filed on 06/05/2024.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: the title is not descriptive. A new title that would include the inventive features of the claimed invention is respectfully requested.
Appropriate correction is required.
Claim Objections
Claims 1, 5-6 are objected to because of the following informalities: Regarding claims 1 and 5-6, the first recitation of abbreviated term “ICP” in the phrase “ICP mass spectrometry device” should be spelled out. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a first chromatogram acquisition processing unit, a second chromatogram acquisition processing unit, and a first correction processing unit in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
a first chromatogram acquisition processing unit – unit 751 appears to be performing a function of the processing unit 75 which is part of a control unit 7, such as a CPU
a second chromatogram acquisition processing unit – unit 752 appears to be performing a function of the processing unit 75 which is part of a control unit 7, such as the CPU.
a first correction processing unit – unit 76 appears to be part of the control unit 7, such as the CPU.
For examination purposes, these units will be understood as the control unit or the CPU being configured to perform different functions.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claims 1, 3, 5 and 6, the claims recite multiple different instances of “an internal standard element” without explaining whether these instances refer to the same or different internal standard elements. In particular, claims 3 and 6 recite both “an internal standard element” and “the internal standard element” without further defining whether these internal standard elements refer to the same or different substances. Further clarification is respectfully requested.
Regarding claims 1 and 5, the claims recite “an ICP mass spectrometry device” without disclosing any structural features or functions exclusive to the ICP mass spectrometry device. In this case, the method step and the apparatus appear to disclose the internal standard calibration procedure applicable to any mass spectrometry device. For examination purposes, the phrase “ICP mass spectrometry device” will be interpreted as being equivalent to a mass spectrometry device. Further clarification is respectfully requested.
Regarding claim 5, the claim recites at least two different instances of “an ICP mass spectrometry device” without explaining whether these instances refer to the same or different devices. Furthermore, as outlined in the “Claim interpretation”, the first chromatogram acquisition processing unit, the second chromatograph acquisition processing unit, and the correction processing unit appear to be different functions performed by the control unit 7, or the CPU. For examination purposes, these units will be interpreted as the control unit or the CPU being configured to perform the functional recitations.
Further clarification is respectfully requested.
Claims 2 and 4 are rejected as being dependent on the rejected base 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.
(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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Maekawa et al. (Pat. No. US 11,644,448) (hereafter Maekawa).
Regarding claim 1, Maekawa teaches a mass spectrometry method comprising:
a sample dividing step that dividing a liquid sample to divided samples with a liquid chromatograph (i.e., sample separation part 204 is provided with a column for separating the sample for each component) (see Column 4, lines 18-30);
an internal standard element mixing step that mixing one of the divided samples with an internal standard element (i.e., an internal standard material having a retention time similar to that of the target analyte and having a mass-to-charge ratio different from that of the target analyte is added to a sample collected from a living body. Standard samples 311 to 313 and an unknown sample 314 obtained by adding a fixed amount of internal standard material 302 to target analytes 301 having several concentrations that match a series of measurement concentrations are measured) (see Column 5, lines 3-24);
a sample introduction step (i.e., standard samples 311 to 313 and an unknown sample 314 obtained by adding a fixed amount of internal standard material 302 to target analytes 301 having several concentrations that match a series of measurement concentrations are measured) (see Column 5, lines 3-24) that introducing the divided samples including the one of the divided samples with an internal standard element into an ICP (please note that the claim does not disclose any structure or functions exclusive to an ICP mass spectrometer. Thus, any internal standard calibration process generally used for other mass spectrometers would properly calibrate the ICP mass spectrometer as well) mass spectrometry device (i.e., mass spectrometry part 205) (see Fig. 2);
a first chromatogram acquisition step that acquiring a first chromatogram by the ICP mass spectrometry device for each component in the divided samples introduced in the sample introduction step (i.e., chromatograph of target analyte 101) (see Fig. 1, 3, and 8);
a second chromatogram acquisition step that acquiring a second chromatogram by the ICP mass spectrometry device for the internal standard element in the one of the divided samples with an internal standard element introduced in the sample introduction step (i.e., chromatograph of the internal standard material 102) (see Fig. 1, 3, and 8); and
a first correction step that correcting the first chromatogram using the second chromatogram (i.e., the calibration curve is generated by associating a ratio of measurement values, that is, a value of (a measurement value of the target analyte)/(a measurement value of the internal standard material) with the known concentration) (see Column 5, lines 3-39).
Regarding claim 2, Maekawa teaches that, in the first correction step, the first chromatogram is corrected by dividing an intensity value at each time of the first chromatogram by an intensity value corresponding to the same time in the second chromatogram (i.e., the calibration curve is generated by associating a ratio of measurement values, that is, a value of (a measurement value of the target analyte)/(a measurement value of the internal standard material) with the known concentration) (see Column 5, lines 3-39).
Regarding claim 3, Maekawa teaches that the one of the divided samples with an internal standard element introduced in the sample introduction step contains an internal standard component having an element different from the internal standard element (i.e., a plurality of different internal standard materials are added to the sample, and a plurality of chromatograms are obtained as the chromatograms of the internal standard materials) (see Column 9, line 65, to Column 10, line 60), and the mass spectrometry method further comprises a second correction step of correcting a peak of a target component contained in the first chromatogram corrected by the first correction step with a peak of an internal standard component contained in the first chromatogram (i.e., since it is common that the internal standard material is measured in a concentration range that can be detected with a sufficient S/N by the detector, it is possible to accurately calculate the peak start point and the peak end point with a relatively simple algorithm. Since the retention time of the peak start point and the peak end point can be applied to the chromatogram of the target analyte, the peak of the target analyte whose concentration range is unknown and whose retention time varies can be reliably detected, thereby drastically reducing the load of the data analysis processing) (see Column 8, line 56, to Column 9, line 63).
Regarding claim 4, Maekawa teaches that, in the second correction step, the peak of the target component is corrected by dividing the intensity value or an area of the peak of the target component contained in the first chromatogram corrected in the first correction step by the intensity value or an area of the peak of the internal standard component contained in the first chromatogram (i.e., A peak calculation part 804 obtains an internal standard measurement value (area and height) and a component measurement value (area and height) from the internal standard peak portion data 808 and the component peak portion data 810, respectively) (see Column 6, line 40, to Column 7, line 52)
Regarding claim 5, Maekawa teaches an ICP (please note that the claim does not disclose any structure or functions exclusive to an ICP mass spectrometer. Thus, any internal standard calibration process generally used for other mass spectrometers would properly calibrate the ICP mass spectrometer as well) mass spectrometry device (i.e., mass spectrometry part 205) (see Fig. 2) into which divided samples including one of the divided samples with an internal standard element (i.e., an internal standard material having a retention time similar to that of the target analyte and having a mass-to-charge ratio different from that of the target analyte is added to a sample collected from a living body. Standard samples 311 to 313 and an unknown sample 314 obtained by adding a fixed amount of internal standard material 302 to target analytes 301 having several concentrations that match a series of measurement concentrations are measured) (see Column 5, lines 3-24) is introduced via a liquid chromatograph, the apparatus comprising:
an internal standard element introduction unit that introduces an internal standard element by mixing a solution of the internal standard element into a liquid sample (i.e., an internal standard material having a retention time similar to that of the target analyte and having a mass-to-charge ratio different from that of the target analyte is added to a sample collected from a living body. Standard samples 311 to 313 and an unknown sample 314 obtained by adding a fixed amount of internal standard material 302 to target analytes 301 having several concentrations that match a series of measurement concentrations are measured) (see Column 5, lines 3-24) introduced from the liquid chromatograph (i.e., sample separation part 204) (see Fig. 2) without interposing the liquid chromatograph;
a first chromatogram acquisition processing unit that acquires a first chromatogram by an ICP mass spectrometry for each component in the divided samples introduced from the liquid chromatograph (i.e., chromatograph of target analyte 101) (see Fig. 1, 3, and 8);
a second chromatogram acquisition processing unit that acquires a second chromatogram by the ICP mass spectrometry for the an internal standard element in the one of the divided samples with an internal standard element introduced into the ICP mass spectrometry device (i.e., chromatograph of the internal standard material 102) (see Fig. 1, 3, and 8); and
a first correction processing unit that corrects the first chromatogram using the second chromatogram (i.e., the calibration curve is generated by associating a ratio of measurement values, that is, a value of (a measurement value of the target analyte)/(a measurement value of the internal standard material) with the known concentration) (see Column 5, lines 3-39).
Regarding claim 6, Maekawa teaches the one of the divided samples with an internal standard element introduced from the liquid chromatograph contains an internal standard component having an element different from the internal standard element (i.e., a plurality of different internal standard materials are added to the sample, and a plurality of chromatograms are obtained as the chromatograms of the internal standard materials) (see Column 9, line 65, to Column 10, line 60), and the ICP mass spectrometry device further comprises a second correction processing unit that corrects a peak of a target component contained in the first chromatogram corrected by the first correction processing unit with a peak of an internal standard component contained in the first chromatogram (i.e., A peak calculation part 804 obtains an internal standard measurement value (area and height) and a component measurement value (area and height) from the internal standard peak portion data 808 and the component peak portion data 810, respectively) (see Column 6, line 40, to Column 7, line 52).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see PTO-892.
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/Tran M. Tran/Examiner, Art Unit 2855
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