DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 April 2026 has been entered.
Response to Arguments
Applicant's arguments filed 26 March 2026 have been fully considered but they are not persuasive.
Rejections under 35 USC § 112(b)
The rejection of claims 1 and 6 have been overcome by cancelling the indefinite language. However, by omission of a claimed element, each claim now raises an issue under 35 USC 112(a) as discussed herein below.
Rejections under 35 USC § 103: Kitano
The remarks have been found persuasive, however upon further consideration, Kitano makes obvious the claimed invention under a different interpretation discussed herein below.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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.
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 plurality of constituent units which are configured to perform mass spectrometry”
“a storage unit which stores…a reference value” in claim 1.
“a parameter adjustment unit configured to adjust the measurement parameter of each unit” in claim 1.
“a model selection unit configured to receive selection of a plurality of models” in claim 1
“a reference value determination unit configured to determine a smallest reference value” 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.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 6 have been amended to broaden the claim so as to omit that the “reference values of intensity of the ion obtained under a condition in which at least one of measurement parameters for the plurality of constituent units is not optimized”. That is, the claim has been broadened to cover reference values obtained under a condition where at least one of the measurement parameters of for the plurality of constituent units is optimized. MPEP 2163 (I) (B) recites:
“Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention…claims to a sectional sofa comprising, inter alia, a console and a control means were held invalid for failing to satisfy the written description requirement where the claims were broadened by removing the location of the control means); Johnson Worldwide Assoc. v. Zebco Corp., 175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (stating that, in Gentry Gallery, the "court’s determination that the patent disclosure did not support a broad meaning for the disputed claim terms was premised on clear statements in the written description that described the location of a claim element--the ‘control means’ --as ‘the only possible location’ and that variations were ‘outside the stated purpose of the invention.’ …”
Here, the claims have been broadened to omit the reference values of intensity to be obtained under unoptimized conditions. However, the instant specification expressly recites:
“ reference value which is a value lower than the maximum value of the measured intensity of the ion is stored in a storage unit in advance, where the maximum value is obtained by optimizing a measurement parameter of each unit. Then, the measurement parameter of each unit is adjusted such that a measured intensity of an ion having a predetermined mass-to-charge ratio equals the reference value. A conventional mass spectrometer adjusts measurement parameters such that a measured intensity of the predetermined ion reaches the maximum value. Therefore, when the mass spectrometer deteriorates over time, it is impossible to measure the ion with the maximum value. The mass spectrometer and the mass spectrometry method according to the present invention can accurately perform mass spectrometry without creating a calibration curve for each analysis by using, as the reference value, an intensity value of an ion that can be reached even when deterioration occurs over time. ”
That is, while the claim has been broadened to cover a reference value having a maximum intensity, the instant specification expressly teaches that doing so would make it “impossible to measure the ion with the maximum value.”
Therefore, since the specification does not support the broad meaning for the claimed “reference value” is premised on clear statements in the written description that describe the necessity of the reference value to be lower than the maximum value.
Claims 2-3 and 5 also fail to meet the written description requirement by virtue of their dependencies on rejected claim 1.
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.
Claims 1, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kitano et al. (WO2019082294, submitted with IDS of 01/11/2023, national stage 371 application published as US 20200321207 is used as the translation).
Regarding claim 1, Kitano et al. teach a mass spectrometer (fig. 4) used with a plurality of different model mass spectrometers ([0081] teaches instead of quad mass filter a TOF may be used, thus different models, see also paragraph [0055] teaches “he spectrum pattern setting mode is a mode to be used …in order to adjust the ion detection sensitivity to that of a mass spectrometer of a different manufacturer or different model to allow for a comparison of mass spectrum data with those acquired with the latter mass spectrometer”) comprising:
a plurality of constituent units (3 and 6 in figure 1) which are configured to perform mass spectrometry (inherent);
a storage unit (91) which stores, for an ion having a predetermined mass-to-charge ratio ([0072] teaches predetermined ion, thus having a mass to charge ratio), a reference value of intensity ([0072], note 91 stores reference value (e.g. of intensity)),
and a parameter adjustment unit (sensitivity setter 95) configured to adjust at least one of the measurement parameters such that a measured intensity of the ion having the predetermined mass-to-charge ratio equals the reference value when a sample containing the ion is measured ([0072] adjust voltage applied to multiplier tube based on whether the detection sensitivity is equal to an ion intensity value) so that the ion having the predetermined m/z is measured at the same measured intensity by each of the plurality of different model mass spectrometers ([0072] teaches the predetermined ion (i.e. inherently having a predetermined m/z) having a reference value is used to determine whether the detection sensitivity is sufficient (i.e. suggesting that the ion is measured and compared to the reference intensity value ). When it is sufficient, the measured intensity value is the reference value. Further, paragraph [0055] “adjusting the ion detection sensitivity in a measurement … in order to adjust the ion detection sensitivity to that of a mass spectrometer of a different manufacturer or different model to allow for a comparison of mass spectrum data with those acquired with the latter mass spectrometer” That is, the ion detection sensitivity of one mass analyzer is adjusted to the different model, suggesting the reference value of paragraph [0072] is envisioned to be the reference value of different model or manufacture mass spectrometer. Therefore, the detection sensitivity of both paragraphs [0055] and [0072] are equal to the ion intensity value for both mass spectrometers).
Kitano et al. fails to expressly teach a plurality of reference values each of which is associated with a respective one of the plurality of different model mass spectrometers; a reference value selection unit configured to receive selection of one of the plurality of reference values, the reference value selection unit including a model selection unit configured to receive selection of one of the plurality of mass spectrometers.
However, Kitano teaches in paragraph [0055] “adjusting the ion detection sensitivity in a measurement … in order to adjust the ion detection sensitivity to that of a mass spectrometer of a different manufacturer or different model to allow for a comparison of mass spectrum data with those acquired with the latter mass spectrometer”. Moreover, Kitano teaches a sensitivity setter that may judge the detection sensitivity relative to a reference intensity value ([0072]).
That is, Kitano recognized that different models/manufacture of mass spectrometers have different detection sensitivities and that in order to compare the spectrum from different mass spectrometers, adjustment of the ion detection sensitivity of one would be necessary relative to the other ([0055]). Kitano additionally recognized that a stored ion intensity value may be used to determine whether or not the detections sensitivity for a predetermined ion is sufficient and adjustment of detection sensitivity ([0072]).
Therefore it would have been obvious to one of ordinary skill in the art to that when using additional different models as discussed in paragraph [0055] to store one ion intensity value as suggested in paragraph [0072] for each model of mass spectrometer (i.e. a plurality of reference values) so that the detection sensitivity of the mass spectrometer being adjusted ([0055]) can produce a mass spectrum that can be compared to the different mass spectrometer, thereby facilitating improved identification accuracy ([0008]). In other words, different detection sensitivities ([0055]) suggest that the intensity value of [0072] would be different for different models of mass spectrometers. Therefore, in order to adjust one model relative to another ([0055]), knowing the reference intensity value for the other model(s) would allow for mass spectrum comparison to accurately occur.
Moreover, Kitano teaches a spectrum pattern setter to receive selection of one of the plurality of spectrum patterns ([0067]) and storing the reference ion intensity value ([0072]). Therefore, when using two or more different models/manufacture mass spectrometers as suggested in paragraph [0055], it would have been obvious to one of ordinary skill in the art to similarly (to the spectrum pattern setter) have an reference value intensity setter including a model selection unit configured to receive selection of one of the plurality of mass spectrometer, such that the user may select the reference value for the one identified model mass spectrometer of the two to be adjusted ([0055]) such that the spectra may be compared as desired in paragraph [0055] and identification accuracy may be improved ([0008]).
Regarding claim 5, while Kitano recognized different mass spectrometers have different sensitivities, Kitano fails to specifically suggest wherein the reference value selection unit further includes: a reference value determination unit configured to determine a smallest reference value among reference values of measured intensities of the ion associated with the plurality of models received by the model selection unit.
However, because different MS have different sensitivities, when using two mass analyzers of different models, it would have been obvious to one of ordinary skill in the art to select the mass spectrometer with the lowest reference value because the mass spectrometer with the lowest reference value would have the lowest detection sensitivity. That is, selecting the lowest reference value would ensure that both mass spectrometers would be able to detect the mass spectrum to be compared ([0055]). In other words, if a higher reference value is selected, the mass spectrometer to be adjusted for detection sensitivity may not be capable of producing accurate data, therefore selecting the lowest would ensure that both mass spectrometers would be able to produce data for comparison as desired in paragraph [0055]. Since the purpose of Kitano is to allow for autotuning ([0007]), it would have been obvious to one of ordinary skill in the art that such a determination would be performed by the controlling processing unit 9 so as to simplify the determination via automation instead of manually determining.
Claim 6 is commensurate in scope and anticipated as discussed above in claim 1.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kitano in view of Booth et al. (WO2019/229449).
Regarding claim 2, Kitano fails to disclose claim 2, however Booth et al. teach comprising, wherein constituent units comprise an ionization unit, an ion transport unit, a front mass separation unit, an ion dissociation unit, a rear mass separation unit, and an ion detection unit, wherein the parameter adjustment unit is configured to adjust respective measurement parameter from unit to unit among the constituent units (page 7, lines 22-28 teaches adjustments may be made to various components of the mass spectrometer, including the ion source and the quadrupoles, page 7 lines 13-14 teach the detector may be adjusted to optimize the linearity of the response. Moreover, page 2, lines 7-9 teaches an upstream filter, collision cell and downstream filter and page 3, line 20 teaches a triple quadrupole (i.e. a CID between two quadrupoles). Since page 7 teaches quadrupoles may be adjusted, this includes all of the front/rear quadrupoles of the triple quad and the collision cell.).
Booth modifies Kitano by suggesting optimization of the entire device.
Since both inventions are directed towards optimization, it would have been obvious to one of ordinary skill in the art to adjust the entire system, in order to have a better calibrated mass spectrometer.
Regarding claim 3, Kitano in view of Booth et al. teaches wherein the adjusted measurement parameter is a value of a direct-current voltage applied to a predetermined electrode (page 7, lines 30-31).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
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