DETAILED ACTION
Response to Arguments
Applicant's arguments filed 27 May 2026 have been fully considered but they are not persuasive.
Rejections under 35 USC § 112(a):
The claim amendment overcomes these rejections, however upon amendment new issues are raised discussed herein below.
Rejections under 35 USC § 103: Kitano
Page 9 of the remarks take the position that Kitano fails to suggest storing a plurality of reference values of intensity of the ion each of which is associated with a respective one of the plurality of mass spectrometers.
This has been found unpersuasive. Initially Kitano clearly teaches a storage unit 91 ([0050]). Moreover, paragraph [0072] expressly recites “It is also possible to previously store, in the storage section 91, a reference value (e.g. ion intensity value) for determining whether or not the detection sensitivity for a predetermined ion is sufficient, and configure the sensitivity setter 95 to automatically adjust the voltage applied to the secondary electron multiplier tube 62 based on that reference value (ion intensity value)”
That is, Kitano suggests storing a reference intensity value in a storage unit. Kitano fails to expressly suggest a plurality of reference values each associated with a respective one of the plurality of mass spectrometers. However, paragraph [0055] recites:
“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, Kitano identifies the problem of comparing data between different manufacturer or models of mass spectrometers. As discussed in the last office action, together paragraphs [0055] and [0072] suggests it would be obvious to one of ordinary skill in the art to store intensity values as reference values for each mass spectrometer, so as to effectuate the desired comparison disclosed in paragraph [0055].
The remarks continue with a discussion of intensity ratio. However, as discussed in the interview summary, the intensity ratio embodiment is not relied upon for teaching the claim limitations. Paragraph [0072] expressly teaches “intensity value” as opposed to intensity ratio discussed in paragraph [0059].
The remarks then suggest that paragraph [0055] is referring to the spectrum pattern setting mode thus requiring the intensity ratio of paragraph [0059].
This has not been found persuasive because [0055] was not relied upon for it’s disclosure of the spectrum pattern setting mode, but rather to provide evidence that it was known to the art that comparison between different manufactures or models of mass spectrometers adjustment of the detection sensitivity is required.
Again this suggests why it would have been obvious to modify Katano’s disclosure of paragraph [0072] to include a plurality of reference intensity values to effectuate comparison between different manufacturers or modes of mass spectrometers.
The remarks then contend that determining whether or not the detection sensitivity for a predetermined ion is sufficient is irrelevant to an ion intensity value obtained by other mass spectrometers.
This has been found unpersuasive because as discussed above, in order to compare MS data from different mass spectrometers adjustment of the detection sensitivity is necessary. Therefore having a reference intensity value for each of the mass spectrometers stored in 91 would have been obvious because it would facilitate detection sensitivity between mass spectrometers to be adjusted such that the spectra may be compared as desired in paragraph [0055] and identification accuracy may be improved ([0008]) in the normal mode in addition to the spectrum matching mode.
The remarks then take the position that paragraph [0072] suggests when the intensity larger than the reference value, there is no need to adjust measurement parameter value and therefore does not suggest measured intensity of the ion equals the reference value.
This has not been found persuasive. Specifically, the grounds of rejection is 1) that it would have been obvious to store a plurality of reference values (see point 5 on page 9 of the Non-Final rejection) and 2) because it would be obvious to account for the different detection sensitivities of different mass spectrometers, it would have been obvious to select a reference value of the lowest sensitive mass spectrometer, such that in normal mode comparison between the different devices would be possible ([0055]). Therefore, it would have also been obvious to one of ordinary skill in the art to lower the detection sensitivity when greater than the intensity value of paragraph [0072] when it is desired to compare the mass spectrum to a lower sensitive detector of a different mass spectrometer.
The remarks have therefore been found unpersuasive and the rejection stands as reiterated 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 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.
Claim 1 fails to meet the written description requirement for reciting “storing a value that is lower than the maximum intensity as the reference value… when the measured intensity is greater than the selected reference value…adjust at least one of measurement parameters for at least one of the plurality of constituent units so that the measured intensity of the ion having the predetermined mass-to-charge ratio is lowered to equal the selected reference value”.
Specifically, the broadest reasonable interpretation of the claim is a reference value of intensity that is lowered to 0 intensity, however the instant specification specifically teaches in paragraph [0029] the smallest measured intensity of ions can be set as the reference value common to all mass spectrometers. That is, there is no disclosure of the open ended range of lower than the maximum intensity value. Indeed lowering the intensity to 0 would obviate the purpose of the analysis. Instead, the instant specification teaches the lower limit is the smallest optimized measured intensity is set as the reference value.
MPEP 2163.05 (III) recites “With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement.”
In the instant case, the claim has a upper limit of below the maximum intensity, however the specification does not support a lower limit of no intensity. The claim is only supported in the specification for teaching that the smallest optimized measured intensity can be set as the reference value common to all mass spectrometers (i.e. providing a lower limit to the claim).
Claims 2-3 fail to meet the written description requirement by virtue of their dependencies on rejected claim 1.
Claim 6 requires commensurate limitations and fails to meet the written description requirement as discussed herein above.
It is noted that this issue may be overcome by amending claim 1 and 6 to require limitations commensurate with the requirements of claim 5.
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 1-3 and 5-6 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.
Claim 1 recites the limitation “each of the plurality of reference values being determined by obtaining a maximum intensity of the ion using initial values of measurement parameters that are optimized so that a measured intensity of the ion is a highest value” is vague and indefinite because the claim does not provide a discernable boundary on what performs the function. The recited function does not follow from the structure recited in the claim i.e. the storage unit, so it is unclear whether the function requires some other structure or is simply a result of operating the storage unit in a certain manner. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claim. See MPEP 2173.05(g) for more information.
Claims 2-3 and 5 are vague and indefinite by virtue of their dependencies on rejected claim 1.
Claim 6 requires limitations commensurate in scope and is rejected for the same reasons as discussed above.
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)), the reference value being determined by obtaining a maximum intensity of the ion using initial values of measurement parameters that are optimized so that a measured intensity of the ion is a highest value ([0072] teaches reference intensity value stored and paragraph [0016] teaches maximizing the detection sensitivity for an ion having a predetermined m/z)
and a parameter adjustment unit (sensitivity setter 95) configured to perform mass spectrometry of a sample containing the ion having the predetermined mass-to-charge ratio, measure an intensity of the ion having the predetermined mass-to-charge ratio ([0072]/[0016]) 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, storing a value that is lower than the maximum intensity as the reference value; 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 and determining whether the measured intensity is greater than the selected reference value and when the measured intensity is greater than the selected reference value adjust the measurement parameter(s) so that the measured intensity of the ion having the predetermined m/z is lowered to equal the selected reference value.
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]).
Lastly, it would have been obvious to lower the detection sensitivity of paragraph [0072] when the measured sensitivity is higher than the reference intensity value because when comparing the mass spectral data of the particular mass spectrometer to another of lower detection sensitivity, it would be obvious to lower the detection sensitivity to the mass spectrometer with the lowest detection sensitivity such that the data may be compared as suggested in paragraph [0055] and identification improved (see further discussion with respect to claim 5 below).
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, wherein the parameter adjustment unit is configured to adjust the at least one of the measurement parameters such that the measured intensity of the ion having the predetermined mass-to-charge ratio equals the smallest reference value..
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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