DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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 1-6 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 “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, wherein each reference value of the plurality of reference values is associated with one of the plurality of different mass spectrometers” is vague and indefinite because the claim does not provide a discernable boundary on what performs the function. The recited function (i.e. obtaining the intensity of the ion) does not follow from the structure recited in the claim i.e. the plurality of constituent units or the mass spectrometer, so it is unclear whether the function requires some other structure or is simply a result of operating the plurality of constituent units or the mass spectrometer 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 2-5 are vague and indefinite by virtue of their dependencies on rejected claim 1.
Claim 5 is further vague and indefinite fore requiring “a smallest reference value among reference values of measured intensities of ions associated with the plurality of models received by the model selection unit” because claim 1 requires “a plurality of reference values of intensity of the ion”. That is, claim 1 appears to suggest that the reference values of the intensity of a single ion, whereas claim 5 requires the reference values of measured intensities to be of ions. Therefore, it is not clear how different reference values of a single ion can be intensities of a plurality of ions. No unambiguous determination can be made.
Claim 6 requires the same limitations and is indefinite for the same reasons 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, 4 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) 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 ([0058] teaches spectrum pattern, wherein figure 8a shows a standard mass spectrum pattern where ion A or B or C has a m/z and intensity), a plurality reference values (914 stores voltages which yield an ion detection sensitivity for a specified spectrum pattern ([0058]). The detection sensitivity associated with each spectrum is interpreted to be the claimed reference values. Paragraph [0061] teaches measured intensity is the detection sensitivity. Since there is a selection of spectrum patterns (see S4) in figure 9, there is a plurality of detection sensitivity values associated with the different ions in the different spectrums) 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 ([0060] teaches lowering the detection sensitivity for ion C via a change of the voltage applied to ion lens 33 or [0070] after voltages are applied (i.e. according to voltages yielding detection sensitivity of selected pattern) the ion detection sensitivity is determined insufficient, thus one of the constituent units is not optimized),
a reference value selection unit (94) configured to receive selection of one of the plurality of reference values (via selection of spectrum pattern detection sensitivity values are set see paragraph [0067]),
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).
Kitano et al. fails to expressly teach each reference value of the plurality of reference values is associated with one of the plurality of different model mass spectrometers; the reference value selection unit including a model selection unit configured to receive selection of one of the plurality of different models 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 ([0072]). Moreover, Kitano teaches voltage information specifies voltages which yield an ion detection sensitivity corresponding to a specific pattern ([0058]). Lastly, Kitano envisioned substituting the quadrupole with a TOF ([0081]).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the reference values (i.e. detection sensitivity associated with each spectrum pattern) such that detection sensitivity associated with a spectrum pattern and corresponding voltages applied to lenses of one instrument as seen in figure 4, further include additional detection sensitivities each associated with lenses of different model mass spectrometers because it would allow for a high degree of matching between detected spectrums such that identification accuracy may be improved ([0008]). Moreover, it would have been obvious to have a model selection tool because it would provide a means to associate the detection sensitivity of a particular spectrum pattern to the model which is desired for spectral matching as discussed in paragraphs [0008] and [0055] in the same way the spectrum patterns are associated with detection sensitivities and voltages applied to individual lenses ([0058] and [0051]).
Regarding claim 4, Kitano et al. teach the parameter adjustment unit is configured to adjust a measurement parameter of each unit such that a measured intensity of the ion having the predetermined mass-to-charge ratio equals the reference value received by the reference value selection unit (see discussion above in claim 1).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881