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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 March 2026 has been entered.
Response to Arguments
Applicant's arguments filed 02 March 2026 have been fully considered but they are not persuasive.
Rejections under 35 USC § 112(f):
The remarks take the position that claim 1 has been amended to remove the nonce term unit. It is noted, that claim 1 has not been amended to remove the term unit or structurally define “a preprocessing unit” or “a mass detection unit” of claim 1. Therefore, the interpretation under 112(f) remains.
Rejections under 35 USC § 112(a):
The remarks take the position that calculating or determining a mass spectrum is not in the claims. The remarks then suggest this amounts to importing subject matter from the specification into the claims.
This has been found unpersuasive. Initially, claim 1 requires “calculating…a degree of matching by comparing a theoretical mass spectrum and the first mass spectrum”
In order for such a comparison to take place, there is inherently a requirement that a theoretical mass spectrum be determined. Without a determination of a theoretical mass spectrum, there would be no spectrum to compare the first mass spectrum to. Paragraph [0005] of the instant published application specifically points to the technical problem with respect to the prior art being erroneous from qualitative analysis. Paragraph [0007] of the instant specification provides the solution being to calculate a theoretical mass spectrum and matching the mass spectrum with the theoretical.
In other words, there is no evidence in the specification that the comparison may occur without a calculation of a theoretical mass spectrum. The remarks do not argue any support of how the calculation is performed and instead take the position that no determination of a theoretical mass spectrum is required by the claims. As discussed above, the comparison in and of itself requires the calculation of a theoretical mass spectrum because a theoretical mass spectrum cannot exist unless it is determined.
As discussed previously, since the specification is silent with respect to how the theoretical mass spectrum is calculated/determined, the claimed comparison is a desired result with no disclosure as to how the result is achieved (i.e. by what algorithm the theoretical mass spectrum is determined, such that the comparison may be made).
The remarks are therefore unpersuasive and the rejection stands as reiterated herein below.
Rejections under 35 USC § 101
The remarks take the position that the improvement is a technical problem recited in paragraph [0002] and paragraph [0005].
The remarks then explain the presently claimed invention provides a solution to the technical problem, which is an improvement to mass spectrometry since the influence of the peak caused by elements other than the measurement target can be eliminated ([0044]).
This has been found unpersuasive. As expressly recited in paragraph [0005] “when there is a peak caused by a factor other than the component to be analyzed, since the peak is also analyzed, an erroneous determination is caused in qualitative analysis” (emphasis added).
There is no claimed or disclosed improvement to mass spectrometry itself. The mass spectrometer is conventional to provide for data gathering such that the abstract idea may be performed. Indeed, paragraph [0005] expressly suggests the problem is with respect to qualitative analysis, not with respect to mass spectrometry. The solution discussed in paragraph [0044] is with respect to the elimination of the influence of the peak by calculation, thus improving data analysis, which is in and of itself an abstract idea. Indeed paragraph [0038] further recites that “since an influence of the peak other than the component to be analyzed can be avoided, an erroneous determination in qualitative analysis can be prevented” clearly demonstrating that this is an improvement in qualitative analysis, not mass spectrometry.
MPEP 2106.05 (b) (III) recites “Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) ”
Here, the mass spectrometer only nominally or insignificantly contributes to the calculation itself in the form of data gathering and therefore does not integrate the exception into significantly more.
MPEP 2106.05(a) recites:
“An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration”
Here, the improvement is clearly directed towards an improvement in qualitative analysis, thus merely an idea of a solution or outcome. This is evident by the fact that there is no particular machine (i.e. the mass spectrometer contributes only for the purposes of data gathering) and the computer is merely a means to apply the abstract idea to a computer.
Improving qualitative analysis is not a field of technology, but rather an abstract idea (mathematical concept). Specifically, the instant specification achieves the qualitative analysis via mathematical concepts of calculating a theoretical mass spectrum and comparing via a degree of matching algorithm (see for instance paragraph [0007]).
MPEP 2106.05(a) (II) recites:
“It is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. ”
Here, since the specification teaches this is an improvement in qualitative analysis and defines the qualitative analysis in terms of an abstract idea (mathematical concept), it is clear that the claims are non-eligible as an improvement in an abstract idea itself is not an improvement in technology.
MPEP 2106.04(d)(1) recites:
“ the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. That is, the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity”
Here, the position of the remarks is that the improvement is towards mass spectrometry. However, this speaks directly in conflict with the instant specification which identifies the problem in qualitative analysis ([0005]) and offers a solution of preventing erroneous determination in qualitative analysis ([0038]). Since qualitative analysis is an abstract idea defined by the claimed and disclosed calculations any improvement to an abstract idea cannot be considered a practical application as it is not an improvement of a technological field, but rather an improvement to an abstract idea. The specification is devoid of any suggestion that mass spectrometry is improved via the claimed method, only that qualitative analysis (i.e. an abstract idea) may be improved weighing strongly against patent eligibility.
Therefore, considering:
Mass spectrometry is only claimed with a high degree of generality, the mass spectrometer is only used for insignificant extra solution (i.e. data gathering), the claimed processor is merely a means to apply the abstract idea and the improvement is disclosed to improve an abstract idea, the claims have no practical application nor significantly more than the abstract idea itself.
The remarks continue asserting the claims require the improvement in the technical field of mass spectrometry, thus having a practical application. As discussed above, the disclose improvement is not mass spectrometry, but rather qualitative analysis which is an abstract idea itself facilitated by the claimed calculations.
The remarks then suggest the claim has additional elements which as a whole suggest an improvement to mass spectrometry. As discussed in detail above, the mass spectrometer is claimed with a high degree of generality and only nominally or insignificantly claimed for the proposes of data gathering upon which the abstract idea (mathematical concepts) are performed. The claimed processor is merely a means to apply the abstract idea. Therefore, as a whole the claim is not significantly more than an abstract idea.
Rejections under 35 USC 103
The remarks have been found unpersuasive. Specifically, the remarks take the position that Sakuta does not disclose determining the presence or absence based on the thresholds because the second threshold is directed towards a determination of the reliability of the measurement.
This has not been found persuasive. Specifically, the claim requires wherein in the determination, the processor compares the degree of matching, by comparing the theoretical mass spectrum and the first mass spectrum, with a first threshold and a second threshold larger than the first threshold, determines that the component to be analyzes is absent when the degree of matching is smaller than the first threshold, and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold.
Initially, the degree of matching is determined based on the comparison of the theoretical mass spectrum and the mass spectrum (see paragraphs [0011] and [0015]). This degree of matching is compared with the first and second thresholds (see paragraphs [0012] and [0016]). This is commensurate with the disclosed method which teaches in paragraph [0033] that the theoretical mass spectrum is compared with the mass spectrum to calculate a degree of matching and paragraph [0037] which teaches the degree of matching is compared with the first and second thresholds to determine presence or absence.
With respect to the reliability of the measurement, while the second threshold is used for reliability (paragraphs [0094]-[0096]), the reliability allows a determination that the measurement is reliable thus allowing the display of the reliability to be higher ([0096]). That is, if the sum of intensities were lower than the second threshold the reliability would be lower indicating that the measurement may have been unreliable and the component may not be present, by having a degree of matching equal to or greater than the second threshold indicates the measurement was reliable and the presence may be determined when higher than the first and second threshold.
The claim does not require how the degree of matching is compared to the thresholds nor does the claim preclude the determination of presence to be based on both the first and second thresholds, therefore does not preclude the interpretation that the second threshold is based on a sum of peaks and the presence is determined based on both being greater than the first threshold and having a high reliability measurement (i.e. greater than a second threshold).
In otherwords, if the degree of matching were lower than the second threshold the measurement is unreliable and the determination of the presence of a component cannot be determined (i.e. determination by first threshold may not be accurate because the measurement is unreliable), however if the degree of matching is greater than the second threshold, the measurement is reliable and thus the presence can be determined (i.e. higher than both the first and second thresholds). Note, the claim does not require any condition of the first threshold when the degree of matching is larger than the second threshold, therefore does not preclude the requirement of the degree of matching being higher than both the first and second thresholds for presence to be determined as suggested in paragraphs [0011]-[0012], [0015]-[0016] and [0095]-[0096].
Therefore, the remarks are 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.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 preprocessing unit” in claim 1.
“a mass detection unit” in claim 11.
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, 2, 6 and 10-12 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 lacks written description for “calculating, by the processor, a degree of matching by comparing the a theoretical mass spectrum and the first mass spectrum, for only a mass in which a peak of the theoretical mass spectrum exists”. Specifically, paragraph [0025] of the published application teaches the calculation is performed by a CPU (i.e. control unit). Paragraph [0028] teaches how the theoretical mass spectrum is calculated based on molecular formula and isotope abundance ratio however there is no disclosed algorithm to use the molecular formula and an isotope abundance ratio to calculate a theoretical mass spectrum. Moreover, [0029] teaches an example of a molecular formula and isotope abundance ratio, however there is no disclosed algorithm to predetermine a theoretical mass spectrum on the basis of an isotope abundance ratio and molecular formula. MPEP 2161.01 (I) recites:
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed
Here, the specification similar to the claims simply restate the claimed function, without any algorithm as to how the molecular formula and the isotope abundance ratio is used to calculate the theoretical mass spectrum. Even in figure 3 only the result of the calculation is shown without any discussion as to how the two variables are used to calculate the theoretical mass spectrum. Moreover, MPEP 2161.01 (I) recites:
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved"). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made.
Here, while the specification does disclose a computer (i.e. generic CPU), the specification does not provide an algorithm to demonstrate that the applicant had possession of the computer and algorithm, therefore claim 1 fails to meet the written description requirement under 35 USC § 112(a).
Moreover, claim 1 lacks written description for “wherein in the determination, the processor compares the degree of matching…with a first threshold and a second threshold larger than the first threshold, determines that the component to be analyzed is absent when the degree of matching is smaller than the first threshold, and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold”
Specifically, thresholds are only disclosed in paragraph [0037] which states that the threshold is determined in advance. However, the specification is silent as to how the first and second threshold are determined. Therefore, this is a desired result of determining the absence or presence of a component by comparing a degree of matching to a threshold, when there is no disclosure as to how to (pre)determine the claimed threshold. Since the controller sets the first threshold and the second threshold, there must be some conditions to be met in setting the first/second thresholds order for the result of absence (i.e. lower than first threshold) and presence (i.e. higher than the second threshold) to be determined. Since there is no disclosure of by what algorithm, the thresholds are predetermined or set, the claim fails to meet the written description requirement by requiring a result with no disclosure as to how the entire result may be achieved (i.e. without the disclosure of how to determine or set the thresholds making the claimed determination, there is no support for the claimed comparison).
Claims 2, 6 and 10-12 fail to meet the written description requirement by virtue of their dependencies on independent claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 6 and 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. MPEP 2106 (III) provides the flow chart for determining whether a claim satisfies the criteria for subject matter eligibility. The analysis below shows the claims fail to meet the eligibility requirements.
The broadest reasonable interpretation of claim 1 is:
A mass spectrometry method using a mass spectrometer, the mass spectrometry method comprising:
ionizing, by a preprocessing unit of the mass spectrometer, a measurement target;
Ionization occurs by a known ionization devices, examples enumerated in paragraph [0023], which are all understood to be well understood routine and conventional.
detecting, by a mass detection unit of the mass spectrometer, a mass of ionized ions and the number of ions in each mass;
mass detection unit described as a “known” mass analyzer [0024] thus is well understood routine and conventional
calculating, by a processor, a first mass spectrum of the measurement target on the basis of a detection result of the mass detection unit;
[0031] teaches that the control unit measures a measurement target and acquires a mass spectrum by receiving an input of the detection signal to obtain the mass spectrum with the mass as a horizontal axis and the ion intensity as a vertical axis (i.e. a mathematical concept)
calculating, by the processor, a degree of matching by comparing a theoretical mass spectrum and the first mass spectrum, for only a mass in which a peak of the theoretical mass spectrum exists; and
[0033]-[0035] teach the degree of matching may be via a correlation coefficient (i.e. mathematical concept)
determining, by the processor and on the basis of the degree of matching, presence or absence of the component to be analyzed in the measurement target.
[0037] teaches this may be done by comparing the degree of matching to a threshold (i.e. mathematical concept).
operating, by the processor, the preprocessing unit and the mass detection unit in a state where the measurement target is absent;
calculating, by the processor, a second mass spectrum upon determining the measurement target is absent on the basis of the detection result of the mass detection unit; and
subtracting, by the processor, the second mass spectrum from the first mass spectrum of the measurement target before calculating the decree of matching, and
correcting, by the processor, a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing units
wherein in the determination, the control unit compares the degree of matching with a first threshold and a second threshold larger than the first threshold, determines that the component to be analyzed is absent when the decree of matching is smaller than the first threshold, and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold.
All performed by control unit according to flow chart of figure 5 and discussion in paragraph [0042]—steps are a mathematical concept applied to a computer and the mass spectrometer is well understood.
Step 1: is the claim to a process, machine, manufacture or composition of matter?
Yes, a process.
Step 2A: prong one: does the claim recite an abstract idea?
Yes. Claim 1 recites a number of calculation steps including:
calculating…a first mass spectrum on the basis of a detection result of the mass detection unit;
calculating…a degree of matching by comparing a theoretical mass spectrum and the first mass spectrum, for only a mass in which a peak of the theoretical mass spectrum exists; and
determining…and on the basis of the degree of matching, presence or absence of the component to be analyzed in the measurement target.
calculating,…a second mass spectrum when the measurement target is absent on the basis of the detection result of the mass detection unit; and
subtracting… the second mass spectrum from the first mass spectrum before calculating the decree of matching,
wherein in the determination… compares the degree of matching, by comparing the theoretical mass spectrum and the first mass spectrum, with a first threshold and a second threshold larger than the first threshold,
determines that the component to be analyzed is absent when the decree of matching is smaller than the first threshold, and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold
and wherein the processor calculates the degree of matching on the basis of an average ion intensity within a range of a predetermined width of the first mass spectrum.
MPEP 2106.04(a) enumerates mathematical concepts as abstract ideas. As discussed above, each of the calculation steps are understood in light of the specification to be mathematical concepts.
Step 2A: prong two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. Claim 1 requires an ionization unit and detection unit. As admitted in the applicants own disclosure each of these elements are known. Therefore, these elements do not amount to significantly more than an abstract idea (i.e. they are well understood, routine and conventional). Moreover, the ionization and detection unit/mass spectrometer are used only for the purpose to gather data to be compared to the theoretical spectra calculated by the controller. MPEP 2106.05(b)(III) recites “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more.” Therefore, since the claim only uses the ionization source/detection unit to gather spectra for the controller, these components do not amount to significantly more.
While claim 1 requires a processor, the processor amounts to nothing more than mere instructions to implement the abstract idea on a computer. MPEP 2106.05(f) recites:
For claim limitations that do not amount to more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners should explain why they do not meaningfully limit the claim in an eligibility rejection. For example, an examiner could explain that implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
Here, the processor is merely used to perform the calculations and determinations directed towards an abstract idea on a generic computer and does not integrate the abstract idea into a practical application. Note “by a processor” is equivalent to “apply it”.
Lastly, note—the disclosed improvement is towards qualitative analysis, which is an abstract idea. Improvement to an abstract idea is not an improvement towards a technological field (see further discussion in response to arguments section above)
Step 2: Does the claim recite additional elements that amount to significantly more than the judiciary exception?
No. As discussed above the ionization unit/detection unit amount to insignificant extra activity because they merely gather data upon which the controller performs calculations. Moreover, the ionization/detection unit as evidenced by the applicant’s disclosure are known, thus well understood, routine and conventional. The addition of a control unit does not amount to significantly more in combination with the ionization/detection unit or individually without because the control unit is merely a means of implementing instructions to perform calculations.
Therefore claim 1 fails to meet the patent eligibility requirements under 35 USC § 101.
Claims 2, 6 and 10-12 either further limit the abstract idea or steps of the processor performs or require the component to be analyzed. However neither of these amount to significantly more, therefore these claims also fail to meet the eligibility requirement for the same reasons as claim 1 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, 2, 6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sakuta (US pgPub 2019/0025174) in view of Kawamura (submitted with IDS of 12/27/2022, copy of machine translation submitted with the office action of 04/24/2025) in view of Wildgoose (US pgPub 20160013036).
Regarding claim 1, Sakuta teaches a mass spectrometry method using a mass spectrometer, the mass spectrometry method (inherent in the apparatus of figure 6) comprising:
ionizing, by a preprocessing unit of the mass spectrometer, a measurement target (inherent to ion source 50);
detecting, by a mass detection unit of the mass spectrometer, a mass of ionized ions and the number of ions in each mass (inherent to mass spectrometry);
calculating, by a processor, a first mass spectrum of the measurement target on the basis of a detection result of the mass detection unit (fig. 7, see paragraph [0077]);
calculating, by the processor, a degree of matching by comparing a predetermined theoretical mass spectrum and the first mass spectrum, for only a mass in which a peak of the theoretical mass spectrum exists ([0080] comparing multiple peaks of mass spectrum N with theoretical peak T (i.e. only compare for a peak of the theoretical mass spectrum that exists));
determining, by the processor and on the basis of the degree of matching, a presence or absence of the component to be analyzed in the measurement target ([0088]-[0089]);
wherein in the determination, the processor compares the degree of matching, by comparing the theoretical mass spectrum and the first mass spectrum ([0011]-[0012] and [0015], note both comparisons uses the theoretical and first mass spectrum to determine matching degree), with a first threshold ([0012]) and a second threshold ([0016]) larger than the first threshold ([0092] teaches the matching degree is equal to or greater than the first threshold presence of DBDE is determined, paragraph [0094] teach the reliability of the presence may be set by comparing the sum of the intensities with the second threshold value suggesting a higher threshold to determine reliability over the first threshold which only determine presence), determines that the component to be analyzed is absent when the decree of matching is smaller than the first threshold ([0092] presence is only determined if equal or greater, thus smaller suggests absence), and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold ([0096] and [0016] equal to or larger than second threshold reliably indicates presence)
and wherein the processor calculates the degree of matching on the basis of an average ion intensity within a range of a predetermined width of the first mass spectrum ([0097]).
Sakuta fails to disclose operating, by the processor, the preprocessing unit and the mass detection unit in a state where the measurement target is absent; calculating, by the control unit, a second mass spectrum when the measurement target is absent on the basis of the detection result of the mass detection unit; and subtracting, by the control unit, the second mass spectrum from the first mass spectrum before calculating the degree of matching.
However, Kawamura teaches operating, by the processor, the preprocessing unit and the mass detection unit in a state where the measurement target is absent; calculating, by the processor, a second mass spectrum upon determining when the measurement target is absent on the basis of the detection result of the mass detection unit; and subtracting, by the control unit, the second mass spectrum from the first mass spectrum before calculating the degree of matching ([0017]-[0020]).
Kawanmura modifies Sakuta by suggesting analysis of a blank sample for creation of background spectrum and subtracting that spectrum from original spectrum.
Since both inventions are directed towards creating a spectrum via a mass spectrometer, it would have been obvious to one of ordinary skill in the art to create a background spectrum and subtract it from the original spectrum of each of the primary references because it would reduce the influence of background, therefore improving the signal to noise and reducing improperly identifying a target compound.
The combined device differs from the claimed invention by not disclosing correcting by the processor a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing unit.
However, Wildgoose teaches correcting by the processor a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing unit ([0005] teaches adding a known lockmass and determining a m/z, if the m/z of the lockmass is shifted (i.e. from known m/z value) adjustments are applied globally to the measured mass to charged ratios, thus correcting a mass of the lockmass and all ions measured).
Wildgoose modifies the combined device by suggesting a lockmass to be used for calibrating a m/z spectrum.
Since both inventions are directed towards creating a spectrum via a mass spectrometer, it would have been obvious to one of ordinary skill in the art to add the lockmass periodically to the measured spectrum because it would enable correction of any shift due to a miscalibrated mass spectrometer.
Regarding claim 2, Sakuta teaches wherein the component to be analyzed is an organic halogen compound ([0078] DBDE comprising bromine atoms (i.e. halogen)), and wherein in calculating the theoretical mass spectrum, the processor calculates, on the basis of a molecular formula of the organic halogen compound (10 bromine atoms, thus based on molecular formula, [0078]) and an isotope abundance ratio of halogen ([0078], 1:1 of isotopes), masses of y + 1 types of isotopes of the organic halogen compound (figure 8 and [0078] shows m/z of isotopes) and an abundance ratio of the organic halogen compound for each mass ([0078]), for each of combinations of the number of carbon atoms x and the number of halogen atoms y of the organic halogen compound (for the combination of carbon and bromine in the DBDH).
Regarding claim 6, Sakuta teaches wherein the control unit calculates the degree of matching by using a correlation coefficient of the number of ions of the mass in which the peak exists ([0080]-[0081]).
Regarding claim 11, Sakuta teaches wherein the component to be analyzed is an organic bromine compound ([0078]).
Regarding 12, Sakuta teaches wherein an ionization method of the preprocessing unit is atmospheric pressure chemical ionization method ([0063])
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yao (JP2013231715) (submitted with IDS of 12/27/2022) in view of Kawamura (submitted with IDS of 12/27/2022, copy of machine translation submitted with the office action of 04/24/2025) in view of Wildgoose (US pgPub 20160013036) and further in view of Sakuta (US pgPub 2019/0025174).
Regarding claim 1, Yao teaches a mass spectrometry method using a mass spectrometer (fig. 3), the mass spectrometry method comprising:
ionizing, by a preprocessing unit of the mass spectrometer, a measurement target (inherent to mass spectrometry);
detecting, by a mass detection unit of the mass spectrometer, a mass of ionized ions and the number of ions in each mass (inherent to mass spectrometry);
calculating, by a processor, a first mass spectrum of the measurement target on the basis of a detection result of the mass detection unit ([0026] profile spectrum data collected by mass analyzer supplied to the target peak setting unit creates a mass spectrum requiring a processor);
calculating, by the processor, a degree of matching by comparing a predetermined theoretical mass spectrum and the first mass spectrum ([0032] degree of fitting between theoretical isotope distribution and profile spectrum, theoretical isotope distribution predetermined (i.e. determined prior to fitting) see paragraph [0024] C)), for only a mass in which a peak of the theoretical mass spectrum exists ([0032] fit performed over predetermined m/z of profile data to theoretical isotope distribution, thus a mass in which a peak exists in the theoretical mass spectrum is evaluated in the degree of fitting in the comparison of two spectrums); and
determining, by the processor and on the basis of the degree of matching, presence or absence of the component to be analyzed in the measurement target ([0032]).
Yao fails to disclose operating, by the processor, the preprocessing unit and the mass detection unit in a state where the measurement target is absent; calculating, by the control unit, a second mass spectrum when the measurement target is absent on the basis of the detection result of the mass detection unit; and subtracting, by the control unit, the second mass spectrum from the first mass spectrum before calculating the degree of matching.
However, Kawamura teaches operating, by the processor, the preprocessing unit and the mass detection unit in a state where the measurement target is absent; calculating, by the processor, a second mass spectrum upon determining when the measurement target is absent on the basis of the detection result of the mass detection unit; and subtracting, by the control unit, the second mass spectrum from the first mass spectrum before calculating the degree of matching ([0017]-[0020]).
Kawanmura modifies Yao by suggesting analysis of a blank sample for creation of background spectrum and subtracting that spectrum from original spectrum.
Since both inventions are directed towards creating a spectrum via a mass spectrometer, it would have been obvious to one of ordinary skill in the art to create a background spectrum and subtract it from the original spectrum of each of the primary references because it would reduce the influence of background, therefore improving the signal to noise and reducing improperly identifying a target compound.
The combined device differs from the claimed invention by not disclosing correcting by the processor a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing unit.
However, Wildgoose teaches correcting by the processor a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing unit ([0005] teaches adding a known lockmass and determining a m/z, if the m/z of the lockmass is shifted (i.e. from known m/z value) adjustments are applied globally to the measured mass to charged ratios, thus correcting a mass of the lockmass and all ions measured).
Wildgoose modifies the combined device by suggesting a lockmass to be used for calibrating a m/z spectrum.
Since both inventions are directed towards creating a spectrum via a mass spectrometer, it would have been obvious to one of ordinary skill in the art to add the lockmass periodically to the measured spectrum because it would enable correction of any shift due to a miscalibrated mass spectrometer.
The combined device differs from the claimed invention by not disclosing wherein in the determination, the processor compares the degree of matching with a first threshold and a second threshold larger than the first threshold, determines that the component to be analyzed is absent when the degree of matching is smaller than the first threshold, and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold.
However, Sakuta teaches wherein in the determination, the processor compares the degree of matching with a first threshold ([0012]) and a second threshold ([0016]) larger than the first threshold ([0092] teaches the matching degree is equal to or greater than the first threshold presence of DBDE is determined, paragraph [0094] teach the reliability of the presence may be set by comparing the sum of the intensities with the second threshold value suggesting a higher threshold to determine reliability over the first threshold which only determine presence), determines that the component to be analyzed is absent when the decree of matching is smaller than the first threshold ([0092] presence is only determined if equal or greater, thus smaller suggests absence), and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold ([0096] and [0016] equal to or larger than second threshold reliably indicates presence) and wherein the processor calculates the degree of matching on the basis of an average ion intensity within a range of a predetermined width of the first mass spectrum ([0097]).
Sakuta modifies the combined device by suggesting a thresholding of the fitting of the combined device (i.e. degree of matching).
Since both inventions are directed towards determining the presence or absence of peaks, it would have been obvious to one of ordinary skill in the art to apply the thresholding to the fitting of the combined device because it would allow the user to reliably and easily determine the presence or absence of a sample.
Regarding claim 6, Yoa teaches wherein the control unit calculates the degree of matching by using a correlation coefficient of the number of ions of the mass in which the peak exists ([0034] the signal intensity values correspond to the number of ions).
Claim 1-2 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Oki (JP2010066036) (submitted with IDS of 12/27/2022) in view of Kawamura (submitted with IDS of 12/27/2022, copy of machine translation submitted with the office action of 04/24/2025) in view of Wildgoose and further in view of Sakuta (US pgPub 2019/0025174).
Regarding claim 1, Oki teaches a mass spectrometry method using a mass spectrometer (fig. 1), the mass spectrometry method comprising:
ionizing, by a preprocessing unit of the mass spectrometer, a measurement target (inherent to mass spectrometry);
detecting, by a mass detection unit of the mass spectrometer, a mass of ionized ions and the number of ions in each mass (inherent to mass spectrometry);
calculating, by the control unit, a first mass spectrum on the basis of a detection result of the mass detection unit (figure 3 and paragraph [0021]);
calculating, by the control unit, a degree of matching by comparing a predetermined theoretical mass spectrum and the first mass spectrum ([0022]-[0023], note the closest peak shape, thus a degree of matching b comparison), for only a mass in which a peak of the theoretical mass spectrum exists ([0022]-[0023] note mass number 351); and
determining, by the control unit and on the basis of the degree of matching, presence or absence of the component to be analyzed in the measurement target ([0023] presence of chlorine atoms can be y=6, alternatively see paragraph [0030]).
Oki fails to disclose operating, by the control unit, the preprocessing unit and the mass detection unit in a state where the measurement target is absent; calculating, by the control unit, a second mass spectrum when the measurement target is absent on the basis of the detection result of the mass detection unit; and subtracting, by the control unit, the second mass spectrum from the first mass spectrum before calculating the degree of matching.
However, Kawamura teaches operating, by the control unit, the preprocessing unit and the mass detection unit in a state where the measurement target is absent; calculating, by the control unit, a second mass spectrum when the measurement target is absent on the basis of the detection result of the mass detection unit; and subtracting, by the control unit, the second mass spectrum from the first mass spectrum before calculating the degree of matching ([0017]-[0020]).
Kawanmura modifies Oki by suggesting analysis of a blank sample for creation of background spectrum and subtracting that spectrum from original spectrum.
Since both inventions are directed towards creating a spectrum via a mass spectrometer, it would have been obvious to one of ordinary skill in the art to create a background spectrum and subtract it from the original spectrum of each of the primary references because it would reduce the influence of background, therefore improving the signal to noise and reducing improperly identifying a target compound.
The combined device differs from the claimed invention by not disclosing correcting by the processor a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing unit.
However, Wildgoose teaches correcting by the processor a mass of the first mass spectrum in accordance with one or more ions added in an ionization reaction in the preprocessing unit ([0005] teaches adding a known lockmass and determining a m/z, if the m/z of the lockmass is shifted (i.e. from known m/z value) adjustments are applied globally to the measured mass to charged ratios, thus correcting a mass of the lockmass and all ions measured).
Wildgoose modifies the combined device by suggesting a lockmass to be used for calibrating a m/z spectrum.
Since both inventions are directed towards creating a spectrum via a mass spectrometer, it would have been obvious to one of ordinary skill in the art to add the lockmass periodically to the measured spectrum because it would enable correction of any shift due to a miscalibrated mass spectrometer.
The combined device differs from the claimed invention by not disclosing wherein in the determination, the control unit compares the degree of matching with a first threshold and a second threshold larger than the first threshold, determines that the component to be analyzed is absent when the decree of matching is smaller than the first threshold, and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold.
However, Sakuta teaches wherein in the determination, the control unit compares the degree of matching with a first threshold ([0012]) and a second threshold ([0016]) larger than the first threshold ([0092] teaches the matching degree is equal to or greater than the first threshold presence of DBDE is determined, paragraph [0094] teach the reliability of the presence may be set by comparing the sum of the intensities with the second threshold value suggesting a higher threshold to determine reliability over the first threshold which only determine presence), determines that the component to be analyzed is absent when the decree of matching is smaller than the first threshold ([0092] presence is only determined if equal or greater, thus smaller suggests absence), and determines that the component to be analyzed is present when the degree of matching is equal to or larger than the second threshold ([0096] and [0016] equal to or larger than second threshold reliably indicates presence)
and wherein the processor calculates the degree of matching on the basis of an average ion intensity within a range of a predetermined width of the first mass spectrum ([0097]).
Sakuta modifies the combined device by suggesting a thresholding of the fitting of the combined device (i.e. degree of matching).
Since both inventions are directed towards determining the presence or absence of peaks, it would have been obvious to one of ordinary skill in the art to apply the thresholding to the fitting of the combined device because it would allow the user to reliably and easily determine the presence or absence of a sample.
Regarding claim 2, Oki teaches wherein the component to be analyzed is an organic halogen compound, and in calculating the theoretical mass spectrum, the control unit calculates, on the basis of a molecular formula of the organic halogen compound and an isotope abundance ratio of halogen, masses of y + 1 types of isotopes of the organic halogen compound and an abundance ratio of the organic halogen compound for each mass, for each of combinations of the number of carbon atoms x and the number of halogen atoms y of the organic halogen compound (fig. 2a-2c show y=5, 6, 7 respectively, thus y+1 and based on a molecular formula and abundance ratio of organic halogen for each mass see paragraphs [0016]-[0019]).
Regarding claim 10, Oki teaches wherein the component to be analyzed is an organic chlorine compound ([0031]).
Regarding claim 11, Oki teaches wherein the component to be analyzed is an organic bromine compound. ([0033])
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881