DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed on March 5, 2026 has been considered.
Drawings
The drawings filed on August 3, 2023 are not acceptable because:
1/ Lines, numbers, and letters are of poor quality, 37 CFR 1.84(l): See Fig. 5.
2/ Numbers and letters are small, 37 CFR 1.84(p)(3): See Fig. 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 17 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 17 has not been further treated on the merits.
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 1-16 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, “determining whether the second peak is likely an artefact and not indicative of a mass or indicative of a mass and not an artefact” is not described in the original disclosure. Instead, page 1, line 38 of the specification discloses “determining whether the second peak is likely an artefact or indicative of a mass”.
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 1-16 and 21 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 pre-AIA the applicant regards as the invention.
Claim 1, “an artefact … not an artefact” is indefinite. Examiner interprets the limitation to read -- an artefact … or [[indicative of]] a mass and not indicative of an artefact --
Claims 6 and 21, “all” is indefinite since it does not recite a definite number. Examiner suggest deleting “all”.
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 1-16 and 19-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Pursuant to the 2019 Revised Patent Subject Matter Eligibility Guidance (MPEP 2106), the following analysis is made:
Under step 1 of the Guidance, the claims fall within a statutory category.
Under step 2A, prong 1, claims 1 and 19 recite an abstract idea of “performing a first deconvolution of the raw experimental mass spectrometry data using a deconvolution algorithm, a wide first input parameter set, and a wide first output parameter set to obtain a deconvolved output” (mathematical concept), “obtaining/identifying discrete peak data from the deconvolved output” (mental process), “simulating raw data for a first peak of the discrete peak data to obtain reference simulated raw discrete data” (mental process), “simulating raw data for a second peak of the discrete peak data to obtain suspect simulated raw discrete data” (mental process), “determining whether the second peak is likely an artefact or indicative of a mass by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data” (mental process, claim 1), “determining a co-efficient of overlap between the suspect simulated raw data and the reference simulated raw data” (mental process, claim 19); “determining whether the second peak is likely an artefact and not indicative of a mass or indicative of a mass and not an artefact by comparing the co-efficient of overlap to a predetermined threshold” (mental process, claim 19).
Under step 2A, prong 2, the claim limitations are not integrated into a practical application (MPEP 2106.04(d)(I)). Obtaining raw experimental mass spectrometry data is directed to an insignificant extra-solution activity (see MPEP 2106.05(g)).
Under step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea (MPEP 2106.05(A)).
Claims 2-16, 20, and 21 are directed to an abstract idea.
Accordingly, claims 1 and 19 and their respective dependent claims 2-16, 20, and 21 are patent ineligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Skilling et al. (US 2013/0200258) in view of Norton (US 2004/0113062).
Regarding claim 1, Skilling et al. discloses a computer-implemented method of analysis of mass spectrometry data (Abstract, lines 1-2; Title; paragraph 0022, lines 4-6; paragraph 0024) comprising:
obtaining raw experimental mass spectrometry data (Abstract, lines 1-2); performing a first deconvolution of the raw experimental mass spectrometry data using a deconvolution algorithm, a wide first input parameter set (at least one measured spectrum of data, claim 1, lines 3-4), and a wide first output parameter set (deconvoluted at least one measured spectrum of data, claim 1, line 5) to obtain a deconvolved output (Abstract, lines 4-6; claim 1, lines 6-7);
obtaining discrete peak data from the deconvolved output (paragraph 0005, lines 1-2);
simulating raw data to obtain reference simulated raw discrete data (mock data, paragraph 0040, lines 6-8);
simulating raw data to obtain suspect simulated raw discrete data (actual data used in calculation with mock data, paragraph 0040, lines 9-12).
Skilling et al. does not disclose simulating raw data for a first peak and second peak of the discrete peak data.
Norton discloses simulating raw data for a first peak and a second peak of the discrete peak data (plural peaks, defined by m/z, are selected from each data are set by automation, paragraph 0051, lines 5-7).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Skilling et al. with automation as suggested by Norton for the purpose of selecting plural peaks defined by m/z and retention times.
Skilling et al. further discloses determining whether a peak is likely indicative of a mass (determine peak is a function of mass, paragraph 0068). Skilling et al. discloses likely indication of mass and does not disclose likely indication of an artefact (determining likelihood of actual data, paragraph 0040, lines 10-12; actual data are about masses, paragraph 0040, lines 1-4, actual data is not disclosed to be induced artefact, see paragraph 0040; mass spectral data can be either naturally occurring variants or artificially induced artefacts, paragraph 0060, lines 1-6) by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data (implied by misfit between actual and mock data, paragraph 0040, lines 9-12; comparing underlying spectrum data with library of spectra, paragraph 0016). Accordingly, it would have been obvious to determine whether a peak is likely indicative of a mass and not an artefact.
It is noted that determining whether the second peak is likely an artefact and not indicative of a mass is an alternative limitation because it is recited in the alternative form.
Regarding claim 2, Skilling et al. discloses the first peak of the discrete peak data is the most intense peak of the discrete peak data (first peak is the most intense peak, Fig. 4).
Regarding claim 3, Skilling et al. discloses the second peak of the discrete peak data is the closest mass to the first peak of the discrete peak data (the second peak of the discrete peak data is the closest to the first peak, Fig. 4, the masses have their associated with intensities, paragraph 0040, line 4).
Regarding claim 4, Skilling et al. discloses comparing the suspect simulated raw discrete data with the reference simulated raw discrete data (implied by misfit between actual and mock data, paragraph 0040, lines 9-12; comparing underlying spectrum data with library of spectra, paragraph 0016).
Skilling et al. does not disclose comparing the suspect simulated raw discrete data with the reference simulated raw discrete data comprises comparing the m/z values of the suspect simulated raw discrete data with the m/z values of the reference simulated raw discrete data.
Norton discloses simulating raw data for a first peak and a second peak of the discrete peak data (plural peaks, defined by m/z, are selected from each data are set by automation, paragraph 0051, lines 5-7).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Skilling et al. with comparing the m/z values of the suspect simulated raw discrete data with the m/z values of the reference simulated raw discrete data as suggested by Norton for the purpose of comparing the suspect simulated raw discrete data with the reference simulated raw discrete data.
Regarding claim 6, the clam discloses “the second peak is identified as likely an artefact if all of the m/z values of the suspect simulated raw discrete data are within the m/z values of the reference simulated raw discrete data” is a contingent limitation (see MPEP 2111.04).
However, the claim does not require “all of the m/z values of the suspect simulated raw discrete data are within the m/z values of the reference simulated raw discrete data”. Thus, “the second peak is identified as likely an artefact” is not required.
Regarding claim 7, the clam discloses “the second peak is identified as likely indicative of a mass if an m/z value of the suspect simulated raw discrete data is not within the m/z values of the reference simulated raw discrete data” is a contingent limitation (see MPEP 2111.04).
However, the claim does not require “an m/z value of the suspect simulated raw discrete data is not within the m/z values of the reference simulated raw discrete data”. Thus, “the second peak is identified as likely indicative of a mass” is not required.
Regarding claim 8, Skilling et al. discloses the data is identified as likely indicative of a mass (paragraph 0040, lines 1-2; 11-13). However, while Skilling et al. does not expressly disclose once the second peak is identified as likely indicative of a mass, comparing the suspect simulated raw discrete data with the reference simulated raw discrete data is ceased. Norton discloses simulating raw data for a first peak and a second peak of the discrete peak data indicative of a mass (plural peaks, defined by m/z, are selected from each data are set by automation, paragraph 0051, lines 5-7). Thus, it would have been obvious to cease comparing the suspect simulated raw discrete data with the reference simulated raw discrete data since the comparing step is to identify a peak as likely indicative of a mass (Skilling et al., paragraph 0040, lines 1-2, 11-13, in view of Norton, paragraph 0051, lines 5-7).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Skilling et al. with a peak is identified as likely indicative of a mass as suggested by Norton for the purpose of ceasing comparing the suspect simulated raw discrete data with the reference simulated raw discrete data.
Regarding claim 9, Skilling et al. discloses the second peak is identified as likely indicative of a mass (calculate how likely the actual data were, paragraph 0040, lines 12-13, based on masses, paragraph 0040, lines 1-2). It would have been obvious to add the suspect simulated raw discrete data (actual data in calculation, paragraph 0040) to the reference simulated raw discrete data, since the suspect simulated raw discrete data is identified as the reference simulated raw discrete data (the actual data likely, paragraph 0040, lines 12-13, is the target, paragraph 0040, lines 1-2, or in the library of known spectra, paragraph 0016)
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Skilling et al. with the second peak is identified as likely indicative of a mass for the purpose of ceasing comparing the suspect simulated raw discrete data with the reference simulated raw discrete data, since the suspect simulated raw discrete data is identified as the reference simulated raw discrete data.
Regarding claim 10, Skilling et al. does not disclose simulating raw data for a further peak of the discrete peak data to obtain further suspect simulated raw discrete data; and determining whether the further peak is likely an artefact or indicative of a mass by comparing the further suspect simulated raw discrete data with the reference simulated raw discrete data.
Norton discloses simulating raw data for plural peaks of the discrete peak data (plural peaks, defined by m/z, are selected from each data are set by automation, paragraph 0051, lines 5-7).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Skilling et al. with automation as suggested by Norton for the purpose of selecting plural peaks defined by m/z and retention times.
Skilling et al. further discloses determining whether a peak is likely indicative of a mass (determine peak is a function of mass, paragraph 0068). Skilling et al. discloses likely indication of mass (determining likelihood of actual data, paragraph 0040, lines 10-12; actual data are about masses, paragraph 0040, lines 1-4) by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data (implied by misfit between actual and mock data, paragraph 0040, lines 9-12; comparing underlying spectrum data with library of spectra, paragraph 0016). Accordingly, it would have been obvious to determine whether a peak is likely indicative of a mass.
It is noted that determining whether the further peak is likely an artefact is an alternative limitation because it is recited in the alternative form
Prior Art Note
Claims 5, 11-16 and 19-21 do not have prior art rejections.
The combination as claimed wherein a method of analysis of mass spectrometry data comprising calculating the width of the theoretical isotope distribution at the charge state z of the m/z value under consideration (claim 5) or setting the smallest m/z value in the reference simulated raw discrete data above the input spectrum threshold percentage as a lower bound of the narrow second input parameter set; and/or setting the largest m/z value in the reference simulated raw discrete data above the input spectrum threshold percentage as an upper bound of the narrow second input parameter set (claim 11) or setting the smallest of the first peak, the second peak, and/or any further peak(s) determined to be indicative of a mass minus the offset value as a lower bound of the narrow second output parameter set; and/or setting the largest of the first peak, the second peak, and/or any further peak(s) determined to be indicative of a mass plus the offset value as an upper bound of the narrow second output parameter set (claim 15) or setting the first peak, the second peak, and/or any further peak(s) determined to be indicative of a mass plus and minus the offset value as included within the narrow second output parameter set (claim 16) or determining whether the second peak is likely an artefact or indicative of a mass by comparing the co-efficient of overlap to a predetermined threshold (claim 19) is not disclosed, suggested, or made obvious by the prior art of record.
Response to Arguments
Applicant's arguments filed on March 6, 2026 have been fully considered.
Applicant’s arguments and amendment with respect to the drawing objections of Figs. 3, 4, and 6 have been fully considered and are persuasive. The drawing objections of Figs. 3, 4, and 6 have been withdrawn.
However, Fig. 5 remains objected to as discussed above.
With regard to the claim objection, Applicants argue “claim 17 has been amended to overcome this objection and Applicant respectfully requests withdrawal of the present objection to claim 17”.
Examiner’s position is that amended claim 17 is a multiple dependent claim and should refer to other claims in the alternative only. Instead, claim 17 is recited to depend from claim 15 AND any one of claims 11 to 14 AND/or claim 15 or 16.
Applicant’s arguments and amendment with respect to the rejections under 35 USC 112(b) of claims 4 and 5 have been fully considered and are persuasive. The rejections under 35 USC 112(b) of claims 4 and 5 have been withdrawn.
However, with regard to the rejections under 35 USC 112(b) of claims 6 and 21, Applicants argue “[t]he term "all" is not required to recite a specific definite number; rather, it is a well-understood term of common usage meaning "every one of" the m/z values in the suspect simulated raw discrete data. The scope of "all" is clearly defined by the context in which it appears - it refers to the entirety of the m/z values within the suspect simulated raw discrete data set, which is itself a finite and determinable set of values generated by the simulating step recited in the claims. As described in the specification at paragraphs [0114]-[0115], the method involves evaluating whether each m/z value of the suspect simulated raw discrete data falls within the m/z values of the reference simulated raw discrete data, and the second peak is identified as likely an artefact only if every such m/z value is accounted for. A person of ordinary skill in the art would understand "all" in this context to mean that the condition must be satisfied for each and every m/z value in the suspect simulated raw discrete data, without ambiguity.”
Examiner’s position is that the entirety of the m/z values is not defined. How many m/z values are there? Thus, “all” is not defined. Accordingly, a person of ordinary skill in the art would not understand how many m/z values of the suspect simulated raw discrete data are within the m/z values of the reference simulated raw discrete data.
With regard to the rejections under 35 USC 101, Applicants argue “claim 1 does not recite any mathematical concept. Claim 1 does not recite any mathematical relationship, mathematical formula or equation, or mathematical calculation. Rather, claim 1 recites a method of analysis of mass spectrometry data comprising, inter alia, performing a first deconvolution of raw experimental mass spectrometry data to obtain a deconvolved output, obtaining discrete peak data from the deconvolved output, simulating raw data for first and second peaks to obtain reference and suspect simulated raw discrete data, and determining whether the second peak is likely an artefact or indicative of a mass by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data. None of these limitations recite a specific mathematical formula, equation, or relationship. The Examiner characterizes the "performing a first deconvolution" step as a "mathematical concept," but this step does not set forth any particular mathematical formula or equation, it recites the application of a deconvolution algorithm to specific physical data (raw experimental mass spectrometry data) using specific parameter sets to produce a specific result (a deconvolved output). At best, the claimed deconvolution step is merely based on or involves mathematical concepts, which is insufficient to establish that the claim recites a mathematical concept under the Guidance. See Thales Visionix, Inc. V. United States).”
Examiner’s position is that claim 1 recites “performing a first deconvolution of the raw experimental mass spectrometry data using a deconvolution algorithm, a wide first input parameter set, and a wide first output parameter set to obtain a deconvolved output”. In light of the specification, the deconvolution algorithm represents a math processing technique (see least-squares based techniques, page 6, line 35-36) between data (between wide first input and output parameters and deconvolved output). Accordingly, claim 1 recites a mathematical concept.
Applicants further argue “the limitations of claim 1 cannot practically be performed in the human mind. As described in the specification, raw experimental mass spectrometry data comprises plots of m/z against intensity spanning thousands of data points across wide mass-to-charge ranges (see, e.g., specification at paragraphs [0081]-[0082]).”
Examiner’s position is that the claim is broader than Applicants’ arguments. While the specification may disclose “raw experimental mass spectrometry data comprises plots of m/z against intensity spanning thousands of data points across wide mass-to-charge ranges”, “raw experimental mass spectrometry data comprises plots of m/z against intensity spanning thousands of data points across wide mass-to-charge ranges” is not recited in the claims.
Applicants further argue “[p]erforming a deconvolution of such raw experimental mass spectrometry data using a deconvolution algorithm with a wide first input parameter set and a wide first output parameter set requires iterative computational processing of vast quantities of numerical data that is far beyond the capability of the human mind.”
As discussed above, “performing a deconvolution of such raw experimental mass spectrometry data using a deconvolution algorithm …” is directed to an abstract idea, because the limitation recites a mathematical concept (i.e., a deconvolution algorithm).
Applicants further argue “simulating raw data for a first peak and a second peak of the discrete peak data to obtain reference and suspect simulated raw discrete data requires generating synthetic mass spectrometry datasets comprising numerous m/z and intensity value pairs across multiple charge states, which is not an operation that a human mind could practically perform.”
Examiner’s position is that, again, the claim is broader than Applicants’ arguments. The limitation of “simulating raw data for a first peak and a second peak of the discrete peak data to obtain reference and suspect simulated raw discrete data requires generating synthetic mass spectrometry datasets comprising numerous m/z and intensity value pairs across multiple charge states” is not recited in the claims. The limitation is broadly interpreted as analyzing data for a first peak and a second peak. Accordingly, the limitation is directed to a mental process because it requires a data analysis.
Applicants further argue “determining whether the second peak is likely an artefact or indicative of a mass by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data involves systematic comparison of the m/z values across these large simulated datasets, including calculating the width of theoretical isotope distributions at given charge states. These operations involve processing and comparing voluminous numerical datasets that are well beyond the practical capability of the human mind. Accordingly, claim 1 does not recite a mental process.”
Examiner’s position is that, again, the claim is broader than Applicants’ arguments. The limitation of “determining whether the second peak is likely an artefact or indicative of a mass by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data involves systematic comparison of the m/z values across these large simulated datasets” is not recited in the claims. Rather, claim 1 recites “determining whether the second peak is likely: an artefact and not indicative of a mass, or indicative of a mass and not an artefact comparing the suspect simulated raw discrete data with the reference simulated raw discrete data”. The limitation requires data analysis. Accordingly, the limitation is directed to an abstract idea.
Applicants further argue "[d]econvolution algorithms may produce artefacts in deconvolved outputs, particularly when non- ideal settings are used to decrease processing time or because of uncertainty in the content of the data. A typical artefact is a peak in the deconvolved output of mass against intensity indicative of a mass of an analyte, when the analyte is not present in the sample analysed." … In contrast, the computer-implemented method recited in claim 1 provides an improvement to the computer functionality compared to these prior art methods by comparing suspect simulated raw discrete data with reference simulated raw discrete data to determine whether a peak is an artefact or not. This, in turn, avoids incorrectly identifying an analyte during sample analysis. Determining whether the second peak is an artefact or indicative of a mass, and repeating the method of analysis for further peaks, allows a full deconvolved spectrum to be produced that excludes artefacts. The number of analytes, and their real masses, present in a sample can be reliably determined (see page 6 lines 29-35, page 12 lines 22-34, and page 13 line 36 to page 14 line 5 of the PCT application).”
Examiner’s position is that the technical solution of “repeating the method of analysis for further peaks, allows a full deconvolved spectrum to be produced that excludes artefacts is not recited in the claims. Thus, the claims do not recite an unconventional technical solution to the prior technical problem of the prior deconvolution algorithms producing artefacts. Accordingly, the claims are not directed to a technological improvement.
Applicants further argue “[t]he Office characterizes "obtaining raw experimental mass spectrometry data" as insignificant extra-solution activity. Applicant respectfully submits that this characterization is in error. Unlike the examples of pre-solution data gathering described in MPEP 2106.05(g), such as obtaining credit card transaction information for use in a fraud detection process, the step of obtaining raw experimental mass spectrometry data in claim 1 is not merely incidental or tangential to the claimed method. Rather, obtaining raw experimental mass spectrometry data is integral to the claimed invention because the raw experimental mass spectrometry data is the specific physical data upon which every subsequent step of the claimed method operates. It is the data that is deconvolved using the deconvolution algorithm with wide parameter sets to obtain the deconvolved output, from which discrete peak data is obtained, and from which simulated raw data is generated for the first and second peaks. Thus Applicant respectfully submits no limitation of claim 1 is insignificant extra-solution activity.”
Examiner’s position is that, again, the claim is broader than Applicants’ arguments. Claim 1 merely recites “obtaining raw experimental mass spectrometry data”. Someone reading raw experimental mass spectrometry data from a sheet of paper can be interpreted as “obtaining raw experimental mass spectrometry data”. Accordingly, “obtaining raw experimental mass spectrometry data” is directed to an insignificant extra-solution of data gathering (MPEP 2106.05(g)).
Applicants further argue “claim 1 recites an ordered combination of steps that, taken together, constitute a non-conventional and non-generic arrangement”.
Examiner’s position is that, as discussed above, claim 1 is directed to an abstract idea (step 2A, prong 1), is not integrated into a practical solution (step 2A, prong 2), and is not significantly more (step 2B). Further, claim 1 is disclosed by Skilling et al. in view of Norton, as discussed above.
With regard to the rejections under 35 USC 103, Applicants argue “Skilling (or Norton) does not disclose or suggest determining whether a second peak in a deconvolved output is likely an artefact and not indicative of a mass, or indicative of a mass and not an artefact.”
Examiner’s position is discussed above. Skilling et al. discloses
determining whether the second peak is likely indicative of a mass and not an artefact (determining likelihood of actual data, paragraph 0040, lines 10-12; actual data are about masses, paragraph 0040, lines 1-4, actual data is not disclosed to be induced artefact, see paragraph 0040; mass spectral data can be either naturally occurring variants or artificially induced artefacts, paragraph 0060, lines 1-6) by comparing the suspect simulated raw discrete data with the reference simulated raw discrete data (implied by misfit between actual and mock data, paragraph 0040, lines 9-12; comparing underlying spectrum data with library of spectra, paragraph 0016).
It is noted that determining whether the second peak is likely an artefact and not indicative of a mass is an alternative limitation because it is recited in the alternative form.
Applicant’s remaining arguments have been considered but are traversed in view of the discussions and grounds of rejection above.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Nghiem whose telephone number is (571) 272-2277. The examiner can normally be reached on M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached at (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAEL P NGHIEM/Primary Examiner, Art Unit 2857 May 25, 2026
Prosecution Insights