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 September 1, 2026 has been considered.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 1, 2026 has been entered.
Drawings
The drawings filed on March 5, 2026 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 12 is objected to because of the following informalities: claim 12, “and” (line 8) should be deleted. Appropriate correction is required.
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 6 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.
Claims 6 and 21, “all” is indefinite since it does not represent 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.
Reasons For Allowance
The following is an examiner’s statement of reasons for allowance:
The combination as claimed wherein a method of analysis of mass spectrometry data comprising performing a second deconvolution of the raw experimental mass spectrometry data using a deconvolution algorithm and a parameter set that excludes peaks determined to be likely artefacts to obtain a second deconvolved output (claims 1, 19) is not disclosed, suggested, or made obvious by the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed on September 1, 2026 have been fully considered.
With respect to the drawing objection, Applicants argue “that Fig. 5, as filed, contains lines, numbers, and letters that are sufficiently clear, legible, and durable to permit adequate reproduction, and that the numbers and letters therein are of a size that is legible upon reproduction. Applicant respectfully notes that the Office withdrew the corresponding objections to Figs. 3, 4, and 6, which contain data of a substantially similar character, scale, and density as Fig. 5.”
Examiner’s position is that while the lines, numbers, and letters in Figs. 3, 4, and 6 are of poor quality, they are legible. However, many of the letters and numbers of Fig. 5 are not legible.
Applicant’s arguments and amendment with respect to the claim objection have been fully considered and are persuasive. The claim objection has been withdrawn.
Applicant’s arguments and amendment with respect to the rejection under 35 USC 112(a) have been fully considered and are persuasive. The rejection under 35 USC 112(a) has been withdrawn.
Applicant’s arguments and amendment with respect to the rejection under 35 USC 112(b) pertaining to “an artefact … not an artefact” have been fully considered and are persuasive. The rejection under 35 USC 112(b) pertaining to “an artefact … not an artefact” has been withdrawn.
With respect to the rejection under 35 USC 112(b) pertaining to “all”, Applicants argue “[t]he claim does not require the skilled person to ascertain a specific number of m/z values. Rather, the claim requires only that a condition be satisfied for every m/z value in the suspect simulated raw discrete data, i.e., that no m/z value of the suspect simulated raw discrete data falls outside the m/z values of the reference simulated raw discrete data. A person of ordinary skill in the art need not know "how many" m/z values exist in the set; the person need only determine whether any m/z value does not satisfy the stated condition. If even one m/z value of the suspect simulated raw discrete data is not within the m/z values of the reference simulated raw discrete data, the condition of "all" is not met. This is a straightforward and well-understood logical evaluation that does not require knowledge of the total number of m/z values. The scope of the claims is clear and definite.”
Examiner’s position is that “all” refers to “the [number of] the m/z values” (claim 6, line 2) or to “the [number of] the suspect simulated raw data” (claim 21, lines 3-4). If “the number of the m/z values” (claim 6, line 2) or “the number of the suspect simulated raw data” is not specified, “all” is not definite. Accordingly, examiner suggests an amendment, e.g., to delete “all” or to specify “the number of the m/z values” (claim 6, line 2) or “the number of the suspect simulated raw data” so “all” can be definite.
With respect to the rejection under 35 USC 101, Applicants argue “[a]s amended, claim 1 now recites performing a second deconvolution of the raw experimental mass spectrometry data using a deconvolution algorithm and a parameter set that excludes peaks determined to be likely artefacts to obtain a second deconvolved output. This added step applies the results of the preceding artefact-determination steps to produce a technologically improved deconvolved output from which artefact peaks have been excluded, thereby providing a concrete technical improvement to the functioning of mass spectrometry data analysis.”
Examiner’s position is that amended claims 1 and 19 do not apply the results of the preceding artefact-determination steps. Amended claims 1 and 19 recite “performing a second deconvolution of the raw experimental mass spectrometry data using … a parameter set that excludes peaks determined to likely artefacts to obtain a second deconvolved output. However, the amended claims do not recite “performing a second deconvolution of the raw experimental mass spectrometry data using … the determined second peak to be likely an artefact”. Thus, the abstract idea (i.e., the determined second peak) is not applied in a meaningful way. It is noted that “to obtain a second deconvolved output” may be just an intended use. Further the second deconvolved output does not exclude an artefact.
Applicants further argue the amended claims provide a concrete technological improvement to the functioning of mass spectrometry data analysis.
Examiner’s position is that an argument that the claims are direct to a technological improvement must comply with MPEP 2106.05(a). Pursuant to MPEP 2106.05(a), “[a]n indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.”
Applicants have not identified a technical problem in the specification and have not explained in the specification an unconventional technical solution expressed in the claim.
Accordingly, the claims are not directed to a technological improvement pursuant to MPEP 2106.05(a).
Applicant’s amendment with respect to the rejections under 35 USC 103 have been fully considered and are persuasive. The rejections under 35 USC 103 have been withdrawn.
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 September 29, 2026
