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 .
Claim Objections
Claims 16 and 17 are objected to because of the following informalities: “comprises from” should read as “comprises.”
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 6-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 6: Claim 6 recites the limitation "the ionization agent." There is insufficient antecedent basis for this limitation in the claim.
Claims 7 and 8 are rejected due to their dependency on claim 6.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Ra et al. (US 20150351662 A1) (hereinafter – Ra).
Re. Claim 1: Ra teaches a method comprising assaying a breath sample from a subject for the presence of Per-and Polyfluoroalkyl Substances (PFAS) (Paragraph 0008: cancer diagnosis via volatile organic compound (VOC) analysis in exhaled breath; Paragraph 0012: “… the method comprising measuring whether a cancer-specific VOC selected from the group consisting of perfluorodecanoic acid, perfluoro-n-pentanoic acid, perfluorononanoic acid, perfluorooctanoic acid, perfluoro-1-heptene, perfluorocyclohexane, 1H,1H-perfluoro-1-heptanol octafluorocyclobutane and perfluoro(methylcyclohexane) is present in exhaled breath gas collected from a patient suspected of having cancer”).
Re. Claim 16: Ra teaches the invention according to claim 1. Ra further teaches the invention wherein the breath sample comprises from 1 to 20 exhaled breaths (Paragraph 0076: “As exhaled breath, an alveolar breath portion was sampled… The exhaled breath collected in the breath sampling bag;” Paragraph 0077: “100 mL of the exhaled breath sample from each of the breast cancer patients and the healthy control group was trapped in an index syringe and adsorbed;” Examiner notes that such citations indicate that Ra obtains at least one breath as a sample).
Re. Claim 17: Ra teaches the invention according to claim 1. Ra further teaches the invention wherein the breath sample comprises from 1 to 5 exhaled breaths (see citation of rejection of claim 16).
Re. Claim 18: Ra teaches the invention according to claim 1. Ra further teaches the invention wherein one or more PFAS is selected from the group consisting of Perfluorobutanoic acid (PFBA), Perfluoropentanoic acid (PFPeA), Perfluorohexanoic acid (PFHxA), Perfluoroheptanoic acid (PFHpA), Perfluorooctanoic acid (PFOA), Perfluorononanoic acid (PFNA), Perfluorodecanoic acid (PFDA), Perfluorobutanesulfonic acid (PFBS), Perfluoropentanesulfonic acid (PFPeS), Perfluorohexanesulfonic acid (PFHxS), Perfluoroheptanesulfonic acid (PFHpS) and Perfluorooctanesulfonic acid (PFOS) (Paragraph 0012: “… the method comprising measuring whether a cancer-specific VOC selected from the group consisting of perfluorodecanoic acid, perfluoro-n-pentanoic acid, perfluorononanoic acid, perfluorooctanoic acid, perfluoro-1-heptene, perfluorocyclohexane, 1H,1H-perfluoro-1-heptanol octafluorocyclobutane and perfluoro(methylcyclohexane) is present in exhaled breath gas collected from a patient suspected of having cancer”).
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 2, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over:
Ra et al. (US 20150351662 A1) (hereinafter – Ra) in view of
Bender et al. (US 20240057890 A1) (hereinafter – Bender).
Re. Claim 2: Ra teaches the invention according to claim 1. Ra does not teach performing the assay using electrospray ionization-high-resolution mass spectrometry analyzer. Instead, Ra uses gas chromatography-mass spectrometry (GS-MS) (Paragraphs 0025).
Bender teaches analogous art in the technology of analyzing biomarkers via VOC detection in exhaled breath (Abstract). Bender further teaches wherein the assay is performed using a secondary electrospray ionization-high-resolution mass spectrometry analyzer (Paragraph 0018: “Alternative detection methods to detect a volatile organic marker in real-time are… secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)”).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of SESI-HRMS of Bender for the GS-MS of Ra. Thus, the simple substitution of one known element for another (i.e., types of mass spectrometry methods) producing a predictable result (analyzing a gas sample obtained from exhaled breath) renders the claim obvious.
Re. Claim 12: Ra as modified by Bender teaches the invention according to claim 2. Ra further teaches the invention wherein the presence of PFAS in the subject's breath is determined by measuring m/z peaks identified as being generated by PFAS compounds (Paragraph 0018: “In order to find fragments having the above molecular weights (molecular weights in the masses of fragmented ions, molecular ions, etc., which are produced when ionizing samples by electron impact or ionic molecular reactions in mass spectrometry and have a certain mass/charge (m/e) ratio), the exhaled breath of each of the healthy control group and the breast cancer group was analyzed again by GC-MS”).
Re. Claim 13: Ra as modified by Bender teaches the invention according to claim 2. Ra further teaches the invention wherein the presence of PFAS in the subject's breath is determined by detecting one or more PFAS compound fingerprints in breath assay data generated by the mass spectrometry analyzer (Paragraphs 0084-0123: detection of multiple perfluoro compounds via identification of fragments having molecular weights 69, 131, and 181).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over:
Ra et al. (US 20150351662 A1) (hereinafter – Ra) in view of
Bender et al. (US 20240057890 A1) (hereinafter – Bender) in further view of
Boumsellek et al. (US 8173959 B1) (hereinafter – Boumsellek).
Re. Claim 3: Ra as modified by Bender teaches the invention according to claim 2, but does not teach the invention wherein the analyzing further comprises automatically configuring the mass spectrometry analyzer to perform selected ion monitoring based on real-time feedback of the measurements of the mass spectrometry analyzer.
Boumsellek teaches analogous art in the technology of mass spectrometry (Title). Boumsellek further teaches the invention wherein the analyzing further comprises automatically configuring the mass spectrometry analyzer to perform selected ion monitoring based on real-time feedback of the measurements of the mass spectrometry analyzer (Col. 19, lines 37-43: “The signal corresponding to the filtered ions is directed towards the QAMS detector operated in the total ion monitoring (TIM) mode. If the target analyte is confirmed, the QAMS is switched to the selected ion monitoring (SIM) mode and is tuned to the molecular weight of the target analyte for detection and deterministic identification”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Ra as modified by Bender to perform selected ion monitoring based on feedback of the measurements of the mass spectrometry as taught by Boumsellek, the motivation being that doing so tunes the analysis to the molecular weight of the target analyte (Col. 19, lines 37-43), increasing the speed of analysis by removing the need to scan an entire mass range.
Re. Claim 4: Ra as modified by Bender and Boumsellek teaches the invention according to claim 3. Boumsellek further teaches the invention wherein the automatic selected ion monitoring restricts the mass spectrometry analyzer to measure a select range of m/z values comprising one or more features of interest (see citation of rejection of claim 3: a quadrupole array mass sensor (QAMS, i.e., a mass spectrometer) is “tuned” to a particular molecular weight, implying that the device scans signals pertaining to that mass/charge ratio; see Fig. 22: mass spectrometer set at a mass-to-charge ratio of m/z=304).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over:
Ra et al. (US 20150351662 A1) (hereinafter – Ra) in view of
Bender et al. (US 20240057890 A1) (hereinafter – Bender) in further view of
Mistrik (US 20060085142 A1) (hereinafter – Mistrik).
Re. Claim 5: Ra as modified by Bender teaches the invention according to claim 2, but does not teach the invention wherein the analyzing further comprises automatically configuring the mass spectrometry analyzer to perform fragmentation if the selected ion monitoring indicates the breath sample comprises one or more features of interest.
Mistrik teaches analogous art in the technology of mass spectrometry (Abstract). Mistrik further teaches the invention wherein the analyzing further comprises automatically configuring the mass spectrometry analyzer to perform fragmentation if the selected ion monitoring indicates the breath sample comprises one or more features of interest (Paragraph 0009: particularly, “…the ions that emerge from the ionization process (precursor ions) can be further isolated and fragmented by means of collision induced dissociation or various other ion activation techniques that give rise to second stage spectra called product spectra. Given the appropriate hardware, the isolation and activation procedures can be successively repeated in several stages. Resulting product spectra exhibit fragmentation peaks from isolated ions, providing an added dimension to the overall fragmentation pattern;” Paragraphs 0012, 0019; Paragraph 0024: “If the product spectra of second and higher stages (MS.sup.n; n>1) are generated from multiple precursor peaks corresponding to the set isolation width, the m/z value of the precursor ion can be calculated from the overall decomposition pattern, or it can be determined according to already recognized fragment structures”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Ra as modified by Bender to perform the automated fragmentation processes as taught by Mistrik, the motivation being that doing so provide an additional dimension to the fragmentation pattern of ions that emerge from the ionization process (Paragraph 0009), and aids in segregating compound classes which exhibit similar or identical fragmentation patterns from (Paragraphs 0005-0010).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over:
Ra et al. (US 20150351662 A1) (hereinafter – Ra) in view of
Bender et al. (US 20240057890 A1) (hereinafter – Bender) in further view of
IONICON. (2020, November 26). Benefits of Selective Reagent Ionization - Mass Spectrometry. SRI-MS | IONICON. https://web.archive.org/web/20201126033036/https://www.ionicon.com/technologies/details/sri-ms (hereinafter -- Ionicon).
Re. Claim 6: Ra as modified by Bender teaches the invention according to claim 2, but does not teach the invention wherein the analyzing further comprises automatically switching the ionization agent of the mass spectrometry analyzer.
Ionicon teaches analogous art in the technology of mass spectrometers (Page 1). Ionicon further teaches the invention wherein the analyzing further comprises automatically switching the ionization agent of the mass spectrometry analyzer (Page 1/5: “SRI-MS is an IONICON exclusive technology allowing to automatically switch between different reagent ions for chemical ionization direct injection mass spectrometry. Currently the range of selective reagent ions includes H3O+, O2+, NO+, NH4+, Kr+ or Xe+”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Ra as modified by Bender to include the method comprising automated switching of ionization agents as taught by Ionicon, the motivation being that doing so allows for separation of a variety of isomers, creating different reaction pathways to be triggered to provide pathways to allow for improved identification of compounds, increasing the number of substances which can be ionized and quantified with an appropriate reagent ion, simplifies quantification, and further increases reagent ion yields and sensitivity (Page 3/5).
Re. Claim 7: Ra as modified by Bender and Ionicon teaches the invention according to claim 6. Ionicon further teaches the invention wherein the automatic ionization agent switching occurs periodically (Page 3/5: “Via fast switching of the reagent ions (for many reagent ions the switching process takes less than 10 s)different reaction pathways can be triggered. By comparing and interpreting these pathways substance identification becomes nearly unambiguous” ).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over:
Ra et al. (US 20150351662 A1) (hereinafter – Ra) in view of
Bender et al. (US 20240057890 A1) (hereinafter – Bender) in further view of
Robinson et al. (US 20120003748 A1) (hereinafter – Robinson).
Re. Claim 9: Ra as modified by Bender teaches the invention according to claim 2, but does not teach the invention wherein the analyzing further comprises automatically switching the polarity of the mass spectrometry analyzer.
Robinson teaches analogous art in the technology of mass spectrometers (Abstract). Robinson further teaches the invention wherein the analyzing further comprises automatically switching the polarity of the mass spectrometry analyzer (Paragraph 0103: particularly, “In some embodiments, the control module automatically changes the potential of the ion extraction electrode 612, each of the plate electrodes 624, and the drift end-plate electrode 625 in response to changes in parameters of the chemical ionization/drift chamber 620, via a feedback loop”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Ra as modified by Bender to include the method of switching the polarity of the mass spectrometry analyzer as taught by Robinson, the motivation being that doing so “can establish as an initial condition or mode an electric field gradient and pressure which defines the optimum e/n (e.g., charge density) setting for a given sample monitoring requirement“ (Paragraph 0103).
Re. Claim 10: Ra as modified by Bender and Robinson teaches the invention according to claim 9. Robinson further teaches the invention wherein the automatic polarity switching occurs periodically (see rejection of claim 9: Examiner notes that a feedback loop implies at least one period).
Re. Claim 11: Ra as modified by Bender and Robinson teaches the invention according to claim 9. Robinson further teaches the invention wherein the automatic polarity switching occurs based on real-time feedback of the measurements of the mass spectrometry analyzer (Paragraph 0012: “Additionally, a control module or feedback loop can be used to control generation of reagent ions and sample ions and their throughput in mass spectrometry systems, for example, by controlling various process parameters of the system. Such parameters include various electrical fields, pressure values, ion and vapor flow rates and ion energies;” Paragraph 0103: see discussion of feedback loop changing potential of ion extraction electrodes).
Claims 14, 15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Ra et al. (US 20150351662 A1) (hereinafter – Ra) in view of
Bender et al. (US 20240057890 A1) (hereinafter – Bender) in further view of
Liu (US 20220369965 A1) (hereinafter – Liu).
Re. Claim 14: Ra as modified by Bender teaches the invention according to claim 13, but does not teach the invention wherein the PFAS compound fingerprints are detected using a machine learning model.
Liu teaches analogous art in the technology of breath compound analysis (Abstract). Liu further teaches the invention wherein compound fingerprints are detected using a machine learning model (Paragraph 0041: recognition of compound patterns, their relative amounts, and type).
It would have been obvious to one having skill in the art before the effective filing date to have modified Ra as modified by Bender to include the use of machine learning to detect identifying features of sensed compounds (e.g., PFAS via mass spectrometry) as taught by Liu, the motivation being that doing so provides rapid analysis of such compounds (Paragraph 0041).
Re. Claim 15: Ra as modified by Bender and Liu teaches the invention according to claim 14. Claim 15 requires:
generating breath assay data for a plurality of subjects using the mass spectrometry analyzer;
obtaining PFAS exposure data for each of the plurality of subjects;
training a machine learning model to identify one or more PFAS compound fingerprints using the breath assay data and the obtained PFAS exposure data; and
applying the trained machine learning model to breath assay data, different from the breath assay data used to train the model,
to generate a composite score regarding the PFAS exposure for a subject or subjects
The method of Liu teaches generating sensor signals for a plurality of subjects (Fig. 4). As applied to PFAS analysis taught by Ra, such data generation would be breath assay data. The method of Liu further teaches obtaining sensor data (Fig. 4). Liu further identifies a training data set, which, in the context of machine learning, would provide sensor data (e.g., PFAS exposure data in the context of the combination). The method of Liu further applies the trained model to a test data set (Fig. 4). Further, Liu states that relative amounts of compounds are identified by the system (Paragraph 0041). Thus, the combination of Ra as modified by Bender and Liu, teaches each requirement of claim 15.
Re. Claim 19: Ra as modified by Bender and Liu teaches the invention according to claim 15. Liu further teaches the invention wherein the composite score is generated based at least in part on whether two or more different PFAS are detected in the breath sample (Paragraph 0041: “relative amounts” implies at least two differing compounds are detected; in the context of the PFAS analysis of Ra, this would result in identification of relative amounts of differing PFAS compounds).
Re. Claim 19: Ra as modified by Bender and Liu teaches the invention according to claim 15. Claim 19 requires a composite score generated based at least in part on whether six or more different PFAS are detected in the breath sample. Liu teaches what is interpretable as a composite score (i.e., determination of relative amounts) based on the number of compounds in the sample, encompassing scenarios where six or more compounds are in the sample. In other words, in the case that six or more compounds are found in the sample, Liu’s differentiation of relative amounts of the six or more compounds teaches the requirements of the composite score of claim 19.
Allowable Subject Matter
Claim 8 would be allowable if the rejection of claim 6 under 35 U.S.C. 112(b) is overcome and the double patenting rejections of the claims are obviated, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior arts of reference are:
Ra et al. (US 20150351662 A1) (hereinafter – Ra);
Bender et al. (US 20240057890 A1) (hereinafter – Bender);
IONICON. (2020, November 26). Benefits of Selective Reagent Ionization - Mass Spectrometry. SRI-MS | IONICON. https://web.archive.org/web/20201126033036/https://www.ionicon.com/technologies/details/sri-ms (hereinafter -- Ionicon).
In the dependency chain of claim 8:
Ra teaches each limitation of claim 1 (i.e., “a method comprising assaying a breath sample from a subject for the presence of Per-and Polyfluoroalkyl Substances (PFAS)”).
Bender teaches each limitation of claim 2 (i.e., “The method according to Claim 1, wherein the assay is performed using a secondary electrospray ionization-high-resolution mass spectrometry analyzer”).
Ionicon teaches each limitation of claims 6 and 7, wherein the mass spectrometry analysis involves automatically switching the ionization agent, and wherein such automatic switching occurs periodically.
None of the prior arts of reference teaches or suggests the requirements of claim 8, i.e., “wherein the automatic ionization agent switching occurs based on real-time feedback of the measurements of the mass spectrometry analyzer.” The automated periodic switching of Ionicon is performed without feedback from measurements since reaction pathways are identified and analyzed after performing a switching process which is agnostic of prior measurements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/382,736 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of the reference application encompasses all limitations of claim 1 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 3, 6, 9, 14, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 19, 22, 26, and 27 of copending Application No. 18/382,736 (hereinafter – the ‘736 application) in view of Ra et al. (US 20150351662 A1) (hereinafter – Ra).
This is a provisional nonstatutory double patenting rejection.
Re. Claim 2: Regarding independent claim 1, claim 1 of the ‘736 application teaches assaying a breath sample, but does not teach assaying for PFAS compounds.
Ra teaches assaying for PFAS compounds (see rejections under 35 U.S.C. 103).
It would have been obvious to one of ordinary skill in the arts to include assaying for PFAS compounds, the motivation being that doing so enables cancer diagnosis (Paragraph 0008).
Thus, claim 1 of the ‘736 application as modified by Ra teaches claim 1 of the instant application.
Claim 2 of the instant application requires wherein the assay is performed using a secondary electrospray ionization-high-resolution mass spectrometry analyzer. This feature is taught by claim 15 of the ‘736 application in view of Ra.
Re. Claim 3: Limitations of claim 3 are taught by claim 16 of the ‘736 application as modified by Ra.
Re. Claim 6: Limitations of claim 6 are taught by claim 19 of the ‘736 application as modified by Ra.
Re. Claim 9: Limitations of claim 9 are taught by claim 22 of the ‘736 application as modified by Ra.
Re. Claim 14: Limitations of claim 14 are taught by claim 26 of the ‘736 application as modified by Ra.
Re. Claim 15: Limitations of claim 15 are taught by claim 27 of the ‘736 application as modified by Ra.
Conclusion
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/JUSTIN XU/Examiner, Art Unit 3791