DETAILED ACTION
Information Disclosure Statement
The information disclosure statement filed 28 August 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restrictions
Claims 1-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 14 January 2026.
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:
An ion detector configured to receive the first portion of the stream of ions from the ion mobility separation device, and perform a first scan of the received ions including detecting first ions having a first mass-to-charge ratio during a first arrival time and detecting second ions having a second mass-to-charge ratio during a second arrival time; …wherein the ion detector switches from detecting the first mass-to-charge ratio during the first arrival time of the first scan to detecting the second mass-to-charge ratio during the second arrival time of the first scan in claim 1.1 The instant specification teaches the ion detector is a filter type mass spectrometer/analyzer ([0064] of the published application).
“a computing device storing a data set” in claim 2 ([0100])
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 18-37 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 18 fails to meet the written description requirement for “an ion detector configured to…perform a first scan of the received ions including detecting first ions having a first mass-to-charge ratio during a first arrival time and detecting second ions having a second mass-to-charge ratio during a second arrival time; …wherein the ion detector switches from detecting the first mass-to-charge ratio during the first arrival time of the first scan to detecting the second mass-to-charge ratio during the second arrival time of the first scan”.
MPEP 2163.03 (V) recites:
“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”
Here, the claimed detector is disclosed to be a filter type quadrupole mass spectrometer ([0064]). Paragraph [0087] and figures 6a-6b teach scanning the detector to detect all ions over two separate scans. However, there is no disclosure as to how the mass filter is scanned such that the two groups may be separated. Similarly with respect to figures 9a-13c scans of the detector are again suggested, however this amounts to a desired result of switching the detector from detecting the first m/z and the second m/z without any disclosure as to how the scan function is performed or the result of switching is achieved.
Therefore, without disclosure as to how the switching of the detector (i.e. mass filter type mass spectrometer) between scans for detecting first and second m/z, the specification fails to meet the written description requirement under 35 USC § 112(a).
Claims 19-27 fail to meet the written description requirement by virtue of their dependencies on rejected claim 18.
Claims 19 and 29 further requires switching of the detector, however as discussed above, there is no disclosure as to how this result is achieved. Specifically, figure 6C and paragraph [0087] teach second time period 174b is scanned separately from the first time period 174a because of the overlapping arrival times. However, the specification is devoid as to how the detector scans the first and third m/z ions of the first arrival time to achieve the claimed switching away as required by claim 19.
Claim 28 requires commensurate limitations as claim 18 above and fails to meet the written description requirement for the same reasons discussed above.
Claims 29-37 fail to meet the written description requirement by virtue of their dependencies on rejected claim 28.
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 19-26 and 29-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 is vague and indefinite for reciting “a second scan of the received ions including detecting third ions having a third mass-to-charge ratio during the first arrival time… the ion detector switches from detecting one of the first mass-to-charge ratio and the second mass-to-charge ratio to detecting the third mass-to-charge ratio” because the detecting of first ions of a first m/z ratio are defined in claim 18 to occur during the first arrival time. Therefore, it is unclear how the first arrival time of the first scan may be the same arrival time of the claimed second scan. That is, the first arrival time of the first scan cannot be the first arrival time of the second scan because the first arrival time is the time where the first ions having a first m/z ratio are detected, whereas claim 19 requires switching away from detecting first m/z ratio to detecting the third m/z ratio. If the detecting of the third m/z occurs during the first ion arrival time, then it is not clear how the detector can detect both first and third m/z ratios during a first arrival time and simultaneously switch away from the first m/z ratio. No unambiguous determination can be made.
Claim 29 requires commensurate limitations and is indefinite for the same reasons discussed above.
Respective claims 20-26 and 30-36 are rejected by virtue of their respective dependencies on claims 19 and 29.
Claim 20 recites the limitation “wherein data detected during the first scan is combined with data detected during the second scan to form a multi-analyte data plot.” is vague and indefinite because the claim does not provide a discernable boundary on what performs the function. The recited function does not follow from the structure recited in the claim i.e. the ion mobility separation device, the ion detector or the controller, so it is unclear whether the function requires some other structure or is simply a result of operating the ion mobility separation device, the ion detector or the controller in a certain manner. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claim. See MPEP 2173.05(g) for more information.
Claim 24 recites the limitation "the…third scan" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-26 and 28-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (US pgPub 2017/0178887).
Regarding claim 18, Park et al. teach a system (fig. 4) for performing multi-analyte targeted data acquisition (intended use, however targeted analysis where only compounds of masses are measured is suggested in [0042]), comprising:
an ion mobility separation device (TIMS mobility separator in figure 4) configured to receive a stream of ions, guide at least a first portion of the stream of ions through the ion mobility separation device, and separate the ions of the first portion based on ion mobility (inherent to TIMS, first and second ion species interpreted to be the first portion separated by TIMS see paragraph [0044]);
an ion detector (triple quad Q1-Q3 in figure 4) configured to receive the first portion of the stream of ions from the ion mobility separation device (downstream TIMS, thus receiving at least a portion of ion stream from AP ion source), and perform a first scan of the received ions including detecting first ions having a first mass-to-charge ratio during a first arrival time and detecting second ions having a second mass-to-charge ratio during a second arrival time ([0042] teaches triple quad determining the time when each of precursor mass elutes from the TIMS cell2 [0043] teaches switching between one ion species and the next ion species and paragraph [0044] teaches scanning between mass ranges, thus ions having different m/z ratios during different times); and
a controller in communication with the ion mobility separation device and the ion detector (inherent such that determination by triple quad based on when mass elutes from TIMS cell),
wherein the ion detector switches from detecting the first mass-to-charge ratio during the first arrival time of the first scan to detecting the second mass-to-charge ratio during the second arrival time of the first scan ([0043] teaches switching time of mass filter Q1 to the next ion species, wherein each ion species have respective m/zs).
Regarding claim 19, Park et al. teach wherein: the ion mobility separation device is configured to guide a second portion of the stream of ions through the ion mobility separation device and separate the ions of the second portion based on ion mobility ([0044] ions are separated by TIMS device…then a third ion species from the same ion mobility scan may be picked in its time interval and mass range. Third ion species interpreted to be the second portion), the ion detector is configured to receive the second portion of the stream of ions from the ion mobility device and perform a second scan of the received ions including detecting third ions having a third mass-to-charge ratio during the first arrival time ([0044] note Q1 picks ion species selected from mass mobility map in fig. 5 and analysis of third species is performed. Figure 5 shows ion masses (i.e. m/z ratio) overlapping time intervals (arrival times). Paragraph [0043] teaches the scan allows up to eleven ion species to be selected. Thus, it is possible for two separate m/z ratios occurring during the same first time interval to be selected and detected separately for analysis, interpreting the overlapping time intervals (separate m/z ratios) to be respective first and third m/z ratios during the first time interval), and the ion detector switches from detecting one of the first mass-to-charge ratio and the second mass-to-charge ratio to detecting the third mass-to-charge ratio ([0044] teaches picking up ion species, by a mass filter, in its time interval and mass range and quantitative measurement. That is, that is switching from first, second and third m/z ratio).
Regarding claim 20, Park et al. teach wherein data detected during the first scan is combined with data detected during the second scan to form a multi-analyte data plot (fig. 5).
Regarding claim 21, Park et al. teach a computing device storing a data set, the data set including data for ions of the first portion of the stream of ions and the second portion of the stream of ions (computer and storage required to generate figure 5, wherein multiple ion masses are seen, see paragraph [0044] for disclosure of first and second ion species (interpreted first and second portions of stream of ions)).
Regarding claim 22, Park et al. teach wherein the computing device is configured to determine the first ions to be detected during the first scan, the second ions to be detected during the first scan, and the third ions to be detected during the second scan based on the data set ([0042] teaches triple quad determines the time when each precursor ion elutes, thus determines first through third ion species discussed in paragraph [0044] (i.e. requiring a computing device for the triple quad to make any determination), interpreting the first scan to be scan of Q1 from species 1-2 and second scan to be scanning from ion species 3-4)
Regarding claim 23, Park et al. teach wherein the data includes one or more of arrival time and mass- to-charge ratio ([0044] Q1 picks up the correct time interval and correct mass range).
Regarding claim 24, Park et al. teach wherein the computing device is configured to group the ions into the first, second, and third scans based on the data (scans of paragraph [0044] by Q1 based on data from fig. 5).
Regarding claim 25, Park et al. teach wherein the ion mobility separation device includes an accumulation region (fig. 2 shows gradient accumulating ions along a region) and an ion mobility separation path (at plateau as gradient decreases, ions are separated by mobility), the accumulation region configured to accumulate the ions into one or more ion packets (ions separated by mobility along gradient) and pulse the one or more ion packets into the ion mobility separation path (release by mobility via decreasing gradient field. Note paragraph [0030] teaches stepwise gradually decreasing electric field is interpreted to be a pulse as the field is dropped in a stepwise manner to release ions).
Regarding claim 26, Park et al. teach wherein the first scan is performed on a first packet of the one or more ion packets, and the second scan is performed on a second packet of the one or more ion packets (first released ion from TIMS device to downstream triple quad and second release to downstream triple quad, where triple quad performs the scan via adjustment of Q1, see paragraph [0042] and [0044]).
Claims 28-36 are the method claims to the apparatus claims 18-26 and commensurate in scope. Therefore the method is inherent to the citations discussed herein above.
Claims 18, 27, 28 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giles (US pgPub 2016/0003773).
Regarding claim 18, Giles teaches teach a system (fig. 1) for performing multi-analyte targeted data acquisition ([0112] mass filter 4 switches between components of interest for targeted experiments where m/z and ion mobility components of interest are derive3d from a library method development stage), comprising:
an ion mobility separation device (2/3) configured to receive a stream of ions, guide at least a first portion of the stream of ions through the ion mobility separation device, and separate the ions of the first portion based on ion mobility (2 is an ion mobility separator thus inherently separates ions based on ion mobility );
an ion detector (elements 4-6 of figure 4) configured to receive the first portion of the stream of ions from the ion mobility separation device ([0112]), and perform a first scan of the received ions including detecting first ions having a first mass-to-charge ratio during a first arrival time and detecting second ions having a second mass-to-charge ratio during a second arrival time ([0112] teaches “The quadrupole mass filter 4 preferably switches between components of interest which elute from the ion mobility spectrometer or separator device 2 within a single ion mobility spectrometer or separator cycle or single cycle of separation thereby providing both improved selectivity”. The switching is interpreted to be a scan, see also paragraph [0135] for scanning the mass filter 4); and
a controller in communication with the ion mobility separation device and the ion detector ([0031]-[0031] control system arranged and adapted to transmit ions from the separator (i.e. control of IMS 2) and [0047]-[0048] control system controls m/z filter),
wherein the ion detector switches from detecting the first mass-to-charge ratio during the first arrival time of the first scan to detecting the second mass-to-charge ratio during the second arrival time of the first scan ([0112] teaches switching between components of interest which elute from the IMS. Paragraph [0118] teaches switching between two m/z ratio settings. Since ions are separated by mobility the filter switches between m/z at first mobility to m/z at second mobility (i.e. arrival times)).
Regarding claim 27, Giles teaches he ion mobility separation device is configured to generate a traveling drive potential that is configured to guide the ions through the ion mobility separation device and separate the ions based on ion mobility ([0113], [0115] and figure 2 teach traveling wave ion guide allows temporal shift at position B are further increased).
Claims 28 and 37 are commensurate in scope and are anticipated by Giles as discussed in the citations above.
Claims 18-19 and 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loboda (USPN 6,744,043).
Regarding claim 18, Loboda teaches teach a system (fig. 5) for performing multi-analyte targeted data acquisition (intended use), comprising:
an ion mobility separation device (fig. 5, ion mobility section 64) configured to receive a stream of ions, guide at least a first portion of the stream of ions through the ion mobility separation device, and separate the ions of the first portion based on ion mobility (inherent to an IMS);
an ion detector (76/82/90) configured to receive the first portion of the stream of ions from the ion mobility separation device (as seen in figure 5), and perform a first scan of the received ions including detecting first ions having a first mass-to-charge ratio during a first arrival time and detecting second ions having a second mass-to-charge ratio during a second arrival time (col. 11, lines 38-49 teach IMS separation followed by mass selection using 76, col. 12, lines 21-27 teaches tuning selector 76 to precursor ion of interest eluting out of the mobility stage, thus many precursor ions can be selected in the quadrupole 76 (i.e. quadrupole 76 scans by tuning to m/z of interest at the moment)); and
a controller (70/80/90) in communication with the ion mobility separation device and the ion detector (70 in communication with 64 and 80/88 in communication with 76/83=2),
wherein the ion detector switches from detecting the first mass-to-charge ratio during the first arrival time of the first scan to detecting the second mass-to-charge ratio during the second arrival time of the first scan (via tuning see col. 12, lines 21-27).
Regarding claim 19, Loboda teach wherein: the ion mobility separation device is configured to guide a second portion of the stream of ions through the ion mobility separation device and separate the ions of the second portion based on ion mobility (col. 12, lines 21-25 teach ions eluting from IMS at a moment, thus a second portion), the ion detector is configured to receive the second portion of the stream of ions from the ion mobility device and perform a second scan of the received ions including detecting third ions having a third mass-to-charge ratio during the first arrival time (col. 12, lines 21-25 teaching tuning quadrupole to precursor of interest at the moment eluted from IMS, thus an addition m/z ratio. Further col. 11, lines 33-49 teaches knowing both the m/z of the parent ion and mobility characteristics, the parent ions can be taken from IMS at the appropriate time and are further subjected to mass selection to ensure elimination of any ions which have similar IMS characteristics but different m/z ratios. That is, during the tuning of col. 12. lines 21-25 the device is capable of a second scan of the filter to select ions of the same time arrival but different m/z (i.e. third m/z ions)), and the ion detector switches from detecting one of the first mass-to-charge ratio and the second mass-to-charge ratio to detecting the third mass-to-charge ratio (via tuning discussed in col. 12, lines 21-25)
Claims 28 and 29 are commensurate in scope and are anticipated by Loboda as discussed in the citations above.
Claims 18, 27, 28 and 37 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Palmer et al. (US pgPub 2022/0163480).
Regarding claim 18, Palmer teaches teach a system (fig. 3) for performing multi-analyte targeted data acquisition (intended use), comprising:
an ion mobility separation device (300) configured to receive a stream of ions, guide at least a first portion of the stream of ions through the ion mobility separation device, and separate the ions of the first portion based on ion mobility (inherent to an IMS see paragraph [0131] teaches separating ions according to ion mobility and [0148] teaches ions emerging from IMS);
an ion detector (100/400) configured to receive the first portion of the stream of ions from the ion mobility separation device ([0148]), and perform a first scan of the received ions including detecting first ions having a first mass-to-charge ratio during a first arrival time and detecting second ions having a second mass-to-charge ratio during a second arrival time ([0148] sequentially select and transmit ions of interest (i.e. to analyzer 400) for detection); and
a controller (500) in communication with the ion mobility separation device and the ion detector ([0240] teaches control system operates the analytical instrument, (i.e. IMS 300 and filter/analyzer 100/400)),
wherein the ion detector switches from detecting the first mass-to-charge ratio during the first arrival time of the first scan to detecting the second mass-to-charge ratio during the second arrival time of the first scan ([0148]).
Regarding claim 27, Giles teaches he ion mobility separation device is configured to generate a traveling drive potential that is configured to guide the ions through the ion mobility separation device and separate the ions based on ion mobility ([0242]).
Claims 28 and 37 are commensurate in scope and are anticipated by Giles as discussed in the citations above.
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.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
1 Note the instant specification teaches prior art detectors are included in triple quadrupole mass spectrometers in paragraph [0006]. Then the specification equates a detector as a mass filter type mass spectrometer ([0064]). As evidenced from paragraph [0006], one of ordinary skill in the art would recognize a detector as part of a triple quad or filter type mass spectrometer and not a detector as a mass filter type mass spectrometer. Therefore, detector is interpreted as a generic nonce word to suggest a filter type mass analyzer. Moreover, a detector by itself cannot perform a scan. If 112(f) is not invoked for the claimed detector, then the claimed invention would lack adequate written description for a detector (i.e. without a mass filter or mass analyzer) to perform a scan. That is, a detector by itself may not perform a scan. In the instant case, 112(f) is interpreted as being invoked, therefore no rejection on this grounds is currently applied.
2 Note paragraph [0011] teaches ion mass stands for m/z