DETAILED ACTION
Response to Arguments
Applicant's arguments filed 03 March 2026 have been fully considered but they are not persuasive.
Drawing objections
The replacement sheets obviate the drawing objections. The objections are withdrawn.
Rejections under 112(b)
While some of the indefinite issues were overcome by amendment, the claims still fail to associate functional language with any particular structure as discussed below.
Rejections under 35 USC § 102(a)(1): Park
The remarks have been found persuasive. Park fails to disclose the first storage zone located at an end of the second channel distal to the ion outlet.
Rejections under 35 USC § 103: Gillig in view of Park
The remarks have been found unpersuasive. Gillig is a US patent application that claims priority to CN201710419157.1, which is referenced in the instant specification ([0049] of the published application). The instant specification uses figures 3 and 5 as reference points to compare to the prior art (figures 2 and 4 of Gillig). It is noted that the structural differences are non-existent. The only difference is the timing and positional application of the fields to create the storage regions (see paragraphs [0053]-[0056]).
Therefore, the claimed apparatus is structurally indistinct from that of Gillig. Moreover, Gillig teaches the fields applied to electrodes of the channel may be changed during accumulation trap and elution stages (see figures 4b and 5b). Therefore, while applying the claimed scan is not specifically disclosed in Gillig, because the voltage applied to each electrode is individually adjustable as evident from the various voltage gradients and steps seen in the fields applied only the channels in figures 4b and 5b, the device is capable of creating the claimed storage zones of the claimed device.
MPEP 2114 (II) recites “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”
Here, all the structure is disclosed (i.e. an IMS). Additionally, since claim 1 is directed towards the manner of operating the device of Gillig, the claim 1 is not distinguished over Gillig.
Claim 13 is written as a method however requires the analyzer in the form of an apparatus (i.e. the ion mobility analyzer is configure to scan…). Therefore because claim 13 does not recite the claimed operation in the form of any particular process, the ion mobility analyzer requirement of claim 13 is treated as a product claim.
Upon further consideration Makarov et al. was additionally found to anticipate at least claims 1 and 13 discussed herein below.
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 1-16 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 1 recites the limitation “analyte ions…pass through a part of the ion mobility analyzer to enter the first storage region and or at least part of the analyte ions which are prestored in the second storage zone pass through a part of the ion mobility analyzer to enter the first ion storage zone” 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 analyzer, so it is unclear whether the function requires some other structure or is simply a result of operating the ion mobility analyzer 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.
Claims 1 and 13 recites the limitation “analyte ions…pass through a part of the ion mobility analyzer to enter the second ion storage zone” 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 analyzer, so it is unclear whether the function requires some other structure or is simply a result of operating the ion mobility analyzer 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.
Claims 1 and 13 recite the limitation “the analyte ions stored in the first ion storage zone in the operating period pass through the ion mobility analyzer to enter a next stage analysis apparatus or be detected by a detector” is vague and indefinite because the claim does not provide a discernable boundary on what performs the function (i.e. ions pass through the ion mobility spectrometer from the ion source, first ion storage zone and second ion storage zone). The recited function does not follow from the structure recited in the claim i.e. the ion mobility analyzer, so it is unclear whether the function requires some other structure or is simply a result of operating the ion mobility analyzer 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 2 recites the limitation “only ions with mobility larger than a pre-set ion mobility K1 can pass through the first channel, and only ions with mobility smaller than a pre-set ion mobility K2 can pass through the second channel, wherein K1<K2, so that only ions with mobility between K1 and K2 can pass through the ion mobility analyzer; or only ions with mobility smaller than a pre-set ion mobility Ki can pass through the first channel, and only ions with mobility larger than a pre-set ion mobility K2 can pass through the second channel, wherein K2<K1, so that only ions with mobility between Ki and K2 can pass through the ion mobility analyzer” 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 analyzer, so it is unclear whether the function requires some other structure or is simply a result of operating the ion mobility analyzer 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 12 recites the limitation “the analyte ions pass through the ion mobility analyzer and enter the mass analyzer, at this time, the operating parameters of the mass analyzer are also set to be suitable for the analyte ions to pass through the mass analyzer” 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 analyzer, so it is unclear whether the function requires some other structure or is simply a result of operating the ion mobility analyzer 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 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 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillig et al. (US pgPub 2019/0162698).
Regarding claim 1, Gillig et al. teach an ion mobility analysis apparatus (fig. 5a/5b), comprising:
an ion source for continuously generating ions (abstract}, which contain analyte ions ([0026]);
a first ion storage zone located downstream of the ion source (see annotated figure below and discussion);
a second ion storage zone located downstream of the ion source (see annotated figure below and discussion); and
an ion mobility analyzer located downstream of the ion source for receiving the ions generated by the ion source and performing mobility analysis (ion mobility device between ion source 2 and detector 3);
wherein the ion mobility analyzer comprises an ion inlet, a first channel, a second channel and an ion outlet, wherein after the ions generated by the ion source enter the ion inlet, they pass through the first channel and the second channel successively and leave the ion mobility analyzer from the ion outlet, wherein the first ion storage zone is located at an end of the second channel distal to the ion outlet, and the second ion storage zone is located at an end of the first channel proximal to the ion inlet (see annotated figure below. Note, the claimed storage regions are generated by the application of particular fields to the channels (see paragraph [0053]). Since the device of Gillig is able to adjust the fields applied along the channels as evident from figures 4b and 5b, Gillig is inherently capable of setting voltages to create storage zones as claimed (see discussion in remarks to arguments section above));
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wherein the ion mobility analyzer is configured to scan at least one operating parameter (figure 4b and 5b show operating parameters vary as a function of time) that varies according to time t as a function f(t) in an operating period from to to ti ((figure 4b and 5b show operating parameters vary as a function of time)), so that ions with different mobilities pass through the ion mobility analyzer sequentially (as seen in figure 4a), the function f(t) is a monotonic function of time t, the analyte ions can pass through the ion mobility analyzer in an operating parameter range of [f(tA), f(tB)], and to≤tA≤tB≤t1 (see discussion below);
the operating period is repeated multiple times, and in each operating period excluding the first operating period:
in the stage of to≤t≤tA, the analyte ions generated by the ion source in the stage of to≤t≤tA, and/or at least part of analyte ions which are pre-stored in the second ion storage zone pass through a part of the ion mobility analyzer to enter the first ion storage zone;
in the stage of tB≤t≤t1, the analyte ions generated by the ion source in the stage of tB<tsti pass through a part of the ion mobility analyzer to enter the second ion storage zone; and
in the stage of tA≤t≤tB, the analyte ions generated by the ion source in the stage of tA≤ti≤tB, the analyte ions stored in the first ion storage zone in the same operating period can pass through the ion mobility analyzer to enter a next stage analysis apparatus or be detected by a detector. (since the fields of Gillig are capable of being scanned to different fields as evident by figures 4b and 5b such that ions of different mobilities pass through the ion mobility sequentially, Gillig is capable of setting the scan to operate as claimed. Note there is no structure required by the claim to perform the claimed operation, “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”
Here, all the structure is disclosed (i.e. an IMS). Additionally, since claim 1 is directed towards the manner of operating the device of Gillig, the claim 1 is not distinguished over Gillig.
Regarding claim 2, Gillig teaches only ions with mobility larger than a pre-set ion mobility K1 can pass through the first channel (define the k value of 36 to be the minimum all ions passing through first channel in figure 4 thus preset values), and only ions with mobility smaller than a pre-set ion mobility K2 can pass through the second channel (define the k vale of 32 to be the maximum value, all ions pass through second channel thus preset values), wherein K1<K2, so that only ions with mobility between K1 and K2 can pass through the ion mobility analyzer (as seen in figure 4a).
Regarding claim 3, Gillig teaches wherein the first channel and the second channel contain a gas flow paralleled to an ion migration direction and a direct current electric field in the opposite direction of the gas flow (E1/E2 opposite of 4/5), and the direct current electric field in the first channel and the direct current electric field in the second channel are different in field strength (as illustrated in figure 4b the gradient in 1st region is higher than in the second region or conversely in figure 5b, the second region is lower than the first region in the elusion stage. Note, there is no claim requirement of the electric field during the operational period claimed in claim 1).
Regarding claim 4, Gillig teaches wherein the operating parameter is an electric field strength (as seen in figure 4B at elution stage).
Regarding claim 5, Gillig teaches wherein the first ion storage zone is located in front of the second channel, and the second ion storage zone is located in front of the first channel (no relative positioning of “in front”, thus define the first “trap” of first channel to be in front of the second channel because it is upstream the second channel thus in front of the second channel. Further the second “trap” of figure 5b is in front of the first channel because it is further downstream of the first channel).
Regarding claim 6, Gillig teaches wherein the first ion storage zone is located in front of the first channel, and the second ion storage zone is located in front of the second channel (see annotated figure 4a above, note storage zone is generated by operating the claimed field, since Gillig is capable of generating the claimed field, the locations would be the same as claimed.).
Regarding claim 7, Gillig teaches wherein the first channel and the second channel are both linear structures (as seen in figure 4A), and ion migration directions in the two channels is opposite (180 degree turn, u-shape as seen in figure 4a results in opposite ion migration directions).
Regarding claim 8, Gillig teaches wherein a radio frequency electric field and a direct current electric field are applied into the first ion storage zone and the second ion storage zone to store the ions ([0061], note storage depends on operational parameters which are within the capabilities of Gillig).
Regarding claim 9, Gillig teaches wherein the mode of scanning the electric field strength segmented scanning (segmented electrodes in paragraph [0063] and scanning in [0068]).
Regarding claim 10, Gillig teaches wherein further comprising a mass analyzer downstream of the ion mobility analyzer ([0067], fig. 3, mass analyzer 29).
Regarding claim 11, Gillig teaches wherein the mass analyzer is a quadrupole mass filter or a magnetic mass analyzer ([0067], triple quadrupole mass analyzer is a quadrupole mass filter).
Regarding claim 12, Gillig teach wherein in the stage of ta≤t≤tB, the analyte ions pass through the ion mobility analyzer (see discussion above) and enter the mass analyzer (as seen in figure 3), at this time, the operating parameters of the mass analyzer are also set to be suitable for the analyte ions to pass through the mass analyzer (inherent for the triple quad to operate with the upstream ion mobility spectrometer).
Claim 13 is the method of claim 1 and is commensurate in scope, thus obvious in view of the discussion above with respect to claim 1.
Claim 14 is taught in Gillig as discussed in claim 2 above.
Claim 15 is taught in Gillig as discussed in claim 3 above.
Claim 16 is taught in Gillig as discussed in claim 4 above.
Claims 1 and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Makarov et al. (US pgPub 2022/0334080).
Regarding claim 1, Makarov et al. teach an ion mobility analysis apparatus (fig. 3), comprising:
an ion source (ion inlet to receive ions ([0154] thus requiring an ion source) for continuously generating ions (electrospray ion source, thus continuous [0228]), which contain analyte ions (inherent);
a first ion storage zone (in either deflector 112a or 112b, see paragraph [0184] ) located downstream of the ion source (112a or 112b downstream ion inlet 120, thus downstream ion source);
a second ion storage zone (126) located downstream of the ion source ([0163] teaches storage region which is downstream ion inlet 120); and
an ion mobility analyzer (fig. 3) located downstream of the ion source for receiving the ions generated by the ion source and performing mobility analysis (IMS receives ions from inlet 120);
wherein the ion mobility analyzer comprises an ion inlet (120), a first channel (channel left to 116), a second channel (channel right to 116) and an ion outlet (122), wherein after the ions generated by the ion source enter the ion inlet (implicit to ion inlet 120), they pass through the first channel and the second channel successively (via deflection not ion path in figure 3 indicated by dotted arrow) and leave the ion mobility analyzer from the ion outlet (122, ion ejection disclosed in paragraph [0183]), wherein the first ion storage zone is located at an end of the second channel distal to the ion outlet (storage region located in either 112a or 112b is located distal to the outlet 122), and the second ion storage zone is located at an end of the first channel proximal to the ion inlet (storage region 126 is proximal to inlet 120);
wherein the ion mobility analyzer is configured to scan at least one operating parameter that varies according to time t as a function f(t) in an operating period from to to ti ((scan voltages is inherent to store and release ions in respective 126/112a/112b over time), so that ions with different mobilities pass through the ion mobility analyzer sequentially (as seen in figure 43), the function f(t) is a monotonic function of time t, the analyte ions can pass through the ion mobility analyzer in an operating parameter range of [f(tA), f(tB)], and to≤tA≤tB≤t1 (inherent to storage and release of ions);
the operating period is repeated multiple times (storage discussed in above paragraphs. The device is intended to be used more than once multiple times), and in each operating period excluding the first operating period:
in the stage of to≤t≤tA, the analyte ions generated by the ion source in the stage of to≤t≤tA, and/or at least part of analyte ions which are pre-stored in the second ion storage zone pass through a part of the ion mobility analyzer to enter the first ion storage zone (either ions from ion inlet to storage zone in 112a/112b or ions stored in storage zone 126. Again because the structure for storage zones are disclosed the timing is within the capabilities of the device);
in the stage of tB≤t≤t1, the analyte ions generated by the ion source in the stage of tB<tsti pass through a part of the ion mobility analyzer to enter the second ion storage zone (ions may be stored in 126, since ions undergo multiple deflections, ions may be stored in 126 after they are stored in 112a or 112b); and
in the stage of tA≤t≤tB, the analyte ions generated by the ion source in the stage of tA≤ti≤tB, the analyte ions stored in the first ion storage zone in the operating period can pass through the ion mobility analyzer to enter a next stage analysis apparatus or be detected by a detector (ions may be released from 126 and by ejected via the ejection process).
Claim 13 is the method of claim 1 and is commensurate in scope, thus obvious in view of the discussion above with respect to claim 1.
Relevant art
US20110133072 teaches two storage regions in an IMS, see figure 1 and paragraph [0062]
Makarov (US pgPub 2022/0334080)
Hoyes (US pgPub 2011/0291001).
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.
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