DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08 June 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 17-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 17-20 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 17 lacks written description for reciting “scanning at least one operating parameter f(t)of the ion mobility analyzer as a monotonic function of time t during an operating period from to to ti, such that ions with different mobilities pass through the ion mobility analyzer sequentially, wherein the analyte ions pass through the ion mobility analyzer within an operating parameter range of [f(tA,f(tB)], where to<tA<tB< t1;during the scanning of the at least one operating parameter f(t), actively maintaining a field strength in the first ion storage zone at a constant value set such that an acting force on the analyte ions is greater than a force generated by a gas flow, thereby causing the first ion storage zone to store ions; and actively maintaining a field strength in the second ion storage zone at a constant value set such that the acting force on the analyte ions is less than the force generated by the gas flow, thereby causing the second ion storage zone to store ions; and repeating the operating period multiple times, wherein in each operating period excluding a first operating period, the method comprises: during a first stage where to≤t <tA, storing, in the first ion storage zone, analyte ions generated by the ion source and/or at least part of analyte ions pre-stored in the second ion storage zone that pass through a part of the ion mobility analyzer; during a second stage where tA ≤t< tB, transmitting, through the ion mobility analyzer to a detector or a next stage analysis apparatus, the analyte ions generated by the ion source and the analyte ions stored in the first ion storage zone during the current operating period; and during a third stage where tb≤t <t1, storing in the second ion storage zone analyte ions generated by the ion source that pass through a part of the ion mobility analyzer”.
Specifically, the claim is drafted as a result achieved by scanning at least one parameter of an ion mobility spectrometer and maintaining a field strength such that two storage regions are created. However, the specification is devoid as to how this result is achieved. Specifically, paragraphs [0043]-[0048] of the instant published application reiterate the same process, however fail to describe any voltage sources, electrodes, processor, computer, program, flow chart, steps or any other means to achieve the claimed result. At best in the description of figure 2 in paragraph [0049] the instant disclosure suggests the IMS is an array of electrodes and control of fields. However, how the fields are generated and scanned (i.e. voltage sources and computer control) are not disclosed raising the issue of possession at to how the scan at least one parameter according to the claimed function and storage regions are achieved on the IMS. In otherwords, how the result is practically implemented on an ion mobility analyzer.
It is noted that paragraph [0049] further compares the difference between the prior art and the instant invention. While the structure is the same, the fields provided by the IMS are different. However, however the specification is notably silent as to how fields are specifically generated in the disclosed IMS and how they are controlled to achieve the desired 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 claims require scanning the IMS according to a function, creating storage zones within the IMS, however the instant specification is devoid of any manner of achieving this desired result. Therefore, claim 17 fails to meet the written description requirement as required under 35 USC § 112(a).
It is noted that during the interview of 29 May 2026, the applicant’s representative indicated the reason a processor to perform the claimed steps could not be amended into the apparatus claims is because the specification fails to disclose such subject matter (see interview summary of 29 May 2026). Similarly, if there is no disclosed mechanism to achieve the claimed result in a method claim, the specification fails to provide adequate written description to achieve the claimed result in the method.
Claims 18-20 also fail to meet the written description requirement by virtue of their dependencies on rejected claim 17.
Additionally, note claims 18-20 each require results achieved with no disclosure as to how those results are achieved and are additionally rejected for the same reasons above with respect to claim 17.
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 17-20 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 17 is vague and indefinite for requiring:
“during the scanning of the at least one operating parameter f(t), actively maintaining a field strength in the first ion storage zone at a constant value set such that an acting force on the analyte ions is greater than a force generated by a gas flow, thereby causing the first ion storage zone to store ions; and actively maintaining a field strength in the second ion storage zone at a constant value set such that the acting force on the analyte ions is less than the force generated by the gas flow, thereby causing the second ion storage zone to store ions”
Specifically, figure 3 shows second storage zone 3. If the force (i.e. the field strength) acting on the analyte ions is “less than the force generated by the gas flow”, it is unclear how the analyte ions could be trapped. That is, the gas flow is towards the right of the page, therefore a force acting on the analyte ions less than the force of the gas flow would cause the ions to flow down channel 40 instead of being trapped. No unambiguous determination can be made
Moreover, claim 17 is vague and indefinite for the same recitation above because it requires ions to be stored in first and second storage regions during the scanning of the at least one operation parameter f(t). The scanning operation f(t) is defined by the period extending from t0 to t1, which requires ions to be transmitted from both first and second storage regions. Therefore, it is not clear how the field strengths are maintained in the storage regions to store ions during the scan, when the scan function requires the storage regions to transmit stored ions in each region. It appears the claim is suggesting that the voltages are only maintained during particular periods of the scan, however no unambiguous determination can be made.
Claims 18-20 are vague and indefinite by virtue of their dependencies on rejected claim 17.
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.
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gillig et al. (US pgPub 2019/0162698) in view of Green (US pgPub 2017/0338093).
Regarding claim 1, Gillig et al. teach an ion mobility analysis method (fig. 4a/4b), comprising:
continuously generating ions comprising analyte ions using an ion source (abstract, analyte ions ([0026]);
directing the generated ions into an ion mobility analyzer (IMS see figure 4a) comprising an ion inlet, a first channel, a second channel, an ion outlet, a first ion storage zone, and a second ion storage zone, 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 first storage region is interpreted as an area of space surrounded by electrodes. Second storage region is actually disclosed to store in paragraph [0070] which recites the electric field gradient of the ion injection area 41 is decreased to a very low value so that no ions can enter the first drift/analyzer region (i.e. in the IMS proximal to the inlet as indicated in the annotated figure below))
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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);
scanning at least one operating parameter f(t)of the ion mobility analyzer as a monotonic function of time t during an operating period from to to ti, such that ions with different mobilities pass through the ion mobility analyzer sequentially, wherein the analyte ions pass through the ion mobility analyzer within an operating parameter range of [f(tA,f(tB)], where to<tA<tB< t1 (as indicated in figure 4b, see trap and elusion stage, where the elution stage scans such that ions of different mobility pass through the IMS sequentially)
during the scanning of the at least one operating parameter f(t), actively maintaining a field strength in the second ion storage zone at a constant value set such that the acting force on the analyte ions is less than the force generated by the gas flow, thereby causing the second ion storage zone to store ions ([0070] ion injection area 41 in figure 4b is set to a constant value during trap and elution scan such that ions are stored, paragraph [0070] expressly recites “the electric field gradient of the ion injection area 41 is decreased to a very low value so that no ions can enter the first drift/analyzer region” (i.e. stored in 41)).
While Gillig teaches a first trapping region ([0070]) and a first area that could be configured to store, Gillig fails to disclose during the scanning of the at least one operating parameter f(t), actively maintaining a field strength in the first ion storage zone at a constant value set such that an acting force on the analyte ions is greater than a force generated by a gas flow, thereby causing the first ion storage zone to store ions; repeating the operating period multiple times, wherein in each operating period excluding a first operating period, the method comprises: during a first stage where to≤t <tA, storing, in the first ion storage zone, analyte ions generated by the ion source and/or at least part of analyte ions pre-stored in the second ion storage zone that pass through a part of the ion mobility analyzer; during a second stage where tA ≤t< tB, transmitting, through the ion mobility analyzer to a detector or a next stage analysis apparatus, the analyte ions generated by the ion source and the analyte ions stored in the first ion storage zone during the current operating period; and during a third stage where tb≤t <t1, storing in the second ion storage zone analyte ions generated by the ion source that pass through a part of the ion mobility analyzer.
However, Green teaches actively maintaining a field strength in the first ion storage zone (storage zone 12 of IMS 10) at a constant value set such that an acting force on the analyte ions is greater than a force generated by a gas flow ([0141] note DC voltage applied to first region 12 of IMS), thereby causing the first ion storage zone to store ions ([0141] accumulating ions in 12);
repeating the operating period multiple times ([0149] teaches repeating cycle of figure 2), wherein in each operating period excluding a first operating period, the method comprises:
during a first stage where to≤t <tA, storing, in the first ion storage zone analyte ions generated by the ion source and/or at least part of analyte ions pre-stored in the second ion storage zone that pass through a part of the ion mobility analyzer ((see figure 2, T0-T1 ions stored in storage region 12 of IMS 10);
during a second stage where tA ≤t< tB, transmitting, through the ion mobility analyzer to a detector or a next stage analysis apparatus, the analyte ions generated by the ion source and the analyte ions stored in the first ion storage zone during the current operating period (fig. 2 T1-T2 ions pass from 12 to downstream region 16 of IMS 10. Note all ions are generated from ion source thus ions stored are ions generated from ion source thus concurrent transmission, see [0143]); and
during a third stage where tb≤t <t1, storing in the second ion storage zone analyte ions generated by the ion source that pass through a part of the ion mobility analyzer (fig. 2, T1-T2 ions are trapped in upstream region 14 note tb equal to t thus occurring at the same time as the second stage, see paragraph [0142]).
Green modifies the method of Gillig by suggesting an additional trapping regions downstream in the IMS inlet (note paragraph [0070] suggests first and second regions be regions of an IMS and paragraph [0133] suggests additional regions (i.e. trapping region 12 may be provided in the IMS)) during the scanning operation of Gillig.
Since both inventions are directed towards IMS, it would have been obvious to one of ordinary skill in the art to modify the scan of Gillig to include the time sequence for ion storage as suggested in Green because “successive populations of ions can be separated according to their ion mobility. It will also be appreciated that the disclosed arrangement can lead to a duty cycle of 100%, since a beam of ions can be continuously passed into the upstream accumulation region, which either accumulates the ions (e.g., during time period T.sub.1-T.sub.2) or passes them through to the first region 12 (e.g., during time period T.sub.2-T.sub.3). This can mean that no ions from the incoming beam of ions are lost to the system or otherwise.” ([0152]).
Regarding claim 18, 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 19, 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 17).
Regarding claim 20, Gillig teaches wherein the operating parameter is an electric field strength (as seen in figure 4B at elution stage).
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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
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