DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on May 15, 2026 is acknowledged. Claims 1-18 are pending. Applicant amended claim 1 to obviate the outstanding objection, and added new claims 7-18.
Terminal Disclaimer
The terminal disclaimer filed on May 15, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 9,714,916 and US 10,613,051 has been reviewed and is accepted. The terminal disclaimer has been recorded. Naturally, the outstanding obviousness double patenting rejections have been withdrawn.
Response to Arguments
Applicant's arguments with respect to the patentability of claims 1-6 have been fully considered but they are not persuasive.
Applicant argues that the outstanding rejection of claim 1 should be withdrawn because the combination of Atchley et al. (“Atchley”), Shine et al. (“Shine”) and Young does not teach/render obvious the recitation “re-counting the same diluted sample without re-acquiring and re-diluting the blood sample by the impedance method after the unblocking operation”. Remarks 9. The argument is not persuasive because Applicant makes presumptions about the modified Atchley method without providing evidence supporting the presumptions. Specifically, Applicant argues, without supporting evidence, that the modified Atchley method would involve sourcing aliquots from a reservoir of undiluted sample and individually diluting each aliquot before counting) (see Remarks 10-11). Contrary to Applicant’s presumption, based on the disclosure of the prior art (see [0033] of Atchley disclosing “continuing the run”, and [0023] and [0128] of Young disclosing that diluted/lysed cells need time to re-equilibrate), there is no basis for presuming that re-counting in the event of pore-blockage would be preceded by acquiring a residual aliquot of an undiluted sample, diluting the aliquot, lysing the cells in the aliquot, and waiting for the aliquot to re-equilibrate. Instead, based on the disclosure of the cited prior art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a reservoir of a diluted/lysed sample from which residual aliquots can be sourced for the purpose of re-counting in the event of pore-blockage. Consequently, modified Atchley method would involve a step of “re-counting the same diluted sample without re-acquiring and re-diluting the blood sample by the impedance method after the unblocking operation” as recited in claim 1.
For the foregoing reason, the outstanding rejections of claims 1-6 are maintained.
Claim Objections
Claims 7-11 and 15-18 are objected to because of the following informalities:
Claims 7-9, 17 and 18 recite a step of “re-counting” the residual diluted sample. Since the residual diluted sample was never previously counted (i.e. while the sample as a whole is re-counted, the specific residual volume is not re-counted), the limitation should be changed to properly reflect the nature of the method step.
Claims 7, 8, 10, 11 and 15-18 are inconsistent in the spelling of the limitation “close(d)” and “open(ed)”.
In claim 16, the limitation “injecting the acquired diluted sample” should be changed to “injecting part of the acquired diluted sample”.
In claim 18, the limitation “near to the” should be changed to “near the”.
Appropriate corrections are required.
Claim 17 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 16. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim (claim 16 is allowable) to object to the other (claim 17) as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Despite minor differences in claim language, claims 16 and 17 appear to be identical in scope.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley (US 2009/0315533 A1) in view of Shine (US 2002/0035879 A1) and Young (US 2003/0092184 A1).
With respect to claim 1, Atchley discloses a method for counting particles, the method comprising the steps of:
counting particles in a sample using a Coulter counter (see [0033]) by a resistance method (see [0034]), and monitoring whether a pore blocking event occurs during counting (see [0033]);
suspending counting (see [0035] disclosing that counting must be suspended while unblocking operation is conducted) and performing an unblocking operation if the pore blocking event occurs (see [0033] and [0053]); and
re-counting the same sample after the unblocking operation (see [0053]).
The method taught by Atchley differs from the claimed invention in that Atchley does not explicitly disclose that the Coulter counter measures impedance. In addition, Atchley does not explicitly disclose that the sample is blood, and Atchley does not disclose the steps of preparing the sample for analysis (i.e. acquiring a sample in a test location, and preparing a diluted sample from the acquired sample).
Regarding the measurement of impedance, given that resistance and impedance are analogous, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the Coulter counter to measure impedance instead of resistance (see also [0022] of Shine disclosing that resistance or impedance is measured in a normal Coulter counter).
Regarding the nature of the sample and the steps of acquiring said sample and subsequently diluting the sample prior to analysis, Atchley discloses that Coulter counters are commonly used to analyze (count and identify) blood cells (see [0005]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have analyzed blood cells using the method taught by Atchley. Naturally, such a method would further comprise a step of acquiring the blood sample at a test location (e.g. a lab, a hospital, a clinic), and preparing the blood sample for analysis via the Coulter counter, for example, diluting it, as taught by Young (see [0023]). If the modifications suggested above are made (i.e. blood is used as the sample, the blood is diluted prior to counting, and change in impedance is used to perform counting), then the method would comprise the steps of:
acquiring a blood sample in a test location;
preparing a diluted sample from the acquired sample;
counting the diluted sample by an impedance method, and monitoring whether a pore blocking event occurs during counting;
suspending counting and performing an unblocking operation if the pore blocking event occurs; and
re-counting the same diluted sample without re-acquiring and re-diluting the blood sample by the impedance method after the unblocking operation.
With respect to claim 2, the method further comprises:
monitoring the pore blocking event during a predetermined period from the beginning of the counting (see [0015] and [0033]); and
outputting the pore blocking event when the pore blocking event is identified (see [0033] disclosing that the Coulter counter automatically takes a predetermined action upon detecting a pore blocking event, meaning the identification of the pore blocking event must be outputted).
With respect to claim 3, the monitoring step comprises:
starting timing once counting starts (see [0015] and [0046]);
instantly determining a received pore voltage in real time* during the timing (see [0015], [0050] and [0064]); and
outputting the pore blocking event when determining that the pore voltage is abnormal (see [0064]).
*While Atchley does not disclose the terms “real time” or “instantly”, based on the disclosure directed to how the pore blocking event is identified and subsequently resolved, it is evident that the pore voltage is determined instantly in real time during the timing.
With respect to claim 4, determining the received pore voltage in real time comprises determining whether the pore voltage is abnormal according to at least one of intensity of the real-time pore voltage (see [0020]), baseline voltage (see [0020]) and pulse form (see [0019]).
With respect to claim 5, the unblocking operation comprises pushing liquid backwards to dislodge pore blocking material (see [0052]).
With respect to claim 12, detection of a pore blocking event occurs over a predetermined period (during the “run”, see [0033]) during which pore voltage is measured in real time (see [0033] and rejection of claim 3 above). While Atchley does not disclose a step of outputting a discharge control signal when the predetermined period is reached (i.e. when the “run” is completed), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have flushed the Coulter counter after the “run” by outputting a discharge control signal so that a subsequent sample can be processed.
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley in view of Shine and Young as applied to claims 1-5 and 12, and further in view of Xu et al. (“Xu”) (CN 101750477 A).
With respect to claim 6, the combination of Atchley, Shine and Young does not teach an unblocking operation that encompasses supplying an electric current to burn off pore blocking material. However, Coulter counters that address pore blocking events by applying an electric current so as to burn off pore blocking material are well-known in the art (see [0031] of Xu). Based on the disclosure of Xu, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Atchley Coulter counter with a means to perform an unblocking operation by supplying an electric current to burn off the pore blocking material. The modification would constitute substitution of one element (reversing flow) for an equivalent (burning off material), which is considered obvious. Alternatively, the modification would provide the Coulter counter with an additional method of performing an unblocking operation in case the unblocking operation taught by Atchley (reversing flow) is unsuccessful.
Claims 7, 10, 11 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley in view of Shine and Young as applied to claims 1-5 and 12, and further in view of Katayama (US 5,731,867).
With respect to claim 7, as discussed above, the modified Atchley method would comprise obtaining a diluted sample. Moreover, it is evident that the Coulter counter comprises a counting cell in which the counting takes place. However, the combination of Atchley, Shine and Young does not explicitly disclose a reaction cell comprising a liquid discharge valve or a liquid addition system.
Katayama discloses a conventional cytometer comprising a reaction cell 3a, a liquid addition system (i.e. a pump 4), and a liquid discharge valve 1 for injecting a sample into a counting cell 7a (see Fig. 1). In light of the disclosure of Katayama and the lack of disclosure by the combination of Atchley, Shine and Young regarding a mechanism for introducing the diluted sample into the counting cell, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the Coulter counter with the set-up taught by Katayama, specifically a Coulter counter comprising a reaction cell in which the diluted sample is stored, a liquid addition system for acquiring the diluted sample from the reaction cell, and a liquid discharge valve for controllably dispensing a portion of the diluted sample into the counting cell. Naturally, the method would comprise a step of using the valve to retain a residual diluted sample in the reaction cell in case of a pore-blocking event.
With respect to claims 10 and 11, to flush the Coulter counter after the analysis (regardless of whether pore-blocking event was detected during analysis), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have outputted a discharge control signal to the liquid discharge valve (i.e. open the valve) to discharge the residual diluted sample that remains in the reaction cell.
With respect to claim 13, the unblocking operation comprises pushing liquid backwards to dislodge pore blocking material (see [0052]).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley in view of Shine, Young and Katayama as applied to claims 7, 10, 11 and 13, and further in view of Xu.
With respect to claim 14, the combination of Atchley, Shine, Young and Katayama does not teach an unblocking operation that encompasses supplying an electric current to burn off pore blocking material. However, Coulter counters that address pore blocking events by applying an electric current between electrodes (anode and cathode) situated on opposing sides of a pore so as to burn off pore blocking material are well-known in the art (see [0031] and Fig. 3 of Xu illustrating electrodes 3 and 4 situated on opposite sides of pore 1). Based on the disclosure of Xu, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Atchley Coulter counter with a means to perform an unblocking operation by supplying an electric current between electrodes situated on opposite sides of the pore to burn off the pore blocking material. The modification would constitute substitution of one element (reversing flow) for an equivalent (burning off material), which is considered obvious. Alternatively, the modification would provide the Coulter counter with an additional method of performing an unblocking operation in case the unblocking operation taught by Atchley (reversing flow) is unsuccessful.
Allowable Subject Matter
Claims 8, 9, 15, 16 and 18 would be allowable if they are rewritten to overcome the applicable objections 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:
As discussed above, Atchley discloses a method for counting particles, wherein the method comprises a step of re-starting the counting when a pore-blocking event is detected during counting. Naturally, Atchley discloses retaining a residual sample for conducting the re-count.
However, Atchley does not disclose suggest the subject matter recited in claims 8, 9, 15 and 18, which are directed to specific ways of retaining a residual sample for rec-counting. Based on the disclosure of Atchley and other relevant prior art, there is no motivation to modify the method taught by Atchley to arrive the at the respective claimed methods.
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 PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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