DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 26, 2023 and June 12, 2025 are being considered by the examiner.
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.
Claims 1-4 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 6 and 1 of US 9,714,916 B2, respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 9,714,916 B2 anticipate the respective claims of the instant application. While the claims of US 9,714,916 B2 do not recite that the sample is blood, given that the sample in the claims of US 9,714,916 B2 comprises particles, it would have been obvious to one of ordinary skill in the art to use blood as the sample in the claims of US 9,714,916 B2 to perform a blood count.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5-8 of US 10,613,051 B2, respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 10,613,051 B2 anticipate the respective claims of the instant application. While the claims of US 10,613,051 B2 do not recite that the sample is blood, given that the sample in the claims of US 10,613,051 B2 comprises particles, it would have been obvious to one of ordinary skill in the art to use blood as the sample in the claims of US 10,613,051 B2 to perform a blood count.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, the limitation “by the acquired sample” in line 3 should be changed to “from the acquired sample”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley et al. (“Atchley”) (US 2009/0315533 A1) in view of Shine et al. (“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 to configure 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 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 to analyze 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 sample for analysis via the Coulter counter, for example, diluting it, as taught by Young (see [0023]).
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 received pore voltage is determined the moment it is received, and the determination is made 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]).
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 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 to provide 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.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796