DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see p. 2, filed 07/21/2026, with respect to the objection to drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see p. 4, filed 07/21/2026, with respect to the objections in claims 1, 17, and 18 have been fully considered and are persuasive. The objections to the claims have been withdrawn.
Applicant’s arguments, see p. 5, filed 07/21/2026, with respect to the 35 U.S.C. 112(b) in claims 1-5 and 7-21 have been fully considered and are persuasive. The rejections to the claims have been withdrawn.
Applicant’s arguments, see p. 6, filed 07/21/2026, with respect to the rejections of claim 1 under 35 U.S.C. § 102 has fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Yabusaki and Kano et al. (See 35 U.S.C § 103 rejection below)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-5, 8, 15-17, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yabusaki (US 6667177 B1) (referenced in IDS) and Kano et al. (US 4303616 A) (referenced in 892).
Regarding claim 1, Yabusaki teaches a counting assembly (See annotated FIG. 4 - leukocyte accumulation container – element 1 – which is utilized for counting leukocytes (p 14. Col. 9 Line 66-67 & Col.10, Lines 1-10) comprising a main body (element 1) with an inner wall defining a sample tank, with a top end of the sample tank is open, and a lower surface of the inner wall forms a bottom end of the sample tank, and is planar (See annotated FIG. 4 below – element 13), and a cross sectional area of the sample tank gradually increases from the bottom end to the top end of the sample tank (Annotated FIG. 4 (element 12 – side wall portion)).
PNG
media_image1.png
367
443
media_image1.png
Greyscale
Yabusaki fails to teach the following limitations:
An outer cylindrical wall
Kano et al. teaches an analysis vessel for particles (abstract), wherein said analyzing vessel (FIG. 7) comprises an outer cylindrical wall and conical interior. Specifically, Kano et al. teaches a vessel chamber (element 1) formed as a depression within a solid cylindrical block (See annotated FIG. 7), as this depressed shape would be easily manufactured through known techniques such as molding inside a cylindrical block.
PNG
media_image2.png
155
525
media_image2.png
Greyscale
It would have been prima facie obvious to a person of ordinary skill in the art to use Kano et al.’s teaching an outer cylindrical wall in Yabusaki’s counting assembly because there are alternative ways in the art of forming a chamber from a cylindrical block. This method of improving Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Kano et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Yabusaki and Kano et al. to obtain the invention as specified in claim 1.
Regarding claim 2, modified Yabusaki teaches the counting assembly of claim 1. Yabusaki also teaches a sample tank that has the shape of an inverted frustrum of a cone (See annotated FIG. 6 below - perspective view of leukocyte accumulation container).
PNG
media_image3.png
458
506
media_image3.png
Greyscale
Regarding claim 3, modified Yabusaki teaches the counting assembly of claim 1. Yabusaki also teaches a sample tank wherein an angle between an inner side wall of the sample tank and a horizontal plane is less than 90° (See annotated FIG. 4 – angle between the horizontal plane and inner wall).
Regarding claim 4, Yabusaki teaches the counting assembly of claim 1. Yabusaki fails to teach wherein the angle between the inner wall of the sample tank and the horizontal plane is 45° - 60°. Nevertheless, it would have been obvious to one of ordinary skill before the effective filing date to perform routine experimentation on the angle between inner wall and horizontal plane to optimize sinking of the test subjects and enriching the bottom of the sample tank. MPEP § 2144.05.II establishes that routine optimization within prior art conditions or through routine experimentation are obvious.
Regarding claim 5, modified Yabusaki teaches the counting assembly of claim 1. Yabusaki also teaches a structure present in the main body (FIG. 4), and the structure has a uniform wall thickness (See thickness of element 12 in FIG. 4).
Regarding claim 8, modified Yabusaki teaches the counting assembly of claim 1. The combination of references of claim 1 would encompass a structure of a hollow enclosed structure formed by the outer cylindrical wall and the inner wall. Therefore, the claim is prima facie obvious.
Regarding claim 15, modified Yabusaki teaches the counting assembly of claim 1. Yabusaki also teaches that the bottom surface of the sample tank is smaller than an imaging target surface of a camera (See annotated FIG. 15 below, where element 521a (image-capturing surface) is bigger than element 13 (bottom portion).
PNG
media_image4.png
333
541
media_image4.png
Greyscale
Regarding claim 16, modified Yabusaki teaches the counting assembly of claim 15. Yabusaki teaches a bottom portion, where the maximum diameter of the bottom portion according to the invention is 0.2 mm to 5 mm. (Col. 3, Lines 41-44). This prior art range overlaps with the claimed range of 1.5 mm to 2.00 mm. Yabusaki later teaches that the shape of the bottom portion is similar to that of an image-capturing surface possessed by the apparatus for counting leukocytes, and the maximum diameter is preferably between 1 to 3 mm (Col 10., 1st paragraph). It has been established that overlapping ranges between the prior art and claimed ranges possess a prima facie case of obviousness (MPEP § 2144.05.I). It would have been obvious to one of ordinary skill before the effective filing date to use the claimed range specifically since it is preferable to have a shape and diameter of a bottom portion similar to that of an image-capturing surface.
Regarding claim 17, Yabusaki teaches a counting device (See annotated FIG. 4 - leukocyte accumulation container – element 1 – which is utilized for counting leukocytes (p 14. Col. 9 Line 66-67 & Col.10, Lines 1-10) comprising a counting assembly (leukocyte accumulation container – element 1) comprising a main body (element 1) with an inner wall defining a sample tank, with a top end of the sample tank is open, and a lower surface of the inner wall forms a bottom end of the sample tank, and is planar (See annotated FIG. 4 below – element 13), and a cross sectional area of the sample tank gradually increases from the bottom end to the top end of the sample tank (Annotated FIG. 4 (element 12 – side wall portion)).
PNG
media_image1.png
367
443
media_image1.png
Greyscale
Yabusaki fails to teach the following limitations:
An outer cylindrical wall
Kano et al. teaches an analysis vessel for particles (abstract), wherein said analyzing vessel (FIG. 7) comprises an outer cylindrical wall and conical interior. Specifically, Kano et al. teaches a vessel chamber (element 1) formed as a depression within a solid cylindrical block (See annotated FIG. 7), as this depressed shape would be easily manufactured through known techniques such as molding inside a cylindrical block.
PNG
media_image2.png
155
525
media_image2.png
Greyscale
It would have been prima facie obvious to a person of ordinary skill in the art to use Kano et al.’s teaching an outer cylindrical wall in Yabusaki’s counting assembly because there are alternative ways in the art of forming a chamber from a cylindrical block. This method of improving Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Kano et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Yabusaki and Kano et al. to obtain the invention as specified in claim 17.
Regarding claim 24, modified Yabusaki teaches the county assembly of claim 1. Furthermore, the combination of references of claim 1 would encompass a counting assembly wherein the main body is a cylindrical solid structure, and the sample tank is a recessed space formed within the cylindrical solid structure. Therefore, the claim is prima facie obvious.
Claims 9, 11, 12, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yabusaki (already referenced) and Kano et al (already referenced) as applied to claim 1, and further in view of Zheng et al. (CN 213091448 U) (cited in IDS) (citing machine translation (MT) provided by applicant).
Regarding claim 9, modified Yabusaki teaches the counting assembly of claim 1. Yabusaki fails to teach a cover plate, where the upper surface of the main body is in contact with a lower surface of the cover plate, wherein the cover plate is provided with one or more sample filling holes and one or more air venting holes. Zheng et al. teaches a cover plate (element 11), with the upper surface of the main body (transparent bottom plate (element 12) is in contact with a lower surface of the cover plate (element 11) (See annotated FIG. 2). Zheng et al. teaches that connecting the cover plate (element 11) and the transparent bottom plate (element 12) seals the counting plate (element 10) (p. 3 of MT provided, 7th paragraph).
PNG
media_image5.png
221
637
media_image5.png
Greyscale
It would have been obvious to a person of ordinary skill in the art to use Zheng et al.’s teaching of a cover plate in contact with the main body in Yabusaki’s counting assembly, as the cover plate allows sealing to occur in the counting assembly. This method of improving Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Zheng et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Yabusaki and Zheng et al. to obtain the invention as specified in claim 9.
Zheng et al. teaches a cover plate (See annotated FIG. 1, element 11) with sample adding hole (FIG. 1, element 14), which allows the sample to be added into the counting device (p. 3 of MT, 3rd paragraph). Zheng et al. also teaches a vent hole (FIG. 1, element 15), which allow the blood samples to smoothly drop into cavity (element 13) (p. 3 of MT, 10th paragraph).
PNG
media_image6.png
359
632
media_image6.png
Greyscale
It would have been obvious to a person of ordinary skill in the art to use Zheng et al.’s teaching of a cover plate in contact with the main body in Yabusaki’s counting assembly, as the cover plate allows sealing to occur in the counting assembly. This method of improving Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Zheng et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Yabusaki and Zheng et al. to obtain the invention as specified in claim 9.
Regarding claim 11, the structure resulting from the combination of the references addressing claim 9 would encompass a structure with a cover plate greater in area than the upper surface of the main body (See FIG. 1 above, cover plate 11 is larger than bottom plate 12).
Regarding claim 12, the structure resulting from the combination of the references addressing claim 9 would encompass a structure with one or more air venting holes and sample filling holes that are circular in shape. (See FIG. 1 above, elements 14 and 15)
Regarding claim 18, Yabusaki teaches the conical counting device of claim 17. Yabusaki teaches a carrier plate (See FIG. 8 - collective type leukocyte accumulation container – element 1A), the carrier plate being provided with at least one hole matching a counting assembly (Yabusaki treats elements 10, 11A, 12A, and 13A as the counting assembly). Furthermore, Yabusaki teaches that the diameter of the at least one hold is greater than an outer diameter of the main body and a diameter of the cover plate (FIG. 8, 11A). However, Yabusaki fails to teach that the counting device includes a cover plate.
Zheng et al. teaches a cover plate (element 11), with the upper surface of the main body (transparent bottom plate (element 12) is in contact with a lower surface of the cover plate (element 11) (See annotated FIG. 2 in claim 9 rejection). Zheng et al. teaches that connecting the cover plate (element 11) and the transparent bottom plate (element 12) seals the counting plate (element 10) (p. 3 of MT provided, 7th paragraph).
It would have been obvious to a person of ordinary skill in the art to use Zheng et al.’s teaching of a cover plate in contact with the main body in modified Yabusaki’s counting device, as the cover plate allows sealing to occur in the counting assembly. This method of improving modified Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Zheng et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Yabusaki and Zheng et al. to obtain the invention as specified in claim 18.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yabusaki (already referenced), Kano et al (already referenced), Zheng et al. (already referenced) as applied to claim 9, and further in view of Zheng et al. (CN 213091449 U) (using machine translation in prior office action).
Regarding claim 10, modified Yabusaki teaches the counting assembly of claim 9. Modified Yabusaki fails to teach that the sample filling holes or air venting holes’ projections have no overlap with a projection of the bottom end of sample tank on the horizontal plane. Zheng et al. teaches a counting plate with a cover plate featuring sample inlet (Please see annotated FIG. 3, element 14) and vent hole (FIG. 3, element 15). Zheng et al. teaches also a counting cell (FIG. 3, element 13), a region defined in the rectangular area, which are used to observe the samples to be tested under lens module (element 40) (para. [0052] of MT).
PNG
media_image7.png
297
658
media_image7.png
Greyscale
It would have been obvious to a person of ordinary skill in the art to use Zheng et al.’s teaching of non-overlapping projections in modified Yabusaki’s counting assembly, as the non-overlapping projections would prevent observation under the lens during analysis and testing. This method of improving modified Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Zheng et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Yabusaki and Zheng et al. to obtain the invention as specified in claim 10.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yabusaki (already referenced), Kano et al. (already referenced), Zheng et al. (already referenced) as applied to claim 9, and in view of Tanaka et al. (US 11768213 B2) (referenced in prior office action)
Regarding claims 13 and 14, modified Yabusaki teaches the counting assembly of claim 9. Modified Yabusaki fails to a protrusion provided on the upper side of an edge of one or more sample filling holes, and second protrusion provided on an underside of an edge of one or more sample filling holes, and an outer side of the second protrusion is in contact with an inner wall of the sample tank. Tanaka et al. teaches a reagent container (element 100) with a protrusion provided through tubular member (element 20), which extends on an upper side (see highlighted region in annotated FIG. 5) and underside (see highlighted region in annotated FIG. 5) of sheet-shaped member (element 31), which is in contact with an inner wall of the sample tank. Tanaka et al. teaches that tubular member 20 allows aspiration tube (element 90) to enter the container and directly move downwards (p. 18, Col. 11, 4th paragraph)
PNG
media_image8.png
436
519
media_image8.png
Greyscale
It would have been obvious to a person of ordinary skill in the art to use Tanaka et al.’s teaching of protruding cylindrical edge in modified Yabusaki’s counting assembly, as the cylindrical protrusion allows an aspiration tube to enter the container directly downwards. This method of improving modified Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Tanaka et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Yabusaki and Tanaka et al. to obtain the invention as specified in claims 13 and 14.
Claims 19, 20, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Yabusaki (already referenced), Kano et al. (already referenced), Zheng et al. (already referenced) as applied to claim 18, and further in view of Clark et al. (US 20150353880 A1) (referenced in prior office action).
Regarding claim 19, modified Yabusaki teaches the device of claim 18. Modified Yabusaki additionally teaches at least one hole attached to each of the one or more counting assemblies. Modified Yabusaki fails to teach that the carrier plate has a count of 24, 48, 96 holes. Clark et al. teaches an apparatus used for cell-counting which includes a storage cartridge (element 1) with 24, 48, or 96 isolated chambers (para. [0053]). Clark et al. further teaches that the isolate chambers can be used to hold aliquots of cell samples to test different reagents (para. [0054]).
It would have been obvious to a person of ordinary skill in the art to use Clark et al.’s teaching of a 24, 48, or 96 chamber configurations in modified Yabusaki’s counting device, as the 24, 48, or 96 isolated chambers allow aliquots of cell samples to be held and tested with different reagents. This method of improving modified Yabusaki’s device was within the ability of one of ordinary skill in the art based on the teachings of Clark et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Yabusaki and Clark et al. to obtain the invention as specified in claims 19.
Regarding claim 20, modified Yabusaki teaches counting device of claim 19. Yabusaki teaches the carrier plate in FIG. 8 as integrally molded with the counting assemblies. (See annotated FIG. 8 below). The structure resulting from the combination of the references addressing claim 20 would result in a carrier plate integrally molded with the one or more counting assemblies.
PNG
media_image9.png
249
503
media_image9.png
Greyscale
Regarding claim 21, modified Yabusaki teaches counting device of claim 19. Yabusaki teaches the carrier plate, where supporting edges are provided on a side of the carrier plate, and the height of one or more supporting edges extending towards a bottom side of the counting assembly is greater than a height of the counting assembly (See annotated FIG. 8 above). The structure resulting from the combination of the references addressing claim 21 would result in supporting edges provided on a side of the carrier plate, and the height of one or more supporting edges extending towards a bottom side of the counting assembly is greater than a height of the counting assembly.
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 JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
