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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-14, in the reply filed on 03/11/2026 is acknowledged. The traversal is on the ground(s) that there is significant overlap between the claims of these groups, where while there are aspects of group I which do not overlap with groups II or III, these additional features of group I would in no way complicate the search or examination of either group II or group III. This is not found persuasive because it is the lack of overlap between the groups that makes the inventions independent or distinct for the reasons stated in the Office Action mailed 01/22/2026 and because the groups have aspects that do not overlap this would require the groups to have a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/11/2026.
Status of Claims
Claims 1-20 remain pending in the application, with claims 1014 being examined and claims 15-20 being withdrawn pursuant to the election filed 03/11/2026.
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 1-14 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 “an imaging region of the flowcell” on line 5, where it is unclear if this imaging region is the same or different from the one described on lines 2-3.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 5 to recite “convey the light to [[an]] the imaging region of the flowcell”
Claims 2-14 are rejected by virtue of being dependent on a rejected claim.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wanders (US-2014/0329265-A1) in view of Belz (WO-2021/094009-A1) mapped using Belz (US-2022/0205925-A1).
Regarding claim 1, Wanders teaches a biological imaging analyzer (see Figure 1) comprising:
a flowcell (flowcell 22) configured to flow biological cells therethrough, the flowcell (22) including an imaging region (first section 22a) where images of the biological cells are captured ([0021], [0070], [0123] see flowcell is constructed of a first or upper section/layer 22a and a second lower section/layer 22b where the upper section 22a has a glass/transparent window pane 60 that is attached/integral to define a portion of a sample flowpath within the flowcell where light travels from light source 42 to illuminate sample particles, Figures 1-3);
a lighting module (light source 42) configured to generate a light ([0079], Figures 1-3);
an imaging module (high optical resolution imaging device 24) configured to capture images of the biological cells at the imaging region (22a) of the flowcell (22) ([0070], Figures 1-3); and
a flowcell holder (gimbaled carrier 55) in operable connection with the flowcell (22) ([0088], Figures 1A-B).
Please note that the biological cells have not been positively recited in the claim, and are therefore not a part of the claimed analyzer.
While Wanders does teach light source 42, Wanders does not teach a light guide configured to convey the light to an imaging region of the flowcell.
In the same problem solving area of illuminating a flow cell, Belz teaches that a system can comprise at least one lighting guide device for guiding light from or to a window such that a light source does not need to be placed directly at the window to prevent heat emission into the flow cell (Belz; [0020]).
It would have been obvious to one skilled in the art to modify the flowcell of Wanders such that it includes a lighting guide that connects the light source to the flowcell as taught by Belz because Belz teaches that the lighting guide allows the illumination source to be placed away from the flow cell to prevent heat emission into the flow cell (Belz; [0020]).
Regarding claim 2, modified Wanders teaches the biological imaging analyzer of claim 1. Wanders further teaches wherein the imaging module (24) comprises a camera (Wanders; [0017] see in some aspects the high optical resolution imaging device comprises a camera).
Regarding claim 3, modified Wanders teaches the biological imaging analyzer of claim 1.
The limitations of claim 3 are directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by modified Wanders and the apparatus of modified Wanders is capable of working on stained blood cells. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Wanders (see MPEP §2115).
Further, please note that the biological cells have not been positively recited in the claim, and are therefore not a part of the analyzer.
However, please see [0229] of Wanders which describes that functional components and/or features of the analyzer include sample staining processing, and [0342] which describes an embodiment where a contrast agent may be used to stain white blood cells.
Regarding claim 4, modified Wanders teaches the biological imaging analyzer of claim 1. Wanders further teaches wherein the light is a pulsed light (Wanders; [0094] see the light source can be a strobe that is flashed in time with operation of the high optical resolution imaging device photosensor).
Regarding claim 5, modified Wanders teaches the biological imaging analyzer of claim 1. Wanders has been modified with Belz such that the light source is now located away from the flowcell, where the light guide guides light to the flowcell instead. As seen in Figures 1A-B of Wanders, the flowcell 22 is placed on the gimbaled carrier 55, where further based on Figures 2-3 it will be second lower section/layer 22b that is the part contacting the gimbaled carrier, where this side also has the light source 42 best seen in Figure 3.
One skilled in the art would find it obvious that the light guide of Belz would need to be in operable connection with the gimbaled carrier of Wanders based on how the flowcell is placed on the gimbaled carrier.
Regarding claim 6, modified Wanders teaches the biological imaging analyzer of claim 5. Wanders has been modified with Belz such that the light source is now located away from the flowcell, where the light guide guides light to the flowcell instead.
As described in claim 5 supra, the light guide of Belz is in operable connection with the gimbaled carrier of Wanders, where one skilled in the art would find it obvious that the light guide will be fixed, and that therefore when the flowcell is attached to the gimbaled carrier the distance between the light guide and flowcell will be fixed.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wanders (US-2014/0329265-A1), Belz (WO-2021/094009-A1) mapped using Belz (US-2022/0205925-A1), and in further view of Duckett (US-2017/0248515-A1).
Regarding claim 7, modified Wanders teaches the biological imaging analyzer of claim 1. Wanders does teach where the light source is a strobe that is flashed in time with operation of the high optical resolution imaging device (Wanders; [0094]), however Wanders does not teach that the light is white light.
In the same problem solving area of illuminating a flow cell, Duckett teaches that a flow cytometer may include a light source to irradiate an assay region of a flow channel of the flow cell with white light (Duckett; [0039]).
Wanders is silent with regards to specific color of light the light source emits, therefore, it would have been necessary and thus obvious to look to the prior art for conventional colors irradiated for flow cells. Duckett provides this conventional teaching showing that it is known in the art to use white light. Therefore, it would have been obvious to one having ordinary skill in the art to make the light source emit white light as taught by Duckett because Duckett teaches that white light is effective for irradiating the assay region of a flow cell (Duckett; [0039]).
Claim(s) 8-12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wanders (US-2014/0329265-A1), Belz (WO-2021/094009-A1) mapped using Belz (US-2022/0205925-A1), and in further view of Petroff (US-2004/0157336-A1).
Regarding claim 8, modified Wanders teaches the biological imaging analyzer of claim 1. Wanders does not teach wherein the flowcell holder (gimbaled carrier 55) includes a connector contacting a portion of the imaging region of the flowcell.
In the same problem solving area of cartridge alignment, Petroff teaches alignment components (Petroff; [0009]).
Specifically, Petroff teaches where a cartridge holder station includes cartridge alignment pins 305 that engages with cartridge alignment features 210 on the cartridge 200 (Petroff; [0064], Figures 2A-2B, 3).
It would have been obvious to one skilled in the art to modify the gimbaled carrier of Wanders to include alignment pins, and to modify the flowcell to have alignment features as taught by Petroff because Petroff teaches that these components ensures that the cartridge is in a preferred orientation and to ensure correct insertion and/or alignment (Petroff; [0064]).
From Figures 2A-B of Petroff it shows the front and back side of the cartridge respectively (Petroff; [0059]), where it is understood that the alignment features run through the entire thickness of the cartridge. Therefore, the flowcell 22 of Wanders will have alignment features that go through both layers 22a and 22b. When the flowcell 22 is then placed in alignment with the alignment pins on the gimbaled carrier, the pins will contact layer 22a (imaging region).
Regarding claim 9, modified Wanders teaches the biological imaging analyzer of claim 8. Petroff further teaches wherein the connector comprises a pair of arcuate ridges (see Figure 3 of Petroff which shows two alignment pins 305, where the pins are circular in shape and are therefore arcuate).
Regarding claim 10, modified Wanders teaches the biological imaging analyzer of claim 9. Petroff further teaches wherein the pair of arcuate ridges include respective engagement surfaces configured to frictionally engage the portion of the imaging region of the flowcell (Petroff; Figure 3 where the flat ends of the alignment pins are engagement surfaces that will contact layer 22a of Wanders flowcell (see claim 8 supra). It is understood that as the pins are inserted into the holes there would be some amount of friction to hold the flowcell in place and is therefore frictionally engaged).
Regarding claim 11, modified Wanders teaches the biological imaging analyzer of claim 10. Wanders has been modified by Petroff such that the gimbaled carrier has alignment pins and the flowcell has corresponding alignment features.
One skilled in the art would find it obvious to place the alignment features on the flowcell on opposite sides of the sample stream 32 (seen in Figures 3A-B of Wanders) such that it does not disrupt the sample stream, as the alignment features are understood to go through both layers 22a and 22b of the flowcell. Therefore the alignment pins will frictionally engage the imaging region of the flowcell on opposite sides of a flowpath.
Regarding claim 12, modified Wanders teaches the biological imaging analyzer of claim 8. Wanders has been modified by Petroff such that the gimbaled carrier has alignment pins. It is described by Wanders [0254] where a metal plate holds or is connected to the flowcell, where one skilled in the art would find it obvious that therefore the gimbaled carrier and the alignment pins of the gimbaled carrier that the flowcell is mounted to is metal.
Regarding claim 14, modified Wanders teaches the biological imaging analyzer of claim 8. Wanders further teaches wherein the portion of the imaging region (22a) of the flowcell (22) comprises glass (Wanders; [0123] see glass window pane 60 is attached to or integral with the first section 22a).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wanders (US-2014/0329265-A1), Belz (WO-2021/094009-A1) mapped using Belz (US-2022/0205925-A1), Petroff (US-2004/0157336-A1), and in further view of translated Kobasa (JP-H05149870-A).
Regarding claim 13, modified Wanders teaches the biological imaging analyzer of claim 12. Wanders does teach a metal plate that holds/connected to the flowcell (Wanders; [0254]), however Wanders does not teach wherein the connector comprises aluminum.
In the same problem solving area of flow cell holders, Kobasa teaches that a flow cell holder is preferably made with aluminum with easy precision processing (Kobasa; [0011]).
Wanders is silent with regards to specific metal of the carrier for the flowcell, therefore, it would have been necessary and thus obvious to look to the prior art for conventional metals used as holders for flowcells. Kobasa provides this conventional teaching showing that it is known in the art to use aluminum. Therefore, it would have been obvious to one having ordinary skill in the art to make the metal plate that holds the flowcell (the gimbaled carrier best seen in Figures 1A-B that also has the alignment pins taught by Petroff) to be made of aluminum because Kobasa teaches that aluminum is an effective material for a flowcell holder.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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