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 .
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 3, 6, 9, 10, 13, 41, and 43 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.
Claims 13, 41, and 43 recites the limitation "the chamber" and “two chambers” in lines 1 or 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 3, 6, 9, and 10, the phrase "as" (the same as “such as”) in lines 2 or 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-10, 12-18, 20-23, 25-40, 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuda (US3898982) in view of Chou et al (WO 2020/037304).
Regarding claim 1, Katsuda teach a kit for collection, mixing, staining, transferring, imaging, and analyzing a sample, comprising:
(i) a sample collecting and transferring device (device (a)), which is used for sample collection, sample mixing, sample staining and sample transferring, wherein the device (a) comprises
part (1) is a capillary tube with a reagent coated inside, which is used for sample collection from the inlet, mixture of the sample with pre-coated reagents inside the inner surface of the tube (Abstract),
part (2) is optional is used for providing an external force to suck in and/or push out the sample in the part (1) (col. 3 lines 30: blow spattering the blood within the capillary tube 11 onto the glass plate);
Katsuda teach a sample distribution and imaging device comprising: two plates opposing to each other, wherein the two plates define an interior cavity (fig. 6C; col. 3 lines 35-40: blood from the capillary tube 11 dropped onto a cover glass 15), Katsuda is silent to an exterior liquid sample contact area or sample inlet on an exterior location of the device (b), wherein the interior cavity is in fluid communication with the exterior liquid sample contact area, the liquid sample is capable of flowing into the spacing between the two plates from the exterior location through sample inlet and a sample landing Zone that is at the exterior location of the device (b) and connected to the sample inlet.
Chou et al teach open configuration sample deposition (Chou: p. 6 step (c) reads on an exterior liquid sample contact area or sample inlet on an exterior location of the device (b), wherein the interior cavity is in fluid communication with the exterior liquid sample contact area, the liquid sample is capable of flowing into the spacing between the two plates from the exterior location through sample inlet and a sample landing Zone that is at the exterior location of the device (b) and connected to the sample inlet). It is desirable to provide sample deposition when the two plates are open and capable of flowing into the spacing between the plates to apply the sample to the two plate device. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the sample contact area on the exterior location of the device of Chou to the device of Katsuda to provide the above advantage of providing sample to the two plate device.
Regarding claim 2, Katsuda/Chou teach a reagent pre-coated inside the cavity. (Katsuda: col. 4 line 16)
Regarding claim 3, Katsuda/Chou teach the reagent coated on the sample collecting and transferring device is surfactant as Zwittergent, anti-coagulation reagents as K2EDTA. (Katsuda: col. 4 line 16: EDTA)
Regarding claim 5, Katsuda/Chou teach the spacing height between the two plates is 2 pm, 3 pm, 5 pm,8pm, 10 pm or in a range between any of these values. (Chou: p. 19: spacer height 20um)
Regarding claim 6, Katsuda/Chou teach the reagent coated on the collecting and transferring device is surfactants Zwittergent, anti-coagulation reagents as K2EDTA (Katsuda: col. 4 line 16: EDTA). .
Regarding claim 7, Katsuda/Chou teach the spacing height between two plates is 10 pm, 15 pm, 20 pm,30 pm, 50 pm, 80 pm, 100 pm, 150 pm or in a range between any of these values. (Chou: p. 19: spacer height 20um)
Regarding claim 8, Katsuda/Chou teach the preferred spacing height between two plates is 30 pm, 50 pm, 80 pm, 100 pm, 150 pm or in a range between any of these values. (Chou: p. 19: spacer height 80um)
Regarding claim 9, Katsuda/Chou teach the reagent coated on the collecting and transferring device is surfactant as Zwittergent, anti-coagulation reagent as K2EDTA, fluorescence dye as Acridine orange, colorimetric dye as methylene blue. (Katsuda: col. 4 line 16: EDTA)
Regarding claim 10, Katsuda/Chou teach the reagent coated on the collecting and transferring device is surfactant as Zwittergent, anti-coagulation reagent as K2EDTA, fluorescence dye as Acridine orange and YOYO, colorimetric dye as methylene blue. (Katsuda: col. 4 line 16: EDTA)
Regarding claim 12, Katsuda/Chou teach the spacing height between two plates is 1 pm, 5 pm, 8 pm, 10 pm, 15 pm, 20 pm, 30 pm, or in a range between any of these values. (Chou: p. 19: spacer height 20um)
Regarding claim 13, Katsuda/Chou teach there are several different spacing areas in the chamber. (Chou: p. 33: different spacer height)
Regarding claim 14, Katsuda/Chou teach the spacing of each area is 1 pm, 2 pm, 3 pm, 5 pm, 10 pm,20 pm, 30 pm, 50 pm, 100 pm, 150 pm or in a range between any two of the values. (Chou: p. 19: spacer height 20um)
Regarding claim 15, Katsuda/Chou teach the spacing of one area is 2 pm, 3 pm, 5 pm, 10 pm, or in a range between any two of the values. (Chou p. 50: uniform height is 2um or more )
Regarding claim 16, Katsuda/Chou teach the difference between two spacing of each area is 0.5 pm,1pm, 2 pm, 3 pm, 5 pm, 10 pm, 20 pm, 30 pm, 50 pm, 100 pm, 150 pm, or in a range between any two of the values. (Chou p. 41: difference between heights 0.5 to 100 microns)
Regarding claim 17, Katsuda/Chou teach the signal measured in imaging area is cell or particle numbers, a colorimetric intensity, a transmitted light intensity, a fluorescence signal intensity, and/or a transmittance and/or absorptance (chou: p. 30 para. 2).
Regarding claim 18, Katsuda/Chou teach the two plates are not aligned at their edges to create the flowing boundary of the sample by capillary force (Katsuda Fig. 6D two plates are not aligned at their edges) .
Regarding claim 20, Katsuda/Chou teach the coating is on at least an interior opposing surface of one or both of the plates (Chou: p. 69 claim 35: both of the plates have a reagent coating).
Regarding claim 21, Katsuda/Chou teach the liquid sample for analyzing is pre-mixed with reagents before flowing into the device (a) or (b). (Katsuda: liquid sample pre-mixes with the reagent in the capillary tube before flowing into the slide 15)
Regarding claim 22, Katsuda/Chou teach the reagent is coated with a slope distribution inside the device to balance the final concentration in the device (a) after adding the liquid sample. (Chou p. 69, claim 33: different sample contact areas of different spacing heights having a coating of the reagent of a different surface concentration reads on "coated with a slope distribution")
Regarding claims 23 and 25, Katsuda/Chou teach there is a slow releasing coating with the reagent inside the device (a), the slow releasing layer delaying the reagents dissolving into the liquid sample after the sample become static after flowing in; the slow releasing materials comprise albumin, carbomers,carboxymethyl cellulose, carrageenan, chitosan, dextrin, polyethylene glycol, polyvinylpyrrolidone, and/or polyvinyl alcohol. (Chou: p. 12 para. 1: release time control material albumin)
Regarding claim 26, Katsuda/Chou teach an acridine orange is coated onto one or both of the two plates. (Chou p. 22 acridine orange)
Regarding claim 27, Katsuda/Chou teach a Zwittergent is coated onto one or both of the two plates. (Chou p. 23: Zwittergent)
Regarding claim 28, Katsuda/Chou teach a Methylene blue and a Zwittergent are coated onto one or both of the two plates. (Chou p. 23: Zwittergent and Methylene blue)
Regarding claim 29, Katsuda/Chou teach an acridine orange and a Zwittergent are coated onto one or both of the two plates. (Chou p. 22-23: Zwittergent and acridine orange )
Regarding claim 30, Katsuda/Chou teach a YOYO dye and a Zwittergent are coated onto one or both of the plates. (Chou: p. 11: YOYO dye and zwittergent)
Regarding claim 31, Katsuda/Chou teach the device further comprises, on one or both plates, multi reagent layers including anti-conglutination, cell lysing, cell staining, release time control material layers, and their combinations (Chou: P. 11).
Regarding claim 32, Katsuda/Chou teach is an array of spacers disposed between the two plates (Chou p. 67 claim 17).
Regarding claim 33, Katsuda/Chou teach the spacers are attached on one of the plates or both plates, wherein the spacers can be used as physical support of the two plates, the geometry reference, dimensional reference, and/or optical reference in the measurements (Chou: p. 6 spacer permanently fixed on one or both of the plates).
Regarding claim 34, Katsuda/Chou teach the lateral dimension of each spacer in each direction is the same or different (Chou p. 14).
Regarding claim 35, Katsuda/Chou teach the lateral dimension for each direction (x or y) is 1 nm or less,3 nm or less, 5 nm or less, 7 nm or less, 10 nm or less, 20 nm or less, 30 nm or less, 40 nm or less, 50 nm or less, 100 nm or less, 200 nm or less, 500 nm or less, 800 nm or less, 1000 nm or less, 1 pm or less, 2 pm or less, 3 pm or less, 5 pm or less, 10 pm or less, 20 pm or less, 30 pm or less, 50 pm or less, 100 pm or less, 150 pm or less, 200 pm or less, 300 pm or less, or 500 pm or less, or in a range between any two of the values. (Chou p. 14).
Regarding claim 36, Katsuda/Chou teach the period of spacer array is between 1 nm to 300 um (Chou p. 20).
Regarding claim 37, Katsuda/Chou teach one dimension of each spacer is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 10 mm, 20 mm or in a range between any of the two values. (Chou p. 8)
Regarding claim 38, Katsuda/Chou teach each spacer is made of plastic, polymer, adhesive materials, dielectric materials. (Chou p. 48)
Regarding claim 39, Katsuda/Chou teach the thickness variation of the spacers is less than 1%, less than 3%, less than 5%, less than 10% or in a range between any of the two values. (Chou p. 53)
Regarding claim 40, Katsuda/Chou teach the spacers function as the adhesive structure to both plates. (Chou p. 49 spacers fixed to both plates)
Regarding claim 44, Katsuda/Chou teach a method of performing biological and chemical assays, comprising the steps:
(1) providing the kit of claim 1 (see rejection above),
(2) collecting a sample into the sample collecting and transferring device, where the sample is mixed and stained by the reagent in the sample collecting and transferring device (Katsuda Abstract);
(3) transferring the sample from the sample collecting and transferring device by providing the external force to push out the sample to the sample landing Zone at the exterior location of the sample distribution and imaging device, where the sample flows into the cavity of the sample distribution and imaging device from the sample landing Zone and mix with reagent inside the sample distribution and imaging device, and distribute inside the sample distribution and imaging device (Katsuda abstract); and
(4) imaging and analyzing the sample inside the sample distribution and imaging device (Chou p. 6: measuring using imaging) .
Regarding claim 45, Katsuda/Chou teach the liquid sample is whole blood, and an analyte to be analyzed is red blood cells, white blood cells and platelets (Chou p.1) .
Regarding claim 46, Katsuda/Chou teach parameters measured in an imaging area is complete blood count, red blood cell count, hemoglobin, platelet count, white blood cell differentiation and count, and/or abnormal cell types (Chou p. 2).
Claim(s) 4, 11, 19, 24, 41, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuda (US3898982) in view of Chou et al (WO 2020/037304) and further in view of Chou et al (US 2018/0246089, hereinafter "Chou 2018").
Regarding claims 4 and 11, Katsuda/Chou teach using a sample but are silent to a volume of the sample collecting and transferring device is 1 ul,3ul,5ul, 10 ul, 15 ul, 20 ul or in a range between any of these values. (Chu: p. 44 c33: total volume less than 0.5 microliters). Chou 2018 teaches volume of the sample deposited "at most 1ul…at most 10ul…or a range of any two of these values"(Chou 2018 Para. 0628). It is desirable to provide adequate sample to be analyzed. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a volume of sample is a result effective variable that gives the well known and expected results of providing adequate sample to be analyzed. In the absence of a showing of unexpected results, the Office maintains the providing sample amounts taught by Chou 2018 would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 19, Katsuda/Chou teach the sample collecting and transferring device coated with starch or polystyrene ( Katsuda col. 3 lines 40-46: reads on hydrophilic or hydrophobic), but are silent to the imaging device each comprises an inner surface having a hydrophobic coating, hydrophilic coating, or both hydrophobic and hydrophilic coatings. Chou 2018 teaches hydrophilic coating of one or both plates (Chou 2018 Para. 1141). It is desirable to provide a hydrophilic coating to aid in the distribution of sample on the plates. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the hydrophilic coating of Chou 2018 to provide the above advantage of aiding in distribution of sample on the plates.
Regarding claim 24, Katsuda/Chou teach the slowing releasing time but is silent to the release time is 3 second, 5 second, 10 second or in a range between any of these values. Chou 2018 teaches the use of slow release time reagents with the release times control by at least 3 seconds, 5 seconds, or at least 10 seconds (Chou 2018: Para. 0142). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a release time of a slow release time reagent is a result effective variable that gives the well known and expected results of providing adequate time desired to have the sample analyzed. In the absence of a showing of unexpected results, the Office maintains the providing slow release times taught by Chou 2018 would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 41 and 43, Katsuda/Chou teach spacer but are silent to separated bonding or adhesive structure between two chambers; separated bonding or adhesive structure outside of two chambers. Chou 2018 teach the separate boding or adhesive structures of the enclosed spacers that provide two chambers. (Fig. 8). It is desirable to provide separate bonding structure to enclose various portions for containing reagents and samples on the device. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the separate bonding or adhesive structure of Chou 2018 to provide the above advantage of containing reagents and samples on the device.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuda (US3898982) in view of Chou et al (WO 2020/037304) and further in view of Chou et al (WO2020/132702 printed on 6/25/20202, hereinafter "Chou 2020").
Regarding claim 42, , Katsuda/Chou are silent to the bonding structure is a paste pad or paste lines. Chou 2020 teaches adhesive paste lines (Chou 2020: Fig. 19A: adhesive 400 is paste, it is noted that adhesive 400 is a line, thus reading on "paste lines"). It is advantageous to provide paste lines to ensure the device remains in the closed position during analysis. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the paste line of Chou 2020 to provide the above advantage of ensuring the device remains in the closed position during analysis
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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