DETAILED ACTION
Priority
This application is a 371 of PCT/IB2022/060511 filed 01 November 2022. The PCT application is a continuation-in-part of application no. 17/851,276 filed 28 June 2022 and also claims a priority benefit to provisional application no. 63/274,551 filed 02 November 2021.
Application no. 17/851,276 and provisional application no. 63/274,551, however, do not contain support for every limitation set forth in independent claim 1 – namely, the auxiliary channel (“an auxiliary channel extending from a second aperture at the first end of the substrate toward the second end of the substrate”). Accordingly, the effective filing date afforded to claims 1-24 is that of the PCT application, which is 01 November 2022.
Application no. 17/851,276 also does not contain support for any of the steps set forth in independent claim 25. Provisional application no. 63/274,551 describes producing a blood/stain dilution that varies over the length of a channel in a microfluidic device. Accordingly, the provisional appears to provide support for the first step “obtaining a blood sample in a volume divided into a plurality of volume portions”. The provisional describes using a RGB-CMOS camera to estimate concentrations of blood inside the channel. The provisional, however, does not appear to expressly provide support for the ”obtaining a hemoglobin value…”, “obtaining a cell count…”, “obtaining a blood volume…” and “applying…to obtain a complete blood cell count” steps set forth in claim 25. Accordingly, the effective filing date afforded to claims 25-31 is that of the PCT application, which is 01 November 2022.
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.
Claim 9 is rejected under 35 U.S.C. 112(bas being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
It is unclear how claim 9 further limits independent claim 1 because independent claim 1 requires a major channel that is separate from the auxiliary channel. Because the major channel and auxiliary channel are defined by distinct claim limitations, it is unclear how they could be interpreted as the same channel. In other words, they must be separate channels as defined by claim 1, and it is unclear what additional features or designs are contemplated by claim 9.
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 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ezra (US 20200024564) in view of Jones (US 20170328924).
With respect to claims 1 and 6, Ezra discloses a microfluidic apparatus comprising a substrate (Figure 6E:112e) having oppositely disposed first and second ends. A mixing chamber (Figure 6E:662) that includes a base is provided, and the mixing chamber extends into the substrate. A plurality of protruding elements (Figure 6E:682) are disposed in the mixing chamber and the base includes a wall corresponding to the shape of the protruding elements. A major channel extends from a first aperture (Figure 6E:673) at the first end of the substrate. The major channel includes a first portion (Figure 6E:672) extending from the first aperture, a second portion (Figure 6E:670) between the protruding elements and the base, and a third portion (Figure 6E:674) that extends toward the second end of the substrate. This is described in paragraphs [0085]-[0094]. Ezra, however, does not expressly disclose an auxiliary channel extending from a second aperture at the first end of the substrate toward the second end of the substrate.
Jones discloses a microfluidic apparatus comprising a substrate having a mixing chamber (Figure 4A:158), a major channel (Figure 4A:162) and an auxiliary channel (Figure 4A:154). More specifically, the auxiliary channel extends from an aperture at a first end of the substrate toward the second end of the substrate. This is described in paragraphs [0063]-[0067].
Before the effective filing date of the claimed invention, it would have been obvious to provide Ezra microfluidic apparatus with an auxiliary channel extending from a second aperture on the first end of the substrate. Jones teaches that such an auxiliary channel may be configured as a photometric chamber that allows for the detection of a particular analyte, such as hemoglobin (“The body of the test cartridge can further define a photometric chamber, which is fluidically coupled to the sample collection port and input channel, for measuring the concentration of an analyte, such as hemoglobin, in the sample”). Jones shows how the auxiliary channel may be formed using known fabrication methods to produce a channel that functions according to a simplified operation (“The photometric chamber is vented and designed to fill itself from the input channel by capillary action”).
With respect to claim 2, Ezra and Jones disclose the combination as described above. Ezra further states in paragraph [0085] that the second portion is generally U-shaped.
With respect to claim 3, Ezra and Jones disclose the combination as described above. Ezra states in paragraph [0040] that the mixing chamber is conical in shape and tapers inwardly. Ezra shows how this allows the protruding elements to be arranged in a rounded manner corresponding to a rounded shape of the wall of the base.
With respect to claims 4 and 17, Ezra and Jones disclose the combination as described above. Ezra further indicates in at least paragraph [0041] that the protruding elements are configured as overlapping impellers provided in a substantially circular arrangement. The impellers are described in paragraph [0042] as being flexible and resilient.
With respect to claim 5, Ezra and Jones disclose the combination as described above. Ezra and Jones each rely on capillary action to generate fluid flow across the substrates and through the major channel.
With respect to claims 7-9, Ezra and Jones disclose the combination as described above. Ezra indicates that the third portion of the major channel is aligned with optics to enable photodetection. Similarly, Jones states that the auxiliary channel is a photometric chamber that is aligned with an optical detector.
With respect to claims 10-12, Ezra and Jones disclose the combination as described above. Ezra and Jones indicate that the first and second apertures are open to the ambient environment in order to facilitate the introduction of a blood sample. Jones shows in Figs 4A-4D and 13 that the aperture 150 is provided along a diagonal surface to receive blood from a fingertip.
With respect to claims 13 and 14, Ezra and Jones disclose the combination as described above. Ezra discloses a plurality of additional cavities 622, 624, 626 that are in communication with the mixing chamber and open to the ambient environment. Jones similarly teaches that additional cavities 138, 146 are provided in communication with the mixing chamber.
With respect to claims 15 and 16, Ezra and Jones disclose the combination as described above. The third portion of Ezra and the auxiliary channel of Jones each include an aperture at a terminal end that is open to the ambient environment. See, for example, the aperture 678 shown by Ezra in Fig. 6E (“The pressure outlet channel 676 terminates in an aperture 678, which is initially sealed (closed). When in operation, when the aperture 678 is punctured, so as to be opened to the ambient environment at, for example, ambient pressure, an air inlet/outlet is created, such that blood (or fluid) and/or blood (or fluid)/stain mixture (which may also include other substances, such as those from a breakable capsule, as detailed below) fills the scanning channel 674”).
With respect to claim 18, Ezra and Jones disclose the combination as described above. Jones indicates that the microfluidic device should be sealed by a plastic film or aluminum foil cover.
With respect to claims 19-24, Ezra and Jones disclose the combination as described above. Ezra indicates in paragraphs [0080]-[0096] that a breakable capsule is placed in the mixing chamber, and that the capsule includes a diluent and/or a staining agent. Those of ordinary skill would have found it obvious to consider known staining agents especially suited for blood analysis, such as methylene blue. Those of ordinary skill would have found it obvious to consider known diluents, such as double distilled water.
Allowable Subject Matter
Claims 25-31 are allowed.
The prior art does not disclose, in the claimed environment, the computer implemented method for determining a complete blood cell count of an unknown sample.
The Jones (US 20170328924) and Jones (US 12,005,441) references (and other related documents) are believed to be the closest prior art. Jones describes a method for obtaining a complete blood count on a sample of whole blood. A diluent, such as a stain, is added to a metered volume of blood sample. A digital camera is used for cell counting as cells pass through an imaging region. Cell concentrations are calculated because the sample volume is predetermined and based on the known volume of a conduit in a rotary valve. A photometric chamber is also provided for measuring the concentration of an analyte, such as hemoglobin. Jones, however, does not recognize that a dilution factor may vary across the length of the imaging region channel, and therefore does not produce a plurality of volume portions. Jones does not obtain a blood volume from each volume portion using the obtained hemoglobin value.
The Zait (US 20190145963) reference teaches optically evaluating a blood sample to obtain a hemoglobin value. Zait further describes separately addressing different portions of a divided blood sample (see Figs. 6-8 and related description). The blood sample is diluted with a staining substance to improve counting. Zait, however, does not teach obtaining a blood volume from each volume portion of the blood sample based on an obtained hemoglobin value. Zait does not teach applying an obtained cell count and obtained blood volumes for each portion to obtain a complete blood cell count.
The Muzykovski (WO 2020/141463) reference describes dividing a blood sample into multiple volume portions, such that a first portion is diluted/stained for cell counting and a second portion is routed to an immunoassay for analyte (e.g., hemoglobin) detection. Similar to the other cited references, Muzykovski also fails to teach the claimed steps of obtaining a blood volume for each volume portion using an obtained hemoglobin value.
The Yamada (US 20160091424), Fritz (US 20060263888), Smith (US 20140270458) and Zahniser (US 20130002847) further disclose the state of the art regarding methods for evaluating a blood sample, but do not teach the claimed method for determining a complete blood cell count.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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