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 without traverse of claims 1-9 in the reply filed on July 27, 2026 is acknowledged.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the Examiner notes that the mixing area is not positively recited, and therefore is not considered as a required structural element of the claim. Also, the Examiner notes that the phrase “configured to” indicates the intended use of the mineral layer and the obstructions, and do not impart any structural limitations to the claimed device.
For claim 2, the Examiner notes that the phrase “by which multiple fluids and/or chemicals are flown into the microfluidic path for mixing in the mixing area” is a process step in a claim directed to a device. Specifically, the phrase “are flown into the microfluidic path” reads as an active process step which is not proper in a claim directed to a device. Similarly, the phrase “is receptive of the second particles and the unreacted fluid passing out of the analysis area” is a process limitation in a claim directed to a device. Specifically, the Examiner notes that the phrase “is receptive” is only meaningful, and can only be evaluated in the context of a process limitation as it requires an output being receptive to second particles and unreacted fluid. Both the second particles and unreacted fluid are not structural elements of the claimed device, thus the phrase “is receptive” is indefinite. Also, the Examiner notes that the claimed multiple fluids and/or chemicals are not structural elements of the device, but instead represent the material worked upon by the device.
For claim 7, the Examiner notes that the phrase “by which multiple fluids and/or chemicals are flown into the microfluidic path for mixing in the mixing area” is a process step in a claim directed to a device. Specifically, the phrase “are flown into the microfluidic path” reads as an active process step which is not proper in a claim directed to a device. Similarly, the phrase “is receptive of the second particles and the unreacted fluid passing out of the analysis area” is a process limitation in a claim directed to a device. Specifically, the Examiner notes that the phrase “is receptive” is only meaningful, and can only be evaluated in the context of a process limitation as it requires an output being receptive to second particles and unreacted fluid. Both the second particles and unreacted fluid are not structural elements of the claimed device, thus the phrase “is receptive” is indefinite. Also, the Examiner notes that the claimed multiple fluids and/or chemicals are not structural elements of the device, but instead represent the material worked upon by the device.
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 1-9 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.
For claim 1, the Examiner is unable to determine the metes and bounds of the term “substantially” as neither the specification, nor the claims provides a definition for what is or is not substantial with respect to the particle size. First, the Examiner notes that the first and second particles are not structural elements of the device, thus the size of the particles are not given patentable weight. Second, the claim does not recite a size of the first particles, thus one of ordinary skill in the art would not be able to determine if the size of the second particles are substantially smaller as there is no reference by which one can compare the size of the second particles. Third, the specification attempts to define “substantially” by stating that it is within the margin of error for analysis available at the present time, however; what Applicant regards as the margin of error may be different for a user other than Applicant, thus the term “substantially” is not defined by the specification or the claims. Claims 2-9 depend directly or indirectly from claim 1, and are also indefinite.
For claim 2, the phrase “by which multiple fluids and/or chemicals are flown into the microfluidic path for mixing in the mixing area” is a process step in a claim directed to a device which is indefinite (MPEP 2173.05(p) II). Specifically, it is unclear whether one infringes on the claim when the device is made, or if infringement only occurs when multiple fluids are flown through the microfluidic path. As such, claim 2 is indefinite for reciting a process limitation in a claim directed to a device.
For claim 2, the phrase “is receptive of the second particles and the unreacted fluid passing out of the analysis area” is a process limitation in a claim directed to a device. Specifically, the Examiner notes that the phrase “is receptive” is only meaningful, and can only be evaluated in the context of a process limitation as it requires an output being receptive to second particles and unreacted fluid. Both the second particles and unreacted fluid are not structural elements of the claimed device, thus the phrase “is receptive” is indefinite. Additionally, the Examiner contends that it is unclear if infringement occurs when the device is made, or if infringement only occurs when an outlet is receptive of the second particles and unreacted fluid. As such, claim 2 is indefinite for reciting a process limitation in a claim directed to a device.
For claim 7, the phrase “by which multiple fluids and/or chemicals are flown into the microfluidic path for mixing in the mixing area” is a process step in a claim directed to a device which is indefinite (MPEP 2173.05(p) II). Specifically, it is unclear whether one infringes on the claim when the device is made, or if infringement only occurs when multiple fluids are flown through the microfluidic path. As such, claim 7 is indefinite for reciting a process limitation in a claim directed to a device.
For claim 7, the phrase “is receptive of the second particles and the unreacted fluid passing out of the analysis area” is a process limitation in a claim directed to a device. Specifically, the Examiner notes that the phrase “is receptive” is only meaningful, and can only be evaluated in the context of a process limitation as it requires an output being receptive to second particles and unreacted fluid. Both the second particles and unreacted fluid are not structural elements of the claimed device, thus the phrase “is receptive” is indefinite. Additionally, the Examiner contends that it is unclear if infringement occurs when the device is made, or if infringement only occurs when an outlet is receptive of the second particles and unreacted fluid. As such, claim 7 is indefinite for reciting a process limitation in a claim directed to a device.
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.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quake (US 2002/0164816) in view of Di Carlo et al., (US 2018/0266452).
Regarding claim 1, Quake teaches a microfluidic device comprising a substrate comprising a microfluidic flow channel (paragraphs 0090, 0145) with an inlet, outlet, and analysis area (chromatography column, paragraph 0090), a cover disposed on the substrate (paragraph 0145), a mineral layer deposited in a mixing layer (paragraph 0099), and a solid phase (obstructions, paragraph 0090) formed in the chromatography column (paragraph 0090). Quake does not teach a microfluidic device having multiple inlets.
Di Carlo et al., teach a microfluidic device having multiple inlets and a single outlet (paragraphs 0012, figure 1 #104). The Examiner is reading this combination as use of a known technique to improve similar devices which would have been obvious to one of ordinary skill in the art (MPEP 2141 III C). Reference to Di Carlo et al., teach introducing different fluids to the microfluidic channel through different inlets (paragraphs 0044, 0055) thus one of ordinary skill would have found it obvious to provide multiple inlets as a means of introducing different fluids into the microchannel. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Quake to include multiple inlets as taught by Di Carlo as utilizing known techniques to improve similar devices requires only routine skill in the art.
Regarding claim 2, Quake teaches the inputs upstream of a mixing area, and downstream of an analysis area (paragraph 0090).
Regarding claim 3, Quake teaches the mineral layer comprising silicates (paragraph 0099).
Regarding claim 4, Quake teaches a solid phase (paragraph 0099), which reads on the claimed blocks. The Examiner notes that the blocks of claim 4 are sufficiently broad so as to read on an obstruction that is shaped like a block, or an obstruction that blocks the channel. For the purposes of examination, the Examiner is reading the term “blocks” as an obstruction that blocks the channel, but does not require the shape of a block.
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quake (US 2002/0164816) in view of Di Carlo et al., (US 2018/0266452) as applied to claim 1 above, and further in view of Klevan et al., (US 2017/0354972).
Regarding claims 5 and 6, Quake in view of Di Carlo et al., do not teach a data acquisition system.
Klevan et al., teach a system for determining samples, isolation, and quantitation of cells wherein a microscope is utilized to analyze cells in a microfluidic channel (paragraph 0029). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Klevan et al., teach that a microscope can be utilized to detect the of specific cells (sperm cells), thus one of ordinary skill in the art would have recognized that a microscope can be utilized to detect a specific cell or analyte. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Quake in view of Di Carlo et al., wherein a microscope is utilized to analyze an analysis area as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 7, Quake teaches the inputs upstream of a mixing area, and downstream of an analysis area (paragraph 0090).
Regarding claim 8, Quake teaches the mineral layer comprising silicates (paragraph 0099).
Regarding claim 9, Quake teaches a solid phase (paragraph 0099), which reads on the claimed blocks. The Examiner notes that the blocks of claim 9 are sufficiently broad so as to read on an obstruction that is shaped like a block, or an obstruction that blocks the channel. For the purposes of examination, the Examiner is reading the term “blocks” as an obstruction that blocks the channel, but does not require the shape of a block.
Conclusion
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/DWAN A GERIDO/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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