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 group I comprising claims 1 – 9 and 11 – 18 in the reply filed on 12/18/2025 is acknowledged.
Claims 10, 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/2025.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim 6 is 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.
Regarding claim 6, the phrase “ … comprising multiple channels of droplet generation feeding into the incubation region” is unclear and therefore considered indefinite. It is unclear of the claim is referring to one or more droplet generators. For claim interpretation and examination purposes, the phrase “multiple channels of droplet generation feeding” is interpreted to mean the presence of multiple channels wherein each channel comprises at least one feature that can generate fluid droplets, e.g., a droplet generator, injector or ejector.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6 – 9 and 11 – 18 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Shkolnikov et al. (US 2023/0285970 A1; hereinafter “Shkolnikov”).
Regarding claim 1, Shkolnikov teaches throughout the publication a microfluidic system structure (paragraphs 30 – 100 and 111 – 119; figures 1 – 4) comprising:
a set of reservoirs, the set of reservoirs comprising a reagent reservoir (e.g., first reservoir 120 and or second reservoir 118; paragraph 26; figures 1 and 3) and an immiscible fluid reservoir (paragraph 30);
an incubation region (e.g., reaction region 110) having an inlet and an outlet;
a set of independent fluidic networks, the set of independent fluidic networks comprising
a first fluidic network (e.g., first microfluidic channel 102) and a second fluidic network (e.g., different and/or additional components, such as a substrate surface comprising microwells, may be coupled to apparatus 100 for processing biochemical reactions; paragraphs 36, 61 and 64) that is not fluidically connected to the first fluidic network,
wherein the first fluidic network (102) is fed by the set of reservoirs (118 and 120), comprises a droplet generator (e.g., droplet generator 106), and connects to the inlet of the incubation region (110), and
wherein the second fluidic network is connected to the outlet of the incubation region (110) (e.g., via a fluid ejector; paragraph 36).
Regarding claim 2, Shkolnikov teaches the microfluidic system of claim 1, wherein the droplet generator encapsulates reagents from the reagent reservoir into droplets (e.g., the droplet generator 106 is capable generating an encapsulated fluid droplet comprising an aqueous solution surrounded by an immiscible oil phase; paragraph 30).
Regarding claim 3, Shkolnikov teaches the microfluidic system of claim 1, wherein the first fluidic network (first microfluidic channel 302) connects to the inlet of the incubation region (reaction region 310) via a fluid actuator (e.g., first fluidic actuator 342-1; paragraphs 33, 83; figure 3A).
Regarding claim 4, Shkolnikov teaches the microfluidic system of claim 3, wherein the fluid actuator is a thermal ink jet actuator (e.g., a fluidic actuator comprising a thermal inkjet resistor (TIJ); paragraph 33).
Regarding claim 6, Shkolnikov teaches the microfluidic system of claim 1, comprising multiple channels of droplet generation feeding into the incubation region (e.g., there are multiple reagent injectors (350-1, 350-Q) capable of feeding fluid into various incubation regions (reaction regions 310-1, 310-2 and 310-M), and including fluid droplet generator 306; figure 3E).
Regarding claim 7, Shkolnikov teaches the microfluidic system of claim 1, further comprising optical components for characterizing content of droplets (e.g., optics system 116; paragraph 31; figure 1D).
Regarding claims 8 and 9, these claims are considered to be statements of intended use or manner of operation, which do not further limit or define the claimed microfluidic system apparatus structure itself. Regarding claim 8, the disclosed apparatus is also capable of ejecting droplets into other additional components, such as microwells, attached to the apparatus for further processing (paragraphs 36, 61 and 64). Regarding claim 9, the disclosed apparatus is clearly capable of using functionalized beads (paragraph 119). The cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). See MPEP §§ 2114 and 2173.05(g).
Regarding claim 11, Shkolnikov teaches the microfluidic system of claim 1, wherein the incubation region comprises an incubation loop (e.g., third microfluidic channel 355 forms a loop with the first microfluidic channel 302; paragraphs 90, 94 and 112; figure 3D).
Regarding claim 12, Shkolnikov teaches the microfluidic system of claim 11, further comprising a first actuator situated proximate to a first junction between the incubation loop and the channel, and a second actuator proximate to a second junction between the incubation loop and the channel (e.g., there are multiple fluid actuators (342-1, 342-2, 342-3 and 342-4) positioned with the first microfluidic channel 302 that forms a loop with the third microchannel 355; paragraphs 90 – 96; figures 3D and 3E).
Regarding claim 13, Shkolnikov teaches the microfluidic system of claim 12, wherein the first actuator comprises a first resistor, and wherein the second actuator comprises a second resistor (the various fluid actuators can comprise a thermal inkjet resistor (TIJ); paragraph 33).
Regarding claim 14, Shkolnikov teaches the microfluidic system of claim 1, further comprising one or more magnetic actuation regions downstream of the incubation region (e.g., magneto-restrictive drive actuators; paragraph 84).
Regarding claim 15, Shkolnikov teaches the microfluidic system of claim 14, further comprising a separation region downstream of the one or more magnetic actuation regions, the separation region comprising one or more side channels (e.g., the fluid droplet of the reaction fluid 119 can be separated from the remaining portion of the reaction fluid 119 by breaking off at the neck shape 178; paragraph 44; figure 1C).
Regarding claim 16, Shkolnikov teaches the microfluidic system of claim 1, further comprising, downstream of the incubation region, a washing reagent reservoir and an elution reagent reservoir (e.g., additional reservoirs or chambers may be included with the apparatus which are capable of functioning as wash a reagent reservoirs; paragraph 82).
Regarding claim 17, Shkolnikov teaches the microfluidic system of claim 1, further comprising a recycling loop having an inlet situated downstream of the incubation region, and an outlet situated upstream of the set of reservoirs (e.g., various microchannels forming a loop can be included, which are capable of functioning as a recycle loop; paragraphs 90, 94 and 112).
Regarding claim 18, Shkolnikov teaches the microfluidic system of claim 1, further comprising one or more actuators to drive fluids flow through the set of independent fluidic networks (e.g., various fluid actuators and reagent injectors; paragraphs 86, 91, 92).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shkolnikov et al. (US 2023/0285970 A1; hereinafter “Shkolnikov”) in view of Shkolnikov et al. (2024/0123446 A1; hereinafter “Shkolnikov ‘446”).
Regarding claim 5, Shkolnikov does not teach the microfluidic system of claim 1, further comprising a sensing region for particle detection, the sensing region comprising impedance sensing electrodes.
However, the use of impedance sensing electrodes for analytical microfluidic apparatus is well known in the art as evidenced by Shkolnikov ‘446 (paragraphs 37, 38 and 45). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a sensing region for particle detection, the sensing region comprising impedance sensing electrodes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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