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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 22, 2026 has been entered.
Response to Arguments
Applicant’s arguments, see remarks/amendments, filed September 25, 2025 with respect to the rejection(s) of claim(s) 1-17 under 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Austin et al., US 5,427,663.
The amendments are insufficient to overcome all of the 112 issues. See rejections herein below.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings were received on March 22, 2026. These drawings are acceptable.
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”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
I is noted that the claims mention fluid (gas and/or liquid, not specified in the claims), and analyte (claim 11). However, no unit outlet, fluid, and analyte are positively claimed as elements of the invention/device. The unspecified fluid (gas and/or liquid). and analyte are materials and/or articles intended to be, can be worked upon, and used with the apparatus. It is noted that claims 1-12 and 16-17 are directed to a device, not a process of use. There is no requirement for the device to be used with any further unclaimed materials or structures (that are not elements of the device) in any process to perform flowing of any fluid, any filtering, nor any other actions/steps.
It is noted that the “inlet unit” and “outlet unit” are not defined as being any specific structure(s) in claim 1. The terms “inlet” and “outlet” are directed to intended use. There is no preclusion from an “inlet” being used as an “outlet” and vice versa. A fluidic resistor can be anything that provides resistance to a fluid.
It is noted that the term “plurality” only requires 2.
As to claims 11-12, 14, and 16-17, it is noted that claims 11-12 and 16-17 are directed to an apparatus and no type of “interaction” of any analyte with anything is ever required to occur. The same is applicable to the method claim 14 which does not provide for any “interacting” (not specified, defined in the claim so as to what is considered as such) step nor any step that requires any interacting (contacting, reacting) of the probe with the analyte is required to occur.
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 6-8 and 14-17 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.
As to claims 6-7, it is unclear what is the nexus of “a width” recited in each the claims to each other and to the “a width” of the trench (fluidic resistor) recited in claim 1, if such are the same or different because the claims do not clearly indicate such.
As to claim 14, it is unclear if applicant intends for the method to require an interacting step because the wherein clause does not provide for such a step nor limits any prior previously claimed step. There no such step recited in the claim. None of the steps requires any “interacting” (not defined as anything specific) of the probe (not defined in the claim as being anything specific) with the analyte(not defined in the claim as being anything specific). Even if applicant intends for an “interacting” step, there is no indication as to what is required to occur to and/or with the analyte and probe to be considered as “interacting” because the claim does not provide for anything that is required to occur to produce any “response” to anything. Therefore, it is also unclear what is considered as a “response” because such is not clearly provided for in the claim What the response is intended to or is subjectively considered as being “indicative of” does not further limit the method. The response can subjectively be considered as being indicative of whatever one so desires (such as the probe and/or analyte being present).
Claim 16 recites the limitation "the respective microfluidic device unit" in the paragraph beginning with “a unit inlet”. There is insufficient antecedent basis for this limitation in the claim. No respective microfluidic device unit has been previously mentioned nor defined in the claim. To provide for antecedent basis, it appears as if the claim should read as “each respective microfluidic device unit microfluidic device unit of the 6x4 array of microfluidic device units comprising:”
Dependent claims 15 and 17 are rejected via dependency upon a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-12 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al., US 2005/0042766 in view of Austin et al., US 5,427,663.
Ohman discloses a microfluidic device including a substrate comprising and an inlet unit 7 leading to cavity/channel; outlet unit (exit) leading from cavity/channel. The device further comprises a filter including a plurality of micro-posts 1 (cylindrical micropillars) along a straight line; and a fluidic resistor (8; 10; 11-12, 16, and/or zones of the channel all such provide a resistance to flow). All of the above structures are fluidically coupled to each other. (Abstract, paragraph 0050-60, 62-65; Figures; and claims 1-29).
Ohman does not disclose the fluidic resistor comprises a curved trench with a width that is at least ten times smaller than a height of the curved trench and the specific dimensional values recited in claims 6-8.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Ohman discloses that the device can comprise curved portions in said capillary pathway (paragraph 0012) and the dimension of the structures of the device are on the micro and/or nano scale. (paragraph 0048).
Austin discloses a microfluidic device including passageways 196 (trenches) that may be made linear, curved, or whatever shape desired so as to be able to observe migration of cells through variously shaped passageways. Passageways 196 may have a width in the range of from about 1.0 micron to about 10.0 microns and a depth with the range of from about 1.0 micron to about 10.0 microns. (curved trench with a width that is at least ten times smaller than a height of the curved trench; column 20, lines 46-48).
It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that the device may be manufactured to have the dimensions as claimed as disclosed by Austin. As such is a design choice, would yield predictable results to one of ordinary skill in the art. Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 2-3, a distance between selected 2 micro posts is less than a width of the fluidic resistor and over 50% of the width. (Ohman; Figures 1-9 and 12-13).
As to claims 4-5, the micro posts were about 100 m high, had a diameter of 20 m and a center-to-center distance of 30 m. (Ohman; paragraph 0050).
As to claims 6-8, see teachings of Austin above.
As to claim 9, the cavity comprises a well 8, 17. (Ohman; Figures 8-9, 12-13; paragraph 0066).
As to claim 10, the substrate is made of silicon, glass, quartz, ceramic, metal or plastic material. e.g. PMMA or Teflon including cover or lid 15 (window) that also comprises a window 17. (Ohman; paragraphs 0064, 66, 86).
As to claims 11-12, any of the posts or structures within the channel can be considered as a probe. The channel can comprise functional elements including devices, reagents, optics and other means to manipulate light e.g. for the purpose of measuring concentrations by absorbance, inducing conformational changes by light irradiation. (Ohman; paragraph 0068; claim 22).
As to claims and 16-17, Ohman does not disclose a plurality (array) of such microfluidic device units.
However, it would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art to recognize that a plurality of such microfluidic devices may be coupled to each other to provide for further sorting of different sizes of particles. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to include a plurality of connected microfluidic devices, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al., US 2005/0042766 in view of Austin et al., US 5,427,663 and further in view of Okumura et al., US 2006/0252044.
Ohman discloses that the channel can comprise functional elements including devices, reagents, optics and other means to manipulate light e.g. for the purpose of measuring concentrations by absorbance, inducing conformational changes by light irradiation. (paragraph 0068; claim 22).
Modified teachings of Ohman do not detecting luminescence emitted by the probe.
Okumura discloses a biochip and a method of employing the biochip for detecting and identifying a reactive interaction between a target contained in an analyte and a bioprobe; wherein luminescence is employed as a means of detection. (Abstract; paragraphs [0001, 09, 11, 16, 22, 30, 96, 102-105, 157, 253, 280-283]).
It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art to employ the device of Ohman to provide for the detection of an analyte by providing for a detection probe within the channel so as to interact with an analyte such that luminescent detection is performed to provide for high-sensitive detection and identification as taught by Okumura.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Richardson; Brian Edward and Dieguez; Lorena et al. disclose microfluidic devices and methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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