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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/01/2023 and 06/10/2025 are being considered by the examiner.
Claim Objections
Claims 5 and 7 are objected to because of the following informalities:
Claim 1, line 4 “return” should read “retuning”;
claim 5, line 4, “blister type-of reservoirs” should read “blister-type of reservoirs”;
claim 7, line 6, “analyse zones” should read “analysis zones”.
Appropriate correction is required.
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, 5 and 7 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “the microfluidic chip is in contact with the microfluidic chip contacting zone of the microfluidic test card”, and the claim also recites “preferably the microfluidic chip is integrated with the microfluidic test card,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination “preferably the microfluidic chip is integrated with the microfluidic test card” is interpreted as merely exemplary, and thus not required.
With respect to claim 5, which recites the broad recitation “…first and second test reagent reservoirs”, and the claim also recites “preferably blister type-of reservoirs” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, “blister type of reservoirs” is interpreted as merely exemplary and not a required feature.
Claim 7 recites the limitation “wherein the reader comprises a computational or lens-free holographic microscope, preferably comprising a laser diode, and complementary metal oxide semiconductor imager” in lines 3-4. It is unclear with whether the adjective “computational” modifies “holographic microscope” or “microscope”. For the purpose of the examination, it is being interpreted that “computational” modifies microscope, and thus “wherein the reader comprises a computational microscope or a lens-free holographic microscope” is being interpreted as “wherein the reader comprises a computational microscope or a lens-free holographic microscope.” In addition, it is unclear whether preferably refers to only “a laser diode” or both a laser diode and “complementary metal oxide semiconductor imager.” For the purpose of examination, it is being interpreted that preferably refers to be both “a laser diode” and “complementary metal oxide semiconductor imager.” Furthermore, claim 7 includes the board recitation “wherein the reader comprises a computational or lens-free holographic microscope,” and the claim also recites “preferably comprising a laser diode, and complementary metal oxide semiconductor imager” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of the examination, “preferably comprising a laser diode, and complementary metal oxide semiconductor imager” is interpreted as merely exemplary and not a required feature.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsao et al. (US 20110008223 A1).
Regarding claim 1, Device for analysis of sample liquid, the device (100)(Figs. 13 and 14) comprising
a microfluidic test card (interface cartridge 102), and
a microfluidic chip (microfluidic chip 18) for processing the sample liquid presented from the microfluidic test card and return processed sample fluid to the microfluidic test card (interpreted as an intended use. Microfluidic chip 18 meets the structural limitation of the intended use. Moreover, Fig. 16 and para. 0091), wherein the microfluidic test card comprises
a sample inlet (112), configured for receiving sample liquid (interpreted as a functional limitation. sample liquid is not positively recited. para. 0091, well 112 is structurally capable of receiving a sample liquid),
first and second pre-processing test reagent channels (the channels 118 that corresponds to the first and second wells 108 from the top in Fig. 16. There are a total of 8 wells 108, para. 0100) having first and second test reagent outlets (the channels 128 corresponds the first and second wells 108 from the top) (para. 0098, Fig. 16 and the inset of Fig. 16), respectively, for presenting test reagent to the microfluidic chip (interpreted as an intended use. test reagent is not positively recited. para. 0096, channels 128 meet the structural limitation of the intended use),
a pre-processing sample channel (132) fluidically communicating with the sample inlet (para. 0091) for receiving sample liquid therefrom (Fig. 16 and para. 0091), and having a sample liquid outlet (the portion of 132 that branches into the first well 108 from the top) (see annotated Fig. A) for presenting the sample liquid to the microfluidic chip (interpreted as an intended use. The sample liquid is not positively recited. Channel 132 meets the structural limitation of the intended use. Moreover, Fig. 16, para. 0091 and 0096-0098, liquid from the sample liquid outlet enters channel 116, which comprises 118, then enter channel 24 in microfluidic chip 18 through 128. See annotated Fig. A),
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Figure A. Annotate Figure 16 of Tsao.
first and second processed sample analysis channels (144a and 144b, which are the channels 144 that corresponds to the first and second wells 108 from the top as shown in Fig. 14) for receiving processed sample liquid from the microfluidic chip, wherein the first and the second processed sample analysis channels comprising a first and second analysis zone (the portion of 144a and 144b on cartridge 102)(see annotated Fig. A), respectively, for analyzing the processed sample liquid (interpreted an intended use. the process sample liquid is not positively recited. The recitation also does not specific structural elements that is required for analyzing the processed sample. 144a and 144b meets the structural limitation of the intended use), and
a microfluidic chip contacting zone (see annotated Fig. A) comprising said sample liquid outlet (see annotated Fig. A) and first and second test reagent outlets (the channels 128 corresponds the first and second wells 108 from the top), configured for connection and fluidic communication with the microfluidic chip (interpretated as a functional. Fig. 16 and para. 0098, fluidic connection between cartridge 102 and the microchip chip 18 in the contacting zone), and
wherein the microfluidic chip comprises
a sample liquid entrance (where channel 24 meets channel 128. Referring to the channels 24 and 28 that correspond to the first 108 from the top)(para. 0096), configured for fluidic communication with the sample liquid outlet of the test card and receiving sample liquid therefrom (interpreted as a functional limitation. Fig. 16 and 17 and para. 0092 and para. 0096, channel 128 is a branch from channel 118, which is capable of fluidic communication with the sample liquid outlet and receiving sample liquid therefrom),
a first microfluidic channel system (the channel 24 corresponds to well 108 from the top)(Figs. 14 and 16) for processing sample liquid (interpreted as an intended use. channel 24 meets the structural limitation of the intended use), configured for fluidic communication with the first reagent outlet (the channel 128 corresponding the first well 108 from the top)(interpreted as a functional limitation. para. 0096 ) and thereby configured to receive first test reagent from the first pre-processing test reagent channel (the channel 118 that corresponds to the first well 108 from the top)(interpreted as a functional limitation. Paras. 0091, 0092 and 0096), and further configured for fluidic communication with the sample liquid entrance (where channel 24 meets channel 128. Referring to the channels 24 and 28 that correspond to the first 108 from the top)(interpreted as functional limitation. para. 0096), and thereby configured to receive sample liquid from the pre-processing sample liquid channel (132)(interpreted as functional limitation. Fig. 16 and paras. 0091, 0092 and 0096), and to allow contacting between sample liquid and first test reagent within the first microfluidic channel system (sample liquid and the first test reagent are not positively recited. Fig. 17 and paras. 0096 and 0101, channel 118 conveys a sample-reagent mixture that originated from corresponding well 108 and well 112, and the mixture eventually enters 24. Since the channel 24 corresponds to the first well 108 from the top is configured to contain the mixture, and thus it allows contacting between fluid from well 112 and fluid from the first well 108 from the top), and
a second microfluidic channel system (the second channel 24 from the top)(Fig. 14 and 16) for processing sample liquid (interpreted as an intended use. channel 24 meets the structural limitation of the intended use), configured for fluidic communication with the second test reagent outlet (the channel 128 corresponding the second well 108 from the top)(interpreted as a functional limitation. para. 0096 ) and thereby configured to receive second test reagent from the second pre-processing test reagent channel (the channel 118 that corresponds to the second well 108 from the top)(interpreted as a functional limitation. Paras. 0091, 0092 and 0096), and further configured for fluidic communication with the sample liquid entrance (where channel 24 meets channel 128. Referring to the channels 24 and 28 that correspond to the second 108 from the top)(interpreted as functional limitation. para. 0096), and thereby configured to receive sample liquid from the pre-processing sample liquid channel (132)(interpreted as functional limitation. Fig. 16 and paras. 0091, 0092 and 0096), and to allow contacting between sample liquid and second test reagent within the second microfluidic channel system (sample liquid and the second test reagent are not positively recited. Fig. 17 and paras. 0096 and 0101, channel 118 conveys a sample-reagent mixture that originated from corresponding well 108 and well 112, and the mixture eventually enters 24. Since the channel 24 corresponds to the second well 108 from the top is configured to contain a mixture of fluid from well 112 and the second well 108 from top, and it allows contacting between the fluid from well 112 and the fluid from the second well 108 from the top),
wherein the first and the second microfluidic channel systems comprises first and second exits (the terminal ends of the channels 24 that corresponds to the first and second wells 108 from the top), respectively, configured in fluidic connection with the first and second processed sample analysis channels (144a and 144b), respectively, of the microfluidic test card (Fig. 14 and para. 0091).
Regarding claim 2, Tsao teaches all of the elements of the current invention as stated above with respect to claim 1. Tsao further teaches wherein the first and the second microfluidic channel systems (the channels 24 corresponds to the first and second wells 108 from the top)(Fig. 14 and 16) comprises a first and a second sample metering channels (the channels 24 corresponds to the first and second wells 108 from the top), respectively, for providing predetermined first and second sample volumes (interpreted as an intended use. The channels 24 corresponds to the first and second wells 108 from the top each has predetermined volume, and thus they meet the structural limitation of the intended use).
Regarding claim 3, Tsao teaches all of the elements of the current invention as stated above with respect to claim 1 wherein the microfluidic chip (18) is in contact with the microfluidic chip contacting zone of the microfluidic test card (see annotated figure A above and also Figs. 14 and 15), preferably the microfluidic chip is integrated with the microfluidic test card.
Regarding claim 4, Tsao teaches all of the elements of the current invention as stated above with respect to claim 1. Tsao further wherein the device is configured for providing capillary driven flows of liquid through channels (interpreted as a functional limitation. para. 0072, capillary action as a means for fluid flow in the device).
Regarding claim 5, Tsao teaches all of the elements of the current invention as stated above with respect to claim 1. Tsao further teaches wherein the first and second pre-processing test reagent channels (the channels 118 that corresponds to the first and second wells 108 from the top in Fig. 16) further having first and second test reagent liquid inlets (the channels 130 corresponding to the first and second wells 108 from the top) fluidically connected to first and second test reagent reservoirs (first and second wells 108 from the left)(Fig. 14 and 16 and para. 0091), respectively, preferably blister type-of reservoirs (see 35 U.S.C. 112(b) above).
Regarding claim 6, Tsao teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation “wherein the sample liquid is blood or liquid derived from blood, and the first test reagent is lysing buffer for lysing of red blood cells present within the first microfluidic channel system, and the second test reagent is dilution buffer for diluting the blood sample present within the second microfluidic channel system,” the sample liquid, the first test reagent and the second test reagent are not positive recited, and thus they are not parts of the invention. Since the limitation is directed to the sample liquid, the first test reagent and the second, this limitation does not further limit the structure of the invention.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tsao et al. (US 20110008223 A1) in view of Sundberg (US 20070026421 A1).
Regarding claim 7, Tsao teaches a system comprising the device for analysis of sample liquid according to claim 1 (see above).
Tsao teaches a microfluidic assembly (100) comprises a cartridge (102) that fluidically interface with a microfluidic chip (18) for PCR and thermal melt analysis (para. 0081). Tsao teaches the cartridge is made from a transparent polymer (para. 0024).
Tsao teaches the analysis often involves optical detection (para. 0006 and 0064); however, for assembly 100, Tsao does not specific an optical detection system for the cartridge for performing PCR and thermal melt analysis, and thus Tsao fails to explicitly teach the system comprising a reader, wherein the reader comprises a computational or lens-free holographic microscope, preferably comprising a laser diode, and complementary metal oxide semiconductor imager, and wherein the reader is configured to receive the device for analysis, and further configured such that the imager is allowed to image the first and second analyze zones of the test card, thereby allowing analyzing sample liquid.
However, assembly 180 (Figs. 18-22, para. 105) of Tsao teaches an optical detection device for detecting optical property of material flowing in the microfluidic process channels in the microfluidic chip for PCR and thermal melt analysis (paras. 0072 and 0120). Tsao further teaches the optical detection device is configured to receive assembly 180 (Fig. 22).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substitute assembly 100 with an optical detection device taught by assembly 180 of Tsao because one of ordinary skill in the art would accordingly have recognized the optical detection device of assembly 180 of Tsao would result in the predictable result of providing an optical detection system for PCR assay and thermal melt analysis.
In addition, Sundberg teaches a microfluidic system comprising a microfluidic device (Fig. 10) for PCR and thermal melt analysis (abstract, paras. 0009, 0184). Sundberg further teaches the PCR and melt analysis involving detecting fluorescence measurement, and the detection involve fluorescence lifetime imaging microscopy (para. 0020). Sundberg further teaches detection system for the microfluidic device comprise detectors including a microscope, a photodiode and an imaging system (para. 0153) and a computer operably coupled to the detectors (para. 0026), containing an instruction set for acquiring data from the detector and for constructing thermal melt curves and control curves from the data (abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the optical device taught by modified Tsao with an optical detection system (reader) comprising detectors that includes a microscope, a photodiodes (laser diode) and an imaging system (imager) and a computer operably couple to the detectors for data acquisition and constructing thermal melt curves taught by Sundberg because one of ordinary skill in the art would accordingly have recognized the detection system taught by Sundberg would result in the predictable result of providing an interface module and detection system for performing PCR and thermal melt analysis (abstract, paras. 0026, 0153)(MPEP 2143)(I)(B).
The teachings of modified Tsao as modified by Sundberg would yield the system comprising a reader (optical detection system), wherein the reader comprises a computational
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/ Primary Examiner, Art Unit 1758