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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Examiner notes the use of “The present invention proposes…” is interpreted as legal phraseology.
Claim Objections
Claim 1 is objected to because of the following informalities: there is a miscellaneous period (“.”) at the end of line 9 of the claim. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: missing the appropriate indefinite article (“an”) in front of “expansion channel” in line 2 of the claim. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: missing the appropriate indefinite article (“an”) in front of “expansion channel” in line 2 of the claim. 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 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.
Claim 1 recites the limitation, “characterized in that a height of a top wall…” in line 3 of the claim. It is unclear what specifically is being “characterized.” Examiner believes this is referring to the microchannel and will be examined as such. Examiner recommends amending the claim to recite "wherein said microchannel is characterized in that..." or an equivalent thereof.
Claim 1 recites the limitation "the liquid waste region" in line 6 of the claim. There is insufficient antecedent basis for the liquid waste region limitation in the claim as a liquid waste region is not previously recited. Examiner recommends amending the claim to recite "a liquid waste region" or an equivalent thereof.
Claim 1 recites the limitation, "an outlet" in line 6 of the claim. "An outlet" is previously recited in line 5 of the same claim. It is unclear if these are the same or different outlets. Based on the clarification within the claim of “an outlet of the/said microchannel”, Examiner believes these are the same outlets (of the microchannel) and will be examined as such. Examiner recommends amending the claim to recite "wherein the outlet of said microchannel..." or an equivalent thereof.
Claims 2-9 are rejected based on their dependence to claim 1.
Claim 5 recites the limitation “or said expansion channels are…” in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim as only a singular expansion channel is previously recited. Based on Figures 3 and 4 of the instant application, Examiner notes there can be two expansion channels, one on either side of the microchannel; however, further amendments will be needed to recite an additional expansion channel. Examiner notes a simpler amendment of “or said expansion channel is…” or an equivalent thereof.
Claim 7 recites the limitation "a liquid waste region" in line 2 of the claim. “A liquid waste region” is previously recited in claim 1 from which claim 7 depends. It is unclear if these are the same or different liquid waste regions. Based on the disclosure of the instant applicant, Examiner believes these to be the same liquid waste regions. Examiner recommends amending the claim to recite “the liquid waste region” or an equivalent thereof.
Claim 7 recites the limitation "through a sample adding well" in line 4 of the claim. “A sample adding well” is previously recited in claim 1 from which claim 7 depends. It is unclear if these are the same or different sample adding wells. Based on the disclosure of the instant applicant, Examiner believes these to be the same sample adding wells. Examiner recommends amending the claim to recite “through the sample adding well” or an equivalent thereof.
Claim 8 recites the limitation "between the buffer adding well..." in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim as “a buffer adding well” is not previously recited in the claim or claims from which claim 8 is dependent (claims 6, 2, or 1). Examiner believes the buffer adding well of claim 8 is the same as the buffer adding well as recited in claim 7. Examiner recommends amending the claim to recite “between a buffer adding well” or amending the claim to depend on claim 7, that positively recites the buffer adding well, or an equivalent thereof.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Li, et. al. (CN 209327360 U; citations made with respect to original copy and English translation provided with IDS dated 16 July 2024) in view of Saito (US 20150086446 A1; cited in IDS dated 16 July 2024) and Adey (US 20020192701 A1).
Regarding claim 1, Li teaches a microfluidic chip comprising a microchannel (Abstract). Li teaches a microfluidic chip comprising a lower substrate 1 and an upper cover sheet 2 with a microchannel 21, specifically narrow portion 212, defined between the two (Fig. 1-2; par. 0048-0049) (a microchannel enclosed and formed by a substrate and a cover sheet). Li teaches the cover sheet 2 further comprises a sample injection hold 23 wherein a sample is introduced (Fig. 2, par. 0049, 0057) (the microchannel is added with a sample fluid through a sample adding well). Li teaches the sample flows from the inlet, through the length of the microchannel 212, until microchannel 212 ends (an outlet of said microchannel) (see circled region in provided Fig. 2 below) and meets the liquid waste tank 22 through capillary action (Fig. 2, par. 0049, 0057) (the sample fluid flows towards an outlet of the microchannel under the capillary force of the microchannel) (wherein an outlet of said microchannel is connected to the liquid waste region).
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Li teaches liquid waste tank 22 further comprises through hole 221 connecting the liquid waste tank 22 with the outside environment (Fig. 2; par. 0049) (said liquid waste region is connected to the outside world via a sample outlet). It is understood that the through hole 221 has two sides/ends, a first end that is facing the inside of the microfluidic device (the sample outlet has at least two ends, one end being close to the outlet of the microchannel) and a second end that is facing outside of the microfluidic device (and the other end being away from the outlet of the microchannel); this can be considered an inherent feature of a hole punched through a substrate because a substrate has a thickness that separates the inner from the outer surface.
Li is silent to characterized in that a height of a top wall of said microchannel is lower than a height of a contact surface of the substrate.
Saito teaches a microchannel (par. 0002) device formed through the combination of two substrates (Abstract). Saito teaches a microchannel formed between a groove 12 within a substrate 10 and a protrusion 14 of a second substrate 11 (Fig. 1-2; par. 0020) (a microchannel enclosed and formed by a substrate and a cover sheet). Saito teaches the microchannel is defined by the lowermost walls of groove 12 and the lowermost wall of protrusion 14 (Fig. 2; par. 0020). As seen in in Figure 2, Saito teaches the maximum height of the microchannel as defined by protrusion 14 is below the contact surfaces of substrate 10 and substrate 11 that can be seen by adhesive layer 13 (characterized in that a height of a top wall of said microchannel is lower than a height of a contact surface of the substrate and the cover sheet). Saito teaches this microchannel structure, wherein the microchannel is formed by engraving a groove in a lower substrate and further defined by a protrusion on an upper substrate (par. 0011), prevents the adhesive layer from altering microchannel shape, leaking into the channel to interfere with liquid flow, and creating voids between the adhered surfaces (par. 0012).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the structure of the engraved microchannel of Li to have a height lower than the contact surface of the lower substrate and upper cover sheet/substrate as taught by Saito because said structural configuration prevents adhesive materials from altering the final shape of the microchannel, leaking into the microchannel, and creating voids between the adhered surfaces (Saito, par. 0012) with reasonable expectation of success. MPEP 2143(I)(G).
Modified Li is silent to the sample outlet is embedded with a water-absorbent material that can be slid within the sample outlet.
Adey teaches a device for low volume (micro) reactions on a microarray formed through adhered layers (Abstract). Adey teaches the fluidic microarray comprises a lower base substrate as microarray slide 3 with additional layers sandwiched between an uppermost support layer 11 (Fig. 2; par. 0032). The layers form an opening for a reaction chamber 13 with an inlet 17 on one end and an outlet 19 on the opposite end is present (Fig. 2; par. 0032). Adey teaches at the outlet 19 end, is a waste collection cap 41 that holds an absorbent material 40 for collecting liquids at the end of the device after the reaction (Fig. 6; par. 0065). Adey teaches the absorbent material 40 can be removed to collect the collected liquid can be analyzed to discarded (par. 0065) (the sample outlet is embedded with a water-absorbent material that can be slid within the sample outlet). Adey teaches the absorbent material helps wick liquid through the device and through the outlet and provides a way to efficiently collect sample material after a reaction to be analyzed (par. 0065).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the sample outlet to further accommodate a removable, water-absorbent material as taught by Adey because the water-absorbent material contributes to the wicking ability of the microfluidic device and provides a means for collecting post-reaction sample material for later analysis (Adey, par. 0065) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 2, modified Li in view of Saito teaches a microchannel formed between a groove 12 within a substrate 10 and a protrusion 14 of a second substrate 11 (Saito, Fig. 1-2; par. 0020). When pressed together, substrate 10 and substrate 11 form three distinct openings/channels that extend along the length of the substrates. The first opening/channel is the microchannel formed from groove 12 and protrusion 14 (Saito, Fig. 2). This configuration simultaneously forms two openings/channels between the surfaces of substrate 10 and substrate 11. As seen in Saito, Figure 2, these openings/channels correspond to where adhesive layer 13 is located. While Saito teaches the openings/channels are filled with an adhesive material 13, the openings still create channels connected to the main microchannel formed by groove 12 and protrusion 14 (Saito, Fig. 2) (characterized in that said microchannel is connected to expansion channel). When adhered together, the trapezoidal shape of protrusion 14 creates upward extensions of the microchannel (see arrow in provided Fig. 2 below) that lead to the adhered surfaces (Saito, Fig. 2) (via an upward connection channel).
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Regarding claim 3, modified Li in view of Saito teaches a microchannel formed between a groove 12 within a substrate 10 and a protrusion 14 of a second substrate 11 (Saito, Fig. 1-2; par. 0020). When pressed together, substrate 10 and substrate 11 form three distinct openings/channels that extend along the length of the substrates. The first opening/channel is the microchannel formed from groove 12 and protrusion 14 (Saito, Fig. 2). This configuration simultaneously forms two openings/channels between the surfaces of substrate 10 and substrate 11. As seen in Saito, Figure 2, these openings/channels correspond to where adhesive layer 13 is located. While Saito teaches the openings/channels are filled with an adhesive material 13, the openings still create channels connected to the main microchannel formed by groove 12 and protrusion 14 (Saito, Fig. 2) (characterized in that said microchannel is connected to expansion channel). When adhered together, the trapezoidal shape of protrusion 14 creates upward extensions, with the protrusion 14 side creating an incline, of the microchannel (see arrow in provided Fig. 2 above) that lead to the adhered surfaces (Saito, Fig. 2) (via an inclined upward connection channel). It is also noted that the walls of groove 12 are not limited to the variation as seen in Saito, Figure 2, but can also have a trapezoidal shape (Saito, Fig. 4A).
Regarding claim 4, modified Li teaches the microchannel 212 extends cross the length of the substrate (Li, Fig. 1) (characterized in that a recess is provided along a length direction of the substrate). Modified Li in view of Saito teaches the microchannel extends along a length of substrate 10 (Saito, Fig. 1) (characterized in that a recess is provided along a length direction of the substrate) and upper substrate 11 has a protrusion 14 that extends below the other surface of substrate 11 to form an upper wall of a microchannel when paired with the groove 12 of substrate 10 (Li, Fig. 2; par. 0020) (the lower surface of the cover sheet projects towards the recess as a top wall of the microchannel, cooperating with the bottom wall of the recess to form the microchannel).
Regarding claim 5, modified Li in view of Saito teaches the microchannel extends along the length of the substrates (Saito, Fig. 1). This means the groove 12 and protrusion 14 and therefore openings/channels for adhesive 13 also extend along the length of the substrates (Saito, par. 0023). The adhesive channels 13 extend alongside microchannel 12 in a parallel fashion across the length of the microchannel 12 (Saito, Fig. 2; par. 0020) (characterized in that said expansion channel extends in a direction parallel to the length of the microchannel).
Regarding claim 6, modified Li in view of Saito teaches adhesive channels 13 are extend along both sides of the microchannel in a parallel fashion (Saito, Fig. 2, par. 0023) (characterized in that said expansion channel is provided… on both sides of the microchannel side edges at the same time).
Regarding claim 7, modified Li teaches the microfluidic chip has three different regions. The first region (see the uppermost outline in provided Fig. 2 below) comprising waste liquid tank 22 at one end of the microchannel 212 and a second region (see lowermost outline in Fig. 2 below) comprising injections holes 23, 24 at the opposite end of microchannel 212 (Li, Fig. 2) (characterized in that said microfluidic chip comprises a sample adding region and a liquid waste region connected to the both ends of the microchannel, respectively). Modified Li teaches the second region comprising injections holes specifically for introducing a sample through sample injection hole 23 and a buffer through buffer injection hole 24 (Li, Fig. 2; par. 0049, 0057-0058) (and said sample adding region is added with sample fluid and buffer through a sample adding well and a buffer adding well, respectively).
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Regarding claim 8, modified Li teaches sample injection hole 23 is located fluidically downstream buffer injection hole 24 and fluidically upstream from of microchannel 212 that comprises the reaction and detection regions (Li, Fig. 1,2) (characterized in that said sample adding well is located between the buffer adding well and the microchannel).
Regarding claim 9, modified Li in view of Saito teaches substrates 10 and 11 can be manufactured in a plurality of ways to form groove 12 and protrusion 14, respectively (Saito, par. 0022). When using an etching or machining method to form these features, specifically forming protrusion 14 in substrate 11, the adhesive channels 13 would be formed etching a groove/recess along the surface of substrate 11 (cover sheet) and combining with the upper surface of substrate 10 (Saito, Fig. 2, 3; par. 0023) (characterized in that said expansion channel is enclosed by a recess provided on the cover sheet and the substrate).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park, et. al. (US 20110294197 A1) teaches a microfluidic chip comprising a microchannel that allows fluid to move through the microchannel by capillary floating (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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