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 .
Status of Claims
The claim set submitted on 11 JANUARY 2024 is acknowledged and considered. In the claim set, Claims 1-15 are presented and pending.
Claims 1-15 are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 5 and 12 are objected to because of the following informalities: In line 1 of the instant claim, ‘wherein an auxiliary’ should be ‘wherein the auxiliary’ . An auxiliary flow channel is already positively claimed in Claim 1 and 9 , respectively. 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.
Claim 9 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.
The instant claim is directed towards a LAMP gene amplification method, however, the method only comprises two steps, a providing chip step and injection a LAMP reactant. It is unclear how LAMP gene amplification is to be occurring if only a step so inject a reactant is performed. How will one determine if gene amplification is occurring or has occurred? What else is being done in this amplification method?
In addition, Claims 10-15 do not further define any more steps to the method. It is unclear how or what is taking place in this method if only an injection steps is positively claimed.
Claims 10-15 are also rejected under 112b as being directly or indirectly from Claim 9.
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 1-3, 5-10 and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SHANGHAI, CN 114367321 A.
An English Machine Translation has been obtained from Google Patents and has been used as the basis of the rejection below.
Applicant’s invention is directed towards a device, a microfluidic chip.
Regarding Claim 1, the reference SHANGHAI discloses a microfluidic chip, Figure 3and 4, comprising:
a fluid inlet; a fluid outlet; and a flow channel constructed to connect the fluid inlet and the fluid outlet to each other, wherein a fluid flows in the flow channel, wherein the flow channel includes a plurality of eddy generation structures connected in series with each other, wherein each of the eddy generation structures includes: a main flow channel; and at least one auxiliary flow channel branching from the main flow channel at a first point thereof, and merging with the main flow channel at a second point thereof spaced apart from the first point in a fluid flow direction, wherein the auxiliary flow channel meets with the main flow channel at an angle in a range of 90 exclusive to 180 exclusive, Figures 3 and 4, page 5, description of Figure 3 and 4.
Additional Disclosures Included are: Claim 2: wherein the microfluidic chip of claim 1, wherein a loop-mediated isothermal amplification (LAMP) reaction is carried out within the flow channel. The instant claim language recites what is to occurring in the flow channel of the device and does not further define the microfluidic chip structurally. The instant claim language is directed towards how the device is intended to be used / operated. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Furthermore, since SHANGHI discloses the claimed invention including all structural limitations, therefore the device would possess the loop-mediated isothermal amplification (LAMP) reaction. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. ; Claim 3: wherein the microfluidic chip of claim 1, wherein the auxiliary flow channel of the eddy generation structure meets with the main flow channel at an angle of 130 to 140⁰, Figure 3 and 4, see zoomed in squares. ; Claim 5: wherein the microfluidic chip of claim 1, wherein an auxiliary flow channel includes: a first portion branching from the first point of the main flow channel and extending by a first length; a second portion extending in a curved manner from an end of the first portion toward the main flow channel; and a third portion extending from an end of the second portion by a second length and merging with the second point of the main flow channel, Figure 3 and 4, page 5, description of Figure 3 and 4. ; Claim 6: wherein the microfluidic chip of claim 1, wherein the at least one auxiliary flow channel includes a plurality of auxiliary flow channels disposed on both opposing sides of the main flow channel and arranged in a zigzag manner along the main flow channel, Figure 3 and 4, entire figure and see zoomed in squares. ; Claim 7: wherein the microfluidic chip of claim 6, wherein the main flow channel is formed in a serpentine structure including a plurality of rows, Figure 3. ; Claim 8: wherein the microfluidic chip of claim 1, wherein the fluid inlet includes a plurality of the fluid inlets, Figure 3, page 4, 2nd full paragraph, 1-3 sample inlet ports.
Applicant’s invention is directed towards a method.
Regarding Claim 9, the reference SHANGHAI discloses a LAMP gene amplification method comprising:
providing a microfluidic chip, wherein the microfluidic chip includes:
a fluid inlet; a fluid outlet; and a flow channel constructed to connect the fluid inlet and the fluid outlet to each other, wherein a fluid flows in the flow channel, wherein the flow channel includes a plurality of eddy generation structures connected in series with each other, wherein each of the eddy generation structures includes: a main flow channel; and at least one auxiliary flow channel branching from the main flow channel at a first point thereof, and merging with the main flow channel at a second point thereof spaced apart from the first point in a fluid flow direction, wherein the auxiliary flow channel meets with the main flow channel at an angle in a range of 90° exclusive to 180 exclusive, Figures 3 and 4, page 5, description of Figure 3 and 4; and injecting a LAMP reactant into the fluid inlet such that the LAMP reactant flows along the flow channel, page 4, 1) mixing: injecting two different biological samples…2) injecting different microsphere solutions…, page 3, paragraph starting with “Encoded microspheres…
Additional Disclosures Included are: Claim 10: wherein the method of claim 9, wherein the auxiliary flow channel of the eddy generation structure meets with the main flow channel at an angle of 130 to 140⁰ , Figure 3 and 4, see zoomed in squares. The instant claim language does not further define any method steps, see 112(b) rejection above. ; Claim 12: wherein the method of claim 9, wherein an auxiliary flow channel includes: a first portion branching from the first point of the main flow channel and extending by a first length; a second portion extending in a curved manner from an end of the first portion toward the main flow channel; and a third portion extending from an end of the second portion by a second length and merging with the second point of the main flow channel, Figures 3 and 4, see in particular zoomed in squares. The instant claim language does not further define any method steps, see 112(b) rejection above. ; Claim 13: wherein the method of claim 9, wherein the at least one auxiliary flow channel includes a plurality of auxiliary flow channels disposed on both opposing sides of the main flow channel and arranged in a zigzag manner along the main flow channel, Figure 3 and 4. The instant claim language does not further define any method steps, see 112(b) rejection above. ; Claim 14: wherein the method of claim 13, wherein the main flow channel is formed in a serpentine structure including a plurality of rows, Figure 3. The instant claim language does not further define any method steps, see 112(b) rejection above. ; and Claim 15: wherein the method of claim 9, wherein the fluid inlet includes a plurality of the fluid inlets, Figures 3 and 4, page 4, 2nd full paragraph, 1-3 sample inlets. The instant claim language does not further define any method steps, see 112(b) rejection above.
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.
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over SHANGHAI, CN 114367321 A.
Regarding Claims 4 and 11 , the SHANGHAI reference discloses the claimed invention directed towards a microfluidic chip as well as a method of using the chip, but is silent in regards to wherein the main flow channel has a width of 80 to 120 mm.
SHANGHAI discloses the microfluidic chip is at the micro/nanometer level, page 3, ‘Background’ , 1st paragraph. SHANGHAI further discloses the diameter of the nanomagnetic balls are 300 nm and the diameter of the quantum dot microsphere is 100 nm, page 5, middle of page. In addition, SHANGHAI discloses the micromixer and detector are connected to each other by a flow channel using a capillary tube, page 5, paragraph starting with ‘Before the invention is used…’.
It is known in the art the capillary tubes are typically microscale in cross‑section, with dimensions often in the micrometer to millimeter range, depending on the application.
Since SHANGHAI discloses the chip at a micro/nanometer level and the balls / microspheres are at the nanometer level, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the width of the main flow channel of the microfluidic chip of SHANGHAI to be 80 to 120 mm to comfortably flow a plurality of balls / microspheres are at the nanometer level without clogging and to use the microfluidic chip for flowing sample with improved reaction speed and flexibility, abstract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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