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 in the reply filed on 08 January 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06 September 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Droplet 200
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 13, 15, 16, and 18 – 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification of the instant application relies exclusively on computational fluid dynamics (cfd) when describing droplet sizes and distributions. Regarding the fluid mixture, there is no disclosure of what type of oil or surfactant may be used—only parameters such as surface tension that would be used in a computational model. There are very limited structural details present in the specification. No discussion is made as to the materials or manufacturing of the microfluidic device.
With regards to the “volume variable” part, the specification merely recites that this part may be responsive to change in magnetic field, electric field, temperature, or pressure; it further recites that the material may comprise a polymer brush, polymer gel, or elastic material. No discussion is made regarding how the change in magnetic field, electric field, temperature, or pressure is applied. No discussion is made of how a polymer brush, polymer gel, or elastic material may be made responsive to a change in conditions. No preferred embodiment is supplied.
Of most concern to the examiner are the limitations of claims 7 – 13, which describe curving or asymmetric structures within the volume variable portion. The specification does not include any details describing how an expanding and contracting material can be made to adjustably conform to such curves. One of ordinary skill in the art would find this to be a significant engineering challenge, especially at a microfluidic scale. The specification does not provide any details about how to tune the responsiveness of shape-changing materials to achieve these curves.
Taken together, it is not clear to one having ordinary skill in the art that applicant had possession of the claimed microfluidic apparatus at the time of filing. Accordingly, claims 1 – 13, 15, 16, and 18 – 20 are rejected as failing to comply with the written description requirement.
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 7 – 13 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.
With regards to claim 7, the claim recites “the adjustable width gradually decreases and then increases along the first length.” It is not clear what aspect of the adjustable width decreases and then increases. This ambiguity amounts to a failure to particularly point out and distinctly claim the subject matter, rendering the claim indefinite. For the purposes of examination, the examiner interprets claim 7 to mean “the adjustable width gradually decreases and then increases in width along the first length,” according to embodiments of Figure 9, eg.
Claims 8 – 13 are rejected as being indefinite due to their dependence upon claim 7.
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, 15, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deng et al (CN 112657565 A, cited on the IDS provided 06 August 2023; Relied upon translation is attached).
With regards to claim 1, Deng et al teaches;
The prior art of Deng et al teaches the microfluidic chip according to claim 1;
The claimed “a substrate and a first flow channel, a second flow channel, and a third flow channel distributed on the substrate; the first flow channel, the second flow channel and the third flow channel intersecting to form a confluence area” has been read on the taught ([0025], “Those skilled in the art will understand that, in addition to the "cross-shaped" microfluidic channel shown in Figure 1, the microfluidic channel of the present invention can also be other shapes of microfluidic channels in related technologies, such as a "T-shaped" microfluidic channel.”; The cross-shaped channel reads on the second and third flow channel intersecting to form a confluence area.);
The claimed “the first flow channel being configured for a flow of a dispersed phase fluid from it” has been read on the taught ([0023], “…the first flow channel 100 is used to introduce the droplet phase…”);
The claimed “the second flow channel being configured for a flow of a continuous phase fluid from it” has been read on the taught ([0023], “…the second flow channel 200 is used to introduce the continuous phase…”);
The claimed “the dispersed phase fluid and the continuous phase fluid forming droplets in the third flow channel, wherein the dispersed phase fluid flows in the first flow channel along a first direction, an orthographic projection of the first flow channel on the substrate has a first width which is constant in a second direction, and the second direction and the first direction are perpendicular to each other in a plane of the substrate” has been read on the taught ([0023], “…when the droplet phase passes through a portion of the inner wall of the third flow channel 300 where the functional layer 400 is located, the functional layer 400 extends and retracts to a first predetermined position in the second direction, thus limiting the droplet 99a formed by the droplet phase.”; see also Figures 1A and 1B.);
The claimed “wherein the droplets flow in the third flow channel along a third direction, the third flow channel comprises a volume variable part extending along the third direction” has been read on the taught ([0023], “…when the droplet phase passes through a portion of the inner wall of the third flow channel 300 where the functional layer 400 is located, the functional layer 400 extends and retracts to a first predetermined position in the second direction, thus limiting the droplet 99a formed by the droplet phase.”; see also Figures 1A and 1B. Functional layer 400 reads on a volume variable part extending along the third direction.);
The claimed “wherein an orthographic projection of the volume variable part on the substrate has an adjustable width in a fourth direction” and “wherein the fourth direction and the third direction are perpendicular to each other in the plane of the substrate” has been read on the taught ([0028], “…in other embodiments of the present invention, referring to FIG2b, the functional layer 400 may extend to the edge of the third channel 300 in the second direction.” The second direction reads of the fourth direction. );
The claimed “wherein the droplets are of different sizes and are generated by controlling a ratio of the adjustable width to the first width” has been read on the taught ([0024], “Those skilled in the art will understand that since the functional layer 400 can extend and retract to the predetermined position in the second direction, it can also form smaller droplets first and then larger droplets, or form droplets of different sizes sequentially according to different needs, as long as the functional layer 400 can extend and retract to different predetermined positions. Those skilled in the art can make flexible choices according to actual needs, and will not elaborate further here.”).
For the ease of discussion in future rejections, Figure 1B of Deng et al has been reproduced below, with annotations describing the claimed directions. These direction annotations align with Figure 3A of the instant application.
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With regards to claim 2, the device according to claim 1 is anticipated by Deng et al.
Deng et al further teaches;
The claimed “wherein the adjustable width has a second width which is constant along the third direction” has been read on the taught ([0031], “Specifically, in some specific embodiments of the present invention, when the width p of the third flow channel is 50 μm, the distance D extending of the functional layer 400 along the first direction can be set to be not less than 100 μm…”; Distance D reads on a second width which is constant along the third direction).
With regards to claim 3, the device according to claim 2 is anticipated by Deng et al.
Deng et al further teaches;
The claimed “wherein the first direction is in a same line with the third direction” has been read on the taught (See annotated Figure 1).
With regards to claim 15, the device according to claim 1 is anticipated by Deng et al.
Deng et al further teaches;
The claimed “wherein the volume variable part of the third flow channel comprises volume phase change material” has been read on the taught ([0029], “…the specific implementation of the aforementioned functional layer 400 extending to different predetermined positions in the second direction can be achieved by making the material of the functional layer 400 include a material that can change its own volume under the predetermined conditions…”; A material that can change its own volume reads on a volume phase change material.).
With regards to claim 16, the device according to claim 15 is anticipated by Deng et al.
Deng et al further teaches;
The claimed “wherein the volume phase change material achieves the adjustable width in response to at least one condition change in magnetic field, electric field, temperature, and pressure” has been read on the taught ([0029], “… the specific implementation of the aforementioned functional layer 400 extending to different predetermined positions in the second direction can be achieved by making the material of the functional layer 400 include a material that can change its own volume under the predetermined conditions […] wherein the predetermined conditions may include at least one of placing the functional layer 400 in an electric field, placing the functional layer 400 in a magnetic field, applying pressure to the functional layer 400, or heating the functional layer 400.”).
With regards to claim 19, the device according to claim 1 is anticipated by Deng et al.
Deng et al further teaches;
The claimed “A droplet generation device, comprising the microfluidic chip according to claim 1” has been read on the taught ([0004], “…one object of the present invention is to provide a microfluidic channel that can form droplets of different sizes…”; Forming droplets reads on a droplet generation device.).
With regards to claim 20, the device according to claim 19 is anticipated by Deng et al.
Deng et al further teaches;
The claimed “a pumping device, which is connected with the first flow channel and the second flow channel to control a flow rate of the dispersed phase fluid entering the first flow channel and a flow rate of the continuous phase fluid entering the second flow channel” has been read on the taught ([0026], “…the injection method of the microfluidic channel 10 is not particularly limited. For example, it can be driven by a pneumatic pump, a plunger pump, or a peristaltic pump. The flow rates of the continuous phase and the droplet phase are adjustable.”).
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 – 13 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al (CN 112657565 A, cited on the IDS provided 06 August 2023; Relied upon translation is attached).
With regards to claim 4, the device of claim 3 is anticipated by Deng et al.
The limitation of “wherein a ratio of the second width to the first width is between 0.5 – 1” relates exclusively to relative dimensions of the device. According to MPEP 2144.04(IV)(A), differences between the relative dimensions of the claimed device and a device having the claimed relative dimensions do not render the claimed device patentably distinct, provided that the two devices would not perform differently—please see In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the case of the instant invention and Deng et al, both devices would create an adjustable range of droplet sizes.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the device of Deng et al with recited limitation of a ratio of the second width to the first width between 0.5 – 1.
With regards to claim 5, the device of claim 4 is obvious over Deng et al.
The limitation of “wherein a droplet size is approximately linear with the ratio of the second width to the first width” does not describe any structural features of the microfluidic device, and is instead a description of intended use. The relationship of the droplet size to the device parameters would be dependent upon the viscosity and surface tension of the fluids in use, as well as upon the fluid injection rate; these, in turn, would be dependent upon a desired function of the device.
As Deng et al teaches all of the structural limitations of the apparatus as defined in claim 5, the additional limitations does not define the instant application over the prior art.
With regards to claim 6, the device of claim 5 is obvious over Deng et al.
The limitation of “wherein a viscosity ratio of the continuous phase fluid to the dispersed phase fluid is in a range of 10:1-50:1, and a surface tension coefficient between the continuous phase fluid and the dispersed phase fluid after adding surfactant is in a range of 1x10-1x10-2N/m, the droplet size is approximately positively correlated linear with the ratio of the second width to the first width” does not describe any structural features of the microfluidic device, and is instead a description of intended use. The fluids used in the device would be dependent upon the particular application of the generated droplets.
As Deng et al teaches all of the structural limitations of the apparatus as defined in claim 6, the additional limitations does not define the instant application over the prior art.
With regards to claim 7, the device of claim 1 is anticipated by Deng et al.
The limitation of “wherein the volume variable part extends a first length along the third direction, and the adjustable width gradually decreases and then increases along the first length” relates exclusively to relative dimensions of the device. According to MPEP 2144.04(IV)(A), differences between the relative dimensions of the claimed device and a device having the claimed relative dimensions do not render the claimed device patentably distinct, provided that the two devices would not perform differently—please see In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the case of the instant invention and Deng et al, both devices would create an adjustable range of droplet sizes.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the device of Deng et al with recited limitations of claim 7.
With regards to claims 8 and 9, the device of claim 7 is obvious over Deng et al.
The limitations of “wherein a ratio of a minimum width to a maximum width is between 0.5 – 1, and the first length is 2 – 5 times the minimum width” and “wherein the maximum width is equal to the first width” relates exclusively to relative dimensions of the device. According to MPEP 2144.04(IV)(A), differences between the relative dimensions of the claimed device and a device having the claimed relative dimensions do not render the claimed device patentably distinct, provided that the two devices would not perform differently—please see In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the case of the instant invention and Deng et al, both devices would create an adjustable range of droplet sizes.
Additionally, these limitations do not include any restrictions on where a minimum or maximum width would be located in the device, and, in the broadest reasonable interpretation, may include minimum and maximum widths in structures which do not interface with the droplet generation area.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the device of Deng et al with recited limitations of claim 8 or claim 9.
With regards to claims 10 – 13, the device of claims 7 and 8 are obvious over Deng et al.
The limitations of claims 10 through 13 all hinge on the shape of the volume variable part within the microfluidic structure.
The shape of the volume variable part is a results-effective variable that would be obvious to one of ordinary skill in the art given routine optimization. In particular, the curved channels implied in claims 10 – 13 would be dependent upon the material used to create the volume variable part, and the means by which the volume change was accomplished. Moreover, the desired shape of the volume variable part would require optimization given the layout of the chip, the possible manufacturing methods, and the desired size of the resulting droplets.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the device of Deng et al to incorporate the limitations of claims 10 – 13.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Deng et al as applied to claim 1 above, and further in view of Bharadwaj et al (US 20200290048 A1).
With regards to claim 18, the device of claim 1 is anticipated by Deng et al.
Deng et al teaches the use of a dispersed and a continuous phase, as read on the taught ([0023], “…the first flow channel 100 is used to introduce the droplet phase, and the second flow channel 200 is used to introduce the continuous phase.”).
However, Deng et al does not explicitly disclose the limitations of claim 18.
In the analogous art of droplet generating devices, Bharadwaj et al teaches;
The claimed “a dispersed phase of the dispersed phase fluid is an aqueous phase, a continuous phase of the continuous phase fluid is an oil phase, and the droplets have a water-in-oil structure” has been read on the taught ([0187], “In a non-limiting example, the first channel can carry a first fluid (e.g., aqueous) and the second channel can carry a second fluid (e.g., oil) that is immiscible with the first fluid. The two fluids can communicate at a junction.”; See also [0247]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Deng et al with the use of an aqueous phase and an oil phase as taught by Bharadwaj et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Deng et al contains the element of a microfluidic droplet generator designed for use with a droplet phase and a continuous phase. The prior art of Bharadwaj et al teaches the use of an aqueous phase and an oil phase for generating droplets. One of ordinary skill in the art could have combined these elements, and each fluid would have the same function as it does separately, for the predictable result of generating water droplets within an oil continuous phase.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Deepak (US 20200261910 A1) teaches the use of curved microfluidic chambers.
Ismagilov et al (US 20170361321 A1) teaches the use of curved microfluidic chambers for transporting fluid plugs within a carrier fluid.
Abate et al (US 20160250638 A1, cited on the IDS filed 06 September 2023) teaches a narrowing a chamber using a pinch valve.
Hong et al (US 20110056575 A1) teaches the use of a valve to generate a droplet and the use of curved microfluidic chambers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797