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 .
Claim Status
Claim 1-5, 7, 10, 20-21, 23-24, 26, 33, 37, 74 and 101-103 are pending with claims 1-5, 7, 10, 20-21, 23-24, 26, 33, and 101-103 under examination and claims 37 and 74 withdrawn from consideration.
Claims 6, 8-9, 11-19, 22, 25, 27-32, 34-36, 38-73, and 75-100 have been canceled.
Response to Amendment
New 112(a) and 112(b) rejection(s) have been set forth in view of the claim amendments.
Based on the amended claims and remarks received on 07/14/2026, the previous prior art rejection over Amini has been withdrawn and a new prior art rejection set forth (see below).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following features must be shown or the feature(s) canceled from the claim(s):
(1) a first fluid, a second fluid, and a third fluid.
(2) flowing the third fluid comprising a plurality of cells into the first fluid.
(3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more.
(4) the jet continuously narrows in width after the junction.
(5) the jet of the first does not spontaneously break into droplets in the second fluid
No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. The meaning of every term used in any of the claims should be apparent from the descriptive portion of the specification with clear disclosure as to its import; and in mechanical cases, it should be identified in the descriptive portion of the specification by reference to the drawing, designating the part or parts therein to which the term applies. A term used in the claims may be given a special meaning in the description. See MPEP § 2111.01 and § 2173.05(a).
Usually the terminology of the claims present on the filing date of the application follows the nomenclature of the specification, but sometimes in amending the claims or in adding new claims, new terms are introduced that do not appear in the specification. The use of a confusing variety of terms for the same thing should not be permitted.
New claims, including claims first presented after the application filing date where no claims were submitted on filing, and amendments to the claims already in the application should be scrutinized not only for new matter but also for new terminology. While an applicant is not limited to the nomenclature used in the application as filed, he or she should make appropriate amendment of the specification whenever this nomenclature is departed from by amendment of the claims so as to have clear support or antecedent basis in the specification for the new terms appearing in the claims. This is necessary in order to insure certainty in construing the claims in the light of the specification See 37 CFR 1.75, MPEP § 608.01(i) and § 1302.01 and § 2103. Note that examiners should ensure that the terms and phrases used in claims presented late in prosecution of the application (including claims amended via an examiner’s amendment) find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description, see 37 CFR 1.75(d)(1). If the examiner determines that the claims presented late in prosecution do not comply with 37 CFR 1.75(d)(1), applicant will be required to make appropriate amendment to the description to provide clear support or antecedent basis for the terms appearing in the claims provided no new matter is introduced. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Applicant(s) have amended claim 1 to require (1) a first fluid, a second fluid, and a third fluid, (2) flowing the third fluid comprising a plurality of cells into the first fluid, (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction, and (5) the jet of the first does not spontaneously break into droplets in the second fluid. However, the combination of elements is not disclosed in the remainder of the specification. Applicant(s) may amend the specification to include the claimed subject matter or cancel the limitations from the claims.
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 1-5, 7, 10, 20-21, 23-24, 26, 33, 37, 74 and 101-103 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.
Claim 1 has been amended to recite “flowing a third fluid comprising a plurality of cells into a first fluid … a jet of the first fluid in the second fluid that extends beyond a junction where the first fluid meets the second fluid by a distance of 4x or more, wherein x is a width of the channel, wherein the jet of the first fluid does not spontaneously break into droplets in the second fluid … wherein the jet continuously narrows in width after the junction”. Support for the amended limitations was not found in applicant’s originally filed disclosure, and therefore constitutes new matter. Therefore, claim 1 requires (1) a first fluid, a second fluid, and a third fluid, (2) flowing the third fluid comprising a plurality of cells into the first fluid, (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction, and (5) the jet of the first does not spontaneously break into droplets in the second fluid. The amended limitations constitute new matter which will be discussed below. A review of originally filed disclose defines:
WRITTEN DESCRIPTION SUPPORT
[0068] “The methods as described herein may include combining a plurality of particles with a third fluid, wherein the third fluid includes a plurality of targets, e.g., reagents, nucleic acids or cells, etc. See, e.g., FIG. 1E, wherein H20 is an exemplary third fluid. In some embodiments, combining the plurality of particles with the third fluid includes causing a portion of the third fluid, and the targets and/or reagents contained therein, to be absorbed by the particles. In some embodiments, combining the plurality of particles with a third fluid includes flowing a third fluid into the first fluid prior to flowing the first fluid into the second fluid, wherein the third fluid is miscible with the first fluid. In certain aspects, the methods as described herein may include combining a plurality of particles with a first fluid, wherein the first fluid includes a plurality of targets, e.g., reagents, nucleic acids or cells, etc.
[0217] “In some other embodiments, the microfluidic device described herein further includes a fifth channel and a sixth channel which form a junction with the first channel upstream of the junction of the first, second, third and fourth channels. In such embodiments, a third fluid may be flowed into the first fluid from the fifth and sixth channels prior to flowing the first fluid into the second fluid, wherein the third fluid is miscible with the first fluid. Exemplary embodiments are depicted in FIGS. 1D, 1E, 2D, 2E, 4A and 4B.
The term “distance” appears in paragraphs [0103] with reference to “the distance between the channel injecting the target droplets from the electrodes applying the electric field”, and [0166-0167] with reference to designing probe sequences, but does not discuss the distance of the channel of a microfluidic device.
The term “length” appears in paragraphs [0027, 0034, 0122, 0133-0134, 0136, 0141, 0150, 0164-0167, 0199, 0212, 0248, 0258, 0264] with reference to lengths of nucleic acids, amino acids, wavelength of fluorescent dye, oligonucleotide, length distributions of target molecules, target genomes, and drop length. However, the written description does not use the term “length” with respect to a length of the jet of the first fluid and second fluid.
The term “width” appears in paragraph [0052] with reference to “In other embodiments, a particle of the plurality of particles may have a diameter or largest dimension that is less than 1% of the channel width or height.” which correlates a particle size to the wide of the channel, but does not relate the jet distance with respect to the width.
DRAWING SUPPORT
Figures 1D shows particle-trigger ordered elastic particles. However, the figure does not show (1) a first fluid, a second fluid, and a third fluid, (2) flowing the third fluid comprising a plurality of cells into the first fluid, (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction. Further, the disclose has provided no indication that the drawings are to scale. Therefore, the ratio and proportions that are attempting to be claimed do not have support in the drawings. See MPEP 2125 (II). See image reproduced below.
Figure 1E shows particle-trigger with co-flow Ordered elastic particles. However, the figure does not show (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction. Further, the disclose has provided no indication that the drawings are to scale. Therefore, the ratio and proportions that are attempting to be claimed do not have support in the drawings. See MPEP 2125 (II). See image reproduced below.
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Figure 2D shows bead-trigger ordered elastic beads. However, the figure does not show (1) a first fluid, a second fluid, and a third fluid, (2) flowing the third fluid comprising a plurality of cells into the first fluid, (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction. Further, the disclose has provided no indication that the drawings are to scale. Therefore, the ratio and proportions that are attempting to be claimed do not have support in the drawings. See MPEP 2125 (II). See image reproduced below.
Figure 2E shows bead-trigger with co-flow ordered elastic beads. However, the figure does not show (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction. Further, the disclose has provided no indication that the drawings are to scale. Therefore, the ratio and proportions that are attempting to be claimed do not have support in the drawings. See MPEP 2125 (II). See image reproduced below.
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Figure 4A shows the device with fluid inlets and outlets. However, the figure does not show (1) a first fluid, a second fluid, and a third fluid, (2) flowing the third fluid comprising a plurality of cells into the first fluid, (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction, (5) the jet of the first does not spontaneously break into droplets in the second fluid. See image reproduced below.
Figure 4B shows the device operation in the dripping and jetting regimes with and without particles. However, the figure does not show (3) a jet of the first fluid in the second fluid extending beyond a junction by a distance of 4x or more, (4) the jet continuously narrows in width after the junction. See image reproduced below.
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Figure 3A shows a stable jet breakup using unpacked rigid particles. However, the figure does not show (4) the jet continuously narrows in width after the junction. See image reproduced below.
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Regarding figures 1A-E, 2A-E, and 3B, the examiner notes that these figures are merely schematics as visual aids, but do not show a real-world setup. Further, the disclose has provided no indication that the drawings are to scale. Therefore, the ratio and proportions that are attempting to be claimed do not have support in the drawings. See MPEP 2125 (II).
Regarding figures 4C, 6A, and 7, the examiner notes that the experimental images of the stream do not show (4) the jet continuously narrows in width after the junction and/or (5) the jet of the first does not spontaneously break into droplets in the second fluid.
Accordingly, support for the amended limitations of claim 1 including “flowing a third fluid comprising a plurality of cells into a first fluid … a jet of the first fluid in the second fluid that extends beyond a junction where the first fluid meets the second fluid by a distance of 4x or more, wherein x is a width of the channel, wherein the jet of the first fluid does not spontaneously break into droplets in the second fluid … wherein the jet continuously narrows in width after the junction” was not found in applicants originally filed disclose. Therefore, claim 1 contains new matter because it includes limitations which were 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. Claims 2-5, 7, 10, 20-21, 23-24, 26, 33, 37, 74 and 101-103 are also rejected by their dependency from claim 1.
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 1-5, 7, 10, 20-21, 23-24, 26, 33, and 101-103 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 pre-AIA the applicant regards as the invention.
Claim 1 lines 4-9 recite “flowing … the first fluid into a second fluid under stable jetting conditions to provide a jet of the first fluid in the second fluid that extends beyond a junction where the first fluid meets the second fluid by a distance of 4x or more, wherein x is a width of the channel, wherein the jet of the first fluid does not spontaneously break into droplets in the second fluid … wherein the jet continuously narrows in width after the junction”. First, the claim first defines a length of the jet as being “4x or more”, but later recites “the jet of the first fluid does not spontaneously break into droplets”. It is unclear if 4x is an entire length of the channel, or if a droplet is formed after the jet reaches the 4x (or more) distance. Second, the claim defines “the jet of the first fluid does not spontaneously break into droplets”, but then later recites “the jet continuously narrows in width”. It is unclear how a jet of fluid can “continuously narrow” without breaking into a droplet. When one immiscible fluid is introduced into another, generally one of two events will occur: the formation of droplets (or bubbles) or the formation of a continuous jet. This response is a consequence of the inner or dispersed fluid becoming unstable due to surface tension forces seeking to minimize the interfacial area (Rayleigh-Plateau instability). Opposing this action are viscous forces which suppress the growth of deformations of the jet that lead to pinch off, and, if present, inertial forces. It is the balance of these forces that determine whether droplets or jets form for a given set of conditions. See Nunes et al., Dripping and jetting in microfluidic multiphase flows applied to particle and fibre synthesis, February 2013, Journal of Physics D: Applied Physics, 42, 114002, p. 2, column 1, first paragraph. In this case, a narrowing jet would be a result of unbalanced forces which would result in the jet pinching off and forming a bulbous droplet at the end. For purposes of applying prior art the examiner is interpreting the claim as forming a jet that narrows at the junction and pinches off into a droplet at a certain distance. Claims 2-5, 7, 10, 20-21, 23-24, 26, 33, 37, 74 and 101-103 are also rejected by their dependency from claim 1.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 7, 10, 20, 23-24, 26, and 101-103 are rejected under 35 U.S.C. 103 as being unpatentable over Amini et al. (US 2017/0128940; already of record – hereinafter “Amini”) in view of Steenblock et al. (US 2014/0179544; already of record – hereinafter “Steenblock”) and Cubaud et al. (Capillary threads and viscous droplets in square microchannels, May 2008, Physics of Fluid, Volume 20, Issue 5, pp. 053302-1 through 053302-11).
Regarding claim 1, Amini disclose a method for generating droplets (Amini; fig. 8, [0006, 0037, 0142-0152]), comprising:
flowing a third fluid comprising a plurality of cells into a first fluid (Amini; fig. 8, Step 1 “Ordered barcoded beads/lysis”, Step 2 “Ordered cell suspension”, [0143]), wherein the third fluid is miscible with the first fluid (Amini disclose the third fluid and first fluid merge, [0037, 0143, 0164]);
flowing in a channel of a microfluidic device the first fluid into a second fluid under stable jetting conditions to provide a jet of the first fluid in the second fluid (Amini disclose fluid from Step 1 and fluid from Step 2 are merged and jetted into oil at Step 3, figs. 8-9, [0143, 0171]) that extends beyond a junction where the first fluid meets the second fluid (Amini disclose the jet extends beyond a junction where the first fluid meets the second fluid; fig. 9, [0171]), wherein the jet of the first fluid does not spontaneously break into droplets in the second fluid (Amini disclose the microfluidic device is designed to generate droplets each containing a single cell and a single bead. The microchannel device is configured to separate, order, and focus streams of barcoded beads to one or more focusing positions within a channel flow field (Step 1). The microchannel device is configured to separate, order, and focus streams of cells to one or more focusing positions within a channel flow field (Step 2). The microchannel device receives an oil as another input (Step 3), and combines the ordered barcoded bead, the ordered cell, and an oil to generate droplets within a-double-undispersed-Poisson statistics, where each droplet contains one bead and one cell; fig. 8, [0143]. Amini further disclose adjusting the flow rate of bead fluid so that every droplet encapsulated one bead wherein the jet of the first fluid does not spontaneously break into droplets in the second fluid; fig. 9 and [0171]. Accordingly, the ordered particles in the first fluid stream prevent the first fluid from spontaneously breaking into droplets in the second fluid resulting in the generation of droplets each with one bead and one cell, as shown in Step 4 of fig. 8; [0142-0143]), and wherein the first fluid is immiscible with the second fluid (Amini disclose the merged stream of beads and cells is then contacted with an oil or other immiscible fluid to create a droplet containing the beads and cells; [0037, 0165]); and
introducing a plurality of particles into the first fluid upstream of the jet, thereby causing the plurality of particles to flow into the jet, thereby triggering break-up of the jet and encapsulation of the plurality of particles and cells in a plurality of monodispersed droplets of the first fluid in the second fluid (Amini; figs. 4 & 8, Step 1, the microchannel device is configured to separate, order, and focus streams of barcoded beads to one or more focusing positions within a channel flow field. The bead triggers breakup of the jet to generate droplets containing one bead and one cell in Step 4; [0018, 0142-0143]),
wherein the plurality of particles comprises rigid particles or hydrogel particles (Amini; [0159]).
Amini does not explicitly disclose the droplets are monodispersed droplets.
However, Steenblock teach the analogous art of a method for generating droplets (Steenblock; fig. 1, #102, [0072]), wherein the droplets are monodispersed droplets (Steenblock; [0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method for generating droplet of Amini with the method for generating monodispersed droplets, as taught by Steenblock, because Steenblock teach the method for generating monodispersed droplets creates a highly uniform size of droplets (Steenblock; [0133]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Amini and Steenblock both teach microchannel flow focusing to generate an emulsion of droplets.
Modified Amini does not teach the jet extends beyond the junction by a distance of 4x or more, wherein x is a width of the channel, or wherein the jet continuously narrows in width after the junction.
However, Cubaud teach the analogous art of flowing in a channel of a microfluidic device a first fluid into a second fluid under stable jetting conditions (Cubaud; figs. 1(a)-1(b) & 3, p. 1 abstract, pp. 2-3 “II. Experimental Procedure”, p. 3 “III. Flow Map”, pp. 4-6, “V. Jetting”), wherein the jet extends beyond the junction by a distance of 4x or more, wherein x is a width of the channel, and wherein the jet continuously narrows in width after the junction (Cubaud disclose threading and jetting conditions where the jet of fluid is 4x or greater and narrows after the junction. Include explanation in view of 112b; figs. 1(a)-1(b) & 3, pp. 4-6, “ IV Capillary Threads”, “V. Jetting”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the jetting conditions of modified Amini with a flow rate ratio such that the jet extends beyond the junction by a distance of 4x or more and the jet continuously narrows in width after the junction, as taught by Cubaud, because Cubaud teach varying the flow rate ratio of the fluids to adjust the length of the jet in the channel allows control the droplet diameter (Cubaud; fig. 3, p. 5, “A. Droplet diameter”). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success modified Amini and Cubaud both teach methods for generating droplets using immiscible liquids.
Regarding claim 2, modified Amini teach the method of claim 1 above, wherein the plurality of particles is introduced into the jet of the first fluid in a disordered configuration (Amini; fig. 9, [0171]).
Regarding claim 3, modified Amini teach the method of claim 1 above, wherein the plurality of particles comprises rigid particles (Amini; [0159]).
Regarding claim 4, modified Amini teach the method of claim 1 above, wherein the plurality of particles is introduced into the jet of the first fluid in an ordered configuration (Amini; figs. 4 & 8, Steps 1 & 2, the microchannel device is configured to separate, order, and focus streams of barcoded beads to one or more focusing positions within a channel flow field. The bead triggers breakup of the jet to generate droplets containing one bead and one cell in Step 4; [0018, 0142-0143]).
Regarding claim 5, modified Amini teach the method of claim 4 above, wherein the plurality of particles is introduced into the jet of the first fluid in a packed configuration (Amini teach barcoded beads, cells, and reagents are merged into droplets; fig. 8, [0143, 0159, 0164]. The examiner notes that paragraph [0050] of applicants printed publication describes a packed configuration as “the particles may include reagents for biochemical functionalization of particles and high-throughput pairing of particles with analytes, e.g., reagents or cells. For example, cells may be paired with particles functionalized with barcodes and/or nucleic acid synthesis reagent”. Accordingly, Amini disclose a packed configuration).
Regarding claim 7, modified Amini teach the method of claim 4 above, wherein the plurality of particles is ordered via inertial ordering (Amini; figs. 4 & 8, [0006, 0018, 0142]).
Regarding claim 10, modified Amini teach the method of claim 1 above, wherein each droplet of the plurality of monodispersed droplets comprises one, and not more than one, particle (The modification of the method for generating droplet of Amini with the method for generating monodispersed droplets, as taught by Steenblock, has previously been discussed in claim 1 above. Amani teach one bead and one cell per droplet; fig. 8, [0143]).
Regarding claim 20, modified Amini teach the method of claim 1 above, wherein the first fluid or the third fluid comprises a polymerizable component (Amini; [0159, 0163]).
Regarding claim 23, modified Amini teach the method of claim 1 above, wherein the third fluid comprises one or more reagents (Amini; [0163-0164]).
Regarding claim 24, modified Amini teach the method of claim 1 above, comprising merging one or more droplets with the jet prior to break-up of the jet (Amini; fig. 8, [0143]).
Regarding claim 26, modified Amini teach the method claim 1 above, wherein the plurality of particles is encapsulated at a rate of 1Hz to 100kHz (Amini; [0174, 0177, 0180, 0183, 0186]).
Regarding claim 101, modified Amini teach the method of claim 3 above, wherein the rigid particles comprise glass, silica, metal, or a combination thereof (Amini disclose magnetic beads; [0159]).
Regarding claim 102, modified Amini teach the method of claim 1 above, wherein the plurality of particles comprises hydrogel particles (Amini disclose hydrogel beads; [0159]).
Regarding claim 103, modified Amini teach the method of claim 102 above, wherein the hydrogel particles comprise a hydrogel selected from the group consisting of agarose, alginate, a polyethylene glycol (PEG), a polyacrylamide (PAA), and a combination thereof (Amini; [0159]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Amini in view of Steenblock and Cubaud, and further in view of Zhang et al. (US 2011/0223314; already of record – hereinafter “Zhang”).
Regarding claim 21, modified Amini teach the method of claim 20 above, comprising the polymerizable component.
Modified Amini does not teach exposing the monodispersed droplets to conditions sufficient to polymerize the polymerizable component.
However, Zhang teach the analogous art of a method for generating droplets (Zhang; fig. 3, [0031]) comprising a polymerizable component (Zhang; fig. 3, #75, “prepolymer-encased droplet), wherein the droplets are exposed to conditions sufficient to polymerize the polymerizable component (Zhang; fig. 3, #50, [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method for generating monodispersed droplets of modified Amini to comprise a UV light source sufficient to polymerize the prepolymer-encasing, as taught by Zhang, because Zhang teaches the UV light sources causes polymerization of the prepolymer layer and encapsulation to form microcapsules 80 (Zhang; fig. 3, [0031]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Amini and Zhang both teach methods for forming droplets comprising particles, wherein the droplets are formed by jetting a first fluid into a second fluid.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Amini in view of Steenblock and Cubaud, and further in view of Abate et al. (US 2017/0022538; already of record – hereinafter “Abate”).
Regarding claim 33, modified Amini teach the method of claim 1 above, wherein the plurality of particles is introduced into the jet of the first fluid in a disordered configuration, resulting in a polydispersed emulsion comprising a population of monodispersed-particle containing droplets (Amini; fig. 9, [0171]).
Modified Amini does not teach wherein the method comprises sorting the monodispersed-particle containing droplets to separate them from other droplets in the polydispersed emulsion.
However, Abate teach the analogous art of a method for generating monodispersed droplets (Abate disclose methods for generating monodispersed droplets having extremely uniform size; figs. 1-4, 6, 11-12, 14, [0124, 0394, 0403, 0405]), wherein the method comprises sorting the monodispersed-particle containing droplets to separate them from other droplets in the polydispersed emulsion (Abate disclose sorting droplets; [0163-0192]. The examiner notes that paragraph [0063, 0188] of applicant’s printed publication describes a disordered configuration as “resulting in a polydispersed emulsion including a population of monodispersed-particles containing droplets and a population of polydispersed droplets that do not contain particles … the method can include a step of sorting the monodispersed-particle containing droplets to separate them from other droplets in the polydispersed emulsion, e.g., based on a size difference of the monodispersed-particle containing droplets relative to non-particle containing droplets”. Accordingly, Abate disclose a disordered configuration comprising a population of monodispersed-particles containing droplets and a population of polydispersed droplets that do not contain particles).
Response to Arguments
Applicant’s arguments, filed 07/14/2026, have been fully considered.
Applicants argues on pages 6-10 of their remarks that the prior art does not teach the claim amendments including the jet continuously extends beyond the junction by a distance of 4x or more and continuously narrows in width after the junction, and cites FIG 1B of applicant’s drawings to support the amended/argued limitations. First, the examiner notes that support for applicant’s amendments was not found in the originally filed disclosure and therefore the limitations include new matter (see 112(a) above). FIG 1B is merely a schematic as visual aid, but does not show a real-world setup. Further, the disclose has provided no indication that the schematics are to scale. Therefore, the ratio and proportions that are attempting to be claimed do not have support in the drawings. See MPEP 2125 (II). Second, the examiner agrees with applicant that the cited prior art does not explicitly teach the amended limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cubaud which teaches a jet that extends beyond a junction by a distance of 4x or more and continuously narrows in width after the junction.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571)272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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