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 .
Response to Arguments
Applicant’s arguments, see the Remarks, filed on 04/21/2026, with respect to the rejection(s) of claim(s) 1-11 and 13-24 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lenji et al. (US20210053063A1).
Applicant noted that Khor et al. is neither a patent nor a patent application. Instead, Khor et al. is a manuscript. Accordingly, Applicant respectfully submitted that Khor et al. is not properly citable against the present application under 35 U.S.C. 102(a)(2). The Examiner agrees with this argument, and the previous 35 U.S.C. 102(a)(2) rejection filed 01/28/2026 was done in error and should have been a 35 U.S.C. 102(a)(1) rejection as non-patent literature (NPL).
Furthermore, Applicant respectfully submitted that the Khor et al. reference was a disclosure made 1 year or less before the effective filing date of the claimed invention made by the present inventors, and, therefore, falls under the exception of 35 U.S.C. 102(b)(1)(A). In this regard, the authors of the Khor et al. reference are Jian Wei Khor, Ulri Nicole Lee, Jean Berthier, Erwin Stefan Peter Berthier, and Ashleigh Brooks Theberge, all of whom are inventors of the present application. Additionally, the present application claimed the priority to U.S. Provisional Application No. 63/340,205, which was filed on May 10, 2022, less than one year after the publication of Khor et al. on April 14, 2022. Applicant respectfully submitted that the presently claimed invention is entitled to the priority date of U.S. Provisional Application No. 63/340,205. Accordingly, Applicant noted that Khor is not properly citable against the claimed invention. The Examiner agrees with this argument, the instant application is entitled to the priority date of U.S. Provisional Application No. 63/340,205, thus the Khor et al. (NPL) of April 14, 2022 does not qualify as prior art.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-11, 13-16, and 18-22 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The instant invention is anticipated by Lenji et al. (US20210053063A1).
Regarding Claim 1, Lenji et al. teaches a fluidic device for autonomous droplet generation (See the Abstract, Claim(s) 19 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), the fluidic device comprising:
a substrate (See the substrate illustrated in Fig. 9A-B, in [0099]-[0104], [0231]), defining:
an inlet reservoir shaped to receive and to carry a carrier liquid (See the inlet fluid reservoirs 904, 905, and 906 , i.e. inlet reservoirs, in Fig. 9A-B in [0231]);
a converging region in fluidic communication with the inlet reservoir and shaped to receive a liquid sample (See how the liquids from reservoir 904 and reservoir 905 or 906 combine in the first channel 902 forming the first liquid, i.e. a converging region, that is dispersed into the continuous phase as droplet in [0231] in Fig. 9A-B);
a constriction adjacent to and in fluidic communication with the converging region, wherein the constriction defines a pathway configured to allow passage of fluid therethrough (See how the two first channels 902 are connected to reservoir 905 and reservoir 906 and connected to a shelf region 920, i.e. a constriction, adjacent a step region 908 in [0231] in Fig. 9A-B and 10-12; Also, see the variations in shelf regions in [0232]-[0254] in Fig. 10A-24B);
a diverging region in fluidic communication with and downstream of the constriction (See the step region 908, i.e. a diverging region, in [0231] in Fig. 9A-B); and
an outlet reservoir in fluidic communication with the diverging region (See the outlet reservoir 907 in [0231] in Fig. 9A-B; Also, see the droplet formation region includes both a shelf region 1220, i.e. a constriction, and a step region 1208, i.e. a diverging region, disposed between the distal end of the first channel 1201 and the step region 1208 that lead to a collection reservoir 1204, i.e. an outlet reservoir in [0234] in Fig. 12),
wherein the fluidic device does not comprise a portion covering the outlet reservoir opposite the substrate (Illustrated in Fig. 1-12);
wherein the fluidic device does not comprise a pump or other powered devices configured to urge liquid through the constriction to generate droplets therewith (See how pumps to externally drive the continuous phase are not necessary in [0078], [0090]).
Regarding Claim 3, Lenji et al. teaches the fluidic device limitations of claim 1.
Lenji et al. further teaches a fluidic device for autonomous droplet generation (See the Abstract, Claim(s) 19 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), wherein a portion of the substrate including the constriction comprises a floor (See the step region 1008 in [0232] in Fig. 10A-E), and wherein the floor defines one or more grooves shaped and positioned to transport a carrier liquid between the converging region and the diverging region (See the shelf regions 1020 in [0232] in Fig. 10A-E).
Regarding Claim(s) 5-6, Lenji et al. teaches the fluidic device limitations of claim 1.
Lenji et al. further teaches a fluidic device for autonomous droplet generation (See the Abstract, Claim(s) 19 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), wherein the substrate comprises a hydrophobic material (See in [0109]-[0197]);
wherein the hydrophobic material is configured such that a droplet of an aqueous solution in contact with the hydrophobic material has a contact angle in a range of about 900 to about 1800 degrees (See in [0109]-[0197]).
Regarding Claim(s) 7-10, Lenji et al. teaches the fluidic device limitations of claim 1.
Lenji et al. further teaches a fluidic device for autonomous droplet generation (See the Abstract, Claim(s) 19 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), wherein the outlet reservoir defines a floor and a wall encircling at least a portion of the floor (See the step region 1008 in [0232] in Fig. 10A-E), wherein the outlet reservoir is configured to receive and carry droplets generated at the constriction (See the outlet reservoir 907 in [0231] in Fig. 9A-B; Also, see the droplet formation region includes both a shelf region 1220, i.e. a constriction, and a step region 1208, i.e. a diverging region, disposed between the distal end of the first channel 1201 and the step region 1208 that lead to a collection reservoir 1204, i.e. an outlet reservoir in [0234] in Fig. 12);
wherein the wall defines a plurality of crenulations shaped to generate a droplet within interstices of a crenulation of the plurality of crenulations (See in [0071]-[0149], [0223] in Fig. 10A-16B);
wherein the floor defines one or more structures shaped to adhere to a droplet generated at the constriction (See in Fig. 10A-16A);
wherein the one or more structures includes one or more chambers shaped to receive the droplet (See in Fig. 1-16A).
Regarding Claim 11, Lenji et al. teaches the fluidic device limitations of claim 1.
Lenji et al. further teaches a fluidic device for autonomous droplet generation (See the Abstract, Claim(s) 19 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), wherein the inlet reservoir is a first inlet reservoir, wherein the constriction is a first constriction, wherein the converging region is a first converging region, and wherein the diverging region is a first diverging region, wherein the fluidic device further comprises: a second inlet reservoir shaped to receive and to carry the carrier liquid; a second converging region in fluidic communication with the second inlet reservoir and shaped to receive a second liquid sample; a second constriction adjacent to and in fluidic communication with the second converging region; a second diverging region in fluidic communication with and downstream of the second constriction, wherein the second diverging region is shaped and positioned to transport droplets generated at the second constriction to the outlet reservoir (See in [0070]-[0234] in Fig. 1-16A; Also, see the variations in shelf regions in [0232]-[0254] in Fig. 10A-24B).
Regarding Claim 13, Lenji et al. teaches a kit for autonomous droplet generation (See the Abstract, Claim(s) 1-3, 5, 7, 9-12, 19, 27 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), the kit (See in Fig. 24A-B)comprising: a fluidic device (See Fig. 1-23C) of Claim 1; and a carrier liquid (See how the device 1900 is configured with a first channel 1902 carries a first fluid 1910 (e.g., aqueous), and the second channel 1904 carries a second fluid 1912 (e.g., oil) that is immiscible with the first fluid 1910 in [0244]-[0246] in Fig. 19).
Regarding Claim(s) 14-16, Lenji et al. teaches the kit limitations of claim 13.
Lenji et al. further teaches a kit for autonomous droplet generation (See the Abstract, Claim(s) 1-3, 5, 7, 9-12, 19, 27 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), the kit (See in Fig. 24A-B)comprising: a fluidic device (See Fig. 1-23C) of Claim 1; and a carrier liquid (See how the device 1900 is configured with a first channel 1902 carries a first fluid 1910 (e.g., aqueous), and the second channel 1904 carries a second fluid 1912 (e.g., oil) that is immiscible with the first fluid 1910 in [0244]-[0246] in Fig. 19);
further comprising a droplet manipulation instrument configured to move a droplet within the carrier liquid (See the collection device, i.e. a droplet manipulation device, in [0002]-[0021], [0254] in Fig. 24A-B and in Claim 1; Also, see the piezoelectric element 1908, the buffer substrate 1905, the acoustic lens 190, and the controller 1918 of device 1900 in [0244]-[0246] in Fig. 19),
wherein the droplet manipulation instrument is selected from the group consisting of tweezers, a stylus, a needle, and combinations thereof (See how the collection device, i.e. a droplet manipulation device, can be a pipette tip or needle connected to a tube in [0002]-[0021], [0073], [0254] in Fig. 24A-B and in Claim 3);
wherein a portion of the droplet manipulation instrument is coated in a material comprised in the substrate of the fluidic device (See in [0109]-[0197]);
wherein a droplet of the carrier liquid in contact with the substrate has a contact angle in in a range of about 00 to about 900 (See in [0109]-[0197]).
Regarding Claim 18, Lenji et al. teaches the kit limitations of claim 13.
Lenji et al. further teaches a kit for autonomous droplet generation (See the Abstract, Claim(s) 1-3, 5, 7, 9-12, 19, 27 and 36, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), further comprising one or more surfactants (See in [0133]-[0176]).
Regarding Claim 19, Lenji et al. teaches a method of autonomous droplet generation (See the Abstract, Claim(s) 11-12, 14-16, and 21-24, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), the method comprising:
introducing a liquid sample into a converging region a fluidic device (See the device(s)s 900-2100 in Fig. 12-24B), the converging region is shaped to receive the liquid sample (See the inlet fluid reservoirs 904, 905, and 906 , i.e. inlet reservoirs, in Fig. 9A-B in [0231]); and
introducing a carrier liquid into an inlet reservoir shaped to receive and to carry the carrier liquid, wherein the converging region is in fluidic communication with the inlet reservoir, thereby urging the liquid sample through a constriction adjacent to and in fluidic communication with the converging region and generating droplets into a diverging region in fluidic communication with and downstream of the constriction and an outlet reservoir in fluidic communication with the diverging region (See the outlet reservoir 907 in [0231] in Fig. 9A-B; Also, see the droplet formation region includes both a shelf region 1220, i.e. a constriction, and a step region 1208, i.e. a diverging region, disposed between the distal end of the first channel 1201 and the step region 1208 that lead to a collection reservoir 1204, i.e. an outlet reservoir in [0234] in Fig. 12; To add, see the variations in shelf regions in [0232]-[0254] in Fig. 10A-24B),
wherein the fluidic device does not comprise a portion covering the outlet reservoir (Illustrated in Fig. 1-12);
wherein the fluidic device does not comprise a pump or other powered devices configured to urge liquid through the constriction to generate droplets therewith (See how pumps to externally drive the continuous phase are not necessary in [0078], [0090]).
Regarding Claim(s) 20-22, Lenji et al. teaches the method limitations of claim 19.
Lenji et al. further teaches a method of autonomous droplet generation (See the Abstract, Claim(s) 11-12, 14-16, and 21-24, and the device(s) 900-2100 in [0070]-[0193], [0199]-[0256] in Fig. 1-24B), wherein the method is performed using a fluidic device according to Claim 1; and wherein the liquid sample is a sperm sample (See how the biological particles may be any type of cell, including without limitation prokaryotic cells, eukaryotic cells, bacterial, fungal, plant, mammalian, or other animal cell type, mycoplasmas, normal tissue cells, tumor cells, or any other cell type, whether derived from single cell or multicellular organisms in [0032]-[0097]);
further comprising: introducing a droplet manipulation instrument into the carrier liquid in which the droplet is disposed, wherein the droplet has a lower density than the carrier liquid, and wherein the carrier liquid wets the droplet manipulation instrument; and translating the droplet manipulation instrument through the carrier liquid adjacent to the droplet, thereby translating the droplet through the carrier liquid; Also, see the variations in shelf regions in [0232]-[0259] in Fig. 10A-24B and in Claim(s) 11-12, 14-16, and 21-24).
Allowable Subject Matter
Claim(s) 2, 4, 17 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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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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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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