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
Claims 1, 10 and 16-18 are amended. Claims 7 and 9 are cancelled. Claims 1-6, 8 and 10-21 have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 is indefinite because it recites that each portion of the liquid droplet comprises a detergent, however, claim 1 has already recited a detergent present of Tween-20 or Tween-80 and it is unclear if the detergent of claim 6 is intended to be the same detergent as claim 1 or an additional detergent.
Claim 8 is indefinite because it recites that each portion of the liquid droplet comprises a surfactant, however, claim 1 has already recited a surfactant present of Triton X-100 and it is unclear if the surfactant of claim 8 is intended to be the same surfactant as claim 1 or an additional surfactant.
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.
Claim(s) 1-6, 8 and 10-21 are rejected under 35 U.S.C. 103 as being unpatentable over Leirs et al. (WO 2018/136509, IDS) in view of Sista et al. (US 2009/0263834).
Regarding claim 1 and 10, Leirs teaches throughout the publication a method of loading wells with liquid droplets, which method comprises:(a) contacting an array of wells with a liquid droplet, wherein (i) one or more wells of the array is of sufficient size to have loaded therein a portion of the liquid droplet, and (ii) each portion of the liquid droplet comprises a solid support and a detergent or surfactant, (b) moving the liquid droplet over the array of wells and whereby a portion of the liquid droplet is loaded into each well of the array; (c) removing any portion of the liquid droplet that is not loaded into wells from the surface of the array; and (d) sealing the loaded wells (see claim 1 and 9 and paragraph 0018, droplet of aqueous fluid may include an ionic or non-ionic surfactant). However, the reference fails to teach that the detergent is Tween-20 or Tween-80 and the surfactant is Triton X-100 and that the liquid droplet is more efficiently loaded as compared to a liquid droplet that lacks a detergent or surfactant.
Sista teaches throughout the publication droplet actuator devices and methods for immunoassays including beads (abstract). More specifically, Sista teaches that bead droplets also incorporated surfactants such as Tween 20 (paragraph 0128) or alternatively increasing the transportability of the droplets by using Triton 100 (paragraph 0095). Sista further teaches at paragraph 0128 that it was observed that in cases with no surfactant or detergent, the attraction was poor and there was significant clumping and aggregation, as in claim 10.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the aqueous fluid droplet of Leirs, Tween20 or Triton X-110 to increase the droplet transport capabilities as taught by Sista because Leirs is generic regarding the type of non-ionic surfactant that can be incorporated within the droplet and one skilled in the art would have been motivated to choose the appropriate fluid based on the desired loading and signal improvements . Additionally, Sista teaches that the presence of the buffer additives allowed for efficient attraction with minimal clumping of the beads and droplets for effective transport throughout the system (see Sista, paragraph 0128).
Although Leirs in view of Sista do not explicitly teach wherein the detergent or surfactant reduces the contact angle between the liquid droplet and the wells, this limitation is deemed an inherent property of the claimed detergent or surfactant and since Leirs in view of Sista teaches the claimed reagents, the references are seen as inherently exhibiting the claimed property.
Regarding claim 2, Leirs teaches the method wherein the wells are nanowells (paragraph 0067).
Regarding claims 3-4, Leirs teaches the method wherein the solid support is a bead and more specifically, wherein the bead is a microparticle (see claim 18 and paragraph 0026).
Regarding claim 5, Leirs teaches the method wherein the solid support comprises an analyte of interest captured on the surface thereof (paragraph 0026).
Regarding claim 6, Leirs in view of Sista teaches the method wherein each portion of the liquid droplet comprises a detergent (Leirs, paragraph 0018).
Regarding claim 8, Leirs teaches the method wherein each portion of the liquid droplet comprises a surfactant (paragraph 0018).
Regarding claims 11-12, Leirs teaches the method wherein moving the liquid droplet over the array of wells comprises applying an electric field across the array (paragraph 0043) and further wherein applying an electric field comprises generating an alternating current (paragraphs 0035 and claim 20).
Regarding claim 13, Leirs teaches the method wherein moving the liquid droplet over the array of wells comprises using a capillary element (paragraph 0047).
Regarding claim 14, Leirs teaches the method wherein the array of wells has a hydrophilic surface (paragraphs 0020 and 0063).
Regarding claim 15, Leirs teaches the method wherein the array of wells has a hydrophobic surface (paragraphs 0020 and 0063).
Regarding claim 16, Leirs teaches a method of detecting and quantifying an analyte of interest in a sample, which method comprises:(a) providing a first liquid droplet containing an analyte of interest; (b) providing a second liquid droplet containing a solid support which comprises a first binding member that specifically binds to the analyte of interest; wherein either the first liquid droplet or the second liquid droplet further comprises a detergent or surfactant; (c) using energy to exert a force to manipulate the first liquid droplet and the second liquid droplet to create a droplet which comprises analyte of interest captured on the surface of the solid support; (d) loading wells in an array with the liquid droplets according to any one of claims 1-15; and (e) detecting and quantifying the analyte of interest (see claims 1 and 9; paragraphs 0018 and 0068).
Regarding claim 17, Leirs teaches the method wherein detecting and quantifying the analyte of interest comprises adding a detectable label to the droplet before loading wells in an array with liquid droplets (paragraph 0033 and claims 11-14).
Regarding claim 18, Leirs teaches the method wherein detecting and quantifying the analyte of interest comprises adding a detectable label to the droplet after loading wells in an array with liquid droplets (paragraph 0033 and claims 11-14).
Regarding claim 19, Leirs teaches the method wherein the second liquid droplet comprises a detectable label (paragraph 0033).
Regarding claim 20, Leirs teaches the method wherein the detectable label comprises at least one second binding member that specifically binds to the analyte of interest (paragraph 0033).
Regarding claim 21, Leirs teaches the method wherein the detectable label comprises a chromagen, a fluorescent compound, an enzyme, a chemiluminescent compound, or a radioactive compound (paragraph 0033).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 11-12, 16-18 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11-12 and 16 of U.S. Patent No. 10,335,791 in view of Huff et al. (US 2018/0104694).
Regarding instant claim 1, Patent 791 recites a method for sealing an array of wells having an aqueous fluid disposed therein by disposing a layer of immiscible fluid over the array of wells, the method comprising:
actuating movement of a droplet of aqueous fluid towards a droplet of immiscible fluid by using digital microfluidics (DMF) electrodes such that the two droplets contact each other thereby forming a biphasic droplet comprising an aqueous phase formed by the droplet of aqueous fluid and a non-aqueous phase formed by the droplet of immiscible fluid;
actuating movement of the aqueous phase of the biphasic droplet by using DMF electrodes thereby pulling the non-aqueous phase present in the biphasic droplet towards an array of wells;
contacting the array of wells with the aqueous phase of the biphasic droplet by actuating movement of the aqueous phase of the biphasic droplet over the array of wells by using DMF electrodes; and
contacting the array of wells with the non-aqueous phase of the biphasic droplet by actuating movement of the aqueous phase of the biphasic droplet to a position adjacent the array of wells by using DMF electrodes such that the non-aqueous phase is pulled over the array of wells,
wherein contacting the array of wells with the non-aqueous phase of the biphasic droplet covers the array of wells with the immiscible fluid thereby sealing the array of wells (see patent claim 1).
Although Patent 791 does not recite that the each portion of the liquid droplet comprises a detergent or surfactant to reduce the contact angle between the liquid droplet and the wells, wherein the detergent is Tween-20 or Tween-80 and the surfactant is Triton X-100 Huff teaches that a binding buffer can be included to alter variables of the assay, binding buffers including non-ionic detergents such as Tween 20 or Triton X-100 (paragraphs 0159-0161).
It would have been obvious to incorporate within the method of Patent 791, a non-ionic detergent as a binding buffer as taught by Huff in order to enhance the reactions conducted in the droplets and nanowells.
Additionally, patent claim 9 reads on instant claims 11 and 12; patent claim 11 reads on instant claims 16-18; patent claim 12 reads on instant claim 20; and patent claim 16 reads on instant claim 21.
Claims 1, 11-12, 16-18 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11-12 and 16 of U.S. Patent No. 11,697,117 in view of Huff et al. (US 2018/0104694).
Regarding instant claim 1, Patent 117 recites a An automated or semi-automated method for sealing an array of wells having an aqueous fluid disposed therein by disposing a layer of immiscible fluid over the array of wells, using a processor to run a program to instruct a device to perform the steps comprising:
actuating movement of a droplet of aqueous fluid towards a droplet of immiscible fluid by using digital microfluidics (DMF) electrodes such that the two droplets contact each other thereby forming a biphasic droplet comprising an aqueous phase formed by the droplet of aqueous fluid and a non-aqueous phase formed by the droplet of immiscible fluid;
actuating movement of the aqueous phase of the biphasic droplet by using DMF electrodes thereby pulling the non-aqueous phase present in the biphasic droplet towards an array of wells;
contacting the array of wells with the aqueous phase of the biphasic droplet by actuating movement of the aqueous phase of the biphasic droplet over the array of wells by using DMF electrodes; and
contacting the array of wells with the non-aqueous phase of the biphasic droplet by actuating movement of the aqueous phase of the biphasic droplet to a position adjacent the array of wells by using DMF electrodes such that the non-aqueous phase is pulled over the array of wells,
wherein contacting the array of wells with the non-aqueous phase of the biphasic droplet covers the array of wells with the immiscible fluid thereby sealing the array of wells (see patent claim 1).
Although Patent 117 does not recite that the each portion of the liquid droplet comprises a detergent or surfactant to reduce the contact angle between the liquid droplet and the wells, wherein the detergent is Tween-20 or Tween-80 and the surfactant is Triton X-100 Huff teaches that a binding buffer can be included to alter variables of the assay, binding buffers including non-ionic detergents such as Tween 20 or Triton X-100 (paragraphs 0159-0161).
It would have been obvious to incorporate within the method of Patent 117, a non-ionic detergent as a binding buffer as taught by Huff in order to enhance the reactions conducted in the droplets and nanowells.
Additionally, patent claim 9 reads on instant claims 11 and 12; patent claim 11 reads on instant claims 16-18; patent claim 12 reads on instant claim 20; and patent claim 16 reads on instant claim 21.
Response to Arguments
Applicant’s arguments filed 01/13/2026 have been considered but are found to be moot in view of the new grounds of rejection applied to the amended claims. As the scope of the invention has changed by incorporating previous dependent claim 7 (originally dependent on claim 6) and previous dependent claim 9 (originally dependent on claim 8) into claim 1, the claims are now unpatentable over the teachings of Leirs in view of Sista – who teaches the benefits of incorporating surfactant or detergent buffer additives within a droplet system including beads, as described above.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677