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 .
Claims 1-2, 5-11, 16-19, 21, 26-27, and 31 are pending. Claims 5-6, 8-10, 16-19, 21, 26-27, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 3-4, 12-15, 20, 22-25, 28-30, and 32-204 are cancelled. Claims 1 and 7-8 are amended. Claims 1-2, 7, and 11 are currently under examination.
Response to Amendment
The Amendment filed 1/14/26 has been entered. Claims 1-2, 5-11, 16-19, 21, 26-27, and 31 are pending.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 1/14/26, with respect to the rejections of claims 1-2, 7, and 11 under 35 USC 103 have been fully considered are found unpersuasive, and the 103 rejections documented in the Non-Final mailed 10/21/25 have been revised to address claim amendments filed 12/19/25 in this Final Office Action. More detailed responses to Applicant’s arguments are provided at the end of each maintained rejection.
Applicant’s arguments, see pages 7-8, filed 1/14/26, with respect to the rejections of claims 1-2, 7, and 11 under nonstatutory double patenting have been fully considered and are found persuasive. Therefore, the rejections documented in the Non-Final mailed 10/21/25 have been withdrawn. However, upon further consideration, new grounds of rejections necessitated by claim amendments are made in this Final Office Action.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 7, and 11 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Abate et al. (2016; WO 2016/065056 A1; FOR citation N in PTO-892 filed 8/6/25).
This rejection is revised/updated in response to claim amendments filed 1/14/26.
Abate et al. teaches “High definition microdroplet printer” (Title).
Relevant to claim 1, Abate et al. teaches “The present disclosure provides methods of delivering discrete entities to a substrate, for example, by: flowing a plurality of discrete entities through a microfluidic device in a carrier fluid, wherein the discrete entities are insoluble and/or immiscible in the carrier fluid; directing the carrier fluid and one or more of the plurality of discrete entities through a delivery orifice to the substrate; and affixing the one or more of the plurality of discrete entities to the substrate” (paragraph 0005).
Further relevant to claim 1, Abate et al. teaches “In some embodiments, the discrete entities as described herein are droplets… Thus droplets according to the present disclosure may be provided as aqueous-in-oil emulsions or oil-in-aqueous emulsions” (paragraph 0059).
These teachings read on claim 1 A method of selectively adding one or more reagents to one or more target molecules comprising: flowing an emulsion comprising a plurality of droplets through a microfluidic device, wherein at least one droplet of the plurality of droplets comprises the one or more target molecules;
Further relevant to claim 1, Abate et al. teaches “In certain embodiments, the width of one or more of the microchannels of the microfluidic device (e.g., input microchannel, pairing microchannel…” (paragraph 00233).
Further relevant to claim 1, Abate et al. paragraph 00140 teaches “One or more reagents may also, or instead, be added using techniques such as droplet coalescence, or picoinjection. In droplet coalescence, a target drop (i.e., the microdroplet) may be flowed alongside a microdroplet containing the reagent(s) to be added to the microdroplet. The two microdroplets may be flowed such that they are in contact with each other, but not touching other microdroplets. These drops may then be passed through electrodes or other aspects for applying an electrical field, wherein the electric field may destabilize the microdroplets such that they are merged together.”
These teachings read on claim 1 flowing a plurality of reagent droplets comprising the one or more reagents through a drop pairing microchannel of the microfluidic device to form one or more paired droplets, wherein at least one of the paired droplets comprises one of the reagent droplets paired with one of the droplets comprising the one or more target molecules.
Further relevant to claim 1, Abate et al. teaches “Single cell barcoding: In some embodiments, the methods, devices, and/or systems described herein can be used to sequence single cells. For example, individual cells can be encapsulated in the droplets and dispensed to the substrate as described herein. The cells can then be lysed and subjected to molecular biological processing to amplify and/or tag their nucleic acids with barcodes. The material from all the droplets can then be pooled for all cells and sequenced and the barcodes used to sort the sequences according to single droplets or cells. These methods can be used, for example, to sequence the genomes or transcriptomes of single cells in a massively parallel format” (paragraph 00127).
Further relevant to claim 1, Abate et al. teaches “Microdroplets may be sorted based on one or more properties. Properties of interest include, but are not limited to… presence or absence of one or more components, e.g., one or more detectable labels” (paragraph 00150).
Further relevant to claim 1, Abate et al. teaches “Sorting may be employed, for example, to remove discrete entities, e.g., microdroplets, in which no cells are present. Encapsulation may result in one or more discrete entities, e.g., microdroplets, including a majority of the discrete entities, e.g., microdroplets, in which no cell is present. If such empty drops were left in the system, they would be processed as any other drop, during which reagents and time would be wasted. To achieve the highest speed and efficiency, these empty drops may be removed with droplet sorting” (paragraph 00151).
These teachings read on claim 1 detecting a property of said at least one droplet comprising the one or more target molecules, wherein the property distinguishes said at least one droplet comprising the one or more target molecules from one or more droplets of the plurality of droplets lacking the one or more target molecules.
Further relevant to claim 1, Abate et al. paragraph 0062 teaches “In some embodiments of the disclosed methods, microfluidic devices are utilized which include one or more droplet makers configured to form droplets from a fluid stream. Suitable droplet makers include selectively activatable droplet makers and the methods may include forming one or more discrete entities via selective activation of the droplet maker. The methods may also include forming discrete entities using a droplet maker, wherein the discrete entities include one or more entities which differ in composition.”
This teaching, and above teachings, read on claim 1 flowing the one or more paired droplets into a selective merger microchannel of the microfluidic device; and selectively merging the one or more paired droplets in the selective merger microchannel based on the detection of the property,
Relevant to claim 2, Abate et al. teaches "Using a detection technique, such as optical detection, fluorescence, Raman microscopy, or other spectrographic techniques that preserve the droplets and the cells within them, it would be possible to monitor the droplets over time. This could be used, for example, to detect a change in a specific reaction or time-dependent expression of a target pathway" (paragraph 00101).
This teaching reads on claim 2 wherein the property is an optical property.
Relevant to claim 7, Abate et al. teaches "For example, applying an electrical field to two or more droplets in close proximity can induce dynamic instability at the oil-water interfaces that results in droplet merger to reduce the surface energy of the oil-water system" (paragraph 0075).
This teaching reads on claim 7 wherein the selective merging comprises applying an electric field to selectively merge the one or more paired droplets.
Relevant to claim 11, Abate et al. teaches "The composition and nature of the discrete entities, e.g., microdroplets, prepared and or utilized in connection with the disclosed methods may vary… In some aspects, discrete entities according to the present disclosure may include a nucleic acid or a plurality of nucleic acids" (paragraph 00132).
This teaching reads on claim 11 wherein the one or more reagents is a nucleic acid.
Abate et al. does not teach a specific embodiment having all the claimed elements. That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious," the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR at 1741. The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. At 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed elements — including droplets, optical properties, electric fields, and nucleic acids — for a method of selectively adding one or more reagents to one or more target molecules, to arrive at compositions "yielding no more than one would expect from such an arrangement."
Applicant’s arguments
Applicant argues that Abate et al. does not teach the amended claim 1 limitations of “a method of using a microfluidic device having a drop pairing microchannel to pair reagent droplets with droplets comprising one or more target molecules. Nor does Abate describe or suggest using a microfluidic device comprising a selective merger microchannel for merging paired droplets based on detection of a property that distinguishes droplets containing a target molecule from those droplets that lack the target molecule” (Remarks 1/14/26, first paragraph of page 7).
Response to Applicant’s Arguments
The Examiner respectfully disagrees with the assertion that Abate et al. fails to teach the argued limitations.
Applicant is reminded that the cited prior art reference must be read in its entirety, not merely selective portions. As set forth in MPEP 2141.02:
Ascertaining the differences between the prior art and the claims at issue requires interpreting the claim language, and considering both the invention and the prior art references as a whole… A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention… However, ‘the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….’ In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004) (emphasis added)
To that end, the Abate et al. teachings within paragraphs 0062, 00140, 00150-00151, and 00233 relevant to claim 1 read on the amended limitations. Abate et al. renders obvious a drop pairing microchannel, paired droplets, distinguishing droplets lacking the one or more target molecules, and use of a selective merger microchannel.
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 1-2, 7, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 14-16, 18, and 24 of U.S. Patent No. 10,434,507 B2 (hereafter, patent ‘507) in view of Abate et al. (2016; WO 2016/065056 A1; FOR citation N in PTO-892 filed 8/6/25).
This new nonstatutory double patenting rejection is necessitated by claim amendments filed 1/14/26.
Instant claims’ 1-2, 7, and 11 method of selectively adding one or more reagents to one or more target molecules is read on by patent ‘507 claims 1-2, 5, 7, 14-16, 18, and 24, wherein both the instant claim and patent read on a microfluidic device that sorts droplets.
Both instant claim 7 and patent claims 2 and 5 rely on electrical fields.
Both instant claims 1 and 2 and patent claims 14-16 rely on sorting droplets via detection of optical properties.
Both instant claims 1 and patent claim 18 rely on droplets containing both target and reagent droplets (or “discrete entities which differ in composition”).
Both instant claim 11 and patent claim 24 rely on droplets containing nucleic acids.
Although patent ‘507 is silent to the claim 1 structures/functions of a drop pairing microchannel, paired droplets, distinguishing droplets lacking the one or more target molecules, and a selective merger channel, these limitations are taught by Abate et al.
The Abate et al. teachings relied in the above 103 rejections of instant claims 1-2, 7, and 11 are applied to the instant nonstatutory double patenting rejection. Abate et al. renders obvious a drop pairing microchannel, paired droplets, distinguishing droplets lacking the one or more target molecules, and use of a selective merger microchannel. The skilled artisan would find it prima facie obvious to modify the patent ‘507 methodology to include the Abate et al. limitations. It is noted that patent ‘507, Abate et al., and the instant application are analogous disclosures within the microfluidic field. The skilled artisan would be motivated to combine the analogous disclosures to arrive at the instantly claimed invention.
Abate et al. teaches “The subject methods and devices may find use in a wide variety of applications, such as increasing the accuracy and/or efficiency of printing, e.g., microdroplet printing, and in assays involving, for example, well-plate analysis” (paragraph 0048). Thus, the skilled artisan would have been motivated to include the Abate et al. limitations within the patent
‘507 methodology in order to take advantage of the “use in a wide variety of applications, such as increasing the accuracy and/or efficiency… in assays”. The skilled artisan would have a reasonable expectation of success based on the disclosures of patent ‘507 in view of Abate et al., as discussed in preceding paragraphs.
Claims 1-2, 7, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 18, 22, 27-28, and 41 of U.S. Patent No. 11,020,736 B2 (hereafter patent ‘736; USPat citation A in PTO-892 filed 10/21/25) in view of Abate et al. (2016; WO 2016/065056 A1; FOR citation N in PTO-892 filed 8/6/25).
This new nonstatutory double patenting rejection is necessitated by claim amendments filed 1/14/26.
Instant claims’ 1-2, 7, and 11 method of selectively adding one or more reagents to one or more target molecules is read on by patent ‘736 claims 1-2, 5, 7, 18, 22, 27-28, and 41, wherein both the instant claim and patent read on a microfluidic device that sorts droplets.
Both instant claim 7 and patent claims 2 and 5 rely on electrical fields.
Both instant claims 1 and 2 and patent claims 18, 22, and 27 rely on sorting droplets via detection of optical properties.
Both instant claims 1 and patent claim 28 rely on droplets containing both target and reagent droplets (or “discrete entities which differ in composition”).
Both instant claim 11 and patent claim 41 rely on droplets containing nucleic acids.
Although patent ‘736 is silent to the claim 1 structures/functions of a drop pairing microchannel, paired droplets, distinguishing droplets lacking the one or more target molecules, and a selective merger channel, these limitations are taught by Abate et al.
The Abate et al. teachings relied in the above 103 rejections of instant claims 1-2, 7, and 11 are applied to the instant nonstatutory double patenting rejection. Abate et al. renders obvious a drop pairing microchannel, paired droplets, distinguishing droplets lacking the one or more target molecules, and use of a selective merger microchannel. The skilled artisan would find it prima facie obvious to modify the patent ‘736 methodology to include the Abate et al. limitations. It is noted that patent ‘736, Abate et al., and the instant application are analogous disclosures within the microfluidic field. The skilled artisan would be motivated to combine the analogous disclosures to arrive at the instantly claimed invention.
Abate et al. teaches “The subject methods and devices may find use in a wide variety of applications, such as increasing the accuracy and/or efficiency of printing, e.g., microdroplet printing, and in assays involving, for example, well-plate analysis” (paragraph 0048). Thus, the skilled artisan would have been motivated to include the Abate et al. limitations within the patent
‘736 methodology in order to take advantage of the “use in a wide variety of applications, such as increasing the accuracy and/or efficiency… in assays”. The skilled artisan would have a reasonable expectation of success based on the disclosures of patent ‘736 in view of Abate et al., as discussed in preceding paragraphs.
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.
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682