DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 39-53, drawn to a method of engulfing, classified in G01N15/1492.
II. Claims 54-58, drawn to a microfluidic device, classified in B01L3/502707.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus of group II can be used to practice another different process such as just flowing droplets and not trapping or engulfing them.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
a. The inventions have acquired a separate status in the art in view of their different classification; and/or
b. The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
c. The inventions require a different field of search (for example, searching different class/subclasses or electronic resources, or employing different search strategies or search queries); and/or
d. The prior art applicable to one invention would not likely be applicable to another invention; and/or
e. The inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Brian Davy on 10/3/25 a provisional election was made without traverse to prosecute the invention of group I, claims 39-53. Affirmation of this election must be made by applicant in replying to this Office action. Claims 54-58 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/22/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 39-58 are pending with claims 39-53 being examined and claims 54-58 deemed withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 49-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 49-50 are rejected based on the follow analysis:
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claims 49-50 recite the abstract idea of “assessing” the engulfed particle which is a mental process.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. After the assessment is made, then no action is taken. Therefore, there is no application.
The claim also recites dispensing a particle and droplet and dielectrophoretically trapping the particle and droplet and then engulfing the particle into the droplet via electrodes. However, this is just a method used to gather data to be used in the abstract idea. However, data gathering to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Additionally, this is recited at such a high level of generality that it amounts to just generally applying the abstract idea per MPEP 2106.05(f), and also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of dispensing a particle and droplet and dielectrophoretically trapping the particle and droplet and then engulfing the particle into the droplet via electrodes. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Link et al (US 20180353913; hereinafter “Link”). Link teaches dispensing a particle and droplet and dielectrophoretically trapping the particle and droplet and then engulfing the particle into the droplet via electrodes (Link teaches dispensing two droplets, one containing cells and one containing particles; Fig. 1, [135]. Link teaches that the particles and droplets are dispensed to the coalescence module; Fig. 1. Link teaches that the coalescence module includes 2 electrodes through which a voltage is applied across; [137-138, 140]. Link teaches that the electrodes are used for DEP to cause the droplets and cells/particles to be trapped/moved in the coalescence module by moving according to electric field; [136, 141]. Link teaches that the cells and droplets are then moved together to fuse/coalesce in the coalescence module, meaning that the droplet engulfs the cell/particle; [135, 145, 149]).
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 39-53 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.
As to claim 39, lines 2-3 are unclear if the liquid is on both the supply and ground electrode or if the liquid is only disposed on the supply electrode. In other words, the chamber comprises both the supply and ground electrode, but it is unclear if the liquid is only on one of the electrodes or on both of the electrodes.
Regarding the step (c) of claim 39, it is unclear how the droplet is trapped with the particle and by the electrodes in step (b) and then somehow the droplet is moved towards the particle at the supply electrode. If both objects are trapped by the electrodes, then how does the droplet move to engulf the particle? Are both the droplet and particle moved together such that they both move and eventually merge at the supply electrode? trap
Claims 40-53 are rejected based on further claim dependency.
As to claim 47, it is unclear what “step (d)” is referring to as no step (d) has previously been recited. Therefore, it is unclear what applicants are intending to define by the limitations of claim 47.
Appropriate correction and/or clarification is required.
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 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.
Claims 39-50, 53 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Link et al (US 20180353913; hereinafter “Link”).
As to claim 39, Link teaches a method of engulfing a particle into a droplet (Link; Fig. 1, [135]), the method using a microfluidic device comprising a droplet generator and a chamber, the chamber comprising a liquid medium disposed on a voltage supply electrode and a ground electrode, wherein the method comprises: (a) dispensing a particle and a droplet into the liquid medium; (b) dielectrophoretically trapping the particle and the droplet using the voltage supply electrode and the ground electrode; and (c) engulfing the particle into the droplet, wherein the engulfing comprises increasing a supply voltage between the voltage supply electrode and the ground electrode, thereby moving the droplet toward the voltage supply electrode and engulfing the particle into the droplet (Link teaches dispensing two droplets, one containing cells and one containing particles; Fig. 1, [135, 198]. Link teaches that the particles and droplets are dispensed to the coalescence module; Fig. 1. Link teaches that the coalescence module includes 2 electrodes through which a voltage is applied across; [137-138, 140]. Link teaches that the electrodes are used for DEP to cause the droplets and cells/particles to be trapped/moved in the coalescence module by moving according to electric field; [136, 141]. Link teaches that the cells and droplets are then moved together to fuse/coalesce in the coalescence module, meaning that the droplet engulfs the cell/particle; [135, 145, 149]).
As to claim 40, Link teaches the method according to claim 39, wherein the liquid medium comprises, consists essentially of, or consists of an oil (Link teaches oil; [80, 87, 93, 95, 98, 99, 130]).
As to claim 41, Link teaches the method according to claim 39, wherein voltage supply electrode is transparent (Link teaches ITO which is transparent; [138]).
As to claim 42, Link teaches the method according to claim 39, wherein voltage supply electrode is an indium tin oxide (ITO) electrode (Link; [138]).
As to claim 43, Link teaches the method according to claim 39, wherein the particle is a microparticle or a cell (Link teaches a cell; [135, 198, 239, 236, 249, 269, 272]).
As to claim 44, Link teaches the method according to claim 39, wherein the method further comprises modifying the engulfed particle (Link teaches combining a cell as the particle with a droplet that has a reagent bead; [198]. Link teaches that fluorescent markers can be used to bind/modify to cells; [191-192]. Link also teaches other modifying reactions; [159, 160, 191, 236, 239, 249]).
As to claim 45, Link teaches the method according to claim 44, wherein the modifying comprises covalently or non-covalently attaching a molecule present in the droplet to the particle (Link teaches combining cells and droplets that include molecules; [135]. Link teaches that molecules can include polypeptides or polynucleotides; [260]. Link teaches combining a cell as the particle with a droplet that has a reagent bead; [198]. Link teaches that fluorescent markers can be used to bind/modify to cells; [191-192]. Link teaches various types of reporter modifications; [274]. Link also teaches other modifying reactions; [159, 160, 191, 236, 239, 249]).
As to claim 46, Link teaches the method according to claim 45, wherein the modifying comprises covalently or non-covalently attaching a nucleotide or polynucleotide present in the droplet to the particle (Link teaches combining cells and droplets that include molecules; [135]. Link teaches that molecules can include polypeptides or polynucleotides; [260]. Link teaches combining a cell as the particle with a droplet that has a reagent bead; [198]. Link teaches that fluorescent markers can be used to bind/modify to cells; [191-192]. Link teaches that nucleotides can be bound to the particle; [191]. Link teaches various types of reporter modifications; [274]. Link also teaches other modifying reactions; [226, 227, 244], see also [159, 160, 191, 236, 239, 249]).
As to claim 47, Link teaches the method according to claim 46, wherein the attaching comprises base-pairing the nucleotide or polynucleotide to a nucleotide or polynucleotide present on the particle prior to step (d) (The examiner is unclear of what step (d) is referring to. Link teaches the base pairing as part of the amplification/PCR process, see claim 46 above).
As to claim 48, Link teaches the method according to claim 45, wherein the modifying comprises covalently or non-covalently attaching an amino acid, polypeptide, sugar or carbohydrate present in the droplet to the particle (Link teaches pairing nucleotides during coalescing; [227]. Link teaches that molecules can include polypeptides or polynucleotides; [260]. Link teaches combining a cell as the particle with a droplet that has a reagent bead; [198]. Link teaches that fluorescent markers can be used to bind/modify to cells; [191-192]. Link teaches that nucleotides can be bound to the particle; [191]. Link teaches various types of reporter modifications; [274]. Link also teaches other modifying reactions; [226, 227, 244], see also [159, 160, 191, 236, 239, 249]).
As to claim 49, Link teaches the method according to claim 39, wherein the method further comprises assessing the engulfed particle (Link teaches detection; [151], Fig. 1. Link also teaches detecting/assessing; [159, 160, 191, 236, 239, 249]).
As to claim 50, Link teaches the method according to claim 49, wherein the particle is a cell, and wherein the method comprises assessing the cell for expression of a polypeptide (Link teaches determining characteristics of cells; [158, 160]. Link teaches that expression of polypeptides can be determined; [192]).
As to claim 53, Link teaches the method according to claim 39, comprising imaging the particle during one or more or more of steps (a)-(c) (Link teaches image analysis during droplet formation; [221]. Link also teaches detection during engulfing process where once engulfing takes place then modifications are detected; [151, 215]).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Link et al (US 20180353913; hereinafter “Link”) in view of Pamula et al (US 20140193807; hereinafter “Pamula”)
As to claims 51-52, Link teaches the method according to claim 39, where the voltage can be varied based on the particle and droplet composition (Link; [141]).
Link does not specifically teach decreasing the voltage to eject the particle from the droplet or subjecting the ejected particle to steps (b) and (c) to re-engulf the particle in a droplet. However, Pamula teaches the analogous art of droplet manipulation where the particles are ejected from the droplet through a decrease in voltage and then the ejected particles are to steps (b) and (c) to re-engulf the particle in a droplet (Pamula teaches that electrodes are used to control movement, and Pamula teaches that the particles 1522 are ejected from droplet 1524 in step d and then the particles are re-engulfed in a droplet 1528 in step e or in a droplet 1530 in step f; Figs. 15, [135-141]. Pamela teaches particles 2515 is ejected from droplet in Fig. 25b/c and then re-engulfed in droplet 2520 in fig. 25c; Figs. 25, [180]. Pamela teaches that the electrodes for moving and trapping the particle have their electric fields altered to capture/eject the particle and also to move the droplet away from the particle, where some of these electrodes would have their voltage decreased during this process to control the movement). It would have been obvious to one of ordinary skill in the art to have modified the coalescing/engulfing step of Link to have including a splitting/ejecting and re-engulfing step as in Pamula because Pamula teaches that splitting/ejecting and re-engulfing the particle with a reagent droplet enables a further treatment of the particle (Pamula; [135-141, 180]), and one of ordinary skill in the art would have been further motivated to perform this process based on the desired treatment of the particle. If it is deemed that modified Link does not specifically teach that during ejection of the particle that the voltage supply is decreased, then Link does teach that the voltage can be varied where depending on the dielectric polarizability of the particles that the particles will either move towards high or low electric field, and also that various cells have different dielectric properties that depend on various factors (Link; [141]). It would have been obvious to a person having ordinary skill in the art to modify the voltage in modified Link during the separation/ejection process of Pamula to have a negative voltage to control particle movement since the voltages for the electric field are known to vary and depend on the dielectric properties of particles and the desired movement (Link; [141]). Therefore, it is evident that Link recognizes that the voltage increase/decrease is a result effective variable since the voltages of the electrodes can vary based on desired movement and since varying the voltage depends on the dielectric properties of particles and the desired movement (Link; [141]). Therefore, it would have been obvious to optimize modified Link’s voltage during splitting/ejecting of particles in Pamula to be negative depending on the cells being treated and the type of treatment being performed.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
McEwen et al (US 20200171501; hereinafter “McEwen”) teaches a droplet 820 as a reagent and a microobject/cell 830/832; Fig. 9. McEwen teaches immiscible oil [328], a droplet with reagents such as nucleic acids for affinity with a microobject such as a cell; [329]. McEwen teaches that the droplets can includes various reagents such as proteins and nucleic acids [333]. McEwen teaches DEP [334], and teaches that the chambers of have DEP configurations [318] where the configuration of the chambers of Fig. 9 can be seen in figures 4-5 [171, 172] and also in Fig. 1E [158] and in Fig. 2 [177]. McEwen teaches changing the voltage [160].
Hunt et al (US 20100255556; hereinafter “Hunt”) teaches changing the electric field to merge/engulf or split/eject the particle and droplets from each other; Fig. 6, 7, [63-67, and [68, 74, 80, 86].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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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.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798