Prosecution Insights
Last updated: April 19, 2026
Application No. 17/663,923

DROPLET COLLECTION UNIT, AND DROPLET COLLECTION APPARATUS AND METHOD

Final Rejection §103§112
Filed
May 18, 2022
Examiner
GORDON, BRIAN R
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Canon Medical Systems Corporation
OA Round
2 (Final)
65%
Grant Probability
Moderate
3-4
OA Rounds
3y 2m
To Grant
83%
With Interview

Examiner Intelligence

Grants 65% of resolved cases
65%
Career Allow Rate
609 granted / 942 resolved
At TC average
Strong +19% interview lift
Without
With
+18.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
51 currently pending
Career history
993
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
26.2%
-13.8% vs TC avg
§102
26.6%
-13.4% vs TC avg
§112
37.3%
-2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 942 resolved cases

Office Action

§103 §112
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 . Election/Restrictions Applicant’s election without traverse of Group I, claims 1-9 in the reply filed on July 30, 2025 is acknowledged. Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Response to Arguments/Amendments It is noted that applicant has amended the claims, but fails to provide for the specific text of the original specification that provides for support for each of the amendments. Therefore, it is hereby requested that applicant provide for the specific text of the originally filed specification that supports each and all amendments. It is noted that applicant has not addressed each of the prior 112 rejections. It is noted that there is no disclosure of any structure that is capable of producing any of the recited materials that can form and be contained in a droplet. The claim does not provide for any specific structure of what is considered as “a generator” nor has applicant indicated what structure(s) disclosed in the specification and drawings are considered as being/defining such generator. Furthermore, the processing circuitry is not defined in the claims by any specific structures that are capable of performing any reactions, detecting, sorting, counting, determining, providing any fluorescent light, dielectrophoresis, and heating and/or cooling (and adjusting, sensing, measuring of such) as recited in the claims. It is noted that while claim 2 has been incorporated into claims 1 and 9, claim 2 did not previously recite the amendment of the last paragraph “control a flow of the produced droplets within the channel to selectively sort particular droplet determined to contain a predetermined amount of the microorganisms from among the produced droplets”, the examiner fails to locate any description of such in the originally filed specification. It is noted that while the specification describes a number of elements that the collection unit comprises, the independent claims 1 and 9 do not positively claim each of such elements disclosed in the specification. See for example Figure 1 and corresponding description of such in the specification. The processing circuitry is not disclosed as being, comprising any structure that can control (regulate) any fluid flow (provide for any motive forces (such as a pump); valve; etc. nor any other structure that can control flow) in a channel that is not positively claimed as a structural element of the apparatus. Furthermore, the processing circuitry alone is not capable of sorting (moving, controlling where droplets are subsequently located based upon detection results of any amount of microorganisms) of any droplets in any unclaimed channel. (the above is also applicable to claims 6-7) According to the specification, a sorting unit (not claimed and not defined as any specific structure) is employed. Therefore, the claims are directed to new matter. As to the objection of claim 9, applicant states: “Applicant respectfully submits that the objection to Claim 9 is rendered moot by the present amendment to that claim, or is otherwise traversed. In particular, Applicant notes that amended Claim 9 recites an additional step not recited in Claim 1, such that Claim I and Claim 9 are not substantial duplicates.” The examiner disagrees. It is noted that the claims are directed to an apparatus defined by the positively claimed structural elements listed in the claims, not a process of use defined by any steps. However, it is presumed that such “additional step” of claim 9 that applicant is referencing is “perform processing of the sorted droplets” which is directed to a possible use of the processing circuitry. No droplets are positively claimed as elements of the invention nor required to be sorted and located anywhere in/on any positively claimed element of the apparatus. The “additional step” does not provide for any structural distinction from the processing circuitry of claim 1. There is no indication as what such circuitry is capable doing to any sorted droplets that is considered as “processing”. Any act that can be done to any droplets can be considered as “processing” including, but not limited to exposing droplets to emitted light, detecting, determining an amount microorganisms in droplets, moving such droplets, etc. There is no structural difference/distinction between claims 1 and 9. Therefore, the objection is hereby maintained. As to applicant remarks directed to “circuitry”, it is noted that while “circuitry” can be and can “connotate” structure, the claims do not define such “processing circuitry” as being nor comprising any specific structural elements. The claims as presently drafted do not define, require, nor limit the processing circuitry as any programmed computer hardware or a processor (CPU). If applicant intends for such circuitry to be limited to, considered as, and/or defined as specific structure, then such structures should be clearly recited in the claims. As to applicant remarks directed to the employment of functional language without the using means-plus-function in the claims, applicant states: Further, as set forth in MPFP§2173.05(g)"Functional language may also be employed to limit the claim without using the means-plus-function format." Further, that section of the MPFP states that "[a] functional limitation must be evaluated and considered, just like any other limitation of the claim or what it fairly conveys to a person of ordinary in art in the context in which it is used." Emphasis added. In this regard, Applicant submits that one of ordinary skill in the art would clearly understand, in light of the disclosure in the specification, that "processing circuitry" can be a processor and "controls various processes in the droplet collection unit 1 in response to various operations, via for example the droplet collection unit 1 or an input interface provided in the system described above."2 Further, the specification clearly states that "[t]he processing circuitry 11 reads and executes a computer program stored in storage circuitry ... and performs a control function, a detection function, and a sorting function. "See paragraph 15 in the published application. Thus, one of ordinary skill in the art would clearly understand that functional claiming is being employed in Claim1 and that the processing circuitry is configured to perform the various functions recited in the claims. Accordingly, Applicant respectfully submits that the claims do not recite any "intended use" features based on the recitation of "configured to" language. It is noted that there is a difference between reciting how positively claimed structural elements of the claimed invention function relative to each other versus reciting how claimed elements can function relative to further unclaimed materials and further unclaimed structures that are not claimed as elements of the invention. It is also noted that the MPEP (in the next to last paragraph of the same section) also states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting. Other factors may be more relevant for particular arts. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise.” As noted above, the claim language does not provide for any structural definition of what structurally defines “a processing circuitry” (including in the respective “configured to…” clauses) , such that any clear and precise boundaries are established as to what is structurally required to be considered as, define a processing circuitry. Furthermore, the MPEP also states: "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.” MPEP 2111 Claim Interpretation; Broadest Reasonable Interpretation [R-10.2019], Section II. Therefore, while the specification provides or an understanding of the claims, limitations recited in the specification, but not claimed will not be read into the claims. As such, while the specification may disclose that the processing circuitry can be a processor, the claim does not require such. Furthermore, there is no requirement for the claimed apparatus to comprise any storage circuitry including any computer program, and it is not required for such processing circuitry to read any such computer program (not specifically defined). As stated above, it applicant intends for the processing circuitry to be defined by specific structures and for the apparatus to comprise a storage circuitry defined as a specific structure that includes a specific stored computer program defined by a specific algorithm, instructions, etc., then the claims should clearly recite such. Otherwise, such will not be read into the claims. The same is applicable to the broad “generator” recited in the claims that is defined in the claims as being specific structure nor as comprising any specific structure. The apparatus of claims 1 and 3-8, and apparatus of claim 9 are defined by the same structures, a generator, light source, detector, and processing circuitry. Applicant’s arguments, see remarks/amendments, filed November 7, 2025 with respect to the 102 rejection(s) of claim(s) 1-9 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 Takagi et al., US 20190381500. Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Objections Applicant is advised that should claim 1 be found allowable, claim 3 and 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 3 is redundant in view of claim 1 because there is no structural difference between claims 3 and 1 and 9 and 1. Claim 3 recites the same “configure to…” clause directed to the processing circuitry as that recited in claim 1. The only difference in the text of claim 3 is “determine a number of the microorganisms” and “determine an amount of the microorganisms”. A number and an amount are one in the same. The specification nor claims provides any distinction from “a number” and “an amount” of the microorganisms. Furthermore, as to the phrases “predetermined number” and “predetermined amount”, it is noted that any number or amount value can be considered as “predetermined”. Here, the claims are directed to an apparatus and there is no requirement for anyone nor anything to make any determination of any number nor amount prior to anything (future event, nor future time). Furthermore, as to claim 9, “the additional step” (referenced in the arguments and addressed above) does not provide for any further structural distinction between the processing circuitry of claim 1 and that of claim 9. See “Response to Arguments/Amendments”. Furthermore, it is noted that the sorting (described in the specification) is based on two possible occurrences of light/fluorescence detection: (1) a signal is not detected (no microorganism is present) or (2) a signal of a microorganism is detected (1 or more). The apparatus is not capable of counting the number of individual cells/microorganisms that are present in a/each single droplet and subsequently sorting a droplet that contains 3 cells from a droplet that contains 4 cells, and further distinguishing (sorting) a droplet containing 5 cells from a droplet containing 4 cells, etc. and so on and so forth…such that the individual droplets are sorted/separated and collected in any other locations other than that provided for by the 2 channels (illustrated in the figures) as implied by the claims. See for example, applicant’s Figures 2-3. Furthermore, it is noted that the specification nor claims specify what is meant, required by “based on an intensity of the fluorescence”. There is no indication, disclosure, teaching, etc. that the detector or any other structural element can provide for an/or detect light intensity and determine any numerical values of intensity of such detected light intensity (power (energy per time) of light per unit area) so as such numerical values are related/correspond to any number/amount of microorganisms that may be/are present in any droplet. As noted above, such “intensity” appears to be related to only 2 alternatives, (1) if 1 or more microorganism is present in a droplet, or (2) no microorganism is present rather than any specific numerical measurement/determination of fluorescence intensity values being correlated with, confirms, etc. that a specific number of microorganisms is present in a droplet (corresponds to specific values of detected fluorescence “intensity”). Claim Interpretation Content of Specification (k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p). The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”. A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus. It is noted that the claims mention a channel, fluid (liquid or gas, but it appears as if the claims are intended to refer to liquid), droplets, microorganism(s), substrate, and enzyme. However, none of the prior are positively claimed as structural elements of the apparatus, droplet collection unit and do not structurally define the apparatus. All of the prior are articles and/or materials intended to be, can be worked upon by, or used with the claimed invention. It is noted that although the preamble refers to the apparatus as “a droplet collection apparatus”, there is no structure positively claimed as being structurally capable of collecting any droplets. It is noted that the generator and processing circuitry are not defined in the claims as being and specific structure(s). It is noted that there are numerous conventionally known structures (pipettes, dispensers, droppers, capillaries, tubes, etc.) that can provide drops to a channel. Furthermore, it is noted that each of the positively claimed elements listed in the claims are not required to be structurally connected to each other. A list of parts that are not required to be structurally connected do not define a single apparatus. It is noted that the claims are replete with “configured to…” clauses such clauses are directed to intended use and/or process steps. Employing the such clause before each and every possible use of a structural element does not necessarily provide for further structure of such element nor structural distinction from a structural equivalent or similar/same structure. The claims are directed to an apparatus defined by a generator, light source, detector, and processing circuitry (in claims 1 and 9), not a process of use. There is not requirement for the apparatus to be used to perform any method, process steps including producing droplets, performing reactions, detecting, determining, sorting, adjusting, processing of anything, nor any other process steps that may be intended by applicant. As noted above, the apparatus does not count any number of cells/microorganisms in any droplets, sorting is based on a cells not being detected or cells being detected based off a light signal. As to claim 4, there is no indication that the detector can distinguish whether any fluorescence is a result of a reaction with any reaction between any unspecified, unclaimed enzyme and substrate. The detector is simply capable of detecting fluorescence. The source of such fluorescence does not further structurally define the detector. The detector of claim 4 is structurally the same detector as provided for in claim 1. The same rational is applicable to claims 5-7 because the claims do not provide for any further structure of the processing circuitry. There is no structural distinction provided for in in claims 5-6. The processing circuitry of claims 5-6 is the same structure as that of claim 1. 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 1 and 3-9 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. As to claims 1 and 9, it is unclear how the positively claimed structural elements provide for “a droplet collection apparatus” because there is no structure positively claimed as an element of the apparatus as being structurally capable of collecting any droplets. Furthermore, it is unclear how the apparatus as claimed can provide for any sorting of droplets without a sorting unit as disclosed in the specification and drawings. Furthermore, it is unclear what is the structural nexus of the generator to the unclaimed channel, if such generator is intended to comprise such channel because the claims do not recite such. Claim 1 recites the limitation "the microorganisms contained in each of the produced droplets " in the paragraph beginning with “determine…”. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “each produced droplet containing a microorganism”. Although no droplets are positively claimed as elements of the apparatus, no produced droplet is recited as containing microorganisms. This is also applicable to claim 9. Dependent claims 3-8 are rejected via dependency upon a rejected claim. It is unclear what is structurally meant, required by claims 3-8 because the claims do not provide for any additional structural element of the apparatus nor further structure of any prior positively claimed element. Each of the claims are directed to a further intended, possible use of the broad, structurally undefined processing circuitry. Employing the phrase “configure to” prior to every possible use, intended use of the processing circuitry does not provide for any further structure of the processing circuitry. As to claim 3, although the claims are directed to an apparatus, it is unclear what is the nexus of and/or difference between the respective paragraphs beginning with “determine” and “control…” as recited in claimed 1 and “determine” and “control…” paragraphs as recited in claim 3. It is unclear if such are the same (in scope or different). See prior remarks above. Claim 6 recites the limitation "the result of the determination" in the last 2 lines. There is insufficient antecedent basis for this limitation in the claim. Although no determination of anything is required to be performed, it is unclear what determination is being referenced because the claim does not clearly recite such. No prior “result” of any determination is previously recited in the claims. As to claim 7, in addition to the prior applicable remarks/rejections recited above, it is unclear what is structurally required of the processing circuitry to be considered as configured to control by dielectrophoresis the flow of produced droplets because as noted above not channel and droplets are positively claimed as elements of the invention; no droplets are required to be produced in nor flow in the unclaimed channel; and the broad, structurally undefined “processing circuitry” is not disclosed (in the specification) as comprising any structure(s) (electrodes or any other structure) that can provide for any dielectrophoresis flow of any unclaimed produced droplets within an unclaimed channel. The “processing circuitry” appears to be only be a “processor” as stated by applicant on page 9 of the remarks filed on 11/7/25 (processors are and were previously conventionally known in the art to be elements of computers, controllers, programmed/programmable structures such as hardware, and other prior known equivalents). As to claim 8, it is unclear what is further structurally required of the processing circuity to be considered as configured to adjust a temperature of the droplets (not claimed as elements of the invention) because the processing circuitry (which is only a processor as noted by applicant; see remarks rejections above) is not disclosed as nor claimed as comprising any structure that can “adjust” any temperature (heat and/or cool) of any unclaimed droplets. It is noted that independent claim 9 employs the same and/or similar language as claim 1. Therefore, applicant should see the applicable rejections of claim 1. Claim 9 recites the limitation "the sorted droplets" in the last line. There is insufficient antecedent basis for this limitation in the claim. Although, no droplets are positively claimed, no droplets are previously mentioned as being sorted. Furthermore, it is unclear what is the nexus of “the sorted droplets” to previously recited produced droplets because the claim does not provide for such. Furthermore, there is no indication as to what the broad, structurally undefined processing circuitry is structurally required to be able to do to any unclaimed sorted droplets to be considered as “processing” on the sorted droplets because the claim does not provide for such. 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 and 3-9 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. The examiner fails to locate any description of such in the originally filed specification. It is noted that while the specification describes a number of elements that the collection unit comprises, the independent claims 1 and 9 do not positively claim each of such elements disclosed in the specification. See for example Figure 1 and corresponding description of such in the specification. The processing circuitry is not disclosed as being, comprising any structure that can control (regulate) any fluid flow (provide for any motive forces (such as a pump); valve; etc. nor any other structure that can control flow) in a channel that is not positively claimed as a structural element of the apparatus. Furthermore, the processing circuitry alone is not capable of sorting (moving, controlling where droplets are subsequently located based upon detection results of any amount of microorganisms) of any droplets in any unclaimed channel. (the above is also applicable to claims 6-7) According to the specification, a sorting unit (not claimed and not defined as any specific structure) is employed. Therefore, the claims are directed to new matter. 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. The factual inquiries 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. Claim(s) 1 and 3-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abate et al., US 2015/0232942 and further in view of Takagi et al., US 20190381500. Abate discloses methods and devices for the detection of components from biological samples and the methods may be used to detect and/or quantify specific components in a biological sample. (Abstract). The microfluidic devices include a cell loading region (droplet generator) to encapsulate a cell to be analyzed in a microdroplet; a first chamber in fluidic communication with the cell loading region, the first chamber having a means for adding a first reagent to the microdroplet, and a heating element; a second chamber in fluidic communication with the first chamber, the second chamber having a means for adding a second reagent to the microdroplet, and a heating element, wherein the heating element may heat the microdroplet at one or more temperatures (control circuitry configure to adjust temperature; claim 8); and a detection region, in fluidic communication with the second chamber, which detects the presence or absence of reaction products from the first or second chamber (control circuitry configured to detect reaction; claim 1 and 9 paragraph 0016-17, Figures 1-2, 5, etc.). As to claims 1, 4-5, and 9 the processing circuitry can detect reactions of droplets via fluorescence. (paragraphs 0018, 13, 26, 31, 44, 67, 88, 92, 128-129, 132, 146-147, etc.; claim 25). The drops appear as peaks in intensity as a function of time, as shown by the output voltage of a PMT, which is proportional to the intensity of the emitted light, as a function of time for detected fluorescent drops. (paragraph 0031). As to claims 1 and 9, Abate discloses the processing circuitry is configured to detect reactions sort droplets based upon such. (paragraphs 0018, 88, 133, 136-137, 173, 270-276,etc.). The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness. Although Abate discloses that in addition to detecting the presence or absence of a microorganism in a droplet. It is also a goal and the apparatus is capable of be used to detect and/or quantify (an amount/number of) specific components in a biological sample, such as tumor cells (e.g., circulating tumor cells). (Abstract). In certain embodiments, the number of biomarkers that can be individually detected within a particular microdroplet can be increased. For example, this may be accomplished by segregation of dyes to different parts of the microdroplet. In particular embodiments, beads (e.g. LUMINEX.RTM. beads) conjugated with dyes and probes (e.g., nucleic acid or antibody probes) may be encapsulated in the microdroplet to increase the number of biomarkers analyzed. (paragraph 0114). However, Abate does not specify that amount (number greater that 1) of microorganisms present in a droplet can be determined by such detection of fluorescence of such droplet. However, Takagi discloses a droplet generation/detection device and a method of employing such device to quantify a number of microorganisms in a droplet. Takagi disclose the control unit 70 has a function of controlling the driving unit 20 and the light source 30. The control unit 70 also has a function of obtaining information that is based on the light volume received by the light receiving element 60 and counting the number of fluorescent-stained cells 350 contained in the liquid droplet 310 (the case where the number is zero is also included). (paragraph 0267). When using a light receiving element including one or a small number of light receiving portion(s), it is conceivable to determine the number of cells contained, based on the fluorescence intensity. (paragraph 0327). Therefore, it would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that the amount/number of microorganisms in a droplet may be determined as taught by Takagi to provide for information/basis for sorting droplets as such would yield predicable results. As to claims 2-3 and 5-6, Abate discloses the methods may be used to detect and/or quantify specific components in a biological sample, such as tumor cells (e.g., circulating tumor cells, or CTCs). (paragraph 0004). The control circuitry is configured to determine an amount/number of microorganisms in a droplet (paragraph 00047, 73-74, 82, 87, 91, 127, 472, 502, 507). As to claim 7, Abated discloses the processing circuitry is configured to perform dielectrophoresis. (paragraphs 0133, 139, 271). As to claim 8, Abate discloses that in certain aspects, the heater includes a Peltier plate, heat sink, and control computer (processing circuitry). The Peltier plate allows for the heating or cooling of the chip above or below room temperature by controlling the applied current. To ensure controlled and reproducible temperature, a computer may monitor the temperature of the array using integrated temperature probes, and may adjust the applied current to heat and cool as needed. (paragraph 108, 218}. 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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday.. 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. 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. /BRIAN R GORDON/Primary Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

May 18, 2022
Application Filed
Aug 06, 2025
Non-Final Rejection — §103, §112
Nov 07, 2025
Response Filed
Jan 20, 2026
Final Rejection — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
65%
Grant Probability
83%
With Interview (+18.6%)
3y 2m
Median Time to Grant
Moderate
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Based on 942 resolved cases by this examiner. Grant probability derived from career allow rate.

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