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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 23, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement filed March 3, 2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Document #3 is not in English. No English translation of the document has been submitted and no concise statement of explanation has been submitted such that the examiner can determine what the document discloses and how such is related to the instant application.
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Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive.
As to the claim objections, applicant asserts:
“Applicant respectfully submits that the objections to Claims 3 and 9 are rendered moot by the present cancellation of Claim 3 and the present amendment to Claim 9. In particular, Applicant notes that amended Claim 9 clearly recites additional features not recited in Claim 1, such that Claim 1 and Claim 9 are clearly not substantial duplicates.”
The examiner disagrees with applicant’s assertion directed to claim 9. Applicant has not indicated what are the specific “additional features” of claim 9 that are different from claim 1; what are the structural differences between the apparatuses as claimed (structural elements provided for in one of the claims that are not provided for the other claim). It is presumed that what applicant now refers to as “additional features” is the same or similar to what applicant previously asserted is “an additional step”. The examiner maintains the previously stated position, response to such in the Final Rejection (1/23/26) hereby incorporated by reference.
Claim 9 does not require any additional structural elements different from the apparatus defined by the positively claimed structural elements of claim 1. The apparatuses of both claims 1 and 9 are structurally the same because each of such is structurally defined as comprising a microchannel, light source, detector, sorting equipment (not defined as being any specific structure), and processing circuitry. The only difference in claim 9 and claim 1 is the last paragraph of claim 9 that does not provide for any further structural element, but is directed to a further intended/possible use of the processing circuitry relative to an unclaimed “particular droplet” and an unclaimed “droplet containing a cell”. Although not positively claimed as elements of the invention, it is noted that a cell is a microorganism. Although not specified by applicant, it is presumed that this is what applicant considers as “additional features”. The examiner disagrees. See prior remarks above. It is noted that if such additional language of the last paragraph of claim 9 was considered as a structural patentable distinction, then the instant applicant and any other applicant could file claims including the same exact language of claims 1 and 9 and choose to add additional language to what the processing circuitry can possible do relative to any droplets (or any other unclaimed material and/or article) and assert that such is also patentable over the claims of the instant application. The claims (language of the claims, positively claimed structural elements) must provide for a distinct structural difference. Here, there is no such structural distinction/difference between claims 1 and 9.
Therefore, the objection is hereby maintained.
As to the amendments being supported by the originally filed specification applicant states:
“The changes to Claim 1 are supported by the originally filed specification and do not add new matter.
In a non-limiting example Applicant notes that paragraph 97 in the published
application in the published application states that "... the droplet collection unit 1 can also sort droplets by the number of microorganisms encapsulated in each droplet. That is, on the basis of determination results, the sorting function 11 c sorts the droplets by the number of microorganisms contained in each droplet. In such a case, as in the second embodiment, the microfluidic chip 20 includes a plurality of the collection ports 28 and the plurality of collection units 17 are connected to the collection ports 28, respectively. The sorting unit 16 is formed to change the application of an electric field so that droplets for each type of microorganisms can be selectively moved in the direction to a corresponding collection port 28. Then, on the basis of the difference in fluorescence intensity, the sorting function 11 c controls the sorting unit 16 so that droplets each having the number of encapsulated
1 See, e.g., paragraphs 26, 33, 34, 42, 44-46, 49, and 97 (footnote at the bottom of page 8 of the response)
microorganisms different from one another are collected by the different collection units 17."
The examiner disagrees that the above provides adequate support for the amendments to the claims. Applicant as not specifically indicated what disclosed in any of the paragraphs (97 nor any of the paragraphs cited in the footnote) of the specification/publication supports/describes each of the amendments. The specification/publication discloses “a channel in the microfluidic chip 20” (such as in paragraphs 21, 23, 26); “a channel 21a is formed between the first inlet 21 and the droplet production area 24” (paragraph 33); and “the microfluidic chip 20 includes microchannels”(paragraph 28; which appears to be the only general broad reference to microchannels in the specification; no microchannel is referenced by any reference number to provide for such is shown in the figures). Although applicant has not specifically stated such, it is presumed that the “a microchannel” as recited in the claim is intended to be the “a channel 21a” and or some other channel provided for in the specification but not referred to as “a microchannel”. Even if so, there is no channel described in the specification, including within of the paragraphs reference by applicant in the remarks, that describes “a microchannel including (i) inlets for introducing microorganisms and substrates that react with enzymes derived from the microorganisms, (ii) a generation region for generating droplets, each produced droplet containing the microorganism and the substrate introduced through the inlets, (iii) a detection region for detecting fluorescence produced in the droplets generated in the generation region, and (iv) collection ports for collecting the produced droplets that have passed through the detection region;
If applicant disagrees, it is hereby requested that applicant specify, provide for the specific text of the specification that describes such in the same way applicant has provided for the specific text of paragraphs 97 and 46 that do not describe a microchannel as now claimed. Furthermore, it is noted that although the specification is directed to a microfluidic chip 20, there is no mention of such microfluidic chip in the claim. It is unclear how the invention can comprise any channel/microchannel without providing for a microfluidic chip that comprises such.
It is noted that there is no description of any microchannel comprising “a generation region” and “detection region” and what structure(s) of the microchannel defines such respective regions. The term “region” does not appear to be present anywhere in the specification. There is no description of any microchannel comprising any structure(s) that can generate/produce any droplets nor any structure(s) of any microchannel that can detect any fluorescence of any produced droplets (not structural elements of the apparatus, not required to be present nor ever generated/produced). Therefore, the claims are directed to new matter. If applicant disagrees, then it is hereby requested applicant provide for the specific text describing the specific structure(s) of a microchannel that structurally define the respective “regions” are structurally capable of that recited in the “for” clauses of the amended claims.
Furthermore, there is no description nor illustration of a microchannel comprising (a plurality of) “collections ports” as now claimed.
Furthermore, the examiner fails to locate where “sorting equipment” as claimed is described in the specification and applicant does not provide for the specific text of the specification that describes such. Therefore, it is unclear what structure(s) disclosed in the specification and shown in the drawings are considered as “sorting equipment”. This is also applicable to “liquid feeding equipment” now recited in the amended claims. The term “equipment” does not appear in the specification.
Although applicant has not stated such, it is presumed that the “sorting equipment” is intended to be the broad “sorting unit 16” that is not defined in the claims by any specific structure(s) (and only illustrated as a rectangular box in Figure 1) and that the “liquid feeding equipment” is intended to be the broad “liquid feeding unit 12” that is not defined in the claims by any specific structure(s) (and only illustrated as a rectangular box in Figure 1).
Applicant further states that:
“Applicant strongly traverses the assertion in the Office Action that reciting "processing circuitry configured to..." is intended use. On the contrary use, it is merely functional claiming, and the use of that language is extremely common in software-related inventions, for example. Moreover, Applicant notes that "processing circuitry" is clearly structural, and part of the apparatus, and Applicant is merely claiming the functionality performed by the processing circuitry, which is for example, computer hardware or a processor (CPU) programmed to perform particular functions.
Further, Figure 1 illustrates "processing circuitry," and paragraphs 14-15 state that the processing circuitry is implemented by a processor, and executes a computer program stored in a storage circuitry.
Moreover, as set forth in MPEP § 2181 and in the USPTO training examples found in "Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications," 76 FR 7, 162 (Feb. 9, 2011), the USPTO discussed the Linear Tech Corp. v. Impala Linear Corp. and the MIT v. Abacus9
Software Federal Circuit cases. Regarding the MIT v. Abacus case, the USPTO stated that "[t]he term 'circuitry' by itself, connotates structure, is defined as structure in dictionaries and has known structural meaning in the art." Emphasis added.
Further, as set forth in MPEP § 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 MPEP states that "[a] functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary in the pertinent art in the context in which it is used." Emphasis added.
In this regard, Applicant notes that apparatus claims in the software arts routinely recite "processing circuitry" followed by functional features, and such features are not ignored as "intended use." In many of those patented claims, "processing circuitry" is the only element in the body of the claim. Applicant respectfully submits that the use of "processing circuitry" is extremely common when claiming the functionality of a processor in U.S. patent claims.
Further, 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 Claim 1 and that the processing circuitry is configured to perform the various functions recited in the claims. Accordingly, application.
Applicant respectfully submits that the claims do not recite any "intended use" features based on the recitation of "configured to" language.
Applicant respectfully submits that the rejections of the claims under 35 U.S.C. § 112(a) are rendered moot by the present amendment to the claims.”
The examiner disagrees. Applicants arguments are essentially same as those previously addressed in the prior Final Office Action. The examiner did not state processing circuitry is not structure. The examiner stated in the Final Office action “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.” Applicant clearly recognizes that the processing circuitry is not claimed as being defined as any specific structures in the claims.
Applicant provides for in the remarks of what examples of the processing circuitry could be such as in the statement “the processing circuitry, which is for example, computer hardware or a processor (CPU) programmed to perform particular functions.” Examples of what the processing circuity can be; what is illustrated in Figure 1; described in paragraphs 14-15; definitions in a dictionary; what is/has been routinely done in the software arts; etc. are not definitive structural elements recited in the instant claims and will not be read (imported) into instant the claims.
"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 2111.01 Plain Meaning [R-01.2024] II.IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION).
Applicant is entitled to be their own lexicographer. However, applicant has not provided any special definition in the specification such as “processing circuitry means…” such that any specific structure(s) would be read into the claims as defining the processing . The “configured to” clause is directed to what the processing circuitry is capable of doing and does not require the processing circuitry to be a programmed computer (nor comprise any other specific structure, hardware, software) that includes any processor, (CPU), software, and/or storage circuitry. If applicant intends for such processing circuitry to be limited to, considered as, and/or defined as specific structure comprising a specific program, software, etc., then such4 should be clearly recited in the claims. Otherwise, such will not be read (imported) into the claims.
Applicant’s remarks directed to functional language are essentially the same as those of the response and addressed in the Final Office Action. The examiner maintains the previously stated position.
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 articles and further unclaimed structures (both identified herein) recited in the claims that are not claimed as elements of the invention. As previously stated, the apparatuses are defined by the positively claimed structural elements listed in the claims, not by any process steps and possible uses with any unclaimed articles and materials.
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. The apparatus cannot function as intended without providing for all of the necessary structures and materials that are not positively claimed as elements of the invention. There is no requirement for any structure(s) comprising sources of liquids containing microorganisms and substrates fluidically connected to the microchannel to be elements of the invention.
As to the art rejection applicant asserts that Abate fails to disclose a microchannel. The examiner disagrees. Abate discloses and apparatus including a microchannel as shown for example in Figure 1. The channel includes multiple structures that can be employed as inlets for any liquids/fluids as desired that can be employed to generate droplets. Furthermore, the apparatus comprises collection ports also illustrated in Figure 1 (see labeling “detection and sort“) and see Figure 2 “waste” and “keep” and text descriptions of figures. For example, paragraph 0018 discloses droplets can flow a through a channel snaking over zones (regions) and droplets are then optically scanned using flow cytometry and sorted using droplet sorting to recover them (right). The droplets may be stored (collected) or used for further analysis, such as being subjected to sequencing (e.g., used as input for a next-gen sequencer, or provided to a sequencing facility).
As to applicants remarks directed to Paragraph 0018 of Abate, it appears that applicant is directed to the possible use method of performing PCR. Applicant further states:
“In particular, the '942 application is silent regarding substrates that react with enzymes derived from the microorganisms as well as the claimed microchannel, as well as controlling the sorting equipment so that a particular droplet containing a predetermined number of the microorganisms is collected in a corresponding collection port, as required by Claim 1.” Such remark is directed to intended use, process steps relative to unclaimed materials and/or articles not any positively claimed structural elements of the apparatus. No substrates, microorganism, enzymes are positively claimed as structural elements of the apparatus and no steps of generation any droplets, controlling, sorting, and collecting of any droplets is required to be performed. The claims are directed to an apparatus defined by the positively claimed structural elements listed on separate intended lines of the claims. Therefore, such remarks directed to such are not commensurate in scope with the claims. The claims must result in a structural difference (positive claimed structural elements) between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Although no such substrates and enzymes are positively claimed as elements of the apparatus, and no such method is required to be performed, it is noted that the apparatus of Abate is structurally capable of generating droplets and allowing for reactions of enzymes and substates. (paragraphs 0476, 516).
As to a processing circuity, the references do teach that as previously stated in the prior Office action. The apparatus of Abate includes a control computer (paragraphs 0108 and 0218) and Takagi discloses and apparatus comprising the control unit 70 includes a CPU 71 and further elements. (See paragraphs 0269-275) structurally equivalent to that as claimed.
Therefore, the rejection is hereby maintained.
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the single microchannel comprising the elements as now recited in the amended claims must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 9 is redundant in view of claim 1 because there is no structural difference between claims 1 and 9.
Furthermore, as to the phrase “predetermined number” 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 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 fluid (liquid or gas, but it appears as if the claims are intended to refer to liquid), droplets, microorganism(s), substrates, enzymes, liquid feeding equipment (not defined by any specific structures in the claims), and cell. 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 the inlets, generation region, detection region, collection ports, and processing circuitry are not defined in the claims as being and specific structure(s). The various “for” can “configure to” clauses do not provide for any structural elements of any of the prior. The names of the prior do not provide for any specific structure. For example, “an inlet” can be any structure (hole, orifice, port, opening, aperture, etc.) through which fluid, microorganisms, or anything else can enter. However, such “inlet” is also not precluded from being considered as and used as an “outlet”. The claims are directed to an apparatus defined by the positively claimed structural elements listed in the claims not by a process of use with any unclaimed articles and materials, including that as may be intended by applicant.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Here the various “for” clauses such as “inlets for…”; “generation region for…”; “detection region for…”; “configured to…”; and other such similar clauses are not considers as being, interpreted as an invocation of 35 U.S.C. 112(f).
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 “for” and “configured to…” clauses (see above remarks)that are directed to intended use and/or process steps. Employing such clauses 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 microchannel, light source, detector, sorting equipment (not defined as being any specific structure), and processing circuitry (in claims 1 and 9), not a process of use. There is no 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.
Claims 4-7 do not provide for any further structure of the processing circuitry and sorting equipment. There is no structural distinction provided for 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 4-9 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 which/what microorganism and substrate is being referenced by the phrase “the microorganism” and “the substrate” in the first paragraph and the paragraph beginning with “generate the droplets…”because the claim previously recites “microorganisms” and “substrates”.
Claims 1 and 9 recite the limitation "each produced droplet" in line 3 of the first paragraph There is insufficient antecedent basis for this limitation in the claim. There is no requirement for any droplets to be produced. If such is intended to refer to droplets that can be generated, then the claim should clearly recite such. Although not positively claimed as elements and no droplets are required to be generated nor produced, it is unclear what is the nexus of the droplets generated and the produced droplets…it is unclear if such are the same or different because the claim does not clearly recite such.
Claims 1 and 9 recite the limitation "the produced droplets that have passed through the detection region" in the first paragraph. There is insufficient antecedent basis for this limitation in the claim. No such produced droplets have been recited as having passed through the detection region.
Claims 1 and 9 recite the limitation "the fluorescence detection results from the detector" in the paragraph beginning with “sorting”. There is insufficient antecedent basis for this limitation in the claim. No such results have been previously mentioned.
Claims 1 and 9 recite the limitation "the droplets in the generation region" in the paragraph beginning with “generate”. There is insufficient antecedent basis for this limitation in the claim. No such droplets have been mentioned as being in the generation region. It is unclear what droplet what droplets are referenced in the phrase.
As to claims 1 and 9, it is unclear what/which inlet is being referenced by “the inlet” in the paragraph beginning with “generate” because the claim previously recites “inlets”.
Claims 1 and 9 recite 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. No such droplets have been mentioned as containing microorganisms.
As to claims 1 and 9, in the last paragraph of claim 1….although no droplet of anything is positively claimed as a structural element of the claimed apparatuses, it is unclear what is required of a droplet to be considered “particular” and what is required of “a number of microorganisms contained within a droplet” to be considered as “predetermined” because the claim does not clearly recite such. Any droplet can be considered as “particular”. Any number of microorganisms can be considered as being “predetermined” relative to a future event and or point in time. See also prior remarks/objections above. Furthermore, it is unclear what is required of a collection of port to be considered as “corresponding” because the claim does not clearly recite such.
As to claims 1 and 4-9, it is unclear what is the structural connectivity of the positively claimed structural elements to each other because the claims do not clearly recite such. The various configured to clauses do not provide for any structural connections. It is noted that unconnected structures not structurally connected are not a single apparatus. It is unclear how the list of structures that are not required to be connected as provided for in the claims define a single apparatus.
Dependent claims 4-8 are rejected via dependency upon a rejected claim.
It is unclear what is structurally meant, required by claims 4-7 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 detector, processing circuitry, and sorting equipment does not provide for any further structure of each of the prior. There is no structural difference in the detector, processing circuitry, and sorting equipment as provided for in claim 1 and that of claims 4-7. Claim 4 is directed to what a reaction between the enzyme and substrate that are not structures of the apparatus and do not structurally define the detector. The fluorescence detector is structurally capable detecting any fluorescence with range of such. What possible reactions between any unclaimed materials or otherwise that can affect or be/produce fluorescence that can be detected does not structurally define the fluorescent detector. There is an exhaustive list of such reactions and different materials that could be possibly detected.
As to claims 4-5, it is unclear what fluorescence is being referenced by “the fluorescence”.
As to claims 4-5, it is unclear which/what enzyme and substrate is being referenced by the phrase “the enzyme” and “the substrate” because claim 1 previously recites “enzymes” and “substrates”. Furthermore, claim 4 appears to contradict that of claim 1 which recites such is based on light from the light source.
Claim 6 recites the limitation "the flow of the produced droplets within the microchannel" in line 3. There is insufficient antecedent basis for this limitation in the claim. Although, no droplets are required to be produced (present as elements of the apparatus), no such flow is previously mentioned in the claim.
As to claim 7, in addition to the prior applicable remarks/rejections recited above, it is unclear what is structurally required of the broad structurally undefined to be considered as configured to sort by dielectrophoresis, the produced droplets because as noted above not no droplets are positively claimed as elements of the invention; no droplets are required to be produced in nor flow in the microchannel; 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 the channel. The “processing circuitry” appears to be a “processor” as stated by applicant in the most recent response and 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 the structural connectivity of the heater to the prior positively claimed structural elements because the claim does not provide for such. Furthermore, although not structural elements of the apparatus, it is unclear what/which droplets are being referenced by “the droplets” because of in view of claim.
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 flow of the particular droplet collected at the corresponding collection port " in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Although, no droplets are positively claimed as elements of the apparatus, no flow of any droplet to anything and no collection of any droplets is required to occur.
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 4-9 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 the invention as now claimed. The claims are directed to new matter. See explanations of such in Response to Arguments above. 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 apparatus cannot function as intended without providing for all of the necessary structures and materials that are not positively claimed as elements of the invention. There is no requirement for the apparatus to comprise any structure(s) comprising sources of liquids containing microorganisms and substrates fluidically connected to the microchannel such that any droplets can be generated/produced, detected, and collected.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 being 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 than 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. (paragraphs 108, 218).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee; Abraham P. et al.; SALMANZADEH; Alireza et al.; Shum; Ho Cheung et al.; CAYER; Devon et al.; ABEYWARDANE; Asitha Adrian et al.; and Lee; Abraham P. et al. disclose sorting devices and methods.
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..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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