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 of Species I., claims 1-6, 8-10, and 12-15 in the reply filed on May 23, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Amended claim 22 has been included in the elected species.
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim.
Response to Arguments
Applicant's arguments filed December 20, 2024 have been fully considered but they are not persuasive.
As to the drawings, it is noted that claim 16 has been canceled and claim 15 has been amended. However, the examiner fails locate any description and illustration of the droplet sorting region comprising a turntable comprising a turntable comprising portions of first and second channels. Therefore, the drawing objection is maintained.
Furthermore, it is noted that while rotary valve 474 is shown as an element of the droplet dispenser 420, there is no description of the valve comprising portions of first and second microfluidic portions as now claimed. Therefore, this appears to be directed to new matter.
It is noted that applicant has amended the claims, but fails to provide for where each amendment is supported/described in the originally filed specification. It is hereby requested that applicant specify where each amendment is supported/described in the specification and what structures disclosed in the specification and drawings are those provided for in each of the claims.
It is noted that applicant states:
“Claim 1 has been amended to specifically include "a sorting input channel," to refer to a "selected droplet," and to specifically include "a dispenser output channel." Claim 1 has been further amended to include the feature from claim 7 that "said droplet ejection mechanism comprises a mechanism configured to increase a pressure in said emulsion flow to direct selected droplets into said dispenser output channel, wherein said droplet ejection mechanism is configured to selectively modulate said pressure to select a droplet in said emulsion flow for ejection". It has also been amended to clarify that the "ejection mechanism is configured to selectively modulate... in response to a previous detection of the droplet by a detector". Basis for this amendment can be found, for example, on page 25 line 37 to page 26 line 3 and page 26 lines 10 to 17.”
The examine disagrees. The specification filed on 6/16/21 includes paragraph numbers, but does not include any line numbers. The examiner fails locate the cited passages. The examiner fails to locate any description of a droplet ejection mechanism as now provided for in the amendment and what structure disclosed in the specification and illustrated in the drawings is such droplet ejection mechanism of the droplet dispenser. Therefore, the amendment appears to be directed to new matter. It is requested that applicant identify what structures disclosed in the specification and drawings correspond to each of the positively claimed elements.
It is noted that the preamble states “for automated sorting”. However, as previously stated in the prior Office Action, there is no electronic device (computer, controller, processor, etc.) positively claimed as an element of the invention that can provide for any automated sorting/operation.
Applicant has not addressed each of the prior 112 rejections and the claims have not been amended to overcome all 112 rejections. See rejections herein.
As to the art rejection, applicant asserts:
“Claim 1 has been amended to incorporate the features of claim 7 and now recites:
"said droplet ejection mechanism comprises a mechanism configured to increase a pressure in said emulsion flow to direct selected droplets into said dispenser output channel, and wherein said droplet ejection mechanism is configured to selectively modulate a pressure in said emulsion flow to eject a selected droplet in said emulsion flow in response to a previous detection of the selected droplet by a detector".
The Examiner appears to assert that the features from claim 7 are taught in Link, but does not explain which portion of Link teaches the features from claim 7. Applicant respectfully disagrees with this assertion, noting that claim 1 is further amended to specify that "said droplet ejection mechanism is configured to selectively modulate a pressure... to eject a selected droplet... in response to a previous detection of the selected droplet by a detector". As such, Applicant believes that Link does not teach the features from claim 1 of a droplet ejection mechanism comprising a mechanism to increase a pressure in an emulsion flow to direct droplets into a dispenser output channel, wherein the droplet ejection mechanism is configured to selectively modulate the pressure to eject a droplet in the emulsion flow in response to a previous detection of the droplet by a detector, as required by amended claim 1. Accordingly, amended claim 1 is believed novel over Link.
These distinguishing features of amended claim 1 have the technical effect that a target droplet can be automatically ejected and dispensed to a reservoir using the selective modulation of pressure in response to the detection of a droplet (see page 36 lines 22 to 26 and 30 to 33). Furthermore, this allows the timing of dispensing of a droplet to be controlled.”
The examiner respectfully disagrees. It is noted that claim 1 has not been amended to only what was previously recited in claim 1. The claim includes new text not previously recited in claim 7, such as “wherein said droplet ejection mechanism is configured to selectively modulate a pressure in said emulsion flow to eject a selected droplet in said emulsion flow in response to a previous detection of the selected droplet by a detector". The configured to clauses are directed to intended use, process of using the droplet ejection mechanism relative to the unclaimed emulsion flow, droplets, reservoir, and detector. There is no requirement for the claimed cartridge to be employed to perform any process steps, use including that as may be intended by applicant. The claim does not provide for what is structurally required (what structural elements of the droplet mechanism) for such be structurally “configured to…” as recited in the claim. There is no element positively claimed that can provide for any automatic selective pressure modulation and selective ejecting as asserted by applicant. Applicant has not identified what structure in the specification is considered as the droplet ejection mechanism as claimed and where such is described in the specification. The droplet mechanism is not an automated device that is and/or comprises any controller, computer, logic controller, etc. that can receive any data, detection results and interpret such results so as to provide for a specific response to modulate any pressure based upon detection by an unclaimed detector. Although, applicant asserts that such is provided for on page 36 lines 22 to 26 and 30 to 33, the examiner fails to locate such. If applicant disagrees, it is hereby requested that applicant provide for the specific text of the specification that describes the droplet ejection mechanism as claimed.
As to applicant arguments directed to detection modules being in communication with an outlet module. The argument is commensurate in scope with the claim. The claim does not positively claim any detector and there is no requirement for anything to be structurally connected to any detector nor for any previous detection nor any other detection of any droplets to be performed and any ejection be performed in response to any detection. The claims are directed to an apparatus not a process of use.
The droplet ejection mechanism appears to be only a structure that can be can be employed to modulate pressure. Clearly Link employs modulation of pressure to control the flow within the device and to dispense droplets. For example, the reference discloses that “the sample tip is connected to a pump capable of driving the sample into the device” (page 30, lines 16-17, see also “gas supply” in the same paragraph); “the invention can use pressure drive flow control, e.g., utilizing valves and pumps, to manipulate the flow of cells, particles, molecules, enzymes or reagents in one or more directions and/or into one or more channels of a microfluidic device” (page 35, lines 1-3); and the pressure at the inlet module can also be regulated by adjusting the pressure on the main and sample inlet channels, for example, with pressurized syringes feeding into those inlet channels (page 35, lines 14-15). See also US 2008/0014589 that appears to be an equivalent publication to WO 2007/133710.
Furthermore it is noted that the reference states “a "main channel" is a channel of the device of the invention which permits the flow of molecules, cells, small molecules or particles past a coalescence module for coalescing one or more droplets, a detection module for detection (identification) or measurement of a droplet and a sorting module, if present, for sorting a droplet based on the detection in the detection module. The main channel is typically in fluid communication with the coalescence, detection and/or sorting modules, as well as, an inlet channel of the inlet module. The main channel is also typically in fluid communication with an outlet module and optionally with branch channels, each of which may have a collection module or waste module.” (page 21 line 35 – page 22, all of the components/modules, including the detection module and outlet module, are in communication with one another).
Therefore, the claims are rejected as given herein.
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 incubation region (droplet input, holding region-chamber, heating device, cooling device -claim 3); the droplet output channel comprising that as recited (i), (ii), (iii) as provided for in claim 4; controller (claim 9); control system (claim 10) the sorting region comprising a turntable comprising potions of first and second microfluidic channel (claims 15) 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.
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 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 mention sorted microfluidic droplets, microfluidic droplets, a droplet, a selected droplet, droplets, a reservoir, an emulsion, an emulsion flow, droplet data, fluid, entities, decoupled droplet, growth media fluid, first and second microfluidic flows, and first and second output flows. However, all of the prior are not positively claimed as elements of the inventions, but are materials/articles that can be are intended to be worked upon.
The claims are replete with language directed to intended use. However, it is noted that the claims are directed to an apparatus, not a process of use. As noted above, the inventions are defined by the positively claimed elements listed in the claims. The apparatus is not required to be used in process at all including that as may be intended by applicant to sort any unclaimed microdroplets, select droplets, dispense any to anywhere/anything, collect any microdroplets in a reservoir (not a structural element of the invention), modulate any pressure of an emulsion flow (not an element of the invention), detect any droplet by a detector (not positively claimed as an element of the invention), nor any other process steps.
The various “configured to…” clauses do not provide for any further structural elements of the apparatus but directed to intended, possible uses. Employ such phrase before recitations of intended, possible uses of structures with further unclaimed materials do not provide for further structure of the invention. Intended, possible uses, and process steps are not structural elements of an apparatus.
It is noted that the terms “input” and “output” do not provide for any further structure, the terms are directed to intended use. An input channel is not structurally precluded from being used as an output channel and vice versa.
It appears that each of the structures provided for in the claims are not identified by corresponding reference numerals in the specification.
It is noted that the term “and/or” is considered as being “or”. The term “or” provides for alternative options, not requirements. Only one option is required to be present.
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.
It is noted that the various “configured to…”, “for…” and “to…” clauses (and similar clauses) employed throughout the claims are directed to intended use and are not considered as an invocation of 112(f), 112, sixth paragraph. For example, such phrases include, but are not limited to: “for automated…”; “to selectively direct…”; “to eject…”; “to control…”; “to hold”; “for incubation”; “to promote…”; “for selecting…”; “for detecting…”; “to determine…”; “to direct…”; “to sense”; “to modulate…”; “to selectively direct…”; “for providing…”; “for preparing…”; “for determining…”; “for sorting…”; “for decoupling…”; “for dispensing…”; “to dispense…” and further similar clauses employed in the claims.
It is noted that the term “or” is directed to alternatives.
Claim Objections
Claims 1-6, 8-10, and 12-15 are objected to because of the following informalities: The claims are not drafted such that each structural element is listed on a separate indented line. Appropriate correction is required.
Applicant is advised that should claim 2 be found allowable, claim 8 and 22 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 8 recites the same intended use of the buffer emulsion region in claim 2. Claim 22 recites the same as that previously recited in the last 2 paragraphs of amended claim 2. Therefore, claim 22 is redundant.
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 1-6, 8-10, 12-15, and 22 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 claim 1, it is unclear what is structurally required of the microfluid cartridge to be considered as for “automated sorting and dispensing of microfluidic droplets….” Because there is no structural element(s) positively claimed that can provide for any automatic sorting and dispensing of microfluidic droplets. The cartridge as claimed is only structurally define by channels and a dispenser.
As to claim 1, it is unclear what is the structural connectivity of the droplet director to the two or more output channels and “selected one of said sorting output channels” because the “configured to selectively direct…” clause does not provide for such. The clause is directed to the intended use of the droplet director relative to an unclaimed droplet that is not a structural element of the invention. A list of parts that are not required to be structurally connected do not define a single apparatus. Therefore, it is unclear how the claims as drafted are considered to define a single apparatus.
As to claims 1 and 12 , although not positively claimed as elements of the invention (not required to present), it is unclear what/which microfluidic droplets are being referenced by the phrase “said microfluidic droplets” because the claim previously recites “sorted microfluidic droplets” in the preamble and “microfluidic droplets” of the emulsion. If applicant intends refer to the microfluidic droplets of the emulsion (not claimed as an element of the invention), the claims should clearly recite such.
It is noted that the term “selected” does not provide for any structure of a droplet (not positively claimed as an element of the invention) nor any channel. The claims are directed to an apparatus not a process of use. There is no requirement for anyone nor anything to “select” any droplet nor channel. Any droplet/channel can be considered as “selected”.
Claim 1 recites the limitation "said selected droplets" in the paragraph beginning with “a droplet dispenser”. There is insufficient antecedent basis for this limitation in the claim.
As to claims 1-6, and 8-10, 12-15, and 22, it is unclear what is the nexus of “sorted microfluidic droplets”, “microfluidic droplets”; “said microfluidic droplets”; “said selected droplets”; the selected droplet”; “the selected droplet from said emulsion flow”; “a droplet”, “a formed droplet” etc. recited throughout the claims relative to each other and the prior recited sorted microfluidic droplets of claim 1 because the claims do not clearly provide for such.
Although, “an emulsion” is not positively claimed an element of the invention. It is unclear what is the nexus of the various droplets recited throughout the claims (see prior rejection above) to the emulsion and the nexus of “an emulsion flow” to the emulsion because the claim does not provide for such.
As to claim 1, it is noted that “a reservoir” is not an element of the cartridge and there is no requirement for any droplets to ever be “selected”, collected in any reservoir, and ejected from any emulsion flow into anything. As noted above, such language is directed to intended use. It is unclear what structure disclosed in the specification corresponds to the ejection mechanism. It does not appear that each of the structures provided for in the claims are not identified by corresponding reference numerals in the specification and drawings.
It is unclear what is the structural connectivity of the dispenser output channel and the ejection mechanism because the claim does not clearly provide for such. The “configured to…” clause does not provide for nor require any structural connectivity. Therefore, it is unclear how such elements that are not required to be connected define a single droplet dispenser. See prior rejection above directed to lack of structural connectivity.
As to claim 1, although emulsion flow of anything is required to occur nor be present anywhere in the claimed apparatus/cartridge, it is unclear from where an emulsion flow is intended to be located such that selected droplets can be ejected into the dispenser channel because the claim does not recite such.
As to claim 1, it is unclear what is further structurally required of the droplet ejection mechanism by the “configured to…” clauses because the clauses do not provide for any further structures of the droplet ejection mechanism. The same is applicable to all “configured to..” clauses of claim 1 and those employed throughout the further dependent claims.
It is unclear how the droplet director and droplet dispenser can select any droplets, selectively modulate pressure, and eject a selected droplet (what is the nexus of such to various previously recited droplets) in said emulsion flow in response to a previous detection of the selected droplet by a detector because neither are described in the specification as being or comprising any computer, programmed controller, processor, logic controller, etc. that can monitor, store, compare, etc. any results to make any determinations, decisions, based upon any results/responses of/from anything.
It is unclear how the invention can be defined relative to a detector because no detector is positively claimed as an element of the invention. Furthermore, although no detection of any selected droplet is ever required to be performed, it is unclear what is “a previous detection” because no relative basis is provided for in the claim. No detection of anything is required to occur prior/previous to anything and no detection result is required to be sent from anything to anything such that any ejection (response) occurs based upon any detection result/determination.
Claims 2-6, 8-10, 12-15, and 22 are rejected via dependency upon rejected claim 1.
As to claims 2 and 22, the phrase “emulsion flow buffer region” does not provide for any structure. No emulsion is required to occur. Although the “configured to…” phrases are directed to intended use relative to an unclaimed emulsion flow and droplets, it is noted that “temporarily” is not directed to any specific amount of time. Any amount of time can be “temporary”. It is unclear how a length (value of distance) can be considered as structurally capable of doing anything. A value of a length of a microchannel is just that a numerical value of distance. There is no indication as what length values are and are not capable of such. Here, there is no specific value provided for in the claim. Any channel length can be considered as such. Furthermore, there is no indication as to what is considered as “an order of microdroplets” what is required to be done to maintain such order as there is no requirement for anything to occur such to attempt to change any order of microdroplets.
It is unclear what microfluidic channel in specification and drawings correspond to the “length of microchannel” because applicant has not provided for such and the examiner fails to locate any description of such with the specification. Therefore, the claims are directed to new matter.
As to claim 3, it is unclear what is the structural connectivity of the heating device and cooling device to the droplet input, chamber, and output because the claim does not provide for such. The “configured to” clause does not provide for nor require any structural connectivity. See prior rejections above directed to lack of structural connectivity. Furthermore, it is noted that a droplet input and output are defined as being any specific structure(s). There is no indication as to what structures disclosed in the specification and drawings correspond to the droplet input, chamber, heating device, cooling device, and output. The examiner fails to locate any description of an incubation region being defined as provided for in the claim. Therefore, the claim is directed to new matter.
As to claim 4, although no “liberation” of anything required to be performed, it is unclear what is meant, required to be considered as “configured to promote liberation” because promoting liberation is not defined in the claim. Promoting liberation does not require any actual liberation of anything to be performed. It is only required that one of (i), (ii), or (iii) be present. It is further unclear what is the nexus of “the selected droplet” to the prior recited “selected droplets” and various other droplets recited in claim 1 because the claim does not provide for such.
As to claim 4, it is presumed that applicant intends for the dispenser output channel to comprise a nozzle. If so, the claim should clearly recite such. However, it is unclear what is required by a narrowing of a nozzle because there claim does not provide for any relative basis of comparison. A nozzle can be consider as being narrower than anything wider than any part of the nozzle.
As to claim 4, it is unclear what is structurally meant by “across” the dispenser output channel because the term vague, ambiguous, and does not provide for any definitive relative location of the mesh. It is presumed that applicant intends for the dispenser output channel to comprise and exit (not defined by nor as being any specific structure). If so, the claim should clearly recite such.
The term “adjacent” in claim 4is a relative term which renders the claim indefinite. The term “adjacent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term does not provide for nor require any structural connectivity. Furthermore, the term does not provide for any definitive relative location. The electrodes can be positioned at some unspecified distance from the exit. What may be considered as “adjacent” by one person may not be considered as such by another and vice versa. It is noted that the “to disrupt the emulsion flow” is directed to intended use/purpose. What can be done is not a requirement. There is no requirement for any emulsion flow to occur in anything nor be disrupted. There is no indication as what is considered as disrupt. The term “disrupt” is also relative as such term is not defined in the claim so as to determine what is required to occur, what is considered as “disrupt”. The examiner fails to locate any description in the specification of the droplet output channel comprising that as recited (i), (ii), (iii) as provided for the claim. Therefore, the claim is directed to new matter.
As to claim 5, it is unclear what is required, structurally required of the droplet dispenser because the claim does not provide for any further structural element of the droplet dispenser. The “configured to selecting…” clause is directed to intended use relative to some unspecified, unclaimed droplets. There is no indication as to how the dispenser is structurally capable of “selecting” droplets. See prior rejection of claim 1 which also addresses such. The claim does not provide for any further structure of the droplet dispenser. There is no structural difference between the droplet dispenser of claim 1 and that of claim 5. Furthermore, although no droplets are positively claimed as elements of the invention, the “biological entities” are not limited to anything specific. It is presumed that the phrase “with” is meant to meant that the droplets include biological entities. It is noted that any number is, can be considered as a “defined” number. It is unclear what is the nexus of “droplets” recited in claim 5 and various droplets recited throughout claim 1.
As to claim 6, in addition to prior applicable rejections above, it is unclear what is the structural connectivity of the plurality of sensors to the prior positively claimed elements of claim 1 because the claim does not provide for such. The configured to clause does not provide not require any structural connectivity to any prior positively claimed element. See prior rejections above directed to lack of structural connective. Furthermore, it is unclear how the entire invention can be claimed, defined relative to itself, “the microfluidic cartridge” as noted above. Two or more locations of the microfluidic cartridge (the entire invention being defined) does not provide for any definite locations nor prior positively claimed structural elements of the invention. Furthermore, it is noted that there is no requirement for any droplet to be detected, velocity of any droplet to be determined (by anyone nor any structure). The sensors are not capable of making any determinations of velocity nor is droplet director capable of directing any droplet based on any outcome/determination made by anyone or anything. The sensors and director are not required be structurally connected and are not logic controllers that make any decisions. There is no indication in the claim that the droplet director is (an electronic device or comprises electronics, computing elements, etc.) capable of determining any droplet velocity (or anything else) and using any determination as a parameter (data) “to direct” any droplet. See prior rejection of claim 1. The examiner fails to locate such sensors and director themselves being capable of determining velocity and using some determination (results, data, information, etc.) as claimed being described in the specification. While each can be used to perform process steps, the sensors and director themselves do not perform such steps as recited in the claim. Furthermore, it is unclear what is the nexus of “a droplet” to the various “droplet” and “droplets” recited throughout claim 1.
As to claim 6, it is unclear what/which droplet is being referenced by “said droplet” because claim 1 recites various droplets including “an emulsion comprising microfluidic droplets” and various other droplet and droplets are mentioned throughout claim 1.
Claim 6 recites the limitations "said detected droplet" and “said velocity determination”. There is insufficient antecedent basis for this limitation in the claim. No droplet has been previously required to be detected and no velocity determination have been required to be performed. The “to detect” and “to determine” clauses are directed to intended use. The claims are directed to an apparatus not a process use with any unclaimed droplet and emulsion.
Claim 8 recites the limitation "the emulsion flow region". There is insufficient antecedent basis for this limitation in the claim. It is unclear what is structurally required to be considered as “emulsion flow buffer flow region” because such “region” has not been structurally defined in the claim. The structural metes and bounds of such region are not provided for in the claim. There is no requirement for any “emulsion buffer flow” of anything to ever occur within any positively claimed structural element. Furthermore, it is unclear what is the structurally connectivity of such emulsion flow buffer region to the previously positively claimed elements of claim 1. It is noted that claim 8 does not provide for any further structure/structural element than claim 2. There is no structural distinction of claim 8 from claim 2. Reciting a further intended use of a structure does not provide for any further structure. Furthermore, it is unclear what is the nexus of “microfluidic droplets” of 8 to various droplets recited in claim 1.
As to claim 9, it is unclear what the phrase “and further comprising a sensor…” modifies…the microdroplet system or the microfluidic cartridge because the claim does not clearly specify such. Therefore, it is unclear what the sensor and controller are elements of. If elements of the microfluidic cartridge, it is unclear what is the structural connectivity of the “a sensor” and controller to each other and to the prior positively claimed elements of the microfluidic cartridge because the claim does not provide for such. Furthermore, it is unclear what structure disclosed in the specification corresponds to the sensor and controller. It is unclear if the controller is actually a device that can provide for motive forces (pump, etc.) or if the controller is intended to be a computer or such similar logic controller. If the prior, such a device such as pump does is not a logic controller, and if the later a computer alone will not be able to modulate any pressure without a structure capable of providing for motive forces being present.
As to claim 9, it is unclear what/which “selected droplet” is being referenced by the phrase “said selected droplet” because claim 1 recites “a selected droplet” and “said selected droplets”. It is presumed that the phrase “the speed and position” is intended to refer to said selected droplet. If so, the claim should clearly recite such.
As to claim 10, it is unclear what is the nexus of “a plurality of reservoirs” and unclaimed “a reservoir” recited in claim 1. It is unclear if the a plurality of reservoirs is inclusive of the a reservoir or different from such. It is further noted that there is no requirement for any droplet to be dispensed from anything to any reservoir. Therefore, it is unclear what is structurally required to be “a control system” and what disclosed in the specification corresponds to such “control system” that is not structurally defined in the claim. A system is not definitive structure. The claim does not provide for what is structurally (structures) defines the control system.
Furthermore, it is unclear what is the nexus of “a dispensed droplet” to the various droplet and droplets recited in 1. However, it is noted that there is no requirement for any dispensing of any droplet to occur from the dispenser output channel to any reservoir.
As to claim 12, it is unclear what is structurally required to be considered as “a droplet sensing system” and “said control system” because each of such systems are not defined by any specific structural elements. See prior rejection of claim 10.
Claim 12 recites the limitation "said microfluidic droplets received in said sorting put channel" in first paragraph. There is insufficient antecedent basis for this limitation in the claim. No microfluidic droplets have been positively claimed as elements of the invention being located/received in the sorting input channel.
As to claim 12, it is unclear what is the nexus of “a selected droplet” and “an individual sensed droplet” to each other and the various droplet and droplets recited in claims 10 and 1. Furthermore, droplet data is not a structural element, not required to be present and is not specified as being and specific data. There is also not requirement for anyone nor anything to retrieve and such data from anyone nor anything. It is unclear what is required is “droplet data” and what is required of such droplet data to be considered as “relating” to said one or more properties because the claim does provide for such. Any data can be subjectively considered/characterized as being “related” to anything one desires.
Claim 12 recites the limitations "said one or more sensed properties" and “the droplet data for an individual sensed droplet”. There is insufficient antecedent basis for these limitations in the claim. No sensing properties of any droplet has been previously performed and no data of any individual droplet has been defined.
There is no indication as what makes data retrievable and there is no requirement for any data to be retrieved by anyone or anything. Furthermore, although not positively claimed as an element of the invention, it is unclear what is required of a reservoir to be considered as “identified” and what is the nexus of such reservoir in claim 12 to the “a reservoir” and “a plurality of reservoirs” of claims 10 and 1 respectively.
As to claim 13, it is unclear what is structurally required of each of the elements listed in the claim because the claim does not provide for such. Instead each of the elements are defined in terms of intended use relative to a droplet, fluid, and other unclaimed materials. For example is unclear what is structurally required of a device to be considered as droplet formation device. It noted that the analyzer does not appear to be capable of making any determination, but is used for determination. It is further unclear what is further structurally required of the microfluidic cartridge because the “configured to...” clause does not provide for any further structural element of the sorting region. The sorting region is not a computer, logic controller, etc. see prior rejection of claim 1.
As to claim 13, it is unclear what is the nexus of “a said selected droplet” in the 3rd and 4th paragraphs to each other and to “a selected droplet”; “the selected droplet” and “said “selected droplets” recited in claim 1.
Claim 13 recites the limitation "said determination by the analyzer" . There is insufficient antecedent basis for this limitation in the claim. No determination has been required to be made. Configured to determine is not a determination.
As to claim 13, it is unclear how the entire invention, a microfluidic system can be defined relative to itself “said microfluidic system” as recited in the last paragraph. It is unclear what is structurally considered a fluid flow path because such is not provided for in the claim. It is unclear what is the nexus of such path to the prior channels. Although the “configured for” clause does not provide for any structural element, it is unclear what is the difference between decoupling and dispensing
As to claim 14, it is unclear what is the nexus of a reservoir to the prior a reservoir of claim 1. It is noted that there is no requirement for any growth media fluid to be present nor and dispensing to such to occur. The configured to dispense clause does not provide for any further structure of the droplet dispenser.
As to claim 22, see rejection of claim 2.
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 1-6, 8-10, 12-15, and 22 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. See prior remarks/rejections above. The examiner fails locate any description of a droplet ejection mechanism as now provided for in the amendment and what structure disclosed in the specification (claim 1); the emulsion flow buffer region comprises a length of microfluidic channel configured to maintain an order of microfluidic droplets within the length of microfluidic channel (claim 2); any description of an incubation region being defined as provided for in the claim 3; the droplet output channel comprising that as recited (i), (ii), (iii) as provided for the claim 4; and the droplet dispense and the droplet sorting region comprising a turntable comprising a turntable comprising portions of first and second channels. (claim 15).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 8-10, 12-15, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Link et al., WO 2007/133710.
Link discloses in Fig. 1: A microfluidic substrate (i.e. cartridge) for handling droplets, comprising inlet modules (a well or reservoir containing molecules, cells, small molecules or particles (page 37, lines 9-11 )) introducing droplets of samples into the main channel (page 37, lines 27-28)) (may be considered sorting input channel), a coalescence module, a detection module, a sorting module and a collection and waste module. The sorting region is the junctions of a channel where the flow can change direction depending on a signal received from the detection module (page 57, lines 8-11 ). An outlet module after the branch channel of the sorting module can terminated with a well or reservoir into which sorted droplets are dispensed (page 57, lines 18-21). Collection apparatus may include dispensing (via a dispenser;) into microtitre plates (page 25, line 24; see also figures 9-10).
As to the droplet ejection mechanism the reference discloses that “the sample tip is connected to a pump capable of driving the sample into the device” (page 30, lines 16-17, see also “gas supply” in the same paragraph); “the invention can use pressure drive flow control, e.g., utilizing valves and pumps, to manipulate the flow of cells, particles, molecules, enzymes or reagents in one or more directions and/or into one or more channels of a microfluidic device” (page 35, lines 1-3); and the pressure at the inlet module can also be regulated by adjusting the pressure on the main and sample inlet channels, for example, with pressurized syringes feeding into those inlet channels (page 35, lines 14-15).
Furthermore it is noted that the reference states “a "main channel" is a channel of the device of the invention which permits the flow of molecules, cells, small molecules or particles past a coalescence module for coalescing one or more droplets, a detection module (sensor, sensing system) for detection (identification) or measurement of a droplet and a sorting module, if present, for sorting a droplet based on the detection in the detection module. The main channel is typically in fluid communication with the coalescence, detection and/or sorting modules, as well as, an inlet channel of the inlet module. The main channel is also typically in fluid communication with an outlet module and optionally with branch channels, each of which may have a collection module or waste module.” (page 21 line 35 – page 22, all of the components/modules, including the detection module and outlet module, are in communication with one another).
As to claims 2, 8, and 22, the device comprises chambers and lengths of channels that can control flow rates and maintain an order of droplets.
As to claim 3, the device comprises inputs, outputs, chambers (noted above) and heating and cooling devices. (page 7, line 8, further throughout the reference).
As to claims 4 and 6, the device comprises nozzles that are narrower than something and electrodes can be used to apply an electric field to the nozzle. (page 42, Electrodes and page 46, line 1).
As to claim 9, electrodes (sensors/sensing system) detect a position of droplets.
The detection module (analyser) interrogates cells, small molecules or particles on the basis of predetermined characteristics (page 46, lines 21-22) and can detect the presence or absence of a species (page 46, lines: 33-34) and then communicate with the sorting module.
The method for using the device of Link may include collecting the droplets and incubating them on the microfluidic substrate (page 10, lines 33-34).
The branch channel of the sorting module may be considered a decoupler which decouples sorted droplets from the main channel (first flow path) to the outlet channel (second flow path) towards the reservoir or we11.
Link provides 2 inlet modules (see Fig. 1), an inlet well
containing cells and a library well containing for example DNA, RNA, protein (page 28, lines 10-11). Droplets from both inlet wells are created and fused in the coalescence module (Fig. 1 ).
The reference also discloses a "processor" or a "microprocessor" (controller/control system) is any component or device able to receive a signal from one or more sensors, store the signal, and/or direct one or more responses (e.g., as described above), for example, by using a mathematical formula or an electronic or computational circuit. (page 55, lines 25-30).
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..
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