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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/22/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 22 June 2026.
Claims 1-18 are pending.
Claims 8-15 are withdrawn.
No claims are cancelled.
Claims 16-18 are newly added.
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 1-7 and 16-18 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.
Claim 1 recites “the first wall and the second wall are in contact against each other and the metering zone is without air” wherein the specification does not define the degree of the term “without air” and thereby does not provide an objective boundary for what “without air” means, particularly given that no vacuum source or immiscible fluid is provided to evacuate all the air from the device, and it is unlikely that every single molecule of air would be removed from the metering zone merely by pushing the walls together. Does “without air” mean “absolutely no air molecules”, “no air bubbles”, “substantially free of air”? Hence, it is unclear at what point the limitation would be satisfied.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 6-7, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breidenthal et al. (US 2009/0134046 A1), hereinafter “Breidenthal”.
Regarding Claim 1, Breidenthal teaches a dilution system for diluting a sample of biological material, comprising a fluidic circuit, wherein the fluidic circuit comprises at least:
a first container C22 configured to contain a sample of biological material containing a biological material to be diluted, the sample being a fluid, a second container C24 configured to contain a first dilution fluid (Figs. 1A-B and [0315]: “The integrated chamber system of the illustrated receptacle 10 includes eleven chambers C16, C18, C20, C22, C24, C26, C28, C30, C32, C34 and C36. The chambers are generally enclosed compartments that may be connected (selectively, temporarily, or permanently) with one or more adjacent chambers so as to permit substances to flow between at least a portion of the adjacent chambers, as well as between various chambers of the integrated system. Each chamber may contain a substance used to perform a process within the receptacle 10 such as, for example, sample material, sample processing reagents for preparing a sample material for further analysis, reactants, solvents, diluents, wash reagents and the like.”),
the first container C22 and the second container C24 being fluidically connected by at least one fluid path C26 (See Fig. 1B which shows chambers C22 and C24 connected by chamber C26, constituting a fluidic path between the first and second chambers.),
at least a first metering member for metering a determined volume of fluid (See the annotated Fig. 1B below.), comprising a first wall and a second wall ([0013]: “Each openable connection may be blocked with one or a combination of barriers, including a seal, valve, or external force (e.g., actuator) applied to the connection, when in a closed state to prevent substance movement between chambers.” – Herein, providing an openable barrier for fluid metering must necessarily comprise the relative movement of at least two walls which join to form a seal and separate to open said seal. Further, all of the valve types mentioned by Breidenthal involve such cooperation of interior walls. Further, such a metering assembly is common in the art of microfluidics; see Dulk et al. (WO 2018/091813 A1) Figs. 3A and 3B, for example.),
the first metering member comprising:
a metering zone configured to change at least from an initial state, in which the first wall and the second wall are in contact against each other and the metering zone is without air, to an operating state, in which the first wall and the second wall are at a distance from each other in such a way as to delimit a determined metering volume, the metering zone attaining the operating state by the conveying of the sample and/or of a dilution fluid into the metering zone ([0006]: “...a first linear path of chambers interconnected by a plurality of openable connections that includes: first and second chambers connected by a first openable connection, where the first and second chambers and the first openable connection are configured to permit substance movement from the first chamber to the second chamber when a substance-moving force is applied to the contents of the first chamber and the first openable connection has been altered from a closed state to an open state...” – Regarding the metering zone without air -- See para. [0360] regarding displacing air in the device with oil such that when liquid flows through the device, no air is within the device. Thus, even in a first/second state where sample fluid is or is not actuated through the device, no air would be present in the metering zone.),
the first metering member being arranged on the fluid path C26 connecting the first container C22 to the second container C24, between the first container C22 and the second container C24 (See the annotated Fig. 1B below, showing the first metering member as on the fluid path C26.), as in Claim 1.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Breidenthal teaches the dilution system discussed above comprising at least a first mixing chamber C28 configured to contain a first mixture of fluid resulting from the mixing of part of the sample and at least part of the first dilution fluid, the first mixing chamber C28 being fluidically connected to the first container C22 and to the second container C24 (See the annotated Fig. 1B below, and para. [0094]: “...a method is provided for mixing substances contained in first and second chambers of a receptacle having a plurality of interconnected chambers...”.), as in Claim 4.
Regarding Claim 6, the prior art meets the limitations of Claim 4 as discussed above. Further, Breidenthal teaches the dilution system discussed above comprising a third container C32, configured to contain a second dilution fluid and at least a second mixing chamber C30 configured to contain a second mixture of fluid resulting from the mixing of part of the first mixture of fluid and at least part of the second dilution fluid, the second mixing chamber C30 being fluidically connected to the first mixing chamber C28 and to the third container C32 (See the annotated Fig. 1B below.), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 6 as discussed above. Further, Breidenthal teaches the dilution system discussed above comprising a second metering member arranged upstream of the second mixing chamber, the second metering member being configured to meter the first mixture of fluid coming from the first mixing chamber and intended to be diluted by the second dilution fluid coming from the third container (See the annotated Fig. 1B below.), as in Claim 7.
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Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, Breidenthal teaches the system discussed above wherein the metering zone is also without air in the operating state (See para. [0360] regarding displacing air in the device with oil such that when liquid flows through the device, no air is within the device. Thus, even in a second state where sample fluid is actuated through the device, no air would be present in the metering zone.), as in Claim 16.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as discussed above. Further, Breidenthal teaches the system discussed above wherein, in the initial state, the first wall and the second wall of the first metering member form a concavity (See para. [0030] discussing valves and actuators as the connections wherein the closing of a valve or actuator into the device forms a concavity as the channel cavity is sealed.), as in Claim 17.
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.
Claims 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Breidenthal. Breidenthal has been discussed above.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Breidenthal does not specifically teach the dilution system discussed above in which the first metering member comprises a fluid inlet connected directly to the first container, and a fluid inlet connected directly to the second container, as in Claim 2.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C).
Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of metering member inlets connected directly to the first and second containers would not perform differently than the prior art device arrangement of metering member inlets connected indirectly to the first and second containers via the fluid path C26, absent evidence of criticality, non-obviousness, or unexpected results associated with the direct connection of metering member inlets to the first and second chambers. -- See further the Drawings section above.
Herein, one of ordinary skill in the art would find it obvious to provide such a direct connection so as to reduce the volume of fluid required for operation of the device, wherein long fluidic channels between chambers and valves introduces unnecessary dead volume. See MPEP 2144(I): The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, Breidenthal does not specifically teach the system discussed above wherein, in the initial state, the first wall and the second wall of the first metering member are each in the form of a hemispherical concave cap and are in contact against each other in the same direction so as to form the concavity, as in Claim 18.
However, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). As the walls therein Breidenthal commensurately actuate to be pressed against one another and/or be sealed by an obstruction as discussed in para. [0030], said walls of Breidenthal would be expected to perform identically as the claimed particular hemispherical shapes. Applicant’s claiming of particulars of the valve/metering member as being opposing structures which are actuated together to pinch off a flow is not sufficient to confer patentability. Many such valve arrangements are present in the prior art including Breidenthal and merely serve the identical purpose as in Breidenthal for metering a flow of fluid between chambers of a microfluidic device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the device of Breidenthal wherein, in the initial state, the first wall and the second wall of the first metering member are each in the form of a hemispherical concave cap and are in contact against each other in the same direction so as to form the concavity as a mere matter of design choice of choosing a particular valve type for metering the flow between chambers.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Breidenthal in view of Devaraju et al. (US 2013/0255799 A1), hereinafter “Devaraju”. Breidenthal has been discussed above.
Regarding Claim 3, the prior art meets the limitations of Claim 2 as discussed above. Further, Breidenthal teaches the dilution system discussed above in which each fluid inlet of the first metering member, in the initial state of the metering zone of the first metering member, is hermetically closed by a fragile valve, each fragile valve being configured to be opened by the pressure of a fluid, from between the sample or the dilution fluid, conveyed to the first metering member ([0013]: “The seal may be a burstable seal (e.g., peelable heat seal, such as chevron or V-shaped seal).”), as in Claim 3.
However, Devaraju teaches a respective microfluidic device comprising actuatable valves (containment valves) and check/burst/fragile valves (interface valves) used at the inlets of said actuatable valves to prevent backflow through the device when the actuatable valves are opened and fluid is flowing therethrough (See Figs. 13A-B and 18A-B; and paras. [0005] discussing the actuatable valve, and [0065] discussing pressure bursting.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the dilution system of Breidenthal above in which each fluid inlet of the first metering member, in the initial state of the metering zone of the first metering member, is hermetically closed by a fragile valve, each fragile valve being configured to be opened by the pressure of a fluid, from between the sample or the dilution fluid, conveyed to the first metering member, such as suggested by Devaraju, so as to prevent backflow through the device; and would have a reasonable expectation of success therein.
Further, the use of check valves for preventing backflow within microfluidic devices is explored prevalently in the art of microfluidics for preventing undesired backflow, wherein one of ordinary skill in the art would find it obvious to provide the system of Breidenthal a check valve upstream of the actuatable valve so as to prevent backflow out of the actuatable valve, thereby reducing error due to dynamic flow into and out of the metering region. See MPEP 2144(I): The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Breidenthal does not specifically teach the dilution system discussed above in which the first metering member comprises at least one fluid outlet connected to the first mixing chamber, each fluid outlet of the first metering member, in the initial state of the metering zone of the first metering member, is hermetically closed by a fragile valve, each fragile valve being configured to be opened by the pressure of a fluid, from between the sample or the first dilution fluid, conveyed toward the first mixing chamber, as in Claim 5.
However, Devaraju teaches a respective microfluidic device comprising actuatable valves (containment valves) and check/burst/fragile valves (interface valves) used at the outlets of said actuatable valves to prevent backflow through the device when the actuatable valves are opened and fluid is flowing therethrough (See Figs. 13A-B and 18A-B; and paras. [0005] discussing the actuatable valve, and [0065] discussing pressure bursting.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the dilution system of Breidenthal in which the first metering member comprises at least one fluid outlet connected to the first mixing chamber, each fluid outlet of the first metering member, in the initial state of the metering zone of the first metering member, is hermetically closed by a fragile valve, each fragile valve being configured to be opened by the pressure of a fluid, from between the sample or the first dilution fluid, conveyed toward the first mixing chamber, such as suggested by Devaraju, so as to prevent backflow through the device; and would have a reasonable expectation of success therein.
Further, the use of check valves for preventing backflow within microfluidic devices is explored prevalently in the art of microfluidics for preventing undesired backflow, wherein one of ordinary skill in the art would find it obvious to provide the system of Breidenthal a check valve downstream of the actuatable valve so as to prevent backflow into the actuatable valve region, thereby reducing error due to dynamic flow into and out of the metering region. See MPEP 2144(I): The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Breidenthal in view of Xu et al. (US 2005/0074340 A1), hereinafter “Xu.
Regarding Claims 3 and 5, Breidenthal does not specifically teach the dilution system discussed above wherein check valves are located upstream at the inlet of the metering member, nor downstream at the outlet of the metering member, as in Claims 3 and 5.
However, Xu teaches a respective metering member having two walls which converge in a closed state and diverge in an open state to allow fluid to pass through, the system further comprising check valves 38 and 40 on either side of the metering member, upstream and downstream respectively, to prevent backflow through the device (See Figs. 5A-C, and para. [0032].).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the dilution system of Breidenthal wherein check valves are located upstream at the inlet of the metering member, and downstream at the outlet of the metering member, as in Claims 3 and 5 respectively, such as suggested by Xu, so as to prevent backflow through the device; and would have a reasonable expectation of success therein.
Response to Arguments
Drawings
Applicant’s amendments sufficiently overcome the Drawings Objection set forth by the previous office action by removing the direct connection language. As such, the Drawings Objection is withdrawn herein.
Rejections under 35 USC 102 and 103
Applicant’s arguments are on the alleged grounds that the advisory action mailed previous to this action failed to account for the metering zone to be without air “in the initial state” wherein Breidenthal allegedly has no way of eliminating air in the metering zone in an initial state.
Applicant’s arguments are not persuasive because Breidenthal teaches fluid flowing through the device, which displaces air from the metering zone ([0038]: “forcing fluid substances to move between directly connected chambers”), and Breidenthal further teaches minimizing/eliminating air within the chambers of the device ([0267]: “Loading may be accomplished by such means as pouring, pipetting, injecting, spotting, drawing (e.g., applied vacuum or syringe), evacuating, exchanging atmospheres, and the like. Keeping the amount of air present in a chamber to a minimum is generally preferred and, for reproducibility, the air/material ratios in like chambers should be kept substantially constant across receptacles prepared for identical uses.” – See also [0360] regarding displacing air with oil in an initial state.). Therefore, Breidenthal teaches the metering zone to be without air “in the initial state”, in as much as is claimed by the initial state therein. Examiner further notes that the valves listed by Breidenthal ([0013]) implicitly exist to eliminate air from a “metering zone” of the valves as each of the valve arrangements is closeable/actuatable to eliminate fluid and its flow when closed, further eliminating air when closed/compressed.
Applicant further argues on the alleged grounds that Breidenthal teaches situations where air and liquid coexist in chambers, and that Breidenthal’s use of oil, as discussed above, to displace air allegedly shows air is present in the initial state.
Applicant’s arguments are not persuasive because while Breidenthal teaches embodiments incorporating air, Breidenthal also teaches minimization of air within the device, and even the use of an oil flow to eliminate air. Breidenthal’s teaching of air and liquid in addition to such elimination of air does not preclude Breidenthal’s anticipation of the instant Claim 1 as the embodiment discussing air elimination is relied upon herein and in the previous correspondence. Additionally, the claim recites that the metering zones are without air, not the chambers, and, as discussed above, the valves discussed by Breidenthal implicitly exist to seal/pinch off an opening, thereby eliminating both air and liquid from the metering zone comprising the valve.
Further, While Breidenthal does teach the use of oil to remove air, such an oil-filled device may represent the first operating state as in the instant claims, which only requires that the walls of the valve be closed. Additionally, as discussed above, such valves eliminate air from the valve metering zone when closed so as to prevent fluid flow and thereby exist without air commensurately as claimed as the valves are normally closed and opened when fluid is ready to be actuated.
Thus, Examiner maintains the rejection of Claim 1 under 35 USC 102 as being anticipated by Breidenthal.
Applicant further alleges that the additional prior art of Xu and/or Devaraju fail to cure the alleged deficiencies of Breidenthal discussed above. However, as discussed above, no such deficiencies exist in Breidenthal, thereby rendering Applicant’s assertion over Xu and/or Devaraju moot.
New Claims
New Claims 16-17 are rejected under 35 USC 103 as being anticipated by Breidenthal. And New Claim 18 is rejected under 35 USC 103 as being unpatentable over Breidenthal.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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