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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 01 December 2025.
Claims 1-15 are pending.
Claims 8-15 are withdrawn.
No claims are cancelled.
No claims are newly added.
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 “direct” connection of the fluid inlet between the metering member, and the second container, as in Claim 2, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Herein, the instant drawings appear to show each metering member as connected to the first/second containers through a short microfluidic channel, as opposed to a “directly” connected inlet arrangement.
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 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, and 6-7 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, 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...”),
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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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 2 is 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.
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
Examiner appreciates Applicant’s clarification regarding the drawings portrayal of the direct connection of the fluid inlets of the metering member and the first and second containers, as in Claim 2. Applicant paints to Fig. 5 as allegedly showing the recited architecture. However, the figures remain failing to show the direct connection of the inlets, wherein in Fig. 5, the second inlet 16b of the metering member 16 does not appear to be directly connected to the second container 11, instead being connected through an additional channel. As such, Examiner respectfully maintains the drawings objection over such “direct” connection architecture as being absent from the instant drawings.
35 USC 102 and 103
Applicant’s arguments are on the grounds Breidenthal allegedly fails to teach a first metering member for metering a specified volume of fluid and configured to change between open and closed operating states, as required by Claim 1. Applicant alleges that the chamber C26 cannot be the metering member because it is a mere processing chamber, and that Breidenthal teaches burstable seals not meeting the actuatable walls of the claim.
Applicant’s arguments are not persuasive because the annotated Breidenthal Fig. 1B above showing the first metering member does not indicate that the first metering member is the chamber C26, as alleged by Applicant, but rather the “openable connection” between chambers C26 and C28 as discussed by Breidenthal in para. [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.” Breidenthal’s teaching of an actuator satisfies the claim 1 requirements of actuatable walls of the valve switching between open and closed operating states as an actuator valve functions by depressing a flexible member into a flow path against an abutting wall, thereby being a two-walled arrangement. See also para. [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...”. As such, Breidenthal does not merely teach burst valves as Applicant alleges.
Applicant further asserts that Devaraju and Xu do not cure the above deficiencies as in Breidenthal.
As discussed above, there are no such deficiencies in Breidenthal and thus, Examiner respectfully maintains the rejection of Claim 1 under 35 USC 102(a)(1) as anticipated by Breidenthal, as well as dependents thereof under 35 USC 102 and 103 over at least Breidenthal and Devaraju, Xu as particularly discussed above and in the body of the action.
Conclusion
THIS ACTION IS MADE FINAL. 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 BENJAMIN JOSEPH KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (703)756-5501. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798