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 .
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive. On page 6 of the remarks, the Applicant specifically argues that Kurowski is not configured to move positions relative to the cassette body between Figure 6a and 6b.
In response to this argument, due to the Amendment to the claim where the insert body is no longer required to be a member of the microfluidic cassette body, this limitation is now taught by Chen et al. where the insert body is configured to be moved towards the one or more fixed piercing structures from a first position (the first component 300 is moved toward the fixed piercing structure by clamping force 355, see Figs. 2a and 3 and [0097]) where the seal is not in contact with the one or more structures to a second position where the seal is in contact with the one or more structures (the first component is moved from a first position where the fixed piercing members 350 are not in contact with seal 330, to a second position where contact is made, see Fig. 2b and 3 and [0097]).
The 103 rejection of claim 1 has been changed to a 102 rejection due the amendments made to the record, and an updated rejection appears on the record below.
On Page 7 of the Remarks, the Applicant also asserts that a person having ordinary skill in the art would have readily appreciated that the flexible layer 310 does not cover the first component 300 and the hollow lance-type connector 350.
In response to this argument, the Examiner respectfully disagrees. The connector 350 of Chen is covered explicitly by the deformable capping layer because the hollow connector 350 enters the fluid reservoir that the deformable capping layer covers, see Fig. 2b, [0096], where the sealant layer is chosen so as to form a leak-proof seal when penetrated by the lance, see [0072]).
Status of Objections and Rejections
All rejections from the previous office action are maintained.
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.
Claims 1-2, 7, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. US 2010/0304986).
Regarding claim 1, Chen et al. teaches a microfluidic cassette (cassette of Fig. 3, mislabeled as Fig. 4 in drawings, comprises microfluidic circuit 345, see [0018] & [0096]) comprising:
a microfluidic cassette body (second component 335, see Fig. 3) comprising at least one fluid flow channel (microfluidic circuit 345, see Fig. 3 and [0096]), and
an insert (first component 300) comprising an insert body (substrate 305 with layers enclosing the ends, see Fig. 3 and [0096]), the insert body comprising at least one chamber containing a reagent (pouch 315 contains liquid 320 (reagent), see Fig. 3 and [0096], liquid includes reagents, see [0064] and [0066]), the at least one chamber comprising a seal configured to prevent fluid from entering the at least one chamber (seal material 330 located at bottom of pouch 315 (chamber), see Fig. 4 and [0096]), wherein the seal is configured to be broken in situ in the microfluidic cassette body when a piercing force is applied to the seal, (the seal material 330 is pierced while in use, see [0096]), and
wherein the microfluidic cassette body and the at least one chamber are configured such that when the seal is broken, the reagent is exposed to fluid flow in the at least one fluid flow channel (when seal is penetrated by hollow lance-type connector 350, aperture 325 is fluidically coupled to microfluidic circuit 345, see [0096]),
the microfluidic cassette body further comprising one or more seal breaking mechanisms configured to break the seal, the one or more seal breaking mechanisms comprising one or more fixed piercing structures configured to pierce the seal in situ in the microfluidic cassette body (seal 330 is penetrated by hollow lance-type connector 350, see Fig. 3 and [0096]), where the insert body is configured to be moved towards the one or more fixed piercing structures from a first position (the first component 300 is moved toward the fixed piercing structure by clamping force 355, see Figs. 2a and 3 and [0097]) where the seal is not in contact with the one or more structures to a second position where the seal is in contact with the one or more structures (the first component is moved from a first position where the fixed piercing members 350 are not in contact with seal 330, to a second position where contact is made, see Fig. 2b and 3 and [0097]),
the microfluidic cassette body further comprising a cover (flexible layer 310) configured to provide a sealed chamber enclosing the one or more structures and the insert (flexible layer 310 provides a seal for the pouch 315 and connector 350, see Fig. 3 and [0096]- [0097]), wherein the insert body (substrate) is secured to an inner surface of the cover, and wherein the cover is resiliently deformable (the substrate is attached to flexible layer 310 where the layer 310 is deformable, see Fig. 2b-3, [0009], and [0096]- [0097]).
Regarding claim 2, Chen et al. teaches the microfluidic cassette of claim 1, further comprising a sealing layer on a surface of the microfluidic cassette body adjacent to the at least one chamber, the sealing layer configured to prevent fluid outside the microfluidic cassette body from contacting the microfluidic cassette body (flexible layer 310 or substrate 340, see Fig. 3 and [0096]).
Regarding claim 7, Chen teaches the microfluidic cassette of claim 6, wherein the one or more fixed piercing structures are adapted configured such that when the seal is pierced, a fluid flow channel through the chamber is formed, the fluid flow channel through the chamber being in fluid communication with the fluid flow channel of the microfluidic cassette body (when seal is penetrated by hollow lance-type connector 350, aperture 325 is fluidically coupled to microfluidic circuit 345, see [0096] in Chen).
Regarding claim 13, modified Chen et al. teaches the microfluidic cassette of claim 1, wherein the cover element is configured to hold the insert body in the first position and is configured to be resiliently deformed to move the insert body into the second position (flexible layer 310 holds at first position, see Fig. 2a, and is compressed (deformed) in a second position, see Fig. 2b-c in Chen).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 2010/0304986)
Regarding claim 8, Chen teaches the microfluidic cassette of claim 1, wherein the one or more fixed piercing structures comprises a first annular wall enclosing a first fluid aperture and a second annular wall enclosing a second fluid aperture, and wherein the first and second fluid apertures are in fluid communication with the fluid flow channel of the microfluidic cassette body (hollow lance-type connectors 350 connect pouches 315 to microfluidic circuit 345 (flow channel), see [0096] in Chen).
Chen teaches, in the embodiment shown in Fig. 3, that one or more pouches may be provided, see [0096]. However, the embodiment of Chen shown in Fig. 3 fails to teach additional hollow lance-type connectors and therefore fails to explicitly teach a second annular wall enclosing a second fluid aperture in fluid communication with the fluid flow channel as claimed.
A later embodiment of Chen et al. teaches additional pouches and hollow lance-type connectors, and therefore teaches a second annular wall enclosing a second fluid aperture in fluid communication with the fluid flow channel (hollow lance-type connectors are in communication with circuit 535, see Fig. 5 and [0100] in Chen).
It would have been prima facie obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have further modified the system of Chen to include the additional hollow lance-type connectors of the later embodiment because doing so would provide piercing elements for each additional pouch. Modified Chen would therefore meet the limitation of a second annular wall enclosing a second fluid aperture in fluid communication with the fluid flow channel as claimed because as shown in Fig. 5 of Chen, the additional lance connectors are connected to microfluidic circuit 535.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 2010/0304986) and further in view of Kurowski et al. (US 2011/0186466).
Regarding claim 14, modified Chen teaches the microfluidic cassette of claim 13, wherein the cassette body (335), but does not teach that the cassette comprises an outer wall enclosing the one or more structures, said outer wall shaped to guide movement of the insert body between the first and second position.
However, the analogous art of Kurowski et al. teaches an outer wall enclosing the one or more structures, said outer wall shaped to guide movement of the insert between the first and second position (intermediate wall 13 encloses separating wedge 25 (structure) and guides insert from full (first position, Fig. 6a) to emptying (second position, see Fig. 6b-c).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the second component (cassette body) of Chen to include the intermediate wall to enclose the piercing structure as shown by Kurowski for the benefit of providing a constriction for fluid to flow after the seal has been broken by the piercing structure (see [0088] in Kurowski). The modification of the second component of Chen to include the intermediate film of Kurowski would have had the reasonable expectation of successfully facilitating controlled actuation of the piercing structure for reagent introduction into a microfluidic system. Chen modified by Kurowski therefore meets the limitation of the cassette having an outer wall that encloses a structure because the structure would be enclosed by the intermediate film to pierce the insert of Chen.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2010/0304986) as applied to claim 8 above, and further in view of Barry et al. (US 2014/0255275).
Regarding claim 9, modified Chen teaches the microfluidic cassette of claim 8, comprising at least one of the first and second annular walls (hollow lance-type connectors of Chen), but previously modified Chen does not teach that the annular walls comprise a cut-out region around a part of a circumference of the at least one of the first and second annular walls.
However, in the analogous art of using burstable reagent storage on biological assays, Barry et al. teaches a piercing member (annular walls) with a cut out around the circumference of the at least one of the first and second annular walls, see Fig. 6C and [0084]- [0085].
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the annular wall of the hollow lance-type connector of modified Chen to include the cut-out of the piercing member, or annular wall, of Barry et al. for the benefit of enhancing the sharpness of the piercing member, or annular wall, see [0084] in Barry et al. Modified Chen would then meet the limitation of having the annular walls comprise a cut-out region around a part of the circumference of the wall as claimed because of the cut-out of Barry et al.
Claim 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2010/0304986) and further in view of Samper et al. (WO 2015/101539).
Regarding claim 15, Chen et al. teaches the microfluidic cassette of claim 1, wherein the seal is breakable in situ (the seal material 330 is pierced (breakable) while in use, see [0096]), but does not explicitly teach that the seal is further configured to be broken when exposed to a temperature substantially above atmospheric temperature.
However, in the analogous art of microfluidic devices containing reagent storage compartments, Samper teaches that the breakable septum (seal) may be broken mechanically using a spike or through various other methods such as laser stress or thermal stress (exposure to high temperatures), see [0031] in Samper et al.
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have substituted the seal material of Chen broken by the lance to be a seal material breakable under thermal stress as exemplified by Samper for the benefit of controlling the selective expose of reagents within a channel (see [0031] in Samper et al.) with a reasonable expectation of success of exposing the reagents in channel and simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP 2143 (B).
Regarding claim 16, Chen et al. teaches that the seal is breakable in situ (the seal material 330 is pierced (breakable) while in use, see [0096]) and wherein the microfluidic cassette comprises at least one pathway that allows light to pass through the microfluidic cassette and contact the seal (microfluidic cassette is made of glass, a transparent material, and therefore allows light to contact seal 330, see [0062]), but does not teach that the seal is further configured to be broken in situ when exposed to a directional beam of light.
However, in the analogous art of microfluidic devices containing reagent storage compartments, Samper teaches that the breakable septum (seal) may be broken mechanically using a spike or through various other methods such as laser stress or thermal stress (exposure to high temperatures), see [0031] in Samper et al, breakable septum (seal) is broken by laser (beam of light), see [0031]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have substituted the seal material of Chen et al. to be breakable by a beam of light, or laser, as exemplified by Samper et al. for the benefit of selectively exposing reagent to a channel due to thermal stress (see [0031] in Samper et al.) with a reasonable expectation of success of exposing the reagents in channel and simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP 2143 (B). Chen modified by Samper would therefore have the reasonable expectation of successfully facilitating the breaking of a seal in situ following exposing the seal material to a direct beam of light, or laser.
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.
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/A.N.M./
Examiner, Art Unit 1758
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758