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 Group I in the reply filed on 8/26/2026 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)). Claims 25-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 6, 9, 10, 12 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2009/0029422, hereinafter Hanafusa.
Regarding claim 1, Hanafusa teaches an apparatus comprising: a body (item 35) having: a first wall (the wall of item 35 surrounding item 35g) defining a well (item 35g) having a port (the bottom opening of item 35j) and a distal end defining an opening (the top opening closed by item 35k) having an opening perimeter, and a second wall (the wall forming item 35i) surrounding the first wall (figure 4E) and having a distal end; a cover (item 35k) coupled to the distal end of the first wall and covering the opening along the opening perimeter at a connected portion and uncoupled from the distal end of the first wall along the opening perimeter at an unconnected portion (item 35h); and an impermeable barrier (item 41) coupled to the distal end of the second wall and covering the well, wherein the unconnected portion forms a vent that allows air flow out of the well (paragraph [0089] and [0094-[0096]).
Regarding claim 6, Hanafusa teaches the first wall has a height (the right side of the wall of item 35 as seen in figure 4E) and the second wall has a height (the right side of the wall of item 35i as seen in figure 4E) that is greater than the height of the first wall (figure 4E).
Regarding claim 9, Hanafusa teaches wherein the body comprises a plurality of wells (items 35, 37, 39 and 51) including the well (item 35), each of the plurality of wells having a corresponding opening and a port (figure 1B).
Regarding claim 10, Hanafusa teaches the body comprises a valve stator (item 63), a first stator port opening into the valve stator (the opening in item 63 on the left side, figure 1B), a second stator port (the opening in item 63 on the right side, figure 1B) opening into the valve stator, a first fluidic line fluidically coupling the first stator port and the port of one of the plurality of wells (the line connecting to item 35, figure 1B), and a second fluidic line fluidically coupling the second stator port and the port of another one of the plurality of wells (the line connecting to item 51, figure 1B).
Regarding claim 12, Hanafusa teaches the distal end of the first wall defines a notch (item 35h) and the unconnected portion is positioned between a portion of the distal end and the cover (figure 4E).
Regarding claim 19, Hanafusa teaches further comprising a third wall (the wall of item 37) defining a second well (item 37g) having a port (the bottom opening of item 37j) and a distal end defining an opening (the top opening closed by item 37k) having an opening perimeter, and a second cover (item 37k) coupled to the distal end of the third wall and covering the opening of the second well along the opening perimeter of the second well at a connected portion and uncoupled from the distal end of the third wall along the opening perimeter of the second well at an unconnected portion (item 37h) and wherein a fourth wall (the wall forming item 37i) surrounds the third wall (figure 5E).
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(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanafusa.
Regarding claim 2, Hanafusa teaches further comprising reagent contained within the well (paragraph [0192]).
Hanafusa fails to teach the reagent is a dried reagent in the well.
Hanafusa further teaches the reagent contained in the reactors 5 may be a dried reagent (paragraph [0196]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., using a dried reagent in the well), and that in combination, each element merely would have performed the same function as it did separately (i.e., acting as reagents), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine the reagent in the well of reference Hanafusa with the dried reagent of reference Hanafusa, since the result would have been predictable.
Regarding claim 4, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Hanafusa and the apparatus of Hanafusa is capable of having liquid flow into the well via the port and rehydrate the dried reagent. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Hanafusa (see MPEP §2114).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanafusa in view of United States Application Publication No. 2013/0240140, hereinafter Kurowski.
Regarding claim 8, Hanafusa teaches the body comprises a thermoplastic (paragraph [0079]), and wherein the impermeable barrier includes a foil which is sealed onto the thermoplastic (paragraph [0095]).
Hanafusa fails to teach the foil has a lacquer backing for bonding to the thermoplastic.
Kurowski teaches a film which is a heat-sealing film which is attached to the substrate via a lacquer (Kurowski, paragraph [0032]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., utilizing a lacquer to seal the foil to the thermoplastic), and that in combination, each element merely would have performed the same function as it did separately (i.e., sealing the well), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine the aluminum foil of reference Hanafusa with the lacquer sealing of reference Kurowski, since the result would have been predictable.
Claim(s) 13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanafusa in view of United States Application Publication No. 2015/0352552, hereinafter Levenberg.
Regarding claim 13, Hanafusa teaches all limitations of claim 1; however, Hanafusa fails to teach the unconnected portion comprises a first unconnected portion and a second unconnected portion, and wherein a first portion of the distal end of the first wall defines a first notch and the first unconnected portion is positioned between the first notch and the cover and wherein a second portion of the distal end of the first wall defines a second notch and the second unconnected portion is positioned between the second notch and the cover.
Levenberg teaches a microfluidic device which utilizes one, two or more vents in the chamber (Levenberg, paragraph [0106]) which allows for the control of the gas to escape while inhibiting flow of the sample fluid from the chamber into the secondary channel (Levenberg, paragraph [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum number of air drain spaces (vents) to a range of at least two which would allow the control of the gas to escape while inhibiting flow of the sample fluid from the chamber into the secondary channel (Levenberg, paragraph [0009]) (MPEP § 2144.05 (II)). In adding the at least second vent, there would be two unconnected portions with each unconnected portion formed by a notch in the first wall.
Regarding claim 15, Hanafusa teaches all limitations of claim 1; however, Hanafusa fails to teach portions of the distal end of the first wall define a plurality of notches, each notch having a notch length, the unconnected portions aligned with the plurality of notches, an unconnected length of each unconnected portion commensurate with the notch length of a corresponding notch.
Levenberg teaches a microfluidic device which utilizes one, two or more vents in the chamber (Levenberg, paragraph [0106]) which allows for the control of the gas to escape while inhibiting flow of the sample fluid from the chamber into the secondary channel (Levenberg, paragraph [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum number of air drain spaces (vents) to a range of at least two which would allow the control of the gas to escape while inhibiting flow of the sample fluid from the chamber into the secondary channel (Levenberg, paragraph [0009]) (MPEP § 2144.05 (II)). In adding the at least second vent, there would be two notches with each of the unconnected portions commensurate with the notch length of a corresponding notch.
Regarding claim 16, Hanafusa teaches all limitations of claim 1; however, Hanafusa fails to teach the connected portion comprises a plurality of connected portions between which the cover and the distal end of the first wall are coupled and the unconnected portion comprises a plurality of unconnected portions between which the cover and the distal end of the first wall are uncoupled.
Levenberg teaches a microfluidic device which utilizes one, two or more vents in the chamber (Levenberg, paragraph [0106]) which allows for the control of the gas to escape while inhibiting flow of the sample fluid from the chamber into the secondary channel (Levenberg, paragraph [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum number of air drain spaces (vents) to a range of at least two which would allow the control of the gas to escape while inhibiting flow of the sample fluid from the chamber into the secondary channel (Levenberg, paragraph [0009]) (MPEP § 2144.05 (II)). In adding the at least second vent, there would be a plurality of connected portions (at least two, corresponding to the number of air drain spaces) and a plurality of unconnected portions (at least two, corresponding to the number of air drain spaces).
Regarding claim 17, modified Hanafusa teaches at least one of the unconnected portions of the plurality of unconnected portions is positioned between two of the connected portions of the plurality of connected portions and wherein the plurality of connected portions comprise radial connected portions and the plurality of unconnected portions comprise radial unconnected portions (the air drain spaces have been added at different locations around the top of the first wall and therefore would have unconnected portions between two of the connected portion with each containing radial portions (see figure 4E).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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