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 .
Claim Rejections - 35 USC § 103
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 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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2015/0136604, hereinafter Nielsen in view of United States Application Publication No. 2014/0255275, hereinafter Barry.
Regarding claim 1, Nielsen teaches a microfluidic cassette (item 3100) comprising: a microfluidic cassette body (figures 31 and 32), the microfluidic cassette body comprising: a fluid flow channel (item 3109); a first piercing member (one of item 3111a) comprising a wall extending out from the microfluidic cassette body (figure 9), the wall enclosing a first fluid aperture (figure 9, opening) that is in fluid communication with the fluid flow channel (figure 32); and a second piercing member (another one of item 3111a) comprising a wall extending out from the microfluidic cassette body (figure 9) and adjacent to the first piercing member (figure 32), the wall enclosing a second fluid aperture (figure 9, opening) that is in fluid communication with the fluid flow channel (figure 32).
Nielsen fails to teach the first piercing member comprises a further fluid aperture located on a portion of the wall of the first piercing member facing away from the second piercing member.
Barry teaches a liquid packaging system which has a puncturing element which has a fluid aperture located on a portion of the wall of the first piercing member (Barry, paragraph [0084] and figure 7A, the single split) to make the increase the sharpness of the piercing member (Barry, paragraph [0084]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a further fluid aperture located on the wall of each of the piercing members which face away from each other because it would increase the sharpness of the piercing member (Barry, paragraph [0084]).
Regarding claim 2, modified Nielsen teaches the further fluid aperture is a slot in the wall of the first piercing member (Barry, figure 7A).
Regarding claim 3, modified Nielsen teaches the slot extends through the wall in a direction from a distal end of the wall towards a proximal end of the wall (Barry, figure 7A).
Regarding claim 4, modified Nielsen teaches the slot is substantially V-shaped and decreases in width in a direction from the distal end of the wall towards the proximal end of the wall (Barry, figure 7A).
Regarding claim 5, modified Nielsen teaches the further fluid aperture is located on the wall at or close to a portion of the wall that extends furthest from the microfluidic cassette body (Barry, figure 7A).
Regarding claim 6, Nielsen teaches wherein one or both of the wall of the first piercing member and the wall of the second piercing member are substantially annular (figure 9).
Regarding claim 7, Nielsen teaches one or both of a distal end of the wall of the first piercing member and a distal end of the wall of the second piercing member are substantially sloped (figure 9).
Regarding claim 8, Nielsen teaches an insert comprising a reagent-containing chamber (items 3102-2105), wherein the reagent-containing chamber comprises a seal (item 3113) pierceable by the first and second piercing members (paragraph [0138]).
Regarding claim 9, Nielsen teaches the insert is secured within the microfluidic cassette body (paragraph [0137]) and is movable from a first position within the microfluidic cassette body where the seal of the reagent-containing chamber is not in contact with the first and second piercing members to a second position within the microfluidic cassette body where the seal is in contact with the first and second piercing members (paragraph [0137]).
Regarding claim 10, Nielsen teaches he microfluidic cassette body further comprises an outer wall (item 3107) enclosing the first and second piercing members (figure 32), the outer wall shaped to guide movement of the insert between the first position and the second position (paragraph [0136]).
Regarding claim 11, Nielsen teaches a cover element (item 3112) arranged to provide a sealed chamber enclosing the first and second piercing members and the insert (paragraph [0138]).
Regarding claim 12, Nielsen teaches the insert is secured to an inner surface of the cover element (figure 32).
Regarding claim 13, Nielsen teaches wherein the second piercing member comprises a further fluid aperture located on a portion of the wall of the second piercing member facing away from the first piercing member (see supra).
Regarding claim 14, Nielsen teaches a microfluidic diagnostic system (abstract) comprising: a microfluidic cassette according claim 1 (see supra); and a microfluidic diagnostic device (item 100) adapted to receive the microfluidic cassette (figure 1-3), the microfluidic diagnostic device comprising one or more actuators (paragraph [0102], cam driven clamping system) adapted to break a seal of a reagent-containing chamber of an insert of the microfluidic cassette (paragraph [0102]).
Response to Arguments
Applicant's arguments filed 5/1/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the piercing member in Barry because it functions as a mechanical piercing structure but does not enclose a fluid aperture in fluid communication with a fluid flow channel of the cassette. Barry is not being utilized for the teaching for a first fluid aperture that is in fluid communication with the fluid flow channel. Rather the reference of Nielsen is being utilized for this teaching which does have one fluid aperture that is in fluid communication with the fluid flow channel. The reference of Barry is being utilized for teaching the further fluid aperture that is recited in claim 1. The further fluid aperture as recited in claim 1 is not specified that it is in fluid communication with a fluid flow channel, but instead only states that the wall of the first piercing member has a further fluid aperture. The fact that the first fluid aperture recited in the claim is in fluid communication with the fluid flow channel, does not make the further fluid aperture also in fluid communication with the fluid flow channel.
Regarding applicant’s argument that the Barry does not teach that the slit is located on a portion of the wall of the first piercing member facing away from the second piercing member is not found persuasive. If one were to add the slit as taught by Barry into the first piercing structure of Nielson, there would at least be a portion of the slit which is facing away from the second piercing member. The claim does not specify how the further fluid aperture is facing away from the second piercing member and if the slit by Barry is added to Nielson, at least a portion of the slit would be facing away as the slit goes through the entire piercing member. Therefore, no matter what orientation the slit is added, there would always be a portion which is facing away from the second piercing member.
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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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