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 Amendment
The Amendment filed on 11/5/2025 has been entered. Claims 1-15 remain pending in the application.
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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2014/0113324, hereinafter Di Carlo in view of WO 2020/013903, hereinafter Simpson.
Regarding claim 1, Di Carlo teaches a method (paragraph [0059]), comprising: flowing a biologic sample containing a plurality of cells along a first fluidic channel (paragraph [0059]) and into an intersection between the first fluidic channel and a second fluidic channel of a microfluidic device (paragraph [0059]); introducing a pressure field having a plurality of different pressure zones at the intersection and into the first fluidic channel via the second fluidic channel (paragraph [0059], based upon fluid dynamics, the pressure near the walls of the second fluidic will be different from the pressure in the middle of the channel, thereby leading to a plurality of different zones); and measuring deformability of a cell among the plurality of cells responsive to the introduction of the pressure field (figure 9B and paragraph [0099]).
Di Carlo fails to teach a plurality of apertures in a channel wall disposed in the intersection.
Simpson teaches a microfluidic device with filter right before the sheath fluid enter the channel (Simpson, figure 7A and paragraph [0039]) so as to filter contaminants out of the fluid flow (Simpson, paragraph [0039]).
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 filter (a plurality of apertures) right before the sheath fluid enters the channel (thereby forming a channel wall in the intersection) because it would filter contaminants out of the fluid flow (Simpson, paragraph [0039]). Regarding the limitation that the plurality of apertures segments the pressure field into the plurality of different pressure zones, as described above the pressure across the channel will be different and therefore the apertures of the filter would divide the flow which is considered to be divided into a plurality of different pressure zones.
Regarding claim 2, Di Carlo teaches wherein introducing the pressure field includes generating a cross-directional flow to the flow of the biologic sample through the first fluidic channel (figure 9A and paragraph [0059]).
Regarding claim 3, Di Carlo teaches wherein the intersection includes a cell probing chamber (figure 9A), and the method further comprises: detecting the cell of the biologic sample in the cell probing chamber (paragraph [0099]); and isolating the cell in the intersection by reducing the flow of the biologic sample through the first fluidic channel (paragraph [0061]).
Regarding claim 4, Di Carlo teaches further comprising imaging the cell while the pressure field causes deformation of the cell via an imaging system and measuring the deformability of the cell based on image data received from the imaging system (figure 9A and paragraph [0099]).
Regarding claim 5, Di Carlo teaches wherein flowing the biologic sample includes flowing the biologic sample in a first direction along the first fluidic channel via a first fluidic pump (paragraph [0051]), and introducing the pressure field in a second direction that crosses the first direction via a second fluidic pump (paragraph [0051]).
Di Carlo fails to specifically teach reducing the flow in the first direction in response to the cell being located in the intersection.
Di Carlo further teaches the forces used to deform the particles can be generated by modulating flow parameters of any one or more of the first flow, the first opposing flow, and the second opposing flow (paragraph [0061]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have reduced the flow in the first direction in response to the cell being located in the intersection because it would allow for modulating the flow parameters and thereby the amount/type of deformation (paragraph [0061]).
Regarding claim 6, Di Carlo teaches further comprising sensing entry of the cell into the intersection via a signal received from a sensor disposed proximate to the intersection (paragraph [0099]).
Regarding claim 7, modified Di Carlo teaches wherein introducing the pressure field includes driving a flow of fluid along the second fluidic channel and toward the channel wall via the pressure field (paragraph [0059]), and segmenting the flow of the fluid into different pressures zones in the intersection via the plurality of apertures in the channel wall (the filter as added by Simpson would segment the flow into different pressure zones).
Response to Arguments
Applicant's arguments filed 11/5/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the references of Di Carlo nor Simpson introduce the pressure field having multiple different pressure zones into an intersection of two fluidic channels is not found persuasive. As described above, Di Carlo described applying a pressure by flow the sheath fluid through a channel. As is known by fluid dynamics, the pressure across the channel would vary based upon the location in the cross-section of the channel. Therefore, the pressure in the channel would vary across the channel. Adding the filter with apertures of Simpson to the device of Di Carlo, the apertures would divide the fluid into a number of different zones. As the pressure across the channel varies the apertures would therefore device the fluid into different pressure zones, thereby reading on the instant limitations.
The fact that apertures in Simpson serve an entirely different purpose of filtration, doesn’t change the fact that the filter with apertures would divide the fluid up into zones and therefore pressures thereby reading on the instant claims.
In response to applicant's argument that the apertures are added for a different reason, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See MPEP § 2145 (II).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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.
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