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, 3, 4 and 6-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection previously set forth in the non-final Office Action mailed 9/11/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 4 and 6-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 6 recites “at least one void space” and line 8 recites “at least one void space,” the claim is therefore unclear if the at least one void space recited in line 8 is the same or different than the at least one void space recited in line 6. Claims 3, 4 and 6-20 are rejected by virtue of their dependence on a rejected base claim.
Claim 1, line 10 recites “the void space has a volume,” this recitation is unclear if this void space is referring to the void space recited in line 6 or line 8. Claims 3, 4 and 6-20 are rejected by virtue of their dependence on a rejected base claim.
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, 3, 4, 6-15, 17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2017/0138858, hereinafter Astier in view of United States Application Publication No. 2018/0266591, hereinafter Spero.
Regarding claim 1, Astier teaches a microfluidic cartridge (figure 5) for purifying target particles or target cells of a predetermined size from contaminants in a sample (intended use MPEP § 2114 (II)), the cartridge comprising a first (item 121) and a second planar (item 127) support the first and second planar support each having a top surface and a bottom surface (figure 5), wherein the top surface of the first planar support comprises at least one embedded channel (the opening where item 122 is) extending from one or more inlets to one or more outlets (paragraph [0017]); the at least one embedded channel comprising a plurality of obstacles (item 122), wherein the microfluidic cartridge comprises at least one void space (the gap between the top of item 122 and the bottom of item 127) configured to be deformed when assembling the first and second planar supports into the microfluidic cartridge (intended use MPEP § 2114 (II)) and wherein the void space has a volume of 10,000 cubic µm or less (paragraph [0017] discusses the processing of picoliter volumes and therefore the maximum total volume of the inside of the device would be on the picoliter range and therefore the portion above item 122 would have a volume of 10,000 cubic µm or less).
Astier fails to teach the bottom surface of the first and second planar support comprise at least one void space configured to be deformed when the bottom of the first planar support is pressed to the bottom of the second planar support.
Spero teaches a flow cell device in which the flow cell units are stacked and arranged in parallel so that any volumetric requirement of the flow cell can be met with a sufficient number of flow cell units (Spero, paragraph [0133]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have stacked the microfluidic cartridges of Astier so that they are stacked and arranged in parallel because it would allow for any volumetric requirement of the flow cell can be met with a sufficient number of flow cell units (Spero, paragraph [0133]). With the additional microfluidic cartridges, the bottom surface of each of the planar supports would have a void space as described in the claim.
If it is determined that Astier fails to teach the void space has a volume of 10,000 cubic µm or less, then Astier and Spero would fail to teach this limitation.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the void space have a volume of 10,000 cubic µm or less since the claimed ranges and the prior art ranges are close enough that one skilled in the art would have expected them to have the same properties, MPEP §2131.03 (III). Further, 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 void space volume to a range of 10,000 cubic µm or less which would allow for the desired amount of fluid in the device (MPEP § 2144.05 (II)).
Regarding claim 3, 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 Astier and Spero and the apparatus of modified Astier is capable of having the void space configured to prevent damage, displacement or deformation of the at least one embedded channel, the one or more inlets, the one or more outlets, the plurality of obstacles. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Astier (see MPEP §2114).
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 Astier and Spero and the apparatus of modified Astier is capable of having the void space configured to prevent damage, displacement or deformation of the plurality of obstacles. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Astier (see MPEP §2114).
Regarding claim 6, Astier teaches wherein the at least one void space comprises a total surface area that is at least about 90% of a total surface area of the at least one embedded of channel (figure 5).
Regarding claim 7, Astier teaches wherein the at least one void space comprises a total surface area that is at least about 100% of a total surface area of the at least one embedded channel (figure 5).
Regarding claim 8, Astier teaches wherein the at least one void space comprises a total surface area that is more than a total surface area of the at least one embedded channel (the total surface area of the channel is interpreted to be the surface area of the channel not including the area taken up by the obstacles which would make the void surface area more).
Astier further teaches that the diameter and spacing of the obstacles can be controlled and tailored to suit specific applications (paragraph [0012]).
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 diameter and spacing of the obstacles to a range so that the total surface area of the void space is at least 110% of the total surface area of the channel which would allow for the desired application for the obstacles (MPEP § 2144.05 (II)).
Regarding claim 9, Astier teaches wherein the at least one void space is separated into two or more void spaces positioned on the bottom surface of the first and/or second planar support opposite the array of obstacles (paragraph [0032], the array would divide the cartridge up and therefore also divide the void space).
Regarding claim 10, Astier teaches wherein the first and/or second planar support is fabricated from two layers of material bonded together (paragraph [0030]).
Regarding claim 11, Astier teaches further comprising an obstacle bonding layer (paragraph [0035] and figure 10, either the intrinsic Si or the N-doped Si) that is bonded to a surface of the planar support and bonded to a top surface of the plurality of obstacles (the top surface of the obstacle is considered the part of the obstacle adhered to the either the intrinsic Si or the N-doped Si) in the at least one embedded channel to prevent fluid or sample from flowing over the plurality of obstacles during operation of the cartridge (intended use MPEP § 2114 (II)).
Regarding claim 12, Astier teaches wherein the obstacle bonding layer comprises one or more passages fluidically connected to the one or more inlets of the at least one embedded channel which permits the flow of sample into the at least one embedded channel and one or more passages fluidically connected to the one or more outlets of the at least one embedded channel that permits the flow of fluid out from the one or more outlets (paragraph [0017] and figure 5).
Regarding claim 13, Astier teaches wherein the obstacles are positioned so as to define a critical size of the cartridge (figure 5) such that, when a sample is applied to an inlet of the cartridge and flows to an outlet, particles or cells in the sample larger than the critical size are separated from particles or cells in the sample smaller than the critical size (intended use MPEP § 2114 (II)).
Regarding claim 14, Astier teaches wherein the one or more outlets comprise at least one product outlet (paragraph [0017]) wherein the target particles or target cells that have a size larger than the critical size of the cartridge are directed to the at least one product outlet (intended use MPEP § 2114 (II)).
Regarding claim 15, Astier teaches wherein the one or more outlets comprise at least one waste outlet (paragraph [0017]), and the contaminants that have a size smaller than the critical size of the cartridge flow to the at least one waste outlet (intended use MPEP § 2114 (II)).
Regarding claim 17, Astier teaches wherein the plurality of obstacles have a circular or ellipsoid shape (figure 5).
Regarding claim 19, Astier teaches wherein the plurality of obstacles are elongated perpendicularly to the direction of fluid flow such that they have a horizontal length (P1) that is different from their vertical length (P2) (figure 5).
Regarding claim 20, Astier fails to teaches wherein P1 is about 10 µm to about 160 µm and P2 is about 5 µm to about 80 µm.
Astier further teaches that the size of the nanopillar changes what wavelength the nanopillars are able to detect (paragraph [0027]).
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 P1 and P2 to a range of 10 µm to about 160 µm and 5 µm to about 80 µm, respectively, which would allow for the desired wavelength to be detected by the nanopillars (MPEP § 2144.05 (II)).
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Astier and Spero as applied to claim 15 above, and further in view of United States Application Publication No. 2017/0248508, hereinafter Ward.
Regarding claim 16, Astier and Spero teach all limitations of claim 15; however, they fail to teach the plurality of obstacles have a diamond shape.
Ward teaches a cell purification device in which the obstacles have a diamond shape (Ward, paragraph [0118]).
Examiner further finds that the prior art contained a device/method/product (i.e., diamond shaped obstacles) which differed from the claimed device by the substitution of component(s) (i.e., round shaped obstacles) with other component(s) (i.e., diamond shaped obstacles), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., round with diamond shaped obstacles), and the results of the substitution (i.e., filtering/concentration the sample) would have been 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 substitute the round obstacles of reference Astier with the diamond obstacles of reference Ward, since the result would have been predictable.
Regarding claim 18, Astier and Spero teach all limitations of claim 15; however, they fail to teach the plurality of obstacles have a hexagonal shape.
Ward teaches a cell purification device in which the obstacles have a hexagonal shape (Ward, paragraph [0118]).
Examiner further finds that the prior art contained a device/method/product (i.e., hexagonal shaped obstacles) which differed from the claimed device by the substitution of component(s) (i.e., round shaped obstacles) with other component(s) (i.e., hexagonal shaped obstacles), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., round with hexagonal shaped obstacles), and the results of the substitution (i.e., filtering/concentration the sample) would have been 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 substitute the round obstacles of reference Astier with the hexagonal obstacles of reference Ward, since the result would have been predictable.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 11/5/2025, with respect to the rejection(s) of claim(s) 1 and 3-7 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Astier and Spero.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the void space is a “crumple zone”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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, Elizabeth Robinson can be reached at (571)272-7129. 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