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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/02/2026 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
1. Claims 20-27, 30, 33-39 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent No. WO2006/076461 to Raman in view of U.S. Patent Application Publication No. 2019/0039042 to Toso et al.
Raman teaches A filtration unit (figures 1A and 3) for separating at least one analyte from a fluid sample (page 1, lines 10-21). The filtration unit includes: an inlet configured to receive the fluid sample (12, figures 1A and 1C; page 7, lines 10-11) and an outlet configured to receive the at least one analyte (52, figures 1A and 1C; page 7, lines 10-11); and a fluid pathway providing fluid communication between the inlet and the outlet (32+50, figures 1A and 1C). The fluid pathway has a longitudinal axis along which the fluid sample flows (axis extending from the inlet 14 to the outlet 52, figure 1A).
A filter is located in the fluid pathway (46, figure 1A; page 8, line 15). At least one surface of the filter is configured to allow the passage of the at least one analyte (page 8, lines 15-19; page 9, lines 11-14). The at least one surface of the filter is substantially transverse to the longitudinal axis of the fluid pathway as shows in Fig. 1A).
An impeller is located adjacent to the filter (40, figures 1A and 2A; page 9, line 30 - page 10, line 21). The impeller is configured to generate tangential fluid flow in the vicinity of the filter (figures 1A and 2A; page 9, line 30 - page 10, line 21; page 10, lines 20-21 of the present application).
The impeller includes a rotatable shaft (42, figures 1A and 2A; page 10, lines 12-13) coupled to at least one blade (44, figures 1A and 2A; page 10, lines 12-13) having a rounded leading edge (figure 2A; page 10, lines 17-19) In this regard, Raman teaches that the impeller can be rotated by a motor which inherently would require a rotating shaft (page 4, lines 1-4). Although Raman does not specify the direction of rotation of the impeller, both edges are rounded, so that the leading edge is necessarily rounded regardless of the rotation being clockwise or counterclockwise.
In Raman each blade comprises at least two opposing faces connected by an edge which is continuous and runs around the entire outer perimeter of the blade. An annotated Fig. 2A of Raman is provided as follows:
[AltContent: textbox (Edge which is continuous and runs around entire outer perimeter of blade)]
[AltContent: arrow][AltContent: textbox (Opposing face)]
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Raman does not teach that the edge of each blade is rounded or filleted such that the edge smoothly connects the opposing faces.
Toso et al. teaches and impeller having at least two blades [0012]
Toso et al. teaches that “[t]he blades 440 can have rounded edges 449 as shown in FIG. 4C, which helps to prevent bead breakage. [0048]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify the impeller or Raman and configured the edges of the blades to have rounded edges as taught by Toso et al. to prevent breaking of particles into smaller sizes that could block or clog the filter/filtration media.
As for the newly added limitation to claim 20 which recites that the impeller is spaced apart from the filter such that the minimum distance between any portion of each blade and the filter is at least 0.5 mm, it would have been obvious to one of ordinary skill in the art to modify Raman to space the impeller blades and any desired distance from the surface of the filter/filtration media, including 0.5 mm above the surface of the filter/filtration media depending on the size of the particles that are to be processed/filtered.
Amending the preamble of claim 1 to recite a filtration unit for separating at “least one analyte from a biological fluid sample” does not incorporate any structural limitation to the filtration unit that, after the preamble, recites “the filtration unit comprising:”
I.) Regarding applicant’s claim 20, as noted above Raman in view of Toso et al. renders all the limitations of claim 20 obvious.
Therefore, Raman in view of Toso et al. renders claim 20 obvious.
II.) Regarding applicant’s claim 21, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 21 depends.
Claim 21 recites that the impeller comprises a plurality of blades each having a rounded or filleted edge.
As noted above, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify the impeller or Raman and configured the edges of the blades to have rounded edges as taught by Toso et al. to prevent breaking of particles into smaller sizes that could block or clog the filter/filtration media.
Therefore, Raman in view of Toso et al. renders claim 21 obvious.
III.) Regarding applicant’s claim 22, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 22 depends.
Claim 22 recites that the rotatable shaft is circular in cross section.
As shown in Fig. 2A of Raman, the rotatable shaft 42 has a circular cross section.
Therefore, Raman in view of Toso et al. renders claim 22 obvious.
IV.) Regarding applicant’s claim 23, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 23 depends.
Claim 23 recites that the impeller is located between the inlet and the filter.
As shown in Fig. 1A of Raman, the impeller 40 is located between the inlet 12 and filter 46.
Therefore, Raman in view of Toso et al. renders claim 23 obvious.
V.) Regarding applicant’s claim 24, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 24 depends.
Claim 24 recites that the impeller is spaced apart from the filter.
Raman teaches that the blades of the impeller “pass over” the top surface of the filter. (page 10, lines 8-10)
Therefore, Raman in view of Toso et al. renders claim 24 obvious.
VI.) Regarding applicant’s claim 25, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 25 depends.
Claim 25 recites that the filter is replaceable.
Since the filter had to be provided when assembling the filtration unit of Raman, the filter can be replaced by disassembling and reassembling the filtration unit.
Therefore, Raman in view of Toso et al. renders claim 25 obvious.
VII.) Regarding applicant’s claim 26, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 26 depends.
Claim 26 recites that the at least one surface of the filter is substantially perpendicular to the longitudinal axis of the fluid pathway.
As shown in Fig. 1A of Raman, the at least one surface of the filter is substantially perpendicular to the longitudinal axis of the fluid pathway.
Therefore, Raman in view of Toso et al. renders claim 26 obvious.
VIII.) Regarding applicant’s claim 27, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 27 depends.
Claim 27 recites that wherein the at least one surface of the filter comprises a plurality of pores sized between 1 nm and 10 pm.
Raman in view of Toso et al. does not teach the pore size of the filter.
It would have been obvious to one of ordinary skill in the art to provide Raman in view of Toso et al. with a filter with a pore size suitable for filtering desired biological and chemical materials, including a pore size of 1 nm to 10 nm.
Therefore, Raman in view of Toso et al. renders claim 27 obvious.
IX.) Regarding applicant’s claim 30, as noted above Raman anticipates claim 20 from which claim 30 depends.
Claim 30 recites that the filtration unit is configured to maintain a fluid flow rate through the filter of 20 - 30 ml per hour.
Raman in view of Toso et al. does not teach that the filtration unit is configured to maintain a fluid flow rate through the filter of 20 - 30 ml per hour.
It would have been obvious to modify Raman in view of Toso et al. to be configured to maintain any desired fluid flow rate through the filter, including a flow rate of 20 - 30 ml per hour to achieve a desired filtration time for a given amount of material.
Therefore, Raman in view of Toso et al. renders claim 30 obvious.
X.) Regarding applicant’s claim 33, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 33 depends.
Claim 33 recites that the impeller is replaceable.
Since the impeller had to be provided when assembling the filtration unit of Raman, the impeller can be replaced by disassembling and reassembling the filtration unit.
Therefore, Raman in view of Toso et al. renders claim 33 obvious.
XI.) Regarding applicant’s claim 34, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 34 depends.
Claim 34 recites that the filtration unit further comprises a stepper motor operably connected to the impeller shaft and wherein the stepper motor is configured to rotate the impeller shaft at 250-450 RPM, in use.
Raman in view of Toso et al. teaches the use of a motor to rotate the impeller, but does not teach the type of motor or the rotation speed of the impeller shaft.
It would have been obvious to one of ordinary skill in the art to use and suitable motor in Raman in view of Toso et al., including a stepper motor and to rotate the impeller any speed for a desired flow rate, including a rotation speed of 250-450 RPM.
Therefore, Raman in view of Toso et al. renders claim 34 obvious.
XII.) Regarding applicant’s claim 35, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 35 depends.
Claim 35 recites that the fluid sample comprises between 100-108 particles/ml of the analyte.
The fluid sample does not incorporate and structural limitations to the claimed filtration unit and therefore is not afforded patentable weight or consideration.
Therefore, Raman in view of Toso et al. renders claim 35 obvious via claim 20.
XIII.) Regarding applicant’s claim 36, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 36 depends.
Claim 36 recites that the analyte is a protein.
The analyte sample does not incorporate and structural limitations to the claimed filtration unit and therefore is not afforded patentable weight or consideration.
Therefore, Raman in view of Toso et al. renders claim 36 obvious via claim 20.
XIV.) Regarding applicant’s claim 37, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 37 depends.
Claim 37 recites that the fluid sample is biological matter.
The fluid sample does not incorporate and structural limitations to the claimed filtration unit and therefore is not afforded patentable weight or consideration.
Therefore, Raman in view of Toso et al. renders claim 37 obvious via claim 20.
XV.) Regarding applicant’s claim 38, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 38 depends.
Claim 38 recites that the fluid pathway is sized to accommodate up to 30 ml of the fluid sample.
Raman in view of Toso et al. does not teach that the fluid pathway is sized to accommodate up to 30 ml of the fluid sample.
It would have been obvious to one of ordinary skill in the art to scale the filtration unit of Raman in view of Toso et al. to accommodate any volume of fluid in the fluid pathway, including up to 30 ml, since changes in size are not patentable when they do not perform differently. (MPEP 2144.04(IV)(A))
Therefore, Raman in view of Toso et al. renders claim 38 obvious.
XVI.) Regarding applicant’s claim 39, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 39 depends.
Claim 39 recites that at least one blade is substantially planar.
As shown in Fig. 2A of Raman, the blades are planar in reference to a horizontal direction.
Therefore, Raman in view of Toso et al. renders claim 39 obvious.
XVII.) Regarding applicant’s claim 41, as noted above Raman in view of Toso et al. renders claim 20 obvious from which claim 41 depends.
Claim 41 recites that the analyte is cell-free DNA.
The type of analyte does not incorporate and structural limitations to the claimed filtration unit and therefore is not afforded patentable weight or consideration.
Therefore, Raman in view of Toso et al. renders claim 41 obvious via claim 20.
Response to Arguments
Applicant’s arguments with respect to claims 20-23, 25-27, 33-39 and 41 have been considered but are moot because the new ground of rejection that relies upon Toso et al as teaching an impeller with rounded edges as necessitated by applicant’s amendments to the claims.
In response to applicant’s argument that Raman does not explicitly disclose impeller blades which are spaced apart from the filter and does not anticipate the required minimum spacing of 0.5 mm, Raman teaches that filters, filtration devices, and filtration methods are commonly used in a wide range of biological and chemical applications (Background of the Invention), which renders it obvious to obvious to one of ordinary skill in the art to modify Raman to space the impeller blades and any desired distance from the surface of the filter/filtration media, including 0.5 mm above the surface of the filter/filtration media depending on the size of the particles that are to be processed/filtered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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