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
Newly submitted claim 40 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 40 is directed to a process. Claims 20-27, 30 and 33-39 are directed to an apparatus for practicing the process. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus can be used to filter components other than plasma from whole blood as recited in claim 40.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 40 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
(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.
1. Claims 20-26, 33, 35-37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Patent No. WO2006/076461 to Raman (cited by applicant).
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);
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 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 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.
As to the newly added claim limitations that 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; and wherein the edge is rounded or filleted, 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)]
[AltContent: textbox (Opposing face face)][AltContent: arrow]
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As can be seen, the opposing faces are connected by an edge that is continuous and runs around the entire outer perimeter of the blades and is curved, i.e., rounded.
I.) Regarding applicant’s claim 20, as noted above Raman teaches all the limitations of claim 1.
Therefore, Raman anticipates claim 20.
II.) Regarding applicant’s claim 21, as noted above Raman anticipates claim 20 from which claim 21 depends.
Claim 21 recites that the impeller comprises a plurality of blades each having a rounded or filleted edge.
As shown in Fig. 2A all the blades of the impeller of Raman have round leading edges.
Therefore, Raman anticipates claim 21.
III.) Regarding applicant’s claim 22, as noted above Raman anticipates claim 20 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 anticipates claim 22
IV.) Regarding applicant’s claim 23, as noted above Raman anticipates claim 20 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 anticipates claim 23.
V.) Regarding applicant’s claim 24, as noted above Raman anticipates claim 20 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 anticipates claim 24.
VI.) Regarding applicant’s claim 25, as noted above Raman anticipates claim 20 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 anticipates claim 25.
VII.) Regarding applicant’s claim 26, as noted above Raman anticipates claim 20 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 anticipates claim 26.
VIII.) Regarding applicant’s claim 33, as noted above Raman anticipates claim 20 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 anticipates claim 33.
IX.) Regarding applicant’s claim 35, as noted above Raman anticipates claim 20 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 anticipates claim 35 via claim 20.
X.) Regarding applicant’s claim 36, as noted above Raman anticipates claim 20 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 anticipates claim 36 via claim 20.
XI.) Regarding applicant’s claim 37, as noted above Raman anticipates claim 20 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 anticipates claim 37 via claim 20.
XII.) Regarding applicant’s claim 39, as noted above Raman anticipates claim 20 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 renders claim 39 obvious.
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.
2. Claims 27, 30 34 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Raman.
I.) Regarding applicant’s claim 27, as noted above Raman anticipates claim 20 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 does not teach the pore size of the filter.
It would have been obvious to one of ordinary skill in the art to provide a filter with a pore size suitable for filtering desired analytes, including a pore size of 1 nm to 10 nm.
Therefore, Raman renders claim 27 obvious.
II.) 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 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 to be configured to maintain any desired fluid flow rate through the filter, including a flow rate of 20 - 30 ml per hour.
Therefore, Raman renders claim 30 obvious.
III.) Regarding applicant’s claim 34, as noted above Raman anticipates claim 20 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 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, 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 renders claim 34 obvious.
IV.) Regarding applicant’s claim 38, as noted above Raman anticipates claim 20 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 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 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))
Response to Arguments
Applicant's arguments filed 12/20/2025 have been fully considered but they are not persuasive.
Applicant argues that Figure 2A of Raman does not disclose at least one blade that has a rounded or filleted edge.
In response, the examiner respectfully disagrees. As shown in annotated Fig. 2A of Raman above, under broadest reasonable interpretation, the limitation “that 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; and wherein the edge is rounded or filleted,” is readable on Fig. 2A of Raman since the edges of the blades in Fig. 2A of Raman are curved. Under broadest reasonable interpretation, the plain meaning of a term refers to its customary meaning given by the ordinary artisan (see MPEP 2111.01). In this case, the term “rounded” merely refers to a curved shape (see https://www.merriam-webster.com/dictionary/rounded).
It is noted that the feature upon which applicant relies (i.e., the edge is filleted such that the edge smoothly connects the opposing faces) is not recited in claim 20. 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Design Patent No. D586836 to Cantrill et al. discloses an impeller that has blades that are chamfered in a manner similar to applicant’s blades.
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 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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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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