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 .
Priority
Applicant’s claim for the benefit of a prior-filed application (371 of PCT/US2021/043387, filed 28 July 2021, which has PRO 63/059,425, filed 31 July 2020) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 and 3-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over SCOTT et al. (US 2014/0017151 A1) in view of YAMAGISHI et al. (Journal of Membrane Science, 105, 1995, pg. 249-259).
Regarding Claim 1, SCOTT discloses a sample preparation device that includes a reservoir 14, a column 18, a holder region with a filtration device 50, and an outlet which when assembled can be placed in a conventional centrifuge tube 70 for centrifugation (FIGs. 2-4, 6; abstract). Briefly, the device comprises generally cylindrical sample reservoir 14 in fluid communication with a column 18 (p0052; FIG. 4) that tapers downwardly and converges at stem 23 to the filtration device 50, which includes first and second membranes 12A and 12B arranged substantially vertically and ends in a collection tip 30 protruding outwardly from the bottom (p0017, p0053, p0057; FIG. 3). When assembled, reservoir 14 slots into filtration device 50, and the overall sample preparation device is housed in a conventional centrifuge tube 70 closeable with a cap 72 (p0063; FIGs. 2, 6). Suitable membranes 12A and 12B include ultraporous membranes for ultrafiltration and include polyethersulfone ultrafiltration membranes (p0058).
SCOTT is deficient in disclosing a coating on a portion of the semipermeable membrane exposed to the filtration chamber.
YAMAGISHI discloses synthetic membranes for purification of solutions and recognizes that these membranes are typically fouled with deposits and build-up of unwanted cells or other suspended particles (§1, par. 1). For polyethersulfone (PES) ultrafiltration membranes (§2.1, par. 1), YAMAGISHI suggests a solution whereby 2-hydroxyethyl methacrylate (HEMA) polymer (i.e., a non-animal-derived ultra-low attachment coating) is attached to the membranes (§1 par. 2) to yield PES membranes modified with HEMA (§2.2, par. 1). Advantageously, such modified membranes yielded improved performance, including higher permeation flux and showed reduced albumin adsorption on the modified membranes (§4, par. 1-2). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to provide HEMA coatings onto PES membranes as taught by YAMAGISHI for the PES membranes disclosed by SCOTT.
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The prior art is deficient in disclosing the coated ultrafiltration device recovers extracellular vesicles in the filtration chamber in an amount greater than a like ultrafiltration device that is uncoated. However, such a limitation is directed toward a material or article worked upon (i.e., extracellular vesicles) by the claimed device and a manner or method by which the claimed device is used (i.e., for extracellular vesicle recovery). The inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935); MPEP §2115). The manner or method in which an apparatus is to be utilized is not subject to the issue of patentability of the apparatus itself (In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); MPEP §2115).
Regarding Claim 3, modified SCOTT makes obvious the device of Claim 1. As shown in the figures, the disclosed sample preparation device comprises a cylindrical tube shape (see reservoir 14, filtration device 50 sections).
Regarding Claim 4, modified SCOTT makes obvious the device of Claim 3. As shown in FIGs. 2 and 3, the bottom of the filtration device 50 comprises a collection tip 30 having a conical shape (i.e., a conical bottom).
Regarding Claim 5, modified SCOTT makes obvious the device of Claim 1. As shown in FIG. 3, the filtration device 50 has a conical shape, tapering towards the bottom, and comprises a collection tip 30 at the bottom (i.e., a closed bottom end), a sample reservoir 11 open to the top (i.e., an open top end opposite the bottom end), and sidewalls containing membranes 12A and 12B (i.e., a sidewall disposed between the bottom end and top end to form the conically shaped filtration chamber; p0057; FIG. 3).
Regarding Claim 6, modified SCOTT makes obvious the device of Claim 5. As shown in FIG. 2, the reservoir 12 segment of the sample preparation device slots into the sample reservoir 11 of the filtration device 50 (i.e., wherein the open top end is disposed at a bottom end of the upper chamber and is in communication with the upper chamber; p0056; FIG. 2).
Regarding Claim 7, modified SCOTT makes obvious the device of Claim 5. As noted earlier, the filtration device 50 includes a housing having two substantially vertically oriented membranes in the sample reservoir 11 (i.e., wherein the semipermeable membrane disposed substantially vertically around the filtration chamber forms at least a portion of the sidewall of the filtration chamber; p0017).
Regarding Claim 8, modified SCOTT makes obvious the device of Claim 1. SCOTT further discloses the membranes 12A and 12B are polyethersulfone ultrafiltration membranes (i.e., wherein the semipermeable membrane comprises a polyethersulfone membrane; p0058).
Regarding Claim 9, modified SCOTT makes obvious the device of Claim 1. As noted earlier, the filtration device 50 includes a housing having two substantially vertically oriented membranes in the sample reservoir 11 (i.e., wherein the semipermeable membrane comprises two membrane portions disposed substantially vertically around the filtration chamber; p0017).
Regarding Claims 10 and 11, modified SCOTT makes obvious the device of Claim 1. The instant limitations “wherein the device is suitable for storage at room temperature prior to use” (Claim 10) and “wherein the device is stored at a temperature of about 4°C prior to use” (Claim 11) are directed toward intended uses of the claimed device. If a prior art structure is capable of performing the intended use as recited, then it meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Regarding Claim 12, modified SCOTT makes obvious the device of Claim 1. As shown in FIG. 6, a cap 72 is screwed onto the top of the assembled device in the centrifuge tube 70 (i.e., wherein the device comprises a cap to seal the upper chamber; p0063).
Regarding Claim 13, modified SCOTT makes obvious the device of Claim 1. The limitations requiring an upper portion and a lower portion wherein the upper portion of the device comprises the upper chamber, filtration chamber, and semipermeable membrane, and wherein the lower portion comprises the lower portion are considered arbitrary designations and do no more to further limit the claimed invention other than to provide additional definitions/groupings already considered in the rejection of Claim 1.
Regarding Claim 14, modified SCOTT makes obvious the device of Claim 13. As shown in FIGs. 2, 5, and 7-9, the separate components of the device are separable (i.e., wherein the upper portion is releasably connected to the lower portion).
Regarding Claim 15, modified SCOTT makes obvious the device of Claim 1. SCOTT discloses the use of the device for separating/purifying proteins for biomedical use (e.g., Examples); such uses require sterile equipment and environment (i.e., wherein the device is sterile).
Regarding Claim 16, modified SCOTT makes obvious the device of Claim 1. As shown in FIG. 6, the device is seated into a conventional centrifuge tube (i.e., wherein the ultrafiltration device is shaped to be received in a centrifuge; FIG. 6, p0063).
Regarding Claims 17-19, modified SCOTT makes obvious the device of Claim 1. As is well-known to one of ordinary skill in the art, conventional centrifuge tubes have 1-1.5 mL, 15 mL, and 50 mL capacities; because SCOTT teaches that the disclosed device can be seated in a conventional centrifuge tube, such instant limitations are met (i.e., wherein the device comprises a 1 mL centrifuge tube (Claim 17); wherein the device comprises a 15 mL centrifuge tube (Claim 18); wherein the device comprises a 50 mL centrifuge tube (Claim 19); p0063). While SCOTT is deficient in explicitly disclosing a 500 µL filtration chamber capacity, a 6 mL filtration chamber capacity, or a 20 mL filtration chamber capacity, SCOTT does disclose exemplary volumes of 3 mL and 11 mL (p0052). The only difference between the prior art and the claimed invention is a recitation of the relative dimensions of the devices. Because the claimed invention would not perform differently than that of modified SCOTT, the claimed invention is not patentably distinct (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP §2144.04). As such, the claimed filtration chamber capacities would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Regarding Claim 20, modified SCOTT makes obvious the device of Claim 1. YAMAGISHI further discloses nominal molecular weight cut-offs of PES membranes of 50 KDa (i.e., wherein the semipermeable membrane comprises a molecular weight cut-off… 50,000 MWCO; §2.1, par. 1).
Response to Amendments/Arguments
Applicant’s amendments filed 05 August 2025 have been fully considered.
Amendments to Claim 14 have addressed the Claim Objection; this Claim Objection has been withdrawn.
Amendments and arguments to Claim 1 with respect to the rejections of Claim(s) 1-20 under 35 U.S.C. 103 as being unpatentable over SCOTT et al. (US 2014/0017151 A1) in view of YAMAGISHI et al. (Journal of Membrane Science, 105, 1995, pg. 249-259) have been fully considered but are not persuasive.
Applicant argues that as-amended Claim 1 now requires “a coated ultrafiltration device comprising… a non-animal derived ultra-low attachment coating” and that the device “recovers extracellular vesicles in the filtration chamber in an amount greater than a like ultrafiltration device that is uncoated” which are not taught by or suggested by SCOTT or YAMAGISHI (pg. 6-7).
The Examiner respectfully disagrees.
YAMAGISHI explicitly discloses the use of a 2-hydroxyethyl methacrylate (HEMA) polymer (i.e., a non-animal-derived ultra-low attachment coating) coating attached to membranes (§1 par. 2). The limitation requiring that the claimed device “recovers extracellular vesicles in the filtration chamber in an amount greater than a like ultrafiltration device that is uncoated” is directed to a material or article worked upon (i.e., extracellular vesicles) by the claimed device and a manner or method by which the claimed device is used (i.e., for extracellular vesicle recovery). The inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935); MPEP §2115). The manner or method in which an apparatus is to be utilized is not subject to the issue of patentability of the apparatus itself (In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); MPEP §2115).
All other arguments have been indirectly addressed.
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 RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vickie Kim can be reached at (571)272-0579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan B Huang/Primary Examiner, Art Unit 1777