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 .
Claim Rejections - 35 USC § 102
(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.
Claim(s) 1-4 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Corso et al., Reproducible and scalable purification of extracellular vesicles using combined bind-elute and size exclusion chromatography, Scientific Reports, Vol. 7 No 1. 2017. pages 1-10 (in IDS).
Regarding claim 1, Corso teaches a method for isolating and purifying extracellular vesicles from a solution containing the extracellular vesicles and unnecessary substances, the isolation and purification method being an adsorbent treatment method in which a solution containing the extracellular vesicles and unnecessary substances is brought into contact with an adsorbent to cause the adsorbent to adsorb and retain the unnecessary substances other than the extracellular vesicles, and the adsorbent being a porous granular material having a pore, an interior of the pore being positively charged, and the adsorbent being capable of adsorbing and retaining, in the interior of the pore, negatively charged unnecessary substances other than the extracellular vesicles (pages 1-2 and 7).
It is noted that Corso fails to explicitly teach the adsorbent being granular but state the form being beads. One skilled in the art would either find that beads would be a subset of granular, or it would have been obvious to provide a different 3D shape that also provides the desired pores and positively charged core, such as granules, with a reasonable expectation of success in doing so.
Regarding claims 2-3, Corso teaches that the solution being treated is a culture supernatant that includes myoblast C2C12, which would be considered at least a derivate or differentiate of mesenchymal stem cells.
Regarding claim 4, Corso teaches that the supernatant was passed through a column packed with the adsorbent.
Regarding claim 7, Corso teaches that the adsorbent is paired with membrane/filtration (page 2).
Regarding claim 8, Corso teaches that the adsorbent and membrane filtration are performed in series/alternatively (page 2).
Regarding claim 9, Corso teaches that the filtration is performed via hollow fibers (page 2).
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.
Claim(s) 5-6, 11-12, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corso et al., Reproducible and scalable purification of extracellular vesicles using combined bind-elute and size exclusion chromatography, Scientific Reports, Vol. 7 No 1. 2017. pages 1-10 (in IDS) in view of Dhelin et al. (US 6,899,863 in IDS) and Bisschops et al. (WO 2008/127087).
Regarding claim 5, Corso fails to teach using a plurality of adsorbents and that the supernatant is passed through the plurality of adsorbents a plurality of times. Dhelin teaches that it is known to use different material for binding/adsorbing in order to adsorb/bind certain contaminants within the solution (C5/L55-C6/L24). As such, one skilled in the art would have found it obvious to provide a plurality of adsorbents in order to remove specific contaminants from the supernatant.
In regards to passing the supernatant through the adsorbents a plurality of times, Bisschops teaches that it is known in adsorbent columns to provide said adsorbent columns in series thereby causing the supernatant to pass through the adsorbents multiple times while allowing for regeneration by removal of the bound compounds from adsorbents not being used while providing repetitive treatment via the columns in series (pages 12-14). As such, one skilled in the art would have it obvious to pass the supernatant through the adsorbent multiple times in order to allow for regeneration by removal of the bound compounds from adsorbents not being used while providing repetitive treatment via the adsorption columns in series.
Regarding claim 6, it is submitted that different adsorbents designed to remove different contaminants would have at least some of the properties cited in claim 6.
Regarding claim 11, Corso teaches a hollow fiber membrane is used with tangential flow and having a molecular weight cut off in the claimed range (page 2). Corso is silent on the inner diameter of the hollow fibers being within the range claimed. It is Examiner’s position that one skilled in the art would have found it obvious to use any size of hollow fiber that would provide the desired filtering benefit, which would include the broad range disclosed by Applicant.
Corso teaches that some of the filtration can occur prior to the adsorbent step and thus fails to teach the specific sequence claimed. Dhelin teaches that filtration steps can occur after adsorbing or binding in a column and that multiple filtration and absorbing steps can be used together (C5/L55-C6/L24). As such, one skilled in the art would have found it obvious to provide the adsorbent and filtration steps in the order claimed as such an order is considered in the art and one skilled in the art would have a reasonable expectation of success in doing so.
In regards to the step of repeating filtration through the membranes, see claim 5 above for providing the method steps in series in order to better treat/concentrate the sample.
It is noted that the prior art fail to teach the specific membrane surface velocity. It is noted that the limitation is directed to an operational parameter that would be controlled via the pressure provided to the membrane and the viscosity of the fluid being treated. As such, one skilled in the art would have found it obvious to optimize or control the flow in the system to be within the broad range claimed as it is merely finding workable ranges.
Regarding claim 12, Dhelin teaches that multiple filtration steps can be used with some of the filtration steps having pores size overlapping the claimed range.
Regarding claims 15-16, the claims are directed to an effect of performing the method. It is submitted that one skilled in the art would find that treating the same/similar fluid with the same treatment steps would result in the same, claimed effects, especially in view of providing multiple treatment steps in series.
Regarding claim 17, it is submitted that the hollow fiber membranes are provided in housings having multiple inlet/outlet ports.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corso et al., Reproducible and scalable purification of extracellular vesicles using combined bind-elute and size exclusion chromatography, Scientific Reports, Vol. 7 No 1. 2017. pages 1-10.
Regarding claim 10, Corso teaches a hollow fiber membrane is used with tangential flow and having a molecular weight cut off in the claimed range (page 2). Corso is silent on the inner diameter of the hollow fibers being within the range claimed. It is Examiner’s position that one skilled in the art would have found it obvious to use any size of hollow fiber that would provide the desired filtering benefit, which would include the broad range disclosed by Applicant.
Allowable Subject Matter
Claims 13-14 and 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER KEYWORTH whose telephone number is (571)270-3479. The examiner can normally be reached 9-5 MT (11-7 ET).
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/PETER KEYWORTH/Primary Examiner, Art Unit 1776
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