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 .
Applicant’s amendment filed 7/17/2026 has been entered. Claim 7 was amended. Claims 1-20 are pending. Claims 1-6 and 15-20 are withdrawn. Claims 7-14 are under examination.
Withdrawn rejections
Applicant's amendments and arguments filed 7/17/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn.
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.
Claim(s) 7-9, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 2009/0211977; published August 27, 2009) in view of Burt et al. (WO 2012/068670; published May 31, 2012).
Applicant claims a medical device comprising a depot; a composition comprising electrosterically stabilized nanocrystalline cellulose disposed within the depot, wherein the stabilized cellulose is configured to bind at least 1000 mg of doxorubicin per gram of electrosterically stabilized nanocrystalline cellulose when the electrosterically stabilized nanocrystalline cellulose is contacted with a fluid comprising doxorubicin; a first conduit having a first end adapted to capture fluid and a second end coupled to the depot. (claim 7)
Miller teach microfluidic transfer devices which mitigate risk of cross contamination (abstract). Devices which remove contaminates from dialysis of blood are desired [0003]. During dialysis blood contains particles of different sizes and waste products are removed to allow proper body function [0004]. The devices comprises an inlet and an outlet fluidly connected to opposite ends of microchannels [0016]. To mitigate cross contamination between the fluid contained in the inlet and outlet there is a transfer layer which seals inlets, outlets and microchannels [0021]. The devices are configured with membranes which can comprise polysulfone-nanocrystalline cellulose [0030]. The first fluid enters microchannel inlet 102 and flows through upper lamina 104 to microchannel 106 via 108 where the fluid contacts transfer layer 110 that comprise the polysulfone-nanocrystalline cellulose membrane [0071].
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Miller do not specify if the stabilized cellulose is configured to bind doxorubicin to the nanocrystalline cellulose when the nanocrystalline cellulose is contacted with a fluid comprising doxorubicin. It is for this reason that Burt et al. is joined.
Burt et al. teach that nanocrystalline cellulose (NCC) interacts with drugs to reversibly bind them to the NCC (page 7, lines 27-30). The NCC bears anionic charges which bind ionic drugs (page 8, lines 1-4). The negatively charged surface of NCC binds to doxorubicin due to its positive charge (page 9, lines 23-29).
Both Miller and Burt are drawn to compositions comprising nanocrystalline cellulose. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Miller et al. and Burt et al. to include stabilized cellulose configured to bind doxorubicin with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings of Miller and Burt to further include stabilized cellulose configured to bind doxorubicin because Burt et al. teach the negatively charged surface of nanocrystalline cellulose binds to doxorubicin due to its positive charge.
Allowable Subject Matter
Claims 10, 12 and 13 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art Miller teaches microchannel devices but does not include a catheter coupled to the medical device, nanocrystalline cellulose coupled to a matrix or blood and/or doxorubicin within the medical device.
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 DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
