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 .
Claims 3, 4, 9 and 20 were amended in the preliminary amendment filed 3/1/2024. Claims 1-20 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 7-14 in the reply filed on 3/11/2026 is acknowledged.
Claims 1-6 and 15-20 are withdrawn. Claims 7-14 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/1/2024 and 8/13/2024 are compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 recites “disposed with in the depot” should be changed to “disposed within the depot”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “comprises electrosterically stabilized nanocrystalline cellulose, wherein the electrosterically stabilized nanocrystalline cellulose binds 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” which is indefinite. It is unclear if the composition necessarily includes doxorubicin as a structural limitation to the composition or if the binding property is just an inherent feature of the electrosterically stabilized nanocrystalline cellulose alone. For the purpose of examination the composition in the medical device comprises only the electrosterically stabilized nanocrystalline cellulose and the binding property of being capable of binding doxorubicin is just an inherent feature.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 7-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sarikhani et al. (Chemotherapy Drug Capture Device Based-on Nanocellulose/Silk Fibroin Microparticle, January 2020, pages 1-40).
Applicant claims a medical device comprising a depot, a composition comprising electrosterically stabilized nanocrystalline cellulose (ENCC) disposed within the depot; a first conduit having a first end adapted to capture fluid and a second end coupled to the depot. (Claim 7)
Sarikhani discloses a chemotherapy drug capturing device for intravenous absorption of doxorubicin which is fabricated with electrostatically stabilized nanocrystalline cellulose (ENCC) which have anionic groups that bind doxorubicin (DOX) (page 2, paragraph 1). The device is designed to be placed into venous artery and capture doxorubicin that is in outflow of the venous flow (page 3, Figure 1). Sarikhani shows that the device is fabricated into a microfluidic device using molded PDMS with inlet and outlet holes bonded with microchannel (page 5, paragraph 1). Microbeads were fabricated comprising silk fibroin and ENCC and concentration was optimized for maximum DOX capturing (page 6, paragraph 2). The device comprises an inlet for the aqueous phase of silk fibroin and ENCC, continuous flow (oil/surfactant) inlets and outlet for collecting microbeads and is illustrated in Figures 2 and 3 (limitation of claims 8-13).
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The device inherently comprises a first conduit that captures the fluid and a second end coupled to the depot.
With respect to claims 7 and 14, Sarikhani is silent to being capable of binding at least 1000 mg of DOX, preferably at least 6000 mg of DOX per gram of ENCC but this appears to be directed to intended use because this does not result in a structural difference between the claimed invention and the prior art.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dang et al. (CA 3159930; published July 26, 2018) teach a medical infusion device comprising a cannula/catheter adapted for subcutaneous insertion, a fluid conduit adapted to deliver the solution from a medical reservoir to the site of infusion and a depot in operable contact with the fluid conduit (abstract).
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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DANIELLE D. JOHNSON
Examiner
Art Unit 1611
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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