CTNF 18/682,965 CTNF 83296 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statements (IDS) submitted on 6/19/25;2/12/24 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-3, 9-14, 16, 18-19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Chattaraj et al. (US 2015/0112302) (“Chattaraj”). Chattaraj discloses: (reference sections provided below are examples and non-limiting) (Claims 1, 18), Chattaraj discloses a drug delivery device (the invention is for use with an infusion pump for delivery of fluid medication; paragraph [0041]) comprising: a reservoir configured to receive a fluid (the infusion pump includes a self-contained reservoir for storing medication; paragraph [0044]); a cannula (penetrating body per claim 18) in fluid communication with the reservoir (a pump for drawing the fluid medication from the reservoir and advancing it by way of an infusion cannula to the tissue of the patient to be treated; paragraph [0044]), the cannula configured to be inserted into subcutaneous tissue or muscle tissue of a patient (the distal end of the cannula is inserted into the patient subcutaneously; paragraph [0044]); and a pump configured to deliver a fluid from the reservoir to the cannula (a pump for drawing the fluid medication from the reservoir and advancing it by way of an infusion cannula to the tissue of the patient to be treated; paragraph [0044]), wherein the cannula comprises a bioactive agent configured to cause a tissue response to decrease a pressure required to deliver fluid from the reservoir (the cannula is provided with a coating 27 of a response-inhibiting agent (bioactive agent) the response-inhibiting agent-coated cannula provides a direct supply of a response-inhibiting agent is directly delivered into a patient's internal tissues environment to achieve an anti-coagulation effect and/or prevent encapsulation of a subcutaneously inserted cannula (decrease pressure required); paragraph [0074]). Claims 2,19: the cannula (penetrating body) comprises at least one of a catheter and a needle (the infusion set includes an insertion needle, which is assembled with the soft cannula; paragraph [0044]). Claim 3: the tissue response comprises at least one of vasodilation, vasoconstriction, increased tissue permeability, increased flow of interstitial fluid, and enzymatic deterioration of extracellular matrix (the response-inhibiting agent is directly delivered into a patient's internal tissue environment to achieve an anti-coagulation effect (increased flow of an interstitial fluid) and/or prevent encapsulation of a subcutaneously inserted cannula; paragraph [0074,0050]). Claim 9: the bioactive agent is configured to immediately initiate a tissue response upon insertion of the cannula into subcutaneous tissue or muscle tissue of a patient (the response-inhibiting agent coats the cannula for an immediate release profile, the cannula is inserted into the patient subcutaneously; paragraphs [0012], [0044][0050]). Claim 10: the bioactive agent is positioned on an inside surface or outside surface of the cannula [0050] [0012] [0079] Claim 11: the bioactive agent comprises a material forming the cannula or a secondary metabolite arising from the degradation of a material forming the cannula [0078] Claim 12: the bioactive agent is embedded within the cannula, the bioactive agent configured to be released at a controlled rate upon insertion of the cannula into subcutaneous tissue or muscle tissue of a patient [0012] [0081] Claim 13: the cannula comprises a coating, the bioactive agent carried in the coating [0012] [0060] [0069] Claim 14: the coating comprises a frangible coating (is released) [0081] Claim 16: the bioactive agent is configured to prevent encapsulation of the cannula and prevent bioformed tissue encapsulation [0047] [0050] Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 4-8, 15, 17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj . Chattaraj discloses the invention as substantially claimed, including the cannula or penetrating body including a response-inhibiting agent [0010]. Chattaraj discloses some typical examples of response-inhibiting agents that can be used but is not exhaustive [0090-0098] [0141]. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute any of the bioactive agents as specified in claims 4-8, 15, 17, 20 for the response-inhibiting agent as taught by Chattaraj as a simple substitution of one known element for another to obtain predictable results (KSR). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DEANNA K HALL/Primary Examiner, Art Unit 3783 Application/Control Number: 18/682,965 Page 2 Art Unit: 3783 Application/Control Number: 18/682,965 Page 3 Art Unit: 3783 Application/Control Number: 18/682,965 Page 4 Art Unit: 3783 Application/Control Number: 18/682,965 Page 5 Art Unit: 3783 Application/Control Number: 18/682,965 Page 6 Art Unit: 3783 Application/Control Number: 18/682,965 Page 7 Art Unit: 3783
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