CTNF 18/098,538 CTNF 77797 DETAILED ACTION 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. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I (claims 1-8) in the reply filed on 02/13/26 is acknowledged. 08-06 AIA Claim s 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II & III , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/13/26 . Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “ a rate-controlling porous or non-porous membrane disposed in the reservoir ” in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 06-31 AIA The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. 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. 07-12-aia AIA (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. 07-15-03-aia AIA Claim s 1-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by D’Amour et al. (US 2019/0328934) . Regarding claim 1 , D’mour discloses a device, in Figs. 1-2D, for delivering one or more therapeutic agents subcutaneously to a mammal in need thereof, the device comprising: Note : Examiner uses Fig. 1B for clarification. a port 85 for receiving one or more therapeutic agents that is to be delivered to a mammal subcutaneously, the port having a stem 85; a reservoir (inside a weld area) in fluid communication with the stem 85 and comprised of at least two areas, the first area being comprised of a more rigid elastic material (e.g., 60 & 63 as film rings at the periphery of the weld area, para [0103]) and the second area being comprised of a less rigid elastic material (inside the weld area, i.e., reservoir area, or non-woven fabric 59, 62, 63, 68), the reservoir being capable of being inserted subcutaneously into a mammal in need of the one or more therapeutic agents and filled (via stem 85) or refilled (via stem 85) to contain the therapeutic agents that are to be delivered to the mammal subcutaneously while at least the reservoir of the device is inserted subcutaneously in the mammal in need of one or more therapeutic agents; and a rate-controlling porous or non-porous membrane 62/65 disposed in the reservoir that allows the one or more therapeutic agents to be delivered to the mammal at a controlled rate; wherein at least the reservoir portion of the device is capable of being inserted subcutaneously into the body of the mammal in need of one or more therapeutic agents and the one or more therapeutic agents can be removed from the reservoir of the device or filled or refilled into the reservoir of the device without the device being removed from the body of the mammal in need of the one or more therapeutic agents, para [0088]. PNG media_image1.png 266 700 media_image1.png Greyscale Regarding claim 2 , wherein the reservoir is further comprised of a reinforcement 61 or composite membrane 61 located between the more rigid elastic material 60 & 63 and the less rigid elastic material 59/68 of the reservoir, see Fig. 1B. Regarding claim 3 , as seen in Fig. 1B, the reinforcement or composite membrane 61 is located in between the film ring 60/63 (rigid material), and less rigid material layers 59, 62, 63, 68; wherein the weld area is located at peripheral of the device, see Fig. 2A. Therefore, the reinforcement or composite membrane 61 is cladded on both sides of the reinforcement or composite membrane with the more rigid elastic material or the less rigid elastic material and the more rigid material and the less rigid material overlap at least a portion of the reinforcement or composite membrane and create a heat seal (at weld) with the reinforcement membrane in the reservoir, see Figs 1B & 2A. Regarding claim 4 , wherein the more rigid elastic material and the less rigid elastic material sufficiently overlap the reinforcement or composite membrane and create a heat sealed joint (at weld area) of the more rigid elastic material, the less rigid elastic material and the reinforcement or composite membrane at least at the outer edges of the reservoir, see Fig. 2A. Regarding claim 5 , wherein at least a substantial portion of both ends (e.g. weld area is at peripheral of the reservoir, see Fig. 2A) of the reservoir are comprised of the more rigid elastic material and at least a substantial portion of the middle of the reservoir is comprised of the less rigid elastic material, see Fig. 2A. Regarding claim 6 , as seen in Fig. 2A, wherein the device does not have a sleeve covering the reservoir, the reservoir is tapered from at least the reservoir to the stem and the largest diameter of the device when the reservoir does not contain any therapeutic agents is the diameter of the port or the stem allowing for easy removal of the device from the mammal in need of one or more therapeutic agents. Note : the device is expanded device when filled of therapeutic agent, therefore, an interior space or volume space in the device is expanded and larger in diameter in vertical direction, see Fig. 9. When the device is emptied, the device is deflated, see Fig. 2A-2D, and therefore the larges diameter (or the length of the device), at this point, the device is allowing for removal easily . 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. 07-21-aia AIA Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over D’Amour et al. (US 2019/0328934) in view of Joseph et al. (US 6,471,689) . Regarding claim 7 , D’Amour discloses all the claimed subject matter as required in the claimed invention except for the limitation that a multi-lumen tube that is in fluid communication with at least the stem of the device. Joseph discloses a drug delivery device comprising: a port 12 for receiving one or more therapeutic agents that is to be delivered to a mammal subcutaneously, a multi-lumen tube 34 & 36 that is in fluid communication with at least the stem 14 of the device, see Fig. 3. It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of D’Amour with providing a multi-lumen tube that is in fluid communication with at least the stem of the device, as taught by Joseph, in order to introduce one or more therapeutic agents in the device at the same time 07-21-aia AIA Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over D’Amour et al. (US 2019/0328934) in view of Kharul et al. (US 2005/0006302) . Regarding claim 8 , D’Amour discloses all the claimed subject matter as required in the claimed invention. D’Amour discloses the rate-controlling membrane 62/65 has porous but does not disclose the limitation that the device further comprises one or more chemical stabilizers or plasticizers to keep the pores of the rate-controlling membrane open. Kharul discloses a pours membrane includes one or more chemical stabilizers or plasticizers (e.g., glycerol, water, poly vinyl pyrolidone, polyethylene glycol, and polyethylene oxide, see claim 10 in Kharul). It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of D’Amour with providing one or more chemical stabilizers or plasticizers, as taught by Kharul, in order to provide viscosity in the pores, having excellent combination of high-water fluid and solute rejection and also to keep the pores of rate-controlling membrane open. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm. 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, Michael Tsai can be reached on 571-270-5246 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Quynh-Nhu H. Vu/ Quynh-Nhu H Vu Primary Examiner, Art Unit 3783 Application/Control Number: 18/098,538 Page 2 Art Unit: 3783 Application/Control Number: 18/098,538 Page 3 Art Unit: 3783 Application/Control Number: 18/098,538 Page 4 Art Unit: 3783 Application/Control Number: 18/098,538 Page 5 Art Unit: 3783 Application/Control Number: 18/098,538 Page 6 Art Unit: 3783 Application/Control Number: 18/098,538 Page 7 Art Unit: 3783