DETAILED ACTION 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. Specification Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because it uses phrases which can be implied (“Disclosed herein are” in line 1). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Objections Claim 1 is objected to because there is a typo regarding “…to transfer insulin form the infusion pump…” as opposed to “…to transfer insulin form from the infusion pump…” in line 4. Appropriate correction is required. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 6-14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Regarding claim 6, the limitation “a cannula extending into a body of the user” in line 3 positively recites and claims human organism (“a body of the user”). It is suggested to amend this limitation to “ a cannula configured to extend extending into a body of the user ”, or similar. Claims 7-14 are rejected for being dependent upon claim 6 . 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. Claim s 1-11 and 15-18 a re rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oberg et al. (US 20220226568). Regarding claim 1, Oberg discloses a n infusion set (insulin delivery system 100) configured to facilitate delivery of insulin from an infusion pump to a user, comprising: an infusion hub (hub 105) configured to be placed on a body of the user (“ the hub 105 can include a patch 330 or other mechanism configured to adhere to the patient ” [ 0100 ]) ; infusion tubing (tubing 103) configured to transfer insulin form the infusion pump to the infusion hub (“ The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106. ” [0100]) ; a cannula (cannula 106) extending from the infusion hub into the body of the user (Figures 1A-1B) ; and a septum (barrel 333 having septum 334) facilitating transfer of the insulin from the infusion tubing to the cannula (“ The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. ” [0100]) , wherein the septum comprises a halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 2 , Oberg discloses th e infusion set of claim 1, wherein the septum (barrel 333 having septum 334) comprises a septum body (Figure 3) Regarding claim 3 , Oberg discloses t he infusion set of claim 2, wherein the septum body comprises the halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 4 , Oberg discloses t he infusion set of claim 2, wherein the septum body is coated with the halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 5 , Oberg discloses t he infusion set of claim 1, further comprising a transfer needle (introducer 332) extending from the infusion tubing configured to pierce the septum (“ an introducer 332 extending from the tubing 103 … The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. ” [0100]; Figure 1B) . Regarding claim 6 , Oberg discloses a n ambulatory infusion pump system (insulin delivery system 100) , comprising: a reservoir (reservoir 101) configured to contain insulin (“ an insulin reservoir 101 (configured to store an insulin medication therein), ” [0100]) ; a cannula (cannula 106) extending into a body of the user (“ The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106. ” [0100]) ; and a septum (barrel 333 having septum 334) facilitating transfer of the insulin from the reservoir to the cannula (“ The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106. ” [0100]) , wherein the septum comprises a halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 7 , Oberg discloses t he ambulatory infusion pump system of claim 6, wherein the septum (barrel 333 having septum 334) comprises a septum body (Figure 3) Regarding claim 8, Oberg discloses t he ambulatory infusion pump system of claim 7, wherein the septum body comprises the halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 9 , Oberg discloses t he ambulatory infusion pump system of claim 7, wherein the septum body is coated with the halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 10 , Oberg discloses t he ambulatory infusion pump system of claim 6, further comprising an infusion hub (hub 105) configured to be placed on a body of the user (“ the hub 105 can include a patch 330 or other mechanism configured to adhere to the patient, ” [0100]) and infusion tubing (tubing 103) , wherein the infusion tubing is configured to transfer the insulin from the reservoir to the septum and the cannula extends from the infusion hub into the body of the user (Figures 1A-1B; “ the hub 105 can include a patch 330 or other mechanism configured to adhere to the patient, a barrel 333 connected to the cannula 106, and an introducer 332 extending from the tubing 103 …T he fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106. ” [0100]) . Regarding claim 1 1, Oberg discloses t he ambulatory infusion pump system of claim 10, further comprising a transfer needle (introducer 332) extending from the infusion tubing configured to pierce the septum (“ an introducer 332 extending from the tubing 103 … The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. ” [0100]; Figure 1B) . Regarding claim 15, Oberg discloses a septum (barrel 333 having septum 334) for use in facilitating delivery of insulin to a user (“ fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106. ” [0100]) , the septum comprising a halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . Regarding claim 16, Oberg discloses th e septum of claim 1 6 , wherein the septum comprising a septum body (Figure 3) Regarding claim 17, Oberg discloses t he septum of claim 16 , wherein the septum body comprises the halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . . Regarding claim 18, Oberg discloses t he septum of claim 18 , wherein the septum body is coated with the halogenated siloxane material (“ the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss. ” [0103]; “ The barriers described herein can include … organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides) ” [0105]) . 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 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Oberg et al. (US 20220226568) in view of Michaud et al. (USPN 9993595) . Regarding claims 12-14, Oberg discloses t he ambulatory infusion pump system of claim 6 . Oberg fails to explicitly disclose the system further comprising an infusion pump containing the reservoir and a pump holder configured to be worn on the body of the user to releasably hold the infusion pump , as required by claim 12; wherein the pump holder includes a cannula port from which the cannula extends into the body of the user , as required by claim 13; and wherein the septum is disposed in the cannula port ; as required by claim 14. Michaud discloses an ambulator infusion pump system (patch pump 100) comprising a reservoir (cartridge 116), a cannula (cannula 188; Figures 11A-11E), and a septum (“a sealing membrane”: “ Retention frame 106 of attachment portion 104 includes an insertion portion 112 through which a disposable needle can be inserted to penetrate a sealing membrane and insert a cannula for medicament delivery. ” [Col 4, lines 11-14]); further comprising an infusion pump (pump 102) containing the reservoir (“ Reusable drive unit 118 of pump includes a drive mechanism 122 that mates with a recess 124 in disposable cartridge 116 to attach the cartridge 116 to the drive unit 118 and provide for delivery of medicament such as insulin from the cartridge 116 to a user through the cannula. ” [Col 4, lines 15-19]) and a pump holder (attachment portion 104) configured to be worn on the body of the user (“ an adhesive backing 107 can be removed from the adhesive patch 108 holding the retention frame 106 and the patch applied to the skin at the desired insertion site. ” [Col 7, lines 45-47]) to releasably hold the infusion pump (“ To mate the pump 102 with the corresponding attachment portion 104, initially hook portion 114 on retention frame 106 is inserted, or hooked, into a recess 138 in the drive unit 118, as shown in FIGS. 1C and 1D. ” [Col 4, lines 22-26]) ; wherein the pump holder includes a cannula port (insertion portion 112) from which the cannula extends into the body of the user (Figures 11A-E) ; and wherein the septum is disposed in the cannula port ( Retention frame 106 of attachment portion 104 includes an insertion portion 112 through which a disposable needle can be inserted to penetrate a sealing membrane and insert a cannula for medicament delivery. ” [Col 4, lines 11-14]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the ambulatory infusion pump of Oberg to include an infusion pump containing the reservoir and a pump holder configured to be worn on the body of the user to releasably hold the infusion pump , wherein the pump holder includes a cannula port from which the cannula extends into the body of the user , and wherein the septum is disposed in the cannula port based on the teachings of Michaud to provide a user-wearable ambulatory infusion pump t hat is able to positioned directly on the infusion site, eliminating the necessity for external tubing (Michaud [Col 1, lines 50-60]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LEAH J SWANSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0394 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9 AM- 5 PM ET . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783