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. 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 appl icant regards as his invention. Claim s 5-6, 9, 14 and 19 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 5 lines 1-2 recite “a portion”. It is not clear if this is the same portion of claim 1 line 13. For purposes of examination, this is interpreted as “the portion”. Claim 6 is rejected at least because it depends from claim 5 . Claim 9 recites that the cassette is configured to perform a manual function. It is not clear how a cassette can perform a manual function. For purposes of examination, this is interpreted as the actuator assembly is configured to be manually transitioned. Claim 9 recites the limitation "the opened condition" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the open condition”. Claim 1 4 recitation of “ the user ” in line 2 is indefinite because it is unclear if it is the same or different from the user of claim s 1 and 13 . Claim 19 recites that the cassette is configured to perform a manual function. It is not clear how a cassette can perform a manual function. For purposes of examination, this is interpreted as the actuator assembly is configured to be manually transitioned. Claim 19 recites the limitation "the opened condition" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the open condition”. Claim 19 recitation of “a receptacle” and “a pump body” in line 4 are indefinite because it is unclear if they are the same or different from the receptacle and pump body of claim 18. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim repeats limitations from claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 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 11 , 13-16 and 18-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Anderson et al. (Anderson) US 5,658,133 . Regarding claim 11, 13-16, 18-20, Anderson teaches a cassette (cassette 86 shown in Fig s. 5 -8A , c 8 ln 1-8 ) comprising: a free flow prevention clamp ( pincher 138 , wherein 192 of pincher 138 pivots toward anvil 182 to pinch outlet tube 144, as shown in Figs. 6 and 7 and described in c 11 ln 65 to c 12 ln 30 ), a housing ( rigid frame 134, c 8 ln 4 ), and an actuator assembly ( slider 136 having gripper bar 202 ), the free flow prevention clamp including a clamping section having a first side and a second side (annotated below; first side coupled to the first elongate section; second side connected to the second elongate section), a first elongate section extending from the first side (annotated below), and a second elongate section extending from the second side (annotated below), the housing supporting the free flow prevention clamp and defining a channel for receiving a tube (outlet tube 144 and Fig. 8A ), the first elongate section and the second elongate section extending parallel to the channel and the clamping section extending across the channel (see Fig 5), wherein the free flow prevention clamp is configurable within the housing in an open condition that allows fluid flow through the tube when force is applied to a portion of the clamping section (open condition Fig 6 , wherein the force is legs 212 abutting the base of the transverse legs 190 , c 11 ln 65 to c 12 ln 30 ) and in a closed condition that prevents fluid flow through the tube when the force is removed from the portion of the clamping section (closed condition Fig 7 , wherein the slider 136 is moved from left to right in Figs. 6-7 ); and the actuator assembly including a portion extending through the housing and configurable for movement between a rest position and a bypass position (actuator includes legs 212 extend on both the top and bottom of the rigid frame 134 ; rest position Fig 7 ; bypass position Fig 6 ), wherein upon actuation by a user of the actuator assembly from the rest position to the bypass position, the actuator assembly applies the force to the portion of the clamping section to position the free flow prevention clamp in the open condition (c 11 ln 65 to c 12 ln 30) , the actuator assembly includes a portion comprising slide configured for manual actuation by the user (gripper bar 202 allows pushing of the actuator assembly), the actuator assembly includes a portion extending within the housing configured for engagement with the clamping section ( l egs 212 abut the base of the transverse legs 190 of the pincher 138; thus actuator assembly engages the clamping section through the legs 190 , c 11 ln 65 to c 12 ln 30 ), the actuator assembly includes at least one pair of legs, the legs configured for slidable engagement into at least one pair of longitudinal openings positioned within the cassette housing (legs can be construed as elements 2 04 ; they slide into a pair of longitudinal openings within the housing, annotated below), wherein the cassette is configured to perform the functions of: transitioning the clamping section to the closed condition upon detachment of the cassette from a receptacle of a pump body (actuator 136 may be slid back and forth to the closed position to prevent free flow upon detachment of the cassette , c 11 ln 65 to c 12 ln 30 ), wherein the cassette is further configured to perform the function of: manually transitioning the clamping section to the opened condition after detachment of the cassette from a receptacle of a pump body (actuator 136 is free to slide back and forth – e.g. from the closed position to the open position), wherein the free flow prevention clamp is a leaf spring (Fig 6-7; clamp is biased downward in the figure when the actuator is moved to the right, and thus construed as a leaf spring). Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claim s 1- 3, 5-13 and 15- 20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim s 1- 2, 6-12 and 16-20 of copending Application No. 18/129,223 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 18/129,223 (reference application). As to claim 4, the Examiner notes that the limitations of the instant claim s 1 and 3 , from which claim 4 depends, are obvious over claim 1 of the reference application a pointed out above. Claim 4 of the instant Application substitutes the term “slide” for “button”. Although the claims at issue are not identical with regard to terminology , they are not patentably distinct from each other because the slide of the present application and the button of the reference application function similarly. Claim 1 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/129,223 (reference application). As to claim 14, the Examiner notes that the limitations of the instant claims 11 and 13, from which claim 14 depends, are obvious over claim 11 of the reference application as pointed out above. Claim 14 of the instant Application substitutes the term “slide” for “button”. Although the claims at issue are not identical with regard to terminology , they are not patentably distinct from each other because the slide of the present application and the button of the reference application function similarly. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Potentially Allowable Subject Matter Claim s 1-10 are potentially allowed , subject to the §112(b) and double patenting rejections above . Claim s 12 and 17 are objected to as being dependent upon a rejected base claim, but would be potentially allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims , as well as successfully addressing the §112(b) and double patenting rejections above . Reasons for Potential Allowance The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed ambulatory pump system of claim 1 and the cassette of claim s 12 and 17 . The closest prior art to claim 1 is Burnard et al. (Burnard) US 2021/0146044 A1. Regarding claim 1, Burnard fails to teach among all the limitations or render obvious an ambulatory pump system as claimed, which includes an actuator assembly including a portion extending through the housing and configurable for movement between a rest position and a bypass position , in combination with the total structure and function of the ambulatory pump system as claimed. The closest prior art to claims 12 and 17 is Anderson et al. (Anderson), US 5,658,133. Regarding claim 12, Anderson fails to teach among all the limitations or render obvious a cassette as claimed, which includes wherein the cassette housing further includes at least one ledge adjacent the clamping section, the at least one ledge supports the clamping section in an open, pre-operational state, and the clamping section is moved off the at least one ledge when the cassette is received by a receptacle of a pump body , in combination with the total structure and function of the cassette as claimed. Regarding claim 17, Anderson fails to teach among all the limitations or render obvious a cassette as claimed, which includes wherein the cassette is configured to perform the functions of: maintaining the clamping section in the open condition prior to a first attachment of the cassette to a receptacle of a pump body; and maintaining the clamping section in the open condition upon the first attachment of the cassette to the receptacle , in combination with the total structure and function of the cassette as claimed. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JOHN A DOUBRAVA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (408)918-7561 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9-5 Pacific Time . 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 Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3383 . 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. /J.A.D./ Examiner, Art Unit 3783 /James D Ponton/ Primary Examiner, Art Unit 3783