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 .
Response to Amendment
This office action is responsive to the amendment filed on July 6, 2026. As directed by the amendment: claims 1, 4-5, 9, 11 and 14-15 have been amended, claims 13 and 19 have been cancelled, and no claims have been added. Thus, claims 1-12, 14-18 and 20 are presently pending in this application. Applicant’s amendments are sufficient to overcome the §112(b) and §112(d) rejections of the previous action.
Terminal Disclaimer
The terminal disclaimer filed on July 6, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 12,721,991 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see Remarks, filed July 6, 2026, with respect to the rejection of newly amended independent claim 11 under 35 U.S.C. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Anderson et al. (Anderson) US 5,658,133, see below.
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.
Claims 11, 14-16, 18 and 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, 14-16, 18 and 20, Anderson teaches a cassette (cassette 86 shown in Figs. 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 an actuator portion (actuator includes legs 212) 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), the actuator portion configured for contact with the clamping section (see annotated Fig. 5 below, wherein the clamping section includes first and second elongate sections, and see c 12 lines 4-10), 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 ( legs 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 204; 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 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).
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Allowable Subject Matter
Claims 1-10 are allowed.
Reasons for Allowance
The following is an Examiner's statement of reasons for allowance: the claims in this application are allowed because the prior art of record fails to disclose either singularly or in combination the claimed ambulatory pump system of claim 1.
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.
Potentially Allowable Subject Matter
Claims 12 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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