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 § 103
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 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.
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.
Claim(s) 1-12, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0360357 A1 to Baker et al. ("Baker") in view of US 4,752,013 A to Miller et al. ("Miller").
As to claim 1, Baker discloses an apparatus, comprising:
a medical device configured to be at least partially insertable into a body tissue of a user (see Fig 1B, element 132 and [0135] – "Before deployment, a sensor 132 of on-skin assembly 102 may be disposed on or at least partially in needle 140. During use, sensor 132 is disposed under the host's skin and a contact portion of on-skin assembly 102 is electrically connected to transmitter 134.");
an inserter configured for at least partially inserting the medical device into the body tissue (see Fig 1B, element 118 and [0129] – "Applicator 100 comprises a housing 104 configured to house an insertion assembly 118 (see FIG. 1B). Housing 104 comprises an aperture 106 through which on-skin assembly 102 (see FIG. 1B) is configured to pass during deployment.");
a housing (see above, element 104);
a removable cap connected to the housing and configured for being removed from the housing before insertion of the medical device (see Fig 1A, element 112 and [0131] – "sealing element 110 comprises a removable cap 112 configured to couple with a portion of housing 104"; see also [0131] – "removable cap 112 covers the actuation member by virtue of the actuation member being disposed on a side of housing 104");
a frangible securing element that secures the flexible connector into the locking position prior to use, wherein the frangible securing element is connected to the flexible connector and the connection is configured to break upon manual force being applied (see Fig 1C, element 164 and [0147] – "sealing element 160 comprises a removable cap 162 configured to couple with a distal portion of housing 104 via frangible member 164. Frangible member 164 may prevent sealing cap 162 from being removed without also removing frangible member 164.").
However, Baker fails to explicitly disclose a flexible connector connecting the removable cap to the housing, the flexible connector being reversibly displaceable from a locking position in which the removable cap is secured to the housing and a releasing position in which the removable cap is released from the housing.
Miller discloses, in a related closure art, a flexible connector connecting a removable cap to a housing (i.e., a bottle neck), the flexible connector being reversibly displaceable from a locking position in which the removable cap is secured to the housing and a releasing position in which the removable cap is released from the housing (see Figs. 1-4, elements 11, 14 and col. 2, lns. 1-10 – "pressing the lever in an inward radial movement will rotate the arc segment outward on its flexure and disengage the ratchet dogs from the ratchet teeth of the bottle neck, permitting rotation of the cap in the removal direction"; see also claim 3 of Miller – "the flexural attachment of the arc segment of the skirt to the closure cap provides a resilient bias urging the ratchet dogs into engagement with the ratchet teeth of the bottle neck"). Examiner notes that the arc segments 11/11a attached to the closure cap via flexures 14/14a constitute the flexible connector, which is reversibly displaceable between the locking position (ratchet dogs 12 engaged with ratchet teeth 13) and the releasing position (ratchet dogs 12a disengaged from ratchet teeth 13a as shown in Fig. 1, lever 15a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connector of Miller into the applicator of Baker in order to achieve the predictable result of providing a reversibly-displaceable cap retention mechanism that, in combination with Baker's frangible member, secures the cap prior to first use while permitting controlled, deliberate removal by the user. Baker expressly recognizes the need for tamper-evidence and premature deployment prevention features (see [0124]-[0125]), and Miller's flexural connector architecture is a well-known, art-recognized solution for providing the predictable result that is a controlled, releasable cap retention with tamper indication.
As to claim 2, Miller further discloses the flexible connector is movable from the locking position into the releasing position by applying a manual force (see col. 2, lns. 1-10, above);
the frangible securing element is configured for being destroyed by the manual force (see Fig 5 and associated text);
and the manual force is applied in a direction that is different from the direction of the force required for removing the removable cap from the housing (see Fig 5).
As to claim 3, Miller further discloses wherein the flexible connector is at least partially integrated into one of the removable cap and the housing and is further configured for remaining with the removable cap or the housing, respectively, after removing the removable cap from the housing (see col 2, lns. 1-5 arc segments 11/11a, which are integrally formed and remain part of cap 1 after removal from the bottle 2).
As to claim 4, Miller further discloses wherein the flexible connector is flexibly displaceable by at least one of manually pressing, twisting or pulling the flexible connector (see Fig 4).
As to claim 5, Miller further discloses wherein the flexible connector comprises at least one of a flexible tongue, a hook, a catch or a pin (arc segments 11/11a function as flexible catch/locking elements).
As to claim 6, Miller further discloses wherein the flexible connector comprises a flexible tongue having a free end and a fixed end, the fixed end being connected to one of the housing and the removable cap, wherein the frangible securing element secures the flexible tongue in the locking position (see col 2, ln 38-45 and 52-55; flexures 14/14a are flexible tongue members having a fixed end connected to the closure portion (the cap 3) and the frangible portion (lines 16/16a) secures the flexible tongue in the locking position prior to first use).
As to claim 7, Miller further discloses wherein:
the flexible connector is movable from the locking position into the releasing position in a releasing direction;
the removable cap is, during removal from the housing, movable in a removing direction;
and the releasing direction is different from the removing direction (see Fig 4).
As to claim 8, Miller further discloses wherein (i) moving the flexible connector from the locking position into the releasing position and (ii) removing the removable cap from the housing require separate mechanical actions by the user (see Figs 3-4 and col 2, lns. 1-10 – the user must first depress levers 15/15a to break the frangible lines and disengage the ratchet dogs and then separately unscrew the cap, which are separate mechanical actions).
As to claim 9, Miller further discloses wherein removing the removable cap from the housing requires a twisting motion of the removable cap (see Fig 4).
As to claim 10, Baker further discloses wherein the medical device comprises at least one of an infusion set for delivery of at least one therapeutic fluid into a body tissue of a user, and an analyte sensor for detecting at least one analyte in a body fluid (see Fig 1B, element 132).
As to claim 11, Baker further discloses wherein the inserter comprises at least one actuator for driving the medical device into the body tissue, wherein the inserter comprises at least one part of the housing, wherein the housing comprises at least one stationary portion configured for resting on the skin of the user and at least one actuation portion configured for being manually actuated by the user for actuating the actuator, wherein the stationary portion and the actuation portion are movable with respect to each other (see Fig 1B, element 118).
As to claim 12, Baker further discloses a preassembled functional module having the medical device and at least one of the following components:
a penetrating member for inserting the medical device into the body tissue, an infusion cannula for delivery of a therapeutic fluid into a body tissue of a user, an analyte sensor, and an electronics unit electrically connected to the medical device (see Fig 1B, element 140).
As to claim 17, Baker in view of Miller discloses a method for preparing the apparatus according to claim 1 for insertion of at least a part of the medical device into a body tissue of a user, the method comprising displacing the flexible connector from the locking position into the releasing position and thereby at least partially destroying the frangible securing element, the method further comprising removing the removable cap from the housing (see treatment of claim 1)
As to claim 19, Baker further discloses placing a distal end of the housing onto the skin of the user and actuating the inserter (see Baker’s claim 9 and Figs 1A-C).
Claim(s) 13-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Miller and further in view of US 2019/0083017 A1 to Walter.
As to claim 13 and 18, Baker/Miller fails to disclose wherein the preassembled functional module comprises a protective cap, wherein removing the removable cap removes the protective cap from the preassembled functional module.
However, in a related invention, Walter discloses a preassembled functional module comprising a protective cap, wherein removing the removable cap removes the protective cap from the preassembled functional module (see [0082] and Fig 5A, elements 216 and 166). It would have been obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Baker/Miller and Walter in order to achieve the predictable result of additional protection for the insertion sharp during shipping and handling while allowing a one-step removal process for both the removable cap and the protective cap.
As to claims 14-16, Walter further discloses wherein, prior to use, the protective cap provides a sterile enclosure for at least part of the penetrating member, wherein removing the removable cap exposes the penetrating member for insertion into the body tissue (see [0039] and [0082]).
Allowable Subject Matter
Claim 20 is allowed.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot given the new grounds of rejection.
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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791