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 .
Information Disclosure Statement
Examiner notes that no IDS has been filed.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 is objected to for a typographical error wherein the claim recites “The detachable component of claim 1, the latch” and should instead recite “The detachable component of claim 1, wherein the latch”.
Appropriate correction is required.
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) 1-8, 13 and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tong et al. (US 20210196935, henceforth Tong).
Regarding claim 1, Tong discloses a detachable component of a wearable medical device (disposable part 314 and reusable part 312, fig. 9, which make up a detachable component relative to release liner 318), the component comprising: a housing (upper housing 342, fig. 20A, and housing 370, fig. 10, make up the claimed housing); a latch (the combination of single latch 322, rail 333, ramped second end 366, cantilevered first end 361, and the tubular housing for reservoir 320 as shown in figs. 11 and 18 make up the claimed latch) operably associated with the housing (latch 322 interfaces with latch element 386 of housing 370, see [0056]), wherein the latch includes a cam (the combination of latch 322, cantilevered first end 361, and ramped second end 366 make up the claimed cam, fig. 11), and wherein: the cam has a first position at which the cam projects outwardly from the housing (position of fig. 14, latch 322 is unbiased by interaction with latch element 386), the cam has a second position at which the cam is shifted inwardly relative to the first position (position of fig. 17, where cantilevered first end 361 is engaging with latch element 386 and thus latch 322 is understood to be slightly biased inwards), the cam has a third position at which the cam is shifted inwardly relative to the second position (position between the first and second positions when latch 322 is being flexed out of position by the front wall of latch element 386 after ramped second end 366 engages with the front wall to bias the latch 322 inwards), the cam is resiliently biased from the second position toward the first position (see [0060], spring assembly 376 pushes against the housing of reservoir 320 which is a biasing away from the second position towards the first position since it is a resistance of the disposable part 314 and the reusable part 312 being fitted together), and fully actuating the cam moves the cam from the first position to the second position (this is the change in position shown between figs. 14 and 17 where the latch 322 is moved from its first position to its second position via the third position, and since it is the difference between the reusable part 312 and the disposable part 314 being fully disconnected or fully connected, is considered to be a full actuation of the cam as claimed); and a handle (the recessed inner portion of latch 322 is a handle as claimed, see fig. 17) accessible from outside the housing (see fig. 17, the recessed inner portion of latch 322 is accessible from the exterior of the device), wherein the handle is movable in an actuating direction (the actuating direction is considered to be a radial inwards direction; the handle is called out as movable radially inwards in [0056] where it says that latch 322 can be depressed by the user) to move the cam from the first or second position to the third position (this movement is a further inward deflection which is a movement to the third position, particularly in [0056] from the second position).
Regarding claim 2, Tong discloses the component of claim 1 wherein: fully actuating the cam moves the cam a first distance from the first position to the second position (the claimed first distance is the travel distance of latch 322 is the lateral movement of latch 322 relative to button 372 between the state of fig. 14 and the state of fig. 17; the claim does not require that the first distance is a measure of the inward movement between positions, only a movement between positions); the handle is movable in the actuating direction to move the cam a second distance from the second position to the third position (this moveable handle requirement is shown through the depressing of latch 322 by the user as called out in [0056] in the inward direction which is the actuating direction, and the handle is also moveable laterally relative to button 372 to a position where latch element 322 is moved less than halfway laterally relative to the distance change between the states of figs. 14 and 17 in the third inward position); and the first and second distances differ by less than 50% (see above, in the third position, the handle can be moved laterally with respect to button 372 between the first, second, and third positions such that the first and second distances are less than 50% different as claimed, since the claim does not require that the distances are a measure of inward or outward movement, but simply a measure of distance changes between the relative positions).
Regarding claim 3, Tong discloses the component of claim 1 wherein: the latch includes an arm (see annotated fig. 18 calling out the claimed arm at the interface of the reservoir 320 and ramped second end 366 which is a small rounded portion) through which the cam is resiliently connected to the housing (see fig. 18, the called out arm provides for an interface between latch 322 and its elements which make up the claimed cam and upper housing 342 via intervening structures such as the tubular housing for reservoir 320); and the arm biases the cam from the first position toward the second position (the arm is understood to provide resilient strength to latch 322 and the called out cam elements thereon to resist the bending caused by deflection from moving reusable part 312 and disposable part 314 together since the cantilevered first end 361 springs back into contact engagement to mate and latch with latching element 386; this then means that the called out arm biases the cam from the first position towards the second position when the corner edge between latch 322 and cantilevered first end 361 is in contact with the latching element 386 since the resilient force of the called out arm would push the edges past each other to push the cantilevered end 361 into matched engagement with latching element 386 in the position of fig. 17).
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Annotated fig. 18 from Tong calling out the claimed arm
Regarding claim 4, Tong discloses the component of claim 1 wherein: the housing includes a wall (the right wall of reusable part 312 as shown in fig. 16 is the claimed wall) having an outer surface (the interior surface of the called out wall is considered to be an outer surface as it forms the shell of reusable part 312 and is outside of reservoir 320 in the assembled system 310) defining a plane (the called out surface is thus considered to define a plane extending across the window formed in reusable part 312 through which latch 322 extends); the cam in the first position projects outwardly from the plane (the radial exterior most surface of latch 322 would extend through the called out plane in the second position of fig. 17 since it extends beyond cantilevered first end 361 which engages with the outer surface); and the cam in the third position is inwardly spaced apart from the plane (in order to allow the reusable part 312 and the disposable part 314 to be disconnected, in the third position, latch 322 must extend inside of the defined plane such as to allow latch 322 to exist inside of the outer wall to allow the parts 312 and 314 to slidable disengage with each other).
Regarding claim 5, Tong discloses the component of claim 1 the latch includes an arm (see annotated fig. 18 calling out the claimed arm at the interface of the reservoir 320 and ramped second end 366 which is a small rounded portion) through which the cam is rotatably connected to the housing (latch 322 is considered to be rotating where it pivots about the called out arm to move between the first, second, and third positions as claimed; the called out arm appears to provide the hinge point about which latch 322 and its associated structures can move, and this movement is considered to be a rotation where it turns about the arm as an axis).
Regarding claim 6, Tong discloses the component of claim 5 further comprising a spring (ramped second end 366, fig. 11, which is considered to be a spring as it would bend due to deflection with latching element 386 during movement between the first and second positions and then return to its original state such as to allow for latch 322 to protrude outwards such that cantilevered first end 361 can be engaged, and since Merriam Webster defines a spring to be “an elastic body or device that recovers its original shape when released after being distorted” which is a definition that is met by this understanding) between the cam and the housing (second end 366 is between latch 322 and upper housing 342 since it provides for latch 322 to connect to upper housing 342), wherein the spring biases the cam from the second position toward the first position (when the device is in the second position and a user has depressed latch 322 as in [0056] to detach the reusable part 312 from the disposable part 314, the tensile forces from bending latch 322 will allow for ramped second end 366 to press against the front edge of latching element 386 such that the two parts are encouraged to separate as latch 322 springs back into place; this is an urging from the second position to the second position and is thus a biasing of the spring of ramp 366 from the second position toward the first position as claimed).
Regarding claim 7, Tong discloses the component of claim 1 wherein: the housing includes: a contact surface (the bottom of chassis 326 which interfaces with adhesive element 316 as shown in a non-relied upon embodiment in fig. 4 as the site at which membrane 38 is placed is a contact surface as claimed) through which the housing is configured to be connected to skin of a patient (the called out housing connects to adhesive element 316 via the called out contact surface and intervening membrane 338, and adhesive element 316 is connected to skin of a patient as in [0011] and [0052]) while the patient wears the medical device (see Abstract, [0011], and [0052]), and a window at the contact surface (this is the window formed by latch element 386 as shown in figs. 16 and 17, which is considered to be at the contact surface as claimed where it is formed immediately adjacent to the contact surface and Merriam Webster defines “at” to mean “used as a function word to indicate presence or occurrence in, on, or near”); and the handle is accessible from outside the housing via the window (see fig. 17).
Regarding claim 8, Tong discloses the component of claim 7 wherein the handle is flush with or recessed relative to the contact surface (the recessed portion of latch 322 is considered to be flush with the called out contact surface where, when taking a section view along the recessed portion of latch 322, the contact surface as called out and the recessed portion would be along the same plane).
Regarding claim 13, Tong discloses a wearable medical device (system 310, fig. 10), comprising: a first component (reusable part 312, fig. 9) including a first housing (housing 370, fig. 10); and a second component (disposable part 314, fig. 9) configured to be detachably connected to the first component (see [0055] and [0056]), wherein the second component includes: a second housing (upper housing 342 and chassis 326, fig. 20A), a latch (the combination of single latch 322, ramped second end 366, cantilevered first end 361, and the tubular housing for reservoir 320 as shown in figs. 11 and 18 make up the claimed latch) operably associated with the second housing (latch 322 and its first and second ends are connected to upper housing 342 and chassis 326 through reservoir 320, which is considered to be an operable association), and a handle (the recessed inner portion of latch 322 is a handle as claimed, see fig. 17) accessible from outside the second housing (see fig. 17, the recessed inner portion of latch 322 is accessible from the exterior of the device), and wherein: the latch includes a cam (the combination of latch 322, cantilevered first end 361, and ramped second end 366 make up the claimed cam, fig. 11) having: a first position at which the cam projects outwardly from the second housing (position of fig. 14, latch 322 is unbiased by interaction with latch element 386), a second position at which the cam is shifted inwardly relative to the first position (position of fig. 17, where cantilevered first end 361 is engaging with latch element 386 and thus latch 322 is understood to be slightly biased inwards), and a third position at which the cam is shifted inwardly relative to the second position (position between the first and second positions when latch 322 is being flexed out of position by the front wall of latch element 386 after ramped second end 366 engages with the front wall to bias the latch 322 inwards), the cam is resiliently biased from the second position toward the first position (see [0060], spring assembly 376 pushes against the housing of reservoir 320 which is a biasing away from the second position towards the first position since it is a resistance of the disposable part 314 and the reusable part 312 being fitted together), the first and second components are shaped to constrain relative movement thereof (see [0056], rail 333 and sliding element 335 cooperate to constrain relative movement of the respective parts 314 and 312) such that detachably connecting the first and second components to one another automatically actuates the cam and thereby moves the cam from the first position to the second position (sliding of parts 312 and 314 together involves actuation of the called out cam as latch 322 engages with latch element 386 to connect the components together; since this is done only through the connection of the two parts 312 and 314 by sliding them together via connection of rail 333 and sliding element 335 and no other steps are needed, this is considered to be an automatic actuation as claimed), and the handle is movable in an actuating direction (the actuating direction is considered to be a radial inwards direction; the handle is called out as movable radially inwards in [0056] where it says that latch 322 can be depressed by the user) to move the cam from the first or second position to the third position (this movement is a further inward deflection which is a movement to the third position, particularly in [0056] from the second position).
Regarding claim 15, Tong discloses the device of claim 13 wherein: the first component includes a pocket (the hollow interior formed by housing 370 is considered to be a pocket, see fig. 22); and the cam is at least partially received within the pocket when the first and second components are detachably connected to one another (the called out cam includes cantilevered first end 361 which is inside of the claimed pocket when the device is in the second position as this is the state at which cantilevered first end 361 engages with the interior of latching element 386 inside of housing 370).
Regarding claim 16, Tong discloses the device of claim 13 wherein: the first component is multi-use (the first component is called the reusable part 312 because it is meant for multiple uses, see [0039] and [0055]); and the second component is single-use (the second component is called the disposable part 314 because it is meant for a single use, see [0011], [0039], [0046], and [0055]).
Regarding claim 17, Tong discloses the device of claim 13 wherein: one of the first and second components includes a pillar (rail 333, fig. 9, which is included on the claimed second component); the other of the first and second components includes a socket (sliding element 335 is the claimed socket which is included on the claimed first component, see fig. 16); and alignment of the pillar and the socket constrains relative movement of the first and second components while detachably connecting the first and second components to one another (see [0056], engagement between rail 333 and sliding element 335 constrains reusable part 312 and disposable part 314 such that they can only slide relative to each other during detachable connecting or disconnecting due to their respective mating and alignment).
Regarding claim 18, Tong discloses the device of claim 13 wherein: the first housing includes a first wall (housing 370 of reusable part 312 has a first wall which is its bottom surface in the orientation of fig. 16 which is pressed against the top surface of chassis 326 in the state of fig. 16); the second housing includes a second wall (the top surface of chassis 326 as shown in fig. 16 is considered to be the second wall as claimed); the cam projects outwardly from the second wall when the cam is in the first position (latch 322 and the called out cam structures protrude upwards from the exposed bottom surface of chassis 326 in the state of fig. 16; this is considered to be an outward projection since the called out cam structures extend away from the top surface of chassis 326); and the first and second walls are parallel and adjacent when the first and second components are detachably connected to one another (see the orientation of fig. 17, the bottom surface of housing 370 and the top surface of chassis 326 are immediately adjacent to one another and the surfaces extend parallel to each other as claimed).
Regarding claim 19, Tong discloses the device of claim 18 wherein the handle defines a recess (see fig. 9, recessed inner portion of latch 322 is the called out handle and thus defines a recess by definition) configured to receive a fingertip (the recessed portion of latch 322 is physically and functionally capable of receiving a user’s fingertip such as to allow for depression of the user as in [0056]) when the first and second components are detachably connected to one another (this is the claimed second position in which the user can depress latch 322, and thus the claimed handle and recess thereof, to move the latch and cam into the third position to allow for detaching of the reusable part and the disposable part from each other).
Regarding claim 20, Tong discloses the device of claim 13 wherein: the first housing includes a first contact surface (the bottom surface of housing 370 of reusable part 312 is a first contact surface as claimed, see fig. 14) through which the first housing is configured to be connected to skin of a patient while the patient wears the medical device (housing 370 is configured to be connected to skin of a patient while the patient wears the medical device at its bottom surface as claimed via intervening structures such as chassis 326, membrane 338, and adhesive element 316, see at least figs. 4 and 14 and see Abstract, [0011], and [0052]); the second housing includes: a second contact surface (the bottom of chassis 326 which interfaces with adhesive element 316 as shown in a non-relied upon embodiment in fig. 4 as the site at which membrane 38 is placed is a contact surface as claimed) through which the second housing is configured to be connected to the skin (the called out housing connects to adhesive element 316 via the called out contact surface and intervening membrane 338, and adhesive element 316 is connected to skin of a patient as in [0011] and [0052]) while the patient wears the medical device (see Abstract, [0011], and [0052]), and a window at the second contact surface (this is the window formed by latch element 386 as shown in figs. 16 and 17, which is considered to be at the contact surface as claimed where it is formed immediately adjacent to the contact surface and Merriam Webster defines “at” to mean “used as a function word to indicate presence or occurrence in, on, or near”); and the handle is accessible from outside the second housing via the window (see fig. 17).
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.
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong et al. (US 20210196935, henceforth Tong) as applied to claim 13 above, and further in view of Hanson et al. (US 20180221573, henceforth Hanson) and Connelly et al. (US Pat. No. 6589229, henceforth Connelly).
Regarding claim 14, Tong discloses the device of claim 13 further comprising: a wireless receiver (see [0051], there is a control button which can be pressed for pairing the device with a smartphone application, meaning that there must be a component capable on the device capable of communicating with external devices, and that component is considered to be a wireless receiver as claimed) at the first component (see [0047], the control electronics including a button are included in the reusable component; while this is disclosed as being for an initial embodiment, it is understood to apply to the chosen embodiment as well since button 72 to control the electronics is present on the reusable part 12 in the initial embodiment and button 372 is a part of the reusable part 312 in the chosen embodiment and no other buttons are used); a reservoir (reservoir 320, fig. 9) at the second component (see fig. 9); a drug delivery mechanism (vents 362, fig. 18) at the second component (see fig. 18); and a controller (control electronics as in [0055]) configured to cause liquid from the reservoir to flow to the drug delivery mechanism (see [0042], [0043], and [0051]).
Tong does not disclose that the drug delivery mechanism is a cannula, or that controller is configured to cause liquid from the reservoir to flow to the cannula at least partially in response to a signal received by the wireless receiver. Hanson teaches a wearable drug delivery device (drug pump 10, fig. 1A) comprising a drug delivery mechanism which is a cannula (cannula of [0064], not shown), and that cannulas and transdermal patches similar to that of Tong are known alternative methods for drug delivery (see [0003], “More recently, parenteral delivery of liquid medicines into the body has been accomplished by administering bolus injections using a needle and reservoir, continuously by gravity driven dispensers, or via transdermal patch technologies”, where needles are cannulas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the transdermal patch delivery system of Tong with a cannula as in Hanson as Hanson teaches that cannulas and transdermal patch systems are replaceable by one of ordinary skill in the art depending on desired drug delivery characteristics for the drug to be delivered in a particular scenario, and further because making such a substitution would have yielded the same, predictable result of drug being delivered into a patient across the skin barrier as a result of a drive mechanism actuation from the device of Tong. Further modification which could need to be made would include needle insertion mechanisms instead of the vent system and transdermal patch of Tong, which could be integrated from the teachings of Hanson as well as needed and as understood by one of ordinary skill in the art.
Tong as modified by Hanson does not disclose the claimed controller which is configured to cause liquid from the reservoir to flow to the cannula at least partially in response to a signal received by the wireless receiver. Connelly teaches a wearable drug delivery device (device 30, fig. 1) comprising a controller (logic controller 58, fig. 10) which is configured to cause liquid from a reservoir (reservoir assembly between membranes 68 and 70, fig. 4, which has liquid as in Col. 9 lines 50-55) to flow to a cannula (delivery cannula 92, fig. 4) at least partially in response to a signal received by a wireless receiver (see Col. 5 lines 3-22, a wireless unit transmits control signals which control flow of the liquid medication).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the controller of Tong to be controlled by signals received by the wireless receiver to cause drug administration as in Connelly as Connelly teaches this control configuration to be an art effective way to control a microprocessor when a user wants to request drug delivery from a separate device (see at least fig. 11B) and because configuring the controller as claimed would have yielded the same, predictable result of having a system which could be controlled by the user to initiate a bolus of drug delivery and because such a configuration would provide a user with multiple methodologies of requesting a bolus to be delivered as they would have the option of pressing a button as in Tong as well as controlling the drug delivery device from an external wireless device to request a bolus.
Allowable Subject Matter
Claims 9-12 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 following is a statement of reasons for the indication of allowable subject matter:
Claim 9 requires a clasp configured to automatically secure the cam of claim 1 in the third position from the first position or the second position in response to a movement from the handle. Claim 1 (which claim 9 depends on) requires that the first position involves the cam extending outwards from the housing, the second position involves the cam extending inwards from the first position, and the third position involves the cam extending inwards from the second position, with full actuation being a movement from the first position to the second position. Thus, claim 9 requires that when the cam moves further inwards from the second position, the clasp is configured to automatically secure it in this more inward position. The prior art of record does not disclose or render obvious in combination this claimed latching structure.
In particular, Tong as relied upon for the rejection of claim 1 discloses the claimed third position as an intermediary between the first and second positions as claimed where latch 322 moves further inwards relative to the final second position, and thus an automatic clasp which secures this intermediary position would prevent latch 322 from functioning as intended as the device would not be able to achieve its second position and the reusable and disposable parts would never be able to function for drug delivery as they are biased away from each other and are only detachably held in place with each other by latching mechanisms. Thus, Tong does not disclose the claimed arrangement, and adding a feature to achieve the claim limitations would destroy the device of Tong.
Further, no other prior art (including the prior art cited below) discloses or renders obvious in combination these claimed features. While snap fits similar to the latch system of Tong are known in the art where there is a third position which has a cam moved inward from a fully actuated second position which is inward from an initial, outwardly extending position for latching pieces together, none of the prior art teaches a clasp to automatically hold the cam in this third, intermediate position.
Claims 10-12 are similarly objected to as allowable based on their dependency on, and thus requirement of the allowable subject matter of, objected to claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hulliger et al. (US 20220031940) is considered relevant prior art regarding a releasable latching arrangement (elements 22 and 23) with a handle which can be accessed through a skin contact surface with a similar interpretation to Tong relied on above but lacks the clasp of claim 9.
Moss et al. (US Pat. No. 5397222) is considered relevant prior art regarding the use of releasable snap fit latches which go through the three claimed positions in a pumping infusion device but lacks clasps for the third positions.
Lawless et al. (US Pat. No. 6231320) is considered relevant prior art regarding the use of a complex latching system with an initial outward position and a second inward position but lacks the claimed third position with a further inward extension of a latching system from a fully actuated second position, see at least the latching assembly shown in figs. 5 and 6.
Hanson et al. ‘400 (US 20120095400) is considered relevant prior art regarding use of a multipositional latching system to connect a disposable part and a reusable part of a wearable medical drug delivery device lacking the claimed three positions of the cam assembly.
Field et al. (US Pat. No. 5472317) is considered relevant prior art teaching a handle button which is accessible from outside of a housing and is actuatable to release a latching assembly from an actuated position but lacks the claimed clasp of claim 9.
Streit et al. (US 20210393871) is considered relevant prior art regarding a modular wearable drug delivery device which is detachable from itself but lacks the claimed latch system.
McKenzie et al. (US 20100049128) is considered relevant prior art regarding a modular wearable drug delivery device which is detachable from itself but lacks the claimed latch system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783