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 § 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.
Claims 1, 2, 4, 10-12, 14, 17, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2017/0021137 to Cole.
Regarding claim 1, Cole teaches an insertion mechanism comprising a housing (106) comprising at least one release window (112) at a distal portion of the housing, a flexible firing arm (230), a button (200) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 8), a catheter hub (Fig. 7, portion above 220) fixed to a catheter, a needle hub (206) fixed to an insertion needle (204), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (212) being larger than an inside of the housing in a relaxed state (Fig. 12) and being compressed to a flexed state within the inside of the housing and engaging the catheter hub to the needle hub the while compressed (Figs. 7-8), a return spring (202) biasing the needle hub in the proximal direction (Fig. 13) and being compressed as the button moves distally (Fig. 11), wherein the firing arm interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0062]), wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally (Fig. 10) and the release and engagement clip becomes aligned with the release window (112), such that arms of the engagement and release clip engage the release window to prevent proximal movement of the engagement and release clip, thereby retaining the catheter hub in an inserted position (Fig. 10, arms 212 engage the release window 112 preventing proximal movement and retaining the catheter hub), and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 13).
Regarding claim 2, Cole teaches the insertion mechanism of claim 1 as shown above, Cole further teaching the needle hub surrounds the button (206 surrounds at least a portion of 200, see Figs. 3 and 5) and the housing (206/210 surrounds a portion of the upstanding portion of the housing to the left of 210 in Figs. 11, 13, and 14).
Regarding claim 4, Cole teaches the insertion mechanism of claim 1 as shown above, Cole further teaching the housing comprises two firing arms on opposite sides of the housing (230 are disposed in both instances of 214, Fig. 3).
Regarding claim 10, Cole teaches the insertion mechanism of claim 1 as shown above, Cole further teaching when the engagement and release clip is in the relaxed state and aligned with the release window the engagement and release clip prevents the catheter hub from moving in a proximal direction (Fig. 12).
Regarding claim 11, Cole teaches a method of inserting a catheter comprising the steps of providing a housing (106) comprising at least one release window (112) at a distal portion of the housing, providing a button (200) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 8), fixing a catheter hub (Fig. 7, portion above 220) to a catheter (Fig. 7), fixing a needle hub (206) to an insertion needle (204), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), inserting an engagement and release clip into inside of the housing in a compressed state (Fig. 7), engaging the catheter hub to the needle hub with the engagement and release clip in the compressed state (Fig. 7), providing a return spring (202) to bias the needle hub in the proximal direction (Fig. 13), the return spring being compressed as the button moves distally (Fig. 11), providing a firing arm (230) that interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0062]), permitting the engagement and release clip to expand toward its relaxed configuration when the button is pressed distally (Fig. 10) and the release and engagement clip becomes aligned with the release window (Fig. 12), and moving the needle hub to a final proximal position with the return spring when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 13).
Regarding claim 12, Cole teaches the method of inserting a catheter of claim 11 as shown above, Cole further teaching surrounding the housing (206/210 surrounds a portion of the upstanding portion of the housing to the left of 210 in Figs. 11, 13, and 14) and the button (206 surrounds at least a portion of 200, see Figs. 3 and 5) with the needle hub.
Regarding claim 14, Cole teaches the method of inserting a catheter of claim 11 as shown above, further comprising forming two firing arms on opposite sides of the housing (230 are disposed in both instances of 214, Fig. 3).
Regarding claim 17, Cole teaches a medicament infusion device comprising a device housing (100) comprising a medicament reservoir connected to a catheter ([0044]), a button housing (106) comprising at least one release window (112) at a distal portion of the housing, a flexible firing arm (230), a button (200) slidable within the button housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 8), a catheter hub (portion above 220) fixed to the catheter, a needle hub (206), fixed to an insertion needle (204), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (212) being larger than an inside of the housing in a relaxed stated and being compressed within the inside of the housing and engaging the catheter hub to the needle hub the compressed state (Fig. 8), a return spring (202) biasing the needle hub in the proximal direction and being compressed as the button moves distally (Fig. 11), wherein the firing arm interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0062]), wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 8), and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 13).
Regarding claim 18, Cole teaches the medicament infusion device of claim 17 as shown above, Cole further teaching the needle hub surrounds the button (206 surrounds at least a portion of 200, see Figs. 3 and 5) and the housing (206/210 surrounds a portion of the upstanding portion of the housing to the left of 210 in Figs. 11, 13, and 14).
Regarding claim 20, Cole teaches the medicament infusion device of claim 17, Cole further teaching the housing comprises two firing arms on opposite sides of the housing (230 are disposed in both instances of 214, Fig. 3).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-8, 10, 11, 13-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2017/0119959 to Cole et al. (“Cole2”) in view of U.S. Patent Publication No. 2017/0290533 to Antonio et al. (“Antonio”).
Regarding claim 1, Cole2 teaches an insertion mechanism (Figs. 7-11) comprising a housing (12/14/100) comprising at least one release window (110) at a distal portion of the housing, a firing mechanism (84/76), a button (26) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 10), a catheter hub (52) fixed to a catheter (28), a needle hub (94) fixed to an insertion needle (at 89), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (105) being larger than an inside of the housing (outer portion of 105 is larger than an innermost portion of 100) in a relaxed stated and being compressed to a flexed state within the inside of the housing (105 is flexed/compressed when passed across 100) and engaging the catheter hub to the needle hub while compressed (36 keeps 56 and 94 together), a return spring (106) biasing the needle hub in the proximal direction and being compressed as the button moves distally (Figs. 7-8), wherein the firing mechanism interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0054]), wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 10), such that arms of the engagement and release clip engage the release window to prevent proximal movement of the engagement and release clip, thereby retaining the catheter hub in an inserted position (Fig. 10, arms 105, [0057], engage window 110 thereby preventing proximal movement and retaining the catheter hub), and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 11), but does not show an arm-type firing mechanism.
Antonio teaches a firing mechanism using a flexible firing arm (5142, [0425]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the detent-type firing mechanism of Cole2 with the arm-type firing mechanism of Antonio to yield the predictable result of providing releasable firing mechanism in a needle insertion device. Both firing mechanisms providing the same function and merely being art-recognized alternatives.
Regarding claim 3, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching the needle hub comprises at least one opening (opening formed by 94) through which the button may move.
Regarding claim 4, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Antonio further teaching a housing comprises two firing arms (5142 “A”, Fig. 52A) on opposite sides of the housing.
Regarding claim 5, Cole2 and Antonio teach the insertion mechanism of claim 3 as shown above, Cole2 further teaching the needle hub comprises at least one opening (opening formed by 94) through which the button may move, but does not explicitly show a second opening.
However, it has been held that the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04). In the instant case the mere duplication of an opening and/or an associated button is a merely design variant absent any unexpected results.
Regarding claim 6, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching the engagement and release clip comprises two arms joined by a connecting member (100, [0052]).
Regarding claim 7, Cole2 and Antonio teach the insertion mechanism of claim 6 as shown above, Cole2 further teaching the connecting member comprises an opening that receives the insertion needle and the catheter (Fig. 7).
Regarding claim 8, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching a septum (62) and wedge (56) connected to the catheter, the insertion needle piercing the septum (Fig. 7).
Regarding claim 10, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching when the engagement and release clip (105) is in the relaxed state and aligned with the release window the engagement and release clip prevents the catheter hub from moving in a proximal direction (Fig. 10).
Regarding claim 11, Cole2 teaches a method of inserting a catheter comprising the steps of providing a housing (12/14/100) comprising at least one release window (110) at a distal portion of the housing, providing a button (26) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 10), fixing a catheter hub to a catheter (Fig. 7), fixing a needle hub to an insertion needle (Fig. 7), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), inserting an engagement and release clip into inside of the housing and flexing the engagement and release clip in a compressed state (105 is flexed/compressed when passed across 100), engaging the catheter hub to the needle hub with the engagement and release clip in the compressed state (36 keeps 56 and 94 together in Fig. 7), providing a return spring (106) to bias the needle hub in the proximal direction, the return spring being compressed as the button moves distally (Figs. 7-9), providing a firing mechanism that interferes with movement of the button in a distal direction until a predetermined force is applied to the button (84/76), permitting the engagement and release clip to expand toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 10), such that arms of the engagement and release clip engage the release window to prevent proximal movement of the engagement and release clip, thereby retaining the catheter hub in an inserted position (Fig. 10, arms 105, [0057], engage window 110 thereby preventing proximal movement and retaining the catheter hub), and moving the needle hub to a final proximal position with the return spring when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 11), but does not teach an arm-type firing mechanism.
Antonio teaches a firing mechanism using a flexible firing arm that flexes to release a button (5142, [0425]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the detent-type firing method of Cole2 with the arm-type firing method of Antonio to yield the predictable result of providing releasable firing mechanism in a needle insertion device. Both firing methods providing the same function and merely being art-recognized alternatives.
Regarding claim 13, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Cole2 further teaching the step of forming at least one opening in the needle hub (opening formed by 94) through which the button may move.
Regarding claim 14, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Antonio further teaching forming two firing arms (5142 “A”, Fig. 52A) on opposite sides of the housing.
Regarding claim 15, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Cole2 further teaching the step of forming at least one opening (opening formed by 94) through which the button may move in the needle hub, but does not explicitly show a second opening.
However, it has been held that the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04). In the instant case the mere duplication of an opening and/or an associated button is a merely design variant absent any unexpected results.
Regarding claim 16, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Cole2 further teaching forming the engagement and release clip with two arms joined by a connecting member (100, [0052]).
Regarding claim 17, Cole2 teaches medicament infusion device (Fig. 1) comprising a medicament reservoir (4) connected to a catheter (28), a housing (12/14/100) comprising at least one release window (110) at a distal portion of the housing, a firing mechanism (84/76), a button (26) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 10), a catheter hub (52) fixed to the catheter, a needle hub (94) fixed to an insertion needle (at 89), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (105) being larger than an inside of the housing (outer portion of 105 is larger than an innermost portion of 100) in a relaxed stated and being flexed to be compressed within the inside of the housing (105 is flexed/compressed when passed across 100) and engaging the catheter hub to the needle hub (36 keeps 56 and 94 together) in the compressed state, a return spring (106) biasing the needle hub in the proximal direction and being compressed as the button moves distally (Figs. 7-8), wherein the firing mechanism interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0054]), wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 10), such that arms of the engagement and release clip engage the release window to prevent proximal movement of the engagement and release clip, thereby retaining the catheter hub in an inserted position (Fig. 10, arms 105, [0057], and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 11), but does not show an arm-type firing mechanism.
Antonio teaches a firing mechanism using a flexible firing arm (5142, [0425]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the detent-type firing mechanism of Cole2 with the arm-type firing mechanism of Antonio to yield the predictable result of providing releasable firing mechanism in a needle insertion device. Both firing mechanisms providing the same function and merely being art-recognized alternatives.
Regarding claim 19, Cole2 and Antonio teach the medicament infusion device of claim 17 as shown above, Cole2 further teaching the needle hub comprises at least one opening (opening formed by 94) through which the button may move.
Regarding claim 20, Cole2 and Antonio teach the medicament infusion device of claim 17 as shown above, Antonio further teaching the housing comprises two firing arms (5142 “A”, Fig. 52A) on opposite sides of the housing.
Regarding claim 21, Cole2 and Antonio teach the medicament infusion device of claim 19 as shown above, Cole2 further teaching the needle hub comprises at least one opening (opening formed by 94) through which the button may move.
However, it has been held that the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04). In the instant case the mere duplication of an opening and/or an associated button is a merely design variant absent any unexpected results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cole2 and Antonio as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2018/0050155 to Avery et al. (“Avery”).
Regarding claim 9, Cole2 and Antonio teach the insertion mechanism of claim 1 as show above, but do not teach the translucent button.
Avery teaches a button comprising a translucent button face (70, [0165]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the button of Cole2 to be transparent as taught by Avery to yield the predictable result of allowing the user to see components beneath the button for confirmation of actuation of the device. Once modified, the button of Cole2, Antonio, and Avery would allow the needle hub to be visible when the insertion mechanism has deployed successfully.
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant's arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. Regarding the Cole reference, Applicant makes a general argument that Cole fails to teach the structure recited in claims 1, 11, and 17. Examiner respectfully disagrees. Regarding at least the new amendments, the compressed state of clip 212 in Fig. 7 is the same as a flexed state since the clips subsequently expand into a relaxed state, and the arms 212 engage the release window 112 in Fig. 10 which prevents proximal movement and retains the catheter hub.
Regarding the Cole2 reference, Applicant argues that the detent Cole2 is not flexed into a compressed state, expand into a relaxed state, and that the button structure retains the catheter hub 36, not the detent. Examiner respectfully disagrees. When detent 105 passes 100 as shown between Figs. 9 and 10, compression or flexure, even if brief or momentary, occurs as a result of movement along the inclined surfaces 102/104; it is noted that the claim language does not exclude a momentary flexure. After the albeit brief compressed state, the expansion of detent 105 back into the original state as shown in Fig. 10 demonstrates the relaxed state. Lastly, as explained in [0055] and shown in Fig. 10, the position of the detent in Fig. 10 locks the catheter hub while releasing the needle carrier. The rejections stand.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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