DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 9-20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by US 20120041392 A1 to Donawick.
As to claim 9, Donawick discloses an apparatus, comprising:
an introducer (118) coupleable to a peripheral intravenous line (702, 712 Fig. 7), the peripheral intravenous line being at least partially insertable into a vein of a patient ([0059]); and
a catheter (128, 102) movable between a first position inside the introducer and proximal to the peripheral intravenous line (Figs. 1 and 7 illustrate catheter 128/102 proximal to the PIV line 702, 712, yet inside introducer 118; 128 is erroneously labeled 114 in Fig. 7) and a second, locked position at least partially outside the introducer such that a distal end of the catheter is distal to the peripheral intravenous line (Fig. 8 illustrates catheter 128/102 both distally partially outside of the introducer and within and extending through PIV line 702/712), a proximal end of the catheter disposed in the introducer and proximal to the peripheral intravenous line when the catheter is in the second position (Fig. 8 illustrates 128/102 in 118 in the second position while also proximal 702/712).
As to claim 10, Donawick discloses the apparatus of claim 9, further comprising: an actuator (106) coupled to the proximal end portion of the catheter and movable along a fixed length of the introducer to move the catheter between the first position and the second position ([0060]).
As to claim 11, Donawick discloses the apparatus of claim 10, wherein the introducer defines a slot (414), the actuator being movable within the slot along the fixed length of the introducer ([0060]).
As to claim 12, Donawick discloses the apparatus of claim 9, wherein a distal end portion of the introducer includes a lock (129) that is coupleable to one of a first port and a second port of an adapter ([0041], [0056], [0060]).
As to claim 13, Donawick discloses the apparatus of claim 9, further comprising: an adapter with a lock at a distal end portion of the introducer and at least one of a first port or a second port of the peripheral intravenous line ([0041], [0056], [0060]).
As to claim 14, Donawick discloses the apparatus of claim 13, wherein the catheter in the second position is extendable through the adapter and the peripheral intravenous line when the adapter is coupled between the lock of the introducer and the peripheral intravenous line such that (i) a distal end of the catheter is distal to the peripheral intravenous line and (ii) a proximal end of catheter is disposed in the introducer and proximal to the adapter (distal portion of catheter 128 is moved to pass through line 712; “the length is chosen so that the length of specialized cannula 128 (and necessarily the lengths of sheath 118 and flexible rod 116) is sufficient to pass a point of constriction or obstruction in a blood vessel once the specialized cannula is inserted.” [0056]; “specialized cannula 128 is inserted through a female catheter hub 702 of a standard I.V. catheter that has been previously inserted into a blood vessel.” [0056]).
As to claim 15, Donawick discloses the apparatus, comprising:
an introducer (118) coupleable to an adapter (129) connected to a port of a peripheral intravenous line (702, 712 Fig. 7) that is at least partially insertable into a vein of a patient ([0059]); and
a catheter (128, 102) movable between a first position inside the introducer and proximal to the adapter (Figs. 1 and 7 illustrate catheter 128/102 proximal to the adapter 129, yet inside introducer 118; 128 is erroneously labeled 114 in Fig. 7) and a second, locked position partially outside the introducer, a proximal end of the catheter in the second position disposed in the introducer and proximal to the adapter (Fig. 8 illustrates 128/102 in 118 in the second position while also proximal 702/712 and 129).
As to claim 16, Donawick discloses the apparatus of claim 15, further comprising: an actuator (106) coupled to the proximal end portion of the catheter and movable along a fixed length of the introducer to move the catheter between the first position and the second position ([0060]).
As to claim 17, Donawick discloses the apparatus of claim 16, wherein the introducer defines a slot (414), the actuator being movable within the slot along the fixed length of the introducer ([0060]).
As to claim 18, Donawick discloses the apparatus of claim 15, wherein the introducer is configured to transition between a first configuration and a second configuration to move the catheter between the first position (slot 414 provides a means for transitioning between a first configuration (actuator 106 near proximal end of slot 414) and a second configuration (actuator 106 moved distally along slot 414 from first configuration).
As to claim 19, Donawick discloses the apparatus of claim 18, where the introducer has a first length when in the first configuration and a second length less than the first length when in the second configuration (e.g., the claim merely sets forth a second length being less than a first length, where annotated Fig. 6, below, shows a first and second length, the second length being less than the first length).
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As to claim 20, Donawick discloses the apparatus of claim 15, wherein the adapter includes at least one of a first port and a second port, in which the peripheral intravenous line is coupleable to at least one of the first port and the second port ([0041], [0056], [0060]).
Claims 1, 4, 5, 9, 15, 18 and 19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 8,808,246 B2 to Cabot et al. (hereinafter, Cabot).
As to claim 1, Cabot discloses an apparatus, comprising:
an introducer (130) coupleable to a peripheral intravenous line (104, 144), the peripheral intravenous line being at least partially insertable into a vein of a patient (col. 7, ll. 13-21); and
a catheter (102) movable from a first position inside the introducer and outside the peripheral intravenous line (as best seen in Fig. 6A) to a second, locked position at least partially outside the introducer and extending through the peripheral intravenous line (as best seen in Fig. 6B), a proximal end of the catheter disposed in the introducer when the catheter is in the first position and the second position (the proximal end of catheter 102 can be seen covered by the introducer 130 in both Figs. 6A and 6B).
As to claim 4, Cabot discloses the apparatus of claim 1, wherein the introducer is configured to transition between a first configuration and a second configuration to move the catheter between the first position and the second position (as seen in movement between Fig. 6A and 6B).
As to claim 5, Cabot discloses the apparatus of claim 4, wherein the introducer has a first length when in the first configuration and a second length less than the first length when in the second configuration (as seen in movement between Fig. 6A and 6B).
As to claim 9, Cabot discloses an apparatus, comprising:
an introducer (130) coupleable to a peripheral intravenous line (104, 144), the peripheral intravenous line being at least partially insertable into a vein of a patient (col. 7, ll. 13-21); and
a catheter (102) movable between a first position inside the introducer and proximal to the peripheral intravenous line (as best seen in Fig. 6A) and a second, locked position at least partially outside the introducer such that a distal end of the catheter is distal to the peripheral intravenous line (as best seen in Fig. 6B), a proximal end of the catheter disposed in the introducer and proximal to the peripheral intravenous line when the catheter is in the second position (the proximal end of catheter 102 can be seen covered by the introducer 130 in both Figs. 6A and 6B while remaining also proximal to the peripheral intravenous line 104, 144).
As to claim 15, Cabot discloses an apparatus, comprising:
an introducer (144) coupleable to an adapter (118) connected to a port (122) of a peripheral intravenous line (104) that is at least partially insertable into a vein of a patient (col. 7, ll. 13-21); and
a catheter (102) movable between a first position inside the introducer and proximal to the adapter (as best seen in Fig. 6A) and a second, locked position partially outside the introducer, a portion of the catheter in the second position extendable through the adapter and the peripheral intravenous line to place a distal end of the catheter distal to the peripheral intravenous line (as best seen in Fig. 6B), a proximal end of the catheter in the second position disposed in the introducer and proximal to the adapter (the proximal end of catheter 102 can be seen covered by the introducer 130 in both Figs. 6A and 6B while remaining also proximal to the adapter 118).
As to claim 18, Cabot discloses the apparatus of claim 15, wherein the introducer is configured to transition between a first configuration and a second configuration to move the catheter between the first position and the second position (as seen in movement between Fig. 6A and 6B).
As to claim 19, Cabot discloses the apparatus of claim 18, wherein the introducer has a first length when in the first configuration and a second length less than the first length when in the second configuration (as seen in movement between Fig. 6A and 6B).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 2, 3, 7 and 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cabot in view of Donawick.
Regarding Claims 2 and 3, Cabot discloses the catheter and collapsible introducer (bellows) of Claim 1, but does not expressly disclose an actuator movable along a fixed length of the introducer within a slot. However, Donawick teaches a catheter placement apparatus comprising an actuator (pusher tab 106) coupled to the proximal end portion of the catheter (pushed body 103) and movable along a fixed length of the introducer (sheath 118) to move the catheter. Donawick further teaches that the introducer defines a slot (track 414), wherein the actuator in moveable within the slot. Donawick teaches that the specialized cannula “is kept from kinking or otherwise distorting… by the flexible rod 116” (paragraph [0060]) and the sheath structure. The slot (track 414) allows the pusher/actuator to interface with the catheter while maintaining this protection. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the introducer of Cabot by incorporating the actuator and slot mechanism of Donawick, because Donawick teaches at paragraph [0060] that such a structure prevents kinking and distorting of the cannula during advancement. Applying this to Cabot would advantageously provide rigid guidance to the collapsible bellows sheath (130), ensuring the catheter advances linearly without bucking the soft bellows material.
Regarding Claim 7 and 8, Cabot discloses the apparatus of Claim 1 but does not expressly disclose an adapter with multiple ports and lock as claimed. However, Donawick teaches an adapter (modified male Luer coupling 129) with a lock at a distal end portion of the introducer. Donawick teaches that this adapted includes a portion configured to couple with the peripheral intravenous line (female Luer lock hub 702). Donawick further teaches that the lock of the introducer is coupled to the adapter, and the catheter (128) in the second position extends through the adapter and the peripheral intravenous line such that a distal end of the catheter is distal to the peripheral intravenous line. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the distal end of Cabot’s introducer to include the adapter and lock mechanism tach by Donawick, as Donawick teaches at paragraphs [0038] and [0056] this would have enabled the device to couple to and access vasculature through a “standard” peripheral intravenous line that is already in place (“previously inserted”), thereby avoiding the need for a new venipuncture or a proprietary interface.
Response to Arguments
Applicant’s arguments with respect to Independent Claim 1.
The Applicant argues that Donawick fails to disclose an introducer “collapsible in an axial direction”, asserting that the track 414 in Donawick collapses in a radial direction. The Examiner maintains the rejection of Claim 1 under 35 U.S.C. 102(b) as anticipated by Cabot. The Applicant’s arguments regarding Donawick’s lack of axial collapse are not persuasive because Claim 1 stands rejected over Cabot, which clearly discloses this feature. As set forth in the previous Office Action, Cabot discloses an introducer (sheath 130) comprising a bellows or concertina structure. This structure is explicitly configured to collapse in an axial direction (shortening its length) as it transitions from a first configuration (Fig. 6A) to a second configuration (Fig. 6B). Thus, Cabot anticipates the “collapsible in an axial direction” limitation.
The Applicant argues that Cabot fails to disclose the “proximal end of the catheter disposed in the introducer” when in the second position. Specifically, the Applicant argues that Fig. 6B, the proximal end 106 extends proximally from the sheath 130 and is therefore “no longer disposed in the introducer”. The Examiner respectfully disagrees. The Applicant’s argument relies on a narrow interpretation of “catheter” and “disposed in”. Under BRI, the “catheter” is reasonably interpreted as the elongate tubular member 102 capable of fluid or instrument delivery. The “proximal end” of this catheter tube 102 is the point at which it terminates and connects to the actuator/hub 106. In the second position (Fig. 6B), the sheath 103 (introducer) is axially compressed. However, the proximal terminus of the actual catheter tube 103 remains situated at the proximal interface of the sheath 103. The term “disposed in the introducer” is broadly interpreted to mean situated within the assembly or protected boundary defined by the introducer. In Cabot, the proximal end of the catheter tube 102 is anchored to the proximal cap of the bellows assembly. While the user-manipulated handle (106) may extend proximally away from the sheath to allow for actuator, the functional proximal end of the catheter tube itself remains within the proximal boundary of the introducer assembly. Consequently, Cabot anticipates the limitation as the catheter tube 102 is contained between the distal and proximal ends of the introducer sheath 130 in both positions.
Applicant’s arguments with respect to Independent Claims 9 and 16.
The Applicant argues that Donawick fails to teach the proximal end of the catheter being disposed in the introducer and proximal to the PIV/adapter. The Applicant asserts that the “pushed body 102” is not part of the catheter (cannula 128), and thus the proximal end of the “catheter” (128) is distal to the hub in Fig. 8. The Examiner maintains the rejection based on Donawick. The argument that the pusher body 102 is distinct from the catheter is not persuasive.
The pusher body 102 is a tubular member physically connected to the cannula 128 to form a continuous elongate body for advancing the device. Without the pusher body 102, the cannula 129 cannot function as intended. Under BRI, a “catheter” is broadly defined as a tubular medical device. The assembly of the cannula 129 and the tubular pusher body 102 collectively forms the “catheter” recited in the claims. When the pusher body 102 is properly considered part of the catheter assembly, the “proximal end” of this assembly is the proximal end of the pusher body (at actuator 106). As show in Donawick Fig. 8 (and even in the Applicant’s annotation), the actuator 106 and the proximal portion of pusher body 102 remain disposed in the introducer (sheath 118) and proximal to the peripheral intravenous line (hub 702/712). Therefore, Donawick anticipates the limitations of Claim 9 and 15 regarding the proximal end position.
The Applicant repeats the argument that Cabot’s proximal end 106 is not “in the introducer” or “proximal to the adapter” in the second position. The Examiner notes that Claims 9 and 15 are rejected under Donawick (as discussed above) and Cabot. Regarding Cabot, the Examiner relies on the same reasoning provided for Claim 1. Under BRI, the proximal end of the catheter tube 102 remains at the proximal interface of the introducer sheath 130. Furthermore, this location is clearly proximal to the placed catheter/PIV (104 and adapter components shown in Fig. 6B. Thus, Cabot also anticipates these claims.
The Applicant’s arguments have been fully considered, however, Claim 1 remains anticipated by Cabot, which disclosed the “axial collapse” (bellows) and the catheter proximal end disposed within the introduced assembly and Claims 9 and 15 remain anticipated by Donawick (and Cabot), where the pusher body 102 is reasonably interpreted as part of the catheter, keeping the proximal end disposed in the introducer and proximal to the PIV.
Accordingly, the rejections are maintained and made FINAL.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791