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.
Claims 1-6, 9-10, 12-23 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al (US 2020/0230358 A1) in view of Byrne-Cabot (WO 2011011436 A2).
Regarding claim 1, Devgon discloses a medical device comprising:
an instrument 260 having a proximal end and a distal end;
an instrument delivery device 210 (introducer) configured to moveably receive the instrument 260 and having:
an outer housing 220 having a proximal end, a distal end, and a sidewall therebetween defining an inner volume; and
an inner housing 265 having a proximal end comprising a grip 269 and a connector with the grip 269, a distal end, and a sidewall therebetween defining an inner volume, the inner housing coupled to the instrument and slidably received within the outer housing in a telescoping relationship (figs 22-24);
the distal end of the instrument delivery device 210 configured to couple the instrument delivery device to an intravenous line via lock 240 [0008]; and
wherein the inner housing 265 is configured to move relative to the outer housing to move the instrument between
a first position (fig 3), in which the inner housing 265 extends proximally from the outer housing 210 and in which the instrument 260 is disposed within the outer housing, and
a second position, in which a portion of the inner housing 265 is received within outer housing (fig 4) and in which the distal end of the instrument 260 is disposed beyond the distal end of the outer housing (fig 25) such that at least a first portion of the instrument 260 is disposed within the intravenous line when the instrument delivery device is coupled to the intravenous line.
Devgon discloses the invention substantially as claimed. However, it fails to disclose a clamp configured to reversibly occlude fluid flow through the inner housing.
Byrne-Cabot teaches, in figures 1-3, a clamp (36, 56) configured to reversibly occlude fluid flow through a tubing 34,52 between connectors 36,58 or 58,59. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Devgon by providing the clamp taught by Byrne-Cabot in order to pinch the inner housing inner volume (fluid pathway) as taught old and well known in the art.
Regarding claim 2, Devgon discloses the outer housing 220 comprises a lock
240 at the distal end thereof, the lock configured to couple the instrument delivery device 210 to an intravenous line (fig 5; abstract; [0008]).
Regarding claim 3, Devgon discloses a joint 216 ([0089], can be seen in fig 4) is arranged at the distal end of the outer housing.
Regarding claim 4, the joint is a rotating joint (threads, [0089]).
Regarding claim 5, Devgon further comprising a septum (seal, [0089-0090]) arranged at the distal end of the outer housing.
Regarding claim 6, further comprising a seal (seal, [0089]) arranged at the proximal end of the instrument.
Regarding claims 9-10, Devgon discloses the instrument is a catheter.
Regarding claims 12-13, Devgon/Byrne-Cabot discloses the invention substantially as claimed. Byrne-Cabot discloses the clamp 36,56 is positioned to block fluid flow through the inner housing, blood withdrawn from the intravenous catheter flows through the catheter and into the volume of the inner housing and/or the volume of the outer housing (figures 1-3); the clamp is positioned to allow fluid flow through the inner housing, blood withdrawn through the intravenous catheter flows through the catheter to the proximal end of the inner housing.
Regarding claim 14, Devgon discloses the inner housing is in fluid communication with the catheter 260, such that fluid flowing proximally from the catheter is received within the inner housing (fig 24).
Regarding claim 15, Devgon discloses the inner housing 265 further comprises a fluid conduit 268 (figs 25-28) in fluid communication with the catheter 260.
Regarding claim 16, Devgon discloses the fluid conduit 265 (figs 27-28) extends proximally beyond the proximal end of the inner housing.
Regarding claim 17, further comprising a fluid conduit ([0106]; the coupler 269 can be connected to fluid conduits such as a fluid reservoir, fluid source, syringe, evacuated container holder pump, and/or the like coupled to the proximal end of the inner housing 265 (at coupler 269).
Regarding claim 18, Devgon further comprising one or support 986 (figs 42-43; [0161-0164]) arranged within the outer housing 910 and configured to limit buckling of the instrument 960 as it is advanced through the outer housing 910.
Regarding claim 19, Devgon discloses in an alternative embodiment the inner housing 1086 is formed of a material with sufficient stiffness to limit and/or prevent buckling of the inner housing as it is advanced through the outer housing [0167]. Therefore, inner housing 265 can be made of the same material.
Regarding claim 20, Devgon discloses an inner diameter of the outer housing (figs 5-7, and 44) is configured such that buckling of the inner housing and/or instrument is limited and/or prevented when the inner housing is advanced through the outer housing.
Regarding claim 21, Devgon further comprising a seal (friction fit at 276 [0202]) arranged about an outer circumference of the instrument, and slidable with the instrument through the outer housing.
Regarding claim 22, further comprising one or more indicia arranged on instrument delivery device (210, fig 3, [0119, 0131]).
Regarding claim 23, Devgon discloses the one or more indicia are visual and/or tactile indicia [0119, 0131].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al (US 2020/0230358 A1) in view of Byrne-Cabot (WO 2011011436 A2), further in view of Burkholz et al (US 20190321590 A1).
Devgon/Byrne-Cabot discloses the invention substantially as claimed. However, it fails to disclose the medical device further comprising lubricant [liquid, 0090] arranged at one or more locations within the outer housing.
Burkholz teaches, ([0067]; figure 1B), that a silicon lubricant can be disposed between catheter 12 (inside outer housing 20) and septum 51. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Devgon/ Byrne-Cabot’s medical device by including a lubricant arranged at one or more locations within the outer housing taught by Burkholz since it would prevent friction between outer and inner housings and instrument during procedure and ease delivery of the instrument.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al (US 2020/0230358 A1) in view of Byrne-Cabot (WO 2011011436 A2), further in view of Devgon et al (US 10,076,272 B2).
Regarding claim 25, Devgon (‘358)/ Byrne-Cabot discloses the invention substantially as claimed. Devgon (‘358) discloses the apparatus/medical device 200 to be used with a peripheral intravenous catheter (PIV) system 105 (fig 2; not shown for figs 3-29). However, Devgon (‘358) does not teach the specifics of the system set forth in claim 25.
Devgon (‘272) teaches (in figures 9-14), a system 6000, comprising:
a catheter assembly 6400 comprising:
a catheter adapter 6300, comprising a distal end; a proximal end;
a lumen 6401 (fig 14) extending between the distal end and the proximal end; and
a side port 6420 arranged between the distal end and the proximal end, the side port in fluid communication with the lumen 6401;
a catheter secured to the distal end of the catheter adapter 6300 and extending distally from the catheter adapter 6300; and
a fluid conduit 6425 having a proximal end coupled to the side port and a distal end, the fluid conduit in fluid communication with the side port; and a medical device (introducer 6100). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Devgon (‘358)/ Byrne-Cabot system (medical device/introducer and PIV system) with the catheter assembly (PIV system) of Devgon (‘272) since such modification is a mere substitution of functionally equivalents parts.
Regarding claim 26, Devgon (‘358)/ Byrne-Cabot discloses the invention substantially as claimed. However, it fails to disclose the distal end of the inner housing has a larger diameter than the proximal end of the inner housing, and wherein the outer housing and the distal end of the inner housing are configured such that the inner housing cannot be pulled completely out of the inner housing.
Devgon (‘272) discloses in figures 56-60 an actuator 15570 (inner housing) having a distal end 15572 (fig 60) with a larger diameter than the proximal end of the inner housing forming a connection wherein the outer housing and the distal end of the inner housing are configured such that the inner housing cannot be pulled completely out of the inner housing (col 30 line 38 – col. 31, line 54). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Devgon (‘358)/ Byrne-Cabot medical device with the distal end larger diameter of Devgon (‘272) by incorporating this enlarged diameter into Devgon (358)’s inner housing 265 and actuator 270 connection (fig 24) to prevent the inner housing 265 from being pulled out of the inner housing from .
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection.
With respect to arguments about the clamp in previous claim 11, the claim did not have enough structure to differentiate from applicants. Devgon (‘358) had the structure as previously claimed as stated in the previous Office action of 07/22/2026.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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