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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 19, 2026 has been entered.
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.
Claims 1, 4, 11, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200016374) (cited by Applicant) (previously cited) in view of Funk (US 20200406008) (cited by Applicant).
Regarding claim 1, Burkholz teaches a catheter extension set (Fig, 1C, 10), comprising: a housing (14), comprising a distal end (16), a proximal end (18), and a lumen (Paragraph [0038] lumen of delivery device 10) extending through the distal end of the housing; a distal connector (40) coupled to the distal end of the housing and configured to couple to a catheter assembly; (Paragraph [0044]; see Fig. 6); a handle (advancement tab 26) (Paragraph [0035]); an advancement element (guide feature 22) comprising a U-shaped channel (24) and a pocket (space occupied by guide feature 22), wherein the advancement element is disposed within the lumen (i.e., interior of housing); (Paragraph [0036]); an instrument extending through the U-shaped channel, (Paragraph [0036]), wherein the instrument comprises a fixed first end (30) and a second end (28), (Paragraph [0037]), wherein in response to distal movement of the handle a first distance, the second end is configured to advance distally a second distance, wherein the second distance is at least twice the first distance (Paragraph [0054]).
However, Burkholz does not teach “a translation feature disposed outside of the lumen between the handle and an outer surface of the housing and within the pocket, such that in response to distal movement of the handle the first distance, the translation feature moves distally outside of the lumen and relative to the outer surface of the housing, the advancement element moves distally within the lumen the first distance, and the second end of the instrument advances distally the second distance.”
Funk, in a related field of endeavor, teaches a catheter device (Figs. 3-4) comprising a translation feature (251) disposed outside of the lumen between the handle (250) and an outer surface of the housing (210) and within the pocket (actuator 250 sits in a slot 213 that resembles a pocket), such that in response to distal movement of the handle the first distance (Figs. 3-4), the translation feature (251) moves distally outside of the lumen and relative to the outer surface of the housing (210), the advancement element (252) moves distally within the lumen (Paragraph [0042] catheter 230 defines a lumen that extends through the proximal end portion 231 and the distal end portion 232) the first distance (D3), and the second end (232) of the instrument advances distally the second distance (D4). (Figs. 3-4; Paragraphs [0047]-[0048], [0050]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the catheter extension set of Burkholz to teach “a translation feature disposed outside of the lumen between the handle and an outer surface of the housing and within the pocket, such that in response to distal movement of the handle the first distance, the translation feature moves distally outside of the lumen and relative to the outer surface of the housing, the advancement element moves distally within the lumen the first distance, and the second end of the instrument advances distally the second distance” as taught by Funk. Doing so provides a catheter with an actuating mechanism that moves freely without kinking, bending, binding, and/or otherwise undesirably deforming, thus creating a catheter being more “pushable” (e.g., able to be advanced without undesired reconfiguration) from the first position to the second position. (Paragraph [0046]).
Regarding claim 4, Burkholz teaches wherein the housing (14) further comprises another lumen, wherein the other lumen extends from the distal end of the housing to the proximal end of the housing and is configured for fluid flow therethrough. (Paragraph [0052] annular space between inner diameter of catheter 12 and outer diameter of guidewire 34).
Regarding claim 11, Burkholz teaches wherein a proximal end (18) of the lumen (Paragraph [0038] lumen of delivery device 10) is closed. (See Fig. 2A).
Regarding claim 25, Burkholz does not teach “wherein in response to the distal movement of the handle the first distance, the translation feature moves distally the first distance along the outer surface of the housing”.
Funk teaches wherein in response to the distal movement of the handle (250) the first distance, the translation feature (251) moves distally the first distance along the outer surface of the housing. (Figs. 3-4).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the catheter extension set of Burkholz to teach “wherein in response to the distal movement of the handle the first distance, the translation feature moves distally the first distance along the outer surface of the housing”. Doing so provides a catheter with an actuating mechanism that moves freely without kinking, bending, binding, and/or otherwise undesirably deforming, thus creating a catheter being more “pushable” (e.g., able to be advanced without undesired reconfiguration) from the first position to the second position. (Paragraph [0046]).
Claims 2 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Funk, further in view of Devgon (US 20170216564) (cited by Applicant) (previously cited).
Regarding claim 2, Burkholz does not teach “wherein the handle does not contact the housing”.
Devgon, in a related field of endeavor, teaches a fluid transfer device (Figs. 5) wherein the handle (first portion 271, tab 272 of actuator 270) does not contact the housing (external members 220, 230 of introducer 210). (See Figs. 17, 19-20).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “wherein the handle does not contact the housing” as taught by Devgon. Doing so enables movement of the actuator relative to introducer with substantially less friction. (Paragraph [0089]).
Regarding claim 5, Burkholz does not teach “an elastomeric seal disposed within the distal connector or a distal end of the housing, wherein the instrument is configured to extend through the elastomeric seal, wherein the elastomeric seal is positioned to allow distal fluid flow into the other lumen but not the lumen.”
Devgon teaches a fluid transfer device (Figs. 11-12) comprising an elastomeric seal (Paragraph [0068])) disposed within the distal connector or a distal end of the housing (external members 220, 230 of introducer 210), wherein the instrument (catheter 260) is configured to extend through the elastomeric seal, wherein the elastomeric seal is positioned to allow distal fluid flow into the other lumen (first portion 214 of inner volume 213) but not the lumen (second portion 215 of inner volume 213). (Paragraph [0071]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “an elastomeric seal disposed within the distal connector or a distal end of the housing, wherein the instrument is configured to extend through the elastomeric seal, wherein the elastomeric seal is positioned to allow distal fluid flow into the other lumen but not the lumen” as taught by Devgon. Doing so provides a mechanism that can limit and/or substantially prevent contamination of the catheter disposed therein.
Regarding claim 6, Burkholz does not teach “a blood collection device in fluid communication with the distal connector and the other lumen”.
Devgon teaches a blood collection device in fluid communication with the distal connector (240) and the other lumen (first portion 214 of inner volume 213). (Figs. 4, 16; Paragraph [0085] the proximal end portion 266 of the secondary catheter 265 is coupled to and/or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidically couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, fluid source, syringe, evacuated container holder).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “a blood collection device in fluid communication with the distal connector and the other lumen” as taught by Devgon. Doing so establishes fluid communication between the reservoir, source, pump, etc. and the catheter. (Paragraph [0085]).
Regarding claim 7, Burkholz does not teach wherein the blood collection device comprises “a syringe or a sharp cannula configured to receive an evacuated blood collection tube”.
Devgon teaches wherein the blood collection device comprises “a syringe or a sharp cannula configured to receive an evacuated blood collection tube”. (Paragraph [0085] the coupler 269 is configured to physically and fluidically couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, fluid source, syringe, evacuated container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), pump, and/or the like.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to teaches wherein the blood collection device comprises “a syringe or a sharp cannula configured to receive an evacuated blood collection tube”. Doing so establishes fluid communication between the collection device and the evacuated tube such that sterile storage of the sample is achieved.
Regarding claim 8, Burkholz does not teach “a proximal connector coupled to a proximal end of the housing”.
Devgon teaches a proximal connector (coupler 269) coupled to a proximal end of the housing. (Figs. 16, 22).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to teaches wherein the blood collection device comprises “a proximal connector coupled to a proximal end of the housing”. Doing so provides a fluid communication between the catheter and the collection device. (Paragraph [0085]).
Regarding claim 9, Burkholz does not teach “a blood collection device coupled to the proximal connector”.
Devgon teaches a blood collection device coupled to the proximal connector (269). (Figs. 4, 16; Paragraph [0085] the proximal end portion 266 of the secondary catheter 265 is coupled to and/or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidically couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, fluid source, syringe, evacuated container holder).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “a blood collection device coupled to the proximal connector” as taught by Devgon. Doing so establishes fluid communication between the reservoir, source, pump, etc. and the catheter. (Paragraph [0085]).
Regarding claim 10, Burkholz as modified does not teach “wherein the handle comprises a gap, wherein the housing further comprises another lumen, wherein the other lumen extends from the distal end of the housing to the proximal end of the housing and is configured for fluid flow therethrough, wherein the other lumen is aligned with the gap, wherein the other lumen is disposed on top of the lumen.”
Devgon teaches wherein the handle (first portion 271, tab 272 of actuator 270) comprises a gap, (See Figs. 11-12 and 19-20, space between wall 277 of actuator 270 and inner surface 223 of introducer 210; Paragraph [0070]) wherein the housing further comprises another lumen (opening 276), wherein the other lumen (Figs. 11-12, first portion 214 of inner volume 213) extends through the distal end of the housing and the proximal end of the housing and is configured for fluid flow therethrough, wherein the other lumen is aligned with the gap, (See Figs. 19-20), wherein the other lumen is disposed on top of the lumen (second portion 215 of inner volume 213). (Figs. 11-12; Paragraph [0071]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “wherein the handle comprises a gap, wherein the housing further comprises another lumen, wherein the other lumen extends from the distal end of the housing to the proximal end of the housing and is configured for fluid flow therethrough, wherein the other lumen is aligned with the gap, wherein the other lumen is disposed on top of the lumen” as taught by Devgon. Doing so provides a structure of the introducer-actuator mechanism that can protect and/or isolate the catheter from a volume outside of the introducer, which in turn, can limit and/or substantially prevent contamination of the catheter. (Paragraph [0093]).
Claim 3, 12 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Funk, further in view of Higgins (US 20140316448) (previously cited).
Regarding claim 3, Burkholz does not teach “wherein portions of the housing configured to be contacted by the translation feature are flexible.”
Higgins, in a related field of endeavor, teaches a handheld guidewire loader (Fig. 2A, device 100) wherein portions of the housing configured to be contacted by the translation feature are flexible. (Figs. 2A, 2C; Paragraph [0028] compression wheels 110 are disposed within the upper portion 104 of the housing 100; housing 102 may comprise a flexible material)
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “wherein portions of the housing configured to be contacted by the translation feature are flexible” as taught by Higgins. Doing so enables the housing to conform to the forces of the translation feature.
Regarding claim 12, Burkholz does not teach “an additional translation feature disposed on an opposite side of the housing from the translation feature and between the outer surface of the housing and the handle, wherein the additional translation feature is configured such that in response to distal movement of the handle the first distance, the additional translation feature moves distally outside of the lumen and relative to the outer surface of the housing.”
Higgins teaches a handheld guidewire loader (Fig. 2A, device 100) comprising an additional translation feature (driving wheels 120, 122) disposed on an opposite side of the housing (110) from the translation feature (compression wheels 110) and between the outer surface of the housing and the handle (Fig. 1, handle 10). (Paragraph [0028]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz to teach “an additional translation feature disposed on an opposite side of the housing from the translation feature and between the outer surface of the housing and the handle,” as taught by Higgins. Doing so provides a mechanism to grip the guide wire and provide a force that helps pull the guide into the device. (Paragraph [0030]).
In addition, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified by Higgins to teach “wherein the additional translation feature is configured such that in response to distal movement of the handle the first distance, the additional translation feature moves distally outside of the lumen and relative to the outer surface of the housing”. Doing so provides a secondary translation feature along a longitudinal axis of the housing that allows for independent control and articulation of a guidewire. (Paragraph [0028]).
Regarding claim 21, Burkholz as modified does not teach “wherein the translation feature is configured to create localized compression of the housing to push the advancement element distally in response to distal movement of the handle.”
Higgins teaches wherein the translation feature (110) is configured to create localized compression of the housing to push the advancement element (180) distally in response to distal movement of the handle. (Figs. 2A, 2C; Paragraph [0028] compression wheels 110 are disposed within the upper portion 104 of the housing 100; housing 102 may comprise a flexible material; Paragraph [0030] Compression wheels 110 may be operably connected to a loading switch 180. When a downward force is applied to the switch 180 (i.e. the switch 180 is engaged), the compression wheels 110 move downwardly into the slot 108 to engage with a guide wire that is inserted into the slot.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “wherein the translation feature is configured to create localized compression of the housing to push the advancement element distally in response to distal movement of the handle” as taught by Higgins. Doing so engaging the guide wire and provide a force that helps pull the guide into the device. (Paragraph [0030]).
Regarding claim 22, Burkholz as modified does not teach “wherein portions of the housing configured to be contacted by the translation feature are flexible, and wherein the translation feature is configured to compress the flexible portions of the housing such that the housing extends into the pocket.”
Higgins teaches wherein portions of the housing (100) configured to be contacted by the translation feature (110) are flexible, and wherein the translation feature is configured to compress the flexible portions of the housing such that the housing extends into the pocket. (Figs. 2A, 2C; Paragraph [0028] compression wheels 110 are disposed within the upper portion 104 of the housing 100; housing 102 may comprise a flexible material; Paragraph [0030] Compression wheels 110 may be operably connected to a loading switch 180. When a downward force is applied to the switch 180 (i.e. the switch 180 is engaged), the compression wheels 110 move downwardly into the slot 108 to engage with a guide wire that is inserted into the slot.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “wherein portions of the housing configured to be contacted by the translation feature are flexible, and wherein the translation feature is configured to compress the flexible portions of the housing such that the housing extends into the pocket” as taught by Higgins. Doing so engaging the guide wire and provide a force that helps pull the guide into the device. (Paragraph [0030]).
Regarding claim 23, Burkholz as modified does not teach “wherein the translation feature is configured to push the advancement element distally in response to distal movement of the handle when the housing is compressed into the pocket.”
Higgins teaches wherein the translation feature (110) is configured to push the advancement element (180) distally in response to distal movement of the handle when the housing is compressed into the pocket. (Figs. 2A, 2C; Paragraph [0028] compression wheels 110 are disposed within the upper portion 104 of the housing 100; housing 102 may comprise a flexible material; Paragraph [0030] Compression wheels 110 may be operably connected to a loading switch 180. When a downward force is applied to the switch 180 (i.e. the switch 180 is engaged), the compression wheels 110 move downwardly into the slot 108 to engage with a guide wire that is inserted into the slot.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include ““wherein the translation feature is configured to push the advancement element distally in response to distal movement of the handle when the housing is compressed into the pocket” as taught by Higgins. Doing so engaging the guide wire and provide a force that helps pull the guide into the device. (Paragraph [0030]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Funk, further in view of Devgon and Lee (U.S. 20210023336) (previously cited).
Regarding claim 13, Burkholz as modified does not teach “an elastomeric seal disposed within the distal connector or a distal end of the housing, wherein the instrument is configured to extend through the elastomeric seal, further comprising a port and an extension tube coupled to the port, wherein the port is disposed distal to the elastomeric seal and configured for fluid flow therethrough”.
Devgon teaches a blood collection device comprising an elastomeric seal disposed within the distal connector or a distal end (212) of the housing, wherein the instrument (210) is configured to extend through the elastomeric seal. (Paragraph [0094]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “an elastomeric seal disposed within the distal connector or a distal end of the housing, wherein the instrument is configured to extend through the elastomeric seal” as taught by Devgon. Doing so provides a substantially fluid tight seal with an inner surface of the lock that defines the lumen. (Paragraph [0094]).
Lee, in a related field of endeavor, teaches a vascular access device (Figs. 1, 7B, 8A) comprising a port (12) and an extension tube (Fig. 1, connecting tube 13) coupled to the port, wherein the port is disposed distal to the elastomeric seal (Fig. 7B, element 30) and configured for fluid flow therethrough. (Paragraph [0043]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “a port and an extension tube coupled to the port, wherein the port is disposed distal to the elastomeric seal and configured for fluid flow therethrough” as taught by Lee. Doing so adjoins the sidewall of the outer overtube and opens to a tubular space of the tubular shaft. (Paragraphs [0008], [0034]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Funk, further in view of Millerd (ES 2575861) (previously cited).
Regarding claim 14, Burkholz as modified does not teach “a grip feature proximate and proximal to the handle when the instrument is in a fully retracted position, wherein an outer surface of the grip feature is textured.”
Millerd, in a related field of endeavor, teaches a safety catheter (Fig. 27a) comprising a grip (13) feature proximate and proximal to the handle (54) when the instrument is in a fully retracted position, (Page 19, lines 4-19) wherein an outer surface of the grip feature is textured. (Page 9, line 19).
As a result, it would have been obvious to one of ordinary skill in the art before the effective date to have modified Burkholz as modified to include “a grip feature proximate and proximal to the handle when the instrument is in a fully retracted position, wherein an outer surface of the grip feature is textured” as taught by Lee. Doing so facilitates handling of the device. (Page 9, line 29-30).
Allowable Subject Matter
Claim 26 is 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:
Regarding claim 26, none of the prior art discloses or suggests, either alone or in combination, “wherein a surface of the advancement element opposite the pocket comprises bumps configured to contact the housing in order to decrease surface area of the advancement element in contact with the housing”, in combination with the other claimed elements.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 3/19/2026, with respect to the rejections of claims 1-14 and 21-23 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Funk is relied upon for the amended feature.
Conclusion
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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/OM PATEL/ Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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