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 .
Response to Amendment
The amendment filed September 19, 2025 has been entered. Claims 1-16 and 21-24 remain pending.
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, 3-4, 11, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200016374) (cited by Applicant) in view of Halbert (WO 2019053508).
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 (28) and a second end (30), (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 advancement element moves distally within the lumen the first distance and the second end of the instrument advances distally the second distance.”
Halbert, in a related field of endeavor, teaches a stent delivery system (Figs. 2, 3, 4B) comprising a translation feature (102) disposed outside of the lumen between the handle (See Fig. 2) and an outer surface of the housing (100) and within the pocket (See Fig. 2, curved space in which 102 rests) such that in response to distal movement of the handle the first distance, the advancement element (slider 104) moves distally within the lumen the first distance and the second end of the instrument (outer sheath 108) advances distally the second distance (See Fig. 3). (Paragraphs [0025]-[0026]).
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 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 Halbert. Doing so allows for precise exposure and initial deployment of the medical device and completed deployment of the medical device more quickly once the physician is satisfied with its placement. (Paragraph [0027]).
Regarding claim 3, Burkholz teaches wherein the housing (14) comprises a flexible extension tube (32). (Fig. 2A; Paragraph [0039]).
Regarding claim 4, Burkholz teaches wherein the housing (14) further comprises another lumen, wherein the other lumen extends through the distal end of the housing and 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 24, Burkholz does not teach “wherein the translation feature comprises at least one of a ball, a wheel, or a roller bearing.”
Halbert teaches wherein the translation feature comprises a wheel (102). (See Fig. 2)
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 comprises at least one of a ball, a wheel, or a roller bearing” as taught by Halbert. Doing so causes longitudinal movement of the advancement feature (slider) and second end of the instrument (sheath). (Paragraph [0026]).
Claims 2 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Halbert, 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 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, 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 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, 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]).
Claims 12 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Halbert, further in view of Higgins (US 20140316448) (previously cited).
Regarding claim 12, Burkholz as modified does not teach “an additional translation feature disposed on an opposite side of the housing from the translation feature and between the housing and the handle.”
Higgins, in a related field of endeavor, 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 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 as modified to include “an additional translation feature disposed on an opposite side of the housing from the translation feature and between the housing and the handle” as taught by Higgins. Doing so helps propel the guide wire axially through the slot to load the guide wire into the device. (Paragraph [0028]).
Regarding claim 21, Burkholz as modified does not teach “wherein the translation feature is configured to create localized compression of the housing.”
Higgins teaches wherein the translation feature (110) is configured to create localized compression of the housing. (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” 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 the housing is flexible, and wherein the translation feature is configured to compress the housing such that the housing extends into the pocket.”
Higgins teaches wherein the housing (100) is flexible, and wherein the translation feature is configured to compress 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 the housing is flexible, and wherein the translation feature is configured to compress 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 compression of the housing into the pocket facilitates distal movement of the advancement element with the handle.”
Higgins teaches wherein the compression of the housing into the pocket facilitates distal movement of the advancement element with 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 housing is flexible, and wherein the translation feature is configured to compress 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]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Halbert, 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]).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Halbert, 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).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 9/19/2025, with respect to the rejections of claims 1-14 have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Halbert is relied upon for the amended feature.
Conclusion
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OM PATEL/ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791