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 March 02, 2026 has been entered. Claims 1-8 and 10-20 remain pending in the application. Claim 9 has been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed January 09, 2026.
Claim Objections
Claim 12 is objected to because there is a lack of antecedent basis for “said range of rotational movement of said catheter assembly” in line 12 as opposed to “said range of rotational movement of said catheter advancer”. Appropriate correction is required.
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 1-4, 6-7, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miner (US 20110224617).
Regarding claim 1, Miner discloses a device (catheter device 100) for inserting a catheter, comprising:
a base (needle hub 120) configured to be gripped by a user;
a needle (introducer needle 160) extending along an axis from a needle hub (proximal end of introducer needle 160) to a distal incising end with a beveled tip (beveled portion 162; Figure 2A);
a catheter (catheter adapter 110 and catheter tube 114) extending along said axis from a hub (catheter adapter 110) to a distal end (tip 140) and slidably translatable over said needle (Figures 1-2B); and
a catheter advancer (inserted portion 124 and biasing arms 130) rotatably seated in said base (“Biasing arms 130 generally comprise a molded extension or feature of the needle hub 120 each having a first end 132 attached to the needle hub 120” [0026]) and constrained thereby to a predetermined range of rotational movement (Figure 2A-2B; “Once the beveled portion 162 of the introducer needle 160 accesses the patient's vasculature, biasing arms 130 are actuated by compressing or pinching 150 the arms 130 to temporarily remove the arch or non-linear profile of each arm 130.” [0030], wherein the biasing arms 130 rotate about the first end 132), the catheter advancer being engageable with said catheter (“the second end 134 of each biasing arm 130 further includes a contact surface 136 configured and positioned in proximity to the annular ridge 116 of catheter adapter 110.” [0026]) and configured to translate said range of rotational movement into a predetermined initial safety advancement of said catheter linearly along said axis and relative to said base and said catheter advancer to a fixed distal position ensheathing the incising end of said needle (“Once the beveled portion 162 of the introducer needle 160 accesses the patient's vasculature, biasing arms 130 are actuated by compressing or pinching 150 the arms 130 to temporarily remove the arch or non-linear profile of each arm 130. By temporarily removing the non-linear profile of each arm 130, the distance between the first end 132 and the second end 134 of each arm 130 is increased thereby repositioning the contact surfaces 136 of the biasing arms 130 in a distal direction 152. As the contact surfaces 136 are repositioned in a distal direction 152, the contact surfaces 136 contact the annular ridge 116 and advance the catheter adapter 110 in a distal direction 152 relative to the needle hub 120. Accordingly, the beveled portion 162 of the needle 160 is withdrawn, or hooded within the catheter tube 114. In some embodiments, the length of the biasing arms 130 is selected so as to accurately hood the beveled portion 162 of the needle 160 thereby preventing overhooding or underhooding inaccuracies.” [0030-0031]; Figures 2A-2B), wherein the catheter advancer remains entirely proximal of the distal tip of said needle during the predetermined initial safety advancement (Figures 2A-2B).
Regarding claim 2, Miner discloses the device for inserting a catheter according to claim 1, wherein said initial safety advancement advances said catheter to a distal position that sheaths the beveled tip of said needle (Figure 2B; “As the contact surfaces 136 are repositioned in a distal direction 152, the contact surfaces 136 contact the annular ridge 116 and advance the catheter adapter 110 in a distal direction 152 relative to the needle hub 120. Accordingly, the beveled portion 162 of the needle 160 is withdrawn, or hooded within the catheter tube 114.” [0031]).
Regarding claim 3, Miner discloses the device for inserting a catheter according to claim 2, wherein said catheter advancer is configured to selectively lock said catheter in a proximal-most position (Figure 2A; “the inserted portion 124 of the needle hub 120 further includes a feature 126 for engaging a detent 128 located on an inner surface 146 of the catheter adapter 110. The interaction between the feature 126 and the detent 128 prevents premature hooding of the needle 160 during catheterization. The interaction further prevents premature hooding of the needle 160 during assembly, packaging and shipment of the intravenous catheter device 100.” [0028]).
Regarding claim 4, Miner discloses the device for inserting a catheter according to claim 3, wherein said catheter advancer is configured to selectively unlock said catheter to allow slidable translation of said catheter along said axis (“As the contact surfaces 136 are repositioned in a distal direction 152, the contact surfaces 136 contact the annular ridge 116 and advance the catheter adapter 110 in a distal direction 152 relative to the needle hub 120. Accordingly, the beveled portion 162 of the needle 160 is withdrawn, or hooded within the catheter tube 114…the length of the biasing arms 130 is selected so as to create sufficient force in the distal direction between the needle hub 120 and the catheter adapter 110 when the biasing arms 130 are actuated by the user. This force is necessarily sufficient to overcome the interaction between the feature 126 and the detent 128 thereby allowing the catheter adapter 110 to move in a distal direction 152 relative to the needle hub 120.” [0031]).
Regarding claim 6, Miner discloses the device for inserting a catheter according to claim 2, wherein said catheter advancer is configured to mechanically prevent the beveled tip of said needle from being unsheathed once said initial safety advancement has been completed (“the inserted portion 124 of the needle hub 120 comprises a feature 128 and the inner surface 146 of the catheter adapter 110 comprises a first and second detent (not shown). Prior to catheterization, the feature 128 is engaged with the first detent (not shown) whereby the beveled portion 162 of the needle 160 is positioned and maintained beyond the tip portion 140 of the catheter tube 114. Upon compression of the biasing arms 130, the feature 126 is displaced from the first detent (not shown) such that the catheter adapter 110 is free to move in a distal direction 152. Once the beveled portion 162 of the needle 160 is hooded, the feature 126 engages the second detent (not shown) thereby preventing further movement of the catheter adapter 110 in the distal direction 152. Thus, the interaction between the feature 128 and the second detent prevents overhooding of the needle 160 during catheterization.” [0032]).
Regarding claim 7, Miner discloses the device for inserting a catheter according to claim 1, wherein said catheter advancer includes a distal finger tab (center of arch of biasing arms 130) projecting radially therefrom relative to said needle for finger-rotation of said catheter advancer within said base (“biasing arms 130 are actuated by compressing or pinching 150 the arms 130 to temporarily remove the arch or non-linear profile of each arm 130.” [0030]).
Regarding claim 10, Miner discloses the device for inserting a catheter according to claim 1, wherein said base has at least one contoured finger grip (gripping surface 122).
Regarding claim 11, Miner discloses the device for inserting a catheter according to claim 1, wherein said catheter advancer is configured to encompass said needle as said catheter advancer slidably translates (Figures 2A-2B, wherein at least inserted portion 124 of needle is encompassed by biasing arms 130).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Miner (US 20110224617) in view of Ibragimov (US 20150305769).
Regarding claim 5, Miner discloses the device for inserting a catheter according to claim 1.
Miner fails to explicitly disclose wherein said catheter advancer is configured to engage said needle hub and rotate said needle about said axis relative to said base when said catheter advancer is moved within said predetermined range of movement.
Ibragimov teaches a device (device 200) for inserting a catheter comprising a needle (hollow needle 230); a catheter (flexible sheath 250); and a catheter advancer (internal cylinder 234, trigger 242, and “a flexible sheath 250 extending from a sheath hub 282, which in turn may be equipped with a protrusion allowing the sheath to be disengaged from the needle hub 240 and slidingly moved along the needle 230 when inserting into the target vessel.” [0056]), wherein said catheter advancer is configured to rotate said needle about said axis relative to said base when said catheter advancer is moved within a predetermined range of movement (“The trigger 242 may then be pressed to cause activation of the actuator leading to an automatic rotation (optionally coupled with a short forward advancement) of the needle tip 220 by about 180 degrees. At this point, the sheath hub 282 may be disengaged from the needle hub 240 and the sheath 250 may be further advanced into the vessel as described above” [0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Miner to include that the catheter advancer is configured to rotate said needle about said axis relative to said base when said catheter advancer is moved within said predetermined range of movement based on the teachings of Ibragimov to avoid double wall puncture when advancing the catheter into the vessel and improve success of the procedure (Ibragimov [0010]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Miner (US 20110224617) in view of Rogers et al. (US 20040087913).
Regarding claim 8, Miner discloses the device for inserting a catheter of claim 1 wherein the catheter advancer (inserted portion 124 and biasing arms 130) comprises an engagement structure (feature 126) for engagement with said catheter (“the inserted portion 124 of the needle hub 120 further includes a feature 126 for engaging a detent 128 located on an inner surface 146 of the catheter adapter 110.” [0028]).
Miner fails to explicitly disclose the engagement structure is helical threads.
Rogers teaches a device for inserting a catheter, comprising a catheter (introducer 3) and a catheter advancer (housing 20) comprising helical threads (threads 35) for engagement with the catheter (“threads 35 to receive thread or detents 14 on introducer 3” [0021]; “when an introducer 3 is connected to housing 20 the needle housing 20 is attached to the introducer by threaded fixture part/detent 14 and threads 35.” [0022]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the detent engagement structures of Miner to instead be helical threads based on the teachings of Rogers to secure the catheter assembly to the catheter advancer, preventing premature disengagement and allowing for simple disengagement to place the catheter in its target position (Rogers [0023]).
Claims 12-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miner (US 20110224617) in view of Kelso et al. (USPN 5186712).
Regarding claim 12, Miner discloses a device (catheter device 100) for inserting a catheter, comprising:
a base (needle hub 120) configured to be gripped by a user (Figures 1-2B);
a needle (introducer needle 160) having a distal incising end (beveled portion 162; Figure 2A) and a proximal needle hub (proximal end of introducer needle 160), the distal incision end having a beveled tip (beveled portion 162; Figure 2A) extending along a length LB of said axis (Figure 2A showing the length of the beveled portion 162);
a catheter assembly (catheter adapter 110 and catheter tube 114) comprising a proximal hub (catheter adapter 110) and a catheter (catheter tube 114) that is slidably translatable over the incising end of said needle (Figures 2A-2B), thereby defining a trim length LT extending along said axis between a distal end of said catheter and a proximal end of said beveled tip of said needle (Figure 2B showing the trim length between the distal end of catheter tube 114 and the proximal end of beveled portion 162); and
a catheter advancer (inserted portion 124 and biasing arms 130) rotatably seated in said base (“Biasing arms 130 generally comprise a molded extension or feature of the needle hub 120 each having a first end 132 attached to the needle hub 120” [0026]), constrained therein to a predetermined range of rotational movement (Figure 2A-2B; “Once the beveled portion 162 of the introducer needle 160 accesses the patient's vasculature, biasing arms 130 are actuated by compressing or pinching 150 the arms 130 to temporarily remove the arch or non-linear profile of each arm 130.” [0030], wherein the biasing arms 130 rotate about the first end 132), and engageable with said catheter assembly (“the second end 134 of each biasing arm 130 further includes a contact surface 136 configured and positioned in proximity to the annular ridge 116 of catheter adapter 110.” [0026]) and configured for translation of said range of rotational movement of said catheter assembly into linear movement of said catheter assembly in a distal direction along said axis by a predetermined length LSAFETY prior to threading said catheter into a patient, wherein LSAFETY is greater than or equal to a sum of LB plus LT plus a nominal distance LN within a range from 1.0% to 40% of LB plus LT (“Once the beveled portion 162 of the introducer needle 160 accesses the patient's vasculature, biasing arms 130 are actuated by compressing or pinching 150 the arms 130 to temporarily remove the arch or non-linear profile of each arm 130. By temporarily removing the non-linear profile of each arm 130, the distance between the first end 132 and the second end 134 of each arm 130 is increased thereby repositioning the contact surfaces 136 of the biasing arms 130 in a distal direction 152. As the contact surfaces 136 are repositioned in a distal direction 152, the contact surfaces 136 contact the annular ridge 116 and advance the catheter adapter 110 in a distal direction 152 relative to the needle hub 120. Accordingly, the beveled portion 162 of the needle 160 is withdrawn, or hooded within the catheter tube 114. In some embodiments, the length of the biasing arms 130 is selected so as to accurately hood the beveled portion 162 of the needle 160 thereby preventing overhooding or underhooding inaccuracies.” [0030-0031]; Figures 2A-2B);
wherein the catheter advancer remains entirely proximal of the distal incising end of said needle during translation of said catheter assembly along said axis by said predetermined length (Figures 2A-2B).
Miner fails to explicitly disclose said base defining a channel extending along an axis.
Kelso teaches a device (intravenous catheter launching device 1) for inserting a catheter, comprising: a base (body 3) configured to be gripped by a user (Figures 2 and 3), said base defining a channel (cavity 13) extending along an axis (Figure 4); a needle (needle 5); a catheter assembly (catheter 7); and a catheter advancer (triggering means 11) rotatably seated in said base (Figures 2 and 4; “Each of the triggers 12 is pivotally mounted on opposite sides 57 of the body 3” [Col 4, lines 58-59]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the base of the device of Miner to include a channel extending along an axis based on the teachings of Kelso to provide a flashback chamber that allows the user to verify that the needle has been correctly placed in a vein (Kelso [Col 5, lines 58-66]).
Regarding claim 13, modified Miner discloses the device for inserting a catheter according to claim 12, wherein a safety advancement sheaths the distal incision end of said needle (Figure 2B; “As the contact surfaces 136 are repositioned in a distal direction 152, the contact surfaces 136 contact the annular ridge 116 and advance the catheter adapter 110 in a distal direction 152 relative to the needle hub 120. Accordingly, the beveled portion 162 of the needle 160 is withdrawn, or hooded within the catheter tube 114.” [0031]).
Regarding claim 14, modified Miner discloses the device for inserting a catheter according to claim 12, wherein said catheter advancer is configured to selectively lock said catheter in a proximal-most position (Figure 2A; “the inserted portion 124 of the needle hub 120 further includes a feature 126 for engaging a detent 128 located on an inner surface 146 of the catheter adapter 110. The interaction between the feature 126 and the detent 128 prevents premature hooding of the needle 160 during catheterization. The interaction further prevents premature hooding of the needle 160 during assembly, packaging and shipment of the intravenous catheter device 100.” [0028]).
Regarding claim 15, modified Miner discloses the device for inserting a catheter according to claim 14, wherein said catheter advancer is configured to selectively unlock said catheter to allow slidable translation of said catheter along said axis (“As the contact surfaces 136 are repositioned in a distal direction 152, the contact surfaces 136 contact the annular ridge 116 and advance the catheter adapter 110 in a distal direction 152 relative to the needle hub 120. Accordingly, the beveled portion 162 of the needle 160 is withdrawn, or hooded within the catheter tube 114…the length of the biasing arms 130 is selected so as to create sufficient force in the distal direction between the needle hub 120 and the catheter adapter 110 when the biasing arms 130 are actuated by the user. This force is necessarily sufficient to overcome the interaction between the feature 126 and the detent 128 thereby allowing the catheter adapter 110 to move in a distal direction 152 relative to the needle hub 120.” [0031]).
Regarding claim 17, modified Miner discloses the device for inserting a catheter according to claim 12, wherein said catheter advancer is configured to mechanically prevent the beveled tip of said needle from being unsheathed once said initial safety advancement has been completed (“the inserted portion 124 of the needle hub 120 comprises a feature 128 and the inner surface 146 of the catheter adapter 110 comprises a first and second detent (not shown). Prior to catheterization, the feature 128 is engaged with the first detent (not shown) whereby the beveled portion 162 of the needle 160 is positioned and maintained beyond the tip portion 140 of the catheter tube 114. Upon compression of the biasing arms 130, the feature 126 is displaced from the first detent (not shown) such that the catheter adapter 110 is free to move in a distal direction 152. Once the beveled portion 162 of the needle 160 is hooded, the feature 126 engages the second detent (not shown) thereby preventing further movement of the catheter adapter 110 in the distal direction 152. Thus, the interaction between the feature 128 and the second detent prevents overhooding of the needle 160 during catheterization.” [0032]).
Regarding claim 18, modified Miner discloses the device for inserting a catheter according to claim 12, wherein said catheter advancer includes a distal finger advancement tab (center of arch of biasing arms 130) projecting radially therefrom relative to said needle axis (“biasing arms 130 are actuated by compressing or pinching 150 the arms 130 to temporarily remove the arch or non-linear profile of each arm 130.” [0030]).
Regarding claim 19, modified Miner discloses the device for inserting a catheter according to claim 12, wherein said base has at least one contoured finger grip (gripping surface 122).
Regarding claim 20, modified Miner discloses the device for inserting a catheter according to claim 12, wherein said catheter advancer is configured to encompass said needle as said catheter advancer slidably translates (Figures 2A-2B, wherein at least inserted portion 124 of needle is encompassed by biasing arms 130).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Miner (US 20110224617) in view of Kelso et al. (USPN 5186712) as applied in claim 12 above, and further in view of Ibragimov (US 20150305769).
Regarding claim 16, modified Miner discloses the device for inserting a catheter according to claim 12.
Modified Miner fails to explicitly teach wherein rotation of said catheter advancer rotates said needle about said axis relative to said catheter.
Ibragimov teaches a device (device 200) for inserting a catheter comprising a needle (hollow needle 230); a catheter (flexible sheath 250); and a catheter advancer (internal cylinder 234, trigger 242, and “a flexible sheath 250 extending from a sheath hub 282, which in turn may be equipped with a protrusion allowing the sheath to be disengaged from the needle hub 240 and slidingly moved along the needle 230 when inserting into the target vessel.” [0056]), wherein rotation of said catheter advancer rotates said needle about said axis relative to said catheter (“The spring-loaded rotating mechanism described above may be actuated (released to cause needle rotation) by depressing a trigger 242 based on a biased spring 246 causing rotation of the internal cylinder 234. The spring 246 may have one end operatively connected to the internal cylinder 234 and the other end operatively connected to the external cylinder 238 so that winding up and then releasing the spring 246 may cause the internal cylinder 234 to rotate inside the external cylinder 238.” [0060]; “The trigger 242 may then be pressed to cause activation of the actuator leading to an automatic rotation (optionally coupled with a short forward advancement) of the needle tip 220 by about 180 degrees. At this point, the sheath hub 282 may be disengaged from the needle hub 240 and the sheath 250 may be further advanced into the vessel as described above” [0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Miner to include wherein rotation of said catheter advancer rotates said needle about said axis relative to said catheter based on the teachings of Ibragimov to avoid double wall puncture when advancing the catheter into the vessel and improve success of the procedure (Ibragimov [0010]).
Response to Arguments
Applicant’s arguments with respect to claims 1-8 and 10-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that Ibragimov does not disclose the limitations of claims 5 and 16 (Remarks, page 3), the examiner respectfully disagrees. As detailed above, Ibragimov teaches a device (200) for inserting a catheter comprising a needle (230); a catheter (250); and a catheter advancer (234, 242, and “a flexible sheath 250 extending from a sheath hub 282, which in turn may be equipped with a protrusion allowing the sheath to be disengaged from the needle hub 240 and slidingly moved along the needle 230 when inserting into the target vessel.” [0056]), wherein said catheter advancer is configured to rotate said needle about said axis relative to said base when said catheter advancer is moved within said predetermined range of movement ([0061]). Ibragimov additionally discloses “Rotating the beveled tip once inside the target vessel allows avoiding double wall puncture while advancing the sheath into the vessel, which therefore may improve the success rate of the procedure” [0010]. Based on this disclosure, it is maintained that one having ordinary skill in the art would have found it obvious to modify the device of Miner to include that the catheter advancer is configured to rotate said needle about said axis relative to said base when said catheter advancer is moved within said predetermined range of movement based on the teachings of Ibragimov to avoid double wall puncture when advancing the catheter into the vessel and improve success of the procedure (Ibragimov [0010]). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783