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 .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 1-13 in the reply filed on 03/23/26 is acknowledged.
Claims 14-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/23/26.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 11/01/23 (3 submission), 01/31/24, 05/20/24, 08/19/24, 11/15/24, 02/18/25, 05/15/25, 11/20/25, and 03/23/26 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
Proximal and distal seals such as in claim 3 should be shown. This drawing objection could be remedied by adding reference numerals to specification [0079] that describes the seals and placing said numerals on the drawing of FIG. 4 (it appears that the seals might be shown on FIG. 4 but are not provided with numerals. The seals do not seem to be shown in any of the other figures).
The longitudinal slot such as in claim 9 should be shown. This drawing objection could be remedied by adding reference numerals to specification [0074] that describes the slot and placing said numeral on the drawing of FIG. 2
The “slider including an extension coupled to a proximal-end portion of the access guidewire within a cavity of the retractable-needle device enclosed by the housing” as in claim 9 does not appear to shown on any of the figures
The “the carriage is configured to engage the slider of the access-guidewire actuator when the carriage is thrust proximally into the cavity of the retractable-needle device” as in claim 11 does not appear to be shown in any of the figures
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “176” has been used to designate both the plunger flange (see FIG.1) and the plunger (see FIG.2). From Applicant disclosure, it appears that this drawing objection could be remedied by correcting the numeral in FIG.1 from 176 to 196, because numeral 196 is for the plunger tab (see [0077] of Applicant disclosure and side-by-side of FIG. 1 and 2 below for ease of reference).
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, lines 1-3 recite “wherein the carriage is configured to engage the slider of the access-guidewire actuator when the carriage is thrust proximally into the cavity of the retractable-needle device”. It is unclear to the examiner how the carriage is configured to “engage” the slider when the carriage (154, see FIG.4) is located on the inside of the housing and the slider (172, see FIG. 2 and [0074]) is located exterior to the housing. The carriage is only shown in FIG. 4. FIG. 4 does not show an engagement between the slider and carriage (see drawing objection above). Therefore, for purposes of examination, the examiner interprets that any internal carriage/ exterior slider disposed on a housing of the prior art would meet the limitation as currently claimed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prestidge et al. (U.S. Patent No. 6,626,868), hereinafter Prestidge.
Regarding claim 1, Prestidge discloses an introducer, comprising:
a retractable-needle device (170, see Fig. 23-25) including an introducer needle having a shaft (20) and a needle tip (22) in a distal-end portion (rightward in FIG. 24) of the shaft (20), a proximal-end portion (see ‘Modified FIG. 24’ below)
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of the shaft (20) disposed in a carriage (24, see Fig. 24 and best description for carriage/needle actuation is explained in reference to embodiment of FIG. 1 in col. 6 line 49- col. 7 line 1. As shown in FIG. 24, FIG. 24 has the same structural components of the flange 24, spring 26, guide means 28 as FIG. 1 and therefore functions as described in col. 6 line 49- col. 7 line 1) of the retractable-needle device; and
a coupling hub (12), the shaft (20) of the introducer needle (shaft 20 and tip 22) extending from the carriage (124), through a sealed blood-flashback chamber (176) of the coupling hub (12), and out a longitudinal through hole (see ‘Modified FIG. 24’ above—there must be a through hole in order for the needle to exit distally) of the coupling hub (12) distal (rightward in FIG.24) of the blood-flashback chamber (176) for establishing a needle tract from an area of skin to a blood-vessel lumen of a patient with the needle tip of the introducer needle (see col 9 lines 59-64: blood flows into chamber 176 when needle tip 22 enters blood vessel).
Regarding claim 2, Prestidge discloses the introducer of claim 1, and Prestidge further discloses wherein a cutout (174, see Fig. 24) of the shaft (20) of the introducer needle is disposed in (as seen in Fig. 24) the blood-flashback chamber (176), the cutout (174) configured to release blood into the blood-flashback chamber (176) upon the needle tip (22) accessing the blood-vessel lumen of the patient (see col. 9 lines 53-67: side opening 174 delivers blood into chamber 176 when tip 22 punctures blood vessel).
Regarding claim 3, Prestidge discloses the introducer of claim 2, and Prestidge further discloses wherein the blood-flashback chamber (176, see Fig. 24) is sealed (see col 9 lines 58-64: flashback chamber formed between guide means 172/28 which are sealing as described in col 9 lines 58-64: means 172 form a seal with needle and col 6 lines 53-54: means 28 form a seal with needle) with a seal (172) in a proximal-end portion (leftward in FIG. 24) of the blood-flashback chamber (174) and another seal (28) in a distal-end portion (rightward in FIG. 24) of the blood-flashback chamber (176).
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Bryan et al. (U.S. PGPUB No. 2017/0274182), hereinafter O’ Bryan.
Regarding claim 1, O’Bryan discloses an introducer, comprising:
a retractable-needle device (see FIG. 1 and [0038]) including an introducer needle (154) having a shaft (see cylindrical needle shaft extending proximally in FIG. 1) and a needle tip (tip of 154 as shown FIG.1, see also [0036]: 154 has sharpened tip) in a distal-end portion (rightward in FIG. 1) of the shaft (see cylindrical needle shaft), a proximal-end portion (see ‘Modified FIG. 1’ below)
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of the shaft (see cylindrical needle shaft) disposed in a carriage (150, see [0033-0035] and [0043-0044]) of the retractable-needle device; and
a coupling hub (120), the shaft (see cylindrical needle shaft) of the introducer needle (154) extending from the carriage (150), through a sealed blood-flashback chamber (134, see [0031]: chamber 134 sealed by septum 138) of the coupling hub (120), and out a longitudinal through hole (see ‘Modified FIG. 1’ above) of the coupling hub (120) distal (rightward in FIG. 1) of the blood-flashback chamber (134, see [0040]: blood flashed into chamber 134) for establishing a needle tract from an area of skin to a blood-vessel lumen of a patient with the needle tip of the introducer needle (154, see [0033], [0036]: needle tip penetrates in insertion configuration, such as in see [0037-0039]: patient vein).
Regarding claim 4, O’Bryan discloses the introducer of claim 1, and O’Bryan further discloses wherein the coupling hub (102, see FIG. 1) includes a side arm (124, see [0031]) extending from a side (top side in view of FIG. 1) of the coupling hub (102) for coupling the retractable-needle device and another medical device together (see [0040]: side arm 124 connects to extension tube 106 leading to luer adapter 110 for connecting to other device such as to convey blood flash).
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over O’Bryan as applied to claim 4 above, and further in view of Real et al. (U.S. PGPUB No. 2016/0067391), hereinafter Real.
Regarding claim 5, O’Bryan discloses the introducer of claim 4, and O’Bryan discloses the another medical device (device at luer adapter 110, see FIG. 1) coupled to (see [0040]: 110 coupled to side arm by way of extension tube 106) the side arm (124) of the coupling hub (102), the another medical device (11) fluidly coupled to the blood-flashback chamber (134) by a side-arm lumen (see [0040]: blood flash moves through side arm and extension tube and therefore there must be a side-arm lumen to convey fluid flow) of the side arm (124) for aspirating blood upon the needle tip (tip of 154) accessing the blood-vessel lumen of the patient (see [0040]).
O’Bryan is silent to “further comprising: a syringe as the other medical device.”
However, Real teaches an introducer (see FIG. 13 for visual of syringe) with another medical device (51) coupled to a side arm of a coupling hub via a luer connection (see [0092]: in another embodiment, side port luer connection provided with syringe. Thus, three way tap as seen in FIG. 13 would be a luer connection instead), further comprising: a syringe as the other medical device (51, see [0092] and [0160]: 51 is syringe).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the luer adapter connecting to another medical device disclosed in O’Bryan to be connected specifically to a syringe as taught by Real for the purpose of allowing a user to manually control aspiration via the syringe plunger (see [0161-0162]), thus achieving “further comprising: a syringe as the other medical device.”
Regarding claim 6, the modified system of O’Bryan teaches the introducer of claim 5, but O’Bryan is silent to “wherein the syringe includes a plunger disposed in the barrel of the syringe, the plunger including a plunger extension extending from a distal-end portion of the plunger along the barrel of the syringe, thereby allowing a clinician to withdraw the plunger from the barrel by proximally pushing a tab of the plunger extension while handling the introducer around the coupling hub.”
However, Real teaches an introducer (see FIG. 13 for visual of syringe) with another medical device (51) coupled to a side arm of a coupling hub via a luer connection (see [0092]: in another embodiment, side port luer connection provided with syringe. Thus, three way tap as seen in FIG. 13 would be a luer connection instead), further comprising: a syringe as the other medical device (51, see [0092] and [0160]: 51 is syringe), wherein the syringe (51) includes a plunger (see ‘Modified FIG. 13’ below and [0161]: syringe has plunger)
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disposed in the barrel (cylindrical form of syringe, see ‘Modified FIG. 13’ above) of the syringe (51), the plunger including a plunger extension (see outline of plunger extending from proximal to distal end within barrel as shown in ‘Modified FIG. 13’ above) extending from a distal-end portion of the plunger along the barrel of the syringe (51, see FIG. 13), thereby allowing a clinician to withdraw the plunger from the barrel by proximally pushing a tab (see ‘Modified FIG. 13’ above) of the plunger extension while handling the introducer around the coupling hub (see [0161]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the luer adapter connecting to another medical device disclosed in O’Bryan to be connected specifically to a syringe including a plunger, plunger extension, and plunger tab as taught by Real for the purpose of allowing a user to manually control aspiration via the syringe plunger (see [0161-0162]), thus achieving “wherein the syringe includes a plunger disposed in the barrel of the syringe, the plunger including a plunger extension extending from a distal-end portion of the plunger along the barrel of the syringe, thereby allowing a clinician to withdraw the plunger from the barrel by proximally pushing a tab of the plunger extension while handling the introducer around the coupling hub”.
Claims 7 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Prestidge as applied to claim 1 above, and further in view of Belson (U.S. PGPUB No. 2019/0240459).
Regarding claim 7, Prestridge discloses the introducer of claim 1, and Prestidge further discloses the coupling hub (12) able to detachably connect to other devices at the proximal end (14, see FIG. 24 and see col. 6 lines 39-48: luer==detachable or other devices mate at end 14).
Prestidge is silent to “the retractable-needle device further including: an access guidewire disposed in a needle lumen of the introducer needle; and an access-guidewire actuator configured to advance a distal-end portion of the access guidewire beyond the needle tip or withdraw the distal-end portion of the access guidewire into the distal-end portion of the shaft of the introducer needle proximal of the needle tip.”
However, Belson teaches an introducer (see FIG. 6B and [0002]) comprising a retractable-needle device (100, see [0011] & [0044]: needle retractable), a coupling hub (108), and an introducer needle (118), the retractable-needle device (100) further including: an access guidewire (120) disposed in a needle lumen (see [0043]: guidewire held within a lumen of needle 118) of the introducer needle (118); and an access-guidewire actuator (114, see [0043]: a slider) configured to advance a distal-end portion (portion of guidewire extending beyond needle tip shown in FIG. 6B) of the access guidewire (120) beyond (as seen in FIG. 6B and described in [0043]) the needle tip (116) or withdraw the distal-end portion of the access guidewire into the distal-end portion of the shaft of the introducer needle proximal of the needle tip.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detachable connection at the proximal end of the coupling hub disclosed in Prestidge to be attached to an access guidewire actuator for actuating an access guidewire disposed in the needle lumen as taught by Belson (such as by providing the guidewire and guidewire actuator in a detachable housing 112, see Belson [0041]) for the purpose of providing the introducer with an actuatable guidewire to aid in venipuncture such that the needle and catheter may be advanced to a desired length in a way that prevents injury to the vein (see [0043-0044]), thus achieving “the retractable-needle device further including: an access guidewire disposed in a needle lumen of the introducer needle; and an access-guidewire actuator configured to advance a distal-end portion of the access guidewire beyond the needle tip or withdraw the distal-end portion of the access guidewire into the distal-end portion of the shaft of the introducer needle proximal of the needle tip”.
Regarding claim 9, the modified system of Prestidge teaches the introducer of claim 7, but Prestidge is silent to “wherein the access-guidewire actuator includes a slider slidably disposed in a longitudinal slot of a housing of the retractable-needle device, the slider including an extension coupled to a proximal-end portion of the access guidewire within a cavity of the retractable-needle device enclosed by the housing.”
However, Belson teaches an introducer (see FIG. 6B and [0002]) comprising a retractable-needle device (100, see [0011] & [0044]: needle retractable), a coupling hub (108), and an introducer needle (118), the retractable-needle device (100) further including: an access guidewire (120) disposed in a needle lumen (see [0043]: guidewire held within a lumen of needle 118) of the introducer needle (118); and an access-guidewire actuator (114, see [0043]: a slider) configured to advance a distal-end portion (portion of guidewire extending beyond needle tip shown in FIG. 6B) of the access guidewire (120) beyond (as seen in FIG. 6B and described in [0043]) the needle tip (116), wherein the access-guidewire actuator (114) includes a slider (see [0043]: 114 is a slider) slidably disposed (see [0043] and sliding in FIG. 6A-C) in a longitudinal slot (126) of a housing (112) of the retractable-needle device (100), the slider (114) including an extension (124) coupled to a proximal-end portion (see ‘Modified FIG. 6B’ below)
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of the access guidewire (120) within a cavity (see ‘Modified FIG. 6B’ above) of the retractable-needle device (100) enclosed by the housing (112).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the access-guidewire actuator taught by Prestidge in view of Belson to be formed as a slider disposed in a longitudinal slot of a housing as taught by Belson for the purpose of forming the guidewire actuation mechanism on a handle that serves as a manipulation tool for the user (see [0041]) and to allow the actuator to be partially or fully advanced within the slot to extend the guidewire by a desired length (see [0043-0044]), thus achieving “wherein the access-guidewire actuator includes a slider slidably disposed in a longitudinal slot of a housing of the retractable-needle device”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire actuator slider taught by Prestidge in view of Belson to include an extension coupled to a proximal-end portion of the guidewire within a cavity of enclosed by the housing as taught by Belson for the purpose of coupling the guidewire and slider together such that movement of the slider moves the distal end of the guidewire (see [0043]), thus achieving “the slider including an extension coupled to a proximal-end portion of the access guidewire within a cavity of the retractable-needle device enclosed by the housing.”
Regarding claim 10, the modified system of Prestidge teaches the introducer of claim 9, and Prestidge further discloses wherein an introducer-needle actuator (124, see FIG. 23) of the retractable-needle device (170) is configured to release (see col 9 lines 7-11: knob 124 moved in slot to release spring 26. Col 9 line 7-11 are first described in relation to embodiment of FIGs.14-16 and are not described again and therefore col 9 line 7-11 also describes function of similar structural elements in Prestidge Figs. 23-25) a compressed compression spring (26) around (Configured to is functional language. 124 releases the spring abutting the carriage and is therefore “configured to” release a spring “around” the carriage) the carriage (24) when actuated (moved in direction of arrow 126, such as shown in FIG. 23) and thrust both the carriage (24) and the introducer needle (20) proximally (see proximal position in Fig. 25) into a cavity (see cavity of 12 in FIG. 24) of the retractable-needle device (170).
Regarding claim 11, the modified system of Prestidge teaches the introducer of claim 10, and Modified Prestidge further teaches wherein the carriage is configured to engage the slider of the access-guidewire actuator when the carriage is thrust proximally into the cavity of the retractable-needle device, thereby withdrawing the access guidewire into the cavity of the retractable-needle device by the distal-end portion thereof together with the introducer needle when the introducer-needle actuator is actuated (see 112b interpretation above. The modified system of Prestidge has an internal carriage 24 and an external slider—see rejection of claim 9 above. Therefore, Modified Prestidge meets the limitation as interpreted under 112b).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Prestidge in view of Belson as applied to claim 7 above, and further in view Burkholz et al. (U.S. PGPUB No. 2019/0321590), hereinafter Burkholz.
Regarding claim 8, the modified system of Prestidge teaches the introducer of claim 7, and Prestidge further discloses a seal (172, see FIG. 24) about a proximal end (leftward in FIG. 24) of the shaft of the introducer needle (20,see col 9 lines 58-59), thereby enabling aspiration of blood upon the needle tip accessing the blood-vessel lumen of the patient (see col 9 line 53- col. 10 line 7: needle passes through aperture of seal and allows for blood to be collected from body once vessel is pentrated).
Modified Prestidge is silent to “wherein a bare, unwound portion of the access guidewire passes through” the seal.
However, Burkholz teaches an introducer (see FIG. 1B and ) with an access guidewire (38), wherein a bare (38 is not disclosed as having any coatings/external hubs/ etc. at the location of the seal 48 and is therefore bare), unwound portion (38 is not coiled at the seal 48 and therefore is “unwound”) of the access guidewire (38, see [0051]) passes through a seal (48).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal at the proximal end of the introducer needle allowing the introducer needle to pass through in a sealing manner as taught by Modified Prestidge to also allow the access guidewire to pass through as taught by Burkholz for the purpose of allowing the guidewire to extend through the seal to a proximal end of the device while preventing blood flow from doing the same (see [0051]), thus achieving “wherein a bare, unwound portion of the access guidewire passes through” the seal.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over O’Bryan as applied to claim 1 above, and further in view of Stone et al. (U.S. PGPUB No. 2019/0282788), hereinafter Stone.
Regarding claim 12, O’Bryan discloses the introducer of claim 1, but O’Bryan is silent to “the introducer further comprising: a clip having a syringe-clipping portion and needle device-clipping portion, the syringe-clipping portion of the clip configured to clip a syringe by a barrel of the syringe and the needle device-clipping portion of the clip configured to clip the retractable-needle device by a body of the retractable-needle device while allowing the retractable-needle device to slide in the needle device- clipping portion of the clip.”
However, Stone teaches an introducer (see FIG. 2 and [0050]) with an inserting device (10,see FIG. 1), the introducer further comprising: a clip (see ‘Modified FIG. 2’below)
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having a syringe-clipping portion (60) and needle device-clipping portion (T-shaped cutout of clip for accommodating actuator 28 and fixing to 24, see ‘Modified FIG. 3’ below),
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the syringe-clipping portion (60) of the clip configured to clip a syringe by a barrel (62) of the syringe (see [0051]: 60 grips syringe barrel 62) and the needle device-clipping portion (see ‘Modified FIG. 3’ above) of the clip configured to clip (FIG. 2 & 3, actuator 28 fed through clip at needle clipping portion and into 24, see [0050-0052] and therefore the clip is “configured to” clip/hold in place the device) the retractable-needle device (10—configured to is functional language. The clip clips an insertion device and is therefore configure to clip a retractable needle device) by a body (28 and 24) of the retractable-needle device while allowing the retractable-needle device to slide in the needle device- clipping portion of the clip (see [0050-0052]: 28 slides).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer disclosed in O’Bryan to include a clip with a needle clipping portion and a syringe clipping portion as taught by Stone for the purpose of retaining the syringe in position (see [0051]), thus achieving “the introducer further comprising: a clip having a syringe-clipping portion and needle device-clipping portion, the syringe-clipping portion of the clip configured to clip a syringe by a barrel of the syringe and the needle device-clipping portion of the clip configured to clip the retractable-needle device by a body of the retractable-needle device while allowing the retractable-needle device to slide in the needle device- clipping portion of the clip”.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over O’Bryan as applied to claim 1 above, and further in view of Real (U.S. PGPUB No. 2016/0067391).
Regarding claim 13, O’Bryan discloses the introducer of claim 1, and O’Bryan further discloses wherein the introducer (see FIG. 1) is configured for introducing a rapidly insertable central catheter ("RICC") (102), the RICC (102) including a catheter tube (126, see [0031]) and an introducing lumen (see [0033]: needle 154 inserted through lumen of 126) of the catheter tube (126) that extends to a distal end (see [0033]: needle 154 disposed in lumen and needle extends to distal end of 102 as shown in FIG. 1 and therefore the lumen must also extend to the distal end) of the RICC (102), and, when the RICC (102) is coupled with the introducer (as in FIG. 1), the shaft of the introducer needle (154) further extends through the introducing lumen of the catheter tube such that the needle tip of the introducer needle extends beyond the distal end of the RICC (as shown in FIG. 1 and described in [0033], [0036-0037]).
O’Bryan is silent to the catheter tube “having a side aperture through a side of the catheter tube in a distal- end portion of the catheter tube, the side aperture opening into an introducing lumen of the catheter tube that extends from at least the side aperture” to a distal end of the RICC.
However, Real teaches an introducer (see FIG. 1 and ) with a catheter tube (2) having a side aperture (30) through a side (see [0155]: opening 30 through side wall) of the catheter tube (2) in a distal- end portion (see [0155]: openings adjacent the distal tip and therefore in distal end portion) of the catheter tube (2), the side aperture (30) opening into an introducing lumen (see [0155]: 30 provides fluid flow into cannula shaft) of the catheter tube (2) that extends from at least the side aperture (30, as described in [0155]) to a distal end (see devices 3 &10 deployed through lumen of 2 and therefore the lumen must extend to a distal end).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end portion of the catheter tube disclosed in O’Bryan to include side apertures as taught by Real for the purpose of providing a further pathway for fluid entry into the catheter tube (see [0155]), thus achieving the catheter tube “having a side aperture through a side of the catheter tube in a distal- end portion of the catheter tube, the side aperture opening into an introducing lumen of the catheter tube that extends from at least the side aperture” to a distal end of the RICC.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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