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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/22/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 07/17/26 has been entered. Claims 1 and 9-11 have been amended. Claims 2-8 and 12-13 are in the original/ previously presented form. Claims 14-20 remain withdrawn. Thus, claims 1-13 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 04/17/26.
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:
The carriage “coupling hub-connecting portion” such as in at least claim 1. Applicant could amend this drawing objection by including a numeral for the “coupling hub-connecting portion” in the specification (i.e.: specification [0072] or [0078] of the current Application’s PGPUB) and placing said numeral on the drawings (i.e.: FIG. 4: see examiner’s ‘Modified FIG.4’ below for example)
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the coupling hub including “a carriage connector” connecting to the coupling hub-connecting portion of the carriage such as in at least claim 1. Applicant could amend this drawing objection by including a numeral for the “carriage connector” in the specification (i.e.: specification [0078] of the current Application’s PGPUB) and placing said numeral on the drawings (i.e.: FIG. 4: see examiner’s ‘Modified FIG.4’ above for example)
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.
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.
Claims 1-13 are 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 1, lines 9-10 recite “a coupling hub including a carriage connector connected to the coupling hub- connecting portion of the carriage.” In view of Applicant disclosure, it is unclear to the examiner how the carriage connector is “connected to” the coupling hub-connecting portion of the carriage. [0078] of the current Application’s PGPUB notes these structures are “configured to connect” but fails to disclose how the connection is achieved. According to the drawings, it seems that maybe these structures are connected by being interdisposed/ perhaps by an interference fit? However, because the structures are not labeled in the drawings, it is not entirely clear to the examiner how exactly the recited “connected to” is achieved between the carriage connector and coupling hub-connecting portion (the examiner could be interpreting the wrong structures in the drawings). Thus, the lack of disclosure in the specification and drawings borders on a 112a new matter issue.
However, for purposes of examination, the examiner will interpret claim 1 lines 9-10 to read “a coupling hub including a carriage connector [[connected]] configured to connect to the coupling hub- connecting portion of the carriage”, which is supported by at least the current Application’s [0078]. Applicant may adopt this interpretation to overcome this 112b rejection and to avoid a 112a new matter rejection. Applicant is also highly encouraged to remedy the drawings objections as presented above to provide further clarity to the claim language and device structures and to avoid a 112a new matter rejection.
Due to claim dependency from claim 1, claims 2-13 are subsequently rejected under 112b.
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 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrison et al. (U.S. PGPUB No. 2020/0001050), hereinafter Garrison.
Regarding claim 1, Garrison discloses an introducer (see FIGs. 9A-H and [0048]), comprising:
a retractable-needle device including an introducer needle (922, see [0052]) having a shaft (see [0052]) and a needle tip (924, see FIG. 9C) in a distal-end portion of the shaft (as shown in FIG. 9C and described in [0052]), a proximal-end portion (leftward end away from tip 924) of the shaft disposed in a carriage (portion of needle hub 920 retaining needle, see ‘Modified FIG. 9D’ below)
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of the retractable-needle device, the retractable- needle device further including an introducer-needle actuator (946, see [0060] & [0066-0067]: 946 withdraws needle), the carriage (portion of needle hub 920 retaining needle, see ‘Modified FIG. 9D’ above) disposed in a cavity (see ‘Modified FIG. 9D’ above of a housing (942) of the retractable-needle device and having a coupling hub-connecting portion (outer surface of projecting portion of carriage that engages hub 904, see ‘Modified FIG. 9D’ above) extending through a distal end of the retractable-needle device (distal end 948 seen in FIG. 9D and see [0063]); and
a coupling hub (904) including a carriage connector (proximal internal surface of hub 904 engaging coupling hub-connecting portion, see ‘Modified FIG. 9D’ above) [[connected]] configured to connect to (carriage connector and coupling hub-connecting portion shown interdisposed, aligning with Applicant disclosure of these structures being configured to connect such as at least in [0078] of Applicant disclosure) the coupling hub- connecting portion of the carriage (see ‘Modified FIG. 9D’ above), the shaft of the introducer needle (922) extending from (see [0052]) the carriage (portion of needle hub 920 retaining needle), through a sealed (chamber 929 sealed by at least septum 934, see [0056] & [0066], and securement with catheter tube 909, see [0048]) blood-flashback chamber (929, numeral seen in FIG. 9H or ‘Modified FIG. 9D’ above and [0053]) of the coupling hub (904), and out a longitudinal through hole (see ‘Modified FIG. 9D’ above and FIG. 9H) of the coupling hub (904) distal of the blood-flashback chamber (929) 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 [0053] & [0056]).
Regarding claim 10, Garrison discloses the introducer of claim 1, and Garrison further discloses wherein the introducer-needle actuator (946, see FIG. 9D) is configured to release a compressed compression spring (944) around (see [0059]) the carriage when actuated and thrust both the carriage and the introducer needle proximally into the cavity of the retractable-needle device (see [0064]).
Regarding claim 11, Garrison discloses the introducer of claim 1, and Garrison further discloses wherein the carriage (portion of 920 retaining needle, see ‘Modified FIG. 9D’ above) includes a proximal flange (radially extending flange extending from carriage to abut internal side of housing, see ‘Modified 9Di’ below),
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and a compression spring (944) is disposed around the carriage (see [0059]) and compressed between the proximal flange of the carriage and a distal wall (see ‘Modified FIG. 9Di’ above) of the housing (942) of the retractable-needle device
Claims 1 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jaramillo et al. (U.S. Patent No. 8,882,715), hereinafter Jaramillo.
Regarding claim 1, Jaramillo discloses an introducer, comprising:
a retractable-needle device (see col 1 lines 19-35 and see col 4 lines 29-38: device withdraws needle 106) including an introducer needle (106, see FIG. 2 and see col 3 line 58- col 4 line 18: stylet 106 has shaft and tip 126) having a shaft and a needle tip (126) in a distal-end portion of the shaft (see FIG. 1), a proximal-end portion (leftward end portion) of the shaft disposed in a carriage (portion of retaining block 202 holding needle, see ‘Modified FIG. 2’ below and see col 4 lines 29-38: needle in retaining block)
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of the retractable-needle device, the retractable- needle device further including an introducer-needle actuator (130, see col 4 lines 29-38 and col 5 lines 4-7: button 130 actuates needle to withdrawn position), the carriage (portion of retaining block 202 holding needle, see ‘Modified FIG. 2’ above) disposed in a cavity of a housing (108, see col 4 line19-24: 108 is plastic tubular portion) of the retractable-needle device and having a coupling hub-connecting portion (see ‘Modified FIG. 2’ above) extending through a distal end of the retractable-needle device (see col 3 lines 32-47: fitting 102 attached at distal end and therefore coupling hub-connecting portion must extend through such distal end such as shown in ‘Modified FIG. 2’ above); and
a coupling hub (102) including a carriage connector (female luer and internal surface, such as surface 114 shown in FIG. 1 and described in col 3 lines 43-54) [[connected]] configured to connect to the coupling hub- connecting portion of the carriage (see col 3 lines 32-47: 102 a fitting such as female luer for mating to rest of assembly), the shaft of the introducer needle extending from the carriage (see FIG. 2 and col 4 lines 14-18), through a sealed (at least the distal end of the chamber is sealed by way of leak-proof connection with catheter 104, see col 3 lines 51-57) blood-flashback chamber of the coupling hub (102, see col 5 lines 13-28: blood visualized through 102 and thus 102, such as within cavity, forms a blood flashback chamber), and out a longitudinal through hole (see ‘Modified FIG. 2’) of the coupling hub (102) distal of the blood-flashback chamber (through hole at distal-most portion of 102 and thus is distal of the blood-flashback chamber) 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 5 lines 13-28: blood vessel penetrated by needle to allow blood to flow through stylet 106 and into coupling hub 102 to visualize blood flow and thus 102 serves as blood flashback chamber. Note line 14 appears to misnumber stylet as 114, but the numeral is corrected in line 26 back to stylet 106).
Regarding claim 10, Jaramillo discloses the introducer of claim 1,and Jaramillo further discloses wherein the introducer-needle actuator (130, see FIG. 2) is configured to release a compressed compression spring (204) around the carriage (as shown in FIG. 2) when actuated and thrust both the carriage and the introducer needle proximally into the cavity of the retractable-needle device (see col. 4 lines 29-38: compressed spring 204 released under release of button 130).
Regarding claim 11, Jaramillo discloses the introducer of claim 1,and Jaramillo further discloses wherein the carriage (portion of retaining block 202 holding needle, see ‘Modified FIG. 2’ above) includes a proximal flange (projecting collar connecting needle holding portion of retaining block to the radially outward longitudinally extending block portion labeled 202, see ‘Modified FIG. 2i’ below),
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and a compression spring (204) is disposed around the carriage and compressed between the proximal flange of the carriage and a distal wall of the housing (108) of the retractable-needle device (see col. 4 lines 29-38).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison as applied to claim 1 above, and further in view of Brimhall et al. (U.S. Patent No. 5,772,636), hereinafter Brimhall.
Regarding claim 2, Garrison discloses the introducer of claim 1, and Garrison further discloses wherein a cutout (930, seen best in FIG. 9E) of the shaft of the introducer needle is disposed in the needle (see FIG. 9E and [0052]), the cutout (930) configured to release blood into the blood-flashback chamber upon the needle tip accessing the blood-vessel lumen of the patient (see [0052] & [0056]: blood flows through flashback notch and into chamber).
Garrison is silent to a cutout being disposed “in the blood-flashback chamber”.
However, Brimhall teaches an introducer (see FIG. 2) comprising an introducer needle (30) having a shaft, the introducer further comprising a sealed (flashback chamber sealed by at least plug 26, see col 4 lines 20-25) blood-flashback chamber (see ‘Modified FIG. 2’ below),
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wherein a cutout (proximal/ rightward cutout 39) of the shaft of the introducer needle (30, see col 4 lines 56-63: needle has pair of notches 39) is disposed in the blood-flashback chamber (see Fig. 2 and col 6 line 47-55), the cutout (rightward cutout 39) configured to release blood into the blood-flashback chamber upon the needle tip accessing the blood-vessel lumen of the patient (see col 6 line 47-55).
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 needle shaft disclosed in Garrison to include a cutout disposed in the flashback chamber as taught by Brimhall for the purpose of visualizing blood flashback through both the catheter tube and the catheter hub (see col 6 lines 47-55), thus achieving a cutout being disposed “in the blood-flashback chamber”.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison in view of Brimhall as applied to claim 2 above, and further in view of Harding (U.S. PGPUB No. 2020/0129738).
Regarding claim 3, the modified system of Garrison teaches the introducer of claim 2, and Garrison further discloses wherein the blood-flashback chamber (929, see FIG. 9H) is sealed with a seal (934, see [0056] & [0066]) in a proximal-end portion (see [0066]) of the blood-flashback chamber (929) and a wedge securement in a distal-end portion of the blood-flashback chamber (see [0048]: tube 909 secured to hub by wedge, known to be fluidic sealing means for catheter attachment to hubs in the art).
Garrison is silent to “another seal” in a distal-end portion of the blood-flashback chamber.
However, Harding teaches an introducer (see [0003-0004], [0055], [0074-0076]) comprising a hub (12, see FIG. 5A and [0075]) with a catheter tube (14) secured to the hub by a wedge (73, see [0079]: “a wedge 73 that secures the catheter 14 within the catheter adapter 12.”), wherein the wedge (73) includes a seal (72, see FIG. 5F and [0079-0080] & [0082]).
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 wedge securement in a distal-end portion of the blood-flashback chamber disclosed in Garrison to include a seal as taught by Harding for the purpose of preventing fluid from traveling distally relative to the seal (see [0080]), thus achieving “another seal” in a distal-end portion of the blood-flashback chamber.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison as applied to claim 1 above, and further in view of O’Bryan et al. (U.S. PGPUB No. 2017/0274182), hereinafter O’Bryan.
Regarding claim 4, Garrison discloses the introducer of claim 1, but Garrison is silent to “wherein the coupling hub includes a side arm extending from a side of the coupling hub for coupling the retractable-needle device and another medical device together.”
However, O’Bryan teaches an introducer (see FIG. 1) comprising a coupling hub (120, see [0031]) and an introducer needle (154, see [0033-0034] & [0036]) extending through a sealed blood-flashback chamber (134, see [0031]: 134 sealed by septum 138), wherein the coupling hub (102) 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).
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 coupling hub disclosed in Garrison to include a side arm for coupling with another medical device as taught by O’Bryan for the purpose of conveying blood flash from the flashback chamber into the side arm and extension tube (see [0040]), which would allow for blood to be collected at a luer port/ other sampling connector attached to the side arm, thus achieving “wherein the coupling hub includes a side arm extending from a side of the coupling hub for coupling the retractable-needle device and another medical device together”.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison in view of 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, the modified system of Garrison teaches the introducer of claim 4, but Garrison is silent to “further comprising: a syringe as the other medical device, the syringe coupled to the side arm of the coupling hub, the syringe fluidly coupled to the blood-flashback chamber by a side-arm lumen of the side arm for aspirating blood upon the needle tip accessing the blood-vessel lumen of the patient.”
However, O’Bryan teaches an introducer (see FIG. 1) comprising a coupling hub (120, see [0031]) and an introducer needle (154, see [0033-0034] & [0036]) extending through a sealed blood-flashback chamber (134, see [0031]: 134 sealed by septum 138), wherein the coupling hub (102) 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), 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 (device at luer adapter) 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]).
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 coupling hub flashback chamber disclosed in Garrison to include a side arm for coupling to another medical device such that the medical device is fluidly coupled to the blood-flashback chamber by a side-arm lumen of the side arm as taught by O’Bryan for the purpose of conveying blood flash from the flashback chamber into the side arm, extension tube, and other medical device (see [0040]), which would allow for blood to be collected at the luer port of the side arm, thus achieving “further comprising: the” another medical device “coupled to the side arm of the coupling hub, the” another medical device “fluidly coupled to the blood-flashback chamber by a side-arm lumen of the side arm for aspirating blood upon the needle tip accessing the blood-vessel lumen of the patient”.
Garrison in view of O’Bryan remain silent to “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 taught by Garrison in view of 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 Garrison teaches the introducer of claim 5, but Modified Garrison 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 taught by Modified Garrison 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 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison as applied to claim 1 above, and further in view of Belson (U.S. PGPUB No. 2019/0240459).
Regarding claim 7, Garrison discloses the introducer of claim 1, and Garrison further discloses the housing (942, see FIG. 9C) being generally hollow (see [0059]).
Garrison 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), an introducer needle (118), and a generally hollow housing (112, see FIG. 6A and [0041-0042]), 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 generally hollow housing disclosed in Garrison to include an access guidewire actuator and an access guidewire disposed in the lumen of the needle as taught by Belson 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 8, the modified system of Garrison teaches the introducer of claim 7, but Garrison is silent to “wherein a bare, unwound portion of the access guidewire passes through a seal about a proximal end of the shaft of the introducer needle, thereby enabling aspiration of blood upon the needle tip accessing the blood-vessel lumen of the patient.”
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), an introducer needle (118), and a generally hollow housing (112, see FIG. 6A and [0041-0042]), 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 a bare, unwound portion of the access guidewire (120) passes through (see [0042-0044]: guidewire delivered via needle lumen and thus also through the seal disposed on needle) a seal (122, see [0042]: hemostasis valve 122) about a proximal end (leftward portion of needle shaft) of the shaft of the introducer needle (118), thereby enabling aspiration of blood upon the needle tip accessing the blood-vessel lumen of the patient (see [0044] and [0038] for further description of blood flashback).
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 needle taught by Garrison in view of Belson to include a seal about the proximal end of the needle shaft as taught by Belson for the purpose of containing the flow of blood flashback and allowing the entire device to be advanced to place the catheter before removing the needle and guidewire (see [0038] and [0044]), thus achieving “wherein a bare, unwound portion of the access guidewire passes through a seal about a proximal end of the shaft of the introducer needle, thereby enabling aspiration of blood upon the needle tip accessing the blood-vessel lumen of the patient.”
Regarding claim 9, the modified system of Garrison teaches the introducer of claim 7, but Garrison is silent to “wherein the access-guidewire actuator includes a slider slidably disposed in a longitudinal slot of the housing of the retractable-needle device.”
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), an introducer needle (118), and a generally hollow housing (112, see FIG. 6A and [0041-0042]), 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 the housing (112) of the retractable-needle device (100).
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 generally hollow housing disclosed in Garrison to include an access guidewire actuator including a slider slidably disposed in a longitudinal slot of the housing and an access guidewire disposed in the lumen of the needle as taught by Belson 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 “wherein the access-guidewire actuator includes a slider slidably disposed in a longitudinal slot of the housing of the retractable-needle device.”
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison 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, Garrison discloses the introducer of claim 1, but Garrison 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 Garrison to include a clip with a needle clipping portion and a syringe clipping portion as taught by Stone for the purpose of retaining the device structure 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 Garrison as applied to claim 1 above, and further in view of Real (U.S. PGPUB No. 2016/0067391).
Regarding claim 13, Garrison discloses the introducer of claim 1, and Garrison further discloses wherein the introducer is configured for introducing a rapidly insertable central catheter ("RICC") (902, see FIG. 9A), the RICC including a catheter tube (909, see FIG. 9D and [0048]) having an introducing lumen of the catheter tube that extends to a distal end of the RICC (see FIG. 9H with introducer needle extending distally from tube 909. Therefore, lumen of 909 must also extend to distal end to allow needle to extend therethrough) and, when the RICC (902) is coupled with the introducer, the shaft of the introducer needle further extends through an introducing lumen of the catheter tube such that the needle tip of the introducer needle extends beyond the distal end of the RICC (see FIG. 9H and [0052], [0056], [0060]).
Garrison 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 Garrison 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.
Response to Arguments
Applicant’s arguments with respect to claim 1 (see page 13 and 14 of Applicant remarks) 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.
Two new 35 U.S.C. § 102 claim rejections under Garrison and Jaramillo have been applied to claim 1 in view of the newly amended claim limitations, rendering the arguments against the previous 35 U.S.C. § 102 claim rejections under Prestidge and O’Bryan moot.
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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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