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 .
Acknowledgment
Claims 1, 11, 20 are amended and field on 12/22/2025.
Claims 2-5, 12-15 are canceled.
A drawing was amended and field on 12/22/2025.
A specification was amended and field on 12/22/2025.
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” a transition” and “outer portion” in claim 20 (Note: it is unclear the end point of the smooth tapered edge and a transition base on the newly amended drawing. The new drawing fails to show a transition which located between the smooth tapered edge and step edge, wherein 226a is a portion of the smooth tapered edge and a transition is 225 should be a transition) 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.
Specification
The amendment filed 12/22/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “ In some embodiments, a transition 225 from the smooth tapered edge 226 to the step 230 may be rounded. In some embodiments, an outer portion 226a of the smooth tapered edge 226 at the proximal end 224 may be rounded” was not disclosed in the original filed disclosure. Specifically the terms such as “ transition” and “an outer portion” was not found in the specification, However, in Fig. 3d as originally filed the smooth edge has a lowest point 227 and it is attached to the step 230. it is unclear wherein the proximal end of smooth tapered edge (is it 227 or 226a).
The applicant may amend the speciation as “ curves and transits to the step 230
Applicant is required to cancel the new matter in the reply to this Office Action.
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 20 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.
Claim 20 recites the limitation "wherein the smooth tapered edge extends to the step and a transition from the smooth tapered edge to the step is rounded, wherein an outer portion of the smooth tapered edge at the proximal end is rounded" in las lines. It is unclear the location of outer portion of the smooth tapered portion and the transition. As the new amendment to the speciation and drawings show 225 to be the transition and 226a to be the outer portion of the smooth tapered portion. It seems are both point to the same location. so that boarder of the smooth tapered edge is unclear. For the purpose of examination, the examiner will interpret the limitation as “wherein the smooth tapered edge extends to the step and a transition from the smooth tapered edge to the step is rounded, wherein an outer edge
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(s) 1, 6-11, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (US. 20180289932A1)(“ Isaacson”) in view of Gupta (WO-2021130649-A1).
Re Claim 1, Isaacson discloses an intravenous catheter assembly (Fig. 2a-6f, abstract, ¶0001, wherein catheter in general explained in Fig 2a and the needle is the embodiment of Fig, 6a), comprising: a catheter adapter (26), comprising a distal end (lower end close to 24), a proximal end (top end), a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (lumen 30, ¶0038), and an inner wall forming the lumen (28, ¶0038); a catheter (24. ¶0038) extending from the distal end of the catheter adapter (Fig. 2b); an introducer needle (22 with a shaft 34, ¶0038) comprising a sharp distal tip (36) and an elongated shaft extending from the sharp distal tip (34), wherein the introducer needle is movable between a ready position in which the sharp distal tip is distal to a distal end of the catheter (Fig. 2a, Fig. 6a) and a retracted position proximal to the ready position (Fig. 2c, Fig. 6b), wherein the elongated shaft comprises a flashback notch (38, ¶0038), wherein the flashback notch comprises a distal end ( right of 38, Fig. 6b) and a proximal end (left end of 38 in Fig, 6b), wherein a width of the flashback notch ( 38 gas a width measured from top side of 38) wherein the flashback notch comprises a smooth tapered edge extending from the distal end in a direction that increases a depth of the flashback notch ( Fig. 6b), wherein the smooth tapered edge extends along at least half of an entire length of the flashback notch between the distal end and the proximal end (Fig, 6b, at least half the curve of 38, Fig. 6b); and a needle guard ( 43) slidably mounted on the introducer needle (Fig. 6a to Fig. 6b), wherein a portion of the needle guard abuts the inner wall of the catheter adapter to retain the needle guard in the catheter adapter when the introducer needle is in the ready position (84, Fig. 6a, ¶0057), wherein in response to movement of the introducer needle from the ready position to the retracted position, the portion of the needle guard is released from the inner wall and blocks the sharp distal tip (Fig. 6b. ¶0049), but it fails to disclose that the width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape wherein the flashback notch comprises a step at the proximal end, the step being transverse to a longitudinal axis of the introducer needle, wherein the smooth tapered edge extends to the step and a transition from the smooth tapered edge to the step is rounded.
However, Isaacson in the embodiment of Fig, 3b discloses a flashback notch (38 in Fig, 2d-3b) comprises a step at the proximal end ( right step), the step being transverse to a longitudinal axis of the introducer needle (annotated Fig. 3b of Isaacson), wherein the smooth tapered edge (lefty extends to the step and a transition from the smooth tapered edge to the step is rounded (annotated Fig. 3b of Isaacson).
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Annotated Fig. 3b of Isaacson
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal edge of the notch of embodiment of Fig. 6a Isaacson so that the flashback notch comprises a step at the proximal end, the step being transverse to a longitudinal axis of the introducer needle, wherein the smooth tapered edge extends to the step and a transition from the smooth tapered edge to the step is rounded as taught by embodiment of Fig. 3b of Isaacson for the purpose of using a suitable shape of the flashback notch so that allow observation of the blood and can be covered by the needle guard (Isaacson, ¶0006, ¶0068).
The modified Isaacson fails to disclose that the width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape
However, Gupta discloses a catheter assembly (Fig.1a, Fig. 8c) and the needle (20) comprises a flashback notch (28 in Fig, 8c) and the width of the flashback notch increases from the distal end (top end of 28) to the proximal end ( lower end of 28) to form a tear-drop shape (Fig. 8c) wherein the flashback notch comprises a step at the proximal end (lower edge of 28), the step being transverse to a longitudinal axis of the introducer needle (Fig. 8c), wherein the smooth tapered edge extends to the step (lower end of 28).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the notch of Isaacson so that the width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape as taught by Gupta for the purpose of using a suitable shape of the flashback notch (Gupta, Page 14, lines 5-8).
Re Claim 6, Isaacson fails to disclose wherein in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle.
However, Gupta disclose a catheter assembly (Fig.1a) and the needle (20) comprises a flashback notch (28, Fig. 3a-b, Fig. 8a-b) and wherein in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle (angle X is between 0 degree to 89 degree, Page 14, lines 3-10).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the notch of Isaacson so that in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle as taught by Gupta for the purpose of using a suitable shape of the flashback notch (Gupta, Page 14, lines 5-8).
Re Claim 7, Isaacson discloses wherein the introducer needle further comprises a needle feature (top and lower section of 54, Fig. 6b) disposed on the elongated shaft, wherein the needle feature comprises a first indent (top indent of 54, Fig. 6b)and a second indent opposite the first indent (lower indent of 54), wherein the first indent is aligned with the flashback notch (Fig. 6b).
Re Claim 8, Isaacson discloses wherein the needle feature comprises a first protrusion (right side of 54) and a second protrusion opposite the first protrusion (left side of 54), wherein the first protrusion and the second protrusion are disposed between the first indent and the second indent (Fig. 6b).
Re Claim 9, Isaacson discloses wherein the first indent is disposed on a top of the introducer needle (Fig. 6b), wherein the second indent is disposed on a bottom of the introducer needle (Fig. 6b), and wherein the first protrusion and the second protrusion are disposed on opposing sides of the introducer needle (Fig. 6b).
Re Claim 10, Isaacson discloses wherein in response to movement of the introducer needle from the ready position to the retracted position, the elongated shaft no longer exerts a force on the portion such that the portion is released from the inner wall and blocks the sharp distal tip (¶0013, Fig. 6b).
Re Claim 11, Isaacson discloses an intravenous catheter assembly (Fig. 2a-6f, abstract, ¶0001, wherein catheter in general explained in Fig 2a and the needle is the embodiment of Fig, 6a), comprising: a catheter adapter (26), comprising a distal end (lower end close to 24), a proximal end (top end), a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (lumen 30, ¶0038), and an inner wall forming the lumen (28, ¶0038); a catheter (24. ¶0038) extending from the distal end of the catheter adapter (Fig. 2b); an introducer needle (22 with a shaft 34, ¶0038) comprising a sharp distal tip (36) and an elongated shaft extending from the sharp distal tip (34), wherein the introducer needle is movable between a ready position in which the sharp distal tip is distal to a distal end of the catheter (Fig. 2a, Fig. 6a) and a retracted position proximal to the ready position (Fig. 2c, Fig. 6b), wherein the elongated shaft comprises a flashback notch (38, ¶0038), wherein the flashback notch comprises a distal end ( right of 38, Fig. 6b) and a proximal end( left end of 38 in Fig, 6b), wherein the flashback notch comprises a smooth tapered edge extending from the distal end in a direction that increases a depth of the flashback notch ( Fig. 6b); and a needle guard ( 43) slidably mounted on the introducer needle (Fig. 6a to Fig. 6b), wherein a portion of the needle guard abuts the inner wall of the catheter adapter to retain the needle guard in the catheter adapter when the introducer needle is in the ready position (84, Fig. 6a, ¶0057), wherein in response to movement of the introducer needle from the ready position to the retracted position, the portion of the needle guard is released from the inner wall and blocks the sharp distal tip (Fig. 6b. ¶0049), but it fails to disclose a width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape, wherein in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle and wherein the flashback notch comprises a step at the proximal end, the step being transverse to a longitudinal axis of the introducer needle, wherein the smooth tapered edge extends to the step and a transition from the smooth tapered edge to the step is rounded.
However, Isaacson in the embodiment of Fig, 3b discloses a flashback notch (38 in Fig, 2d-3b) comprises a step at the proximal end ( right step), the step being transverse to a longitudinal axis of the introducer needle (annotated Fig. 3b of Isaacson), wherein the smooth tapered edge (lefty extends to the step and a transition from the smooth tapered edge to the step is rounded (annotated Fig. 3b of Isaacson).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal edge of the notch of embodiment of Fig. 6a Isaacson so that the flashback notch comprises a step at the proximal end, the step being transverse to a longitudinal axis of the introducer needle, wherein the smooth tapered edge extends to the step and a transition from the smooth tapered edge to the step is rounded as taught by embodiment of Fig. 3b of Isaacson for the purpose of using a suitable shape of the flashback notch so that allow observation of the blood and can be covered by the needle guard (Isaacson, ¶0006, ¶0068).
The modified Isaacson fails to disclose that the width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape, and wherein in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle
However, Gupta discloses a catheter assembly (Fig.1a, Fig. 8c) and the needle (20) comprises a flashback notch (28 in Fig, 8c) and the width of the flashback notch increases from the distal end (top end of 28) to the proximal end ( lower end of 28) to form a tear-drop shape (Fig. 8c) wherein the flashback notch comprises a step at the proximal end (lower edge of 28), the step being transverse to a longitudinal axis of the introducer needle (Fig. 8c), wherein the smooth tapered edge extends to the step (lower end of 28) and wherein in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle (angle X is between 0 degree to 89 degree, Page 14, lines 3-10).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the notch of Isaacson so that the width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape, and wherein in an orthogonal side view projection of the intravenous catheter assembly, every tangent to the smooth tapered edge is at an angle of 30 degree or less with respect to a longitudinal axis of the introducer needle as taught by Gupta for the purpose of using a suitable shape of the flashback notch (Gupta, Page 14, lines 5-8).
Re Claim 16, Isaacson discloses wherein the introducer needle further comprises a needle feature (top and lower section of 54, Fig. 6b) disposed on the elongated shaft, wherein the needle feature comprises a first indent (top indent of 54, Fig. 6b)and a second indent opposite the first indent (lower indent of 54), wherein the first indent is aligned with the flashback notch (Fig. 6b).
Re Claim 17, Isaacson discloses wherein the needle feature comprises a first protrusion (right side of 54) and a second protrusion opposite the first protrusion (left side of 54), wherein the first protrusion and the second protrusion are disposed between the first indent and the second indent (Fig. 6b).
Re Claim 18, Isaacson discloses wherein the first indent is disposed on a top of the introducer needle (Fig. 6b), wherein the second indent is disposed on a bottom of the introducer needle (Fig. 6b), and wherein the first protrusion and the second protrusion are disposed on opposing sides of the introducer needle (Fig. 6b).
Re Claim 19, Isaacson discloses wherein the smooth tapered edge extends along at least half of an entire length of the flashback notch between the distal end and the proximal end ( top half curve edge of 38).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gupta in view of Isaacson.
Re Claim 20, Gupta discloses an introducer needle (Fig. Fig 1a-b), comprising: a sharp distal tip (24); and an elongated shaft (22) extending from the sharp distal tip (Fig, 1a-8c), wherein the elongated shaft comprises a flashback notch (28, Fig., 8a-c), wherein the flashback notch comprises a distal end ( top end of 28) and a proximal end ( lower end of 28), wherein the flashback notch comprises a smooth tapered edge (side edge of 28) extending from the distal end in a direction that increases a depth of the flashback notch (Fig. 8a-8c), wherein a width of the flashback notch increases from the distal end to the proximal end to form a tear-drop shape (Fig. 8c), wherein the flashback notch comprises a step at the proximal end (step at the lower end of 28), the step being transverse to a longitudinal axis of the introducer needle (Fig. 8c), wherein the smooth tapered edge extends to the step (Fig. 8c) and, wherein an outer portion of the smooth tapered edge at the proximal end is rounded (Page 16, lines 16-21), but it fails to disclose that a transition from the smooth tapered edge to the step is rounded.
However, Isaacson in the embodiment of Fig, 3b discloses a flashback notch (38 in Fig, 2d-3b) comprises a step at the proximal end ( right step), the step being transverse to a longitudinal axis of the introducer needle (annotated Fig. 3b of Isaacson), wherein the smooth tapered edge (lefty extends to the step and a transition from the smooth tapered edge to the step is rounded (annotated Fig. 3b of Isaacson).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal edge of the notch of Gupta so that the transition from the smooth tapered edge to the step is rounded as taught by Isaacson for the purpose of using a suitable shape of the flashback notch so that allow observation of the blood and can be covered by the needle guard (Isaacson, ¶0006, ¶0068).
Response to Arguments
Applicant’s arguments, see remark, filed 12/22/2025, with respect to the rejection(s) of claim(s) 1, 11, 20 under Isaacson or Gupta have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Isaacson in view is Gupta for claims 1, 11 and Gupta in view of Isaacson for claim 20. The round transition between at the proximal step can be seen in Isaacson; Fig. 3b. Also Gupta has a round smooth taper edge.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783