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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/11/2026 has been entered.
Acknowledgment
Claims 1, 11, 20 are amended and field on 6/11/2026.
A drawing was amended and field on 6/11/2026.
A specification was amended and field on 6/11/2026.
The drawings’ objection and specification’s objection in the action mailed on 3/11/2026 are withdrawn due to the amendment of drawing and speciation.
112a rejection in the action mailed on 3/11/2026 is withdrawn due to the amendment to claims.
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 (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 a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge, wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step.
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 wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step (annotated Fig. 3b of Isaacson, deepest point is the lowest point in the transition section).
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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 wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step 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 a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge
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) and wherein a depth ( depth measure from side view Fig, 8c ) of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge (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 and wherein a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge 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 a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge.
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 wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step (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 wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step 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 and wherein a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge
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) and wherein a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge (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, 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 and wherein a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge 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 a depth of the smooth tapered edge increases proximally along an entirety of the smooth tapered edge from the distal end of the smooth tapered edge to a deepest point at a proximal end of the smooth tapered edge ( lower point of 28 is the deepest point), (Page 16, lines 16-21), but it fails to wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step.
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 wherein the flashback notch further comprises a transition that curves upwardly from the deepest point to the step (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 flashback notch further comprises a transition that curves upwardly from the deepest point to the step as taught by Isaacson for the purpose of using a desired shape of joining the two surfaces of the notches and improving the first stick success and allowing the observation of the blood and can be covered by the needle guard (Isaacson, ¶0006, ¶0038).
Response to Arguments
Applicant’s arguments, see remark, filed 6/11/2026, with respect to the rejection(s) of claim(s) 1, 11, 20 by combining Isaacson or Gupta have been fully considered and are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, at least Isaacson discloses most of the elements of the invention except that some portion of the shape of the notch and Gupta discloses the tear- drop shape. Also, with regards to the transition’s curvature can be seen in Isaacson ( Also, a microscopic transition’s curvature can be argued to be located in Gupta). The two art are combinable as only part of the notch shape is modified between the two notches.
Conclusion
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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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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