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 Species (A) of push button (Fig. 7a-c) and species (2) for the barrel (Fig, 12-13d) (which read on claims 1-7, 12-16) in the reply filed on 12/23/2025 is acknowledged.
Claims 8-11, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US 20120016307 A1) (“Burkholz”).
Re Claim 1, Burkholz discloses a catheter system (Figs. 1-6), comprising: a catheter assembly (Fig. 2, 20, ¶0025), comprising: a catheter adapter (26), comprising a distal end (lower end), a proximal end (close to 32), and a catheter adapter lumen ( lumen inside 26) extending through the distal end of the catheter adapter and the proximal end of the catheter adapter ( Fig. 2); a catheter (¶0026, 28) extending from the distal end of the catheter adapter (Fig, 2); a needle assembly (22, ¶0025), comprising: a barrel (40, ¶0028), comprising a proximal end ( top end) and a distal end; (lower end) an introducer needle (30), comprising a sharp distal tip (52) and a proximal end (close to 56); a needle hub (36) affixed to the introducer needle and movably disposed in the barrel (Fig. 1 to Fig.6); a spring (58) disposed around the needle hub (Fig. 2); a push button (38) configured for selective engagement with the needle hub (¶0034, Fig. 2), wherein the push button holds the needle hub against the bias of the spring (¶0034), wherein the introducer needle extends beyond the distal end of the barrel (Fig. 2) and through the catheter when the catheter adapter is adjacent to the distal end of the barrel (Fig. 2); a projection (lower edge of the 38 that engages the needle hub 36) extending from the push button for engagement with the catheter adapter to prevent movement of the push button when the catheter adapter is adjacent to the distal end of the barrel (¶0034); a distally-extending arm (86) contacting an inner surface of the barrel (Fig. 6, ¶0049), wherein the distally- extending arm is configured to drag along the inner surface of the barrel in response to depression of the push button and expansion of the spring (86 is capable to drag along the inner surface of the barrel, ¶0049).
Re Claim 4, Burkholz discloses wherein the needle assembly further comprises a clip (62) separate from the spring (Fig. 6), wherein the clip comprises the distally-extending arm (86, ¶0049).
Re Claim 5, Burkholz discloses wherein the distally-extending arm is a first distally- extending arm ( left 86, Fig. 6), wherein the needle assembly further comprises a second distally-extending arm opposite the first distally-extending arm ( right 86, Fig. 6).
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20120016307 A1) (“Burkholz”) in view of Spier et al. (US 4921490) (“Spier”).
Re Claim 2, Burkholz fails to disclose wherein a distal end of the distally-extending arm comprises a hook.
However, Spier discloses a needle system (Figs. 11-13), comprising: a needle (39) and wherein a distal end (43t) of the distally-extending arm (43) comprises a hook (Fig. 13) .
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 arm of Burkholz so that a distal end of the distally-extending arm comprises a hook as taught by Spier for the purpose of controlling expanding the spring and covering the needle tip after expanding to prevent the injury (Spier, Col. 8, lines 30-40).
Re Claim 3, Burkholz fails to disclose wherein the distally-extending arm is monolithically formed as a single unit with the spring.
However, Spier discloses a needle system (Figs. 1-13), comprising: a needle (39) and the distally-extending arm (43) is monolithically formed as a single unit with the spring (as both spring 40 and 38 are secured together and can be formed by the same material as a single unit, Fig. 11).
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 arm and the spring of Burkholz so that the distally-extending arm is monolithically formed as a single unit with the spring as taught by Spier for the purpose of controlling expanding the spring and covering the needle tip after expanding to prevent the injury (Spier, Col. 8, lines 30-40).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20120016307 A1) (“Burkholz”) in view of Djordjevic et al. (US 20110306933A1) (“Djordjevic”).
Re Claim 6, Burkholz fails to disclose wherein the needle assembly further comprises a clip separate from the spring, wherein the clip comprises a coil, wherein a first end of the coil comprises the first distally-extending arm, wherein a second end of the coil comprises the second distally-extending arm.
However, Djordjevic discloses a needle system (Figs. 1-13), comprising: a needle (30) and wherein the needle assembly further comprises a clip (50 in Fig. 7 ) separate from the spring (48), wherein the clip comprises a coil (76), wherein a first end of the coil comprises the first distally-extending arm, (52a) wherein a second end of the coil comprises the second distally-extending arm (52b).
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 needle assembly of Burkholz so that the needle assembly further comprises a clip separate from the spring, wherein the clip comprises a coil, wherein a first end of the coil comprises the first distally-extending arm, wherein a second end of the coil comprises the second distally-extending arm as taught by Djordjevic for the purpose of permitting or preventing expanding the spring as desired (Djordjevic, ¶0038).
Re Claim 7, Burkholz fails to disclose wherein a distal end of the first distally-extending arm comprises a hook, wherein a distal end of the second distally-extending arm comprises a another hook.
However, Djordjevic discloses a needle system (Figs. 1-13), comprising: a needle (30) and wherein the needle assembly further comprises a clip (50 in Fig. 7 ) separate from the spring (48), wherein a distal end of the first distally-extending arm comprises a hook ( left 58 of 52a), wherein a distal end of the second distally-extending arm comprises a another hook ( right 58 of 52b).
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 needle assembly of Burkholz so that a distal end of the first distally-extending arm comprises a hook, wherein a distal end of the second distally-extending arm comprises a another hook. arm as taught by Djordjevic for the purpose of permitting or preventing expanding the spring as desired (Djordjevic, ¶0038).
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20120016307 A1) (“Burkholz”) in view of Hopman et al. (US 20130310750 A1) (“Hopman”).
Re Claim 12, Burkholz discloses a catheter system (Figs. 1-6), comprising: a catheter assembly (Fig. 2, 20, ¶0025), comprising: a catheter adapter (26), comprising a distal end (lower end), a proximal end (close to 32), and a catheter adapter lumen (lumen inside 26) extending through the distal end of the catheter adapter and the proximal end of the catheter adapter ( Fig. 2); a catheter (¶0026, 28) extending from the distal end of the catheter adapter (Fig, 2); a needle assembly (22, ¶0025), comprising: a telescopic barrel (34, 40, Fig. 2-3), comprising a main barrel (40) and an inner sleeve (34) nested within the main barrel (Fig. 3), wherein the main barrel comprises a side hole ( near 38, Fig. 2),; an introducer needle (30), comprising a sharp distal tip (52) and a proximal end (top end of 30); a needle hub (36) affixed to the introducer needle and coupled to the telescopic barrel (Fig. 2); and a spring (58) disposed around the needle hub (Fig. 2), and further it discloses a push button (38), but it fails to disclose wherein the inner sleeve comprises a distally-extending arm forming a push button within the side hole, wherein the push button is configured for selective engagement with the main barrel wherein when the push button is within the side hole, the push button holds the needle hub against the bias of the spring.
However, Hopman discloses a catheter system (Figs. 10-11), comprising: a catheter (30) and a needle introducer (36), a main barrel (94) with a side hole (113) and inner sleeve (128) comprises a distally-extending arm (108) forming a push button (111 and/or 116) within the side hole (Fig. 10), wherein the push button is configured for selective engagement with the main barrel ( Fig. 10-11), wherein when the push button is within the side hole, the push button holds the needle hub against the bias of the spring (112, ¶0054-¶0055).
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 main barrel and inner sleeve of Burkholz so that the inner sleeve comprises a distally-extending arm forming a push button within the side hole, wherein the push button is configured for selective engagement with the main barrel wherein when the push button is within the side hole, the push button holds the needle hub against the bias of the spring as taught by Hopman for the purpose of providing an art recognized push button that capable to lock the introducer needle in as desired location with respect to the main barrel (Hopman , Fig. 10-11, ¶0053-¶0055).
Re Claim 13, Burkholz discloses wherein in response to depression of the push button, the spring is configured to expand (Fig. 3), wherein in response to the spring expanding, the telescopic barrel expands and the introducer needle is retracted into the telescopic barrel (Fig. 3).
Re Claim 14, Burkholz fails to disclose wherein the push button comprises a distal stop surface configured to contact a rim of the main barrel to prevent collapsing of the telescopic barrel after the telescopic barrel expands and the introducer needle is retracted into the telescopic barrel.
However, Hopman discloses a catheter system (Figs. 10-11), comprising: a catheter (30) and a needle introducer (36), a main barrel (94) with a side hole (113) and inner sleeve (128) comprises a distally-extending arm (108) forming a push button (111 and/or 116) within the side hole (Fig. 10), the push button comprises a distal stop surface (106 and/or lower surface of 111) configured to contact a rim of the main barrel (top end of 110) to prevent collapsing of the telescopic barrel after the telescopic barrel expands and the introducer needle is retracted into the telescopic barrel (Fig. 11, ¶0054-¶0055).
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 main barrel and inner sleeve of Burkholz so that the push button comprises a distal stop surface configured to contact a rim of the main barrel to prevent collapsing of the telescopic barrel after the telescopic barrel expands and the introducer needle is retracted into the telescopic barrel as taught by Hopman for the purpose of providing an art recognized push button that capable to lock the introducer needle in as desired location with respect to the main barrel (Hopman , Fig. 10-11, ¶0053-¶0055).
Re Claim 15, Burkholz fails to disclose wherein the distal stop surface is perpendicular to a longitudinal axis of the telescopic barrel.
However, Hopman discloses a catheter system (Figs. 10-11), comprising: a catheter (30) and a needle introducer (36), a main barrel (94) with a side hole (113) and inner sleeve (128) comprises a distally-extending arm (108) forming a push button (111 and/or 116) within the side hole (Fig. 10), the push button comprises a distal stop surface (106 and/or lower surface of 111) is perpendicular to a longitudinal axis of the telescopic barrel (106 and/or lower surface of 111 is substationally perpendicular to the axis of 118)
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 main barrel and inner sleeve of Burkholz so that the distal stop surface is perpendicular to a longitudinal axis of the telescopic barrel as taught by Hopman for the purpose of providing an art recognized push button that capable to lock the introducer needle in as desired location with respect to the main barrel (Hopman , Fig. 10-11, ¶0053-¶0055).
Re Claim 15, Burkholz discloses further comprising a vent plug at a proximal end of the telescopic barrel (60, ¶0032).
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).
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, 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.
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.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783