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 .
Claim Objections
Claim 16 is objected to because of the following informalities: Line 19 reading “to enable passage” should read --to enable a passage--. Appropriate correction is required for the purpose of appropriate positive recitation and clarity.
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 16-25 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. The limitation of Lines 13-14 of Claim 16 reading “a safety clip at least partially housed within the chamber at the distal portion of the housing having a proximal wall and first and second guard arms” is being found indefinite where it is unclear what structure has “a proximal wall and first and second guard arms,” the safety clip, chamber or housing. The claim is being interpreted as though the safety clip has “a proximal wall and first and second guard arms.” Appropriate correction and/or clarification is required.
Claims 16-25 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. Line 20 of Claim 16 recites the limitation “two opposed safety clip retention tabs.” Lines 33-34 recite the claim limitation “the first and second needle tip retention tabs.” Claims 22-23 refer to “the respective safety clip retention tabs.” It is unclear from the claims whether these structures are referencing one another. Furthermore, these structures are not recited in the specification, making it nearly impossible to determine what structure they are referencing in the figures. Appropriate correction and/or clarification is required.
Claims 27-29 and 31-33 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. Line 7 of Claim 27 recites the limitation “respective needle tip retention tabs.” Lines 12-13 recite the claim limitation “two opposed safety clip retention tabs.” It is unclear from the claims whether these structures are referencing one another. Furthermore, these structures are not recited in the specification, making it nearly impossible to determine what structure they are referencing in the figures. Appropriate correction and/or clarification is required.
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.
Claims 16-25, 27-29 and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harding et al. (USPGPub 2010/0191189).
Re Claim 16, Harding teaches a safety catheter assembly (as seen in Harding Figs. 1 and 46), comprising: a catheter hub (24) having a proximal portion, the proximal portion including an open proximal end and a distal end wherefrom a catheter (21) extends distally (Harding ¶ 0144-0145); a needle (31) having a sharp distal tip (32) and a proximal end (Harding ¶ 0146); a handle (34) operably coupled to the proximal end of the needle (31) (as seen in Harding Fig. 46), the handle (34) having a distal portion defining a socket (Harding ¶ 0213-0215; Fig. 43 - wherein proximal portion of housing 40 fits within socket of handle 34); and a safety clip assembly (40, 1221) including a housing (40) having a distal portion (45) and a proximal portion (43), the proximal portion (43) of the housing (40) having an extension (structure defining cavity 42) configured to matingly fit to the socket at the distal portion of the handle (34), a tab (flared portions at distal end of needle shield 40) extending upwardly relative to the housing (40) at a distal end of the housing (40) (as seen in embodiments of Harding Figs. 1 and 43), the distal portion of the housing (40) defining a chamber (42) (Harding ¶ 0147).
Harding further teaches a safety clip (1221) (Harding Fig. 47; ¶ 0147) at least partially housed within the chamber (42) at the distal portion (45) of the housing (40) (as seen in Harding Figs. 47-48), said safety clip (1221) having a proximal wall (1100) and first and second guard arms (2191, 2192) extending from the proximal wall (1100) (Harding Fig. 49), the first and second guard arms (2191, 2192) having respective distal ends whereat first and second hook features (2195), respectively, are configured to selectively grip the catheter hub (24) (as seen in Harding Fig. 47), respective needle tip retention tabs (2193) at the first and second guard arms (2191, 2192) include first and second apertures (2194) each configured to enable passage of the needle (31) therethrough (as seen in Harding Fig. 47), the safety clip (1221) further including two opposed safety clip retention tabs (650) extending from the proximal wall (1100) (Harding embodiment of Fig. 18) to provide an interference fit with a wall portion (660) of the chamber (42) to prevent the safety clip (1221) from moving distally out of the housing (40) (Harding Fig. 18; ¶ 0043 - wherein the “spring clip can be used in combination with any of the locks discussed above for preventing unwanted distal movement of the introducer needle with respect to the needle shield”, ¶ 0180).
Finally, Harding teaches wherein the safety clip assembly (40, 1221) is configured to transition between a first position (as seen in Harding Fig. 47) in which the first and second guard arms (2191, 2192) are restrained by the passage of the needle (31) through the first and second apertures (2194) of the respective needle tip retention tabs (2193) such that the catheter hub (24) is gripped by the first and second hook features (2195) extending from the respective distal ends of the first and second guard arms (2191, 2192) (Harding ¶ 0218-0219), and a second position (as seen in Harding Fig. 48) in which the needle (31) is proximally withdrawn through the first and second apertures (2194) to enable the first and second guard arms (2191, 2192) to be naturally biased apart to release the catheter hub (24) from being gripped by the first and second hook features (2195) and to un-restrain the first and second needle tip retention tabs (2193) such that the first and second needle tip retention tabs (2193) naturally return to a position that prevents the sharp distal tip (32) of the needle (31) within the safety clip (1221) from moving distally (Harding ¶ 0218-0219).
Re Claim 17, Harding teaches wherein the safety clip is constructed of a resilient thin web of metal (Harding ¶ 0205 - stainless steel).
Re Claim 18, Harding teaches wherein the first and second hook features (2195) of the first and second guard arms (2191, 2192), respectively, are shaped and sized to closely conform to an outer diameter and extending ridge and/or external ears (26) of the catheter hub (24) (Harding Figs. 47-48).
Re Claim 19, Harding teaches wherein the first and second guard arms (2191, 2192) are operably coupled to the proximal wall (1100) (Harding Fig. 49).
Re Claim 20, Harding teaches wherein the proximal wall includes an opening (1130) configured to enable an elongate body of the needle (31) to pass therethrough, but inhibits passage of a needle feature (38) of the needle (31) therethrough (Harding ¶ 0220 - wherein having the proximal wall 1100 prevent proximal movement of discontinuous portion 38 is a disclosed embodiment).
Re Claim 21, Harding teaches wherein in the second position (Harding Fig. 48), the sharp distal tip (32) of the needle (31) is captured in the safety clip (1221) as the sharp distal tip (32) is prevented from moving proximally relative to the safety clip (1221) by interference between the needle feature (38) and the opening of the proximal wall (1100) (Harding ¶ 0220 - wherein having the proximal wall 1100 prevent proximal movement of discontinuous portion 38 is a disclosed embodiment) and the sharp distal tip (32) is prevented from moving distally relative to the safety clip (1221) by the two opposed safety clip retention tabs (650) (Harding Fig. 18; ¶ 0043 - wherein the “spring clip can be used in combination with any of the locks discussed above for preventing unwanted distal movement of the introducer needle with respect to the needle shield”, ¶ 0180).
Re Claim 22, Harding teaches wherein the respective safety clip retention tabs (2193) are constructed of a resilient material (Harding ¶ 0205 - stainless steel) and extend from the proximal wall (1100) at an oblique angle (as seen in Harding Fig. 18).
Re Claim 23, Harding teaches wherein the first and second guard arms (2191, 2192) extend from opposite sides of the proximal wall (1100) (Harding Figs. 47-49); and wherein the respective safety clip retention tabs (650) extend from sides of the proximal wall (1100) different from where the first and second guard arms (2191, 2192) extend from the proximal wall (1100) (Harding Fig. 18; ¶ 0043 - wherein the “spring clip can be used in combination with any of the locks discussed above for preventing unwanted distal movement of the introducer needle with respect to the needle shield”, ¶ 0180).
Re Claim 24, Harding teaches wherein the distal end at the distal portion (45) of the housing (40) has a larger dimension than the open proximal end of the catheter hub (24) (as seen in Harding Figs. 46-47) such that the open proximal end of the catheter hub (24) fits into the distal end of the housing (40) and at least the open proximal end at the proximal portion of the catheter hub (24) is covered by the distal portion of the housing (40) in the first position (Harding Fig. 47).
Re Claim 25, Harding teaches wherein the distal end of the housing (40) opens to the chamber wherein the safety clip (1221) is positioned proximal from the distal end of the housing (40) (as seen in Harding Fig. 47); and wherein when the safety clip assembly (40, 1221) is in the first position (Harding Fig. 47), the catheter hub (24) is gripped by the safety clip (1221) and the proximal portion of the catheter hub (24) including the open proximal end is covered by the distal portion of the housing (40) (as seen in Harding Fig. 47).
Re Claim 27, Harding teaches a catheter hub (24) (as seen in Harding Figs. 1 and 46) having a proximal portion, the proximal portion including an open proximal end and a distal end wherefrom a catheter (21) extends distally (Harding ¶ 0144-0145); a needle (31) having a sharp distal tip (32) and a proximal end operably coupled to a handle (34) (as seen in Harding Fig. 46), the handle (34) having a socket (Harding ¶ 0213-0215; Fig. 43 - wherein proximal portion of housing 40 fits within socket of handle 34) defined within a distal portion of the handle (34); a safety clip (1221) having a proximal wall (1100) that has an opening (1130) through which the needle (31) extends (Harding Fig. 47; ¶ 0198-0199), first and second guard arms (2191, 2192) having respective needle tip retention tabs (2193) and distal hook features (2195) extending distally from opposite sides of the proximal wall (1100), an aperture (2194) is provided for each of the respective needle tip retention tabs (2193) (Harding Fig. 49) such that there are respective apertures for the respective needle tip retention tabs (2193) (as seen in Harding Fig. 49), the respective apertures configured to be in alignment to enable the needle (31) to pass through in a ready for use position (as seen in Harding Fig. 47), two opposed safety clip retention tabs (650) extending from opposite sides of the proximal wall (1100) away from where the first and second guard arms (2191, 2192) extend (Harding embodiment of Fig. 18).
Harding further teaches a housing (40) including a proximal portion (43), the housing (40) further having a distal portion (45) that has a chamber (42) adapted to retain at least a portion of the safety clip (2191, 2192) (Harding ¶ 0147), a tab (flared portions at distal end of needle shield 40) extending upwardly relative to the housing (40) at a distal end of the distal portion (43) (as seen in embodiments of Harding Figs. 1 and 43), the two opposed safety clip retention tabs (650) being deflectable and are configured to create an interference fit with at least a portion (660) of the chamber to inhibit the safety clip (1221) from moving distally out of the chamber (42) (Harding Fig. 18; ¶ 0043 - wherein the “spring clip can be used in combination with any of the locks discussed above for preventing unwanted distal movement of the introducer needle with respect to the needle shield”, ¶ 0180), the proximal portion (43) of the housing (40) having an extension matingly fittable within the socket defined within the distal portion of the handle (34) (Harding ¶ 0213- 0215; Fig. 43 - wherein proximal portion of housing 40 fits within socket of handle 34).
Finally, Harding teaches wherein the safety catheter assembly (40, 1221) is in the ready for use position (as seen in Harding Fig. 47) when the respective apertures (2194) of the respective needle tip retention tabs (2193) are in alignment and the needle (31) passes through the in alignment apertures to bias the first and second guard arms (2191, 2192) and the distal hook features (2195) to grip the catheter hub (24) (Harding ¶ 0218- 0219); and wherein the safety catheter assembly (40, 1221) is in a safe position (Harding Fig. 48) when the needle (31) is proximally withdrawn through the respective apertures (2194) with the sharp distal tip (32) of the needle (31) proximal of the needle tip retention tabs (2193) to un-bias the first and second guard arms (2191, 2192) and to remove the distal hook features (2195) from the catheter hub (24) (Harding ¶ 0218-0219).
Re Claim 28, Harding teaches wherein the distal end at the distal portion (45) of the housing (40) has a larger dimension than the open proximal end of the catheter hub (24) (as seen in Harding Figs. 46-47) such that the open proximal end of the catheter hub (24) is adapted to fit into the distal end of the housing (40) and be covered by the distal portion of the housing (40) in the first position (Harding Fig. 47).
Re Claim 29, Harding teaches wherein the chamber at the distal portion of the housing (40) has an open distal end and the safety clip (1221) is positioned in the chamber (as seen in Harding Fig. 47); and wherein when the safety clip assembly (40, 1221) is in the first position (Harding Fig. 47), the catheter hub (24) is gripped by the safety clip (1221) and the proximal portion of the catheter hub (24) including the open proximal end is covered by the distal portion (45) of the housing (40) (as seen in Harding Fig. 47).
Re Claim 31, Harding teaches wherein the respective hook features (2195) of the first and second guard arms (2191, 2192) each are shaped and sized to closely conform to an outer diameter and/or external ears (26) of the catheter hub (24) (Harding Figs. 47-48).
Re Claim 32, Harding teaches wherein the proximal wall (1100) includes the opening (1130) configured to enable the needle (31) to pass but prevents passage of a needle feature (38) of the needle (31) (Harding ¶ 0220 - wherein having the proximal wall 1100 prevent proximal movement of discontinuous portion 38 is a disclosed embodiment).
Re Claim 33, Harding teaches wherein the respective safety clip retention tabs are constructed of a resilient material (Harding ¶ 0205 - resilient stainless steel) and extend from the proximal wall at an oblique angle.
Response to Arguments
Applicant’s arguments filed 10/15/2025 with respect to claim objections and 112 rejections have been fully considered and are persuasive. All previously provided claim objections and 112 indefinite rejections are hereinafter withdrawn.
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive. Applicant’s arguments beginning at the top of Page 8 of the response are directed to Fig. 4 of Harding. Examiner does not rely upon the embodiment of Harding Fig. 4 in the current rejection or any previous rejection of the present case. Therefore, these arguments are hereinafter moot. Applicant’s arguments move to the Harding embodiments of Figs. 18 and 47 in Pages 9-10 of the response. Applicant’s arguments hinges on the two embodiments being incompatible. However, not only does prior art Harding encourage the combination of the Harding embodiments of Figs. 18 and 47, the applicant has used the teachings of Harding to recreate exactly what Harding encourages and suggests, and now argues Harding’s combination would somehow be non-functional where applicant’s invention is the very combination of Harding Figs. 18 and 47. Applicant has used prior art Harding as an instruction manual to build the device claimed in the present case. Examiner could not in good faith allow the present case on the basis of what prior art Harding teaches, suggests, and encourages.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783