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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/26/2026 has been entered.
Claim Objections
Claim 16 is objected to because of the following informalities: Line 13 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Line 15 reading “the housing at a distal end of the distal portion of the housing” should read --the safety clip housing at a distal end of the distal portion of the safety clip housing--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Line 16 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Line 18 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: Line 2 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: Line 4 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: Line 5 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: Line 2 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: Line 3 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: Line 6 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: Line 18 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: Line 20 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: Line 25 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: Line 2 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: Line 4 reading “the housing and be covered by the distal portion of the housing” should read --the safety clip housing and be covered by the distal portion of the safety clip housing--. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: Line 2 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: Line 6 reading “the housing” should read --the safety clip housing--. Appropriate correction is required.
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.
Claims 16-25, 27-29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Harding et al. (USPGPub 2010/0191189) in view of Ishida (USPN 6,221,050).
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 defining an interior cavity (as can be seen in Harding Fig. 47), 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 safety clip housing (40) having a distal portion (45) and a proximal portion (43), the proximal portion (43) of the safety clip 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 safety clip housing (40) at a distal end of the safety clip housing (40) (as seen in embodiments of Harding Figs. 1 and 43), the distal portion of the safety clip housing (40) defining a chamber (42) having an interior wall (Harding ¶ 0147 - interior walls of internal cavity 42, internal cavity interpreted as extending from proximal end to distal end of needle shield 40).
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 safety clip 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 tabs (2193) at the first and second guard arms (2191, 2192) include first and second apertures (2194) each configured to enable the needle (31) to pass therethrough (as seen in Harding Fig. 47), the safety clip (1221) further including two opposed safety clip tabs (650) extending from the proximal wall (1100) (Harding embodiment of Fig. 18) to provide an interference fit with respective portions of the interior wall 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 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 respective needle tip tabs (2193) such that the first and second needle tip tabs (2193) naturally return to a position that prevents the sharp distal tip (32) of the needle (31) withdrawn within the safety clip (1221) from moving distally (Harding ¶ 0218-0219).
However, Harding fails to teach a blood control valve secured within the interior cavity of the catheter hub, the blood control valve configured to inhibit blood from escaping from the catheter hub after withdrawal of the needle. Ishida teaches a catheter assembly (1) comprising a catheter hub (3) with an interior cavity (34) therein, wherein a blood control valve (7) is secured within the interior cavity (34) of the catheter hub (3) (Ishida Col. 4 Lines 59-67), the blood control valve (7) configured to inhibit blood from escaping from the catheter hub (3) after withdrawal of a needle (4) and fouling the area surrounding the catheter hub (Ishida Col. 1 Lines 33-45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the catheter hub of Harding to comprise a blood control valve secured within the interior cavity of the catheter hub, the blood control valve configured to inhibit blood from escaping from the catheter hub after withdrawal of the needle as disclosed by Ishida to prevent fouling the area surrounding the catheter hub (Ishida Col. 1 Lines 33-45).
Re Claim 17, Harding in view of Ishida teach all of the limitations of Claim 16. Harding teaches wherein the safety clip is constructed of a resilient thin web of metal (Harding ¶ 0205 - stainless steel).
Re Claim 18, Harding in view of Ishida teach all of the limitations of Claim 16. 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 in view of Ishida teach all of the limitations of Claim 16. 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 in view of Ishida teach all of the limitations of Claim 19. 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 in view of Ishida teach all of the limitations of Claim 20. 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 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 in view of Ishida teach all of the limitations of Claim 16. Harding teaches wherein the two opposed safety clip 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 in view of Ishida teach all of the limitations of Claim 16. 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 two opposed safety clip 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 in view of Ishida teach all of the limitations of Claim 16. 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 in view of Ishida teach all of the limitations of Claim 16. 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 defining an interior cavity (as can be seen in Harding Fig. 47), a catheter (21) extends distally from the distal end (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 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 tabs (2193) (Harding Fig. 49) such that there are respective apertures for the respective needle tip 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 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 safety clip housing (40) including a proximal portion (43), the safety clip housing (40) further having a distal portion (45) that has an interior wall (Harding ¶ 0147 - interior walls of internal cavity 42, internal cavity interpreted as extending from proximal end to distal end of needle shield 40) defining 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 safety clip 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 tabs (650) of the safety clip (1221) in interference contact with respective portions of the interior wall to retain the safety clip (1221) 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 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 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 in view of Ishida teach all of the limitations of Claim 27. 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 in view of Ishida teach all of the limitations of Claim 27. 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 in view of Ishida teach all of the limitations of Claim 27. 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 in view of Ishida teach all of the limitations of Claim 27. 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 in view of Ishida teach all of the limitations of Claim 27. Harding teaches wherein the respective safety clip 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 03/26/2026 with respect to claim objections and 112 indefinite rejections have been fully considered and are persuasive. Due to amendments to the claims, claim objections and 112 indefinite rejections are hereinafter withdrawn.
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive. Applicant’s arguments directed to prior art Harding begin in the middle of Page 9 of the response. Near the top of Page 10 of the response, applicant argues, “First of all, applicant takes exception to the allegation by the examiner that applicant "has used prior art Harding as an instruction manual to build the device claimed in the present case."” Applicant is free to combine prior art references at will. In addition, examiner has not rejected the present case on the basis of “rejecting patents solely by finding prior art corollaries for the claimed elements would permit an examiner to use the claimed invention itself as a blueprint for piecing together elements in the prior art to defeat the patentability of the claimed invention” as applicant suggests. As previously stated, prior art Harding encourages the combining of Harding embodiments 18 and 47. It is unclear how this combination would be non-functional given applicant’s own admission that Harding embodiments 18 and 47 was the inspiration for the device of the present case. Applicant is free to use the teachings of prior art Harding to create the combination as claimed in the present case. However, applicant has received a prior art rejection over Harding in the present case not for relying on the teachings of prior art Harding, but because prior art Harding anticipates the claimed invention of the present case. Examiner cannot in good faith move the present case to allowance on the basis of what prior art Harding teaches, suggests, and encourages.
Conclusion
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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/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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