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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/23/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 09/23/2025. As directed by the amendment: Claims 1, 4 and 15-16 have been amended, claims 2-3, 6, 9-12, 18 have been cancelled, and claim 20 has been added. Thus, claims 1, 4-5, 7-8, 13-17, and 19-20 are presently pending in the application.
Applicant’s amendments to the claims have overcome the previous drawing objections and 112 rejections previously set forth in the Final Office Action mailed 03/25/2025.
Response to Arguments
Applicant’s arguments, filed 09/23/2025, with respect to the rejection of the claims under have been fully considered and are persuasive. Applicant argues that the references do not disclose the amendments to the independent claims; examiner agrees. Therefore, the rejection has been withdrawn; however, upon further consideration, a new ground(s) of rejection is made in view of Savage (US 6669679), Yoon (US 5752970), and Schulman (US 5531679).
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 1, 4, 7, 13-14, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Savage (US 6669679) in view of Yoon (US 5752970) and Schulman (US 5531679).
Regarding Claim 1, Savage discloses an antithrombotic medical instrument (Fig.1) comprising: a base (12) with a port for connection to an infusion set (syringe) (lines 60-63 in column 5); a vascular catheter (10) extending from the base (Fig.1), and the vascular catheter (10) comprises a main body (14 and 16) of tubular configuration (Fig.1) having a longitudinal axis (48) along a length of the vascular catheter and a tip (18) to be inserted into a blood vessel (lines 1-5 in column 7); wherein the base (12) with the port is proximal (36) on the vascular catheter (Fig.1) and said tip (18) is distal (20) along the length of the vascular catheter (10) (Fig.1); a plurality of lateral conduits (42) distributed along the length of the vascular catheter (Fig.2); a cover (valve); said lateral conduits each have an inner entrance (see annotated figure below) in an inner wall and an outer entrance (see annotated figure below) in the outer wall of the tubular configuration, said lateral conduits extend at an angle (A) in the range of 10⁰ to 60⁰ to the longitudinal axis of the catheter (lines 11-14 in column 9) from the inner entrance in the inner wall to the outer entrance in the outer wall of the tubular configuration by which the outer entrance is offset from the inner entrance in a direction towards the base (the inner and outer entrances are offset as seen in the
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annotated figure below).
Savage does not appear to disclose a tip is closed or closable and an elastomeric cover over each lateral conduit joins an outer wall of the tubular configuration and extends toward the base to open outward.
Yoon teaches it was known in the art to have a closable tip 26 as seen in Figs.3-4
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Savage to incorporate the teachings of Yoon to have a closed or closable tip in order to prevent fluid flow when a medical instrument is withdrawn and preventing leakage round the instrument when inserted into the catheter (lines 1-9 in column 2).
Schulman teaches it was known in the art to a conduit/opening 22 and a silicone rubber antireversion means over conduit 22 wherein the silicone rubber joins an outer wall of side wall 24 and extends toward base 26 to open outward (since it extends in both directions) as seen in Figs. 1 and 4B (lines 28-39 in column 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Savage to incorporate the teachings of Schulman to have an elastomeric cover over each lateral conduit joins an outer wall of the tubular configuration and extends toward the base to open outward in order to control fluid through the openings (lines 57-63 in column 6).
Regarding Claim 4, Savage as modified discloses a medical instrument according to claim 1 and further discloses wherein lateral conduits are at different circumferential positions of the catheter (lines 23-39 in column 9).
Regarding Claim 7, Savage as modified discloses a medical instrument according to claim 1, and further discloses wherein the catheter comprises a proximal portion (14) without lateral conduits (Fig.3).
Regarding Claim 13, Savage as modified discloses a medical instrument according to claim 1 and Yoon further teaches wherein the tip (26) is self-closing comprising a collapsible tip made of an elastomeric material (lines 6-12 in column 4), wherein there is a distal opening (opening at distal end (towards the patient) in said collapsible tip (Fig.1) configured to be opened by a trocar (36) that extends in use through the collapsible tip opening (Fig.3) and to collapse closed upon withdrawal of the trocar (Fig.4) (lines 6-12, 27-32, and 58-61 in column 4).
Regarding Claim 14, Savage as modified discloses a medical instrument according to claim 1 and Schulman further teaches wherein said elastomeric cover opens with the flow of the fluid inside the catheter and closes when the flow of the fluid inside the catheter stops (lines 28-39 and 57-63 in column 6).
Regarding Claim 17, Savage as modified discloses a medical instrument according to claim 1 and further discloses wherein each lateral conduit (42) has an internal diameter (0.33 mm) that is uniform through the tubular configuration (lines 29-31 in column 12).
Regarding Claim 19, Savage as modified discloses a medical instrument according to claim 1 and Schulman further teaches wherein at least one of said lateral conduits (22) protrudes from the main body (24) (the lateral conduits protrude from the body when the silicone rubber antireversion means opens as seen in Fig.4B)
Claims 5 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Savage, Yoon, and Schulman as applied to claim 1 above, and further in view of Person (US 5807349).
Regarding Claim 5, Savage as modified discloses all the limitations of claim 1 above.
Savage does not appear to disclose lateral conduits having different angles to the longitudinal axis of the catheter.
Person teaches it was known in the art to have lateral conduits 84 and 86 having different angles to the longitudinal axis of the catheter as seen in Figs.13-14.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Savage to incorporate the teachings of Person to have lateral conduits having different angles to the longitudinal axis of the catheter in order to facilitate delivery of fluids (lines 23-29 in column 2).
Regarding Claim 15, Savage as modified discloses all the limitations of claim 1 above.
Savage does not appear to disclose a first one of said lateral conduits more distal from the base than a second one of said lateral conduits, wherein the angle to the longitudinal axis of the catheter of the first one of the lateral conduits is greater than the angle to the longitudinal axis of the second one of the lateral conduits.
Person teaches it was known in the art to have a first lateral conduit 84 more distal than a second lateral conduit 86 wherein the angles of the conduits can be cut at different angles relative to the longitudinal axis (lines 23-29 in column 2). Person does not explicitly teach the angle to the longitudinal axis of the catheter of the first one of the lateral conduits is greater than the angle to the longitudinal axis of the second one of the lateral conduits.
However, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have the medical instrument in Savage to have an angle to a longitudinal axis of a catheter of a more distal first conduit greater than an angle to the longitudinal axis of the catheter of a second lateral conduit, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the medical instrument of Savage would not operate differently with the claimed angle. Further applicant places no criticality on the angle, indicating simply that more distal conduits “preferably” have larger angles (specification; page 5, lines 14-16).
Regarding Claim 16, Savage as modified discloses all the limitations of claim 1 above.
Savage does not appear to disclose there is no position on a main body of tubular configuration where a plurality of said lateral conduits have diametrically opposed openings.
Person teaches it was known in the art to have non-diametrically opposed conduits 84 and 86 as seen in Figs.13-14.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Savage to incorporate the teachings of Person to have no position on a main body of tubular configuration where a plurality of said lateral conduits have diametrically opposed openings in order to have conduits with different angles to facilitate delivery of fluids (lines 23-29 in column 2).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Savage, Yoon, and Schulman as applied to claim 7 above and further in view over Appling (US 5250034).
Regarding Claim 8, Savage as modified discloses all the limitations of claim 7 above.
Savage does not appear to disclose said proximal catheter portion has a minimum length of 3 mm.
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have the medical instrument in Savage to have a minimum length of the proximal catheter portion of 3 mm, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the medical instrument of Savage would not operate differently with the claimed length. Further applicant places no criticality on the range claimed, indicating simply that the length “preferably” has the claimed length (specification; page 8, line 37).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Savage (US 6669679) in view of Schulman (US 5531679) and Appling (US 5250034).
Regarding Claim 20, Savage discloses an antithrombotic medical instrument (Fig.1) comprising: a base (12) with a port for connection to an infusion set (syringe) (lines 60-63 in column 5); a vascular catheter (10) extending from the base (Fig.1), and the vascular catheter (10) comprises a main body (14 and 16) of tubular configuration (Fig.1) having a longitudinal axis (48) along a length of the vascular catheter and a tip (18) to be inserted into a blood vessel (lines 1-5 in column 7); wherein the base (12) with the port is proximal (36) on the vascular catheter (Fig.1) and said tip (18) is distal (20) along the length of the vascular catheter (10) (Fig.1); a plurality of lateral conduits (42) distributed along the length of the vascular catheter (Fig.2); a cover (valve); said lateral conduits each have an inner entrance (see annotated figure below) in an inner wall and an outer entrance (see annotated figure below) in the outer wall of the tubular configuration, said lateral conduits (42) extend at an angle (A) in the range of 10⁰ to 60⁰ to the longitudinal axis of the catheter (lines 11-14 in column 9) from the inner entrance in the inner wall to the outer entrance in the outer wall of the tubular configuration by which the outer entrance is offset from the
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inner entrance in a direction towards the base (see annotated figure below).
Savage does not appear to disclose a tip is blinded thereby being absent an opening and an elastomeric cover over each lateral conduit joins an outer wall of the tubular configuration and extends toward the base to open outward.
Appling teaches it was known in the art to have a catheter 100 with a tip with no opening/end hole (lines 63-64 in column 7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Savage to incorporate the teachings of Appling to have a blinded tip thereby being absent an opening in order not need a separate guide wire to steer that catheter wherein the catheter comprises a braid/coil to provide sufficient pushability to allow the catheter to be steered through the vascular system and applicant appears to have placed no criticality on the claimed tip simply the tip opening “may be” absent (blinded-tip catheter) (page 7, lines 2-3 in specification).
Schulman teaches it was known in the art to a conduit/opening 22 and a silicone rubber antireversion means over conduit 22 wherein the silicone rubber joins an outer wall of side wall 24 and extends toward base 26 to open outward (since it extends in both directions) as seen in Figs. 1 and 4B (lines 28-39 in column 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Savage to incorporate the teachings of Schulman to have an elastomeric cover over each lateral conduit joins an outer wall of the tubular configuration and extends toward the base to open outward in order to control fluid through the openings (lines 57-63 in column 6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TANIA M ISMAIL whose telephone number is (313)446-6625. The examiner can normally be reached Monday-Thursday 8:00-3:30 pm.
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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783