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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Response to Amendment
The amendment filed 12/22/2025 has been entered. Claim 1-15, 22-28 are pending in the application. Claims 2, 5-15 are withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 22, 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2013/0158338) in view of Hobbs (US 5,584,821) and further in view of Oborn (US 2017/0165453).
Regarding claim 1, Kelly discloses a dual lumen coaxial cannula assembly (Para 0029) comprising: a first infusion tube (12, Fig 3) having a first elongate body defining a first lumen (29, Fig 3) therethrough, the first elongate body having a proximal end (30, Fig 3), a distal end (32, Fig 3), and a sidewall (36, Fig 3) extending circumferentially therebetween (See Fig 3); a second drainage tube (14, Fig 1) co-axially aligned with the first infusion tube and having a second elongate body with a second lumen defined by a space between the first infusion tube and the second drainage tube (the second lumen is required for the first infusion tube 12 to be inserted inside as shown in Fig 1; Para 0029), the second elongate body having a proximal end (42, Fig 5), a distal end (44, Fig 5), and a sidewall (48, Fig 5) extending circumferentially therebetween (See Fig 5); a connector (22, Fig 1) attached to the proximal end of the first infusion tube and the proximal end on the second drainage tube (Para 0033); and a distal tip (38, Fig 3) defining a distal lumen therethrough (See Fig 4), the distal tip having a proximal end, a distal end, and a sidewall extending circumferentially therebetween, the distal tip connected to the distal end of the first elongate body (See Fig 4),
Kelly is silent regarding the distal tip extends distally beyond the distal end of the first elongate body, and wherein the distal lumen defined by the inner surface of the distal tip is in fluid communication with the first lumen defined by the inner surface of the first elongate body, wherein the distal tip is comprised of a material having a Shore durometer hardness of at least 5 A less than a Shore durometer hardness of the first elongate body; wherein the distal end of the first elongate body includes a distally facing tapered distal face and the proximal end of the distal tip includes a proximally facing tapered proximal face, wherein the tapered distal face of the first elongate body is bonded directly to the tapered proximal face of the distal tip in an abutting interface; and wherein the tapered distal face tapers distally toward the first lumen of the first elongate body around an entire circumference of the first elongate body; wherein the tapered proximal face mates with the tapered distal face at the abutting interface to axially align the first lumen and the distal lumen during bonding of the distal tip to the first elongate body.
Hobbs teaches a cannula assembly (10, Fig 1) comprising: a first infusion tube having a first elongate body (14, Fig 1) defining a first lumen therethrough (See lumen in Fig 2), the first elongate body having a proximal end, a distal end, and a sidewall extending circumferentially therebetween; a connector (12, Fig 1) attached to the proximal end of the first elongate body (See Fig 1); and a distal tip (16, Fig 1) defining a distal lumen therethrough, the distal tip having a proximal end, a distal end, and a sidewall extending circumferentially therebetween, the distal tip connected to the distal end of the first elongate body (Col 4, lines 30-38), wherein the distal tip is comprised of a material having a lower hardness than a hardness of the first elongate body (Abstract); wherein the distal tip extends distally beyond the distal end of the first elongate body (See Fig 2A wherein tip material 30 extends distal to the shaft materials 26 and 28), and wherein the distal lumen defined by the inner surface of the distal tip is in fluid communication with the first lumen defined by the inner surface of the first elongate body (See Fig 2A); wherein the distal end of the first elongate body includes a distally facing tapered distal face (distal end of 28, Fig 2A) and the proximal end of the distal tip includes a proximally facing tapered proximal face (proximal end of 30, Fig 2A), wherein the tapered distal face of the first elongate body is bonded directly to the tapered proximal face of the distal tip in an abutting interface; and wherein the tapered distal face tapers distally toward the first lumen of the first elongate body around an entire circumference of the first elongate body; wherein the tapered proximal face mates with the tapered distal face at the abutting interface to axially align the first lumen and the distal lumen during bonding of the distal tip to the first elongate body (Col 4, lines 30-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kelly to have the distal tip be comprised of a material having a lower hardness than a hardness of the first elongate body, and wherein the proximal face of the distal tip and distal face of the elongated body are tapered and abut as taught by Hobbs in order to have a tip that can avoid injury to the walls of the blood vessels and provide substantial surface fusion between the tip and elongate body to resist failure and separation during use (Col 1, lines 13-15; Col 4, lines 39-44).
The modified invention of Kelly and Hobbs disclose all of the elements of the invention as discussed, however, is silent regarding the distal tip is comprised of a material having a Shore durometer hardness of at least 5 A less than a Shore durometer hardness of the first elongate body.
Oborn teaches a cannula assembly (1310, Fig 21) comprising a first infusion tube having a first elongate body (1311, Fig 21) defining a first lumen therethrough, the first elongate body having a proximal end, a distal end, and a sidewall extending circumferentially therebetween (See Fig 21); and a distal tip (1350, Fig 21) defining a distal lumen (1364, Fig 22A) therethrough, the distal tip having a proximal end, a distal end, and a sidewall extending circumferentially therebetween, the distal tip connected to the distal end of the first elongate body (See Fig 22A), wherein the distal tip is comprised of a material having a Shore durometer hardness of at least 5 A less than a Shore durometer hardness the first elongate body (Para 0102-0103; the first elongate body has a Shore hardness of 60D [roughly equivalent to 100A] while the distal tip has a Shore hardness in a range of 75A-85A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip and first elongate body to have a Shore hardness of 85A and 100A, respectively, as taught by Oborn in order to have a first elongate body that can prevent kinking, enable power injection therethrough, and improving insertability into the body of a patient while the distal tip is atraumatic to the patient’s vasculature (Para 0102-0103).
Regarding claim 3, the modified invention of Kelly, Hobbs, and Oborn discloses the distal tip and the distal end of the first elongate body are tapered to increase a surface area of a connection between the distal tip and the distal end of the first elongate body (Col 4, lines 30-44 -Hobbs).
Regarding claim 22, the modified invention of Kelly, Hobbs, and Oborn discloses the interface is oblique to a longitudinal axis of the first infusion tube (See Fig 2A; Col 4, lines 30-44 -Hobbs).
Regarding claim 25, Kelly discloses a dual lumen coaxial cannula assembly (Para 0029) comprising: a first infusion tube (12, Fig 3) having a first elongate body defining a first lumen (29, Fig 3) therethrough, the first infusion tube having a proximal end (30, Fig 3), a distal end (32, Fig 3), and a sidewall (36, Fig 3) extending circumferentially therebetween; a second drainage tube (14, Fig 1) co-axially aligned with the first infusion tube and having a second elongate body with a second lumen defined by a space between the first infusion tube and the second drainage tube (the second lumen is required for the first infusion tube 12 to be inserted inside as shown in Fig 1; Para 0029), the second drainage tube having a proximal end (42, Fig 5), a distal end (44, Fig 5), and a sidewall (48, Fig 5) extending circumferentially therebetween (See Fig 5), the distal end of the first infusion tube extending distal of the distal end of the second drainage tube (See Fig 1); a connector (22, Fig 1) attached to the proximal end of the first infusion tube and the proximal end on the second drainage tube (Para 0033); and a distal tip (38, Fig 3) defining a distal lumen therethrough (See Fig 4), the distal tip having a proximal end defining a proximally facing proximal face, a distal end, and a sidewall extending circumferentially therebetween (See Fig 4),
Kelly is silent regarding the distal end defining a distally facing distal face; wherein the proximal face at the proximal end of the distal tip is bonded directly to the distal face at the distal end of the first infusion tube at an interface in an abutting configuration, wherein the distal tip extends distally beyond the distal end of the first infusion tube, and wherein the distal lumen defined by the inner surface of the distal tip is in fluid communication with the first lumen defined by the inner surface of the first elongate body, wherein the distal tip is comprised of a material having a Shore durometer hardness of at least 5 A less than a Shore durometer hardness of the first elongate body; and wherein a circumferential distalmost edge of the tapered distal face extends around an entire circumference of the first infusion tube in a plane perpendicular to a longitudinal axis of the first infusion tube.
Hobbs teaches a cannula assembly (10, Fig 1) comprising: a first infusion tube having a first elongate body (14, Fig 1) defining a first lumen therethrough (See lumen in Fig 2), the first elongate body having a proximal end, a distal end, and a sidewall extending circumferentially therebetween; a connector (12, Fig 1) attached to the proximal end of the first elongate body (See Fig 1); and a distal tip (16, Fig 1) defining a distal lumen therethrough, the distal tip having a proximal end, a distal end, and a sidewall extending circumferentially therebetween, the distal tip connected to the distal end of the first elongate body (Col 4, lines 30-38), wherein the distal tip is comprised of a material having a lower hardness than a hardness of the first elongate body (Abstract); wherein the distal tip extends distally beyond the distal end of the first elongate body (See Fig 2A wherein tip material 30 extends distal to the shaft materials 26 and 28), and wherein the distal lumen defined by the inner surface of the distal tip is in fluid communication with the first lumen defined by the inner surface of the first elongate body (See Fig 2A); wherein the distal end of the first elongate body includes a distally facing tapered distal face (distal end of 28, Fig 2A) and the proximal end of the distal tip includes a proximally facing tapered proximal face (proximal end of 30, Fig 2A), wherein the tapered distal face of the first elongate body is bonded directly to the tapered proximal face of the distal tip in an abutting interface; and wherein the tapered distal face tapers distally toward the first lumen of the first elongate body around an entire circumference of the first elongate body; wherein the tapered proximal face mates with the tapered distal face at the abutting interface to axially align the first lumen and the distal lumen during bonding of the distal tip to the first elongate body (Col 4, lines 30-44); and wherein a circumferential distalmost edge of the tapered distal face extends around an entire circumference of the first infusion tube in a plane perpendicular to a longitudinal axis of the first infusion tube (See Fig 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kelly to have the distal tip be comprised of a material having a lower hardness than a hardness of the first elongate body, and wherein the proximal face of the distal tip and distal face of the elongated body are tapered and abut as taught by Hobbs in order to have a tip that can avoid injury to the walls of the blood vessels and provide substantial surface fusion between the tip and elongate body to resist failure and separation during use (Col 1, lines 13-15; Col 4, lines 39-44).
The modified invention of Kelly and Hobbs disclose all of the elements of the invention as discussed, however, is silent regarding the distal tip is comprised of a material having a Shore durometer hardness of at least 5 A less than a Shore durometer hardness of the first elongate body.
Oborn teaches a cannula assembly (1310, Fig 21) comprising a first infusion tube having a first elongate body (1311, Fig 21) defining a first lumen therethrough, the first elongate body having a proximal end, a distal end, and a sidewall extending circumferentially therebetween (See Fig 21); and a distal tip (1350, Fig 21) defining a distal lumen (1364, Fig 22A) therethrough, the distal tip having a proximal end, a distal end, and a sidewall extending circumferentially therebetween, the distal tip connected to the distal end of the first elongate body (See Fig 22A), wherein the distal tip is comprised of a material having a Shore durometer hardness of at least 5 A less than a Shore durometer hardness the first elongate body (Para 0102-0103; the first elongate body has a Shore hardness of 60D [roughly equivalent to 100A] while the distal tip has a Shore hardness in a range of 75A-85A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip and first elongate body to have a Shore hardness of 85A and 100A, respectively, as taught by Oborn in order to have a first elongate body that can prevent kinking, enable power injection therethrough, and improving insertability into the body of a patient while the distal tip is atraumatic to the patient’s vasculature (Para 0102-0103).
Regarding claim 26, the modified invention of Kelly, Hobbs, and Oborn discloses the interface is oblique to the longitudinal axis of the first infusion tube (See Fig 2A; Col 4, lines 30-44 -Hobbs).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2013/0158338) in view of Hobbs (US 5,584,821) and further in view of Oborn (US 2017/0165453) and further in view of Helgerson (US 6149996).
Regarding claim 4, the modified invention of Kelly, Hobbs, and Oborn discloses all of the elements of the invention as discussed above, however, is silent regarding the distal tip and the distal end of the first elongate body are roughened to increase a surface area of a connection between the distal tip and the distal end of the first elongate body.
Helgerson teaches a catheter assembly comprising an elongate body (12, FI g1) and a distal tip (30, Fig 1) wherein the distal tip and the distal end of the first elongate body are roughened to increase a surface area of a connection between the distal tip and the distal end of the first elongate body (Col 2, lines 60-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip and first elongate body disclosed by Kelly, Hobbs, and Oborn to have roughened surfaces as taught by Helgerson in order to provide an enhanced mechanical boding between the distal tip and the distal end of the first elongate body (Col 2, lines 60-63).
Claims 23-24 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2013/0158338) in view of Hobbs (US 5,584,821) and further in view of Oborn (US 2017/0165453) and further in view of Ishikawa (US 2017/0239442).
Regarding claim 23, the modified invention of Kelly, Hobbs, and Oborn discloses all of the elements of the invention as discussed above, however, is silent regarding the first elongate body includes a plurality of infusion apertures extending through a sidewall of the first elongate body.
Ishikawa teaches a cannula assembly (Device of Fig 2) comprising a first elongate body (19, Fig 2) and a distal tip (60, Fig 2), wherein the first elongate body includes a plurality of infusion apertures (15, Fig 3) extending through a sidewall of the first elongate body (See Figs 2 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first elongate body disclosed by Kelly, Hobbs, and Oborn to include a plurality of infusion apertured as taught by Ishikawa in order to inject a fluid at any desired position along the entire circumference of the catheter (Para 0030).
Regarding claim 24, the modified invention of Kelly, Hobbs, Oborn, and Ishikawa discloses the plurality of infusion apertures are located proximal of the interface (See Fig 2 of Ishikawa).
Regarding claim 27, the modified invention of Kelly, Hobbs, and Oborn discloses all of the elements of the invention as discussed above, however, is silent regarding the first elongate body includes a plurality of infusion apertures extending through a sidewall of the first elongate body.
Ishikawa teaches a cannula assembly (Device of Fig 2) comprising a first elongate body (19, Fig 2) and a distal tip (60, Fig 2), wherein the first elongate body includes a plurality of infusion apertures (15, Fig 3) extending through a sidewall of the first elongate body (See Figs 2 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first elongate body disclosed by Kelly, Hobbs, and Oborn to include a plurality of infusion apertured as taught by Ishikawa in order to inject a fluid at any desired position along the entire circumference of the catheter (Para 0030).
Regarding claim 28, the modified invention of Kelly, Hobbs, Oborn, and Ishikawa discloses the plurality of infusion apertures are located proximal of the interface (See Fig 2 of Ishikawa).
Response to Arguments
Applicant’s arguments files 12/22/2025, on Pages 7-10, regarding Kelly, Lovgren, and Oborn failing to teach the amended limitations have been fully considered but are moot in view of the current rejection that relies on Hobbs to teach the relationship between the distal tip and elongate tube as currently claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm 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, Kevin Sirmons can be reached on 571-272-4965. 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.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785