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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/12/2026 has been entered.
Status of Claims
Claims 1-10 and 37-38 are pending and examined on the merits.
Claims 1 and 10 are currently amended.
Claim 38 is new.
Claims 13-14, 16-18, 21-22, 24, and 27-28 are withdrawn for being drawn to non-elected inventions.
Claims 11-12, 15, 19-20, 23, 25-26, and 29-36 are cancelled.
Response to Amendment
Applicant amendments filed 05/12/2026 have been fully considered.
Response to Arguments
Applicant provided amendments to the independent claims which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 05/12/2026 have been fully considered but they are moot. Mordant (U.S. Pre Grant Pub. No. 2020/0054817 A1), (U.S. Pre Grant Pub. No. 2007/0060911 A1), Navia (U.S. Patent No. 6,626,872 B1), and Macoviak (U.S. Patent No. 6,099,506 B1) are introduced/re-introduced as new primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented via the amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-9, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Mordant (U.S. Pre Grant Pub. No. 2020/0054817 A1) in view of Webster (U.S. Pre Grant Pub. No. 2007/0060911 A1).
Regarding claim 1, Mordant teaches: A bi-directional perfusion cannula (see at least Abstract and para. [0010]) for use in peripheral veno- arterial extracorporeal membrane oxygenation of a patient (see at least para. [0001]),
the cannula (see injection cannula 1 in Fig. 2 and para. [0098]) comprising a cannula main body (see at least Fig. 2) having a primary lumen (see LP in Fig. 6) at least partially defined by a side wall (see circumference of LP in Fig. 6), the primary lumen leading to a distal end of the cannula main body (see for example Figs. 2 and 5), wherein
the main body further comprises passing a second cannula therethrough (see LAc in Figs. 2 and 6 shown as passing through the main body), the second cannula is arranged for providing anterograde blood perfusion (see at least para. [0084 and 0098]) and
wherein the second cannula enters the main body at a first position on a first side of the side wall of the main body (see for example outlet 27 in Fig. 6) and leaves the main body at a second position on a second side of the side wall of the main body located opposite the first side across the primary lumen (as shown in Fig. 5, distal aperture 20’ is across lumen LP and offset from entry of LAc; see also Fig. 6),
the first position and the second position being angularly offset from one another about a projected cross section of the main body (see at least Fig. 6).
However, Mordant fails to explicitly teach that the main body comprises a passage for passing a second cannula therethrough, the passage being oriented such that when a second cannula is inserted into the passage the second cannula is arranged for providing anterograde blood perfusion, or wherein the passage enters the main body at a first position on a first side of the side wall of the main body and leaves the main body at a second position on a second side of the side wall of the main body located opposite the first side across the primary lumen, as required by the claim.
Webster teaches an analogous rapid exchange catheter embodiment (see Abstract and Fig. 14D) having a similar cannula with a main body (321) and a second cannula (327) having a passage through the sidewalls for the second cannula to span the primary lumen (see para. [0112]; since guide structure 327 is inserted through rapid exchange port 325 and distal guide port 323, a passage exists between rapid exchange port 325 and distal guide port 323).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mordant to incorporate the teachings of Webster by including a passage for passing a second cannula therethrough such that the passage allows for the passage of the LAc of Mordant at least in order to allow the LAc to extend along the length of the catheter shaft through the guide lumen, as taught by Webster (see para. [0091]) and to make the LAc removable. In addition, in the combined device of Mordant in view of Webster, the passage is oriented such that when a second cannula is inserted into the passage the second cannula is arranged for providing anterograde blood perfusion (see at least para. [0084 and 0098] of Mordant) and the passage enters the main body at a first position on a first side of the side wall of the main body and leaves the main body at a second position on a second side of the side wall of the main body located opposite the first side across the primary lumen (see for example Fig. 6; as shown in Fig. 5, distal aperture 20’ is across lumen LP and offset from entry of LAc).
Regarding claim 2, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant in view of Webster teaches wherein the passage is a preformed channel having a sidewall which leads from the first position to the second position (see for example Fig. 14D of Webster; see also Fig. 2 of Mordant).
Regarding claim 3, Mordant in view of Webster teaches the invention as discussed above in claim 2. Additionally, Mordant in view of Webster teaches wherein the preformed channel is attached to the sidewall of the main body along a portion thereof (see at least Figs. 5-6 of Mordant showing distal aperture 20’ attached to the sidewall of LP).
Regarding claim 4, Mordant in view of Webster teaches the invention as discussed above in claim 3. Additionally, Mordant in view of Webster teaches wherein the preformed channel is attached to an upper portion of the sidewall of the main body (see for example Fig. 6 of Mordant showing LAc extending from outlet 27 on an upper portion of the sidewall of LP; as discussed above, the passage of Webster surrounds LAc) and the second position is located at a lower portion of the sidewall of the main body (as shown in Fig. 6 of Mordant, output aperture 20’ of LAc is on a lower portion of the sidewall of LP).
Regarding claim 5, Mordant in view of Webster teaches the invention as discussed above in claim 3. Additionally, Mordant in view of Webster teaches wherein the preformed channel is attached to a side portion of the sidewall of the main body (see at least Fig. 6 of Mordant) and the second position is located at a lower portion of the sidewall of the main body (see at least Figs. 5-6 of Mordant).
Regarding claim 7, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant in view of Webster teaches wherein a distal portion of the main body has a generally circular cross section (see for example area around distal aperture 20’ in Fig. 6 of Mordant) and a second portion of the main body including the passage has a non-circular cross section with at least one protrusion providing an increased cross sectional area compared with the distal portion (as broadly recited, and as shown in Fig. 6 of Mordant, a non-circular cross section is considered to be between outlet 27 and inlet 28 such that a cross-sectional area of LP and the area between outlet 27 and inlet 28 is non-circular with protrusion 24 providing an increased cross-sectional area compared with the area around distal aperture 20’).
Regarding claim 8, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant in view of Webster teaches wherein a distal portion of the main body has a generally circular cross section (see at least Fig. 2) and a second portion of the main body including the passage has a generally circular cross section (see at least Fig. 2) with the second portion having an increased cross sectional area compared with the distal portion (as broadly recited, and as shown in Fig. 2, LAc has a greater cross-sectional area adjacent proximal end 20 than adjacent lateral aperture 20’).
Regarding claim 9, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant in view of Webster teaches wherein the passage is within a sidewall of the main body (as discussed above, the passage of Webster surrounds LAc of Mordant which is shown as being within a sidewall of LP; see at least Fig. 6).
Regarding claim 37, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant in view of Webster teaches wherein the first position is located on an external surface of the first side of the side wall of the main body (see outlet 27 in Fig. 6 of Mordant).
Regarding claim 38, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant in view of Webster teaches wherein the external surface of the first side of the side wall of the main body is opposite an internal surface of the first side of the side wall of the main body facing the primary lumen (see at least Fig. 6).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mordant (U.S. Pre Grant Pub. No. 2020/0054817 A1) in view of Webster (U.S. Pre Grant Pub. No. 2007/0060911 A1), as applied above to claim 1, and further in view of Navia (U.S. Patent No. 6,626,872 B1).
Regarding claim 6, Mordant in view of Webster teaches the invention as discussed above in claim 1. However, Mordant in view of Webster fails to explicitly teach wherein the passage is terminated by a seal, as required by the claim.
Navia teaches an analogous perfusion cannula (see Abstract) comprising a port 50 at an end of a distal shaft section 14 and a lumen 51 that extends within the distal shaft section 14 (see col. 6, lines 25-47). As broadly recited, the port 50 of Navia is considered to be a seal at least because the port allows lumen 51 to extend through the distal shaft section 14 (see Fig. 9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mordant in view of Webster to incorporate the teachings of Navia by terminating the passage by a port that act like a seal at least in order to provide a shunt within a human blood vessel to allow blood or perfusion fluid flow through the distal shaft section 14, as taught by Navia (see col. 6, lines 35-37).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mordant (U.S. Pre Grant Pub. No. 2020/0054817 A1) in view of Webster (U.S. Pre Grant Pub. No. 2007/0060911 A1), as applied above to claim 1, and further in view of Macoviak (U.S. Patent No. 6,099,506 B1).
Regarding claim 10, Mordant in view of Webster teaches the invention as discussed above in claim 1. Additionally, Mordant teaches wherein the main body has through holes on either side of the main body (see for example outlet 27 and lateral aperture 20’ in Fig. 6). However, Mordant in view of Webster fails to explicitly teach the through holes each including a seal and providing the passage for the second cannula therethrough, as required by the claim.
Macoviak teaches an analogous cannula (see Abstract) comprising a closure seal 12 that is engaged to secure the cannula and prevent leakage of fluid (see col. 9, lines 54-56; see also Figs. 9-22).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mordant in view of Webster to incorporate the teachings of Macoviak by making the through holes each include a seal and providing the passage for the second cannula therethrough at least in order to prevent leakage of fluid, as taught by Macoviak (see col. 9, lines 54-56).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
