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 .
Response to Amendment
This office action is responsive to the amendment filed on January 26, 2026. As directed by the amendment: claims 1 and 18 have been amended and claim 17 has been cancelled. Thus, claims 1-10, 12, 14-16, 18, 19, 21-26, 28-29, 31, 33, and 34 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every 112(a)/(b) rejections previously set forth in the Non-Final Office Action mailed October 24, 2025.
Response to Arguments
Applicant’s arguments, filed January 26, 2026, with respect to the rejection(s) of claim(s) 1 and 18 under 102(a)(1) have been fully considered and are persuasive, specifically in regards to the prior art teaching or disclosing the outer lumen providing fluid communication between a first extension leg and a vasculature surrounding the multi-lumen catheter. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claim 16 is objected to because of the following informalities: the claim should be amended to recite “the first extension leg” since the first extension leg was previously introduced in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 16, the claim recites that the first extension leg is in fluid communication with the inner lumen and a second extension leg is in fluid communication with the outer lumen. There is insufficient support for a first extension leg to be in communication with both the inner and outer lumen, as required by claims 1 and 16. Additionally, there is insufficient support for both a first and second extension leg to be in communication with the outer lumen.
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.
Claim(s) 1-3, 5-7, 10, 12, 14, 15, 18, 19, 23-26, 28, 29, 31, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feig (US 20150306361) in view of Volk (US 20070250036).
Regarding claim 1, Feig discloses a multi-lumen catheter (fig. 16), comprising:
an outer wall (sleeve 8 in fig. 16) defining an outer lumen (cavity 50 and passage 57 form a lumen in fig. 16) having an outer lumen diameter (cavity 50 has an expanded diameter shown in fig. 16) and extending along a central longitudinal axis (fig. 16), the outer lumen providing fluid communication between a first extension leg disposed at a proximal end (suction port 60A in fig. 16) and a distal tip of the outer wall (distal end 8B in fig. 16), the distal tip defining an outer opening providing fluid communication between the outer lumen and a vasculature surrounding the multi-lumen catheter (fig. 16); and
an inner wall (inner conduit 56 in fig. 16) defining an inner lumen extending co-axially with the outer lumen (first hollow passage 55 in fig. 17), a distal tip of the inner wall defining an inner opening providing fluid communication with the inner lumen (distal end 56D in fig. 16).
However, Feig does not teach or disclose the inner wall transitionable between a first position and a second position, the inner lumen in the first position having a first inner lumen diameter, and the inner lumen in the second position having a second inner lumen diameter larger than the first inner lumen diameter.
Volk discloses a multi-lumen catheter (fig. 5a) including an inner wall which serves as a guidewire lumen (inner shaft 32 in fig. 5a) transitionable between a first position and a second position (fig. 7a and 7b), the inner lumen in the first position having a first inner lumen diameter (fig. 7b), and the inner lumen in the second position having a second inner lumen diameter larger than the first inner lumen diameter (fig. 7a; paragraph 95). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner wall of Feig to comprise the EAP segments of Volk so that the inner wall is transitionable between a first position and a second position, the inner lumen in the first position having a first inner lumen diameter, and the inner lumen in the second position having a second inner lumen diameter larger than the first inner lumen diameter, as taught by Volk. Volk teaches that this modification enables the inner wall to provide better guidewire movement and better column strength depending on the position of the inner wall (paragraph 95).
Regarding claim 2, in the modified catheter of Feig, Volk discloses the inner wall is elastically deformable radially outwards from the first position to the second position (paragraph 118 discloses the EAP of the shaft can be made from elastomers so that the shaft would be elastically deformable).
Regarding claim 3, in the modified catheter of Feig, Volk discloses one of the first inner lumen diameter or the second inner lumen diameter is less than the outer lumen diameter (fig. 5a shows that both first and second inner lumen diameters would be less than the outer lumen diameter).
Regarding claim 5, in the modified catheter of Feig, Feig discloses the outer wall is formed of a first material (paragraph 112 discloses Nylon). Volk discloses the inner wall is formed of a second material, different from the first material (paragraph 118 discloses various polymers of the EAP which are not Nylon).
Regarding claim 6, in the modified catheter of Feig, Volk discloses the second material is more compliant, provides a lower durometer, is softer, or provides a lower modulus of elasticity relative to the first material (paragraph 118 discloses various elastomers which would have a lower modulus of elasticity than Nylon).
Regarding claim 7, in the modified catheter of Feig, Feig discloses the first material of the outer wall includes a plastic, polymer, urethane, or polyurethane (paragraph 112 discloses various polymers). Volk discloses the second material of the inner wall includes one of silicone rubber, rubber, or elastomer (paragraph 118 discloses various elastomers).
Regarding claim 10, modified Feig teaches all of the claimed limitations set forth in claim 1, as discussed above, and further discloses the outer wall defines a first thickness and the inner wall defines a second thickness (fig. 16). While Feig further appears to disclose that the first thickness is a uniform thickness along a longitudinal length of the catheter (fig. 16), Feig does not explicitly teach or disclose this limitation.
However, Feig teaches that the balloon (balloon 10 in fig. 16) can comprise a uniform thickness (paragraph 71). Since Feig teaches that the balloon and the outer wall (sleeve 8 in fig. 16) can be made from the same material (paragraph 121) and have the same thickness (paragraphs 111 and 123), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the outer wall of modified Feig to have a uniform thickness along a longitudinal length since it appears that doing so would not impact operation of the device and doing so would simplify manufacture since the outer wall and the balloon could be made identically.
Regarding claim 12, in the modified catheter of Feig, Feig discloses the outer lumen diameter defines a uniform diameter along a longitudinal length of the multi-lumen catheter (at least the length where the sleeve 8 is bonded to conduit 54 is uniform).
Regarding claim 14, in the modified catheter of Feig, Feig discloses the inner lumen defines a first longitudinal length (fig. 16), and the outer lumen defines a second longitudinal length (fig 16), the second longitudinal length being less than the first longitudinal length (fig. 16 shows the overall length of the sleeve 8 is shorter than the overall length of conduit 16).
Regarding claim 15, in the modified catheter of Feig, Feig discloses a distal tip of the outer lumen is configured to terminate in an upper arm portion of a patient, and a distal tip of the inner lumen is configured to terminate in a superior vena cava (the distal tips of the outer and inner lumens are capable of terminating in the claimed regions since the claim does not presently require this function to occur simultaneously).
Regarding claim 18, Feig discloses a catheter system, comprising:
a first wall (sleeve 8 in fig. 16) defining a first lumen (cavity 50 and passage 57 in fig. 16 form a lumen) extending along a central longitudinal axis (fig. 16) between a first extension leg disposed at a proximal end (suction port 60A in fig. 16) and a first opening disposed at a distal tip of the first wall and communicating with the first lumen (opening at distal end 8B in fig. 16);
a second wall (intermediate conduit 59 in fig. 16) defining a second lumen having a central longitudinal axis extending co-axially with the central longitudinal axis of the first lumen (passage 61 in fig. 16 and interior of balloon 10 form a “lumen”), the first wall encircling the second wall (a portion of the sleeve 8 encircles a portion of conduit 59), the second wall having a second opening disposed at a distal tip of the second wall (see dotted line below) and communicating with the second lumen (the distal tip of conduit 59 communicates with the interior of balloon 10 which is part of the second lumen); and
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a third wall (inner conduit in fig. 16) defining a third lumen having a central longitudinal axis extending co-axially with each of the central longitudinal axes of the first lumen and the second lumen (first hollow passage 55 in fig. 16), the first wall and the second wall encircling the third wall (fig. 16), the third wall having a third opening disposed at a distal tip of the third wall and communicating with the third lumen (opening at distal tip end 56D in fig. 16).
However, Feig does not teach or disclose the third wall is elastically deformable radially outwards.
Volk teaches a similar catheter comprising an innermost wall configured to receive a guidewire (inner shaft 32 in fig. 5a) and which is elastically deformable radially outwards (fig. 7c-f shows the shaft can deform from a smaller diameter in fig. 7c/d to a larger diameter in fig. 7e/f; paragraph 118 discloses that the EAP can be an elastomer so as to be elastically deformable). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the third wall (i.e. the innermost wall of Feig which can receive a guidewire) to be elastically deformable radially outwards, as taught by Volk. Volk teaches that this modification enables the inner wall to provide better guidewire movement and better column strength depending on the position of the inner wall (paragraph 95).
Regarding claim 19, in the modified system of Feig, Feig discloses one or both of the second lumen and the third lumen define a lumen diameter is less than a lumen diameter of the first lumen (both the second and third lumen diameters are less than the diameter of the first lumen in fig. 16).
Regarding claim 23, in the modified system of Feig, Feig discloses the first wall is formed of a first material (paragraph 69 discloses sleeve 8 can be made from Nylon). Volk discloses the third wall is formed of a second material, different from the first material (paragraph 118 discloses elastomeric EAPs which are different from Nylon).
Regarding claim 24, in the modified system of Feig, Feig discloses the second wall is formed of a second material (paragraph 106 discloses the conduits can be made from PEBAX). Volk discloses the third wall is formed of a third material different from the first material and the second material (paragraph 118 discloses elastomeric EAPs which are different from both the first and second materials).
Regarding claim 25, in the modified system of Feig, Volk discloses the third material is more compliant, provides a lower durometer, is softer, or provides a lower modulus of elasticity relative to the first material (paragraph 118 discloses various elastomers which would have a lower modulus of elasticity than Nylon).
Regarding claim 26, in the modified system of Feig, Feig discloses the first material includes a plastic, polymer, urethane, or polyurethane (paragraph 112 discloses various polymers). Volk discloses the third material includes one of silicone rubber, rubber, or elastomer (paragraph 118 discloses various elastomers).
Regarding claim 28, in the modified system of Feig, Volk discloses one or more of the first wall, the second wall, or the third wall define different wall thicknesses (fig. 7d shows an in actuated state, the third wall would have different wall thickness along its diameter due to the overlapping nature of the EAP).
Regarding claim 29, modified Feig teaches all of the claimed limitations set forth in claim 18, as discussed above. While Feig appears to disclose that the first wall, the second wall and the third wall define a uniform wall thickness along a longitudinal length of the catheter system (fig. 16), modified Feig does not explicitly teach or disclose this limitation.
However, it would have been obvious to have had the first, second, and third walls define a uniform wall thickness along a longitudinal length as an obvious matter of design choice. Doing so would not have altered operation of the system since Feig appears to already this disclose this feature and since it appears that Applicant has placed no criticality on this feature (paragraph 12 discloses that the thicknesses can either be uniform or non-uniform).
Regarding claim 31, modified Feig teaches all of the claimed limitations set forth in claim 18, as discussed above. While Feig appears to disclose that the first lumen, the second lumen and the third lumen define a uniform lumen diameter along a longitudinal length of the catheter system (at the length along where the first wall bonds to the outer conduit 54, the diameters of the first, second and third lumens appear uniform along this length), modified Feig does not explicitly teach or disclose this limitation.
However, it would have been obvious to have had the first lumen, the second lumen and the third lumen define a uniform lumen diameter along a longitudinal length of the catheter system as an obvious matter of design choice. Doing so would not have altered operation of the system since Feig appears to already this disclose this feature and since it appears that Applicant has placed no criticality on this feature (paragraphs 12 and discloses that the diameters can either be uniform or non-uniform).
Regarding claim 34, in the modified system of Feig, Feig discloses one of the second lumen or the third lumen terminate at a point proximal of a distal tip of the catheter system (fig. 16 shows that the inside of balloon 10 terminates proximal to a distal tip of the catheter system).
Allowable Subject Matter
Claims 4, 8, 9, 18, 21, 22, and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4 and 8, the closest prior art is Feig modified with Volk which does not teach or disclose an outer surface of the inner wall contacts/impinges an inner surface of the outer wall when the inner lumen is in the second position. In modified Feig, the outer and inner walls are separated by balloon (10 in fig. 7 of Feig). As such, the inner wall cannot contact/impinge the inner surface of the outer wall in the second position.
Regarding claim 9, the closest prior art is Feig which discloses the outer wall defines a first thickness and the inner wall defines a second thickness (fig. 16A). However, it appears in the figures that the first thickness is significantly less than the second thickness (fig. 2 shows a comparable embodiment having an outer wall 8 and an inner wall 6) so that the second thickness is not less than the first thickness.
Regarding claim 21, the closest prior art is Feig which does not teach or disclose the second wall is configured to elastically deform radially outwards until an outer surface of the second wall impinges on an inner surface of the first wall.
Regarding claim 33, see reasons for indicating allowable subject matter provided in Non-Final Rejection mailed on 10/24/2025.
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.
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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