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 .
Priority
The instant application is a 371 of App. no. PCT/IL2023/050090 filed on 01/26/2023 which claims priority to U.S. Provisional App. no. 63/306,193 filed on 02/03/2022.
Claims 1-4, 8, 13-17, and 22-31 receive priority to the prior-filed application, filed on 02/03/2022.
Election/Restrictions
Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/03/2026.
In light of the preliminary amendment filed 05/07/2025 in which claims 5-7, 9-12, and 18-21 were cancelled and in light of the response to restriction requirement filed 08/03/2026 in which claim 31 was withdrawn, claims 1-4, 8, 13-17, and 22-31 are pending in the instant application and claims 1-4, 8, 13-17, and 22-30 are examined on the merits herein.
Claim Objections
Claims 15-16 and 23 are objected to because of the following informalities:
Claims 15-16 and 23 recite the limitation “wherein when…” in ln. 1 and ln. 2, respectively. This should read “wherein, when…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by EP/0280225 A2 to Parravicini.
Regarding claim 1, Parravicini discloses an apparatus for use with an extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass (CPB) (col. 1:1-5), the apparatus comprising:
a venous cannula, which has a proximal end and a distal tip, and is shaped so as to define:
a blood-drainage lumen through the venous cannula, and
at or near the distal tip, one or more openings between the blood-drainage lumen and outside the venous cannula (Fig. 1, venous cannula 1 comprising distal tip 4 and proximal end 12 comprising lumen 3 and openings 5 at distal tip 4);
a connector, which is coupled to the proximal end of the venous cannula in fluid communication with the blood-drainage lumen, and is configured to be coupled to the ECMO or CPB machine (col. 3:29-39, not shown connector allows for joining of proximal end 12 to vein line leading to ECMO apparatus);
a distal balloon, which is fluid-tight and is coupled to the venous cannula near the distal tip of the venous cannula (Fig. 1, balloon 6 at distal tip 4; col. 3:7-20; col. 4:2-32);
an external proximal balloon, which is configured to be disposed outside a body of a subject (Fig. 1, external balloon 11; col. 3:21-28; col. 3:43-52); and
a balloon-connection lumen, which couples the distal balloon in fluid communication with the external proximal balloon (Fig. 1, balloon-connection lumen 9; col. 3:14-28).
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.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Parravicini as applied above, and further in view of US/2017/0291010 A1 to Bonneau.
Regarding claims 2-4, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to disclose
(Claim 2) wherein the distal balloon is elastic;
(Claim 3) wherein the elastic distal balloon is more compliant than the external proximal balloon; and
(Claim 4) wherein the external proximal balloon is elastic such that when the external proximal balloon contains fluid, the external proximal balloon applies pressure to the fluid contained therewithin.
Bonneau teaches a cannula comprising a distal balloon and an external proximal balloon
(Claims 2 and 3) wherein the distal balloon is elastic and more compliant than the external proximal balloon (para. 0038-0039; para. 0048, 40 Shore A durometer external proximal balloon, 25 Shore A distal balloon, durometer of external proximal balloon 108 may be equal to or 50% greater than that of distal balloon 114; Shore A durometer scale is for flexible rubbers and elastomers; Fig. 1, distal balloon 114 and external proximal balloon 108 on cannula 100),
(Claim 4) wherein the external proximal balloon is elastic such that the external proximal balloon applies pressure to fluid contained therein (para. 0038-0039; para. 0048), and
wherein this configuration of the distal balloon and the external proximal balloon is one way to ensure that the external proximal balloon has a desired opening pressure relative to the distal balloon to provide a user with positioning information of the cannula in the body (para. 0038-0039).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the distal balloon and the external proximal balloon of Parravicini to comprise balloons as described in Bonneau, because Bonneau teaches that this configuration of the distal balloon and the external proximal balloon is one way to ensure that the external proximal balloon has a desired opening pressure relative to the distal balloon to provide a user with positioning information of the cannula in the body (para. 0038-0039).
Claims 8, 17, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Parravicini as applied above.
Regarding claim 8, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to explicitly disclose wherein a distance between a proximal end of the distal balloon and the distal tip is no more than 7 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parravicini such that a distance between a proximal end of the distal balloon and the distal tip is no more than 7 cm since it has been held that “where the only difference between the prior art and the claims was a 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” See MPEP 2144.04. In the instant case, the device of Parravicini would not operate differently with the claimed distance between the proximal end of the distal balloon and the distal tip and since the cannula is meant to be inserted into a lumen of a vena cava over a distance of 2-3 cm (col. 1:16-28) the device would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance is within the claimed ranges “[f]or some applications” (specification pg. 2:28-29).
Regarding claim 17, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to explicitly disclose wherein, when the external proximal balloon is unconstrained and inflated at 10 cm H2O, a volume of the external proximal balloon is 50-250 ml.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parravicini such when the external proximal balloon is unconstrained and inflated at 10 cm H2O, a volume of the external proximal balloon is 50-250 ml since it has been held that “where the only difference between the prior art and the claims was a 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” See MPEP 2144.04. In the instant case, the device of Parravicini would not operate differently with the claimed volume and since the cannula of Parravicini is configured to allow the user to determine inflation of the distal balloon by visually or manually checking the inflation of the external proximal balloon (col. 3:43-52), the device would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance is within the claimed ranges “[f]or some applications” (specification pg. 11:18-20).
Regarding claims 23-25, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to explicitly disclose
(Claim 23) wherein, when the external proximal balloon is unconstrained and inflated with an external-proximal-balloon volume of fluid at 10 cm H20, and the distal balloon is unconstrained and inflated with a distal-balloon volume of fluid at 10 cm H20: the external-proximal-balloon volume is no less than the distal-balloon volume;
(Claim 24) wherein the external-proximal-balloon volume equals at least 125% of the distal-balloon volume; and
(Claim 25) wherein the external-proximal-balloon volume equals at least 200% of the distal-balloon volume.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parravicini such that when the external proximal balloon is unconstrained and inflated with an external-proximal-balloon volume of fluid at 10 cm H20, and the distal balloon is unconstrained and inflated with a distal-balloon volume of fluid at 10 cm H20: the external-proximal-balloon volume is no less than the distal-balloon volume, 125% of the distal-balloon volume, or 200% of the distal-balloon volume since it has been held that “where the only difference between the prior art and the claims was a 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” See MPEP 2144.04. In the instant case, the device of Parravicini would not operate differently with the claimed volume and since the device of Parravicini is configured to allow the user to determine inflation of the distal balloon by visually or manually checking the inflation of the external proximal balloon (col. 3:43-52), the device would function appropriately having the claimed inflation volumes. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the inflation volumes are within the claimed ranges “[f]or some applications” (specification pg. 9:29-10:4).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Parravicini as applied above, and further in view of US/2002/0058960 A1 to Hudson.
Regarding claims 14-16, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to disclose
(Claim 14) wherein, when the distal balloon is unconstrained and inflated at 10 cm H20, a greatest external dimension of the distal balloon, measured perpendicular to a central longitudinal axis of the venous cannula, is 5-7 cm;
(Claim 15) wherein, when the distal balloon is unconstrained and inflated at 10 cm H20, a greatest external dimension of the distal balloon, measured perpendicular to a central longitudinal axis of the venous cannula, equals 200% - 500% of an outer diameter of the venous cannula; and
(Claim 16) wherein, when the distal balloon is unconstrained and inflated at 10 cm H20, a volume of the distal balloon is 3-30 ml.
Hudson teaches a balloon cannula for facilitating hemostasis within a body cavity or passageway comprising a distal balloon (para. 0002; Fig. 19, distal balloon 191 on balloon cannula 195).
Further, Hudson teaches that the maximum volume and dimensions of a distal balloon need to be optimized such that “the balloon always has the capacity to fill the cavity” (para. 0125). The volume and dimensions of the balloon are disclosed to be result effective variables in that changing the volume and dimensions of the balloon affects the seal and fill of the balloon within the body. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Parravicini device to have dimensions within the claimed ranges, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parravicini by making the greatest external dimension of the distal balloon be 5-7 cm or 200%-500% of an outer diameter of the cannula and the volume of the distal balloon be 3-30 ml as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Parravicini as applied above, and further in view of U.S. Patent no. 7,762,261 B1 to Fortuna.
Regarding claim 13, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to disclose one or more springs arranged to apply external pressure to an external surface of the external proximal balloon.
Fortuna teaches a balloon cannula comprising an external proximal balloon and a distal balloon, and one or more springs arranged to apply external pressure to an external surface of the external proximal balloon to visually indicate an acceptable pressure range in the inflation line (col. 5:35-59; col. 7:10-38; Fig. 1, balloon cannula 26 comprising external proximal balloon 28 and distal balloons 14/16; Fig. 14-15, spiral spring 25 arranged around external proximal balloon 28).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the external proximal balloon of Parravicini to comprise the spring of Fortuna, because Fortuna teaches that their spring provides a visual indicator of an acceptable pressure range in the inflation line at all times, reflecting immediate inflation and deflation status (col. 5:35-59; col. 7:10-38).
Claims 22 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Parravicini as applied above, and further in view of U.S. Patent no. 4,351,342 A to Wiita.
Regarding claim 22, the cited prior art discloses the invention of claim 1. Parravicini further discloses wherein the balloon surrounds the venous cannula near the distal tip of the venous cannula (Fig. 1), that the balloon can take any suitable shape (col. 4:52-55), and that the venous cannula may provide partial or total occlusion of the lumen (Abstract); however, Parravicini differs from the instantly claimed invention in that Parravicini fails to disclose wherein the balloon partially surrounds the venous cannula.
Wiita teaches a balloon cannula (col. 6:47-8:10; Fig. 16, catheter 320) wherein the distal balloon partially surrounds the cannula near the distal tip of the cannula, such that at least a portion of the one or more balloon-coinciding lateral openings are not covered by the distal balloon (Fig. 18, balloon 328 partially surrounds catheter 320 at the area with the balloon-coinciding lateral openings 350 at distal end 324), and wherein the balloon circumscribing the balloon-coinciding lateral openings provides cushioning to prevent the patient’s organ tissue from being suctioned into the catheter to avoid damage to the tissue, enhances drainage of the organ, and prevents trauma and inflammation of the organ by the tip of the cannula (col. 1:49-61).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the venous cannula and distal balloon of Parravicini to comprise the structures and arrangements as explained above of Wiita, because Wiita teaches that these structures and arrangements provide cushioning to prevent the patient’s organ tissue from being suctioned into the catheter to avoid damage to the tissue, enhance drainage of the organ, and prevent trauma and inflammation of the organ by the tip of the cannula (col. 1:49-61).
Regarding claims 26-30, the cited prior art discloses the invention of claim 1. Parravicini further discloses that the venous cannula may provide partial or total occlusion of the lumen (Abstract) and (Claim 26) wherein distal and proximal ends of the distal balloon are sealed to an external surface of a wall of the venous cannula at respective distal and proximal balloon sites along the venous cannula (col. 3:7-13).
Parravicini differs from the instantly claimed invention in that Parravicini fails to disclose
(Claim 26) wherein the one or more openings include one or more balloon-coinciding lateral openings through the wall of the venous cannula at respective lateral-opening sites that are longitudinally between the distal and proximal balloon sites, and wherein the apparatus is configured such that the distal balloon, when not inflated, does not occlude the one or more balloon-coinciding lateral openings;
(Claim 27) wherein a wall of the distal balloon is shaped so as to define one or more balloon- wall lateral openings through the wall of the distal balloon, and wherein the wall of the distal balloon is sealed to the external surface of the wall of the venous cannula around respective borders of at least a portion of the one or more balloon-coinciding lateral openings, such that the one or more balloon-wall lateral openings are in fluid communication with the blood-drainage lumen via the at least a portion of the one or more balloon-coinciding lateral openings, respectively;
(Claim 28) wherein the distal balloon entirely surrounds the venous cannula near the distal tip of the venous cannula;
(Claim 29) wherein the distal balloon partially surrounds the venous cannula near the distal tip of the venous cannula, such that at least a portion of the one or more balloon-coinciding lateral openings are not covered by the distal balloon; and
(Claim 30) wherein the apparatus is configured such that upon inflation of the distal balloon, when unconstrained, to at least a threshold pressure, the distal balloon occludes at least one of the one or more balloon-coinciding lateral openings.
Wiita teaches a balloon cannula (col. 6:47-8:10; Fig. 16, catheter 320)
(Claim 26) wherein distal and proximal ends of the distal balloon are sealed to the cannula at respective distal and proximal balloon sites along the cannula (col. 7:14-40; Fig. 19), wherein one or more openings include one or more balloon-coinciding lateral openings through the wall of the venous cannula at respective lateral-opening sites that are longitudinally between the distal and proximal balloon sites (col. 7:14-40; Fig. 19, balloon-coinciding lateral openings 350 through wall of catheter 320), and wherein the apparatus is configured such that the distal balloon, when not inflated, does not occlude the one or more balloon-coinciding lateral openings (Fig. 19, balloon 328 in a non-inflated state not fully occluding balloon-coinciding lateral openings 350 by nature of balloon 328 being adhered to the inner perimeter of balloon-coinciding lateral openings 350 and taper of balloon 328);
(Claim 27) wherein a wall of the distal balloon is shaped so as to define one or more balloon- wall lateral openings through the wall of the distal balloon (col. 7:14-40; Fig. 16, balloon-wall lateral openings 362), and wherein the wall of the distal balloon is sealed to the external surface of the wall of the venous cannula around respective borders of at least a portion of the one or more balloon-coinciding lateral openings, such that the one or more balloon-wall lateral openings are in fluid communication with the lumen via the at least a portion of the one or more balloon-coinciding lateral openings, respectively (col. 5:3-7; col. 7:14-40; Fig. 22);
(Claim 28) wherein the distal balloon entirely surrounds the cannula near the distal tip of the cannula (Fig. 18, balloon 328 surrounds catheter 320 outside of the area with the balloon-coinciding lateral openings 350 of distal end 324);
(Claim 29) wherein the distal balloon partially surrounds the cannula near the distal tip of the cannula, such that at least a portion of the one or more balloon-coinciding lateral openings are not covered by the distal balloon (Fig. 18, balloon 328 partially surrounds catheter 320 at the area with the balloon-coinciding lateral openings 350 at distal end 324);
(Claim 30) wherein the apparatus is configured such that upon inflation of the distal balloon, when unconstrained, to at least a threshold pressure, the distal balloon occludes at least one of the one or more balloon-coinciding lateral openings (Fig. 22, balloon 328 in an inflated state partially occluding balloon-coinciding lateral openings 350 by nature of balloon 328 being adhered to the inner perimeter of balloon-coinciding lateral openings 350); and
wherein the balloon circumscribing the balloon-coinciding lateral openings provides cushioning to prevent the patient’s organ tissue from being suctioned into the catheter to avoid damage to the tissue, enhances drainage of the organ, and prevents trauma and inflammation of the organ by the tip of the cannula (col. 1:49-61).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the venous cannula and distal balloon of Parravicini to comprise the structures and arrangements as explained above of Wiita, because Wiita teaches that these structures and arrangements provide cushioning to prevent the patient’s organ tissue from being suctioned into the catheter to avoid damage to the tissue, enhance drainage of the organ, and prevent trauma and inflammation of the organ by the tip of the cannula (col. 1:49-61).
Alternatively, claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Parravicini as applied above, and further in view of US/2010/0081991 A1 to Swisher.
Regarding claim 23, the cited prior art discloses the invention of claim 1. Parravicini differs from the instantly claimed invention in that Parravicini fails to explicitly disclose wherein, when the external proximal balloon is unconstrained and inflated with an external-proximal-balloon volume of fluid at 10 cm H20, and the distal balloon is unconstrained and inflated with a distal-balloon volume of fluid at 10 cm H20: the external-proximal-balloon volume is no less than the distal-balloon volume.
Swisher teaches a balloon cannula comprising a distal balloon and an external proximal balloon wherein, when the external proximal balloon is unconstrained and inflated with an external-proximal-balloon volume of fluid at 10 cm H20, and the distal balloon is unconstrained and inflated with a distal-balloon volume of fluid at 10 cm H20: the external-proximal-balloon volume is no less than the distal-balloon volume (para. 0025, balloons 30a/b are substantially identical and formed from the same material such that they would act the same under the same pressure; Fig. 2A, cannula 10 comprising distal balloon 30a and external-proximal-balloon 30b), and wherein this configuration of the balloons allows for a clinician to observe the external-proximal-balloon to obtain a roughly accurate estimate of the size of the internal balloon (para. 0025).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the balloons of Parravicini as configured as taught in Swisher, because Swisher teaches that this configuration of the balloons allows for a clinician to observe the external-proximal-balloon to obtain a roughly accurate estimate of the size of the internal balloon (para. 0025).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2011/0190737 A1 to Rocco discloses a cannula comprising balloon-coinciding lateral openings. US/2002/0160134 A1 to Ogushi discloses a cannula comprising a pilot balloon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 3 September 2026
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