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
The amendment filed October 27th 2025 has been entered. Claims 1-6 and 26-31 are pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed May 2nd 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the catheter tube forming a central lumen, a first inflation lumen fluidly communicating with the positioning balloon, a second inflation lumen fluidly communicating with the occluding balloon, and at least one additional lumen, the subject matter of claim 27, and
a single occluding balloon serving as both the positioning means and the occlusion means, the subject matter of claim 5, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (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 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(s) 1, 5-6, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas (US 20180008763 A1).
Regarding claims 1 and 6, Thomas discloses an interventional ostium occlusion catheter (angioplasty catheter including a balloon used to occlude a vessel, [0016] & Fig. 4; also see abstract and [0015]-[0016] for discussion of use during an intervention procedure) comprising: a catheter tube having at least one port at a first end (angioplasty balloon catheter including an infusion lumen and being connected at a first end to a perfusion device, [0016] & Fig. 4; the connection between the catheter and the perfusion device is being interpreted as a port, Fig. 4; additionally, Thomas discloses “The catheter can be any of a variety of perfusion catheters known in the art, such as those used to infuse drugs, blood and blood substitutes into the blood vessels of the heart”, [0066]; perfusion catheters, as is known in the art, inherently include at least one port, as is supported in [0007]),
a tip at a second end opposite the first end (the distal end of the angioplasty balloon catheter including a tip, [0016] and [0047] & Fig. 4; “The perfusate is discharged from the distal end of the catheter.”, [0067]; “…perfusate coming out of the tip of the catheter”, [0047]), and a central lumen (“an angioplasty catheter includes a perfusion lumen.”, [0066] & Fig. 4);
a positioning means joined to a surface of the catheter tube distal from the at least one port (balloon mounted on the tip of the catheter is being interpreted as the positioning means, [0036] & Fig. 4; “The balloon mounted on the tip of the catheter is introduced into the coronary artery until it traverses the thrombus and/or occlusion.”, [0036]; the catheter’s position is dictated by where the balloon is; alternatively, a perfusion catheter including two balloons is disclosed, [0068]; in a two balloon configuration, the proximal ballon can be interpreted as the positioning means);
an occlusion means joined to the surface of the catheter tube distal from the at least one port, wherein the occlusion means is an occluding balloon (balloon mounted on the tip of the catheter is also being interpreted as the occluding means, [0036] and claim 1 & Fig. 4; “the balloon completely occludes blood flow in the artery.”, [0028] & Fig. 4; in a two balloon configuration, the distal balloon can be interpreted as the occluding means, [0068]); an external blood pumping mechanism coupled to the at least one port (“the fluid is infused directly through a pump that can be free-standing from any extracorporeal circuit”, [0027] & Fig. 4; “the fluid is actively perfused by a pump”, [0043]; “a roller pump or centrifugal pump, in which the speed of the spinning head (and the resistance of the system) determines the flow of blood or perfusate”, [0050]; the pump would necessarily be coupled to the port on the catheter to facilitate infusion); and
a pressure feedback mechanism operative to measure pressure conditions at the tip and communicate pressure measurements to the first end of the catheter tube (“a sensor measures the level of occlusion of an artery prior to intervention. In certain embodiments, the percentage occlusion provides a baseline reading used to generate initial parameters for oxygen levels. In certain other embodiments, the level of occlusion is used to regulate the length of time of infusion of the modulated oxygen content fluid…. the occlusion is measured using a pressure sensor, such as a sensor or meter on the catheter.”, [0058]; pressure sensor on the catheter provides a microprocessor with data, the microprocessor positioned at the first end, see [0055] & Fig. 4; sensors disclosed to be positioned on the distal tip of the catheter, [0019]).
Regarding claim 5, Thomas discloses all the limitations of claim 1. Thomas further discloses the interventional ostium occlusion catheter of wherein a single occluding balloon serves as both the positioning means and the occlusion means (the balloon at the tip of the catheter serves to both occlude, see [0028] and [0067], and position the catheter, see [0036]).
Regarding claim 29, Thomas discloses all the limitations of claim 1. Thomas further discloses the interventional ostium occlusion catheter wherein the external blood pumping mechanism is a reperfusate pump (“The perfusate in which oxygen is regulated can be leukocyte-depleted blood of the same patient or a donor. In one embodiment, blood will be removed from the patient, put though a filter that removes a significant portion of the leukocytes, in certain cases neutrophils, and then used to perfuse the area distal to the tip of the catheter. In one embodiment, blood may be withdrawn from the sheath used for arterial access but may be withdraw from the patient using any other method of arterial or venous access that will provide the desired blood flow for perfusion. The mode of withdrawal may be using gravity or a pump as long as the desired blood flow is achieved. The blood is then passed through a leukocyte-removal filter to remove a clinically advantageous amount of leukocytes from the blood.”, [0048]; the pump functions as a reperfusate pump, see abstract, [0014], and claim 1).
Regarding claim 30, Thomas discloses all the limitations of claim 29. Thomas further discloses the interventional ostium occlusion catheter wherein the reperfusate pump is coupled to a perfusion flow port (the connection between the catheter and the perfusion device being interpreted as a port, [0016] & Fig. 4, is intended to facilitate perfusion flow, [0066]-[0067]; the pump would necessarily be coupled to the port, see Fig. 4).
Regarding claim 31, Thomas discloses all the limitations of claim 1. Thomas further discloses the interventional ostium occlusion catheter wherein the catheter tube forms a central perfusion lumen sized to accommodate both infusion flow (the balloon catheter including a perfusion lumen, [0066]-[0067] and claim 1) and passage of an interventional therapy catheter (a second catheter with a stent can be deployed, [0029]; “a treatment catheter dimensioned to be threaded through the infusion lumen of the vascular perfusion catheter”, claim 1).
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 2-3 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20180008763 A1) as applied to claim 1 above, and further in view of Bridges (US 20060258980 A1).
Regarding claim 2, Thomas discloses all the limitations of claim 1. Thomas further discloses the interventional ostium occlusion catheter wherein the at least one port includes a perfusion flow port (the connection between the catheter and the perfusion device being interpreted as a port, [0016] & Fig. 4, is intended to facilitate perfusion flow, [0066]-[0067]). Thomas discloses the balloon being inflated, see [0007], [0036], and [0068] and that “[t]he catheter can be any of a variety of perfusion catheters known in the art, such as those used to infuse drugs, blood and blood substitutes into the blood vessels of the heart” (see [0066]) but fails to explicitly disclose the catheter tube further comprising another port selected from a group consisting of: a therapy catheter port, a positioning balloon port, an occluding balloon port, and any combination thereof.
However, Bridges teaches a perfusion catheter used to infuse drugs (catheter 40 for retrograde perfusion of the heart that provides drugs, abstract and [0001] & Fig. 3-4) comprising: a catheter tube comprising a perfusion flow port (cannula 42 including infusion lumen 52 connected to connector 50 for attaching catheter 40 to a source of drug, [0023]-[0024] & Fig. 3-4) and another port selected from a group consisting of: a positioning balloon port and an occluding balloon port (secondary lumen 62 and 64 used for separately inflating balloons 66 and 68, [0025]-[0026] & Fig. 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Thomas with Bridge to include the catheter tube further comprises an occluding balloon port or a positioning balloon port since such a modification would provide a structure for inflating the balloon and yield predictable results pertaining controlled vessel occlusion with an inflatable balloon (see [0025] and [0028] of Bridge).
With regard to claim 3, the positioning means is being interpreted as the proximal balloon and the occluding means is being interpreted as the distal balloon (this alternative configuration cited in claim 1 above). In this configuration, Thomas discloses all the limitations of claim 1. Thomas further discloses the interventional ostium occlusion catheter wherein the positioning means is a positioning balloon (the proximal balloon at the tip of the catheter serves to position the catheter, see [0036]; “The balloon mounted on the tip of the catheter is introduced into the coronary artery until it traverses the thrombus and/or occlusion.”; the catheter is positioned based on the position of the balloon).
Thomas discloses that “[t]he catheter can be any of a variety of perfusion catheters known in the art, such as those used to infuse drugs, blood and blood substitutes into the blood vessels of the heart” (see [0066]) but fails to explicitly disclose a positioning balloon configured to be smaller than an inner diameter of an access vessel and larger than an inner diameter of an ostium of the access vessel.
However, Bridges teaches a perfusion catheter used to infuse drugs (catheter 40 for retrograde perfusion of the heart that provides drugs, abstract and [0001] & Fig. 3-4) comprising a positioning ballon configured to be smaller than an inner diameter of an access vessel and larger than an inner diameter of an ostium of the access vessel (balloon 66 is configured to expand to a size greater than that of the coronary ostium 22, [0029] & Fig. 4; the balloon 66 would have to be smaller than an inner diameter of an access vessel in order for the catheter to be inserted; the balloon is inserted in a deflated condition, see [0017]-[0018] and [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the positioning balloon and occluding balloon of Thomas with Bridges to include the positioning ballon configured to be smaller than an inner diameter of an access vessel and larger than an inner diameter of an ostium of the access vessel since such a modification would allow the balloon to expand to seal an ostium and anchor the catheter to the desired ostium (see abstract, [0017]-[0018] and [0029] of Bridge). As modified, the proximal and distal balloons of Thomas can function like balloons 66 and 68 of Bridges, sealing an ostium and forming an anchor ([0028]-[0029] of Bridges).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20180008763 A1) as applied to claim 1 above, and further in view of Kaye (US 20070203445 A1).
With regard to claim 4, the positioning means is being interpreted as the proximal balloon and the occluding means is being interpreted as the distal balloon (this alternative configuration cited in claim 1 above). In this configuration, Thomas discloses all the limitations of claim 1. Thomas discloses that “[t]he catheter can be any of a variety of perfusion catheters known in the art, such as those used to infuse drugs, blood and blood substitutes into the blood vessels of the heart” (see [0066]) but fails to explicitly disclose the catheter wherein the positioning means is nitinol wire needles configured to engage an ostium atraumatically.
However, Kaye teaches an interventional ostium occlusion catheter ([0025] and [0070] teaching the device used for perfusion) with two inflatable occlusion balloons designed to occlude an ostium (see [0049], [0053] & Figs. 3E and 3F) or the catheter having one occluding balloon and a wire support (Figs. 3A and 3B). Kaye further teaches substituting an inflatable occlusion balloon with a braided/woven nitinol support structure (support structure 324, [0043] & Fig. 3C; the woven structure is being interpreted as wire needles), which is being interpreted as a positioning means that is capable of engaging the ostium atraumatically (see [0044], [0046]-[0047] & Fig. 3C).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Thomas with Kaye to include the positioning means as nitinol wire needles since such a modification would allow for the positioning means to be collapsible for percutaneous delivery to a deployment site and then resume a known shape (see [0046] of Kaye). Kaye also teaches equivalently using an inflatable occlusion balloon or wire support structure in [0043]. As combined, the proximal ballon of Thomas would be substituted with the support structure 324 of Kaye.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20180008763 A1) as applied to claim 1 above, and further in view of den Heijer (US 5807331 A).
With regard to claim 26, the positioning means is being interpreted as the proximal balloon and the occluding means is being interpreted as the distal balloon (this alternative configuration cited in claim 1 above). In this configuration, Thomas discloses all the limitations of claim 1. Thomas further discloses the interventional ostium occlusion catheter wherein the positioning means is a positioning balloon (the proximal balloon, of the two ballons, is being interpreted as the positioning means, [0068] and [0036]) and the occlusion means is an occluding balloon (the distal balloon, of the two balloons, is being interpreted as the occlusion means, [0068] and [0028]).
Thomas discloses that “[t]he catheter can be any of a variety of perfusion catheters known in the art, such as those used to infuse drugs, blood and blood substitutes into the blood vessels of the heart” (see [0066]), with one of the exemplary catheters being “U.S. Pat. No. 5,807,331 by den Heijer and Solar, assigned to Cordis Corp., which provides an active perfusion catheter where fluids are perfused past the obstruction during balloon inflation”, but fails to explicitly disclose the catheter wherein the positioning balloon and the occluding balloon are spaced apart from one another forming a gap of tubular catheter material therebetween.
However, den Heijer teaches “an active perfusion balloon catheter 1 comprising a main catheter shaft 2 having dilatation balloon 3 and occlusion balloon 4” (see Col 3 lines 6-9 & Fig 1). Balloons 3 and 4 seen spaced apart from one another forming a gap of tubular catheter 1 material therebetween in Fig. 1.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the positioning balloon and the occluding balloon of Thomas with den Heijer to include the positioning balloon and the occluding balloon spaced apart from one another forming a gap of tubular catheter material therebetween since den Heijer teaches this to be an art effective configuration for a two balloon catheter intended to deliver perfusate from a perfusion pump (see Col 1 lines 8-13 and Col 3 lines 19-23) and explicitly contemplated for use with the system of Thomas (see [0066] of Thomas).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20180008763 A1), in view of den Heijer (US 5807331 A), and further in view of Bridges (US 20060258980 A1).
Regarding claim 27, Thomas, as modified, discloses all the limitations of claim 26. Thomas further discloses the interventional ostium occlusion catheter wherein the catheter tube forms a central lumen (the balloon catheter comprising an infusion lumen which is being interpreted as a central lumen, [0015]).
However, Thomas fails to explicitly disclose a first inflation lumen fluidly communicating with the positioning balloon, a second inflation lumen fluidly communicating with the occluding balloon, and at least one additional lumen.
However, Bridges teaches a perfusion catheter used to infuse drugs (catheter 40 for retrograde perfusion of the heart that provides drugs, abstract and [0001] & Fig. 3-4) comprising a first inflation lumen fluidly communicating with the positioning balloon (inflation lumen 62 for inflating balloon 66, [0025]-[0026] & Fig. 3-4; balloon 66 used to position the catheter at a location adjacent an ostium exterior, [0029]), a second inflation lumen fluidly communicating with the occluding balloon (inflation lumen 64 for inflating balloon 68, [0025]-[0026] & Fig. 3-4; balloon 68 used for forming an occlusive plug, [0028]), and at least one additional lumen (an additional secondary lumen can be provided for pressure transduction or delivery of a second substance, [0025]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Thomas with Bridges to include a first inflation lumen fluidly communicating with the positioning balloon, a second inflation lumen fluidly communicating with the occluding balloon, and at least one additional lumen, since such a modification would provide structure for separately inflating the balloons and monitoring the pressure within the vessel during a surgical procedure and yield predictable results pertaining to controlled vessel occlusion with an inflatable balloon and pressure transduction (see [0025] and [0028] of Bridge).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20180008763 A1) as applied to claim 1 above, and further in view of Garrison (US 20050059931 A1).
Regarding claim 28, Thomas discloses all the limitations of claim 1. Thomas discloses that “[t]he catheter can be any of a variety of perfusion catheters known in the art, such as those used to infuse drugs, blood and blood substitutes into the blood vessels of the heart” (see [0066]), but fails to explicitly disclose the catheter wherein the pressure feedback mechanism comprises a pressure sensing channel formed by the catheter tube that provides fluid communication between the tip and a pressure sensor at a proximal end of the catheter tube.
However, Garrison teaches a catheter (catheter system for localized administration of agents, designed for improvement in retrograde perfusion, abstract and [0003] & Fig. 1) wherein the pressure feedback mechanism (“Infusion pressure can also be regulated actively, e.g., by monitoring the infusion pressure at the infusion site with a fluid pressure feedback and using this feedback pressure to control flow through the regulator located at the input to the catheter system.”, [0019]) comprises a pressure sensing channel formed by the catheter tube (pressure monitoring lumen 15 formed by catheter 4, [0045] & Figs. 3-7) that provides fluid communication between the tip and a pressure sensor at a proximal end of the catheter tube (“The proximal end of pressure monitoring lumen 15 can be coupled with a pressure sensor to measure the pressure at the infusion site. In addition… lumen 15 can be coupled with a pressure regulator and used to provide a fluid pressure feedback.”, [0045], [0093], and [0100]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Thomas with Garrison to include the pressure feedback mechanism comprising a pressure sensing channel formed by the catheter tube that provides fluid communication between the tip and a pressure sensor at a proximal end of the catheter tube, since such a modification would allow for monitoring of pressure at the infusion site with a high degree of accuracy, help control flow through a regulator, and help prevent the fluid pressure at the infusion site from exceeding a maximum desired pressure that might injure the patient ([0019], [0091], and [0100] of Garrison).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783