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 03/12/2026. As directed by the amendment: claims 1, 5, 8, 10, 14, 15, 16, 19, 20, 22, 23, 24 & 26 have been amended. Claims 6, 18 and 21 have been cancelled. Claims 27 and 28 have been cancelled.
Thus, claims 1-5, 7-17, 19, 20 & 22-28 are pending in this application.
Applicant’s amendments to the specification and claim have overcome each and every objection previously set forth in the Non-final Office Action mailed on 12/12/2025.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the Non-final Office Action mailed on 12/12/2025.
Claim Objections
Claims 5 and 28 are objected to because of the following informalities:
Claim 5, line 3, “ballon” should read “balloon”.
Claim 28, line 1, “ballon” should read “balloon”.
Appropriate correction is required.
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.
Claims 1-5 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1).
Regarding claim 1, Patel discloses a balloon catheter (1) comprising: an elongate shaft (13) having an internal hollow body (19); a balloon (14, 42) at a distal end (12) of the shaft (fig 1, 6), the balloon being inflatable and deflateable in accordance with a pressure of a fluid supplied to the inside of the balloon through the internal hollow body of the shaft (para 0169); and a radially collapsible conduit (15) positioned exterior to the elongate shaft and juxtaposed between the elongate shaft and the balloon (fig 1); wherein the radially collapsible conduit is connected to the balloon for operative radial expansion as the balloon inflates, and, when radially expanded, the radially collapsible conduit has an open distal end (24) and an open proximal end (23) both of which are in fluid communication with the environment, thereby defining a passthrough (22) configured for maintained blood flow during use of the balloon catheter (para 0162, 0175 and 0190).
Patel fails to teach said balloon comprising: a plurality of internal chambers that are inflatable to differing pressures, thereby, when inflated, the balloon has a generally hourglass shape having a neck between a distal end and a proximal end of the balloon; and a port at the neck of the balloon in open communication with a delivery tube housed within the internal hollow body and in open communication with an environment external to the balloon but teach the balloon catheter includes a second inflatable balloon that is connected to the guidewire body (para 0208-9) and the wall of the inflatable balloon can optionally include one or more openings or pores 16 that are configured to allow fluid (e.g., a fluid that includes therapeutic material) in the interior of the inflatable balloon to flow or extrude through the one or more pores when the inflatable balloon is partially or fully pressurized by the fluid in the interior of the inflatable balloon (para 0161).
However, Lawinger et al disclose a balloon catheter (10) comprising: an elongate shaft (102, fig 5) having an internal hollow body (124); and a balloon (110) at a distal end (100) of the shaft, and the balloon comprising: a plurality of internal chambers (106 and 108) that are inflatable to differing pressures (para 0057, can be filled separately, thus that they are capable of being filled to different pressures), thereby, when inflated, the balloon has a generally hourglass shape (fig 5) having a neck (114) between a distal end and a proximal end of the balloon (fig 5); and a port at the neck (opening of right neck 114) of the balloon in open communication with a delivery tube (120) housed within the internal hollow body and in open communication with an environment external to the balloon (fig 5, generator 120 delivers electrical energy to external environment through lumen 124).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the balloon of Patel and incorporate the teachings of Lawinger et al to have said balloon comprising: a plurality of internal chambers that are inflatable to differing pressures, thereby, when inflated, the balloon has a generally hourglass shape having a neck between a distal end and a proximal end of the balloon; and a port at the neck of the balloon in open communication with a delivery tube housed within the internal hollow body and in open communication with an environment external to the balloon. This would provide the benefit of having a shape to isolate the target lesion from the remainder of the artery and form a seal that retains the plaque within the neck of the balloon and having a port at the neck allows fluid such as therapeutic fluid to be directly delivered at the treatment site (fig 5 and para 0084).
Regarding claim 2, Patel in view of Lawinger et al discloses the balloon catheter of claim 1,
Lawinger et al further disclose wherein the plurality of internal chambers of the balloon are inflated sequentially (para 0022-23 and 0096) or simultaneously (para 0024, 0057 and claim 21).
Regarding claim 3, Patel in view of Lawinger et al discloses the balloon catheter of claim 2,
Lawinger et al further disclose wherein the plurality of internal chambers are controllably inflatable (para 0021, said internal chambers are fully capable of being controllably inflatable by the an user).
Regarding claim 4, Patel in view of Lawinger et al discloses the balloon catheter of claim 3,
Lawinger et al further disclose wherein the plurality of internal chambers comprise at least a distal chamber (108), a neck chamber (114), and a proximal chamber (106).
Regarding claim 5, Patel in view of Lawinger et al discloses the balloon catheter of claim 4,
Lawinger et al further disclose wherein the port includes a radially extendable tube (126A-B) fixed to the neck chamber of the balloon (fig 5) and configured to extend radially with the ballon as the balloon inflates (conductor tubes 126A and 126B extend outward to said right neck chamber 114 when inflated, fig 5).
Regarding claim 27, Patel in view of Lawinger et al discloses the balloon catheter of claim 1,
Lawinger et al further disclose wherein the balloon has a plurality of segments radially and a plurality of segments longitudinally (fig 5).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Chauhan (US 5613980 A).
Regarding claim 7, Patel in view of Lawinger et al discloses the limitations of claim 1 but fail to teach wherein the elongate shaft is bifurcated at the distal end into a first hollow body and a second hollow body and comprises a flexible saddle between and joining the first and second hollow bodies; wherein at least a most proximal of the plurality of internal chambers is fully circumferential and is positioned on the elongate shaft prior to the flexible saddle, and the port is positioned in one of the first and second hollow bodies.
However, Chauhan discloses a balloon catheter (14) comprising an elongate shaft (18) and a balloon (20), wherein the elongate shaft is bifurcated at the distal end into a first hollow body (22) and a second hollow body (24) and comprises a flexible saddle (26) between and joining the first and second hollow bodies (fig 3); wherein at least a most proximal (66) of the plurality of internal chambers (66, 68, 70) is fully circumferential and is positioned on the elongate shaft prior to the flexible saddle (fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the balloon catheter of Patel in view of Lawinger et al and incorporate the teachings of Chauhan to have said balloon catheter, wherein the elongate shaft is bifurcated at the distal end into a first hollow body and a second hollow body and comprises a flexible saddle between and joining the first and second hollow bodies; wherein at least a most proximal of the plurality of internal chambers is fully circumferential and is positioned on the elongate shaft prior to the flexible saddle, and the port is positioned in one of the first and second hollow bodies. This would provide the benefit of using said balloon catheter at a bifurcated region to provide an effective and safe system when performing a procedure in a bifurcated artery because the plurality of internal chambers are properly placed in their corresponding branch vessels before the inflation of the balloon to avoid kinking of said internal chambers (see col 5, lines 16-26).
Regarding claim 8, Patel in view of Lawinger et al and Chauhan discloses the balloon catheter of claim 7,
Chauhan further teaches wherein the radially collapsible conduit (lumen 18) juxtaposed to the elongate shaft is bifurcated to continue along each of the first and second hollow bodies (fig 3); wherein the radially collapsible conduit has an open proximal end (32, 30) and first and second open distal ends (50, 52) positioned for fluid communication with the environment (fig 5).
Regarding claim 9, Patel in view of Lawinger et al and Chauhan discloses the balloon catheter of claim 8,
Chauhan further teaches wherein flexible saddle enables the first and second hollow bodies to separate from one another into a Y-shape as the balloon is inflated (see fig 3).
Regarding claim 10, Patel in view of Lawinger et al and Chauhan discloses the balloon catheter of claim 7,
Chauhan further teaches wherein a first balloon portion (68) connected to a first hollow body (22) and a second balloon portion (70) connected to the second hollow body (24) comprise at least two internal chambers each (fig 3); wherein the first balloon portion (68) and the second balloon portion (70) are less than fully circumferential (fig 3).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Sepetka et al (US 5882334 A).
Regarding claim 11, Patel in view of Lawinger et al discloses the limitations of claim 1 but fail to teach said balloon catheter comprising a cuff operatively connecting the balloon to the elongate shaft; wherein the cuff is rotatable relative to the elongate shaft.
However, Sepetka et al teach a ballon catheter (1, fig 1) comprising an elongate shaft (11), a balloon (23) and a cuff (32) operatively connecting the balloon to the elongate shaft (col 12, lines 10-23); wherein the cuff is rotatable relative to the elongate shaft (col 14, lines 36-39 and lines 61-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the balloon catheter of Patel in view of Lawinger et al and incorporate the teachings of Sepetka et al to have a cuff operatively connecting the balloon to the elongate shaft; wherein the cuff is rotatable relative to the elongate shaft. This would provide the benefit of enabling an operator to position/reposition said balloon selectively and accurately during deployment at a treatment site (col 8, lines 47-59 and col 12, lines 1-9).
Regarding claim 12, Patel in view of Lawinger et al and Sepetka et al discloses the balloon catheter of claim 11,
Sepetka et al further teach the cuff is linearly translatable along the elongate shaft (col 12, lines 24-26).
Regarding claim 13, Patel in view of Lawinger et al and Sepetka et al discloses the balloon catheter of claim 11,
Sepetka et al further teach wherein the balloon in a deflated state lay inside an outer perimeter defined by the cuff (figs 1 and 3A).
Claims 14, 19, 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Avneri et al (US 20190125396 A1).
Regarding claim 14, Patel in view of Lawinger et al discloses the limitations of claim 1,
Lawinger et al further disclose a method of removing plaque from a lesion (34) in a lumen (112) of a patient in need thereof (para 0042), the method comprising: deploying a balloon (110) catheter according to claim 1 to a target lesion in need of plaque treatment (fig 5, para 0042); inflating the balloon of the balloon catheter to its generally hourglass shape with the proximal and distal ends of the balloon in direct contact with normal endothelium proximal and distal to the target lesion and the neck of the balloon at the target lesion, thereby isolating the target lesion from the remainder of the artery (fig 5), wherein the neck of the balloon includes a port (opening of the neck) defining access to the target lesion (fig 5); introducing a tool (120) via the port (fig 5); cutting an opening in the endothelium at the target lesion with the tool, thereby providing access to the plaque inside the target lesion (fig 5 and para 0064-in order to break lesion 34, the blood vessel endothelium needs to be cut into an opening); liquifying the plaque with a laser to form liquified plaque (para 0042- The pressure pulse wave may impact the calcified lesion to fracture or disrupt at least part of the lesion and para 0085- cavitation generator 120 may include an optical fiber laser); and removing the plaque from inside the target lesion through the opening in the endothelium (para 0098, lesion is removed to retore the vasculature to a normal flow diameter).
Patel in view of Lawinger et al fail to teach cutting an opening in the endothelium at the target lesion with the tool to define a flap of endothelium.
However, Avneri et al disclose a method of removing plaque from an artery (abstract) wherein the method further includes advancing a cutting tool (40) to the target lesion (12) through a balloon catheter (31, see figs 3A-E); cutting an opening into the endothelium of the target lesion with the tool to define a flap of endothelium (fig 3E and para 0040 and 0098).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cutting of Patel in view of Lawinger et al and incorporate the teachings of Avneri et al to have said method further includes cutting an opening into the endothelium of the target lesion with the tool to define a flap of endothelium. This would provide the benefit of accessing the plaque inside the target lesion, and removing a layer of plaque from the entire interior surface of a lumen of a patient without cutting the vessel wall (see para 0037).
Regarding claim 19, Patel in view of Lawinger et al discloses the limitations of claim 1 and 14 and further teach wherein the cutting tool (120) is a laser (para 0085) but fail to teach the opening is a circular cut and the flap of endothelium has a connection tether of 25 to 45 degrees.
However, Avneri et al discloses a method of enlarging a lumen of an artery (abstract) wherein the method further includes advancing a cutting tool (40) creating a flap of endothelium and access to plaque inside the target lesion (fig 3E) wherein the opening is a circular cut (para 0096, finger may be round to create a circular opening) and the flap of endothelium has a connection tether (fig 3E).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cutting of Patel in view of Lawinger et al and incorporate the teachings of Avneri et al to have said method further teach the opening is a circular cut and the flap of endothelium has a connection tether. This would provide the benefit of accessing the plaque inside the target lesion, and removing a layer of plaque from the entire interior surface of a lumen of a patient without cutting the vessel wall (see para 0037).
Avneri et al fail to expressly teach the connection tether of 25 to 45 degrees but teach the connection tether has some degrees (fig 3E).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the flap of Avneri et al by making the connection tether of 25 to 45 degree 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, Patel in view of Lawinger et al and Avneri et al discloses the method of claim 19,
Avneri et al further teach wherein the connection tether is at a position of upstream arterial flow, thereby arterial flow holds the flap of endothelium closed subsequent to the treatment (para 0091 and 0156).
Regarding claim 22, Patel in view of Lawinger et al and Avneri et al discloses the method of claim 14,
Avneri et al further teach a method of enlarging a lumen of an artery comprising aspirating inside the target lesion (para 0123-24 and 0154).
Regarding claim 23, Patel in view of Lawinger et al and Avneri et al discloses the method of claim 14,
Avneri et al further teach a method of enlarging a lumen of an artery comprising closing the flap of endothelium (para 0149-150).
Regarding claim 24, Patel in view of Lawinger et al and Avneri et al discloses the method of claim 14,
Avneri et al further teach a method of enlarging a lumen of an artery comprising administering a drug treatment to one or more of a sub-endothelium space between the endothelium and muscularis, an interior surface of the flap of endothelium, or an exterior surface of the flap of endothelium (para 0010-11, para 0091).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Avneri et al (US 20190125396 A1) and Pacetti (US 7753926 B1).
Regarding claim 15, Patel in view of Lawinger et al and Avneri et al discloses the limitations of claims 1 and 14 but fail to teach said method further teach comprising additional inflation of the balloon to push liquified plaque toward the opening.
However, Pacetti discloses a method of removing a plaque further comprising additional inflation of the balloon to push liquified plaque toward the opening (fig 12A-D, col 10, lines 15-39).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cutting of Patel in view of Lawinger et al and Avneri and incorporate the teachings of Pacetti to further comprising additional inflation of the balloon to push liquified plaque toward the opening. This would provide the benefit causing the buildup of enough pressure within vulnerable plaque to cause its rupture and preventing the vulnerable plaque from forming scar tissue that obstructs blood flow (col 10, lines 33-39).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Avneri et al (US 20190125396 A1) and in view of Hsiai et al (US 20190183392 A1).
Regarding claim 16, Patel in view of Lawinger et al and Avneri et al discloses the limitations of claims 1 and 14 but fails to teach said method further comprising determining the lipid burden of the plaque.
However, Hsiai et al disclose devices and methods that can be used to locate plaques in an artery and determine the likelihood of rupture based on plaque content (para 0070) comprising determining the lipid burden of the plaque (para 0121).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Patel in view of Lawinger et al and Avneri et al and incorporate the teachings of Hsiai et al to have said method comprising determining the lipid burden of the plaque. This would provide the benefit of having an improved method to identify the degree of plaque present at the treatment site (para 0121).
Regarding claim 17, Patel in view of Lawinger et al and Avneri et al discloses the method of claim 16,
Hsiai et al further teach wherein determining the lipid burden includes application of near-infrared spectroscopy plus intravascular ultrasound or a capacitive micromachines ultrasound transducer (para 0005 and 0023).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Avneri et al (US 20190125396 A1) and in view of Mohr et al (US 5921954 A).
Regarding claim 25, Patel in view of Lawinger et al and Avneri et al discloses the limitations of claims 1, 14, and 24 but fails to teach said method, wherein the drug treatment comprises collagen and/or carbon dots comprising stem cells.
However, Mohr et al disclose a method for treating aneurysms and other body structures by applying a hardening softening agent such as RF energy to a hardenable/softenable substance such as collagen (col 2, lines 2-14).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to further modify Patel in view of Lawinger et al and Avneri et al by adding a step of administering a drug treatment comprising collagen to the treatment site, as taught by Mohr, for the purpose of hardening and covering the weak region of the blood vessel wall, and providing a base onto which epithelial cells of the blood vessel grow (col. 2 lines 10-14 of Mohr).
Regarding claim 26, Patel in view of Lawinger et al and Avneri et al and Mohr et al discloses the method of claim 25,
Mohr et al further teach said method comprising activating collagen by application of an activating wavelength of energy (col 2, lines 26-46).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1) and further in view of Peacock et al (US 5549551 A).
Regarding claim 28, Patel in view of Lawinger et al discloses the limitations of claim 1 and further discloses wherein the plurality of internal chambers comprises 4 to 16 segments (fig 5 of Lawinger et al comprises more than 4 segments of chambers) but fails to teach said segment, each independently and controllable inflatable to a selected pressure and a selected size.
However, Peacock et al disclose a balloon catheter (80) comprising a plurality of internal chambers comprises 4 to 16 segments (83, 84, 85, each section has two segments) wherein each independently and controllable inflatable to a selected pressure and a selected size (col 3, lines 10-18 and col 6, lines 29-46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the balloon catheter of Patel in view of Lawinger et al and incorporate the teachings of Peacock et al to have each segment independently and controllable inflatable to a selected pressure and a selected size. This would provide the benefit of having an inflatable balloon segment may be inflated proportionately to the size the stenotic lesion size (col 1, lines 60-63 and col 2, lines 27-49).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 03/12/2026, with respect to the rejection(s) of claim(s) 1-26 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Patel (US 20200316350 A1) in view of Lawinger et al (US 20190117242 A1).
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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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
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