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 .
Election/Restrictions
Applicant’s election without traverse of Species 2, Figs. 16-17, directed to claims 1-5, 7-9 and 16-20 in the reply filed on August 24, 2026, is acknowledged.
Claims 6 and 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, last two lines recite “the proximal balloon segment and the distal balloon segment may be inflated independently of each other.” (emphasis added). The limitation “may be” renders the scope of the claim unclear because it is unclear that limitation after “may be” is part of the claimed invention or not. For examination purpose this limitation has been interpreted as the proximal balloon segment and the distal balloon segment are inflated independently of each other.
Claim 2, last line recites “may all be inflated independently of each other.” This limitation is rejection for the same reason as claim 1 above.
Claims 3-5 and 7-9 are rejected for the same reason as claim 1 by virtue of dependency on claim 1.
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)(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) 1-2, 5 and 7-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2024/025897 (hereinafter “Leshecz”).
Referring to claim 1, Leshecz discloses a prosthetic heart valve delivery system (abstract, Figs. 1, 6 and 14A-14C) comprising:
a handle 16 (Fig. 1, para. [0090]);
an outer catheter (inflation tube(s) 20 as shown in Fig. 6, which is reproduced below, paras. [0090] and [0139]) extending distally from the handle ;
a balloon (balloon assembly 100 as shown in Fig. 6, which is reproduced below) mounted to a distal end portion of the outer catheter;
a prosthetic heart valve 12 (Figs. 1 and 5) and configured to be received over the balloon (para. [0090]: “A balloon expandable prosthetic device 12, such as balloon expandable prosthetic heart valve 200, can be carried in a crimped state over the balloon assembly 100.”);
a balloon inflation system configured to inflate and deflate the balloon (para. [0093]: “In such cases, fluid can be supplied independently to each passageway, such as by being connected to a separate fluid source (e.g., a separate syringe or a separate outlet of an inflation pump), allowing each inflation tube 20 or each subset of inflation tubes 20 to be independently utilized to deliver inflation tubes to balloons 102 or subset of balloons 102 mounted on the distal ends of the corresponding inflation tubes 20.”); and
wherein the balloon 100 includes a proximal balloon segment and a distal balloon segment positioned distal to the proximal balloon segment, and an interior volume of the proximal balloon segment is fluidly isolated from an interior volume of the distal balloon segment so that the proximal balloon segment and the distal balloon segment may be inflated independently of each other (Fig. 6 shows the balloon 100 includes four individual toroid balloons 102d, para. [0139]: “The total number of separate inflation tubes 20d can correspond to the number of toroid balloons 102d, such as four inflation tubes 20d that can be coupled to the four toroid balloons 102d in the illustrated example, with each inflation tube 20d including a single tube opening 24, optionally at an end of a side port 23, aligned with and in communication with the radially oriented opening 118 of the corresponding toroid balloon 102d”).
PNG
media_image1.png
448
508
media_image1.png
Greyscale
Referring to claim 2, Leshecz discloses the prosthetic heart valve delivery system of claim 1, wherein the balloon includes a center balloon segment positioned between the proximal balloon segment and the distal balloon segment, an interior volume of the center balloon segment being fluidly isolated from the interior volume of the proximal balloon segment and the interior volume of the distal balloon segment so that the proximal balloon segment, center balloon segment, and distal balloon segment may all be inflated independently of each other (Fig. 6 shows two toroid balloon located between distal toroid balloon and proximal toroid balloon. The two toroid balloon has been interpreted as a center balloon segment).
Referring to claim 5, Leshecz discloses the prosthetic heart valve delivery system of claim 1, further comprising a first inflation lumen extending from the balloon inflation system to the proximal balloon segment, and a second inflation lumen extending from the balloon inflation system to the distal balloon segment, the balloon inflation system configured to pass inflation media through the first inflation lumen to the proximal balloon segment and to pass inflation media through the second inflation lumen to the distal balloon segment independently of passing inflation media through the first inflation lumen to the proximal balloon segment (Fig. 6 shows the balloon 100 includes four individual toroid balloons 102d, para. [0139]: “The total number of separate inflation tubes 20d can correspond to the number of toroid balloons 102d, such as four inflation tubes 20d that can be coupled to the four toroid balloons 102d in the illustrated example, with each inflation tube 20d including a single tube opening 24, optionally at an end of a side port 23, aligned with and in communication with the radially oriented opening 118 of the corresponding toroid balloon 102d”).
Referring to claim 7, Leshecz discloses the prosthetic heart valve delivery system of claim 5, wherein the first inflation lumen is spaced apart from the second inflation lumen, the first and second inflation lumens extending in parallel to each other (Fig. 6 shows each inflation tube 20d are parallel to each other, para. [0139]).
Referring to claim 8, Leshecz discloses the prosthetic heart valve delivery system of claim 7, wherein the proximal balloon segment is toroidal when inflated, and the distal balloon segment is toroidal when expanded (Fig. 6).
Referring to claim 9, Leshecz discloses the prosthetic heart valve delivery system of claim 1, wherein the proximal balloon segment has a first shape when inflated, and the distal balloon segment has a second shape when inflated, the first shape and the second shape being the same (Fig. 6).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leshecz in view of Houser (US 5,865,801, hereinafter “Houser”).
Referring to claim 3, Leshecz discloses the prosthetic heart valve delivery system of claim 1 but fails to disclose a first sensor operably coupled to the proximal balloon segment and a second sensor operably coupled to the distal balloon segment, the first sensor configured to relay data to the balloon inflation system indicative of a state of expansion of the proximal balloon segment, the second sensor configured to relay data to the balloon inflation system indicative of a state of expansion of the distal balloon segment.
Referring again to claim 3, however, in the same field of endeavor, which is a balloon catheter for delivery an implant (col. 7, lns. 54-57), Houser discloses each balloon segment includes a pressure sensor to allow the surgeon to monitor pressure of each balloon segment and adjusting the pressure of each balloon segment independently (col. 8, lns. 4-22: “Once the balloon 182 and stent 181 are located at the appropriate location within the vessel 180 and adjacent the obstruction 194, the balloon compartments 186-192 are inflated to deform the stent 181 into contact with the obstruction 194. The physician is able to control stent deployment by adjusting the inflation of the balloon dilatation compartments as necessary. Greater inflation may be required for dilatation compartments 190 and 192 than compartments 186 and 188. Thus, compartments 190 and 192 can be monitored so that over inflation (that could cause vessel damage) in the obstructed area 196 would be avoided. Furthermore, by viewing the pressure between the artery wall and balloon with regard to the balloon inflation pressure, the physician can determine that the stent is fully deployed.”).
Referring still to claim 3, in view of Houser’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a pressure sensor to each balloon segment of Leshecz balloon to allow the surgeon to adjust the pressure in each balloon segment as desire and to ensure that the prosthetic valve is fully contact with the tissue.
Claim(s) 4 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leshecz in view of Houser as applied to claim 3 above and further in view of Kassab (US 2010/0168836, hereinafter “Kassab”).
Referring to claim 4, the modified system of Leshecz discloses the prosthetic heart valve delivery system of claim 3, but fails to disclose the first sensor is a first pressure sensor positioned in fluid communication with the interior volume of the proximal balloon segment and the second sensor is a second pressure sensor positioned in fluid communication with the interior volume of the distal balloon segment. However, in the same field of endeavor, which is a balloon catheter for deployment of a stent valve to the heart (Figs. 9-9D), Kassab discloses pressure sensor is located inside the balloon 30 for accurate determination of the balloon cross-section area during stent valve deployment (para. [0072]). In view of Kassab’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have located the pressure sensor inside each balloon segment to further provide the advantage of allowing the surgeon to accurately determine of the balloon cross-sectional area during deployment of the stent valve to the heart.
Referring to claim 16, in view of the rejection of claims 3 and 4 above, the modified system of Leshecz discloses a method of implanting a prosthetic heart valve (Leshecz: Figs. 14A-14C, which are reproduced below, paras. [0177]-[0179]), the method comprising:
advancing a delivery catheter through a vasculature of a patient while the prosthetic heart valve 200 is crimped over a balloon of the delivery catheter, the balloon including a proximal balloon segment and a distal balloon segment positioned distal to the proximal balloon segment (Fig. 6);
positioning the prosthetic heart valve within a native valve annulus of the patient while the prosthetic heart valve is crimped over the balloon;
independently advancing inflation media into the proximal balloon segment and into the distal balloon segment so that the proximal balloon segment expands independently of the distal balloon segment (Leshecz: para. [0140]: “This configuration provides improved control over the inflation procedure, allowing each of the toroid balloons to be independently inflated through a respective inflation tube coupled thereto. For example, one or more of the toroid balloons 102 can be inflated at a rate which is greater than that of one or more other toroid balloons, or one or more of the toroid balloons 102 can be less or more inflated, to result in a greater or narrower toroidal outer diameter To, than that of one or more other toroid balloons.”);
while the proximal and distal balloon segments are inflating, determining a state of inflation of the proximal balloon segment and a state of inflation of the distal balloon segment (Leshecz in view of Houser and Kassab would disclose this step);
comparing the state of inflation of the proximal balloon segment to the state of inflation of the distal balloon segment to determine if there is uneven balloon inflation; and upon determining that there is uneven balloon inflation, adjusting a rate of inflation of one or both of the proximal balloon segment or the distal balloon segment to compensate for the uneven balloon inflation (Leshecz in view of Houser and Kassab would disclose this step).
PNG
media_image2.png
374
744
media_image2.png
Greyscale
Referring to claim 17, the modified system of Leshecz (see rejection of claims 3-4 above) discloses the method of claim 16, wherein a first pressure sensor is positioned in fluid communication with an interior volume of the proximal balloon segment, and a second pressure sensor is positioned in fluid communication with an interior volume of the distal balloon segment.
Referring to claim 18, the modified system of Leshecz (see rejection of claims 3-4 above) discloses the method of claim 17, wherein the first pressure sensor relays pressure information of the proximal balloon segment to a motorized balloon inflation system operably coupled to the balloon, and the second pressure sensor relays pressure information of the distal balloon segment to the motorized balloon inflation system (in paragraph [0106] Leshecz discloses a pump to inject inflation fluid to balloon segments, thus, a pump inherently has a motor).
Referring to claim 19, the modified system of Leshecz discloses the method of claim 18, wherein the state of inflation of the proximal balloon segment is determined based on the relayed pressure information from the first pressure sensor, and the state of inflation of the distal balloon segment is determined based on the relayed pressure information from the second pressure sensor (Houser: col. 8, lns. 12-14: “The physician is able to control stent deployment by adjusting the inflation of the balloon dilatation compartments as necessary.” Claim 1: “a balloon dilatation means for supplying a fluid under pressure individually to said dilatation compartments; said dilatation means controllable to adjust the dilatation pressures to different values in at least first and second selected ones of the dilatation compartments”).
Referring to claim 20, the modified system of Leshecz discloses the method of clam 19, wherein a processor operably coupled to the motorized balloon inflation system performs the determination that there is uneven balloon inflation, and upon determining that there is uneven balloon inflation, the processor causes the motorized balloon inflation system to adjust the rate of inflation of one or both of the proximal balloon segment or the distal balloon segment (Houser: col. 8, lns. 12-14: “The physician is able to control stent deployment by adjusting the inflation of the balloon dilatation compartments as necessary.” Claim 1: “a balloon dilatation means for supplying a fluid under pressure individually to said dilatation compartments; said dilatation means controllable to adjust the dilatation pressures to different values in at least first and second selected ones of the dilatation compartments”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
Prosecution Insights