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 .
Status of Claims
Claims 1-20 are pending and examined below
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.
Claim(s) 1-7 and 10-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique” (Nijhoff) in view of US 2024/00089848 (Burnham)
Regarding claim 1, Nijhoff discloses a method of delivering a medical device, the method comprising:
providing a prosthetic heart valve (page 556, “balloon-expandable SAPIEN and SAPIEN XT valves) including a collapsible and expandable stent having struts and a valve assembly coupled to the stent (page 556, wherein the SAPIEN has a stent with struts and a valve assembly), the valve assembly having a plurality of leaflets and a cuff (page 556, “tri-leaflet bovine pericardial valve….synthetic fabric sealing cuff);
providing a delivery device including a catheter extending between a proximal end and a distal end (Page 556, “transcatheter aortic valve implantation”), an inflatable balloon disposed at the distal end of the catheter (Page 556, “deployment balloon”)
inflating the inflatable balloon in a first stage (Page 556, “instead of instant complete inflation, the first step”).
Nijhoff doesn't explicitly teach or disclose at least one sensor disposed proximal the inflatable balloon, measuring a first pressure with the at least one sensor; and calculating a fluid resistance factor during the first stage.
Burnham discloses at least one sensor disposed proximal the inflatable balloon (Fig. 1, sensors 530 disposed proximal the balloon); measuring a first pressure with the at least one sensor (¶0043, “pressure sensor”); and calculating a fluid resistance factor during the first stage (¶0025, wherein monitoring fluid flow rate corresponds to calculating a fluid resistance factor”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Nijhoff with a sensor disposed proximal the inflatable balloon, measuring a first pressure with the sensor, and calculating a fluid resistance factor, as taught by Burnham, in order to facilitate in the proper expansion of the medical device (¶0009)
Regarding claim 2, Nijhoff further discloses wherein inflating the inflatable balloon in a first stage comprises inflating the inflatable balloon to approximately 15% of its full volume (Page 556, wherein ±1/3 of the full deployment contrast volume corresponds to approximately 15%)
Regarding claim 3, Nijhoff discloses a first stage of inflation (see rejection of claim 1) but doesn't explicitly teach or disclose measuring pressure that first stage.
Burnham discloses measuring a first pressure with at least one sensor comprises measuring a first pressure during the first stage (¶0026, wherein a pressure sensor used for known pressure volume compliance corresponds to measuring a first pressure during a first stage)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first inflation stage of Nijhoff to include measuring pressure, as taught by Burnham, in order to facilitate proper expansion of the medical device (¶0009)
Regarding claim 4, Nijhoff further discloses inflating the inflatable balloon in a second stage (Page 556, “second stage”)
Regarding claim 5, Nijhoff further discloses wherein inflating the inflatable balloon in a second stage is performed after the first stage (Page 556, wherein “second stage” is understood to come after “first step”)
Regarding claim 6, Nijhoff further discloses wherein inflating the inflatable balloon in a second stage comprises inflating the inflatable balloon at least until the inflatable balloon is in contact with a native valve annulus (Page 556, wherein “prosthesis was fully deployed” is understood to mean contact with the native valve annulus, see also Fig. 1 caption, “correct position of the valve with respect to the aortic annulus plane”)
Regarding claim 7, Nijhoff discloses a second stage (see rejection of claim 5) but doesn't explicitly teach or disclose calculating a balloon pressure during the second stage using the fluid resistance factor
Burnham discloses calculating a balloon pressure (¶0026, wherein pressure volume compliance calculations corresponds to calculating balloon pressure) during the second stage using the fluid resistance factor (¶0025, wherein “monitor the fluid flow rate corresponds to using a fluid resistance factor)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Nijhoff with a step to measure balloon pressure during the second stage of inflation, as taught by Burnham, in order to improve placement of the valve in order to facilitate proper expansion of the medical device (¶0009)
Regarding claim 10, Nijhoff discloses a method of delivering a medical device, the method comprising:
providing a prosthetic heart valve (page 556, “balloon-expandable SAPIEN and SAPIEN XT valves) including a collapsible and expandable stent having struts (Page 556, “stainless steel frame”) and a valve assembly coupled to the stent, the valve assembly having a plurality of leaflets and a cuff (Page 556, “tri-leaflet bovine pericardial vale…partially covered with a synthetic fabric sealing cuff”);
providing a delivery device including a catheter extending between a proximal end and a distal end (Page 556, “balloon-expandable”), an inflatable balloon disposed at the distal end of the catheter (Page 556, “balloon-expandable”),
inflating the inflatable balloon in a first stage (Page 556, “partial inflation of the balloon”); and
analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage (Fig. 1, wherein aortic angiography corresponds to analyzing an effect on a first parameter (pressure) on valve inflation).
Nijhoff discloses a catheter with an inflatable balloon but doesn't explicitly teach or disclose a sensor disposed proximal the inflatable balloon.
Burnham discloses at least one sensor disposed proximal the inflatable balloon (See Fig. 1, wherein sensor 530 is disposed proximally relative to the balloon)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the catheter of Nijhoff with a sensor disposed proximal the inflatable balloon, as taught by Burnham, to facilitate in the proper expansion of the medical device (¶0009)
Regarding claim 11, Nijhoff discloses a first stage (see rejection of claim 10) but doesn't explicitly teach or disclose analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of fluid viscosity on inflation of the inflatable balloon.
Burnham discloses analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of fluid viscosity on inflation of the inflatable balloon (¶0025, wherein sensor can be used to monitor the fluid flow rate corresponds to analyzing an effect of fluid viscosity on the inflation of the inflatable balloon).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Nijhoff with an analysis of the effect of fluid viscosity on the inflation of the inflatable balloon, as taught by Burnham, to facilitate in the proper expansion of the medical device (¶0009)
Regarding claim 12, Nijhoff discloses analyzing inflation during a first stage (See rejection of claim 10) but doesn't explicitly teach or disclose analyzing an effect of an inflation media on inflation of the inflatable balloon.
Burnham discloses analyzing an effect of an inflation media on inflation of the inflatable balloon (¶0025, wherein monitoring flow rate and total volume delivered to the inflatable balloon corresponds to analyzing an effect of an inflation media)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Nijhoff with a step to analyze the effect of an inflation media on inflation of the inflatable balloon, as taught by Burnham, in order to facilitate in the proper expansion of the medical device (¶0009)
Regarding claim 13, Nijhoff doesn't explicitly teach or disclose wherein the inflation media comprises a mixture of saline and contrast solution.
Burnham discloses an inflation media which comprises a mixture of saline and contrast solution (¶0019, saline and dye mixture”).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Nijhoff to inflate the balloon with a mixture of saline and contrast solution, as taught by Burnham, in order to facilitate in the proper expansion of the medical device (¶0009)
Regarding claim 14, Nijhoff further discloses analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of catheter length on inflation of the inflatable balloon (Fig. 1, wherein an angiography that shows inflation of the balloon corresponds to analyzing an effect of catheter length on inflation of the inflatable balloon”)
Regarding claim 15, Nijhoff further discloses wherein analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of catheter diameter on inflation of the inflatable balloon (Fig. 1, wherein an angiography that shows inflation of the balloon corresponds to analyzing an effect of catheter length on inflation of the inflatable balloon”)
Regarding claim 16, Nijhoff further discloses wherein inflating the inflatable balloon in a first stage comprises inflating the inflatable balloon to approximately 15% of its full volume (Page 556, wherein “±1/3 of the full deployment contrast volume” corresponds to approximately 15%)
Regarding claim 17, Nijhoff further comprising inflating the inflatable balloon in a second stage (Page 556, “second stage”)
Regarding claim 18, Nijhoff wherein inflating the inflatable balloon in a second stage is performed after the first stage (Page 556, wherein “second stage” is understood to come after “first step”)
Regarding claim 19, Nijhoff discloses wherein inflating the inflatable balloon in a second stage comprises inflating the inflatable balloon at least until the inflatable balloon is in contact with a native valve annulus (Page 556, wherein “prosthesis was fully deployed” is understood to mean contact with the native valve annulus, see also Fig. 1 caption, “correct position of the valve with respect to the aortic annulus plane”)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique” (Nijhoff) in view of US 2024/00089848 (Burnham), as applied to claims above and further in view of US 2019/0254819 (Hoffer)
Regarding claim 9, Nijhoff discloses a first stage of inflation (see rejection of claim 1) but doesn't explicitly teach or disclose recrimping the prosthetic heart valve. Burnham doesn't explicitly teach or disclose recrimping the prosthetic heart valve after the first stage.
Hoffer discloses re-crimping the prosthetic heart valve after the first stage (¶0006, “crimping the valve for repositioning”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Nijhoff in view of Burnham with a step that includes re-crimping after the first stage, as taught by Hoffer, in order to reposition the valve within a patient’s aortic annulus (¶0006).
Claim(s) 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique” (Nijhoff) in view of US 2024/00089848 (Burnham), as applied to claims above and further in view of US 2013/0297010 A1 (Bishop)
Regarding claim 8, Nijhoff discloses a first stage of inflation (see rejection of claim 1) but doesn't explicitly teach or disclose expanding the inflatable balloon in an unconstrained state prior to implantation. Burnham doesn't explicitly teach or disclose expanding the inflatable balloon in an unconstrained state prior to implantation
Bishop discloses expanding the inflatable balloon in an unconstrained state prior to implantation
discloses wherein inflating the inflatable balloon in a first stage comprises expanding the inflatable balloon in an unconstrained state prior to implantation (¶0122, wherein “this allows the ballon to be pre-inflated with a non-solidifying material such as a gas or liquid” corresponds to an unconstrained state)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first stage of Nijhoff in view of Burnham to be inflated in an unconstrained state, as taught by Bishop, in order to calibrate the device.
Regarding claim 20 Nijhoff further discloses inflating the inflatable balloon in a first stage comprises expanding the inflatable balloon in air prior to implantation (
Bishop discloses an inflatable balloon which is expanded in air prior to implantation (¶0122, “this allows the ballon to be pre-inflated with a non-solidifying material such as a gas or liquid”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first stage of Nijhoff in view of Burnham to be inflated in air prior to implantation, as taught by Bishop, in order to calibrate the device.
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
“TAVI Under Pressure: Intra-balloon Pressure Profiles During Balloon-Expandable TAVR – First Data from a Feasibility Study”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAXIMILIAN TOBIAS SPENCER whose telephone number is (571)272-8382. The examiner can normally be reached M-F 8am-5pm.
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, Jerrah Edwards can be reached on 408.918.7557. 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.
/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
