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 .
Claim Objections
Claims 9 and 16 objected to because of the following informalities:
In claim 1, line 2, “(i) — (iv) below” is unnecessary and should be removed.
In claim 9, line 2, “advanced a least 15 cm” should be “advanced at least 15 cm”.
In claim 16, line 2, “range of range of 4-13 cm” should be “range of 4-13 cm”. Appropriate correction is required.
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.
Claim(s) 1 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim-866 (EP3662866) in view of Lee (US20200000592).
Regarding claim 1, Kim-866 discloses a method of treating tricuspid valve regurgitation in a patient's heart (100, Figs. 1-2), comprising: having a transcatheter device (100) comprising: (i) a main shaft (20); (ii) a proximal portion (lower portion of 20 and 60) comprising a proximal segment of the main shaft (lower portion of 20, see Figs. 1-2); (iii) a distal tail (upper portion of 20 and 30) comprising a distal portion of the main shaft (upper portion of 20, see Figs. 1-2); (iv) a spacer body (10) mounted on the main shaft and located between the proximal segment of the main shaft and the distal tail (see Figs. 1-2); advancing the transcatheter device through an inferior vena cava (see Fig. 2 and paragraphs [0041] and [0057] — [0058]); advancing the transcatheter device through a right atrium of the heart (see Fig. 2 and paragraphs [0041] and [0057] — [0058]); advancing the transcatheter device across a tricuspid valve and into a right ventricle of the heart (see Fig. 2 and paragraphs [0057] — [0058]); advancing the transcatheter device towards a pulmonary artery (see Fig. 2 and paragraphs [0057] — [0058]); and positioning the spacer body between leaflets of the tricuspid valve (see Fig. 2 and paragraphs [0057]— [0058]).
Kim-866 fails to explicitly disclose the method step of advancing the distal tail into the pulmonary artery for a distance of at least 10 cm into the pulmonary artery. However, Kim-866 discloses the step of a fixing member for the pulmonary artery is installed in the pulmonary artery (see paragraph [0014]) and also Kim-866 discloses the device may be moved through the inferior vena cava, the tricuspid valve, and the pulmonary artery in sequence to position the blocking part 10 in the orifice of the tricuspid valve (see paragraph [0058]). As seen in Fig. 2, the distal tail 30 goes pass the pulmonary valves and into the pulmonary artery and as such the distance of the distal tail advancement into the pulmonary artery is disclosed to be a result effective variable in that changing the distance of advancement of the distal tail affects the placement of the blocking part 10. Further, it appears that one having ordinary skill in the art would have reasonable success in modifying the method of Kim-866 to comprise step of advancing the distal tail into the pulmonary artery at least 10 cm, as it involves only adjusting the amount of advancement to properly position blocking part 10. 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 method of Kim-866 to comprise a step of advancing the distal tail into the pulmonary artery and set the distance of the distal tail advancing into the pulmonary to be at least 10 cm 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).
Kim-866 further fails to disclose the method step of inserting the transcatheter device into a femoral vein. Lee also discloses a transcatheter method for treating tricuspid valve regurgitation (see paragraphs [0103] and [0105] — [0106] and Fig. 12) and teaches the step of inserting the transcatheter device into a femoral vein (see paragraph [0103]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kim-866 to incorporate the step of inserting the transcatheter device into the femoral vein, as taught by Lee, in order to effectively and safely deliver a device to a patient’s heart for installation (see paragraph [0103]).
Regarding claim 9, Kim-866, as modified by Lee, discloses the method of claim 1 but fails to explicitly disclose wherein the distal tail of the transcatheter device is advanced at least 15 cm into the pulmonary artery.
However, Kim-866, as modified by Lee, discloses the step of a fixing member for the pulmonary artery is installed in the pulmonary artery (see paragraph [0014]) and also Kim-866 discloses the device may be moved through the inferior vena cava, the tricuspid valve, and the pulmonary artery in sequence to position the blocking part 10 in the orifice of the tricuspid valve (see paragraph [0058]). As seen in Fig. 2, the distal tail 30 goes pass the pulmonary valves and into the pulmonary artery and as such the distance of the distal tail advancement into the pulmonary artery is disclosed to be a result effective variable in that changing the distance of advancement of the distal tail affects the placement of the blocking part 10. Further, it appears that one having ordinary skill in the art would have reasonable success in modifying the method of Kim-866, as modified by Lee, to comprise step of advancing the distal tail into the pulmonary artery at least 15 cm, as it involves only adjusting the amount of advancement to properly position the blocking part 10. 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 method of Kim-866, as modified by Lee, to comprise a step of advancing the distal tail into the pulmonary artery and set the distance of the distal tail advancing into the pulmonary to be at least 15 cm 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 10, Kim-866, as modified by Lee, discloses the method of claim 1 but fails to disclose wherein the spacer body has an opening through which blood flows through the spacer body.
Lee also discloses a spacer body (31) and further teaches the spacer body (31) has an opening (Fig. 3A1-3A3) through which blood flows through the spacer body (see 3A1-3A3). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the spacer body of Kim-866 to incorporate the spacer body of Lee having an opening through which blood flows through, in order to allow controlled blood flow through the valve and prevent complete blockage (see paragraph [0005]).
Regarding claim 11, Kim-866, as modified by Lee, discloses the method of claim 1 and Kim-866 further discloses wherein the pulmonary artery is a left-side pulmonary artery (see Fig. 2 and [0057] — [0058]).
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim-866 in view of Lee as applied to claim 1 above, and further in view of Kim-916 (US20200229916).
Regarding claim 2, Kim-866, as modified by Lee, discloses the method of claim 1 but fails to disclose the method further comprising positioning the spacer body to abut against a supraventricular crest of the heart
Kim-916 also discloses a method a transcatheter method for treating tricuspid valve regurgitation (see abstract) an teaches the spacer body (10) being positioned to abut against the supraventricular crest of the heart (see Figs. 11-12). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the spacer body of Kim-866, as modified by Lee, to abut against the supraventricular crest of the heart, as taught by Kim-916, in order to stably block the orifice of the tricuspid valve and maintain the centerline orientation of the orifice of the tricuspid valve without being affected by the movement of the diaphragm during breathing (see paragraphs [0014] — [0015]).
Regarding claim 3, Kim-866, as modified by Lee and Kim-916, discloses the method of claim 2 but fails to disclose wherein the abutting against the supraventricular crest occurs at a location within the distal half of the spacer body.
Kim-916 further teaches the distal half of the spacer body (10) is abutting against the supraventricular crest of the heart (see Figs. 11-12). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the spacer body of Kim-866, as modified by Lee, to abut against the supraventricular crest of the heart, as taught by Kim-916, in order to stably block the orifice of the tricuspid valve and maintain the centerline orientation of the orifice of the tricuspid valve without being affected by the movement of the diaphragm during breathing (see paragraphs [0014] — [0015]).
Regarding claim 4, Kim-866, as modified by Lee and Kim-916, discloses the method of claim 2 but fails to disclose wherein the tricuspid valve has a tricuspid annulus and there is an annular plane defined for the tricuspid annulus; wherein the annular plane is along an x-axis of the tricuspid annulus and orthogonal to a Y-axis of the tricuspid annulus; wherein the spacer body is positioned at an oblique angle relative to the annular plane.
Kim-916 further teaches the tricuspid valve has a tricuspid annulus (opening of the tricuspid valve, see Figs. 11-12) and there is an annular plane defined for the tricuspid annulus (the plane in which the opening of the valve lies on, see Figs. 11-12), wherein the annular plane is along an x-axis of the tricuspid annulus (see Figs. 11-12, plane lies along the opening of the tricuspid valve) and orthogonal to a Y-axis of the tricuspid annulus (see Figs. 11-12, the plane lies orthogonal to the longitudinal axis of the tricuspid valve); wherein the spacer body is positioned at an oblique angle relative to the annular plane (see Figs. 11-12 and paragraphs [0015]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the spacer body of Kim-866, as modified by Lee, to be positioned at an oblique angle relative to the annular plane, as taught by Kim-916, in order to stably block the orifice of the tricuspid valve and maintain the centerline orientation of the orifice of the tricuspid valve without being affected by the movement of the diaphragm during breathing (see paragraphs [0014] — [0015]).
Regarding claim 5, Kim-866, as modified by Lee and Kim-916, discloses the method of claim 2 and further discloses wherein the main shaft (20) comprises a lumen (through which guidewire is inserted), and the method further comprises: inserting a guidewire into the femoral vein (see Figs. 10-11 and paragraphs [0088] — [0089]); advancing the guidewire through the inferior vena cava (see Figs. 10-11 and paragraphs [0088] — [0089]); advancing the guidewire through the right atrium (see Figs. 10-11 and paragraphs [0088] — [0089]); advancing the guidewire to traverse the tricuspid valve and into the right ventricle (see Figs. 10-11 and paragraphs [0088] — [0089]); introducing the guidewire into the lumen of the shaft (see Figs. 10-11 and paragraphs [0088] — [0089]); advancing the transcatheter device over the guidewire (see Figs. 10-11 and paragraphs [0088] — [0089]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim-866 in view of Lee as applied to claim 1 above, and further in view of Roelandt et al. (US5207228).
Regarding claim 6, Kim-866, as modified by Lee, discloses the method of claim 1 but fails to disclose wherein the distal tail is advanced past a first branching point of the pulmonary artery.
Roelandt also discloses a method transcatheter method for treating tricuspid valve regurgitation (see Figs. 3-5, col 4 lines 34-51) and teaches a distal tail being advanced past a first branching point of the pulmonary artery (see Figs. 3-5, 68 is advanced past the first branching point of the pulmonary artery). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kim-866, as modified by Lee, to comprise the step wherein the distal tail is advanced past the first branching point of the pulmonary artery, as taught by Roelandt, in order to stably block the orifice of the tricuspid valve and maintain the centerline orientation of the orifice of the tricuspid valve without being affected by the movement of the diaphragm during breathing (see Kim-916 paragraphs [0014] — [0015]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable Kim-866 in view of Lee, Kim-916, and Roelandt as applied to claim 6 above, and further in view of and Chin (US4696304).
Regarding claim 7, Kim-866, as modified by Lee and Roelandt, discloses the method of claim 6 but fails to disclose wherein the distal tail is advanced past a second branching point of the pulmonary artery.
Chin also discloses a method transcatheter method for treating tricuspid valve regurgitation and teaches the distal tail of a catheter (see Figs. 1-3) is advanced past a second branching point of the pulmonary artery (see Fig. 3, the distal tip advanced past 2 branching arteries from the main pulmonary artery). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kim-866, as modified by Lee and Roelandt, to comprise the step wherein the distal tail is advanced past a second branching point of the pulmonary artery, as taught by Chin, in order to stably block the orifice of the tricuspid valve and maintain the centerline orientation of the orifice of the tricuspid valve without being affected by the movement of the diaphragm during breathing (see Kim-916 paragraphs [0014] — [0015]).
Regarding claim 8, Kim-866, as modified by Lee, Roelandt, and Chin, discloses the method of claim 7, and Chin further discloses wherein the distal tail of the transcatheter device is advanced past a third branching point of the pulmonary artery (see Fig. 3, distal tip advances past 3 branching arteries from the main pulmonary artery before being resting in pulmonary artery 78). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kim-866, as modified by Lee and Roelandt, to comprise the step wherein the distal tail of the transcatheter device is advanced past a third branching point of the pulmonary artery, as taught by Chin, in order to stably block the orifice of the tricuspid valve and maintain the centerline orientation of the orifice of the tricuspid valve without being affected by the movement of the diaphragm during breathing (see Kim-916 paragraphs [0014] — [0015]).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim-866 in view of Fischell et al. (US5759174).
Regarding claim 12, Kim-866 discloses a transcatheter device (see Figs. 6-7) comprising: a main shaft (17) having a distal tail (section of 20 that is between spacer body 16 and fixing member 30), an inflatable balloon (16) mounted on the main shaft, and a controller (18) attached to the proximal end of the shaft in such a way the controller is configured to change the balloon’s size and position (see paragraphs [0078], the controller is adjusting the size of the implant 16 and can be moved to change the position of the implant); but fails to disclose the device comprising an inner shaft, and an outer shaft, the inner shaft having a lumen for insertion of a guidewire, the outer shaft having a lumen for insertion of the inner shaft; and wherein a distal end of the balloon is mounted on the inner shaft and a proximal end of the balloon is mounted on a distal end of the outer shaft.
Fischell discloses a related catheter device (10) comprising an inflatable balloon (24 or 24’) and teaches the device comprising an inner shaft (12), and an outer shaft (11), the inner shaft having a lumen for insertion of a guidewire (see Figs. 8-9, 19), the outer shaft having a lumen for insertion of the inner shaft (see Figs. 8-9, outer shaft encompasses the inner shaft); wherein a distal end of the balloon is mounted on the inner shaft (12) and a proximal end of the balloon is mounted on a distal end of the outer shaft (11; see Figs. 8-9). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the main shaft of Kim-866 to comprise an inner shaft, and an outer shaft, the inner shaft having a lumen for insertion of a guidewire, the outer shaft having a lumen for insertion of the inner shaft; the inflatable balloon mounted on the main shaft wherein a distal end of the balloon is mounted on the inner shaft and a proximal end of the balloon is mounted on a distal end of the outer shaft, as taught by Fischell, in order to assist in effectively positioning and dilating the balloon (see col 1 lines 13-20).
Regarding claim 14, Kim-866, as modified by Fischell, discloses the transcatheter device of claim 12 and further discloses wherein the distal tail (section of 20 that is between spacer body 16 and fixing member 30) comprises at least a bend (see Fig. 6, connecting tube 20 contains a bend).
Claim(s) 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim-866 in view of Fischell as applied to claim 12 above, and further in view of Kim-381 (WO2021168381).
Regarding claim 13, Kim-866, as modified by Fischell, discloses the transcatheter device of claim 12 but fails to disclose wherein the balloon has a non-linear shape.
Kim-381 also discloses a transcatheter device (10) that has a spacer body (see Fig. 18A-B, 16) in the same art of tricuspid regurgitation treatment and teaches the spacer body being made up of a balloon (12e) and a stent (16a) within the balloon (see pg. 17 lines 15-18) in which the balloon has a non-linear shape (see pg. 7 lines 6-10 and Fig. 18A). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon of Kim-866, as modified by Fischell, to comprise a non-linear shape, as taught by Kim-381, in order to achieve the predictable result of reducing the incomplete closure of the tricuspid valve and reduce its regurgitation (see pg. 15 lines 10-14).
Regarding claim 16, Kim-866, as modified by Fischell, discloses the transcatheter device of claim 12 but fails to disclose wherein the balloon has a length in the range of 4-13 cm.
Kim-381 also discloses a transcatheter device (10) having a spacer body (16) and teaches the spacer body having a length in the range of 4-13 cm (see pg. 7 lines 14-17, spacer body has a length in the range of 20-60 mm which would be 2-6 cm which overlaps the range of 4-13 cm as claimed). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon of Kim-866, as modified by Fischell, to comprise a length in the range of 2-6 cm, as taught by Kim-381, in order to provide a coaptation surface for leaflets of the tricuspid valve (see pg. 7 lines 14-17).
Further 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 length of the balloon of Lee, as modified by Fischell, from between 2-6 cm to between 4-13 cm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim,541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim-866 in view of Fischell, as applied to claim 12 above, and further in view of Gulachenski (US6544217).
Regarding claim 15, Kim-866, as modified by Fischell, discloses the transcatheter device of claim 12 but fails to disclose wherein the distal tail comprises a proximal segment and a distal segment, wherein the distal segment has a thinner diameter than the proximal segment.
Gulachenski discloses a related balloon catheter device comprising a distal tail (see Fig. 1, portion of 26 that is distal to balloon 40). having a proximal segment (see annotated figure below) and a distal segment (see annotated figure below). Gulachenski teaches the distal segment has a thinner diameter than the proximal segment (see Fig. 1 and col 2 lines 66-67 the distal portion 26 of catheter 20 is tapered at the end to facilitate insertion and manipulation in the body of the patient). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tail of Kim-866, as modified by Fischell, to comprise a proximal segment and a distal segment, wherein the distal segment has a thinner diameter than the proximal segment, as taught by Gulachenski, in order to facilitate insertion and manipulation in the body(col 2 lines 66-67).
PNG
media_image1.png
481
399
media_image1.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 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, Melanie Tyson can be reached at 571-272-9062. 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.
/JUSTIN ZHI-DE YAO/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights