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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 5 is objected to because of the following informalities: the Applicant has presented two different claims both numbered as “claim 5.” Proper claim numbering is required. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: in line 1, “where” should read --wherein--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: in line 1, “where” should read --wherein--. Appropriate correction is required.
Claim 15 objected to because of the following informalities:
in line 13, “barbs” should read --barbs;--
in line 14, “proximally” should read --proximally; and--
Appropriate correction is required.
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 4-6, 9, 10, and 15 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 4 recites the limitation "the connector" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
The first of the two claims labeled as claim 5 is dependent on rejected claim 4, thus is also rendered indefinite. Appropriate correction is required.
Claims 6, 9, and 10 are dependent on claim 5. The Applicant has presented two claims labeled as claim 5. It is unclear which claim 5 that claims 6, 9, and 10 are dependent on. Appropriate correction is required.
Claim 15 recites the limitation "the LAA" in lines 12-15. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 15 recites the limitation "the ostium" in line 15. There is insufficient antecedent basis for this limitation in the claim. 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz (US 2011/0082495 A1) in view of Cully et al. (US 2014/0046347 A1) (“Cully”).
Regarding claim 1, Ruiz discloses (Figures 3-5C) a system for deploying a left atrial appendage exclusion device (45), comprising: a delivery catheter (100), the delivery catheter comprising: a lumen (101); an invagination catheter (80), the invagination catheter comprising: arms (52; Figure 3), the arms configured to engage the left atrial appendage (Figure 5C; paragraph 0037); the invagination catheter inside the lumen (101) of the delivery catheter (Figures 4A-5C), and movable relative to the delivery catheter (paragraph 0044); a disk assembly (60) comprising: a fabric material (63, paragraph 0038); a frame (62) attached to the fabric material (paragraph 0038); a disk catheter (90), the disk catheter removably attached to the frame (Figure 4C).
Ruiz fails to disclose the arms having barbs for piercing the left atrial appendage.
In the same field of endeavor, Cully teaches (Figures 2A-4B, 11A-11C) a system for deploying a left atrial appendage exclusion device comprising arms (212) having barbs (219) for piercing the left atrial appendage (paragraphs 0035-0037).
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 arms disclosed by Ruiz to have barbs for piercing the left atrial appendage, as taught by Cully. This modification would provide tissue penetration to secure the arms to the anatomy of the patient (Cully, paragraphs 0035-0037).
Regarding claim 2, Ruiz as modified by Cully teaches (Ruiz, Figures 3-5C) a hub (51), the hub configured to connect the arms (52) to the delivery catheter (80).
Regarding claim 3, Ruiz as modified by Cully teaches (Ruiz, Figures 4B, 4C, 5C) a connector (56), the connector configured to attach the disk assembly (60) to the hub (51).
Regarding claim 4, Ruiz as modified by Cully teaches (Ruiz, Figures 3-5C) the connector (56) is a tube, the tube having a lip (55) that frictionally mates with a cutout (66) on the disk assembly (60).
ALTERNATE EMBODIMENT OF RUIZ
Regarding claim 1, Ruiz discloses (Figures 6-8) a system for deploying a left atrial appendage exclusion device (45’), comprising: a delivery catheter (100’), the delivery catheter comprising: a lumen (101’); an invagination catheter (90’), the invagination catheter comprising: arms (62’; Figure 6), the arms configured to engage the left atrial appendage (Figure 8; paragraph 0037); the invagination catheter inside the lumen (101’) of the delivery catheter (Figures 7A-8), and movable relative to the delivery catheter (paragraph 0060); a disk assembly (50’) comprising: a fabric material (53’, paragraph 0038); a frame (62) attached to the fabric material (paragraph 0054); a disk catheter (80’), the disk catheter removably attached to the frame (Figure 7C).
Ruiz fails to disclose the arms having barbs for piercing the left atrial appendage.
In the same field of endeavor, Cully teaches (Figures 2A-4B, 11A-11C) a system for deploying a left atrial appendage exclusion device comprising arms (212) having barbs (219) for piercing the left atrial appendage (paragraphs 0035-0037).
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 arms disclosed by Ruiz to have barbs for piercing the left atrial appendage, as taught by Cully. This modification would provide tissue penetration to secure the arms to the anatomy of the patient (Cully, paragraphs 0035-0037).
Regarding claim 2, Ruiz as modified by Cully teaches (Ruiz, Figures 6-8) a hub (61’), the hub configured to connect the arms (62’) to the delivery catheter (90’ paragraph 0059).
Regarding claim 3, Ruiz as modified by Cully teaches (Ruiz, Figures 6-8) a connector (64’), the connector configured to attach the disk assembly (50’) to the hub (61’).
Regarding claim 4, Ruiz as modified by Cully teaches (Ruiz, Figures 6-8) the connector (64’) is a tube, the tube having a lip (66’) that frictionally mates with a cutout (55’) on the disk assembly (50’).
Regarding claim 5, Ruiz as modified by Cully teaches (Ruiz, Figures 7A-8) a threaded portion (58’) on the disk assembly (50’) and a threaded portion (82’) on the disk catheter (80’), the threaded portion on the disk catheter removably connected to the threaded portion on the disk assembly (Figures 7A-8).
Claims 1, 5, 6, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (US 2013/0006343 A1) in view of Lee (US 2007/0083232 A1).
Regarding claims 1, 11, and 13, Kassab discloses (Figures 1A-4B) a system for deploying a left atrial appendage exclusion device, comprising: a delivery catheter (200), the delivery catheter comprising: a lumen; an invagination catheter (106) configured to engage the left atrial appendage (Figures 1B, 2A, 3A); the invagination catheter inside the lumen of the delivery catheter (Figure 1B), and movable relative to the delivery catheter (paragraphs 0039, 0041, 0048); a disk assembly (204) comprising: a fabric material (paragraph 0041); a frame (202, 300) attached to the fabric material (paragraph 0041); a disk catheter (102), the disk catheter removably attached to the frame (paragraphs 0038-0044).
Kassab fails to disclose the invagination catheter is a suture having arms with barbs for piercing the left atrial appendage. Kassab fails to disclose the suture is comprised of a bioabsorbable material. Kassab discloses that the invagination catheter is a vacuum tube that adheres to the LAA apex. However, Kassab discloses other capture implements, such as barbs, jaw-like devices, and the like, can also be used (paragraph 0015).
In the same field of endeavor, Lee teaches (Figures 1-11 and 16a-16d) a delivery catheter (120), the delivery catheter comprising a lumen; and an invagination catheter, wherein the invagination catheter is a suture (100) comprising arms (70), the arms having barbs (75) for piercing the left atrial appendage; the invagination catheter inside the lumen of the delivery catheter (Figures 16a-16d), and movable relative to the delivery catheter. Lee teaches piercing the LAA with the barbs to engage the LAA (Figures 16a-16d). Lee teaches that the suture (100) is comprised of a bioabsorbable material (paragraph 0042).
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 invagination catheter disclosed by Kassab to be a suture having arms with barbs for piercing the left atrial appendage, wherein the suture is comprised of a bioabsorbable material, as taught by Lee. Kassab discloses that barbs can be used to adhere to the LAA apex (paragraph 0015). Lee teaches that arms with barbs are effective at grasping or hooking tissue (Lee, paragraph 0044).
Regarding claims 5 and 6, Kassab as modified by Lee teaches the arms and barbs are comprised of a bioabsorbable material (Lee, paragraph 0045).
Regarding claim 15, Kassab discloses (Figures 1A-4B) a method of invaginating a left atrial appendage (130), the method comprising providing a delivery catheter (200, the delivery catheter comprising: a lumen; an invagination catheter (106), the invagination catheter inside the lumen of the delivery catheter (Figure 1), and movable relative to the delivery catheter (paragraph 0015); a disk assembly (204) comprising: a fabric material (paragraph 0041); a frame (202, 300), attached to the fabric material (paragraph 0041); a disk catheter (102), the disk catheter removably attached to the frame (paragraph 0042); inserting the invagination catheter into the LAA (Figures 1B, 2A); engaging the LAA with the invagination catheter (paragraph 0040); invaginating the LAA by partially removing the invagination catheter proximally (Figure 4B; paragraph 0044); and covering the ostium (132) of the LAA with the disk assembly (paragraph 0041).
Kassab fails to disclose the invagination catheter comprising: arms, the arms having barbs for piercing the left atrial appendage and piercing the LAA with the barbs to engage the LAA. Kassab discloses that the invagination catheter is a vacuum tube that adheres to the LAA apex. However, Kassab discloses other capture implements, such as barbs, jaw-like devices, and the like, can also be used (paragraph 0015).
In the same field of endeavor, Lee teaches (Figures 1-11 and 16a-16d) a catheter comprising arms (70), the arms having barbs (75) for piercing the left atrial appendage. Lee teaches piercing the LAA with the barbs to engage the LAA (Figures 16a-16d).
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 invagination catheter disclosed by Kassab to include arms with barbs that pierce the LAA to engage to adhere to the LAA. Kassab discloses that barbs can be used to adhere to the LAA apex (paragraph 0015). Lee teaches that arms with barbs are effective at grasping or hooking tissue (Lee, paragraph 0044).
Claims 7, 8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz (US 2011/0082495 A1) in view of Cully et al. (US 2014/0046347 A1) (“Cully”) as applied to claim 1 above, and further in view of Solymar et al. (US 2003/0149463 A1) (“Solymar”).
Regarding claims 7 and 8, Ruiz as modified by Cully teaches the invention substantially as claimed (see rejection of claim 1 on page 4 above). However, the combined teaching fails to teach that the fabric material and the frame are comprised of a bioabsorbable material.
Solymar teaches an analogous exclusion device (Figures 11-16) comprising a fabric material (214) that is comprised of a bioabsorbable material (paragraph 0049). Solymar teaches a frame (202) that is also comprised of a bioabsorbable material (paragraph 0042). Solymar teaches that the exclusion device may be entirely bioabsorbable (paragraphs 0002, 0009).
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 fabric material and the frame material of the exclusion device taught by Ruiz in view of Cully to be comprised of a bioabsorbable material, as taught by Solymar, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, this modification would provide an exclusion device that is entirely bioabsorbable (Solymar, paragraphs 0002, 0009).
Regarding claim 14, Ruiz as modified by Cully and Solymar teaches the invention substantially as claimed. However, the combined teaching fails to teach that the frame is between 20 and 25 mm in diameter.
In an alternate embodiment, Ruiz teaches (Figures 11A-13) a disk assembly (200) comprising a frame (202), wherein the frame is between 24-32 mm in diameter in order to allow the disk assembly to overlap the endocardial tissue surrounding the ostium of the LAA (paragraph 0082).
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 diameter of the frame taught by Ruiz in view of Cully and Solymar above to be between 20 and 25 mm in diameter, as taught in the alternate embodiment of Ruiz, 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). Further, Applicant appears to have placed no criticality on the claimed range, indicating only that “in some embodiments the frame is between 20 and 25mm in diameter” (see paragraph 0016 of the Specification). Further, this modification would allow the disk assembly to overlap the endocardial tissue surrounding the ostium of the LAA (Ruiz, paragraph 0082).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (US 2013/0006343 A1) in view of Lee (US 2007/0083232 A1) as applied to claim 5 above, and further in view of Willard et al. (US 2018/0368857 A1) (“Willard”).
Regarding claim 9, Kassab in view of Lee teaches the invention substantially as claimed. The combined teaching fails to teach that the bioabsorbable material is a PLLA material. However, Lee teaches that bioabsorbable materials are well-known in the art and can be readily selected by a skilled artisan.
Willard teaches that a PLLA material is a bioabsorbable material (paragraph 0184).
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 bioabsorbable material taught by Kassab in view of Lee above to be a PLLA material, as taught by Willard, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 10, Kassab in view of Lee teaches the invention substantially as claimed. The combined teaching fails to teach that the bioabsorbable material is a PLGA material. However, Lee teaches that bioabsorbable materials are well-known in the art and can be readily selected by a skilled artisan.
Willard teaches that a PLGA material is a bioabsorbable material (paragraph 0184).
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 bioabsorbable material taught by Kassab in view of Lee above to be a PLGA material, as taught by Willard, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kassab (US 2013/0006343 A1) in view of Lee (US 2007/0083232 A1) as applied to claim 11 above, and further in view of Sauer, MD (US 2021/0085330).
Regarding claim 12, Kassab as modified by Lee teaches the invention substantially as claimed. The combined teaching fails to teach that the suture is braided. However, Lee teaches that the suture is a standard surgical suture (paragraph 0042, claim 37).
Sauer, MD teaches that it was known in the art before the effective filing date of the claimed invention that the term “suture” covers any thread, cable, wire, filament, strand, line, yarn, gut, or similar structure, whether natural and/or synthetic, in monofilament, composite filament, or multifilament form (whether braided, woven, twisted, or otherwise held together), as well as equivalents, substitutions, combinations, and pluralities thereof for such materials and structures (paragraph 0028).
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 suture taught by Kassab in view of Lee to be braided, as taught by Sauer, MD. Kassab as modified by Lee teaches that the suture is a standard surgical suture. Sauer, MD teaches that it was well known in the art before the effective filing date of the claimed invention for a standard surgical suture to be braided (paragraph 0028). Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771