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 invention II, the method for occluding a left atrial appendage in the reply filed on 03/16/2026 is acknowledged.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2026.
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 12-17 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 12 recites the limitation “a left atrial appendage occlusion device comprising” in line 8. It is not clear if this is the same left atrial appendage occlusion device recited in line 2, or a different. For the purpose of prior art examination “a left atrial appendage occlusion device comprising” in line 8 will be interpreted as “the left atrial appendage occlusion device further comprising”. Appropriate correction is required.
Claim 13 recites the limitation “wherein the endoskeleton further comprises barbs” in line 1. It is not clear if these are the same as “barbs” in claim 12, line 10, or different ones. For the purpose of prior art examination “wherein the endoskeleton further comprises barbs” will be interpreted as the same barbs from claim 12. Appropriate correction is required.
Claim 15 recites the limitation "the hypotube" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is not clear if this refers to the “endoskeleton” or another element. For the purpose of prior art examination this limitation will be interpreted as “the endoskeleton”. Appropriate correction is required.
Claims 14 and 16-17 are rejected as being dependent on claim 12.
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) 12-13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” in view of Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman”.
Claim 12
Kreidler discloses: A method of occluding a left atrial appendage ("LAA) (see Fig. 8, [0132], [0024], left atrial appendage implant), comprising: delivering a system 10 + 234 (see Fig. 8, [0132]) for deploying a left atrial appendage occlusion device 10 (see Fig. 8, [0132]) to the left atrial appendage (see [0024]), the system 10 + 234 comprising: a delivery catheter 234 (see Fig. 8, [0132]), the delivery catheter 234 comprising: a balloon 230 (see Fig. 8, [0132]) attached to a distal end 232 (see Fig. 8, [0132]) of the delivery catheter 234; the balloon 230 having a preformed shape (see Fig. 8, the shape of 230 when inflated, the balloon having a circular expanded shape) when inflated; a left atrial appendage occlusion device 10 (see 112b rejection above, interpreted as “the left atrial appendage occlusion device) comprising: an endoskeleton 220/228 (see Fig. 8, [0126]-[0128]), the endoskeleton constructed of a flexible material (see [0086], stainless steel, which applicant defines as a flexible material, see applicant patent application publication [0012]) and comprising barbs 195 (see Fig. 8, [0129]); inflating the balloon 230 from a deflated form to the preformed shape (see Fig. 8 [0132], positioned within 10 and inflated); expanding the endoskeleton 220/228 (see [0216], balloon expandable stents plastically deform, Fig. 8 is a balloon expanded stent) with the inflated balloon 230; plastically deforming (see [0216], balloon expandable stents plastically deform, Fig. 8 is a balloon expanded stent) the endoskeleton 220/228 from a first, compressed form (see [0216], delivered in the first, reduced diameter configuration) to a second, expanded form (see [0216], plastically deform to a larger diameter during expansion); deflating the balloon (see [0132], the balloon is deflated and removed, leaving the expanded device in place); removing the balloon 230 and the delivery catheter 234 (see [0132], the balloon is deflated and removed, leaving the expanded device in place); wherein the endoskeleton 220/228 is configured to remain in the second, expanded form (see [0132] and [0216], the balloon is deflated and removed, leaving the expanded device in place).
Kreidler does not explicitly disclose: a barrier layer; wherein the balloon is constructed of a compliant material.
However, a variant embodiment (Fig. 10) of Kreidler teaches in the same field of invention a left atrial occlusion device 10 (see Fig. 10) with an endoskeleton 228. The variant embodiment (Fig. 10) of Kreidler further teaches: a barrier layer 15 (see Fig. 10, [0135]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the left atrial appendage occlusion device of Kreidler (Fig. 8) to incorporate the teachings of a variant embodiment of Kreidler (Fig. 10) and have a left atrial appendage occlusion device with a barrier layer. Motivation for such can be found in Kreidler as the barrier can facilitate cellular ingrowth (see [0087]).
Kreidler (Figs. 8) and (Fig. 10) does not explicitly teach: wherein the balloon is constructed of a compliant material.
However, Kauphusman in a similar field of invention teaches an occlusive medical device (see Fig. 1) with a balloon 106 (see Fig. 1). Kauphusman further teaches: wherein the balloon 106 is constructed of a compliant material (see [0018], the balloon is made of polyurethane, which the applicant defines as compliant material, see applicant’s patent application publication [0141])
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon of Kreidler to incorporate the teachings of Kauphusman and have a balloon for a medical device constructed of a compliant material. This is due to the use of compliant materials such as polyurethane for balloons (see [0018] of Kauphusman) are common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 13
The combination of Kreidler and Kauphusman teaches: The method of claim 12, see 103 rejection above. Kreidler further discloses: wherein the endoskeleton 220/228 further comprises barbs 195, and further comprising the step of pushing the barbs 195 into the left atrial appendage (see [0132], inflating the balloon, thereby engaging barbs with the surrounding tissue, the surrounding tissue being the tissue of the LAA).
Claim 16
The combination of Kreidler and Kauphusman teaches: The method of claim 12, see 103 rejection above. Kreidler does not explicitly disclose: further comprising the step of injecting contrast media to identify the presence of blood flow between the left atrium and the left atrial appendage.
However, a variant embodiment (see Figs. 29A-38C) of Kreidler a method of occluding a left atrial appendage (see Figs. 29A-38C, [0169]) with a delivery system 500 (see Figs. 29A-38C, [0169]). Kreidler (Figs. 29A-38C) further teaches: further comprising the step of injecting contrast media (see [0169], contrast injection proximally and distally of the implant) to identify the presence of blood flow between the left atrium and the left atrial appendage (see [0169], facilitate in-vivo assessment of the positioning and seal quality of the implant 304 of the LAA, seal quality determines the presence of blood flow between the left atrium and the left atrial appendage, as good seal quality means no blood would flow between the two as the implant occludes the LAA).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kreidler to incorporate the teachings of a variant (Figs. 29A-38C) embodiment of Kreidler and teach a method of occluding a left atrial appendage with the step of injecting contrast media to identify the presence of blood flow between the left atrium and the left atrial appendage. Motivation for such can be found in Kreidler as this allows in-vivo assessment of the positioning and seal quality of the implant (see [0169]).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler and Kauphusman as applied to claim 12 above, and further in view of Prabhu (US 20080188924 A1), herein referenced to as “Prabhu”.
Claim 14
The combination of Kreidler and Kauphusman teaches: The method of claim 12, see 103 rejection above. The combination of Kreidler and Kauphusman does not explicitly teach: wherein the endoskeleton is comprised of a material with an elastic modulus between 100-310 GPA.
However, Prabhu in a similar field of invention teaches an endoskeleton 10 (see Figs. 1-4) that is expandable via a balloon 22 (see Figs. 2-3, [0049]), the endoskeleton 10. Prabhu further teaches: wherein the endoskeleton 10 is comprised of a material stainless steel (see [0022], stainless steel) with an elastic modulus between 100-310 GPA (see [0055], stainless steel has a module of elasticity (E) of 200 GPa which is in between 100 and 310).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoskeleton with a material of stainless steel of modified Kreidler to incorporate the teachings of Prabhu and have the endoskeleton wherein the material has an elastic modulus between 100-310 GPA. Motivation for such can be found in Prabhu, as a GPA between 100 and 310, namely 200, is typical in the field of art for stainless steel for expandable endoskeletons/stents (see [0055]), giving sufficient rigidity to require balloon expansion.
Claim 15
The combination of Kreidler, Kauphusman, and Prabhu teaches: The method of claim 14, see 103 rejection above. Kreidler further discloses: wherein the hypotube 220/228 (see 112b rejection above, interpreted as “the endoskeleton”) has a pattern cut into it the pattern of 220/228 (see [0124], cut from a tube stock), the pattern the pattern of 220/228 configured to allow the hypotube to expand outward under pressure from the balloon (see [0216], plastically deform to a larger diameter during expansion).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler and Kauphusman as applied to claim 12 above, and further in view of Kassab et al (US 20190133528 A1), herein referenced to as “Kassab”.
The combination of Kreidler and Kauphusman teaches: The method of claim 12, see 103 rejection above. The combination of Kreidler and Kauphusman does not explicitly teach: further comprising the steps of inserting a sizing balloon into the left atrial appendage; inflating the sizing balloon with a known amount of inflation media; deflating the sizing balloon; removing the sizing balloon; using the known amount of inflation media to calculate the size of the left atrial appendage.
However, Kassab in a similar field of invention teaches a method of occluding a left atrial appendage (see Figs. 16-19, [0209]) with a left atrial appendage occlusion device 152 (see Fig. 19). Kassab further teaches: further comprising the steps of inserting a sizing balloon 30 (Fig. 17, [0207]-[0208], inserting 30 into 151, the LAA) into the left atrial appendage; inflating the sizing balloon 30 with a known amount of inflation media (see [0208], inflation of balloon 30, various conductance measurements (used to determine a luminal organ parameter, see also [0146], volume of 5 ml, displace local vascular blood volume momentarily, but is predefined based on luminal organ); deflating the sizing balloon (see [0034], deflating the balloon); removing the sizing balloon (see Fig. 19, [0209], after sizing balloon is used to determine sizing, it is removed, no longer in Fig. 19, and then the occluder 152 can be positioned in the LAA to occlude the LAA); using the known amount of inflation media (see [0146]) to calculate the size of the left atrial appendage (see [0207]-[0208], obtaining a size parameter of the LAA).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kreidler to incorporate the teachings of Kassab and teach a method of occluding a left atrial appendage with the steps of inserting a sizing balloon into the left atrial appendage; inflating the sizing balloon with a known amount of inflation media; deflating the sizing balloon; removing the sizing balloon; using the known amount of inflation media to calculate the size of the left atrial appendage. Motivation for such can be found in Kassab as this allows for placement of an appropriately-sized occluder so that the left atrial appendage itself can be effectively occluded without exerting unnecessary force against said opening or aperture of atrial appendage or said atrial appendage itself, which could potentially cause rupture of the atrial appendage (see [0209]).
Conclusion
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771