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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/18/2025. As directed by the amendment: claim 6 has been amended and claims 15-20 have been withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 6-7, filed 10/18/2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” in further view of Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman” have been fully considered but they are not persuasive.
The applicant argues that Kreidler does not teach a knit fabric. Specifically, they argue the disclosure of PET does not teach a knit fabric. The applicant argues that it is not commonly known to be a knit material in fiber form and that the applicant does not teach that all PET is knit. The examiner respectfully disagrees.
One of ordinary skill in the art recognizes that PET is a knit material in medical devices. Besides the applicant’s specification that specifically discloses in [0131] “In a preferred embodiment the barrier layer 700 is constructed of a knit fabric with very small pore sizes. The pore cross section dimension is preferably in the range of 0.00003 sq.in. to 0.00008 sq.in., e.g., 0.000041 sq.in. The material is PET (Polyethylene terephthalate).” PET is commonly used as an implantable medical textile, as evidenced by Aran Biomedical in “Implantable Grade Polyester Yarn (PET) (https://www.aranbiomedical.com/implantable-grade-polyester-yarn/) published July 9, 2020, as accessed by the Wayback Machine which states “One of the most widely used yarns in the manufacture of implantable medical fabrics, is Polyethylene terephthalate (PET). This is the most common resin of the Polyester family, and the fibre is often known in the medical field as Dacron or Terylene; the trade name given by the larger resin providers.” Dacron is additionally noted in the disclosure of a PET material used in the barrier (see [0218] of Kreidler).
The applicant makes a similar argument that Kauphusman does not teach that the balloon is constructed of a compliant material, stating that a teaching of polyurethane does not teach a compliant material. The examiner respectfully disagrees.
One of ordinary skill in the art would realize that a material to create a balloon would need to be compliant, otherwise the balloon would not be able to be inflated to function as a balloon. Hence disclosure of a polyurethane in the context of a balloon/inflatable device would require the material to have some form of compliance. This is further evidenced in Kauphusman (see [0018]) where an elastomeric material such as silicone is offered as an alternative, elastomeric materials exhibiting elastic, hence flexible and compliant properties.
As such the rejection of claim 1 will be maintained.
Applicant’s arguments, see pages 7-8, filed 10/18/2025, with respect to the rejection(s) of claim(s) 6 under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” in further view of Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman” have been fully considered and are persuasive.
The applicant has amended claim 6 to further recite “wherein the pattern comprises longitudinal struts and longitudinal gaps, and wherein the hypotube… resulting in a larger longitudinal gap between the longitudinal struts in the proximal portion than in the distal portion.”
The examiner agrees that the combination of Kreidler and Kauphusman does not explicitly teach “resulting in a larger longitudinal gap between the longitudinal struts in the proximal portion than in the distal portion”.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kreidler in view of Kauphusman and Clark et al (US 20130138138 A1).
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
6
5
proximal portion
proximal region
6
5-6
distal portion
distal region
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, and 10-14 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 further view of Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman”.
Claim 1
Kreidler discloses: a system 10 + 234 (see Fig. 8, [0132]) for deploying a left atrial appendage occlusion device 10 (see Fig. 8, [0132]) comprising: a delivery catheter 234 (see Fig. 8, [0132]), the delivery catheter 234 comprising: a lumen inflation lumen of 234 (see [0132]); a balloon 230 (see Fig. 8, [0132]) attached to a distal end 232 (see Fig. 8, [0132]) of the delivery catheter 234 and in fluid communication with the lumen inflation lumen of 234 (see [0132], provides communication between an inflation media source outside the patient and the balloon); the balloon 230 having a preformed shape when inflated (see Fig. 8, the balloon having a circular expanded shape); a left atrial appendage occlusion device 10 (see Fig. 8, [0132]) comprising: an endoskeleton 220/228 (see Fig. 8, [0126]-[0128]), the endoskeleton 220/228 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]), wherein the endoskeleton 220 is configured to undergo plastic deformation (see [0216], balloon expandable stents plastically deform, Fig. 8 is a balloon expanded stent) from a first, compact form (see [0216], first, reduced diameter configuration) into a second, expanded form (see [0218] and Fig. 8, enlarged diameter) when the balloon 230 expands; remaining in the second expanded form when the balloon deflates (see [0132], the balloon is deflated and removed, leaving the expanded device in place).
Kreidler (Fig. 8) does not explicitly disclose: a barrier layer comprising a knit fabric.
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: and a barrier layer 15 (see Fig. 10, [0135]) comprising a knit fabric (see [0087] is a membrane that material can be determined by routine experimentation by those of skill in the art, [0097], the barrier layer is a membrane made of polyethylene terephthalate which the applicant discloses as a knit material in their patent application publication [0131]).
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 comprising a knit fabric. 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: a sheath.
However, a variant embodiment of Kreidler (Fig. 20) teaches in the same field of invention a system 304 + 360 + 366 for deploying a left atrial appendage occlusion device 304 (see Fig. 20) with a delivery catheter 360 (see Fig. 20). The variant embodiment (Fig. 20) of Kreidler further teaches: a sheath 366 (see Fig. 20, [0167]).
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 system for deploying a left atrial appendage occlusion device of Kreidler (Fig. 8/10) to incorporate the teachings of a variant embodiment (Fig. 20) of Kreidler and have a system for deploying a left atrial appendage occlusion device with a sheath. Motivation for such can be found in Kreidler as this sheath allows for navigation of the body via transeptal access (see [0064] and [0187]).
Kreidler (Figs. 8), (Fig. 10), and (Fig. 20) 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 2
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. Kreidler further discloses: wherein the flexible material (see [0086]) is a stainless steel (see [0086], stainless steel).
Claim 4
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. Kreidler further discloses: wherein the endoskeleton 228 is a hypotube the tube that forms 228 (see [0034], the frame of the device is formed by cutting slots out of a tube, hence a hypotube).
Claim 5
The combination of Kreidler and Kauphusman teaches: The system of claim 4, see 103 rejection above. Kreidler further discloses: wherein the hypotube (see [0034], cutting slots) has a pattern cut into it (see [0034] and Fig. 8, the slots into the tube is the pattern), the pattern configured to allow the hypotube to expand outward under pressure from the balloon (see Fig. 8, [0132], the balloon can expand 228, which is the hypotube into the expanded configuration, causing 195 to engage surrounding tissue).
Claim 10
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. Kauphusman further teaches: wherein the balloon 106 is constructed of a polyurethane (see [0018], polyurethane).
Claim 11
The combination of Kreidler and Kauphusman teaches: The system of claim 6, see 103 rejection above. Kreidler further discloses: wherein the barbs 195 are located in the distal half the distal half of 228 (see Fig. 8) of the endoskeleton 228.
Claim 12
The combination of Kreidler and Kauphusman teaches: The system of claim 6, see 103 rejection above. Kreidler further discloses: wherein the barbs 195 are configured to open outward (see Fig. 8, the barbs 195 are opened outward to engage tissue, [0132]) when the endoskeleton 228 is in the expanded form (see Fig. 8, the expanded form of 228).
Claim 13
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. Kreidler further discloses: wherein the endoskeleton 228 further comprises a ring 222 (see Fig. 8, [0125], a hub is a form of ring, see also Fig. 7 for a visual example), the ring 222 having a lumen the lumen of the hub that 232 fits into (see Fig. 8) with an inner diameter the inner diameter of 222 (see Fig. 8), the inner diameter the inner diameter of 222 of the ring 222 being slightly larger than the outer diameter of the balloon 230 before inflation (see [0132], the diameter of 222 allows the balloon to deflate and be withdrawn out of 228/10, hence the diameter of the ring 222 is larger than the outer diameter of balloon before inflation, which is equivalent to after deflation).
Claim 14
The combination of Kreidler and Kauphusman teaches: The system of claim 13, see 103 rejection above. Kreidler further discloses: wherein the inner diameter the inner diameter of 222 of the ring 222 is smaller than the outer diameter the outer diameter of 234 (see Fig.8, the outer diameter of 234 is larger than the inner diameter of 222 as can be seen in Fig. 8) of the catheter 234.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” and Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman” as applied to claim 1 above, and further in view of Prabhu (US 20080188924 A1), herein referenced to as “Prabhu”.
Claim 3
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. The combination of Kreidler and Kauphusman does not explicitly teach: wherein the flexible material has 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 comprising a flexible material (see [0022], stainless steel). Prabhu further teaches: wherein the flexible material stainless steel has 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 comprising a flexible material of stainless steel of modified Kreidler to incorporate the teachings of Prabhu and have the endoskeleton wherein the flexible 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(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” and Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman” as applied to claim 5 above, and further in view of Clark et al (US 20130138138 A1), herein referenced to as “Clark”.
Claim 6
The combination of Kreidler and Kauphusman teaches: The system of claim 5, see 103 rejection above. The combination of Kreidler and Kauphusman does not explicitly teach: wherein the pattern comprises longitudinal struts and longitudinal gaps, and wherein the hypotube has a proximal region and a distal region, wherein more material has been removed from the proximal region than has been removed from the distal region, resulting in a larger longitudinal gap between the longitudinal struts in the proximal portion than in the distal portion.
However, Clark in a similar field of invention teaches a left atrial appendage occlusion device (see Figs. 1 and 3-4) with a hypotube 10 (see Figs. 3-4) with a pattern the pattern that forms 10 (see Fig. 3). Clark further teaches: wherein the pattern the pattern that forms 10 (see Fig. 3) comprises longitudinal struts 30 (see Figs. 3-4, [0041]) and longitudinal gaps the gaps between 30 (see Fig. 3, [0074] and [0076], laser cut), and wherein the hypotube 10 has a proximal region 32 (see Figs. 3-4, [0046]) and a distal region 38 (see Figs. 3-4, [0046]), wherein more material has been removed from the proximal region 32 than has been removed from the distal region 38 (see Fig. 3, [0074] and [0076], the gaps between 30 in the region of 32 are larger than in the region of 38, hence more material is removed), resulting in a larger longitudinal gap the gap between 30 in the region 32 is larger than the gaps between 30 in region 38 (see Fig. 3) between the longitudinal struts in the proximal portion 32 than in the distal portion 38.
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 Clark and teach a left atrial appendage occlusion device with the pattern comprises longitudinal struts and longitudinal gaps, and wherein the hypotube has a proximal region and a distal region, wherein more material has been removed from the proximal region than has been removed from the distal region, resulting in a larger longitudinal gap between the longitudinal struts in the proximal portion than in the distal portion. Motivation for such can be found in Clark as this pattern improves circumferential strength without foreshortening or excessive distortion (see [0008]).
Claim 7
The combination of Kreidler, Kauphusman, and Clark teaches: The system of claim 6, see 103 rejection above. Kreidler further discloses: wherein the flexible material (see [0086], stainless steel, which applicant defines as a flexible material, see applicant patent application publication [0012]) is semi-compliant (stainless steel requires a balloon to expand, rather than self-expanding, but can still expand, hence it is semi-compliant).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” and Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman” as applied to claim 1 above, and further in view of Widomski et al (US 20130018414 A1), herein referenced to as “Widomski”.
Claim 8
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. Kreidler further discloses: proximal balloon end 232 (see Fig. 8, [0132]) is attached to the distal end the distal end of 234 (see Fig. 8, [0132]) of the delivery catheter 234 (see Fig. 8, [0132])).
The combination of Kreidler and Kauphusman does not explicitly teach: further comprising a balloon catheter, wherein a distal balloon end is attached to the balloon catheter and where the balloon catheter is configured to move laterally with respect to delivery catheter.
However, Widomski in a similar field of invention teaches a system 600 (see Fig. 14, [0003] and [0151]) for deploying a left atrial appendage occlusion device 700 (see Fig. 14) comprising a balloon 700 (see Fig. 14) and a delivery catheter 626 (see Fig. 14). Widomski further teaches: further comprising a balloon catheter 612 (see Fig. 14, [0151]), wherein a distal balloon end 616 (see Fig. 14, [0153]) is attached to the balloon catheter 612 (see Fig. 14, [0153], 612 extends to a distal end 620 and 620 is connected to 616, the distal end of the balloon).
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 system of modified Kreidler to incorporate the teachings of Widomski and have a system for deploying a left atrial appendage occlusion device further comprising a balloon catheter, wherein a distal balloon end is attached to the balloon catheter. Motivation for such can be found in Widomski as allows the balloon to also deliver a substance for stimulating a tissue growth to the tissue surface of a cardiac opening, removed from the cardiac opening, and withdrawn from the patient (see [0151]).
The language, "where the balloon catheter is configured to move laterally with respect to delivery catheter," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Kreidler and Widomski meets the structural limitations of the claim, and is capable of the balloon catheter to move laterally with respective to the deliver catheter as the balloon catheter is not directly coupled to the delivery catheter (see Fig. 14 of Widomski).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al (US 20040220610 A1), herein referenced to as “Kreidler” and Kauphusman et al (US 20100292687 A1), herein referenced to as “Kauphusman” as applied to claim 1 above, and further in view of Lee (US 20120323270 A1), herein referenced to as “Lee”.
Claim 9
The combination of Kreidler and Kauphusman teaches: The system of claim 1, see 103 rejection above. The combination of Kreidler and Kauphusman does not explicitly disclose: wherein the left atrial appendage occlusion device comprises a central valve.
However, Lee in a similar field of invention teaches a left atrial appendage occlusion device 18 (see Fig. 4) with an endoskeleton 20 (see Fig. 4) and a barrier layer 22 (see Fig. 4). Lee further teaches: wherein the left atrial appendage occlusion device 18 comprises a central valve 24 (see Fig. 4, [0034]).
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 modified Kreidler to incorporate the teachings of Lee and have wherein the left atrial appendage occlusion device comprises a central valve. Motivation for such can be found in Lee as this assists the occlusion device in the sealing of the LAA by providing a back-up seal of the barrier layer (see [0038]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771