DETAILED ACTION
Status of the Application
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 .
Applicant's election with traverse of Group I, claims 1-17 and Species 1(a): the polymer coating is disposed on the membrane, in the reply filed on 22 July 2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious search and/or examination burden if restriction was not required. This is not found persuasive because a serious search/examination burden exists based on the different groupings. As stated in the Restriction Requirement, the product of Group I (no struts, not self-expanding) is structurally different than the product of Group II (plurality of struts, self-expanding) and the product of Group I is not limited to- and can be made by a different process than that required for Group III. The groups would require a separate search based on divergent subject matter and different fields of search, etc. and there is no reasonable expectation that the searches would be coextensive in scope. Furthermore, the species (disclosed in Group I, claims 1-17) are independent or distinct due to the placement of the polymer coating (disposed on the membrane versus on the support structure). Thus, a serious search burden exists. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending in this action. Claims 8-11 and 18-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and non-elected species of invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 22 July 2025.
Claims 1-7 and 12-17 have been examined. Claims 1-7 and 12-17 are rejected.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/28/2022, 11/11/2022, 11/20/2024 and 04/14/2025 have been considered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Interpretation
The following limitations are considered “intended use” limitations:
In claim 1, “for permanent placement across an atrial appendage ostium in a patient”
In claim 1, “a membrane…configured to extend across the ostium of the atrial appendage when the support structure is in the expanded deployed configuration”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan et al. (US 2014/0277074 A1, hereinafter “Kaplan”).
Regarding claims 1-3 and 12-17, Kaplan teaches devices and methods for occluding the left atrial appendage (LAA) to prevent blood from clotting with the LAA and subsequently embolizing, particularly for patients with atrial fibrillation (see Abstract, page 1, [0002, 0008]) (this reads on a device for permanent placement across an appendage ostium in a patient; further this is an intended use limitation as noted above). The device comprises an expandable, open cell foam body having a proximal end, a distal end and a side wall. A skin (reads on membrane as claimed) covers at least the proximal (atrial) end of the body, and an expandable lumen extends through the body. The lumen can support a portion of a delivery catheter and/or a guidewire, but collapses to a near zero cross sectional area when such components are removed. The body is compressible within a delivery catheter having an inside diameter or no more than about 20 F and can self-expand to a diameter of at least about 25 mm when released from the delivery catheter (page 1, [0009]) (corresponds to a device comprising a support structure having a contracted delivery configuration and an expanded deployed configuration defining a radially enlarged portion). In one embodiment, the skin comprises ePTFE (expanded polytetrafluoroethylene). The skin may extend throughout the length of the guidewire lumen, and may cover at least a portion of the distal end and the proximal end of the body. In one embodiment, the skin comprises a tubular ePTFE sleeve, which extends through the guidewire lumen in the open cell foam body and everts back over the outside of the body, for connection to itself to encase the open cell foam body and line the guidewire lumen (this reads on a “membrane attached to the support structure configured to extend across the ostium of the atrial appendage” and reads on “a polymeric coating disposed on at least one of the support structure and the membrane”). Preferably, at least one tissue ingrowth surface is provided on the side wall of the body, such as by providing at least one aperture through the skin to place the open cell foam body in direct contact with the adjacent tissue. The system may additionally comprise a guidewire, having an inflatable balloon thereon. Preferably, at least one tissue ingrowth area is provided on the body, such as by exposing the open cell foam body through at least one window in the skin; the implant can be a metal stent, balloon expandable stent or self-expandable stent (page 1, [0010] – page 2, [0014]; (page 4, [0065]).
The heart 100 is shown in Fig. 1 with left atrial appendage (LAA) 102 which is a cavity emanating from the left atrium (LA) 104. The LAA 102 is quite variable in shape in all dimensions (page 2, [0043-44]). In one embodiment, the occlusion device or plug is placed within the LAA 200 at its opening to the LA 202; the plug comprises an expandable media such as an open cell foam which enables collapse and expansion of the plug and also to enhance ingrowth of tissue into the foam. The foam plug 204 is at least partially encapsulated within a thin strong layer 206 such as ePTFE (expanded polytetrafluoroethylene), polyolefin or polyester. Alternatively, bioabsorbable materials could be used such as PLA, PGA, PCL, PHA or collagen (page 2, [0045-47]). The ePTFE or foam material may include one or two or more radioopaque markers (page 3, [0048]). The outer ePTFE layer may have a wall thickness between about 0.0001” and about 0.001” thick and serves to allow collapse and pull on the plug without tearing the foam material. The ePTFE material also has pores (reads on claim 14 - a film including a plurality of pores) with pore sizes within the range of from about 4µ (microns) to about 110µ (microns) (page 3, [0049]); this pore size reads on claim 15 having a pore size of 20-150µ and anticipates the claimed pore size with sufficient specificity therefor. The outer covering 206 may be constructed of materials other than ePTFE such as woven fabrics, meshes or perforated films made of FEP, polypropylene, polyethylene, polyester or nylon and the plug can be coated with materials to enhance echogenic profile, thromboresistance, promote cellular ingrowth and coverage, etc. The outer covering has holes in it to permit contact of the LAA tissue with the foam plug to encourage ingrowth of tissue into the foam plug pores. The holes may be 1 to 5 mm in diameter, the length of which may be 80% of the length of the foam plug and the width may be 1-5 mm (page 3, [0050-51]). In one embodiment, the implant is provided with proximal and distal end caps of ePTFE, joined together by axially extending strips of ePTFE; the strips being spaced apart to provide laterally facing windows through which the open cell foam body will be in direct contact with the tissue wall of the left atrial appendage. This outer covering could be a mesh or netting as well (page 3, [0052]).
The implant, LAA inclusion device may contain a drug or other bioactive agent, which may be injected via the deployment catheter or impregnated within the open cell foam or coated on the implant. Useful bioactive agents include those that: modulate thrombosis, encourage cellular ingrowth, etc. (page 5, [0076-77, 83]). Anti-thrombotics recited include anticoagulants and anti-platelet agents (reads on DOAC-Direct Oral Anti-Coagulants of claim 1), wherein specific anticoagulants disclosed include rivaroxaban and apixaban (reads on specific DOAC recited in claim 2); antibiotic agents can also be included (see page 5, [0078-80]).
Regarding claim 17, Kaplan discloses various agents that would read on the “modulating compounds”, particularly in the absence of any specific modulating compounds recited in the claim. Thus, Kaplan sufficiently meets this claim limitation.
In sum, Kaplan anticipates a device as presently claimed, based on the teachings and disclosure of Kaplan, as delineated above.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slaughter et al. (US 2015/0250482 A1, hereinafter “Slaughter”).
Regarding claims 1 and 3, Slaughter discloses an atrial appendage closure device and methods for occluding a left atrial appendage (reads on a device for permanent placement across an appendage ostium in a patient; further this is an intended use limitation as noted above). The device includes an insertion rod having a first end and second end. An occluding member having an outer surface and inner surface is connected to the first end of the insertion rod. The occluding member is moveable between a retracted position and a deployed position such that, in the deployed position, the occluding member is configured to provide a seal between a left atrial appendage and a left atrium of a heart (this reads on a support structure having a contracted delivery configuration and an expanded deployed configuration, as claimed); (see Abstract, page 1, [0002-0012], page 2, [0015]). To further facilitate use of the atrial appendix closure device and promote integration of the device into the heart of a subject, the outer surface, the inner surface, or both the outer surface and inner surface of the occluding member are coated with an extracellular matrix (238) and coated with growth factors using methods known to one of ordinary skill in the art. Growth factors include those stimulating cellular growth, proliferation, platelet-derived growth factor and combinations thereof. The extracellular matrix includes polysaccharides and proteins, including heparin sulfate and polysaccharides such as hyaluronic acid, collagen, etc. (reads on polymer coating) (page 2, [0013]); (page 3, [0034-0035].
Slaughter discloses that regardless of the ultimate configuration of the occluding member upon deployment, the occluding member (30) is typically comprised of a flexible material or membrane (38) that is supported by a plurality of ribs (39) and/or a reinforcing mesh to provide a flexible structure that is capable of being moved between a retracted and deployed position (page 3, [0032, Fig. 2B) (this reads on a membrane attached to the support structure and configured to extend across the ostium, as claimed).
In sum, Slaughter anticipates a device as presently claimed, based on the teachings and disclosure of Slaughter, as delineated above.
Claim Rejections - 35 USC § 103
17. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
18. 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.
19. 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.
20. 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.
21. Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (US 2014/0277074 A1, hereinafter “Kaplan”).
22. With respect to the claimed ratio, amounts and coat density of DOAC recited in claims 4-6, while Kaplan does not teach the exact amounts/ranges, ratios or coat density of the DOAC, Kaplan does teach inclusion of the same bioactive agents (anti-thrombotics/anti-coagulants and anti-platelet agents, for example) for the same field of endeavor, the drug provided within/on a device for occluding left atrial appendage and depending upon the desired clinical performance (page 5, [0076-80]). Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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). Therefore, it is the position of the office that the instant invention is rendered prima facie obvious based on the explicit teachings of Kaplan.
23. Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (US 2014/0277074 A1, hereinafter “Kaplan”) in view of Trollsas et al. (US 2008/0200377 A1, hereinafter “Trollsas”).
24. The teachings of Kaplan are discussed above. Kaplan teaches the use of polymers/ polymeric coatings in their device, but does not teach poly(vinylidene fluoride)-co-hexafluoropropylene) (PVDF-HFP) nor the thickness of the polymeric coating (PVDF-HFP).
25. In the same field of endeavor, Trollsas teaches a composition containing polymeric particles in a solution for treating coronary artery diseases and methods for introducing a delivery device into a blood vessel (see page 1, [0008-10]). The device of Trollsas includes stents coated with active agents (page 1, [0014]). Suitable bioabsorbable/biodegradable polymers used in a body stent include fluorinated polymers such as poly(vinylidene fluoride)-co-hexafluoropropylene) (PVDF-HFP) see page 17, [0072-0074, 0078].
26. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include polymers such as the PVDP-HFP taught by Trollsas within the drug delivery device of Kaplan in order to provide for improved and beneficial drug delivery that is enhanced via the use of bioabsorbable or biodegradable polymers beneficial for treating coronary artery disease. While the thickness of the polymer coating is not disclosed in Trollsas, a certain level of thickness of the coating would be present. Moreover, Trollsas specifically teaches use of the same polymer coating applied for the same purpose (to treat coronary disease) and applied to the same types of devices (i.e., stents). Thus, it would be expected and one can reasonably conclude that the same beneficial properties attributed to the polymer coating would be achieved, at various thicknesses, including at the coating thickness levels recited by applicant (of about 10-20 µm).
27. Claim(s) 2, 4-6, 12, 13, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slaughter et al. (US 2015/0250482 A1, hereinafter “Slaughter”) in view of Kaplan et al. (US 2014/0277074 A1, hereinafter “Kaplan”).
28. Regarding claims 2, 4-6, 12, 13 and 16, Slaughter teaches an atrial appendage closure device and methods for occluding a left atrial appendage (reads on a device for permanent placement across an appendage ostium in a patient; further this is an intended use limitation as noted above). The device includes an insertion rod having a first end and second end. An occluding member having an outer surface and inner surface is connected to the first end of the insertion rod. The occluding member is moveable between a retracted position and a deployed position such that, in the deployed position, the occluding member is configured to provide a seal between a left atrial appendage and a left atrium of a heart (this reads on a support structure having a contracted delivery configuration and an expanded deployed configuration, as claimed); (see Abstract, page 1, [0002-0012], page 2, [0015]). To further facilitate use of the atrial appendix closure device and promote integration of the device into the heart of a subject, the outer surface, the inner surface, or both the outer surface and inner surface of the occluding member are coated with an extracellular matrix (238) and coated with growth factors using methods known to one of ordinary skill in the art. Growth factors include those stimulating cellular growth, proliferation, platelet-derived growth factor and combinations thereof. The extracellular matrix includes polysaccharides and proteins, including heparin sulfate and polysaccharides such as hyaluronic acid, collagen, etc. (reads on polymer coating) (page 2, [0013]); (page 3, [0034-0035].
29. Slaughter discloses that regardless of the ultimate configuration of the occluding member upon deployment, the occluding member (30) is typically comprised of a flexible material or membrane (38) that is supported by a plurality of ribs (39) and/or a reinforcing mesh to provide a flexible structure that is capable of being moved between a retracted and deployed position (page 3, [0032, Fig. 2B) (this reads on a membrane attached to the support structure and configured to extend across the ostium, as claimed).
30. While Slaughter teaches the inclusion of growth factors include those stimulating cellular growth, proliferation, platelet-derived growth factor and combinations thereof and extracellular matrix materials including, for example, heparin sulfate (page 3, [0034-0035], Slaughter does not teach the specific Direct Oral Anti-Coagulants (DOAC) recited in instant claim 2.
31. Kaplan teaches devices and methods for occluding the left atrial appendage (LAA) to prevent blood from clotting with the LAA and subsequently embolizing, particularly for patients with atrial fibrillation (see Abstract, page 1, [0002, 0008]). Useful bioactive agents include those that: modulate thrombosis, encourage cellular ingrowth, etc. (page 5, [0076-77, 83]). Anti-thrombotics recited include anticoagulants and anti-platelet agents (reads on DOAC-Direct Oral Anti-Coagulants of claim 1), wherein specific anticoagulants disclosed include rivaroxaban and apixaban (reads on specific DOAC recited in claim 2) (see page 5, [0078-80]).
32. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include the specific anticoagulants (DOAC), such as rivaroxaban and apixaban, as taught by Kaplan within the atrial appendage delivery device of Slaughter who also teaches bioactive agents (growth factors, etc.) in order to provide for enhanced and improved drug delivery to a patient via the use of bioactive agents (i.e., anticoagulants).
33. With respect to the claimed coating ratios, amounts, and coat density of DOAC recited in claims 4-6 and 12, 13 and 16, while Slaughter does not teach the exact amounts/ranges, coating ratios or coat density of the DOAC, Slaughter does teach inclusion of the same bioactive agents (platelet-derived growth factors, and heparin for example) for the same field of endeavor, for an atrial appendage closure device and therefore, beneficial results would be expected (see Abstract, page 1, [0002-0012]). Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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). Therefore, it is the position of the office that the instant invention is rendered prima facie obvious based on the explicit teachings of Slaughter.
34. Regarding claim 17, Slaughter discloses various agents (i.e., platelet-derived growth factors, heparin, etc.) that would read on the “modulating compounds”, particularly in the absence of any specific modulating compounds recited in the claim. Thus, Slaughter sufficiently meets this claim limitation.
35. Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slaughter et al. (US 2015/0250482 A1, hereinafter “Slaughter”) in view of Trollsas et al. (US 2008/0200377 A1, hereinafter “Trollsas”).
36. The teachings of Slaughter are discussed above. Slaughter teaches the inclusion of polymers (i.e., polysaccharides, proteins) in their device, but does not teach poly(vinylidene fluoride)-co-hexafluoropropylene) (PVDF-HFP) nor the thickness of the polymeric coating (PVDF-HFP).
25. In the same field of endeavor, Trollsas teaches a composition containing polymeric particles in a solution for treating coronary artery diseases and methods for introducing a delivery device into a blood vessel (see page 1, [0008-10]). The device of Trollsas includes stents coated with active agents (page 1, [0014]). Suitable bioabsorbable/biodegradable polymers used in a body stent include fluorinated polymers such as poly(vinylidene fluoride)-co-hexafluoropropylene) (PVDF-HFP) see page 17, [0072-0074, 0078].
26. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include polymers such as the PVDP-HFP taught by Trollsas within the drug delivery device of Slaughter in order to provide for improved and beneficial drug delivery that is enhanced via the use of bioabsorbable or biodegradable polymers beneficial for treating coronary artery disease. While the thickness of the polymer coating is not disclosed in Trollsas, a certain level of thickness of the coating would be present. Moreover, Trollsas specifically teaches use of the same polymer coating applied for the same purpose (to treat coronary disease) and applied to the same types of devices (i.e., stents/implants). Thus, it would be expected and one can reasonably conclude that the same beneficial properties attributed to the polymer coating would be achieved, at various thicknesses, including at the coating thickness levels recited by applicant (of about 10-20 µm).
Correspondence
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/HUMERA N. SHEIKH/Supervisory Patent Examiner, Art Unit 1784