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 10/30/2025. As directed by the amendment: claims 10-20 have been canceled, and new claims 21-31 have been added. Thus, claims 1-9, 21-31 are presently pending in the application.
Response to Arguments
Applicant's arguments filed page 9 of the remarks filed on 10/30/2025 have been fully considered are persuasive. Applicant argues the prior art Pelled discloses polymeric layers 84 and 86 formed by electrospining process, but does not disclose the electrospun polymers may comprise silk. Although the examiner agrees with the argument, Pelled discloses in an alternative embodment, see in Figures 21-24, sealing member 300 may be made from any various fabrics including natural fibers such as silk.
Allowable Subject Matter
Claims 4 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to teach nor render obvious wherein the plurality of undulations are present in the collapsed configuration, and wherein the plurality of undulations are configured to straighten when the implantable prosthetic valve is in the expanded configuration and wherein at least a portion of the inner skirt further comprises a first perforated material having a first surface facing the annular frame and an opposite second surface and wherein the first material is disposed on the first surface and/or the second surface of the first perforated material; and/or wherein at least a portion of the outer skirt further comprises a second perforated material having a first surface facing the annular frame and an opposite second surface and wherein the second material is disposed on the first surface and/or the second surface of the second perforated material; and/or wherein at least a portion of the leaflet structure comprises a third perforated material having a first surface facing the annular frame and an opposite second surface and wherein the third material is disposed on the first surface and/or the second surface of the third perforated material; and/or wherein the first, second, and/or third perforated material comprises a porous fabric or membrane, wherein the porous fabric or membrane comprises one or more biocompatible polymers that are resorbable, non-resorbable or a combination thereof.
Claim 31 is allowed. The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach wherein each fiber of the plurality of fibers has a first extending direction and a plurality of undulations; and wherein the implantable prosthetic valve is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration; and wherein the plurality of undulations are present in the collapsed configuration, and wherein the plurality of undulations are configured to straighten when the implantable prosthetic valve is in the expanded configuration.
Claim Rejections - 35 USC § 103
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.
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) 1-2, 5-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelled et al. U.S. Publication 2016/0317305 A1.
Regarding Claim 1, Pelled et al. discloses an implantable prosthetic valve comprising: an annular frame 310 having an inner surface and an outer surface (Figure 23-24), wherein the frame has an inflow end and an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end; a leaflet structure 14 positioned within the frame (as seen in Figures 1-3 and paragraphs [0021-0022]); an inner skirt 302 positioned along the inner surface of the frame 12; at least one outer skirt 306 positioned around the outer surface of the frame 12; wherein at least a portion of one of the leaflet structure, the inner skirt, or the at least one outer skirt comprises a material comprising a plurality of fibers (paragraph [0065], [0069]) and wherein the implantable prosthetic valve is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (abstract and paragraphs [0023], [0029] and [0057]). However, in the embodiment used in the rejection above, Figures 21-24 does not expressly disclose wherein at least one fiber of the plurality of fibers comprises electrospun silk. However, in an alternative embodiment, Figures 18-19f, Pelled et al. teaches a sealing member 16 formed from also laminated/encapsulated between one or more layers or filaments of ePTFE and fabric (paragraphs [0035-0036]), wherein the laminate sealing member is formed from a plurality of polymer fibers that is formed using an electrospining process ([0041], [0047] and [0069]) for the purpose of encapsulating the frame with the polymer sealing material using an electrical charge to drawn very fine fibers from a liquid to encapsulating the fibers to the frame (paragraph [0047]). 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 skirt of Pelled to further include at least one fiber formed from electrospining as taught in Figures 18-20 for the purpose of encapsulating the frame with the polymer sealing material using an electrical charge to drawn very fine fibers from a liquid to encapsulating the fibers to the frame.
Regarding Claim 2, Pelled et al. discloses wherein at least a portion of the inner skirt comprises the material comprising the plurality of fibers (paragraphs [0041], [0047], [0069]), and wherein the material present in the at least a portion of the inner skirt is a first material (formed of two different tubes of polymer, see paragraph [0041]), wherein the first material has a first surface facing the annular frame and an opposite second surface (as seen in Figure 18); and/or wherein at least a portion of the outer skirt comprises the material comprising the plurality of fibers, and wherein the material present in the at least a portion of the outer skirt is a second material (formed of two different tubes of polymer, see paragraph [0041]), wherein the second material has a first surface facing the annular frame and an opposite second surface (as seen in Figure 18); and/or wherein at least a portion of the leaflet structure comprises the material comprising the plurality of fibers, and wherein the material present in the at least a portion of the leaflet structure is a third material (paragraph [0022], pericardial tissue), wherein the third material has a first surface facing the annular frame and an opposite second surface (as seen in Figure 2).
Regarding Claim 5, Pelled et al. discloses wherein at least a portion of the inner skirt is attached to the annular frame by direct electrospinning of the plurality of fibers on at least a portion of the inner surface of the annular frame (paragraphs [0041-0042]); and/or wherein at least a portion of the outer skirt is attached to at least a portion of the annular frame by direct electrospinning of the plurality of fibers on at least a portion of the outer surface of the annular frame (paragraphs [0041-0042]).
Regarding Claim 6, Pelled et al. discloses wherein the plurality of fibers further comprise thermoplastic polyurethane (TPU), polyurethane (PU), implantable elastane polymer, polyester (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluorethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), Polyvinylidene fluoride (PVDF), Polyamides (Nylons), polypropylene, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(ester urethane)urea, polylactic acid (PLA), polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA) or any combination thereof (paragraph [0041]).
Regarding Claim 7, Pelled et al. discloses wherein the plurality of fibers comprises a biocompatible fiber (paragraph [0041]).
Regarding Claim 9, Pelled et al. discloses sealing member 300 having an inner skirt 302 and outer skirt 306 can be laminated with or encapsulated between one or more films of ePTFE (paragraph [0071]). However, in the embodiment used in the rejection above, Figures 21-24 does not expressly disclose wherein at least a portion of the first surface of the first material comprises a first auxiliary layer, and/or wherein the first, second, and/or third auxiliary layer comprises one or more thermoplastic polyurethane (TPU), polyurethane (PU); implantable elastane polymer, or polyethylene, polypropylene, polymethylmethacrylate (PMMA), polystyrene (PS), polytetrafluoroethylene (PTFE), polyamide, polyethylene terephthalate (PET), polyethersulfone, poly-lactic-co-glycolic acid (PLGA). In an alternative embodiment as seen in Figures 18-20, Pelled et al. teaches wherein at least a portion of the first surface of the first material comprises a first auxiliary layer 18 (a reinforcing layer, paragraphs [0035-0036] and as seen in Figures 17-19C), and/or wherein the first, second, and/or third auxiliary layer comprises one or more thermoplastic polyurethane (TPU), polyurethane (PU); implantable elastane polymer, or polyethylene, polypropylene, polymethylmethacrylate (PMMA), polystyrene (PS), polytetrafluoroethylene (PTFE), polyamide, polyethylene terephthalate (PET), polyethersulfone, poly-lactic-co-glycolic acid (PLGA) (see paragraph [0038]) for the purpose of encapsulating portion of the frame with a plurality of layers that strengthen the sealing member 16 and resist tearing and prevent paravalvular leakage (paragraph [0039]). 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 skirt of Pelled to further include at least a portion of the first surface of the first material comprises a first auxiliary layer formed from one or more thermoplastic polyurethane (TPU), polyurethane (PU); implantable elastane polymer, or polyethylene, polypropylene, polymethylmethacrylate (PMMA), polystyrene (PS), polytetrafluoroethylene (PTFE), polyamide, polyethylene terephthalate (PET), polyethersulfone, poly-lactic-co-glycolic acid (PLGA) as taught in Figures 18-20 for the purpose of encapsulating portion of the frame with a plurality of layers that strengthen the sealing member and resist tearing and prevent paravalvular leakage.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelled et al. U.S. Publication 2016/0317305 A1 in view of Levi et al. U.S. Publication 2019/0046314 A1.
Regarding Claim 3, Pelled et al. does not expressly disclose wherein each fiber of the plurality of fibers has a first extending direction and a plurality of undulations. Levi et al. teaches an implantable prosthetic valve 200 as seen in Figures 9 and 20 in the same field of endeavor comprising an annular frame 202 and a leaflet structure 14 positioned within the frame 202 (as seen in Figures 1-3 and paragraphs [0021-0022] and [0089]); an inner skirt 211 positioned along the inner surface of the frame 202 (paragraph [0090]); at least one outer skirt 212 positioned around the outer surface of the frame 202 (paragraph [0090]); wherein at least a portion of one of the leaflet structure, the inner skirt, or the at least one outer skirt comprises a material comprising a plurality of fibers (as seen in Figures 9-12B and 20), wherein at least one fiber of the plurality of fibers comprises electrospun silk (paragraph [0081]), wherein each fiber of the plurality of fibers has a first extending direction and a plurality of undulations (as seen in Figure 11, paragraphs [0090-0092]), for the purpose of having a skirt that is configured to promote sealing by obstructing blood flow past the skirt and increasing the dwell time of blood in the vicinity of the filaments (paragraph [0090]). 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 skirt of Pelled to further include a plurality of fibers that has a first extending direction and a plurality of undulations as taught by Levi et al. for the purpose of having a skirt that is configured to promote sealing by obstructing blood flow past the skirt and increasing the dwell time of blood in the vicinity of the filaments.
Claim(s) 21 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. U.S. Publication 2019/0046314 A1 in view of Chadha et al. U.S. Publication 2017/0172736 A1.
Regarding Claim 21, Pelled et al. discloses an implantable prosthetic valve comprising: an annular frame 310 having an inner surface and an outer surface (Figure 23-24), wherein the frame has an inflow end and an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end; a leaflet structure 14 positioned within the frame (as seen in Figures 1-3 and paragraphs [0021-0022]); an inner skirt 302 positioned along the inner surface of the frame 12; at least one outer skirt 306 positioned around the outer surface of the frame 12; wherein at least a portion of one of the leaflet structure, the inner skirt, or the at least one outer skirt comprises a material comprising a plurality of fibers (paragraph [0065], [0069]) and wherein the implantable prosthetic valve is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (abstract and paragraphs [0023], [0029] and [0057]). However, in the embodiment used in the rejection above, Figures 21-24 does not expressly disclose wherein at least one fiber of the plurality of fibers comprises electrospun silk. However, in an alternative embodiment, Figures 18-19f, Pelled et al. teaches a sealing member 16 formed from also laminated/encapsulated between one or more layers or filaments of ePTFE and fabric (paragraphs [0035-0036]), wherein the laminate sealing member is formed from a plurality of polymer fibers that is formed using an electrospining process ([0041], [0047] and [0069]) for the purpose of encapsulating the frame with the polymer sealing material using an electrical charge to drawn very fine fibers from a liquid to encapsulating the fibers to the frame (paragraph [0047]). 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 skirt of Pelled to further include at least one fiber formed from electrospining as taught in Figures 18-20 for the purpose of encapsulating the frame with the polymer sealing material using an electrical charge to drawn very fine fibers from a liquid to encapsulating the fibers to the frame. However, Pelled et al. does not expressly disclose wherein the plurality of fibers have an average diameter from about 3 nm to 15,000 nm. Chadha et al. teaches an implantable heart valve (paragraph [0002], [0004]) in the same field of endeavor comprising a fabric forming an inner and outer fabric skirt, the fabric formed from a plurality of fibers formed from natural fibers such as silk (paragraph [0040]) and having an average diameter of about 10 microns to about 70 microns (paragraphs [0014], [0046]) for the purpose of altering the thickness of the fabric based on the size of the diameter (paragraph [0045]). 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 skirt of Pelled to further include a plurality of fibers having an average diameter of at least 10 microns as taught by Chadha et al. for the purpose of altering the thickness of the fabric based on the size of the diameter.
Regarding Claim 29, in the embodiment used in the rejection above, Figures 21-24 does not expressly disclose wherein at least a portion of the plurality of fibers has a random orientation or a predetermined aligned orientation. However, in an alternative embodiment, Figures 18-19f, Pelled et al. teaches a sealing skirt 16 in the same field of endeavor laminated/encapsulated between one or more layers or filaments of ePTFE and fabric (paragraphs [0035-0036]), wherein the laminate sealing member is formed from a plurality of polymer fibers that is formed using an electrospining process ([0041], [0047] and [0069]) and having a highly crystalline structure as well as having orientation relative to the axis of expansion to provide dimensional stability to the tubular material (paragraph [0049]). 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 skirt of Figures 21-24 to further include a plurality of fibers that has a high crystalline structure and have orientation relative to the axis of expansion as taught in Figures 18-20 for the purpose of providing dimensional stability to the tubular structure.
Regarding Claim 30, Pelled et al. discloses the first material, second material to be formed of PTFE, wherein the limitation “wherein the first material and/or the second material, and/or the third material exhibit tensile strength from greater than 0 MPa to about 20 MPa, and/or elongation at break from greater than 0% to about 600%, and/or a water contact angle from about 0° to about 180°” are material properties of said material. The prior art discloses the same material (ePTFE or PTFE) for the first and or second material, therefore, the disclosed polymeric material is fully capable of having the claimed material property of tensile strength and elongation and water contact angle.
Claim(s) 22-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. U.S. Publication 2019/0046314 A1 in view of Chadha et al. U.S. Publication 2017/0172736 A1 and further in view of Kaplan et al. U.S. Publication 2013/0172999 A1.
Regarding Claim 22, Pelled et al. does not expressly disclose at least a portion of the first, second or third material exhibits porosity having an average pore size about 100 nm to about 100 micrometers. Kaplan et al. teaches an implant formed from a first layer 104, second layer 104, wherein the first and second layers are formed from silk fibroin (paragraphs [0021], [0023], [0056-0057]) and having pores, wherein the pores 106 have a size of about 100 microns (paragraph [0057]) wherein the pore size alters the porosity and interconnection of the channels of the pores to lower or increase the porosity of the silk layer (paragraphs [0063-0064]). 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 Pelled’s skirt having a plurality of layers to further include a plurality of pores having a pore size of about 100 microns as taught by Kaplan for the purpose of altering the porosity of the silk layer.
Regarding Claim 23, the limitation “wherein the average fiber diameter and/or pore size is controlled by a concentration of an active material in an electrospining solution” is a product by process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
Regarding Claim 24, Pelled et al. discloses the skirt 300 comprises a natural material, silk (see paragraph [0069]). Pelled et al. further discloses the skirt comprises a plurality of layers, wherein each of the plurality of layers is disposed on each other (paragraph [0071]).
Regarding Claim 25, 26, Pelled et al. does not expressly disclose wherein the average fiber diameter or pore size is varied along the first material and or the second material. Kaplan et al. teaches an implant formed from a first layer 104, second layer 104, wherein the first and second layers are formed from silk fibroin (paragraphs [0021], [0023], [0056-0057]) and having pores, wherein the pores 106 are varied in each of the layers (paragraph [0073], [0106], [0115-0118]) to form distinct sub layer with distinct pore size distribution (paragraph [0119]) wherein the pore size alters the porosity and interconnection of the channels of the pores to lower or increase the porosity of the silk layer (paragraphs [0063-0064]). 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 Pelled’s skirt having a plurality of layers to further include a plurality of pores having varying pore sizes in each layer as taught by Kaplan for the purpose of altering the porosity of the silk layer.
Regarding Claim 27, Pelled et al. discloses sealing member 300 having an inner skirt 302 and outer skirt 306 can be laminated with or encapsulated between one or more films of ePTFE (paragraph [0071]). However, in the embodiment used in the rejection above, Figures 21-24 does not expressly disclose wherein the plurality of fibers further comprises thermooplastic polyurethane (TPU), polyurethane (PU); implantable elastane polymer, or polyethylene, polypropylene, polymethylmethacrylate (PMMA), polystyrene (PS), polytetrafluoroethylene (PTFE), polyamide, polyethylene terephthalate (PET), polyethersulfone, poly-lactic-co-glycolic acid (PLGA). In an alternative embodiment as seen in Figures 18-19f, Pelled et al. teaches wherein the skirt comprises a plurality of fibers comprises PTFE fibers (see paragraph [0038] and [0041]) for the purpose of encapsulating portion of the frame with a plurality of layers that strengthen the sealing member 16 and resist tearing and prevent paravalvular leakage (paragraph [0039]). 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 skirt of Pelled to further include a plurality of fibers formed from PTFE as taught in Figures 18-20 for the purpose of encapsulating portion of the frame with a plurality of layers of PTFE that strengthen the sealing member and resist tearing and prevent paravalvular leakage.
Regarding Claim 28, Pelled et al. discloses the skirt 300 comprises a natural material, silk (see paragraph [0069]). Pelled et al. further discloses the skirt comprises a plurality of layers, wherein each of the plurality of layers is disposed on each other and formed of ePTFE (paragraph [0071]), therefore there is another layer without silk.
Conclusion
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774