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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Response to Amendment
The amendment filed 11/25/2025 has been entered. Claims 1-3, 7, and 10-33 remain pending in the application. Claim 33 has been added.
Response to Arguments
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 11, with respect to the rejections of claim 1 under WO 2017004360 A1 (hereafter—Snyders--) in view of US 20140188219 A1 (hereafter—Conklin--) have been fully considered and are not persuasive.
Regarding the Applicant’s argument, it is agreed upon that Snyders as modified by Conklin fails to disclose wherein the pinhead is situated within the hollowed portion. However, the Instant Application does not disclose the pinhead being situated within the hollowed portion solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Conklin’s pinhead and hollowed portion would perform equally and function as intended with the pinhead being sized to be situated within the hollow portion. The location of the pinhead with respect to the hollowed portion of the receptive guide does not change the function of the pinhead and guide combination to allow the valve to expand. Whether or not the pinhead exceeds the slot boundary or not does not affect the function of the device, as the pin shaft still slides within the hollowed portion of the receptive guide. Therefore, it would have been obvious to one having ordinary skill in the art to make the pinhead is situated within the hollowed portion, as an obvious matter of design choice within the skill of the art.
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 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.
Claims 1-3, 7, 10-11, 13-16, 20-27, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017004360 A1 (hereafter—Snyders--) in view of US 20140188219 A1 (hereafter—Conklin--).
Regarding Claim 1, Snyders discloses an implantable device for heart valve replacement, comprising: a regenerative heart valve comprising regenerative tissue (see paragraphs [0019] and [0021]), wherein the regenerative heart valve comprises a first end and a second end (see annotated first and second end of heart valve in Figures 2 and 3 below); and a first ring structure (see 22 in Figure 3 below) attached to the first end of the regenerative heart valve (see first ring structure attached to the first end of the heart valve in Figures 2 and 3 below), wherein the regenerative tissue is configured to grow and integrate with native tissue (see paragraph [0021]) while maintaining a valvular shape of the regenerative heart valve (see paragraph [0020]), wherein the first ring structure is further adapted to expand as the heart valve annulus expands (see paragraph [0021], see also paragraph [0020] denoting the collar can be compressed with the first ring structure inside of it which illustrates its ability to change diameter due to its coiled nature).
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SHowever, Snyders fails to disclose wherein the first ring structure comprises at least one segment having two overlapping interconnected ends such that when the ring expands the overlapping ends remain fastened together, and wherein the first ring structure is further adapted to expand as the heart valve annulus expands, wherein the two overlapping interconnected ends are fastened together using a pin extending from a first overlapping end into a receptive guide on a second overlapping end, wherein the pin comprises a shaft and a pinhead, wherein the pinhead is at an opposite end of the shaft from the first overlapping end, wherein the pinhead comprises a cross-sectional width greater than a cross-sectional width of the shaft, wherein the receptive guide comprises an aperture in which the shaft passes therethrough to allow the pin to move in one direction such that the two overlapping ends move in opposing directions, wherein the cross-sectional width of the pinhead is wider than the aperture in at least one direction such that the pinhead cannot pass through the aperture.
Conklin discloses an implantable device for heart valve replacement (see Abstract, see also device in Figures 6A-6D below), comprising: a heart valve, wherein the heart valve comprises a first end and a second end (see annotated first and second end of heart valve in Figure 2A below, using the Figure 2A as they do not show the embodiment of the ring structure of Figure 6A-6D attached to a heart valve, in which paragraph [0075] denotes that the embodiment of the ring in Figures 6A-6D can be mounted on a heart valve with commissure posts and leaflets as shown in Figure 2A-2D); and a first ring structure (see first ring structure in Figure 6A below) attached to the first end of the regenerative heart valve (see first ring structure attached to the first end of the heart valve in Figures 2A and 2C below), wherein the first ring structure is further adapted to expand as the heart valve annulus expands (see paragraph [0079] denoting the pin and slot mechanism of the first ring structure 150 allows the heart valve to radially expand). Conklin teaches wherein the first ring structure comprises at least one segment having two overlapping interconnected ends such that when the ring expands the overlapping ends remain fastened together (see overlapping ends in Figure 6A below, see also paragraph [0079] denoting that pin 152 may have an enlarged distal portion 153 having a diameter larger than the slot width, which thereby prevents the pin 152 from being pulled out of the slot 154, which means the two ends stay connected), and wherein the first ring structure is further adapted to expand as the heart valve annulus expands (see paragraph [0079]), wherein the two overlapping interconnected ends are fastened together using a pin extending from a first overlapping end into a receptive guide on a second overlapping end (see annotated ends, pin, and receptive guide in Figures 6A and 6B below, see also paragraph [0079]), wherein the pin comprises a shaft and a pinhead (see annotated shaft and pinhead in Figure 6A below), wherein the pinhead is at an opposite end of the shaft from the first overlapping end (see annotated shaft and pinhead in Figure 6A below), wherein the pinhead comprises a cross-sectional width greater than a cross-sectional width of the shaft (see paragraph [0079] denoting that pin 152 may have an enlarged distal portion 153 having a diameter larger than the slot width, which thereby prevents the pin 152 from being pulled out of the slot 154), wherein the receptive guide comprises an aperture and a hollowed portion within the second overlapping end (the hollowed portion is the space within the aperture), wherein the shaft passes through the aperture, wherein the receptive guide is configured to allow the pin to move in one direction such that the two overlapping ends move in opposing directions (see paragraph [0079], see also aperture in Figure 6A below), wherein the cross-sectional width of the pinhead is wider than the aperture in at least one direction such that the pinhead cannot pass through the aperture (see paragraph [0079] denoting that pin 152 may have an enlarged distal portion 153 having a diameter larger than the slot width, which thereby prevents the pin 152 from being pulled out of the slot 154).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first ring of Snyders at least one segment having two overlapping interconnected ends such that when the ring expands the overlapping ends remain fastened together, wherein the first ring structure is further adapted to expand as the heart valve annulus expands, wherein the two overlapping interconnected ends are fastened together using a pin extending from a first overlapping end into a receptive guide on a second overlapping end, wherein the pin comprises a shaft and a pinhead, wherein the pinhead is at an opposite end of the shaft from the first overlapping end, wherein the pinhead comprises a cross-sectional width greater than a cross-sectional width of the shaft, wherein the receptive guide comprises an aperture and a hollowed portion within the second overlapping end, in which the shaft passes through the aperture, wherein the receptive guide is configured to allow the pin to move in one direction such that the two overlapping ends move in opposing directions, wherein the cross-sectional width of the pinhead is wider than the aperture in at least one direction such that the pinhead cannot pass through the aperture, as by doing so would allow the device to radially expand, but provides a fixed limit on the maximum expansion that will be permitted as taught by Conklin (see paragraph [0079]).
Snyders as modified further fails to disclose wherein the pinhead is situated within the hollowed portion.
The Instant Application does not disclose the pinhead being situated within the hollowed portion solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Conklin’s pinhead and hollowed portion would perform equally and function as intended with the pinhead being sized to be situated within the hollow portion. Therefore, it would have been obvious to one having ordinary skill in the art to make the pinhead is situated within the hollowed portion, as an obvious matter of design choice within the skill of the art.
The limitations “wherein the first ring structure is adapted to provide support for the regenerative tissue when the regenerative heart valve is situated at a heart annulus wherein the regenerative tissue is configured to grow and integrate with native tissue while maintaining a valvular shape of the regenerative heart valve” are functional limitations that are given limited patentable weight. The prior art is not required to disclose placement in an annulus of a pediatric patient, but merely have the capability of being used in the recited manner. In this case, Snyders, modified by Conklin, discloses the device able to be placed in the annulus of a pediatric patient. The Snyders stent, as modified by Conklin, has dimensions and ability to expand, as well as is covered in regenerative tissue, making it suitable for the purpose of being wherein the first ring structure is adapted to provide support for the regenerative tissue when the regenerative heart valve is situated at a heart annulus wherein the regenerative tissue is configured to grow and integrate with native tissue while maintaining a valvular shape of the regenerative heart valve.
Regarding Claim 2, Snyders as modified discloses the device as in claim 1 further comprising a first tissue layer encasing the first ring structure (see 20 in Figure 3 below encasing ring structure 22), wherein the first tissue layer mitigates the first ring structure from being exposed to the native surrounding tissue when situated at the site of replacement (see 20 in Figure 3 below encasing the entirety of ring structure 22).
Regarding Claim 3, Snyders as modified discloses the device as in claim 1 wherein the heart valve is an aortic valve (see paragraph [0019]) and the first ring structure provides sufficient support such that the regenerative tissue is able to grow in presence of forces that occur in the native aortic root (see paragraph [0020] and [0021]).
Regarding Claim 7, Snyders as modified discloses the device as in claim 1.
However, Snyders as modified fails to disclose wherein the pinhead extends from the first overlapping end orthogonally to the direction of movement between the two overlapping ends when the ring expands.
Conklin teaches wherein the pinhead extends from the first overlapping end orthogonally to the direction of movement between the two overlapping ends when the ring expands (see annotated pin and direction of movement in Figure 6B below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first ring of Snyders to have the pinhead extending from the first overlapping end orthogonally to the direction of movement between the two overlapping ends when the ring expands as Conklin teaches that by doing so enables the ring to slidingly connecting adjacent segments for expansion (see paragraph [0079]).
Regarding Claim 10, Snyders as modified discloses the device as in claim 1, wherein the first ring structure is constructed from a biodegradable material (see paragraph [0020]).
Regarding Claim 11, Snyders as modified discloses the device as in claim 10, wherein the biodegradable material is, polylactic acid (PLA) (see paragraph [0020]).
Regarding Claim 13, Snyders as modified discloses the device as in claim 10, wherein the first tissue layer is adapted to capture degraded particles of the first ring structure (see 20 in Figure 3 above encasing the entirety of ring structure 22). Given that the ring structure is fully encased in the tissue layer, it is interpreted that it would capture degraded particles of the ring structure.
Regarding Claim 14, Snyders as modified discloses the device as in claim 1.
However, Snyders fails to disclose wherein the first ring structure is constructed from a metallic material.
Nevertheless, Conklin teaches wherein the first ring structure is constructed from a metallic material, such as stainless steel (see paragraph [0078]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the ring structure of Snyders to be made of a metallic material such as stainless steel, 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 15, Snyders as modified wherein the metallic material is selected from the group consisting of: stainless steel, cobalt-chromium alloys, titanium, and titanium alloys (see claim 14 rejection above).
Regarding Claim 16, Snyders as modified discloses the device as in claim 1, wherein the first ring structure is attached to the base of the heart valve, and wherein the attachment is provided by sutures or an adhesive (see sutures in Figure 2 above attached the ring structure to the rest of the heart valve).
Regarding Claim 20, Snyders as modified discloses the device as in claim 2, wherein the tissue sleeve is formed from autologous tissue derived from an individual to be treated (see paragraph [0022]).
Regarding Claim 21, Snyders as modified discloses the device as in claim 1, wherein the tissue of the regenerative heart valve is formed in vitro (see paragraph [0022] mentioning culture techniques).
Regarding Claim 22, Snyders as modified discloses the device as in claim 1, wherein the tissue of the regenerative heart valve is formed from autologous tissue derived from an individual to be treated (see paragraph [0022] denoting that tissue for the heart valve can be harvested from the patient).
Regarding Claim 23, Snyders as modified discloses the device as in claim 1, wherein the tissue of the regenerative heart valve is grown on a biodegradable scaffold (see paragraph [0022]).
Regarding Claim 24, Snyders as modified discloses the device as in claim 23, wherein the biodegradable scaffold is made of material from a decellurized extracellular matrix (see paragraph [0022]).
Regarding Claim 25, Snyders as modified discloses the device as in claim 1.
The limitations “wherein the regenerative heart valve is trained in a bioreactor system that simulates physiological and mechanical pressures that occur in an aortic root” are functional limitations that are given limited patentable weight. The prior art is not required to disclose the regenerative heart valve being trained in a bioreactor system that simulates physiological and mechanical pressures that occur in an aortic root, but merely have the capability of being used in the recited manner. In this case, Snyders, modified by Conklin, discloses the device able to be placed in the annulus of a pediatric patient. The Snyders stent, as modified by Conklin, has dimensions and material makeup suitable for the purpose of being trained in a bioreactor system that simulates physiological and mechanical pressures that occur in an aortic root.
Regarding Claim 26, Snyders as modified discloses the device as in claim 1, wherein the tissue of the regenerative heart valve is grown from mesenchymal stem cells. Specifically, Snyders discloses use of bone-marrow derived mesenchymal stem cells (see paragraph [0022]).
Regarding Claim 27, Snyders as modified discloses the device as in claim 26, where the cell source is mesenchymal stem cells derived from human bone marrow (see paragraph [0022]).
Regarding Claim 33, Snyders as modified discloses the device as in claim 1, wherein the shaft of the pin is configured to remain internally within the receptive guide (see annotated pin and receptive guide in Figures 6A and 6B below, see also paragraph [0079]).
Snyders as modified further fails to disclose wherein the pinhead of the pin is configured to remain internally within the receptive guide.
The Instant Application does not disclose the pinhead of the pin remaining internally within the receptive guide solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Conklin’s pinhead and receptive guide would perform equally and function as intended with the pinhead being sized to be situated internally within the receptive guide. Therefore, it would have been obvious to one having ordinary skill in the art to make the pinhead of the pin be configured to remain internally within the receptive guide, as an obvious matter of design choice within the skill of the art.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017004360 A1 (hereafter—Snyders--) in view of US 20140188219 A1 (hereafter—Conklin--), as applied to claim 10 above, and in view of KR 20050107426 (hereafter—KR’426--).
Snyders as modified discloses the device according to claim 10, Snyders also discloses the biodegradable material PLA designed to degrade at a timeframe.
However, Snyders fails to disclose that the timeframe to which the biodegradable material is designed to degrade is approximately selected from: 6, 12, 18, 24, 30 and 36 months.
Nevertheless, KR’426 teaches that it is well known in the art of biodegradable implants that implant polymer compositions made up of polylactic acid (PLA) and polyglycolic acid (PGA) (see paragraph 77 in the description of embodiments) have a scaffold degeneration rate which can be altered and determined by the polymers used to form the implant (see paragraph 138 in the description of embodiments) based on the molecular weight of the compound (see paragraph 139 in the description of embodiments). Taking it further, KR’426 teaches an expected degradation rate of PGA fibers being months and PLLA (a specific type of PLA) matrices typically taking more than a year (see paragraph 140 in the description of embodiments) and that by combining the two, the overall compound would have a slower degradation rate than if it was PGA alone (see paragraph 138 in the description of embodiments). KR’426 additionally teaches that the molecular weight and molecular weight distribution of the polymers effect the rate at which the composition degrades (see paragraph 144 in the description of embodiments).
Since Snyder does, however, disclose that the biodegradable material of the scaffold is PLA; the rate of degradation of the biodegradable material constitutes a defined value of the scaffold. Therefore, the rate of degradation of the PLA is recognized as a result-effective variable, i.e. a variable which achieves a recognized result. In this case, the recognized result is that the rate of degradation will depend on the type of polymeric material being used, the molecular weight and molecular weight distribution of the polymers, as taught by KR’426.
Therefore, since the general conditions of the claim, i.e. that the scaffold of Snyder is made up of a biodegradable PLA polymer, were disclosed in the prior art by Snyder, and KR’426 teaches that the rate of degradation will depend on the material being used, the molecular weight and molecular weight distribution of the polymers; it is not inventive to discover the optimum workable range or value by routine experimentation, and it would have been obvious to one of ordinary skill in the art at the time of the invention was filed to provide Snyder’s degradation timeframe to be of a desired timeframe 6, 12, 18, 24, 30, or 36 months. In re Aller, 105 USPQ 233/In re Boesch, 205 USPQ 215 (CCPA 1980).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017004360 A1 (hereafter—Snyders--) in view of US 20140188219 A1 (hereafter—Conklin--), as applied to claim 26 above, and in view of US 9675450 B2 (hereafter –Straka--).
Snyders as modified discloses the device as in claim 26.
However, Snyders as modified fails to disclose wherein the cell source is vascular tissue derived from peripheral arteries or umbilical veins.
Nevertheless, Straka discloses an implantable device for heart valve replacement, comprising: a regenerative heart valve comprising regenerative tissue (see column 3, row 10); and a first ring structure adapted to be situated at the base of the heart valve (see ring structure 2 in Figure 3 below) to provide support for the regenerative tissue such that when the heart valve is situated at the site of replacement (see column 9, row 58), the regenerative tissue can grow and integrate with native tissue (see column 3, row 10) while maintaining the valvular shape of the heart valve (see column 9, row 58) and wherein the tissue of the regenerative heart valve is grown from stem cells, progenitor endothelial cells, and growth factors to the heart valve (see column 5, lines 17-26). Straka teaches where the cell source is vascular tissue derived from peripheral arteries ((see column 4, rows 19-25) mentioning peripheral blood).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have tissue of the regenerative heart valve of Snyders to be comprised of vascular tissue derived from peripheral arteries 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.
Claims 17-19 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017004360 A1 (hereafter—Snyders--) in view of US 20140188219 A1 (hereafter—Conklin--), as applied to claim 1 above, and in further view of Matheny et al US 2016/0317300 A1 (hereafter—Matheny--).
Regarding Claim 17, Snyders as modified discloses the device as in claim 1.
However, Snyders fails to disclose a second ring structure to provide support for the regenerative tissue such that when the heart valve is situated at the site of replacement; and a second tissue layer encasing the second ring structure, wherein the second tissue layer mitigates the second ring structure from being exposed to the native surrounding tissue when situated at the site of replacement.
Nevertheless, Matheny discloses an implantable device for heart valve replacement (see paragraph [0029]), comprising: a regenerative heart valve comprising regenerative tissue (see tissue 10c in Figure 13 below, see also paragraph [0036]); and a first ring structure adapted to be situated at the base of the heart valve (see first ring structure 64 in Figure 13 below) to provide support for the regenerative tissue such that when the heart valve is situated at the site of replacement (see paragraphs [0112], [0120], and [0125]), the regenerative tissue can grow and integrate with native tissue (see paragraph [0036]) while maintaining the valvular shape of the heart valve (see paragraph [0031]). Matheny teaches an expandable (see paragraph [0254]) second ring structure (see 62 in Figure 13 above) to provide support for the regenerative tissue (see tissue layer 10c over the second ring structure); and a second tissue layer encasing the second ring structure (see tissue layer 10c over the second ring structure), wherein the second tissue layer mitigates the second ring structure from being exposed to the native surrounding tissue when situated at the site of replacement (see tissue layer 10c encasing the entirety of the second ring structure in Figure 13 below, see also paragraph [0263]). Given that the ring structure is fully encased in the tissue layer, it is interpreted that it would capture degraded particles of the ring structure.
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Therefore it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have tissue of the regenerative heart valve of Snyders to additionally have the expandable second ring structure of Matheny added to the second end of the heart valve to the struts 30 and to have the encasing tissue layer of Matheny to be the second tissue layer, as by doing so would promote further modulated healing of the valve structure and connecting cardiovascular structure tissue as well as promote secure attachment to cardiovascular structures (regarding the second tissue layer, see paragraphs [0265], see also paragraph [0024]) and would enhance the structural integrity of the valve when subjected to cardiac cycle induced stress (see paragraphs [0022] and [0023] describing the main strength of their invention).
The limitation “adapted to be situated on an effluent side of the heart valve, the regenerative tissue is configured to grow and integrate with native tissue while maintaining the valvular shape of the heart valve” are functional limitations that are given limited patentable weight. The prior art is not required to disclose direction of which the rings are situated or if the regenerative, but merely have the capability of being used in the recited manner. In this case, Snyders, modified by Conklin discloses the device able to be placed in the annulus of a pediatric patient. The Snyders second ring structure, as modified by Conklin and Matheny, has dimensions and ability to expand, as well as is covered in regenerative tissue, making it suitable for the purpose of being wherein the second ring structure is adapted to provide support for the regenerative tissue wherein the regenerative tissue is configured to grow and integrate with native tissue while maintaining a valvular shape of the regenerative heart valve, as well as be situated on an effluent side of the heart valve.
Regarding Claim 18, Matheny discloses the device as in claim 1, wherein the second ring structure is expandable (see above claim 17 rejection, see also paragraph [0254]).
Regarding Claim 19, Snyders discloses the device as in claim 2.
However, Snyders as modified fails to disclose wherein the tissue sleeve is formed from pericardial tissue derived from an animal source.
Nevertheless, Matheny teaches wherein the tissue sleeve is formed from pericardial tissue derived from an animal source (see paragraph [0075], line 8).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the tissue of the regenerative heart valve of modified Snyders to incorporate pericardial tissue derived from an animal source, 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 29, Snyders as modified discloses the device as in claim 1.
However, Snyders as modified fails to disclose wherein the tissue of the regenerative heart valve incorporates bioactive molecules.
Nevertheless, Matheny discloses an implantable device for heart valve replacement (see paragraph [0029]), comprising: a regenerative heart valve comprising regenerative tissue (see tissue 10c in Figure 13 below, see also paragraph [0036]); and a first ring structure adapted to be situated at the base of the heart valve (see first ring structure 64 in Figure 13 below) to provide support for the regenerative tissue such that when the heart valve is situated at the site of replacement (see paragraphs [0112], [0120], and [0125]), the regenerative tissue can grow and integrate with native tissue (see paragraph [0036]) while maintaining the valvular shape of the heart valve (see paragraph [0031]). Matheny teaches wherein the tissue of the regenerative heart valve incorporates bioactive molecules (see paragraphs and [0085] and [0087]) that promote regeneration, differentiation (see paragraph [0156] and [0157]), and mitigate inflammation (see paragraphs [0157], [0158], and [0159]) and immune- mediated destruction of the regenerative valve (see paragraph [0150]) including vascular epithelial growth factor (VEGF), transforming growth factor beta (TGF-β), or insulin-like growth factor (IGF) (see paragraph [0085]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the tissue of the regenerative heart valve of modified Snyders to incorporate bioactive molecules that promote regeneration and differentiation of cells as well as mitigate inflammation and immune mediated destruction chosen from the group of vascular epithelial growth factor (VEGF), transforming growth factor beta (TGF-β), or insulin-like growth factor (IGF), as taught by Matheny, as by doing so would modulate a physiological or biological process or cellular activity to induce proliferation and growth of tissue (see paragraph [0084]), as well as treats and prevents bodily inflammation (see paragraph [0098]), as the inflammation response is substantially reduced when compared to inflammation that takes place in the absence of an ECM prosthetic tissue valve of the invention (see paragraphs [0161] and [0163]).
Regarding Claim 30, Snyders as modified discloses the biomolecules promote regeneration and differentiation (see above claim 29 rejection, see also paragraphs [0156] and [0157]).
Regarding Claim 31, Snyders as modified discloses the biomolecules are of: vascular epithelial growth factor (VEGF), transforming growth factor beta (TGF-β), or insulin-like growth factor (IGF) (see above claim 29 rejection, see also paragraph [0085]).
Regarding Claim 32, Snyders as modified discloses the biomolecules mitigate inflammation (see above claim 29 rejection, see also paragraphs [0157], [0158], and [0159]) and immune- mediated destruction of the regenerative valve (see above claim 29 rejection, see also paragraph [0150]).
Conclusion
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774