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 Arguments
Applicant's arguments filed 07/11/25 have been fully considered but they are not persuasive.
On pages 9-10 regarding prior art rejections, Applicant argues the prior art fails to teach alternating open-cell portions and closed-cell portions, each closed-cell portion comprising a plurality of connected cells which increase structural rigidity relative towards open-cell portions.
The Examiner respectfully disagrees, noting that open-cell configurations are understood to have less structural rigidity than closed-cell configurations. Further, the prior art explicitly indicates that the expansion is to occur at these open-cell, expanding locations. Since deformation occurs at these locations but not at the remainder of the frame, it is inherent that those locations are the ones with less structural rigidity compared to the remainder of the frame, or the entirety of the frame would expand.
On pages 10-12 regarding rejections over Bonhoeffer, Applicant argues that a stented valve is different than a valved conduit, and gives a definition for each.
The Examiner respectfully disagrees and recommends Applicant point out what part of the claim language Applicant believes Bonhoeffer lacks in order to overcome a rejection over Bonhoeffer, since no difference can be found in the structure required by the claim, and the structure of Bonhoeffer.
On pages 12-13 Applicant argues that changing the shape of the frame of Bonheffer would “fundamentally alter the mechanical behavior of the support system “and so “compromise the intended function of the device”.
The Examiner respectfully disagrees, noting a lack of proof for Applicant’s statements, and reminds Applicant that the arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim limitation “transcatheter means” for implanting the valve system in claim 18 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because there is no reference to a “transcatheter means” in the specification anywhere. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 5-6, 11, 13, 16, 18, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonhoeffer et al. (US 20090264989 A1) hereinafter known as Bonhoeffer in view of Justino (US 20050137682 A1), further in view of Colavito et al. (US 20190282360 A1) hereinafter known as Colavito.
Regarding claim 2 Bonhoeffer discloses a growth-accommodating (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2411(I). In this case, the patented apparatus of Bonhoeffer discloses (as detailed above) all the structural limitations required to perform the recited functional language (of being growth-accommodating), therefore was considered to anticipate the claimed apparatus. See, for example the Abstract) transcatheter ([0002]) prosthetic valve system comprising:
an expandable stent frame (Figures 1-2, 23-24 items 12/36), comprising an open-cell portion (Figures 1-2, 23-24, the part where the frame 12/36 shows a zig-zag jog and allows expansion) and a second portion (Figures 1-2, 23-24 the part where the frame 12/36 is somewhat straight around the circumference and does not expand), and
a multitude of leaflets (Figure 1 item 16), attached to the stent frame to form a heart valve (Figure 1),
wherein the valve system is collapsible over a delivery catheter to be implanted ([0002] a transcatheter valve is collapsible over a delivery catheter for implantation. Alternatively, please see the 103 rejection below);
wherein the valve system is twice expandable via a first balloon and a second balloon, wherein the first balloon is used to deploy the valve into the first position and the second balloon is used to expand the valve into the second position which has a larger diameter than the first position (Abstract, [0002], [0010]-[0011] (see the alternative 103 rejection below regarding the ability to expand via a first balloon));
but is silent with regards the open-cell (expanding) portions alternating with the second (non-expanding) portions,
the second portion comprising a closed-cell portion, each closed-cell portion being a rhombus with no right angles,
each leaflet being configured to maintain coaptation when the valve is in a first position, or in a second (larger diameter) position, each leaflet also having at least one foldable leaflet surface, and
(alternatively) the valve system being collapsible over a first balloon catheter to be delivered and expanded to the first position.
However, regarding claim 2 Justino teaches that stents can include stent frames which include closed-cell portions having the shape of a rhombus with no right angles (Figure 22a). Bonhoeffer and Justino are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Bonhoeffer so that the second portion included closed cell portions shaped as is taught by Justino since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). Further, the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of a well-known shape of cells for the second portion of Bonhoeffer would have occurred to the person of ordinary skill as obvious to try.
Further, regarding claim 2 Colavito teaches a growth-accommodating heart valve ([0021]) which includes a frame ([0170]) and a multitude of leaflets (Figure 2 item 106) attached to the frame ([0171]), the leaflets being configured to maintain coaptation when the valve is in a first position, or in a second (larger diameter) position ([0091]),
the frame comprising (expanding) portions alternating with second (non-expanding) portions (Figures 40-42, 48-52 shows how Colavito’s expanding frame has three areas of expanding frame alternating with three areas of non-expanding frame), wherein each leaflet has at least one foldable leaflet surface (the Examiner notes that every surface of a flexible leaflet is inherently “foldable”. See also [0006]), wherein the valve system is collapsible over a delivery catheter to be implanted ([0255] transcatheterally deliverable; [0241] the valve can be transcatheterally delivered with adjustment features to allow for expansion from the collapsed delivery configuration) so the valve system is twice expandable via two balloons ([0009], [0170], and [0258] (Fig 49) where selective expansion features can straighten past a frame’s general expanded state diameter, so that upon diametric expansion, the selective expansion features reduce their degree of undulation thus creating a larger frame diameter). Bonhoeffer and Colavito are involved in the same field of endeavor, namely growth-accommodating heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Bonhoeffer Justino Combination to have the leaflets folded in order to maintain coaptation at two diameters as is taught by Colavito in order to allow the valve to function properly with the right amount of leaflet coaption at both diameters (in other words, the valve of Bonhoeffer would not be functional unless the leaflets maintained coaptation as it expands). It would have also been obvious to allow the valve to be delivered initially via balloon catheter as is taught by Colavito in order to simplify delivery during initial surgery, thus avoiding opening a patient’s chest which can result in extra risk to a patient’s health. It would additionally have been obvious to have alternating open-cell (expanding) portions and second portions as is taught by Colavito in order to have a symmetrically expanding valve which is able to closely match the originally implanted commissure locations, which are desirably matching the native commissure locations upon initial delivery/expansion. This enables biomimetic function of the replacement valve.
Regarding claim 5 the Bonhoeffer Justino Colavito Combination teaches the valve of claim 2 substantially as is claimed,
wherein Colavito further teaches each leaflet has two side edges (see Figure 2 item 106 which includes two straight sides) and a curved edge (Figure 6 item 106 which includes a curved area where the leaflet attaches to the inner surface 110 of support structure 102) that forms a sector shape (Figure 2).
Regarding claim 6 the Bonhoeffer Justino Colavito Combination teaches the valve of claim 5 substantially as is claimed,
wherein Colavito further teaches the at least one foldable leaflet surface of each leaflet is folded along a line in the center of the leaflet and between the bisecting line and the curved edge to form a centrally-located folded flap (Figure 19 item 306; [0207]), thereby reducing at least one dimension of the leaflet and forming the valve into the first position (Figure 18; [0208]).
However, regarding claim 6, Merriam-Webster defines “bisecting” as “to divide into two usually equal parts”. While Colavito discloses the leaflet is folded in the center portion (Figure 19 item 306), it isn’t entirely clear whether this fold in the central region is actually occurring symmetrically to divide the leaflet into equal parts. However, the definition of “bisecting” is fairly ambiguous as regards to whether or not equal parts are actually required.
Accordingly, if Colavito does not already disclose the fold line as meeting the definition of “bisecting”, from the above analysis, the person of ordinary skill in the art at the time the invention was filed would have found it at least obvious to perform the fold as bisecting the leaflet, since the location of the fold line is considered non-essential. It has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04(IV)(B). It appears that the disclosed device would perform equally well shaped as taught by Colavito.
Regarding claim 11 the Bonhoeffer Justino Colavito Combination teaches the valve of claim 2 substantially as is claimed,
wherein Bonhoeffer further discloses the leaflets comprise a biologic or synthetic material ([0038]).
Regarding claim 13 the Bonhoeffer Justino Colavito Combination teaches the valve of claim 2 substantially as is claimed,
wherein Bonhoeffer further discloses the stent frame is expandable to accommodate the second position of the valve (Abstract; Figures 2, 24; [0043]).
Regarding claim 16 the Bonhoeffer Justino Colavito Combination teaches the valve of claim 2 substantially as is claimed,
wherein Bonhoeffer further discloses the valve system is implantable inside a heart chamber as a replacement to one of the four native heart valves ((this is stated as an intended use (see explanation in the rejection to claim 2 above). See also [0048])
Regarding claim 18 the Bonhoeffer Justino Colavito Combination teaches a transcatheter device for mitigating progressive valve regurgitation in a patient in need thereof (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of the Combination teaches (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus of mitigating progressive regurgitation if implanted accordingly), the device comprising the valve of claim 2 (see the explanation to the rejection of claim 2 above),
wherein the valve system is capable of being implanted via a transcatheter means into said patient to replace the function of a native or prosthetic heart valve,
wherein the system is capable of being deployed using a first inflatable balloon such that the valve is in the first position, and when the patient’s cardiac dimensions enlarge, the system is capable of being expanded during a second inflatable balloon such that the valve is in the second position to accommodate the larger cardiac dimensions (see the rejection to claim 2 above).
Regarding claim 22 Bonhoeffer discloses a growth-accommodating (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2411(I). In this case, the patented apparatus of Bonhoeffer discloses (as detailed above) all the structural limitations required to perform the recited functional language (of being growth-accommodating), therefore was considered to anticipate the claimed apparatus. See, for example the Abstract) transcatheter ([0002]) prosthetic valve system comprising:
an expandable stent frame (Figures 1-2, 23-24 items 12/36), comprising an open-cell portion (Figures 1-2, 23-24, the part where the frame 12/36 shows a zig-zag jog) which is configured to expand (see Figure 1 (compressed open cells) as compared to Figure 2 (expanded open cells)) and a second portion (Figures 1-2, 23-24 the part where the frame 12/36 is somewhat straight around the circumference) which is configured to provide increased structural rigidity to the open-cell portion (see [0043] only the open-cell portion deflects/expands, with the remainder maintaining its structural rigidity), and
a multitude of leaflets (Figure 1 item 16), attached to the stent frame to form a heart valve (Figure 1),
wherein the valve system is twice expandable via a first balloon and a second balloon, wherein the first balloon is used to deploy the valve into the first position and the second balloon is used to expand the valve into the second position which has a larger diameter than the first position (Abstract, [0002], [0010]-[0011] (see the alternative 103 rejection below regarding the ability to expand via a first balloon));
but is silent with regards to the second portion comprising a closed-cell portion, there being a plurality of connected cells within each closed-cell portion,
each leaflet having at least one foldable leaflet surface such that when the leaflet is folded the valve is in a first position and when it is unfolded it is in a second position,
each leaflet being configured to maintain coaptation when the valve is in the first position, or in the second (larger diameter) position, and
(alternatively) the valve system being collapsible over a first balloon catheter to be delivered and expanded to the first position.
However, regarding claim 22 Justino teaches that stents can include stent frames which include closed-cell portions (Figure 22a). Bonhoeffer and Justino are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Bonhoeffer so that the second portion included closed cell portions shaped as is taught by Justino since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). Further, the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of a well-known shape of cells for the second portion of Bonhoeffer would have occurred to the person of ordinary skill as obvious to try. Further, as regards the closed-cell portions being configured to provide “increased structural rigidity” relative to open-cell portions, the person of ordinary skill in the art would ensure the closed-cell portions still maintain the structural rigidity Bonhoeffer intends the second portion to have, so they maintain their shape while the open-cell portions expand (Bonhoeffer [0043]).
Further, regarding claim 22 Colavito teaches a growth-accommodating heart valve ([0021]) which includes a frame ([0170]) and a multitude of leaflets (Figure 2 item 106) attached to the frame ([0171]), the leaflets being configured to maintain coaptation when the valve is in a first position, or in a second (larger diameter) position ([0091]),
the frame comprising (expanding) portions alternating with second (non-expanding) portions (Figures 40-42, 48-52 shows how Colavito’s expanding frame has three areas of expanding frame alternating with three areas of non-expanding frame), wherein each leaflet has at least one foldable leaflet surface (the Examiner notes that every surface of a flexible leaflet is inherently “foldable”. See also [0006]) such that when the foldable leaflet surface is folded, the valve is in a first position and when the leaflet surface is unfolded, the valve is in a second position ([0006], [0193]-[0194]),
wherein the valve system is capable of being twice expandable via two balloons (The system is understood to be capable of being expandable via two balloons if desired. The device is understood to be capable of expansion twice, to two different diameters if desired. See also [0009], [0170], and [0258] (Fig 49) where selective expansion features can straighten past a frame’s general expanded state diameter, so that upon diametric expansion, the selective expansion features reduce their degree of undulation thus creating a larger frame diameter). Bonhoeffer and Colavito are involved in the same field of endeavor, namely growth-accommodating heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Bonhoeffer Justino Combination to have the leaflets folded as is taught by Colavito in order to allow the valve to function properly with the right amount of leaflet coaption at both diameters. It would additionally have been obvious to have alternating open-cell (expanding) portions and second portions as is taught by Colavito in order to have a symmetrically expanding valve which is able to closely match the originally implanted commissure locations, which are desirably matching the native commissure locations upon initial delivery/expansion. This enables biomimetic function of the replacement valve.
Further, as regards there being a plurality of connected cells within each closed-cell portion, the Combination as a whole should be considered. Notably, while Bonhoeffer teaches there is only one open-cell (e.g. expanding) portion (Figure 1 item 11) in their valve with a larger second portion (the straight parts of Figure 1 item 12), Colavito teaches that there can be three expanding portions alternating with non-expanding portions (Figures 40-42, 48-52). With the assumption that there are now three open-cell (expanding) portions in the Combination, and with the modification in view of Justino which has the frame in the non-open-cell (non-expanding, second) portions in the form of rhombus-shaped closed cells, the Combination now includes a set of closed cells with three interruptions where expanding open-celled jogs exist. While the number of cells could be considered variable by a person of ordinary skill, Figure 22a of Justino shows about 20 (closed) cells circumferentially, and at least 6 cells vertically. A person of ordinary skill would understand just about any number of closed-cells could exist between the open-cell jogs of the Combination based on intended use and design targets, but they would reasonably understand that at least two (e.g. a plurality) of closed cells would be left together in any one of the three closed-cell portions.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/ Primary Examiner, Art Unit 3774 07/28/25