DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 05/16/2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed 04/03/2024 (3 pages in length) fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 112
The rejection of claim(s) 15 in the previous Office Action under this section, 2nd paragraph (pre-AIA ) or subsection (b) (AIA ), for being indefinite is hereby withdrawn in view of Applicant’s Amendment
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 7-15 is/are rejected under pre-AlA35 U.S.C. 103(a) as being unpatentable over US 2004/0215333 Al to Duran et al. (hereinafter “Duran") in view of US 2003/0212454 A1 to Scott et al. (hereinafter “Scott”) and US 2005/0113910 A1 to Paniagua et al. (hereinafter “Paniagua”), (all references cited in an IDS dated 04/03/2024).
Regarding claim 7, Duran discloses (see abstract; Figs. 1-13; and [0031]-[0077]) an assembly configured for replacing an aortic or pulmonary heart valve in a human patient, comprising: a transcatheter (see at least [0039] & [0050]-[0051]), prosthetic aortic or pulmonary heart valve (see at least [0006]-[0010)), including: a frame ("stent" 22, see [(0042]-[0048]) that is expandable and collapsible (see at least [0042]); and a tissue leaflet assembly (15) sutured directly to the frame (see at least [0066]- [0067]), wherein the tissue leaflet assembly includes three substantially dry ("freeze-drying", see [0038], note also incorporation by reference to US 6,277,555) leaflets (see at least [0031]) leaflets that each include a free edge that has a curved profile configured to increase total surface area between operating leaflets (see [0032]-[0033]), wherein a single piece of treated mammalian pericardial tissue is used to form the three substantially dry leaflets (see [0032] & [0063]-[0065]), wherein the frame and the tissue leaflet assembly are collapsible as an integral unit (see [0042], [0047], [0050], & [0072]-[0074], they collapse together once attached to each other) such that a cell structure of the frame and an orientation of the leaflets of the tissue leaflet assembly are maintained during a collapsing of the transcatheter, prosthetic aortic or pulmonary heart valve (see [0042], [0047], [0050], & [0072]-[0074], the cell structure of the mesh frame is maintained as the cells simply collapse in size but otherwise the cell structures remain the same, further, the orientation of the leaflets is maintained as the free edges of the leaflets are still in contact with each other); a percutaneously insertable valve delivery mechanism ("delivery catheter system", see at least [(0050]/[0053]/[0072]- [0074]) wherein the transcatheter, prosthetic aortic or pulmonary heart valve is releasably and coaxially mounted onto a balloon catheter of the percutaneously insertable valve delivery mechanism (see Fig. 12 and [0072]), and wherein the balloon catheter includes a guidewire lumen (35, accommodating guidewire 32, see Fig. 12 and [0072]); and a sterile package (see [0038], "packaged" and "sterilized") containing the transcatheter, prosthetic aortic or pulmonary heart valve that is releasably and coaxially mounted onto the balloon catheter (see [0038], "valve, stent, and delivery system...packaged" and "valve placed within endovascular stent system is then collapsed within a delivery catheter system; see also Fig. 12 and [0072]).
Duran further discloses (claim 8) wherein the frame comprises a stent ("stent" 22, see [0042]- [0048]); (claim 9) wherein the treated mammalian pericardial tissue has an ultimate tensile strength of greater than about 12 MegaPascals (see [0063], Duran's pericardium is sourced from pig, calf, or horse - as evidenced by US 2012/0059487 A1 to Cunanan et al., pig (porcine) or horse (equine) pericardium is shown having an ultimate tensile strength of greater than 12 MPa, and since ultimate tensile strength is an inherent property of a material, Duran's treated pericardium would exhibit these ultimate tensile strengths); and (claim 10) wherein the treated mammalian pericardial tissue does not include a matrix that has been exposed to a polymer infiltrate (nowhere does Duran disclose that the treated mammalian pericardial tissue has a matrix that has been exposed to a polymer infiltrate - Duran does not disclose any type of infiltrate/infiltration/penetration etc. of the tissue by any type of polymer whatsoever, therefore it is clearthat Duran would inherently disclose that the treated mammalian pericardial tissue does not include a matrix that has been exposed toa polymer infiltrate, because Duran would have disclosed the presence of the claimed limitation if it were present in the inventive disclosure).
Duran discloses the invention substantially as claimed as discussed above, however, with respect to claim 7, Duran fails to specifically disclose wherein the treated mammalian pericardial tissue used to form the three substantially dry leaflets has a thickness of between about 50 to 300 um; and has been treated with glutaraldehyde and glycerol; and wherein the balloon catheter has a size of 12 to 14 French.
Scott discloses (see abstract and [0011]-[0017]) the use of compressed bovine pericardial tissue having a thickness of between 50-300 um (.23mm which is 230 um, see [0017]) in the same field of endeavor for the purpose of thinning the leaflets to an appropriate thickness which has the same tensile strength as thicker prior art leaflets but which enables the minimally-invasive valve to be reduced to a smaller insertion profile (see [0011]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Duran’s assembly to have a tissue thickness of 230 um in order to provide a leaflet with an appropriate thickness which has the same tensile strength as thicker prior art leaflets but which enables the minimally-invasive valve to be reduced to a smaller insertion profile.
Paniagua discloses a percutaneously implantable replacement heart valve and a method of making the same by treating the tissue (see abstract), wherein the valve comprises treated mammalian pericardial tissue (see [0046]), wherein the treated mammalian pericardial tissue is treated with glutaraldehyde and glycerol (see [0049]) in the same field of endeavor for the purpose of removing unwanted layers of the pericardial tissue and for removing lipids to make the surfaces smoother and more compact and biocompatible by decreasing the molecular distance of collagen fibers, while also making the material stronger and more homogenous and biocompatible (see [0049]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Duran's assembly (as modified by Scott above) by treating the tissue with glutaraldehyde and glycerol, as taught by Paniagua, in order to remove unwanted layers of the pericardial tissue and for removing lipids to make the surfaces smoother and more compact and biocompatible by decreasing the molecular distance of collagen fibers, while also making the material stronger and more homogenous and biocompatible.
Regarding the claim limitation of the catheter having a size of 12-14 French, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the catheter between 12-14 French since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, then the claimed device is not patentably distinct from the prior art device. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) and MPEP 2144.04(IV)(A). The claimed catheter size is a suitable size for use in transcatheter valve implantation, and therefore the claimed device would not perform differently than Duran’s device.
With respect to claims 11-12, the combination of Duran, Scott, and Paniagua, discloses the invention substantially as claimed as discussed above, and would further disclose wherein the treated mammalian pericardial tissue has been treated with distilled water or isopropyl alcohol because Paniagua discloses treating the mammalian pericardial tissue with distilled water and isopropyl alcohol (see [0049]) in the same field of endeavor for the purpose of removing unwanted layers of the pericardial tissue and for removing lipids to make the surfaces smoother and more compact and biocompatible by decreasing the molecular distance of collagen fibers, while also making the material stronger and more homogenous and biocompatible (see [0049]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Duran's assembly (as modified by Scott and Paniagua) by treating the tissue with distilled water and isopropyl alcohol, as further taught by Paniagua, in order to remove unwanted layers of the pericardial tissue and for removing lipids to make the surfaces smoother and more compact and biocompatible by decreasing the molecular distance of collagen fibers, while also making the material stronger and more homogenous and biocompatible.
With respect to claims 13-15, the combination of Duran, Scott, and Paniagua, discloses the invention substantially as claimed as discussed above, and would further, Paniagua discloses wherein the tissue leaflet assembly comprises two or more integrated cusp and leaflet folded structures that each include a mobile leaflet section and a cuff wall section located radially outside the mobile leaflet section such that in a closed position at least a portion of free edges of the mobile leaflet sections are in contact with each other (see [0047]-[0051]); wherein the tissue leaflet assembly comprises one or more pleats that are sutured to the frame (see [0050]-[0053]); and wherein the cuff wall section extends longitudinally beyond the free edges of the mobile leaflet sections (see [0046]-[0047]) in the same field of endeavor for the purpose of reducing the extent of suturing otherwise required by better resembling the natural form and function of the valve leaflets while also reducing the risk of tearing of the cusps or leaflets (see [0026]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Duran's assembly (as modified by Scott and Paniagua) by forming cusp and leaflet folded structures, pleats or having the longitudinally extending cuff section, as further taught by Paniagua, in order to reduce reducing the extent of suturing otherwise required by better resembling the natural form and function of the valve leaflets while also reducing the risk of tearing of the cusps or leaflets.
Allowable Subject Matter
Claim 16 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 following is a statement of reasons for the indication of allowable subject matter: none of the prior art of record, alone or in combination, teaches or suggests forming pleats of a tissue leaflet assembly by commissure folds positioned along a length of the assembly.
Response to Arguments
Applicant's arguments filed 05/16/2025 have been fully considered but they are not persuasive. Applicant alleges that Duran fails to implicitly or explicitly disclose the limitation “the cell structure of the frame and an orientation of the leaflets of the tissue leaflet assembly are maintained”… because Duran neither explicitly addresses this feature and thus necessarily fails to implicitly address this feature because Duran’s assembly could not maintain its cell structure or leaflet orientation. The Examiner respectfully disagrees, because although Applicant is correct about the standards for inherency, Applicant is too narrowly interpreting this broad limitation – when the limitation is given the proper broadest reasonable interpretation, it is clear that this limitation is met either explicitly or inherently.
First, with respect to the concept of “cell structure”, this term is broad so as to encompass a variety of characteristics about the structure of the cells of a stent frame. For example, one “cell structure” that is well known in the art of stent frames is an open cell versus a closed cell. Closed cells are cells which are defined entirely by a strut or wire traversing the entire outer perimeter of the cell. Open cells, by contrast, have at least some portion of the cell which is not defined by a strut or wire thus leaving an opening. As is understood in the art, neither a closed cell nor an open cell changes structure/configuration when transitioning from a collapsed configuration to an expanded configuration (and back to a collapsed configuration). A closed cell remains a closed cell, and an open cell remains an open cell. Duran discloses a “tubular mesh” at [0042]. A mesh is well understood to correspond to a closed cell characterization. Nonetheless, regardless of whether Duran’s stent has a closed cell or open cell configuration, when the stent is collapsed together with its tissue leaflet assembly, the cells will not transition to the opposing configuration (open to closed, or closed to open). Thus, it is inherent, and necessarily true, that the cell structure is maintained during a collapsing (because if it weren’t maintained, then the closed cell configuration when collapsed would no longer be closed cell when expanded again in the body, which would damage the intended purpose of having a closed cell configuration).
Likewise, the leaflet orientation is similarly broad. For example, the orientation could refer to the orientation of each of the three leaflets relative to the other leaflets. Duran discloses that the leaflets are sutured at the commissures to facilitate correct positioning and anchoring of the valve within the stent frame (see [0034]). Thus, because each of the leaflets is sutured and thus “anchored” to a particular “arc” of the circumference of the stent frame, when the stent frame is collapsed, the relative orientation of that particular leaflet will not change relative to the other leaflets (i.e., it will still be located between the other two leaflets along the outer periphery of the leaflet structure). This is also inherent, or else Duran’s teaching of “correct positioning and anchoring” as just described would be negated if the leaflets re-oriented themselves when the device was collapsed for delivery. Accordingly, this limitation is met by the combination of references, and Applicant’s arguments are not persuasive.
Applicant’s arguments with respect to claim 14 are also not persuasive. As shown by Applicant’s attached definition of “pleat”, the definition is “fold”. Paniagua discloses a variety of folds in Figs. 9A-C and [0049], and explicitly uses the term “pleat” in [0050]. At least because Fig. 9A shows a fold (or “pleat”) along the entire length of the flattened leaflet material, the entire leaflet material constitutes a fold (as shown in Fig. 9B) and thus any suture attachment point at any point along the leaflet material would constitute a pleat at that location. Nonetheless, Paniagua explicitly discloses suturing the lengthwise pleats at [0050]. Accordingly, Applicant’s arguments are not persuasive.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771