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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-24, drawn to a system for preventing paravalvular leak associated with a replacement structural cardiac valve, classified in A61F2/2409.
II. Claims 25-42, drawn to a method for preventing paravalvular leak following cardiac valve replacement, classified in A61F2/2466.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process of using that product, as the product does not require being deployed by a method involving the steps of a. using a first delivery catheter included with the system, operable to deploy the ring, engaging the cardiac valve’s annulus with the zone-specific, strained and resilient anchors at a predetermined orientation; and b. using a second delivery catheter included with the system, transitioning the resilient prosthetic valve scaffold from the insertion configuration to the operable configuration within the internal circumference of the ring, such that the ring encloses the resilient prosthetic valve scaffold’s hyperboloid vertex.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Different search queries, different search strategies and different areas of search are required for each different group as claimed. For example, Group I would require a search in at least A61F2/2409, along with a unique text search. Group II would require a search in at least A61F2/2466, along with a unique text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Christopher Bolten on 12/17/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-24. Affirmation of this election must be made by applicant in replying to this Office action. Claims 25-42 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claims 8, 9, 10, and 17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the hyperboloid vertex" in line 2. There is insufficient antecedent basis for this limitation in the claim, as there is no "hyperboloid vertex" introduced in the claim or claims from which the claim depends on.
Claim 9 recites the limitation "the vertex" in line 2. There is insufficient antecedent basis for this limitation in the claim, as there is no "vertex" introduced in the claim or claims from which the claim depends on.
Claim 10 recites the limitation "the vertex" in line 2. There is insufficient antecedent basis for this limitation in the claim, as there is no "vertex" introduced in the claim or claims from which the claim depends on.
Claim 10 recites the limitation " the external circumference of the resilient prosthetic" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, as there is no "external circumference" introduced in the claim or claims from which the claim depends on.
Claim 17 recites the limitation "the left trigon and the right trigon" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim, as there is no "right trigon" or "left trigon" introduced in the claim or claims from which the claim depends on.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--).
Regarding Claim 1, Dumontelle discloses a system for preventing paravalvular leak (PVL) associated with a replacement structural cardiac valve, comprising: a ring (100), operably coupled to a tissue annulus of a structural cardiac valve (see Abstract), the ring operable to actively couple the tissue to the ring, and prevent axial translation of the ring relative to the tissue annulus (see paragraph [0103]).
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This embodiment of Dumontelle fails to disclose a resilient prosthetic valve scaffold, enclosed within, and coupled to the ring operable to engage both the ring and a portion of the structural cardiac valve, wherein the system is operable to prevent axial translation between the ring and the resilient prosthetic valve scaffold.
Another embodiment of a ring of Dumontelle discloses a resilient prosthetic valve scaffold, enclosed within (see annotated resilient prosthetic valve scaffold enclosed in a ring in Figure 23A below), and coupled to the ring operable to engage both the ring and a portion of the structural cardiac valve (see paragraphs [0221] and [0222] denoting that the valve 2310 is within the ring, and then coupled to a two or three leaflet valve), wherein the system is operable to prevent axial translation between the ring and the resilient prosthetic valve scaffold (see paragraph [0221] denoting that the ring and scaffold 2310 are in continuous contact).
Claims 2-4, 9-12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--).
Regarding Claim 2, Dumontelle discloses the system of claim 1, wherein the ring (113) comprises: a hollow tube (see paragraph [0098]) comprising:
i. a first end; and
ii. a second end (see annotated ends in Figure 1B below);
i. a first end; and
ii. a second end (see annotated ends in Figure 1B below);
c. at least one snap mechanism configured to connect the first end and the second end together, forming a ring with a predetermined internal circumference (see paragraph [0110]);
d. a plurality of anchor deployment zones (650a,b,c); and
e. a plurality of zone-specific, strained and resilient anchors (104), each zone-specific, strained and resilient anchor configured to transition between insertion configuration within the ring and deployment configuration, wherein each of the zone-specific strained anchors are configured to engage the annulus tissue of the structural cardiac valve, continuously bias the tissue toward the ring, and prevent axial translation of the ring relative to the annulus (see paragraph [0143]).
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Dumontelle fails to disclose a mesh fabric sleeve having a plurality of openings defined therein.
Reich discloses a ring structure with anchors that is implanted into the body to repair a mitral valve (see paragraph [0418], see also Figure 2I below). Reich teaches a mesh fabric sleeve having a plurality of openings defined therein (see paragraph [0400]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a mesh fabric sleeve having a plurality of openings defined therein, as by doing so would promote tissue growth into the braid of the sleeve as taught by Reich (see paragraph [0400]).
Regarding Claim 3, Dumontelle as modified discloses the system of claim 2.
The limitation “wherein the resilient prosthetic valve scaffold is operable to transition from an insertion configuration to an operative configuration” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the prosthetic valve scaffold being made from a flexible material that can expand and contract (see paragraph [0222] and Figures 23C and 23A showing that the scaffold can expand and constrict), the valve scaffold is able to transition from an insertion configuration to an operative configuration.
Regarding Claim 4, Dumontelle as modified discloses the system of claim 3, wherein, in the operative configuration the resilient prosthetic valve scaffold forms a hyperboloid of one sheet (see annotated scaffold in Figure 23A above), having a basal end and an apical end defining a longitudinal axis, wherein the ring is sized and configured to accommodate the resilient prosthetic valve scaffold (see annotated ring, axis, basal and apical ends in Figure 23A above).
Regarding Claim 9, Dumontelle as modified discloses the system of claim 4, wherein the resilient prosthetic valve scaffold is accommodated within the ring at the vertex of the hyperboloid of one sheet (see annotated valve and ring in Figure 23A above). The limitation “vertex” is being defined as “a point that terminates a line or curve” (see Merriam Webster online definition 2b).
Regarding Claim 10, Dumontelle as modified discloses the system of claim 9, in the operable configuration, the external circumference of the resilient prosthetic valve scaffold at the vertex has an external circumference that is larger than the internal circumference of the ring (see annotated cross section that is D-shaped in Figure 23A, which is bigger than the inside of the ring). The limitation “vertex” is being defined as “a point that terminates a line or curve” (see Merriam Webster online definition 2b).
Regarding Claim 11, Dumontelle as modified discloses the system of claim 4, wherein the ring has a D-shape having a major axis and a minor axis (see annotated D-shaped ring and axis’s in Figure 1B above); and wherein, in the operable configuration, the resilient prosthetic valve scaffold has a cross section, transverse to the longitudinal axis having a D-shape, defining a major axis that is longer than the major axis of the D-shaped ring and a minor axis that is larger than the minor axis of the D-shaped ring (see annotated cross section that is D-shaped in Figure 23A, which is bigger than the inside of the ring), the resilient prosthetic valve scaffold configured to bias the ring radially (see annotated prosthetic valve and ring in Figure 23A above).
Regarding Claim 12, Dumontelle as modified discloses the system of claim 2, wherein the mesh fabric sleeve comprises a woven fabric with a thread density configured to allow ingrowth of portion of the structural cardiac valve into the ring, and provide a seal between the tissue annulus and the ring (see claim 2 rejection above).
Regarding Claim 18, system of claim 4, wherein the hyperboloid of one sheet is asymmetric (see annotated prosthetic valve in Figure 23A above).
Dumontelle as modified fails to disclose wherein the longitudinal axis of the apical end is shorter than the longitudinal axis of the basal end. However, such a modification would have involved a mere change in the shape of a component. As well known in the art, the anatomy of a patient’s heart varies widely due to age, race, height, weight, health, injuries, birth defects, etc. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the longitudinal axis of the apical end be shorter than the longitudinal axis of the basal end for the purpose of accommodating a particular patient’s anatomy.” Additionally, a change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--), as applied to claim 12 above, in further view of US 6258122 B1 (hereafter --Tweden--).
Regarding Claim 13, Dumontelle as modified discloses the system of claim 12.
Dumontelle as modified fails to disclose wherein the sleeve is coated with an agent configured to promote neo-endocardial tissue ingrowth into the mesh fabric sleeve.
Tweden discloses heart valve annuloplasty devices to improve heart valve function (see Abstract). Tweden teaches wherein the device is coated with an agent configured to promote tissue ingrowth into the mesh fabric sleeve, such as platelet-derived growth factor (PDGF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include wherein the device is coated with an agent configured to promote tissue ingrowth into the mesh fabric sleeve, such as platelet-derived growth factor (PDGF), as by doing so would promote more tissue growth, as it may be further facilitated through use of growth factors as taught by Tweden (see column 7, lines 24-39).
The intended use recited in the claim (“neo-endocardial tissue ingrowth”) has been considered but deemed not to impose any structural difference between the claimed invention and Tweden’s device. Tweden’s device is structured as claimed and is therefore capable of being used for supporting neo-endocardial tissue ingrowth, as it’s capable of supporting general tissue ingrowth (see column 7, lines 24-39).
Regarding Claim 19, Dumontelle as modified discloses the system of claim 13, wherein the agent configured to promote tissue ingrowth into the mesh fabric sleeve is at least one of: insulin-like growth factor 1 (IGF-1), neuregulin, and platelet-derived growth factor (PDGF), or a composition comprising the foregoing (see claim 13 rejection above).
The intended use recited in the claim (“neo-endocardial tissue ingrowth”) has been considered but deemed not to impose any structural difference between the claimed invention and Tweden’s device. Tweden’s device is structured as claimed and is therefore capable of being used for supporting neo-endocardial tissue ingrowth, as it’s capable of supporting general tissue ingrowth (see column 7, lines 24-39).
Claims 5 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--), as applied to claim 4 above, in further view of US 20250099232 A1 (hereafter –Becerra--).
Regarding Claim 5, Dumontelle as modified discloses the system of claim 4.
Dumontelle as modified fails to disclose wherein the resilient prosthetic valve scaffold further comprises a plurality of resilient clamps, operable, upon transition from the insertion configuration to the operative configuration, to engage at least one of: a native leaflet, and a native cusp of the structural cardiac valve.
Becerra discloses a prosthetic valve designed to anchor into the heart for improved deployment, sealing, and anchoring into the implantation site (see Abstract). Becerra teaches wherein the resilient prosthetic valve scaffold further comprises a plurality of resilient clamps, operable, upon transition from the insertion configuration to the operative configuration, to engage at least one of: a native leaflet, and a native cusp of the structural cardiac valve (see paragraph [0321], see also Figures 14 and 15 showing that there can be four anchors (clamps), see Figures 69 and 70 for the embodiment of the anchor 498 that clamps a leaflet against the device, see also paragraph [0196] denoting even more than 4 anchors/clamps can be connected to the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include wherein a plurality of resilient clamps, operable, upon transition from the insertion configuration to the operative configuration, to engage at least one of: a native leaflet, and a native cusp of the structural cardiac valve, as by doing so would enable the device to clamp a leaflet between the anchor 498 and the device to secure a leaflet between the anchor and the device (see paragraph [0321]).
Regarding Claim 14, Dumontelle as modified discloses the system of claim 4, wherein the structural cardiac valve is a mitral valve (see paragraphs [0221] and [0222] denoting that the valve 2310 is within the ring, and then coupled to a two or three leaflet valve).
Becerra discloses a prosthetic valve designed to anchor into the heart for improved deployment, sealing, and anchoring into the implantation site (see Abstract). Becerra teaches wherein the resilient prosthetic valve scaffold comprises a resilient anterior clamp and a resilient posterior clamp (see paragraph [0321], see also Figures 14 and 15 showing that there can be four anchors (clamps), see Figures 69 and 70 for the embodiment of the anchor 498 that clamps a leaflet against the device, see also paragraph [0196] denoting even more than 4 anchors/clamps can be connected to the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a resilient anterior clamp and a resilient posterior clamp, as by doing so would enable the device to clamp a leaflet between the clamps and the device to secure a leaflet between the anchor and the device (see paragraph [0321]).
The limitation “the resilient anterior clamp sized to engage a native anterior leaflet of the mitral valve, and wherein the resilient posterior resilient clamp is configured to engage a native posterior leaflet of the mitral valve” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the modified device comprising of a plurality of resilient clamps, operable, upon transition from the insertion configuration to the operative configuration, to engage a native leaflet (see claim 5 above, one of the anchors being “the posterior clamp” another being the ”anterior clamp”), the modified device would be capable of having a resilient anterior clamp sized to engage a native anterior leaflet of the mitral valve, and wherein the resilient posterior resilient clamp is configured to engage a native posterior leaflet of the mitral valve.
Regarding Claim 15, Dumontelle as modified discloses the system of claim 4, wherein the structural cardiac valve is a tricuspid valve (see paragraphs [0221] and [0222] denoting that the valve 2310 is within the ring, and then coupled to a two or three leaflet valve).
Dumontelle as modified fails to disclose wherein the resilient prosthetic valve scaffold comprises a first resilient clamp, a second resilient clamp, and a third resilient clamp.
Becerra discloses a prosthetic valve designed to anchor into the heart for improved deployment, sealing, and anchoring into the implantation site (see Abstract). Becerra teaches wherein the resilient prosthetic valve scaffold comprises a resilient anterior clamp, a resilient septal clamp, and a resilient posterior clamp (see paragraph [0321], see also Figures 14 and 15 showing that there can be four anchors (clamps), see Figures 69 and 70 for the embodiment of the anchor 498 that clamps a leaflet against the device, see also paragraph [0196] denoting even more than 4 anchors/clamps can be connected to the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a resilient anterior clamp, a resilient septal clamp, and a resilient posterior clamp, as by doing so would enable the device to clamp a leaflet between the clamps and the device to secure a leaflet between the anchor and the device (see paragraph [0321]).
The limitation “the resilient anterior clamp is sized to engage to a native anterior cusp of the tricuspid valve, wherein the resilient septal clamp is sized to engage to a native septal cusp of the tricuspid valve, and wherein the resilient posterior clamp is sized to engage to a native posterior cusp of the tricuspid valve” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the modified device comprising of a plurality of resilient clamps, operable, upon transition from the insertion configuration to the operative configuration, to engage a native leaflet (see rejection above, one of the anchors being “the posterior clamp”, another being the ”anterior clamp”, and another being the “septal clamp”), the modified device would be capable of having a resilient anterior clamp, a resilient septal clamp, and a resilient posterior clamp, the resilient anterior clamp is sized to engage to a native anterior cusp of the tricuspid valve, wherein the resilient septal clamp is sized to engage to a native septal cusp of the tricuspid valve, and wherein the resilient posterior clamp is sized to engage to a native posterior cusp of the tricuspid valve.
Regarding Claim 16, Dumontelle as modified discloses the system of claim 4, wherein the structural cardiac valve is an aortic valve (see paragraphs [0221] and [0222] denoting that the valve 2310 is within the ring, and then coupled to a two or three leaflet valve).
Dumontelle as modified fails to disclose wherein the resilient prosthetic valve scaffold comprises a first resilient clamp, a second resilient clamp, and a third resilient clamp.
Becerra discloses a prosthetic valve designed to anchor into the heart for improved deployment, sealing, and anchoring into the implantation site (see Abstract). Becerra teaches wherein the resilient prosthetic valve scaffold comprises a first resilient clamp, a second resilient clamp, and a third resilient clamp (see paragraph [0321], see also Figures 14 and 15 showing that there can be four anchors (clamps), see Figures 69 and 70 for the embodiment of the anchor 498 that clamps a leaflet against the device, see also paragraph [0196] denoting even more than 4 anchors/clamps can be connected to the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a first resilient clamp, a second resilient clamp, and a third resilient clamp, as by doing so would enable the device to clamp a leaflet between the clamps and the device to secure a leaflet between the anchor and the device (see paragraph [0321]).
The limitation “the first resilient clamp is sized to engage a native right coronary cusp (RCC) of the aortic valve, wherein the second resilient clamp is sized to engage a native left coronary (LCC) cusp of the aortic valve, and wherein the third resilient clamp is sized to engage a native non-coronary cusp (NCC) of the aortic valve” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the modified device comprising of a plurality of resilient clamps, operable, upon transition from the insertion configuration to the operative configuration, to engage a native leaflet (see rejection above, one of the anchors being “the first clamp”, another being the ”second clamp”, and another being the “third clamp”), the modified device would be capable of having a first resilient clamp, a second resilient clamp, and a third resilient clamp, the first resilient clamp is sized to engage a native right coronary cusp (RCC) of the aortic valve, wherein the second resilient clamp is sized to engage a native left coronary (LCC) cusp of the aortic valve, and wherein the third resilient clamp is sized to engage a native non-coronary cusp (NCC) of the aortic valve.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--), as applied to claim 4 above, in even further view of US 20120101567 A1 (hereafter –Jansen--).
Regarding Claim 7, Dumontelle as modified discloses the system of claim 4.
Dumontelle as modified fails to disclose wherein the resilient prosthetic valve scaffold, further comprises a plurality of spurs, each spur extending in the apical direction, the plurality of spurs operable to engage at least one of: the portion of the structural cardiac valve [and at least a portion of the ring].
Jansen discloses a resilient prosthetic valve scaffold for anchoring into the heart (see Figure 3, see also Abstract). Jansen teaches wherein the resilient prosthetic valve scaffold, further comprises a plurality of spurs, each spur extending in the apical direction, the plurality of spurs operable to engage at least one of: the portion of the structural cardiac valve (see paragraph [0051], see also spurs in Figure 3b below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a plurality of spurs, each spur extending in the apical direction, the plurality of spurs operable to engage at least one of: the portion of the structural cardiac valve, as by doing so would enable the device to grip into the natural vessel wall (see FIG. 3a, 3b) are proposed for secure anchoring of the valve stent in the vessel, as taught by Jansen (see paragraph [0051]).
Although not required due to the “at least one of” clause, the limitation “engage at least a portion of the ring” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the modified device comprising spurs, said spurs would be capable of engaging a portion of the ring.
Claims 6, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--), as applied to claim 4 above, in even further view of US 20170189177 A1 (hereafter –Schweich--).
Regarding Claim 6, Dumontelle as modified discloses the system of claim 4.
Dumontelle as modified fails to disclose wherein the resilient prosthetic valve scaffold, further comprises a plurality of apical fiducials, configured to orient the resilient prosthetic scaffold within the ring, relative to the structural cardiac valve.
Schweich discloses a resilient prosthetic valve scaffold for anchoring into the heart (see Figure 14, see also Abstract). Schweich teaches wherein the resilient prosthetic valve scaffold, further comprises a plurality of apical fiducials (226) (see annotated fiducials in Figure 20 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a plurality of apical fiducials, as by doing so would enable the device to be capable of holding radiopaque marker material, attachment points for suture loops or other elements which are additional control points for delivery and retrieval of the assembly, locations to secure a positional delivery frame, and the like (see paragraph [0161]).
The limitation “configured to orient the resilient prosthetic scaffold within the ring, relative to the structural cardiac valve” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the modified device having fiducials at the apical point that are able to act as control points for delivery and retrieval of the assembly (see paragraph [0161]), the fiducials are capable of orienting the resilient prosthetic scaffold within the ring, relative to the structural cardiac valve.
Regarding Claim 8, Dumontelle as modified discloses the system of claim 4.
Dumontelle as modified fails to disclose wherein the resilient prosthetic valve scaffold further comprises a plurality of apertures defined at the hyperboloid vertex.
Schweich teaches wherein the resilient prosthetic valve scaffold further comprises a plurality of apertures defined at the vertex (see annotated apertures in Figure 20 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further include a plurality of apertures defined at the hyperboloid vertex, as by doing so would enable the device to be capable of holding radiopaque marker material, attachment points for suture loops or other elements which are additional control points for delivery and retrieval of the assembly, locations to secure a positional delivery frame, and the like (see paragraph [0161]).
Regarding Claim 17, Dumontelle as modified discloses wherein the structural cardiac valve is a mitral valve (see paragraphs [0221] and [0222] denoting that the valve 2310 is within the ring, and then coupled to a two or three leaflet valve), the resilient prosthetic valve scaffold comprising a pair of spaced apart anterior fiducials and a single posterior fiducial (see claim 6 rejection above, one of the fiducials being anterior, another being posterior).
The limitation “configured to orient the resilient prosthetic scaffold within the ring such that the pair of spaced apart anterior fiducials are adjacent the left trigon and the right trigon” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the modified device having fiducials at the apical point that are able to act as control points for delivery and retrieval of the assembly (see paragraph [0161]), the fiducials are capable of orienting the resilient prosthetic scaffold within the ring such that the pair of spaced apart anterior fiducials are adjacent the left trigon and the right trigon.
Claims 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--), as applied to claim 4 above, in even further view of US 20230028375 A1 (hereafter –Senesh--).
Regarding Claim 20, Dumontelle as modified discloses the system of claim 4.
Dumontelle as modified fails to disclose wherein the exterior of the resilient prosthetic valve scaffold is covered with the mesh fabric forming a continuous skirt, the continuous skirt comprises a woven fabric with a thread density configured to allow ingrowth of portion of the structural cardiac valve into the skirt, and provide a seal between the resilient prosthetic valve scaffold and the ring.
Senesh discloses a resilient prosthetic valve scaffold (100, see Abstract). Senesh teaches wherein the exterior of the resilient prosthetic valve scaffold is covered with the mesh fabric forming a continuous skirt, the continuous skirt comprises a woven fabric with a thread density configured to allow ingrowth of portion of the structural cardiac valve into the skirt, and provide a seal between the resilient prosthetic valve scaffold and the ring (see paragraph [0071], [0115], and [0118]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the resilient prosthetic valve scaffold be covered with the mesh fabric forming a continuous skirt, the continuous skirt comprises a woven fabric with a thread density configured to allow ingrowth of portion of the structural cardiac valve into the skirt, and provide a seal between the resilient prosthetic valve scaffold and the ring, as by doing so would promote tissue growth for sealing of the valve against the native tissue (see paragraph [0070]).
Regarding Claim 22, Dumontelle as modified discloses the system of claim 20, further comprising a plurality of leaflets operably coupled to at least one of: the apertures, and the continuous skirt, the leaflets operable as the replacement structural cardiac valve (see paragraphs [0221] and [0222] denoting that the valve 2310 is within the ring, and then coupled to a two or three leaflet valve).
Regarding Claim 23, Dumontelle as modified discloses the system of claim 22, comprising four leaflets operable as replacement for a mitral valve (see paragraph [0214] denoting that there can be up to four valve leaflets within the valve prosthesis).
Claims 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210015609 A1 (hereafter --Dumontelle--) in view of US 20190167425 A1 (hereafter –Reich--), in even further view of US 20230028375 A1 (hereafter –Senesh--), as applied to claim 20 above, in even further view of US 6258122 B1 (hereafter --Tweden--).
Regarding Claim 21, Dumontelle as modified discloses the system of claim 20.
Dumontelle as modified fails to disclose wherein the woven fabric is impregnated with an agent configured to promote neo-endocardial tissue ingrowth into the mesh fabric sleeve.
Tweden discloses heart valve annuloplasty devices to improve heart valve function (see Abstract). Tweden teaches wherein the device is coated with an agent configured to promote tissue ingrowth into the mesh fabric sleeve, such as platelet-derived growth factor (PDGF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the fabric be impregnated with an agent configured to promote tissue ingrowth into the mesh fabric sleeve, such as platelet-derived growth factor (PDGF), as by doing so would promote more tissue growth, as it may be further facilitated through use of growth factors as taught by Tweden (see column 7, lines 24-39).
The intended use recited in the claim (“neo-endocardial tissue ingrowth”) has been considered but deemed not to impose any structural difference between the claimed invention and Tweden’s device. Tweden’s device is structured as claimed and is therefore capable of being used for supporting neo-endocardial tissue ingrowth, as it’s capable of supporting general tissue ingrowth (see column 7, lines 24-39).
Regarding Claim 24, Dumontelle as modified discloses the system of claim 21, wherein the agent configured to promote neo-endocardial tissue ingrowth into the skirt is at least one of: insulin-like growth factor 1 (IGF-1), neuregulin, and platelet-derived growth factor (PDGF), or a composition comprising the foregoing (see claim 21 rejection above).
The intended use recited in the claim (“neo-endocardial tissue ingrowth”) has been considered but deemed not to impose any structural difference between the claimed invention and Tweden’s device. Tweden’s device is structured as claimed and is therefore capable of being used for supporting neo-endocardial tissue ingrowth, as it’s capable of supporting general tissue ingrowth (see column 7, lines 24-39).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20120123531 A1: This reference discloses a D-shaped ring with anchors, a hollow body, two ends, and a snap connection of the two ends, for implantation into an annulus of a patient.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774