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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/18/26 has been entered.
Response to Arguments
Applicant's arguments filed 05/18/26 have been fully considered but they are not persuasive.
On page 6 regarding drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully disagrees, noting the item 51 still refers to two distinct elements. This objection is maintained.
On page 6 regarding claim objections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws the objections of the claim.
On pages 6-7 regarding 112a rejections Applicant argues the term “blood-tight” is a direct translation from the parent application.
The Examiner respectfully agrees and withdraws the 112 rejection of record.
On pages 7 regarding 112b rejections Applicant argues amendments overcome the 112 rejections of record.
The Examiner respectfully agrees and withdraws 112b rejections.
On pages 7-8 regarding prior art rejections Applicant argues amendments overcome the rejection of record since Jing’s connector (2) is not an “integral braided continuation of the proximal and distal stents” but rather comprises “at least two independent silk threads”.
The Examiner respectfully disagrees, noting whether or not something is one-piece when in a retracted configuration and an expanded configuration does not have anything to do with whether or not it is made of different parts. It appears Applicant is arguing that claiming a “unitary one-piece assembly” in both the retracted and deployed configuration means the different parts cannot be connected together. However, “unitary” is defined by Merriam-Webster as “of or relating to a unit; based on or characterized by unity or units; having the character of a unit: undivided, whole”. Merriam-Webster further defines “one-piece” as “consisting of or made in a single undivided piece”. In other words, whether or not the connecting piece 2 of Jing is braided or not braided, does not affect whether or not Jing’s device is an undivided, single piece when in a retracted configuration or a deployed configuration. It only indicates that the pieces are not separate from one another when in the two configurations. There is no reason to think that whether Jing’s pieces are braided together or not would have any bearing on whether or not the parts are connected together to form a single undivided piece, meaning Jing meets the language of the claim. Additionally, while Applicant states the connecting piece (2) is “silk”, the disclosure appears to state that this connector (2), along with both stents (1) and (3) are all made of the same material, for example Nitinol (see page 5 paragraph 5). Silk is not mentioned.
On page 8 Applicant argues further that Jing discusses coating an aortic valve stent (1) as opposed to an aortic stent (3).
The Examiner respectfully disagrees, noting both stents (1) and (3) are shown and described as being coated. See Figure 1 which shows coating (4), and at least page 3 paragraph 3 which describes how stent (3) is “covered with artificial coating (4)”.
On pages 8-9 Applicant argues Frid teaches away from applying an impermeable cover layer to its framework ([0052]), and instead relies on a multilayer braid porosity to laminate blood flow ([0007]-[0008]). Applicant argues a person of ordinary skill starting from Jing would not modify it to be one-piece since this would eliminate flexibility.
The Examiner respectfully points out a teaching reference cannot “teach away” from anything, since it is not being modified. As regards the suggestion that Jing would not be modified to be one-piece, the Examiner respectfully disagrees, noting flexibility does not appear to be related to whether something is constructed in one piece or multiple pieces before connection.
Drawings
The drawings are objected to because:
-item 51 is used to represent multiple elements in the figures. The specification attaches item 51 to “tapered portion of the first portion” and “flared portion of the first portion” in the specification
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1-2, 7, 9-10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing et al. (CN 107019581 A) hereinafter known as Jing in view of Frid et al. (US 20190015228 A1), hereinafter known as Frid.
Regarding claim 1 Jing discloses an aortic root replacement device (Figure 1) which is moveable between a deployed configuration and a retracted configuration (page 6 paragraph 4),
wherein the device comprises:
an intraventricular stent (Figure 1 item 1) with a proximal portion (the inner diameter of stent 1 where the intraventricular stent connects to portion 5) and a distal portion (the outer diameter of stent 1 where the intraventricular stent has a free end), the intraventricular stent being flared from the proximal to the distal portion (Figure 1 shows stent 1 flared from the proximal (connected) to distal (free) end) such that when the device is deployed in the ventricular below the aortic valve, the device is held in position in the ventricle (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Jing was considered capable of performing the cited intended use. See, for example Figure 4),
an aortic valve unit (Figure 1, items 3/4/5),
an aortic stent extending from the intraventricular stent (Figure 1 item 3),
wherein the intraventricular stent, valve unit, and aortic stent form a unitary one-piece assembly in both configurations (page 3, paragraph 10 the elements form an integrated structure; page 4 last paragraph to page 5 first paragraph: “the connecting piece (2) is a flexible connector…two ends of the wires respectively connected with aortic valve bracket (1) and the aorta bracket (3)” The three parts (1), (2), and (3) are connected together, forming a unitary one-piece assembly. The Examiner notes that while Jing shows this construction in Figure 1 during the deployed configuration, it is not explicit in whether or not the device is the same one-piece unitary and connected construction when in the retracted configuration. However, without explaining how the various pieces would be delivered separately and connected in situ, the person of ordinary skill in the art at the time the invention was filed would have found it obvious to have the pieces be a unitary one-piece assembly in the retracted configuration as well as the deployed configuration in order to ease delivery for the physician and ensure proper assembly, thus increasing patient safety, and since there is apparently no guidance in Jing as regards how the various parts could or would be connected after delivery and before expansion.), and
wherein the aortic stent is coated with a biocompatible material (page 3 paragraph 3 the aortic stent (3) is covered with coating (4) (see also Figure 4 item 4), and page 7 paragraph 4 the coating is a bovine pericardium) such that the aortic stent is blood-tight to provide a seal against blood leakage (pericardium is inherently blood-tight), and
wherein the aortic stent comprises at least three openings configured to align with an provide blood flow communication to coronary arteries (Figure 1 shows multiple openings around element 2; Figure 4 shows how they align with coronary arteries. See also page 6 paragraph 5),
but is silent with regards to the aortic stent comprising a mesh.
However, regarding claim 1 Frid discloses an aortic root replacement device (Figures 11-12) which is moveable between a deployed configuration and a retracted configuration (Abstract: the framework is self-expandable; [0049], [0051]), wherein the device comprises an intraventricular stent (Figure 11 item 8) with a proximal portion (the inner diameter of stent 8 where the intraventricular stent connects to portion 5) and a distal portion (the outer diameter of stent 8 where the intraventricular stent has a free end), the intraventricular stent being flared from the proximal to the distal portion (Figure 11 shows stent 8 flared from the proximal (connected) to distal (free) end) such that when the device is deployed in the ventricular below the aortic valve, the device is held in position in the ventricle ([0031], Figure 7), an aortic valve unit (Figures 11-12, item 10), an aortic stent extending from the intraventricular stent (Figures 11-12 item 20), wherein the intraventricular stent, valve unit, and aortic stent form a unitary assembly in both configurations (Abstract), and
wherein the aortic stent comprises a mesh ([0052]).
Jing and Frid are involved in the same field of endeavor, namely aortic aneurysm devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Jing by having the aortic stent comprise a mesh as is taught by Frid since this is a known configuration for stents to be made, and the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the substitution of the zigzag struts for mesh struts would have been obvious to one of ordinary skill. This is understood to result in the pericardium-coated (Jing Figure 1 item 4) mesh (Frid [0052]) being blood tight.
Regarding claim 2 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
wherein Jing further discloses the aortic stent comprises a first portion extending from the intraventricular stent (Figure 1 from element c to d) and a tubular portion extending from the first portion (Figure 1 from element d to e), and
wherein Frid further teaches the aortic stent comprises a first portion extending from the intraventricular stent (Figures 11-12 item 4) and a tubular portion extending from the first portion (Figures 11-12 item 3).
Regarding claim 7 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
wherein Frid further teaches the aortic valve unit is connected to the proximal portion of the intraventricular stent, and is disposed at a junction between the two stents (Figures 11-12 shows the valve unit 10 connected to and located between the two stents).
Regarding claim 9 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
wherein Jing further discloses the openings comprise three windows configured to provide blood flow communication between the aortic stent and the coronary arteries (Figures 1, 4).
Regarding claim 10 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
wherein Jing further discloses the aortic stent comprises a coupling portion having an increased diameter (e.g. the proximal end of the aortic stent 3, whose diameter is increased to at least part of the distal end of the aortic stent 3 near element c) and configured for overlap with another prosthesis intended to be inserted into the aorta of a patient (this is stated as an intended use, which the distal end of the aortic stent 3 is understood capable of doing if desired),
and wherein Frid further teaches the aortic stent comprises a coupling portion having an increased diameter (e.g. the proximal end of the aortic stent 20, whose diameter is increased to at least part of the distal end of the aortic stent 20 near the valve unit 10) and configured for overlap with another prosthesis intended to be inserted into the aorta of a patient (this is stated as an intended use, which the distal end of the aortic stent 20 is understood capable of doing if desired).
Regarding claim 12 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
wherein Jing further discloses the biocompatible material is pericardium (page 7 paragraph 4 the aortic valve stent is coated with a bovine pericardium).
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing and Frid as is applied above, further in view of Chouinard et al. (US 6585758 B1) hereinafter known as Chouinard.
Regarding claim 4 the Jing Frid Combination teaches the device of claim 2 substantially as is claimed,
wherein Frid further teaches the first portion consists of a first mesh ([0052]),
the tubular portion consists of a second mesh ([0052]),
the intraventricular stent consists of a third mesh ([0052]),
but is silent with regards to the three meshes having different mechanical properties.
However, regarding claim 4 Chouinard teaches first, second, and third meshes have different mechanical properties (Figure 3 items 12 (top), 14 (middle), 12 (bottom), respectively; Column 3 lines 28-49 the middle section has a different architecture than the proximal and distal ends, and the distal end section can be different in architecture from the proximal end when one is positioned upstream the other). Jing and Chouinard are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Jing Frid Combination so that the meshes have different mechanical properties as is taught by Chouinard in order to create a stent with a variable flexibility and radial strength throughout, thereby enabling the structure to exhibit strength where needed, and flexibility where needed, depending on the final destination of the implant device.
Claims 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing and Frid as is applied above, further in view of as is applied above, further in view of Koop et al. (US 20220054260 A1) hereinafter known as Koop.
Regarding claim 5 the Jing Frid Chouinard Combination teaches the device of claim 4 substantially as is claimed,
wherein Chouinard further discloses the first mesh (braided section) has a radial force different than a radial force of the second mesh (wound section) (Abstract),
wherein the first mesh is configured to provide a flexibility necessary for a curvature of an aortic root where the first portion is intended to be positioned (as is best understood, since all the meshes of Chouinard are configured for placement within the vasculature of a patient, they are inherently able to provide the flexibility necessary for the aortic root), and
wherein the second mesh is configured to allow to obtain different lengths of the tubular portion (spiral mesh) (Column 3 lines 3-6),
but is silent with regards to the first mesh radial force being greater than the radial force of the second mesh.
However, regarding claim 5 Koop teaches that within an aortic valve replacement, it can be desirable for the location nearest to the valve to have a greater radial force than the downstream end (Figure 2 shows the areas z1, z2 which are positioned near the annulus, including a high radial force for sealing, whereas the region z3 which is downstream from regions z1/z2 has a less high radial force due to its different architecture/netting. See [0065], [0079], [0109]-[0110]). Jing and Koop are involved in the same field of endeavor, namely valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the radial force of the device of the Jing Frid Chouinard Combination so that the first mesh has a greater radial strength than the second mesh as is taught by Koop in order to ensure the force adjacent the valve is greater than that downstream, thus ensuring the device won’t migrate or move undesirably, which increases the safety for the patient and effectiveness overall.
Regarding claim 6 the Jing Frid Chouinard Combination teaches the device of claim 4 substantially as is claimed,
wherein Koop further teaches a valve device that includes an intraventricular stent positionable within a ventricular with a third mesh (Figure 2 item z1), which has a tighter mesh than first (Figure 2 item z2) and second (Figure 2 item z3) meshes for a first portion and tubular portion of an aortic stent, respectively (Figure 2 shows the mesh being the tightest in the inflow area z1; see also [0065] the finely netted region is near the inflow region) to ensure sealing in an area in which it is intended to be disposed ([0065]). Jing and Koop are involved in the same field of endeavor, namely prosthetic valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Jing Frid Chouinard Combination so that the mesh is tightest at the inflow end as is taught by Koop in order to ensure a high radial force for sealing in this area.
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing and Frid as is applied above, further in view of Spence (US 20180153690 A1).
Regarding claim 11 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regards to the intraventricular stent having a notch on the periphery of the proximal portion.
However, regarding claim 11 Spence teaches a valved device which includes a notch formed on a periphery of a proximal ventricular portion (Figure 19a-c item 240; [0227]). Jing and Spence are involved in the same field of endeavor, namely valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Jing Frid Combination by including a notch on the periphery of the proximal portion of the intraventricular stent as is taught by Spence in order to allow the minimization of contact between the stent of the device and any electrical structures which might be present in the heart, thus avoiding potential damage to the patient ([0227])
Claims 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing and Frid as is applied above, further in view of Manash et al. (US 20200000579 A1) hereinafter known as Manash.
Regarding claim 13 the Jing Frid Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regards to there being an envelope.
However, regarding claim 13 Manash teaches an assembly that includes a stent (Figure 50 item 900) and an envelope (Figure 50 item 914) configured for wrapping around the aorta of a patient and the aortic stent when the device is deployed in the aorta (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Manash was considered capable of performing the cited intended use. See, for example at least Figure 50 which shows the sealing envelope 914 wrapped around the inside of the aorta). Jing and Manash are involved in the same field of endeavor, namely valved stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Jing Frid Combination by including an envelope to wrap around the aorta as is taught by Manash in order to create an additional layer to help in sealing around the device, which might benefit a patient who uses the device for treating an aneurysm.
Regarding claim 14, the Jing Frid Manash Combination teaches the device of claim 13 substantially as is claimed,
but is silent with regards to the envelope being made of felt.
However, regarding claim 14 Manash teaches that skirts are present on the device to help seal and prevent leakage ([0168]), and that the sealing skirts can be made of felt ([0140]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the material of the envelope of Manash so that it was made of felt as is taught by Manash since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, any sealing material would have been obvious to try (see also [0172]).
Conclusion
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 06/04/26
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