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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 121-140, drawn to a prosthetic heart valve, classified in A61F 2/2418.
II. Claims 141-151, drawn to a method of delivering a heart valve using a catheter, classified in A61F 2/2436.
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 prosthetic heart valve can be delivered to a heart location without use of a catheter but performed by a surgeon in an open heart surgery. Additionally it could be said the method of treating a native valve of a heart could be performed with a material different prosthetic valve without the valve frame requiring a valve sealing cover and the anchor structure requiring an anchor sealing cover.
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:
the inventions have acquired a separate status in the art in view of their different classification; also the different features between the inventions.
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 Stephen Komarec on 11/26/2025 a provisional election was made without traverse to prosecute the invention of Group I, a prosthetic valve represented by claims 121-140. Affirmation of this election must be made by applicant in replying to this Office action. Claims 141-151 are 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).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 766. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 121-140 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 121, the recitation of “spacing between the plurality of connection elements form at least one window sized in accordance with a native valve leaflet” was not described in the written description such that one understands what feature or region of the anchoring structure is defining this recited construction. Further claims 122-127, 129, 130, 132, 133 recite the window(s) without proper written support to detail this feature(s) as recited in these claims also.
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 121-140 are 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.
In claim 121, lines 11,12 recite “a valve sealing cover extending across the inflow region and the outflow region and configured to prevent flow through the expandable valve frame” which is ambiguous because the recitation implies transverse or as recited in the claim across the frame and then states this cover prevents flow through the frame that would imply blocking blood through a lumen of the valve frame, to operate just as the leaflets do. Therefore, is the valve sealing cover meant to assist the leaflets or is it operating some other way? Please note the terms “region” are vague and arbitrary with no specific boundaries or locations, just used to establish there are two ends to the frame, thus no clear understanding of this valve sealing cover is across the passage where blood flows through the valve frame or does Applicant mean on surfaces of the wall of the frame? Further the claim recites “an anchor sealing cover extending over the anchoring structure to prevent flow through the anchoring structure” which is ambiguous because the recitation implies transverse or as recited in the claim over the anchoring structure and then states this cover prevents flow through the anchoring structure which surrounds the valve frame that would imply blocking blood through a lumen of the valve frame, to operate just as the leaflets do. Therefore, is the anchor sealing cover meant to assist the leaflets or is it operating some other way? The recitation to “prevent flow through” is ambiguous since blood flow extends through the lumen of the two structures and therefore creates ambiguity since the claim is vague as to where specifically these valve and anchor sealing covers are specifically positioned relative to the flow path of blood through the device. In claim 139, it is not understood how the expandable valve frame is configured to transition between a blood-flow permitting state and a blood flow preventing state because once deployed does the frame collapse and open with systole and diastole condition of the heart? One can understand the deployment blocking blood flow and then upon deployment with expansion of the frame the heart valve permits flow therethrough but only leaflets open and close to control flow, not the frame. Where is support for this recited feature? It is not clear how to explain this function other than normal understanding that leaflets control flow. Dependent claims are also indefinite for failing to define any more details to specifically establish meaning of the placement of the covers.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 121-139 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ganesan et al. (2016/0270911). Fig. 36 shows a prosthetic valve device with an expandable valve frame 300 forming an annular flow path extending in an axial direction, the expandable valve frame comprising: an inflow region; a mid-region connected to the inflow region; an outflow region connected to the mid-region. Fig. 38 shows a plurality of leaflets 350a-c mounted to the expandable valve frame 300 to control flow through the annular flow path. Fig. 37 shows and a valve sealing cover 340 extending across the inflow region and the outflow region and configured to prevent flow through the expandable valve frame; and an anchoring structure 200 configured to surround the expandable valve frame. Ganesan et al. disclose (paragraph 123) there is a connection between the expandable valve frame via a plurality of connection elements (multiple portions of covering see paragraph 124 or other coupling components, see paragraph 146). Fig. 9 shows the anchoring structure comprising: an atrial region 240 configured to be positioned within the native atrium of the heart, see paragraph 101; an annular region 250 configured to surround the expandable valve frame (see Fig. 18), positioned within the native annulus of the heart; a ventricular region 220 configured to be positioned within the native ventricle of the heart, see Fig. 4. Please note claims are given their broadest reasonable interpretation and since features are recited generically along with connections being arbitrary, it can be construed the spacing between the plurality of connection elements form at least one window (opening or area) sized in accordance with a native valve leaflet, see Fig. 7 showing the anchor structure 200 receiving or engaging with the native valve leaflet (17,19). see Fig. 12 shows an anchor sealing cover 270 extending over the anchoring structure to prevent flow through the anchoring structure, see paragraph 124, being placed on entire anchor structure. Regarding claim 122, Ganesan discloses (paragraph 16) that the anchor structure is to be placed to avoid blood flow obstruction, thus it is inherent that there is a void as this is the general understanding of a “window’ to provide an opening for passage (see Fig. 7 showing native valve 17 through frame opening) therethrough. Regarding claim 123, since the anchor structure is across the valve opening and has “at least one window” it inherently can permit blood to flow therethrough as there does not have to be covering material (paragraph 124), thus the openings would permit blood to pass through. With respect to claim 124, Ganesan disclose the anchor structure is designed and placed such that it does not push against the native leaflet when the prosthetic heart valve is expanded, thus it inherently forms a gap in the ventricular regions, see paragraph 62, detailing the structure does not impede natural valve. With respect to claims 125,126 as best understood ( no detail of windows in spec) Fig. 6 shows a plurality of windows 220a-d of the anchor structure and about the circumference perimeter. Regarding claim 127, Ganesan discloses (see paragraph 112) each of the plurality of leaflets is located in a window. With respect to claim 128, Ganesan shows (Fig. 11) each of the plurality of connection elements comprises an axially extending member 260 extending from the anchoring structure to connect to the expandable valve frame. Regarding claims 129,130 it can be construed at the vertices or point of intersection for frame components of the anchor structure where the bride or connecting members extend therefrom it forms what can be construed as a heel structure joining the anchoring structure with the plurality of connection elements as seen in Fig. 11 and there are windows “adjacent” the heel structures. With respect to claim 131, Ganesan shows (Fig. 15) how each of the heel structures comprises a curved structure configured to conform with a ceiling of a ventricle of the deficient native atrioventricular valve. With respect to claim 132, Ganesan shows (Figs. 36-38) there can be three leaflets (350a-c) and three arches 310a-c that match up with windows of anchoring structure. With respect to claim 133, Fig. 38 shows the anchoring structure further comprises a plurality of atrial conformance structures 240a,d aligned with the plurality of windows. Regarding claim 134, Fig. 9 shows each of the plurality of atrial conformance structures comprises an atrial release member 214,226 for attaching to a delivery system. With respect to claim 135, Fig. 19 shows each of the plurality of connection elements comprises a ventricular release member 212 for attaching to a delivery system. With respect to claim 136, Fig. 10 shows adjacent connection elements of the plurality of connection elements are connected by a leaflet attachment rail. Regarding claim 137, Ganesan discloses (paragraphs 105,106) each of the leaflet attachment rails comprises a flexure geometry to allow flexure of the leaflet attachment rail. Regarding claim 138, Figs. 2,16 show how the prosthetic heart valve device is configured to controllably transition between a radially compressed state configured for delivery, and a radially expanded state (Fig. 19) configured for implantation. With respect to claim 139, as best understood Ganesan discloses (paragraph 185) that the heart valve has leaflets to control blood flow through its structure with Figs. 40,41 illustrating this. Fig. 17 shows the valve frame collapsed and Fig. 19 shows the valve frame expanded and open.
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.
Claim(s) 140 is rejected under 35 U.S.C. 103 as being unpatentable over Ganesan et al. (2016/0270911) in view of Freudenthal (WO 2014026870). Ganesan et al. is explained supra. However, Ganesan et al. did not explicitly detail that the inflow region has a first stiffness; the mid-region has a second stiffness; and the outflow region has a third stiffness. Freudenthal teaches (Figs. 10,11) that a prosthetic heart valve frame is configured with the inflow region has a first stiffness; the mid-region has a second stiffness; and the outflow region has a third stiffness. It would have been obvious to one of ordinary skill in the art to provide a different stiffness in the inflow, outflow and middle region of the prosthetic valve as taught by Freudenthal in the valve of Ganesan et al. such that one can be flexible in implanted states and during delivery, see pages 4,5,20 of translation of Freudenthal.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799