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
Applicant’s election without traverse of group 1 (claims 1-2, 5, 7, 9-10, 13-15) in the reply filed on 09/17/26 is acknowledged.
Claims 19-20, 27, 29-31, 33-34, 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/17/26.
Claim Objections
Claims 1-2, 7, 9, 13-14, are objected to because of the following informalities:
Claim 1 is objected to for referring to “the form” and “the closed position” with improper antecedent basis.
Claim 2 is objected to for missing a comma after “connected struts”.
The claim is further unclear since it claims “each connected” when it appears some words are missing between “each “ and “connected”. It is unclear further whether or not this is referred to “each plurality” or “each strut”.
Claims 7, 9, and 13 are objected to for referring to materials by abbreviations without first spelling out what those abbreviations refer to.
Claim 14 is objected to for referring to “at least two or more thicknesses” when it is unclear how, if at all, this relates to the previously claimed “variable thickness”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 9, 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bolduc (US 20210353421 A1).
Regarding claim 1 Bolduc discloses a polymeric heart valve system (the system of Bolduc is understood to be able to be used as a heart valve system if implanted in a heart valve location) comprising:
a supportive frame (Figure 8 item 39) and a plurality of polymeric leaflets (Figure 5 item 21, Figure 2 item 13),
wherein the frame comprises a plurality of openings (Figure 8 shows the frame 39 with openings between its struts; [0012] the stent includes interstitial spaces to allow it to deform to expand) and the is embedded in a polymeric matrix in a form of a polymeric sleeve ([0051] the stent 39 is wholly or partially embedded within the wall of the tubular outer body 37; [0015] the outer body is made of a polymer; [0012]),
wherein each of the leaflets are a continuum of the sleeve without sutures ([0044]), and each of the leaflets are connected to the sleeve at an attachment end (Figure 3 item 16), and
wherein the leaflets are able to open and close at an operative end (Figures 1-2 item 15), and when the leaflets are in a closed position the operative ends of the leaflets abut each other (Figure 1a, Figure 3; Abstract).
Regarding claim 2 Bolduc discloses the system of claim 1 substantially as is claimed,
wherein Bolduc further discloses the frame is formed from a plurality of interconnected struts each connected to one or more other struts via a joint (Figure 9 shows the stent 39 having vertically oriented struts which join to one another at a peak or valley).
Regarding claim 9 Bolduc discloses the system of claim 1 substantially as is claimed,
wherein Bolduc further discloses the sleeve is made of thermoplastic polymers ([0015]).
Regarding claim 13 Bolduc discloses the system of claim 1 substantially as is claimed,
wherein Bolduc further discloses the leaflets are made of thermoplastic polymers ([0015]).
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 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 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc as is applied above in view of Chin et al. (US 20170056175 A1) hereinafter known as Chin.
Regarding claim 5 Bolduc discloses the system of claim 1 substantially as is claimed,
but is silent with regards to the frame comprising a crown region which the matrix is not located.
However, regarding claim 5 Chin teaches a frame of a stent can include a crown region which a matrix is not located (Figure 18a-b item 185). Bolduc and Chin are involved in the same field of endeavor, namely valves prostheses It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the valve of Buldoc so that there is a crown region outside the matrix as is taught by Chin in order to allow a space which can assist in anchoring the stent after implantation against body tissue and prevent migration.
Regarding claim 7 Bolduc discloses the system of claim 1 substantially as is claimed,
but is silent with regards to the material of the frame.
However, regarding claim 7 Chin teaches a frame of a stent can be made of stainless steel ([0053]). Bolduc and Chin are involved in the same field of endeavor, namely valve prostheses. 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 frame of the stent of Bolduc so that it was stainless steel as is taught by Chin 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.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc as is applied above in view of Hoang et al. (US 20150157455 A1) hereinafter known as Hoang.
Regarding claim 10 Bolduc discloses the system of claim 1 substantially as is claimed,
but is silent with regards to the sleeve comprising an anti-leak flap thereon.
However, regarding claim 10 Hoang teaches a valve that includes an anti-leak flap thereon ([0117]). Bolduc and Hoang are involved in the same field of endeavor, namely valve prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Bolduc so that there is an anti-leak flap as is taught by Hoang in order to prevent leakage of blood around the valve after implantation, thus improving the function of the valve after implantation.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc as is applied above in view of Guo et al. (US 20210059819 A1) hereinafter known as Guo.
Regarding claim 14 Bolduc discloses the system of claim 1 substantially as is claimed,
wherein Bolduc further discloses each of the leaflets has a variable thickness ([0018]), wherein in a given cross-section each of the leaflets has at least two or more thicknesses ([0018] a non-uniform thickness leaflet which is thinner near the outlet end will inherently have at least two thicknesses at a specific cross-section),
but is silent with regards to whether or not the thickness has a center line of symmetry.
However, regarding claim 14 Guo teaches that a leaflet thickness has a center line of symmetry ([0034]). Bolduc and Guo are involved in the same field of endeavor, namely valve prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Bolduc so that the thickness has a center line of symmetry as is taught by Guo since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Bolduc.
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc as is applied above in view of Kruse et al. (US 20040024452 A1) hereinafter known as Kruse.
Regarding claim 15 Bolduc discloses the system of claim 1 substantially as is claimed,
but is silent with regards to the minimum thickness of the leaflets.
However, regarding claim 15 Kruse teaches a valve which includes leaflets having a minimum thickness in a range from about 50-200 microns or about 200-600 microns ([0063]).
(As is defined by the specification, the term "about" is understood to describe values either above or below the stated value, which the term "about" modifies, in a range of approx. +/- 10%)
Bolduc and Kruse are involved in the same field of endeavor, namely hvalve prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Bolduc so that it included a minimum thickness within the range taught by Kruse since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A). In this case, the person of ordinary skill would find it obvious to try any minimum thickness known in the art
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
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