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 .
Response to Arguments
Applicant's arguments filed 01/19/26 have been fully considered but they are not persuasive.
On page 8 Applicant argues amendments overcome the objections and rejections of record. Applicant argues Girard teaches away from amended claim 1 since holes are formed via laser cutting. Applicant argues further that Girard teaches leaflet and a skirt portion that are formed as a single piece, which means they need not be attached together.
The Examiner respectfully refers to the rejection below regarding amended claims, but points out Girard [0037] indicates the leaflets and skirts need not be integral, making Applicant’s argument moot.
Specification
The disclosure is objected to because of the following informalities:
The specification says various figures show a “dark shading” but there isn’t any dark shading in the mentioned figures (e.g. 10a-b).
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 is objected to for referring to “the functional state” with improper antecedent basis.
Appropriate correction is required.
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 18-20, 22-23 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 pre-AIA the applicant regards as the invention.
Claim 18-20 are indefinite for claiming the pleats comprise a “bagpipe shape” when the Examiner is unclear what a “bagpipe” shape might entail. The specification does not elaborate on what shape(s) would or would not be included in a bagpipe shape. The Examiner is unable to determine what shapes would or would not fall within the scope of this claim.
Claims 22-23 are indefinite for claiming the ends of the stent-structure are spaced apart from the inflow/outflow end of the flow passage. Notably, the “flow passage”, now shown in figure 17b, appears to be coincident with the inflow and outflow end of the stent structures. In other words, there is no space between what the Examiner considers to be (and Applicant identifies as) a flow passage and the ends of the stent-structure. The Examiner notes that the stent-structure itself would appear to define the flow passage, since it creates a passage through which fluid can flow, making it even more unclear whether these claims are 1) elected and 2) supported. Since the Examiner cannot determine what the flow passage is, the Examiner cannot determine if these are part of the elected embodiment(s), and also cannot determine if this is supported.
Remaining claims are rejected for depending on a rejected claim.
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.
Claims 1-3, 6, 9, 16-21, 29, 31-32, 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (US 20190053894 A1) hereinafter known as Levi in view of Yi et al. (US 20180133002 A1) hereinafter known as Yi, further in view of Tegels (US 20210030537 A1).
Regarding claim 1 Levi discloses a medical implant (10) comprising a stent-structure (12), one or more skirts (16/18), and a valve assembly (14) comprising one or more leaflets (41),
wherein the stent has a longitudinal axis (e.g. vertically through the lumen of the stent 12), circumference (Figures 1-3), first end (15), and second end opposite the first end (19), wherein the stent surrounds an inner volume (Figures 2-3), and the stent has a plurality of struts (22/24/26/28/31/32 etc.) forming cells (40; [0047]),
wherein one skirt of the one or more skirts at least partially covers an outer side of the stent and extends at least partially outside the stent (Figures 1-3 item 18) OR the valve assembly is arranged within the inner volume of the stent (Figures 2-3),
but is silent with regards to the skirt comprising one or more laser markings that partially penetrate a thickness of the skirt.
However, regarding claim 1 Yi teaches that a heart valve (Abstract) can include one or more laser markings ([0068], [0038]) that at least partially penetrate a thickness of a material of the skirt ([0020], [0068] the outer covering can include suture marks made by laser drilling; [0038] the suturing marks can comprise a suturing point (distinct from a hole)), and Tegels teaches that markings on prosthetic devices can be holes or markings that only partially penetrate a thickness of a material ([0040]). Levi, Girard, and Tegels are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Levi by including laser markings within the skirt of the valve of Levi as is taught by Yi and Tegels in order to provide a guide defining where suture attachment is desired, thus easing assembly of the valve.
Regarding claim 2 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses the stent is compressible (Abstract; the frame is radially expandable and collapsible).
Regarding claim 3 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses the skirt which at least partially covers the outer side of the stent comprises protrusions extending radially outward toward a circumference of the stent in the functional state (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also Figures 1-3 which show protrusions between creases 170). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 6 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses the one skirt at least partially covering the outer side of the stent is an outer skirt (18), and the implant comprises an inner skirt at least partially covering an inner side of the stent (16) (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also Figure 3 which shows both an inner 16 and outer 18 skirt). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 9 the Levi Yi Tegels Combination teaches the implant of claim 6 substantially as is claimed,
wherein Levi further discloses the outer skirt is affixed to each strut or each second strut of the stent at the first end (15) along a full circumference of the first end (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also [0117]). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 16 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses the one skirt at least partially covering the outer side of the stent has one or more pleats (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also item 170). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 17 the Levi Yi Tegels Combination teaches the implant of claim 16 substantially as is claimed,
wherein Levi further discloses the pleats extend in a direction from the first end to the second end OR in a direction of the longitudinal axis OR are bent at an angle of less than 30° with respect to the longitudinal axis (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also Figures 1-3). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 18 the Levi Yi Tegels Combination teaches the implant of claim 16 substantially as is claimed,
wherein Levi further discloses the pleats comprise a bagpipe shape (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, as the Examiner best understands, the pleats 170 of Figures 1-3 are bagpipe shaped). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 19 the Levi Yi Tegels Combination teaches the implant of claim 18 substantially as is claimed,
wherein Levi further discloses some of the pleats form a top opening see (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also Figures 1-3 item 166; [0011]). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 20 the Levi Yi Tegels Combination teaches the implant of claim 19 substantially as is claimed,
wherein Levi further discloses some of the pleats comprise a through-hole, slit, OR side opening (the limitations of this claim are not required, since the valve assembly is arranged in the inner volume of the stent. However, see also Figure 2 item 167). (not required if the valve assembly is arranged in the inner volume of the stent)
Regarding claim 21 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses the implant defines a flow passage for guided/controlled fluid flow (e.g. along the longitudinal axis of the implant, through the lumen seen in figures 2-3) which has an inflow end and opposite outflow end (Figures 2-3).
Regarding claim 29 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses one of the skirt(s) and one of the leaflet(s) are formed of a biological tissue ([0042]).
Regarding claim 31 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Yi further teaches the laser marking are optically visible ([0038], [0068]).
Regarding claim 32 the Levi Yi Tegels Combination teaches the implant of claim 1 substantially as is claimed,
wherein Levi further discloses the implant is a vascular implant (Abstract; heart valve).
Regarding claim 34 Levi discloses a medical implant (10) comprising a stent-structure (12), one or more skirts (16/18), and a valve assembly (14),
wherein the stent has a longitudinal axis (e.g. vertically through the lumen of the stent 12), circumference (Figures 1-3), first end (15), and second end opposite the first end (19), wherein the stent surrounds an inner volume (Figures 2-3), and the stent has a plurality of struts (22/24/26/28/31/32 etc.) forming cells (40; [0047]),
wherein one skirt of the one or more skirts at least partially covers an outer side of the stent and extends at least partially outside the stent (Figures 1-3 item 18) OR the valve assembly is arranged within the inner volume of the stent (Figures 2-3),
but is silent with regards to the leaflet comprising one or more laser markings that partially penetrate a thickness of the leaflet.
However, regarding claim 34 Yi teaches that a heart valve (Abstract) can include one or more laser markings ([0068], [0038]) that at least partially penetrate a thickness of a material of the leaflet ([0020], [0068] the outer covering can include suture marks made by laser drilling; [0038] the suturing marks can comprise a suturing point (distinct from a hole)), and Tegels teaches that markings on prosthetic devices can be holes or markings that only partially penetrate a thickness of a material ([0040]). Levi, Girard, and Tegels are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Levi by including laser markings within the leaflet of the valve of Levi as is taught by Yi and Tegels in order to provide a guide defining where suture attachment is desired, thus easing assembly of the valve.
Regarding claim 35 the Levi Yi Tegels Combination teaches the implant of claim 34 substantially as is claimed,
wherein Levi further discloses the one or more leaflets comprise two tabs (Figures 17-19 show winged tabs on each leaflet).
Regarding claim 36 the Levi Yi Tegels Combination teaches the implant of claim 35 substantially as is claimed,
wherein Levi further discloses the tabs are attached to a commissural post of the stent-structure (Figures 1 and 19 item 122).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 02/02/26
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