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 .
Claim Objections
Claims 1, 3, 7-9, 12-13, 16-19 are objected to because of the following informalities:
Claim 1 is objected to for referring to “delivery” and deployment of the stent when it is unclear how this delivery relates to the previously disclosed “delivery” within a vasculature that is earlier mentioned.
Claim 3 is objected to for referring to the stent including “three commissure posts” when it is unclear how this relates, if at all, to the previously claimed “plurality of commissure posts”.
Claim 7 is objected to for referring to “three of the six inflow markers” multiple times, making it unclear if these same three markers are being referenced twice, or whether this is a different overlapping set of three markers, or a different non-overlapping set of three markers, or some other set of three markers.
Claims 8-9 are objected to for referring to “the plurality of rows” multiple times, when there have been multiple “rows of struts and crowns” that have been referred to between claims 1 and 8. It is unclear which of the plurality of rows might be being referenced here.
Claim 12 is objected to for referring to “delivery” and deployment of the stent when it is unclear how this delivery relates to the previously disclosed “delivery” within a vasculature that is earlier mentioned.
Further, the claim is objected to for claiming “an outflow marker positioned one” when it appears a word is missing between “positioned” and “one” (e.g. “on”).
Claim 13 is objected to for claiming the stent includes “three commissure posts” when it is unclear how this relates, if at all, to the previously claimed “plurality of commissure posts”.
The claim is further unclear for referring to “the plurality of inflow makers” when it is unclear how this relates to the previously claimed “inflow marker” of claim 12.
Further, the claim is unclear for claiming the plurality of inflow markers comprises “at least three inflow markers”, but, if this is related to the previously claimed single “inflow marker” of claim 12, it is unclear how a single marker comprises three markers. This appears to be an error in grammar.
Further, the claim is unclear for referring to “a corresponding inflow marker” when it is unclear how this relates (if at all) to the previously claimed “inflow marker”.
Claim 16 is objected to for claiming “the plurality of inflow markers” when claim 12, from which this depends, has only identified there being one inflow marker. It is unclear what “plurality” is being referenced.
Claim 17 is objected to for claiming “the plurality of inflow markers” when claim 12, from which this depends, has only identified there being one inflow marker. It is unclear what “plurality” is being referenced.
Further, the claim is objected to for referencing “corresponding commissure posts” when it is unclear how this relates to the previously claimed “plurality of commissure posts” or “one of the commissure posts”.
The claim is further objected to for referencing “three of the six inflow markers” multiple times, making it unclear if these same three markers are being referenced twice, or whether this is a different overlapping set of three markers, or a different non-overlapping set of three markers, or some other set of three markers.
Claims 18-19 are objected to for referring to “the plurality of rows”. While it is believed this is referring back to the “plurality of rows of struts and crowns” from claim 12, it is unclear if this means there are a plurality of rows of struts AND a plurality of rows of crowns, whether this refers to multiple rows that comprise struts and crows together, or some other meaning. It is further unclear if the “plurality of rows” of struts and crowns might be referring to the rows of the inflow portion or the outflow portion.
Claim 20 is not objected to. However, it faces objection upon allowance of remaining claims, since it appears to be a duplicate claim.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, each commissure post includes a downstream portion downstream a pair of struts of the row of struts and crowns of the outflow portion such that the pair of struts intersect the commissure post at a mid-portion thereof must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to because item 838 is in the figures but not the specification.
Further, the specification defines item 820 as “crowns” but this is clearly a “node” as is defined in the specification (intersection of struts).
Further, in figure 8b, item 872 and 862 are pointing at the same structure defined in figure 8a is being the “containment member”, making it appear these elements are actually the same structure with different names.
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
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 1, 11, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US 20150230923 A1) in view of Spencer et al. (US 20040039436 A1) hereinafter known as Spencer.
Regarding claim 1 Levi discloses a transcatheter valve prosthesis ([0034] transcatheter heart valve) comprising:
a stent (100/200) having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve ([0034] valves are capable of crimping and expanding; [0040]), wherein the stent comprises an inflow portion (103/203) an outflow portion (105/205) with a row (Figures 6-9 row IV) of struts (222/322) and crowns (considered to be the junctions between the struts), and a plurality of commissure posts connecting the inflow to the outflow portions (130/120/230/220/320/330),
wherein each commissure post includes a downstream portion downstream a pair of struts of the row of struts and crowns of the outflow portion such that the pair of struts intersect the commissure post at a mid-portion thereof (see Figures 7-9 in which the commissure post extends slightly further downstream than the struts 222/322 in row IV which intersect it at a mid-portion, which is considered to be the portion of the commissure post between the two ends),
but is silent with regards to there being an outflow marker on the downstream portion of the commissure post.
However, regarding claim 1 Spencer teaches a valve prosthesis can have a commissure post (Figure 14a item 235) with a downstream portion which comprises an outflow marker positioned on the downstream portion of one of the commissure posts of the plurality (Figure 14a item 232),
wherein the outflow marker is capable of being visible relative to the stent in one or more images captured during delivery and deployment of the stent (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the apparatus of Spencer teaches (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0187]). Levi and Spencer 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 prosthesis of Levi so that the downstream portion of one of the commissure posts included an outflow marker as is taught by Spencer in order to allow the cardiac interventionalist to visualize the stent during implantation, thus easing delivery and resulting a more accurate implantation.
Regarding claims 11 and 20 the Levi Spencer Combination teaches the valve prosthesis of claim 1 substantially as is claimed,
wherein Spencer further teaches the outflow marker is the only outflow marker coupled to any of the commissure posts (see Figure 14-14a).
Claims 2-10, 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi and Spencer as is applied above, further in view of Wu (US 20130325107 A1).
Regarding claim 2 the Levi Spencer Combination teaches the valve prosthesis of claim 1 substantially as is claimed,
wherein Spencer further teaches there can be an inflow marker coupled to the inflow portion of the stent (Figure 14 item 230),
but is silent with regards to there being a plurality of inflow markers coupled to the inflow portion of the stent which are axially aligned with the commissure posts.
However, regarding claim 2 Wu teaches a valve prosthesis ([0025], Figure 8) that includes a stent that has a plurality of inflow markers coupled to the inflow portion of the stent, wherein at least some of the inflow markers are axially aligned with outflow markers (Figure 8 shows markers 360 and 355 on both inflow and outflow ends of the stent). Levi and Wu are involved in the same field of endeavor, namely endovascular 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 the Levi Spencer Combination so that there are also a plurality of inflow markers as is taught by Wu in order to ensure the entirety of the prosthesis can be visualized by the cardiac interventionalist, which will ease implantation. The Examiner notes that the Combination, which already teaches the outflow markers are positioned on the downstream portion of the commissure posts (Spencer Figure 14a item 235), is understood to accordingly have the inflow markers align with the commissure posts, since this is where the outflow markers of the Combination are positioned.
Regarding claim 3 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 2 substantially as is claimed,
wherein Levi further discloses the stent includes three commissure posts (Figures 1-9, items 130/120/230/220/320/330),
wherein Wu further teaches the plurality of inflow markers comprises at least three inflow markers (Figure 8 shows at least 6 markers 360/355), and a corresponding inflow marker of the three is axially aligned with the [outflow markers] (which are positioned on the commissure posts, according to the Combination).
Regarding claim 4 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 2 substantially as is claimed,
wherein Levi further discloses a plurality of axial struts coupling the inflow portion to the outflow portion (132/232),
wherein the plurality of axial struts are alternatingly disposed with the commissure posts around a circumference of the stent (Figure 1-9).
Regarding claim 5 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 4 substantially as is claimed,
wherein Levi further discloses the plurality of commissure posts comprises exactly three commissure posts (Figures 1-9, items 130/120/230/220/320/330), and
the plurality of axial struts comprises exactly three axial struts alternating disposed with the commissure posts around the circumference such that each axial strut is disposed between two of the three commissure posts (Figures 1-9, items 132/232/332).
Regarding claim 6 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 5 substantially as is claimed,
wherein Wu further teaches the plurality of inflow markers comprises at least three inflow markers (Figure 8 shows at least 6 markers 360/355), and a corresponding inflow marker of the three is axially aligned with the [outflow markers] (which are positioned on the commissure posts, according to the Combination).
Regarding claim 7 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 5 substantially as is claimed,
wherein Wu further teaches the plurality of inflow markers comprises six inflow markers (Figure 1 shows six markers on each end 360, 355),
wherein the Combination further teaches three of the six inflow markers are axially aligned with corresponding commissure posts of the exactly three posts, and three of the six inflow markers are aligned with corresponding axial struts of the three axial struts (the Examiner refers to Wu teaching equidistant markers around the stent circumference (Figure 1) and notes that when applied to the valve of the Combination, the equal spacing would have markers aligned with both the commissure posts (Levi 130/120/230/220) and the axial struts (Levi 132/232)).
Regarding claim 8 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 2 substantially as is claimed,
wherein Levi further discloses the inflow portion comprises a plurality of rows (rows I-III) of struts (112/114/116/118/214/216/218/314/316/318) and crowns (considered to be the junctions between the struts),
and wherein the stent has a first node at a junction between a first row of the plurality of rows and a second row of the plurality of rows (see Annotated Figure 8, below),
and wherein Wu further teaches inflow markers (Figure 8 items 360/355) coupled to the stent at a first node at a junction of two rows (Figure 8 shows markers positioned at nodes). 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 the Levi Spencer Wu Combination to have the inflow markers coupled at a node of a junction of rows as is taught by Wu since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, positioning the markers at any known location on a stent would have been obvious to try.
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Regarding claim 9 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 8 substantially as is claimed,
wherein Levi further discloses a second node is disposed at a junction between the second and third row of the plurality of rows (see Annotated Figure 8, above).
Regarding claim 10 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 9 substantially as is claimed,
wherein Levi further discloses the first node is elongated longitudinally relative to the second node (see Annotated Figure 8, where one of the nodes is longitudinally elongated compared to the other node).
Regarding claim 12 Levi discloses a transcatheter valve prosthesis ([0034] transcatheter heart valve) comprising:
a stent (100/200) having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve ([0034] valves are capable of crimping and expanding; [0040]), wherein the stent comprises an inflow portion (103/203) an outflow portion (105/205) with a row (Figures 1-5 row V, and/or Figures 6-9 row IV) of struts (122/222/322) and crowns (considered to be the junctions between the struts), and a plurality of commissure posts connecting the inflow to the outflow portions (130/120/230/220),
wherein the inflow portion comprises a plurality of rows (Figures 1-5 rows I-VI and/or Figures 6-9 rows I-III) of struts (112/114/116/118/214/216/218/314/316/318) and crowns (considered to be the junctions between the struts)
but is silent with regards to there being an outflow marker on one of the commissure posts,
and an inflow marker positioned in the inflow portion which is aligned axially with the outflow marker.
However, regarding claim 12 Spencer teaches a valve prosthesis can have a commissure post (Figure 14a item 235) which comprises an outflow marker (Figure 14a item 232) and an inflow marker positioned in the inflow portion (Figure 14 item 230)
wherein the outflow and inflow marker are capable of being visible relative to the stent in one or more images captured during delivery and deployment of the stent (this functional limitation is taught by Spencer (see [0187]).). Levi and Spencer 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 prosthesis of Levi so that the downstream portion of one of the commissure posts included an outflow marker as is taught by Spencer in order to allow the cardiac interventionalist to visualize the stent during implantation, thus easing delivery and resulting a more accurate implantation.
Further, regarding claim 12 Wu teaches a valve prosthesis ([0025]) which includes inflow and outflow markers which are axially aligned (Figure 8 shows axially aligned markers 360 and 355 on inflow and outflow ends of the stent). Levi and Wu 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 filed to modify the valve of the Levi Spencer Combination so that the inflow and outflow markers are aligned axially as is taught by Wu ensure both ends of the stent can be visualized during implantation, thus easing installation by the cardiac interventionalist.
Regarding claim 13 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 12 substantially as is claimed,
wherein Levi further discloses the stent includes three commissure posts (Figures 1-9, items 130/120/230/220/320/330),
wherein Wu further teaches the plurality of inflow markers comprises at least three inflow markers (Figure 8 shows at least 6 markers 360/355), and a corresponding inflow marker of the three is axially aligned with the [outflow markers] (which are positioned on the commissure posts, according to the Combination).
Regarding claim 14 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 12 substantially as is claimed,
wherein Levi further discloses a plurality of axial struts coupling the inflow portion to the outflow portion (132/232),
wherein the plurality of axial struts are alternatingly disposed with the commissure posts around a circumference of the stent (Figure 1-9).
Regarding claim 15 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 14 substantially as is claimed,
wherein Levi further discloses the plurality of commissure posts comprises exactly three commissure posts (Figures 1-9, items 130/120/230/220/320/330), and
the plurality of axial struts comprises exactly three axial struts alternating disposed with the commissure posts around the circumference such that each axial strut is disposed between two of the three commissure posts (Figures 1-9, items 132/232/332).
Regarding claim 16 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 15 substantially as is claimed,
wherein Wu further teaches the plurality of inflow markers comprises at least three inflow markers (Figure 8 shows at least 6 markers 360/355), and a corresponding inflow marker of the three is axially aligned with the [outflow markers] (which are positioned on the commissure posts, according to the Combination).
Regarding claim 17 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 15 substantially as is claimed,
wherein Wu further teaches the plurality of inflow markers comprises six inflow markers (Figure 1 shows six markers on each end 360, 355),
wherein the Combination further teaches three of the six inflow markers are axially aligned with corresponding commissure posts of the exactly three posts, and three of the six inflow markers are aligned with corresponding axial struts of the three axial struts (the Examiner refers to Wu teaching equidistant markers around the stent circumference (Figure 1) and notes that when applied to the valve of the Combination, the equal spacing would have markers aligned with both the commissure posts (Levi 130/120/230/220) and the axial struts (Levi 132/232)).
Regarding claim 18 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 17 substantially as is claimed,
wherein Levi further discloses the inflow portion comprises a plurality of rows (rows I-III) of struts (112/114/116/118/214/216/218/314/316/318) and crowns (considered to be the junctions between the struts),
and wherein the stent has a first node at a junction between a first row of the plurality of rows and a second row of the plurality of rows (see Annotated Figure 8, below),
and wherein Wu further teaches inflow markers (Figure 8 items 360/355) coupled to the stent at a first node at a junction of two rows (Figure 8 shows markers positioned at nodes). 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 the Levi Spencer Wu Combination to have the inflow markers coupled at a node of a junction of rows as is taught by Wu since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, positioning the markers at any known location on a stent would have been obvious to try.
Regarding claim 19 the Levi Spencer Wu Combination teaches the valve prosthesis of claim 18 substantially as is claimed,
wherein Levi further discloses a second node is disposed at a junction between the second and third row of the plurality of rows (see Annotated Figure 8, above).
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 07/16/26
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