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 07/24/25 have been fully considered but they are not persuasive.
On pages 7-8 regarding specification and drawing objections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully notes that since the amendments made to the drawings include new matter, the drawings submitted 07/24/25 cannot be entered. Accordingly, while some objections have been overcome in view of the amendments to the specification or claims, the remaining objections stand since drawings cannot be entered. However, the Examiner wishes to note that if drawings were entered, the objection with regards to item 58 (which was removed from the figures), item 200 (which was added to figure 6), and the items 102 and 50 being seen in figure 7, would be overcome.
On page 8 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws corrected claim objections, but notes amendments have created additional objections (see below).
On page 8 regarding 101 and 112 rejections, Applicant argues amendments overcome the rejections of record.
The Examiner respectfully withdraws the rejections which were addressed, but notes that since some of them were not addressed in the amendments or response, these are maintained (see below).
On page 9 regarding 35 U.S.C. 102 rejections, Applicant argues Piot does not provide evidence that the second wire element 110 has a variable width or three landing areas (see Figures 5 and 6i). Applicant argues Piot also fails to disclose the inner and outer skirts, arguing that the inner liner 121 is just an alternative to the outer line, and there isn’t any discussion of the inner and outer liners connecting.
The Examiner respectfully agrees Piot does not disclose the variable widths, and notes the rejection of record relies upon Meyer to teach this feature. As regards Piot teaching only an inner and outer skirt in the alternative, the Examiner respectfully disagrees, since Piot states there can be both inner and outer skirts (page 21 third paragraph). Additionally, all the elements of the valve are understood to be fixedly connected together to form the valve as a whole.
On pages 10-11 regarding 35 U.S.C. 103 rejections, Applicant argues Meyer figures 6-7 and [0051] gives guidance regarding the placement of notches, and a person reading Meyer would have chosen to thin the strut in the radial direction of the tubular body as opposed to the circumferential direction.
The Examiner respectfully disagrees, noting Meyer explicitly discloses notches being formed in any 3d direction within the strut, and describes in [0043] how the notches can be “any size or shape, and may have any orientation on the strut 36”.
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: 58.
The drawings are objected to because Figure 1 shows item 111 but it is not pointing to an artificial leaflet as is indicated by the specification. Further, the specification states that an artificial leaflet outflow supporting portion is represented by item 111c but the figures do not show item 111c pointing towards an “artificial leaflet outflow supporting portion”. Further, the specification states that item 80 refers to a corresponding grid element, but figure 1 which references item 80 appears to be pointing towards a space, or part of the longitudinal axis.
Further, the specification refers to the delivery device 200 and delivery device 80 with reference to figure 6, but figure 6 does not show either of these items.
Further, the specification refers to the intermediate portion 102 and support arms 50 as being shown in Figure 7 but these items are not shown in Figure 7.
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, the: valve leaflets, inner skirt, inner circumferential surface, outer circumferential surface, grid, valve leaflets being disposed on the intermediate portion of the inner cavity, the inner skirt being affixed to the second longitudinal end portion of the inner cavity, the inner skirt being fixedly connected with the valve leaflets, the outer skirt being affixed to the second longitudinal end portion of the outer cavity of the tubular body and fixedly connected with the inner skirt, grid nodes, and a plurality of grid elements 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the circumferential direction of the tubular body, platform section, first bending section, second bending section, lower landing area, middle landing area, upper landing area, first end of the lower arm, the second end of the lower arm.
Claim Objections
Claims 7, 10, 12 are objected to because of the following informalities:
Claim 7 is objected to for claiming “the tubular body that narrower in width” since it appears a word is missing between “that” and “narrower”.
Claim 10 is objected to for referring to the “metal grip” when it is believed this should read “metal grid”.
Further, the claim is objected to for referring to “a second node” with improper antecedent basis.
Claim 12 is objected to for claiming the lower support arm is at an angle of 45-55 when it appears a unit of measure is missing from “45-55” (e.g. angles, radians, etc.).
Appropriate correction is required.
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 1, 5-7, 9-10, 12-13 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter, for claiming the support arms are integrally formed on the tubular body without being welded or fastened to the tubular body. The specification has support for the arms to be integrally formed on the tubular body without welding, and has support for the arms being integrally formed without a “synthetic process”, but there is no part of the specification, as it is originally filed, that states the arms cannot be “fastened” to the tubular body. This is accordingly considered new matter.
Claim 7 is rejected for having new matter, since the originally filed specification fails to have support for the lower arm having a first end which connects to the tubular body which is narrower than a second end that is connected to the lower landing area. The comparative widths of these locations are not mentioned in the specification, and nor are these specific ends mentioned. This is accordingly considered new matter.
Claim 10 is rejected for having new matter, for claiming the “lower support arm and the upper support arm of a support arm are affixed to the first node and a second node, respectively”. Figure 7 shows a first node (61) and a second node (62), and also shows a support arm which connects to both nodes. However, the claim requires the lower support arm (52) to be connected to the first node (61), and the upper support arm (53) to be connected to the second node (62), when it appears to be impossible for this arrangement to occur. As the Examiner best understands, the lower support arm 52 would couple to the lower node, which in the case of Applicant’s figures, would be item 62. Similarly, the upper support arm 53 would couple to the upper node, which in the case of Applicant’s figures, would be item 61. Accordingly, there is not support for the arrangement Applicant has claimed.
Remaining claims are rejected for depending on a claim with new matter.
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 1, 5-7, 9-10, 12-13 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 1 is indefinite for claiming the “transcatheter aortic valve implantation device” is “structurally fitted” but it is unclear what this means. The specification refers to the phrase only four times (twice in the body of the specification, twice in the title/priority information), and at no point in time is its meaning elucidated. The Examiner cannot understand the meaning behind the term and/or understand what special meeting the term imparts to the claimed device.
The claim is further unclear for claiming “a structurally fitted transcatheter aortic valve implantation device” which includes a valve device, leaflets, and skirts, when the Examiner understands an “implantation device” as a device which facilitates implantation, whereas the remainder of the claims appear to be drawn towards a device which is implanted as opposed to the delivery device. The Examiner is accordingly unclear what the claim is intending to claim and whether or not the Applicant considers a valve and its constituent components to be a part of an implantation device.
Further, the claim states that the inner and outer circumferential surfaces “at least extending substantially concentrically” with the longitudinal axis but it is unclear what this means. It is unclear what Applicant means when stating that something is “at least extending substantially concentrically”, since Applicant hasn’t defined what happens beyond “at least” extending substantially concentrically. Additionally, the specification fails to explain what it means to be “substantially concentrically” (e.g. as opposed to “extending concentrically” or not extending concentrically. Without a standard for measuring whether something is extending “substantially concentrically” or not, the boundaries of the claim cannot be determined.
Claim 10 is indefinite for claiming the first, second, and third nodes are “along a longitudinal direction of the tubular body”, when figure 7, the only figure to reference these nodes, shows three nodes located not along any particular direction, but rather being oriented more in a zig-zag fashion, as none of them line up, particularly not lining up in the direction of the longitudinal axis of the device. It is accordingly unclear what Applicant means by stating the three nodes are “along a longitudinal direction”, and whether this is new matter, or whether the Examiner is missing Applicant’s intent.
Further, the claim is indefinite for claiming the “lower support arm and the upper support arm of a support arm are affixed to the first node and a second node, respectively”. Figure 7 shows a first node (61) and a second node (62), and also shows a support arm which connects to both nodes. However, the claim requires the lower support arm (52) to be connected to the first node (61), and the upper support arm (53) to be connected to the second node (62), when it appears to be impossible for this arrangement to occur. The Examiner is accordingly unclear how the lower arm is connecting to the upper node, and how the upper arm is connecting to the lower node, as the claim requires.
Remaining claims are indefinite for depending on an indefinite 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.
Claim(s) 1, 5-7, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piot (WO 2016055262 A1) in view of Meyer et al. (US 20060271161 A1) hereinafter known as Meyer.
Regarding claim 1 Piot discloses a structurally fitted transcatheter aortic valve implantation device (Abstract) comprising:
a valve stent (50), a plurality of valve leaflets (121), an inner skirt and an outer skirt (page 10 last paragraph),
wherein the valve stent is radially compressible (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 patented apparatus of Piot discloses (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 the Abstract),
wherein the valve stent comprises a tubular body (55) made of a metal grid (Figure 2, page 8 last line) and having a circumference extending along a longitudinal axis (60),
wherein the tubular comprises a first longitudinal end portion (65) a second longitudinal end portion (70), and an intermediate portion disposed between the first and second end portions (75),
wherein the tubular body has an inner circumferential surface (85) defining an inner cavity of the tubular body and an outer circumferential surface (90) defining an outer surface of the tubular body (page 1 last two lines; Figure 2),
wherein the inner and outer circumferential surfaces extend concentrically along the longitudinal axis (Abstract, Figure 2),
wherein a plurality of support arms (100) are provided on the intermediate portion (Figure 2), and are spaced from each other around a circumferential direction of the tubular body (Figure 2; page 12 last paragraph) and are integrally formed on the tubular body without being welded or fastened to the tubular body (page 13 line 1 fixedly connected as opposed to formed separate then attached; page 13 3rd paragraph integral provided),
wherein the leaflets are disposed on the intermediate portion of the inner cavity (page 20 paragraph 3-4; Figures 4b-c item 121),
the inner skirt is affixed to the second longitudinal end portion of the inner cavity (page 21 first paragraph) and fixedly connected with the valve leaflets (page 20 paragraph 3 the valve 120 is fixedly attached to the inner lumen 95 of the tubular body 55 which has the inner skirt; page 21 first paragraph),
wherein the outer skirt is affixed to the second longitudinal end portion of the outer cavity and fixedly connected with the inner skirt (page 21 first paragraph and second paragraph, where the prosthesis includes both an inner and outer liner; all elements of the prosthesis are understood to be fixedly connected together to form the valve), and
each support arm comprises a lower support arm, a first bending section, a platform section, a second bending section, and an upper support arm that are connected in sequence (Annotated Figure 5),
each of the lower support arm, platform section, and upper support arm comprises a lower landing area, a middle landing area, and an upper landing area, respectively (Annotated Figure 5),
but is silent with regards to the lower, middle, and upper landing areas having a width in a circumferential direction being larger than a maximum width of the first/second bending sections.
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However, regarding claim 1 Meyer teaches that struts (Figure 4 item 36) in a bending region (Figure 4 item 50a) of an endovascular prosthesis can have a width in a circumferential direction that is larger than a maximum width than bending sections (Figure 4 shows notches 76 which extend inward in a circumferential direction (left/right in the figure), [0043]). Piot and Meyer are involved in the same field of endeavor, namely expandable endovascular prostheses with outwardly bending regions. 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 Piot so that the D-shaped arms’ bending sections have smaller circumferential widths as compared to landing areas, as is taught by Meyer, since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of any known method of encouraging deformation or bending within the desired area, to achieve the desired shape, would have been an obvious technique to try to enable the support arms to bend to form the outwardly extending arms in Piot.
Regarding claim 5 the Piot Meyer Combination teaches the device of claim 1 substantially as is claimed,
wherein the Combination further teaches each of the lower, middle, and upper landing area has a maximum width that are of a same value (Piot’s disclosure shows the arms which are all the same maximum width. While modification in view of Meyer encourages a reduction in width at bending locations, the reduction in width is not present at landing areas, meaning the Combination would obviously keep the width of the landing areas the same value).
Regarding claim 6 the Piot Meyer Combination teaches the device of claim 5 substantially as is claimed,
wherein Piot further discloses the support arms are distributed around the circumferential direction of the tubular body (page 12 last paragraph).
Regarding claims 7 the Piot Meyer Combination teaches the device of claim 6 substantially as is claimed,
wherein Piot further teaches the lower arm has a first end connected to the tubular body and a second end connected to the lower landing area (Annotated Figure 5),
and wherein the Combination further teaches the lower arm’s first end connected to the tubular body is narrower than the second end connecting to the narrow area (see the rejection to claim 1 above with regards to the notched/narrowed areas occurring at any location bending is desired. Since at least a few embodiments of Piot show the outward bending starting at the location it connects with the tubular body (Figure 6b, 6d, 6f, 6h, etc.), the person of ordinary skill would have found it obvious to have the connection of the lower arm to the tubular body narrowed as a bending section.).
Regarding claim 10 Piot discloses the device of claim 1 substantially as is claimed,
wherein Piot further discloses the metal grid comprises a plurality of grid notes (81) connected through a plurality of grid elements (82),
the intermediate portion comprises a first, second, and third node (see at least Figures 4b-c where at least three nodes are seen), along a longitudinal direction of the tubular body (as is best understood, see Figures 4b-c which show nodes which are positioned along a longitudinal direction), wherein the lower support arm and upper support are affixed to the first node and second node, respectively (Figures 4b-c show at least two nodes 81 where upper and lower support arms (with reference to Annotated Figure 5) attach, within the intermediate portion).
Regarding claim 11 the Piot Meyer Combination teaches the device of claim 1 substantially as is claimed,
wherein Piot further discloses a minimum width between the support arms and adjacent grid elements are capable of receiving only one laser beam during laser cutting, thereby maximizing a landing area of the support arms (as is best understood, the structure of Piot being the same as what is claimed, the structure is understood to perform the same way if receiving a laser beam).
Regarding claim 12 Piot discloses the device of claim 10 substantially as is claimed,
wherein Piot further teaches, in an expanded state, the lower support arm is at an angle with the outer surface of the tubular body (see the annotated figure 5 below, which shows the lower support arm extending at an angle from the body. While drawings are not understood to be drawn to scale, they are not understood to be drawn completely inaccurately either. The figure provided below shows that the lower support arm extends at an angle somewhat midway from 0-90 degrees. Midway from 90 degrees include 45 degrees. Accordingly, the person of ordinary skill in the art, when viewing figure 5 of Piot, would understand that it is obvious for the lower support arm to extend at an angle 45 degrees with the outer surface of the tubular body, since the figures approximate this angular extension).
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Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piot and Meyer as is applied above in view of Renati (US 20020058897 A1).
Regarding claim 9 the Piot Meyer Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regards to the tubular body and arms being machined by laser cutting.
However, regarding claim 9 Piot discloses the tubular body and support arms are made of wire elements,
and Renati teaches that wires can be machined by laser cutting ([0118]). Piot and Renati are involved in the same field of endeavor, namely wire endoprostheses. 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 Piot Meyer Combination by having the tubular body and arms be laser cut as is taught by Renati 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, any known method of production of a wire device would have been obvious to try.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piot and Meyer as is applied above, further in view of Biadillah et al. (US 20140018915 A1) hereinafter known as Biadillah.
Regarding claim 13 the Piot Meyer Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regards to the inner and outer skirt being made of animal pericardium.
However, regarding claim 13 Biadillah vteaches that valve skirts can be made of animal pericardium ([0053]). Piot and Biadillah are involved in the same field of endeavor, namely 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 material of the skirts of the Piot Meyer Combination so that they are made from animal pericardium as is taught by Biadillah since 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 use of any known biologically compatible material would have been obvious to substitute.
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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 08/01/25