DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 08/06/25 have been fully considered but they are not persuasive.
On page 12 regarding prior art rejections Applicant argues Bailey fails to disclose the lower flange portion being configured to grasp tissue by clamping tissue therebetween during transition.
The Examiner respectfully points out that the claimed device of Bailey only needs to be capable of performing this clamping or grasping function in order to anticipate the language of the claims, since the requirement for the grasping/clamping references a functional limitation, with structures the claimed device is intended to grasp or clamp. However, since Bailey discusses how the self-expansion of the stent structure allows the expansion of the atrial and ventricular anchors, for the purposes of grasping native tissue therebetween to anchor the prosthesis, Bailey does actually discuss how their device is capable of this grasping/clamping.
Claim Objections
Claims 25-26, 29-30, 39, 47, 50, 53-54 are objected to because of the following informalities:
Claim 25 is objected to for repeating the same paragraph twice.
The claim is further objected to for referring to ‘the outer surface of the middle region” with improper antecedent basis.
Claim 26 is objected to for referring to “the subvalvular apparatus” and “the ventricular side” with improper antecedent basis.
Claim 29 is objected to for referring to ‘tissue” when it is unclear how, if at all, this relates to the previously claimed “tissue” of claim 25.
Claim 30 is objected to for referring to “atrial tissue”, when it is unclear how, if at all, this relates to the previously claimed “tissue” of claim 25.
Claim 39 is objected to for referring to “the second ends of the flange elements” with improper antecedent basis.
Claim 47 is objected to for referring to “the ventricular side”, “the annulus”, “the subvalvular apparatus”, “the outer surface of the middle region”, “the direction”, and “the upper flange portion” with improper antecedent basis.
Further, the claim is unclear for referring to “a ventricular side of a mitral or tricuspid annulus” when it is unclear how, if at all, this relates to the previously claimed “ventricular side of the annulus”.
Claim 50 is objected to for claiming “the lower flange portion is configured to transitions in space” when it appears there is an extraneous “s” on the word “transition”.
Further, there is improper antecedent basis for “the ventricular side”, “the annulus”, “the subvalvular apparatus”, and “the outer surface of the middle region”.
Further, the claim is unclear for referring to “a ventricular side of a mitral or tricuspid annulus” when it is unclear how, if at all, this relates to the previously claimed “ventricular side of the annulus”.
Claim 53 is objected to for being substantially the same as claim 52.
Claim 54 is objected to for referring to “tissue” when it is unclear how, if at all, this relates to the previously claimed “tissue” of claim 50.
Further, the claim is objected to for referring to “the direction” 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 32, 47-49 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 32 is indefinite for referring to the lower flange portion being oriented “substantially” parallel relative to the long axis of the stent, when the specification fails to describe what is or is not included in the scope of the term. The Examiner is unable to determine, for example, if one of the flanges was oriented 10 degrees off from the long axis of the stent, would meet the limitations of the claim. Without a standard for measuring, the boundaries of the claim cannot be determined.
Claim 47 is indefinite for claiming “the upper flange portion transitions in space”, but it is unclear what this is referring to. The claim has previously identified an upper region, as well as a lower flange portion. Both of these are considered equally possible to be what Applicant intends to refer to with this phrase, but it is unclear.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 102
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) 25-34, 39, 47-57 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bailey et al. (US 20060167543 A1) hereinafter known as Bailey.
Regarding claim 25 Bailey discloses a mitral valve prosthesis ([0002]) comprising:
a self-expanding stent ([0021]) having an unexpanded state (Figure 19 item 10) and an expanded state (Figures 7-11) that includes a long axis (10);
a framework that defines inner and outer surfaces (seen near elements 11b (inner) and 11a (outer)), and upper (44) and lower (42) flange portions interposed by a middle region (20);
wherein the lower flange portion is at a first longitudinal end of the middle region ([0022]) and comprises a plurality of protruding flange elements (considered to be the struts of flange 42), and the upper flange portion is at a second longitudinal end of the middle region ([0022]);
and a valve (28) attached to the inner surface of the middle region of the stent (Figure 10);
wherein when the stent is in the unexpanded state, the upper and lower flange portions are configured to be oriented along the long axis (Figure 19 shows stent 10 ([0065] representative of stent 40)), and
when the stent transitions from the unexpanded to the expanded state, the upper and lower flange portions are both configured to transition in space so they are no longer oriented along the long axis (Figures 7-11; [0022]),
wherein the lower flange portion is configured to grasp tissue at a ventricular side of an annulus by clamping the tissue between the lower flange portion and outer surface of the middle region after the stent transitions from the unexpanded state to the expanded state (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 Bailey 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 [0022], which describes how the flange expands to engage the native tissue and anatomic structures proximal to the valve so the flange and middle section abuts and outwardly radially compresses the anatomic valve leaflets against the vascular wall to anchor the valve in place. Then, the second flange is deployed and radially expands to contact the vascular wall as well, and retain the prosthesis in position; see also [0021] which describes how this occurs via self-expansion), and
wherein the lower flange portion is configured to bend back towards the middle region when the stent is in the expanded state ([0022]).
Regarding claims 26-28, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses the lower flange is capable of anchoring the stent within the mitral annulus by grasping the subvalvular apparatus (claim 26), the chordae (claim 27), and/or the left ventricular wall (claim 28) at a ventricular side of the annulus (this is stated as functional limitation of the lower flange (see the explanation in the rejection above). See also [0022] which describes how the flanges are intended to grasp native tissue to sandwich it therebetween, along with [0056]-[0060] which describes how and where the mitral valve embodiment can be positioned adjacent the mitral annulus (and thus within reach of any of the claimed tissue elements))
Regarding claims 29-30, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses the upper flange portion is capable of anchoring the stent within the mitral annulus by grasping tissue atrial tissue (claim 30) between the upper flange portion and the outer surface of the middle region (claim 29) (this is stated as an intended use of the upper flange (see the explanation in the rejection above). See also [0022] which describes how the flanges are intended to grasp native tissue to sandwich it therebetween, along with [0056]-[0060] which describes how and where the mitral valve embodiment can be positioned adjacent the mitral annulus (and thus within reach of the claimed tissues)).
Regarding claim 31, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses the lower flange is oriented at an oblique angle relative to the long axis when the stent is in the expanded state ([0022] acute, obtuse).
Regarding claim 32, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses the lower flange is oriented parallel to the long axis when the stent is in the unexpanded state (Figures 19-20a).
Regarding claim 33, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses the stent is self-expanding ([0021]).
Regarding claim 34, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses the stent comprises a wire weave ([0021]).
Regarding claim 39, Bailey discloses the valve of claim 25 substantially as is claimed,
wherein Bailey further discloses when the stent transitions from the unexpanded to the expanded state, the second end of the flange elements of the lower (claim 39) flange moves towards the middle region of the stent (See Figures 20a-g along with Figures 7-11 which shows how the stent transitions from the flanges 42, 44 lying parallel with the longitudinal axis of the stent, to moving outwardly (i.e. towards the middle region of the stent) to be positioned as outwardly extending flanges 42, 44 to grasp native valve tissue therebetween ([0022])).
Regarding claim 47 Bailey discloses a mitral valve prosthesis ([0002]) comprising:
a self-expanding stent ([0021]) having an unexpanded state (Figure 19 item 10) and an expanded state (Figures 7-11) that includes a long axis (10);
a wire ([0021]) framework that defines inner and outer surfaces (seen near elements 11b (inner) and 11a (outer)), and upper (44) and lower (42) regions interposed by a middle region (20);
wherein the lower region comprises a lower flange portion is at a first longitudinal end of the middle region ([0022]) and comprises a plurality of protruding flange elements (considered to be the struts of flange 42),
and a valve (28) attached to the inner surface of the middle region of the stent (Figure 10);
wherein when the stent is in the unexpanded state, the lower flange portion is straightened and oriented along the long axis such that the flower flange portion points downwards away from the middle region (Figure 19 shows stent 10 ([0065] representative of stent 40)), and
during transition of the stent from the unexpanded to the expanded state, the upper flange portion is configured to transition in space so it is no longer oriented along the long axis (Figures 7-11; [0022]),
wherein the lower flange portion is configured to anchor to the ventricular side of the annulus and the subvalvular apparatus by grasping tissue at a ventricular side of an annulus by trapping the tissue between the lower flange portion and outer surface of the middle region by the flange elements exerting a force in the direction of the middle region as the stent transitions from the unexpanded state to the expanded state (This is stated as a functional limitation of the lower flange portion (see the explanation in the rejection to claim 25 above. See also [0022], which describes how the flange expands to engage the native tissue and anatomic structures proximal to the valve so the flange and middle section abuts and outwardly radially compresses the anatomic valve leaflets against the vascular wall to anchor the valve in place. Then, the second flange is deployed and radially expands to contact the vascular wall as well, and retain the prosthesis in position; see also [0021] which describes how this occurs via self-expansion), and
wherein the lower flange portion is configured to bend back towards the middle region when the stent is in the expanded state ([0022]).
Regarding claim 48, Bailey discloses the valve of claim 47 substantially as is claimed,
wherein Bailey further discloses the stent is self-expanding ([0021]).
Regarding claim 49, Bailey discloses the valve of claim 47 substantially as is claimed,
wherein Bailey further discloses the stent comprises nitinol ([0021]).
Regarding claim 50 Bailey discloses a mitral valve prosthesis ([0002]) comprising:
a self-expanding stent ([0021]) having an unexpanded state (Figure 19 item 10) and an expanded state (Figures 7-11) that includes a long axis (10);
a wire ([0021]) framework that defines inner and outer surfaces (seen near elements 11b (inner) and 11a (outer)), and upper (44) and lower (42) flange regions interposed by a middle region (20);
wherein the lower region comprises a lower flange portion is at a first longitudinal end of the middle region ([0022]) and comprises a plurality of protruding flange elements (considered to be the struts of flange 42),
wherein during transition of the stent from the unexpanded to the expanded state, the lower flange portion is configured to transition in space so it is no longer oriented along the long axis (Figures 7-11; [0022]),
wherein the lower flange portion is configured to anchor to the ventricular side of the annulus and the subvalvular apparatus by grasping tissue at a ventricular side of an annulus by clamping the tissue between the lower flange portion and outer surface of the middle region as the stent transitions from the unexpanded state to the expanded state (This is stated as a functional limitation of the lower flange portion (see the explanation in the rejection to claim 25 above. See also [0022], which describes how the flange expands to engage the native tissue and anatomic structures proximal to the valve so the flange and middle section abuts and outwardly radially compresses the anatomic valve leaflets against the vascular wall to anchor the valve in place. Then, the second flange is deployed and radially expands to contact the vascular wall as well, and retain the prosthesis in position; see also [0021] which describes how this occurs via self-expansion), and
wherein the lower flange portion is configured to bend back towards the middle region when the stent is in the expanded state ([0022]).
Regarding claims 51 and 56 Bailey discloses the prosthesis of claim 50 substantially as is claimed,
wherein Bailey further discloses when the stent is in the unexpanded state, the lower flange portion is straightened along the axis (Figure 19 shows stent 10 ([0065] representative of stent 40)).
Regarding claims 52-53 Bailey discloses the prosthesis of claim 50 substantially as is claimed,
wherein Bailey further discloses when the stent is in the unexpanded state, the lower flange portion points downwards away from the middle region (Figure 19 shows stent 10 ([0065] representative of stent 40)).
Regarding claims 54 Bailey discloses the prosthesis of claim 50 substantially as is claimed,
wherein Bailey further discloses the protruding flange elements of the lower flange portion are configured to grasp tissue at the ventricular side of the mitral annulus by clamping the tissue between the lower flange portion and the outer surface of the middle region by the protruding flange elements exerting a force in the direction of the middle region as the stent transitions from the unexpanded to the expanded state (this is stated as a functional limitation which the claimed device is considered capable of achieving during its implantation. See the explanation above, long with [0022].).
Regarding claim 55, Bailey discloses the valve of claim 50 substantially as is claimed,
wherein Bailey further discloses the stent is self-expanding ([0021]).
Regarding claim 57, Bailey discloses the valve of claim 50 substantially as is claimed,
wherein Bailey further discloses the stent comprises nitinol ([0021]).
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 08/28/25