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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/12/25 has been entered.
Response to Arguments
Applicant's arguments filed 10/03/25 have been fully considered but they are not persuasive.
On page 10 regarding amended claims, Applicant argues Moriss does not show the loaded condition, and then argues that Moriss teaches a configuration where arms “point back towards sheath 20 and are last to deploy”. .
The Examiner respectfully disagrees, noting Figure 12d shows the arms in a loaded condition. Further, it shows the arms’ free ends pointing radially outward (e.g. not towards a proximal sheath end) as the claim is amended to require.
On pages 12-13 Applicant argues the prior art references are “incompatible” with one another.
This argument is moot, since Moriss discloses the claimed invention alone.
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, the proximal end of the tubular delivery sheath, the plurality of engaging arms pointing away from the proximal end of the tubular delivery sheath, the arms’ free end, the arms’ distalmost end, 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: proximal end of the tubular delivery sheath, distalmost end of the engaging arms.
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 20, 23-25, 27-32 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 20 is rejected for having new matter for claiming the plurality of engaging arms’ free ends point away from a proximal end of the tubular delivery sheath. The Examiner notes that while the originally filed disclosure has support for the arms to be placed within a delivery sheath, there isn’t any part of the disclosure that indicates what end the arms may or may not be facing towards/away from. Notably, as the Examiner best understands the term, a “proximal” end of a catheter’s sheath generally refers to a part of the delivery device that is closer to the person inserting the catheter (e.g. near a handle). However, the orientation of the prosthetic tricuspid valve within the sheath, location of insertion, and method of delivery of the prosthetic valve to the heart and in place within a patient is not disclosed, discussed, or depicted anywhere in the originally filed disclosure. Notably, the directions the arms’ free ends would face would appear to depend on all these elements, since adjustment of any one could change the orientation of the valve within the sheath. There is accordingly no information regarding which end of the sheath the free ends of the arms face or do not face when in the loaded condition, and this is accordingly considered to be new matter.
Claim 32 is additionally rejected for having new matter, for claiming “each of the arms includes a distalmost end that is farthest from the tubular delivery sheath”, when there is no depiction, discussion, or disclosure of a distalmost end of the arms as it relates to the tubular delivery sheath. Notably, the Examiner is unclear, since a delivery sheath is understood to be extending radially around the arms, meaning the arms (or ends of arms) would be the same distance from the sheath.
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.
Claim 32 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 is indefinite for claiming “each of the engaging arms includes a distalmost end that is farthest from…the tubular delivery sheath”. As the Examiner best understands (since there are no depictions of the arms within the delivery sheath, and no description in the specification of the arms within the delivery sheath), the arms lie radially within the delivery sheath. The figures, as the Examiner best understands them, appear to indicate the arms might lie flat when being delivered (although this is not entirely clear since it also is not discussed). It is accordingly unclear accordingly, how one end of the arms can be “farthest from” the sheath that supposedly surrounds it, as opposed to them all lying radially (presumably at the same distance) inside the sheath.
It is possible the intent behind the claim is something else however, and possible that something is missing from the claim, as it is possible the engaging arms’ distalmost end is farthest from the tubular delivery sheath as compared to a few other things distance from the tubular delivery sheath. Notably, the term “farthest” indicates it could be a comparison term of how far the arms are from the sheath as compared to multiple other elements’ distance from the sheath. However, the Examiner cannot guess at this from the language of the claim.
Further, the Examiner notes that the claim refers to the “distalmost end” of the engaging arms, when claim 20, from which this claim depends, has already discussed/established the engaging arms’ “free end”. It is unclear how, if at all, these two ends are related, since the disclosure fails to show or depict either element in the figures.
Based on the uncertainty regarding the subject matter of the claim, the Examiner is unsure of how to interpret this claim in terms of the prior art. However, if the claim is clarified sufficiently, it will be able to be considered in relation to prior art.
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) 20, 23-25, 27-30, is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moriss et al. (US 20150327994 A1) hereinafter known as Moriss (as is evidenced by Gabbay (US 20080114452 A1)).
Regarding claim 20 Moriss discloses a method of treating a native tricuspid valve ([0091] an aortic valve is a native tricuspid valve; alternatively, the Examiner notes that since Moriss describes their leaflets being useful for replacing either bi-leaflet or tri-leaflet valves in the heart, and there are only four valves in the healthy human heart, the person of ordinary skill in the art at the time the invention was filed would have found it obvious for treating the native tricuspid valve in the manner consistent with tri-leaflet repair) comprising:
providing a tubular delivery sheath (Figures 2b1-2, 8-12 all show delivery sheaths (e.g. item 20, 226, 200, 238, etc.));
loading a prosthetic tricuspid valve within the sheath (Figures 2b1-2, 8-12),
wherein the valve includes: a collapsible and self-expandable stent ([0203]) extending along a longitudinal axis (110a) and having an inflow and outflow end ([0098]), the stent including a plurality of struts forming a plurality of cells ([0150]) annularly arranged around the stent in at least two rows (for example, Figure 2a1), wherein a first row is positioned adjacent the outflow end of the stent (for example, Figure 2a1 near the bottom of the figure); and a collapsible and expandable valve assembly within the stent ([0166], [0103]) which includes a cuff ([0148]) and a plurality of leaflets ([0155]), the cuff covering at least some of the cells ([0148]); and a plurality of engaging arms (120) disposed adjacent the first row of cells (for example, Figure 2a1; see also [0098]) and being disposed radially outward of the cuff (for example, see Figure 2a1), each of the arms being connected to the stent ([0098], see also, for example Figure 2a1) and having a free end (for example, see Figure 2a1; see also [0098] atraumatic tips), the arms being pivotally moveable between a loaded condition in which the free end of the arms points away from a proximal end of a tubular delivery sheath (Figure 12d shows the arms’ free ends pointing radially outward (a direction away from a proximal end of a delivery sheath)), a partially-released condition, and a fully-released condition ([0110]), in response to axial movement of the sheath ([0110] the arms automatically expand in response to the support’s expansion, [0166] the support self-expands when the sheath is withdrawn (axially)), and
withdrawing the sheath toward an operator by a first distance (Figure 12f) to transition the arms from the loaded condition where the arms are oriented substantially parallel with the longitudinal axis of the stent to the partially-released condition in which each of the arms extends radially outward from the stent to form a first angle with the longitudinal axis (Figure 12f), and
withdrawing the sheath toward the operator by an additional second distance after the first distance (Figure 12g) to transition the arms from the partially-released condition to the fully-released condition in which each of the arms extends radially outward from the a second angle with the longitudinal axis of the stent, wherein the first angle is larger than the second angle ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to close the distance to grasp the leaflets more tightly),
wherein a combination of the axial movement of the sheath and biasing of the engaging arms is solely responsible for transitioning the arms from the partially-released to the fully-released condition ([0110] the arms automatically expand in response to the support’s expansion, [0166] the support self-expands when the sheath is withdrawn (axially). See also evidence from Gabbay [0020] who indicates that “automatic” movement is known to be attributable to self-expansion),
Regarding claim 23 Moriss discloses the method of claim 21 substantially as is claimed,
wherein Moriss further discloses transitioning the arms includes moving the arms back closer to the longitudinal axis to capture one or more native leaflets between the arms and the stent ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to close the distance to grasp the leaflets more tightly).
Regarding claim 27 Moriss discloses the method of claim 21 substantially as is claimed,
wherein Moriss further discloses withdrawing the sheath comprises sequentially transitioning each of the arms from the loaded to the partially-released condition, and from the partially-released condition to the fully-released condition ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended from the loaded condition to the partially-released condition; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to the fully-released condition to close the distance to grasp the leaflets more tightly).
Regarding claim 30 Moriss discloses the method of claim 21 substantially as is claimed,
wherein Moriss further discloses the sheath withdrawing the second distance transitions each of the arms from an intermediate configuration in the partially-released condition to a relaxed configuration in the fully-released condition ([0102], [0203], [0110]).
Regarding claim 24 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses a sequential release from the sheath causes each of the arms to extend further away from the longitudinal axis and then back closer to the axis ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to close the distance to grasp the leaflets more tightly).
Regarding claim 25 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the arms are spaced circumferentially from one another ([0164]).
Regarding claim 26 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the arms include a curved, smooth atraumatic feature adjacent a terminal end ([0120]; see also, for example, Figure 2a5 item 122).
Regarding claim 28 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the sheath is withdrawn to release the arms simultaneously (see Figure 12f; the arms are the same length indicating their release is simultaneous).
Regarding claim 29 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses loading the valve includes radially compressing the arms in the loaded condition within the sheath (see Figure 12e).
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) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss (evidenced by Gabbay) as is applied above, further in view of Quill et al. (US 20140194975 A1) hereinafter known as Quill.
Regarding claim 31 the Moriss Combination teaches the method of claim 20 substantially as is claimed. Moriss further teaches the arms move from the partially-released to the fully-released configuration automatically when the stent is self-expanded ([0110], and Gabbay indicates that automatic movement indicates self-expansion ([0020]), which indicates to the person of ordinary skill that the arms are expanded to the various partially-released and fully-released configurations once they are free from the sheath. Moriss is not explicit within their disclosure regarding the position of the stent when the arms transition from the partially-released to fully-released configurations. However, various embodiments (see at least Figures 9, 11), show the stent being partially located within the sheath even though arms are released, although other embodiments show the stent fully out of the sheath when the arms are expanding.
Further, regarding claim 31 Quill teaches that stents with arms can be deployed with the stent remaining in the sheath until the arms are fully deployed ([0008]. Moriss and Quill are involved in the same field of endeavor, namely valves. The person of ordinary skill in the art, at the time the invention was filed, would have accordingly found it obvious to have at least a portion of the stent maintained within the sheath when the sheath withdraws the second distance and the arms transition from the partially-released to the fully-released condition 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, the person of ordinary skill would have found it obvious to try either method (having the arms deployed with the stent either partially retained in the sheath, or fully released).
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 01/28/26