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 . Claims 1-23 are pending and examined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show inflow portion 108 and outflow portion 118 in Fig. 6A as recited in paragraph [0108] as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 § 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 1-23 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 1 recites the limitation “the tissue bumper comprising a tissue strip wrapped around at least one angled outflow strut in the row of angled outflow struts, the axial strut, and a portion of a first row of angled struts of the plurality of rows of angled inflow struts.” It is unclear if this “at least one” modifies only one of the angled outflow strut in the row of angled outflow struts, the axial strut, or a portion of a first row of angled struts of the plurality of rows of angled inflow struts, or, if it modifies all of the angled outflow strut in the row of angled outflow struts, the axial strut, and a portion of a first row of angled struts of the plurality of rows of angled inflow struts.
Claim 1 recites the limitation “the stent” in lines 3 & 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same or different from the “annular stent”. For the purpose of examination, they are regarded as the same.
Claim 2 recites the limitation “a first end portion the tissue strip…” in line 4. It is unclear if this is missing the word “of” in between “portion” and “the”.
Claim 4 recites the limitation “a first end portion the tissue strip…” in line 2. It is unclear if this is missing the word “of” in between “portion” and “the”.
Claim 7 recites the limitation “the first and second ends of the tissue bumper” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “the stent” in lines 2 & 12. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same or different from the “annular stent”. For the purpose of examination, they are regarded as the same.
Claim 23 recites the limitation “each the strip of material…” in line 2. It is unclear if this is missing the word “of” in between “each” and “the”.
All dependent claims are likewise rejected.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 17-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ben Zaken et al. (US 20230240840 A1) hereinafter, Ben.
Regarding claim 1, Ben teaches
a prosthetic heart valve (Fig. 19) that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (radially compressed and a radially expanded configuration, ¶0009), the prosthetic heart valve comprising:
an annular stent (106, Fig. 19) having a longitudinal axis extending between an inflow end (104, Fig. 11) of the stent and an outflow end (102, Fig. 11) of the annular stent (Figs. 11 or 19), the annular stent comprising:
an inflow portion comprising a plurality of rows of angled inflow struts (portion of 104, Fig. 11),
an outflow portion comprising a row of angled outflow struts (portion of 102, Fig. 11), and
a transition portion comprising an axial strut (113, Fig. 14B) and a commissure post (128, Fig. 14B);
a prosthetic valve (100, Fig. 14A) including a leaflet structure (124, Fig. 14A) positioned within the stent (106, Fig. 14A) and secured to the at least one commissure post (128, Fig. 14B); and
a tissue bumper (170, Fig. 19) configured to reduce abrasion caused by contact by the leaflet structure with the annular stent (170, act to protect the leaflets 124 from damage as they open against the frame 106, ¶0594),
the tissue bumper comprising a tissue strip (biocompatible material, ¶0419) wrapped around at least one angled outflow strut in the row of angled outflow struts, the axial strut, and a portion of a first row of angled struts of the plurality of rows of angled inflow struts (170, Fig. 20).
Regarding claim 17, Ben teaches
a prosthetic heart valve (Fig. 19) comprising:
an annular stent (106, Fig. 19) having a longitudinal axis extending between an inflow end (104, Fig. 11) of the stent and an outflow end (102, Fig. 11) of the annular stent (106, Fig. 11), the annular stent comprising:
an inflow portion comprising a plurality of rows of angled inflow struts (portion of 104, Fig. 11),
an outflow portion comprising a row of angled outflow struts (portion of 102, Fig. 11), and
a transition portion comprising three commissure posts (128, Fig. 14B) and three frame portions (portions between 128, Fig. 14B),
each of the commissure posts (128, Fig. 14B) having a proximal end coupled to the inflow portion and a distal end coupled to the outflow portion extending from the inflow portion to the outflow portion (Fig. 14B), and
each frame portion having first end coupled to the inflow portion and a second end coupled to the outflow portion (Fig. 14B), wherein
the commissure posts and the frame portions alternate around a circumference of the annular stent (Fig. 14B);
a prosthetic valve (100, Fig. 14A) including a leaflet structure (124, Fig. 14A) positioned within the stent (106, Fig. 14A) and secured to the commissure posts (128, Fig. 14B); and
protective bumpers (170, Fig. 19) configured to reduce abrasion caused by contact by the leaflet structure with the annular stent (170, act to protect the leaflets 124 from damage as they open against the frame 106, ¶0594), each protective bumper covering a respective frame portion of the three frame portions (170, Figs. 19 & 20).
Regarding claim 18, Ben teaches
wherein each of the frame portions is directly connected to two adjacent commissure posts (128, Fig. 14B) by two angled outflow struts of the row of angled outflow struts (angles struts of outflow portion, Fig. 14B), the two angled outflow struts extending in opposite directions from the frame portion (Fig. 14B).
Regarding claim 19, Ben teaches
further comprising a skirt (120, Fig. 14A) coupled to the inflow portion of the annular stent, wherein the skirt and the protective bumpers (170, Fig. 20) are separate pieces of material.
Regarding claim 20, Ben teaches
wherein the bumpers are tissue bumpers (biocompatible material, therefore it could be tissue, ¶0419).
Regarding claim 21, Ben teaches
wherein the tissue bumpers comprise pericardium tissue (¶0401).
Regarding claim 22, Ben teaches
wherein each bumper comprises a strip of material wrapped around the respective frame portion (170, Fig. 20).
Regarding claim 23, Ben teaches
wherein each the strip of material (170, Fig. 20) further wraps around at least one angled outflow strut in the row of angled outflow struts and/or a portion of a first row of angled struts of the plurality of rows of angled inflow struts (170, Fig. 20).
REASONS FOR ALLOWANCE
Claims 2-16 allowed.
The following is an examiner’s statement of reasons for allowance:
During the search of the prior art, Ben were found to be most relevant to the claimed invention. Ben discloses a prosthetic heart valve with a plurality of protective covers which are relevant structures of the independent and dependent claims.
However, Ben fail to disclose, teach, or suggest, in part, a center portion of the tissue strip is wrapped around an outflow end of the commissure post; a first end portion the tissue strip extends from the commissure post in a first direction and is wrapped around outflow struts of the row of angled outflow struts to the axial strut; the first end portion extends along and is wrapped around the axial strut toward the inflow end of the annular stent of the claimed invention wherein the first end portion extends in a second direction opposite the first direction from an inflow end of the axial strut and wraps around angled inflow struts of the first row of angled inflow struts. Although overlapping elements within a device are known in the art, there is no indication or motivation for a teaching reference to wrap the stent in the orientation as recited in claim 2.
Accordingly, claims 2-16 are allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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