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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
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.
Status of the Claims
Claim(s) 21-40 is/are pending.
Claim Objections
Claims 30, 33, and 40 are objected to because of the following informalities:
Claims 30 and 40 each recites “the outside”, which should be “the outside of the stent structure”.
Claim 33 recites “one barb structure”, which should be “one of the at least one barb structure”.
Claim 33 recites “one second mesh units”, which should be “one of the second mesh units”.
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 21-40 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21, lines 4-5 recites “the mesh structure”. As introduced there are “mesh structures”. Thus, it is unclear which one of the multiple mesh structures is being referred back to.
Claim 21, line 7 recites “one of the second mesh units”. It is unclear if this is the same or different “one” than that introduced in line 6. For purposes of examination the Examiner considers this language to be met when any one of the second mesh units meets the required limitation.
Claim 21, lines 7-8 recites “one barb structure”. It is unclear if this is the same or different “one” barb structure than that in line 7 preceding this instance. For purposes of examination the Examiner considers this language to be met when any one of the barb structures meets the required limitation.
Claim 21, line 8 recites “the one of the second mesh units”. It is unclear which “one” is being referred back to as there are multiple introductions of “one of the second mesh units”. The Examiner notes this issue becomes moot if the issue for claim 21, line 7 becomes definite.
Claim 26, line 1 recites “the barb structure”. It is unclear which bar structure is being referred back to because claim 25, from which claim 26 depends, requires “each” barb.
Claim 31, line 6 recites “the elastic element”. It is unclear which elastic element is referred back to as each barb has an elastic element (line 4).
The term "thorn-like" in each of Claim 31, lines 8 and 9 and Claim 32, lines 2 and 4, is a relative term which renders the claim indefinite. The term "thorn-like" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “thorn-like” (i.e. what is the structure that is “like” a thorn). Therefore, this term is indefinite.
Claim 31, line 12 recites “an angle”. It is unclear if this is the same or a different angle than that introduced earlier in the claim(s). For purposes of examination the Examiner notes this limitation is being interpreted as “a second angle” (and the first instance to be “a first angle”).
Claim 31, line 12 recites “a straight line”. It is unclear if this is the same or a different straight line than that introduced earlier in the claim(s). For purposes of examination the Examiner notes this limitation is being interpreted as “a second straight line” (and the first instance to be “a first straight line”).
Claim 33, lines 3-4 recites “one of the second mesh units”. It is unclear if this is the same or a different “one” than that introduced earlier in the claim(s). For purposes of examination the Examiner notes this limitation is being interpreted as met when any one of the second mesh units meets the required limitation.
Claim 33, line 4 recites “one barb structure”. It is unclear if this is the same or a different “one” than that introduced earlier in the claim(s). For purposes of examination the Examiner notes this limitation is being interpreted as met when any one of the barb structures meets the required limitation.
Claim(s) 22-25, 27-30, and 34-40 are rejected as dependent from a rejected claim.
Claim Rejections - 35 USC § 103
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 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 21-27 and 29-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi, et al (Levi) (US 2012/0123529 A1) in view of McGunkin, et al (McGunkin) (US 2002/0002401 A1).
Regarding Claim 21, Levi teaches an implant (e.g. Figure 1, heart valve, abstract), comprising:
a tubular stent structure (e.g. Figure 1, #12) and a skirt (#s 16, 18), the stent structure is radially compressible or expandable (e.g. abstract); the stent structure comprises mesh structures that are circumferentially distributed (e.g. Figures 1, 5); the skirt is arranged on a surface of the stent structure (e.g. [0051]); the mesh structure comprise a plurality of first mesh units and a plurality of second mesh units (e.g. annotated Figure 5 below); an area of one of the first mesh units is larger than an area of one of the second mesh units (e.g. annotated Figure 5 below).
Levi discloses the invention substantially as claimed but fails to teach the stent structure is provided with at least one barb structure, a size of one of the second mesh units is substantially the same as a size of one barb structure, and one barb structure is accommodated in the one of second mesh units.
McGunkin teaches a mesh support frame having at least one barb structure (e.g. Figures 1-2) at the second mesh units (e.g. [0013]).
McGunkin and Levi are concerned with the same field of endeavor as the claimed invention, namely stent supports to be anchored in vascular tissue.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Levi to have the barb structures at the second mesh units as taught by McGunkin in order to secure the device to the tissue and limit axial and radial movement for better securement (e.g. McGunkin, [0013]).
The combination of Levi and McGunkin teaches: a size of one of the second mesh units is substantially the same as a size of one barb structure (e.g. McGunkin, Figure 3, the barbs are the same radial thickness as the strut they are housed within, which is the respective second mesh unit), and one barb structure is accommodated in the one of second mesh units (e.g. McGunkin, Figures 3, 5).
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Annotated Figure 5, Levi
Regarding Claim 22, a junction is provided between two adjacent first mesh units and each second mesh unit is arranged at the junction (e.g. Levi, annotated Figure 5 above).
Regarding Claim 23, the first mesh units are hexagonal structures and one edge of one hexagonal structure overlaps one edge of another hexagonal structure to form the junction (e.g. Levi, annotated Figure 5 above).
Regarding Claim 24, each first mesh unit is provided with at least one arc-shaped bulge structure along an axial direction of the stent structure and the arc-shaped bulge structure protrudes in a direction away from the first mesh unit (e.g. Levi, annotated Figure 5 above).
Regarding Claim 25, each barb structure comprises a connection end, a first position, and a free end (e.g. McGunkin, annotated Figure 5 below); the connection end is connected to the junction (in the combination, this is the location where the barb attaches); the free end extends out of the second mesh unit (e.g. McGunkin, Figure 3, in the expanded configuration the barb extends radially outward); the first position is located between the connection end and the free end (e.g. McGunkin, annotated Figure 5 below); and an angle (F1) formed between a straight line formed by the connection end and the first position and a central axis of the stent structure is greater than an angle (F2) formed between a straight line formed by the connection end and the free end and the central axis of the stent structure (e.g. McGunkin, annotated Figure 4 below).
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Annotated Figure 5, McGunkin
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Annotated Figure 4, McGunkin
Regarding Claim 26, the barb structure comprises a first section and a second section connected to each other; the first section is between the connection end and the first position; the second section is between the first position and the free end (e.g. McGunkin, annotated Figure 5 above; these sections are inherently present); and the free end is a sharp end structure (e.g. McGunkin, Figure 5).
Regarding Claim 27, the first section is a straight bar-shaped structure (e.g. McGunkin, annotated Figure 5 above), and a first surface of the second section facing an outer side of the stent structure is provided with an arc-shaped structure (e.g. McGunkin, annotated Figure 5 above, recess in the free end).
Regarding Claim 29, the barb structures and the stent structure are integrally formed by cutting a tubular product (e.g. McGunkin, Figure 5).
Regarding Claim 30, the implant is a heart valve (e.g. Levi, abstract); the heart valve further comprises a valve structure (e.g. Levi, [0051], #14); the valve structure comprises a plurality of valve leaflets fitting one another (e.g. Levi, Figure 2); each valve leaflet comprises a flange (e.g. Levi, Figure 2, 25, 29, #s 124); and the flange passes through the second mesh unit in a direction from the inside of the stent structure to the outside (e.g. Levi, Figure 29).
Regarding Claim 31, the combination of Levi and McGunkin teaches an implant (discussed supra for claim 21), comprising: a tubular stent structure (discussed supra for claim 21) and at least one barb structure arranged on the stent structure (discussed supra for claim 21 and see elastic element in this claim), wherein the stent structure comprises a plurality of mesh structures circumferentially distributed (discussed supra for claim 21); one barb structure is accommodated in one of the mesh structures (discussed supra for claim 21); each barb structure comprises an elastic element (e.g. McGunkin, annotated Figure 3 below, boxed portion); one end of each elastic element is connected to each mesh structure to form a connection end (e.g. McGunkin, annotated Figure 5 above); the elastic element is configured to protrude outwardly from the stent structure to form a first position (e.g. McGunkin, Figures 1, 3; at least the portion in Figure 1 extends radially outward) and then bend from the first position to the stent structure (e.g. McGunkin, Figure 5, for example, when collapsed); a window structure is arranged on the elastic element (e.g. McGunkin, annotated Figure 3, opening into which #28 collapses); a thorn-like structure connected to the window structure is arranged in the window structure (e.g. McGunkin, Figure 1, extension #28); the thorn-like structure has a free end extending from the window structure to a direction away from the stent structure (e.g. McGunkin, Figure 1); and an angle formed between a straight line formed by the connection end and the first position and a central axis of the stent structure is greater than an angle formed between a straight line formed by the connection end, and the free end and the central axis of the stent structure (discussed supra for claim 25).
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Annotated Figure 3, McGunkin
Regarding Claim 32, the connection ends are connected to distal ends of the mesh structures (e.g. McGunkin, annotated Figure 5 above), and the thorn-like structures are connected to proximal ends of the window structures (e.g. McGunkin, annotated Figure 5 above, via the intervening structures of the barb/elastic element).
Regarding Claim 33, the mesh structures comprise a plurality of first mesh units and a plurality of second mesh units (discussed supra for claim 21); an area of one of the first mesh units is larger than an area of one of the second mesh units (discussed supra for claim 21); a size of one of second mesh units is substantially the same as a size of one barb structure (discussed supra for claim 21); and one barb structure is accommodated in the one of second mesh units (discussed supra for claim 21).
Regarding Claim 34, a junction is provided between two adjacent first mesh units; and each second mesh unit is arranged at the junction (discussed supra for claim 22).
Regarding Claim 35, the first mesh units are hexagonal structures; and one edge of one hexagonal structure overlaps one edge of the other hexagonal structure to form the junction (discussed supra for claim 23).
Regarding Claim 36, the stent structure is radially compressible or expandable (discussed supra for claim 21) and when the stent structure radially compresses or expands, the first mesh units circumferentially compress or expand along the stent structure (e.g. Levi, Figures 17-18 (collapsed) versus Figures 1-3 (expanded)); each first mesh unit is provided with at least one arc-shaped bulge structure along an axial direction of the stent structure; and the arc-shaped bulge structure protrudes in a direction away from the first mesh unit (discussed supra for claim 24).
Regarding Claim 37, the free end is a sharp end structure (discussed supra for claim 26).
Regarding Claim 38, at least one barb structure and the stent structure are connected into a whole after being respectively formed (e.g. McGunkin, Figure 5).
Regarding Claim 39, at least one barb structure and the stent structure are integrally formed by cutting a tubular product (discussed supra for claim 29).
Regarding Claim 40, the implant is a heart valve (discussed supra for claim 30); the heart valve further comprises a valve structure (discussed supra for claim 30); the valve structure comprises a plurality of valve leaflets fitting one another (discussed supra for claim 30); each valve leaflet comprises a flange (discussed supra for claim 30); and the flange passes through the second mesh unit in a direction from the inside of the stent structure to the outside (discussed supra for claim 30).
Claim 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi, et al (Levi) (US 2012/0123529 A1) in view of McGunkin, et al (McGunkin) (US 2002/0002401 A1) as discussed supra and further in view of Bolling, et al (Bolling) (US 2010/0249920 A1).
Regarding Claim 28, the combination of Levi and McGunkin teaches the first section is a straight bar-shaped structure (e.g. McGunkin, annotated Figure 5 above).
The combination of Levi and McGunkin discloses the invention substantially as claimed but fails to teach and the second section is a curved structure.
Bolling teaches a heart valve having a barb structure that has a curved free end (e.g. abstract, Figure 1A, #120, two curved portions).
Bolling and the combination of Levi and McGunkin are concerned with the same field of endeavor as the claimed invention, namely heart valves anchored to the implantation site,
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Levi and McGunkin by incorporating the barb structure shape as taught by Bolling as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of connecting a heart valve implant to tissue at an implantation site. Further, Bolling recognizes that multiple shapes are able to perform the anchoring function (e.g. Bolling, [0072]).
Relevant Prior Art
US 2020/0000579 A1 to Manash teaches a heart valve have a section of hexagonal mesh units and barbs that extend from a strut and retract within the strut (e.g. Figures 43-46B).
US 2008/0114442 A1 to Mitchell, et al teaches a stent structure having barbs that are housed within the structs (e.g. Figure 12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 10/31/2025