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 .
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 8 and 9 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 8 recites “the radial force exerted by the stent”, which renders the claim indefinite. It is unclear in what direction and what elements of the stent are exerting this force. Claim 9 depends from claim 8 and is indefinite for the same reason.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-13, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 10,729,530 (Opie et al.).
Opie discloses a stent (101) having a substantially tubular body having a proximal end and an opposing distal end;
and a scaffold having a plurality of interconnected struts forming a plurality of radial axial rows of radial support cells and a plurality of flexible axial rows of flexible support cells (see marked up figure below);
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wherein the plurality of radial axial rows and the plurality of flexible axial rows are disposed in an alternating pattern along a circumferential axis of the stent;
wherein a center axis of each radial axial row and flexible axial row is parallel to a longitudinal axis of the stent (shown above);
wherein each radial axial row is arranged so as to be offset along the longitudinal axis of the stent from each adjacent radial axial row;
and wherein each radial support cell is formed from four of the plurality of interconnected struts of the scaffold which are arranged so as to be symmetrical along both the longitudinal axis and the circumferential axis of the stent (each radial support cell has a symmetrical diamond shape).
Regarding claim 3, due to the flexibility and expandability of the stent structure, the four struts that form said radial support cells are disposed such that a pair of opposing vertical struts are oriented substantially perpendicular to the longitudinal axis of the stent (see marked up figure below).
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Regarding claim 4, the language “ wherein the vertical struts of each radial support cell is configured for buckling inwardly toward one another when exposed to a radial force” is a functional recitation that is not given full patentable weight. The prior art is not required to disclose this function. The capability of the flexible struts to buckle under the pressure of a sufficient radial force meets the claim limitation, wherein a radial force can be applied by an operator’s hand, a surgical tool, etc.
Claim 5 is similarly treated as a functional recitation, wherein the capability of the flexible vertical struts of each radial support cell to deform from a linear shape to a curved shape having a large radius when exposed to a sufficient radial force meets the claim requirement.
Claim 6 is similarly treated as a functional recitation, wherein the capability
Of the vertical struts of each radial support cell to deform outwardly from one another when exposed to a tensile force while the stent is in a longitudinally constrained configuration meets the claim requirement. A tensile force capable of causing outward bending can be applied by an operator’s hand, a surgical tool, etc.
In regards to claim 7, Opie the angle between the struts is greater than zero degrees when the stent is in the longitudinally constrained configuration (Fig. 21C & 25; wherein a constrained configuration encompasses varying degrees of compression).
Claim 8 recites another functional recitation that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the function in order to meet the claim requirement. The stent is capable of being manipulated by sufficient external forces applied by an operator or surgical tool such that at least some component of the stent exerts a radial force in some direction on some object that is lower than when in the stent is longitudinally constrained than when the stent is unconstrained or radially constrained. Similarly, the stent is capable of exerting a radial force when it is longitudinally constrained at least to some extent that permits the stent to be compressed and loaded into a stent delivery system for insertion into a body lumen, as recited by claim 9.
Regarding claim 10, Opie discloses at least one radiopaque element formed on the stent (see description of marker formed of additional material such as nitinol or platinum attached to stent at column 8, lines 46-62).
Regarding claims 11-12, the at least one radiopaque element is positioned on one or both of the proximal end and distal end of the stent (wherein Opie explains markers are placed at locations of electrodes 131, where it can be seen they are located along the length of the stent in Figure 7C). This is considered to meet the limitation of “a length” in claim 12.
Regarding claim 13, see description of marker formed of additional material such as nitinol or platinum attached to stent at column 8, lines 46-62).
In regards to claim 16, the stent of Opie has a single piece construction (all the struts are interconnected to form a unitary structure) of a shape memory material (col 15, lines 40-55). Regarding the term laser cut, this is not given patentable weight, as the process by which a product is made is not germane to the issue of patentability of the device itself. Nonetheless, Opie discloses a laser cut construction at column 8, lines 46-62).
Regarding claim 18, Opie discloses a stent having a substantially tubular body comprising a proximal end and an opposing distal end;
a scaffold having a plurality of interconnected struts forming a plurality of radial axial rows of radial support cells and a plurality of flexible axial rows of flexible support cells;
and an at least one radiopaque element formed on the stent (see description of marker formed of additional material such as nitinol or platinum attached to stent at column 8, lines 46-62);
wherein the plurality of radial axial rows and the plurality of flexible axial rows are disposed in an alternating pattern along a circumferential axis of the stent;
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wherein a center axis of each radial axial row and flexible axial row is parallel to a longitudinal axis of the stent;
wherein each radial axial row is arranged so as to be offset along the longitudinal axis of the stent from each adjacent radial axial row;
and wherein each radial support cell is formed from four of the plurality of interconnected struts of the scaffold which are arranged so as to be symmetrical along both the longitudinal axis and the circumferential axis of the stent (the radial cells have a symmetrical diamond shape).
Allowable Subject Matter
Claim 17 is allowed.
Claims 2, 14 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claims 2 and 17, Opie fails to disclose that two adjacent flexible axial rows have mirror symmetry along the longitudinal axis of the stent.
US Patent App. Pub. No. 2018/0214286 (Chanduszko) discloses a stent with a plurality of radial axial rows of radial support cells and a plurality of flexible axial rows of flexible support cells (see marked up figure below);
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wherein the plurality of radial axial rows and the plurality of flexible axial rows are disposed in an alternating pattern along a circumferential axis of the stent;
wherein a center axis of each radial axial row and flexible axial row is parallel to a longitudinal axis of the stent (shown above);
wherein each radial support cell is formed from four of the plurality of interconnected struts of the scaffold which are arranged so as to be symmetrical along both the longitudinal axis and the circumferential axis of the stent (each radial support cell has a symmetrical diamond shape)
and wherein adjacent flexible axial rows have mirror symmetry along the longitudinal axis of the stent.
Chanduszko fails to form the pattern such that each radial axial row is offset along the longitudinal axis of the stent from each adjacent radial axial row.
In regards to claims 14 and 15, the prior art fails to disclose or render obvious that adjacent radial support cells are connected by coil spanning a break therebetween, in combination with the elements of claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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