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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “first stent layer means” and “connecting wire means” in claim 20.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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)(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) 1-4 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 20200268500 to Brandeis.
Regarding claim 1, Brandeis discloses a stent (see Fig. 8A) comprising: an outer stent layer 802 comprising at least one first stent wire braided into a first tubular shape; wherein the at least one first stent wire comprises a DFT wire (para [0415] and 0419 discloses 802 to be a woven mesh material made of shape memory material (SMM); para [0026] discloses SMM can be DFT wires) and, an inner stent layer 801 comprising one or more second stent wires braided into a second tubular shape (para [0412] discloses 801 as an inner mesh) wherein the outer stent layer is connected to the inner stent layer (see Fig. 8A).
Regarding claim 2, Brandeis disclose that the second stent wires comprise DFT wires (inner mesh layer 801 can be made of SMM such as DFT wires; [0151], [0026]).
Regarding claim 3. Brandeis discloses that the second stent wire can also be a made of non-DFT wires, such as flexible mesh materials ([0420], flexible mesh materials such as polyurethane, etc [0027]).
Regarding claim 4, Brandeis discloses another stent embodiment in Fig. 8B comprising: an outer stent layer 812 comprising at least one first stent wire braided into a first tubular shape; wherein the at least one first stent wire comprises a DFT wire (para [0429] mesh material made of shape memory material (SMM); para [0026] discloses SMM can be DFT wires) and, an inner stent layer 811 comprising one or more second stent wires braided into a second tubular shape (para [0428] discloses 811 as an inner mesh), wherein the outer stent layer is connected to the inner stent layer (see Fig. 8B), and a third layer 813 comprising one or more third stent wires braided into a third tubular shape ([0430] mesh), wherein the outer stent layer 812 is positioned within the third stent layer 813).
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.
Claims 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200268500 to Brandeis in view of US 20210137715 to Ringwala et al.
Regarding claim 5, Brandeis discloses all the limitations of the claim, as applied to claim 1 above, but is silent with regards to the outer stent layer is braided with only a single DFT wire.
However, Ringwala discloses that it is known for a stent having a stent layer 130 be made of a mesh material that is braided from a single stent wire [0046].
Therefore, it would have been obvious to one of ordinary skill in the art at before the effective filing date of the claimed invention to modify the outer stent layer of Brandeis to be made of a single wire instead of multiple wires since it has been held that a simple substitution of one known means for another known means would yield predictable results. In this instance, it would be substituting the multiple wires layer of Brandeis with the single wire layer of Ringwala.
Regarding claim 6, Brandeis discloses the inner stent layer be made of a plurality of wires that are composed of a non-DFT material ([0422] mesh woven from a combination of metal and polymer materials).
Claims 7-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200268500 to Brandeis in view of US 20210030570 to Pung et al.
Regarding claim 7, Brandeis discloses all the limitations of the claims, including the inner and outer layer connected to each other as a unit shown in Fig. 8B, but fails to disclose one or more connecting wires connected to the first stent layer and the second stent layer; wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer.
However, Pung discloses a stent a stent having an inner stent layer and an outer stent layer, and one or more connecting wires connected to the first stent layer and the second stent layer (one or more support wires 814 connected to outer layer wires 102 and inner layer wires 204; Fig. 23-26; [0110]); wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer (support wires 814 comprise nitinol, which is a shape memory material, and are capable of having a shape set to have a secondary shape prior to connection with inner layer wires 204 and the outer layer wires 102; Fig. 23-26; [0106 and 0110-0112]).
Therefore, 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 stent of Brandeis to include one or more connecting wires connected to the first stent layer and the second stent layer; wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer, as taught by Pung, for the advantages of providing additional radial compression resistance as well as insertion force resistance and locking the two stent layers together to overcome any manufacturing defects and ensure proper deployment.
Regarding claim 13, Brandeis discloses a stent (see Fig. 8A) comprising: a first stent layer 802 comprising at least one first stent wire braided into a first tubular shape; wherein the at least one first stent wire comprises a DFT wire (para [0415] and 0419 discloses 802 to be a woven mesh material made of shape memory material (SMM); para [0026] discloses SMM can be DFT wires).
Brandeis fails to disclose one or more connecting wires connected to the first stent layer; wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer.
However, Pung discloses a stent a stent having an inner stent layer and an outer stent layer, and one or more connecting wires connected to the first stent layer and the second stent layer (one or more support wires 814 connected to outer layer wires 102 and inner layer wires 204; Fig. 23-26; [0110]); wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer (support wires 814 comprise nitinol, which is a shape memory material, and are capable of having a shape set to have a secondary shape prior to connection with inner layer wires 204 and the outer layer wires 102; Fig. 23-26; [0106 and 0110-0112]).
Therefore, 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 stent of Brandeis to include one or more connecting wires connected to the first stent layer; wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer, as taught by Pung, for the advantages of providing additional radial compression resistance as well as insertion force resistance and locking the two stent layers together to overcome any manufacturing defects and ensure proper deployment.
Regarding claims 8 and 15, Brandeis in view of Pung discloses all the limitations of claims 7 and 13, respectively, and wherein Pung further discloses wherein the secondary shape of the one or more connecting wires 814 has a diameter larger than an expanded diameter of the stent (see Fig. 27, wire 814 has a diameter that is larger than overall diameter of the stent).
Regarding claims 9 and 16, Brandeis in view of Pung discloses all the limitations of claims 7 and 13, respectively, and wherein Pung further discloses wherein the secondary shape of the one or more connecting wires 814 is helically wound.
Regarding claim 10, Brandeis in view of Pung discloses all the limitations of claim 9, and wherein Pung further discloses wherein the connecting wires 814 is substantially similar to a braid pitch of the stent (see Fig. 27, therefore the connecting wire of Pung can be modified to the stent of Brandeis and have the same braid pitch of the stent).
Regarding claims 11 and 17, Brandeis in view of Pung discloses all the limitations of claims 9 and 13, respectively, and wherein Pung further discloses a first coil disposed around a first end portion of one of the one or more connecting wires and around a first portion of the at least one stent wire (windings 816 are formed about support wires 814 and outer layer wires 102 at the proximal end of support wires 814; Fig. 23-26; [0110-0111]), and a second coil disposed around a second end portion of one or the one or more connecting wires and around a second portion of the at least one stent wire (windings 816 are formed about support wires 814 and outer layer wires 102 at the distal end of support wires 814; fig. 23-26; [0110-0111]).
Regarding claims 12 and 18, Brandeis in view of Pung discloses all the limitations of claims 9 and 13, respectively, and wherein Pung further discloses the one or more connecting wires comprise a first connecting wire connected along a first region of the stent and a second connecting wire connected along a second region of the stent (one or more support wires 814 connected to outer layer wires 102 and inner layer wires 204; fig. 23-26; [0110]).
Regarding claim 14, Brandeis in view of Pung discloses all the limitations of claim 13, and wherein the modified device of Brandeis further discloses a second stent layer 801 braided from a plurality of second stent wires. The modified device of Brandeis would also have the connecting wires of Pung be interwoven with the first and second stent layer, as disclosed by Pung (one or more support wires 814 woven between the outer layer wires 102 and inner layer wires 204; fig. 23-26; [0110-0111]).
Regarding claims 19, Brandeis in view of Pung discloses all the limitations of claim 13, and wherein Pung further discloses the connecting wires 814 having a diameter larger than an expanded diameter of the stent (see Fig. 27, wire 814 has a diameter that is larger than overall diameter of the stent).
Regarding claim 20, Brandeis discloses a stent (see Fig. 8A) comprising: a first stent layer means 802 comprising at least one first stent wire braided into a first tubular shape; wherein the at least one first stent wire comprises a DFT wire (para [0415] and 0419 discloses 802 to be a woven mesh material made of shape memory material (SMM); para [0026] discloses SMM can be DFT wires).
Brandeis fails to disclose one or more connecting wires means for connecting to the first stent layer means; wherein the one or more connecting wire means are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer.
However, Pung discloses a stent a stent having an inner stent layer and an outer stent layer, and one or more connecting wires connected to the first stent layer and the second stent layer (one or more support wires 814 connected to outer layer wires 102 and inner layer wires 204; Fig. 23-26; [0110]); wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer (support wires 814 comprise nitinol, which is a shape memory material, and are capable of having a shape set to have a secondary shape prior to connection with inner layer wires 204 and the outer layer wires 102; Fig. 23-26; [0106 and 0110-0112]).
Therefore, 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 stent of Brandeis to include one or more connecting wires connected to the first stent layer means; wherein the one or more connecting wires are composed of a shape memory material and have been shape set to have a secondary shape prior to connection with the first stent layer and the second stent layer, as taught by Pung, for the advantages of providing additional radial compression resistance as well as insertion force resistance and locking the two stent layers together to overcome any manufacturing defects and ensure proper deployment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARWIN P EREZO whose telephone number is (571)272-4695. The examiner can normally be reached M-F 7am-4pm.
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/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771