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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-4, 7, 9-14 and 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200268500 to Brandeis in view of US 20200155732 to Rangwala et al.
Regarding claims 1 and 21, Brandeis discloses a stent (see Fig. 8A) comprising: an 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) and, a second stent layer 801 comprising one or more second stent wires braided into a second tubular shape (para [0412] discloses 801 as an inner mesh). Brandeis is silent with regards to the stent comprising 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; wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer.
Rangwala discloses a stent having connecting wires 154 (reinforcement elements 154 are viewed as connecting wires) that are helically wound around the stent (reinforcing element 154 can be sufficiently long to go over and under the wire segments, can extend to at least a proximal 1/3 of the stent, which will inherently provide a helical arrangement; Fig. 12, [0091], [0094]) wherein the connecting wires are composed of a shape memory material [0083]; wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer (the reinforcement elements 154 can be slid over wire segments of the stent and will therefore have a diameter that is greater than any portion of the stent; [0089]).
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 device of Brandeis to use the connecting wires (reinforcement elements 154) of Rangwala because Rangwala discloses that the reinforcement elements helps increase stiffness along the associated region of the stent and help the stent to open during deployment [0012]. Note that Rangwala discloses that the reinforcement elements can be attached to any portion of the stent and can therefore be applied to first or second stent layer of Brandeis. Note that the secondary shape would be a helical coil when slid over the wires of the stent.
Regarding claim 2, Brandeis, as modified by Rangwala, discloses 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, as modified by Rangwala, 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, as modified by Rangwala, discloses another stent embodiment in Fig. 8B comprising: a first 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, a second 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 first stent layer is connected to the second 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 first stent layer 812 is positioned within the third stent layer 813).
Regarding claim 7, Brandeis, as modified by Rangwala, discloses the one or more connecting wires capable of having the secondary shape set prior to connection with the first stent layer and the second stent layer. Note that the claim recites a product by process limitation and as set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Regarding claim 13, Brandeis discloses a stent (see Fig. 8A) comprising: an 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 is silent with regards to the stent comprising 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; wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer.
Rangwala discloses a stent having connecting wires 154 (reinforcement elements 154 are viewed as connecting wires) that are helically wound around the stent (reinforcing element 154 can be sufficiently long to go over and under the wire segments, can extend to at least a proximal 1/3 of the stent, which will inherently provide a helical arrangement; Fig. 12, [0091], [0094]) wherein the connecting wires are composed of a shape memory material [0083]; wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer (the reinforcement elements 154 can be slid over wire segments of the stent and will therefore have a diameter that is greater than any portion of the stent; [0089]).
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 device of Brandeis to use the connecting wires (reinforcement elements 154) of Rangwala because Rangwala discloses that the reinforcement elements helps increase stiffness along the associated region of the stent and help the stent to open during deployment [0012].
Regarding claims 9 and 16, Brandeis, as modified by Rangwala discloses all the limitations of claims 1 and 13, respectively, and wherein Rangwala further discloses wherein the secondary shape of the one or more connecting wires (reinforcement elements 154) are helically wound on the stent.
Regarding claim 10, Brandeis, as modified by Rangwala, discloses all the limitations of claim 9, and wherein Rangwala discloses that the connecting wires (reinforcement elements 154) are slid over the connecting wire and therefore has same pitch as the stent wire.
Regarding claims 11 and 17, Brandeis as modified by Rangwala discloses all the limitations of claims 9 and 13, respectively, and wherein Rangwala discloses that at least a portion of the connecting wires (reinforcement elements 154) are coils.
Regarding claims 12 and 18, Brandeis as modified by Rangwala discloses all the limitations of claims 9 and 13, respectively, and wherein Rangwala 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 (the modification would have connecting wires connected to both the first and second stent layers).
Regarding claim 14, Brandeis as modified by Rangwala 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 be interwoven with the first and second stent layer.
Regarding claims 19, Brandeis as modified by Rangwala discloses all the limitations of claim 13, and wherein Rangwala further discloses wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer (the reinforcement elements 154 can be slid over wire segments of the stent and will therefore have a diameter that is greater than any portion of the stent; [0089]).
Regarding claims 20 and 22, Brandeis discloses a stent (see Fig. 8A) comprising: an 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 is silent with regards to the stent comprising 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; wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer.
Rangwala discloses a stent having connecting wires 154 (reinforcement elements 154 are viewed as connecting wires) that are helically wound around the stent (reinforcing element 154 can be sufficiently long to go over and under the wire segments, can extend to at least a proximal 1/3 of the stent, which will inherently provide a helical coil arrangement; Fig. 12, [0091], [0094]) wherein the connecting wires are composed of a shape memory material [0083]; wherein the one or more connecting wires are shape set such that, in an expanded configuration, the one or more connecting wires form a secondary shape having a diameter that is greater than a diameter of the first stent layer (the reinforcement elements 154 can be slid over wire segments of the stent and will therefore have a diameter that is greater than any portion of the stent; [0089]).
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 device of Brandeis to use the connecting wires (reinforcement elements 154) of Rangwala because Rangwala discloses that the reinforcement elements helps increase stiffness along the associated region of the stent and help the stent to open during deployment [0012]. Note that the secondary shape would be a helical coil when slid over the wires of the stent.
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 20200155732 to Rangwala et al., as applied to claim 1 above, and in further view of US 20210137715 to Ringwala et al.
Regarding claim 5, Brandeis, as modified by Rangwala, discloses all the limitations of the claim, as applied to claim 1 above, but is silent with regards to the first 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 first 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, as modified by Rangwala and Ringwala, 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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-Th 6am-2:30 pm Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marivelisse Santiago-Cordero can be reached at 571-272-7839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
DARWIN P. EREZO
Supervisory Patent Examiner
Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights