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 .
Priority
This application claims priority from provisional application 63/139684 filed 01/20/2021.
Status of Claims
Claims 1-22 are pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the open cells and open cells not connected (see 112 rejection below for more details), distal peaks are free from constraint (claims 2, 3, and 17 see 112 rejection below for more details), a second distal cell strut (the specification identifies 30 as the second distal cell strut but this strut is actually at the proximal end of the cell 20 as seen in Figure 6), a set of straight connecting elements associated with each pair of said closed cells (claim 3, there is only 1 straight connecting element in each ring connecting adjacent pairs of closed cells, there is no set unless each set contains struts from other sets) a first apex of an adjacent second apex of an adjacent pair of circumferentially spaced cells (claim 3 see 112 rejection below for more details), a set of flexible connecting elements associated with each pair of said closed cells (claim 3, there is only 1 flexible connecting element in each ring connecting adjacent pairs of closed cells, there is no set unless each set contains struts from other sets), each ring with 6 pairs of closed cells (claims 6 and 9, each embodiment discloses 3 pairs of 6 cells), each ring with 2 pairs, or 4-10 pairs of closed cells (claims 7 and 8, each embodiment discloses 3 pairs of 6 cells), a flexible connecting element with a V configuration (claim 13) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 1-22 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.
Each of the independent claims introduce open cells and require them to be not connected, which is stated within the original specification. The specification identifies these cells as 18/118/218 but there is no explanation as to what makes the cells open. The specification merely states that the closed cells are not connected. A person of ordinary skill in the art would not be able to identify why the identified cells are considered open compared to the other cells. All the cells of the stent have struts defining their entire perimeter. These struts and connectors appear to enclose them, which would not lend them to being considered open. Additionally, every cell of the entire stent is disclosed as being interconnected by the various struts. There are no loose or floating cells not connected to any other cells. Specifically, as seen in Figure 4, the cells 18 are even directly connected to adjacent open cells forming a continuous ring about the stent circumference.
Each of the independent claims also introduce closed cells and require them to be connected, which is stated within the specification. The specification identifies these cells as 20/22/120/220/222 but there is no explanation as to what makes the cells closed. The specification merely states that the closed cells are resheathable. It is noted that whether a stent is resheathable does not depend solely on the shape or structure of the cells because basically every stent is capable of being resheathed if placed in the right situation with the right tools and personnel. A person of ordinary skill in the art would not be able to identify why the identified cells are considered closed. Both open and closed cells have struts defining their entire perimeter. These struts and connectors appear to enclose them, but their central space is open radially inwardly and radially outwardly.
Therefore, it is unclear how the two types of cells can be considered open, closed, or not connected.
Claims 2, 3, and 17 are rendered indefinite by the requirement that the distal peaks are free from constraint. It appears that the peaks do not have a connection member like the proximal peaks, but there is no clarification within the original disclosure as to what would and would not qualify as a constraint. The distal peaks have a specific bend, a specific thickness, are made from a specific material, and have struts extending therefrom connecting to surrounding struts. Each of these aspects constrains the distal peaks in some manner. Only a free floating portion would essentially have no constraints. Therefore, a person of ordinary skill in the art would not be able to determine what would and would not qualify as a peak free from constraint. The applicant is advised to amend the claim to better define how the peak has the two angled struts but not an additional connecting element.
Claims 3 and 17 are rendered indefinite by the requirement for the third distal cell strut to connect the second strut to the first strut at the distal peak at the distal end of the ring. The specification identifies 28 as the first strut, 30 as the second strut, and 32 as the third connecting strut. While the third strut connects to the first strut at the distal peak at the distal end, it is unclear how this is actually connecting the first and second struts at this point. The third strut has a substantial length meaning it connects to the first and second struts at substantially different points, not a singular point. The applicant is advised to amend claim 3 to recite “a third distal cell strut connecting said first distal cell strut to said second distal cell strut, the third distal cell strut connects to the first distal cell at a distal peak at a distal end of the ring”.
Claims 3 and 17 are also rendered indefinite for the same reason explained above with respect to the third proximal cell strut. The applicant is advised to amend the claim in the same manner suggested above but substituting proximal in place of distal
Claim 3 is also rendered indefinite for the requirement that “said first straight connecting element functions as a second straight connecting element to a first apex of an adjacent second apex of an adjacent pair of circumferentially spaced closed cells”. It is unclear how the adjacent pair of circumferentially spaced closed cells can have a first apex of a second apex. The applicant is advised to amend this to just say “a second straight connecting element to second apex of an adjacent pair of circumferentially spaced closed cells”.
Claim 5 lacks antecedent basis for the term SMA because it has the incorrect dependency. The applicant is advised to amend claim 5 to depend upon claim 4.
Claim 15 is rendered indefinite by the requirement in b) for each distally directed connecting element connecting a closed cell to an adjacent circumferentially spaced closed cell via an associated distally directed connecting element. This is requiring two distally connecting elements to connect to each other to connect the closed cells, but there doesn’t appear to be any embodiments allowing for this unless we are calling portions of each distally directed connecting element separate distally directed connecting elements. The applicant is advised to delete the phrase “via an associated distally directed connecting element of said adjacent circumferentially spaced closed cell.”
Claims 15 and 17 are further rendered indefinite by the requirement for the pushwire assembly structure. The preamble of claims 15, 17, and 1 define a stent not a system of assembly including additional structures. It is unclear how the pushwire assembly can be considered as part of the stent. Furthermore, the claim has this structure positioned under the clause stating that each ring of the closed cells comprises. It is unclear how each ring can comprise a pushwire assembly and still function as intended by the applicant. The applicant is advised to delete element d) from claim 15.
Examiner’s Note
In view of the extensive 112 rejections outlined above, the claims are being rejected as best understood. With regards to open and closed cells these phrases are being interpreted in name only because the applicant’s cells are both fully surrounded with struts and have open interiors.
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, 10, 11, and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cam et al (Cam) US 20170231789 A1.
1. Cam discloses a stent (Figure 10A-C), comprising:
a hybrid network cluster of open cells and closed cells (see figure 10A, the stent of Cam is considered to be a hybrid network because it includes a variety of different shaped cells) arranged wherein said closed cells are connected (cells are connected by shared struts see marked up figure below) in a configuration to be resheathable (all stents are capable of being placed within a sheath depending on the size and configuration of the sheath); and,
wherein open cells are not connected (see figure below showing open cells arranged and connected in the same manner as the applicant’s own invention, therefore it reads upon this as much as the applicant’s own invention) and the stent can be unsheathed (all stents are capable of being placed within a sheath then having it removed depending on the size and configuration of the sheath) to enhance flexibility (unsheathing every stent inherently improved flexibility because the sheath compresses and retains the stent in a fixed position).
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4. Cam discloses the hybrid cluster is formed of a shape memory alloy (SMA) such as Nitinol [0079].
10. Cam discloses the hybrid network cluster of open cells and closed cells has a diameter in a range of 2mm to 12mm in a fully open position [0084].
11. Cam discloses the hybrid network cluster of open cells and closed cells has a length in a range of 10mm to 60mm in a fully open position ([0012] discloses the different sections include lengths that added up fall within the claimed range, for example taking the smallest length of each section the total would be 15 mm).
20. Cam discloses a method for deploying a resheathable stent for stent assisted coiling of hemorrhagic aneurysms and for treatment of intracranial atherosclerotic disease [0009], comprising:
a) inserting a catheter 180 into a vasculature of a patient (Figures 18A-E), wherein a resheathable stent system (the system comprises the stent shown in Figures 10A-C) is disposed with the catheter (Figures 18A-E), the resheathable expandable stent comprising:
a hybrid network cluster of open cells and closed cells (see marked up figure above, the stent of Cam is considered to be a hybrid network because it includes a variety of different shaped cells) arranged wherein said closed cells are connected in a configuration (see figure above showing them pairs in direct contact) to be resheathable (all stents are capable of being placed within a sheath depending on the size and configuration of the sheath); and,
wherein open cells are not connected (see figure above showing open cells arranged and connected in the same manner as the applicant’s own invention, therefore it reads upon this as much as the applicant’s own invention) and the stent can be unsheathed to enhance flexibility (unsheathing every stent inherently improved flexibility because the sheath compresses and retains the stent in a fixed position), and,
wherein longitudinal movement of a shaft relative to the resheathable expandable stent expands and contracts the resheathable stent (Figures 18A-E).
21. Cam discloses a method for deploying a resheathable stent retriever for treatment of ischemic stroke to retrieve a blood clot in the vessels [0009]:
a) inserting a catheter 180 into a vasculature of a patient (Figures 18A-E), wherein a resheathable stent system (the system comprises the stent shown in Figures 10A-C) is disposed with the catheter, the resheathable stent system device comprising:
a hybrid network cluster of open cells and closed cells (see marked up figure above, the stent of Cam is considered to be a hybrid network because it includes a variety of different shaped cells) arranged wherein said closed cells are connected (see figure above showing them pairs in direct contact) in a configuration to be resheathable (all stents are capable of being placed within a sheath depending on the size and configuration of the sheath); and,
wherein open cells are not connected (see figure above showing open cells arranged and connected in the same manner as the applicant’s own invention, therefore it reads upon this as much as the applicant’s own invention) and the stent can be unsheathed to enhance flexibility (unsheathing every stent inherently improved flexibility because the sheath compresses and retains the stent in a fixed position), and,
wherein longitudinal movement of a shaft relative to the resheathable expandable stent expands and contracts the resheathable stent (Figures 18A-E).
22. Cam discloses a retrievable stent (Figures 10A-C), comprising:
a hybrid network cluster of open cells and closed cells (see marked up figure above, the stent of Cam is considered to be a hybrid network because it includes a variety of different shaped cells) arranged wherein said closed cells are connected (see figure above showing them pairs in direct contact) in a configuration to be resheathable (all stents are capable of being placed within a sheath depending on the size and configuration of the sheath); and,
wherein open cells are not connected (see figure above showing open cells arranged and connected in the same manner as the applicant’s own invention, therefore it reads upon this as much as the applicant’s own invention) and the retrievable stent can be unsheathed (all stents are capable of being placed within a sheath then having it removed depending on the size and configuration of the sheath) to enhance flexibility (unsheathing every stent inherently improved flexibility because the sheath compresses and retains the stent in a fixed position); and, wherein a ring of proximal closed cells are tapered (the ring at the far right of the above figure is considered to be tapered because of the tapered rounded tips at the extreme far right) and the stent is retrievable (every stent is inherently retrievable if the operator has the right tools).
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moriuchi et al (Moriuchi) USPN 5,879,381.
Moriuchi discloses a stent delivery system for delivery and deploying an expandable stent (Figure 11), comprising:
a) a catheter 10;
b) a shaft 11 comprising a distal end 12, disposed within the catheter (Figure 11); and,
c) an expandable stent 1 (Figures 1-5) comprising a proximal end and a distal end (top and bottom of Figures 1-5), wherein the shaft is coupled to the expandable stent (Figure 11) and the shaft is disposed within the expandable stent (Figure 11), wherein the expandable stent comprises:
a hybrid network cluster of open cells and closed cells (the stent of Moriuchi is considered to be a hybrid network because it includes a variety of different shaped cells, such as circular closed cells and the irregular shaped open cells inbetween) arranged wherein said closed cells are connected (Figures 1-5 show the closed circular cells in direct contact by straight struts) in a configuration to be resheathable (all stents are capable of being placed within a sheath then having it removed depending on the size and configuration of the sheath); and, wherein open cells are not connected (see figures 1-5 showing open cells arranged around the closed cells and connected in the same manner as the applicant’s own invention, therefore it reads upon this as much as the applicant’s own invention) and the stent can be unsheathed to enhance flexibility (unsheathing every stent inherently improved flexibility because the sheath compresses and retains the stent in a fixed position).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cam in view of Pappas et al (Pappas) USPN 8,075,610 B2.
Cam discloses the invention substantially as claimed being described above. However, Cam does not disclose the use of a graft.
Pappas teaches the use of an expandable stent including a graft cover formed from ePTFE (19:4-10) in the same field of endeavor for the purpose of aiding with attachment to the implant site and promoting ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to combine the ePTFE graft taught by Pappas with the stent of Cam in order to better anchor the stent to the implant site and promote ingrowth.
Allowable Subject Matter
It is also noted that the closest prior art with respect to the shape and connecting elements is (Herklotz) USPN 6,264,688 B1, however the above art rejection relied upon different art to make a more complete rejection of the additional claim features. See annotated figure below for details of Herklotz.
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The prior art of record, including Herklotz, does not disclose the flexible connecting element is attached to proximal peaks of a ring and a valley of an adjacent spaced ring or that the cells include diamond like shapes
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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