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 Objections
Claim(s) 1, 4-6 is/ are objected to because of the following informalities:
Within claim 1, line 1 (and claim 1, line 8; and claim 4, lines 2-3; and claim 5, lines 3-4; and claim 6, lines 3-4): “self-expanding state” should be rewritten as –self-expanded state” (in order to correct the grammar thereof).
Within claim 5, line 4: “satisfy” should be rewritten as –satisfies—(in order to correct the grammar thereof).
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.
Claim(s) 1-8 is/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.
Within claim 1, line 8: Applicant claims, “the self-expanding state in a tubular shape”; it is unclear, and therefore indefinite, if the “tubular shape” is the same as OR different from the tubular shape within claim 1, line 1. For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --the self-expanded state-- (which corrects the grammar, as discussed above, but also eliminated the duplicative tubular shape which would already be required of the self-expanded state as established within claim 1, line 1; correction will also be require in: claim 4, lines 2-3; claim 5, lines 3-4; claim 6, lines 3-4).
Within claim 1, lines 9-11: Applicant claims, “a cross-sectional shape of each of the wires […] in a length direction thereof”; it is unclear, and therefore indefinite, what Applicant is considering the “length direction thereof”, the “length direction” is not clearly and explicitly defined by Applicant’s disclosure, further the “length” of wires within stents is typically (within the art) associated with the distance between the ends of the wires (within Applicant’s figure 7b the “length” is typically associated as the distance shown by 201 or 202 or 203). Additionally, within claim(s) 2-3 and Applicant’s disclosure it appears Applicant is trying to instead claim the width of the wires (which is orthogonal to the thickness). For the purposes of examination, Examiner is assuming when Applicant is referring to the “length direction thereof” in the aforementioned claim requirement should be rewritten as “width direction orthogonal to the radial direction thereof” (note: correction will also be required within claims 2-3). Claim(s) 2-8, which depend from claim 1, inherit all the problems associated with claim 1.
Within claim 4, line 2: Applicant claims, “the rhombic shape”; it is unclear, and therefore indefinite, if the shape of the cell is substantially rhombic (as required by claim 1, line 7) OR rhombic (as required by claim 4, line 2). For the purposes of examination, Examiner is assuming “the rhombic shape” within claim 4, line 2 should be --the substantially rhombic shape--. Claim(s) 5-6, which depend from claim 4, inherit all the problems associated with claim 1.
Claim 9 recites the limitation "the radial direction" in line 19. There is insufficient antecedent basis for this limitation in the claim.
Within claim 9, lines 18-19: Applicant claims, “a cross-sectional shape of each of the wires […] in a length direction thereof”; it is unclear, and therefore indefinite, what Applicant is considering the “length direction thereof”, the “length direction” is not clearly and explicitly defined by Applicant’s disclosure, further the “length” of wires within stents is typically (within the art) associated with the distance between the ends of the wires (within Applicant’s figure 7b the “length” is typically associated as the distance shown by 201 or 202 or 203). For the purposes of examination, Examiner is assuming when Applicant is referring to the “length direction thereof” in the aforementioned claim requirement should be rewritten as “width direction orthogonal to the radial direction thereof”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-9 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Pollock et al. (US 2010/0256737 A1 – as cited by Applicant).
With respect to claim 1:
Pollock et al. discloses a stent (prosthesis 24), as can be seen in figs. 1-4 and 10, having a tubular shape in a self-expanded state (expanded configuration 44) (paragraph [0069]), comprising:
a first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) comprising a plurality of wires (the individual curved segments 34 thereof) (paragraphs [0058-0059]); and
a second wire group (portions of curved segments 34 angling in a counter clockwise direction around the circumference of the prosthesis 24) comprising a plurality of wires (the individual curved segments 34 thereof) intersecting with the wires (the individual curved segments 34 thereof) of the first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) at a plurality of locations (merge sections 28) (paragraphs [0058-0059]), wherein
the wires (the individual curved segments 34 thereof) of the first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) and the wires (the individual curved segments 34 thereof) of the second wire group (portions of curved segments 34 angling in a counter clockwise direction around the circumference of the prosthesis 24) intersect with each other so as to form a plurality of cells (cells 20) having a substantially rhombic shape, as can be seen in fig. 1, in the self-expanded state (expanded configuration 44), and
a cross-sectional shape of each of the wires (the individual curved segments 34 thereof) in the first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) and the second wire group (portions of curved segments 34 angling in a counter clockwise direction around the circumference of the prosthesis 24) is a rectangular shape that is thicker in a radial direction (with a radial thickness 40 of 0.014”) of the tubular shape than in a length direction (width direction 42 of 0.007”) thereof (paragraph [0063]).
With respect to claim 2:
Wherein when a thickness (radial thickness 40) of the cross-sectional shape of each of the wires (the individual curved segments 34 thereof) in the first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) and the second wire group (portions of curved segments 34 angling in a counter clockwise direction around the circumference of the prosthesis 24) in the radial direction is represented by t (radial thickness 40 of 0.014”), and a length of a short width (width direction 42) orthogonal to the thickness (radial thickness 40) is represented by w (width direction 42 of 0.007”), a following formula:
w/t < 0.90 is satisfied (0.007/0.014=.5) (paragraph [0063]).
With respect to claim 3:
Wherein when a thickness (radial thickness 40) of the cross-sectional shape of each of the wires (the individual curved segments 34 thereof) in the first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) and the second wire group (portions of curved segments 34 angling in a counter clockwise direction around the circumference of the prosthesis 24) in the radial direction is represented by t (radial thickness 40 of 0.014”), and a length of a short width (width direction 42) orthogonal to the thickness (radial thickness 40) is represented by w (width direction 42 of 0.007”), a following formula:
w/t < 0.81 is satisfied (0.007/0.014=.5) (paragraph [0063]).
With respect to claim 4:
Wherein the rhombic shape, as can be seen in fig. 1, of the plurality of the cells (cells), in the self- expanded state (expanded configuration 44) is a rhombus shape (the curved segments 34 are not disclosed to be of different lengths by Pollack et al., as such they must have, and appear to be shown to have, uniform lengths, resulting in a rhombus shape) in which a long diagonal line extends in a circumferential direction (circumferential direction) (note: Applicant has not claimed the length of the “long diagonal line” in relation to any other structure; as such, Examiner is considering the circumferential dimension of the cell to be a “long diagonal line” in the expanded configuration).
With respect to claim 7:
Wherein intersecting portions (merge sections 28) between the wires (the individual curved segments 34 thereof) in the first wire group (portions of curved segments 34 angling in a clockwise direction around the circumference of the prosthesis 24) and the second wire group (portions of curved segments 34 angling in a counter clockwise direction around the circumference of the prosthesis 24) are integrally formed (cut from the metallic cylinder) without overlapping with each other in the radial direction of the tubular shape (paragraphs [0009, 0057, 0067, 0076]).
With respect to claim 8:
Wherein a stent graft (vascular graft 52) is not integrated with the stent (prosthesis 24), as can be seen in fig. 10 (paragraph [0073]).
With respect to claim 9:
Pollock et al. discloses a method for manufacturing a stent (prosthesis 24), as can be seen in figs. 1-4 and 10, comprising:
forming a mesh tubular body (prosthesis 24) from a tubular body (thick walled cylinder 22) made of a shape memory alloy (nitinol) by laser processing (laser cutting) (paragraph [0074]),
wherein in the mesh tubular body (prosthesis 24), a plurality of meandering structures (rows of curved segments 34, in fig. 1 there are 4 “meandering structures”) are arranged in an axial direction of the mesh tubular body (prosthesis 24), and apexes of arc portions (at merge locations 28) of the meandering structures (rows of curved segments 34) adjacent to each other are connected to each other and integrated (at merge locations 28) (paragraphs [0058-0059]), and
wherein in each of the plurality of the meandering structures (rows of curved segments 34), wires (curved segments 34) meander in a circumferential direction of the mesh tubular body (prosthesis 24) at an equal pitch, as can be seen in figs. 1-2;
enlarging the mesh tubular body (prosthesis 24) in a diameter direction of the mesh tubular body (prosthesis 24) so as to have a decided diameter (stretched into an expanded configuration) (paragraph [0078]); and
causing (due to annealing) the mesh tubular body (prosthesis 24) to memorize the resulting enlarged shape (expanded configuration) in the diameter direction of the mesh tubular body (prosthesis 24) (paragraph [0078]),
wherein the wires (curved segments 34) intersect with each other (at merge locations 28) so as to form a plurality of cells (cells) having a substantially rhombic shape, as can be seen in fig. 1, in a state where the mesh tubular body (prosthesis 24) is enlarged in the diameter direction to the decided diameter (expanded configuration), and
a cross-sectional shape of each of the wires (the individual curved segments 34 thereof) is a rectangular shape that is thicker in the radial direction (with a radial thickness 40 of 0.014”) of the mesh tubular body than a length direction (width direction 42 of 0.007”) thereof (paragraph [0063]).
Claim Rejections - 35 USC § 103
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 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(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al. (US 2010/0256737 A1 – as cited by Applicant) in view of GUPTA (WO 2017/173366 A1).
Pollock et al. discloses the invention substantially as claimed, as discussed above. However, Pollock et al. does not disclose the substantially rhombic shaped cells (cells) to comprise an obtuse angle is represented by σ and an acute angle is represented by ϒ in an internal angle, the plurality of the cells in the self-expanded state in a tubular shape satisfies a following formula: σ / ϒ ≥ 1.22 (as required by claim 5) or σ / ϒ ≥ 1.36 (as required by claim 6).
GUPTA teaches a stent (stent 100), as can be seen in fig. 1A, having a tubular shape in a self-expanded state (relaxed state) (paragraph [0035]) comprising a plurality of wires (struts 112) which intersect with each other so as to form a plurality of cells (cells 110) having a substantially rhombic shape (paragraph [0036]). In the self-expanded state (relaxed state) each cell (cell 110) has an obtuse angle is represented by σ (longitudinal angle 112) and an acute angle is represented by ϒ in an internal angle (circumferential angle 132) (paragraph [0041]). The plurality of the cells (cell 110) in the self-expanded state satisfies a following formula: σ / ϒ ≥ 1.22 or 1.36 (we know the struts 112 are all the same length (paragraph [0039]), and the ratio of the width (134) to the length (124) is between 1.1 to 3.5 (paragraph [0037]) we can calculate the afore claimed angles; for example, when the ratio of the width (134) to the length (124) is 2, then obtuse angle σ is about 126˚ and acute/ internal angle is ϒ is about 53˚, which thereby satisfies the aforementioned formula). The cells (cell 110) having the aforementioned substantially rhombic shape results in a highly kink resistant stent and increased radial force (paragraph [0044]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the substantially rhombic shaped cells (cells), as disclosed by Pollack et al., such that they have the wider circumferential dimension (thus resulting in the obtuse angle σ / acute angle ϒ ≥ 1.22 or 1.36), as taught by GUPTA, in order to improve the kink resistance and increase the radial force of the stent, as taught by GUPTA.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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, Jerrah Edwards can be reached at (408)918-7557. 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.
/REBECCA S PRESTON/ Examiner, Art Unit 3774