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 .
Election/Restrictions
Applicant’s election without traverse of species D in the reply filed on 1/19/26 is acknowledged.
Claims 1-9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/19/26.
Drawings
The drawings have been received on 3/27/24 and these drawings have been objected to under 37 CFR 1.84 for the following reasons: the clarity is not well defined and legible for all figures. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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(s) 10 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singhal et al. US 2013/0317541 in view of US Chanduszko US 2005/0267524.
Regarding claim 10, Chanduszko system comprising: an outer conduit having proximal and distal ends (paragraph 0007, 0022; proximal and distal ends of delivery catheter); a metal backbone 30 including: (a) a first portion that extends distally from the foam distal end and which is not covered by the foam (see annotated figure 3 below, struts 32a, 32b, 32c), (b) a second portion that extends proximally from the foam proximal end and which is not covered by the foam (see annotated figure 3 below, struts 34a, 34b, 34c); and(c) a third portion that extends from the foam proximal end to the foam distal end and which is covered by the foam and which couples the first and second portions of the metal backbone to each other (see annotated figure 3 below, foam covered central portion 38), wherein the foam and the metal backbone are both included within the outer conduit adjacent to the distal end of the outer conduit (paragraph 0007, collapsed within the delivery catheter and extended out the distal end of the catheter when released); wherein the metal backbone first portion: (a) is configured to transition from a secondary shape (for example, shown in similar embodiment of figure 1 prior to expansion prior to slits expanding, formed from a tube or linear shape) to a primary shape (figure 3, once released from catheter struts 32a, 32b, 32c expand) (b) is in the metal backbone first portion secondary shape and is located between the foam distal end and the distal end of the outer conduit (when placed within the delivery catheter the central portion 38 with foam is proximal to the portions 32 prior to delivery); wherein the metal backbone second portion: (a) is configured to transition from a secondary shape (for example, shown in similar embodiment of figure 1 prior to expansion prior to slits expanding, formed from a tube or linear shape) to a primary shape (figure 3, once released from catheter struts 34a, 34b, 34c expand); (b) is in the metal backbone second portion secondary shape and is located between the foam proximal end and the proximal end of the outer conduit (when placed within the delivery catheter the central portion 38 with foam is distal to the portions 34 prior to delivery).
PNG
media_image1.png
272
466
media_image1.png
Greyscale
Chanduszko discloses a foam along the central portion (paragraph 0025), but fails to disclose the foam being a shape memory polymer (SMP) foam having proximal and distal ends and that transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature.
Singhal et al. discloses system (for example, figures 1A-3A) comprising; a shape memory polymer (SMP) foam (figure 3B, paragraph 0022, distal and proximal wings connected by an axis covered by a shape memory polymer foam), the foam having proximal and distal ends and that transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature (paragraph 0045, foam expands to the primary shape when heated to body temperature), a foam component to achieve a complete seal (paragraph 0034) which expands to fill the opening upon heating to body temperature (paragraph 0045).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide a shape memory polymer (SMP) foam, as taught by Singhal et al., as known in the art to provide a foam that may expand once deployed and heated to body temperature to achieve a complete seal of the opening.
Regarding claim 12, Chanduszko discloses wherein: the metal backbone includes a tube (paragraph 0025, 3 slits made at each end of a tube 30) having first and second struts (figure 3); the metal backbone first portion includes the first struts (figure 3, struts 32a, 32b, 32c) and the metal backbone second portion includes the second struts (figure 3, struts 33a, 32b, 32c).
Regarding claim 13, Chanduszko discloses wherein the first struts are linear in the metal backbone first portion secondary shape (tubular within catheter prior to being deployed, for example, shown in similar embodiment linear configuration figure 1).
Regarding claim 14, Chanduszko in combination discloses wherein: the SMP foam has an axis that extends through the proximal and distal ends of the SMP foam (axis through foam 36, along axis of portion 38, figure 3); the first struts have a first length, measured parallel to the axis, in the metal backbone first portion secondary shape (for example, length of struts along tube in the linear configuration, having a similar configuration as shown in figure 1); the first struts have a second length, measured parallel to the axis, in the metal backbone first portion primary shape (once expanded radially outward, figure 3); the second length is less than the first length (figure 3, length as measured between the foam and the height of the strut along the axis is less in the expanded configuration, as the struts are opened radially outward and thereby do not extend as far longitudinally along the axis).
Regarding claim 15, Chanduszko discloses wherein: the metal backbone first portion includes a first plurality of resilient arms that are free from one another at distal ends of the first plurality of resilient arms (struts 32a, 32b, 32c, figure 3, free at end opposite central portion 38) and are fixedly coupled to each other at proximal ends of the first plurality of resilient arms (struts 32a, 32b, 32c, figure 3, coupled adjacent portion 38, figure 3); the metal backbone second portion includes a second plurality of resilient arms that are free from one another at distal ends of the second plurality of resilient arms (struts 34a, 34b, 34c, figure 3, free at end opposite central portion 38) and are fixedly coupled to each other at proximal ends of the second plurality of resilient arms (struts 34a, 34b, 34c, figure 3, coupled adjacent portion 38, figure 3).
Regarding claim 16, Chanduszko system comprising: an outer conduit having proximal and distal ends (paragraph 0007, 0022; proximal and distal ends of delivery catheter); a metal backbone 30 including: (a) a first portion that extends distally from the foam distal end and which is not covered by the foam (see annotated figure 3 below, struts 32a, 32b, 32c), and (c) a second portion that extends from the foam proximal end to the foam distal end and which is covered by the foam and which couples the first and second portions of the metal backbone to each other (see annotated figure 3 below, foam covered central portion 38), wherein the foam and the metal backbone are both included within the outer conduit adjacent to the distal end of the outer conduit (paragraph 0007, collapsed within the delivery catheter and extended out the distal end of the catheter when released); wherein the metal backbone first portion: (a) is configured to transition from a secondary shape (for example, shown in similar embodiment of figure 1 prior to expansion prior to slits expanding, formed from a tube or linear shape) to a primary shape (figure 3, once released from catheter struts 32a, 32b, 32c expand) (b) is in the metal backbone first portion secondary shape and is located between the foam distal end and the distal end of the outer conduit (when placed within the delivery catheter the central portion 38 with foam is proximal to the portions 32 prior to delivery).
PNG
media_image2.png
272
466
media_image2.png
Greyscale
Chanduszko discloses a foam along the central portion (paragraph 0025), but fails to disclose the foam being a shape memory polymer (SMP) foam having proximal and distal ends and that transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature.
Singhal et al. discloses system (for example, figures 1A-3A) comprising; a shape memory polymer (SMP) foam (figure 3B, paragraph 0022, distal and proximal wings connected by an axis covered by a shape memory polymer foam), the foam having proximal and distal ends and that transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature (paragraph 0045, foam expands to the primary shape when heated to body temperature), a foam component to achieve a complete seal (paragraph 0034) which expands to fill the opening upon heating to body temperature (paragraph 0045).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide a shape memory polymer (SMP) foam, as taught by Singhal et al., as known in the art to provide a foam that may expand once deployed and heated to body temperature to achieve a complete seal of the opening.
Regarding claim 17, Chanduszko discloses wherein: the metal backbone includes a tube having struts (for example, paragraph 0025, tube 30 with slits forming struts 32a, 32b, 32c and 34a, 34b, 34c at a proximal and distal end); the metal backbone first portion including the struts (figure 3, struts 32a, 32b, 32c) and the metal backbone second portion does not include struts (center portion 38 without struts, figure 3).
Regarding claim 18, Chanduszko discloses wherein the struts are linear in the metal backbone first portion secondary shape (for example, shown in similar embodiment of figure 1, tubular linear configuration within catheter) and are curved in the metal backbone first portion primary shape (figure 3, struts 32a, 32b, 32c curved radially outward).
Regarding claim 19, Chanduszko in combination discloses wherein: the SMP foam has an axis that extends through the proximal and distal ends of the SMP foam (axis through foam 36, along axis of portion 38, figure 3); the struts have a first length, measured parallel to the axis, in the metal backbone first portion secondary shape (for example, length of struts along tube in the linear configuration, having a similar configuration as shown in figure 1); the struts have a second length, measured parallel to the axis, in the metal backbone first portion primary shape (once expanded radially outward, figure 3); the second length is less than the first length (figure 3, length as measured between the foam and the height of the strut along the axis is less in the expanded configuration, as the struts are opened radially outward and thereby do not extend as far longitudinally along the axis).
Regarding claim 20, Chanduszko discloses wherein: the metal backbone first portion includes a first plurality of resilient arms that are free from one another at distal ends of the first plurality of resilient arms (struts 32a, 32b, 32c, figure 3, free at end opposite central portion 38) and are fixedly coupled to each other at proximal ends of the first plurality of resilient arms (struts 32a, 32b, 32c, figure 3, coupled adjacent portion 38, figure 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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, Darwin Erezo can be reached at (571) 272-4695. 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.
/CHRISTINA C LAUER/Examiner, Art Unit 3771