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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/31/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/317,508, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, Application No. 63/317,508 fails to disclose a cord comprising: a first cord tail portion configured to pass through the side shaft opening, a second cord tail portion configured to pass through the side shaft opening, and a medial cord portion between the first and second cord tail portions, the medial cord portion being configured to be disposed around a circumferential portion of the expandable distal end portion in the closed state, as recited in claim 1. Accordingly, claims 1-15 have an effective filing date of 4/27/2022.
Response to Arguments
The previous rejection of claim(s) 1-15 and 20-23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been overcome in light of the amendments made to claim(s) 1 on 8/31/2026.
The previous rejection of claim(s) 10 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends has been overcome in light of the amendments made to claim(s) 10 on 8/31/2026.
Applicant’s arguments with respect to claim(s) 1, 3, 9-15 and 20-23 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. Milliman (US 2007/0051375 A1) is now relied upon to teach the expandable distal end portion comprising a plurality of pleats that are folded onto one another in a folded configuration in the closed state and that unfold in the opened state.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 9-15 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928 A1) in view of Milliman (US 2007/0051375 A1) in view of Sinnott et al. (US 6,508,789 B1).
Regarding claims 1, 10 and 20-23, Salahieh discloses a medical access system (implant system; Fig. 1A) comprising: an expandable access sheath (sheath 18; Figs. 1A, 56A-57, 62) comprising: a hub (advancement actuator 20; Fig. 1A), and a shaft (body of 18) extending distally from the hub (Fig. 1A), the shaft having an expandable distal end portion (Figs. 56A-56B, 57, 62; [0064]) configured to be in an open state (Figs. 56A or 56B, 62) and a closed state (Fig. 57) and a side shaft opening (opening shown in Fig. 62) on the expandable distal end portion in fluid communication with a shaft delivery lumen extending through the shaft (Fig. 62); and a cord (drawing string 54) comprising: a first cord tail portion (longitudinal length of one of the draw strings 54 that extends up to and through the opening in Fig. 62) configured to pass through the side shaft opening (Fig. 62), a second cord tail portion (longitudinal length of the other one of the draw strings 54 that extends up to and through the opening in Fig. 62) configured to pass through the side shaft opening (Fig. 62), and a medial cord portion (portion of 54 surrounding the distal end of 18) between the first and second cord tail portions, the medial cord portion being configured to be disposed around a circumferential portion of the expandable distal end portion in the closed state (Figs. 57, 62).
Salahieh discloses wherein the expandable distal end portion is at least bunched together i.e., folded on one another in the closed state (as the lines in the expandable distal end portion of Fig. 57 are folds) and unfolded in the open state (Fig. 62).
Saalahieh fails to explicitly disclose the folds are pleats.
However, Milliman teaches a medical access system (Fig. 15) comprising: a shaft (introducer 500) having an expandable distal end portion (distal end portion 114; Fig. 15 which expands similar to that shown in Figs. 16-17), the expandable distal end portion comprising a plurality of pleats (pleats 520b) that are folded onto one another in a folded configuration in a closed state (Fig. 15; [0064]) and that unfold in the open state (Fig. 17; [0064]-[0065]).
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 expandable distal end portion of Salahieh to include a plurality of pleats that are folded onto one another in a folded configuration in the closed state rather than folded by bunching and that unfold in the opened state as taught by Milliman. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of a reduced diameter distal end portion that is expandable.
Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein a proximal portion of the first tail cord portion and a proximal portion of the second tail cord portion may be maintained in a tensioned or relaxed configuration and manually moved to achieve the open and closed states (as the draw string 54 may be connected proximally to an actuator in the actuation controller i.e. 20 and manually or automatically moved to the expanded or closed position; [0064]).
Salahieh modified fails to explicitly disclose wherein the hub is configured to secure proximal portions of both the first and second cord tail portions to maintain the expandable distal end portion in the open state or in the closed state, wherein a proximal portion of the first cord tail portion and a proximal portion of the second cord tail portion are configured to be released from the hub of the expandable access sheath to facilitate transition to the open state, wherein the hub is configured to hold the first and second cord tail portions in a tensioned configuration corresponding to the closed state and in a released configuration corresponding to the open state, wherein the hub is configured to secure the first cord tail portion and the second cord tail portion to control transformation between the open state and the closed state, wherein the hub is configured to maintain tension in the cord by securing proximal ends of the first and second cord tail portions to maintain the expandable distal end portion in the closed state, wherein the hub is configured to: release proximal ends of the first and second cord tail portions to reduce tension in the cord to allow the expandable distal end portion to transition from the closed state to the open state; and after transitioning from the closed state to the open state, secure the proximal ends of the first and second cord tail portions with the expandable distal end portion in the open state.
However, Sinnott teaches a medical system (catheter 1; Figs. 1A-1B) comprising a hub (hub 2), and a shaft (tubing 3) extending distally from the hub (Figs. 1A-1B), the shaft having an expandable distal end portion (as the shaft curves to an expanded configuration) and being moveable between a first released configuration (Fig. 1A) and a second tensioned configuration (Fig. 1B) via a cord (cord 4) extending through a lumen of the shaft and out of the hub proximally such that the hub (4) is configured to secure a proximal portion of the cord (4) to maintain the expandable distal end portion in the un-tensioned configuration and in the tensioned configuration (as the free end of the cord 4 may be wrapped around and tied to a fixed object, such as the hub 2 of the catheter 1, as illustrated in Fig. 1B; column 1, lines 55-65). Because the cord extends out of the proximal end of the hub, it may be tied to the hub by a user at any time to hold, maintain, and/or secure the cord in a tensioned configuration and/or a released configuration. Similarly, the cord may be untied at any point in time by the user to control transformation between the released and/or tensioned configurations. Sinnott teaches this is a traditional method of securing a tensioned cord (column 1, lines 55-65).
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 manually actuatable proximal ends of the first and second cord tail portions of modified Salahieh to extend out of and proximally past the hub and to be secured to and release from the hub as claimed in light of the teachings of Sinnott. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods of securing cords with no change in their respect functions, and the combination would have yielded the predictable result of maintaining the cord in the released (open state) and/or the tensioned (closed state).
Regarding claim 3, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein the cord is configured to be removed from the expandable access sheath to allow the expandable distal end portion to assume the open state (as both ends of the draw string 54 may extend back to the proximal end of the deployment tool and if both ends are at the proximal end of the deployment tool, then at least one end is free to be pulled along the entire length of the sheath, thereby removing the draw string altogether; [0065]).
Regarding claim 9, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein a portion of at least one of the first cord tail portion and the second cord tail portion is configured to be positioned around a portion of the circumferential portion of the expandable distal end portion to allow the expandable distal end portion to transform to the open state from the closed state (Figs. 62, 56A-56B, 57).
Regarding claim 11, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein the first and second cord tail portions are disposed along the shaft delivery lumen proximal of the side shaft opening (Fig. 62).
Regarding claim 12, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein respective portions of the first and second cord tail portions extend proximally from the shaft delivery lumen (Fig. 62) into a hub delivery lumen of the hub (as the proximal ends of 54 may be connected to an actuator in the actuation controller i.e. inside 20; [0064]).
Regarding claim 13, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein portions of the first and second cord tail portions extend proximally of a proximal end of the hub (as the proximal ends of 54 may extend back to the proximal end of the deployment tool, which is proximal of 20; [0065]).
Regarding claim 14, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein the first and second cord tail portions (54) assume a tensioned state to transform the expandable distal end portion from the open state to the closed state (via manually or automatic pulling; [0064]-[0065]).
Regarding claim 15, Salahieh modified discloses the invention as claimed above, and Salahieh further discloses wherein the circumferential portion (portion of 54 surrounding the distal end of 18) of the expandable distal end portion is a medial portion along a longitudinal dimension of the expandable distal end portion (as the circumferential portion of 54 is spaced proximally from a distal most end of the expandable distal end portion; Fig. 62).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928 A1) in view of Milliman (US 2007/0051375 A1) in view of Sinnott et al. (US 6,508,789 B1), as applied to claim 1 above, and further in view of Ganesan et al. (US 2022/0096231 A1).
Regarding claim 2, Salahieh modified fails to disclose wherein: the side shaft opening comprises a first side shaft opening and a second side shaft opening; and the first and the second cord tail portions are configured to extend through a respective one of the first and second side shaft openings and extend proximally along a portion of the shaft delivery lumen.
However, Ganesan teaches a cord (control wire) that exits from a first orifice of a catheter, loops around an expandable anchor assembly (200) then reenters a second orifice of the catheter ([0085]) and when the cord is loosened, the anchor assembly is permitted to expand (Figs. 10-16; [0084]-[0085]), similar to the draw string of Salahieh.
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 side shaft opening of modified Salahieh to comprise a first and a second opening such that the first and the second cord tail portions are configured to extend through a respective one of the first and second side shaft openings and extend proximally along a portion of the shaft delivery lumen in light of the teachings of Ganesan. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the user to manipulate the proximal ends of the cord to open and close the expandable distal end portion. Further, the addition of a second side shaft opening would help to prevent the first and second tail portions from becoming tangled with one another.
3. Claim(s) 4-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928 A1) in view of Milliman (US 2007/0051375 A1) in view of Sinnott et al. (US 6,508,789 B1), as applied to claim 1 above, and further in view of Sondreaal (US 9,987,155 B1).
Regarding claim 4, Salahieh modified discloses the invention as claimed above, and further discloses the first and second cord tail portions configured to extend through the side shaft opening (Fig. 62) and the cord (54) may be attached to an introducer (a slidably movable element of the inner catheter or inner member of the sheath; [0065]) but fails to explicitly disclose the introducer comprising: a central lumen extending through at least a portion of the introducer; and a side introducer opening on a distal portion thereof, the side introducer opening in fluid communication with the central lumen, and while the expandable distal end portion is in the closed state, at least a portion of the introducer being configured to be slidably received within the shaft delivery lumen, and the side introducer opening being configured to be within the shaft delivery lumen, and the first and second cord tail portions being configured to extend through the side shaft opening and the side introducer opening and along at least a portion of the central lumen of the introducer.
However, Sondreaal teaches a medical system (catheter assembly 100; Fig. 3B) comprising an expandable access sheath (graft implant 104) and an introducer (catheter shaft 102), the introducer comprising: a central lumen (lumen through 102) extending through at least a portion of the introducer (Fig. 3B); and a side introducer opening (access hole 328) on a distal portion thereof, the side introducer opening in fluid communication with the central lumen (Fig. 3B), and while an expandable distal end portion is in a closed state, at least a portion of the introducer being configured to be slidably received within the shaft delivery lumen (because constraining line 120 passes freely through hole 328 along the interior of the catheter shaft 102 to the outside of the body of the patient, the user may slide the catheter shaft 102 relative to the line 120; column 7, lines 26-30), and the side introducer opening (328) being configured to be within the shaft delivery lumen (as 102 is slidable relative to 104), and the first and second cord tail portions (ends of 120) being configured to extend through the side introducer opening and along at least a portion of the central lumen of the introducer (Fig. 3B). Alternatively, Sondreaal teaches the first and second cord tail portions can extend within the shaft delivery lumen (Fig. 3A; column 7, lines 21-26), similar to that of Salahieh.
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 system of modified Salahieh to include the introducer as claimed as taught by Sondreaal. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the cord to extend proximally to the proximal end of the device.
Regarding claim 5, modified Salahieh discloses wherein the side shaft opening of the expandable distal end portion in the closed state is configured to be aligned with the side introducer opening (because the catheter shaft 102 of Sondreaal is slidable with respect to the sheath 18 of Salahieh in the modification).
Regarding claim 8, modified Salahieh discloses wherein the cord is configured to be removed from around the expandable access sheath and the central lumen of the introducer while the at least a portion of the introducer is received within the shaft delivery lumen to allow the expandable distal end portion to assume the open state (as both ends of the draw string 54 of Salahieh may extend back to the proximal end of the deployment tool and if both ends are at the proximal end of the deployment tool, then at least one end is free to be pulled along the entire length of the sheath, thereby removing the draw string altogether; [0065]; and the free ends of the cord 120 of Sondreaal are free floating within the interior of the catheter shaft 102 to the outside of the body of the patient; column 7, lines 26-30).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928 A1) in view of Milliman (US 2007/0051375 A1) in view of Sinnott et al. (US 6,508,789 B1) in view of Sondreaal (US 9,987,155 B1), as applied to claim 4 above, and further in view of Ganesan et al. (US 2022/0096231 A1).
Regarding claim 6, modified Salahieh fails to disclose wherein: the side shaft opening comprises a first side shaft opening and a second side shaft opening; the side introducer opening comprises a first side introducer opening and a second side introducer opening; and the first and the second cord tail portions are configured to extend through a respective one of the first and second side shaft openings and a respective one of the first and second side introducer openings.
However, Ganesan teaches a cord (control wire) that exits from a first orifice of a catheter, loops around an expandable anchor assembly (200) then reenters a second orifice of the catheter ([0085]) and when the cord is loosened, the anchor assembly is permitted to expand (Figs. 10-16; [0084]-[0085]), similar to the draw string of Salahieh.
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 side shaft opening of modified Salahieh to comprise a first and a second opening and to modify the side introducer opening to comprise a first side introducer opening and a second side introducer opening such that the first and the second cord tail portions are configured to extend through a respective one of the first and second side shaft openings and a respective one of the first and second side introducer openings in light of the teachings of Ganesan. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the user to manipulate the proximal ends of the cord to open and close the expandable distal end portion. Further, the addition of a second side shaft opening would help to prevent the first and second tail portions from becoming tangled with one another.
Regarding claim 7, modified Salahieh discloses wherein: the introducer is configured to be translated proximally relative to the expandable access sheath to withdraw the introducer from within the shaft delivery lumen (because constraining line 120 of Sondreaal passes freely through hole 328 along the interior of the catheter shaft 102 to the outside of the body of the patient, the user may slide the catheter shaft 102 relative to the line 120; column 7, lines 26-30).
Modified Salhieh fails to disclose a first and second side introducer openings are configured to slide proximally along at least a portion of the first and second cord tail portions extending through the shaft delivery lumen as the introducer is translated proximally.
However, Ganesan teaches a cord (control wire) that exits from a first orifice of a catheter, loops around an expandable anchor assembly (200) then reenters a second orifice of the catheter ([0085]) and when the cord is loosened, the anchor assembly is permitted to expand (Figs. 10-16; [0084]-[0085]), similar to the draw string of Salahieh.
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 side introducer opening of modified Salahieh to comprise a first side introducer opening and a second side introducer opening such that the first and second side introducer openings are configured to slide proximally along at least a portion of the first and second cord tail portions extending through the shaft delivery lumen as the introducer is translated proximally in light of the teachings of Ganesan. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the user to manipulate the proximal ends of the cord to open and close the expandable distal end portion. Further, the addition of a second side shaft opening would help to prevent the first and second tail portions from becoming tangled with one another.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached at (571)272-7134. 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.
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights