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 Amendment
The claims filed on February 25th, 2026, have been entered. Claims 1-2, 10-12, and 23-29 remain pending in the Application. The claim amendments overcome the previous claim objections and 112(b) rejections.
Response to Arguments
Applicant's arguments filed February 25th, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that the modification of Roslin et al. (Pub. No. 2010/0069930) to include delivery through the catheter of Ewers et al. (Pub. No. 2014/0148828) would make device of Roslin et al. unworkable because the arms would not be able to diverge from the openings in the sides of the device. Examiner respectfully disagrees. The plurality of flexible arms 400 of Roslin et al. extend out of ports 110 in the distal portion of the device body 100, and extending the device body 100 of out a catheter would place the ports out of 100, which would allow 400 to extend and diverge without impediment.
Second, Applicant argues that the combination of Roslin et al. and Ewers et al. does not disclose that the plurality of arms of Roslin et al. are formed as divergent from the center of the Ewers et al. catheter, that the arms are extending out of a single opening in the distal end of the shaft, and that the arm lengths are measured from that same opening because the Roslin et al. arms are extending out of multiple ports. Examiner respectfully disagrees. As described in the Non-Final Rejection dated November 25th, 2025, the distal end of the introducing catheter 11 of Ewers et al. is being treated as the single opening for addressing the claim limitations, as the arms 400 only need to extend out of the single opening (which 400 would do when the Roslin et al. device is deployed through 11), be divergent from the center of that same opening (which 400 are illustrated doing in FIGs. 1A-1B and would be divergent from 11 when extending distally out of the end of 11), and have their length from that opening be adjustable (which 400 satisfies by being actuated by 140). The arms can also extend through the ports 110, as long as they meet those limitations.
Third, Applicant argues that insufficient motivation is provided for how Roslin et al. and Ewers et al. are being combined because Roslin et al. does not face the same problem as the present inventor, and neither Roslin et al. nor the present inventor face the problem of deploying multiple medical devices simultaneously. Examiner respectfully disagrees. Applicant cites this requirement from Ecolochem, Inc. v. S. California Edison Co., but the quotation actually comes from WMS Gaming, Inc. v. International Game Tech., 184 F.3d 1339, 1355, 51 USPQ2d 1385, 1397 (Fed. Cir. 1999), and the Ecolochem decision only states that this is a requirement after determining there was no evidentiary basis for the district court finding of a suggestion, teaching, or motivation to combine the prior art references being cited against the claimed invention. In contrast, as stated in the Non-Final Rejection, an evidentiary basis for a motivation combining Roslin et al. and Ewers et al. was provided, in that one of ordinary skill in the art would find the ability to simultaneously deploy multiple medical devices is an advantage.
Fourth, Applicant argues that the further modification by Kieturakis (Pub. No. 2012/0116362) does not work because Kieturakis uses a pair of rigid tools instead of a plurality of flexible arms, because the tools do not extend out of an opening in a distal end of a shaft and diverge, and because in comparison to the present invention not limiting movement of the distal ends of the arms as they are pushed or pulled, the lock prevents movement. Examiner respectfully disagrees. While Kieturakis discloses the sleeve 16 as being substantially rigid ([0046]), and the cores 18 of the tools as being rigid ([0047]), the central section which is being placed through the sleeve is flexible ([0047]), and that is the portion being locked into place. Additionally, Kieturakis was being used to teach the brake system, not the divergence of the tools. Finally, the braking elements described in claims 2, 12, 24-25, 27, and 29 only need to frictionally engage the arms to resist length change (which is how far out from the distal opening the arms are extending), which is what the brakes 17 and 19 of Kieturakis do to the tools 12a and 12b.
Fifth, Applicant brought up the Interview conducted on February 23rd, 2026, regarding the arm lengths are adjusted by pushing or pulling the arms near the distal end thereof. After further considering Roslin et al., Examiner maintains that the limitation considers the capability of the flexible arms to be adjusted at or near their distal ends, and that an operator could manually push or pull the ends of 400 to make the adjustment in Roslin et al. as there is no structure preventing this action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 10-11, 23, 26, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roslin et al. (Pub. No. 2010/0069930) in view of Ewers et al. (Pub. No. 2014/0148828).
Regarding claim 1, Roslin et al. discloses a device for delivery of a graft for attachment to tissue (60; [0046]; FIGs. 1A-4), comprising:
an actuator (130; [0047] 130 comprises four 140);
a plurality of flexible arms (400), wherein the plurality of flexible arms is in communication with and moves in response to movement of the actuator ([0053] when 140 are advanced, 400 are advanced), wherein distal ends of the plurality of flexible arms extend out of a distal end of a shaft (FIGs. 1A-1B: 400 extend out of the distal end of 100) and movement of the actuator forms the distal ends of the plurality of flexible arms as divergent from each other (FIG. 1B: 400 diverge from each other) and divergent from a center to form the distal ends of the plurality of flexible arms in a radial array (FIG. 1B: 400 diverge from the longitudinal axis defined by 100), wherein the center is the distal end of the shaft (FIG. 1B: the longitudinal axis defined by 100 is the center of the distal end of 100);
wherein lengths of the plurality of flexible arms are independently adjustable relative to lengths of other arms of the plurality of flexible arms by pushing and pulling the flexible arms at or near a distal end thereof to differentiate lengths of the plurality of flexible arms ([0107] 400 are advanced serially one at a time, which will cause the length of each 400 relative to the other 400 to be independently adjusted by the movement of 140), the lengths measured from the distal end of the shaft to the distal end of the flexible arms (FIG. 1B: the length of adjustment is how far each 400 is out of the distal end of 100), and the lengths of the flexible arms are independently adjustable for forming various sizes of grafts in a generally planar configuration when the plurality of flexible arms are formed in a radial array ([0048] when 400 are fully extended in the array from the distal end of 100, the mesh 200 is formed in a planar sheet; FIG. 1B).
Roslin et al. does not disclose wherein distal ends of the plurality of flexible arms extend out of an opening in the distal end of the shaft, as each of the plurality of flexible arms extends out a separate opening (110) in the distal end of the shaft (FIG. 1B).
Ewers et al. teaches a surgical system (10; FIGs. 1A-B; [0076]) comprising an introducing catheter (11) and two medical devices (13, 14) where the introducing catheter is inserted and guided to the surgical site before allowing the multiple medical devices to operate on the surgical site ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Roslin et al. to comprise an introducing catheter, as taught by Ewers et al., for the purpose of being able to deploy multiple medical devices at the same time. The modification would provide an opening in the distal end of the introducing catheter (Ewers et al. FIG. 1B), and the lengths of the plurality of flexible arms can be measured from that opening.
Regarding claim 10, Roslin et al. as modified by Ewers et al. further discloses the plurality of flexible arms are formed by actuation of the actuator as generally parallel to each other for removal of the flexible arms from within a surgical incision (Roslin et al. FIG. 1A: 400 can be retracted by pulling up on 130 and 140, which will make them generally parallel to each other for 100 to be retracted).
Regarding claim 11, Roslin et al. discloses a device for delivery of a graft for attachment to tissue (60; [0046]; FIGs. 1A-4), comprising:
an actuator (130; [0047] 130 comprises four 140);
a plurality of flexible arms (400) and a plurality of sleeves (300), wherein each sleeve of the plurality of sleeves surrounds a portion of one of the flexible arms of the plurality of flexible arms (FIG. 4: 400 are surrounded at least partially by 300 in both deployment and retraction), and a distal end of each of the flexible arms extends out of a distal end of the sleeve of the plurality of sleeves that surrounds the flexible arm (FIG. 4: the distal end of 400 extends out of 300 when deployed);
wherein the plurality of sleeves is in communication with and moves in response to movement of the actuator ([0053] when 130 is advanced, 300 are advanced), wherein distal ends of the plurality of sleeves extend out of a distal end of a shaft (FIGs. 1A-1B: 300 extend out of the distal end of 100) and an actuation of the actuator simultaneously forms the distal ends of the plurality of sleeves as divergent from a center to form the distal ends of the plurality of flexible arms as divergent from each other and in a radial array ([0047] when 130 is depressed, 300 are simultaneously extended, and FIG. 1B: 300 diverge from each other and from the longitudinal axis defined by 100), wherein the center is the distal end of the shaft (FIG. 1B: the longitudinal axis defined by 100 is the center of the distal end of 100);
wherein lengths of the plurality of flexible arms are independently adjustable relative to lengths of other arms of the plurality of flexible arms by pushing and pulling the flexible arms at or near a distal end thereof to differentiate lengths of the plurality of flexible arms ([0107] 400 are advanced serially one at a time, which will cause the length of each 400 relative to the other 400 to be independently adjusted by the movement of 140), the lengths measured from the distal end of the shaft to the distal end of the flexible arms (FIG. 1B: the length of adjustment is how far each 400 is out of the distal end of 100), and the lengths of the flexible arms are independently adjustable for forming various sizes of grafts in a generally planar configuration when the plurality of flexible arms are formed in a radial array ([0048] when 400 are fully extended in the array from the distal end of 100, the mesh 200 is formed in a planar sheet; FIG. 1B).
Roslin et al. does not disclose wherein distal ends of the plurality of sleeves extend out of an opening in the distal end of the shaft, as each of the plurality of sleeves extends out a separate opening (110) in the distal end of the shaft (FIG. 1B).
Ewers et al. teaches a surgical system (10; FIGs. 1A-B; [0076]) comprising an introducing catheter (11) and two medical devices (13, 14) where the introducing catheter is inserted and guided to the surgical site before allowing the multiple medical devices to operate on the surgical site ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Roslin et al. to comprise an introducing catheter, as taught by Ewers et al., for the purpose of being able to deploy multiple medical devices at the same time. The modification would provide an opening in the distal end of the introducing catheter (Ewers et al. FIG. 1B), and the lengths of the plurality of flexible arms can be measured from that opening.
Regarding claim 23, Roslin et al. discloses a device for delivery of a graft for attachment to tissue (60; [0046]; FIGs. 1A-4), comprising:
a plurality of flexible arms (400), wherein distal ends of the plurality of flexible arms extend out of a distal end of a shaft (100), and
an actuation of an actuator (130) simultaneously forms distal ends of each of the plurality of flexible arms as divergent from each other and divergent from a center to form the distal ends of the plurality of flexible arms in a radial array ([0047] when 130 is depressed, 300 are simultaneously extended, and 400 are within 300, and FIG. 1B: 300 diverge from each other and from the longitudinal axis defined by 100), wherein the center is in the distal end of the shaft (FIG. 1B: the longitudinal axis defined by 100 is the center of the distal end of 100);
wherein lengths of the plurality of flexible arms are independently adjustable relative to lengths of other arms of the plurality of flexible arms by pushing and pulling the flexible arms at or near a distal end thereof to differentiate lengths of the plurality of flexible arms measured from the distal end of the shaft to the distal end of the flexible arms ([0107] 400 are advanced serially one at a time, which will cause the length of each 400 relative to the other 400 to be independently adjusted by the movement of 140)
wherein the lengths of the flexible arms are independently adjustable for forming various sizes of grafts in a generally planar configuration when the plurality of flexible arms are formed in a radial array ([0048] when 400 are fully extended in the array from the distal end of 100, the mesh 200 is formed in a planar sheet; FIG. 1B).
Roslin et al. does not disclose wherein distal ends of the plurality of flexible arms extend out of an opening in the distal end of the shaft, as each of the plurality of flexible arms extends out a separate opening (110) in the distal end of the shaft (FIG. 1B).
Ewers et al. teaches a surgical system (10; FIGs. 1A-B; [0076]) comprising an introducing catheter (11) and two medical devices (13, 14) where the introducing catheter is inserted and guided to the surgical site before allowing the multiple medical devices to operate on the surgical site ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Roslin et al. to comprise an introducing catheter, as taught by Ewers et al., for the purpose of being able to deploy multiple medical devices at the same time. The modification would provide an opening in the distal end of the introducing catheter (Ewers et al. FIG. 1B), and the lengths of the plurality of flexible arms can be measured from that opening.
Regarding claim 26, Roslin et al. as modified by Ewers et al. further discloses the plurality of flexible arms are formed by actuation of the actuator as generally parallel to each other for removal of the flexible arms from within a surgical incision (Roslin et al. FIG. 1A: 400 can be retracted by pulling up on 130 and 140, which will make them generally parallel to each other for 100 to be retracted).
Regarding claim 28, Roslin et al. as modified by Ewers et al. further discloses the plurality of flexible arms are formed by actuation of the actuator as generally parallel to each other for removal of the flexible arms from within a surgical incision (Roslin et al. FIG. 1A: 400 can be retracted by pulling up on 130 and 140, which will make them generally parallel to each other for 100 to be retracted).
Claim(s) 2, 12, 24-25, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roslin et al. in view of Ewers et al., and in further view of Kieturakis (Pub. No. 2012/0116362).
Regarding claims 2, 12, and 29, Roslin et al. as modified by Ewers et al. discloses the invention as claimed in claims 1, 11, and 23, respectively, as discussed above. Roslin et al. does not disclose a brake positioned between the distal end of each flexible arm and the actuator, wherein the plurality of flexible arms frictionally engage the brake, and wherein the brake contacts the plurality of flexible arms and resists length change of the plurality of flexible arms.
Kieturakis teaches in the same field of endeavor of systems for laparoscopic procedures (Abstract), and discloses a system (10; [0045]; FIGs. 1-2) comprising a plurality of flexible arms (12a, 12b), an actuator (22), and a brake (17, 19), wherein the brake is positioned between the distal end of each flexible arm and the actuator (FIG. 1: 17 and 19 are between 12a and 12b, and 22, respectively), wherein the plurality of flexible arms frictionally engage the brake ([0049] each 17 engages 12a and 12b to hold them against the respective 19 to keep 12a and 12b from moving through friction), and wherein the brake contacts the plurality of flexible arms and resists length change of the plurality of flexible arms (FIG. 1: 17 and 19 keep the distal ends of 12a and 12b from getting farther away from the opening in 14 which defines their distal length) for the purpose of preventing the distal ends of the plurality of flexible arms from interfering with each other when being deployed and manipulated ([0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Wilk to include a brake, as taught by Kieturakis, for the purpose of preventing the distal ends of the plurality of flexible arms from interfering with each other when being deployed and manipulated.
Regarding claims 24-25, and 27, Roslin et al. as modified by Ewers et al. discloses the invention as claimed in claims 1, 11, and 23, respectively, as discussed above. Roslin et al. does not disclose a brake positioned between the distal end of each flexible arm and a cavity in a body, wherein the plurality of flexible arms frictionally engage the brake, and wherein the brake contacts the plurality of flexible arms and resists length change of the plurality of flexible arms.
Kieturakis teaches in the same field of endeavor of systems for laparoscopic procedures (Abstract), and discloses a system (10; [0045]; FIGs. 1-2) comprising a plurality of flexible arms (12a, 12b), an actuator (22), and a brake (17, 19), wherein the brake is positioned between the distal end of each flexible arm and a cavity in a body (FIG. 2: 17 and 19 are between the distal ends of 12a and 12b, and the body cavity which the proximal end of 12a and 12b are located in), wherein the plurality of flexible arms frictionally engage the brake ([0049] each 17 engages 12a and 12b to hold them against the respective 19 to keep 12a and 12b from moving through friction), and wherein the brake contacts the plurality of flexible arms and resists length change of the plurality of flexible arms (FIG. 1: 17 and 19 keep the distal ends of 12a and 12b from getting farther away from the opening in 14 which defines their distal length) for the purpose of preventing the distal ends of the plurality of flexible arms from interfering with each other when being deployed and manipulated ([0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Wilk to include a brake, as taught by Kieturakis, for the purpose of preventing the distal ends of the plurality of flexible arms from interfering with each other when being deployed and manipulated.
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 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, 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.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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