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
This Office action is in response to the applicant’s communication filed 05/22/2026.
Status of the claims:
Claims 1, 6, 7, 13, 17, 19, and 21 – 29 are pending in the application.
Claims 1, 6, 7, 13, 17, and 19 are amended.
Claims 21 – 29 are new.
Claim Objections
The objections to claims 5, 6, 18, and 19 in the previous action dated 03/09/2026 have been withdrawn in light of the Applicant’s amendments filed 05/22/2026. Specifically, the objection to claim 5, regarding the phrase “wherein the outer sheath is configured to close the pincer by moving distally relative to the inner member and to open the pincer by moving proximally relative to the inner member”, the objection to claim 6, regarding the phrase “the line loop”, the objection to claim 18, regarding the phrase “the second end”, the objection to claim 19, regarding the phrases “the pincer prongs” and “into closed configuration”, have all been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below.
Claims 25 and 28 have been objected to for the following informalities:
Claims 25 and 28 recite “the catheter defines a plurality of lumens” and “separate lumens of the catheter”, respectively, although the lines do no rise to the level of being indefinite as they are understood by the Examiner to mean “the at least one lumen of the catheter defines a plurality of lumens” and “separate lumens of the at least one lumen of the catheter”, as their respective independent claims already defines “at least one lumen” of the catheter and Applicant’s disclosure does not disclose multiple ‘groups’ of lumens, the Examiner suggests the lines be amended to read “the at least one lumen of the catheter defines a plurality of lumens” and “separate lumens of the at least one lumen of the catheter” for the purpose of maintaining consistent language throughout the claims;
Appropriate corrections 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.
The rejection of claims 6, 7, and 14 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 03/09/2026 have been withdrawn in light of the Applicant’s amendments filed 05/22/2026. Specifically, the rejection of claim 6, regarding the lack of clarity in the phrase "the pincer includes first and second pincer prongs", the rejection of claim 7, regarding the lack of clarity in the phrase "the first and second pincer prongs", the rejection of claim 14, regarding the lack of clarity in the phrase “the second end portion includes a pincer”, and the rejection of claim 7 for being dependent on an indefinite claim have all been withdrawn as the appropriate corrections have been made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejections of claims 1, 13, and 17 under U.S.C 35 102(a)(1) with respect to Dell, recited in the previous action dated 03/09/2026 have been withdrawn in light of the Applicant’s amendments filed 05/22/2026. Specifically, the rejection of claims 1, 13, and 17, with respect to Dell have been withdrawn because Dell does not anticipate first and second proximal element actuators comprising pincer prongs as recited in the current claim set. However, the previous combination of Dell and Rothstein relied upon in the previous rejection to teach the pincer prong limitations is maintained; wherein, Rothstein is relied upon to teach the pincer prongs.
Claims 1, 6, 13, 17, 19, and 21 – 29 are rejected under 35 U.S.C. 103 as being unpatentable over Dell et al (US 2013/0066342 A1) (previously recited) and in view of Rothstein (US 2011/0264191 A1) (previously recited).
Regarding claims 1 and 6, Dell discloses a fixation system (interventional tool 10) for engaging tissue of a patient (abstract, paragraphs [0110 – 0111], and Figs. 7,10A), comprising:
an implantable fixation device (fixation device 14) (paragraphs [0119 – 0120] and Figs. 7,10A) comprising:
a first arm and a second arm (left and right arms 53 – when looking in Fig. 7) (paragraph [0120] and Fig. 7) ,
a first proximal element (left proximal element 16) moveable relative to the first arm between a first position and a second position and a second proximal element (right proximal element 16) moveable relative to the second arm between a first position and a second position (paragraphs [0020], [0121 – 0122], [0135], and Figs. 7,9B-11B) ; and
a delivery device (catheter 86 and shaft 12) (paragraph [0128] and Figs. 8A-14) comprising:
a catheter (catheter 86) having a proximal end portion and a distal end portion (paragraph [0128]), the catheter defining at least one lumen (lumen shown in Fig. 10A) extending between the proximal end portion and the distal end portion (paragraph [0128] and Fig. 9A-11B),
a first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the first proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the first proximal element actuator coupled to the first proximal element at the second end portion of the first proximal element actuator and actuatable to move the first proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B) and
a second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the second proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the second proximal element actuator coupled (coupled at loop 48) to the second proximal element at the second end portion of the second proximal element actuator and actuatable to move the second proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B);
wherein the first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) is configured such that, while coupled to the first proximal element, axial tensioning of the first proximal element actuator moves the first proximal element toward the second position, and release of the axial tensioning of the first proximal element actuator allows the first proximal element to return toward the first position (paragraph [0146]), and the second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) is configured such that, while coupled to the second proximal element, axial tensioning of the second proximal element actuator moves the second proximal element toward the second position, and release of the axial tensioning of the second proximal element actuator allows the second proximal element to return toward the first position (paragraph [0146]).
Dell discloses in paragraphs [0130] and [0154 – 0156], wherein the proximal element actuators can be connected to the proximal elements via various means; thereby, teaching wherein the type of means for coupling the proximal element actuators to the proximal elements is not critical to the invention. Furthermore, Dell makes obvious a portion of [claim 6] wherein the first and second proximal elements (left and right proximal elements 16) each include a loop (line loop 48) extending therefrom for the purpose of reducing friction on the proximal element lines 90 (i.e., the first and second proximal actuators) (paragraph [0130]).
However, Dell is silent regarding [claims 1 and 6] (i) wherein the second end portion of the first proximal element actuator comprises a first outer sheath axially moveable relative to a first inner member having a first pincer, the first outer sheath configured to move distally relative to the first inner member to close the first pincer and couple the first proximal element actuator to the first proximal element/the first loop, and to move proximally relative to the first inner member to open the first pincer and decouple the first proximal element actuator from the first proximal element/the first loop, and (ii) wherein the second end portion of the second proximal element actuator comprises a second outer sheath axially moveable relative to a second inner member having a second pincer, the second outer sheath configured to move distally relative to the second inner member to close the second pincer and couple the second proximal element actuator to the second proximal element/the second loop, and to move proximally relative to the second inner member to open the second pincer and decouple the second proximal element actuator from the second proximal element/the second loop.
As to the above, Rothstein teaches an implant delivery system comprising an implantable device (stent 50; which equates to the fixation device 14 of Dell) and a delivery device (delivery system 10) comprising a catheter (sheath 24; which equates to the catheter 86 of Dell) comprising a lumen therethrough (paragraph [0037] and Fig. 1), first and second proximal element actuators (capturing wires 14; which equate to proximal element lines 90 of Dell), wherein each of the first and second proximal actuators comprising a first and second outer sheath (respective sleeves 20) axially moveable relative to an inner member (body portion of capturing wires 14; which equates to the body portion of the proximal element lines 90 of Dell) having a distal pincer (distal end 30 with upper and lower portions 34,36) with a pair of prongs (upper and lower portions 34,36), adjustable between an open and closed configuration (Figs. 18,19), configured to couple to a loop (openings within stent 50; which equates to the line loops 48 of Dell) of the implantable device (stent 10) when the outer sheath (sleeves 20) move distally, over the pincer prongs (upper and lower portions 34,36), to close the pincer (distal end 30) and to decouple from the loop (openings within stent 50; which equates to the line loops 48 of Dell) of the implantable device (stent 10) when the outer sheath (sleeves 20) move proximally relative to the inner member (body portion of capturing wires 14; which equates to the body portion of the proximal element lines 90 of Dell) (paragraphs [0042], [0046], and Figs. 1–7,18,19).
It should be understood that Dell and Rothstein are known references in the art that teach means of coupling an implantable device to the delivery system via multiple elongate members (abstract, paragraphs [0110 – 0111], [0121 – 0122], [0130], [0133 – 0135], and Figs. 7,9B-11B – Dell ; abstract, paragraphs [0037], [0042], [0046], and Figs. 1–7,18,19 – Rothstein); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one coupling mechanism for another (i.e., modifying Dell to incorporate the pincers and slidable sheaths similar to that of Rothstein), and the results of the substitution would have been predictable and resulted in the modified proximal element actuators of Dell being able to function as intended to properly couple and decouple the proximal elements to and from the delivery system. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that although the means for coupling the proximal element actuators / lines 90 to the proximal elements have been modified to include the pincer prongs on each end and the moveable outer sheaths 20 used to close the prongs, Dell makes obvious wherein the system remains configured to independently tension and release the proximal element actuators / lines 90 in order to move the proximal elements for the reasons discussed in paragraphs [0146 – 0148] of Dell; and therefore, the proximal element actuators / lines 90 with the pincer prongs, are configured to move relative to stationary outer sheaths 20 of the modified device in the manner claimed.
Regarding claim 7, as discussed above, it would have been obvious to modify each of the first and second proximal element actuators of Dell to incorporate a pincer in view of Rosthstein. Additionally, Rothstein teaches wherein the first and second pincer prongs (upper and lower portions 34,36) are formed of a shape memory material such that they are biased outwardly (paragraph [0038] and Figs. 3,18). Therefore, the combination encompasses wherein each of the first and second pincers are made up of shape memory material.
Regarding claim 13, Dell discloses a fixation system (interventional tool 10) for engaging tissue of a patient (abstract, paragraphs [0110 – 0111], and Figs. 7,10A), comprising:
an implantable fixation device (fixation device 14) (paragraphs [0119 – 0120] and Figs. 7,10A) comprising:
a first arm and a second arm (left and right arms 53 – when looking in Fig. 7) (paragraph [0120] and Fig. 7) ,
a first proximal element (left proximal element 16) moveable relative to the first arm between a first position and a second position and a second proximal element (right proximal element 16) moveable relative to the second arm between a first position and a second position (paragraphs [0020], [0121 – 0122], [0135], and Figs. 7,9B-11B); and
a delivery device (catheter 86 and shaft 12) (paragraph [0128] and Figs. 8A-14) comprising:
a catheter (catheter 86) having a proximal end portion and a distal end portion (paragraph [0128]), the catheter defining at least one lumen (lumen shown in Fig. 10A) extending between the proximal end portion and the distal end portion (paragraph [0128] and Fig. 9A-11B),
a first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the first proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the second end portion of the first proximal element actuator being releasably coupled (coupled at loop 48) to the first proximal element (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B), and
a second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the second proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the second end portion of the second proximal element actuator being releasably coupled (coupled at loop 48) to the second proximal element (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B);
wherein the first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B), while coupled to the first proximal element, is configured to be moved relative to the catheter to move the first proximal element between the first position and the second position (paragraphs [0146 – 0147]), and the second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B), while coupled to the second proximal element, is configured to be moved relative to the catheter to move the second proximal element between the first position and the second position (paragraphs [0146 – 0147]).
However, Dell is silent regarding (i) wherein the second end portion of the first proximal element actuator comprises a first pincer actuatable between a closed configuration in which the second end portion of the first proximal element actuator is coupled to the first proximal element and an open configuration in which the second end portion of the first proximal element actuator is decoupled from the first proximal element, and (ii) wherein the second end portion of the second proximal element actuator comprises a second pincer actuatable between a closed configuration in which the second end portion of the second proximal element actuator is coupled to the second proximal element and an open configuration in which the second end portion of the second proximal element actuator is decoupled from the second proximal element.
As to the above, Rothstein teaches an implant delivery system comprising an implantable device (stent 50; which equates to the fixation device 14 of Dell) and a delivery device (delivery system 10) comprising a catheter (sheath 24; which equates to the catheter 86 of Dell) comprising a lumen therethrough (paragraph [0037] and Fig. 1), first and second proximal element actuators (capturing wires 14; which equate to proximal element lines 90 of Dell), wherein each of the first and second proximal actuators comprising a first and second outer sheath (respective sleeves 20) axially moveable relative the first and second proximal element actuators (capturing wires 14), the first and second proximal element actuators (capturing wires 14) having a distal pincer (distal end 30 with upper and lower portions 34,36) with a pair of prongs (upper and lower portions 34,36), adjustable between an open and closed configuration (Figs. 18,19), configured to couple to respective first and second proximal elements on the implantable device (openings within stent 50; which equates to the line loops 48 of Dell) when the outer sheath (sleeves 20) move distally, over the pincer prongs (upper and lower portions 34,36), to close the pincer (distal end 30) and to decouple from the first and second proximal elements on the implantable device (openings within stent 50) when the outer sheath (sleeves 20) moves proximally relative to the respective the first and second proximal element actuators (capturing wires 14) (paragraphs [0042], [0046], and Figs. 1–7,18,19).
It should be understood that Dell and Rothstein are known references in the art that teach means of coupling an implantable device to the delivery system via multiple elongate members (abstract, paragraphs [0110 – 0111], [0121 – 0122], [0130], [0133 – 0135], and Figs. 7,9B-11B – Dell ; abstract, paragraphs [0037], [0042], [0046], and Figs. 1–7,18,19 – Rothstein); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one coupling mechanism for another (i.e., modifying Dell to incorporate the pincers and slidable sheaths similar to that of Rothstein), and the results of the substitution would have been predictable and resulted in the modified proximal element actuators of Dell being able to function as intended to properly couple and decouple the proximal elements to and from the delivery system. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that although the means for coupling the proximal element actuators / lines 90 to the proximal elements have been modified to include the pincer prongs on each end and the moveable outer sheaths 20 used to close the prongs, Dell makes obvious wherein the system remains configured to independently tension and release the proximal element actuators / lines 90 in order to move the proximal elements for the reasons discussed in paragraphs [0146 – 0148] of Dell; and therefore, the proximal element actuators / lines 90 with the pincer prongs, are configured to move relative to stationary outer sheaths 20 of the modified device in the manner claimed.
Regarding claims 17 and 19, Dell discloses a fixation system (interventional tool 10) for engaging tissue of a patient (abstract, paragraphs [0110 – 0111], and Figs. 7,10A), comprising:
an implantable fixation device (fixation device 14) (paragraphs [0119 – 0120] and Figs. 7,10A) comprising:
a first arm and a second arm (left and right arms 53 – when looking in Fig. 7) (paragraph [0120] and Fig. 7) ,
a first proximal element (left proximal element 16) moveable relative to the first arm between a first position and a second position and a second proximal element (right proximal element 16) moveable relative to the second arm between a first position and a second position (paragraphs [0020], [0121 – 0122], [0135], and Figs. 7,9B-11B); and
a delivery device (catheter 86 and shaft 12) (paragraph [0128] and Figs. 8A-14) comprising:
a catheter (catheter 86) having a proximal end portion and a distal end portion (paragraph [0128]), the catheter defining at least one lumen (lumen shown in Fig. 10A) extending between the proximal end portion and the distal end portion (paragraph [0128] and Fig. 9A-11B),
a first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the first proximal element actuator having a length extending from a first end (end not attached to the proximal element 16) of the first proximal element actuator and terminating at a second end (end attached to the proximal element 16) of the first proximal element actuator (paragraph [0130] and Figs. 9A,10A,11A), the first proximal element actuator releasably coupled to the first proximal element at the second end of the first proximal element actuator and actuatable to move the first proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B), and
a second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the second proximal element actuator having a length extending from a first end (end not attached to the proximal element 16) of the first proximal element actuator and terminating at a second end (end attached to the proximal element 16) of the first proximal element actuator (paragraph [0130] and Figs. 9A,10A,11A), the second proximal element actuator releasably coupled to the second proximal element at the second end of the second proximal element actuator and actuatable to move the second proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B);
wherein the first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B), while coupled to the first proximal element (proximal element 16), is configured to be moved in a proximal-distal direction relative to the catheter to move the first proximal element between the first position (paragraphs [0146 – 0148]) and the second position, and the second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B), while coupled to the second proximal element (proximal element 16), is configured to be moved in a proximal-distal direction relative to the catheter to move the second proximal element between the first position and the second position (paragraphs [0146 – 0148]).
However, Dell is silent regarding [claims 17 and 19] (i) wherein the second end of the first proximal element actuator is defined by a first pair of pincer prongs moveable between a closed configuration in which the second end of the first proximal element actuator is coupled to the first proximal element and an open configuration in which the second end of the first proximal element actuator is decoupled from the first proximal element, the first proximal element actuator includes a first sheath slidable over the first pair of pincer prongs between a distal position in which the first sheath urges the first pair of pincer prongs into the closed configuration and a proximal position in which the first pair of pincer prongs are in the open configuration, and (ii) wherein the second end of the second proximal element actuator is defined by a second pair of pincer prongs moveable between a closed configuration in which the second end of the second proximal element actuator is coupled to the second proximal element and an open configuration in which the second end of the second proximal element actuator is decoupled from the second proximal element, and the second proximal element actuators includes a second sheath slidable over the second pair of pincer prongs between from a distal position in which the second outer sheath urges the second pair of pincer prongs into the closed configuration and a proximal position in which the second pair of pincer prongs are in the open configuration.
As to the above, Rothstein teaches an implant delivery system comprising an implantable device (stent 50; which equates to the fixation device 14 of Dell) and a delivery device (delivery system 10) comprising a catheter (sheath 24; which equates to the catheter 86 of Dell) comprising a lumen therethrough (paragraph [0037] and Fig. 1), first and second proximal element actuators (capturing wires 14; which equate to proximal element lines 90 of Dell), wherein each of the first and second proximal actuators comprising a first and second outer sheath (respective sleeves 20) axially moveable relative the first and second proximal element actuators (capturing wires 14), the first and second proximal element actuators (capturing wires 14) having a distal pincer (distal end 30 with upper and lower portions 34,36) with a pair of prongs (upper and lower portions 34,36), adjustable between an open and closed configuration (Figs. 18,19), configured to couple to respective first and second proximal elements on the implantable device (openings within stent 50; which equates to the line loops 48 of Dell) when the outer sheath (sleeves 20) move distally, over the pincer prongs (upper and lower portions 34,36), to close the pincer (distal end 30) and to decouple from the first and second proximal elements on the implantable device (openings within stent 50) when the outer sheath (sleeves 20) moves proximally relative to the respective the first and second proximal element actuators (capturing wires 14) (paragraphs [0042], [0046], and Figs. 1–7,18,19).
It should be understood that Dell and Rothstein are known references in the art that teach means of coupling an implantable device to the delivery system via multiple elongate members (abstract, paragraphs [0110 – 0111], [0121 – 0122], [0130], [0133 – 0135], and Figs. 7,9B-11B – Dell ; abstract, paragraphs [0037], [0042], [0046], and Figs. 1–7,18,19 – Rothstein); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one coupling mechanism for another (i.e., modifying Dell to incorporate the pincers and slidable sheaths similar to that of Rothstein), and the results of the substitution would have been predictable and resulted in the modified proximal element actuators of Dell being able to function as intended to properly couple and decouple the proximal elements to and from the delivery system. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that although the means for coupling the proximal element actuators / lines 90 to the proximal elements have been modified to include the pincer prongs on each end and the moveable outer sheaths 20 used to close the prongs, Dell makes obvious wherein the system remains configured to independently tension and release the proximal element actuators / lines 90 in order to move the proximal elements for the reasons discussed in paragraphs [0146 – 0148] of Dell; and therefore, the proximal element actuators / lines 90 with the pincer prongs, are configured to move relative to stationary outer sheaths 20 of the modified device in the manner claimed.
Regarding claims 21, 24, and 27, as discussed above, it would have been obvious to modify each of the first and second proximal element actuators of Dell to incorporate a pincer in view of Rosthstein. Additionally, the combination makes obvious wherein the first proximal element actuator (left, single line, proximal element line 90) is configured to be withdrawn / pass / removed from the catheter by being proximally translated through the at least one lumen after the first outer sheath (one of the sheaths 20 – Rosthstein) is moved proximally to open the first pincer (upper and lower portions 34,36 – Rosthstein) and the second proximal element actuator (right, single line, proximal element line 90) is configured to be withdrawn / pass / removed from the catheter by being proximally translated through the at least one lumen after the second outer sheath (another of the sheaths 20 – Rosthstein) is moved proximally to open the second pincer (upper and lower portions 34,36 – Rosthstein) (Examiner’s note: it should be understood that the preceding limitations are intended use which requires only that the structure of the prior art be capable of functioning as claimed. With that said, and as stated in the rejection of claims 1, 13, and 17, the combination makes obvious to one of ordinary skill in the art for the proximal element actuators of Dell with the pincer prongs of Rosthstein to remain actuatable relative to the catheter (and thus also be actuatable relative to the added sheaths 20 when the sheaths 20 are stationary), for the purpose of being able to open and close the proximal elements 16 so that the proximal elements 16 can be still be moved at the desired variety of angles and distances – paragraphs [0136], [0146 – 0148] of Dell. Paragraph [0136] also teaches wherein the proximal element actuators of Dell are withdrawn / removable from the system. Therefore, the combination makes encompasses wherein the structure of Dell in view of Rosthstein is capable of functioning as claimed).
Regarding claims 22, 25, and 28, as discussed above, it would have been obvious to modify each of the first and second proximal element actuators of Dell to incorporate a pincer in view of Rosthstein. Additionally, Dell makes obvious:
[claim 23] wherein the at least one lumen (central lumen of shaft 302; which equates to the shaft 86 in the initial embodiment of Dell) comprises a first lumen and a second lumen (proximal element line lumens 342) (paragraph [0206] and Fig. 42B), the first proximal element actuator (left, single line, proximal element line 90) extending through the first lumen (left proximal element line lumen 342 – Fig. 42B) and the second proximal element actuator (right, single line, proximal element line 90) extending through the second lumen (right proximal element line lumen 342 – Fig. 42B);
[claim 25] wherein the catheter (catheter 302) defines a plurality of lumens (central lumen and proximal element line lumens 342) (paragraph [0206] and Fig. 42B]), the first proximal element actuator (left, single line, proximal element line 90) extending through a first lumen of the plurality of lumens (left proximal element line lumen 342 – Fig. 42B) and the second proximal element actuator (left, single line, proximal element line 90) extending through a second lumen of the plurality of lumens (right proximal element line lumen 342 – Fig. 42B).
[claim 28] wherein the first proximal element actuator and the second proximal element actuator (left and right, single line, proximal element lines 90) extend through separate lumens of the catheter (proximal element line lumens 342) (paragraph [0206] and Fig. 42B]).
(Examiner’s note: Dell teaches in a separate embodiment, Fig. 42B, wherein each of the proximal element lines 90 (i.e., each of the proximal element actuators) can extend through its own lumen that extends through the catheter – paragraph [0206]. It would have been prima facie obvious to a person of ordinary skill in the art to modify the embodiment of Fig. 10 of Dell to incorporate a separate lumen for each of the proximal element lines 90 (i.e., each of the proximal element actuators) for the purpose of preventing the lines from tangling within the central lumen. “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)).
Regarding claims 23, 26, and 29, as discussed above, it would have been obvious to modify each of the first and second proximal element actuators of Dell to incorporate a pincer in view of Rosthstein. Additionally, Dell discloses wherein the first proximal element actuator (left, single line, proximal element line 90) is operable independently of the second proximal element actuator (left, single line, proximal element line 90) (paragraph [0148]).
Response to Arguments
Applicant's arguments filed 05/22/2026 have been fully considered but they are not persuasive. More specifically:
Regarding Applicant’s argument that “Even as applied to the amended independent claims, the proposed combination does not teach or suggest the actuation features recited in the amended claims. Rothstein's capturing wires 14 are attached at their proximal ends to a wire connection member 16, which is in turn attached to an extension tube 18 of the delivery system. (Rothstein at 1 [0031]-[0032].) During deployment, only the sleeves 20 translate proximally to release the captured stent. (Rothstein at 1 [0046]-[0047].) The capturing wires themselves remain stationary.” and “Because Rothstein does not teach a pincer interface used for actuation, the proposed combination of Dell and Rothstein does not teach the actuation behavior recited in the amended claims. Accordingly, the amended independent claims are not rendered obvious by the combination of Dell in view of Rothstein”, the Examiner acknowledges that the capture wires 14 of Rosthstein do not actuate, however the Examiner is not relying on means of actuation for the capture wires 14; furthermore, Dell discloses that the proximal element actuators are capable of being translated relative to the catheter system, and the modification made to Dell in view of Rosthstein does not take away the ability for the said proximal element actuators to able to be translated relative to the catheter system (and the added sheaths of Rothstein that open and close the pincer prongs).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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