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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 21st, 2026, has been entered.
Response to Amendment
The claims filed on August 21st, 2026, have been entered. Claims 1-22 remain pending in the Application.
Response to Arguments
Applicant's arguments filed August 21st, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that the newly added claim limitations to claims 1, 21, and 22 overcome the 103 rejection over Gomez et al. (U.S. Patent No. 8,852,208) in view of Shellenberger et al. (U.S. Patent No. 12,023,041; henceforth referred to as “Shellenberger ‘041”), and Shellenberger (Pub. No. 2018/0271527; henceforth referred to as “Shellenberger ‘527”) because neither Shellenberger references disclose medical clips with biasing elements in the form of a spring. Examiner respectfully disagrees. As explained in the Final Rejection dated February 24th, 2026, claim 7 (which is dependent on claim 1) does not require the medical clip to have the biasing element, so the leaf spring in the proximal end region of Shellenberger ‘041 satisfies the claim limitation, and claim 1 does not claim any biasing element.
Second, Applicant argues that the clips of Shellenberger ‘041 and Shellenberger ‘527 are mirror-symmetrical to each other and therefore do not teach the proximal end regions as claimed. Examiner respectfully disagrees. If the clip of Shellenberger ‘041 were turned slightly in one direction (as necessitated by the stabilizing members 126 and 136) while the clip of Shellenberger ‘527 were turned slightly in the opposite direction (as necessitated by the stabilizing members 762 and 764), then their proximal end regions as claimed cannot be symmetrical to each other relative to a common plane (such as a horizontal plane). This change in orientation also means that the two clips are not identical to each other when loaded into the other reference’s appliers, as their orientation would not permit them to fit into the new proximal end region as claimed.
Third, Applicant argues with regards to claim 7 that Shellenberger ‘041 does not disclose a medical clip with a biasing element because the leaf spring 140 is part of the instrument and not part of the clip. Examiner acknowledged this in the Final Rejection, and noted that the proximal end regions are claimed as volumes around the clips which in some instances include portions of the clips themselves, while in other instances explicitly not containing portions of the clips themselves. As long as the biasing element is claimed as part of the proximal end region, rather than of the clip, the leaf spring 140 of Shellenberger ‘041 satisfies the limitation.
Fourth, Applicant argues with respect to the rejection of claims 21 and 22 in further view of Weisshaupt et al. (Pub. No. 2013/0184726) because Weisshaupt et al. only discloses a single type of medical clip. Examiner respectfully disagrees. In the Final Rejection, Weisshaupt et al. was brought in to teach substituting the hinge proximal end of both Shellenberger references’ clips with the spring proximal end of the Weisshaupt et al. clip, and was never used to teach different types of medical clips.
Fifth, Applicant further argues that one of ordinary skill in the art would not be motivated to modify the Shellenberger references in view of Weisshaupt et al. because the clip of Weisshaupt et al. has an asymmetrical design with respect to the clip plane. Examiner respectfully disagrees. While Weisshaupt et al. has an asymmetrical spring end 186, the orientation of the spring can go either clockwise or counterclockwise, and the orientation will allow the spring to fit within the stabilizing members of either Shellenberger et al. reference. Therefore, the modification of Weisshaupt et al. can be made to the clips of either Shellenberger et al. reference without removing the structural characteristics that allow the clips to meet the claim limitations, such as being unable to fit within the other’s proximal end regions.
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) 1-7 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gomez et al. (U.S. Patent No. 8,852,208) in view of Shellenberger et al. (U.S. Patent No. 12,023,041; henceforth referred to as “Shellenberger ‘041”), and Shellenberger (Pub. No. 2018/0271527; henceforth referred to as “Shellenberger ‘527”).
Regarding claim 1, Gomez et al. discloses a surgical system (claim 1) comprising a plurality of clip appliers (claims 7-8: the system can include a plurality of surgical instruments, where the plurality of surgical instruments can include clip appliers). Gomez et al. does not disclose the claimed limitations of the application instruments and medical clips.
Shellenberger ‘041 teaches in the same field of endeavor of systems for applying surgical clips (Abstract) and discloses an application system for medical clips (100; FIGs. 1-9; C5:L1-L25), comprising:
at least one application instrument (102; FIG. 2) for applying a type of medical clip and at least one medical clip (50; FIG. 4) of that type, wherein the application instrument comprises two tool elements (110, 112) that are movable relative to one another (FIGs. 6-7: 110 and 112 are actuated to open or close the jaws),
wherein the at least one medical clip of that type has a proximal end region (56) and two connecting portions (FIG. 4: sections of 52 and 54 that are distally adjacent to 56 and that are in contact with 126 and 136), which distally adjoin the proximal end region defining a volume region (FIG. 4: 56 defines a volume) and connect the proximal end region to two clamping arms (52, 54) of the at least one medical clip of that type that are movable relative to each other (FIG. 4: 56 is the hinge connecting 52 to 54),
wherein the two tool elements comprise between them an end region receptacle (distal ends of 122 and 132; FIG. 2) that is open in the distal direction for accommodating the proximal end region in a positive-locking manner (FIG. 4: 122 and 132 both face distally and positive-lock 50 in place) and each tool element comprises a connecting portion receptacle (FIG. 2: proximal ends of 122 and 132) for at least partially accommodating a respective accommodation portion of the connecting portions (FIG. 4: the proximal ends of 122 and 132 hold their respective accommodation portions of 56), and
wherein at least one distinguishing element (126, 136) is formed on at least one of the two tool elements (FIG. 2: 126 and 136 are part of 110 and 112) in such a way that the at least one distinguishing element engages into a volume region (FIG. 3: 126 and 136 extend into different volumes within 122 and 132 than established by 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted one of the application systems of Gomez et al. for the application system of Shellenberger ‘041 because both application systems are disclosed as equivalent structures for deploying a medical clip from an application instrument to secure tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
Shellenberger ‘527 teaches in the same field of endeavor of systems for applying surgical clips (Abstract) and discloses an application system (FIG. 10) comprising:
at least one application instrument (700; FIG. 10; [0045]) for applying a type of medical clip and at least one medical clip (200) of that type, wherein the application instrument comprises two tool elements (702, 704) that are movable relative to one another ([0047] 702 and 704 may move towards each other to close on 200, or move away from each other to release 200),
wherein the at least one medical clip of that type has a proximal end region (FIG. 10: 200 has a proximal region at the hinge between 202 and 204) and two connecting portions (FIG. 10: sections which connect the hinge to 202 and 204, respectively), which distally adjoin the proximal end region defining a volume region (FIG. 10) and connect the proximal end region to two clamping arms (202, 204) of the at least one medical clip of the type that are movable relative to each other ([0047] 202 and 204 move towards each other when pushed by 702 and 704, respectively),
wherein the two tool elements comprise between them an end region receptacle (720, 724) that is open in the distal direction for accommodating the proximal end region in a positive-locking manner (FIG. 10: 762 and 764 are fit within 720 and 724, respectively, to positive-lock 200 in place) and each tool element comprises a connecting portion receptacle (708) for at least partially accommodating a respective accommodation portion of the connecting portions (FIG. 10: 708 accommodates the accommodation portions of 202 and 204), and
wherein at least one distinguishing element (710, formed of 762 and 764) is formed on at least one of the two tool elements (FIG. 10: 762 and 764 are formed on 702 and 704, respectively) in such a way that the at least one distinguishing element engages into a volume region (FIG. 10: 762 and 764 protrude into the area of the proximal end of the clip).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further substituted one of the application systems of Gomez et al. for the application system of Shellenberger ‘527 because both application systems are disclosed as equivalent structures for deploying a medical clip from an application instrument to secure tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
The application system of Shellenberger ‘041 (henceforth the first application system) has the at least one first distinguishing element arranged in the bottom left and the top right of the first end region receptacle when viewed from a distal position facing the first application instrument (FIG. 3), and the application system of Shellenberger ‘527 (henceforth the second application system) has the at least one second distinguishing element arranged in the bottom right and the top left of the second end region receptacle when viewed from the same perspective. Therefore, the at least one first distinguishing element engages into the second volume region (defined by the second type of medical clip in Shellenberger ‘527) and the at least one second distinguishing element engages into the first volume region (defined by the first type of medical clip in Shellenberger ‘041).
Furthermore, the first medical clip of Shellenberger ‘041 defines a first clip plane (Shellenberger ‘041 FIG. 3: the horizontal plane of the clip) where the first proximal end region is asymmetrical with respect to the first clip plane (Shellenberger ‘041 FIG. 2: the stabilizing members 126 and 136 mean that when the clip is loaded, the clip is not symmetric to the horizontal plane of the clip), the second medical clip of Shellenberger ‘527 defines a second clip plane (Shellenberger ‘527 FIG. 10: the horizontal plane of the clip) where the second proximal end region is asymmetrical with respect to the second clip plane (Shellenberger ‘527 FIG. 10: the stabilizing members 762 and 764 mean that when the clip is loaded, the clip is not symmetric to the horizontal plane of the clip), and wherein the first proximal end region and the second proximal end region do not coincide when the first medical clip of Shellenberger ‘041 and the second medical clip of Shellenberger ‘527 are aligned such that the first clip plane defines the second clip plane (Shellenberger ‘041 FIG. 3 and Shellenberger ‘527 FIG. 10: since the stabilizing members 126 and 762 are on opposite sides of the clip when facing the front of the appliers, and the stabilizing members 136 and 764 are also on opposite sides, the proximal end regions will not coincide while the two clip planes are both the horizontal planes).
Regarding claim 2, Gomez et al. as modified by Shellenberger ‘527 further discloses the at least one second application instrument comprises a second actuating device (Shellenberger ‘527 706) for moving the two second tool elements relative to one another (Shellenberger ‘527 [0047] 706 is manipulated to cause 702 and 704 to move closer to each other or farther away from each other) from a second accommodation position, in which a second medical clip of the second type corresponding to the second application instrument can be accommodated with its second end region in the second end region receptacle (Shellenberger ‘527 [0047] and FIG. 10: 702 and 704 can be kept in an open position, where 200 can be inserted into 720 and 724), into a second application position, in which the two second tool elements are moved toward one another and the second clamping arms are moved away from one other for applying the second medical clip of the second type (Shellenberger ‘527 [0047] 702 and 704 can be moved into a closed position).
Regarding claim 3, Gomez et al. as modified by Shellenberger ‘527 further discloses the two second tool elements of the at least one second application instrument are pivotable relative to one another about a common second pivot axis ([0047] 702 and 704 may move towards each other to close on 200, or move away from each other to release 200).
Regarding claim 4, Gomez et al. as modified by Shellenberger ‘041 further discloses the at least one first application instrument comprises a first actuating device (Shellenberger ‘041 150; C8:L28-37) for moving the two first tool elements relative to one another (Shellenberger ‘041 C8:L28-37: 150 causes 110 and 112 to either open or close) from a first accommodation position, in which a first medical clip of the first type corresponding to the first application instrument can be accommodated with its first end region in the first end region receptacle (Shellenberger ‘041 C8:L28-37: the open position, where 50 can be inserted into 110 and 112), into a first application position, in which the two first tool elements are moved toward one another and the first clamping arms are moved away from one other for applying the first medical clip of the first type (Shellenberger ‘041 C8:L28-37: the closed position, where 50 is closed by 110 and 112 moving towards each other to compress 50).
Regarding claim 5, Gomez et al. as modified by Shellenberger ‘041 further discloses the two first tool elements of the at least one first application instrument are pivotable relative to one another about a common first pivot axis (Shellenberger ‘041 FIGs. 6-7: 110 and 112 are actuated to open or close the jaws).
Regarding claim 6, Gomez et al. as modified by Shellenberger ‘041 further discloses:
a) the first accommodation portions substantially directly adjoin the first proximal end region (Shellenberger ‘041 FIGs. 4-5: the accommodation portions of 56 directly adjoin 56) and
b) the second accommodation portions directly adjoin the second proximal end region (Shellenberger ‘041 FIG. 10: the accommodation portions of 200 are directly adjoin the hinge of 200).
Regarding claim 7, Gomez et al. as modified by Shellenberger ‘041 and Shellenberger ‘527 further discloses:
a) the first proximal end region comprises a first biasing element (Shellenberger ‘041 56; C6:L25-27 and C6:L45-47; FIG. 6) and
Regarding claim 16, Gomez et al. as modified by Shellenberger ‘041 and Shellenberger ‘527 further discloses the at least one first distinguishing element is configured in the form of a first coding element that cooperates with any medical clip (Shellenberger ‘041 FIG. 3: 126 and 136 are coding elements that can cooperate with any medical clip) and wherein exclusively the first medical clip of the first type corresponding to the first coding element can be accommodated in the first end region receptacle of the first application instrument in a positive-locking manner (since the Shellenberger ‘527 has the distinguishing elements in the top left and bottom right of the volume when facing the instrument from a distal direction, and Shellenberger ‘041 has the distinguishing elements in the top right and bottom left from the same perspective, only the first medical clip will fit into the first application instrument’s first end region receptacle).
Regarding claim 17, Gomez et al. as modified by Shellenberger ‘041 and Shellenberger ‘527 further discloses: a respective one of the two first coding elements formed on each first tool element of the at least one first application instrument (Shellenberger ‘041 FIG. 3: 126 and 136 are formed on 110 and 112, respectively) and a respective one of the two second coding elements is formed on each second tool element of the at least one second application instrument (Shellenberger ‘527 FIG. 10: 762 and 764 are formed on 702 and 704, respectively).
Regarding claim 18, Gomez et al. as modified by Shellenberger ‘041 and Shellenberger ‘527 further discloses the at least one second distinguishing element is configured in the form of a second coding element that cooperates with any medical clip (Shellenberger ‘527 [0047] 710 can work with any medical clip of a size which can be inserted into the volume limited by 710) and wherein exclusively the second medical clip of the second type corresponding to the second coding element can be accommodated in the second end region receptacle of the second application instrument in a positive-locking manner (Since the Shellenberger ‘527 has the distinguishing elements in the top left and bottom right of the volume when facing the instrument from a distal direction, and Shellenberger ‘041 has the distinguishing elements in the top right and bottom left from the same perspective, only the second medical clip will fit into the second application instrument’s second end region receptacle).
Regarding claim 19, Gomez et al. as modified by Shellenberger ‘041 further discloses:
a) the two first tool elements are convertible into one another in the region of the first end region receptacle by rotation by 180 degrees relative to a first longitudinal axis of the first end region receptacle (Shellenberger ‘041 FIG. 7: 110 and 112 can be brought into each other to be at a 180-degree angle relative to the longitudinal axis defined by the distal ends of 122 and 132, respectively) and
Claim(s) 8-15 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gomez et al. in view of Shellenberger ‘041 and Shellenberger ‘527, and in further view of Weisshaupt et al. (Pub. No. 2013/0184726).
Regarding claims 8-15 and 20, Gomez et al. as modified by Shellenberger ‘041 and Shellenberger ‘527 discloses the invention as claimed in claim 1, as discussed above. None of the three references discloses the limitations of the medical clips of either type as claimed in claims 8-15. However, Weisshaupt et al. teaches in the same field of endeavor of medical clips (Abstract), and discloses a medical clip (180; FIG. 6; [0080]) that has a proximal end region (186) and two connecting portions (192, 194), which distally adjoin the proximal end region defining a volume region (FIG. 6: 186 defines a volume) and connect the proximal end region to two clamping arms (182, 184) of the at least one medical clip of the type that are movable relative to each other ([0080] 182 and 184 are shown midway between the rest position and the application position, and are movable to either position by moving toward or away from each other, respectively). It would have been obvious to one of ordinary skill in the art before the effective filing date to have further substituted the medical clip of Shellenberger ‘527 (V-shaped hinge) for the medical clip of Weisshaupt et al. (spring coil) because both medical clips are disclosed as equivalent structures for securing tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
Regarding claim 8, Gomez et al. as modified by Weisshaupt et al. further discloses:
b) the second clamping arms abut against one another in a second basic position of the at least one second medical clip of the second type (Weisshaupt et al. [0081] 182 and 184 are set to a default closed position where 182 and 184 are pressed against each other) and are movable away from one another against the action of a second biasing element from the second basic position into a second opening position (Weisshaupt et al. [0081] 182 and 184 can be moved away from each other against the force of 186 when 192 and 194 are pressed towards each other).
Regarding claim 9, Gomez et al. as modified by Weisshaupt et al. further discloses:
b) the second connecting portions intersect in a second connection region of the at least one second medical clip of the second type (Weisshaupt et al. FIG. 6: 196 and 198 overlap each other in the center of the clip).
Regarding claim 10, Gomez et al. as modified by Weisshaupt et al. further discloses a second biasing element is configured in the form of a second coil spring with at least one complete winding (Weisshaupt et al. FIG. 6: 186 is a coil spring with a complete rotation).
Regarding claim 11, Gomez et al. as modified by Weisshaupt et al. further discloses:
b) the at least one second medical clip of the second type defines a second clip plane (Weisshaupt et al. FIG. 6: 180 defines a clip plane by 182 and 184), wherein a second coil spring defines a second coil spring longitudinal axis (Weisshaupt et al. FIG. 6: 186 defines a longitudinal axis going through the intersection of 196 and 198), wherein the second coil spring longitudinal axis extends perpendicularly to a second coil spring plane (Weisshaupt et al. FIG. 6: the longitudinal axis through 196 and 198 goes through both the plane of 182 and 184, and a plane defined by the angle of 186), and wherein the second coil spring plane is inclined relative to the second clip plane by a second angle of inclination (Weisshaupt et al. FIG. 6: the plane defined by the original 186 is at a slightly negative angle of inclination compared to the plane defined by 182 and 184).
Regarding claim 12, Gomez et al. as modified by Weisshaupt et al. further discloses:
b) the second coil spring is wound counterclockwise (Weisshaupt et al. FIG. 6: 186 has a counterclockwise rotation from 192 to 194) and wherein the second angle of inclination has a negative value (Weisshaupt et al. FIG. 6: the plane defined by the original 186 is at a slightly negative angle of inclination compared to the plane defined by 182 and 184).
Regarding claim 13, claim 12 presented alternative options a) and b), and claim 13 is dependent on claim 12. Since alternative option b) was selected in the rejection, and claim 13 only modifies alternative option a), claim 13 does not need to be addressed by further prior art discussion.
Regarding claim 14, Gomez et al. as modified by Weisshaupt et al. further discloses the at least one second application instrument is configured corresponding to the second medical clip of the second type with a second coil spring wound counter-clockwise (Weisshaupt et al. FIGs. 1 and 6: the clip applier 12 corresponds to the counter-clockwise clip 180).
Regarding claim 15, Gomez et al. as modified by Weisshaupt et al. further discloses:
b) the second angle of inclination has a value in a range between 0 degrees and about – 40 degrees (Weisshaupt et al. FIG. 6: the plane defined by 186 has a barely negative angle compared to the plane defined by 182 and 184).
Regarding claim 20, Gomez et al. as modified by Weisshaupt et al. further discloses the at least one second medical clip of the second type are configured in the form of aneurysm clips (Weisshaupt et al. [0033] 180 are aneurysm clips).
Regarding claim 21, Gomez et al. discloses a surgical system (claim 1) comprising a plurality of clip appliers (claims 7-8: the system can include a plurality of surgical instruments, where the plurality of surgical instruments can include clip appliers). Gomez et al. does not disclose the claimed limitations of the application instruments and medical clips.
Shellenberger ‘041 teaches in the same field of endeavor of systems for applying surgical clips (Abstract) and discloses an application system for medical clips (100; FIGs. 1-9; C5:L1-L25), comprising:
at least one application instrument (102; FIG. 2) for applying a type of medical clip and at least one medical clip (50; FIG. 4) of that type, wherein the application instrument comprises two tool elements (110, 112) that are movable relative to one another (FIGs. 6-7: 110 and 112 are actuated to open or close the jaws),
wherein the at least one medical clip of that type has a proximal end region (56) and two connecting portions (FIG. 4: sections of 52 and 54 that are distally adjacent to 56 and that are in contact with 126 and 136), which distally adjoin the proximal end region defining a volume region (FIG. 4: 56 defines a volume) and connect the proximal end region to two clamping arms (52, 54) of the at least one medical clip of that type that are movable relative to each other (FIG. 4: 56 is the hinge connecting 52 to 54),
wherein the two tool elements comprise between them an end region receptacle (distal ends of 122 and 132; FIG. 2) that is open in the distal direction for accommodating the proximal end region in a positive-locking manner (FIG. 4: 122 and 132 both face distally and positive-lock 50 in place) and each tool element comprises a connecting portion receptacle (FIG. 2: proximal ends of 122 and 132) for at least partially accommodating a respective accommodation portion of the connecting portions (FIG. 4: the proximal ends of 122 and 132 hold their respective accommodation portions of 56), and
wherein at least one distinguishing element (126, 136) is formed on at least one of the two tool elements (FIG. 2: 126 and 136 are part of 110 and 112) in such a way that the at least one distinguishing element engages into a volume region (FIG. 3: 126 and 136 extend into different volumes within 122 and 132 than established by 50) and wherein the first proximal end region comprises a first biasing element (Shellenberger ‘041 56; C6:L25-27 and C6:L45-47; FIG. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted one of the application systems of Gomez et al. for the application system of Shellenberger ‘041 because both application systems are disclosed as equivalent structures for deploying a medical clip from an application instrument to secure tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
Shellenberger ‘527 teaches in the same field of endeavor of systems for applying surgical clips (Abstract) and discloses an application system (FIG. 10) comprising:
at least one application instrument (700; FIG. 10; [0045]) for applying a type of medical clip and at least one medical clip (200) of that type, wherein the application instrument comprises two tool elements (702, 704) that are movable relative to one another ([0047] 702 and 704 may move towards each other to close on 200, or move away from each other to release 200),
wherein the at least one medical clip of that type has a proximal end region (FIG. 10: 200 has a proximal region at the hinge between 202 and 204) and two connecting portions (FIG. 10: sections which connect the hinge to 202 and 204, respectively), which distally adjoin the proximal end region defining a volume region (FIG. 10) and connect the proximal end region to two clamping arms (202, 204) of the at least one medical clip of the type that are movable relative to each other ([0047] 202 and 204 move towards each other when pushed by 702 and 704, respectively),
wherein the two tool elements comprise between them an end region receptacle (720, 724) that is open in the distal direction for accommodating the proximal end region in a positive-locking manner (FIG. 10: 762 and 764 are fit within 720 and 724, respectively, to positive-lock 200 in place) and each tool element comprises a connecting portion receptacle (708) for at least partially accommodating a respective accommodation portion of the connecting portions (FIG. 10: 708 accommodates the accommodation portions of 202 and 204), and
wherein at least one distinguishing element (710, formed of 762 and 764) is formed on at least one of the two tool elements (FIG. 10: 762 and 764 are formed on 702 and 704, respectively) in such a way that the at least one distinguishing element engages into a volume region (FIG. 10: 762 and 764 protrude into the area of the proximal end of the clip).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further substituted one of the application systems of Gomez et al. for the application system of Shellenberger ‘527 because both application systems are disclosed as equivalent structures for deploying a medical clip from an application instrument to secure tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
The application system of Shellenberger ‘041 (henceforth the first application system) has the at least one first distinguishing element arranged in the bottom left and the top right of the first end region receptacle when viewed from a distal position facing the first application instrument (FIG. 3), and the application system of Shellenberger ‘527 (henceforth the second application system) has the at least one second distinguishing element arranged in the bottom right and the top left of the second end region receptacle when viewed from the same perspective. Therefore, the at least one first distinguishing element engages into the second volume region (defined by the second type of medical clip in Shellenberger ‘527) and the at least one second distinguishing element engages into the first volume region (defined by the first type of medical clip in Shellenberger ‘041).
Shellenberger ‘527 does not disclose the second proximal end region comprises a second biasing element.
Weisshaupt et al. teaches in the same field of endeavor of medical clips (Abstract), and discloses a medical clip (180; FIG. 6; [0080]) that has a proximal end region (186) and two connecting portions (192, 194), which distally adjoin the proximal end region defining a volume region (FIG. 6: 186 defines a volume) and connect the proximal end region to two clamping arms (182, 184) of the at least one medical clip of the type that are movable relative to each other ([0080] 182 and 184 are shown midway between the rest position and the application position, and are movable to either position by moving toward or away from each other, respectively), where the proximal end region comprises a biasing element (186; [0081]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have further substituted the medical clip of Shellenberger ‘527 (V-shaped hinge) for the medical clip of Weisshaupt et al. (spring coil) because both medical clips are disclosed as equivalent structures for securing tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
Furthermore, the first medical clip of Shellenberger ‘041 defines a first clip plane (Shellenberger ‘041 FIG. 3: the horizontal plane of the clip) where the first proximal end region is asymmetrical with respect to the first clip plane (Shellenberger ‘041 FIG. 2: the stabilizing members 126 and 136 mean that when the clip is loaded, the clip is not symmetric to the horizontal plane of the clip), the second medical clip of Shellenberger ‘527 defines a second clip plane (Shellenberger ‘527 FIG. 10: the horizontal plane of the clip) where the second proximal end region is asymmetrical with respect to the second clip plane (Shellenberger ‘527 FIG. 10: the stabilizing members 762 and 764 mean that when the clip is loaded, the clip is not symmetric to the horizontal plane of the clip), and wherein the first proximal end region and the second proximal end region do not coincide when the first medical clip of Shellenberger ‘041 and the second medical clip of Shellenberger ‘527 are aligned such that the first clip plane defines the second clip plane (Shellenberger ‘041 FIG. 3 and Shellenberger ‘527 FIG. 10: since the stabilizing members 126 and 762 are on opposite sides of the clip when facing the front of the appliers, and the stabilizing members 136 and 764 are also on opposite sides, the proximal end regions will not coincide while the two clip planes are both the horizontal planes).
Regarding claim 22, Gomez et al. discloses a surgical system (claim 1) comprising a plurality of clip appliers (claims 7-8: the system can include a plurality of surgical instruments, where the plurality of surgical instruments can include clip appliers). Gomez et al. does not disclose the claimed limitations of the application instruments and medical clips.
Shellenberger ‘041 teaches in the same field of endeavor of systems for applying surgical clips (Abstract) and discloses an application system for medical clips (100; FIGs. 1-9; C5:L1-L25), comprising:
at least one application instrument (102; FIG. 2) for applying a type of medical clip and at least one medical clip (50; FIG. 4) of that type, wherein the application instrument comprises two tool elements (110, 112) that are movable relative to one another (FIGs. 6-7: 110 and 112 are actuated to open or close the jaws),
wherein the at least one medical clip of that type has a proximal end region (56) and two connecting portions (FIG. 4: sections of 52 and 54 that are distally adjacent to 56 and that are in contact with 126 and 136), which distally adjoin the proximal end region defining a volume region (FIG. 4: 56 defines a volume) and connect the proximal end region to two clamping arms (52, 54) of the at least one medical clip of that type that are movable relative to each other (FIG. 4: 56 is the hinge connecting 52 to 54),
wherein the two tool elements comprise between them an end region receptacle (distal ends of 122 and 132; FIG. 2) that is open in the distal direction for accommodating the proximal end region in a positive-locking manner (FIG. 4: 122 and 132 both face distally and positive-lock 50 in place) and each tool element comprises a connecting portion receptacle (FIG. 2: proximal ends of 122 and 132) for at least partially accommodating a respective accommodation portion of the connecting portions (FIG. 4: the proximal ends of 122 and 132 hold their respective accommodation portions of 56), and
wherein at least one distinguishing element (126, 136) is formed on at least one of the two tool elements (FIG. 2: 126 and 136 are part of 110 and 112) in such a way that the at least one distinguishing element engages into a volume region (FIG. 3: 126 and 136 extend into different volumes within 122 and 132 than established by 50) and wherein the first proximal end region comprises a first biasing element (Shellenberger ‘041 56; C6:L25-27 and C6:L45-47; FIG. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted one of the application systems of Gomez et al. for the application system of Shellenberger ‘041 because both application systems are disclosed as equivalent structures for deploying a medical clip from an application instrument to secure tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
Shellenberger ‘527 teaches in the same field of endeavor of systems for applying surgical clips (Abstract) and discloses an application system (FIG. 10) comprising:
at least one application instrument (700; FIG. 10; [0045]) for applying a type of medical clip and at least one medical clip (200) of that type, wherein the application instrument comprises two tool elements (702, 704) that are movable relative to one another ([0047] 702 and 704 may move towards each other to close on 200, or move away from each other to release 200),
wherein the at least one medical clip of that type has a proximal end region (FIG. 10: 200 has a proximal region at the hinge between 202 and 204) and two connecting portions (FIG. 10: sections which connect the hinge to 202 and 204, respectively), which distally adjoin the proximal end region defining a volume region (FIG. 10) and connect the proximal end region to two clamping arms (202, 204) of the at least one medical clip of the type that are movable relative to each other ([0047] 202 and 204 move towards each other when pushed by 702 and 704, respectively),
wherein the two tool elements comprise between them an end region receptacle (720, 724) that is open in the distal direction for accommodating the proximal end region in a positive-locking manner (FIG. 10: 762 and 764 are fit within 720 and 724, respectively, to positive-lock 200 in place) and each tool element comprises a connecting portion receptacle (708) for at least partially accommodating a respective accommodation portion of the connecting portions (FIG. 10: 708 accommodates the accommodation portions of 202 and 204), and
wherein at least one distinguishing element (710, formed of 762 and 764) is formed on at least one of the two tool elements (FIG. 10: 762 and 764 are formed on 702 and 704, respectively) in such a way that the at least one distinguishing element engages into a volume region (FIG. 10: 762 and 764 protrude into the area of the proximal end of the clip).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further substituted one of the application systems of Gomez et al. for the application system of Shellenberger ‘527 because both application systems are disclosed as equivalent structures for deploying a medical clip from an application instrument to secure tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
The application system of Shellenberger ‘041 (henceforth the first application system) has the at least one first distinguishing element arranged in the bottom left and the top right of the first end region receptacle when viewed from a distal position facing the first application instrument (FIG. 3), and the application system of Shellenberger ‘527 (henceforth the second application system) has the at least one second distinguishing element arranged in the bottom right and the top left of the second end region receptacle when viewed from the same perspective. Therefore, the at least one first distinguishing element engages into the second volume region (defined by the second type of medical clip in Shellenberger ‘527) and the at least one second distinguishing element engages into the first volume region (defined by the first type of medical clip in Shellenberger ‘041).
None of the three references discloses the at least one first medical clip of the first type defines a first clip plane, wherein the first coil spring defines a first coil spring longitudinal axis, wherein the first coil spring longitudinal axis extends perpendicularly to a first coil spring plane, and wherein the first coil spring plane is inclined relative to the first clip plane by a first angle of inclination and wherein the at least one second medical clip of the second type defines a second clip plane, wherein the second coil spring defines a second coil spring longitudinal axis, wherein the second coil spring longitudinal axis extends perpendicularly to a second coil spring plane, and wherein the second coil spring plane is inclined relative to the second clip plane by a second angle of inclination.
Weisshaupt et al. teaches in the same field of endeavor of medical clips (Abstract), and discloses a medical clip (180; FIG. 6; [0080]) that has a proximal end region (186) and two connecting portions (192, 194), which distally adjoin the proximal end region defining a volume region (FIG. 6: 186 defines a volume) and connect the proximal end region to two clamping arms (182, 184) of the at least one medical clip of the type that are movable relative to each other ([0080] 182 and 184 are shown midway between the rest position and the application position, and are movable to either position by moving toward or away from each other, respectively), where the one medical clip defines a clip plane (Weisshaupt et al. FIG. 6: 180 defines a clip plane by 182 and 184), wherein a coil spring defines a coil spring longitudinal axis (Weisshaupt et al. FIG. 6: 186 defines a longitudinal axis going through the intersection of 196 and 198), wherein the coil spring longitudinal axis extends perpendicularly to a coil spring plane (Weisshaupt et al. FIG. 6: the longitudinal axis through 196 and 198 goes through both the plane of 182 and 184, and a plane defined by the angle of 186), and wherein the coil spring plane is inclined relative to the clip plane by an angle of inclination (Weisshaupt et al. FIG. 6: the plane defined by the original 186 is at a slightly negative angle of inclination compared to the plane defined by 182 and 184).. It would have been obvious to one of ordinary skill in the art before the effective filing date to have further substituted the medical clips of Shellenberger ‘041 (V-shaped hinge) and Shellenberger ‘527 (V-shaped hinge) for the medical clip of Weisshaupt et al. (spring coil) because all three medical clips are disclosed as equivalent structures for securing tissue, and the substitution of one for the other would have had the predictable result of allowing for securing tissue with a medical clip.
Furthermore, the first medical clip of Shellenberger ‘041 defines a first clip plane (Shellenberger ‘041 FIG. 3: the horizontal plane of the clip) where the first proximal end region is asymmetrical with respect to the first clip plane (Shellenberger ‘041 FIG. 2: the stabilizing members 126 and 136 mean that when the clip is loaded, the clip is not symmetric to the horizontal plane of the clip), the second medical clip of Shellenberger ‘527 defines a second clip plane (Shellenberger ‘527 FIG. 10: the horizontal plane of the clip) where the second proximal end region is asymmetrical with respect to the second clip plane (Shellenberger ‘527 FIG. 10: the stabilizing members 762 and 764 mean that when the clip is loaded, the clip is not symmetric to the horizontal plane of the clip), and wherein the first proximal end region and the second proximal end region do not coincide when the first medical clip of Shellenberger ‘041 and the second medical clip of Shellenberger ‘527 are aligned such that the first clip plane defines the second clip plane (Shellenberger ‘041 FIG. 3 and Shellenberger ‘527 FIG. 10: since the stabilizing members 126 and 762 are on opposite sides of the clip when facing the front of the appliers, and the stabilizing members 136 and 764 are also on opposite sides, the proximal end regions will not coincide while the two clip planes are both the horizontal planes).
Conclusion
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.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
