386550DETAILED 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/18/26 has been entered.
Response to Amendment
Applicant amended claims 1 and 11. Claims 1-6 and 8-17 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 10-11 of Applicant’s Remarks, filed 06/18/26, with respect to the rejections of claims 1-4 and 10 under 35 U.S.C. 103 as unpatentable over Sundt in view of Atkinson and in further view of Henry, of claim 5 in further view of Perez-Cruet, of claim 6 in further view of Al Haddad, of claim 8 in further view of Palushi, of claim 9 in further view of Salvadori, of claims 11-13 and 15-17 as unpatentable over Schultz in view of Sundt, in further view of Atkinson, and in further view of Henry, and of claim 14 in further view of Perez-Cruet have been fully considered and are persuasive in light of the amendments to independent claims 1 and 11. Accordingly, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
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.
Claims 1, 3-4, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over McKinley (US 7,226,413 B2) in view of Atkinson (US 5,599,333 A), in further view of Lopez et al. (US 2009/0105692 A1), and in further view of Henry (US 2016/0038661 A1).
Regarding claim 1, McKinley discloses a surgical device (Figs. 2a-f and 3, feat. 30; Col. 4, line 57 – Col. 6, line 16) comprising: a handle portion extending along a handle axis from a distal end to a proximal end, the handle portion having a fluid chamber that extends within an interior portion of the handle portion (Figs. 2a-b, feat. 32; Col. 3, lines 35-50; Col. 4, line 57 – Col. 5, line 13: handle portion 32 is hollow, and therefore defines a fluid chamber); a first port disposed on a first portion of the handle portion, the first port defining a first port channel that extends from an open end portion of the first port to a first portion of the fluid chamber of the handle portion such that the first port channel is in fluid communication with the fluid chamber of the handle portion, wherein the first port is configured to be coupled to a vacuum source (Figs. 2a-b, feat. 35; Col. 3, lines 35-50; Col. 4, line 57 – Col. 5, line 13), a second port disposed on a second portion of the handle portion, the second port defining a second port channel that extends from an open end portion of the second port to a second portion of the fluid chamber of the handle portion such that the second portion channel is in fluid communication with the fluid chamber of the handle portion, wherein when the second port is in a first open position, the fluid chamber of the handle portion is vented to the atmosphere, and when the second port is in a second closed position, the fluid chamber of the handle portion is not vented to the atmosphere (Figs. 2a-b, feat. 44; Col. 4, line 57 – Col. 5, line 13); a shaft extending along a shaft axis from a proximal end to a distal end, wherein one or more inner surface of the shaft defines a shaft channel that extends from a shaft channel proximal end at the proximal end of the shaft to a shaft channel distal end at the distal end of the shaft (Figs. 2a-f, feat. 36; Col. 4, line 57 – Col. 5, line 13), wherein the shaft is rotatably coupled to the handle portion (Fig. 2b and 3, feats. 36 and 56; Col. 5, line 14 – Col. 6, line 16: shaft 36/56 is coupled to handle 32/57 so that it can move relative to the handle in at least one axis, such as rotationally relative to the handle) such that the shaft channel proximal end is disposed within a third portion of the fluid chamber of the handle portion such that the shaft channel is in fluid communication with the fluid chamber of the handle portion (Col. 4, line 57 – Col. 5, line 13); and a first suction tip at the distal end of the shaft, the first suction tip having a first cross-sectional shape that is configured to engage a first type of tissue on a patient (Figs. 2a and 2c-d, feat. 42; Col. 4, lines 3-19; Col. 4, line 57 – Col. 5, line 13), wherein when the first port is coupled to the vacuum source, and when the second port is in the second closed position, the distal end of the shaft is at a low pressure via the vacuum source such that a portion of the first suction tip engages a portion of the first type of tissue of the patient and body fluid at or adjacent to the portion of the first type of tissue of the patient displaces from the shaft channel distal end through the shaft channel, into the fluid chamber, through the first port channel, and out of the open end portion of the first port, and wherein when the first port is coupled to the vacuum source, and when the second port is in the first open position, the fluid chamber is vented to the atmosphere such that the distal end of the shaft is not at the low pressure of the vacuum source, and body fluid at or adjacent to the portion of the patient is not displaced from the shaft channel distal end through the shaft channel (Col. 3, lines 35-50; Col. 4, line 57 – Col. 5, line 13).
McKinley does not disclose a third port as claimed, that the shaft is non-removably coupled to the handle portion, or that the first suction tip is removably secured to the distal end of the shaft and comprises a deformable material.
Atkinson teaches a suction adapter (Col. 2, lines 25-62) for controlling the suction applied to a fluid drainage tube (Col. 1, lines 47-57) comprising a housing (Figs. 2-5, feat. 10; Col. 2, lines 25-62) with a fluid chamber (12) in fluid communication (22, 24) with a ventilation tube (20) which terminates at the edge of the housing in a pair of opposed ventilation ports (18; Col. 2, lines 41-44). The housing further comprises a suction port connected to a vacuum source (14) and a fluid port connected to a drainage tube (16; Col. 2, lines 25-33). Atkinson teaches that the surgeon may apply suction to the drainage tube by covering both of the opposed ventilation ports with their thumb and finger, which closes the fluid chamber off from the atmosphere (Col. 3, lines 31-46). Atkinson teaches that such a configuration advantageously allows the surgeon to easily control the applied suction (Col. 1, lines 47-57). One side of the opposed ventilation port of Atkinson is analogous to the port (McKinley: Figs. 2a-b, feat. 44) of McKinley used to control the applied suction, and modifying the device to include the other side of the opposed ventilation port of Atkinson would improve the ease by which the surgeon would be able to control the suction applied by the device as taught by Atkinson. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by McKinley so that it includes a third port disposed on a third portion of the handle portion, the third port defining a third port channel that extends from an open end portion of the third port to a fifth portion of the fluid chamber of the handle portion such that the third port channel is in fluid communication with the fluid chamber of the handle portion, wherein when the third port is in a first open position, the fluid chamber of the handle portion is vented to the atmosphere, and when the third port is in a second closed position and the second port is in the second closed position, the fluid chamber of the handle portion is not vented to the atmosphere in order to allow the surgeon to more easily control the applied suction as taught by Atkinson.
McKinley in view of Atkinson does not disclose that the shaft is non-removably coupled to the handle portion or that the first suction tip is removably secured to the distal end of the shaft and comprises a deformable material.
Lopez teaches a medical connector (Figs. 1-3; ¶0041-0049) comprising a first body (1) with a semi-spherical portion held within a cavity of a base (6) such that the first body can rotate relative to the base without allowing for translational movement (¶0041), and thereby preventing the body from being removed from the base. Lopez teaches that this advantageously provides a leak tight connection without any risk of disconnection between the body and the base (¶0006-0011). Lopez teaches that this is superior to threaded connections, which incur the risk of the threads unscrewing, leading to disconnections and leaks (¶0004-0006). McKinley discloses that the connection between the shaft (McKinley: Fig. 3, feat. 56) and the handle (McKinley: 57) is secured by threads (McKinley: 58, 60; Col. 5, lines 30-40). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by McKinley in view of Atkinson so that that the shaft is non-removably coupled to the handle portion as taught by Lopez in order to provide a leak tight connection between the shaft and the handle while minimizing the risk of disconnection as taught by Lopez.
McKinley in view of Atkinson and in further view of Lopez does not disclose that the first suction tip is removably secured to the distal end of the shaft and comprises a deformable material.
Henry teaches a surgical aspiration apparatus (Figs. 2-4, feat. 100; ¶0021) comprising a rigid handle (110; ¶0021-0022) attached to a flexible tube portion (140; ¶0023-0024) with a soft tip portion (150; ¶0024-0026) releasably or removably attached to the tip of the tip of the tube portion. The flexible tube portion of Henry is a homologous structure to the shaft (McKinley: Figs. 2a-b, feat. 36) of McKinley because both the tube portion of Henry and the shaft of McKinley are attached to handle portions, and therefore the soft tip portion of Henry is analogous to the suction tip of McKinley. Henry teaches that the soft tip portion may be made of a flexible, and therefore deformable, material and advantageously provides a cushion upon contact with the patient’s tissue (¶0026). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by McKinley in view of Atkinson and in further view of Lopez so that the first suction tip is removably secured to the distal end of the shaft and comprises a deformable material in order to provide a cushion upon contact as taught by Henry.
Regarding claim 3, McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry suggests the device of claim 1, and McKinley further discloses that the open end portion of the second port is disposed along or adjacent to an outer surface of the handle portion such that the open end portion of the second port is configured to be engaged by a finger of a user holding the handle portion such that: (a) when the user places the finger completely over the open end portion of the second port, the second port is in the second closed position in which the fluid chamber of the handle portion is not vented to the atmosphere, and (b) when the user removes the finger from the open end portion of the second port, the second port is in the first open position in which the fluid chamber of the handle portion is vented to the atmosphere (Figs. 2a-b, feat. 44; Col. 4, line 57 – Col. 5, line 13). Regarding claim 4, McKinley further discloses that at least a portion of the shaft is non-linear (Figs. 2a-b, feat. 36; Col. 4, line 57 – Col. 5, line 13). Regarding claim 9, McKinley further discloses that the shaft is a molded plastic material (Col. 6, lines 24-34). Regarding claim 10, McKinley further discloses that the fluid chamber extend within the interior portion of the handle portion from a proximal end to a distal end (Figs. 2a-b, feat. 32; Col. 3, lines 35-50; Col. 4, line 57 – Col. 5, line 13: handle portion 32 is hollow, and therefore defines a fluid chamber. The handle further provides fluid communication between the shaft 36 at one end and the vacuum port 35 at the other, and therefore the fluid chamber extends between the two ends).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McKinley in view of Atkinson, in further view of Lopez, in further view of Henry, and in further view of Sundt (US 4,878,900 A).
Regarding claim 2, McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry suggests the device of claim 1. McKinley further discloses that the shaft (Fig. 3, feat. 56) comprises a spherical rotational adapter (Fig. 3, feat. 66) for inserting into the third portion of the handle (Fig. 3, feat. 57) and allowing the shaft to rotate (Col. 5, lines 40-64). As discussed above, Lopez teaches that the connector body (Lopez: Figs. 1-3, feat) comprises a semi-spherical portion (13), which is homologous to the spherical rotational adapter of McKinley, which is received in a cavity of a base (6), which is homologous to the third portion of the handle of McKinley. Lopez. Lopez further teaches that the body further comprises an insertion portion (Lopez: Figs. 1-3, feat. 14; ¶0041-0045) which inserts into a deeper portion of the base (Lopez: 18; ¶0048). Therefore, McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry further suggests a rotational adapter fixedly secured to a portion of the shaft at or adjacent to the proximal end of the shaft, the rotational adapter comprising: an insertion portion extending along the shaft axis from a proximal end of the rotational adapter to the distal end of the handle portion, the insertion portion being disposed with a fourth portion of the fluid chamber such that the insertion portion is configured to rotate relative to the handle portion within the fourth portion of the fluid chamber.
McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry does not suggest that the rotational adapter comprises an engagement portion disposed at the distal end of the insertion portion, the engagement portion having a shape of a disk, with a circumferential portion of the disk adapted to be rotated by a user to rotate the rotation adapter and the shaft about the shaft axis.
Sundt teaches a suction probe for surgery (Figs. 1-3; Col. 2, lines 7-20) comprising a handle (10) connected to a suction member (11) comprising a shaft (26; Col. 2, line 44 – Col. 3, line 17) secured in a rotational adapter (21). The rotational adapter further comprises a disk shaped knurled member (24) which the surgeon may grasp to rotate the suction member (Col. 2, line 44 – Col. 3, line 17). The disk shaped knurled member advantageously provides a positive non-slip grasping surface (Col. 2, line 44 – Col. 3, line 17). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry so that the rotational adapter comprises an engagement portion disposed at the distal end of the insertion portion, the engagement portion having a shape of a disk, with a circumferential portion of the disk adapted to be rotated by a user to rotate the rotation adapter and the shaft about the shaft axis in order to provide a positive non-slip grasping surface for the surgeon as taught by Sundt.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McKinley in view of Atkinson, in further view of Lopez, in further view of Henry, and in further view of Perez-Cruet et al. (US 2012/0078059 A1).
Regarding claim 5, McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry suggests the device of claim 4, but does not disclose the claimed shaft geometry of claim 5.
Perez-Cruet teaches a surgical suction device (Figs. 1-2, feat. 10; ¶0015) comprising a handle portion (14) and a shaft (12). The shaft comprises an offset curved section (20; ¶0015) such that the shaft comprises a first portion aligned with the longitudinal axis of the handle (14), a second portion comprising the offset curved section which has an axis that is oblique to the first portion (20), and a third portion which has an axis that is oblique to the second portion but parallel to the first portion (Fig. 2). Perez-Cruet teaches that such a configuration advantageously provides the surgeon with greater visibility of the tip (16) of the shaft (¶0015). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry so that the shaft comprises: a first shaft portion extending from the proximal end of the shaft to a first intermediate point, wherein the first shaft portion extends along a first shaft axis portion of the shaft axis; a second shaft portion extending from the first intermediate point to a second intermediate point, wherein the second shaft portion extends along a second shaft axis portion of the shaft axis, and wherein the second shaft axis portion is oblique relative to the first shaft axis portion; and a third shaft portion extending from the second intermediate point to the distal end of the shaft, wherein the third shaft portion extends along a third shaft axis portion of the shaft axis, and wherein the second shaft axis portion is oblique relative to the third shaft axis portion, and the third shaft axis portion is parallel to but radially offset from the first shaft axis portion in order to improve the visibility of the tip of the shaft for the surgeon as taught by Perez-Cruet.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McKinley in view of Atkinson, in further view of Lopez, in further view of Henry, and in further view of Al Haddad (US 2022/0249747 A1).
Regarding claim 6, McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry suggests the device of claim 1, but does not disclose that at least a portion of the handle portion is made from a deformable polymer material.
Al Haddad discloses an aspiration device (Fig. 1, feat. 110; ¶0045) comprising a handle portion (112) and a shaft (114). The handle portion comprises an ergonomic grip (224; ¶0057) which may be made of deformable polymer materials such as silicone, memory foam, or elastomeric materials in order to allow the user to hold the handle comfortably (¶0058). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry so that at least a portion of the handle portion is made from a deformable polymer material in order to allow the user to hold the handle comfortably as taught by Al Haddad.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McKinley in view of Atkinson, in further view of Lopez, in further view of Henry, and in further view of Palushi et al. (US 2019/0374688 A1).
Regarding claim 8, McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry suggests the device of claim 1. McKinley discloses shafts which are bent (Fig. 1g and 2a-b), and therefore does not disclose that the shaft axis is linear from the proximal end of the shaft to the distal end of the shaft.
Palushi teaches surgical suction devices (Figs. 1-2, feat. 60; ¶0015; Figs. 3-5, feat. 160; ¶0026) comprising a handle portion (70; ¶0016-0019; 170; ¶0026-0027) attached to a shaft (62; ¶0016-0017; 162; ¶0026-0028). Palushi teaches that the shaft may be bent (Figs. 1-2, feat. 62; ¶0016) or straight (Figs. 3-4, feat. 162; ¶0028). Palushi teaches that bent shafts may cause difficulty in clearing obstructions (¶0023-0024), and that therefore that straight, or linear, shafts may reduce the difficulty of clearing obstructions. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by McKinley in view of Atkinson, in further view of Lopez, and in further view of Henry so that the shaft axis is linear from the proximal end of the shaft to the distal end of the shaft in order to reduce the difficulty of clearing obstructions as taught by Palushi.
Claim 11-13 and 16-17 are rejected under 35 U.S.C. 102 as being unpatentable over Schultz et al. (US 7,955,318 B1) in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry.
Regarding claim 11, Schultz discloses a kit (Figs. 1, feat. 100 and 170; Col. 9, lines 12-28; Figs. 8A-B, feat. 170; Col. 15, line 42 – Col. 16, line 18; Fig. 17, feat. 400; Col. 19, lines 39-56) comprising: a surgical device (Fig. 1, feat. 121; Col. 9, lines 12-28; Col. 10, line 54 – Col. 11, line 62) comprising: a handle portion extending along a handle axis from a distal end to a proximal end, the handle portion having a fluid chamber that extends within an interior portion of the handle portion (Fig. 1, feat. 140; Col. 10, line 54 – Col. 11, line 40); a first port disposed on a first portion of the handle portion (Fig. 1, feats. 154 and 158; Col. 10, line 62 – Col. 11, line 15), the first port defining a first port channel that extends from an open end portion of the first port to a first portion of the fluid chamber of the handle portion such that the first port channel is in fluid communication with the fluid chamber of the handle portion, wherein the first port is configured to be coupled to a vacuum source (Fig. 1, feats. 109, 125, and 110’; Col. 9, lines 49-62; Col. 10, line 16 – Col. 11, line 15: first port 154 couples with conduit 125 via couplings 158 and 110’ to be put in fluid communication with vacuum supply conduit 109); a second port disposed on a second portion of the handle portion (Fig. 1, feat. 160; Col. 11, lines 16-40), the second port defining a second port channel that extends from an open end portion of the second port to a second portion of the fluid chamber of the handle portion such that the second port channel is in fluid communication with the fluid chamber of the handle portion (Col. 11, lines 16-40: aperture valve 160 extends through the outer wall of the handle 140 to the interior of the hollow tubular handle), wherein when the second port is in a first open position, the fluid chamber of the handle portion is vented to the atmosphere, and when the second port is in a second closed position, the fluid chamber of the handle portion is not vented to the atmosphere (Col. 11, lines 16-40: a user can apply a finger or thumb over aperture valve 160 to control the exposure of the interior of the handle 140 to the ambient atmosphere); a shaft extending along a shaft axis from a proximal end to a distal end (Fig. 1-2, feat. 156; Col. 10, line 62 – Col. 11, line 40), wherein one or more inner surfaces of the shaft defines a shaft channel that extends from a shaft channel proximal end at the proximal end of the shaft to a shaft channel distal end at the distal end of the shaft, such that the shaft channel proximal end is disposed within a third portion of the fluid chamber of the handle portion such that the shaft channel is in fluid communication with the fluid chamber of the handle portion (156; Col. 10, line 62 – Col. 11, line 40); a first suction tip configured to be removably secured to the distal end of the shaft, the first suction tip having a first cross-sectional shape that is configured to engage a first type of tissue on a patient (Figs. 1-2, feat. 111; Col. 11, line 63 – Col. 12, line 9; Col. 12, lines 32-42: narrow bore suction tip 111 allows suctioning of the trachea and adjacent pulmonary structures), wherein the first suction tip comprises a first deformable material (Col. 11, line 63 – Col. 12, line 9: narrow bore suction tip 111 is flexible); and a second suction tip configured to be removably secured to the distal end of the shaft, the second suction tip having a second cross-sectional shape that is configured to engage a second type of tissue on the patient (Figs. 1-2, feat. 116; Col. 11, line 63 – Col. 12, line 31: blunt tip suction tip 116 allows fine atraumatic suctioning of wide surface areas); wherein when the first port is coupled to the vacuum source, and when the second port is in the second closed position, the distal end of the shaft is at a low pressure via the vacuum source such that (a) a portion of the first suction tip engages a portion of the first type of tissue of the patient or (b) a portion of the second suction tip engages a portion of the second type of tissue of the patient, and body fluid at or adjacent to the portion of the first type of tissue or the second type of tissue of the patient displaces from the shaft channel distal end through the shaft channel (Col. 11, line 63 - Col. 12, line 42), into the fluid chamber, through the first port channel, and out of the open end portion of the first port (Col. 11, lines 16-40: a user can apply a finger or thumb over aperture valve 160 to control the exposure of the interior of the handle 140 to the ambient atmosphere), and wherein when the first port is coupled to the vacuum source, and when the second port is in the first open position, the fluid chamber is vented to the atmosphere such that the distal end of the shaft is not at the low pressure of the vacuum source, and body fluid at or adjacent to the portion of the first type of tissue of the patient is not displaced from the shaft channel distal end through the shaft channel (Col. 11, lines 16-40: a user can apply a finger or thumb over aperture valve 160 to control the exposure of the interior of the handle 140 to the ambient atmosphere).
Schultz does not disclose that the shaft is rotatably and non-removably coupled to the handle portion, that the device comprises a third port as claimed, or that the second suction tip comprises a second deformable material.
McKinley teaches a suction surgical device (Figs. 2a-f and 3, feat. 30; Col. 4, line 57 – Col. 6, line 16) comprising a handle (Figs. 2a-b, feat. 32) coupled to a rotatable shaft (Fig. 2b, feat. 3, feats. 36 and 56; Col. 5, line 14 – Col. 6, line 16) in order to allow the user to adjust the geometry and position of the shaft relative to the handle (Col. 1, lines 57-67). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device in the kit disclosed by Schultz so that the shaft is rotatably coupled to the handle portion in order to allow the user to adjust the geometry and position of the shaft relative to the handle as taught by McKinley.
Schultz in view of McKinley does not disclose that the shaft is both rotatable and non-removable, that the device comprises a third port as claimed, or that the second suction tip comprises a second deformable material.
As discussed above, Lopez teaches a medical connector (Figs. 1-3; ¶0041-0049) comprising a first body (1) with a semi-spherical portion held within a cavity of a base (6) such that the first body can rotate relative to the base without allowing for translational movement (¶0041), and thereby preventing the body from being removed from the base. Lopez teaches that this advantageously provides a leak tight connection without any risk of disconnection between the body and the base (¶0006-0011). Lopez teaches that this is superior to threaded connections, which incur the risk of the threads unscrewing, leading to disconnections and leaks (¶0004-0006). McKinley discloses that the connection between the shaft (McKinley: Fig. 3, feat. 56) and the handle (McKinley: 57) is secured by threads (McKinley: 58, 60; Col. 5, lines 30-40). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of the kit suggested by Schultz in view of McKinley so that that the shaft is both rotatably and non-removably coupled to the handle portion as taught by Lopez in order to provide a leak tight connection between the shaft and the handle while minimizing the risk of disconnection as taught by Lopez.
Schultz in view of McKinley and in further view of Lopez does not disclose a third port as claimed, or that the second suction tip comprises a second deformable material.
Atkinson teaches a suction adapter (Col. 2, lines 25-62) for controlling the suction applied to a fluid drainage tube (Col. 1, lines 47-57) comprising a housing (Figs. 2-5, feat. 10; Col. 2, lines 25-62) with a fluid chamber (12) in fluid communication (22, 24) with a ventilation tube (20) which terminates at the edge of the housing in a pair of opposed ventilation ports (18; Col. 2, lines 41-44). The housing further comprises a suction port connected to a vacuum source (14) and a fluid port connected to a drainage tube (16; Col. 2, lines 25-33). Atkinson teaches that the surgeon may apply suction to the drainage tube by covering both of the opposed ventilation ports with their thumb and finger, which closes the fluid chamber off from the atmosphere (Col. 3, lines 31-46). Atkinson teaches that such a configuration advantageously allows the surgeon to easily control the applied suction (Col. 1, lines 47-57). One side of the opposed ventilation port of Atkinson is analogous to the ports (Schultz: Fig. 1, feat. 160; McKinley: Figs. 2a-b, feat. 44) of Schultz and McKinley used to control applied suction in the device of Schultz in view of McKinley and in further view of Lopez, and modifying the device to include the other side of the opposed ventilation port of Atkinson would improve the ease by which the surgeon would be able to control the suction applied by the device as taught by Atkinson. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of the kit suggested by Schultz in view of McKinley and in further view of Lopez so that a third port disposed on a third portion of the handle portion, the third port defining a third port channel that extends from an open end portion of the third port to a fifth portion of the fluid chamber of the handle portion such that the third port channel is in fluid communication with the fluid chamber of the handle portion, wherein when the third port is in a first open position, the fluid chamber of the handle portion is vented to the atmosphere, and when the third port is in a second closed position and the second port is in the second closed position, the fluid chamber of the handle portion is not vented to the atmosphere in order to allow the surgeon to easily control the applied suction as taught by Atkinson.
Schultz in view of McKinley, in further view of Lopez, and in further view of Atkinson does not disclose that the second suction tip comprises a second deformable material.
Henry teaches a surgical aspiration apparatus (Figs. 2-4, feat. 100; ¶0021) comprising a rigid handle (110; ¶0021-0022) attached to a flexible tube portion (140; ¶0023-0024) with a soft tip portion (150; ¶0024-0026) attached to the tip of the tip of the tube portion. Henry teaches that the soft tip portion may be made of a flexible, and therefore deformable, material and advantageously provides a cushion upon contact with the patient’s tissue (¶0026). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the kit suggested by Schultz in view of McKinley, in further view of Lopez, and in further view of Atkinson so that the second suction tip comprises a second deformable material in order to provide a cushion upon contact as taught by Henry.
Regarding claim 12, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry suggests the kit of claim 11. As discussed above, in the modified kit of Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry, the second suction tip comprises the deformable material taught by Henry, while the first suction tip comprises a deformable material disclosed by Schultz. As discussed above, Henry teaches a soft tip portion made of a flexible, and therefore deformable, material that provides a cushion upon contact with the patient’s tissue (¶0026). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the kit suggested by Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry so that the first deformable material is the same as the second deformable material so that the first suction tip also provides a cushion upon contact as taught by Henry.
Regarding claim 13, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry suggests the kit of claim 11. McKinley further discloses that at least a portion of the shaft is non-linear (Figs. 2a-b, feat. 36; Col. 4, line 57 – Col. 5, line 13). Therefore, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry further discloses that at least a portion of the shaft is non-linear.
Regarding claim 16, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry suggests the device of the kit of claim 11. Schultz further discloses that the open end portion of the second port is disposed along or adjacent to an outer surface of the handle portion such that the open end portion of the second port is configured to be engaged by a finger of a user holding the handle portion (Fig. 1, feat. 160; Col. 11, lines 16-40) such that: (a) when the user places the finger completely over the open end portion of the second port, the second port is in the second closed position in which the fluid chamber of the handle portion is not vented to the atmosphere (Col. 11, lines 26-30), and (b) when the user removes the finger from the open end portion of the second port, the second port is in the first open position in which the fluid chamber of the handle portion is vented to the atmosphere (Col. 11, lines 30-40).
Regarding claim 17, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry suggests the kit of claim 11. Schultz further discloses that the kit may comprise three or more types of suction tips (Figs. 8A-B, feat. 170; Col. 15, line 42 – Col. 16, line 18; Fig. 17, feats. 101 and 400; Col. 19, lines 39-56). As discussed above, Henry teaches a soft tip portion made of a flexible, and therefore deformable, material that provides a cushion upon contact with the patient’s tissue (¶0026). Therefore, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry further discloses a third suction tip configured to be removably secured to the distal end of the shaft, the third suction tip having a third cross-sectional shape that it configured to engage a third type of tissue on the patient, wherein the third suction tip comprises a third deformable material.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, in further view of Henry, and in further view of Perez-Cruet.
Regarding claim 14, Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry suggests the kit of claim 13, but does not disclose that the shaft comprises: a first shaft portion extending from the proximal end of the shaft to a first intermediate point, wherein the first shaft portion extends along a first shaft axis portion of the shaft axis; a second shaft portion extending from the first intermediate point to a second intermediate point, wherein the second shaft portion extends along a second shaft axis portion of the shaft axis, and wherein the second shaft axis portion is oblique relative to the first shaft axis portion; and a third shaft portion extending from the second intermediate point to the distal end of the shaft, wherein the third shaft portion extends along a third shaft axis portion of the shaft axis, and wherein the second shaft axis portion is oblique relative to the third shaft axis portion, and the third shaft axis portion is parallel to but radially offset from the first shaft axis portion.
Perez-Cruet teaches a surgical suction device (Figs. 1-2, feat. 10; ¶0015) comprising a handle portion (14) and a shaft (12). The shaft comprises an offset curved section (20; ¶0015) such that the shaft comprises a first portion aligned with the longitudinal axis of the handle (14), a second portion comprising the offset curved section which has an axis that is oblique to the first portion (20), and a third portion which has an axis that is oblique to the second portion but parallel to the first portion (Fig. 2). Perez-Cruet teaches that such a configuration advantageously provides the surgeon with greater visibility of the tip (16) of the shaft (¶0015). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the kit suggested by Schultz in view of McKinley, in further view of Lopez, in further view of Atkinson, and in further view of Henry so that the shaft comprises: a first shaft portion extending from the proximal end of the shaft to a first intermediate point, wherein the first shaft portion extends along a first shaft axis portion of the shaft axis; a second shaft portion extending from the first intermediate point to a second intermediate point, wherein the second shaft portion extends along a second shaft axis portion of the shaft axis, and wherein the second shaft axis portion is oblique relative to the first shaft axis portion; and a third shaft portion extending from the second intermediate point to the distal end of the shaft, wherein the third shaft portion extends along a third shaft axis portion of the shaft axis, and wherein the second shaft axis portion is oblique relative to the third shaft axis portion, and the third shaft axis portion is parallel to but radially offset from the first shaft axis portion in order to improve the visibility of the tip of the shaft for the surgeon as taught by Perez-Cruet.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schultz in view of McKinley in further view of Lopez, in further view of Atkinson, in further view of Henry, and in further view of Sundt.
Regarding claim 15, Schultz in view of McKinley in view of Lopez, in further view of Atkinson, and in further view of Henry suggests the kit of claim 11. McKinley further teaches that the shaft (Fig. 3, feat. 56) comprises a spherical rotational adapter (Fig. 3, feat. 66) for inserting into the third portion of the handle (Fig. 3, feat. 57) and allowing the shaft to rotate (Col. 5, lines 40-64). As discussed above, Lopez teaches that the connector body (Lopez: Figs. 1-3, feat) comprises a semi-spherical portion (13), which is homologous to the spherical rotational adapter of McKinley, which is received in a cavity of a base (6), which is homologous to the third portion of the handle of McKinley. Lopez. Lopez further teaches that the body further comprises an insertion portion (Lopez: Figs. 1-3, feat. 14; ¶0041-0045) which inserts into a deeper portion of the base (Lopez: 18; ¶0048). Therefore, Schultz in view of McKinley in view of Lopez, in further view of Atkinson, and in further view of Henry further suggests a rotational adapter fixedly secured to a portion of the shaft at or adjacent to the proximal end of the shaft, the rotational adapter comprising: an insertion portion extending along the shaft axis from a proximal end of the rotational adapter to the distal end of the handle portion, the insertion portion being disposed with a fourth portion of the fluid chamber such that the insertion portion is configured to rotate relative to the handle portion within the fourth portion of the fluid chamber.
Schultz in view of McKinley in view of Lopez, in further view of Atkinson, and in further view of Henry does not suggest that the rotational adapter comprises an engagement portion disposed at the distal end of the insertion portion, the engagement portion having a shape of a disk, with a circumferential portion of the disk adapted to be rotated by a user to rotate the rotation adapter and the shaft about the shaft axis.
Sundt teaches a suction probe for surgery (Figs. 1-3; Col. 2, lines 7-20) comprising a handle (10) connected to a suction member (11) comprising a shaft (26; Col. 2, line 44 – Col. 3, line 17) secured in a rotational adapter (21). The rotational adapter further comprises a disk shaped knurled member (24) which the surgeon may grasp to rotate the suction member (Col. 2, line 44 – Col. 3, line 17). The disk shaped knurled member advantageously provides a positive non-slip grasping surface (Col. 2, line 44 – Col. 3, line 17). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device in the kit suggested by Schultz in view of McKinley in view of Lopez, in further view of Atkinson, and in further view of Henry so that the rotational adapter comprises an engagement portion disposed at the distal end of the insertion portion, the engagement portion having a shape of a disk, with a circumferential portion of the disk adapted to be rotated by a user to rotate the rotation adapter and the shaft about the shaft axis in order to provide a positive non-slip grasping surface for the surgeon as taught by Sundt.
Conclusion
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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