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 .
Claim Rejections - 35 USC § 103
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 1-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (USPGPub 2018/0256396) in view of Bourne et al. (USPGPub 2015/0157501) above, and further in view of Banko (USPGPub 2014/0276369). It is noted here that Yan et al. has a Chinese publication dated 02/10/2016 that comprises the same disclosure as USPGPub 2018/0256369. For ease of communication, examiner will rely on the USPGPub.
Re Claim 1, Yan teaches an ophthalmic device (Yan Figs. 1 and 2) comprising: a horn (201), an inner needle tube (60) having an inner wall and an outer wall (Yan Fig. 3; ¶ 0034), and an outer needle sleeve (70) (Yan ¶ 0031), wherein the inner needle tube (60) extends through a bore of the outer needle sleeve (70) (as seen in Yan Fig. 3), wherein an interior bore of the inner needle tube (60) is part of an aspiration line (Yan ¶ 0033), and a gap between an inner wall of the outer needle sleeve (70) and the outer wall of the inner needle tube (60) (as seen in a distal end near the side port 71 of Yan Fig. 3). However, Yan fails to teach wherein the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube is part of an irrigation line, and wherein the aspiration line and the irrigation line are in fluid communication with each other at distal ends of the aspiration line and the irrigation line relative to the housing.
Bourne teaches an ultrasonic aspiration and irrigation integrated device (600) (Bourne Fig. 6) comprising an inner needle tube (610) and an outer needle sleeve (615), wherein a gap (617-1) between the inner wall of the outer needle sleeve (615) and the outer wall of the inner needle tube (610) is part of an irrigation line (Bourne ¶ 0047), and wherein the aspiration line and the irrigation line are in fluid communication with each other at distal ends of the aspiration line and the irrigation line relative to the housing (615) (Bourne ¶ 0046-0048; Annotated Fig. 6 below - wherein fluid exiting irrigation line can be aspirated through aspiration line), wherein the irrigating fluid aids in aspirating emulsified tissue away from the anterior capsule of the eye and also aids in maintaining a constant pressure within the anterior capsule of the eye.
It well-known in the art of phacoemulsification that irrigating fluid will prevent the vibrating needle from overheating during a phacoemulsification procedure (Bourne ¶ 0001-0006) and that said irrigation fluid aids in maintaining a constant pressure within the anterior chamber of the eye, thus preventing collapse of the anterior chamber during an ocular medical procedure (Bourne ¶ 0005). In addition, it is noted here that Yan teaches a gap “between the outer sheath inner wall and the inner needle 60 outer wall,” and that modifying this gap to carry irrigation fluid based on the teachings of Bourne is well within the ordinary skill of the art (Yan ¶ 0033). Furthermore, by modifying this gap to carry irrigating fluid such that it is an irrigation line, the aspiration line and the irrigation line would be in fluid communication with each other at a common port (port 71 of Yan, Fig. 3) at distal ends of the aspiration line and the irrigation line relative to the housing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inner needle tube and the outer needle sleeve of Yan wherein the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube is part of an irrigation line, and wherein the aspiration line and the irrigation line are in fluid communication with each other at a common port at distal ends of the aspiration line and the irrigation line relative to the housing, wherein such teachings by Bourne are such that the irrigating fluid aids in aspirating emulsified tissue away from the anterior capsule of the eye and also aids in maintaining a constant pressure within the anterior capsule of the eye. Furthermore, it is also well-known in the art of phacoemulsification that irrigating fluid will prevent the vibrating needle from overheating during a phacoemulsification procedure (Bourne ¶ 0001-0006) and aid in maintaining a constant pressure within the anterior chamber of the eye, thus preventing collapse of the anterior chamber during an ocular medical procedure (Bourne ¶ 0005).
Yan in view of Bourne fail to teach a housing, the horn placed inside the housing, the outer needle sleeve extending from a distal end of the housing. Banko teaches an ultrasonic aspiration and irrigation integrated device (as seen in Banko Fig. 1) comprising a housing (108), a horn (104), and a working tip (130) comprised of an aspiration line (132) and an irrigation line (134), wherein the horn (104) is placed inside the housing (108) and the working tip (130) extends from a distal end of the housing (108), the housing for protecting the horn and for receiving irrigation fluid from an irrigation connector and for expelling aspiration fluid through an aspiration connector (Banko ¶ 0042-0043). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the ophthalmic device of Yan in view of Bourne include a housing, wherein the horn is placed inside the housing and the outer needle sleeve extends from a distal end of the housing, just such an embodiment as disclosed by Banko for protecting the horn and for receiving irrigation fluid from an irrigation connector and for expelling aspiration fluid through an aspiration connector (Banko ¶ 0042-0043).
Yan in view of Bourne also fail to each an irrigation sleeve coupled to the housing, both the inner needle tube and the outer needle sleeve extend through the irrigation sleeve, wherein the outer needle sleeve includes an irrigation side port through the outer needle sleeve, the irrigation side port located inside the irrigation sleeve. Banko teaches an irrigation sleeve (154) coupled to the housing (108) (Banko ¶ 0043), both the aspiration line (132) and the irrigation line (134) extend through the irrigation sleeve (154) (Banko Fig. 1 - proximal end of irrigation line 134), wherein the irrigation line (134) includes an irrigation side port (as seen in Fig. 1) through the irrigation line (134), the irrigation side port located inside the irrigation sleeve (154), the irrigation sleeve (154) for creating a fluid tight seal with the housing (Banko ¶ 0043). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the ultrasonic aspiration and irrigation device of Yan in view of Bourne to include an irrigation sleeve coupled to the housing, both the inner needle tube and the outer needle sleeve extend through the irrigation sleeve, wherein the outer needle sleeve includes an irrigation side port through the outer needle sleeve, the irrigation side port located inside the irrigation sleeve, a similar embodiment as disclosed by Banko wherein the irrigation sleeve (154) for creating a fluid tight seal with the housing (Banko ¶ 0043).
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Re Claim 2, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 1. Yan fails to teach wherein the irrigation line includes an irrigation connector and an irrigation tube arranged on the housing, and wherein the irrigation tube is configured as a tube attached to the housing or a channel placed in the housing. Bourne teaches wherein the irrigation line includes an irrigation connector (614) and an irrigation tube (130) arranged on the housing (615) (Bourne Figs. 2 and 6; ¶ 0028, 0047), and wherein the irrigation tube (130) is configured as a tube attached to the housing and a channel placed in the housing, the configuration for connecting and disconnecting the ultrasonic aspiration and irrigation integrated device from an irrigation source (Bourne Figs. 2 and 6; ¶ 0028, 0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the irrigation line of Yan in view of Bourne above, and further in view of Banko to include an irrigation connector and an irrigation tube arranged on the housing, and wherein the irrigation tube is configured as a tube attached to the housing or a channel placed in the housing as disclosed by Bourne, the configuration for connecting and disconnecting the ultrasonic aspiration and irrigation integrated device from an irrigation source (Bourne Figs. 2 and 6; ¶ 0028, 0047).
Re Claim 3, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 1. Yan teaches wherein the outer needle sleeve (70) comprises a closed flat distal end surface (72) (Yan Figs. 2 and 3; ¶ 0028 - wherein the figures show a flat surface and Yan encourages non-sharp smooth surfaces), wherein an aspiration side port (71) of the outer needle sleeve (70) is located near an end of the outer needle sleeve (70) (Yan Fig. 3; ¶ 0027). In the modified device of Yan in view of Bourne above, and further in view of Banko, the irrigation side port and the aspiration side port of the outer needle sleeve would be located on opposite ends of the outer needle sleeve. Furthermore, in the modified device of Yan in view of Bourne above, and further in view of Banko, the common part would be at the aspiration sideport (71) (Yan Fig. 1).
Re Claim 4, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 3. Yan teaches wherein a distal end surface of the inner needle tube (60) and an inner wall of the closed flat distal end surface (72) of the outer needle sleeve (70) are separated by a space (71-1) (as seen below in Yan Annotated Fig. 3), and wherein the space is in fluid communication with the aspiration side port (71) (as seen in Yan Fig. 3).
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Re Claim 5, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 1. Yan teaches wherein a proximal end of the inner needle tube (60) is provided with a connecting body (50), and wherein the inner needle tube (60) is fixed to the horn (201) by the connecting body (50) (Yan Fig. 1; ¶ 0033).
Re Claim 6, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 5. Yan further teaches wherein the connecting body (50) comprises a cone- shaped proximal segment (53) with a split (54), a middle segment (52) with an external thread structure (Yan 1 0032), and a distal segment (51) for applying a locking force (Yan ¶ 0031); wherein an outer diameter of the middle segment (52) is greater than a maximum outer diameter of the cone-shaped proximal segment (53) (as seen in Yan Figs. 2 and 4), and wherein the horn (201) has an internal thread that matches the external thread on the middle segment (52) (Yan ¶ 0032); wherein an interior of the connecting body (50) comprises a center bore (55), wherein the central bore (55) comprises a first diameter area (diameter area of counter bore 8 as seen in Yan Fig. 4) and a second diameter area (diameter area of center bore 8 as seen in Yan Fig. 4), the first diameter area being larger than the second diameter area; wherein the second diameter area is located in an interior of a cone-shaped proximal segment (53) and of the middle segment (52) (as seen in Yan Fig. 2), and has a diameter that is similar to an outer diameter of the inner needle tube (60) (as seen in Yan Fig. 4); and wherein the first diameter area is located in an interior of the distal segment (51) and has a diameter that is greater than an outer diameter of the outer needle sleeve (70) (as seen in Yan Fig. 4).
Re Claim 7, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 6. Yan teaches wherein the first diameter area has a step surface, and a proximal end of the outer needle sleeve (70) is inserted against the step surface (Yan Fig. 4; ¶ 0031).
Re Claim 8, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 1. Yan fails to teach wherein at a distal end of the irrigation sleeve is a needle sleeve holding hole, and wherein an internal diameter of the needle sleeve holding hole under natural condition is less than an outer diameter of the outer needle sleeve. Bourne teaches an irrigation sleeve (proximal end of irrigation sleeve 615 with threading) made using silicon or nitrile rubber (Bourne ¶ 0080), the sleeve being soft to prevent damage to the eye during an ophthalmic procedure. Banko teaches the irrigation sleeve (154) attached at the distal end of the housing (108) (as seen in Banko Fig. 1), wherein at a distal end of the irrigation sleeve (154) is a needle sleeve holding hole, and wherein an internal diameter of the needle sleeve holding hole under natural condition is less than an outer diameter of the working tip (130) for forming a fluid tight seal at the distal end of the housing (108) (Banko ¶ 0043). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the irrigation sleeve of Yan in view of Bourne above, and further in view of Banko such that at a distal end of the irrigation sleeve is a needle sleeve holding hole, and wherein an internal diameter of the needle sleeve holding hole under natural condition is less than an outer diameter of the outer needle sleeve for forming a fluid tight seal at the distal end of the housing (108) (Banko ¶ 0043).
Re Claim 9, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 8. Yan fails to teach a threaded connection between the irrigation sleeve and the housing. Banko teaches a threaded connection between the irrigation shoulder sleeve (154) and the housing (108) for forming a fluid tight seal at the distal end of the housing (108) (Banko ¶ 0043). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the irrigation sleeve of Yan in view of Bourne above, and further than Banko comprise a threaded connection to the housing as disclosed by Banko for forming a fluid tight seal at the distal end of the housing (108) (Banko ¶ 0043).
Re Claim 10, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 8. Yan fails to teach wherein the irrigation sleeve and the housing are attached together to form a sealed irrigation space; the irrigation space forming a part of the irrigation line; the irrigation space at one side is connected through the irrigation side port to the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube, at the other side is connected to the irrigation connector and the irrigation tube on the housing.
Banko teaches wherein the irrigation sleeve (154) and the housing (108) are attached together to form a sealed irrigation space (158) (Banko ¶ 0043); the irrigation space (158) forming a part of the irrigation line for preventing leaking of irrigation fluid from the housing (as seen in Banko Fig. 1; ¶ 0043). Bourne teaches wherein the irrigation space (617) at one side is connected through the irrigation side port (618) to the gap between the inner wall of the outer needle sleeve (615) and the outer wall of the inner needle tube (610), at the other side is connected to the irrigation connector (614) and the irrigation tube (130) on the housing (665), the configuration for providing a fluid path from a proximal end of the housing to the irrigation side port (Bourne ¶ 0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the ultrasonic aspiration and irrigation integrated device of Yan in view of Bourne above, and further in view of Banko wherein the irrigation sleeve and the housing are attached together to form a sealed irrigation space; the irrigation space forming a part of the irrigation line; the irrigation space at one side is connected through the irrigation side port to the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube, at the other side is connected to the irrigation connector and the irrigation tube on the housing as disclosed by Bourne and Banko for preventing leaking of irrigation fluid from the housing (as seen in Banko Fig. 1; ¶ 0043) and for providing a fluid path from a proximal end of the housing to the irrigation side port (Bourne ¶ 0047).
Re Claim 11, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 10. Yan fails to teach wherein the irrigation side port is located within the irrigation space. However, in the modified Claim 1 ultrasonic aspiration and irrigation integrated device of Yan in view of Bourne above, and further in view of Banko, the irrigation side port would be located within the irrigation space.
Re Claim 12, Yan teaches an ophthalmic device (Yan Figs. 1 and 2) comprising: a horn (201), an inner needle tube (60) (Yan Fig. 3; ¶ 0034) and an outer needle sleeve (70) (Yan ¶ 0031), wherein the inner needle tube (60) is received inside of the outer needle sleeve (70) and extends through an interior of the outer needle sleeve (70) (Yan Figs. 1-3); wherein a proximal end of the inner needle tube (60) is fixed at a distal end of the horn (201) by a connecting body (50) (Yan ¶ 0033); wherein the ophthalmic device comprises an aspiration line (Yan ¶ 0033); wherein the aspiration line comprises an interior bore of the inner needle tube (60), a central bore (55) of the connecting body (50), an inner bore of the horn (202) and the aspiration connector (as seen in Yan Figs. 1-4; ¶ 0032-0033), and wherein an outermost distal end of the inner needle tube (60) and an inner wall of a closed distal end of the outer needle sleeve (70) are separated by a space (71-1) (as seen above in Yan Annotated Fig. 3), and wherein the space is in fluid communication with an aspiration side port (71) of the outer needle sleeve (70) (as seen in Yan Fig. 3).
Yan fails to teach wherein the ultrasonic aspiration and irrigation integrated device comprises an irrigation line, wherein the irrigation line comprising a gap between an inner wall of the outer needle sleeve and an outer wall of the inner needle tube, and wherein a junction area is formed at the gap by the aspiration line and the irrigation line at the distal end. Bourne teaches an ultrasonic aspiration and irrigation integrated device (600) (Bourne Fig. 6) comprising an irrigation line, the irrigation line comprising a gap (617-1) between an inner wall of the outer needle sleeve (615-1) and an outer wall of the inner needle tube (610) (as seen in Bourne Annotated Fig. 6 above), and wherein a junction area is formed at the gap (617-1) by the aspiration line and the irrigation line at the distal end (as seen in Bourne Annotated Fig. 6 above; ¶ 0046-0048), wherein the irrigating fluid aids in aspirating emulsified tissue away from the anterior capsule of the eye and also aids in maintaining a constant pressure within the anterior capsule of the eye. It is also well-known in the art of phacoemulsification that irrigating fluid will prevent the vibrating needle from overheating during a phacoemulsification procedure (Bourne ¶ 0001-0006).
It is well-known in the art of phacoemulsification that irrigating fluid will prevent the vibrating needle from overheating during a phacoemulsification procedure (Bourne ¶ 0001-0006) and that said irrigation fluid aids in maintaining a constant pressure within the anterior chamber of the eye, thus preventing collapse of the anterior chamber during an ocular medical procedure (Bourne ¶ 0005). In addition, it is noted here that Yan teaches a gap “between the outer sheath inner wall and the inner needle 60 outer wall” (Yan ¶ 0033). Modifying this gap to carry irrigation fluid based on the teachings of Bourne is well within the ordinary skill of the art. Furthermore, by modifying this gap to carry irrigating fluid such that it is an irrigation line, the aspiration line and the irrigation line would be in fluid communication with each other at the aspiration side port (port 71 of Yan, Fig. 3) at distal ends of the aspiration line and the irrigation line relative to the housing. Finally, the limitation “to induce cavitation” is a functional limitation and a product of the structure of Yan in view of Bourne. MPEP 2173.05(g).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inner needle tube and the outer needle sleeve of Yan to comprise an irrigation line, wherein the irrigation line comprising a gap between an inner wall of the outer needle sleeve and an outer wall of the inner needle tube, and wherein a junction area is formed at the gap by the aspiration line and the irrigation line at the distal end, wherein the irrigating fluid aids in aspirating emulsified tissue away from the anterior capsule of the eye and also aids in maintaining a constant pressure within the anterior capsule of the eye.
Yan also fails to teach a housing, the horn placed inside the housing, an irrigation sleeve coupled to the housing, wherein the housing and the irrigation sleeve cooperate to define a sealed irrigation space, an inner needle tube and an outer needle sleeve extending from a distal end of the housing through the irrigation sleeve wherein a proximal end of the outer needle sleeve is attached at the distal end of the housing by the irrigation sleeve; an irrigation side port in a proximal end of the outer sleeve proximate to the housing that opens into the sealed irrigation space, the sealed irrigation space between the irrigation sleeve and the housing, an irrigation connector, and an irrigation tube.
Banko teaches an ultrasonic aspiration and irrigation integrated device (as seen in Banko Fig. 1) comprising a housing (108), a horn (104) placed inside the housing (108) (Banko Fig. 1), an irrigation sleeve (154) coupled to the housing (108), wherein the housing (108) and the irrigation sleeve (154) cooperate to define a sealed irrigation space (158), an aspiration line (132) and an irrigation line (134) extending from a distal end of the housing (108) through the irrigation sleeve (154) wherein a proximal end of the irrigation line (134) is attached at the distal end of the housing by the irrigation sleeve (154) (as seen in Banko Fig. 1); an irrigation side port (as seen in Fig. 1 - proximal end of irrigation line 134) in a proximal end of the irrigation line (134) proximate to the housing (108) that opens into the sealed irrigation space (158) (Banko ¶ 0043), the sealed irrigation space (158) between the irrigation sleeve (154) and the housing (108), an irrigation connector (connector for tube 164), and an irrigation tube (164) (Banko Fig. 1), the housing for protecting the horn and for receiving irrigation fluid from an irrigation connector and for expelling aspiration fluid through an aspiration connector (Banko ¶ 0042-0043) and the irrigation sleeve (154) for creating a fluid tight seal with the housing (Banko ¶ 0043).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the ophthalmic device of Yan in view of Bourne include a housing, wherein the horn is placed inside the housing, wherein the housing and the irrigation sleeve cooperate to define a sealed irrigation space, an inner needle tube and an outer needle sleeve extending from a distal end of the housing through the irrigation sleeve wherein a proximal end of the outer needle sleeve is attached at the distal end of the housing by the irrigation sleeve; an irrigation side port in a proximal end of the outer sleeve proximate to the housing that opens into the sealed irrigation space, the sealed irrigation space between the irrigation sleeve and the housing, an irrigation connector, and an irrigation tube, the configuration as disclosed by Banko wherein the housing protects the horn and for receives irrigation fluid from an irrigation connector and expels aspiration fluid through an aspiration connector (Banko ¶ 0042-0043) whereas the irrigation sleeve (154) creates a fluid tight seal with the housing (Banko ¶ 0043).
Re Claim 13, Yan in view of Bourne and Banko teach all of the limitations of Claim 12. Yan further teaches a loose fit is provided between the proximal end of the outer needle sleeve (70) and the connecting body (50) (Yan ¶ 0032-0033; Fig. 4).
Re Claim 14, Yan in view of Bourne and Banko teach all of the limitations of Claim 12. Yan further teaches wherein the outer needle sleeve (70) comprises an aspiration side port (71) in a distal end opening of the inner needle tube (60) (as seen in Yan Fig. 3), (as seen in Yan Fig. 3). In the modified device of Yan in view of Bourne and Banko, the outer needle sleeve comprises the aspiration side port and the irrigation side port arranged at both ends, respectively, of the outer needle sleeve, and wherein the aspiration side port (71) would be the opening into the aspiration line and the irrigation line (Yan Annotated Fig. 3).
Re Claim 15, Yan in view of Bourne and Banko teach all of the limitations of Claim 12. Yan teaches wherein the outer needle sleeve (70) comprises a closed flat end surface (72) located at the distal end (Yan Figs. 2 and 3; ¶ 0028 - wherein the figures show a flat surface and Yan encourages non-sharp smooth surfaces).
Re Claim 16, Yan in view of Bourne and Banko teach all of the limitations of Claim 14. Yan fails to teach wherein the irrigation sleeve is threaded with the housing. Banko teaches wherein the irrigation sleeve (154) is threaded with the housing (108) for forming a fluid tight seal at the distal end of the housing (108) (Banko ¶ 0043). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the irrigation sleeve of Yan in view of Bourne above, and further than Banko comprise a threaded connection with the housing as disclosed by Banko for forming a fluid tight seal at the distal end of the housing (Banko ¶ 0043).
Re Claim 17, Yan in view of Bourne and Banko teach all of the limitations of Claim 12. Yan further teaches wherein the connecting body (50) comprises a cone-shaped proximal segment (53) with a split (54), a middle segment (52) with an external threaded structure (Yan ¶ 0032), a distal segment (51) for applying a locking force (Yan ¶ 0030), wherein the outer diameter of the middle segment (52) is greater than a maximum outer diameter of the cone shaped proximal segment (53) (as seen in Yan Figs. 2 and 4), wherein the horn (201) has an internal thread that matches the external threaded structure of the middle segment (52) (Yan ¶ 0030 and 0032), wherein an interior of the connecting body (50) comprises a central bore (55) comprising a first diameter area (diameter area of counter bore 8 as seen in Yan Fig. 4) and a second diameter area (diameter area of center bore 8 as seen in Yan Fig. 4), the first diameter area being larger than the second diameter area (as seen in Yan Fig. 4), wherein the second diameter area is located at an interior of the cone-shaped proximal segment (53) and the middle segment (52) and has a diameter that is comparable to the outer diameter of the inner needle tube (60) (Yan Figs. 3-4), wherein the first diameter area is located in the interior of the distal segment (51) and its diameter is greater than an outer diameter of the outer needle sleeve (70) (Yan Figs. 3-4), wherein the first diameter area has a step surface and a proximal end of the outer needle sleeve (70) is inserted against the step surface (Yan Fig. 4; ¶ 0031).
Re Claim 18, Yan in view of Bourne and Banko teach all of the limitations of Claim 17. Yan further teaches wherein the proximal end of the inner needle tube (60) is flush or protruded with the proximal end of the cone-shaped section (53) such that the protruding length does not exceed one eighth of the wavelength of the ultrasonic operating frequency of the instrument (Yan Figs. 1-3).
Re Claim 20, Yan teaches an ultrasonic device (Yan Figs. 1-3), comprising: a horn (201); a needle sleeve (70) having an internal bore (as seen in Yan Fig. 3); a needle tube (60) received in the internal bore of the needle sleeve (70), the needle tube (60) including an opening at an outermost distal end of the needle tube (60) and an internal lumen in communication with the opening (Yan ¶ 0033); a gap between an outer wall of the needle tube (60) and an internal wall of the needle sleeve (70), the gap extending along a length of the needle tube (60) and a length of the needle sleeve (70) (as seen in a distal end near the side port 71 of Yan Fig. 3); and a space (71-1) between the outermost distal end of the needle tube (60) and an inner wall of a closed distal end of the needle sleeve (70), and the opening and internal lumen of the needle tube (60) are part of an aspiration line of the ultrasonic device (Yan ¶ 0033).
However, Yan fails to disclose wherein the wherein the gap is part of an irrigation line of the ultrasonic device, and wherein the irrigation line and the aspiration line are in fluid communication with each other at distal ends of the aspiration line and the irrigation line through the gap and the space. Bourne teaches an ultrasonic aspiration and irrigation integrated device (600) (Bourne Fig. 6) comprising an inner needle tube (610) and an outer needle sleeve (615), wherein a gap (617-1) between the inner wall of the outer needle sleeve (615) and the outer wall of the inner needle tube (610) is part of an irrigation line (Bourne ¶ 0047), and wherein the aspiration line and the irrigation line are in fluid communication with each other at distal ends of the aspiration line and the irrigation line through the gap (Bourne ¶ 0046-0048; Annotated Fig. 6 above - wherein fluid exiting irrigation line can be aspirated through aspiration line), wherein the irrigating fluid aids in aspirating emulsified tissue away from the anterior capsule of the eye and also aids in maintaining a constant pressure within the anterior capsule of the eye.
It is well-known in the art of phacoemulsification that irrigating fluid will prevent the vibrating needle from overheating during a phacoemulsification procedure (Bourne ¶ 0001-0006) and that said irrigation fluid aids in maintaining a constant pressure within the anterior chamber of the eye, thus preventing collapse of the anterior chamber during an ocular medical procedure (Bourne ¶ 0005). In addition, it is noted here that Yan teaches a gap “between the outer sheath inner wall and the inner needle 60 outer wall” (Yan ¶ 0033). Modifying this gap to carry irrigation fluid based on the teachings of Bourne is well within the ordinary skill of the art. Furthermore, by modifying this gap to carry irrigating fluid such that it is an irrigation line, the aspiration line and the irrigation line would be in fluid communication with each other at a common port, the aspiration side port (port 71 of Yan, Fig. 3) at distal ends of the aspiration line and the irrigation line relative to the housing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inner needle tube and the outer needle sleeve of Yan wherein the wherein the gap is part of an irrigation line of the ultrasonic device, and wherein the irrigation line and the aspiration line are in fluid communication with each other at distal ends of the aspiration line and the irrigation line through the gap, as disclosed by Bourne, wherein the irrigating fluid aids in aspirating emulsified tissue away from the anterior capsule of the eye and also aids in maintaining a constant pressure within the anterior capsule of the eye. It is also well-known in the art of phacoemulsification that irrigating fluid will prevent the vibrating needle from overheating during a phacoemulsification procedure (Bourne ¶ 0001-0006).
Yan also fails to teach a housing, the horn placed inside the housing, an irrigation sleeve coupled to the housing; a sealed irrigation space between the irrigation sleeve and the housing the needle sleeve extending from irrigation sleeve; wherein the irrigation line includes an irrigation side port in the needle sleeve that is in fluid communication with the sealed irrigation space. Banko teaches an ultrasonic aspiration and irrigation integrated device (as seen in Banko Fig. 1) comprising a housing (108), a horn (104) placed inside the housing (108), an irrigation sleeve (154) coupled to the housing (108) (Banko Fig. 1); a sealed irrigation space (158) between the irrigation sleeve (154) and the housing (108), an aspiration line (132) extending from irrigation sleeve (154) (as seen in Banko Fig. 1); wherein the irrigation line (134) includes an irrigation side port (proximal end of irrigation line 134) in the needle sleeve (154) that is in fluid communication with the sealed irrigation space (158) (Banko Fig. 1), the housing for protecting the horn and for receiving irrigation fluid from an irrigation connector and for expelling aspiration fluid through an aspiration connector (Banko ¶ 0042-0043) and the irrigation sleeve (154) for creating a fluid tight seal with the housing (Banko ¶ 0043).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the ophthalmic device of Yan in view of Bourne include a housing, the horn placed inside the housing, an irrigation sleeve coupled to the housing; a sealed irrigation space between the irrigation sleeve and the housing the needle sleeve extending from irrigation sleeve; wherein the irrigation line includes an irrigation side port in the needle sleeve that is in fluid communication with the sealed irrigation space, the configuration as disclosed by Banko wherein the housing for protects the horn and for receives irrigation fluid from an irrigation connector and expels aspiration fluid through an aspiration connector (Banko ¶ 0042-0043) whereas the irrigation sleeve (154) creates a fluid tight seal with the housing (Banko ¶ 0043).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (USPGPub 2018/0256396) in view of Bourne et al. (USPGPub 2015/0157501) above, and further in view of Banko (USPGPub 2014/0276369) as applied to Claim 17 above, and further in view of Pond (USPGPub 2007/0244425).
Re Claim 19, Yan in view of Bourne above, and further in view of Banko teach all of the limitations of Claim 17. Yan in view of Bourne and Banko fail to teach wherein the proximal end of the inner needle tube is attached through adhesive to the central bore of the cone-shaped proximal segment of the connecting body. Pond teaches an ultrasonic aspiration and irrigation integrated device comprising a connecting body and an inner needle tube (32), wherein the proximal end of the inner needle tube (32) is attached through adhesive to the central bore of the cone-shaped proximal segment of the connecting body for securely adhering the inner needle tube to the connecting member (Pond ¶ 0026; as seen in Pond Fig. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the connecting member of Yan in view of Bourne above and further in view of Banko comprise an adhesive wherein the proximal end of the inner needle tube is attached through the adhesive to the central bore of the cone-shaped proximal segment of the connecting body as disclosed by Pond for securely adhering the inner needle tube to the connecting member (Pond ¶ 0026; as seen in Pond Fig. 2).
Response to Arguments
Applicant's arguments filed 06/13/2026 have been fully considered but they are not persuasive. In the last paragraph of Page 9 of the response, applicant argues ports 618 are not part of the outer needle sleeve. However, as can be clearly seen in Fig. 6 of Bourne, the ports 618 are within an outer needle sleeve. In the first full paragraph of Page 10, applicant argues the prior art fails to teach an irrigation sideport. However, examiner relies upon prior art Banko to teach said limitation. Banko is not relied upon to teach an outer sleeve.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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