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 .
Formal Matters
Applicant’s Response and Amendments filed 11/7/2025 is acknowledged. Claims 3, 7, 10, 12, 16, 19, 21-23, 25, 27-34, 37-44, and 45-59 are cancelled. New claims 60-62 are added. Claims 1, 24, 26, 36, and 45 are currently amended. Claims 1, 2, 4-6, 8, 9, 11, 13-15, 17, 18, 20, 24, 26, 35, 36, 45, and 60-62 are pending and under examination.
Objections Withdrawn
The objections to the drawings is withdrawn in light of Applicant’s amendments.
The objection to the disclosure is withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments are drawn to the claim amendments, some of which are derived from now cancelled claim 23. Applicant’s arguments have been fully considered, but they are not persuasive in light of the modified rejections, necessitated by amendment, as set forth below. Additionally, new claim rejections are set forth below, drawn to new claims 60-62 and also in light of amendments to the claims necessitating the new claim rejections.
Modified and New Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-6, 8, 9, 11, 13-15, 17, 18, 20, 24, 26, 36, 45, and 60-62 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al., US 20090259260 (15 October 2009) in view of Goldberg et al., US 20160235440 (18 August 2018) (both previously cited of record).
Regarding amended claim 1, Bentley teaches a device for meniscal repair (FIGs 48A-48E) comprising:
a handle (FIGs 48A-C, handle 460) comprising an axial bore (FIG 48D, cavity 477) extending between a first inlet (FIG 48D) and an outlet (FIG 48C), and a first attachment portion (FIG 48D, pin 484);
a cannula (sheath 480) coupled to the outlet, wherein the cannula comprises a through bore cooperative with the axial bore of the handle (FIGs 48B, 48C; ¶¶209, 213),
wherein a portion of the axial bore at the first inlet of the handle is sized and shaped to form a socket, wherein the socket provides access to the axial bore of the handle and the through bore of the cannula (¶¶180, 183).
Bentley does not teach that the proximal end of the cannula is angled at an angle selectable from multiple angles between 0° and 90°.
Bentley does not expressly teach a fluid injection member for injecting a fluid, wherein the fluid injection member comprises a third projection sized and shaped to be received within the socket of the handle, a needle extending from a distal end to a proximal end of the fluid injection member, a second inlet providing a fluid passageway extending between the second inlet to a proximal end of the needle, the proximal end of the needle is flexible and flexes to the angle of the proximal end of the cannula and wherein, in use, the fluid is a biological agent or an adhesive or a local anaesthetic or an adjuvant agent used for meniscal repair.
Goldberg teaches cannulas (FIG 1, cannula 18) coupled to outlets (FIG 6, ports 22A-D) wherein the cannula (18) comprises a through bore (interior lumen 11A) cooperative with the axial bore of the handle (handle 21, pushrod 20; ¶¶25, 85) and a proximal end of the cannula that is angled at an angle selectable from multiple angles between 0° and 90° (FIG 6, supply ports 22A-22D, ¶89).
Goldberg teaches a fluid injection member (10) for injecting a fluid (¶¶88-89), wherein the fluid injection member comprises a third projection sized and shaped to be received within the socket of the handle (FIGs 4-5B, 21; delivery ports 22, ¶88), a needle extending from a distal end to a proximal end of the fluid injection member (FIGs 4, 22; 16, ¶88), a second inlet (interior lumen 11B) providing a fluid passageway extending between the second inlet to a proximal end of the needle (¶89), the proximal end of the needle is flexible and flexes to the angle of the proximal end of the cannula (“second end 17B terminates with a tissue piercing tip and aperture 16”, ¶¶84, 89; FIGs 2, 6) and wherein, in use, the fluid is a biological agent or an adhesive or a local anaesthetic or an adjuvant agent used for meniscal repair (biological glue, adhesive, glue, fibrin/thrombin, ¶89).
Bentley and Goldberg teach surgical fixation systems comprising cannulas. Although Bentley teaches the claimed base device comprising a cannula, handle, axial bore, handle socket, and lumen, Bentley does not teach that the proximal end of the cannula is angled at an angle selectable from multiple angles between 0° and 90° and Bentley does not teach a fluid injection member for injecting a fluid, wherein the fluid injection member comprises a third projection sized and shaped to be received within the socket of the handle, a needle extending from a distal end to a proximal end of the fluid injection member, a second inlet providing a fluid passageway extending between the second inlet to a proximal end of the needle, the proximal end of the needle is flexible and flexes to the angle of the proximal end of the cannula and wherein, in use, the fluid is a biological agent or an adhesive or a local anesthetic or an adjuvant agent used for meniscal repair.
Goldberg specifically addresses selectable cannula angles and fluid injection members comprising multiple projections, inlets, and outlets. Because Bentley includes a delivery apparatus 400 with a delivery apparatus body 460 typically secured to one or more shafts 461 with each shaft defining a lumen 464 and or slot (¶180) as well as a displacement (push) rod 463 that may be axially slidable along at least a portion of the lumen (¶180) and is configured to provide a user with a structure to manipulate the distal portion of the shaft 461 within a patient (¶183), a person of ordinary skill in the art, seeking better control of the handle, delivery device, or the fixation device, would reasonably consult Goldberg’s multiple selectable cannula angle solution. Goldberg’s selectable cannula angle solution can be incorporated alongside Bentley’s delivery apparatus and delivery body (same general location and interaction with the displacement (push) rod) using known assembly methods without redesigning Bentley’s core device and delivery path.
Because the references address the same engineering problem (device assemblies for the delivery of surgical fixation components) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a selectable cannula component that permits a range of cannula angles and fluid injection components for biological agents or adhesives (broadly interpreted as a fixation component), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Bentley modified by Goldberg teaches the device for meniscal repair of claim 1, as set forth above.
Bentley teaches the device further comprising a deployment member (FIGs 48A, C, D; actuator 462), wherein the deployment member comprises a first projection sized and shaped to be received within the socket of the handle (FIGs 48A, C, D; ¶180), an injector assembly (displacement rods 463, shaft 461) configured to incrementally advance through the through bore of the cannula from a distal end to the proximal end of the cannula (¶¶180, 181), wherein the injector assembly comprises one or more anchors (¶181, two or more anchors 451), wherein the anchors are urged through the through bore in a predefined sequence to the proximal end, and a user operable actuator coupled to the injector assembly, wherein the user operable actuator provides an axial driving force to actuate the injector assembly (FIGs 48B, 48C; ¶¶ 183, 190, 193).
Regarding claim 4, Bentley modified by Goldberg teaches the device for meniscal repair of claim 2, as set forth above.
Bentley teaches wherein the incremental advancement of the injector assembly through the through bore of the cannula provides a deployment of an anchor of the one or more anchors from the proximal end of the cannula (¶180).
Regarding claim 5, Bentley modified by Goldberg teaches the device for meniscal repair of claim 2, as set forth above. Bentley teaches wherein the actuation of the user operable actuator to incrementally advance the injector assembly through the through bore of the cannula provides a tactile and audible indication of a deployment of the corresponding anchor of the one or more anchors (¶¶133, 216).
Regarding claim 6, Bentley modified by Goldberg teaches the device for meniscal repair of claim 2, as set forth above.
Bentley teaches wherein the deployment member further comprises a deployment needle sized and shaped to be received within the through bore of the cannula (¶130 hollow needle or cannula 711; ¶134, pointed needles or cannulas 711; ¶170, 171 slotted needle cannula/needle hypotube 428).
Goldberg teaches wherein the deployment needle comprises a flexible end which flexes to the angle of the proximal end of the cannula (“second end 17B terminates with a tissue piercing tip and aperture 16”, ¶¶84, 89; FIGs 2, 6).
Bentley teaches whereby the deployment needle deploys the anchor of the one or more anchors at the proximal end of the cannula (FIGs 11-13; ¶130, T-anchor; ¶134 anchors 709 (or barbs); ¶171 T-anchor 316).
Regarding claim 8, Bentley modified by Goldberg teaches the device for meniscal repair of claim 2, as set forth above, wherein one of the handle or the deployment member further comprises an indicating means to provide a visual indication of a deployment of the corresponding anchor (¶104, visualization of the procedure; ¶105, endoscope guidance; FIG 21, ¶165, marking 538 on the delivery tool; ¶¶166, 167 visual indication).
Regarding claim 9, Bentley modified by Goldberg teaches the device for meniscal repair of claims 2, as set forth above.
Bentley teaches wherein the deployment member (FIG 48D, actuator 462) further comprises a second attachment portion (groove 485) co-operable with the first attachment portion (guide/pin 484) to form an attachment mechanism to effect securement of the deployment member to the handle (FIG 48D; ¶¶194, 216, 217), and wherein one of the handle or the deployment member comprises a user operable release for the attachment mechanism (¶218).
Regarding claim 11, Bentley modified by Goldberg teaches the device for meniscal repair of claims 9, as set forth above.
Bentley teaches wherein at least one of the first (guide/pin 484) or second attachment (groove 485) portions comprises a biasing means (FIG 48D; ¶216, spring 496) which biases the first or second attachment portions into a capture position with respect to the other attachment portion (¶216), and wherein the user operable release acts against the biasing means, thereby releasing one of the first or second attachment portions from the capture position (¶218).
Regarding claim 13, Bentley modified by Goldberg teaches the device for meniscal repair of claim 1, as set forth above.
Bentley teaches the device further comprising a cutter member (¶170 suture cutting blade assembly 420), wherein the cutter member comprises a second projection sized and shaped to be received within the socket of the handle (FIGs 40, 43; ¶130), a pusher assembly configured to incrementally advance a cutting needle through the through bore of the cannula from a distal end to the proximal end of the cannula (¶175, spring 316; ¶¶131-133 ejection rod 715), wherein a cutting edge of the cutting needle is urged through the through bore in a predefined sequence to the proximal end (¶218), a user operable actuator (462) coupled to the pusher assembly (715), wherein the user operable actuator provides an axial driving force to actuate the pusher assembly (715, ¶132).
Goldberg teaches wherein the needle comprises a flexible end which flexes to the angle of the proximal end of the cannula (“second end 17B terminates with a tissue piercing tip and aperture 16”, ¶¶84, 89; FIGs 2, 6).
Regarding claim 14, Bentley modified by Goldberg teaches the device for meniscal repair of claim 13, as set forth above.
Bentley teaches wherein the incremental advancement of the pusher assembly (715) through the through bore of the cannula progressively protrudes the cutting edge of the cutting needle through the proximal end of the cannula (¶133, distance and manner advanced regulated by feel or by architecture of the device).
Goldberg teaches wherein the needle comprises a flexible end (“second end 17B terminates with a tissue piercing tip and aperture 16”, ¶¶84, 89; FIGs 2, 6).
Regarding claim 15, Bentley modified by Goldberg teaches the device for meniscal repair of claim 13, as set forth above.
Bentley teaches wherein the actuation of the user operable actuator (462) to incrementally advance the pusher assembly (715) through the through bore of the cannula provides a tactile and audible indication of the advancement of the cutting needle through the through bore of the cannula (¶133, distance and manner advanced regulated by feel or by architecture of the device).
Regarding claim 17, Bentley modified by Goldberg teaches the device for meniscal repair of claim 13, as set forth above.
Bentley teaches wherein one of the handle (460) or the cutter member (420) further comprises an indicating means to provide a visual indication of the incremental advancement of the cutting edge through the through bore of the cannula (¶166, “It may also be advantageous for the delivery tool 500 to have a perceptible (i.e., audible, tactile, visual) indication that the treatment device has been fully deployed”).
Regarding claim 18, Bentley modified by Goldberg teaches the device for meniscal repair of claim 13, as set forth above.
Bentley teaches wherein the cutter member (¶170 suture cutting blade assembly 420) further comprises a third attachment portion (FIG 48D, extending portions 485b) co-operable with the first attachment portion (guide/pin 484) to form an attachment mechanism to effect securement of the cutter member to the handle (¶216, flange; ¶217 extending portions), and wherein one of the handle or the cutter member comprises a user operable release for the attachment mechanism (¶218).
Regarding claim 20, Bentley modified by Goldberg teaches the device for meniscal repair of claim 17, as set forth above.
Bentley teaches wherein at least one of the first (guide/pin 484) or third attachment portions (FIG 48D, extending portions 485b) comprises a biasing means which biases the first or third attachment portions into a capture position with respect to the other attachment portion (FIG 48D; ¶216, spring 496), and wherein the user operable release acts against the biasing means, thereby releasing one of the first or third attachment portions from the capture position (¶¶216-218).
Regarding claim 24, Bentley modified by Goldberg teaches the device for meniscal repair of claim 1, as set forth above.
Goldberg teaches wherein the second inlet is sized and shaped to receive the fluid to be injected through the fluid passageway, whereby the fluid is expelled at the proximal end of the needle (¶89, “the liquid or gel can be delivered through the supply port 22 or directly to and through the elongate cannula 18 and can exit the interior lumen 11B of the elongate cannula 18 through the one or more delivery ports 28 (shown in FIGS. 4-5B) and the tissue piercing tip and aperture 1”).
Regarding claim 26, Bentley modified by Goldberg teaches the device for meniscal repair of claim 1, as set forth above.
Goldberg teaches wherein the fluid injection member (10) further comprises a fourth attachment portion (FIGs 1, 2; ¶89, pushrod 20).
Bentley teaches displacement rod 463, ¶194 (comparable to Goldberg’s pushrod 20) that is co-operable with the first attachment portion (FIG 48D, guide/pin 484; ¶¶194, 216) to form an attachment mechanism (FIG 48D, guide 484) to effect securement of the fluid injection member (Goldberg: 10, FIG 20A) to the handle (Bentley: FIG 48D; Goldberg 21), and wherein one of the handle or the fluid injection member comprises a user operable release for the attachment mechanism (Bentley: the pulling of finger grip 404, ¶¶167, 169).
Regarding independent claim 36, Bentley teaches a device for meniscal repair (FIGs 48A-48E) comprising:
a handle (FIGs 48A, C, D, handle 460) comprising an axial bore (FIG 48D, cavity 477) extending between a first inlet (FIG 48D) and an outlet (FIG 48C), and a first attachment portion (FIG 48D, guide/pin 484);
a cannula (711) coupled to the outlet, wherein the cannula comprises a through bore cooperative with the axial bore of the handle (FIGs 48B, C; ¶¶209, 213),
wherein a portion of the axial bore at the first inlet of the handle is sized and shaped to form a socket, wherein the socket provides access to the axial bore of the handle and the through bore of the cannula (¶¶180, 183), and a deployment member (FIGs 48A, C, D, actuator 462), comprising a first projection sized and shaped to be received within the socket of the handle (FIGs 48A, C, D; ¶180), a deployment needle sized and shaped to be received within the through bore comprising a flexible end which flexes to the angle of the proximal end (¶130 hollow needle or cannula 711; ¶134, pointed needles or cannulas 711; ¶170, 171 slotted needle cannula/needle hypotube 428),
an injector assembly configured to incrementally advance through the through bore of the cannula from a distal end to the proximal end (displacement rods 463, shaft 461), a user operable actuator coupled to the injector assembly (FIGs 48A, C, D, actuator 462), wherein the user operable actuator provides an axial driving force to actuate the injector assembly (FIGs 48B, C; ¶¶ 183, 190, 193), and a second attachment portion (groove 485) co-operable with the first attachment portion (guide/pin 484) to form an attachment mechanism to effect securement of the deployment member to the handle (FIG 48D; ¶¶194, 216, 217).
Bentley does not teach that the proximal end of the cannula is at an angle between 0° and 90°.
Goldberg teaches cannulas (FIG 1, cannula 18) coupled to outlets (FIG 6, ports 22A-D) wherein the cannula (18) comprises a through bore (interior lumen 11A) cooperative with the axial bore of the handle (handle 21, pushrod 20; ¶¶25, 85) and a proximal end of the cannula that is angled at an angle selectable from multiple angles between 0° and 90° (FIG 6, supply ports 22A-22D, ¶89).
Bentley and Goldberg teach surgical fixation systems comprising cannulas. Although Bentley teaches the claimed base device comprising a cannula, handle, axial bore, handle socket, and lumen, Bentley does not teach that the proximal end of the cannula is angled at an angle selectable from multiple angles between 0° and 90°. Goldberg specifically addresses selectable cannula angles and fluid injection members comprising multiple projections, inlets, and outlets. Because Bentley includes a delivery apparatus 400 with a delivery apparatus body 460 typically secured to one or more shafts 461 with each shaft defining a lumen 464 and or slot (¶180) as well as a displacement (push) rod 463 that may be axially slidable along at least a portion of the lumen (¶180) and is configured to provide a user with a structure to manipulate the distal portion of the shaft 461 within a patient (¶183), a person of ordinary skill in the art, seeking better control of the handle, delivery device, or the fixation device, would reasonably consult Goldberg’s multiple selectable cannula angle solution. Goldberg’s selectable cannula angle solution can be incorporated alongside Bentley’s delivery apparatus and delivery body (same general location and interaction with the displacement (push) rod) using known assembly methods without redesigning Bentley’s core device and delivery path. Because the references address the same engineering problem (device assemblies for the delivery of surgical fixation components) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a selectable cannula component that permits a range of cannula angles and fluid injection components for biological agents or adhesives (broadly interpreted as a fixation component), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding independent claim 45, Bentley teaches a device for meniscal repair (FIGs 48A-48E) comprising:
a handle (FIGs 48A, C, D, handle 460) comprising an axial bore (FIG 48D, cavity 477) extending between a first inlet (FIG 48D) and an outlet (FIG 48C), and a first attachment portion (FIG 48D, guide/pin 484);
a cannula (711) coupled to the outlet, wherein the cannula comprises a through bore cooperative with the axial bore of the handle (FIGs 48B, C; ¶¶209, 213),
wherein a portion of the axial bore at the first inlet of the handle is sized and shaped to form a socket, wherein the socket provides access to the axial bore of the handle and the through bore of the cannula (¶¶180, 183); and
a cutter member (¶170 suture cutting blade assembly 420), wherein the cutter member comprises a second projection sized and shaped to be received within the socket of the handle (FIGs 40, 43; ¶130), a pusher assembly (715) configured to incrementally advance a cutting needle through the through bore of the cannula from a distal end to the proximal end of the cannula (¶175, spring 316; ¶¶131-133), wherein a cutting edge of the cutting needle is urged through the through bore in a predefined sequence to the proximal end (¶218), a user operable actuator (FIGs 48A, C, D, actuator 462) coupled to the pusher assembly (715), wherein the user operable actuator (FIGs 48A, C, D, actuator 462) provides an axial driving force to actuate the pusher assembly (¶215), and a third attachment portion (FIG 48D, extending portions 485b) co-operable with the first attachment portion (guide/pin 484) to form an attachment mechanism to effect securement of the cutter member to the handle (¶¶216-218).
Bentley does not teach that the proximal end of the cannula is at an angle between 0° and 90° or wherein the cutting needle comprises a flexible end which flexes to the angle of the proximal end.
Goldberg teaches cannulas (FIG 1, cannula 18) coupled to outlets (FIG 6, ports 22A-D) wherein the cannula (18) comprises a through bore (interior lumen 11A) cooperative with the axial bore of the handle (handle 21, pushrod 20; ¶¶25, 85) and a proximal end of the cannula that is angled at an angle selectable from multiple angles between 0° and 90° (FIG 6, supply ports 22A-22D, ¶89). Goldberg also teaches that “second end 17B terminates with a tissue piercing tip and aperture 16”(¶¶84, 89; FIGs 2, 6).
Bentley and Goldberg teach surgical fixation systems comprising cannulas. Although Bentley teaches the claimed base device comprising a cannula, handle, axial bore, handle socket, and lumen, Bentley does not teach that the proximal end of the cannula is angled at an angle selectable from multiple angles between 0° and 90°. Goldberg specifically addresses selectable cannula angles and fluid injection members comprising multiple projections, inlets, and outlets. Because Bentley includes a delivery apparatus 400 with a delivery apparatus body 460 typically secured to one or more shafts 461 with each shaft defining a lumen 464 and or slot (¶180) as well as a displacement (push) rod 463 that may be axially slidable along at least a portion of the lumen (¶180) and is configured to provide a user with a structure to manipulate the distal portion of the shaft 461 within a patient (¶183), a person of ordinary skill in the art, seeking better control of the handle, delivery device, or the fixation device, would reasonably consult Goldberg’s multiple selectable cannula angle solution. Goldberg’s selectable cannula angle solution can be incorporated alongside Bentley’s delivery apparatus and delivery body (same general location and interaction with the displacement (push) rod) using known assembly methods without redesigning Bentley’s core device and delivery path. Because the references address the same engineering problem (device assemblies for the delivery of surgical fixation components) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a selectable cannula component that permits a range of cannula angles and fluid injection components for biological agents or adhesives (broadly interpreted as a fixation component), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding new claim 60, Bentley modified by Goldberg teaches the device for meniscal repair of claim 26, as set forth above.
Bentley teaches wherein the first (FIG 48D, guide 484; ¶¶194, 216) or fourth attachment (Bentley: displacement rod 463, ¶194; Goldberg: FIGs 1, 2; ¶89, pushrod 20) portions comprises a biasing means (FIG 48D; ¶216, spring 496, guide/pin 484) which biases the first or fourth attachment portions into a capture position (within groove 485) with respect to the other attachment portion (¶¶216, 217).
Regarding new claim 61, Bentley modified by Goldberg teaches the device for meniscal repair of claim 60, as set forth above.
Bentley teaches wherein the user operable release (the pulling of finger grip 404, ¶¶167, 169) acts against the biasing means, thereby releasing one of the first or fourth portions from the capture position (¶¶167, 169).
Regarding new claim 62, Bentley modified by Goldberg teaches the device for meniscal repair of claim 1, as set forth above.
Bentley teaches wherein the needle is sized and shaped to be received within the through bore of the cannula (¶130).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al., US 20090259260 (15 October 2009), in view of Goldberg et al., US 20160235440 (18 August 2018), and further in view of Langley et al., US 20180021517 (25 January 2018) (all previously cited of record).
Regarding claim 35, Bentley modified by Goldberg teaches the device for meniscal repair of claim 1, as set forth above.
Bentley modified by Goldberg does not teach wherein the cannula is manufactured of a transparent or a translucent material.
Langley teaches cannulas and insertion tubes that are transparent or have transparent portions (¶¶10-12, 40, 43, 44, 64). Optical advantages of having a transparent cannula are taught at ¶40.
Bentley, Goldberg, and Langley teach surgical fixation systems comprising cannulas. Although Bentley teaches the claimed base device comprising a cannula, handle, axial bore, handle socket, and lumen, and Goldberg specifically addresses selectable cannula angles and fluid injection members comprising multiple projections, inlets, and outlets. Neither Bentley nor Goldberg teach transparent cannulas. Langley teaches that in some cannula applications, transparency is desired, particularly in the sections around and distal from the remote center of the cannula so that when an endoscopic device is inserted through the cannula, the endoscopic device can be pulled back at least partially into the cannula thereby providing a wider field of view of the surgical or treatment site (¶38). Langley teaches optical advantages of having a transparent cannula at ¶¶40, 64.
Because the references address the same engineering problem (the use of cannulas to deliver surgical fixation devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (using a cannula or portion thereof that is transparent or made of translucent material for its optical advantages), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
New Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4-6, 8, 9, 11, 13-15, 17, 18, 20, 24, 26, 35, 45, and 60-62 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a third projection" in line 11. There is insufficient antecedent basis for this limitation in the claim. There are no first and second projections in amended independent claim 1 and no first projections in claim 45. Claims 2 and 36 recite first projections. Claims 13 and 45 recite second projections. Claims 2, 4-6, 8, 9, 11, 13-15, 17, 18, 20, 24, 26, 35, and 60-62 are rejected as being dependent on claim 1.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771