DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 02/19/2026 has been entered. Claims 30, 59-82 are pending in the application.
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 30, 59-62, 69-72, 74, 81-82 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 2017/0216092) in view of Badawi (US 2018/0271699) and further in view of Oberkircher (US 2015/0223977) and further in view of Utz (US 10,232,107).
Regarding claim 30, A cannulation device (400, Fig 7) for administering an active agent containing composition to an eye (Para 0045, lines 14-17) comprising: an elongated body (handle of device 400, Fig 7) with a proximal end and a distal end; a hollow needle (410, Fig 8) with a proximal end (end opposite distal tip 426, Fig 7), a distal end (426, Fig 7), and a lumen (lumen that cannula 408 extends from in Fig 8), wherein the proximal end of the needle is fixed to the distal end of the elongated body (“fixed to” is defined by Merriam-Webster as “affixed or attached to”. Therefore, the proximal end of the needle and distal end of the elongated body are at least indirectly fixed or attached to one another as they do not come apart. The claim is not narrow enough to require direct attachment of the two components) and the distal end of the needle is beveled or sharpened for scleral penetration (Para 0046; See Fig 7); a cannula (408, Fig 8) comprising an elongated, flexible tubular element with a lumen and a rounded atraumatic distal tip to be deployed through the needle (See Fig 8; Para 0047; the inner cannula 408 is blunt at the tip and at least rounded around its circumference); a pathway for transfer of liquid or semi-solid materials from the elongated body to the proximal lumen of the tubular element; and a deployment mechanism (414, Fig 7) coupled to the proximal end of the elongated tubular element (it is at least indirectly coupled) to advance the elongated tubular element through the distal end of the needle into the eye, once that the hollow needle has penetrated through the sclera of the eye (Para 0047; See Fig 8); wherein: the distal portion of the tubular element is contained in a lumen of the needle prior to deployment of the tubular element (Para 0047).
Singh is silent regarding the needle does not move relative to the elongated body; administering an active agent containing composition to the suprachoroidal space or supraciliary space of an eye and wherein: a segment of the tubular element including the distal tip and extending proximally from the distal tip is configured to be illuminated by transmitting light from a proximal portion of the tubular element to the distal tip such that light exits the segment through an outer surface of the wall and visualization of the tubular element within the suprachoroidal or supraciliary space is enabled.
Badawi teaches an analogous device for administering an active agent containing composition to an eye (Para 0002): comprising an elongate body (1004, Fig 10A), a hollow needle (1012, Fig 10A), a cannula (1022, Fig 10B), and a deployment mechanism (1014, Fig 10A); wherein the proximal end of the needle is fixed to the distal end of the elongated body and wherein the needle does not move relative to the elongated body (Para 0088-0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the deployment mechanism disclosed by Singh to comprise the pinion gear mechanism as taught by Badawi, resulting in the wherein the proximal end of the needle is fixed to the distal end of the elongated body while the cannula is slidable relative to the needle, in order to have a device that can be operated with either hand and allows for flipping the orientation to change the direction of cannulation if desired (Para 0082).
The modified invention of Singh and Badawi discloses all of the elements of the invention as discussed above, however, is silent regarding administering an active agent containing composition to the suprachoroidal space or supraciliary space of an eye and wherein: a segment of the tubular element including the distal tip and extending proximally from the distal tip is configured to be illuminated by transmitting light from a proximal portion of the tubular element to the distal tip such that light exits the segment through an outer surface of the wall and visualization of the tubular element within the suprachoroidal or supraciliary space is enabled.
Oberkircher teaches an analogous device for administering an active agent containing composition to the suprachoroidal space or supraciliary space of an eye (Para 0026; Para 0177; Para 0184).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannulation device disclosed by Singh to be sized and dimensioned to be able to access and deliver a therapeutic to the suprachoroidal space of an eye in order to treat macular degeneration or other ocular diseases (Para 0009 -Oberkircher; Singh also teaches that while the device is described in relation to retinal detachment, it can be used for other procedures to remove or deliver fluids to the eye in Para 0030).
The modified invention of Singh and Oberkircher disclose all of the elements of the invention as discussed above, however, is silent regarding a segment of the tubular element including the distal tip and extending proximally from the distal tip is configured to be illuminated by transmitting light from a proximal portion of the tubular element to the distal tip such that light exits the segment through an outer surface of the wall and visualization of the tubular element within the suprachoroidal or supraciliary space is enabled.
Utz teaches an analogous a cannula (108, Fig 1) comprising an elongated, flexible tubular element with a wall defining a lumen (304, Fig 5) wherein a segment of the tubular element including the distal tip and extending proximally from the distal tip is configured to be illuminated by transmitting light from a proximal portion (602, Fig 6) of the tubular element to the distal tip such that light exits the segment through an outer surface of the wall and visualization of the tubular element within the tissue is enabled (Col 9, lines 22-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular elements be made of a light transmitting material as taught by Utz in order to have a cannula that can be easily located and identified the cannula (Col 3, lines 52-57).
Regarding claim 59, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding the fluid pathway from the proximal end of the tubular element is connected to an injection port or Luer connector.
Singh further teaches the fluid pathway (328, Fig 6) from the proximal end of the tubular element is connected to an injection port (332, Fig 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid pathway to comprise an injection port as further taught by Singh in order to be able to connect an external fluid chamber to the device (Para 0042).
Regarding claim 60, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding the fluid pathway from the proximal end of the tubular element is connected to a reservoir in the body of the device.
Singh further teaches the fluid pathway (628, Fig 10) from the proximal end of the tubular element is connected to a reservoir (631, Fig 10) in a body (602, Fig 10) of the device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid pathway to be connected to a reservoir in the body of the device as further taught by Sing in order to have a device wherein the fluid removed can be easily identified by the user (Para 0050).
Regarding claim 61, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses the deployment mechanism (1014, Fig 10A -Badawi) additionally comprises a force element (1020, Fig 10B -Badawi) configured to apply a deployment force on the tubular element to advance the tubular element through the needle lumen (Para 0082, Para 0088 -Badawi) and an actuator (Wheels of mechanism 1014, Fig 10A -Badawi) to activate the deployment mechanism (Para 0082, Para 0088 -Badawi).
Regarding claim 62, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses a damping mechanism or frictional element (gear teeth on force element 1020, Fig 10B) to limit a speed of cannula deployment (Para 0082, Para 0088 -Badawi; the teeth only allow the cannula to be deployed at the speed that the wheels are turning).
Regarding claim 69, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses the tubular element is configured to conduct light by using the wall of the tubular element to conduct light (Col 9, lines 22-55 -Utz).
Regarding claim 70, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses the tubular element is configured for internal reflection (Col 9, lines 22-55 -Utz).
Regarding claim 71, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses the tubular element is illuminated along the entire length of the tubular element (Col 9, lines 22-55 -Utz).
Regarding claim 72, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses the light transmitted from the proximal portion of the tubular element provides illumination at the distal tip of the tubular element (Col 9, lines 22-55 -Utz).
Regarding claim 74, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses the needle (410, Fig 8 -Singh) comprises a curved distal tip (426, Fig 7 -Singh) to direct the tubular element at an angle from the long axis of the needle toward the posterior region of the eye (See Fig 8 -Singh).
Regarding claim 81, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses a material for administration in the reservoir (631, Fig 10 -Singh) wherein the material for administration is a fluid, semi-solid or dried composition for rehydration to a semi-solid (“fluid”; Para 0049 -Singh).
Regarding claim 82, the modified invention of Singh, Badawi, Oberkircher, and Utz discloses a method for the treatment of a disease or condition by delivery of a liquid or semi-solid material to the suprachoroidal space or supraciliary space of an eye comprising (Para 0045, lines 14-17 -Singh; Para 0026; Para 0184 - Oberkircher): placing the distal end of the cannulation device of claim 30 (See Rejection of claim 30) on the surface of the eye and advancing the needle of the device into the sclera (Para 0046 -Singh); activating the deployment mechanism (Para 0046 -Singh); advancing the needle while providing illumination to the proximal end of the tubular element to illuminate the distal tip of the tubular element (Col 9, lines 22-55 -Utz); advancing the distal tip of the needle to deploy the tubular element to the suprachoroidal space or supraciliary space (Para 0026; Para 0184 – Oberkircher; Para 0082 -Badawi); verifying the position of the tubular element by viewing the illumination of the tubular element through the sclera (Col 9, lines 22-55 -Utz); and delivering the material for administration through the lumen of the tubular element to the suprachoroidal space or supraciliary space (Para 0026; Para 0184 - Oberkircher).
Claims 63-68 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 2017/0216092) in view of Badawi (US 2018/0271699) and further in view of Oberkircher (US 2015/0223977) and further in view of Utz (US 10,232,107) and further in view of Yamamoto (US 11096822).
Regarding claim 63, The modified invention of Singh, Badawi, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding a distal element with a distal seal attached to the distal end of the device thereby sealing or blocking the needle lumen from advancement of the tubular element out of the needle, wherein: the distal seal acts as a tissue interface and is penetrable by the distal tip of the needle by the application of pressure on the surface of an eye with the distal end of the device; the penetrated distal element becomes slidable on the needle to allow advancement of the needle into tissue; and the penetrated distal seal opens a path for advancement of the tubular element from the distal end of the needle.
Yamamoto teaches a cannulation device comprising a distal element (23, Fig 7) with a distal seal attached to the distal end of the device thereby sealing or blocking the needle lumen (Col 13, lines 35-62), wherein: the distal seal acts as a tissue interface and is penetrable by the distal tip of the needle by the application of pressure on the surface of an eye with the distal end of the device; the penetrated distal element becomes slidable on the needle to allow advancement of the needle into tissue (See Fig 10); and the penetrated distal seal opens a path from the distal end of the needle (Col 13, lines 35-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannulation device disclosed by Singh, Badawi, Oberkircher, and Utz to include a distal element over the needle as taught by Yamamoto in order to prevent delivery of the cannula or material until the device is located against the tissue and the needle has been inserted (Col 3, lines 21-37).
Regarding claim 64, The modified invention of Singh, Badawi, Oberkircher, Utz, and Yamamoto discloses collapsible element (27, Fig 10 - Yamamoto) between the elongated body of the device and the distal element, wherein the collapsible element is configured to prevent distal movement of the distal element (Col 13, lines 35-62 - Yamamoto).
Regarding claim 65, The modified invention of Singh, Badawi, Oberkircher, Utz, and Yamamoto discloses the collapsible element (27, Fig 10 - Yamamoto) comprises elongated struts (See Fig 10- Yamamoto).
Regarding claim 66, The modified invention of Singh, Badawi, Oberkircher, Utz, and Yamamoto discloses the collapsible (27, Fig 10 - Yamamoto) element comprises Nitinol or polyimide (Col 10, lines 41-45 -Yamamoto).
Regarding claim 67, The modified invention of Singh, Badawi, Oberkircher, Utz, and Yamamoto discloses the deployment mechanism (1014, Fig 10A -Badawi) additionally comprises a force element (1020, Fig 10B -Badawi) configured to apply a deployment force on the tubular element to advance the tubular element through the needle lumen where the penetration of the distal seal by the distal end of the needle provides actuation of the deployment mechanism (Para 0082, Para 0089- Badawi; Col 13, lines 35-62 – Yamamoto; the tubular member can’t fully actuate until the needle has pierced the seal and thus penetration of the distal seal provides or allows actuation to the deployment mechanism ).
Regarding claim 68, The modified invention of Singh, Badawi, Oberkircher, Utz, and Yamamoto discloses a damping mechanism (gear teeth on force element 1020, Fig 10B) to limit the speed of cannula deployment (Para 0082, Para 0088 -Badawi; the teeth only allow the cannula to be deployed at the speed that the wheels are turning).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 2017/0216092) in view of Badawi (US 2018/0271699) and further in view of Oberkircher (US 2015/0223977) and further in view of Utz (US 10,232,107) and further in view of Adams (US 9,308,051) and further in view of Taranekar (US 8,552,083).
Regarding claim 73, The modified invention of Singh, Badawi, Oberkircher, and Utz discloses all of the elements of the innovation as discussed above, however, is silent regarding the tubular element comprises a polymer and a low refractive index coating.
Adams teaches an analogous cannula (100, Fig 1B) wherein a segment of the tubular element including the distal tip and extending proximally from the distal tip is configured to be illuminated by transmitting light from a proximal portion of the tubular element to the distal tip such that light exits the segment through an outer surface of the wall (Col 4, lines 47-63) and wherein the tubular element comprises a polymer (Col 5, lines 41-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the tubular element to be a polymer as taught by Adams in order to have a tubular element that is flexible and nonreactive to body tissues and fluids and can withstand repeated sterilizations (Col 5, lines 41-47).
Taranekar teaches an ultra-low refractive index curable coating for optical and bio-medical applications (Col 1, lines 44-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular element to include a low refractive index coating as taught by Taranekar in order to provide desirable properties to the tubular element, e.g., low coefficient of friction, improved wear/abrasion resistance, enhanced chemical resistance, low surface energy, water/oil and stain repellency and improved surface smoothness and gloss (Col 1, lines 12-20).
Claims 75 and 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 2017/0216092) in view of Badawi (US 2018/0271699) and further in view of Oberkircher (US 2015/0223977) and further in view of Utz (US 10,232,107) and further in view of Badawi ‘958 (US 10299958).
Regarding claim 75, The modified invention of Singh, Badawi, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding the needle comprises an inner deflecting element in the lumen of the needle at the needle bevel to direct the tubular element at an angle from the long axis of the needle toward the posterior region of the eye.
Badawi ‘958 teaches a cannulation device for administering an active agent containing composition to an eye (Col 1, lines 6-8) comprising an elongated body (300, Fig 3) with a hollow needle (306, Fig 3) at a distal end; wherein the needle comprises an inner deflecting element (304, Fig 3; the inner wall of the curved portion deflects the tubular element) in the lumen of the needle at the needle bevel to direct the tubular element at an angle from the long axis of the needle toward the posterior region of the eye (Col 21, lines 6-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle to comprise an inner deflecting element as taught by Badawi ‘958 in order to allow for easy, atraumatic, and controlled access into the eye (Col 21, lines 6-24).
Regarding claim 79, The modified invention of Singh, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding the tubular element has a curved configuration in an unconstrained state and regains a curved configuration when deployed from the distal end of the needle.
Badawi ‘958 teaches a cannulation device for administering an active agent containing composition to an eye (Col 1, lines 6-8) comprising a tubular element (“elongate member”) that has a curved configuration in an unconstrained state and regains a curved configuration when deployed from the distal end of the needle (“cannula”) (Col 22, lines 9-17; Col 22, lines 62-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular element to have a curved configuration as taught by Badawi ‘958 in order to have a tubular element that can more easily circumnavigate within the eye (Col 22, lines 62-67).
Regarding claim 80, The modified invention of Singh, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding the cannula additionally comprises a lubricious coating.
Badawi teaches a cannula additionally comprises a lubricious coating (Col 19, lines 39-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula to include a lubricious coating as taught by Badawi ‘958 in order to reduce the friction between the ocular tissue and the cannula during the procedure (Col 19, lines 39-45).
Claims 76-78 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 2017/0216092) in view of Badawi (US 2018/0271699) and further in view of Oberkircher (US 2015/0223977) and further in view of Utz (US 10,232,107) and further in view of Norman (US 2017/0095646).
Regarding claim 76, The modified invention of Singh, Badawi, Oberkircher, and Utz discloses all of the elements of the invention as discussed above, however, is silent regarding the distal tip of the cannula comprises a material with greater flexibility than the proximal main shaft of the cannula.
Norman teaches an analogous cannula (258, Fig 12A) wherein the distal tip (268, Fig 12A) of the cannula comprises a material with greater flexibility than the proximal main shaft of the cannula (Para 0160, lines 1-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cannula to have a more flexible distal tip as taught by Norman in order to have a cannula that can better deal with anticipated curvature in the path the catheter must follow (Para 0160, lines 1-18).
Regarding claim 77, The modified invention of Singh, Badawi, Oberkircher, Utz, and Norman discloses all of the elements of the invention as discussed above, however, is silent regarding the distal tip of the cannula comprises a material of greater flexibility is at least 1 mm in length.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the distal tip of the cannula having the material of greater flexibility to be at least 1mm since Norman teaches those different lengths of the segments can be selected (Para 0160) and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 78, The modified invention of Singh, Badawi, Oberkircher, Utz, and Norman discloses the cannula distal tip and main shaft comprises polyurethane, polyurethane copolymers, polysiloxane, polysiloxane copolymers, or polyether block amide (“PEBAX” a.k.a. polyether block amide, Para 160 -Norman).
Response to Arguments
Applicant’s arguments filed 02/19/2026, on pages 2-3, regarding Selover failing to teach the amended claim limitations have been fully considered but are moot in view of the current rejection that relies on Utz to teach the illuminated tubular element.
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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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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