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 .
Election/Restrictions
Applicant's election with traverse of claims 8-14 in the reply filed on 01/04/2026 is acknowledged. The traversal is on the ground(s) that claims as amended recite various steps being performed by the very elements which are recited in the device claims 8-14. The claims of group I, claims 1-7 shall be considered for rejoinder.
Applicant's election with traverse of claims 8-14 in the reply filed on 01/04/2026 is acknowledged. The traversal is on the ground(s) that claims 15-24 as amended recites limitations that are closely related that would not be a serious search burden to search them all together. This argument is fully considered and is persuasive. The restriction requirement of claims 15-24 is now withdrawn.
Claims 8-24 are pending, claims 1-7 are considered withdrawn.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 8-9, 15-17, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2017031570A1 to Gooi et al. (hereinafter “Gooi” – also published as US 20180235462 A1) in view of US 20140221822 A1 to Ehlers et al. (hereinafter “Ehlers”).
Regarding claim 8. (Currently Amended) Gooi discloses a system, comprising: a laser light source (e.g. para 0060, “laser 250”): a processor (para 0060 “controller 240”), wherein the processor is configured to: receive optical coherence tomography (OCT) data for tissue of an eye of a subject (para 0060 “OCT-A using OCT-A camera 350”), where the OCT data was obtained in vivo (para 0060), process the OCT data to identify collector channels in the tissue of the eye (para 0060 “Using the image guidance of angle structures from dynamic OCT-A, the system identifies the inner wall of Schlemm's canal 120 and/or the trabecular meshwork 130”), and based on the collector channels identified by processing the OCT data, suggest one or more target locations in the tissue for laser treatment (para 0060 “controller 240 guides laser 250 to move in a specific direction until the laser dot coincides with the desired location for excision”), and, wherein the laser light source is configured to perform a laser treatment on the eye at one or more selected target locations among the suggested target locations (para 0060 “excision using laser 250”) but fails to disclose generate an OCT representation of the tissue of the eye a visual observation apparatus configured to produce a visual representation of at least a portion of the eye: and one or more viewing devices configured to present at least one of the visual representation, the OCT representation, and an indication of at least one of the suggested target locations; while presenting at least one of the visual representation, the OCT representation, and the indicator of the at least one suggested target location.
Ehlers, from a similar field of endeavor teaches an OCT guided procedure having a feedback element configured to communicate the relative position of the instrument and the target to a user in a human (para 0004, 0006, etc.) wherein the feedback element includes one or more displays to provide, for example, a numerical or graphical indicator, or one of more other visual indicators (para 0030) [] to confirm the correct anatomic localization of instruments relative to structures of interest [], provide rapid feedback to the surgeon regarding instrument location, identify key surgical planes, and provide depth information regarding the instrument's location within a tissue, above a tissue, or below a tissue (para 0020, 0030-0031). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified with the teachings of Ehlers to provide the predictable result of providing feedback to the surgeon to guide during the surgery.
Regarding claim 9. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 8, further comprising an OCT system which is configured to perform OCT imaging during the laser treatment, wherein the processor is configured to guide the laser to perform photodisruption at the one or more selected target locations based on locations of the collector channels identified by processing the OCT data (para 0060 “femtosecond laser”, 0065 “Femtosecond laser photodisrupts tissue”).
Regarding claim 15. (Currently Amended) A system, comprising: a laser light source (e.g. para 0060, “laser 250”); a viewing arrangement (para 0011 display); and a processor (para 0060 “controller 240”), wherein the processor is configured to: receive optical coherence tomography (OCT) data for tissue of corneo- scleral angle structures of an eye of a subject (para 0060 “OCT-A using OCT-A camera 350”), the laser light source, wherein the one or morebut fails to disclose cause the viewing arrangement to indicate to a user of the system one or more target locations for laser treatment.
Ehlers, from a similar field of endeavor teaches an OCT guided procedure having a feedback element configured to communicate the relative position of the instrument and the target to a user in a human (para 0004, 0006, etc.) wherein the feedback element includes one or more displays to provide, for example, a numerical or graphical indicator, or one of more other visual indicators (para 0030) [] to confirm the correct anatomic localization of instruments relative to structures of interest [], provide rapid feedback to the surgeon regarding instrument location, identify key surgical planes, and provide depth information regarding the instrument's location within a tissue, above a tissue, or below a tissue (para 0020, 0030-0031). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified with the teachings of Ehlers to provide the predictable result of providing feedback to the surgeon to guide during the surgery.
Regarding claim 16. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, wherein the processor is further configured to indicate to the user the one or moregraphical visual elements which are displayed to the user by the viewing arrangement (Ehlers, para 0030).
Regarding claim 17. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, further comprising an OCT system configured to perform OCT imaging of the tissue during the laser treatment, wherein the processor is further configured to guide the user to perform the laser treatment at the one or more target locations
Regarding claim 23. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, wherein the viewing arrangement is configured to display an OCT-generated image of the tissue to the user, wherein the OCT-generated image is generated from the OCT data (Ehlers, para 0018-0019, etc.), and wherein the processor is configured to receive from the user an indication of one or more of the
Regarding claim 24.(Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 23,wherein the OCT-generated image shows the one or more collector channels in the tissue (see rejection of claim 15 as modified).
Claim(s) 10-14, 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gooi as modified by Ehlers as applied to claims 8-9, 15-17, 23-24 above, and further in view of US Pat No. 7192412 to Zhou et al. (hereinafter “Zhou”).
Regarding claim 10. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 8, but fails to disclose wherein the processor is configured to identify the one or more suggested target locations for the laser treatment by identifying locations in the tissue which have a greatest density of collector channels.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 11. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 8, but fails to disclose wherein the processor is configured to process the OCT data to identify sizes of collector channels in the tissue of the eye, and wherein the processor is configured to identify the one or more suggested target locations for the laser treatment based on the sizes of the collector channels.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 12. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 8, but fails to disclose wherein the processor is configured to select identify the one or more suggested target locations for the laser treatment by identifying locations in the tissue where there are a greatest number of collector channels.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 13. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 8, but fails to disclose wherein the processor is configured to process the OCT data to identify obstructions of collector channels in the tissue of the eye, and wherein the processor is configured to identify the one or more suggested target locations for the laser treatment by selecting identifying locations in the tissue where the collector channels are least obstructed.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
It is noted that the claim does not provide any details regarding how obstructions are identified. Under its broadest reasonable interpretation, determining the channels would include determining areas where obstructions have occurred. Furthermore, MPEP 2143 under KSR provides such modification would be obvious to try. Furthermore, Zhou is concerned with fining the ideal target to provide the best improvement in outflow, and as such, Zhou’s teachings would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 14. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 8, but fails to disclose wherein the processor is configured to process the OCT data to identify flows of fluids by collector channels in the tissue of the eye, and wherein the processor is configured to identify the one or more suggested target locations for the laser treatment by identifying locations in the tissue where the flows of fluids through the collector channels are greatest.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 4, ln 22, col 5, ln 41-50, etc., Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 18. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, wherein the processor is configured to process the OCT data to identify the collector channels in the tissue of the eye, and is further configured to suggest the target locations in the tissue for the laser treatment (para 0060 “Using the image guidance of angle structures from dynamic OCT-A, the system identifies the inner wall of Schlemm's canal 120 and/or the trabecular meshwork 130”) but fails to disclose on densities of collector channels at the target locations.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 19. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, but fails to disclose wherein the processor is configured to process the OCT data to identify sizes of collector channels in the tissue of the eye, and wherein the processor is configured to suggest the target locations in the tissue for the laser treatment based on to the sizes of collector channels at the target locations.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 20. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, but fails to disclose wherein the processor is configured to suggest the target locations in the tissue for the laser treatment based on numbers of collector channels at the
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Regarding claim 21 (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, but fails to disclose wherein the processor is configured to process the OCT data to identify obstructions of collector channels in the tissue of the eye, and wherein the processor is configured to suggest the target locations in the tissue for laser treatment based on the obstructions in the collector channels.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
It is noted that the claim does not provide any details regarding how obstructions are identified. Under its broadest reasonable interpretation, determining the channels would include determining areas where obstructions have occurred. Furthermore, MPEP 2143 under KSR provides such modification would be obvious to try. Furthermore, Zhou is concerned with fining the ideal target to provide the best improvement in outflow, and as such, Zhou’s teachings would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 22. (Currently Amended) Gooi as modified by Ehlers renders obvious the system of claim 15, but fails to disclose wherein the processor is configured to process the OCT data to identify flows of fluids by collector channels in the tissue of the eye, and wherein the processor is configured to suggest the target locations in the tissue for the laser treatment based on the flows of fluids through the collector channels.
Zhou, from a similar field of endeavor, teaches treating glaucoma by implanting at least one stent implant targeted at or near to the collector channels, and teaches providing numerical modeling of the outflow system of the eye that provides essential information to determine the best implant location based on the collector channel distribution and size [] determined from micro-anatomical studies or by real-time imaging (Col. 4, ln 22, col 5, ln 41-50, etc., Col. 13, ln 56-Col 14, ln 4). Placing a stent into Schlemm's canal through the trabecular meshwork yields the best improvement in outflow facility when it is placed near a large collector channel or a group of smaller ones that combine to have a larger equivalent hydraulic diameter (Col. 13, ln 56-Col 14, ln 4). It would have been obvious before the effective filing date of the claimed invention to modify the disclosure of Gooi as modified by Ehlers with the teachings of Zhou, because doing so would allow for identifying the ideal target outflow area and provide the predictable result of achieving the best improvement in outflow.
Double Patenting
Claims 8-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 10,517,760. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US application read over all the limitations of the pending claimed application.
Claims 8-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 27-28, 39-40 of U.S. Patent No. 11,058,584. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US application read over all the limitations of the pending claimed application.
Claims 8-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,918,515. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US application read over all the limitations of the pending claimed application.
Claims 8-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 of U.S. Patent No. 10,993,840. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US application read over all the limitations of the pending claimed application.
Claims 8-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-10 of U.S. Patent No. 12,102,562. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US application read over all the limitations of the pending claimed application.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796