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.
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) 1, and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable by Gooding(US 20150190278 A1) in view of Dick(US 20140074074 A1).
Regarding claim 1, Gooding discloses the a method of performing ophthalmic surgery, comprising: positioning a patient interface relative to a patient’s eye, wherein the patient interface at least partially defines an interface chamber with the patient’s eye; filling the interface chamber with an immersion fluid; replacing a fluid in an anterior chamber of the patient’s eye with the immersion fluid, wherein the immersion fluid includes a refractive index that matches a refractive index of a cornea of the patient’s eye; and positioning a laser system relative to the patient interface, the laser system including: a laser source configured to generate a femtosecond laser beam; and an optical delivery and scanner system in communication with the laser source to direct 3D scanned and focused laser beams through the patient interface and into the patient’s eye(The intermediate section 256 may comprise a stiff housing 270 to couple the eye to the docking structure 210. A channel 272 can be formed in housing 270 to allow placement of fluid into the chamber 218 and release of fluid from chamber 218 so as to inhibit pressure increases when container 218 is formed with the anterior surface of the eye[0107]. The assembly 62 is operable to project and scan optical beams into the patient's eye 43. The cutting laser subsystem 44 includes an ultrafast (UF) laser 64 (e.g., a femtosecond laser). Using the assembly 62, optical beams can be scanned in the patient's eye 43 in three dimensions: X, Y, Z. [0063]. Apparatus to treat an eye with an ophthalmic laser system comprises a patient interface having an annular retention structure to couple to an anterior surface of the eye. The retention structure is coupled to a suction line to couple the retention structure to the eye with suction. Liquid is added above the eye to act as a transmissive medium. A coupling sensor is coupled to the suction line to determine coupling of the retention structure to the eye.[abstract]. The patient interface 52 is used to restrain the position of the patient's eye 43 relative to the system 2[0055]. A fluid collecting container can be coupled to the annular structure to receive and collect liquid or viscous material from the container. A fluid stop comprising a float valve or a porous structure can be coupled to an outlet of the fluid collecting container so as to inhibit passage of the liquid or viscous material when the container has received an amount of the liquid or viscous material greater than a volume of a patient interface container on the eye. The fluid stop can inhibit the passage of liquid or viscous material to structures downstream of the fluid stop such as a pressure regulator and vacuum pump, so as to provide consistent gas flow. The coupling sensor can be coupled upstream of the porous structure to provide a rapid measurement of the coupling of the retention structure to the eye, and may be coupled upstream of the fluid collecting container to further improve the response time of the coupling sensor[0011]). Gooding fails to explicitly state “replacing a fluid in an anterior chamber of the patient’s eye with the immersion fluid, wherein the immersion fluid includes a refractive index that matches a refractive index of a cornea of the patient’s eye”.
However, Dick teaches “The fluid in the anterior chamber can also be exchanged with a suitable OVD to provide a homogeneous optical medium in the chamber so as to enhance uniformity of transmission of the light beam 6 through the anterior chamber[0091]. Accordingly, in many embodiments, the system 2 is configured to compensate for the OVD disposed in the anterior chamber by using an index of refraction for the OVD. For example, the system 2 can be configured to receive a user input that specifies the index of refraction for the OVD used, or that is otherwise processed to determine the index of refraction for the OVD used. The index of refraction for the OVD in the anterior chamber can then be used, in conjunction with the measured configuration of the anterior chamber, to control the z-adjust device 40 and/or the scanning device 50 such that the scanning of the focal point of the light beam 6 is accomplished so as to account for the presence of the OVD in the anterior chamber. For example, the index of refraction of the OVD in the anterior chamber and the measured configuration of the anterior chamber can be used with known optical modeling methods (e.g., ray tracing) to suitably account for the configuration and optical characteristics of the anterior chamber so as to accurately scan the focal point of the light beam 6 to incise the lens capsule and/or lens nucleus as desired[0095]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the laser eye system of Gooding with the fluid replacement of the laser eye surgery of Dick. Doing so would specify fluid switching in the anterior chamber in order to ensure the eye has the correct refractive index for the laser surgery.
Regarding claim 3, Gooding in view of Dick teaches the method of claim 1, wherein the patient interface includes a suction ring for engaging the patient’s eye and removing possible air bubbles in the immersion fluid(The first suction line 222 can be coupled to the suction ring placed on the eye, and the first suction line coupled to the fluid collector comprising container 231 and porous structure 232P as described herein. The coupling sensor 228 can be coupled to the suction ring and the first line 222 upstream of the porous structure 232P as described herein, for example. The coupling sensor 228 is coupled to the control electronics with communication paths 60 as described herein. The second line 224 to vacuum clamp the docking structure 210 can be coupled to the fluid collector comprising container 241 and fluid stop 242 comprising porous structure 242P or float valve 242F as described herein[0112]).
Regarding claim 4, Gooding in view of Dick teaches the method of claim 3, wherein the patient interface includes a liquid interface housing extending from the suction ring(The intermediate section 256 may comprise a stiff housing 270 to couple the eye to the docking structure 210. A channel 272 can be formed in housing 270 to allow placement of fluid into the chamber 218 and release of fluid from chamber 218 so as to inhibit pressure increases when container 218 is formed with the anterior surface of the eye. The housing 270 may comprise an annular channel 274 formed in a posterior surface of the housing to receive the annular suction ring 260[0107]).
Regarding claim 5, Gooding in view of Dick teaches the method of claim 4, wherein the patient interface includes an entry window at least partially defining the interface chamber with the liquid interface housing(Fig. 10).
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding to teach the material of claim 5. Gooding does not explicitly state an entry window by the system does contain a transparent lens that partially defines the chamber and housing of the system. The lens allows laser light to shine through it, fundamentally performing the same task as the window claimed in the method.
Regarding claim 6, Gooding in view of Dick teaches the method of claim 1, wherein positioning the patient interface relative to the patient’s eye includes applying negative pressure to a suction ring on the patient interface(That is, there is a constant negative pressure differential toward the patient interface 360 which moves fluid in that direction.[0129]).
Regarding claim 7, Gooding in view of Dick teaches the method of claim 1, wherein the immersion fluid includes Densiron-68(The liquid or viscous material may comprise a viscosity and a density greater than a gas such as air, and the liquid or viscous material may comprise one or more of a solvent, water, a liquid material, a solution, saline, a viscous material, or a viscoelastic material[0011]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding to teach the material of claim 7. Gooding does not explicitly state Densiron-68 but it does disclose the liquid may be any viscous material, which includes Densiron-68.
Regarding claim 8, Gooding in view of Dick teaches the method of claim 1, wherein the immersion fluid includes HWS-46-3000(The liquid or viscous material may comprise a viscosity and a density greater than a gas such as air, and the liquid or viscous material may comprise one or more of a solvent, water, a liquid material, a solution, saline, a viscous material, or a viscoelastic material[0011]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding to teach the material of claim 8. Gooding does not explicitly state HWS-46-3000 but it does disclose the liquid may be any viscous material, which includes HWS-46-3000.
Regarding claim 9, Gooding in view of Dick teaches the method of claim 1, wherein the immersion fluid includes Oxane H(The liquid or viscous material may comprise a viscosity and a density greater than a gas such as air, and the liquid or viscous material may comprise one or more of a solvent, water, a liquid material, a solution, saline, a viscous material, or a viscoelastic material[0011]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding to teach the material of claim 9. Gooding does not explicitly state Oxane-H but it does disclose the liquid may be any solvent, which includes Oxane-H.
Claim(s) 2, 12, 16, 17, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gooding in view of Dick, and further in view of Dewey(US 20170189233 A1).
Regarding claim 2, Gooding in view of Dick teaches the method of claim 1, but fails to disclose wherein the refractive index of the immersion fluid is greater than or equal to 1.37 and less than or equal to 1.40.
However, Dewey teaches “While the index of refraction of tissue such as eye can vary with wavelength as described herein, approximate baseline values include: aqueous humor 1.33; cornea 1.38; vitreous humor 1.34; and lens 1.36 to 1.41, in which the index of the lens can differ for the capsule, the cortex and the nucleus, for example[0074]. While distortions of the anterior corneal surface can be corrected in a manner similar to the posterior surface with ray tracing, work in relation to embodiments suggests that coupling the eye to the patient interface with a fluid contacting the patient interface and having an index of refraction similar to the cornea can decrease the effect of distortions of the anterior corneal surface[0173]”.
It would be obvious to one ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the refractive index of the laser surgery system of Dewey. Doing so would specify the refractive index used in the system for the fluid/liquid.
Regarding claim 12, Gooding in view of Dick teaches the method of claim 1, but fails to disclose wherein the ophthalmic surgery includes a femtosecond laser adjusted intraocular lens (IOL) procedure. However, Dewey teaches “The laser eye surgery system 2 and the optical measurements obtained therewith may be used intra-operatively, i.e., during a cataract surgery or other surgical procedure, for, e.g., intraoperative eye diagnostics, determining IOL position and/or orientation, surgical planning, and control/or of a laser surgical system[0242]”.
It would be obvious to one ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the IOL of the laser surgery system of Dewey. Doing so would specify a kind of procedure used during laser eye surgery.
Regarding claim 16, Gooding discloses the a system for performing ophthalmic surgery, comprising: a patient interface for attaching to a patient’s eye, wherein the patient interface at least partially defines an interface chamber; an immersion fluid for filling the interface chamber and an anterior chamber of the eye; and a laser system positionable relative to relative to the patient interface, the laser system including: a laser source configured to generate a femtosecond laser beam; and a focusing lens in optical communication with the laser source to direct the laser beam through the patient interface and into the patient’s eye(The intermediate section 256 may comprise a stiff housing 270 to couple the eye to the docking structure 210. A channel 272 can be formed in housing 270 to allow placement of fluid into the chamber 218 and release of fluid from chamber 218 so as to inhibit pressure increases when container 218 is formed with the anterior surface of the eye[0107]. The assembly 62 is operable to project and scan optical beams into the patient's eye 43. The cutting laser subsystem 44 includes an ultrafast (UF) laser 64 (e.g., a femtosecond laser). Using the assembly 62, optical beams can be scanned in the patient's eye 43 in three dimensions: X, Y, Z. [0063]. Apparatus to treat an eye with an ophthalmic laser system comprises a patient interface having an annular retention structure to couple to an anterior surface of the eye. The retention structure is coupled to a suction line to couple the retention structure to the eye with suction. Liquid is added above the eye to act as a transmissive medium. A coupling sensor is coupled to the suction line to determine coupling of the retention structure to the eye.[abstract]. The patient interface 52 is used to restrain the position of the patient's eye 43 relative to the system 2[0055]). Gooding fails to disclose “an immersion fluid for filling the interface chamber and an anterior chamber of the eye, wherein the immersion fluid includes a refractive index of greater than or equal to 1.36 and less than or equal to 1.40”.
However, Dick teaches “The fluid in the anterior chamber can also be exchanged with a suitable OVD to provide a homogeneous optical medium in the chamber so as to enhance uniformity of transmission of the light beam 6 through the anterior chamber[0091]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the laser eye system of Gooding with the fluid replacement of the laser eye surgery of Dick. Doing so would specify fluid switching in the anterior chamber in order to ensure the eye has the correct refractive index for the laser surgery.
However, Dewey teaches “While the index of refraction of tissue such as eye can vary with wavelength as described herein, approximate baseline values include: aqueous humor 1.33; cornea 1.38; vitreous humor 1.34; and lens 1.36 to 1.41, in which the index of the lens can differ for the capsule, the cortex and the nucleus, for example[0074]. While distortions of the anterior corneal surface can be corrected in a manner similar to the posterior surface with ray tracing, work in relation to embodiments suggests that coupling the eye to the patient interface with a fluid contacting the patient interface and having an index of refraction similar to the cornea can decrease the effect of distortions of the anterior corneal surface[0173]”.
It would be obvious to one ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the refractive index of the laser surgery system of Dewey. Doing so would specify the refractive index used in the system for the fluid/liquid.
Regarding claim 17, Gooding in view of Dick and Dewey teaches the system of claim 16, wherein the patient interface includes a suction ring for engaging the patient’s eye, a liquid interface housing extending from the suction ring, and an entry window at least partially defining the interface chamber with the liquid interface housing(Gooding - The first suction line 222 can be coupled to the suction ring placed on the eye, and the first suction line coupled to the fluid collector comprising container 231 and porous structure 232P as described herein. The coupling sensor 228 can be coupled to the suction ring and the first line 222 upstream of the porous structure 232P as described herein, for example. The coupling sensor 228 is coupled to the control electronics with communication paths 60 as described herein. The second line 224 to vacuum clamp the docking structure 210 can be coupled to the fluid collector comprising container 241 and fluid stop 242 comprising porous structure 242P or float valve 242F as described herein[0112]. The intermediate section 256 may comprise a stiff housing 270 to couple the eye to the docking structure 210. A channel 272 can be formed in housing 270 to allow placement of fluid into the chamber 218 and release of fluid from chamber 218 so as to inhibit pressure increases when container 218 is formed with the anterior surface of the eye. The housing 270 may comprise an annular channel 274 formed in a posterior surface of the housing to receive the annular suction ring 260[0107]. [Fig. 10]).
Regarding claim 19, Gooding in view of Dick and Dewey teaches the system of claim 16, but Gooding fails to disclose wherein the ophthalmic surgery includes a femtosecond laser adjusted intraocular lens (IOL) procedure.
However, Dewey teaches “The laser eye surgery system 2 and the optical measurements obtained therewith may be used intra-operatively, i.e., during a cataract surgery or other surgical procedure, for, e.g., intraoperative eye diagnostics, determining IOL position and/or orientation, surgical planning, and control/or of a laser surgical system[0242]”.
It would be obvious to one ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the IOL of the laser surgery system of Dewey. Doing so would specify a kind of procedure used during laser eye surgery.
Regarding claim 20, Gooding in view of Dick and Dewey teaches the system of claim 16, wherein positioning the patient interface relative to the patient’s eye includes applying negative pressure to a suction ring on the patient interface(Gooding - That is, there is a constant negative pressure differential toward the patient interface 360 which moves fluid in that direction.[0129]).
Claim(s) 10, 11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gooding in view Dick, and further in view of Schuele(US 20170326003 A1).
Regarding claim 10, Gooding in view of Dick teaches the method of claim 1, but fails to explicitly state wherein the ophthalmic surgery includes femtosecond laser assisted cataract surgery (FLACS). However, Schuele teaches “The method of claim 18, wherein the laser is a femtosecond laser[claim 22]. A system to modify a laser cataract surgery device, comprising: a numerical aperture device which is configured to attach to a laser cataract device and position the focal length of the laser to a depth between the posterior of a lens in the eye and at least three millimeters in front of a retina in the eye[claim 29]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the FLACS of the laser eye surgery system of Schuele. Doing so would specify one type of surgery performed with the method disclosed.
Regarding claim 11, Gooding in view of Dick and Schuele teaches the method of claim 10, wherein replacing the fluid in the anterior chamber of the patient’s eye with the immersion fluid occurs through an opening in a cornea(Gooding - A suitable liquid 386 (e.g., a sterile buffered saline solution (BSS)) is then introduced to the patient interface 360 (preferably through open apertures, not shown) so as to settle by gravity into a fluid chamber 388 therein, filling the chamber and rising into contact with the optical lens 32. Alternatively, the liquid 386 may be introduced into the chamber 386 above the eye E prior to coupling the upper member 364 to the lower member 366. The fluid chamber 388 includes at least that portion of the through bore in the patient interface 360 within the eye-contacting member 366, below the lens 382, and within the conical field of view A. The posterior (lower) surface of the optical lens 382 is thus spaced vertically from the anterior (upper) surface of the patient's cornea across a region of the suitable liquid 386, which acts as an optically transmissive medium. Although not shown, inlet and outlet ports to the chamber 388 are provided in the eye-contacting member 366 for supplying and draining liquid as needed, in particular for maintaining a pressure equilibrium[0124]).
Regarding claim 13, Gooding in view of Dick teaches the method of claim 1, but fails to disclose wherein the ophthalmic surgery includes at least one of femtosecond retinal treatment procedure, epiretinal membrane and internal limiting membrane surgery, disintegration of retinal drusens, or cutting vitreous traction fibers.
However, Schuele teaches “The laser systems here may make clean cuts in the vitreous humor to deal with these floaters without causing damage to the retina. These femtosecond laser pulses can treat the vitreous much closer to retina than existing nanosecond/sub-nanosecond IR systems, which helps address the worst floaters with close proximity[0107]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the femtosecond laser treatment of the laser eye surgery system of Schuele. Doing so would specify a type of surgery and targeted eye areas treated with the method disclosed.
Regarding claim 14, Gooding in view of Dick teaches the method of claim 1, but fails to disclose wherein the ophthalmic surgery includes a femtosecond laser-based floater removal procedure. However, Schuele discloses “As described, the systems and methods here may use a femtosecond laser to cut various planes in the vitreous humor of the eye for treatment of floaters or other treatments[0129]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the femtosecond laser treatment of the laser eye surgery system of Schuele. Doing so would specify a type of surgery and targeted eye areas treated with the method disclosed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gooding in view of Dick, and further in view of Kindt(US 11026840 B2).
Regarding claim 15, Gooding in view of Dick teaches the method of claim 1, but fails to disclose wherein the ophthalmic surgery includes a laser induced refractive index change (LIRIC) procedures or Perfect Lens treatment. However, Kindt teaches “Such methods are also referred to as LIRIC (laser induced refractive index change). In particular, LIRIC is brought about by virtue of laser radiation being focused into the treatment region and leading there to a change in the structure of the material, said structure change remaining permanently, keeping the material transparent and modifying the local refractive index of the material and hence the refractive power of the transparent tissue (cornea, lens)(Background of invention, paragraph 7)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the LIRIC of the ophthalmic surgery method of Kindt. Doing so would specify one type of surgery performed with the method disclosed.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gooding in view of Dick and Dewey, and further in view of Schuele(US 20170326003 A1).
Regarding claim 18, Gooding in view of Dick and Dewey teaches the system of claim 17, but fails to disclose wherein the ophthalmic surgery includes femtosecond laser assisted cataract surgery (FLACS). “The method of claim 18, wherein the laser is a femtosecond laser[claim 22]. A system to modify a laser cataract surgery device, comprising: a numerical aperture device which is configured to attach to a laser cataract device and position the focal length of the laser to a depth between the posterior of a lens in the eye and at least three millimeters in front of a retina in the eye[claim 29]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic laser system of Gooding with the FLACS of the laser eye surgery system of Schuele. Doing so would specify one type of surgery performed with the method disclosed.
Response to Arguments
Applicant’s arguments, see Remarks, filed 7/7/2026, with respect to the rejection(s) of claim(s) 1, 3-4, and 6 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dick(US 20140074074 A1) in combination with Gooding. New art Dick discloses the swapping of fluids in the anterior chamber of the eye in order to allow for the refractive index of the eye to match the index of the laser[0091-0095]. Therefore Dick in combination with Gooding and the rest of the prior art disclose the limitations of all claims and the 103 rejections stand.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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