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
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.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinto (US Pub No.: 2017/0258577) in view of Bos (US Pub No.: 2020/0113736).
Regarding claim 1, Pinto (US Pub No.: 2017/0258577) discloses a method to optimize depth of focus and the quality of the image in the periphery of the visual field (performed via a lens in the abstract that has an extended depth of field in [0003]. Depth of focus details in [0390]-[0391]), which uses intraocular lenses (in the abstract and [0006]) comprising a central part (figure 2 part 201) and a peripheral part (figure 2 parts 205a, 205b, 205c, and 205d), the central part being the optical part (disclosed in [0350]) and the peripheral part comprising mechanical fasteners (the haptics defined in [0351] are mechanical fasteners to fasten the intraocular lens into the eye) wherein the central part comprises: - an aspherical concave anterior surface, which is the surface closest to the iris of the eye once the lens has been implanted in the eye (in [0265], where it is understood that the anterior surface is the one closest to the iris of the eye), and - an asphericaI convex posterior surface, which is the surface closest to the retina of the eye once the lens (600) has been implanted in the eye (in [0264], where it is understood that the posterior surface is the surface of the lens closest to the retina), such that: - the radius of curvature of the posterior surface of the central part is smaller than the radius of curvature of the anterior surface of the central part, with a ratio between radii of between 2:1 and 6:1 (as per the radius of curvature of the posterior surface being between 0-20mm in [0172] and the radius of curvature of the anterior surface being between 0-1mm in [0167], a ratio of 2:1 to 6:1 is provided for), and - the mechanical fasteners are arranged at an angle of between 0˚ and 10˚ with respect to a plane passing through the intersections between the central part and the peripheral part (the haptics 205a-d in figure 2 are depicted at being at a 0 degree angle with respect to the central part and peripheral part intersection) and which is perpendicular to the optical axis of the eye in which the lens is intended to be implanted. wherein the method comprises the following steps (as per [0351], the haptics stabilize the lens such that the lens is along the optical axis of the eye, where said axis is assumed to be the line part 3 in figure 2. As such, the haptics 205 are perpendicular to the optic axis of the eye and the lens itself): - to provide a series of intraocular lenses (600) of different net asphericity value (multiple aspheric orders in different portions in [0050]. As multiple asphericity values are disclosed, the device of Pinto will provide multiple lenses with similar structures but different aspheric values),
However, Pinto does not teach details with respect to a visual simulator and details thereof. Instead, Bos (US Pub No.: 2020/0113736) teaches wherein - to place a patient in front of a visual simulator of adaptive optics (patient testing with a simulation in [0046], with simulating a visual accommodation in [0081] fur use of optimizing an intraocular lens in [0086]), which emulates different intraocular lens profiles with different net asphericity value (creating an aspherical intra cortical lens in [0254], lens simulation in [0081]), - realization of different simulations with different intraocular lens profiles through a visual test at different distances (in [0553], a distance value is evaluated), - selection of the optimal result of the visual test (selecting of gradients after a simulation is carried out in [0064], selecting of a lens after the simulation in [0359]), and determination of the net asphericity value of the intraocular lens (aspheric details in [0254] with a selection of a lens with details that affect an asphericity in [0359]), and - choice of the intraocular lens presenting the determined net asphericity value for its implantation in the patient's eye (choosing an intraocular lens in [0081] and [0359]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the simulation details of Bos into Pinto for the purpose of providing a means to select parameters of an intraocular lens (in [0359] of Bos) that are provided for in Pinto to allow for a tailoring of the device of Pinto to better suit a patient.
Regarding claim 3, Pinto in view of Bos teach the method to optimize depth of focus and the quality of the image in the periphery of the visual field according to claim 1 in which Pinto discloses the intraocular lenses are ones in which the central part has a circular aspect (part 201 of Pinto in figure 2 is depicted as being circular).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinto (US Pub No.: 2017/0258577) in view of Bos (US Pub No.: 2020/0113736) in further view of Paul (US Pub No.: 2016/0346076).
Regarding claim 2, Pinto in view of Dos teach the method to optimize depth of focus and the quality of the image in the periphery of the visual field according to claim 1. However, Pinto does not teach wherein said intraocular lenses are ones in which the mechanical fasteners are arranged at an angle of 2˚ with respect to a plane passing through the joints between the central part and the peripheral part and which is perpendicular to the optical axis of the eye in which the lens is intended to be implanted.
Instead, Paul (US Pub No.: 2016/0346076) teaches wherein said intraocular lenses are ones in which the mechanical fasteners are arranged at an angle of 2˚ with respect to a plane passing through the joints between the central part and the peripheral part (in [0014], a range between 0 degrees to 45 degrees is present, where 2 degrees will fall between the stated range) and which is perpendicular to the optical axis of the eye in which the lens is intended to be implanted (as parts 335 in figure 10 are the haptics which are being implemented into the IOL of Pinto, the haptics of the combination involving Paul are still perpendicular to the optical axis of the eye). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the haptic degree details of Paul into the device of Pinto for the purpose of providing a haptic, detailed in [0011]-[0015], where the haptic design will minimize an axial displacement in [0011], with the specific angle measurements of the haptics being selected to accommodate for a deformation that occurs when the lens is in the eye, as per [0018].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinto (US Pub No.: 2017/0258577) in view of Bos (US Pub No.: 2020/0113736) in further view of Schaper (US Pub No.: 2010/0161048).
Regarding claim 4, Pinto in view of Dos teach the method to optimize depth of focus and the quality of the image in the periphery of the visual field according to claim 1. However, Pinto does not teach in which the intraocular lenses are ones in which the central part has an oval aspect.
Instead, Schaper (US Pub No.: 2010/0161048) teaches wherein the intraocular lenses are ones in which the central part has an oval aspect (an oval optic element is disclosed in [0025]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the oval shaped optic of Schaper into the combination involving Pinto for the purpose of providing a different shaped optic that allows for a maximizing of a diameter of an optic while minimizing the size of a surgical incision, as per [0026], where the oval or elliptical shaped optic will allow for said maximizing of an optic diameter.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinto (US Pub No.: 2017/0258577) in view of Neal (US Pub No.: 2018/0064338).
Regarding claim 5, Pinto (US Pub No.: 2017/0258577) discloses a method to optimize depth of focus and the quality of the image in the periphery of the visual field (performed via a lens in the abstract that has an extended depth of field in [0003]. Depth of focus details in [0390]-[0391]), which uses intraocular lenses (in the abstract and [0006]) comprising a central part (figure 2 part 201) and a peripheral part (figure 2 parts 205a, 205b, 205c, and 205d), the central part being the optical part (disclosed in [0350]) and the peripheral part comprising mechanical fasteners (the haptics defined in [0351] are mechanical fasteners to fasten the intraocular lens into the eye) wherein the central part comprises: - an aspherical concave anterior surface), which is the surface closest to the iris of the eye once the lens has been implanted in the eye (in [0265], where it is understood that the anterior surface is the one closest to the iris of the eye), and - an asphericaI convex posterior surface, which is the surface closest to the retina of the eye once the lens has been implanted in the eye (in [0264], where it is understood that the posterior surface is the surface of the lens closest to the retina), such that: - the radius of curvature of the posterior surface of the central part is smaller than the radius of curvature of the anterior surface of the central part, with a ratio between radii of between 2:1 and 6:1 (as per the radius of curvature of the posterior surface being between 0-20mm in [0172] and the radius of curvature of the anterior surface being between 0-1mm in [0167], a ratio of 2:1 to 6:1 is provided for), and - the mechanical fasteners are arranged at an angle of between 0˚ and 10˚ with respect to a plane passing through the intersections between the central part and the peripheral part (the haptics 205a-d in figure 2 are depicted at being at a 0 degree angle with respect to the central part and peripheral part intersection) and which is perpendicular to the optical axis of the eye in which the lens is intended to be implanted wherein said method comprises the following steps (as per [0351], the haptics stabilize the lens such that the lens is along the optical axis of the eye, where said axis is assumed to be the line part 3 in figure 2. As such, the haptics 205 are perpendicular to the optic axis of the eye and the lens itself).
However, Pinto does not teach a - measurement of eye shape and/or refraction at the periphery, and - depending on the measurements made, to customize the shape of the intraocular lens (600) and its net asphericity for its implantation in the patient's eye.
Instead, Neal (US Pub No.: 2018/0064338) teaches a - measurement of eye shape and/or refraction at the periphery (wavefront sensor to determine a refraction of an entire eye in [0027]. Measuring a cornea shape also in [0064]), and - depending on the measurements made, to customize the shape of the intraocular lens and its net asphericity for its implantation in the patient's eye (use of measured data to select IOL characteristics in [0133]-[0134]. Selection based on asphericity in [0137]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the evaluation of an eye to determine a lens to be implanted presented in Neal into the lens device of Pinto in order to allow for a selection of a lens that will best treat a visual deficiency, as disclosed in [0141]. As the lens of Pinto has a plurality of variable parameters, the system in [0133]-[0141] of Neal provides a system to tailor the lens of Pinto.
Regarding claim 7, Pinto in view of Neal teach the method to optimize depth of focus and the quality of the image in the periphery of the visual field according to claim 5 in which Pinto discloses that the intraocular lenses are ones in which the central part has a circular or oval aspect (part 201 of Pinto in figure 2 is depicted as being circular).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinto (US Pub No.: 2017/0258577) in view of Neal (US Pub No.: 2018/0064338) in further view of Paul (US Pub No.: 2016/0346076).
Regarding claim 6, Pinto in view of Neal teach the method to optimize depth of focus and the quality of the image in the periphery of the visual field, according to claim 5. However, Pinto does not teach wherein said intraocular lenses are ones in which the mechanical fasteners are arranged at an angle of 2˚ with respect to a plane passing through the joints between the central part and the peripheral part and which is perpendicular to the optical axis of the eye in which the lens is intended to be implanted.
Instead, Paul (US Pub No.: 2016/0346076) teaches wherein said intraocular lenses are ones in which the mechanical fasteners are arranged at an angle of 2˚ with respect to a plane passing through the joints between the central part and the peripheral part (in [0014], a range between 0 degrees to 45 degrees is present, where 2 degrees will fall between the stated range) and which is perpendicular to the optical axis of the eye in which the lens is intended to be implanted (as parts 335 in figure 10 are the haptics which are being implemented into the IOL of Pinto, the haptics of the combination involving Paul are still perpendicular to the optical axis of the eye). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the haptic degree details of Paul into the device of Pinto for the purpose of providing a haptic, detailed in [0011]-[0015], where the haptic design will minimize an axial displacement in [0011], with the specific angle measurements of the haptics being selected to accommodate for a deformation that occurs when the lens is in the eye, as per [0018].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cumming (US Pub No.: 2015/0245905) considered for the haptic angle details shown in figure 2. Zando-Azizi (US Pub No.: 2009/0228101) considered for the radius of curvature details of a posterior and anterior side of a lens in [0147]-[0148].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AREN PATEL whose telephone number is (571)272-0144. The examiner can normally be reached 7:00 - 4:30 M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah C. Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774