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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/08/2024, 06/21/2024, 08/16/2024, 12/23/2024 was filed and is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-10, 14, 18, 21, 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Back (US 2022/0296361, of record)
Regarding claim 1, Back discloses a contact lens (see Fig 49A), the lens including an optic zone (see Fig 49A; Para [0314]; ophthalmic lens includes a central optical zone 4901 and an annular zone 4902) comprising: a central region, the central region having a first optical axis (see Fig 49A; Para [0314]; ophthalmic lens includes a central optical zone 4901 and an annular zone 4902; a first optical axis is taken to be the solid axis going through the center of the lens as seen in Fig 49A), a centre of curvature that is on the first optical axis (see Fig 49A; Para [0315]; a central zone 4901 has a specific radius of curvature centered on the optical axis), and a diameter that is less than 2.0 mm (see Fig 49A; Para [0069-0070]; first optical zone/central zone may have a diameter of around 2.0 mm); and an annular region comprising a plurality of concentric treatment zones, wherein each treatment zone has a radial sagittal power profile that increases with increasing radial distance from the optical axis (see Fig 49B; Para [0319]; annular region 4902 of lens has treatment zones that increase in power with increase in radial distance).
As Back’s diameter is similar to the claimed range (i.e., less than 2.0 mm to around 2.0 mm of the prior art), a prima facia case of obviousness exists (see MPEP 2144.05. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein at least two of the treatment zones have different radial sagittal power profiles (see Fig 49B; Para [0319-0320]; power profiles of various treatment zones 4901a-d are distinct/different).
Regarding claim 3, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein the annular zone comprises between 2 and 10 concentric treatment zones (see Fig 49B; Para [0320]; annular zone may comprise between 2-10 curve infusions/treatment zones).
Regarding claim 4, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein each of the plurality of concentric treatment zones has a different radial sagittal power profile (see Fig 49B; Para [0320]; each treatment zone has a different radial power profile as seen in Fig 49B).
Regarding claim 5, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein each treatment zone has a radial width of between about 0.1 and 2.5 mm (see Fig 49A; Para [0298]; zones have widths of 0.05 to 3 mm).
As Back’s width is similar to the claimed range (i.e., 0.1 and 2.5 mm compared to 0.05 to 3 mm of the prior art), a prima facia case of obviousness exists (see MPEP 2144.05. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 6, Back discloses the contact lens according to claim 1 (see Fig 51B), wherein each treatment zone has a radial sagittal power gradient of between about 0.5 D/mm and about 20.0 D/mm (see Fig 51B; Para [0327-0329]; with a width of 1mm and a depth of focus of 1.5D the power gradient of the lens is calculated to be 1.5D/mm).
Regarding claim 7, Back discloses the contact lens according to claim 1 (see Fig 49A). having a nominal distance power of between +0.5 D and -15.0D (see Fig 49A; see Table 1; Para [0338]; example lens may have nominal central zone powers of 0, -1, -2, -3).
Regarding claim 8, Back discloses the contact lens according to claim 7 (see Fig 49A). Back further discloses wherein at least one treatment zone has a radial curvature power that is greater than the nominal distance power of the lens (see Fig 49B; Para [0317-0320]; the first treatment zone 4901a has a greater power, greater by p-a, as seen by Fig 49B).
Regarding claim 9, Back discloses the contact lens according to claim 7 (see Fig 49A), wherein each treatment zone has a radial curvature power that is greater than the nominal distance power of the lens (see Fig 49B; Para [0317-0320]; the treatment zones each have a power that is greater than the nominal power, m-a, as seen in Fig 49B).
Regarding claim 10, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein the radial curvature power of the central region is equal to the nominal distance power (see Fig 49B; Para [0317-0320]; the central region 4901 has a power of m-a).
Regarding claim 14, Back discloses the contact lens according to claim 7 (see Fig 49B), wherein each treatment zone provides a radial curvature add power of between +2.0 D and 10.0 D (see Table 1; Para [0338-0339]; an add power of the annular region may be between +2.50 and +4.50 as seen on Table 1).
Regarding claim 18, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein the radial sagittal power profile across the central region is approximately flat (see Fig 49B; Para [0317-0320]; the radial power profile of the center region 4901 is flat at m-a as seen in Fig 49B).
Regarding claim 21, Back discloses the contact lens according to claim 1 (see Fig 49A). Back further discloses wherein the radial curvature power of each treatment zone results from the curvature of an anterior surface and/or a posterior surface of the lens (see Fig 49A; Para [0314]; radial power of each zone comes from anterior surface curvature 4902a-d).
Regarding claim 23, Back discloses the contact lens according to claim 1. Back further
discloses wherein the lens is formed using a lathing process or a cast molding process (see Fig 49A; Para [0345]; lens may be formed by lathe or molding processes).
Regarding claim 24, Back discloses a method of manufacturing a contact lens, the method comprising: forming a contact lens according to claim 1 (see Fig 49A; Para [0106; 0345]; the method of forming Backs ophthalmic lens, which may be a contact lenses, is in Para [0345]).
Claims 11, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Back (US 2022/0296361, of record) in view of Griffin (US 2017/0227788)
Regarding claim 11, Back discloses the contact lens according to claim 1. Back does not disclose wherein the nominal distance power of the lens is greater than the radial curvature power of the central region. Back and Griffin are related because both disclose lenses with radial sagittal power profiles.
Griffin discloses a contact lens with radial sagittal power profiles (see Fig 4) wherein the nominal distance power of the lens is greater than the radial curvature power of the central region (see Fig 4; Para [0074-0076]; sagittal power profile across the central region from -1mm to 1mm is curved and the nominal of -1D is greater than the radial between -1mm to 1mm which is around 0D).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein the nominal distance power of the lens is greater than the radial curvature power of the central region is curved of Griffin for the purpose of allowing for presbyopia correction without affecting a user’s vision (Para [0025])
Regarding claim 19, Back discloses the contact lens according to claim 1. Back does not disclose wherein the radial sagittal power profile across the central region is curved. Back and Griffin are related because both disclose lenses with radial sagittal power profiles.
Griffin discloses a contact lens with radial sagittal power profiles (see Fig 4) wherein the radial sagittal power profile across the central region is curved (see Fig 4; Para [0074-0076]; sagittal power profile across the central region from -1mm to 1mm is curved).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein the radial sagittal power profile across the central region is curved of Griffin for the purpose of allowing for presbyopia correction without affecting a user’s vision (Para [0025])
Regarding claim 20, Back in view of Griffin discloses the contact lens according to claim 19. Back does not disclose wherein the radial sagittal power profile across the central region has a quadratic or parabolic shape.
Griffin discloses wherein the radial sagittal power profile across the central region has a quadratic or parabolic shape (see Fig 4; Para [0074-0076]; a central region from -1mm to 1mm from center is parabolic in its power profile shape).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein the radial sagittal power profile across the central region has a quadratic or parabolic shape of Griffin for the purpose of allowing for presbyopia correction without affecting a user’s vision (Para [0025])
Regarding claim 22, Back discloses the contact lens according to claim 1. Back and Griffin are related because both disclose wherein the lens comprises an elastomer material, a silicone elastomer material, a hydrogel material, or a silicone hydrogel material, or mixtures thereof. Back and Griffin are related because both disclose lenses with radial sagittal power profiles.
Griffin discloses a contact lens with radial sagittal power profiles (see Fig 4) wherein the lens comprises an elastomer material, a silicone elastomer material, a hydrogel material, or a silicone hydrogel material, or mixtures thereof (see Fig 4; Para [0115]; lens are made of hydrogel materials such as etafilcon).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein the lens comprises an elastomer material, a silicone elastomer material, a hydrogel material, or a silicone hydrogel material, or mixtures thereof of Griffin for the purpose of allowing for presbyopia correction without affecting a user’s vision (Para [0025])
Claims 12-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Back (US 2022/0296361, of record) in view of Wooley (US 2012/0327363)
Regarding claim 12, Back discloses the contact lens according to claim 7. Back does not disclose wherein alternate concentric treatment zones provide higher radial curvature powers and lower radial curvature powers, wherein the higher radial curvature power is greater than the nominal distance power of the lens. Back and Wooley are related because both disclose contact lenses with annular regions.
Wooley discloses a contact lens with annular regions (see Fig 7) wherein alternate concentric treatment zones provide higher radial curvature powers and lower radial curvature powers, wherein the higher radial curvature power is greater than the nominal distance power of the lens (see Fig 7; Para [0067]; lenses A and B have treatment zones which have higher and lower powers, the higher powers are greater than the nominal power of the lens as seen in the chart in Fig 7).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein alternate concentric treatment zones provide higher radial curvature powers and lower radial curvature powers, wherein the higher radial curvature power is greater than the nominal distance power of the lens of Wooley for the purpose of improving presbyopia correction (Para [0019])
Regarding claim 13, Back in view of Wooley discloses the contact lens according to claim 12. Back does not disclose wherein the lower radial curvature add power is greater than the nominal distance power of the lens.
Wooley discloses a contact lens with annular regions (see Fig 7) wherein the lower radial curvature add power is greater than the nominal distance power of the lens (see Fig 7; Para [0067]; lenses A and B have treatment zones which have higher and lower powers, the lower powers are also greater than the nominal power of the lens as seen in the chart in Fig 7).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein the lower radial curvature add power is greater than the nominal distance power of the lens of Wooley for the purpose of improving presbyopia correction (Para [0019])
Regarding claim 17, Back discloses the contact lens according to claim 1. Back does not disclose wherein at least one treatment zone is a sagittal add treatment zone, having a radial sagittal power is greater than the nominal distance power of the lens across the width of that treatment zone. Back and Wooley are related because both disclose contact lenses with annular regions.
Wooley discloses a contact lens with annular regions (see Fig 7) wherein at least one treatment zone is a sagittal add treatment zone, having a radial sagittal power is greater than the nominal distance power of the lens across the width of that treatment zone (see Fig 7; Para [0067]; lenses A and B have treatment zones which have powers that are greater than the nominal of -2.65 or -1.8, respectively as seen in Fig 7).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein at least one treatment zone is a sagittal add treatment zone, having a radial sagittal power is greater than the nominal distance power of the lens across the width of that treatment zone of Wooley for the purpose of improving presbyopia correction (Para [0019])
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Back (US 2022/0296361, of record) in view of Fiala (US 2002/0063848)
Regarding claim 15, Back discloses the contact lens according to claim 1. Back does not disclose wherein at a point halfway across the radial width of an innermost of the treatment zones, the radial sagittal power of that treatment zone matches the nominal distance power of the lens. Back and Fiala are related because both disclose contact lens with power profiles.
Fiala discloses a contact lens (see Fig 7) wherein at a point halfway across the radial width of an innermost of the treatment zones, the radial sagittal power of that treatment zone matches the nominal distance power of the lens (see Fig 7; Para [0089-0091]; the sagittal power of the different zones, defined to be the from a local maximum to a local minimum, matches a nominal power of 5D at a point halfway as seen in Fig 7)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein at a point halfway across the radial width of an innermost of the treatment zones, the radial sagittal power of that treatment zone matches the nominal distance power of the lens of Fiala for the purpose of improving the objective optical properties (Para [0009-0020])
Regarding claim 16, Back in view of Fiala discloses the contact lens according to claim 15. Back does not disclose wherein at a point halfway across the radial width of each treatment zone, the radial sagittal power of that treatment zone matches the nominal distance power of the lens.
Fiala discloses wherein at a point halfway across the radial width of each treatment zone, the radial sagittal power of that treatment zone matches the nominal distance power of the lens (see Fig 7; Para [0089-0091]; the sagittal power of the different zones, defined to be the from a local maximum to a local minimum, matches a nominal power of 5D at a point halfway as seen in Fig 7 in each treatment zone).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Back with wherein at a point halfway across the radial width of each treatment zone, the radial sagittal power of that treatment zone matches the nominal distance power of the lens of Fiala for the purpose of improving the objective optical properties (Para [0009-0020])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brennan (US 2017/0115509) discloses a contact lens with annular power regions for ADD power profiles.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL ANDRES SANZ whose telephone number is (571)272-3844. The examiner can normally be reached Monday-Friday 8:30 am -5:30 pm.
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, Pinping Sun can be reached at (571) 270-1284. 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.
/G.A.S./Examiner, Art Unit 2872
/WILLIAM R ALEXANDER/Primary Examiner, Art Unit 2872