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 Arguments
Applicant's arguments filed 08/21/2025 have been fully considered but they are not persuasive. With respect to arguments against Zhao and Christie, it is argued that one of ordinary skill in the art would not add in the annular mask of Christie into Zhao as said mask will alter the light required by a radially outer zone, where specific quantities of light is required by said zones of Zhao to achieve a desired wavefront. Additionally, the provided motivation for doing so will be improper in view of Zhao. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, examiner still asserts that the improving of a (in [0156]-[0158]) is beneficial as this would also block optical aberrations as per [0011]. An improved focusing (in [0191]-[0193]) is also a benefit that one of ordinary skill in the art would find beneficial. The mask is also defined to have apertures to allow for a pass through of light, with [0158] disclosing that the mask “can block light that enters at large angles off of the optical center axis of the lens body.” As such, Examiner states that the wavefront generation of Zhao will not be impeded as Zhao does not disclose a reliance on light that enter at “large angles off of the optical center axis” for a generation of wavefront. With respect to the mask not enhancing rotational misalignment or maintaining a visual acuity level, examiner notes that the mask itself is not claimed to be the element that maintains a visual acuity level or enhances a rotational misalignment.
Regarding claim 33 and 35, applicant argues that the mask of Wortz will limit a light to a radially outer zone, limiting the wavefront generation of Zhao. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the mask of Wortz creates a pinhole effect (as per column 38 lines 16-46 of Wortz) that provide the benefit of reducing a blurring and improving an image sharpness while improving a depth of focus, as per the benefits known in the art of a pinhole effect and IOL mask. Examiner asserts that there is no clear teaching that said pinhole effect, that will still allow light to pass through the pinholes of the mask, will impede the functionality of the wavefront generation of Wortz as a full impedance of light is not present in Wortz.
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) 17-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US Pub No.: 2009/0323020) in view of Christie (US Pub No.: 2011/0040376).
Regarding claim 17, Zhao (US Pub No.: 2009/0323020) discloses an intraocular lens (in the abstract) comprising: a refractive element comprising a first power in a first meridian (lens and meridian details in [0084]) and a second power greater than the first power in a second meridian (multiple meridians with different powers disclosed in [0084]), a magnitude of the first and second powers and a location of the first and second meridians configured to correct astigmatism in a human eye (use of zones of the lens to treat an astigmatism in [0053]-[0054]).
However, Zhao does not teach a mask configured to block a substantial portion of light from passing through an annular region thereof and to permit a substantial portion of light to pass through a central aperture thereof to enhance an astigmatism correction rotational misplacement range wherein the intraocular lens is configured to maintain a same visual acuity level from 0 to +/- 1.5 diopters of cylinder.
Instead, Christie teaches an intraocular lens (in the abstract) a mask (part 208 in [0156], figures 2A-2B) configured to block a substantial portion of light from passing through an annular region thereof (the mask allows only a subset of light rays to pass through the lens, as per paragraph [0166]) and to permit a substantial portion of light to pass through a central aperture thereof to enhance an astigmatism correction rotational misplacement range (permitting of a subset of light rays to pass through a central portion of the lens in [0166]), wherein the intraocular lens is configured to maintain a same visual acuity level from 0 to +/- 1.5 diopters of cylinder (in [0192]-[0193] of Christie, which teaches visual acuity details for a range of diopters). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 18, Zhao in view of Christie teaches the intraocular lens of Claim 17, wherein Christie teaches the mask is placed on a face of an optic comprising the refractive element (in certain embodiments, like figure 25F where the mask is defined as part 8052 in [0262]). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 19, Zhao in view of Christie teaches the intraocular lens of Claim 18, wherein Christie teaches that the mask is formed on a piggyback element configured to place the mask on the face of the optic (being the transition zone 8056 shown in figure 25F and [0262]). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 20, Zhao in view of Christie teaches the intraocular lens of Claim 17, wherein Christie teaches the mask is embedded in an optic comprising the refractive element (shown in embodiments shown in 25B-25D, where the mask is parts 8022, 8032, and 8042). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 21, Zhao in view of Christie teaches the intraocular lens of Claim 17, wherein Christie teaches the mask comprises an aperture of less than about 2.8 mm (an aperture of 1-2 mm in diameter is disclosed in [0168] of Christie). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 22, Zhao in view of Christie teaches the intraocular lens of Claim 17, wherein Christie discloses the mask comprises a plurality of small holes disposed through the annular region to secure the mask to an optic comprising the refractive element (being the plurality of light transmission holes in the mask, disclosed in [0160] of Christie). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 23, Zhao in view of Christie teaches the intraocular lens of Claim 17, wherein the mask is configured to increase depth of focus by a magnitude equivalent to up to 2 diopters of add power (in paragraphs [0192]-[0193] of Christie). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 24, Zhao in view of Christie teaches the intraocular lens of Claim 17, wherein Christie teaches the mask comprises an elastic material (a polymer used to create a mask disclosed in [0201], with elastic modulus details in [0253]). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 25, Zhao discloses an intraocular lens (in the abstract) comprising: a refractive element comprising a first power in a first meridian lens and meridian details in [0084]) and a second power greater than the first power in a second meridian multiple meridians with different powers disclosed in [0084]), a magnitude of the first and second powers and a location of the first and second meridians configured to correct astigmatism in a human eye (use of zones of the lens to treat an astigmatism in [0053]-[0054]).
However, Zhao does not teach a mask configured to block a substantial portion of light from passing through an annular region thereof and to permit a substantial portion of light to pass through a central aperture thereof to enhance an astigmatism correction rotational misplacement range, wherein the intraocular lens is configured to maintain visual acuity of at least 20/20 from 0.0 diopters to +/- 2.0 diopters of defocus.
Instead, Christie teaches a mask (part 208 in [0156], figures 2A-2B) configured to block a substantial portion of light from passing through an annular region thereof and to permit a substantial portion of light to pass through a central aperture thereof (the mask allows only a subset of light rays to pass through the lens, as per paragraph [0166]) to enhance an astigmatism correction rotational misplacement range (permitting of a subset of light rays to pass through a central portion of the lens in [0166]), wherein the intraocular lens is configured to maintain visual acuity of at least 20/20 from 0.0 diopters to +/- 2.0 diopters of defocus (in [0192]-[0193] of Christie, which teaches visual acuity details for a range of diopters). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 26, Zhao in view of Christie teaches he intraocular lens of Claim 25, wherein Christie teaches the mask is placed on a face of an optic comprising the refractive element (in certain embodiments, like figure 25F where the mask is defined as part 8052 in [0262]). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 27, Zhao in view of Christie teaches the intraocular lens of Claim 26, wherein Christie teaches the mask is formed on a piggyback element configured to place the mask on the face of the optic (being the transition zone 8056 shown in figure 25F and [0262]). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 28, Zhao in view of Christie teaches the intraocular lens of Claim 25, wherein Christie teaches the mask is embedded in an optic comprising the refractive element (shown in embodiments shown in 25B-25D, where the mask is parts 8022, 8032, and 8042). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 29, Zhao in view of Christie teaches the intraocular lens of Claim 25, wherein Christie discloses the mask comprises an aperture of less than about 2.8 mm (an aperture of 1-2 mm in diameter is disclosed in [0168] of Christie). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 30, Zhao in view of Christie teaches the intraocular lens of Claim 25, wherein Christie teaches the mask comprises a plurality of small holes disposed through the annular region to secure the mask to an optic comprising the refractive element (being the plurality of light transmission holes in the mask, disclosed in [0160] of Christie). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 31, Zhao in view of Christie teaches the intraocular lens of Claim 25, wherein Christie teaches the mask is configured to increase depth of focus by a magnitude equivalent to up to 2 diopters of add power (in paragraphs [0192]-[0193] of Christie). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Regarding claim 32, Zhao in view of Christie teaches the intraocular lens of Claim 25, wherein Christie teaches the mask comprises an elastic material (a polymer used to create a mask disclosed in [0201], with elastic modulus details in [0253]). 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 mask as presented in Christie into the device of Zhao for the purpose of providing a mask that improves a light blocking (in [0156]-[0158]) and an improved focusing (in [0191]-[0193]).
Claim(s) 33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US Pub No.: 2009/0323020) in view of Wortz (US Patent No.: 9,358,103).
Regarding claim 33, Zhao discloses a method of correcting astigmatism comprising: placing an intraocular lens into an eye of a patient (in the abstract), the intraocular lens comprising a cylinder power component aligned with a meridian thereof (lens and meridian details in [0084]),confirming the meridian of the intraocular lens is misaligned by an amount exceeding five degrees of a pre-operatively defined rotational position (in [0054]. Zhao also discloses an implantation of a lens with a δ of about 5 degrees in [0013]-[0015], which implies an angle of slightly above 5 degrees is provided for); and confirming the eye achieves functional acuity (as treatment of astigmatisms is disclosed in Zhao, like in [0054], a treatment of an eye to achieve a functional acuity is implied with the treatment of astigmatism, Misalignment in [0014] and [0054]-[0056]).
However, Zhao does not teach and a mask comprising a small aperture surrounded by an opaque member.
Instead, Wortz (US Patent No.: 9,358,103) teaches a mask (in column 38 lines 16-46) comprising a small aperture surrounded by an opaque member (aperture detailed in column 38 lines 16-46 with a “darkening all but the central 1-2mm…of the prosthetic capsular device” constituting an opaque member). 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 mask as presented in Wortz into Zhao for the purpose of providing a mask for an intraocular lens as the mask of Wortz creates a pinhole effect (as per column 38 lines 16-46 of Wortz) that provide the benefit of reducing a blurring and improving an image sharpness while improving a depth of focus, as per the benefits known in the art of a pinhole effect and IOL mask.
Regarding claim 35, Zhao in view of Wortz teach the method of Claim 33, further comprising confirming visual acuity is at least 20/20 (as the device of Wortz is used with intraocular lenses, disclosed in column 1 lines 37-65). 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 mask as presented in Wortz into Zhao for the purpose of providing a mask for an intraocular lens as the mask of Wortz creates a pinhole effect (as per column 38 lines 16-46 of Wortz) that provide the benefit of reducing a blurring and improving an image sharpness while improving a depth of focus, as per the benefits known in the art of a pinhole effect and IOL mask.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US Pub No.: 2009/0323020) in view of Wortz (US Patent No.: 9,358,103) in further view of Bogaert (US Pub No.: 2011/0166652).
Regarding claim 34, Zhao in view of Wortz teach the method of Claim 33. However, Zhao in view of Wortz does not teach wherein the lens is misaligned by an amount in a range of 5 degrees to 15 degrees. Instead, Bogaert (US Pub No.: 2011/0166652) teaches wherein the range extends from within 5 degrees to within 15 degrees. (a tolerance of 10 degrees is disclosed in [0045]. Lens misalignment also in [0045]). 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 range details of Bogaert into the combination involving Zhao and Wortz as doing so is known in the art to improve a depth of focus of a lens, and further detailed in [0047]-[0050].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Webb (US Pub No.: 2020/0337831) considered for a mask to increase a depth of focus, disclosed in the abstract. Vilupuru (US Pub No.: 2018/0125639) considered for the mask to increase a depth of focus in the abstract with aperture details also disclosed here.
THIS ACTION IS MADE FINAL. 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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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774