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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/17/2025 has been entered.
Response to Amendment
The Amendment filed July 17, 2025 has been entered. Claims 1-25 remain pending in the application.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 8, 9, 12, 13, 14, 15, 16, 17-19, 20, 21, 22 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Stoy et al. (WO2014/111769, English version based on US2020/0038549).
Regarding claims 1, 9, 12, 20, 21, 22, Stoy discloses that, a method of inducing a non-uniform cross-link density in a polymeric material (for example, in [0026], the optical parameters of the implant are adjusted (lines 9-10) and the irradiation produces elongated cavities or voxel inside the hydrogel ophthalmic implant (i.e., the voxel depth is a variable) (lines 12-15)), comprising:
providing a previously cross-linked, three-dimensional polymeric matrix comprising a plurality of cross-linked bonds ((for example) as shown in Fig. 8 ([0041]); it is noticed that, when the 3d polymeric matrix is molded in Fig. 8, a cross-link process of the monomer mixture is occurred (See Example 1 ([0198]))); and
at a time prior to implanting the polymeric matrix in an eye (e.g., in [0172] (as shown in Fig. 6B), Stoy discloses that, (at least) the zone 15 or 16 can be created by the modification of a hydrogel according to the present invention using a laser. The hydrogel modification can be carried out either preoperatively or postoperatively (lines 7-11)),
irradiating the previously cross-linked, three-dimensional polymeric matrix with ionizing energy (for example, electromagnetic radiation (ABSTRACT); It is noticed that, electromagnetic radiation includes seven types of radiation including x-rays and electron beams and charged particles such as electrons and protons creating electromagnetic fields for transporting energy (related to claim 9)) to break at least some of the plurality of cross-linked bonds ([0060], lines 1-5) and thereby create a non-uniform cross-link density (or refractive index) ([0068], lines 7-10 (i.e., at least part of the released monomers and/or fragments may re-polymerize and create a denser network structure with a higher refractive index than the parent hydrogel (i.e., the reduction of refractive index from the voxels to the hydrogel)); [0157], lines 1-4) within the three-dimensional polymeric matrix (related to claim 12 and claim 22) (It is noticed that, the matrix with a higher refractive power (or a higher index of refraction) has a higher cross-link density (related to claim 20) ([0068]; it is noticed that, an additional feature of the invention is creation of a gradient (i.e., the equivalence to the creation of a gradually varying reduced cross-link density from each individual voxel the corresponding hydrogel) of refractive index in the vicinity of individual voxels ([0068], lines 1-3); Here, each voxel can be considered as one portion of an optic of the intraocular lens (related to claim 21)).
Regarding claims 2, 5, 6, 8, Stoy discloses that, at a time subsequent to the irradiating step, positioning the three-dimensional polymeric matrix in a hydrating solution ([0192] (i.e., the lens implanted (related to claim 5 (ABSTRACT)) in the deformed and partially dehydrated state achieved by contacting with a suitably hypertonic aqueous solution of physiologically acceptable salts (related to claim 8 (BSS)))), which causes a non-uniform swelling of the matrix, which thereby creates a non-uniform refractive index in the three-dimensional polymeric matrix ([0190], lines 7-10 (i.e., gradient of swelling and charge density); it is noticed that, the gradient of swelling should be in a reasonable range (related to claim 6) to guarantee the proper functions of the implanted lens).
Regarding claim 4, Stoy discloses that, as illustrated in Figs. 3A, 6A, 6B, 6C, the non-uniform refractive index in the three-dimensional polymeric matrix adapts the matrix, when in an eye, to focus light from a wide range of distances without moving or changing shape ([0102] (for example, in all distances covered by the focal range of the lens), [0106], [0107]).
Regarding claims 13, 14, Stoy discloses that, as illustrated in Figs. 3A, 5C, for instance, 8A1 may have higher refractive power than 8A2 and serve for near focus ([0124], lines 1-7). It is noticed that, the matrix with a higher refractive power (or a higher index of refraction) has a higher cross-link density. Thus, Stoy discloses that, the irradiating step creates a first region (for example, the zone 8A2 on the surface 5 (related to claim 14) (as shown in Figs. 3A, 5C)) of the matrix with a first cross-link density that is less than a second cross-link density of a second region (for example, the zone 8A1 on the surface 5 (as shown in Figs. 3A, 5C)) of the matrix.
Regarding claim 15, Stoy discloses that, as illustrated in Fig. 3A, the irradiating step occurs at a time subsequent to a haptic having been formed integrally with the three-dimensional polymeric matrix (ABSTRACT, [0140]).
Regarding claim 16, Stoy discloses that, the irradiated three-dimensional polymeric matrix is dimensionally stable through steam sterilization as part of a "wet pack" ([0192], [0201] (i.e., sterilized by autoclaving (in steam))) and is hydrolytically stable during long term use ([0123], lines 1-3 (for example, position stability)).
Regarding claims 17, 18, 19, Stoy discloses that, the preferred composition of a hydrogel for the three-dimensional polymeric matrix includes the group of 2-hydroxyethylmethycrylate (2-HEMA) (related to claims 17, 18) ([0073], lines 11-12). Stoy discloses that, the in situ-adjustable hydrogel ophthalmic implant includes acrylic monomer (related to claims 17, 18) ([0023], lines 10-11). Stoy discloses that, these implantable lenses are made from hydrogels that incorporate a biological component, usually collagen (related to claim 19) ([0081], lines 1-2).
Claim 24 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Stoy et al. (WO2014/111769, English version based on US2020/0038549).
Regarding claim 24, Stoy discloses that, a method of inducing a non-uniform cross-link density in a polymeric material (for example, in [0026], the optical parameters of the implant are adjusted (lines 9-10) and the irradiation produces elongated cavities or voxel inside the hydrogel ophthalmic implant (i.e., the voxel depth is a variable) (lines 12-15)), comprising:
at a time prior to implanting the polymeric matrix in an eye (e.g., in [0172] (as shown in Fig. 6B), Stoy discloses that, (at least) the zone 15 or 16 can be created by the modification of a hydrogel according to the present invention using a laser. The hydrogel modification can be carried out either preoperatively or postoperatively (lines 7-11)),
breaking a plurality of cross-link bonds ([0060], lines 1-5) in a region of previously cross-linked, three-dimensional polymeric matrix (for example, electromagnetic radiation (ABSTRACT); It is noticed that, electromagnetic radiation includes seven types of radiation including x-rays and electron beams and charged particles such as electrons and protons creating electromagnetic fields for transporting energy) by irradiating the region with ionizing energy while leaving intact polymer chains within the region, and wherein breaking the plurality of cross-link bonds within the region creates a non-uniform cross-link density ([0068], lines 7-10 (i.e., at least part of the released monomers and/or fragments may re-polymerize and create a denser network structure with a higher refractive index than the parent hydrogel); [0157], lines 1-4) within the region; and
at a time subsequent to breaking the plurality of cross-link bonds within the region, positioning the three-dimensional polymeric matrix in a hydrating solution (e.g., the parent hydrogel ([0068], line 10), which causes a non-uniform swelling of the three-dimensional polymeric matrix ([0190], lines 7-10 (i.e., gradient of swelling and charge density); it is noticed that, the gradient of swelling should be in a reasonable range), which thereby creates a non-uniform refractive index in the three-dimensional polymeric matrix.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-6, 8, 9, 12, 13, 14, 15, 16, 17-19, 20, 21, 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Stoy et al. (US2020/0038549) in view of Klima (US 2006/0064162).
Regarding claims 1, 9, 12, 20, 21, 22, 23, Stoy discloses that, as illustrated in Figs. 3A, 6A, 6B, 6C, 8, a method of inducing a non-uniform cross-link density in a polymeric material (ABSTRACT), comprising:
providing a previously cross-linked, three-dimensional polymeric matrix comprising a plurality of cross-linked bonds ((for example) as shown in Fig. 8 ([0041])); and
at a time prior to implanting the polymeric matrix in an eye (e.g., in [0172] (as shown in Fig. 6B), Stoy discloses that, (at least) the zone 15 or 16 can be created by the modification of a hydrogel according to the present invention using a laser. The hydrogel modification can be carried out either preoperatively or postoperatively (lines 7-11)),
irradiating the previously cross-linked, three-dimensional polymeric matrix with ionizing energy (for example, electromagnetic radiation (ABSTRACT); It is noticed that, electromagnetic radiation includes seven types of radiation including x-rays and electron beams and charged particles such as electrons and protons creating electromagnetic fields for transporting energy (related to claim 9)) to break at least some of the plurality of cross-linked bonds ([0060], lines 1-5) and thereby create a non-uniform cross-link density (or refractive index) ([0068], lines 7-10 (i.e., at least part of the released monomers and/or fragments may re-polymerize and create a denser network structure with a higher refractive index than the parent hydrogel (i.e., the reduction of refractive index from the voxels to the hydrogel)); [0157], lines 1-4) within the three-dimensional polymeric matrix (related to claim 12 and claim 22) (It is noticed that, the matrix with a higher refractive power (or a higher index of refraction) has a higher cross-link density (related to claim 20) ([0068]; it is noticed that, an additional feature of the invention is creation of a gradient (i.e., the equivalence to the creation of a gradually varying reduced cross-link density from each individual voxel the corresponding hydrogel) of refractive index in the vicinity of individual voxels ([0068], lines 1-3); Here, each voxel can be considered as one portion of an optic of the intraocular lens (related to claim 21)).
However, Stoy does not explicitly disclose applying ionizing energy such as x-rays in electromagnetic radiation. In the same field of endeavor, intraocular lens, Klima discloses that, by applying electromagnetic radiation (e.g., heat infrared, ultraviolet, laser, x-rays) to one or more portions of intraocular lens, the intraocular lens can be changed or adjusted ([0012], [0013] (lines 9-10) (related to claim 23)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stoy to incorporate the teachings of Klima to apply variably ionizing energy such as x-rays to one or more portions of intraocular lens. Doing so would be possible to adjust the properties of the ophthalmic lens implanted (or in vivo) in the human eye, as recognized by Klima ([0012], [0013]).
Regarding claims 2, 5, 6, 8, Stoy discloses that, at a time subsequent to the irradiating step, positioning the three-dimensional polymeric matrix in a hydrating solution ([0192] (i.e., the lens implanted (related to claim 5 (ABSTRACT)) in the deformed and partially dehydrated state achieved by contacting with a suitably hypertonic aqueous solution of physiologically acceptable salts (related to claim 8 (BSS)))), which causes a non-uniform swelling of the matrix, which thereby creates a non-uniform refractive index in the three-dimensional polymeric matrix ([0190], lines 7-10 (i.e., gradient of swelling and charge density); it is noticed that, the gradient of swelling should be in a reasonable range (related to claim 6) to guarantee the proper functions of the implanted lens).
Regarding claim 4, Stoy discloses that, as illustrated in Figs. 3A, 6A, 6B, 6C, the non-uniform refractive index in the three-dimensional polymeric matrix adapts the matrix, when in an eye, to focus light from a wide range of distances without moving or changing shape ([0102] (for example, in all distances covered by the focal range of the lens), [0106], [0107]).
Regarding claims 13, 14, Stoy discloses that, as illustrated in Figs. 3A, 5C, for instance, 8A1 may have higher refractive power than 8A2 and serve for near focus ([0124], lines 1-7). It is noticed that, the matrix with a higher refractive power (or a higher index of refraction) has a higher cross-link density. Thus, Stoy discloses that, the irradiating step creates a first region (for example, the zone 8A2 on the surface 5 (related to claim 14) (as shown in Figs. 3A, 5C)) of the matrix with a first cross-link density that is less than a second cross-link density of a second region (for example, the zone 8A1 on the surface 5 (as shown in Figs. 3A, 5C)) of the matrix.
Regarding claim 15, Stoy discloses that, as illustrated in Fig. 3A, the irradiating step occurs at a time subsequent to a haptic having been formed integrally with the three-dimensional polymeric matrix (ABSTRACT, [0140]).
Regarding claim 16, Stoy discloses that, the irradiated three-dimensional polymeric matrix is dimensionally stable through steam sterilization as part of a "wet pack" ([0192], [0201] (i.e., sterilized by autoclaving (in steam))) and is hydrolytically stable during long term use ([0123], lines 1-3 (for example, position stability)).
Regarding claims 17, 18, 19, Stoy discloses that, the preferred composition of a hydrogel for the three-dimensional polymeric matrix includes the group of 2-hydroxyethylmethycrylate (2-HEMA) (related to claims 17, 18) ([0073], lines 11-12). Stoy discloses that, the in situ-adjustable hydrogel ophthalmic implant includes acrylic monomer (related to claims 17, 18) ([0023], lines 10-11). Stoy discloses that, these implantable lenses are made from hydrogels that incorporate a biological component, usually collagen (related to claim 19) ([0081], lines 1-2).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Stoy et al. (US2020/0038549) as applied to claim 2 above, further in view of Dong et al. (US 2016/0189570).
Regarding claims 7, 8, Stoy discloses implanting the ophthalmic lens into eyes (ABSTRACT). However, Stoy does not positioning the three-dimensional polymeric matrix in a hydrating solution comprising implanting the three-dimensional polymeric matrix in an eye and wherein the hydrating solution comprises aqueous humor in the eye. In the same field of endeavor, artificial eye, Dong discloses that, as illustrated in Figs. 2-5, the body 132 can define the cavity 134 configured to be filled with the liquid. The cavity 134 can simulate the anterior chamber of the human eye that is filled with aqueous humor. The liquid can be any clear liquid that has an index of refraction similar that of the aqueous humor. For example, the liquid can be balanced salt solution (BSS) (related to claim 8) ([0031], lines 1-7). Dong discloses that, the liquid contacts at least a portion of the lens element 138 and at least a portion of the cornea element 136 ([0031], lines 13-15).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stoy to incorporate the teachings of Dong to position the three-dimensional polymeric matrix in a hydrating solution comprising implanting the three-dimensional polymeric matrix in an eye and wherein the hydrating solution comprises aqueous humor in the eye. Doing so would be possible to develop suitable materials for implanting the ophthalmic lens matching physical properties of the corresponding part of the human eye, as recognized by Dong ([0032]).
Claims 3, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Stoy et al. (US2020/0038549) and Klima (US 2006/0064162) as applied to claim 1 above, further in view of Gupta et al. (US 5,470,892).
Regarding claim 3, Stoy in the combination does not explicitly disclose that, the three-dimensional polymeric matrix has a surface anti-reflective layer from 50 nm to 100 microns thick. In the same field of endeavor, ophthalmic lens, Gupta discloses that, by using polymerizable additives as a component of the resin formulation, the surface of the resulting optic antireflective of the optic is rendered, for example, in which having a layer of 0.3 microns thickness (in the claimed range of from 50 nm to 100 microns) (col. 22, lines 27-44).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stoy to incorporate the teachings of Gupta to provide that the three-dimensional polymeric matrix has a surface anti-reflective layer from 50 nm to 100 microns thick. Doing so would be possible to extinguish the reflection of radiation, as recognized by Gupta (col. 22, lines 27-44).
Regarding claims 10-11, Stoy in the combination does not explicitly disclose, the three-dimensional polymeric matrix is in stationary position and moving an ionizing energy source in at least one direction or the ionizing energy source is in stationary position and moving the three-dimensional polymeric matrix in at least one direction. Gupta discloses that, as illustrated in Fig. 10, the lens blank or preformed lens with the mold is rotated in an effort to facilitate curing throughout the lens (col. 18, lines 7-9). Further, Gupta discloses that, as illustrated in Fig. 10, chambers 98 and 100 include actinic radiation or UV radiation sources 102 and choppers 104. Choppers 104 are driven by a mechanism (for rotation) (not shown). Choppers 104 include a disk 106 having a UV transparent portion 108 and opaque portions 110 (col. 14, lines 61-66). It is noticed that, the integration of radiation sources 102 and choppers 104 is proving the curing energy to the lens blank or preformed lens. Thus, at least Gupta is capable to provide either the three-dimensional polymeric matrix is in stationary position and moving an ionizing energy source in at least one direction or the ionizing energy source is in stationary position and moving the three-dimensional polymeric matrix in at least one direction.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stoy to incorporate the teachings of Gupta to provide that the three-dimensional polymeric matrix has a surface anti-reflective layer from 50 nm to 100 microns thick. Doing so would be possible to have a method and an apparatus to utilize a resin formulation to form high quality optics easily and quickly, as recognized by Gupta (col. 5, lines 15-27).
Claim 25 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Stoy et al. (WO2014/111769, English version based on US2020/0038549) in view of Klima (US 2006/0064162).
Regarding claim 25, Stoy discloses that, a method of inducing a non-uniform cross-link density in a polymeric material, comprising:
providing a previously cross-linked, three-dimensional polymeric matrix (“matrix”) comprising a plurality of cross-linked bonds; and
at a time prior to implanting the polymeric matrix in an eye (e.g., in [0172] (as shown in Fig. 6B), Stoy discloses that, (at least) the zone 15 or 16 can be created by the modification of a hydrogel according to the present invention using a laser. The hydrogel modification can be carried out either preoperatively or postoperatively (lines 7-11)),
creating a gradually varying reduction in cross-link density within the matrix ([0068], lines 7-10 (i.e., at least part of the released monomers and/or fragments may re-polymerize and create a denser network structure with a higher refractive index than the parent hydrogel (i.e., the reduction of refractive index from the voxels to the hydrogel)); [0157], lines 1-4) (It is noticed that, the matrix with a higher refractive power (or a higher index of refraction) has a higher cross-link density ([0068]; it is noticed that, an additional feature of the invention is creation of a gradient (i.e., the equivalence to the creation of a gradually varying reduced cross-link density from each individual voxel the corresponding hydrogel) of refractive index in the vicinity of individual voxels ([0068], lines 1-3); Here, each voxel can be considered as one portion of an optic of the intraocular lens).
However, Stoy does not explicitly disclose applying ionizing energy such as x-rays in electromagnetic radiation. In the same field of endeavor, intraocular lens, Klima discloses that, by applying electromagnetic radiation (e.g., heat infrared, ultraviolet, laser, x-rays) to one or more portions of intraocular lens, the intraocular lens can be changed or adjusted ([0012], [0013] (lines 9-10)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stoy to incorporate the teachings of Klima to apply variably ionizing energy such as x-rays to one or more portions of intraocular lens to create the different refractive index in the matrix. Doing so would be possible to adjust the properties of the ophthalmic lens implanted (or in vivo) in the human eye, as recognized by Klima ([0012], [0013]).
Response to Arguments
Applicant's arguments filed 7/17/2025 have been fully considered. They are not persuasive.
In response to applicant’s arguments (as amended) in claims 1, 24, 25 that the base reference Stoy provides the approach that is ‘an in situ-modification of the three-dimensional polymeric matrix’, it is not persuasive.
In [0172] (as shown in Fig. 6B), Stoy discloses that, the zone 15 or 16 can be created by the modification of a hydrogel according to the present invention using a laser. The hydrogel modification can be carried out either preoperatively or postoperatively (lines 7-11). Here, specifically, ‘preoperatively’ can be considered that the modification of the three-dimensional polymeric matrix is conducted prior to implanting. In other words, ‘in situ- modification of the three-dimensional polymeric matrix’ is not the solitary option in the teachings of Stoy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIBIN LIANG whose telephone number is (571)272-8811. The examiner can normally be reached on M-F 8:30 - 4:30.
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, Alison L Hindenlang can be reached on 571 270 7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIBIN LIANG/Examiner, Art Unit 1741
/John J DeRusso/Primary Examiner, Art Unit 1744