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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
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.
Status of the Claims
Claim(s) 1-2, 6-11, and 13-20 is/are pending. Claim(s) 18-19 is/are withdrawn. Claim(s) 3-5 and 12 is/are canceled.
Allowable Subject Matter
Claim 20 is allowable over the prior art and would be allowed if the non-prior art rejections below are addressed.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/9/2025 has been entered.
Response to Arguments
Applicant’s arguments, filed 9/10/2025, entered at RCE on 10/9/2025, with respect to claims 1-2, 6-11, 13-17, and 20 have been considered but are moot in view of the new grounds of rejection. The Examiner notes the change in prior art was necessitated by the Applicants amendments.
With respect to the previously cited prior art Applicant argues the amended language is not taught. New prior art has been introduced to teach the new language. Therefore, this argument is moot.
With respect to Sarfarazi used herein Applicant argues that the haptic cross-sections are not oriented in the correct direction. As noted in the current prior art rejection, Sarfarazi teaches the cross sections shown can replace an elliptical cross section, which is what is taught by Kelman. Thus the orientation in Figure 21 replaces the ellipse. Sarfarazi’s Figure 21 is oriented along the major axis mirroring the elliptical major axis. Thus, the pointed end is the inner peripheral surface and the curved surface is the outer peripheral surface.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 6-10, 14-16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, and 8 of U.S. Patent No. 11,337,794 in view of Sarfarazi (US 2003/0130730 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the prior patent claims the features of the instant claims as detailed in the following table.
Current Claim(s)
Prior Claim(s)
1, 6, 14, 20
1, 8
7-10, 14-16
2, 4-6
The ‘794 patent claims the invention substantially as claimed but fails to teach the inner peripheral surface comprises a profile different than a profile of the outer peripheral surface.
Sarfarazi teaches a haptic cross section having the inner peripheral surface comprises a profile different than a profile of the outer peripheral surface (e.g. Figures 21-22, where the inner peripheral surface is the pointed end and the outer peripheral surface is the rounded end).
The ‘794 patent’s claims and Sarfarazi are concerned with the same field of endeavor as the claimed invention, namely IOLs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘794 patent’s claims such that the cross section of the haptic is that as taught by Sarfarazi, and thus the inner and outer profiles are different from one another, as it is a simple substitution of one known element (e.g. Sarfarazi, [0012], the shapes of Sarfarazi are substituted for an elliptical cross-section, which is the cross-section of Kelman, e.g. Figures 5A, B) for another to obtain predictable results (MPEP 2143(I)) of a flexible haptic (e.g. Sarfarazi, [0012]) and to provide structural solutions to provide customized fitted correction, and accordion structural solutions to ease the insertion of complex lenses into the capsular bag of the eye (e.g. Sarfarazi, abstract).
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.
Claim(s) 1-2, 6, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelman (US 4,863,465) in view of Sarfarazi (US 2003/0130730 A1).
Regarding Claim 1, Kelman teaches an ophthalmic device (e.g. Figures 2A, 4-5) comprising:
an optic including an optic axis (#12); and
a haptic structure coupled with the optic (#s 14, 16) and for retaining the ophthalmic device within a capsular bag of a patient's eye (e.g. column 5, lines 1-12), wherein the haptic structure comprises an open loop (each of #s 14, 16), at least a portion of the haptic structure comprises a cross-section having a continuously-curved outer peripheral surface for contacting the capsular bag (e.g. Figures 4, 5A-B) and an inner peripheral surface opposite the outer peripheral surface (e.g. Figures 4, 5A-B),
the cross-section is oriented parallel to the optical axis (e.g. Figures 4, 5A-5B, column 3, lines 15-18; the cross section is perpendicular to the wire of the haptic and thus parallel to the optical axis), and
the cross-section further comprises a rounded corner separate from the outer peripheral surface (e.g. Figures 5A-B, as the cross-section is with elliptical or circular depending on the location along the length of the haptic, both of these shapes have an inner periphery that is rounded; as this is the inner surface it is separate from the outer periphery).
Kelman discloses the invention substantially as claimed but fails to teach the inner peripheral surface comprises a profile different than a profile of the outer peripheral surface.
Sarfarazi teaches a haptic cross section having the inner peripheral surface comprises a profile different than a profile of the outer peripheral surface (e.g. Figures 21-22, where the inner peripheral surface is the pointed end and the outer peripheral surface is the rounded end).
Kelman and Sarfarazi are concerned with the same field of endeavor as the claimed invention, namely IOLs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kelman such that the cross section of the haptic is that as taught by Sarfarazi, and thus the inner and outer profiles are different from one another, as it is a simple substitution of one known element (e.g. Sarfarazi, [0012], the shapes of Sarfarazi are substituted for an elliptical cross-section, which is the cross-section of Kelman, e.g. Figures 5A, B) for another to obtain predictable results (MPEP 2143(I)) of a flexible haptic (e.g. Sarfarazi, [0012]) and to provide structural solutions to provide customized fitted correction, and accordion structural solutions to ease the insertion of complex lenses into the capsular bag of the eye (e.g. Sarfarazi, abstract).
Regarding Claim 2, the open loop is C-shaped (e.g. Kelman, Figures 2A, 4).
Regarding Claim 6, the outer peripheral surface is smoothly curved (e.g. Sarfarazi, Figure 22).
Regarding Claim 11, at least a portion of the cross-section is convex (e.g. Sarfarazi, Figure 22).
Regarding Claim 13, at least a portion of the cross-section is substantially flat (e.g. Sarfarazi, Figure 22).
Claims 7-9 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelman (US 4,863,465) in view of Sarfarazi (US 2003/0130730 A1) as discussed supra and further in view of Deacon, et al (Deacon) (US 2008/0077238 A1).
Regarding Claims 7-9, the combination of Kelman and Sarfarazi discloses the invention substantially as claimed but fails to teach the haptic structure comprises a texture for reducing posterior capsular opacification (PCO).
Deacon teaches an IOL having a textured surface covering the haptic for reducing PCO (e.g. [0011], Figure 3, #128).
Deacon and the combination of Kelman and Sarfarazi are concerned with the same field of endeavor, namely IOLs having haptic surfaces.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Kelman and Sarfarazi such that the texture on the haptics is that as taught by Deacon in order to reduce PCO (e.g. Deacon, [0011]).
Regarding Claim 14, the combination of Kelman and Sarfarazi teaches an ophthalmic device (discussed supra for claim 1) comprising:
an optic including an optic axis (discussed supra for claim 1); and
a haptic structure coupled with the optic and for retaining the ophthalmic device within a capsular bag of a patient's eye (discussed supra for claim 1), the haptic structure comprising an open loop (discussed supra for claim 1), at least a portion of the haptic structure comprising a cross-section having a continuously-curved outer peripheral surface for contacting the capsular bag (discussed supra for claim 1).
The combination of Kelman and Sarfarazi discloses the invention substantially as claimed but fails to teach the haptic structure further comprises a texture for reducing posterior capsular opacification (PCO).
Deacon teaches an IOL having a textured surface covering the haptic for reducing PCO (e.g. [0011], Figure 3, #128).
Deacon and the combination of Kelman and Sarfarazi are concerned with the same field of endeavor, namely IOLs having haptic surfaces.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Kelman and Sarfarazi such that the texture on the haptics is that as taught by Deacon in order to reduce PCO (e.g. Deacon, [0011]).
Regarding Claim 15, the texture comprises at least one of a wavy surface, a set of repeated lines forming a square profile, or a saw tooth (e.g. Deacon, Figure 4, a cross-section through the pattern results in a square wave).
Regarding Claim 16, the texture comprises a roughened surface (e.g. Deacon, Figure 4).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelman (US 4,863,465) in view of Sarfarazi (US 2003/0130730 A1) as discussed supra and further in view of Avery, et al (Avery) (US 2009/0076603 A1).
Regarding Claim 10, the combination of Kelman and Sarfarazi discloses the invention substantially as claimed but fails to teach the haptic structure comprises a coating for reducing adherence of the haptic structure to the capsular bag.
Avery teaches a coating on at least a portion of the peripheral surface for reducing adherence of the haptic to the capsular bag (e.g. [0063)).
Avery and the combination of Kelman and Sarfarazi are concerned with the same field of endeavor, namely IOLs with haptics.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Kelman and Sarfarazi such that there is a coating on at least a portion of the peripheral surface for reducing adherence of the haptic to the capsular bag as taught by Avery in order to provide for rapid release of the haptic (e.g. Avery, [0063]).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelman (US 4,863,465) in view of Sarfarazi (US 2003/0130730 A1) and in view of Deacon, et al (Deacon) (US 2008/0077238 A1) as discussed supra and further in view of Avery, et al (Avery) (US 2009/0076603 A1).
Regarding Claim 17, the combination of Kelman, Sarfarazi, and Deacon discloses the invention substantially as claimed but fails to teach the haptic structure further comprises a coating, the first coating comprising at least one of polyehtylene glycol (PEG), plasma, parylene, or Erufosine.
Avery teaches a coating on at least a portion of the peripheral surface for reducing adherence of the haptic to the capsular bag by using a coating comprising PEG (e.g. [0063]).
Avery and the combination of Kelman, Sarfarazi, and Deacon are concerned with the same field of endeavor, namely coatings for IOL haptics.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Kelman, Sarfarazi, and Deacon such that there is a coating on at least a portion of the peripheral surface for reducing adherence of the haptic to the capsular bag as taught by Avery in order to provide for rapid release of the haptic (e.g. Avery, [0063]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 10/29/2025