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.
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 Claim(s) 18-19 is/are withdrawn.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.
Response to Arguments
Applicant's arguments with respect to the Double Patenting rejections filed 2/27/2026 have been fully considered but they are not persuasive.
Double Patenting rejections are not held in abeyance and are therefore maintained as long as they are applicable.
“As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03.Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995” (MPEP 804, I, B, 1).
Applicant argues the prior art fails to teach the amended language.
Applicant’s arguments with respect to the prior art and claim(s) 1-2, 6-11, and 13-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, Jansen has been added to teach that the teardrop shape from Safarazi is rounded on the inner 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) and Jansen (US 5,376,115).
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 rounded corner separate from 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 (cross-section shape), 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).
The combination of the ‘794 claims and Safarazi claims the invention substantially as claimed but fails to teach the cross-section further comprises a rounded corner separate from the outer peripheral surface.
Jansen teaches haptic cross-sectional shapes where all corners are rounded (e.g. Figures 15-17).
Jansen and the combination of the ‘794 claims and Sarfarazi are concerned with the same field of endeavor as the claimed invention, namely IOLs having 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 the ‘794 claims and Sarfarazi by incorporating the rounded corners as taught by Jansen as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of a haptic having the desired vaulting properties (e.g. Jansen, column 5, lines 3-20) and a haptic supporting the lens when implanted in the eye.
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) and further in view of Jansen (US 5,376,115).
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
Kelman discloses the invention substantially as claimed but fails to teach the cross-section has a teardrop shape and the cross-section further comprises a rounded corner separate from the outer peripheral surface.
Sarfarazi teaches a haptic cross section having a teardrop shape (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 cross-section is a teardrop shape, 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).
The combination of Kelman and Safarazi discloses the invention substantially as claimed but fails to teach the cross-section further comprises a rounded corner separate from the outer peripheral surface.
Jansen teaches haptic cross-sectional shapes where all corners are rounded (e.g. Figures 15-17).
Jansen and the combination of Kelman and Sarfarazi are concerned with the same field of endeavor as the claimed invention, namely IOLs having 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 by incorporating the rounded corners as taught by Jansen as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of a haptic having the desired vaulting properties (e.g. Jansen, column 5, lines 3-20) and a haptic supporting the lens when implanted in the eye.
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) and further in view of Jansen (US 5,376,115) 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 teardrop cross-section having a continuously-curved outer peripheral surface for contacting the capsular bag and an inner peripheral surface with a rounded corner opposite the outer peripheral surface (discussed supra for claim 1).
The combination of Kelman, Sarfarazi, and Jansen 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, Sarfarazi, and Jansen 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, Sarfarazi, and Jansen 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) in view of Jansen (US 5,376,115) 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) ) in view of Jansen (US 5,376,115) 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, Jansen, 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, Jansen, 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, Jansen, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/9/2026
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