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) 1-20 is/are pending. Claim(s) 3 and 13-20 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, Species 1-1, and Species 2-2 in the reply filed on 5/21/2026 is acknowledged.
Claims 3 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, Species 1-2, and Species 2-1, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/21/2026.
Information Disclosure Statement
The information disclosure statement filed 2/10/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the lined through FOR document was not provided in English or with an English equivalent. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Claim limitation “see Table I below” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “see Table I below” coupled with functional language “see Table I below” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) see Table I below has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: see Table I below.
Table I: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
(Original Specification)
1
mechanism
attachment
[0009], [0011] a suture
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: see Table II below.
Table II: Language Not Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
(in the claim)
6
mechanism
attachment
suture
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4-7, and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wortz, et al (Wortz) (US 9,358,103 B1).
Regarding Claim 1, Wortz teaches a device for insertion into an eye (e.g. Figure 58E, #5880, column 39, lines 1-21), comprising:
a capsule (#5880) having an outer surface (e.g. Figure 58E, radially outer surface of the rounded rectangle) defining an inner chamber configured to receive an intraocular lens (IOL) (e.g. Figure 58G, #5892 is an IOL within the inner chamber), wherein the capsule has an anterior aperture configured to allow the IOL to pass into the inner chamber (e.g. Figure 58G, anterior is the surface shown when looking at the page) and the capsule defines a posterior aperture to allow for passage of light (e.g. Figure 58A, 58C; column 65, lines 28-64, #5810 is optionally present, thus in Figure 58C when #5810 is not present, there is a posterior opening where it would have been located; column 68, lines 42-59, when #5810 is present it is able to be rotated relative to housing #5812, when #5810 rotates, there must be a posterior opening in which it rotates; thus, in each of these embodiments, there must be a posterior opening; any opening is devoid of structure when the IOL, #5810, is not present, and thus allows for passage of light therethrough), and
an attachment mechanism for attaching the capsule to a sclera of the eye (e.g. column 69, line 52 to column 70, line 5).
Regarding Claim 2, the capsule being formed from an optically clear material (e.g. column 65, lines 38-64).
Regarding Claim 4, the capsule is formed from a polymer (e.g. column 65, lines 38-64).
Regarding Claim 5, there is a flexible outer ring (e.g. Figure 58A, # 5820, column 65, lines 38-64 and column 65, line 65 to column 66, line 16).
Regarding Claim 6, the attachment mechanism comprises a suture (e.g. column 69, line 52 to column 70, line 5).
Regarding Claim 7, the suture is a loop (e.g. column 66, line 61 to column 67, line 7, the suture uses #5828, which is an opening to attach the device to the sclera; in order to make such an attachment, the suture will at least be looped around the edge of the opening in #5828 forming a loop there; see also e.g. column 71, lines 37-57).
Regarding Claim 10, there is a notch, discontinuity, or gap (e.g. Figure 58A, notch #5824, the openings discussed supra and the spacing between #s 5827s are examples of gaps, and the openings are an example of discontinuities).
Regarding Claim 11, the device is a material having strength, stability, and biocompatibility (e.g. column 65, lines 38-64, materials of the device; all materials inherently have a strength and a stability; the materials disclosed are biocompatible).
Regarding Claim 12, the device is compatible with IOLs configured to be used in a natural capsule (e.g. column 12, lines 23-42; the IOLs used in the prosthetic capsular are any IOL, which includes those designed for implantation in a natural capsule).
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 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wortz, et al (Wortz) (US 9,358,103 B1) as discussed supra and further in view of Snyder (US 2002/0091442 A1).
Regarding Claim 8, Wortz discloses the invention substantially as claimed but fails to teach there is a double arm suture.
Snyder teaches an IOL having a double arm suture used to anchor the device in the eye (e.g. [0034]).
Wortz is concerned with the same field of endeavor as the claimed invention, namely artificial capsules for IOLs. Snyder is concerned with the same field of endeavor as the claimed invention, namely double arm sutures used in the eye.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wortz’s generic suture to specifically be a double arm suture as taught by Snyder in order to provide a guiding and anchoring means for the IOL haptics (e.g. Snyder, [0034]).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wortz, et al (Wortz) (US 9,358,103 B1) as discussed supra, alone.
Regarding Claim 9, Wortz discloses the invention substantially as claimed but fails to teach the posterior aperture measures between 2 mm and 4 mm.
Wortz teaches the size of the lens placed within the aperture is 4 mm to 5 mm (e.g. column 65, lines 28-37).
Wortz is concerned with the same field of endeavor as the claimed invention, namely artificial capsules for 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 Wortz such that the posterior aperture measures between 2 mm and 4 mm since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Relevant Prior Art
US 2014/0371852 A1 to Aharoni, et al teaches a support structure for holding a lens having anterior and posterior apertures and an attachment mechanism (e.g. abstract, Figures 1, 6).
US 2003/0204256 A1 to Peng, et al teaches a support structure for holding a lens having an anterior aperture and an attachment mechanism (e.g. Figures 1-2).
US 2005/0085907 A1 to Hanna teaches a support structure for holding a lens having anterior and posterior apertures and an attachment mechanism (e.g. abstract, Figures 21-22).
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.
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 6/3/2026
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