Response to Arguments
Applicant's arguments filed 07/07/25 have been fully considered but they are not persuasive.
On page 8 regarding new matter rejections, Applicant argues claim 30 was “already examined and found allowable” in a previous rejection. Applicant argues [0044] states that a tilt adjustable lens can be tilted to provide ankle kappa correction, and concludes “[t]he angle is thus set”. Applicant argues further that types of intraocular lenses (IOLs) would “implicitly or inherently be non-variable in response to accommodation of the individual’s eye”, and states that Figures 4 and 7 shows IOLs with a non-variable angle, arguing this alone also provides support for the claim language.
The Examiner respectfully points out that the arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c). Statements that the angle is non-variable in response to accommodation of the eye are unsupported, making this argument unpersuasive. The Examiner also notes no part of [0044] that references eye accommodation, or an angle being non-variable. Further, the figures do not appear to show either variability or non-variability. This rejection is accordingly maintained.
On pages 8-9 Applicant argues claim 33 is supported since the disclosure refers to the term “optic”, and illustrates the optic as a single optic.
The Examiner respectfully disagrees, noting a single optic as opposed to a dual optic lens are not understood to take any particular shape or structure, making it unclear why Applicant believes a figure alone can show the type of optic being used. This rejection is accordingly maintained.
On page 10 regarding claim 57 Applicant argues that the term “mechanical axis” is “an understood term” since the Examiner guessed at its meaning in order to apply prior art.
The Examiner respectfully disagrees, noting the Examiner guessing at the meaning of the claim does not impart definiteness, but merely compact prosecution. While illustrated based on the amendments made to the specification, the Examiner is still unclear as to what the axis is and accordingly, what the boundaries of the claim are.
On pages 11-12 Applicant argues amendments overcome the prior art of record.
The Examiner respectfully disagrees, maintaining the prior art rejections.
Claim Objections
Claim 33 is objected to because of the following informalities:
Claim 33 is objected to for the sentence beginning with “a platform coupled…” being a run-on sentence which makes it unclear whether the haptics belong to the platform or the optic. Appropriate correction is required.
Specification
The amendment filed 07/07/25is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
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Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30-33, 35, 53, 55, 57-60, 63-69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 30 is rejected for having new matter, as there is no support in the originally filed disclosure for the platform to be coupled to the optic such that the angle is non-variable in response to accommodation of the individual’s eye. The originally filed disclosure does not appear to address the angle being non-variable in any way, or the eye being accommodated.
Claim 33 is rejected for containing new matter for claiming the IOL is a “single optic” IOL when the original disclosure fails to mention the type of lens anywhere.
Claim 68 is rejected for having new matter for claiming the IOL is a “single optic” IOL when the original disclosure fails to mention the type of lens anywhere.
Remaining claims are rejected for depending on a claim with new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 57-58, 63 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 57 and 63 are indefinite for claiming the platform has a “mechanical axis” but it is unclear what a “mechanical axis” is. The disclosure fails to discuss any axis of the platform, making it unclear if this is perhaps a longitudinal axis, or some other type of axis relating to the platform.
Remaining claims are indefinite for depending on an indefinite claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 33-35, 53-59 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ferrari (US2013/0331936).
Regarding claim 33, Ferrari discloses an intraocular lens 6 (Paragraph 0045; Figures 7-8) for reducing negative dysphotopsia (Paragraph 0016: intraocular lenses disclosed are manufactured for the purpose of providing angle kappa correction by tilting an optic with respect to a platform/haptic structure as shown in Figs. 5-10; Instant Specification Paragraph 0007: providing a tilt adjustment of an optical axis of an optic of an IOL with respect to a platform based on measurements of an angle kappa reduce negative dysphotopsia) comprising: an optic 7 having an optical axis (Figure 8: imaginary axis extending through the center of optic 7 perpendicular to plane P), the optic 7 being centered upon the optical axis (Figures 7-8: optic 7 is circular and therefore centered upon a respective optical axis); and a platform 8 coupled to the optic 7 (Figures 7-8: platform 8 comprising a flat peripheral region surrounding optic 7 and inclined asymmetric ends/haptics 80,81) and configured to support the optic 7 (Paragraph 0045: platform 8 comprises haptics) including haptics (80, 81), the haptics together extending in a single orientation plane (see annotated figure 8, below where the haptics together extend within a single plane), from an inner portion of each of the haptics to an outer periphery of each of the haptics (Figure 8 shows how the haptics also each extend from an inner portion adjacent the optic to an outer periphery (outermost end)), wherein the optical axis is tilted with respect to the platform 8 such that the optical axis extends at an angle that is not perpendicular with the orientation plane (Paragraph 0045: end portions/haptics 80 and 81 of platform 8 form an angle with the main plane P of symmetry of the optical portion 7, defining an orientation plane at said offset angle; Figure 8), wherein the tilt of the optical axis is adapted to provide angle kappa correction in an individual's eye (Paragraph 0043: inclination of lugs 50, 51 in intraocular lens/ IOL 3 is aimed at bringing a correction depending on the value of the kappa angle; Paragraph 0045: intraocular implants 3 and 6 provide analogous correction as shown in Figs. 9-10), wherein the platform 8 is coupled to the optic 7 such that the angle is non-variable in response to accommodation of the individual's eye (Paragraph 0016: purpose of the platform 8 is to angularly correct orientation of the optical portion with respect to the angle kappa, and therefore the angle of the platform 8 must remain constant to provide correction after implantation), and wherein the intraocular lens 6 is a single optic 7 intraocular lens 6 (Figures 7-8).
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Regarding claim 34, Ferrari further discloses that the optical axis is tilted with respect to an orientation plane of haptics 80, 81 coupled to the intraocular lens 6 (Figure 8).
Regarding claim 35, Ferrari further discloses that a degree of tilt of the optical axis is set based on an angle kappa of one or more individuals' eyes (Paragraph 0043: inclination and difference in length of the haptics are selected to bring correction depending on the value of the kappa angle of an individual).
Regarding claim 53, Ferrari further discloses that the optic 7 is tilted with respect to the platform 8 to provide angle kappa correction in the individual's eye (Paragraph 0043; Figures 7-8: optic 7 is tilted with respect to the haptics 80, 81 of platform 8, wherein the inclination and length of the haptics 80, 81 of the platform 8 correct for angle kappa).
Regarding claim 54, Ferrari further discloses that the platform 8 includes haptics 80, 81 (Figures 7-8; Paragraph 0043).
Regarding claim 55, Ferrari further discloses that the optic 7 comprises a multifocal lens (Paragraphs 0008 and 0015: optic may be single-focus or multi-focus).
Regarding claim 56, Ferrari further discloses that the optical axis is not perpendicular with the orientation plane of the haptics 80, 81 (Figures 7-8).
Regarding claim 57, Ferrari further discloses that the platform 8 has a mechanical axis, and the optical axis is angled with respect to the mechanical axis (Annotated Figure 8: mechanical axis interpreted as axis perpendicular to haptics 80, 81 of platform 8).
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Annotated Figure 8
Regarding claim 58, Ferrari further discloses that the single orientation plane comprises a plane (Figure 8: plane defined by inclination angle of the haptics 80, 81 with respect to the optic 7) that the haptics 80, 81 position the optic 7 in within an eye (Figures 7-8; Paragraph 0045: end portions 80 and 81 of which extend diametrically on both sides of the optical portion 7, are aimed at positioning the intraocular implant in the capsular bag).
Regarding claim 59, Ferrari further discloses that the tilt of the optical axis centers the optic 7 with respect to a visual axis of the individual's eye (Paragraphs 00012 and 0043: inclination of the haptics 80, 81 provides angle kappa correction, i.e., the angular distance between the best fix axis/BFA and visual axis; Figures 9-10: visual axis V).
Conclusion
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/09/25
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