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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 10/27/2025 is acknowledged. Claims 15-17 and 19-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: Applicant is reminded to keep claim terms consistent throughout the entirety of the claims. Specifically, “a region of an optical element” is sometimes referred to as just “the region” while other times it is referred to properly as “the region of an optical element”. While it is clear in the current context of claim 1 what this limitation is referring to, it leads to indefiniteness issues in dependent claims; see 112b rejections below. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “axicon shape of the optical region” of claim 9 must be shown or the feature(s) canceled from the claim(s). Specifically, the examiner takes the position that such a drawing is “necessary for the understanding of the subject matter sought to be patented”. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 2, 3, 6, 9-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claim 2] The limitation “generated inferior” is indefinite, as it’s unclear what it means in the currently claimed context. Specifically, the claims require that one correction is generated inferior to another. It is emphasized that “inferior” is modifying the generation, not the correction, therefore it’s unclear how generation of a correction can be inferior to another correction. Par 0014 of applicant’s specification provides a non-conclusive example of an inferior correction, e.g. a first correction of 5 diopters and a second correction of 4 diopters. While this provides context to what applicant may have intended, it does not clarify the claim language, as the specification describes an inferior correction while the claim language refers to an inferior generation. Also, applicant’s emphasis in the specification that the example in the specification was “purely exemplarily and not conclusive at all” makes it clear that the limitation is broader than the disclosed example, however such a scope is unclear as it’s unclear what else this term could encompass. For examination purposes, the examiner interprets this as inferior correction, i.e. a higher diopter correction in the core region as compared to the edge region.
[Claim 3] The limitation “the region” lacks proper antecedent basis, and is indefinite based on the fact that there are three previous regions claimed, i.e. “a region of an optical element”, “a core region” and an “edge region”. It’s unclear what region this refers to. For examination purposes, the examiner interprets this as the “region of an optical element” which includes both the edge and core regions.
[Claim 6] The limitation “the region to be treated” lacks proper antecedent basis. The claims have never previously defined a region that is treated. For examination purposes, the examiner is interpreting this claimed region to be the same as “the region of an optical element”
[Claim 9] The limitation of “an axicon shape of the optical region” is indefinite. First and foremost, “the optical region” lacks antecedent basis. For examination purposes, the examiner interprets this as the optical element, which, according to the specification, includes an eye. Second, an axicon is a conically-shaped lens that produces a ring-shaped beam. It’s unclear if the claimed shape refers to the conically-shaped lens or the resulting ring-shaped beam. It is emphasized that “axicon” is not a commonly known or used shape to describe the shape of an optical region, i.e. eye. Furthermore, it’s unclear how an optical region/eye can even be shaped like a cone or a ring. From Par 0021 of applicant’s specification, it appears that the axicon shape refers to the pattern of irradiation lines, but 1. this is not claimed, as the claims require the optical region/eye to have an axicon shape and 2. it’s unclear how a series/pattern of 2- dimensional lines can have an axicon/3D shape.
[Claim 10] The limitation “the second irradiation line” lacks antecedent basis, as the independent claim requires “a plurality of second irradiation lines”. Therefore, it’s unclear if this limitation refers to a single one of these plurality of second irradiation lines or if this is intended to refer to all the second irradiation lines. For examination purposes, as long as one of the second irradiation lines has the claimed feature, the claim language is met.
[Claims 11-12] The limitation “different second corrections” is indefinite. First and foremost, the independent claim already requires “a second optical correction different from the first optical correction in the edge region”. So it’s unclear if this claim requires an additional second correction or if it is merely referring back to the previously recited second correction. Do the claims require multiple second corrections or just one? Secondly, it’s unclear what these second corrections are different from, e.g. are they different from each other or different from the first correction. Par 0024 of applicant’s specification provides some clarity as to what is intended, which is how the claims will be interpreted for examination purposes. Specifically, the core zone has one correction, e.g. a 5 diopter correction, and the edge zone has two separate corrections one at an outer edge and another at an inner edge, e.g. a 4 diopter correction at the inner edge of the edge region and a 3 diopter correction at the outer edge of the edge region.
[Claim 13] Applicant’s use of “in particular” creates indefiniteness issues, as the claims recite both a broad and narrow range in the same claim. Therefore, it’s unclear if the limitations that follow “in particular” are optional or required. For examination purposes, the examiner is interpreting these limitations as optional.
[Claim 14] The limitation “the control of the laser is effected such that…” is indefinite as it’s unclear if/how this limitation serves to further limit any of the previously recited method steps. Specifically, the only “control” ever mentioned in the claims is in the preamble of independent claim 1 “a method for controlling a laser”. Therefore, this limitation does not pertain to any specific method step, but the method, as a whole. Second, this appears to be a statement of fact and not a method step, which creates question the metes and bounds of the limitation and particularly when infringement would occur. For examination purposes, as long as the prior art reference teaches performing the method on corneal tissue, the examiner takes the position that the limitation is met, as inherently/implicitly such corneal data must be taken into account when performing laser surgery on the cornea.
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.
Claims 1, 3-8, 11, 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0243082 to Zheleznyak et al., which incorporates the entirety of US 2012/0310340 to Knox et al.
[Claim 1] Zheleznyak discloses a method for controlling a laser of a laser device (Fig. 11) comprising at least the following steps:
generating a plurality of first laser pulses (femtosecond laser pulses directed to central zone 1106; Par 0147) with a first energy density (implicit/inherent; any/all plurality of pulses necessarily have a first energy density) within a preset energy range and below a photodisruption regime (“below the optical breakdown threshold of the tissue or optical device material to provide refractive structures that exhibit a change in refractive index, and exhibit little or no scattering loss, and scanning over the select regions with the laser such that ablation or removal of the tissue or optical device material is not observed in the irradiated region” Par 0015) of a polymer material (“cornea or natural crystalline lens, or of an intraocular lens, contact lens or inlay” Par 0147) of a region of an optical element;
irradiating a core region (center/central zone 1106; Fig. 11) of the region with the first laser pulses, wherein a refractive index of the polymer material changes at each irradiation spot irradiated with the first laser pulses depending thereon (“wherein central zone 1106 is written to provide a desired degree of dioptric power for foveal vision correction” Par 0147. Knox Par 0007 explains/details the principles of how changing the refractive index of a material via refractive structures results in a change to the dioptric/focusing power);
generating a plurality of first irradiation lines within the core region by means of a plurality of irradiation spots and thereby generating a first optical correction in the core region (Knox makes it clear that the refractive structures formed/written in the polymeric material, which are responsible for providing the desired degree of dioptric power, include a series of lines; Pars 0105 and 0122 and Figs. 1A-B of Knox);
generating a plurality of second laser pulses (femtosecond laser pulses directed to peripheral zone 1108; Par 0147) with a second energy density (implicit/inherent; any/all plurality of pulses necessarily have a second energy density) within the energy range and below a photodisruption regime (“below the optical breakdown threshold of the tissue or optical device material to provide refractive structures that exhibit a change in refractive index, and exhibit little or no scattering loss, and scanning over the select regions with the laser such that ablation or removal of the tissue or optical device material is not observed in the irradiated region” Par 0015) of the polymer material (“cornea or natural crystalline lens, or of an intraocular lens, contact lens or inlay” Par 0147) of the region of the optical element, wherein the second energy density is different from the first energy density (Both Zheleznyak, in Pars 0089 and 0133, and Knox, in Par 0105 and Figs 16A-B, make it clear that the pulse energy, average power and scan rate of the laser achieve the desired change in refractive index and therefore dioptric power; these laser parameters define the energy density, as a change in any one of these parameters will affect/change the energy density, as defined by applicant in Par 0008 of their specification. Because Zheleznyak discloses different dioptric powers for the central and peripheral zones Par 0147, it’s clear that in order to achieve these different dioptric powers, the laser parameters that define energy density are changed/different. See further explanation below.);
irradiating an edge region of the region (peripheral zone 1108), which surrounds the core region (1106) at least in certain areas, with the second laser pulses, wherein the refractive index of the polymer material changes at each irradiation spot irradiated with the second laser pulses depending thereon (peripheral zone 1108 is written to provide a change in refractive index putting a myopic defocus on the peripheral retina); and
generating a plurality of second irradiation lines within the edge region by means of a plurality of irradiation spots and thereby generating a second optical correction different from the first optical correction in the edge region (Knox makes it clear that the refractive structures formed/written in the polymeric material, which are responsible for providing the desired degree of dioptric power, include a series of lines; Pars 0105 and 0122 and Figs. 1A-B of Knox).
For clarity, with reference to Fig. 11 and Par 0147 of Zheleznyak, it’s clear that laser pulses below the photodisruption threshold are directed to two different zones (central 1106 and peripheral 1108) in a polymeric material in order to cause/create the effect of different dioptric powers or refractive indices in each of the two zones; It is emphasized that this is the same result/effect of applicant’s invention (see Par 0014 of applicant’s specification). The disclosed embodiment of Fig. 11 does not specifically detail HOW this effect/result/correction is achieved. However, when considering the reference as a whole, including the incorporated reference of Knox, it’s clear that this effect of different dioptric powers/refractive indices is caused by writing/forming refractive structures, i.e. plurality of lines, having different laser parameters, including pulse energy, average pulse and/or scan rate, which are parameters that inherently define/result in different energy densities; see citations above. For example, Par 0008 of applicant’s specification makes it clear that the BRI of the claimed energy density as the density of irradiation spots within the lines. It is noted that the scan speed/rate is inversely proportional/related to this density of spots within the lines. Specifically, faster scan speeds reduce the energy delivered per area (lower density), while slower speeds increase it. Similarly, an increase or decrease in pulse energy (Joules/J) would also result in an increase or decrease, respectively, of energy density or fluence (J/cm2). Therefore, Zheleznyak anticipates the claimed method steps.
[Claims 3-4] As shown in Fig. 11, peripheral zones (1108) are annularly shaped and all zones (1106 and 1108) are concentric to each other. The examiner contends that the plurality lines that form these zones are therefore “annularly generated” and “generated concentrically to each other”. It is emphasized that the claim language does not refer to the shape of the lines themselves, but how they are generated.
[Claim 5] Par 0147 discloses that the diameters of the core and edge regions are selected or preset, as well as the fact that the desired degree of correction in each zone is preset to fix a specific visual condition in the patient. Either of these parameters are considered a preset transition from the core region to the edge region, as “transition” is a relatively broad term.
[Claim 6] From Par 0147 it’s clear that when the laser is being directed to a cornea, the outer zone 1104 does not receive treatment, i.e. no correction occurs here. Therefore, the peripheral zones (1108) are considered an edge region used as a transitional zone from the region to be treated (central zone 1106) to a region not to be treated (1104). Specifically, any zone/area located between a treatment region and a non-treatment area, such as peripheral zones (1108), are interpreted as reading on the limitation “used as a transitional zone”
[Claim 7] Zheleznyak discloses “wherein central zone 1106 is written to provide a desired degree of dioptric power for foveal vision correction” (Par 0147); this is a predefined correction.
[Claim 8] As discussed above, in relation to claim 1, Zheleznyak discloses adjusting/controlling the laser pulse energy of the laser pulses as well as adjusting the scan rate/speed to obtain the desired corrections. It is reiterated that adjusting the scan rate inherently adjusts the respective distance of the irradiation spots to each other.
[Claim 11] Zheleznyak discloses multiple peripheral zones (1108). In terms of claim interpretation, these peripheral zones are collectively, as a whole, interpreted as the edge region, with each individual peripheral zone being an inner edge and outer edge. Specifically, the peripheral zone closest to the core/central zone (1106) is the inner edge and the peripheral zone closest to the outer zone (1104) is an outer edge. It’s clear from Par 0147 that each zone is irradiated to provide a different correction.
[Claim 13] Zheleznyak discloses the claimed laser parameters (Par 0016). Specifically, a wavelength between 600 and 1000 nm, a pulse duration between 10 fs and 100 fs and a repetition frequency between 1MHz and GHz; all of which are specific examples within the claimed ranges (MPEP 2131.03)
[Claim 14] Zheleznyak discloses that the method is performed on a cornea (Par 0147). Therefore, inherently/necessarily, the claimed corneal data, i.e. surface shape, thickness and/or overall shape, must be taken into account in order to obtain the desired correction; see 112b rejection above.
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.
Claims 2, 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zheleznyak, as applied to claims 1 and 11 above.
[Claim 2] Zheleznyak discloses that the correction in the central zone is different than the correction in the peripheral zones and are specifically tailored to fix a visual impairment in the patient, but is silent to what correction is lower/inferior. However, it’s clear that they must 1. Be different and 2. Are result-effective to achieve the desired correction. Therefore, there are only two options, the edge zone is either a higher or lower/inferior correction than the central/core zone, making it obvious to try either option based on the desired correction needed by the specific patient and visual impairments being treated.
[Claim 9] Zheleznyak is silent to an axicon shape of the optical region. However, based on the 112b rejections, it’s unclear exactly what is meant by this limitation. In an attempt to provide compact prosecution, the examiner takes the position that applicant has provided no criticality, unexpected result or any reason as to why this shape is functionally significant. Therefore, the examiner contends that such a change a shape is obvious as a matter of routine engineering/design choice; see MPEP 2144.05.
[Claim 10] As discussed in relation to claim 1 and 8, Zheleznyak discloses adjusting the laser pulse energy to obtain different corrections in each region, but is silent to whether the first or second laser pulses are lower. Similar to claim 2, the examiner contends that such a choice is obvious to try, as there are only two options, i.e. lower or higher, and/or an obvious optimization of a result effective variable, as such a choice will depend on the necessary correction in the patient.
[Claim 12] See explanation of claims 2 and 10 above. It would be obvious to try either a higher or lower correction in the inner edge, as compared to the outer edge, as this is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and/or an obvious optimization of a result-effective variable, as the choice will depend on the visual impairment and desired correction in the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/
Primary Examiner, Art Unit 3796