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 .
Status of Claims
Claims 23-38 are currently pending and under consideration.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 23-27 and 38 (steps under (i) in claim 38), drawn to ophthalmic mask for application to an eyeball of an eye during a punctual irradiation of the eye with light.
Group II, claim(s) 28-38 (steps under (ii) in claim 38), drawn to an ophthalmic device for the treatment, in particular laser treatment, of an eye.
Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II are two distinct inventions with group I claiming an ophthalmic mask and group II claiming a device for guiding and holding the eye open during treatment. Groups I and II do not share a technical feature. Therefore, unity of invention is lacking a priori.
During a telephone conversation with Michael Frodsham on March 10, 2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 28-38. Affirmation of this election must be made by applicant in replying to this Office action. Claims 23-27 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is recommended to amend claim 29 which currently refers to claim 0 to reference correct claim number.
Further, claim 38 is included in both groups because steps in (i) depends from claim 23 (group I) and steps in (ii) are related to the device of group II. As such, applicant is further recommended to amend the claim to be consistent with the elected group. As group II was elected, the claim will be interpreted as the steps in (ii). For the purposes of examination, claim 38 is being interpreted as follows (an independent claim only including (ii) steps):
“A method comprising the steps of: applying a support body of an ophthalmic device to an eyeball of an eye, and inserting a distal end of a light guide of a light applicator, which is designed to emit laser light (L, L', L"), into a retaining element or fixing element of the at least one retaining element or fixing element of the ophthalmic device; wherein the distal end is detachably held by the retaining element or fixing element on the guide body of the ophthalmic device, and when the support body is placed on the eyeball, and the laser light (L, L', L") is locally applicable to the eyeball or components thereof in a targeted manner through the light guide.”
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 17, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on May 29, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: “for example according to any one of claims 11 to 22” in ¶[0158] is directed towards cancelled claims. It is advised to make changes to the spec as claims are amended.
Appropriate correction is required.
Claim Objections
Claim 38 is objected to because of the following informalities: “of the ophthalmic device, and when the support body” in line 15 should be changed to “of the ophthalmic device when the support body” for grammar. Appropriate correction is required.
Claim Interpretation
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.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "a grip element which is set up to hold the support body on the eyeball and/or to press it against the eyeball" in claims 28-37.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A grip element is interpreted as described in ¶[0037] of the specification: “a grip element, for example a handle, e.g. a handle-like grip” and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 29, “ring bead” is a toroidal or bead-like in shape, with curves oriented towards the first side or a rounded contact surface or line for gentle contact with the eyeball or cornea (¶[0163]).
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 28-38 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 28 recites the limitation "the treatment" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination this will be interpreted as “treatment”.
Claim 28 recites the limitation "the cornea" in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination this will be interpreted as “a cornea”.
Claim 28 recites “the retaining element” in line 11. Prior citation of retaining element recited “one or more” retaining elements. It is unclear if this limitation is directed to one of the one or more retaining elements or all of the one or more retaining elements. For the purposes of examination this will be interpreted as “the one or more retaining elements”.
Regarding claims 28, 30, 35, and 36, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c)(I) “If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 28 recites the broad recitation for the treatment of an eye, and the claim also recites in particular laser treatment which is the narrower statement of the range/limitation. For the purposes of examination this will be interpreted as “for treatment of an eye”.
In the present instance, claim 28 recites the broad recitation for direct support on an eyeball, and the claim also recites in particular for direct support on the cornea of an eye which is the narrower statement of the range/limitation. For the purposes of examination this will be interpreted as “for direct support on an eyeball”.
In the present instance, claim 28 recites the broad recitation the guide body is movably, and the claim also recites in particular slidably which is the narrower statement of the range/limitation. For the purposes of examination this will be interpreted as “the guide body is movable”.
In the present instance, claim 29 recites the broad recitation a complementary slide bearing surface, and the claim also recites preferably an axial slide bearing, and further recites further preferably designed as a tapered slide bearing which are the narrower statement of the range/limitation. For the purposes of examination this will be interpreted as “a complementary slide bearing surface”.
In the present instance, claim 30 recites the broad recitation at least one retaining element or fixing element, and the claim also recites preferably all retaining elements or fixing which is a narrower statement of the range/limitation. For the purposes of examination this will be interpreted as “at least one retaining element or fixing element”.
In the present instance, claim 30 recites the broad recitation a channel, and the claim also recites the channel is preferably designed and arranged such that light (L) is applicable to the eyeball or components thereof through the inserted free end (F) of the light guide, upon movement of the guide body, and even further recites in particular at least locally along the predetermined path which are narrower statements of the range/limitation. For the purposes of examination this will be interpreted as “a channel”.
In the present instance, claim 35 recites the broad recitation a predetermined angle (N), and the claim also recites the angle (N) is preferably between 35 and 45 degrees, even further recites in particular at about 40 degrees, and even further recites further preferably, a longitudinal axis of the channel is inclined at the predetermined angle to the central axis of the guide body which are narrower statements of the range/limitation. For the purposes of examination this will be interpreted as “a predetermined angle of 40 degrees”.
In the present instance, claim 36 recites the broad recitation the guide body is coupled loss-proof to the support body, and the claim also recites preferably via complementary coupling elements, such as snap-in surfaces, complementary tongue and groove connections and/or a tongue and groove connection, which are further preferably formed in bearing surfaces, in particular slide bearing surfaces, which are narrower statements of the range/limitation. For the purposes of examination this will be interpreted as “the guide body is coupled loss-proof to the support body”.
In the present instance, claim 36 recites the broad recitation the free end (F) of the light guide held on or by the retaining element or fixing element and facing the first side follows a circular path, and the claim also recites which preferably has a diameter in the range between 15 and 25, preferably between 17 mm and 19 mm, in particular approximately 18.75 mm, which are narrower statements of the range/limitation. For the purposes of examination this will be interpreted as “the free end (F) of the light guide held on or by the retaining element or fixing element and facing the first side follows a circular path with a diameter of 18-19 mm”.
In the present instance, claim 37 recites the broad recitation a device for engaging and retaining the eyelids of the eye when the support body is placed on the eyeball, and the claim also recites wherein the device is preferably formed on the support body, which is a narrower statement of the range/limitation. For the purposes of examination this will be interpreted as “a device for engaging and retaining the eyelids of the eye when the support body is placed on the eyeball”.
Claim 29 recites “according to claim 0” and it is unclear which claim it is dependent on. For the purposes of examination, this will be interpreted as depending on claim 28.
Regarding claims 29, 30, 35, 36, and 37, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c)(I) “If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim”.
Claim 29 the recitation of “and/or” at the end of the first limitation is unclear. It is not clear whether this is dividing the first limitation “the support body has a ring bead on the first side for resting on the eyeball” from the rest of the claim (ie. “the support body has a ring bead on the first side for resting on the eyeball” and/or “the support body has a slide bearing surface and the guide body has a complementary slide bearing surface, which form a slide bearing, preferably an axial slide bearing and the slide bearing is further preferably designed as a tapered slide bearing”) or if it is separating the first two limitations separate from the third limitation (ie. “the support body has a ring bead on the first side for resting on the eyeball and/or the support body has a slide bearing surface and the guide body has a complementary slide bearing surface, which form a slide bearing, preferably an axial slide bearing” and “the slide bearing is further preferably designed as a tapered slide bearing.”). For the purposes of examination, the “and/or” will be interpreted as the former:
“the support body has a ring bead on the first side for resting on the eyeball; and/or
the support body has a slide bearing surface and the guide body has a complementary slide bearing surface, which form a slide bearing, preferably an axial slide bearing, and the slide bearing is further preferably designed as a tapered slide bearing”.
The term “at least locally” in claim 30 is a relative term which renders the claim indefinite. The term “at least locally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This renders the limitation “upon movement of the guide body, in particular at least locally along the predetermined path” indefinite.
Claim 33 recites the limitation "the … disk surface" and “the ring body or disk body axis” and “the respective ring body or disk body”. There is insufficient antecedent basis for these limitation in the claim. For examination the claim will be interpreted as “wherein the first and/or second cone or a disk surface are/is coaxially aligned with a ring body or disk body axis of a respective ring body or disk body”.
Claims 34 and 35 recites the limitation "the central axis (M)”. There is insufficient antecedent basis for these limitation in the claim. For examination the claim will be interpreted as “a central axis (M)”.
The term “about” in claim 35 is a relative term which renders the claim indefinite. The term “about 40 degrees” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The range of “angle (N)” is rendered indefinite by the use of the relative term “about.” The limitation “about 40 degrees” will be interpreted as angles within and outside of “35-45 degrees” for the purposes of examination.
The term “approximately” in claim 36 is a relative term which renders the claim indefinite. The term “approximately 18.75 mm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed “diameter” is rendered indefinite by the use the relative term “approximately.” The limitation “approximately 18.75 mm” will be interpreted as diameters within and outside of “18-19 mm” for the purposes of examination.
Regarding claim 36, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As claims 29 (as stated above), 30, 31, 32, 35, 36, and 37 depend on claim 28, they are rejected for the same reasons as claim 28.
As claims 33 and 34 depend on claim 31, they are rejected for the same reasons as claim 31.
Claim 38 recites the limitation "of the at least one retaining element or fixing element”. There is insufficient antecedent basis for these limitation in the claim. For examination the claim will be interpreted as “inserting a distal end of a light guide of a light applicator, which is designed to emit laser light (L, L', L"), into a retaining element or fixing element of at least one retaining element or fixing element of the ophthalmic device”.
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 (i.e., changing from AIA to pre-AIA ) 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.
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 38 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heitel (US 20140222050 A1, published Aug. 8, 2014).
Regarding claim 38, Heitel teaches a method comprising the steps of: applying a support body of an ophthalmic device (Fig. 1 “the stabilization device 10 suitably comprises an ocular attachment ring 12, by means of which the stabilization device 10 is coupled to the eye” in ¶[0037] and Fig. 8 element 20) to an eyeball of an eye (“The support ring 20 is disposed within the annular cavity 106 of the suction ring 18 and is configured to prevent buildup of intraocular pressure when the ocular stability device 10 is placed on the eyeball. In this way, the device 10 can be more easily removed from the eyeball after completion of a laser surgery procedure.” In ¶[0068]), and inserting a distal end of a light guide of a light applicator (Fig. 8 “The lens cone 12 is configured to engage with the laser surgical device (not shown) and to maintain the applanation lens 14 and hence, a portion of the eye, a known distance from a delivery tip of the laser surgical device.” in ¶[0057] and “base ring 22 is configured to attach to a distal end of the laser surgical device” in ¶[0058]), which is designed to emit laser light (L, L', L"), into a retaining element or fixing element of at least one retaining element or fixing element of the ophthalmic device (Fig. 1 “a lens cone 16 and an applanation lens 18, which in combination with the lens cone 16 is used to establish an appropriate optical path alignment between the cornea and a laser optical path” in ¶[0037] and Fig. 8 “ocular stabilization device 10 includes a lens cone 12, an applanation lens 14” in ¶[0057] and “the apex ring 24 define openings that are suitably aligned and dimensioned to provide unobstructed passage for a laser beam” in ¶[0058]); wherein the distal end is detachably held by the retaining element or fixing element on the guide body of the ophthalmic device (Fig. 8 “The lens cone 12 is configured to engage with the laser surgical device (not shown) and to maintain the applanation lens 14 and hence, a portion of the eye, a known distance from a delivery tip of the laser surgical device.” in ¶[0057] and “base ring 22 is configured to attach to a distal end of the laser surgical device” in ¶[0058]), and when the support body is placed on the eyeball, and the laser light (L, L', L") is locally applicable to the eyeball or components thereof in a targeted manner through the light guide (Fig. 3 “The patient interface 100 includes a lens cone 160 to establish an appropriate optical path alignment between the cornea and a laser optical path.” In ¶[0045] and “The stabilization device grips, holds or affixes the eye to the applanation lens, or laser optic, during a laser surgical procedure, so as to minimize or preclude differential motion of the human eye with respect to the laser optical path during the laser procedure.” In ¶[0036]).
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.
Claims 28, 32, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Heitel in view of Belkin et al. (US 20130123761 A1, published May 16, 2013, previously cited in the IDS, hereinafter referred to as “Belkin”).
Regarding claim 28, Heitel teaches an ophthalmic device for treatment of an eye (Fig. 1 the stabilization device 10 in ¶[0037] and “the ocular stabilization device … is an apparatus that attaches to a human eye and holds (fixes) the eye in all three axes (x, y and z) from translational and rotational movement with respect to the incident beam of a laser surgical device” in ¶[0036]), comprising: a support body with a first side for direct support on an eyeball (Fig. 1 “the stabilization device 10 suitably comprises an ocular attachment ring 12, by means of which the stabilization device 10 is coupled to the eye” in ¶[0037] and Fig. 8 element 20), the support body having a grip element which is set up to hold the support body on the eyeball and/or to press it against the eyeball (Fig. 1 “a gripper device 14” in ¶[0037] and “attachment fitting 44 coupled to a vacuum source” in ¶[0039] and Fig. 8 “a gripper component 16, a suction or attachment ring 18, and the support ring 20” in ¶[0057]); and a guide body (Fig. 1 “lens cone 16” in ¶[0037] and Fig. 8 “lens cone 12” in ¶[0057]) which has at least one retaining element or fixing element for releasably holding a free end (F) of a light guide on the guide body (Fig. 8 “The lens cone 12 is configured to engage with the laser surgical device (not shown) and to maintain the applanation lens 14 and hence, a portion of the eye, a known distance from a delivery tip of the laser surgical device.” in ¶[0057] and “base ring 22 is configured to attach to a distal end of the laser surgical device” in ¶[0058]) in such a way that, when the support body is placed on the eyeball, light (L) can be selectively applied to the eyeball or components thereof through the light guide (Fig. 1 “a lens cone 16 and an applanation lens 18, which in combination with the lens cone 16 is used to establish an appropriate optical path alignment between the cornea and a laser optical path” in ¶[0037] and Fig. 8 “ocular stabilization device 10 includes a lens cone 12, an applanation lens 14” in ¶[0057] and “the apex ring 24 define openings that are suitably aligned and dimensioned to provide unobstructed passage for a laser beam” in ¶[0058]); wherein the guide body is movably mounted on the support body (“the devices' component parts are [not] permanently affixed to one another: indeed, the component parts are separable and interchangeable at will. Rather, the stabilization device 10 (Fig. 1 and 8) is intended to form a single composite interface structure between a human cornea and a surgical laser once the component parts have been aligned with a patient's eye and with respect to the laser delivery system” in ¶[0038]).
Although the guide body of Heitel is capable of moving relative to the support body since the pieces are separable. Heitel does not disclose wherein the guide body is movably mounted on the support body in such a way that the one or more retaining element or fixing element moves along a predetermined path when the guide body moves relative to the support body.
Belkin’s invention relates to medical devices, and in particular to such devices for use in ophthalmology. Apertures, having circular or arched cross-section, are transparent to electromagnetic radiation of the treatment beams of interest and allow them to pass through, while the rest of the plate is opaque to these beams. The plate with one or more apertures may be rotatable so that each aperture/transparent region can be positioned over different locations of the scleral limbus while scanning the limbal area (¶[0015]). The treatment beam may be quickly and precisely delivered to the treatment area and this condition may be accurately maintained during the treatment, thus allowing the treatment to be quick and with the desirably high light intensity and energy as regions outside the treatment area are prevented from being reached by the treatment beam (¶[0021]). The opaque element may be rotatable about the center of the circular array (this moves the location of the laser beam in a predetermined path) (¶[0043]). The treatment beam may be initially split into an array of beams supplied to the plate by an array of optical fibers (¶[0057]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to attach the guide body to the support body in such a way that that the one or more retaining elements or fixing elements move along a predetermined path as taught by Belkin in the device of Heitel to treat the entire lumbus (¶[0057]) while preventing treatment outside of the treatment area.
Regarding claim 32, Heitel teaches wherein the support body is substantially in the form of a ring body or disk body (Fig. 1 “the stabilization device 10 suitably comprises an ocular attachment ring 12, by means of which the stabilization device 10 is coupled to the eye” in ¶[0037] and Fig. 8 element 20).
Regarding claim 36, Heitel does not disclose the guide body is mounted on the support body in such a way that the free end (F) of the light guide held on or by the retaining element or fixing element and facing the first side follows a circular path, which has a diameter of 18-19 mm, when the guide body is moved relative to the support body.
Belkin teaches that the opaque element may be rotatable about the center of the circular array (this moves the location of the laser beam in a predetermined path which is a circular path) (¶[0043]).
The instant specification discloses the appropriate ranges that apply to the claimed invention in ¶[0066] as having a diameter in the range between 15 mm and 25 mm, preferably between 17 and 19 mm, in particular around 18.75 mm. However, the specification does not disclose that the specifically claimed range(s) of 18-19 mm is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Belkin teaches that the circular array of apertures may have a diameter in the range from 11 to 13 mm, which is the typical diameter of the sclera limbus and the plate 21 may have as many as 200 apertures (equally) spaced along the peripheral circumference of the plate 21, so that 200 spots in the sclera limbus can be treated simultaneously (¶[0056]), the prior art therefore provides teaching that the diameter is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed range(s) of 18-19 mm provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that the diameter is selected based on the treatment region, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 18-19 mm by normal optimization procedures known in the arts depending on the area to be treated.
Claims 29, 31, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Heitel in view of Belkin (hereinafter referred to as “modified Heitel”), in further view of Hüelsewiede et al. (DE 102018127692 A1, published May 7, 2020, hereinafter referred to as “Hüelsewiede”).
Regarding claims 29 and 31, modified Heitel discloses the ophthalmic device of claim 28.
Modified Heitel does not disclose wherein: the support body has a slide bearing surface and the guide body has a complementary slide bearing surface, which form a slide bearing, and wherein: the support body comprises a first cone or cone surface forming a slide bearing surface for a complementary second cone or cone surface formed on the guide body; and the second cone or cone surface rests on the first cone or cone surface.
Hüelsewiede’s invention relates to relates to a sliding bearing arrangement for the radial and axial support of a shaft section extending along an axial longitudinal direction by providing an alternative sliding bearing arrangement for the radial and axial bearing of a shaft section, whereby permanently backlash-free operation is to be ensured (¶[0003]). This problem is solved according to the invention by a sliding bearing arrangement for the radial and axial support of a shaft section extending along an axial longitudinal direction, with a sliding bearing bushing mounted on the shaft section in a rotationally fixed manner, wherein the sliding bearing bushing has a radially outer external conical sliding surface, and with a housing-forming counter-running body with a receptacle corresponding complementarily to the external conical sliding surface of the sliding bearing bushing and with an internal conical counter-sliding surface for the sliding contact with the sliding surface of the sliding bearing bushing, wherein the sliding bearing arrangement is permanently free of play regardless of wear of the sliding surface of the sliding bearing bushing, in that the counter-running body and the shaft section with the rotationally fixed sliding bearing bushing are under permanent preload relative to each other in the axial longitudinal direction during operation and thereby the external conical sliding surface of the sliding bearing bushing and the internal conical counter-sliding surface of the counter-running body are pressed against each other in the axial longitudinal direction (¶[0004]). The sliding bearing bushing is applied to the shaft section in a rotationally fixed manner and, in an atypical way, its radially outer side is designed as a sliding surface (¶[0006]). In contrast, it proves advantageous if the shaft section is designed with an outer cone shape and the sliding bearing bushing is designed with an inner cone shape accordingly, so that it can be slid onto the shaft section in the axial longitudinal direction and, in particular, pressed onto it (¶[0007]). Fig. 1 shows a sliding bearing bushing 8 mounted on the shaft section 6 in a rotationally fixed manner, with a radially outer externally conical sliding surface 10 (second cone surface on the guide body) and with a housing-forming counter-running body 12 with a receptacle 14 for the sliding bearing bushing 8. This receptacle 14 is designed to be complementary to the externally conical sliding surface 10 of the sliding bearing bushing 8 (first cone surface on the support body). The slightly conical inclination of the sliding surface 10 and the counter-sliding surface 16 provides radial and axial support for the shaft section 6 with respect to the counter-running body 12 (¶[0022]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a the support body comprising a first cone or cone surface forming a slide bearing surface for a complementary second cone or cone surface formed on the guide body where the second cone or cone surface rests on the first cone or cone surface and they form a slide bearer as taught by Hüelsewiede in the device of modified Heitel in order to provide radial and axial support for the laser system and provide a means for the rotational functionality.
Regarding claim 33, Heitel discloses wherein the second cone (Fig. 1 “lens cone 16” in ¶[0037] and Fig. 8 “lens cone 12” in ¶[0057]) is coaxially aligned with a ring body axis (see annotated Fig. 8 below) of a respective ring body (Fig. 1 “the stabilization device 10 suitably comprises an ocular attachment ring 12, by means of which the stabilization device 10 is coupled to the eye” in ¶[0037] and Fig. 8 element 20) or disk body (“The component parts of the stabilization device 10 (Fig. 1 and 8) are illustrated in exploded view, and are intended to be collapsed vertically, such that each of the individual portions of the device are in mechanical engagement with appropriate other portions, such that the completed device is provided in a generally unitary structure” in ¶[0038]).
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Regarding claim 34, modified Heitel does not disclose wherein the first cone or cone surface tapers towards the first side and/or wherein the first cone or cone surface is oriented towards a central axis (M) of the support body.
As can be seen in Fig. 1 of Hüelsewiede’s invention, the slightly conical inclination of the sliding surface 10 and the counter-sliding surface 16 tapers along an axial longitudinal direction 4 (central axis) (¶[0022]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over modified Heitel in view of Wallfeld et al. (DE 19500708 A1, published Sept. 18, 1996, hereinafter referred to as Wallfeld).
Regarding claim 30, modified Heitel discloses the ophthalmic device of claim 28.
Modified Heitel does not disclose wherein: at least one retaining element or fixing element is designed as a channel into which the free end (F) of the light guide can be inserted.
Wallfeld’s invention relates to a device that makes it easier for the surgeon to reproducibly position a laser probe on the corneal surface of an eye (¶[0005]). In order to determine not only the position of the laser probe by the device, but also the angle at which the laser probe should hit the cornea, it is advantageous to form guides in the bores (channels) that make it possible to place the laser probe only at a certain angle to the cornea (¶[0011]). The front end of the laser probe (free end of the light guide) is then inserted successively into the inclined bores 4 to 11 (Fig.’s 1-2) in such a way that the position of the laser probe and the angle of the laser probe to the corneal surface are determined by the bore (¶[0026]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to design the retaining of fixing element as a channel into which the free end of the light guide could be inserted as taught by Wallfeld in the ophthalmic device of modified Heitel in order to reproducibly position the laser probe on the surface of the eye.
Claims 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over modified Heitel in view of Dorin et al. (WO 2020093060 A2, published May 7, 2020, hereinafter referred to as Dorin).
Regarding claim 35, Heitel does not disclose wherein: the retaining element or fixing element is arranged such that the free end (F) of the light guide is inclined at a predetermined angle (N) to a central axis (M) of the guide body, wherein the predetermined angle (N) is 35-45 degrees.
The instant specification discloses the appropriate ranges that apply to the claimed invention in ¶[0061] as preferably between 35 and 45 degrees, in particular approximately or substantially 40 degrees. The specification discloses that the specifically claimed range(s) 35-45 degrees is particularly suitable for irradiating the ciliary muscle in connection with the treatment of glaucoma.
Dorin’s invention relates to trans-scleral ab externo IOP lowering and trans-pupillary neuroprotection laser treatments for the clinical management of patients with ocular hypertension and/or glaucoma and for the treatment and/or prevention of related diseases (pg. 1 ln. 10-12). FIG. 4L schematically illustrates an eye 70 having a cornea 72 and an optical axis OA that passes near the center of the cornea and is normal (perpendicular) to the surface of the cornea. A laser energy source (such as a CW diode laser) 74 is spaced outwardly from eye 70 and directs a laser beam 76 toward the surface of the eye at an angle Q to OA to irradiate the surface of the eye and create a thermal wave that penetrates to the aqueous outflow structures and/or the ciliary body. The laser beam does not continue into the center of the globe, but to illustrate the angle between the laser beam and OA the path of the laser is traced in a dashed line to the center of the eye. In this example, the angle Q is 30-50 degrees, for example 35-40 degrees, but the angle at which beam 76 impinges the eye may vary because the therapeutic effect of the disclosed method is achieved by the generation of a heat wave that can nonspecifically propagate through the sclera to heat the aqueous outflow structures and/or the ciliary body (pg. 27 ln. 27 – pg. 28 ln. 4).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to arrange the retaining element or fixing element so that the free end of the lightguide is inclined at a predetermined angle of 35-40 degrees as taught by Dorin in the device of modified Heitel in order to treat the ciliary body for glaucoma.
Regarding claim 37, modified Heitel discloses the ophthalmic device of claim 28.
Modified Heitel does not disclose the ophthalmic device further comprising: a device for engaging and retaining the eyelids of the eye when the support body is placed on the eyeball.
Dorin, in Fig. 7A, illustrates the speculum as it would be placed in a subject’s eye to expose the sclera for the trans-scleral procedure and, in Fig. 7B, schematically illustrates the assembled patient interface in the eye (pg. 15 ln. 18-20). Interface 100 may also include an eye speculum 132 (FIGS. 6A and 6B) that includes a pair of opposing plastic arms 134, 136 that are joined at a flexible pivot point 142 that biases arms 134, 136 to the open positions shown in FIGS. 6A and 6B. The unjoined open ends of arms 134, 136 each carry curved a speculum blade 138, 140 that are configured to fit within the palpebral fissure of the eye. Speculum 132 is sufficiently flexible about pivot point 142 that the speculum arms 134, 136 may be moved toward one another to narrow the distance between blades 138, 140 and facilitate insertion of the speculum into an eye to better expose the sclera that is to be irradiated. The outward bias of arms 134, 136 will return the arms to the open position shown in FIGS. 6A and 6B to maintain exposure of the targeted eye tissue to be treated. Different size speculums may be used to open the eyelids to a preselected distance, for example 20 mm, 22 mm or 24 mm at the point of greatest separation between the eyelids (pg. 36 ln. 6-16).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a device for engaging and retaining the eyelids when the support body is placed on the eyeball as taught by Dorin in the ophthalmic device of modified Heitel in order to better expose the region of the eye to be treated.
Conclusion
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/E.N.C./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792