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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendment filed July 1, 2026 has been entered. Claims 28-30 and 34-42 remain pending in the application. Applicant’s amendments have overcome some 112 and the previous 103 grounds of rejection previously set forth in the Non-Final Office Action mailed Apr. 2, 2026.
Applicant is advised that all added claim language should be underlined. Claim 38 appears to have added “according to claim 28” without marking it with underlining.
It is noted that claims 39-42 are identified with incorrect status identifiers. As these claims were not present in the previous amendment, the status of “Currently Amended” should read “New”. Further, as these claims are newly added they should not have any markup present.
Response to Arguments
Claim Objections:
Applicant amended claims and addressed all previous claim objections and the objections have been withdrawn.
Specification:
Applicant amended specification and addressed all previous specification objections, and the objections have been withdrawn.
35 U.S.C. § 112:
Applicant amended claims and addressed most of the previous 112 claim rejections, outstanding rejections are below.
35 U.S.C. § 102:
Applicant amended claims and addressed previous 35 USC 102 rejection, and the 35 USC 102 rejection has been withdrawn.
35 U.S.C. § 103:
Applicant’s arguments with respect to claim(s) 28-30 and 34-42 have been considered but are moot because of the new grounds of rejection. Responses below address arguments that are still pertinent to the new rejection.
On page 11 of Applicant’s response, applicant argues the Huelsewied is a non-analogous art use and could not be combined to have channels. In response to applicant's argument that Huelsewied is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Huelsewied’s invention is concerned with the same mechanical properties as the instant application including a sliding bearing arrangement for the radial and axial support whereby permanently backlash-free operation is to be ensured. Further, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 device for engaging and retaining the eyelids of the eye" in Claim 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 device for engaging and retaining is interpreted as described in ¶[0067] of the specification: “an eyelid speculum” 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 29, 34-35, and 39-40 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 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.
Claims 34 and 35 recites the limitation "the central axis (M)”. There is insufficient antecedent basis for these limitations in the claim. For examination the claim will be interpreted as “a central axis (M)”.
Claims 39-40 are dependent on claim 35 and are rejected for the same reasons as claim 35.
Claim 36 recites “on woe more of complementary coupling elements, snap-in surfaces, complementary tongue and groove connection, and a tongue and groove connection, which are formed in the slide bearing surfaces” which is not clear whether this is a Markush claim or not. Further, complementary tongue and groove connection and a tongue and groove connection are the same component. This claim will be interpreted as “one or more of complementary coupling elements, which are formed in the slide bearing surfaces”.
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 28-30, 34-36, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Fontana et al. (BR 102020004113 A2, published Sept. 14, 2021, hereinafter referred to as “Fontana”), in view of Hüelsewiede et al. (DE 102018127692 A1, published May 7, 2020, previously cited, hereinafter referred to as “Hüelsewiede”), and Benetsuto et al. (JP H01274759 A, published Nov. 2, 1989, hereinafter referred to as “Benetsuto”).
Regarding claim 28, Fontana teaches an ophthalmic device for laser treatment of an eye (“an optical device is used where the beam from a laser is provided by conventional optical fiber, and the device proposed here is the refractive guide and support mechanism” ¶[24]), comprising: a support body with a first side for direct support on an eyeball, of an eye, and with a second side facing away from the first side (Fig. 2A “base optical ring (2-1) has the function of positioning itself precisely with respect to the limbus in the iris boundary sclera, and resting on the radius of the sphere of the patient's eye” ¶[26]), a handle configured to enable a user to hold the support body on the eyeball, the handle extending obliquely relative to and in a direction from the first side to the second side (Fig. 2A “handle (2-5)” ¶[27]); and a guide body which has at least one channel (Fig. 3A “the hole (3-3) is intended for the placement of its probe, indicated as item (3- 5) in figure 3B” ¶[29]) into which a free end (F) of a light guide can be inserted and for releasably accommodating and holding the free end (F) of the light guide on the guide body 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. 2A “Another ring (2-3) is mounted on the ring (2-1), which is responsible for supporting the optical fiber, shown as (2-6). When all are fitted over the patient's eye, as in Figure 2B, the operator or physician holds the device by the handle (2-5), oriented so that it is in the temporal region of the respective eye on the patient, and places the optical fiber ( 2-6) in the holes (2-3) present in the part (2-2).” ¶[27]); wherein the guide body is slidably and rotatably mounted on the support body in such a way that the at least one channel rotates about a central axis (M) of the support body when the guide body moves rotates about the central axis relative to the support body (Fig. 2A “The optical part (2-2) slides up the optical base (2-1), thus allowing the operator to rotate the optical support (2-2) with respect to the base (2-1), thus allowing the fiber is positioned in various positions and orientations on the circumference of the limb, just below it.” ¶[28]); and that a movement of the guide body and an accompanying movement of the at least one channel relative to the support body can be effected by the light guide, held by the channel, as a manipulator (“it rotates the ring 3-2, using the fiber end itself as a manipulator” ¶[44]); the support body and the guide body formed as annular ring bodies (Fig. 2A “base optical ring (2-1)” ¶[26] and “ring (2-3)” ¶[27]), forming slide bearing surfaces between the guide body and the support body and enable rotary movement of the guide body about the central axis, the slide bearing surfaces forming an axial slide bearing with sliding surfaces (“that is, into the seat (3-15) and base (3-22) making the assembly work as an axial sliding bearing, enabling the guide ring (3-2) to rotate freely on an axis parallel to the axis of the patient's optical eye. This enables the optical fiber (3-5) to be positioned at various angles of rotation with respect to the axis of the eye, as shown in Figure 4A.” ¶[31]), and a viewing aperture being present in the center of the annular bodies (See Fig.’s 2A-2B and 4B - the eye is visible in the middle of the assembled rings).
Fontana does not disclose the support body having a handle, and having a conical structure tapering in a funnel shape towards the first side, the guide body inserted into the support body from the second side, a first conical surface of the guide body facing away from the central axis and extending around the central axis is in contact with a second conical surface of the support body facing the central axis and extending around the central axis, the first and second conical surfaces; the at least one channel extending in a wall of the guide body substantially parallel to the slide bearing surfaces.
Fontana does teach the angle of the channel can be any angle (“the optical fiber (3-5) to be positioned at various angles of rotation with respect to the axis of the eye, as shown in Figure 4A” ¶[31]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the channel extend substantially parallel to the slide bearing surfaces because there are a finite number of angles the channel can be positioned in order to effect treatment into the eye.
Fontana does not disclose the support body having a handle, and having a conical structure tapering in a funnel shape towards the first side, the guide body inserted into the support body from the second side, a first conical surface of the guide body facing away from the central axis and extending around the central axis is in contact with a second conical surface of the support body facing the central axis and extending around the central axis, the first and second conical surfaces.
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 Fontana in order to provide radial and axial support for the laser system and provide a means for the rotational functionality.
Although Fontana teaches a handle, Fontana and Hüelsewiede do not disclose the handle being on the support body.
Benetsuto’s invention relates to an eyeball fixing method and apparatus for fixing a patient's head to the eyeball so as not to obstruct the operation when performing an operation on the outer corneal surface of the eyeball, and an apparatus for fixing the eyeball. A key feature of this device is a ring member 60 having a rigid tubular handle 62, which projects from the ring member 60 at the desired angle as seen in Fig. 4.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the handle extending obliquely relative to and in a direction from the first side to the second side as taught by Benetsuto in the ophthalmic device of Fontana and Hüelsewiede to place and hold the device on the eyeball.
Regarding claim 29, Fontana teaches wherein: the support body has a ring bead on the first side for resting on the eyeball (“according to the top view 3C, where the surface (3-17) has a sphere radius in order to fit over the sclera of the eyeball” claim 4).
Regarding claim 30, Fontana teaches wherein: the at least one channel is designed and arranged such that light (L) is applicable to different sections of the eyeball or components thereof through the inserted free end (F) of the light guide upon rotating the guide body using the light guide as a manipulator (“that is, into the seat (3-15) and base (3-22) making the assembly work as an axial sliding bearing, enabling the guide ring (3-2) to rotate freely on an axis parallel to the axis of the patient's optical eye. This enables the optical fiber (3-5) to be positioned at various angles of rotation with respect to the axis of the eye, as shown in Figure 4A.” ¶[31]).
Regarding claim 34, Hüelsewiede discloses wherein the first conical surface tapers towards the first side and is oriented towards a central axis (M) (Fig. 1 “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]).
Regarding claim 35, Fontana teaches wherein: the at least one channel 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 (see Fig. 3B (3-3) – this angle is inherently predetermined as it is a part of the structure).
Regarding claim 38, Fontana, Hüelsewiede, and Benetsuto teach the device of claim 28 with channels. Fontana also teaches a method comprising the steps of: applying a support body of an ophthalmic device to an eyeball of an eye (Fig. 2A “base optical ring (2-1) has the function of positioning itself precisely with respect to the limbus in the iris boundary sclera, and resting on the radius of the sphere of the patient's eye” ¶[26] and “base fixing ring (2-1) has the function of precisely positioning itself in relation to the limbus (2-8) in the iris and sclera boundary, and spherical surface (3-17) capable of resting on the radius of the patient's eyeball sphere (2-7)” in claim 3), and inserting a distal end of a light guide of a light applicator (“to allow the positioning of a conventional optical fiber and thus create a refractive optical path suitable for sending the laser beam at determined positions of the ciliary body through the scleral tissue, close to the limbus” ¶[16]), which is designed to emit laser light (L, L', L"), into one channel of at least one channel of the ophthalmic device; wherein the distal end is detachably held by the channel on the guide body of the ophthalmic device (Fig. 3A “the hole (3-3) is intended for the placement of its probe, indicated as item (3- 5) in figure 3B” ¶[29]), 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 (“to allow the positioning of a conventional optical fiber and thus create a refractive optical path suitable for sending the laser beam at determined positions of the ciliary body through the scleral tissue, close to the limbus” ¶[16]); and rotating the guide body and accordingly the at least one channel relative to the support body using the light guide as a manipulator (“it rotates the ring 3-2, using the fiber end itself as a manipulator” ¶[44]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to substitute the ophthalmic device of claim 28 with the ophthalmic device of Fontana as the features serve the same purpose and the results of the substitution would have been predictable.
Regarding claim 36, Hüelsewiede teaches wherein: the guide body is coupled loss-proof to the support body via one or more of complementary coupling elements, complementary tongue and groove connections, and a tongue and groove connection, which are formed in the slide bearing surfaces (“It can also provide advantageous if the slide bearing bushing and the shaft section are, in particular additionally, positively coupled to each other, especially by means of a tongue and groove connection, in a rotationally fixed manner” ¶[0010] as this provides a means to keep the two components together).
Regarding claim 40, Fontana teaches wherein a longitudinal axis of the at least one channel is inclined at the predetermined angle to the central axis (M) of the guide body (as can be seen in Fig. 3B (3-3) is sized to fit the optical fiber and therefore the longitudinal axis of the channel is inclined at the same angle as the light guide).
Claims 37, 39, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Fontana, Hüelsewiede, and Benetsuto (hereinafter referred to as “modified Fontana”), as applied to claims 28 and 35 above, an in further view of Dorin et al. (WO 2020093060 A2, published May 7, 2020, previously cited, hereinafter referred to as “Dorin”).
Regarding claim 37, modified Fontana discloses the ophthalmic device of claim 28.
Modified Fontana 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’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). 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 Fontana in order to better expose the region of the eye to be treated.
Regarding claim 39, modified Fontana discloses the ophthalmic device of claim 25. Modified Fontana does not explicitly disclose wherein the predetermined angle (N) is between 35 and 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. While Fontana teaches the ciliary muscle and therefore would need an angle that is capable of treating the ciliary muscle, Fontana does not disclose a specific angle.
Dorin’s 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 Fontana in order to treat the ciliary body for glaucoma.
Regarding claim 42, modified Fontana and Dorin do not disclose wherein the device for engaging and retaining the eyelids is integrally formed on the support body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the device for engaging and retaining the eyelids integrally formed on the support body, since it has been held that making parts integral to a device involves only routine skill in the art. MPEP2144.04(V)(B): In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.)
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over modified Fontana, as applied to claim 28 above, an in further view of Belkin et al. (US 20130123761 A1, published May 16, 2013, previously cited, hereinafter referred to as “Belkin”).
Regarding claim 41, Fontana teaches the circular path (“This enables the optical fiber (3-5) to be positioned at various angles of rotation with respect to the axis of the eye, as shown in Figure 4A” ¶[31]).
Modified Fontana does not disclose wherein the guide body is mounted on the support body in such a way that the free end (F) of the light guide held by one of the at least one channel and facing the first side follows a circular path, which has a diameter in the range between 15 and 25 mm, when the guide body is moved relative to the support body.
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 15-25 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.
Belkin’s invention relates to medical devices, and in particular to such devices for use in ophthalmology (¶[0001]). 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 15-25 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 15-25 mm by normal optimization procedures known in the arts depending on the area to be treated.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Muehlhoff et al. (US 20080234707 A1) – element 41 and 42 for ring bead in claim 29
Will (US 20040267294 A1) – claim 29 ring bead as shown in Fig. 4
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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