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: the current application has the effective filing date of 11/30/2021 according to the priority chain on the record.
Claim Status
Applicant’s election without traverse of Group I claims 1-21 in the reply filed on 05/08/2025 is acknowledged. Accordingly, non-elected Groups II and III claims 68-71 are withdrawn from examination.
Claim Objection
Claims 2-4 are objected to because of the following informalities: these claims are apparatus claims that includes gerunds typically used in method claims. For example, claim 2 recites “the laser treatment assembly transmits in a near-infrared wavelength…”, this claim should be amended to “the laser treatment assembly is configured to transmit in a near-infrared wavelength…”. Appropriate correction is required.
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 1-21 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.
Regarding claim 1, the term “reversibly couple” is indefinite as it is not defined by structure and the term ‘reversibly’ is also a relative term. It is the Examiner’s best guess that “reversibly couple” refers to a relationship of coupling in which a particular part is the male component, and another part is the female component, for coupling. However, as the claim is currently presented, the particular male or female components cannot be ascertained. Applicant’s clarification is required.
Claim 5 recites “about 200 microns” and “about 100 microns”; the term “about” in this claim is a relative term which renders the claim indefinite. The term “about” 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.
Regarding claim 11, the limitation “the illumination light guide is potted in a recess of the illumination source” is vague and indefinite. It is not clear to the Examiner what is meant by ‘potted’ and as to why an “illumination source” would comprise a ‘recess.’
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 1-11 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 10,758,118 B2 (hereinafter “Chen”) in view of Uram et al. US 2019/0216306 A1 (hereinafter “Uram”).
Regarding claim 1, Carter discloses an intraocular cyclophotocoagulation device (Abstract: device contains embodiments for cyclophotocoagulation) comprising:
a proximal, reusable portion (handheld device body 102) comprising:
a proximal housing (housing 106) portion having a distal end region (distal end 120; see col.11, ll.43-65);
a laser treatment assembly (therapeutic light source/laser 108) comprising a laser diode (col.10, ll.5-6; 108 is a semi-conductor laser diode or an LED) and a collimating lens (internal optics 116) positioned a distance distal to the laser diode and configured to collimate light from the laser diode into a collimated laser beam and direct the collimated laser beam towards the distal end region of the proximal housing portion (col.11, ll.43-57 “ collimating lens mechanically and optically coupled with the light source 108”); and
a distal, disposable portion (replaceable or single-use tip 104) comprising: a
distal housing portion (various tips with corresponding housing shown in Figs.8-9B, e.g. 104a-104f) having an elongate shaft extending distally from a distal end region of the distal housing portion, the distal housing portion having a proximal end region (proximal end 122 and distal applicator end 124) configured to reversibly couple with the distal end region of the proximal housing portion (col.12, ll.5-33; col.17, ll.11-18 coupling between tip 104 and housing 106 including corresponding female and male coupling components; this is taken to encompass “reversibly couple” recited in this claim);
a laser guide (fiber tip 130) extending through the elongate shaft (as shown in Fig 2) and an aspheric lens (optics 126) positioned within the distal housing portion to receive the collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward a proximal end of a fiberoptic of the laser guide (col.12, ll.44-col.13, ll.32 outputting therapeutic light onto a treatment area; col.15, ll.54-col.16, ll.4); and
an illumination light guide (illumination light conduit 132) extending through the elongate shaft, an illumination source (col.5, ll.55-60 illumination source; also see col.11, ll.58-65) positioned within the distal housing portion and arranged relative to a proximal end of a fiberoptic of the illumination light guide (col.11, ll.58-65 and col.14, ll.43-55).
Chen teaches that the disposable portion comprising multimode fiber having corresponding imaging optics (col.12, ll.64-col.13, ll.2), but does not teach the proximal, reusable portion comprising an imaging assembly; and also does not teach the distal, disposable portion comprising an imaging guide extending through the elongate shaft and an objective lens located at a distal end region of the elongate shaft, the objective lens arranged to focus an image onto a distal end of a fiberoptic of the imaging guide.
Uram, another prior art reference in the field of a handheld laser devices for ophthalmological surgery ([0020]), teaches a laser video endoscope that comprises a laser guide, illumination guide and image guide engendering though an optical prove and through handpiece that supports the probe (see Abstract, [0011-0012, 0017]). Specifically, see [0025-0026, 0052, 0053, 0064-0065] the cross-sectional view of the handheld probe 78 illustrates a bundle of fibers including laser guide 88, illumination guide 80 and imaging guide 86; also see Figs. 12, 15, and 17. The imaging guide fibers extends through the prove and handpiece to carry images to be processed by an image assembly/processing electronic 32; see [0056-0058]. Furthermore, Uram teaches that portions of the probe and handpiece (including laser, illumination and imaging guides) are disposed after each procedure, and electronics (including imaging assembly 32) are reused ([0019, 0058, 0062]). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Chen’s cyclophotocoagulation device (as shown in Fig. 2) to further include an imaging assembly in the reusable portion, and a corresponding imaging guide in the disposable portion; in view of Uram; the motivation for doing so is because it provides the added advantage of video images of the eye, such that the operating surgeon can view the image during the course of manipulating the surficial probe (Uram: [0057: last sentence]).
Regarding claim 2, Chen modified discloses the device of claim 1, Chen further teaches wherein the laser diode of the laser treatment assembly transmits in a near-infrared wavelength that is configured to burn and shrink tissue. (Chen: col.10, ll.7-10; 810nm falls within the NIF range of 750-2500nm)
Regarding claim 3, Chen modified discloses the device of claim 1, Chen further teaches wherein the collimated laser beam is unchanged with minimal divergence or convergence crossing a junction from the reusable portion to the disposable portion. (Chen: col.11, ll.50-53)
Regarding claim 4, Chen modified discloses the device of claim 1, Chen further teaches wherein the aspheric lens corrects for spherical aberration and provide focus of both paraxial and marginal rays so that all light of the collimated laser beam enters the proximal end of the fiberoptic of the laser guide. (Chen: col.11, ll.50-58 beam shaping optical components is taken to encompass “aspheric lens” in this claim)
Regarding claim 5, Chen modified discloses the device of claim 1, but Chen does not mention the dimensions of the various taught components. However, it would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to select a fiberoptic for the laser guide to be about 200 microns in diameter so as to result in a collimated laser beam having a focusing spot that is about 100 microns; the motivation for doing so is to optimize therapeutic results for a particular type of ophthalmic treatment. (Chen: col.15, ll.9-14 treatment guide’s size dependent on intended treatment type)
Regarding claim 6, Chen modified discloses the device of claim 1, Chen further teaches wherein the objective lens is monolithic and apertureless. (see Chen optics 126 is monolithic and apertureless as illustrated in Figs. 2 and 10)
Regarding claim 7, Chen modified discloses the device of claim 1, but does not disclose wherein the objective lens has a frustoconical configuration having a smaller diameter entry surface and a maximal diameter exit surface, the exit surface positioned proximal to the entry surface near the distal end of the fiberoptic of the imaging guide. However, Chen: col.11, ll.50-58 discloses that internal optic s including any necessary beam shaping components; accordingly, it would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to use a beam shaping optic that has a frustoconical configuration, the motivation for doing so is to optimize therapeutic results for a particular type of ophthalmic treatment. (Chen: col.11, ll.50-58 and col.15, ll.9-14 dependent on intended treatment type.)
Regarding claim 8, Chen modified discloses the device of claim 1, but does not disclose wherein the objective lens has an hourglass configuration comprising an entry surface, an exit surface and a neck located between the entry surface and the exit surface, wherein the neck has a smaller diameter than a diameter of the entry surface or a diameter of the exit surface. However, Chen: col.11, ll.50-58 discloses that internal optic s including any necessary beam shaping components; accordingly, it would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to use a beam shaping optic that has a hourglass configuration, the motivation for doing so is to optimize therapeutic results for a particular type of ophthalmic treatment. (Chen: col.11, ll.50-58 and col.15, ll.9-14 dependent on intended treatment type.)
Regarding claim 9, Chen modified discloses the device of claim 1, Chen discloses the ophthalmic laser system using a laser energy with the lasing wavelength in the NIR range (col.10, ll.48-59), and produces therapeutic light that has a 1-mm spot size; wherein the optical element is configured to map the received therapeutic light with the 1-mm spot size into a plurality of 10-μm or smaller spots (see claim 1), but does not explicitly disclose wherein the objective lens has a depth of focus that is between 1-6 mm. However, it would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to select an objective lens that has a depth of focus between 1-6mm; the motivation for doing so is to optimize therapeutic results for a particular type of ophthalmic treatment. (Chen: col.15, ll.9-14 treatment guide’s size dependent on intended treatment type.)
Regarding claim 10, Chen modified discloses the device of claim 1, Chen further teaches, wherein the proximal end of the fiberoptic of the illumination light guide (conduit 132) is affixed on or near an emitting die of the illumination source. (Chen: col.11, ll.58-65 and col.14, ll.48-55 inherent so as to guide illumination light. The Examiner also notes that the “emitting die” does not appear to be a positively recited structure.)
Regarding claim 11, Chen modified discloses device of claim 10, wherein the fiberoptic of the illumination light guide (conduit 132) is potted in a recess of the illumination source. (This claim is rejected under 35 USC 112(b) indefiniteness; it is the Examiner’s interpretation that the illumination light guide as shown in Chen Fig. 13 illustrates the guide is situated in a recess area; alternatively, see Uram: Fig.12: illumination guide 42 is potted in a recess as shown.)
Regarding claim 13, Chen modified discloses device of claim 1, Chen further teaches where an actuator that is a slider configured to increase intensity of the laser light emitted. (Chen: Fig.2: user interface 114 including mechanical dials to adjust parameters of the therapeutic light source or other laser settings, see col. 11; ll.32-40)
Regarding claim 14, Chen modified discloses the device of claim 13, wherein the slider is positioned in the reusable portion (see Chen Fig. 2: 114), neither Chen nor Uram discloses wherein the slider is positioned on the disposable portion. However, this would have been an obvious design choice to do so, because user interface including buttons and dials can be placed anywhere along the probe, including either on either the disposable portion or reusable portion, for the convenience of the operator. The placement of the slider would not affect the function or operation of the disclosed device.
Regarding claim 15, Chen modified discloses the device of claim 1, wherein the elongate shaft is curved. (As shown in Chen Figs. 8-9B, the disposable portion, i.e. tip 104a-f, has a curved elongated shaft)
Regarding claim 16, Chen modified discloses the device of claim 15, Uram disclose teaches the imaging, image processing and video display ([0057]), but neither Chen nor Uram discloses wherein the device provides a field of view that is between 45-150 degrees. However, this would have been an obvious design choice to do so at the time of invention, because the field of view is dictated by the type of ophthalmic procedure to be performed. Since Chen’s device is adapted to be adjustable for various types of treatments, it is necessary to enable the imaging guide and assembly to provide a range of field of view depending on the selected type of treatment (see Chen col.13, ll.34-col.14, ll.3; Uram: [0057, 0059]).
Regarding claim 17, Chen modified discloses the device of claim 1, wherein the distal end region of the proximal housing portion (of the reusable portion 102) tapers and is sized to be received within a corresponding shaped region at the proximal end region of the distal housing portion (of disposable portion/tip 104). (see Chen col. 12, ll. 14-66 regarding coupling)
Regarding claim 18, Chen modified discloses the device of claim 17, Chen col.17, ll.10-18 discloses a variety of mechanical engagement methods, including by threads, snap-fit and magnetic; but does not explicitly disclose wherein the distal end region of the proximal housing portion and the proximal end region of the distal housing portion couple together under a spring-load. However, since Chen notes that the engagement mechanism is mechanical and can deviated from the exclusively recited tread ably, snap-fit, magnetically engagements; thus it would have been obvious to a person of ordinary skill in the art at the time of invention to use a spring-loaded engagement, because it is within the scope of the invention to do so (see Chen: col.12, ll.18-20 other variations possible; col. 17, ll.40-42 “The proximal connector 162 may be configured to mechanically couple with the distal end 120 of the device body 102, (threadably, snap-fit, magnetically, or the like”)
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen and Uram as applied to claim 1, and further in view of Carter et al. US 2020/0360185 A1 (hereinafter “Carter”).
Regarding claims 19-21, Chen in view of Uram disclose the device of claim 1, but does not disclose a fluid channel extending within the disposable portion. Carter, another prior art reference in the analogous art of discloses a device for performing an ophthalmic procedure in an eye including a hand-held probe comprising a reusable portion (2021) and a disposable portion (2005) as shown in Fig. 2A-2B. The disposable portion is an elongate shaft (as shown in Fig. 3A-3B: camshaft 405, [0101]) further housing a fluid channel (415, [0101]) extending therethrough the elongate shaft of the disposable portion ([0103] “The pair of tubes 415 can be aligned with the longitudinal axis A (rotational axis) of the camshaft 405. ”), and wherein the fluid channel (415) is in communication with fluid system 110 and is configured to deliver cooled liquid to an eye (see Fig. 1C and [0084] fluid aspiration to the eye; [0137: last sentence] delivers irrigation fluid to the eye). It would have been obvious to a person of ordinary skill in the art at the time of invention to further modify Chen include the fluid channel in view of Carter; the motivation for doing so is to provide fluid management during an ophthalmic procedure (Carter: [0005]).
Claim 4 is (alternatively) rejected under 35 U.S.C. 103 as being unpatentable over Chen and Carter as applied to claim 1, and further in view of Raksi US 10,821,023 B2.
Regarding claim 4, Chen modified discloses the device of claim 1, Chen further teaches wherein the aspheric lens corrects for spherical aberration and provide focus of both paraxial and marginal rays so that all light of the collimated laser beam enters the proximal end of the fiberoptic of the laser guide. (Chen: col.11, ll.50-58 beam shaping optical components is taken to encompass “aspheric lens” in this claim). Alternatively, Raksi, a prior art reference in the field of delivering high resolution imaging of an eye for ophthalmological procedures (see Abstract and Fig. 7), teaches a laser system comprising a laser source 200 that produces a laser beam through focusing optics 700, specifically, the focusing objective 700 include an aspheric exit lens 710 having an eye-facing, concave surface 711 and a convex surface 712 opposite the concave surface (col.16, ll.43-63). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Chen’s beam shaping optics to include an aspheric lens, in view of Raksi, the motivation for doing so is because the curvature of the aspheric lens accommodates the natural curvature of the eye (Raksi: col. 16, ll.55-60: “…aspheric convex surface 712 in combination with the spherical concave surface 711 result in an exit lens 710 having varying thickness, with the outer perimeter edges 715 of the lens being thinner than the central, apex region 717 of the lens”)
Conclusion
Note to Applicant: Claim 12 is not rejected under prior art rejections, but remain rejected at the independent claims are rejected under 35 USC 112(b) indefiniteness. The Applicant is encouraged to schedule an interview with the Examiner to discuss the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
August 21, 2025
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