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 .
Response to Arguments
Applicant's arguments filed on 02/06/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Examiner maintains that Raksi discloses the structural limitations recited in claim 1. Examiner notes that the limitations of, “…for contactless treatment..”, and “wherein the ophthalmic apparatus is configured to operate without any optics contacting the eye” are directed towards intended use of the apparatus. In response to applicant's argument that Raksi fails to disclose contactless treatment, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner notes that if the patient interface 800 was removed from the surgical system 1000, the system would still be capable of performing contactless treatment of glaucoma.
Examiner further notes that it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Raksi with the ophthalmic apparatus being configured to operate without any optics contacting the eye as taught by Belkin. Such a modification would provide the predictable results of reducing the risk of infection by limiting contact with the tissue and reducing production cost by limiting the number of component required.
Moreover, Raksi discloses laser treatment targeting the scleral spur and corneoscleral meshwork [00118] and Belkin discloses laser treatment through the scleral limbus (Claim 1). Examiner maintains that the scleral spur, corneoscleral meshwork, and the scleral limbus are all regions of the sclera and teach delivering a laser through the sclera under the broadest reasonable interpretation.
Ban (WO 2019/017975) discloses a photodetector configured to detect backscattered probe light for detecting micro-cavitation ([0062] photodetector 306 may effectively scan the RPE layer of the eye 100 and can measure microbubbles). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Raksi with a photodetector configured to detect backscattered probe light for detecting micro-cavitation as taught by Ban. Such a modification would provide the predictable results of measuring exposure of the targeted RPE cells to the therapeutic radiation by measuring the formation and/or bursting of microbubbles (Ban, [0034]).
Regarding claim 12, Belkin discloses a method of contactless treatment of glaucoma characterised by determining through a sclera as the entry pathway into the eye the location and/or the shape and/or the asymmetry of a trabecular meshwork, all without any physical contact with the eye other than the treatment laser beam (Claim 1).
Belkin fails to expressly disclose a beam energy sufficient to generate micro-bubbles, wherein the micro bubbles are detected by a photodetector by means of backscattered probe light through the sclera as an exit pathway out of the eye. However, Ban discloses delivering a treatment laser beam with a beam energy sufficient to generate micro-bubbles [0034], wherein the micro bubbles are detected by a photodetector by means of backscattered probe light through the sclera as an exit pathway out of the eye [0062], all without any physical contact with the eye other than the treatment laser beam (Fig. 3B).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Belkin with a beam energy sufficient to generate micro-bubbles, wherein the micro bubbles are detected by a photodetector by means of backscattered probe light through the sclera as an exit pathway out of the eye as taught by Ban. Such a modification would provide the predictable results of measuring exposure of the targeted RPE cells to the therapeutic radiation by measuring the formation and/or bursting of microbubbles (Ban, [0034]).
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
As currently written, claim 1 recites, “wherein the detection system comprises a controller configured to control the treatment laser and an eye-probe sub-system (27) emitted a co-axial probe beam (38)”. Examiner suggests amending the claim to recite, “wherein the detection system comprises a controller configured to control the treatment laser and an eye-probe sub-system (27) configured to emit [[emitted]] a co-axial probe beam (38)”.
Regarding claim 14, the limitation of “whereupon the treatment laser beam is directed at that location…” could be interpreted as delivering the treatment to a location different from the trabecular meshwork. Examiner suggests amending the claim to recite, “whereupon the treatment laser beam is directed at the trabecular meshwork [[that location]] in order to improve clarity.
Appropriate correction is respectfully requested.
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.
Claim 16 is 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 16 recites the limitation "the pattern" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3, and 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 2, the limitations of “a treatment laser module delivering a treatment laser beam” and “a detection system for detecting the location and/or the shape of the trabecular meshwork of the patient's eye” are recited in claim 1. Therefore, claim 2 fails to recite any additional limitations that further limit the system of claim 1. Dependent claims inherit the same deficiencies.
Regarding claim 3, the limitation of “wherein said detection system comprises a tomography system and/or comprises an optical coherence tomography (OCT) system for detecting the location and/or the shape, of the trabecular meshwork of the patient's eye and/or the micro-cavitation” fails to further limit claim 1 because claim 1 recites, “wherein the detection system comprises…an eye-probe sub-system…wherein the eye-probe sub-system comprises an optical coherence tomography (OCT) system that further determines the location, the shape, or an asymmetry of the trabecular meshwork”.
Regarding claim 9, the limitation of “wherein an eye-probe sub-system comprises a photo-detector” fails to further limit the system of claim 1 because amended claim 1 recites “wherein the eye-probe sub-system comprises…a photodetector configured to detect backscattered probe light for detecting micro- cavitation”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 6-7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Raksi (WO 2020/018242) in view of Belkin (US 10363169) and further in view of Ban (WO 2019/017975).
Regarding claim 1, Raksi discloses an ophthalmic apparatus (Fig. 7: surgical system 1000) for contactless treatment of glaucoma in a patient's eye from the front of the patient's eye through sclera without any of the ophthalmic apparatus in physical contact with the eye comprising a treatment laser module ([0073] FS laser 200) delivering a treatment laser beam ([0076] beam 201) through the sclera,
a detection system ([0073] a first imaging component 300 and an optional second imaging component 400) configured to detect at least one of a location, a shape, or an asymmetry of the trabecular meshwork of the patient's eye and to detect micro-cavitation formed on account of the treatment laser beam being guided through the sclera in the patient's eye, at the trabecular meshwork of the patient's eye ([00115] laser beam 201 is commanded to a location of a surgical volume 720, as identified by the OCT imaging apparatus and/or the visual observation device 400),
wherein the detection system comprises a controller (Fig. 7: controller system 100) configured to control the treatment laser and an eye-probe sub-system ([0073] first imaging component 300) emitted a co-axial probe beam [0087],
wherein the eye-probe sub-system comprises an optical coherence tomography (OCT) system ([0077] OCT imaging apparatus 300) that further determines the location, the shape, or an asymmetry of the trabecular meshwork prior to delivery of the treatment laser beam through the sclera ([0077] imaging devices assist the surgeon in docking the eye to the system and identifying surgical locations; [00118] laser treatment targets ocular tissues that affect the trabecular outflow pathway 40. These ocular tissues may include the trabecular meshwork 12, the scleral spur 14, and the corneoscleral meshwork 16), and
wherein the ophthalmic apparatus is configured to operate without any optics contacting the eye (Examiner notes that if the patient interface 800 was removed from the surgical system 1000, the system would still be capable of performing contactless treatment of glaucoma). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to remove the patient interface 800 in order to reduce the risk of infection by limiting direct contact with the eye.
Raksi fails to disclose a photodetector configured to detect backscattered probe light for detecting micro- cavitation, and
wherein the beams are delivered through the sclera as the entry pathway into the eye and are focused behind and through the sclera of a patient's eye to the trabecular meshwork.
Belkin discloses wherein the beams are delivered through the sclera as the entry pathway into the eye and are focused behind and through the sclera of a patient's eye to the trabecular meshwork (Claim 1). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Raksi with wherein the beams are delivered through the sclera as the entry pathway into the eye and are focused behind and through the sclera of a patient's eye to the trabecular meshwork as taught by Belkin. Such a modification would provide the predictable results of altering some of the trabecular meshwork in order to improve the flow of aqueous humor through the trabecular meshwork (Belkin, Col. 1, lines 26-29).
Ban discloses a photodetector configured to detect backscattered probe light for detecting micro- cavitation ([0062] photodetector 306 may effectively scan the RPE layer of the eye 100 and can measure microbubbles). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Raksi with a photodetector configured to detect backscattered probe light for detecting micro-cavitation as taught by Ban. Such a modification would provide the predictable results of measuring exposure of the targeted RPE cells to the therapeutic radiation by measuring the formation and/or bursting of microbubbles (Ban, [0034]).
Regarding claim 2, Raksi discloses a treatment laser module ([0073] FS laser 200) delivering a treatment laser beam (Figure 7: combined laser/OCT/visual beam 701), and comprising a detection system ([0073] a first imaging component 300 and an optional second imaging component 400) for detecting the location and/or the shape of the trabecular meshwork of the patient's eye ([00115] laser beam 201 is commanded to a location of a surgical volume 720, as identified by the OCT imaging apparatus and/or the visual observation device 400).
Regarding claim 3, Raksi discloses wherein said detection system comprises a tomography system and/or comprises an optical coherence tomography (OCT) system ([0073] OCT imaging apparatus 300) for detecting the location and/or the shape of the trabecular meshwork of the patient's eye ([0077] OCT imaging apparatus 300 assists in identifying surgical locations) and/or the micro-cavitation ([00123] Using image guidance to help minimize the amount of gas created and gas-induced tissue movements).
Regarding claim 6, Raksi discloses a treatment laser module ([0073] FS laser 200) delivering a treatment laser beam ([0076] beam 201) to a scanner ([0076] Beam conditioner and scanners 500) and an objective focusing lens ([0076] focusing objective 700), and comprising a co-axial probe beam emitted from an eye-probe sub-system ([0088] combined laser/OCT beam 701), said beams focused behind the sclera and through to a trabecular meshwork of a patient's eye ([00118] treating the trabecular meshwork 12 and/or scleral spur 14 to affect trabecular outflow).
Raksi fails to disclose the apparatus including a detector within the eye-probe sub-system that senses backscattered light from the probe beam and detects the formation of micro-bubbles formed on account of the treatment laser beam inducing damage to the melanin cells in the trabecular meshwork.
However, Ban discloses a detector that senses backscattered light from the probe beam and detects the formation of micro-bubbles formed on account of the treatment laser beam inducing damage to the melanin cells in the trabecular meshwork ([0062] photodetector 306 may effectively scan the RPE layer of the eye 100 and can measure microbubbles). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Raksi with a detector that senses backscattered light from the probe beam and detects the formation of micro-bubbles formed on account of the treatment laser beam inducing damage to the melanin cells in the trabecular meshwork as taught by Ban. Such a modification would provide the predictable results of measuring exposure of the targeted RPE cells to the therapeutic radiation by measuring the formation and/or bursting of microbubbles (Ban, [0034]).
Regarding claim 7, Raksi discloses wherein said apparatus comprises an energy control system (Figure 7: control system 100), which modulates the treatment laser beam independent of information of the detection system [0075].
Regarding claim 9, the modified Raksi discloses the system of claim 1 as discussed above, but fails to disclose herein an eye-probe sub-system comprises a photo-detector. However, Ban discloses a photodetector ([0062] photodetector 306 may effectively scan the RPE layer of the eye 100 and can measure microbubbles). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the eye-probe sub-system as taught by Raksi with a photodetector as taught by Ban. Such a modification would provide the predictable results of measuring exposure of the targeted RPE cells to the therapeutic radiation by measuring the formation and/or bursting of microbubbles (Ban, [0034]).
Regarding claim 10, Raksi discloses wherein the probe beam is represented by the treatment laser beam ([0088] combined laser/OCT/visual beam 701).
Regarding claim 11, Raksi discloses wherein the wavelength of the treatment laser beam is in the absorption range of melanin cells and the probe beam is infra-red (Figure 7: combined laser/OCT/visual beam 701; [0024] To this end, the laser beam may have a wavelength between 330 nanometers and 2000 nanometers; [00113] This design produces diffraction limited focusing of 1030 nm wavelength laser beams and 850 nm wavelength OCT beams).
Claim(s) 12-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Belkin (US 10363169) in view of Ban (WO 2019/017975).
Regarding claim 12, Belkin discloses a method of contactless treatment of glaucoma (Fig. 6B) characterised by determining through a sclera as the entry pathway into the eye (Claim 1: directing the electromagnetic radiation using the beam-shaping device through an entire thickness of a scleral limbus) the location and/or the shape and/or the asymmetry of a trabecular meshwork (Claim 1: irradiating one or more regions of a trabecular meshwork of an eye with the electromagnetic radiation generated by the laser source), all without any physical contact with the eye other than the treatment laser beam (Claim 1: without any contact with the eye).
Belkin fails to expressly disclose a beam energy sufficient to generate micro-bubbles, wherein the micro bubbles are detected by a photodetector by means of backscattered probe light.
However, Ban discloses delivering a treatment laser beam with a beam energy sufficient to generate micro-bubbles ([0034] formation and/or bursting of microbubbles that form on melanosomes of the targeted RPE cells in response to exposure to the therapeutic radiation),
wherein the micro bubbles are detected by a photodetector by means of backscattered probe light ([0062] photodetector 306 may effectively scan the RPE layer of the eye 100 and can measure microbubbles or other phenomena across the RPE layer),
all without any physical contact with the eye other than the treatment laser beam (Fig. 3B).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Belkin with a beam energy sufficient to generate micro-bubbles, wherein the micro bubbles are detected by a photodetector by means of backscattered probe light as taught by Ban. Such a modification would provide the predictable results of measuring exposure of the targeted RPE cells to the therapeutic radiation by measuring the formation and/or bursting of microbubbles (Ban, [0034]).
Regarding claim 13, the modified Belkin discloses the method of claim 12 as discussed above, but fails to disclose whereby the energy of the treatment laser beam is controlled and adjusted depending on the effect of micro- bubbles or micro-cavitation, and/or of the location and or the shape of the trabecular meshwork.
However, Ban discloses the energy of the treatment laser beam is controlled and adjusted depending on the effect of micro- bubbles or micro-cavitation, and/or of the location and or the shape of the trabecular meshwork ([0020] therapeutic radiation may induce a change in the target area of the eye of the patient, such as formation and/or bursting of microbubbles, which may be measured optically; optical filter may filter out radiation at the wavelength of the therapeutic radiation).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Belkin with the energy of the treatment laser beam is controlled and adjusted depending on the effect of micro- bubbles or micro-cavitation, and/or of the location and or the shape of the trabecular meshwork as taught by Ban. Such a modification would provide the predictable results of reducing optical noise from reflected therapeutic radiation (Ban, [0020]).
Regarding claim 15, Belkin discloses whereby the beams follow a pattern in accordance with inputs from an energy control system (Col. 4, lines 62-67: a control unit connected to the illumination unit and configured and operable for operating the illumination unit in first and second illumination modes; Col. 5, lines 39-41: control unit may operate the first source, as well as a second source, in a pulse mode).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Belkin (US 10363169) in view of Ban (WO 2019/017975) and Raksi (WO 2020/018242) an further in view of Friedman et al (US 2011/0196350) hereinafter Friedman.
Regarding claim 14, the modified Belkin discloses the method of claim 12 as discussed above, but fails to disclose whereby an optical coherence tomography (OCT) system is firstly used to identify the location of the trabecular meshwork, whereupon the treatment laser beam is directed at that location and either a pre-set laser energy dose is delivered to the location or the energy dose is increased until the optical coherence tomography (OCT) system detects micro-bubbles.
Raksi discloses whereby an optical coherence tomography (OCT) system is firstly used to identify the location of the trabecular meshwork ([00115] a surgical volume 720, as identified by the OCT imaging apparatus; [00118] laser treatment targets ocular tissues that affect the trabecular outflow pathway 40. These ocular tissues may include the trabecular meshwork 12). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Belkin with whereby an optical coherence tomography (OCT) system is firstly used to identify the location of the trabecular meshwork as taught by Raksi. Such a modification would provide the predictable results of reducing the intra-ocular pressure by targeting ocular tissues that affect the trabecular outflow pathway (Raksi, [00118]).
Friedman discloses whereupon the treatment laser beam is directed at that location and either a pre-set laser energy dose is delivered to the location or the energy dose is increased until the optical coherence tomography (OCT) system detects micro-bubbles ([0095] OCT system 100 of FIG. 1 may be employed to provide feedback on the segmentation process by monitoring bubble creation and tissue displacement; the pulse energy may be increased if the abovementioned system(s) do not detect sufficient tissue segmentation). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Belkin with the treatment laser beam is directed at that location and either a pre-set laser energy dose is delivered to the location or the energy dose is increased until the optical coherence tomography (OCT) system detects micro-bubbles as taught by Friedman. Such a modification would provide the predictable results of determining the extend of the bubbles created and/or the amount of actual tissue separation resulting from the treatment (Friedman, [0095]).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Belkin (US 10363169) in view of Ban (WO 2019/017975) and further in view of Raksi (WO 2020/018242).
Regarding claim 16, the modified Belkin discloses the method of claim 12 as discussed above, but fails to disclose wherein the pattern comprises radial lines extending from an inner radius (R1) to an outer radius (R2), the radii corresponding to extremes of the likely position of a trabecular meshwork. However, Raksi discloses wherein the pattern comprises radial lines extending from an inner radius (R1) to an outer radius (R2), the radii corresponding to extremes of the likely position of a trabecular meshwork (Figure 9c: the window 801 of a patient interface 800, concave surface 812, convex surface 813; [0094] With reference to FIG. 9c, the concave surface 812 is characterized by a radius of curvature r.sub.e, while the convex surface 813 is characterized by a radius of curvature r.sub.w; Figure 11a; [00122] The surgical volume 900 in the trabecular meshwork, extends from the anterior chamber 7 and through the inner wall of the Schlemm’s canal 18).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Belkin with the pattern comprises radial lines extending from an inner radius (R1) to an outer radius (R2), the radii corresponding to extremes of the likely position of a trabecular meshwork as taught by Raksi. Such a modification would provide the predictable results of reducing the intra-ocular pressure by targeting ocular tissues that affect the trabecular outflow pathway (Raksi, [00118]).
Conclusion
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).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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