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 Amendment
This office action is responsive to the amendment filed on 8/20/2025. As directed by the amendment: claims 14-17, 19-20, and 23-24 have been amended; no claims have been cancelled; and no claims have been added. Thus, claims 1-26 are presently pending in this application.
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 23-24 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 23, line 5 recites “the user interface”, however it is unclear if the Applicant is referring to the “user interface” recited in claim 14, line 6 or claim 23, line 2.
Claim 23, line 7 recites “the image”, however it is unclear if the Applicant is referring to the “image” recited in claim 14, line 10 or claim 23, line 5.
Claim 24, line 5 recites “the user interface”, however it is unclear if the Applicant is referring to the “user interface” recited in claim 14, line 6 or claim 24, line 2.
Claim Rejections - 35 USC § 103
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.
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 14-24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kamaev et al. (US 20170021021 A1) in view of Herekar et al. (US 20190105519 A1) further in view of Tereschenko et al. (RU 2269985 C1) (provided by the examiner on 6/5/2025).
Regarding claim 14, Kamaev discloses an antimicrobial treatment system (Fig. 13, Paragraphs [0043] and [0129]) comprising:
an illumination system (110/112) configured to deliver illumination that activates a photosensitizing agent (130) applied to a cornea (Paragraph [0046]); and
a controller (120) configured to control the illumination system (Paragraph [0182]), the controller including a user interface (Paragraph [0193]), the controller including one or more processors (122) and one or more computer readable media (124, Paragraph [0182]), the one or more processors configured to execute instructions from the computer readable media to cause the controller to:
detect an ulcerative region on a cornea (Paragraphs [0043] and [0182]); and
cause the illumination system to deliver the illumination to activate the photosensitizing agent applied to the ulcerative region according to a set of parameters for treating the ulcerative region (Paragraph [0182]).
Kamaev is silent regarding
the controller including an imaging system, the one or more processors configured to execute instructions from the computer readable media to cause the controller to:
provide an image of the cornea;
process the image to identify a border of an ulcerative region on the cornea.
In analogous art, Herekar teaches a controller including an imaging system (Paragraph [0198]), one or more processors configured to execute instructions from computer readable media to cause the controller to:
provide an image of a cornea (Paragraph [0198]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the controller of Kamaev to incorporate the teachings of Herekar to incorporate an imaging system and to have modified the one or more processors of Kamaev to incorporate the teachings of Herekar to incorporate being configured to execute instructions from the computer readable media to further cause the controller to: provide an image of the cornea in order to see the tissue treated and plan the treatment (Paragraph [0198]).
Kamaev in view of Herekar are silent regarding
the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
process the image to identify a border of an ulcerative region on the cornea.
In analogous art, Tereschenko teaches applying light along an outer contour of the ulcer of the eye (Paragraph [0017]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the one or more processors of Kamaev in view of Herekar to incorporate the teachings of Tereschenko to incorporate applying light along an outer contour of the ulcer of the eye in order to ensure complete treatment of the ulcer. The modification of Kamaev in view of Herekar further in view of Tereschenko would teach the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to: process the image to identify a border of the ulcerative region because in order to treat the outer contour of the ulcer, as taught by Tereschenko, one would have to identify the border of the ulcerative region on the cornea from the image.
Regarding claim 15, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
identify at least one additional treatment zone on the cornea outside the ulcerative region (Paragraph [0182], Kamaev); and
cause the illumination system to deliver additional illumination to activate the photosensitizing agent applied the at least one additional treatment zone according to a set of parameters for treating the at least one additional treatment zone, wherein the set of parameters for treating the at least one additional treatment zone is different from the set of parameters for treating the ulcerative region (Paragraph [0182], Kamaev).
Regarding claim 16, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 15, wherein the at least one additional treatment zone is defined by the border of the ulcerative region (Paragraph [0182], Kamaev).
Regarding claim 17, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 15, wherein the at least one additional treatment zone is defined by a peripheral region beyond the border of the ulcerative region (Paragraph [0182], Kamaev).
Regarding claim 18, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 15, wherein activation of the photosensitizing agent in the at least one additional treatment zone generates cross-linking activity (Paragraph [0182], Kamaev).
Regarding claim 19, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the illumination is restricted to the ulcerative region (Paragraph [0047], Kamaev), and activation of the photosensitizing agent in the ulcerative region generates an antimicrobial effect (Paragraph [0129], Kamaev), and wherein the antimicrobial effect is associated with at least one of: (i) oxygen depletion; (ii) generation of singlet oxygen; or (iii) generation of hydrogen peroxide (Paragraphs [0136] and [0185], Kamaev).
Regarding claim 20, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to determine the set of parameters for treating the ulcerative region to increase at least one of: (i) the oxygen depletion; (ii) the generation of singlet oxygen; or (iii) the generation of hydrogen peroxide (Paragraphs [0136] and [0185], Kamaev).
Regarding claim 21, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the set of parameters for treating the ulcerative region includes at least one of: a concentration of the photosensitizing agent, a level of ambient oxygen applied to the cornea, an irradiance of the illumination, or a time for applying the photosensitizing agent to the cornea or delivering the illumination (Paragraph [0186], Kamaev).
Regarding claim 22, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, further comprising an oxygen source (140/142, Kamaev) configured to provide a concentration of ambient oxygen to the cornea (Paragraph [0058], Kamaev).
Regarding claim 23, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the controller includes a user interface (Paragraph [0193], Kamaev).
Kamaev is silent regarding
the user interface having a display, and the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
provide an image of the cornea on the display of the user interface;
receive, via the user interface, input identifying a point within the ulcerative region as shown in the image.
In analogous art, Herekar teaches a user interface (“Display”) with a display (“Display”), and the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
provide an image of the cornea on the display of the user interface (Paragraph [0198]);
receive, via the user interface, input identifying a point within the ulcerative region as shown in the image (Paragraph [0198]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the one or more processors of Kamaev in view of Herekar further in view of Tereschenko to incorporate the teachings of Herekar to incorporate being configured to execute instructions from the computer readable media to further cause the controller to: provide an image of the cornea on the display of the user interface; and receive, via the user interface, input identifying a point within the ulcerative region as shown in the image in order to see the tissue treated and plan the treatment (Paragraph [0198]).
Regarding claim 24, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the controller includes a user interface (Paragraph [0193], Kamaev).
Kamaev is silent regarding
the user interface having a display, and the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
provide the image of the cornea on the display of the user interface; and
receive, via the user interface, input identifying the border of the ulcerative region.
In analogous art, Herekar teaches a user interface (“Display”) with a display (“Display”), and the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
provide an image of the cornea on the display of the user interface (Paragraph [0198]);
receive, via the user interface, input identifying a point within the ulcerative region as shown in the image (Paragraph [0198]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the one or more processors of Kamaev in view of Herekar further in view of Tereschenko to incorporate the teachings of Herekar to incorporate being configured to execute instructions from the computer readable media to further cause the controller to: provide an image of the cornea on the display of the user interface; and receive, via the user interface, input identifying a point within the ulcerative region as shown in the image in order to see the tissue treated and plan the treatment (Paragraph [0198]).
Kamaev in view of Herekar are silent regarding
the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
receive, via the user interface, input identifying the border of the ulcerative region.
In analogous art, Tereschenko teaches applying light along an outer contour of the ulcer of the eye (Paragraph [0017]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the one or more processors of Kamaev in view of Herekar further in view of Tereschenko to incorporate the teachings of Tereschenko to incorporate applying light along an outer contour of the ulcer of the eye in order to ensure completely treatment of the ulcer. The modification of Kamaev in view of Herekar further in view of Tereschenko would teach the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to: receive, via the user interface, input identifying a border of the ulcerative region because in order to treat the outer contour of the ulcer, as taught by Tereschenko, one would have to identify the border of the ulcerative region from the image.
Regarding claim 26, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, wherein the photosensitizing agent is riboflavin and the illumination is ultraviolet (UV) light (Paragraph [0059], Kamaev).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over over Kamaev et al. (US 20170021021 A1) in view of Herekar et al. (US 20190105519 A1) further in view of Tereschenko et al. (RU 2269985 C1) further in view of Rubinfeld et al. (US 20150088231 A1).
Regarding claim 25, Kamaev in view of Herekar further in view of Tereschenko disclose the antimicrobial treatment system of claim 14, but are silent regarding wherein the one or more processors are configured to execute instructions from the computer readable media to further cause the controller to:
track a change in a location of the ulcerative region relative to the illumination system,
wherein the illumination is delivered to the ulcerative region based on the change in the location.
In analogous art, Rubinfeld teaches
wherein one or more processors are configured to execute instructions from computer readable media to further cause a controller to:
track a change in a location of an ulcerative region relative to an illumination system,
wherein an illumination is delivered to the ulcerative region based on the change in the location (Paragraph [0050]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the one or more processors of Kamaev in view of Herekar further in view of Tereschenko to incorporate the teachings of Rubinfeld to incorporate being configured to execute instructions from the computer readable media to further cause the controller to: track a change in a location of the ulcerative region relative to the illumination system, wherein the illumination is delivered to the ulcerative region based on the change in the location in order to move the device into position when used for phototherapy and to position the device at an appropriate distance from the eye (Paragraph [0050]).
Response to Arguments
Applicant's arguments filed 8/20/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments, on page 8, that Tereschenko does not teach “a user interface and a controller performing processing to identify the border of the ulcerative region”, the Examiner agrees. However, while the references alone do not teach the limitations of claim 14, it is the modification of Kamaev in view of Herekar further in view of Tereschenko that would teach claimed limitations. The Examiner notes that Kamaev and Herekar teach a user interface (see Paragraph [0193] of Kamaev and Paragraph [0198] of Herekar). Kamaev was modified by Herekar to teach providing an image of a cornea (See Paragraph [01098] of Herekar) and Tereschenko taught applying light along an outer contour of the ulcer of the eye (See Paragraph [0017] of Tereschenko). Therefore one of ordinary skill in the art would understand that by treating the outer contour of the ulcer, as taught by Tereschenko, one would have to identify the border of the ulcerative region on the cornea from the image (imaging of the eye as taught by Herekar).
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.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783