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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 11, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 17 of U.S. Patent No. 12,102,564. Although the claims at issue are not identical, they are not patentably distinct from each other because the prior patented claims encompass all of the limitations of the instant claims and therefore anticipate them.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,102,564 in view of Claus et al. (U.S. Patent Application Publication No. 2016/0278983) hereinafter referred to as Claus; in view of Hipsley et al. (U.S. Patent Application Publication No. 2019/0105200) hereinafter referred to as Hipsley.
Prior patented claims teach all of the instant claims excepting for wherein the treatment region setting unit divides the set treatment region into a plurality of sub-regions based on a patient's eyeground condition, and wherein the radiation density setting unit sets the radiation density of the treatment beam for each of the plurality of sub-regions.
Attention is drawn to the Claus reference, which teaches wherein a treatment region setting unit divides a set treatment region into a plurality of sub-regions based on a patient's eyeground condition (¶¶[0117-0119] plurality of treatment locations in a treatment plan overlaid over a real-time image of the total treatment area).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the treatment planning of the patent claims in U.S. Patent No. 12,102,564 to include sub-division into treatment locations, as taught by Claus, because Claus that the developed treatment plan may optimize laser parameters to improve the procedure in a variety of ways, such as improving effectiveness, reducing time, minimizing necrosis, etc. (Claus ¶[0093]).
U.S. Patent No. 12,102,564 as modified does not teach wherein the radiation density setting unit sets the radiation density of the treatment beam for each of the plurality of sub-regions.
Attention is drawn to the Hipsley reference, which teaches a radiation density setting unit sets the radiation density of the treatment beam for each of a plurality of sub-regions (Fig. 1A-4, ¶[0175], ¶[0567]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser parameter setting of U.S. Patent No. 12,102,564 as modified to include per location density setting, as taught by Hipsley, because the adjustable dose and inflammation control provided by adjustable micropore density minimize unfavorable outcomes such as coagulation zones (Hipsley ¶[0567]).
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.
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: display unit, treatment region setting unit, treatment beam radiating unit, radiation density setting unit, and control unit, in claim 1; and display unit in claim 19.
The display unit is depicted in Fig. 1.
The treatment region setting unit is disclosed in Fig. 2 as part of a general purpose computer.
The treatment beam radiating unit is depicted in Fig. 1-2.
The radiation density setting unit is disclosed in Fig. 2 as part of a general purpose computer.
The control unit is disclosed in Fig. 2 as part of a general purpose computer.
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.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 11-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (U.S. Patent Application Publication No. 2016/0331585) hereinafter referred to as Kim; in view of Claus et al. (U.S. Patent Application Publication No. 2016/0278983) hereinafter referred to as Claus; in view of Hipsley et al. (U.S. Patent Application Publication No. 2019/0105200) hereinafter referred to as Hipsley.
Regarding claim 1, Kim teaches an ophthalmic treatment apparatus (Abstract) comprising:
a display unit for displaying an image of a patient's eyeground (Fig. 11);
a treatment region setting unit for setting a treatment region on the basis of the image of the patient's eyeground (¶[0037] determine location through display unit interface);
a treatment beam radiating unit for radiating a treatment beam to the set treatment region (¶[0005], ¶[0037]);
a radiation density setting unit for setting radiation density of the treatment beam radiated to the set treatment region (¶[0075], ¶[0082], the examiner interprets “radiation density of the treatment beam radiated to the set treatment region” as the spot density of treatment beams radiated to the region); and
a control unit for controlling the treatment beam radiating unit so as to radiate the treatment beam onto the set treatment region on the basis of the set density (¶[0082], ¶[0084]).
Kim does not teach wherein the treatment region setting unit divides the set treatment region into a plurality of sub-regions based on a patient's eyeground condition, and wherein the radiation density setting unit sets the radiation density of the treatment beam for each of the plurality of sub-regions.
Attention is drawn to the Claus reference, which teaches wherein a treatment region setting unit divides a set treatment region into a plurality of sub-regions based on a patient's eyeground condition (¶¶[0117-0119] plurality of treatment locations in a treatment plan overlaid over a real-time image of the total treatment area).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the treatment planning of Kim to include sub-division into treatment locations, as taught by Claus, because Claus that the developed treatment plan may optimize laser parameters to improve the procedure in a variety of ways, such as improving effectiveness, reducing time, minimizing necrosis, etc. (Claus ¶[0093]).
Kim as modified does not teach wherein the radiation density setting unit sets the radiation density of the treatment beam for each of the plurality of sub-regions.
Attention is drawn to the Hipsley reference, which teaches a radiation density setting unit sets the radiation density of the treatment beam for each of a plurality of sub-regions (Fig. 1A-4, ¶[0175], ¶[0567]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser parameter setting of Kim as modified to include per location density setting, as taught by Hipsley, because the adjustable dose and inflammation control provided by adjustable micropore density minimize unfavorable outcomes such as coagulation zones (Hipsley ¶[0567]).
Regarding claim 2, Kim as modified teaches the ophthalmic treatment apparatus of claim 1.
Kim further teaches wherein the set treatment region is displayed in an overlapping manner on an eyeground image displayed on the display unit (Fig. 11).
Regarding claim 3, Kim teaches the ophthalmic treatment apparatus of claim 2.
Kim further teaches wherein information about the set radiation density is displayed in an overlapping manner on the eyeground image displayed on the display unit (Fig. 11, shading).
Hipsley also teaches wherein information about the set radiation density is displayed in an overlapping manner on the eyeground image displayed on the display unit (Fig. 2K-18, Fig. 2K-19).
Regarding claim 4, Kim as modified teaches the ophthalmic treatment apparatus of claim 1.
Kim further teaches wherein the radiation density setting unit provides a plurality of options corresponding to various radiation densities to a user through the display unit (Fig. 11, Density slider, dot patterns).
Regarding claim 5, Kim as modified teaches the ophthalmic treatment apparatus of claim 4.
Kim further teaches wherein the plurality of options is provided using at least one of a plurality of dot patterns distributed at different densities (Fig. 11, dot patterns).
Regarding claim 6, Kim as modified teaches the ophthalmic treatment apparatus of claim 1.
Kim further teaches wherein the radiation density setting unit is configured so that the user may directly input a radiation density value, and displays a distribution shape corresponding to the input radiation density value to the user (Fig. 11, Density slider, dot patterns).
Regarding claim 7, Kim as modified teaches the ophthalmic treatment apparatus of claim 3.
Kim further teaches wherein the information about the set radiation density displayed on the display unit is displayed using at least any one of a dot pattern distributed at a set density, a color, a shade, a pattern, or a value (Fig. 11, dot patterns, and shaded portion).
Hipsley also teaches wherein information about the set radiation density is displayed in an overlapping manner on the eyeground image displayed on the display unit (Fig. 2K-18, Fig. 2K-19).
Regarding claim 8, Kim as modified teaches the ophthalmic treatment apparatus of claim 1.
Kim further teaches wherein the display unit displays an eyeground sample chart in which main organs of the eyeground are schematically displayed, and the treatment region setting unit sets the treatment region on the eyeground sample chart (Fig. 11).
Regarding claim 9, Kim as modified teaches the ophthalmic treatment apparatus of claim 1.
Kim further teaches wherein the display unit displays an eyeground sample chart in which main organs of the eyeground are schematically illustrated so as to set the radiation density of the treatment beam and the set treatment region is displayed, and the radiation density setting unit sets the information about the set radiation density in the treatment region displayed on the eyeground sample chart (Fig. 11, dot patterns, and shaded portion).
Hipsley also teaches wherein information about the set radiation density is displayed on an eyeground image displayed on a display unit (Fig. 2K-18, Fig. 2K-19).
Regarding claims 11-17/19-20, the claims are directed to a method comprising substantially the same subject matter as claims 1-10 and are rejected under substantially the same sections of Kim, Claus, and Hipsley.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim, Claus, and Hipsley as applied to claims 1 and 11 above, and further in view of Ha (U.S. Patent Application Publication No. 2014/0243936).
Regarding claims 10 and 18, Kim as modified teaches the ophthalmic treatment apparatus/method of claim 1/11.
Kim as modified does not teach wherein, for each of the plurality of sub-regions, the treatment beam radiating unit randomly radiates the treatment beam to the sub-region at the set radiation density.
Attention is brought to the Ha reference, which teaches wherein, for each of a plurality of sub-regions, the treatment beam radiating unit randomly radiates the treatment beam to the sub-region at the set radiation density (¶¶[0043-0044], Fig. 3-4).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the radiation pattern of Kim as modified to include random delivery, as taught by Ha, to avoid unwanted destruction of tissue due to a degradation phenomenon (Ha, ¶[0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2014/0058367 to Dantus teaches varying spot density to improve patient outcomes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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