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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show endo-illuminator tool”212” as described in page 6 lines 16-17 of the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “at least one light-absorbing layer” recited in claim 15 and the “at least one light-reflecting layer” recited in claims 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 15 and 16 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. Claims 15 and 16 recite “at least one light-absorbing layer” and “at least one light reflecting layer,” respectively. However, the claimed features (i.e., light-absorbing layer and light-reflecting layer) cannot be determined from the applicant’s disclosure and, therefore renders indefinite the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richards et al., US Patent No. 5,024,518 (hereinafter “Richards”), discloses ophthalmic contact with internal fixation light for examination of the optical nerve.
Regarding claim1, Richards discloses an ophthalmic device for illuminating an interior region of a patient’s eye, the device comprising: a polymeric, optically transparent body/gonioscopic lens 10 using an epoxy compound, see col. 3 lines 5-7 (e.g., any of a class of plastics, or other materials that are polymers of epoxides) having a first surface contoured to conform to a corneal surface of the patient’s eye 12 and a second surface opposed to the first surface (Figs. 1-2 and col. 2 lines 25-28 ); a light source/light emitting diode 22, 40; and an optical element/ lens 44, 26 (Figs. 1-3), for directing light through the first surface such that, with the first surface in contact with the corneal surface of the patient’s eye, a portion of interior region of the patient’s eye illuminated by the light source is visible through the first and second surfaces (Fig. 3 and col. 3 line 55-61).
Regarding claim 2, in at least one embodiment, the light source/LED 40 is centered on a central axis of the optical element/lens 44(see Fig. 3).
Regarding claim 4, Richards teaches in at least one embodiment shown in Fig. 3, the light source/LED 40 is embedded within the optically transparent body/gonioscopic lens 10 (col. 3 lines 55-57).
Regarding claim 5, Richards teach that the light source is a light emitting diode 22 (col. 2, line 32-34).
Regarding claim 7, Richards teaches a battery back 20 is electrically connected to the light emitting diode (Fig. 1 and col. 2 lines 31-33). In Richards further teaches “Electrical leads 42 connect the LED 40 to a battery pack (not shown)”
Regarding claims 9-11, the device further comprises at least one lens system 26 mounted on the gonioscopic lens that is adjustable to alter at least one position10 shown in Figs. 1- 2. The device further comprises at least one focusing lens 44 to alter/adjust the light directed to the patient’s eye, wherein the at least one focusing element is a lens as claimed.
Regarding claims 13 and 14, Richards further teaches the device comprises a hand 16 and supporting arrangement bar 18 projecting from the body away from the first surface, wherein the handle is disposed away from the light source, thereby minimizing light backscatter as claimed (see Fig. 1 and col. 2 lines 29-31).
Regarding claim 18, the first surface of the optical body has a curvature that conforms to a curvature of the corneal surface (see Fig. 1 and col. 2 lines 25-28). In col. 3 lines 57-58, Richards further teaches “Electrical leads 42 connect the LED 40 to a battery pack (not shown).”
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.
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.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Bhadri et al., Pub. No. 2015/0265466 (hereinafter “Bhadri”). Regarding claim 6, Richards does not teach one or more secondary light sources having different wavelengths and intensity, or a controller for controlling operation of the light source illuminating the patient’s eye. Bhadri teaches the use of multiple LEDs of various wavelengths/colors or intensity. The different sources provide different wavelengths/colors and can be configured in designated pattern for maximum light output efficiency. Therefore, it would have been obvious to one of ordinary skill in the art to use one or more secondary light sources to provide maximum light output efficiency. Moreover, one of the advantages of using this configuration is that by controlling the current to the LED and the light can be tuned to various intensities (col. 0113).
Regarding claim 8, the use of a controller for controlling operation of a light source during treatment of a patient’s eye is well known in the art. Bhadri discloses a medical device adapted to illuminate the interior of a patient’s eye via a light during treatment (par. 0006). Bhadri further discloses an LED power control that gives the surgeon illumination options (par. 0106).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of known prior art. Richards does not teach the radius of the first surface contoured to conform the corneal surface of the patient’s eye. nonetheless, the examiner takes an official notice that the average radius of the central human cornea is approximately about 7.8 mm for the anterior (front) surface, and 605 mm for the posterior (back) surface (refer to Dai, US Pat. No. 8,550,625 col. 15 line 50 to col. 16 line 2). Examiner further notes that the exact radius can vary between individuals, with common values ranging from roughly about 7.0 to about 8.5 mm for the anterior surface. Therefore, the time applicant’s invention was filed it would have been obvious to one of ordinary skill in the art to use a first surface that has a radius curvature of from 7.0 mm to about 8mm in order to place the illumination device on the corneal surface of a patient’s eye as presently claimed.
Allowable Subject Matter
Claims 12 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of t base cl claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED M FARAH whose telephone number is (571)272-4765. The examiner can normally be reached Mon - Fri. 9:30AM -10:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AHMED M FARAH/Primary Examiner, Art Unit 3792