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
The objection to the specification is withdrawn based on applicant’s amendments.
Applicant's amendments and associated arguments filed 6/12/2026 regarding the objection to the Priority claim and the 103 rejections have been fully considered but they are not persuasive. Applicant argues that 14/741,868 provides support for the newly amended claims, and therefore both Ganiban and Kehren are not prior art. The Examiner respectfully disagrees. Claim 1 recites that the light feature applies light to an outside of a sclera “at, or along areas of depression” and is “used to illuminate anatomical features inside the eye.” Neither of these features are disclosed in par. 0016 (or anywhere else) of 14/741,868. The effective filing date is still considered 3/7/2022 and both Ganiban and Kehren qualify as prior art. The rejections are still considered proper.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/14/2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 14/741,868, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 1 recites that the light feature applies light to an outside of a sclera “at, or along areas of depression” and is “used to illuminate anatomical features inside the eye.” Neither of these features are disclosed in par. 0016 (or anywhere else) of 14/741,868. Therefore, the current application has an effective filing date of 3/7/2022.
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 1, 2, 4-6, 10-14, 17, 18 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Ganiban et al. (US 2015/0359529, hereinafter Ganiban) in view of Kehren et al. (EP 3738558, hereinafter Kehran, such that all citations refer to the included English Translation of the document).
Regarding claims 1, 2, 4-6 and 10, Ganiban discloses a device for scleral depression, including a solid depressor 19 having a constant thickness from 2-8mm with tapered ends, a height from 2-8mm a fixed arc length between 30 and 360 degrees and is sized to fit in a fornix (par. 0040 and 0048 and figures 6-7D). A vertical arm 20 has a length between 6-14mm and is attached to the depressor (par. 0048 and figure 6). A handle 21/23 is attached to the vertical arm for holding the depressor in position in the fornix (figures 6-7D and par. 0048). The depressor is shaped to follow a general curvature of the circumference of a globe of the eye (claim 3) and the depressor further comprises a self-contained, wired or wireless, light source with one or more LEDS for applying light to the outside of the sclera of the eye such that the light is visible inside the globe of the eye (par. 0016 and claim 29). The depressor remains in position in the fornix until removes and creates a fixed predetermined scleral depression along an arc between 30 and 360 degrees along the fornix of the eye (claims 1 and 4, par. 0007, 0009).
Ganiban is silent as to applying light at, or along, areas of depression, to illuminate anatomical features inside the eye. Kehren also discloses a scleral depressor 1/2 and thus is analogous art with Ganiban (figure 1 and the 4th paragraph on page 3 of the translation). The depressor includes a light guide 16 that extends through the handle and is thus part of the handle that allows for light to be applied through the depressor to the outside of the sclera of the eye at, or along, areas of depression, to illuminate anatomical features inside the eye (figures 1 and 2 and pages 7-8). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to use the light feature of Ganiban to apply light at, or along, areas of depression, to illuminate anatomical features inside the eye as taught by Kehren, as Kehren discloses that the delivery of light at or along areas of depression allows for a user to press areas into a field of vision to see anatomical features that would not normally be in a field of vision (see paragraph overlapping pages 7 and 8 for motivation).
Regarding claims 11-13, the depressors covers an arc from 30-135 degrees, including 80-120 degrees and 90 degrees and is 4-5mm in thickness (par. 0048).
Regarding claim 14, the device is designed to interface with a lid speculum (par. 0048).
Regarding claim 17, see claim 9.
Regarding claim 18, see claim 10.
Regarding claims 27-31, see claims 19-23.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-6, 10-14, 17, 18 and 27-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,266,395 in view of Kehren. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose all of the limitations of the current claims with the exception of applying light at, or along, areas of depression, to illuminate anatomical features inside the eye. Kehren also discloses a scleral depressor 1/2 and thus is analogous art with the patented claims (figure 1 and the 4th paragraph on page 3 of the translation). The depressor includes a light guide 16 that extends through the handle and is thus part of the handle that allows for light to be applied through the depressor to the outside of the sclera of the eye at, or along, areas of depression, to illuminate anatomical features inside the eye (figures 1 and 2 and pages 7-8). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to use the light feature of the patented claims to apply light at, or along, areas of depression, to illuminate anatomical features inside the eye as taught by Kehren, as Kehren discloses that the delivery of light at or along areas of depression allows for a user to press areas into a field of vision to see anatomical features that would not normally be in a field of vision (see paragraph overlapping pages 7 and 8 for motivation).
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 Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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