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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 21-27 in the reply filed on 4/6/2026 is acknowledged.
Claims 28-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/6/2026.
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 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,097,148 in view of Fu et al. (2019/0060122). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses performing anterior cuts (top cuts) and posterior cuts (bottom cuts) wherein the cuts are curved (circular or oval) and the cuts have a transition zone that forms a side tab that is an intersection of the top and bottom cuts. The patent also discloses the top and bottom cuts approach a longitudinal axis at the same angle but fails to disclose that these angles are parallel to one another. Claim 10 of the patent discloses a laser but fails to disclose the XY scanner and Z scanner as claimed. Regarding the parallel nature of the anterior and posterior transition zones, Applicant indicates the angle of the transition zone is not critical in par. [0044] of the specification, “The surrounding plano transition zone has a uniform thickness, and may be either parallel to the anterior corneal surface or angled towards the anterior corneal surface, to further promote the mating of the bed and cap surfaces in the optical zone” and that the purpose of this transition zone is to “To address the problem of improper surface mating and higher order spherical aberration”. Fu, in the same field of endeavor of lenticular extraction, discloses that the edges of the cuts can be made symmetric (Fig. 12) for the purpose of reducing the creation of folds and aberrations (see par. [0073-0074]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in claims 1 and 10 of the Patent to include symmetrical edges to the cuts, as taught and suggested by Fu, for the purpose of allowing the top and bottom cuts to match and thus reduce aberrations in the cuts. Furthermore, determining the exact angle of the top and bottom cuts with respect to each other would only involve routine optimization and experimentation since it is a result effective variable and the end purpose of the parallel configuration claimed in the current application and the more generic symmetrical configuration disclosed in Fu are the same (reduce aberrations). Lastly, Fu disclose using an XY scanner and Z scanner for the purpose of adjusting the depth, width and height of the cuts to further enhance the precision of the cuts (par. [0042]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in claims 1 and 10 of the Patent to include the XY scanner and Z scanner, as taught and suggested by Fu, for the purpose of adjusting the depth, width and height of the cuts to further enhance the precision of the cuts.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,005,001 in view of Fu et al. (2019/0060122) . Claim 1 of the Patent requires “an anterior lenticule incision and a posterior lenticule incision in the cornea, wherein the anterior lenticule incision includes a curved anterior optical zone, an anterior transition zone connected to and surrounding the anterior optical zone, and an anterior edge zone connected to and surrounding the anterior transition zone, wherein the posterior lenticule incision includes a curved posterior optical zone, a posterior transition zone connected to and surrounding the posterior optical zone, and a posterior edge zone connected to and surrounding the posterior transition zone, wherein the anterior optical zone and the posterior optical zone overlap each other in a top view along a direction parallel to an optical axis of the eye, the anterior transition zone and the posterior transition zone overlap each other in the top view, and the anterior edge zone and the posterior edge zone overlap each other in the top view, wherein the anterior and posterior lenticule incisions form the lenticule of corneal tissue between them, wherein the anterior edge zone and the posterior edge zone intersect each other to form an outer edge of the lenticule, and wherein the anterior transition zone and the posterior transition zone are parallel to each other and form a plano transition zone of the lenticule between them.” The Patent fails to disclose the XY scanner and Z scanner as claimed. However, Fu discloses using an XY scanner and Z scanner for the purpose of adjusting the depth, width and height of the cuts to further enhance the precision of the cuts (par. [0042]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in claim 1 of the Patent to include the XY scanner and Z scanner, as taught and suggested by Fu, for the purpose of adjusting the depth, width and height of the cuts to further enhance the precision of the cuts.
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.
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 21, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Fu (2016/0089270).
Regarding Claims 21 and 24, Fu discloses a laser device 14; an XY scanner 28; a Z scanner 20; objective lens 23; and a controller 22 (Fig. 2). Fu further discloses the controller 22 controls the scanners to perform anterior cuts (top cuts) and posterior cuts (bottom cuts) wherein the cuts are curved (concave) and the cuts have a transition zone that forms side tabs that are intersections of the top and bottom cuts (Fig. 12). These symmetrical cuts provide the benefit of reducing aberrations (par. [0068-0069]). Fu fails to disclose that the transition zones have anterior and posterior portions that are parallel to each other. However, determining the exact angle of the top and bottom cuts with respect to each other would only involve routine optimization and experimentation since it is a result effective variable and the end purpose of the parallel configuration claimed in the current application and the more generic symmetrical configuration disclosed in Fu are the same (reduce aberrations). Additionally, it would have been an obvious matter of design choice to make the different portions of the transition zones of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Again, the purpose of both the claimed parallel configuration and the disclosed symmetrical configuration of Fu is to reduce aberrations.
In regard to Claim 25, Fu discloses the transition zones extend laterally (an angle of zero degrees), see Fig. 12.
Claims 21-26 rejected under 35 U.S.C. 103 as being unpatentable over Fu (2019/0060122).
Regarding Claims 21, 22 and 24, Fu discloses a laser device 14; an XY scanner 28; a Z scanner 20; objective lens 23; and a controller 22 (Fig. 2). Fu further discloses the controller 22 controls the scanners to perform anterior cuts (top cuts) and posterior cuts (bottom cuts) wherein the cuts are curved (convex) and the cuts have a transition zone that forms side tabs that are intersections of the top and bottom cuts (Fig. 16). These symmetrical cuts provide the benefit of reducing tissue step formation (par. [0104-0106]). Fu fails to disclose that the transition zones have anterior and posterior portions that are parallel to each other. However, determining the exact angle of the top and bottom cuts with respect to each other would only involve routine optimization and experimentation since it is a result effective variable and the end purpose of the parallel configuration claimed in the current application and the more generic symmetrical configuration disclosed in Fu are the same (reduce aberrations). Additionally, it would have been an obvious matter of design choice to make the different portions of the transition zones of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Again, the purpose of both the claimed parallel configuration and the disclosed symmetrical configuration of Fu is to reduce aberrations.
With regard to Claim 23, Fu discloses all of the claimed invention except for the exact dimensions of the transition zones. Fu does disclose relative dimensions of the zones (par. [0103]) but again, the exact measurands are not disclosed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the measurement values claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In regard to Claim 25, Fu discloses the transition zones extend laterally (an angle of zero degrees), see Fig. 16.
Regarding Claim 26, Fu discloses the anterior and posterior edge zones have a smooth profile (par. [0104]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fu (2019/0060122) in view of Bischoff et al. (2010/0331830). With regard to Claim 23, Fu discloses all of the claimed invention except for the exact dimensions of the transition zones. Fu does disclose relative dimensions of the zones (par. [0103]) but again, the exact measurands are not disclosed. Bishcoff discloses limiting the transition zone widths to 0.1-1 mm (100-1000 micrometers) for the purpose of avoiding regression problems (par. [0019]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Fu reference to include a transition zone width of 100-1000 micrometers, as taught and suggested by Sayegh, for the purpose of treating astigmatism by relaxing the curvature of the cornea.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Fu (2019/0060122) in view of Sayegh (2016/0302915). Fu discloses all of the claimed invention except for forming arcuate incisions in the cornea that are located inside of the outer edge of the lenticule in the top view. However, Applicant indicates corneal arcuate incisions are a known procedure for treating myopia, particular myopic astigmatism (oar. [0055] of the publication of the current application). Likewise, Sayegh discloses providing a plurality of arcuate incisions in the cornea for the purpose of treating astigmatism by relaxing the curvature of the cornea (par. [0032-0033]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Fu reference to include a plurality of arcuate incisions in the cornea, as taught and suggested by Sayegh, for the purpose of treating astigmatism by relaxing the curvature of the cornea.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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