The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 9, 2026 has been entered.
Response to Arguments
Applicant’s arguments on pages 11-12 of the remarks filed on September 9, 2026, with respect to the prior art have been fully considered and are persuasive. The arguments directed to Fu-2 on those pages are persuasive, and the prior art rejections have been withdrawn.
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.
Claim 1 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,903,878 in view of Fu et al. (WO 2016/209312) and Liu et al. (US Patent Pub. No. 2020/0289318), and further in view of Krause et al. (WO 2014/135218).
Regarding claim 1, the claim correspondence shown below illustrates how claim 1 of the instant application relates to claim 16 of the Patent:
Instant Application
US Patent No. 11,903,878
A method implemented in an ophthalmic surgical laser system for incising a cornea of a patient's eye to form a corneal flap, the method comprising
16. A method implemented in an ophthalmic surgical laser system for incising a cornea of a patient's eye to form a corneal flap, the method comprising:
controlling a laser delivery system of the ophthalmic surgical laser system to deliver a pulsed laser beam to the cornea;
controlling a laser delivery system of the ophthalmic surgical laser system to deliver a pulsed laser beam to the cornea;
controlling a high frequency scanner of the ophthalmic surgical laser system to scan the pulsed laser beam back and forth to form a laser scan line; and
controlling a high frequency scanner of the ophthalmic surgical laser system to scan the pulsed laser beam back and forth to form a laser scan line; and
controlling a scan line rotator, an XY-scanner and a Z-scanner of the ophthalmic surgical laser system to move the laser scan line in the cornea to form the corneal flap, including forming a pocket cut, forming a bed of the flap and forming a side cut of the flap,
controlling a scan line rotator, an XY-scanner and a Z-scanner of the ophthalmic surgical laser system to move the laser scan line in the cornea to form the corneal flap, including forming a bed of the flap and forming a side cut of the flap,
wherein the bed is located in a horizontal plane at a first depth from an anterior corneal surface, the bed defining a hinge line, wherein the pocket cut extends from a second depth posterior to the bed to the depth of the bed, wherein the pocket cut is formed before forming the bed,
wherein the side cut extends from the bed upwards to the anterior corneal surface to form a side of the flap, the side cut surrounding an entire periphery of the bed except the hinge line, and
wherein the bed is located in a horizontal plane parallel to an anterior corneal surface of the cornea,
wherein the side cut extends from the bed upwards to the anterior corneal surface to form a side of the flap,
wherein forming the bed of the flap consists of:
forming a bed cut by scanning the laser scan line in successive overlapping parallel raster scan passes, wherein the bed cut is connected to the pocket cut that has been formed; and
after forming the bed cut, forming a single ring cut along a periphery of the bed except for an area of the hinge line by scanning the laser scan line along a circumference of the bed, wherein the ring cut covers all areas of the bed not covered by the bed cut;
wherein the step of forming the side cut includes forming a plurality of side cut layers in a sequence, each side cut layer extending within a depth range relative to the anterior corneal surface, the depth range being larger than twice a size of the pulsed laser beam, wherein all except one of the plurality of side cut layers are located entirely within the cornea without reaching the anterior corneal surface, and wherein the plurality of side cut layers are aligned with each other and connect with each other to form the side cut.
wherein the step of forming the side cut includes forming a plurality of side cut layers in a sequence, each side cut layer extending within a depth range from the anterior corneal surface, wherein all except one of the plurality of side cut layers are located entirely within the cornea without reaching the anterior corneal surface, and wherein the plurality of side cut layers are aligned with each other and connect with each other to form the side cut, and wherein the plurality of side cut layers are formed in a sequence from deeper side cut layers to shallower side cut layers.
The underlined portions above illustrate the distinctions. Specifically, the defining of a hinge line, the side cut excluding the hinge line and the “wherein forming the bed of the flap consists of” language and recitations thereafter are not found in the Patent.
Fu discloses an ophthalmic surgical laser system I for making an incision in a target material such as a cornea of an eye (see paragraph 49 and Figure 1A). Particularly, the system and its associated method of use comprise:
wherein forming the bed of the flap consists of: forming a bed cut by scanning the laser scan line in successive overlapping parallel raster scan passes (see paragraph 105, “[A]s illustrated in FIG. 12A. For example, in order to cover an intended lamellar dissection area 142, the X" stage 7 may move the raster line 143 up and down systematically across the surgical field along path 144 to cover the full flap bed and provide a bed cut. The width of each pass may be selected so as to provide overlapping cuts where tissue is cut a plurality of times by the raster”).
Fu does not explicitly state that there is a hinge line, and therefore does not explicitly state other limitations that include a hinge line, such as the following aspects of claim 1: “the bed defining a hinge line… the side cut surrounding an entire periphery of the bed except the hinge line” (see lines 11-13 of claim 1), nor “forming a single ring cut along a periphery of the bed except for an area of the hinge cut by scanning the laser scan line along circumference of the bed, wherein the ring cut covers all areas of the bed not covered by the bed cut” (see the last three lines of claim 1).
However, Figure 13 illustrates a hinge line at a right-side of the bed cut (therefore reading on “the bed defining a hinge line”), but simply never states that it is a hinge line. Additionally, this figure also illustrates a ring cut at the periphery of the bed cut with the exception of the hinge line portion, which reads on “forming a single ring cut along a periphery of the bed except for an area of the hinge cut by scanning the laser scan line along circumference of the bed, wherein the ring cut covers all areas of the bed not covered by the bed cut”. See the reproduction of this specific side of Figure 13 below with labels added:
PNG
media_image1.png
619
628
media_image1.png
Greyscale
Fu explicitly states in paragraph 107 that “Turning to FIG. 13, combinations of the above scanning patterns ([i.e., Figures 12A – 12C]) may be provided within a surgical area.”
However, Fu never explicitly states that the area marked in the above reproduction of Figure 13 as “Hinge Line” is free from having a side cut.
Liu teaches an ophthalmic laser surgical system, and most particularly, shows in Figures 6A and 6B that “corneal flap is formed by a bed cut which is parallel to the anterior corneal surface, and a side cut which is perpendicular or near perpendicular to the anterior corneal surface and which extends between the anterior corneal surface and the bed cut. In the top view, the side cut forms an incomplete circle surrounding the bed incision, with an uncut portion which forms a hinge of the flap” (see paragraph 43). It is also noted that Figure 6B illustrates the raster scanned bed cut, the ring cut, and the side cut, while Figure 6A also illustrates the hinge (no cut) as a dashed line.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the straight line, or arc segment, shown and labeled above in the reproduction of Figure 13 from Fu represents a hinge line, which as illustrated and described by Liu would have the absence of a side cut even within Fu, since if this portion of also had a side cut then there would be no flap, there would simply be an entire mostly circular section of the cornea that would fall out (e.g., since the entire section from the bed up to the anterior surface of the cornea would be cut).
However, neither Fu nor Liu discuss the creation of a pocket cut prior to forming the bed and side cuts.
Krause teaches an apparatus for creating incisions in a human cornea (see Abstract). Krause teaches the creation of a reservoir, such that “The reservoir extends at least partially deeper into the corneal tissue than the flap incision. Gases generated during creation of the flap incision can accumulate in the reservoir and may subsequently be absorbed by surrounding corneal tissue” (see page 5, line 30 through page 6, line 5). “[T]he reservoir 54 includes a plurality of sections of different shapes and/or different orientations. In such embodiments, the reservoir 54 may have a bend at the interconnection of two adjacent sections. The reservoir 54 may have any number of sections, e.g., two or three or four. … In general, any suitable shape may be chosen for the second section 58” (see page 12, line 36 through page 13, line 14). Figure 14 of Krause illustrates an order of “create reservoir”, after which there is “create bed incision”, after which there is “create lateral incision” (i.e., side cut).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include a reservoir (or “pocket cut”), as taught by Krause, within the methods of Fu with Liu, to “avoid the generation of an opaque bubble layer when the flap is created” (see page 5, lines 33-34) such that “Gases generated during creation of the flap incision can accumulate in the reservoir and may subsequently be absorbed by surrounding corneal tissue” (see page 6, lines 3-5).
While the language in the instant application of “the depth range being larger than twice a size of the pulsed laser beam” with reference to the formation of the plurality of side cuts is not found in the patented claim, this makes the patented claim broader (i.e., the genus), which therefore means that the patent encompasses the narrower subject matter of the claim of the instant application (i.e., the species).
Therefore, claim 1 of the instant application is rejected over claim 16 of the patent.
Allowable Subject Matter
Claims 17-18, 20 and 22 allowed.
Claims 2-3, 5-16 and 21 are objected to as being dependent upon a rejected base claim. However, no prior art rejection is made against claim 1, so the double patenting rejection needs to be overcome.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach the creation of a flap, as claimed, including the specifics of utilizing a high frequency scanner and creating a plurality of side cut layers in aa sequence, where each side ut layer extends within a depth range relative to the anterior corneal surface that is larger than twice a size of the pulsed laser beam.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES KISH/ Primary Examiner, Art Unit 3792
