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
Response to Arguments
Applicant’s arguments with respect to previous prior art rejections of the claims have been considered but are not persuasive. Specifically, the applicant argues that Krause does not teach using a high frequency scanner; “rather, the incision is simply formed by scanning the laser bean in the x-y plane” (see page 12 of the remarks). “With this type of laser scanning system, it would not have been obvious to form a bed cut ‘by scanning the laser scan line in successive overlapping parallel raster scan passes,’ or a ring cut ‘by scanning the laser scan line along a circumference of the bed,’ as recited in instant claim 1. Thus, Krause provides no teaching or suggestion, or any motivation, for forming the bed in the manner and sequence recited in instant claim 1.” The examiner finds this argument moot, since Fu was relied upon to teach the forming a bed cut by scanning the laser scan line in successive overlapping parallel raster scan passes (see paragraph 105 of Fu and the previous rejection, and the rejection below) and Fu was also relied upon (specifically Figure 13) for the teachings of a ring cut formed by scanning the laser scan line along a circumference of the bed (see the previous rejection and the rejection below which describe Figure 13 of Fu). Therefore, Krause was not relied upon for any of this subject matter and instead was relied upon for the deficiencies of previous claim 9 – i.e., the creation of a pocket cut and creating the pocket cut first. 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). Additionally, 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).
MPEP 2145(III) states that "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981), and "Combining the teachings of references does not involve an ability to combine their specific structures." In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973). Therefore, the argument that Krause may not be combined with Fu simply because Krause fails to teach a high frequency scanner is not persuasive. The combination provides the teaching of creating a reservoir to allow gases generated during creation of the flap incision to accumulate in the reservoir, and one of ordinary skill in the art at the time of the filing of the invention would find this incorporation obvious to incorporate into the methods of Fu.
With regard to the arguments directed to the double patenting rejections, it is noted that the applicant’s arguments that “The claimed number and order of the bed cut and the ring cut recited in claim 1 is important for reducing opaque gas bubbles which may interfere with the formation of the bed cut and for other considerations” (see page 9 of the remarks before the quote)… “US 11,903,878 describes forming the bed with four cuts: a low energy hinge cut 102 which connects to the pocket cut, a low energy first ring cut 103, then a bed cut 104, and then a normal energy second ring cut 105, and explains the reason for such a cutting order in terms of reducing gas bubble formation and minimizing uncut tissue bridge” (see page 9 of the remarks after the quote). “Further, the sequence of forming the bed cut and then the single ring cut recited in claim 1 would not have been obvious from US 11,903,878, Fu, and Liu. As pointed out above, US 11,903,878 describes forming two ring cuts, one before and one after the bed cut. The reference explains the reason for the described number and order of the cuts; such reasoning provides no motivation to change that sequence, and in fact teaches away from the cutting steps and cutting order recited in instant claim 1” (see page 10 of the remarks). This argument is not persuasive.
MPEP 804 states “There are generally two types of double patenting rejections. One is the "same invention" type double patenting rejection based on 35 U.S.C. 101 which states in the singular that an inventor "may obtain a patent." The second is the "nonstatutory-type" double patenting rejection based on a judicially created doctrine grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent.” Therefore, it is clear that double patenting is directed to, and based upon, the claimed subject matter of the two documents in question. The applicant’s arguments against the double patenting rejection essentially is based upon the specification of US Patent 11,903,878, even though specific citations are not provided. Claim 1 of US Patent 11,903,878 recites at the most “wherein the pocket cut is formed first, the bed is formed after the pocket cut, and the side cut is formed after the bed.” Claims detailing “forming the bed with four cuts” as argued by the applicant are not found in claim 1 of the Patent, but at best are found in claim 2, for which no double patenting rejection has been made. The double patenting rejection previously applied is Claims 1, 4 and 9 of the instant application against claims 1 and 16 of the Patent. For at least these reasons, the arguments are not persuasive and the double patenting rejection remains applicable.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 4 and 9 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 and 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).
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Regarding claims 1 and 9, the below claim correspondence shows how claims 1 and 9 of the instant application read on claim 1 of the Patent (it is noted that the current amendment to claim 1 simply moved some of the subject matter of previous claim 9 into claim 1, and therefore the correspondence illustrated remains directly applicable to a combined rejection of claims 1 and 9:
As can be seen, 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 .sup." 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:
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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).
Regarding claim 4, it is noted that the subject matter of claim 4 is taught, although worded differently, by claim 2 of the Patent, in that claim 2 recites two side cuts that are at different depths, which reads on “forming a plurality of side cut layers in a sequence” as well as the remainder of the recitations of claim 4 as a matter of obviousness.
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.
Claims 1, 3, 7-15, 17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al. (WO 2016/209312) in view of Liu et al. (US Patent Pub. No. 2020/0289318), and further in view of Krause et al. (WO 2014/135218).
Regarding claims 1, 9, 17 and 20, 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:
controlling a laser delivery system of the ophthalmic surgical laser system to delivery a pulsed laser beam to the cornea (see paragraph 49, “A laser 2 may comprise a femtosecond laser capable of providing pulsed laser beams… a laser beam delivery system may be used to scan the pulsed laser beam to produce an incision in the material, create a flap of material, create a pocket within the material”; also see paragraph 61, “The controller 13 is configured to direct the laser delivery system to output the pulsed laser beam in a desired pattern at the focal point of the target in the eye so as to modify the target”);
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 (see paragraph 15, “In some embodiments, the laser delivery system may deliver the pulsed laser beam at the focal point of the target in a patient' s eye in a raster pattern”; also see paragraphs 51 and 52; see paragraph 87, “The scanner 3 of the system 1 may be a high frequency resonant optical scanner”; see paragraph 13, “A controller is operably coupled with the laser delivery system, the xy-scan device and the z-scan device”);
controlling a scan line rotator (see paragraph 17, “The laser system may further include a scan-line rotator”; also see paragraph 51), an XY-scanner (see paragraph 51, “a moveable XY stage 7 for deflecting or directing the pulsed laser beam from the laser 1 on or within the target”), and a Z-scanner (see paragraph 51, “a fast-Z scan device 8” and/or “an auto-Z device 10”) of the ophthalmic surgical laser system to move the laser scan line in the cornea to form the corneal flap (see Abstract, “create a flap of material”), including forming a bed of the flap (see paragraph 39, “Figs. 12A-12C illustrate bed cut scanning patterns”) and forming a side cut of the flap (see paragraph 41, “Figs. 14A-14B illustrate side cut scanning patterns”);
wherein the bed is located in a horizontal plane at a first depth from an anterior corneal surface (see paragraph 67, which last two sentences state “The slow-Z scan 26 sets the focus at a fixed depth and may set the Z-baseline. For example, the slow-Z scan 26 is stationary during a bed cut”; therefore illustrating a first depth for a bed cut), and wherein the side cut extends from the bed upwards to the anterior corneal surface to form a side of the flap (see Figs. 14A and 14B, and paragraph 108, “With a fast Z scan device and X-Y stage, a 90° side-cut can be generated where 0° is defined as the radial direction in the lamellar cut bed. A 90° side- cut can be applied for flap creation, for example”), and
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:
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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.” Additionally, it is noted that Figures 12A, 12B and 12C each show a bed cut being made without any side cuts present, while Figure each of Figures 13 illustrate the side cut along with the bed cut, providing evidence that the bed cut may exist prior to the side cut. And finally, paragraph 133 states that “All methods described herein can be performed in any suitable order”.
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).
It is additionally noted with regard to claim 17 that Figure 1A illustrates the system of Fu, and all system components discussed in claim 17 are addressed in the rejection of claim 1 above.
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).
Regarding claim 3, the following reproduction of Figure 12A from Fu illustrates that each raster scanned line will overlap slightly more than 50% of the previous raster scan line (i.e., if one is viewing the circles as the coverage area), or would overlap by just slight less than 50% (i.e., if one is viewing the horizontal dots within the circles as the coverage area). Either way, this area of coverage is between 20-80% overlap, as claimed. It is re-iterated that Fu explicitly teaches that “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” (see paragraph 105).
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Regarding claim 7, Fu teaches that “The side cut need not be vertical and may also be angled to better match the tissue” (see the last sentence of paragraph 110).
Regarding claim 8, it is noted that neither Fu nor Liu explicitly teach that the side cut is at an angle of between 30o to 150o relative to the bed cut. However, Fu teaches that “The side cut need not be vertical and may also be angled to better match the tissue” (see the last sentence of paragraph 110). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that Fu’s teaching that the side cut need not be vertical but at an angle would be within the range of 30o to 150o relative to the bed cut, because if the angle were too large from being perpendicular to the bed cut, then the flap would be extremely large at the anterior surface and difficult to handle. Additionally, and more importantly, it is noted that 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 (see MPEP 2144.05(II)(A)).
Regarding claim 10, Fu teaches that “a pulse repetition rate of between 5 MHz and 25 MHz” (see Abstract).
Regarding claim 11, Fu teaches in paragraph 110, as an example, that the raster scan may occur at 10 kHz, which is greater than 1 kHz.
Regarding claim 12, Fu teaches in paragraph 16 that “The laser delivery system may be configured to produce the pulsed laser beam having a pulse energy between the range of 1 nJ and 5 μ J.”
Regarding claim 13, Fu teaches that “The resonant scanner 3 produces a line raster pattern with a length of the raster pattern between 0.5 mm and 2 mm” (see paragraph 87).
Regarding claim 14, it is noted that this claim recites that the controller controls the XY-scanner and the Z-scanner such that a particular speed of the high frequency scanner ensues, producing a distance of 6µm within a single period. The claims do not specify any particular attributes of the XY-scanner or the Z-scanner that set them apart from those discussed in Fu. Additionally, the “high frequency scanner” is described in the specification of the instant application as follows: “a high frequency fast scanner (e.g., the resonant scanner 21 of FIG. 6B) is used to scan the beam back and forth to produce a short, fast scan line… the laser system may use an 8 kHz (e.g. between 7 kHz and 9 kHz, or more generally, between 0.5 kHz and 20 kHz, or greater than 1 kHz) resonant scanner 21 to produce a fast scan line of about 1 mm (e.g., between 0.9 mm and 1.1 mm, or more generally, between 0.2 mm and 1.2 mm) and a scan speed of about 25 m/sec” (see paragraph 25 of PGPUB 2024/0197532, representative of the originally filed specification of the instant application). Fu teaches in paragraph 110, as an example, that the raster scan may occur at 10 kHz with 1 mm scan length, which is greater than 1 kHz, and greater than 8 kHz. It is noted that the claims, however, fail to recite these characteristics of the high frequency scanner. As such, the Fu reference teaches all of the components necessary to produce the effect of traversing a distance less than 6µm within a single period, absent a showing of criticality and absent there being any claimed features of the necessary components that read over the teachings of the Fu reference.
Regarding claim 15, it is noted that Fu and Liu do not specifically discuss the shape of the flap, but generally show it as circular. However, Krause teaches that “It will be understood that in alternate embodiments, the bed incision 42 may extend over a complete circular area or may have a non-circular outline, e.g., an elliptical outline” (see page 9, lines 18-24). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to create an elliptical flap shape, as taught by Krause, within the methods of Fu, since the use of one shape or another would amount to choosing from a finite number of different shaped pockets/reservoirs, which has previously been held as unpatentable (KSR v. Teleflex), and Krause explicitly states that an alternative to a circular shape could be an elliptical shape.
Regarding claims 21-22, Krause teaches that “A bed incision 42 is created at step 220. Gases generated during the creation of the bed incision 42 can disperse into the reservoir 54” (see page 14, lines 19-28). Since the “gases generated during the creation of the bed incision can disperse into the reservoir”, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to begin the bed incision at a location that intersects with the reservoir/venting channels, because if this were not the case then the gases generated during the remainder of the bed cut would not disperse into the reservoir, which is the explicit reason taught for creating the reservoir.
Claims 2, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fu in view of Liu and Krause as applied to claims 1 and 17 above, and further in view of Kittelmann et al. (US Patent Pub. No. 2010/0305553).
Fu in combination with Liu and Krause is described above in the rejection of claims 1 and 17. However, neither of these references discuss the blanking pulses by temporarily increasing a pulse repetition rate, as recited in claim 16, nor specifics about the energy parameters for the bed versus the side cuts as in claims 2 or 18.
Regarding claims 2 and 18, Kittelmann teaches that “The quality of an incision to be made with fs laser radiation is influenced by the precise compliance with relevant parameters such as the pulse energy, the focus diameter, the focal plane and also the spacing of adjacent focal locations (spots). These parameters can be separately optimized well for various types of incision guidance” and then specifies the flap-bed incision and the peripheral marginal incision (see paragraph 7; also see paragraph 54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to optimize the laser parameters, including the pulse energy, depending on the type of cut being performed (i.e., bed cut or edge/side/peripheral cut), as taught by Kittelmann, and to optimize this parameter in the methods of Fu in order to producing a good quality, and uniformly optimized cut (as mentioned in the above quote above from Kittelmann).
Regarding claim 16, Kittelmann teaches a system for ophthalmic laser surgery, in which “The control unit (190) has furthermore been set up to control the modulator unit (170) in accordance with a beam-deflection pattern established for the incision geometry in such a manner that in predetermined parts of the beam-deflection pattern at least some of the laser pulses have a reduced pulse energy or are suppressed” (see Abstract). Paragraph 15 discusses a reason for such reduction of pulse energy. In the last sentence of paragraph 16, Kittelmann states that “It will be understood that a variation of the pulse repetition rate is not intended to be ruled out, and may be implemented in addition to an energy modulation of the pulses.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application utilize a variation of a pulse repetition rate alone or in combination with energy modulation of pulses, as taught by Kittelmann, as a means for reducing overall energy deposition in areas where two scan lines are in close proximity and/or overlap, as described in paragraph 15 of Kittelmann. It would be obvious to one of ordinary skill in the art to include this technique in the system and methods of Fu as combined with Liu since Fu teaches that “[t]he width of each pass may be selected so as to provide overlapping cuts where tissue is cut a plurality of times by the raster” (see paragraph 105), but does not address how to ensure proper energy deposition is maintained in such overlapping areas.
Claims 4-6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fu in view of Liu and Krause as applied to claim 1 above, and further in view of Fu et al. (US Patent Pub. No. 2014/0200563), herein referred to as Fu-2.
Fu in combination with Liu and Krause is described above in the rejection of claim 1. Figures 14A and 14B of Fu illustrate a generally sinusoidal scan pattern for creation of a side cut, which therefore fails to teach the forming of a plurality of layers.
Regarding claims 4 and 19, Fu-2 teaches various different cutting/scan patterns for use in ophthalmic laser surgery (see Abstract). Specifically, Figure 4A illustrates a “laser cuts a circle from point 401 to point 402 and back around to point 401, and then proceeds to the next cut” (see paragraph 34). Figure 5A additionally shows a method of forming a vertical side cut, in which individual layers are formed and stacked atop one another (see paragraph 36, which also mentions how this is useful during refractive surgery to create a corneal flap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to perform a side cut during a flap creation procedure by generating multiple stacked layers, as taught by Fu-2, as a functional equivalent to the sinusoidal version illustrated in Figures 14A and/or 14B of Fu, and because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Regarding claim 5, in view of the rejections of claim 5 under 35 U.S.C. 112(b) above, figures 14A and 14B of Fu read on claim 5. Additionally, it is noted that Figures 6A and 6B of Fu-2 illustrate a similar pattern.
Regarding claim 6, it is noted that Figures 6B of Fu-2 illustrates a raster scanning pattern that, when used for creation of a side cut as described throughout Fu-2, would result in overlapping raster scans in a depth direction.
Conclusion
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
Martin (US Patent Pub. No. 2016/0213517), which teaches “In the embodiments shown, the program instructions provide for the production of the first auxiliary channel
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48 before the production of the flap 42, and then the production of the second auxiliary channel 50. Thus, even before commencement of the production of the bed incision 44, a possibility exists for removing the gases, developed during the production of the bed incision 44, out of the region of the bed incision 44, to the surface of the cornea” (see paragraph 45). “It may be provided that the lateral incision 46 (not represented) is produced after the bed incision 44, or that the lateral incision 46 is produced after the second auxiliary channel 50 and before the bed incision 44” (see paragraph 53). Additionally, Figure 1 illustrates the system including a laser and scanning mechanisms for producing the raster scan shown in Figures 3A-B.
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 JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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