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 Amendment
The amendment filed March 30th, 2026 has been acknowledged. Claims 1-17 remain pending in the application and are under examination.
Response to Arguments
Applicant’s arguments filed have been March 30th, 2026 fully considered but are moot in view of a new grounds of rejection. Nevertheless, to advance prosecution, Examiner addressed the following argument.
Applicant argues that the claimed value ranges (in particular, those recited in claims 2 - 5 and 7) are critical and unexpected, pointing to [0036 - 0045] of the instant specification. However, it is not apparent from those portions what specifically is allegedly unexpected or how some of the claimed ranges could patentably distinguish from the prior art. Consider every parameter mentioned in the claims at issue:
Skirt outer diameter. The instant specification [0036] discusses that the inventors tested values between 15mm and 20mm and concluded that the entire range is suitable. In fact, they concluded that more than the entire range is suitable, discussing that as low as 14mm and as high as 21mm - ranges outside of the tested range - are suitable. This doesn’t not suggest of modeling that produced unexpected results. Moreover, a typical human eye is approximately 24mm and it is apparent that the skirt of Accurso (‘664) is somewhat smaller than the full diameter of the eye (fig 2), clearly, to fit an eye. Accordingly, the claimed range (at least for claim 2) is essentially the full range that would be obvious for anyone to try. It is nearly the full range even possible to have.
Skirt Length. Similar to the skirt outer diameter, the claimed range (at least in claim 2), essentially encompasses the entire range one of ordinary skill would consider for Accurso. Looking at Accurso (fig 5), it is apparent that the drawing is generally to scale (or at least not grossly out of scale). The distance from the lens to the skirt bottom is approximately 1/5 of the length of the skirt outer diameter. Given the outer diameter range of 15-20, as discussed above, one fifth of that is a range of approximately 3-4, precisely in the claimed range, showing that the claimed range is relatively large and includes the entire range one of ordinary skill would consider for Accurso. Moreover, the results Applicant describes [0037] are explicitly discussed by Accurso as effects of interest (e.g. vacuum seal [0023], applanation amount [0037]).
Skirt thickness. The instant specification [0039] describes the skirt thickness as achieving some desired amount of flexibility. Notably, Accurso explicitly discloses that the skirt is flexible, why it is flexible, and that it should be “thin” [0028]. Moreover, one of ordinary skill would readily appreciate that the thickness of such a component would directly affect its flexibility. Thus, this too would have been obvious to optimize and to arrive at the claimed range. And, as above, the claimed range for thickness (at least in claim 2) is considerably large. It is not demonstrated that the claimed skirt thickness range achieves some particularly unexpected result. Moreover still, as will be discussed below, Accurso explicitly discloses the claimed range for stiffness (related to flexibility). (Additionally, it is noted that the skirt of Accurso (fig 5) has various thicknesses, any one of which can be relied on as corresponding to the claimed thickness.)
Skirt gap width. The instant specification explicitly states, “This parameter does not significantly impact suction ring performance.” [0040]. Thus, this does not yield an unexpected result.
Stiffness of the skirt material. Accurso discloses that the diaphragm is made of a material that is of a Shore A durometer between 20 - 65 [0026], which is within the claimed range (at least for claim 2), and that the skirt is made of the same material as the diaphragm [0041]. Accordingly, Accurso explicitly discloses the claimed limitation directed to this parameter. Insofar as this may be further affected by thickness, it is noted that the skirt is approximately the same thickness as the diaphragm, ranging at different points from thinner than the diaphragm to thicker. Moreover, as above, the claimed range is relatively large, encompassing nearly the entire range of the Shore A scale labelled as “soft” and “medium soft”. Given that Accurso desires flexibility, this is an obvious range in which to look. The instant specification [0041] discusses results relating to maintaining a vacuum, grasping the eye, and decreasing intraocular pressure (IOP). Given that Accurso’s skirt is meant to hold a vacuum which secures the device to an eye [0013], these results would also be expected. Additionally, one of ordinary skill would readily appreciate that such forces would impose a pressure on the eye and such a pressure need be considered at least for safety. It is not demonstrated that the claimed range achieves a particularly unexpected level of IOP, vacuum seal, grasp, etc.
Skirt flare. Accurso explicitly discloses an embodiment with a flared skirt (fig 2), thus it is self-evident that the angle is of interest. Accordingly, Accurso demonstrates that this too would be a known results yielding parameter. The instant specification explains that the claimed range “fits” the eye. However, it is self-evident that fitting the eye would be a matter of interest to Accurso and could hardly be unexpected.
Applicant argues that the various value ranges are critical and unexpected as they were obtained through modeling and testing and many of the results would not have been expected prior to modeling and testing. However, while the instant specification explains how the numerical value ranges were obtained through modeling, it does not demonstrate that the values obtained are critical and unexpected, as explained above. See Gardner v TEC Systs., Inc. in MPEP 2144.04(IV)(A). Further, these numerical value ranges could be optimized by one of ordinary skill in the art before the effective filing data of the instant application through modeling and testing, as the numerical value ranges in the instant application were achieved through modeling and testing.
Claim Objections
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description 14a. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 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.
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 1-8, 11-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable by Accurso (US 20180303664 A1) in view of Teuma (US 12564514).
In re claim 1, Accurso discloses patient interface device (abstract) for coupling a patient’s eye to an ophthalmic surgical laser system (abstract), comprising:
a cone substrate (Fig. 5: 111), including a rigid frustoconical shaped shell (111), configured to be coupled to the ophthalmic surgical laser system (Fig.5: 122 aligns with 111; [0030]); and
a flexible (abstract) suction ring (112) joined to a lower end of the rigid shell (Fig. 5),
wherein the cone substrate and the suction ring are integrally joined together as a single piece (abstract),
wherein the suction ring includes
a base portion (portion of 112 adjacent 111 and 114; see annotated Fig. 5 below: base portion) joined to the lower end of the rigid shell (Fig. 5),
a circular [0028] skirt [0028] extending downwardly from the base portion [0028],
a circular [0027] diaphragm (114)
extending from the base portion [0041] and
disposed inside of the skirt (Fig. 5), and
a contact lens (113)
joined to the diaphragm [0041] and
disposed in a center opening of the diaphragm (Fig. 5), and
wherein when the skirt contacts a surface of the patient’s eye, the skirt, the diaphragm, the contact lens and the surface of the eye form a vacuum chamber ([0028]: 12C when vacuum is applied) [0028].
PNG
media_image1.png
575
715
media_image1.png
Greyscale
Accurso lacks:
wherein the circular diaphragm has
a proximal portion which extends downwardly from a location where it joins the base portion and is spaced apart from the skirt by a ring shaped gap, and
a distal portion which bends radially inwardly to define the center opening,
Teuma discloses an interface device (Fig. 17: 1700) to be used with laser eye surgery systems (Col. 17, ln. 46-47) wherein the device has a flexible ring and inner engagement member (1704 and left 1703a label; i.e. diaphragm) which extends downwardly from an outer engagement member (upper portion of right 1703a; i.e. base portion) and is spaces apart from the skirt (lower right 1703a) by a gap (area between right and left 1703a) and then bends radially inwardly toward the window (1701).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the patient interface device as taught by Accurso with the engagement member shape as taught by Teuma because the shape of the engagement members would provide the diaphragm with more flexibility, making it safer for direct contact with the eye. Such a combination would yield wherein the circular diaphragm has a proximal portion which extends downwardly from a location where it joins the base portion and is spaced apart from the skirt by a ring shaped gap, and a distal portion which bends radially inwardly to define the center opening.
In re claim 2, the proposed system lacks:
wherein an outer diameter of the skirt is between 14 mm and 21 mm, a skirt length defined as a vertical distance from a lower surface of the contact lens to a distal end of the skirt is between 3 mm and 6.5 mm, a thickness of the skirt is between 0.25 mm and 3 mm, and a stiffness of the skirt is between 20A and 70A Shore durometer.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein a thickness of the skirt is between 0.25 mm and 3 mm, 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. While Accurso does not disclose the specific thickness of the skirt, Accurso does disclose wherein the flexible skirt portions have a relatively thin cross-section to establish and maintain conformal contact with the anterior corneal surface [0028], with the thickness of the skirt as a known results yielding parameter. One having ordinary skill in the art would know to optimize thickness so that the skirt is soft and flexible. In re Aller, 105 USPQ 233. See above in Response to Arguments (C).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein a stiffness of the skirt is between 20A and 70A Shore durometer, 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. While Accurso does not disclose the specific stiffness of the skirt, Accurso does disclose wherein the flexible skirt portions are soft, flexible, and deformable [0023, 0028], with the stiffness of the skirt as a known results yielding parameter. One having ordinary skill in the art would know to optimize the stiffness and thickness so that the skirt is soft and flexible. In re Aller, 105 USPQ 233. See above in Response to Arguments (E).
Teuma discloses an outer diameter for a major axis between 17 mm and 22 mm and an outer diameter for a minor axis between 16 mm and 19 mm (Col. 9, ln. 1-10).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein an outer diameter of the skirt is between 14 mm and 21 mm, 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. Teuma discloses that the outer shape of the housing should be sized so that it fits in the opening for the eye in the face and fits between the eye lids (Col. 9, ln. 1-10). One having ordinary skill in the art would know to optimize the outer diameter in for the device to fit in the eye opening for the eye. In re Aller, 105 USPQ 233. See above in Response to Arguments (A).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide, a skirt length defined as a vertical distance from a lower surface of the contact lens to a distal end of the skirt is between 3 mm and 6.5 mm, 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. Teuma discloses that the outer member engages the sclera along the entirety of its length (Col. 14, 17-22) to form reduced pressure zones (Col. 17, ln. 41-45), with the length being a known results yielding parameter. One having ordinary skill in the art would know to optimize the skirt length so that it can engage with the sclera. In re Aller, 105 USPQ 233. See above in Response to Arguments (B).
In re claim 3, Accurso lacks:
wherein the outer diameter of the skirt is between 15 mm and 19 mm, the skirt length is between 5.47 mm and 5.52 mm, the thickness of the skirt is between 0.42 and 0.62 mm, and the stiffness of the skirt is between 30A and 42A Shore durometer.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the outer diameter of the skirt is between 15 mm and 19 mm, the skirt length is between 5.47 mm and 5.52 mm, the thickness of the skirt is between 0.42 and 0.62 mm, and the stiffness of the skirt is between 30A and 42A Shore durometer. See above Response to Arguments and 35 U.S.C. 103 analysis for claim 2 regarding optimization.
In re claim 4, Accurso lacks:
wherein the outer diameter of the skirt is 19 mm, the skirt length is 5.5 mm, and the thickness of the skirt is 0.5 mm.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the outer diameter of the skirt is 19 mm, the skirt length is 5.5 mm, and the thickness of the skirt is 0.5 mm. See above Response to Arguments and 35 U.S.C. 103 analysis for claim 2 regarding optimization.
In re claim 5, the proposed combination lacks:
wherein a width of the ring shaped gap between the skirt and the proximal portion of the diaphragm at locations where both join the base portion is approximately 5.5 mm.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein a width of the ring shaped gap between the skirt and the proximal portion of the diaphragm at locations where both join the base portion is approximately 5.5 mm, 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. Teuma discloses a ring shaped gap (Fig. 17) formed by inner and outer engagement members with an inner and outer diameter that forms the reduced pressure zones (Col. 17, ln. 33-40), where the width of the ring shaped gap would be determined by the inner and outer diameters and the thickness of the skirt (see above 35 U.S.C. 103, In re claim 2). In re Aller, 105 USPQ 233. See above Response to Arguments (D).
In re claim 6, Accurso discloses wherein the skirt extends from the base in a vertical direction (Fig. 5).
In re claim 7, Accurso discloses wherein the skirt extends from the base with a flare (Fig. 2).
The proposed combination lacks:
wherein the skirt extends from the base with a flare of 5 to 8 degrees.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the skirt has a flare of 5 to 8 degrees, 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. While Accurso does not disclose the angle at which the skirt extends from the base, Accurso does disclose a skirt flare as the skirt lies on the eye (Fig. 2). Optimizing the angle of the skirt would help the flexible skirt to conform to the shape of the eye [0028]. One having ordinary skill in the art would know to optimize the stiffness and thickness so that the skirt is soft and flexible. In re Aller, 105 USPQ 233. See above Response to Arguments (F).
In re claim 8, Accurso discloses:
wherein the distal portion of the diaphragm that extends radially inwardly forms a flange (Fig. 5: 114 extents inward), and
wherein the contact lens is joined to an inner circumference of the flange (Fig. 5: 114 inserted into 113G; [0041]).
In re claim 11, Accurso discloses wherein the suction ring defines at least one vacuum port (Fig. 2: 12D) open on an interior surface (12B) of the skirt [0028], the patient interface device further including a suction tubing (Fig. 1: 15) coupled to another end of the vacuum port [0028].
In re claim 12, Accurso discloses:
wherein the cone substrate further includes a tubing guide arm (16) that extends from the shell (Fig. 1), and
wherein the suction tubing extends along the tubing guide arm [0029].
In re claim 13, Accurso discloses wherein cone substrate is formed of a hard plastic material [0024].
In re claim 14, Accurso discloses wherein the suction ring is formed of a soft [0023] thermoplastic elastomer ([0012]). The suction ring and diaphragm are formed of the same material [0041].
In re claim 17, Accurso discloses wherein a lower surface of the contact lens is either flat or curved [0025].
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Accurso (US 20180303664 A1) in view of Teuma (US 1256451) in further view of Lagarto (US 20230149217 A1) and/or Garcia (US 20170281407).
In re claim 9, the proposed system lacks:
wherein the suction ring further includes a plurality of scleral support pads joined to the diaphragm and extending downwardly and evenly spaced in a circumferential direction, and
wherein a bottom surface of each scleral support pad is sloped, being lower at a radially outer end and higher at a radially inner end.
Scleral support structures are a known feature of patient interface devices for laser eye surgery, as evidenced in the examples of Lagarto and Garcia.
Lagarto discloses:
wherein the suction ring further includes a plurality of scleral support pads (Fig. 5: 323 and 324) joined to skirt (Fig. 5) and extending downwardly [0023] and evenly spaced in a circumferential direction [0024], and
wherein a bottom surface of each scleral support pad is sloped [0024], being lower at a radially outer end and higher at a radially inner end (Fig. 5).
In addition, Garcia discloses:
wherein the suction ring further includes a plurality of scleral support pads (Fig. 7: 327; [0063]) joined to skirt (Fig. 7: 322) and extending downwardly (Fig.7) and evenly spaced in a circumferential direction (Fig. 7), and
wherein a bottom surface of each scleral support pad is sloped (Fig. 7: see the bottom of 327), being lower at a radially outer end and higher at a radially inner end (Fig. 7: the slope of the bottom extends towards the interior of the ring as it rises).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the patient interface device as taught by Accurso by implementing the known scleral support pads as they reduce intraocular pressure and prevent major deformation of the sclera while still allowing for a good vacuum seal. In addition, it would have been obvious to one of ordinary skill in the art to attach the sclera support pads to the diaphragm on the interior of the skirt as the sclera would be in direct contact with the diaphragm without the sclera support pads.
In re claim 10, the proposed system lacks
wherein a width of the scleral support pads in the circumferential direction is approximately 1.63 mm, a width of the scleral support pads in the radial direction is approximately 1.56 mm, a vertical length of the scleral support pads defined from a bottom of the contact lens is approximately 1.20 mm at a radially inner end and 1.91 mm at a radially outer end.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein a width of the scleral support pads in the circumferential direction is approximately 1.63 mm, a width of the scleral support pads in the radial direction is approximately 1.56 mm, a vertical length of the scleral support pads defined from a bottom of the contact lens is approximately 1.20 mm at a radially inner end and 1.91 mm at a radially outer end, 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Accurso (US 20180303664 A1) in view of Teuma (US 1256451) in further view of Vogler (CN 103221003 B).
In re claim 15, Accurso discloses wherein the cone substrate and the diaphragm are formed integrally by overmolding [0027].
The proposed system lacks:
wherein the cone substrate and the suction ring are formed integrally by overmolding.
Vogler discloses a patient interface device wherein the cone substrate and the suction ring are formed integrally by multi-component injection molding (i.e. overmolding) (Pg. 6, ln 44-55).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the single-piece patient interface device as taught by Accurso by forming the cone substrate and the suction ring using overmolding as taught by Vogler as this allows for a single-piece patient interface device that has different regions composed of different materials, for example, allowing a rigid shell and a flexible suction ring.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Accurso (US 20180303664 A1) in view of Teuma (US 1256451) in further view of Garcia (US 12419785 B2).
In re claim 16, the proposed system lacks:
wherein the cone substrate includes a plurality of slot features configured to attach the patient interface device to the ophthalmic surgical laser system.
Garcia discloses a patient interface device wherein the cone substrate includes a plurality of slot features (Fig. 1: 26) configured to attach the patient interface device to the ophthalmic surgical laser system (Col. 7 ln: 47-53).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the patient interface device as taught by Accurso with the plurality of slot features as taught by Garcia, since such a modification would provide the predictable results of allowing the user to easily install and the patient interface device onto the laser delivery head and confirm it was installed properly.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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, David E Hamaoui can be reached at (571) 270-5625. 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.
/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights