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 29 January 2026 has been entered. Claim(s) 1-24 remain pending in the application with claims 18-24 withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection to the claims, and each and every rejection under 35 U.S.C. 112(b) and 35 U.S.C. 102 previously set forth in the Office Action mailed 30 July 2026.
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.
Claim(s) 1-10, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadas (US 20220322938 A1) in view of Thomas (US 20100152565 A1).
Regarding claim 1, Hadas teaches an ocular compression device for wearing on the face of a user (Paragraph 0052-0055—a system for determining an IOP of a subject…includes a pressurizing device…part of a goggle or mask…), comprising:
a goggle body frame surrounding the eyes of the user wherein the goggle body frame has a transverse direction and a longitudinal direction (Fig. 1 and 4—adjustable pressure mask; Paragraph 0054, 0065, 0082-- mask itself can be made adjustable with varying widths, inter-pupil distances, heights, nasal recess, temple covers and more…);
at least one pressure probe (Paragraph 0053-0055- a pressurizing device for applying pressure of varying magnitude over an external surface of an eye of the subject …pressurizing device can alternatively be a pad configured for applying a controlled pressure…);
wherein the at least one pressure probe is adjustable in the longitudinal direction to contact the face of the user and apply extraocular pressure using mechanical force to elevate the intraocular pressure of at least one eye of the user (Paragraph 0053-0055-- pressurizing device can alternatively be a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open…); and
wherein the ocular compression device is configured to permit optical access to the at least one eye of the user while the extraocular pressure is applied (Paragraph 0055—when the eye or eyes are open…; paragraph 0082-- front of the mask in front of the eyes is transparent so the optics can capture images of the eyes).
Hadas additionally teaches the goggle body frame may be adjustable to accommodate different facial shapes and inter-pupil distances (Paragraph 0065).
Hadas does not explicitly disclose at least one spanner connected to the goggle body frame; at least one pressure probe connected to the at least one spanner; and wherein the at least one spanner is adjustable in the transverse direction to align the at least one pressure probe with at least one eye of the user.
Thomas, in the same field of endeavor of an ocular compression device for wearing on the face of a user (Fig. 2), teaches a device comprising a frame surrounding the eyes of the user wherein the frame has a transverse direction and a longitudinal direction (Tonometer 202); at least one spanner connected to the frame (Spanners 214, 216 with screws 210, 212); at least one pressure probe connected to the at least one spanner (Paragraph 0040—ocular stabilizer 208 and ocular probe (not shown) in contact with the patient’s eye to be tested; ocular stabilizer 208 and probe are connected to spanners 214, 216 via tonometer 202); wherein the at least one spanner is adjustable in the transverse direction to align the at least one pressure probe with at least one eye of the user (Paragraph 0040-- the tonometer 202 can swing in and out of position or be moved sideways as necessary along the rails 214, 216 to place the ocular stabilizer 208 and ocular probe (not shown) in contact with the patient's eye to be tested 218).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas to include a spanner for the adjustment of position of the at least one pressure probe as described by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Regarding claim 2, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the goggle body frame is secured to the head of the user with a headband to provide fit for the head of the user (Paragraph 0065, 0084-- The strap holding the mask to the face should be made adjustable to fit heads of different sizes…).
Regarding claim 3, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the goggle body frame is connected to a goggle body lining made of a soft material in contact with the face of the user to alleviate discomfort (Paragraph 0083-- The frame edges towards the skin are covered with a very soft seal 42).
Regarding claim 4, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the at least one pressure probe is aligned with at least one lower globe of an eye or one upper globe of an eye (Paragraph 0055, claim 11-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open).
Regarding claim 5, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the at least one pressure probe comprises two pressure probes such that the at least one pressure probe comprises a pressure probe aligned with to the lower globe of each eye of the user (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that applying a controlled pressure over one or both eyelids when both eyes are open indicates that pressurizing devices may be applied in alignment with either of the upper or lower globe of the eye for each eye). For additional clarification, it is noted that Hadas additionally teaches that the system may measure IOP of both eyes at the same time (Paragraph 0018, 0054).
As noted above, Thomas discloses a spanner used to adjust the positioning of the pressure probe (Fig. 2—spanner 214, 216).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas including pressurizing devices to apply pressure to one location of each eye to include a spanner for the adjustment of position of each pressure probe as described by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Regarding claim 6, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the at least one pressure probe is comprised of two pressure probes such that the at least one pressure probe comprises a pressure probe aligned with to the upper globe of each eye of the user (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that applying a controlled pressure over one or both eyelids when both eyes are open indicates that pressurizing devices may be applied in alignment with either of the upper or lower globe of the eye for each eye). For additional clarification, it is noted that Hadas additionally teaches that the system may measure IOP of both eyes at the same time (Paragraph 0018, 0054).
As noted above, Thomas discloses a spanner used to adjust the positioning of the pressure probe (Fig. 2—spanner 214, 216).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas including pressurizing devices to apply pressure to one location of each eye to include a spanner for the adjustment of position of each pressure probe as described by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Regarding claim 7, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the at least one pressure probe of the ocular compression device is comprised of two pressure probes such that the at least one pressure probe comprises a pressure probe aligned with to the upper and lower globe of a single eye of the user (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that applying a controlled pressure over one or both eyelids when the eye is open indicates that pressurizing devices may be applied in alignment with both of the upper or lower globe of a single eye). For additional clarification, it is noted that Hadas additionally teaches that the system may measure IOP of both eyes at the same time (Paragraph 0018, 0054).
As noted above, Thomas discloses a spanner used to adjust the positioning of the pressure probe (Fig. 2—spanner 214, 216).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas including pressurizing devices to apply pressure to two locations of one eye to include a spanner for the adjustment of position of each pressure probe as described by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Regarding claim 8, the combination of Hadas and Thomas teaches the device of claim 1. Hadas additionally teaches wherein the at least one pressure probe of the ocular compression device arise comprised of four pressure probes such that the at least one pressure probe comprises a pressure probe aligned with to the upper and lower globe of each eye of the user (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that applying a controlled pressure over one or both eyelids when the eye or both eyes are open indicates that pressurizing devices may be applied in alignment with both of the upper or lower globe of the eye for each eye). For additional clarification, it is noted that Hadas additionally teaches that the system may measure IOP of both eyes at the same time (Paragraph 0018, 0054).
As noted above, Thomas discloses a spanner used to adjust the positioning of the pressure probe (Fig. 2—spanner 214, 216).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas including pressurizing devices to apply pressure to multiple locations of each eye to include a spanner for the adjustment of position of each pressure probe as described by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Regarding claim 9, the combination of Hadas and Thomas discloses the device of claim 1. Thomas additionally discloses wherein the spanner is comprised of a spanner housing and a spanner linear actuation subassembly (Fig. 2—spanner 214, 216, spanner actuation subassembly 210, 212).
Regarding claim 10, the combination of Hadas and Thomas discloses the device of claim 4. Hadas additionally teaches wherein the at least one pressure probe is comprised of a pressure probe housing and an eye rest (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that whatever portion of the pad is in contact with the eyelids would constitute an eye rest while the remainder of the pad would constitute a probe housing). Hadas additionally teaches the goggle body frame may be adjustable to accommodate different facial shapes and inter-pupil distances (Paragraph 0065).
However, Hadas does not explicitly disclose wherein the at least one pressure probe is comprised of a pressure probe linear actuation subassembly.
Thomas additionally discloses wherein the pressure probe is comprised of a pressure probe housing, a pressure probe linear actuation subassembly, and an eye rest (pressure probe housing (not shown) following the same structure as pressure probe 102 of Fig. 1B, ocular stabilizer 208 serves as an eye rest, linear actuation subassembly as part of tonometer 202 in Fig. 2; paragraph 0040-- the tonometer 202 can swing in and out of position or be moved sideways as necessary along the rails 214, 216 to place the ocular stabilizer 208 and ocular probe (not shown) in contact with the patient's eye to be tested such that this “swing in and out” motion may be seen to linearly actuate the ocular probe into contact with the eye; Figs. 1A-1B and paragraphs 0041-0043 demonstrate that the ocular probe of Thomas may include a motor to move the probe along a linear path).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas, including a pressure probe which applies pressure to the eye and a generally adjustable device, to include a pressure probe linear actuation subassembly as disclosed by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Regarding claim 12, the combination of Hadas and Thomas discloses the device of claim 9. Thomas additionally discloses wherein the spanner linear actuation subassembly is manipulated manually by hand or automatically via an electric motor (Fig. 2—spanner linear actuation subassembly consists of screws 212, 210 which may be manually manipulated by hand).
Regarding claim 13, the combination of Hadas and Thomas discloses the device of claim 10. Thomas additionally discloses wherein the pressure probe linear actuation subassembly is manipulated manually by hand or automatically via an electric motor (paragraph 0040--the tonometer 202 can swing in and out of position or be moved sideways as necessary along the rails 214, 216 to place the ocular stabilizer 208 and ocular probe (not shown) in contact with the patient's eye to be tested such that this “swing in and out” motion may be seen to manually linearly actuate the ocular probe into contact with the eye; Figs. 1A-1B and paragraphs 0041-0043 demonstrate that the ocular probes of Thomas generally may include a motor to move the probe along a linear path).
Regarding claim 14, the combination of Hadas and Thomas discloses the device of claim 10. Hadas additionally teaches wherein the extraocular pressure is static, optionally in combination with dynamic (Paragraph 0055—controlled pressure).
Regarding claim 15, the combination of Hadas and Thomas discloses the device of claim 10. Hadas additionally teaches wherein the extraocular pressure imparts an intraocular pressure from 5 mm Hg to 60 mm Hg (Paragraph 0054-0055--gradually increasing/decreasing pressure over a range of 0-120 mmHg, where it is noted that the pressurizing device may be a cup or a pad and the range of pressure encompasses the claimed range).
Regarding claim 16, the combination of Hadas and Thomas discloses the device of claim 10. Hadas additionally teaches wherein the ocular compression device is used to screen the user for ocular diseases and abnormalities (Paragraph 0002). However, Hadas does not explicitly disclose that the ocular diseases and abnormalities include ocular hypertension, glaucoma, or a combination thereof.
Thomas teaches wherein the ocular compression device is used to screen the user for ocular hypertension, glaucoma, or a combination thereof (Paragraph 0021).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas to be used to screen for ocular hypertension and/or glaucoma as discussed by Thomas in order to predictably improve the applicability of the device for different screening functions, as both of these conditions are known in the art to relate to IOP.
Claim(s) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadas in view of Thomas further in view of Fresco (US 20020169390 A1).
Regarding claim 11, the combination of Hadas and Thomas discloses the device of claim 10. However, Hadas is silent as to the shape of the eye rest. Thomas additionally discloses wherein the eye rest is in the shape of a crescent (Paragraph 0039-- The cup is crescent-shaped and is sized to form a snug fit around the eyeball over the eyelid to reduce or preferably eliminate movement of the eye during the test). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the eye rest of the pad of Hadas to have a crescent shape as discussed by Thomas in order to improve the fit of the pad to the eye shape and reduce movement of the eye during the test, thus improving accuracy of diagnostic tests performed with the system.
Thomas does not explicitly disclose that the crescent is “asymmetrical”.
Fresco discloses that a contact member of the probe which contacts the eye can be any desired shape and that a circular disk is conventional in the art (Paragraph 0032, 0035-- first head or contact member 40, which can be any desired shape. As illustrated in FIG. 1, the first contact member 40 is preferred to present a flat, circular disk surface, as indicated by 44, i.e. as a conventional applanation tonometer). As Thomas discloses the use of a crescent-shaped eye rest in order to form a snug fit with the eye and Fresco discloses that a contact member may be any shape, with disk-shaped being the most conventional, it would have been obvious to one having ordinary skill in the art to modify the crescent shape of the modified Hadas to be more asymmetrical, which may predictably improve the snug fit for users whose eyes are not symmetrical, and which may be done by making the crescent shape partially circular, as is conventional in the art according to Fresco and where Fresco teaches that the shape of the contact member may be a matter of design choice.
Regarding claim 17, the combination of Hadas and Thomas discloses the device of claim 1.
Hadas additionally teaches wherein the goggle body frame is secured to the head of the user with a headband to provide fit for the head of the user (Paragraph 0065, 0084-- The strap holding the mask to the face should be made adjustable to fit heads of different sizes…);
wherein the goggle body frame is connected to a goggle body lining made of a soft material in contact with the face of the user to alleviate discomfort (Paragraph 0083-- The frame edges towards the skin are covered with a very soft seal 42)wherein the spanner is comprised of a spanner housing and a spanner linear actuation subassembly (Fig. 2—spanner 214, 216, spanner actuation subassembly 210, 212);
wherein the at least one pressure probe is comprised of two pressure probes such that the at least one pressure probe comprises a pressure probe aligned with to the lower globe of each eye of the user (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that applying a controlled pressure over one or both eyelids when both eyes are open indicates that pressurizing devices may be applied in alignment with either of the upper or lower globe of the eye for each eye). For additional clarification, it is noted that Hadas additionally teaches that the system may measure IOP of both eyes at the same time (Paragraph 0018, 0054).
Hadas additionally teaches wherein the at least one pressure probe is comprised of a pressure probe housing and an eye rest (Paragraph 0055-- a pad configured for applying a controlled pressure over one or bath eyelids when the eye or eyes are open, where it is noted that whatever portion of the pad is in contact with the eyelids would constitute an eye rest while the remainder of the pad would constitute a probe housing). Hadas additionally teaches the goggle body frame may be adjustable to accommodate different facial shapes and inter-pupil distances (Paragraph 0065).
Hadas additionally teaches wherein the extraocular pressure is static, optionally in combination with dynamic (Paragraph 0055—controlled pressure).
Hadas does not explicitly disclose at least one spanner connected to the goggle body frame; at least one pressure probe connected to the at least one spanner; and wherein the at least one spanner is adjustable in the transverse direction to align the at least one pressure probe with at least one eye of the user; wherein the at least one spanner is comprised of a spanner housing and a spanner linear actuation subassembly; wherein the at least one pressure probe is comprised of a pressure probe linear actuation subassembly; wherein the eye rest is in the shape of a crescent; wherein the spanner linear actuation subassembly is manipulated manually by hand or automatically via an electric motor; wherein the pressure probe linear actuation subassembly is manipulated manually by hand or automatically via an electric motor.
Thomas, in the same field of endeavor of an ocular compression device for wearing on the face of a user (Fig. 2), teaches a device comprising a frame surrounding the eyes of the user wherein the frame has a transverse direction and a longitudinal direction (Tonometer 202); at least one spanner connected to the frame (Spanners 214, 216 with screws 210, 212); at least one pressure probe connected to the at least one spanner (Paragraph 0040—ocular stabilizer 208 and ocular probe (not shown) in contact with the patient’s eye to be tested; ocular stabilizer 208 and probe are connected to spanners 214, 216 via tonometer 202); wherein the at least one spanner is adjustable in the transverse direction to align the at least one pressure probe with at least one eye of the user (Paragraph 0040-- the tonometer 202 can swing in and out of position or be moved sideways as necessary along the rails 214, 216 to place the ocular stabilizer 208 and ocular probe (not shown) in contact with the patient's eye to be tested 218).
Thomas additionally discloses wherein the spanner is comprised of a spanner housing and a spanner linear actuation subassembly (Fig. 2—spanner 214, 216, spanner actuation subassembly 210, 212); wherein the pressure probe is comprised of a pressure probe housing, a pressure probe linear actuation subassembly, and an eye rest (pressure probe housing (not shown) following the same structure as pressure probe 102 of Fig. 1B, ocular stabilizer 208 serves as an eye rest, linear actuation subassembly shown as part of tonometer 202 in Fig. 2); wherein the eye rest is in the shape of an crescent (Paragraph 0039); wherein the spanner linear actuation subassembly is manipulated manually by hand or automatically via an electric motor (Fig. 2—spanner linear actuation subassembly consists of screws 212, 210 which may be manually manipulated by hand); wherein the pressure probe linear actuation subassembly is manipulated manually by hand or automatically via an electric motor (Fig. 2--, linear actuation subassembly shown as part of tonometer 202 consists of a screw which may be manipulated manually by hand).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas to include a spanner and spanner linear actuation subassembly for the adjustment of position of each of the at least one pressure probe as described by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Hadas, including a pressure probe which applies pressure to the eye and a generally adjustable device, to include a pressure probe linear actuation subassembly as disclosed by Thomas in order to predictably improve the device by enabling greater control and adjustment of the pressure application of Hadas in order to account for differences in anatomy, already discussed as a goal of Hadas in making the mask itself adjustable (see paragraph 0065).
Thomas does not explicitly disclose that the crescent is “asymmetrical”.
Fresco discloses that a contact member of the probe which contacts the eye can be any desired shape and that a circular disk is conventional in the art (Paragraph 0032, 0035-- first head or contact member 40, which can be any desired shape. As illustrated in FIG. 1, the first contact member 40 is preferred to present a flat, circular disk surface, as indicated by 44, i.e. as a conventional applanation tonometer). As Thomas discloses the use of a crescent-shaped eye rest in order to form a snug fit with the eye and Fresco discloses that a contact member may be any shape, with disk-shaped being the most conventional, it would have been obvious to one having ordinary skill in the art to modify the crescent shape of the modified Hadas to be more asymmetrical, which may predictably improve the snug fit for users whose eyes are not symmetrical, and which may be done by making the crescent shape partially circular, as is conventional in the art according to Fresco and where Fresco teaches that the shape of the contact member may be a matter of design choice.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, newly applied reference Hadas has been relied upon to disclose the argued features.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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