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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art reli1ed upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-8, and 10-15 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Liu et al. (hereinafter ‘Liu’, U.S. PGPub No. 2020/0289318).
In regards to claim 1, Liu discloses a method implemented in an ophthalmic laser system, comprising (a) delivering a treatment laser beam to an eye tissue based on a plurality of laser treatment parameters to form incisions in the eye tissue ([0026]: "FIG. 1 schematically illustrates a surgical ophthalmic laser system in which a cornea contact detection method according to embodiments of the present invention may be implemented. Not all components shown in FIG. 1 are necessary.", [0056]: "Prior to treatment, an off-line calibration step (step S80) is performed to establish the various analysis algorithms, based on empirical studies of abnormal confocal signal behaviors corresponding to different scan patterns...including to determine the parameters such as the threshold values of intensity change."), (b) continuously measuring an intensity value of a portion of a back-reflected treatment beam from the eye tissue ([0033]: "After the back-reflected laser light is focused by the objective lens 26 into a parallel beam and pass through the other optical components including the scanning devices, a part of the reflected laser light is reflected by the beam splitter 13 into the confocal detection assembly 20. The confocal detection assembly 20 includes a lens 31 (referred to as the confocal lens), a pinhole 32, and a light intensity detector 33 such as photodiodes."), (c) continuously comparing the intensity value of the back-reflected treatment beam to a threshold intensity value in real time, (d) when the intensity value of the back-reflected treatment beam is below the threshold intensity value, adjusting at least some of the laser treatment parameters in real time ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold."), and (e) delivering the treatment laser beam to the eye tissue based on the adjusted laser treatment parameters to form the incisions in the eye tissue ([0012]: "...and detected by a photodetector behind the pinhole; based on the confocal signal, the controller detecting, in real time, a loss of the direct contact between the output surface of the patient interface device and the eye tissue; and in response to detecting the loss of the direct contact, the controller performing a predefined corrective action.").
In regards to claim 3, Liu discloses that the adjusting in step (d) includes increasing a laser pulse energy ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold.").
In regards to claim 4, Liu discloses obtaining position data representing a location of the laser beam delivered in the eye ([0034]: "The confocal optical system, which is integrated in the laser treatment path and uses the treatment laser as the source as described above, can be used to detect the PI output surface position, and to calibrate the objective lens setting so as to control the Z position of the laser beam focus relative to the PI output surface."), based on the position data, identifying a region of the incisions that is currently being formed and selecting the threshold intensity value corresponding to the identified region of the incisions that is currently being formed ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold.").
In regards to claim 5, Liu discloses a method implemented in an ophthalmic laser system, comprising (a) delivering a treatment laser beam to an eye tissue based on a plurality of laser treatment parameters to form incisions in the eye tissue ([0026]: "FIG. 1 schematically illustrates a surgical ophthalmic laser system in which a cornea contact detection method according to embodiments of the present invention may be implemented. Not all components shown in FIG. 1 are necessary.", [0056]: "Prior to treatment, an off-line calibration step (step S80) is performed to establish the various analysis algorithms, based on empirical studies of abnormal confocal signal behaviors corresponding to different scan patterns...including to determine the parameters such as the threshold values of intensity change."), '(b) continuously measuring an intensity value of a portion of a back-reflected treatment beam from the eye tissue ([0033]: "After the back-reflected laser light is focused by the objective lens 26 into a parallel beam and pass through the other optical components including the scanning devices, a part of the reflected laser light is reflected by the beam splitter 13 into the confocal detection assembly 20. The confocal detection assembly 20 includes a lens 31 (referred to as the confocal lens), a pinhole 32, and a light intensity detector 33 such as photodiodes."), (c) continuously comparing the intensity value of the back-reflected treatment beam to previous intensity values, (d) when the intensity value drops by more than a threshold amount within a predetermined time interval, adjusting at least some of the laser treatment parameters in real time ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold."), and (e) delivering the treatment laser beam to the eye tissue based on the adjusted laser treatment parameters to form the incisions in the eye tissue ([0012]: "...and detected by a photodetector behind the pinhole; based on the confocal signal, the controller detecting, in real time, a loss of the direct contact between the output surface of the patient interface device and the eye tissue; and in response to detecting the loss of the direct contact, the controller performing a predefined corrective action.").
In regards to claim 6, Liu discloses that the adjusting in step (d) includes increasing a laser pulse energy ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold.").
In regards to claim 7, Liu discloses obtaining position data representing a location of the laser beam delivered in the eye ([0034]: "The confocal optical system, which is integrated in the laser treatment path and uses the treatment laser as the source as described above, can be used to detect the PI output surface position, and to calibrate the objective lens setting so as to control the Z position of the laser beam focus relative to the PI output surface."), based on the position data, identifying a region of the incisions that is currently being formed, and selecting the threshold amount based on the identified region of the incisions that is currently being formed ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold.").
In regards to claim 8, Liu discloses a method implemented in an ophthalmic laser system, comprising (a) delivering a treatment laser beam to an eye tissue based on a plurality of laser treatment parameters to form incisions in the eye tissue ([0026]: "FIG. 1 schematically illustrates a surgical ophthalmic laser system in which a cornea contact detection method according to embodiments of the present invention may be implemented. Not all components shown in FIG. 1 are necessary.", [0056]: "Prior to treatment, an off-line calibration step (step S80) is performed to establish the various analysis algorithms, based on empirical studies of abnormal confocal signal behaviors corresponding to different scan patterns...including to determine the parameters such as the threshold values of intensity change."), (b) continuously measuring an intensity value of a portion of a back-reflected treatment beam from the eye tissue ([0033]: "After the back-reflected laser light is focused by the objective lens 26 into a parallel beam and pass through the other optical components including the scanning devices, a part of the reflected laser light is reflected by the beam splitter 13 into the confocal detection assembly 20. The confocal detection assembly 20 includes a lens 31 (referred to as the confocal lens), a pinhole 32, and a light intensity detector 33 such as photodiodes."), (c) continuously analyzing the intensity value of the back-reflected treatment beam based on predefined statistical characteristics to determine incision quality, (d) when the incision quality is determined to be sub-optimal, adjusting at least some of the laser treatment parameters in real time ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold."), and (e) delivering the treatment laser beam to the eye tissue based on the adjusted laser treatment parameters to form the incisions in the eye tissue ([0012]: "...and detected by a photodetector behind the pinhole; based on the confocal signal, the controller detecting, in real time, a loss of the direct contact between the output surface of the patient interface device and the eye tissue; and in response to detecting the loss of the direct contact, the controller performing a predefined corrective action.").
In regards to claim 10, Liu discloses that the adjusting in step (d) includes increasing or decreasing a laser pulse energy ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold.").
In regards to claim 11, Liu discloses obtaining position data representing a location of the laser beam delivered in the eye ([0034]: "The confocal optical system, which is integrated in the laser treatment path and uses the treatment laser as the source as described above, can be used to detect the PI output surface position, and to calibrate the objective lens setting so as to control the Z position of the laser beam focus relative to the PI output surface."), based on the position data, identifying a region of the incisions that is currently being formed, and selecting the statistical characteristics based on the identified region of the incisions that is currently being formed ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold.").
In regards to claim 12, Liu discloses that the statistical characteristics include a matrix of multi-variables including signal mean and standard deviation at different cutting locations ([0053]: "The controller analyzes, in real time, the confocal signal to detect abnormal behaviors in the signal (step S87). In this step, the controller applies different algorithms to analyze the confocal signal in different time periods, depending on the laser beam scan pattern currently being performed during each time period.", [0056]: "Prior to treatment, an off-line calibration step (step S80) is performed to establish the various analysis algorithms, based on empirical studies of abnormal confocal signal behaviors corresponding to different scan patterns. This may be accomplished by performing different laser beam scan patterns in test samples, deliberately introducing suction breaks in the PI device during the scans, recording the corresponding confocal signals, and analyzing the confocal signal before and after suction breaks to design the analysis algorithms, including to determine the parameters such as the threshold values of intensity change.").
In regards to claim 13, Liu discloses a method implemented in an ophthalmic laser system, comprising (a) delivering a treatment laser beam to an eye tissue based on a plurality of laser treatment parameters to form incisions in the eye tissue ([0026]: "FIG. 1 schematically illustrates a surgical ophthalmic laser system in which a cornea contact detection method according to embodiments of the present invention may be implemented. Not all components shown in FIG. 1 are necessary.", [0056]: "Prior to treatment, an off-line calibration step (step S80) is performed to establish the various analysis algorithms, based on empirical studies of abnormal confocal signal behaviors corresponding to different scan patterns...including to determine the parameters such as the threshold values of intensity change."), (b) continuously measuring an intensity value of a portion of a back-reflected treatment beam from the eye tissue ([0033]: "After the back-reflected laser light is focused by the objective lens 26 into a parallel beam and pass through the other optical components including the scanning devices, a part of the reflected laser light is reflected by the beam splitter 13 into the confocal detection assembly 20. The confocal detection assembly 20 includes a lens 31 (referred to as the confocal lens), a pinhole 32, and a light intensity detector 33 such as photodiodes."), (c) obtaining position data representing a location of the laser beam delivered in the eye, and based on the position data, identifying regions of the incisions that are currently being formed ([0034]: "The confocal optical system, which is integrated in the laser treatment path and uses the treatment laser as the source as described above, can be used to detect the PI output surface position, and to calibrate the objective lens setting so as to control the Z position of the laser beam focus relative to the PI output surface."), for each of at least two different regions of the incision, (d) selecting analysis criteria based on the identified region of the incision, wherein the analysis criteria for the two different regions are different ([0054]: "In practice, the controller both controls the scanning devices based on predefined scan patterns and performs the confocal signal analyses; therefore, each time the controller changes the scan pattern to a new pattern, the controller can change the confocal signal analysis algorithm to a corresponding algorithm at the same time. This way, the confocal signal analysis algorithm is synchronized with the scan pattern."), (e) continuously analyzing the intensity value of the back-reflected treatment beam based on selected criteria ([0033]: "After the back-reflected laser light is focused by the objective lens 26 into a parallel beam and pass through the other optical components including the scanning devices, a part of the reflected laser light is reflected by the beam splitter 13 into the confocal detection assembly 20. The confocal detection assembly 20 includes a lens 31 (referred to as the confocal lens), a pinhole 32, and a light intensity detector 33 such as photodiodes."), (e) continuously analyzing the intensity value of the back-reflected treatment beam based on selected criteria; (f) adjusting at least some of the laser treatment parameters in real time based on results of the analysis in step (e) ([0053]: "Thus, for example, during a bed cut for a corneal flap, the controller detects whether the confocal signal experiences a sudden drop in intensity that exceeds a predefined threshold; during a side cut, the controller detects whether the sharp peaks of the confocal signal, which are synchronized with the zero depth position during the side cut, experience a sudden increase in intensities that exceeds another predefined threshold."), and (g) delivering the treatment laser beam to the eye tissue based on the adjusted laser treatment parameters to form the incisions in the region ([0012]: "...and detected by a photodetector behind the pinhole; based on the confocal signal, the controller detecting, in real time, a loss of the direct contact between the output surface of the patient interface device and the eye tissue; and in response to detecting the loss of the direct contact, the controller performing a predefined corrective action.").
In regards to claim 14, Liu discloses that the two different regions include a center region and an edge region of a lenticule incision ([0047]: "The behavior of the confocal signal during the top and bottom lenticule cuts and side cut, which are located insider the cornea, is similar to that during the bed cut in corneal flap formation; the behavior of the confocal signal during the entry cut is similar to that during the side cut in corneal flap formation, described earlier.").
In regards to claim 15, Liu discloses that the position data include data from a plurality of scanning motor encoders ([0043]: " As shown in FIG. 6A, the side cut is performed by placing the fast scan line tangentially along the circle, moving the fast scan line in the Z direction back and forth between the depth of the bed cut and a position above the PI output surface, while also moving the fast scan line in the X-Y direction along the circle, forming a wave pattern along the side surface.").
Allowable Subject Matter
Claims 2 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claims 2 and 9, there is no indication in prior art in the same field of the invention involve ophthalmic laser systems wherein the threshold intensity value is calculated based on calibration data collected form incisions performed on other eyes, wherein some incisions had black spot occurrences or were tissue-bridge-free or had tissue adhesion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 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, Carl Layno can be reached at (571) 272-4949. 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.
/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796