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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1. Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claims 1 and 11, the claims recite “the one or more control signals causing the laser beam to visit one or more regions of the cornea via linear scanning and retracement to constitute a scan pattern at a repetition frequency greater than 8 Hz, wherein the cross-linking agent passes through the corneal epithelium and is delivered to the corneal stroma”. However, there is no mention of retracing or retracements in the Applicant’s specification. The term retracement would generally mean going back along the same path, which is not happening in the Applicant’s invention (see Fig. 15). Clarification is needed. As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
2. Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “retracement” in claim 1, 10-11, and 20 is used by the claim to mean general scanning in horizontal and vertical directions while the accepted meaning is known to be going back over something. The term is indefinite because the specification does not clearly redefine the term.
Claims 2-9 and 12-19 are rejected by virtue of their dependency.
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.
3. Claim(s) 1-4, 6-9, 11-14, and 16-19 is/are rejected under 335 U.S.C. 103 as being unpatentable over Friedman (US 20160310319 A1) in view of Fu (US 20160374857 A1).
In regards to claim 1, Friedman discloses a system for treating an eye having a corneal epithelium and a corneal stroma (Abstract and Par. 0028), comprising:
a laser light source configured to provide photoactivating light (Par. 0023 and 0035 disclose a laser light source to provide photoactivating light);
a scanning system configured to receive the photoactivating light as a laser beam and to move the laser beam over a cornea treated with a cross-linking agent (Par. 0031 discloses an optical element with mirrors, i.e. a scanning system, for receiving and directing the light to the cornea. Abstract discloses the cornea is treated with a cross-linking agent); and
a controller configured to provide one or more control signals to programmatically control the laser light source and the scanning system (Par. 0023 and Fig 1 discloses a controller that can control the parameters of the light source and optical elements), the one or more control signals causing the laser beam to visit one or more regions of the cornea to constitute a scan pattern at a repetition frequency greater than 8 Hz (Par. 0030 discloses the controller can control the light source to visit regions of the cornea based on a scanning pattern and Par. 0037 teaches a frequency of 0.01 Hz to 1000 Hz),
wherein the cross-linking agent passes through the corneal epithelium and is delivered to the corneal stroma (Par. 0028 teaches that the cross-linking agent goes through the epithelium to the stroma),
wherein the photoactivating light causes the cross-linking agent in the one or more exposed regions to react with oxygen to generate cross-linking activity in the one or more exposed regions (Par. 0024 discloses the cross-linking activity being a result of the photoactivating light and oxygen), and
wherein the one or more control signals programmatically control the laser light source (Par. 0030 teaches a control system to control the functions of the system).
While Friedman discloses general scan patterns, they do not explicitly teach linear scanning and retracement. However, in the same field of endeavor, Fu discloses a system for performing laser ophthalmic surgery (Abstract) wherein the laser is applied to the cornea in a raster scan line to allow for overlapping scan lines (Par. 0015 and 0104; Fig 12a, 12b, and 14b – this is based on the Examiner’s best understanding of the Applicant’s term “retracement”, see 112a and 112b rejections applied above) in order to cover the entire treatment area and ensure tissue separation (Par. 0103 and 0109).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Friedman and modified them by having the system use a raster scan line, as taught and suggested by Fu, in order to cover the entire treatment area and ensure tissue separation (Par. 0103 and 0109 of Fu).
In regards to claim 2, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 1, wherein the light source is operable to adjust a power associated with the laser beam, and the scan pattern is optimized according to the power associated with the laser beam (Par. 0032 of Friedman discloses the controller can control the power associated with the light source).
In regards to claim 3, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 1, wherein the scanning mirror system is operable to adjust a speed of the laser beam as the laser beam moves over the cornea, and the scan pattern is optimized according to the speed of the laser beam (Par. 0037 of Friedman discloses adjusting the rate of the beam).
In regards to claim 4, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 1, further comprising one or more optical elements configured to receive the photoactivating light and determine a spot size associated with the laser beam, wherein the scan pattern is optimized according to the spot size associated with the laser beam (Par. 0034 of Friedman discloses optical elements to receive the light and apply it based on a scan pattern which comprises pixels on a topography for the laser to follow, i.e. spot sizes are provided for the laser).
In regards to claim 6, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 1 wherein the scan pattern causes the laser beam to visit the one or more exposed regions while keeping one or more adjacent regions unexposed to the photoactivating light, and the one or more adjacent unexposed regions provide oxygen for diffusion into the one or more exposed regions (Par. 0034 of Friedman teaches applying the beam in a spiral pattern and it can be either continuous or it can be pulsed which would allow for some regions to be unexposed).
In regards to claim 7, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 1, wherein the scan pattern is defined by a pulsing of the laser beam according to a duty cycle (Par. 0034 of Friedman discloses the pattern being defined by a duty cycle of the light), wherein, as the scanning mirror system scans the laser beam over the cornea, the pulsing causes the laser beam to visit the one or more exposed regions when the laser beam is on during the duty cycle while adjacent regions are unexposed to the photoactivating light when the laser beam is off during the duty cycle, and the adjacent unexposed regions provide oxygen for diffusion into the one or more exposed regions (Par. 0034 and 0037 of Friedman disclose where the duty cycle being on or off allows for the pulsed light source to follow a spatially determined pattern).
In regards to claim 8, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 7, wherein the pulsing of the laser beam has a frequency that varies according to a position of the laser beam in the scan pattern (Par. 0034 of Friedman discloses varying frequency along the scanning pattern).
In regards to claim 9, the combined teachings of Friedman and Fu as applied to claim 1 disclose the system of claim 1, wherein the one or more exposed regions correspond to a plurality of discrete dots defining the scan pattern (Par. 0034 of Friedman discloses a scan pattern which comprises pixels on a topography, i.e. discrete dots).
In regards to claim 11, Friedman discloses a method for treating an eye having a corneal epithelium and a corneal stroma (Abstract and Par. 0028), comprising:
generating photoactivating light with a laser light source (Par. 0023 and 0035 disclose a laser light source to provide photoactivating light);
directing the photoactivating light as a laser beam to a scanning mirror system (Par. 0031 discloses an optical element with mirrors, i.e. a scanning system, for receiving the laser light); and operating the scanning mirror system to cause the laser beam to move over a cornea and visit one or more regions of the cornea to constitute a scan pattern, wherein the photoactivating light causes a cross-linking agent in the one or more exposed regions to react with oxygen to generate cross-linking activity in the one or more exposed regions (Par. 0030 discloses the controller can control the light source to visit regions of the cornea based on a scanning pattern. Par. 0024 discloses the cross-linking activity being a result of photoactivating light and oxygen) at a repetition frequency greater than 8 Hz (Par. 0037 teaches a frequency of 0.01 Hz to 1000 Hz),
wherein the cross-linking agent passes through the corneal epithelium and is delivered to the corneal stroma (Par. 0028 teaches that the cross-linking agent goes through the epithelium to the stroma),
optimizing the scan pattern by programmatically controlling the laser light source (Par. 0030 teaches a control system to control the functions of the system).
While Friedman discloses general scan patterns, they do not explicitly teach linear scanning and retracement. However, in the same field of endeavor, Fu discloses a system for performing laser ophthalmic surgery (Abstract) wherein the laser is applied to the cornea in a raster scan line to allow for overlapping scan lines (Par. 0015 and 0104; Fig 12a, 12b, and 14b – this is based on the Examiner’s best understanding of the Applicant’s term “retracement”, see 112a and 112b rejections applied above) in order to cover the entire treatment area and ensure tissue separation (Par. 0103 and 0109).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Friedman and modified them by having the system use a raster scan line, as taught and suggested by Fu, in order to cover the entire treatment area and ensure tissue separation (Par. 0103 and 0109 of Fu).
In regards to claim 12, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 11, wherein optimizing the scan pattern includes adjusting a power associated with the laser beam (Par. 0032 of Friedman discloses the controller can control the power associated with the light source).
In regards to claim 13, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 11, wherein optimizing the scan pattern includes adjusting a speed of the laser beam, and the scan pattern is optimized according to the speed of the laser beam (Par. 0037 of Friedman discloses adjusting the rate of the beam).
In regards to claim 14, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 11, wherein optimizing the scan pattern includes determining a spot size associated with the laser beam (Par. 0034 of Friedman discloses optical elements to receive the light and apply it based on a scan pattern which comprises pixels on a topography for the laser to follow, i.e. spot sizes are provided for the laser.
In regards to claim 16, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 11 wherein the scan pattern causes the laser beam to visit the one or more exposed regions while keeping one or more adjacent regions unexposed to the photoactivating light, and the one or more adjacent unexposed regions provide oxygen for diffusion into the one or more exposed regions (Par. 0034 of Friedman teaches applying the beam in a spiral pattern and it can be either continuous or it can be pulsed which would allow for some regions to be unexposed).
In regards to claim 17, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 11, wherein optimizing the scan pattern includes defining the scan pattern to pulse the laser beam according to a duty cycle, wherein, as the scanning mirror system scans the laser beam over the cornea, the pulsing causes the laser beam to visit the one or more exposed regions when the laser beam is on during the duty cycle while adjacent regions are unexposed to the photoactivating light when the laser beam is off during the duty cycle, the adjacent unexposed regions provide oxygen for diffusion into the one or more exposed regions (Par. 0034 of Friedman discloses the pattern being defined by a duty cycle of the light and Par. 0034 and 0037 disclose where the duty cycle being on or off allows for the pulsed light source to follow a spatially determined pattern).
In regards to claim 18, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 17, wherein the pulsing of the laser beam has a frequency that varies according to a position of the laser beam in the scan pattern (Par. 0034 of Friedman discloses varying frequency along the scanning pattern).
In regards to claim 19, the combined teachings of Friedman and Fu as applied to claim 1 disclose the method of claim 11, wherein the one or more exposed regions correspond to a plurality of discrete dots defining the scan pattern (Par. 0034 of Friedman discloses a scan pattern which comprises pixels on a topography, i.e. discrete dots).
4. Claims 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman and Fu, and in view of Abe (US 20050080467 A1).
In regards to claims 5 and 15, the combined teachings of Friedman and Fu as applied to claim 1/11 disclose the system or method of claims 1 or 11, respectively, except for wherein the scanning mirror system includes a galvanometer pair, the galvanometer pair including a first mirror configured to move the laser beam along a first axis and a second mirror configured to move the laser beam along a second axis.
However, in the same field of endeavor, Abe discloses a laser treatment apparatus that comprises a galvanometer with a first and second mirror that can scan the laser along different axis’ (Par. 0023) in order to change an inclination angle, thereby changing the direction of the optical axis of the light and beams to be reflected.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Friedman and Fu and modified them by having a laser treatment apparatus that comprises a galvanometer with a first and second mirror that can scan the laser along different axis’, as taught and disclosed by Abe, in order to change an inclination angle, thereby changing the direction of the optical axis of the light and beams to be reflected.
5. Claims 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman and Fu, and in further view of L'Esperance (US 4718418 A).
In regards to claims 10 and 20, the combined teachings of Friedman and Fu as applied to claim 1/11disclose the system of claim 1/11, except for wherein linear scanning and retracement comprises at least a first horizontal scan line and a second horizontal scan line, the second horizontal scan line disposed parallel to and vertically below the first horizontal scan line.
However, in the same fiend of endeavor, L'Esperance discloses a device for corneal surgery (Abstract), wherein there are multiple horizontal scan lines disposed parallel and vertically below one another (Fig 3), in order to improve the resolution.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have taken the teachings of Friedman and Fu and modified them by having a series of horizontal scan lines, as taught and suggested by L'Esperance, in order to improve the resolution.
.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571) 272-4156. 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.
/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
