DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 18 December 2024 has been considered by the Examiner.
Claim Rejections - 35 USC § 112
3. 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.
4. Claim 8 is 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.
Claim 8 recites the limitation "using the determined area" in line 13. There is insufficient antecedent basis for this limitation in the claim. The Examiner respectfully submits that it is unclear if the determined area of claim 8 is the same as the determined area from claim 1. Specifically, claim 1 recites a position measurement system that is configured to determine an area in the cornea comprising the eye colorant. Meanwhile, claim 8 recites a second position measurement system configured to determine the area in the cornea comprising the eye colorant. However, the limitation of claim 8 that recites “using the determined area” is unclear, as the Examiner cannot determine if the “the determined area” of claim 8 is the same or different from “the determined area” of claim 1. The Examiner suggests that Applicant amends claim 8 to recite a “second determined area” which would distinguish from the determined area of claim 1.
Claim Rejections - 35 USC § 102
5. 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.
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.
6. Claims 1-7 and 14-15 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Homer (US 2005/0049584 A1).
Regarding claim 1, Homer teaches an ophthalmological system for ablative removal of eye colorant arranged in a cornea of an eye of a patient (the Examiner respectfully submits that Applicant’s specification states that the focal spot of the laser provides an anulus shaped cut on the cornea to provide direct access to eye colorant which covers the iris [0028]. Furthermore, the Examiner respectfully submits that eye colorant is considered to be an eye color or pigmentation which is inherently known to be formed on the iris rather than the cornea. Similarly, Homer teaches a laser that provides laser pulses through the cornea to remove the pigment color which covers the iris [0027, 0029, 0040-0042]), the ophthalmological system comprising:
a. a position measurement system configured to determine an area in the cornea comprising the eye colorant (before the surgical procedure, an optical scanning or measurement device may be used to map or identify the iris pigmentation (e.g., colorant) under the cornea [0040-0042]);
b. a laser source configured to generate a pulsed laser beam (one or more lasers may be selected to provide the laser pulses during the treatment [0040-0042]);
c. a focusing optics configured to make the pulsed laser beam converge onto a focal spot in the cornea (the one or more lasers may be a femtosecond laser which includes focusing optics to focus the laser energy at a specific depth of penetration within the cornea to reach the pigmentation (e.g., colorant) which covers the iris [0037, 0040-0042]);
d. a scanner system configured to deflect the pulsed laser beam to target locations in the cornea (an optical guidance or positioning device may be used to deflect or guide the laser beam through the cornea to the target pigmentations (e.g., colorant) that covers the iris [0040-0041]); and
e. an electronic circuit configured to control the scanner system to direct the focal spot to process a determined area comprising the eye colorant in the cornea for ablative removal of the eye colorant arranged in the cornea (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser energy (e.g., femtosecond laser pulses) through a specific depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]. Specifically, the laser energy is configured to ablate or remove the target pigmentations (e.g., colorant) which covers the iris [0029, 0040-0041]).
Regarding claim 2, Homer teaches wherein the position measurement system further is configured to determine position reference data of the area comprising the eye colorant to be treated (before the surgical procedure, an optical scanning or measurement device may be used to map or identify the iris pigmentation (e.g., colorant) under the cornea [0040-0042]. The Examiner respectfully submits that the mapping data is considered to be the position reference data [0040-0042]. Furthermore, the femtosecond laser may be applied at a specific depth of penetration within the cornea to reach the pigmentation (e.g., colorant) which covers the iris [0037, 0040-0042]).
Regarding claim 3, Homer teaches wherein the laser source comprises a femtosecond laser source ([0040-0042]).
Regarding claim 4, Homer teaches wherein the electronic circuit further is configured to control a scanner device of the scanner system to move the focal spot with a scanning speed along a processing path generated based on the determined area comprising the eye colorant (the computer system includes one or more processors that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser beam (e.g., femtosecond laser beam) through a specific depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]. The Examiner respectfully submits that the “scanning speed along a processing path” is inherent while scanning and processing the mapping data for the pigmentations (e.g., colorant) [0040-0042]).
Regarding claim 5, Homer teaches wherein the position measurement system is configured to determine a depth position of the area comprising the eye colorant within the cornea (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser beam (e.g., femtosecond laser beam) through a predetermined depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]), and wherein the electronic circuit further is configured to at least one of move the focal spot to process the determined area comprising the eye colorant, using the determined depth position of the area comprising the eye colorant, or control at least one laser parameter of the puled laser beam to process the determined area using the determined depth position of the area (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser beam (e.g., femtosecond laser beam) through a predetermined depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]).
Regarding claim 6, Homer teaches wherein the electronic circuit is further configured to control the scanner system to move the focal spot to form a cut extending at least partially from the outer surface of the cornea into the cornea, thereby forming a cornea flap, which is moveable for providing direct access to the area comprising the eye colorant in the cornea (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser pulses (e.g., femtosecond laser pulses) through a predetermined depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]. The Examiner respectfully submits that the femtosecond laser is an “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]).
Regarding claim 7, Homer teaches wherein the ophthalmological system further comprises:
f. an access device configured to form a cut in the cornea, which extends from an outer surface of the cornea into the cornea thereby forming a cornea flap, which is moveable for providing direct access to the area comprising the eye colorant in the cornea (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser pulses through a predetermined depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]. Specifically, one or more lasers may be selected to perform this procedure [0040-0042]. The Examiner respectfully submits that one or more of the lasers may be an access device, such as an “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]).
Regarding claim 14, Homer teaches wherein the electronic circuit of the ophthalmological system is configured to control the scanner system to move the focal spot along a surface of the cornea, which was previously at least partially covered by the eye colorant for leveling the surface of these locations (as stated previously in claim 1, the Examiner respectfully submits that Applicant’s specification states that the focal spot of the laser provides an anulus shaped cut on the cornea to provide direct access to eye colorant which covers the iris [0028]. Similarly, Homer teaches the optical scanning or measurement device may be used to map the iris pigmentation (e.g., colorant) under the cornea [0040-0042]. The pigmentation (e.g., colorant) may be mapped before, during, and/or after the laser treatment [0040-0042]. In this case, during the treatment, the optical scanning or measurement device may scan regions of the eye which previously contained pigmentation (e.g., colorant) [0040-0042]. Furthermore, the femtosecond laser may be applied and focused at a predetermined depth of penetration within the cornea (e.g., focal spot) to reach the pigmentation (e.g., colorant) [0037, 0040-0042]).
Regarding claim 15, Homer teaches a computer program product comprising a non-transitory computer-readable medium having stored thereon computer program code for controlling a processor of an ophthalmological system for ablative removal of eye colorant arranged in a cornea of an eye of a patient (the Examiner respectfully submits that Applicant’s specification states that the focal spot of the laser provides an anulus shaped cut on the cornea to provide direct access to eye colorant which covers the iris [0028]. Furthermore, the Examiner respectfully submits that eye colorant is considered to be an eye color or pigmentation which is inherently known to be formed on the iris rather than the cornea. Similarly, Homer teaches a computer system comprising a memory which stores a computer software code that controls one or more processors to activate the laser source to deliver laser pulses through the cornea to remove the pigment color which covers the iris [0027, 0029, 0040-0042]. The Examiner further submits that the memory of the computer system may be a hard disk drive or CD-ROM which are known to be types of non-transitory computer readable memory [0041]), wherein the ophthalmological system comprises a position measurement system configured to determine an area in the cornea comprising the eye colorant using images of the cornea (before the surgical procedure, an optical measurement or scanning device (e.g., imaging) may be used to map or identify the iris pigmentation (e.g., colorant) under the cornea [0040-0042]. In response, the femtosecond laser may be applied at a specific depth of penetration within the cornea to reach the pigmentation (e.g., colorant) which covers the iris [0037, 0040-0042]), a laser source configured to generate a pulsed laser beam (one or more lasers may be selected to provide the laser pulses during the treatment [0040-0042]), a focusing optics configured to make the pulsed laser beam converge onto a focal spot in the cornea (the one or more lasers may be a femtosecond laser which includes focusing optics to focus the laser energy at a specific depth of penetration within the cornea to reach the pigmentation (e.g., colorant) which covers the iris [0037, 0040-0042]), a scanner system configured to deflect the pulsed laser beam to target locations in the cornea (an optical guidance or positioning device may be used to deflect or guide the laser beam through the cornea to the target pigmentations (e.g., colorant) that covers the iris [0040-0041]), the computer program code is configured to control the processor such that the processor directs the focal spot of the scanner system to process the determined area comprising at least partially the eye colorant for ablative removal of the eye colorant arranged in the cornea of the eye (the computer system includes one or more processors that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser energy (e.g., femtosecond laser pulses) through a specific depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]. Specifically, the laser energy is configured to ablate or remove the target pigmentations (e.g., colorant) which covers the iris [0029, 0040-0041]).
Claim Rejections - 35 USC § 103
7. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Homer.
Regarding claim 8, Homer suggests the ophthalmological system according to claim 7, wherein the access device is provided by a standalone access cutting ophthalmological device (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser pulses through a predetermined depth of the cornea to the target pigmentations (e.g., colorant) which covers the iris [0040-0042]. Specifically, one or more lasers may be selected to perform this procedure [0040-0042]. The Examiner respectfully submits that one or more of the lasers may be an access device, such as an “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]) comprising:
a. the position measurement configured to determine the area in the cornea comprising the colorant (before the surgical procedure, an optical scanning or measurement device may be used to map or identify the iris pigmentation (e.g., colorant) under the cornea [0040-0042]))
b. a second laser source configured to generate a second pulsed laser beam (one or more lasers may be selected to provide the laser pulses during the treatment [0040-0042]);
c. a second focusing optics configured to make the second pulsed laser beam converge onto a second focal spot in the cornea (the one or more lasers may be a femtosecond laser which includes focusing optics to focus the laser energy at a specific depth of penetration within the cornea to reach the target pigmentation zones (e.g., colorants) which covers the iris [0037, 0040-0042]);
d. the scanner system configured to deflect the second pulsed laser beam to target locations in the cornea (an optical guidance or positioning device may be used to deflect or guide the laser beam through the cornea to the target pigmentations (e.g., colorant) that covers the iris [0040-0041]); and
e. a second electronic circuit configured to control the scanner system to move the second focal spot inside the cornea to form the cut extending at least partially from the outer surface of the cornea into the cornea using the determined area, thereby forming the cornea flap, which is moveable for providing direct access to the area comprising the eye colorant (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser energy from the one or more lasers through a specific depth of the cornea to the target pigmentation zones (e.g., colorant) which covers the iris [0040-0042]. As stated previously above, the one or more lasers may be a “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]).
Homer does not explicitly teach the ophthalmological system comprising:
a second position measurement system configured to determine the area in the cornea comprising the eye colorant
d. a second scanner system configured to deflect the second pulsed laser beam.
e. the second electronic circuit configured to control the second scanner to move the second focal spot inside the cornea to form the cut extending at least partially from the outer surface of the cornea into the cornea using the determined area
The Examiner respectfully submits that Homer teaches the use of a second laser source, a second focal spot, a position measurement system, a scanner system, and a second electronic circuit (see the explanation above). Thus, configuring the exact number of position measurement systems and scanner systems that are utilized by the second electronic circuit to move the second focal spot to form the cut on the cornea at the determined area (e.g., area consisting of the colorant) would be a matter of duplicating the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 9, Homer teaches wherein the second laser source of the access cutting ophthalmological device comprises a femtosecond laser source for producing femtosecond laser pulses (the one or more lasers may be femtosecond lasers which provide femtosecond laser pulses [0040-0042]. Specifically, the one or more femtosecond lasers may be a “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040-0042]).
Regarding claim 10, Homer teaches wherein the second electronic circuit is further configured to control the second scanner system to move the focal spot inside the cornea to generate the cut such that a portion of the cornea flap remains in contact with the rest of the cornea, enabling that the cornea flap is flippable away for enabling access and flippable back for enabling to cover the area, which previously comprised the eye colorant (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser energy from the one or more lasers through a specific depth of the cornea to the target pigmentation zones (e.g., colorant) which covers the iris [0040-0042]. Specifically, the one or more lasers may be a “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]. The Examiner respectfully submits that it is inherent that the flap on the eye’s surface (e.g., corneal surface) would be flippable to uncover or cover the area which contains the pigmentation zones (e.g., colorant) [0040-0042]).
Regarding claim 11, Homer teaches wherein the second electronic circuit further is configured to control the second scanner system to move the focal spot inside the cornea to generate an at least partially annulus shaped cut, thereby forming an at least partially annulus shaped cornea flap, which is moveable for providing direct access to the eye colorant comprising location, and which keeps the center portion of the cornea unaffected (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser energy from the one or more lasers through a specific depth of the cornea to the target pigmentation zones (e.g., colorant) which covers the iris [0040-0042]. Specifically, the one or more lasers may be a “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]. Furthermore, the Examiner respectfully submits that respectfully submits that the pulsed laser beam may form a circular or annular spot shape which would inherently create a circular or annular flap on the eye surface (e.g., corneal surface) that can be moved out the way to access the target pigmentation zones (e.g., colorant) [0021, 0040-0042]. Lastly, it is noted that the that patient’s cornea is kept intact and unaffected during the treatment [0040, 0042]).
Regarding claim 12, Homer teaches wherein the second electronic circuit further is configured to control the second scanner system to move the focal spot inside the cornea to generate the cut such the cut is arranged adjacent to the area comprising the eye colorant (the computer system includes one or more processors (e.g., electronic circuits) that are coupled to optical scanning and optical guidance systems for mapping the pigmentation (e.g., colorant) and directing the focus of the laser energy from the one or more lasers through a specific depth of the cornea to the adjacent pigmentation zones (e.g., colorant) which covers the iris [0040-0042]. Specifically, the one or more lasers may be a “IntraLase femtosecond laser” which is known to be used to perform a LASIK procedure consisting of delivering laser pulses to create a flap on the eye’s surface (e.g., corneal surface) [0040]. The Examiner respectfully submits that it is inherent that the flap on the eye’s surface (e.g., corneal surface) would be flippable to cover or uncover the adjacent pigmentation zones (e.g., colorant) that are treated during the procedure [0040-0042]).
9. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Homer in view of Donitzky et al. (US 2012/0083775 A1).
Regarding clam 13, Homer teaches the ophthalmological system according to claim 1. Homer does not explicitly teach wherein the ophthalmological system further comprises a patient interface, with a contact body, which contact body brings an outer surface of the cornea in an applanated form in a state where the patient interface is applied on the eye; and
the electronic circuit further is configured to control the scanner system to at least one of:
move the focal spot at locations on the applanated locations of the cornea comprising at least partially the eye colorant, or move the focal spot inside the cornea to generate the cut extending at least partially from the outer surface of the cornea into the cornea, thereby forming the cornea flap.
The prior art by Donitzky is analogous to Homer, as they both teach a laser that is configured to deliver a laser beam to the cornea ([0031]).
Donitzky teaches wherein the ophthalmological system further comprises a patient interface (patient adapter 20 [0030]), with a contact body (the patient adapter 20 comprises a contact element 24 having an abutment face 26 for the cornea [0030]), which contact body brings an outer surface of the cornea in an applanated form in a state where the patient interface is applied on the eye ([0030-0031]); and
the electronic circuit further is configured to control the scanner system to move the focal spot inside the cornea to generate the cut extending at least partially from the outer surface of the cornea into the cornea, thereby forming the cornea flap (the control computer 30 is coupled to the the scan module 16 to control the location of the beam focus (e.g., focal spot) of the laser beam 14 such that a flap arises in the cornea of the eye 22 bearing against the contact element 24 [0031]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Homer’s ophthalmological system to comprise a patient interface having a contact body that contacts the patient’s cornea while the electronic circuit controls the focal spot inside the cornea to generate a cut that forms the cornea flap, as taught by Donitzky. The advantage of such modification will allow for securing the patient’s cornea against the contact body while the laser creates the flap in the cornea (see paragraphs [0030-0031] by Donitzky).
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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