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 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.
Claims 23-27, 29-39, 41-42, 44, 47-48, and 51 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.
Claim 23 recites the limitation "the processing zone from the difference" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “the processing zone from a difference” and suggests amending.
Claims 24-25 are rejected based on their dependency on claim 23.
Claim 26 recites the limitation "account the influence" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “account an influence” and suggests amending.
Claim 27 recites the limitation "the range between x-ray radiation via the range of visible light" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “a range between x-ray radiation via a range of visible light” and suggests amending.
Claims 29-34 are rejected based on their dependency on claim 23.
Claim 35 recites the limitation "the processing zone from the difference" in lines 18-19. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “the processing zone from a difference” and suggests amending.
Claims 36-38 are rejected based on their dependency on claim 35.
Claim 39 recites the limitation "the range between x-ray radiation via the range of visible light" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “a range between x-ray radiation via a range of visible light” and suggests amending.
Claims 41-42, 44, and 48 are rejected based on their dependency on claim 35.
Claims 47 is rejected based on its dependency on claim 23.
Claim 51 recites the limitation "apparatus with the aid" in line 6. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “apparatus with an aid” and suggests amending.
Claim Rejections - 35 USC § 102
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.
Claim(s) 23-27, 29-30, 32-39, 41-42, 44, 46, and 51 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2019/147952 Knox et al., hereinafter “Knox”.
Regarding claim 23, Knox discloses a planning method (Abstract and Para 1) to generate control data for a control unit of a laser processing apparatus (Para 6) utilized in a surgical procedure to change a refractive index in a processing zone of a transparent organic or inorganic material (Para 6 and 12-13 the transparent material is corneal tissue, that is known and acknowledged by the specification to be a transparent material of the eye), the method comprising: characterizing an actual behavior of an indicator structure (Para 6; the actual behavior is the behavior that is inherently causing the patient to undergo internal refractive index changing, the desired refractive index profile reflects the changes from an initial actual behavior of an eye) in an examination zone arranged in an optical path downstream of a processing zone of the transparent organic or inorganic material transilluminated by examination radiation (Para 29; the scan region is interpreted to be the examination zone and the focal spot is the processing zone that includes the transparent material, i.e. the corneal tissue, see Para 12-13); defining a target behavior of the indicator structure in the examination zone (Para 6; the intended performance; “achieve a desired refractive index profile”); determining a change profile of the refractive index in the processing zone from a difference between actual behavior of the indicator structure in the examination zone and the target behavior of the indicator structure in the examination zone (Para 6 and 8); determining a scanning pattern of focal spots of pulsed processing laser radiation of the laser processing apparatus for processing the transparent organic or inorganic material in the processing zone to implement the change profile of the refractive index in the processing zone (Para 6; scanning traces in the optical material); determining control data for the control unit of the laser processing apparatus for implementing the scanning pattern (Para 6); and repeating aforementioned steps iteratively at predetermined intervals, wherein the characterization of the actual behavior of the indicator structure in the examination zone implemented most recently is always adopted as a new actual behavior (Refer to claim 37 that shows the steps being repeated twice, at a first wavelength, then again at a second. To overcome this rejection easily, examiner suggests defining that the repetition occurs more than two times).
Regarding claim 24, Knox discloses determining a target distribution of the refractive index in a processing zone from the target behavior of the indicator structure in the examination zone (Para 6-7, 9, and 12) and determining an actual distribution of the refractive index in the processing zone from the actual behavior of the indicator structure in the examination zone (Para 6-7, 9, and 12).
Regarding claim 25, Knox discloses using indicator structures in a plurality of examination zones for characterizing the actual behavior and for defining the target behavior (Para 6; “writing test patterns in sections of one or more enucleated ocular globes”), wherein: the examination zones are arranged in the optical path upstream and downstream of the processing zone (Para 6), and further comprising comparing a behavior of an upstream indicator structure in an examination zone upstream of the processing zone to behavior of a downstream indicator structure in an examination zone downstream of the processing zone, and/or comparing a behavior of an indicator structure in an examination zone arranged in the optical path downstream of the processing zone but not downstream of a region of the processing zone processed by application of the scanning pattern of focal spots to the behavior of an indicator structure downstream of the region of the processing zone processed by use of the scanning pattern (Para 6).
Regarding claim 26, Knox discloses taking into account an influence of at least one zone which represents a distorting transmitting medium in the optical path of the examination radiation (Para 6-9; This is inherent, the controller must account for structures like a tear film that is naturally present in a patient’s eye).
Regarding claim 27, Knox discloses making use of the pulsed processing laser radiation of the laser processing apparatus (Para 6), at least one examination radiation from a range between x-ray radiation via a range of visible light and microwave radiation up to ultrasound for characterizing the actual behavior or both (Para 13), and choosing at least one of the following processes for detection purposes: interferometric detection including optical coherence tomography (OCT) and a phase-sensitive OCT, confocal detection; fundus camera recordings, refractometric measurement, wavefront measurement and ultrasound imaging (Para 55 and 58).
Regarding claim 29, Knox discloses determining the scanning pattern of focal spots for implementing the change profile of the refractive index such that at least some of the processing zone is swept-over multiple times by the pulsed processing laser radiation (Para 8-9 and 29).
Regarding claim 30, Knox discloses the control data comprise at least one of target coordinates of the focal spots, a pulse energy of the pulsed processing laser radiation and a processing time (Para 6, 8, and 43).
Regarding claim 32, Knox discloses using a closed loop for tracking a change in the refractive index in the processing zone and completing the closed loop when the target behavior of the indicator structure and hence the desired change profile of the refractive index is implemented (Para 6-9; the disclosure of Knox is using a closed loop, they are determining the change and implementing it using its own feedback to adjust the parameters, no outside data is fed to the system).
Regarding claim 33, Knox discloses the transparent organic or inorganic material to be processed comprises a tissue of a patient's eye (Para 6 and 13), and wherein the processing zone is arranged in at least one of the following regions of the patient's eye: a cornea, a natural lens or an intraocular lens, and/or wherein the examination zone is arranged in the retina of the patient's eye (Para 13).
Regarding claim 34, Knox discloses the processing zone is arranged in at least one of the following regions of the patient's eye: a cornea, a natural lens or an intraocular lens, and/or wherein the examination zone is arranged in the retina of the patient's eye (Para 13).
Regarding claim 35, Knox discloses a planning device (Abstract and Para 1) to generate control data for a control unit of a laser processing apparatus (Para 6) to change a refractive index in a processing zone of a transparent organic or inorganic material (Para 6 and 12-13 the transparent material is corneal tissue, that is known and acknowledged by the specification to be a transparent material of the eye), the laser processing apparatus comprising: a laser device with a laser source that generates pulsed processing laser radiation (Para 6); a focusing apparatus that focuses the pulsed processing laser radiation at a focus in the processing zone (Para 6); a scanning apparatus that scans the focus of the pulsed processing laser radiation in the processing zone of the transparent organic or inorganic material (Para 6); and an examination apparatus that detects examination radiation to characterize an actual behavior of an indicator structure in an examination zone using a detection apparatus (Para 29; the scan region is interpreted to be the examination zone and the focal spot is the processing zone that includes the transparent material, i.e. the corneal tissue, see Para 12-13), wherein the planning device comprises an interface that supplies data from the examination apparatus and an interface that transmits control data to the control unit of the laser processing apparatus (Para 6), and wherein the planning device is configured: to record the actual behavior of the indicator structure in the examination zone arranged in an optical path downstream of the processing zone of the transparent organic or inorganic material transilluminated by the examination radiation (Para 6; the actual behavior is the behavior that is inherently causing the patient to undergo internal refractive index changing, the desired refractive index profile reflects the changes from an initial actual behavior of an eye), to define a target behavior of the indicator structure in the examination zone (Para 6; the intended performance; “achieve a desired refractive index profile”), to determine a change profile of the refractive index in the processing zone from a difference between the actual behavior and the target behavior of the indicator structure in the examination zone (Para 6 and 8), to determine a scanning pattern of focal spots of the pulsed processing laser radiation for processing the transparent organic or inorganic material in the processing zone for implementing the change profile of the refractive index in the processing zone (Para 6; scanning traces in the optical material), and to establish the control data for the control unit of the laser processing apparatus therefrom (Para 6), wherein the planning device is furthermore configured to, at predetermined intervals during the processing of the transparent organic or inorganic material in the processing zone, supply data from the examination apparatus, the data describing the actual behavior of the indicator structure, and configured to transmit control data to the control unit of the laser processing apparatus, wherein most recently described behavior of the indicator structure in the examination zone is always adopted as new actual behavior of the indicator structure for the purposes of ascertaining the control data (Refer to claim 37 that shows the steps being repeated twice, at a first wavelength, then again at a second. To overcome this rejection easily, examiner suggests defining that the repetition occurs more than two times).
Regarding claim 36, Knox discloses to determine a target distribution of the refractive index in a processing zone from the target behavior of the indicator structure in the examination zone (Para 6-7, 9, and 12) and an actual distribution of the refractive index in the processing zone from the actual behavior of the indicator structure in the examination zone (Para 6-7, 9, and 12).
Regarding claim 37, Knox discloses to record the actual behavior of indicator structures in a plurality of examination zones and use these to define the target behavior (Para 6; “writing test patterns in sections of one or more enucleated ocular globes”), wherein at least one of the plurality of examination zones is arranged in the optical path upstream and downstream of the processing zone (Para 6), and a behavior of an indicator structure in an examination zone upstream of the processing zone is compared to the behavior of the indicator structure in an examination zone downstream of the processing zone, and a behavior of an indicator structure in an examination zone arranged in the optical path downstream of the processing zone but not downstream of a region of the processing zone processed by use of the scanning pattern of focal spots is compared to the behavior of an indicator structure downstream of the region of the processing zone processed by the use of the scanning pattern (Para 6).
Regarding claim 38, Knox discloses to take account of influence of at least one zone which represents a distorting transmitting medium in the optical path of the examination radiation (Para 6-9; This is inherent, the controller must account for structures like a tear film that is naturally present in a patient’s eye).
Regarding claim 39, Knox discloses for characterizing the actual behavior of the indicator structure, use is made of at least one of the pulsed processing laser radiation of the laser processing apparatus (Para 6) and at least one examination radiation from a range between x-ray radiation via a range of visible light and microwave radiation up to ultrasound (Para 13), and wherein one of the following apparatuses is chosen for detection purposes: an interferometer including optical coherence tomography (OCT) and a phase- sensitive OCT, a confocal detector, a fundus camera, a refractometer, a wavefront measuring device and an ultrasound imaging system (Para 55 and 58).
Regarding claim 41, Knox discloses to determine the scanning pattern of focal spots to implement the change profile of the refractive index such that at least some of the processing zone is swept-over multiple times by the pulsed processing laser radiation (Para 8-9 and 29).
Regarding claim 42, Knox discloses the control data comprise at least one of target coordinates of the focal spots, a pulse energy of the pulsed processing laser radiation and a processing time (Para 6, 8, and 43).
Regarding claim 44, Knox discloses the transparent organic or inorganic material to be processed comprises a tissue of a patient's eye (Para 6 and 13), and wherein the processing zone is arranged in at least one of the following regions of the patient's eye: a cornea, a natural lens or an intraocular lens, and/or wherein the examination zone is arranged in the retina of the patient's eye (Para 13).
Regarding claim 46, Knox discloses laser processing apparatus for processing a transparent organic or inorganic material (Abstract and Para 6), comprising a laser device with a laser source for generating pulsed processing laser radiation (Para 6); a focusing apparatus for focusing the pulsed processing laser radiation on a focus in the processing zone (Para 6); a scanning apparatus for scanning the focus of the pulsed processing laser radiation in the processing zone of the transparent organic or inorganic material (Para 6); an examination apparatus which detects examination radiation for characterizing an actual behavior of an indicator structure in an examination zone using a detection apparatus (Para 6 and 29; the scan region is interpreted to be the examination zone and the focal spot is the processing zone that includes the transparent material, i.e. the corneal tissue, see Para 12-13), a control unit for controlling the laser processing apparatus by means of control data, and a planning device for generating control data for the control unit (Para 6), as claimed in claim 35.
Regarding claim 51, Knox discloses a method for changing a refractive index in a transparent organic or inorganic material (Abstract and Para 6), comprising: generating control data for a laser processing apparatus for changing the refractive index using a planning method (Para 6) as claimed in claim 23, and processing the transparent organic or inorganic material, including a tissue of a patient's eye, by the laser processing apparatus with an aid of the control data (Para 6 and 13).
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) 31 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/147952 Knox et al., hereinafter “Knox”, in view of US 2008/0208525 Kikawa et al., hereinafter “Kikawa”.
Regarding claim 31, Knox discloses all the limitations of claim 30.
Knox does not disclose determining only a subset of the target coordinates of the focal spots in the processing zone and interpolating further target coordinates between two target coordinates of this subset.
However, Kikawa discloses an imaging apparatus (Abstract) and teaches determining only a subset of the target coordinates of the focal spots in the processing zone and interpolating further target coordinates between two target coordinates of this subset (Para 114-115 and 122).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed interpolating coordinates as taught by Kikawa, in the invention of Knox, in order to form a complete image/scan (Kikawa; Para 114).
Claim(s) 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/147952 Knox et al., hereinafter “Knox”, in view of US 2019/0183678 Rathjen et al., hereinafter “Rathjen”.
Regarding claim 47, Knox discloses planning method for generating control data for a control unit of a laser processing apparatus for changing a refractive index in a processing zone of a transparent organic or inorganic material (Abstract and Para 6) as claimed in claim 23.
Knox does not disclose a computer program product with program code which, when executed on a computer, carries out the method.
However, Rathjen discloses an ophthalmic apparatus that uses laser sources (Abstract) and teaches a computer program product with program code which, when executed on a computer, carries out the method (Para 52).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a computer program as taught by Rathjen, in the invention of Knox, in order to control the different components of the method (Rathjen; Para 52).
Regarding claim 48, Knox discloses a planning device for generating control data for a control unit of a laser processing apparatus for changing a refractive index in a processing zone of the transparent organic or inorganic material (Para 6) as claimed in claim 35, including by a processor of such a planning device, and which, when executed by the planning device, generates control data in order to operate the laser processing apparatus (Para 6).
Knox does not disclose a computer program product with program code which is readable on a planning device for generating control data for a control unit of a laser processing apparatus
However, Rathjen discloses an ophthalmic apparatus that uses laser sources (Abstract) and teaches a computer program product with program code which is readable on a planning device for generating control data for a control unit of a laser processing apparatus (Para 52).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a computer program as taught by Rathjen, in the invention of Knox, in order to control the different components of the method (Rathjen; Para 52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796