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 .
Status of Claims
Claims 1-10 and 12-13 are currently pending and under consideration.
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 1-10 and 12 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.
The term “conventional” in claim 1 is a relative term which renders the claim indefinite. The term “conventional” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation of “laser parameters” is rendered indefinite by the use of the relative term “conventional” since the determination of conventional laser parameter would be based on type of conditions being treated and the specification does not seem to disclose any specific conditions with laser parameters. Dependent claims 2-10 and 12 are also rejected for the same reasons set forth for claim 1.
Regarding claims 4 and 10, the phrase “in particular” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purpose of examination, the phrase following the limitation “in particular” has been interpreted as an optional limitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it recites a computer program per se. MPEP 2106.03(I) states “a product claim to a software program that does not also contain at least one structural limitation (such as a "means plus function" limitation) has no physical or tangible form, and thus does not fall within any statutory category.” To narrow the claim to those embodiments that fall within a statutory category, the claim can be amended to “non-transitory computer-readable storage medium” described in [0029] of the USPGPub. Version of the specification.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-2, 4, 9-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mosquera (US 20220183884) in view of Peyman (US 20190307551 A1, published 10/10/2019).
Regarding claim 1, Mosquera discloses a method for providing control data for an ophthalmological laser of a treatment apparatus for treating a cornea (“treatment apparatus with an eye surgical laser for the removal of a volume body from a…cornea”, [0029]), wherein the method comprises the following steps performed by a control device (“can be provided by a control device” [0029]): setting conventional laser parameters for removing a predetermined correction volume from the cornea (“for removing the volume body…pulsed laser pulses in a pattern predefined by the control data into the cornea” [0029]) , wherein the laser parameters include at least a laser pulse energy (“between 700nm and 780nm can also be selected as the wavelength range” [0017]) and a number of laser pulses ([0029]) of the laser; wherein the laser parameters increased in power have a higher laser pulse energy and/or a higher number of laser pulses compared to the conventional laser parameters (“emit laser pulses in a wavelength range between 300nm and 1400nm, preferably between 700nm and 1200nm…a femtosecond laser is particularly well suitable” [0017]); and providing the control data (“temporary storage of at least one control dataset” [0018]), and the conventional laser parameters in the remaining areas of the correction volume ([0029]).
However, Mosquera does not disclose the cornea which has been treated with a cross-linking method, and providing laser parameters increased in power in areas of the correction volume, in which change to the cornea by the cross-linking method is expected, which includes the laser parameters increased in power in the areas of the correction volume in which change to the cornea by the cross-linking method is expected.
Peyman teaches a method of corneal implantation with cross-linking (Abstract). In one or more embodiments, all or part of the donor cornea is cross-linked ([0169]), and the power of the ultraviolet (UV) laser may also be increased so as to cross-link the tissue of the donor cornea faster ([0169]). Cross-linking can change the refractive power of the donor cornea to any suitable degree ([0167]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the cross-linking treatment and increased laser parameters of Peyman with the method for providing control data for an ophthalmological laser of Mosquera because the combination of these approaches maximizes available treatment methods for improving the sight of a patient.
Regarding claim 2, in the modified device of Mosquera, Mosquera does not disclose the change in the cornea changed by the cross-linking method is expected from a surface of a stroma of the cornea down to a preset depth in the cornea.
Peyman teaches that the cross-linker drops penetrate typically a depth of 150-200 microns of the anterior corneal stroma ([0241]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the preset depth into the cornea of the cross-linking method of Peyman with the method for providing control data of Mosquera because this method can reduce and eliminate the potential of corneal transplant rejection (Peyman, [0241]).
Regarding claim 4, in the modified device of Mosquera, Mosquera does not disclose that the preset depth is preset up to a depth value of 100 um, in the stroma of the cornea.
Peyman teaches that cross-linker drops penetrate typically a depth of 150-200 microns of the anterior corneal stroma ([0241]).
The specification discloses the appropriate ranges that apply to the claimed invention on page 4 as up to 100um. However, the specification does not disclose that the specifically claimed range of the preset depth value is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range.
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Peyman teaches that the depth value is 150-200 microns the prior art therefore provides teaching that the depth value is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed range of depth value provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that the acceptable range of depth for cross-linking absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range of depth value by normal optimization procedures known in the corneal cross-linking arts.
Regarding claim 9, Mosquera discloses a control device, which is configured to perform a method according to claim 1 (“the present invention relates to a control device, which is configured to perform one of the above described methods” [0015]).
Regarding claim 10, Mosquera discloses a treatment apparatus with at least one eye surgical laser for separation of a corneal volume (“treatment apparatus with at least one eye surgical laser for the separation of a tissue predefined by the control data, in particular of a corneal volume” [0016]) of a human or animal eye by optical breakdown, in particular by photodisruption and/or photoablation (“of a human or animal eye by means of photodisruption and/or photoablation” [0016]), and at least one control device according to claim 9 (“the present invention relates to a control device, which is configured to perform one of the above described methods” [0015]).
Regarding claim 12, Mosquera discloses a computer-readable medium for storing a computer program, the computer program comprising commands which cause a treatment apparatus to execute a method according to claim 1 (“computer program including commands, which cause the treatment apparatus…to execute the method steps… computer-readable medium, on which the computer program…is stored” [0020-0021]).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Mosquera in view of Peyman (hereinafter known as “the modified device of Mosquera”) as applied to claims 1 and 2 above, and further in view of Mule et. al, (Central corneal regularization (CCR): an alternative approach in keratoconus treatment, Eye Vis (Lond), https://pmc.ncbi.nlm.nih.gov/articles/PMC6912938/#:~:text=An%20innovative%20concept%20introduced%20by,within%20the%20same%20surgical%20session., published 12/16/2019, hereinafter known as Mule).
Regarding claim 3, in the modified device of Mosquera, Mosquera does not disclose the change in the cornea is assumed as a gradient down to the preset depth in the cornea, wherein the laser parameters increased in power are provided depending on the gradient.
Mule teaches an approach that combines corneal customized transepithelial therapeutic ablation to treat irregular corneal optics and accelerated corneal collagen cross-linking (Abstract). The treatment of the HOCMAs (higher order corneal morphological aberrations) towards the periphery gradually decreases within a large total ablation diameter (Background).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the gradual decrease of laser as the gradient progresses of Mule with the method of providing control data of Mosquera because the stromal tissue removal and the surgical invasiveness is kept to a minimum (Mule, Background).
Regarding claim 5, in the modified device of Mosquera, Mosquera does not disclose the change in the cornea by the cross-linking method is assumed as a gradient in a radial direction, wherein a higher degree of cross-linking is assumed in a center of the cornea than in a periphery of the cornea, wherein the laser parameters increased in power are provided depending on the gradient in the radial direction.
Mule teaches the connecting refractive zone, designed with a constant slope in each radial direction (Surgical Technique). Treatment of the HOCMAs (higher order corneal morphological aberrations) towards the periphery gradually decreases within a large total ablation diameter (Background).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the gradual decrease of laser as the gradient progresses in the radial direction of Mule with the method of providing control data of Mosquera because the stromal tissue removal and the surgical invasiveness is kept to a minimum (Mule, Background).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mosquera in view of Peyman as applied to claim 1 above, and in further view of Muller et. al, (US 20120215155 A1, published 8/23/2012, hereinafter known as Muller).
Regarding claim 6, in the modified device of Mosquera, Mosquera does not disclose the areas, in which change by the cross-linking method is expected, are determined from predetermined measurement data.
Muller teaches devices and approaches for activating cross-linking within corneal tissue to stabilize and strengthen the corneal tissue following an eye therapy treatment (Abstract). The feedback information is based on the measurements and provides input to the controller ([0049]). The controller then analyzes the feedback information to determine how to adjust the application of the initiating element ([0049]). The delivery system can be adapted to incorporate the feedback system and can adjust any combination of the optical in order to control the activation of the cross-linking agent within the cornea based on the feedback information received from the feedback system ([0049]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the feedback information loop to adjust treatment of Muller with the method for providing control data of Mosquera because these measurements can be indicative of the progress of strengthening and stabilizing the corneal tissue (Muller, [0049]).
Regarding claim 8, in the modified device of Mosquera, Mosquera does not disclose the areas, in which change by the cross-linking method is expected, are ascertained depending on a previously known duration of the cross-linking method and/or a previously known treatment performance of the cross-linking method.
Muller teaches the developed treatment plan can include a number of applications of the cross-linking agent…the timing, duration, power, energy dosage, and pattern of the initiating element for each treatment with the initiating element ([0073]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of information regarding previously known duration of the cross-linking method of Muller with the method for providing control data of Mosquera because the treatment can be adapted based on feedback information of the biomechanical properties of the cornea that is gathered in real-time (Muller, [0073]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mosquera in view of Peyman as applied to claim 1 above and in further view of Hohla (US 20030225400 A1, published 12/04/2003).
Regarding claim 7, in the modified device of Mosquera, Mosquera does not disclose a warning signal is generated if it is ascertained that the areas of the correction volume which have been changed by the cross-linking method exceeds a preset threshold value.
Hohla teaches a compact excimer laser system (Abstract). The computer system can generate warning messages or disable both the power source within the automated lamellar keratoplasty system and the vacuum source within the automated lamellar keratoplasty system should there be a failure ([0036]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a warning signal in the event of a failure of Hohla with the method for providing control data of Mosquera because this will prevent further harm to the patient if the device were to fail.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mosquera, Peyman, and Muller (hereinafter known as “the modified device of Muller”) as applied to claim 6 above, and further in view of Yun et. al, (US 20200187771 A1, published 06/18/2020, hereinafter known as Yun).
Regarding claim 13, in the modified device of Muller, Muller does not disclose the areas in which change by the cross-linking method is expected are determined from a Brillouin spectroscopy.
Yun teaches systems and methods for measuring the mechanical properties of ocular tissue, such as the lens or corneal tissue, for diagnosis as well as treatment monitoring purposes (Abstract). A Brillouin spectroscopy system is provided for evaluating a tissue in an eye tissue region of a patient ([0011]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a Brillouin spectroscopy of Yun with the method for providing control data of Mosquera in the modified device of Muller because the system advantageously improves signal filtering so that highly scattering tissues can be probed (Yun [0038]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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, Unsu Jung can be reached at 571-272-8506. 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.
/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792