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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 March 2026 has been entered.
This Office Action is responsive to the amendment filed with the RCE filed on 02 March 2026. As directed by the amendment: Claim 24 has been amended, Claims 1-15 have been cancelled, and Claims 37 and 38 have been added. Claims 29-35 were previously withdrawn due to a Restriction Requirement. Thus, Claims 16-28 and 36-38 are presently under consideration in this application.
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.
Claims 16-23, 25-28 and 36-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claim 16 is directed to a method for predictive maintenance of an apparatus for refractive surgery on an eye (i.e. method). Claims 16-23, 25-28 and 36 are directed to an abstract idea as described in detail below.
Step 2A – Prong 1
Claim 16 is directed to a method for predictive maintenance of an apparatus for refractive surgery on an eye. Claim 16 recites steps including “determining at least one parameter of a preparation and/or implementation of a refractive surgery”; and “continuously analyzing and monitoring a functionality of the apparatus on the basis of the determined parameter of the preparation and/or the implementation of the refractive surgery” and “controlling the functionality of the apparatus”.
The limitations of “determining”, “analyzing”, and “controlling the functionality” as drafted, under their broadest reasonable interpretation, is merely a mental process, because the steps are akin to having a doctor or medical professional providing an assessment of a surgical procedure. Therefore, these steps may be performed mentally by a human actor by merely observation or analysis of data, and then mentally assessing a medical procedure.
Claims 17-23, 25-28 and 36-38 depend from Claim 16, and only recite additional steps of navigating or refining the process with additional analysis or determination steps and data gathering, with generic “control” steps”, and therefore are also directed to an abstract idea, since this may also be directed to a mental process (e.g., mentally assessing treatment/procedures).
If claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A – Prong 2
The judicial exception is not integrated into a practical application. Claim 16 only recites the additional elements of “an apparatus for refractive surgery using a laser beam”. Claims 17-23, 25-28 and 36-38 depend from Claim 16, and only recite “a sensor” and “a contact glass”, and other additional steps of analysis or determination of the recited method.
These additional elements are recited at a high-level of generality (i.e., most refractive surgical systems would have these components). Therefore these elements are considered to be recited at a high level of generality and only provide conventional, well known computing/surgical functions that do not add meaningful limits to practicing the abstract idea. Furthermore, this judicial exception is not integrated into a practical application because the elements of “an apparatus for refractive surgery using a laser beam”, “a sensor”, and “a contact glass” are part of pre-solution activity involved in data gathering for the assessment, and are not explicitly claimed treatment steps.
Therefore, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore the claims are directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the judicial exception into a practical application (Step 2A – Prong 2), the additional elements of using computer components to perform the process steps amounts to no more than mere instructions to apply the exception using generic computer elements. The only structural elements recited in the claims are: “an apparatus for refractive surgery using a laser beam”, “a sensor”, and “a contact glass”.
These additional elements are recited at a high-level of generality (i.e., most refractive surgical systems would be known to have these components). For example, see the Bischoff et al., Chernyak, and Somani et al. references cited below which describe known refractive surgical systems.
Claims 16-23, 25-28 and 36-38 depend from Claim 16, and only recite additional steps of navigating or refining the process with additional analysis or determination steps and data gathering, and do not recite additional structure nor practical applications. Furthermore, the structural elements of “an apparatus for refractive surgery using a laser beam”, “a sensor”, and “a contact glass” do NOT include specific steps on actually performing specific treatment based on the analysis/determination steps, and therefore are also insufficient to amount to significantly more than the judicial exception. This pre-solution activity involved in data gathering could further encompass additional mental processes (e.g. analyzing collected data based on pre-solution activity). In order for the claims to rise to being integrated into a practical application, the treatment step needs to claim specific treatment applied responsive to the method (see MPEP 2106.04(d)(2)).
Therefore, Claims 16-23, 25-28 and 36-38 are directed to an abstract idea, and the claims are not patent eligible under 35 USC 101.
It is noted that Claim 24 has been amended to recite, “wherein the determination of the parameter characterizing the effect on the eye by the apparatus comprises a determination of arising optical structures in an image of the eye during application of the laser beam to the eye, wherein the arising optical structures comprise bright spots and/or dark spots; and wherein controlling the functionality of the apparatus includes controlling a power of the laser beam based on a result of the determination of the arising optical structures”. The limitation “wherein controlling the functionality of the apparatus includes controlling a power of the laser beam based on a result of the determination of the arising optical structures” is directed to a tangible output/treatment step which is therefore “integrated into a practical application”. Therefore, Claim 24 is directed to patent-eligible subject matter.
Claim Rejections - 35 USC § 103
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.
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.
Claims 16, 18-22, 24-26, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (US Publication No. 2011/0034911, previously cited) in view of Somani et al. (US Publication No. 2002/0198515, previously cited).
Regarding Claim 16, Bischoff et al. discloses a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Paragraph 0006, Abstract), the method comprising:
determining at least one parameter of a preparation and/or implementation of a refractive surgery (Paragraph 0006, Abstract), wherein the preparation and/or the implementation of the refractive surgery are carried out at least in part by the apparatus for refractive surgery using the laser beam (Paragraph 0006, 0014-0015, 0027, 0061);
continuously analyzing and monitoring the functionality of the apparatus (generating control data for an eye-surgery treatment, Paragraph 0015, 0027-0029, 0042, 0043; monitoring functionality, 0064, 0072) on the basis of the determined parameter of the preparation and/or the implementation of the refractive surgery (data/parameters, Paragraph 0006, 0014-0015, 0027-0029, 0061),
controlling the functionality of the apparatus (monitoring/controlling functionality, 0064, 0067, 0072, 0075, 0081, 0111; Claim 9);
wherein the at least one parameter characterizes one or more of the following properties of the preparation and/or implementation of the refractive surgery (Paragraph 0006, 0014-0015, 0027-0029, 0061):
a provision of the laser beam by the apparatus (laser planning/targeting, Paragraph 0061-0064, 0068-0069, 0071-0073; Claim 9-10); an effect on the eye by the apparatus (corneal deformation, Paragraph 0077-0078, 0043-0045); an external influence on the preparation and/or the implementation of the refractive surgery from outside of the apparatus (planning/targeting computations and control data comparison, Paragraph 0043-0045, 0067-0069); and a suitability of the effect on the eye by the laser beam for a further proceeding of the refractive surgery on the eye (surgical method of Paragraphs 0111-0113; laser planning/targeting, Paragraph 0068-0069, 0071-0073; Claim 9-10).
Although Bischoff et al. discloses a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Paragraph 0006, Abstract) and controlling the functionality of the apparatus based on the monitoring (monitoring/controlling functionality, 0064, 0067, 0072, 0075, 0081, 0111; Claim 9), Bischoff et al. does not disclose that the continuous analyzing and monitoring to perform predictive maintenance of the apparatus for refractive surgery on the eye.
Somani et al. teaches a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Abstract) by continuous analyzing and monitoring to perform predictive maintenance of the system/apparatus (analyzing/monitoring calibration and functionality of laser and tracking systems of the surgical apparatus for acceptable levels of system performance including fault detection, Paragraph 0005, 0010-0012, 0018-0020, 0043-0045, 0060, Claims 1-9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the continuous analyzing and monitoring, in the method disclosed by Bischoff et al., to perform predictive maintenance of the apparatus for refractive surgery on the eye, as taught by Somani et al., in order to “achieve a desired ultimate surface change in the cornea” (Paragraph 0004, Somani et al.), “ensure removal of the intended shape and quantity of the corneal tissue so as to provide the desired shape and refractive power modification to the patient's cornea” (Paragraph 0005, Somani et al.), and to prevent “tissue ablation at an undesired location on the patient's cornea which in turn leads to less than ideal corneal sculpting results” (Paragraph 0005, Somani et al.).
Regarding Claim 18, Bischoff et al. discloses the method further comprising one or more of: implementing a measure for improving the functionality of the apparatus (Paragraph 0002-0005, 0015); providing a notification about the functionality of the apparatus (generating data and specifying coordinates, Abstract, Paragraph 0002-0005, 0027, 0028, 0029); and adjusting or modifying an operation of the apparatus (adjusting focus or other parameters, Paragraph 0067, 0068, 0071, 0072, 0080, Claims 9-10).
Regarding Claim 19, Bischoff et al. discloses the method further wherein the analysis of the functionality of the apparatus (Paragraph 0006, Abstract) on the basis of the determined parameter comprises: comparing the determined parameter of the preparation and/or the implementation of the refractive surgery on the basis of the determined parameter with a predetermined intended value (data/parameters, Paragraph 0006, 0014-0015, 0027-0029, 0061); and assessing the functionality of the apparatus for refractive surgery on the basis of the comparison of the determined parameter with the predetermined intended value (planning/targeting computations and control data comparison, Paragraph 0043-0045, 0067-0069).
Regarding Claims 20-22, Bischoff et al. discloses the method further wherein the determination of a parameter characterizing the provision of the laser beam by the apparatus comprises a determination of a state of a contact glass of the apparatus (Paragraph 0002-0005), wherein the laser beam is applied to the eye through the contact glass (Paragraph 0002-0005), and wherein the determination of the state of the contact glass comprises a determination of optical structures in an image of optical radiation passing through the contact glass (Paragraph 0014-0015, 0027-0029), and wherein the determination of the optical structures comprises a determination of optical edges in the image (optical edge zones, Paragraph 0043-0045, 0077-0085), wherein the determination of the optical edges comprises a determination of edges running in a straight line and/or edges running in a circle (Paragraph 0043-0045, 0105-0109; straight or circular path, see 15, 26, Figs. 4-7).
Regarding Claim 24, Bischoff et al. discloses the method further wherein the determination of the parameter characterizing the effect on the eye by the apparatus comprises a determination of arising optical structures in an image of the eye during application of the laser beam to the eye (optical characteristics of images, Abstract, Paragraph 0018, 0056, Claim 15, 23), wherein the arising optical structures comprise bright spots (spots/points of light, Abstract, Paragraph 0018, 0056, Claim 15, 23), wherein controlling the functionality of the apparatus includes controlling a power of the laser beam based on a result of the determination of the arising optical structures (power of laser adjustment, Paragraph 0018, 0025-0027, 0052, 0056; Claims 15 and 23)
Regarding Claim 25, Bischoff et al. discloses the method further wherein the determination of the parameter characterizing the effect on the eye by the apparatus comprises a determination of a structure of a part of the eye impinged by the laser beam (shape/deformation of eye, Paragraph 0002-0005, 0027-0029, 0044-0049; Claims 9-10).
Regarding Claim 26, Bischoff et al. discloses the method further wherein the determination of the parameter characterizing the external influence on the preparation and/or the implementation of the refractive surgery from outside of the apparatus (planning/targeting computations and control data comparison, Paragraph 0043-0045, 0067-0069) comprises a determination of a movement path of at least one part of the apparatus during the preparation and/or the implementation of the refractive surgery along the optical axis of the eye (path curves, Paragraph 0072, 0073, 0078, 0112; optical axis OA in Figs. 4-7).
Regarding Claim 37, Bischoff et al. discloses the method further wherein the functionality of the apparatus relates to a precision of an impingement of the eye with the laser beam (increased precision of laser surgical operation, Paragraph 0008, 0012, 0014, 0044, 0067).
Claims 16-18, 25, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Chernyak (US Publication No. 2003/0223037, previously cited) in view of Somani et al. (US Publication No. 2002/0198515, previously cited).
Regarding Claim 16, Chernyak discloses a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Abstract, Paragraph 0007, 0011-0013), the method comprising: determining at least one parameter of a preparation and/or implementation of a refractive surgery (Abstract, Paragraph 0007, 0011-0013, 0017-0019), wherein the preparation and/or the implementation of the refractive surgery are carried out at least in part by the apparatus for refractive surgery using the laser beam (Abstract, Paragraph 0007, 0011-0013, 0017-0019; Claims 1, 22, 32);
and continuously analyzing and monitoring the functionality of the apparatus (analysis/monitoring over time of data for surgical improvement, Paragraph 0009-0019) on the basis of the determined parameter of the preparation and/or the implementation of the refractive surgery, and
controlling the functionality of the apparatus (controlling functionality/paramters for laser/surgery procedures, Paragraph 0009-0019, 0075, 0077, 0081, 0086, 0099; Claims 1, 22, 32),
wherein the at least one parameter characterizes one or more of the following properties of the preparation and/or implementation of the refractive surgery (Abstract, Paragraph 0007, 0011-0013, 0017-0019; Claims 1, 22, 32):
a provision of the laser beam by the apparatus (laser beam provision and adjustment, Paragraph 0004, 0011, 0015, 0018, 0065, 0067);
an effect on the eye by the apparatus (predetermined/planned effects, Paragraph 0004, 0067, 0086);
an external influence on the preparation and/or the implementation of the refractive surgery from outside of the apparatus (planning/targeting computations and control data comparison, Paragraph 0009-0019, 0075, 0077, 0086; Claims 1, 22, 32);
and a suitability of the effect on the eye by the laser beam for a further proceeding of the refractive surgery on the eye (laser planning/targeting, Paragraph 0009-0019, 0075, 0077, 0081, 0086, 0099; Claims 1, 22, 32).
Although Chernyak discloses a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Abstract, Paragraph 0007, 0011-0013) and controlling the functionality of the apparatus based on the monitoring (analysis/monitoring over time of data for surgical improvement, Paragraph 0009-0019; Claim 1), Chernyak does not disclose that the continuous analyzing and monitoring to perform predictive maintenance of the apparatus for refractive surgery on the eye.
Somani et al. teaches a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Abstract) by continuous analyzing and monitoring to perform predictive maintenance of the system/apparatus (analyzing/monitoring calibration and functionality of laser and tracking systems of the surgical apparatus for acceptable levels of system performance including fault detection, Paragraph 0005, 0010-0012, 0018-0020, 0043-0045, 0060, Claims 1-9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the continuous analyzing and monitoring, in the method disclosed by Chernyak, to perform predictive maintenance of the apparatus for refractive surgery on the eye, as taught by Somani et al., in order to “achieve a desired ultimate surface change in the cornea” (Paragraph 0004, Somani et al.), “ensure removal of the intended shape and quantity of the corneal tissue so as to provide the desired shape and refractive power modification to the patient's cornea” (Paragraph 0005, Somani et al.), and to prevent “tissue ablation at an undesired location on the patient's cornea which in turn leads to less than ideal corneal sculpting results” (Paragraph 0005, Somani et al.).
Regarding Claim 17, Chernyak discloses the method further comprising receiving data from a sensor (implementing sensor data, Paragraph 0064, 0077-0083, 0087), wherein determining the at least one parameter of the preparation and/or implementation of the refractive surgery is based on the data from the sensor (implementing and analyzing sensor data, Paragraph 0064, 0077-0083, 0087).
Regarding Claim 18, Chernyak discloses the method further comprising one or more of: implementing a measure for improving the functionality of the apparatus (planning/targeting using data for improved surgical outcomes, Paragraph 0009-0019, 0075, 0077, 0081, 0086, 0099; Claims 1, 22, 32); and adjusting or modifying an operation of the apparatus (planning/targeting using data for improved surgical outcomes, Paragraph 0009-0019, 0075, 0077, 0081, 0086, 0099; Claims 1, 22, 32).
Regarding Claim 25, Chernyak discloses the method further wherein the determination of the parameter characterizing the effect on the eye by the apparatus comprises a determination of a structure and/or a texture of a part of the eye impinged by the laser beam (structure or texture of eye, Paragraph 0003-0004, 0067, 0081, 0093, 0098, 0140-0141).
Regarding Claim 36, Chernyak discloses the method further wherein the determination of the parameter characterizing the effect on the eye by the apparatus comprises a determination of a homogeneity of a structure and/or a texture of the part of the eye impinged by the laser beam (structure or texture of eye, Paragraph 0003-0004, 0067, 0081, 0093, 0098, 0140-0141).
Regarding Claim 38, Chernyak discloses the method further comprising measuring a measurement value (wavefront measurement values, Paragraph 0013, 0015, 0017, 0064, 0072-0077), wherein the at least one parameter of the preparation and/or implementation of the refractive surgery is determined based on the measured measurement value (basing at least one parameter of the preparation and/or implementation of the refractive surgery on the wavefront measurement values, Paragraph 0013, 0015, 0017, 0086, 0087, 0108, 0130; Claim 32).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (US Publication No. 2011/0034911, previously cited) and/or Chernyak (US Publication No. 2003/0223037, previously cited), in view of Somani et al. (US Publication No. 2002/0198515, previously cited), further in view of Juhasz et al. (US Publication No. 2013/0050649, previously cited).
Regarding Claim 23, both Bischoff et al. and Chernyak disclose the method for controlling a functionality of an apparatus for refractive surgery on an eye as described in detail above. However, none of Bischoff et al., Chernyak, nor Somani et al. explicitly discloses wherein the determination of the parameter characterizing the effect on the eye by the apparatus for the purposes of monitoring the functionality of the apparatus comprises a determination of a docking time of the apparatus on the eye and/or a determination of a number of necessary docking attempts until the apparatus successfully docks on the eye.
Juhasz et al. teaches a method of controlling a laser surgical system for the eye (Abstract, Paragraph 0002, 0009, 0010, 0051) including a determination of a parameter characterizing the effect on the eye by the apparatus for the purposes of monitoring the functionality of the apparatus (Paragraph 0002-0005, 0009-0012, Claims 1, 10, 32) comprising a determination of a docking time of the apparatus on the eye (analysis and reduction in docking time, Paragraph 0017, 0046, 0056, 0059, 0110, 0113-0115) or a determination of a number of necessary docking attempts until the apparatus successfully docks on the eye (docking and alignment attempts until successful, Paragraph 0007, 0010, 0012-0017; reducing misalignment, Paragraph 0017, 0023, 0063-0065, 0080-0082, 0093).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to determine a docking time of the apparatus on the eye and/or to determine of a number of necessary docking attempts until the apparatus successfully docks on the eye, as taught by Juhasz et al., in the method for controlling a functionality of an apparatus for refractive surgery on an eye disclosed by either Bischoff et al. and/or Chernyak and Somani et al. in combination, in order to increase precision and alignment of the position of the eye/structures after docking is achieved, and to reduce the time of the docking procedure during the overall surgery, as also taught by Juhasz et al. (reducing misalignment and increasing precision for surgical targets, Paragraph 0001-0005, 0010-0017, 0108-0110; reduction in docking time, Paragraph 0017, 0046, 0056, 0059, 0110, 0113-0115).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (US Publication No. 2011/0034911, previously cited) and/or Chernyak (US Publication No. 2003/0223037, previously cited), in view of Somani et al. (US Publication No. 2002/0198515, previously cited), further in view of Grantcharov (Publication No. 2017/0249432, previously cited).
Regarding Claim 27, both Bischoff et al. and Chernyak disclose the method for controlling a functionality of an apparatus for refractive surgery on an eye as described in detail above. However, none of Bischoff et al., Chernyak, nor Somani et al. explicitly discloses wherein the determination of the parameter characterizing the external influence on the preparation and/or the implementation of the refractive surgery from outside of the apparatus comprises a determination of acoustic background noises before and/or during the preparation and/or the implementation of the refractive surgery.
Grantcharov teaches a method of characterizing the external influence on the preparation and/or the implementation of the surgery (Abstract) including a determination of acoustic background noises (acoustic sensors and ambient noise determination, Paragraph 0063, 0074, 0097, 0098, 0104, 0107, 0131, 0133, 0180, 0185) before and/or during the preparation and/or the implementation of the surgery (before, during, or after surgical procedure analysis, Paragraph 0022-0023, Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make a determination of acoustic background noises before and/or during the preparation and/or the implementation of the surgery, as taught by Grantcharov, in the method for controlling a functionality of an apparatus for refractive surgery on an eye disclosed by either Bischoff et al. and/or Chernyak and Somani et al. in combination, in order to reduce surgical errors and to improve surgical outcomes by reducing outside distractions related to analyzed noise level, as also taught by Grantcharov (Paragraph 0022-0023, 0180, 0222, 0236).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (US Publication No. 2011/0034911, previously cited) and/or Chernyak (US Publication No. 2003/0223037, previously cited), in view of Somani et al. (US Publication No. 2002/0198515, previously cited), further in view of Suckewer et al. (US Publication No. 2008/0051772, previously cited).
Regarding Claim 28, both Bischoff et al. and Chernyak disclose the method for controlling a functionality of an apparatus for refractive surgery on an eye as described in detail above. However, none of Bischoff et al., Chernyak, nor Somani et al. explicitly discloses wherein the determination of the parameter characterizing the suitability of the effect of the eye by the laser beam for the further proceeding of the refractive surgery on the eye comprises a determination of a time required for a surgical removal of a lenticule following the effect on the eye by the laser beam.
Suckewer et al. teaches a method of controlling a functionality of an apparatus for refractive surgery on an eye (Abstract, Paragraph 0036-0037) comprising a determination of the parameter characterizing the suitability of the effect of the eye by the laser beam for the further proceeding of the refractive surgery on the eye (Abstract, Paragraph 0003-0005, 0010, 0028-0029) comprises a determination of a time required for a surgical removal of a lenticule following the effect on the eye by the laser beam (variation of time window for lenticule removal procedure, Paragraph 0030).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to determine a time required for a surgical removal of a lenticule following the effect on the eye by the laser beam, as taught by Suckewer et al., in the method for controlling a functionality of an apparatus for refractive surgery on an eye disclosed by either Bischoff et al. and/or Chernyak and Somani et al. in combination, for overall surgical timing/planning, in order to precisely and accurately remove the lenticule of any shape including complex shapes without the need for creating a flap, as also taught by Suckewer et al. (Paragraph 0009-0010, 0030).
Response to Arguments
35 U.S.C. 101
The Applicant's arguments filed in the RCE filed 02 March 2026 with respect to the previous 35 USC 101 rejections of Claims 16-23, 25-28 and 36 have been fully considered by they are not persuasive.
Step 2A, Prong One:
The Applicant argues (Pages 11-12 of RCE):
Again, the method is directed to (emphasis added) "predictive maintenance of an apparatus for refractive surgery on an eye using a laser beam" comprising the above cited steps. (See claim 1.) It seems that the fact that the method is directed to predictive maintenance was ignored in the analysis in the Office Action (see also discussion of the raised 103 rejection).
Predictive maintenance means that a possible future failure of the system is recognized before that failure actually occurs. The steps of determining at least one parameter of a preparation and/or implementation of a refractive surgery"; and "continuously analyzing and monitoring a functionality of the apparatus on the basis of the determined parameter of the preparation and/or the implementation of the refractive surgery" and "controlling the functionality of the apparatus" must be read in that context.
In the field of refractive surgery, e.g. the SMILE (Small Incision Lenticule Extraction) method mentioned in the application, a precision that is required when detaching the lenticule in the cornea by means of the laser beam is at least in the m range. A human operator is physically neither capable of analyzing nor monitoring the functionality of an apparatus performing the refractive surgery such that said precision can be achieved or maintained in the future, or recognize when it cannot be achieved or maintained in the future.
Therefore, claim 16 does not recite a mental process because it does not contain limitations that can practically be performed in the human mind because the human mind is not equipped to perform the claim limitations. See SRIInt'l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019)
However, the Examiner disagrees with this argument. As described above, Claim 16 recites steps including “determining at least one parameter of a preparation and/or implementation of a refractive surgery”; and “continuously analyzing and monitoring a functionality of the apparatus on the basis of the determined parameter of the preparation and/or the implementation of the refractive surgery” and “controlling the functionality of the apparatus”. The limitations of “determining”, “analyzing”, and “controlling the functionality” as drafted, under their broadest reasonable interpretation, is merely a mental process, because the steps are akin to having a doctor or medical professional providing an assessment of a surgical procedure. It is noted that “a method for predictive maintenance of an apparatus” is simply an observational method for determining the functionality of that apparatus. Therefore, these steps may be performed mentally by a human actor (i.e., a doctor observing a surgical procedure performed by an apparatus) by merely observation or analysis of data, and then mentally assessing a medical procedure.
Claims 17-23, 25-28 and 36-38 depend from Claim 16, and only recite additional steps of navigating or refining the process with additional analysis or determination steps and data gathering, with generic “control” steps”, and therefore are also directed to an abstract idea, since this may also be directed to a mental process (e.g., mentally assessing treatment/procedures).
If claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III). Therefore, Claims 16-28 and 36 are directed to an abstract idea.
The Applicant further argues that specifically Claims 17 and 37 are patent-eligible (see Pages 12-13 of RCE). However, the Examiner disagrees with these arguments, since “receiving data from a sensor” and “wherein the functionality of the apparatus relates to a precision of an impingement of the eye with the laser beam” merely relate to pre-solution activity of data-gathering, and are not sufficient to integrate the abstract idea into a practical application.
Step 2A, Prong Two and Step 2B:
The Applicant argues (Page 13 of RCE):
There seems to be a misunderstanding what the disclosure is directed to. The disclosure is directed to predictive maintenance of an apparatus for refractive surgery, and not the treatment. There is no need to claim treatment steps. The practical application predicative maintenance of the apparatus, i.e., to detect possible future failure of the apparatus before the failure even occurs.
However, the Examiner disagrees with these arguments. With respect to Claim 16, the claim only recites the additional elements of “an apparatus for refractive surgery using a laser beam”. Claims 17-23, 25-28 and 36-38 depend from Claim 16, and only recite “a sensor” and “a contact glass”, and other additional steps of analysis or determination of the recited method. These additional elements are recited at a high-level of generality (i.e., most refractive surgical systems would have these components). Therefore these elements are considered to be recited at a high level of generality and only provide conventional, well known computing/surgical functions that do not add meaningful limits to practicing the abstract idea. Furthermore, this judicial exception is not integrated into a practical application because the elements of “an apparatus for refractive surgery using a laser beam”, “a sensor”, and “a contact glass” are part of pre-solution activity involved in data gathering for the assessment/analysis/monitoring, and are not explicitly claimed treatment steps.
Therefore, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore Claims 16-23, 25-28 and 36-38are directed to an abstract idea.
Furthermore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the judicial exception into a practical application (Step 2A – Prong 2), the additional elements of using computer components to perform the process steps amounts to no more than mere instructions to apply the exception using generic computer elements. The only structural elements recited in the claims are: “an apparatus for refractive surgery using a laser beam”, “a sensor”, and “a contact glass”.
These additional elements are recited at a high-level of generality (i.e., most refractive surgical systems would be known to have these components). For example, see the Bischoff et al., Chernyak, and Somani et al. references cited above which describe known refractive surgical systems.
Claims 17-23, 25-28 and 36-38 depend from Claim 16, and only recite additional steps of navigating or refining the process with additional analysis or determination steps and data gathering, and do not recite additional structure nor practical applications. Furthermore, the structural elements of “an apparatus for refractive surgery using a laser beam”, “a sensor”, and “a contact glass” do NOT include specific steps on actually performing specific treatment based on the analysis/determination steps, and therefore are also insufficient to amount to significantly more than the judicial exception. This pre-solution activity involved in data gathering could further encompass additional mental processes (e.g. analyzing collected data based on pre-solution activity). In order for the claims to rise to being integrated into a practical application, the treatment step needs to claim specific treatment applied responsive to the method (see MPEP 2106.04(d)(2)).
The Applicant specifically argues (Pages 15-16 of RCE) that Claims 20, 21, and 38 are not directed to an abstract idea, because these claims recite steps such as “measuring” and “determining a state of a contact glass”. However, these steps are part of pre-solution activity involved in data gathering for the assessment, analysis, and monitoring (which may be performed mentally by a human actor), and are not explicitly claimed treatment steps
Therefore, Claims 16-23, 25-28 and 36-38 are directed to an abstract idea, and the claims are not patent eligible under 35 USC 101.
The Examiner agrees with the Applicant’s arguments with respect to Claim 24. See Pages 13-15 of RCE. Therefore, the 35 U.S.C. 101 rejection of Claim 24 has been withdrawn. It is noted that Claim 24 has been amended to recite, “wherein the determination of the parameter characterizing the effect on the eye by the apparatus comprises a determination of arising optical structures in an image of the eye during application of the laser beam to the eye, wherein the arising optical structures comprise bright spots and/or dark spots; and wherein controlling the functionality of the apparatus includes controlling a power of the laser beam based on a result of the determination of the arising optical structures”. The limitation “wherein controlling the functionality of the apparatus includes controlling a power of the laser beam based on a result of the determination of the arising optical structures” is directed to a tangible output/treatment step which is therefore “integrated into a practical application”. Therefore, Claim 24 is directed to patent-eligible subject matter.
35 U.S.C. 103
The Applicant's arguments filed in the RCE with respect to the previous 35 U.S.C. 103 rejections of Claims 16-28 and 36 have been fully considered but are not persuasive. The Applicant specifically argues (Page 17 of RCE):
The "fault detection" in Somani only recognizes or detects a failure when the failure already occurred …
In predictive maintenance, on the other hand, the malfunction is detected before the fault occurs. In other words, predictive maintenance aims to detect the malfunction before it occurs so that countermeasures can be taken to prevent the malfunction from occurring in the first place. This is not disclosed in Somani et al.
However, the Examiner disagrees with these arguments. In response to these Applicant's arguments that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a specific definition of “predictive maintenance” as argued) are not recited in rejected Claim 16. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Thus, the Examiner maintains that Somani et al. teaches a method for controlling a functionality of an apparatus for refractive surgery on an eye using a laser beam (Abstract) by continuous analyzing and monitoring to perform predictive maintenance of the system/apparatus (analyzing/monitoring calibration and functionality of laser and tracking systems of the surgical apparatus for acceptable levels of system performance including fault detection, Paragraph 0005, 0010-0012, 0018-0020, 0043-0045, 0060, Claims 1-9). The Examiner maintains that analyzing/monitoring calibration and functionality of laser and tracking systems of the surgical apparatus for acceptable levels of system performance including fault detection as taught by Somani et al. reads on “predictive maintenance” as currently claimed.
Therefore, the Examiner maintains that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the continuous analyzing and monitoring, in the method disclosed by Chernyak and/or Bischoff et al., to perform predictive maintenance of the apparatus for refractive surgery on the eye, as taught by Somani et al., in order to “achieve a desired ultimate surface change in the cornea” (Paragraph 0004, Somani et al.), “ensure removal of the intended shape and quantity of the corneal tissue so as to provide the desired shape and refractive power modification to the patient's cornea” (Paragraph 0005, Somani et al.), and to prevent “tissue ablation at an undesired location on the patient's cornea which in turn leads to less than ideal corneal sculpting results” (Paragraph 0005, Somani et al.).
If the Applicant intends on “predictive maintenance” to be specifically limited “to detect the malfunction before it occurs so that countermeasures can be taken to prevent the malfunction from occurring in the first place” (see Page 17 of RCE), then Claim 16 should be amended to explicitly reflect this definition/interpretation.
Therefore, Claim 16 remains rejected as described in detail above. No additional specific arguments were made with respect to the previous 35 U.S.C. 103 rejections of dependent Claims 17-28 and 36, nor with respect to the previously cited Juhasz et al., Grantcharov, nor Suckewer et al. references, nor with respect to new Claims 37-38.
Therefore, Claims 16-28 and 36-38 remain rejected as described in detail above.
Conclusion
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796