DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Responsive to the communication dated 3/19/2026
Claim 1 is amended.
Claims 1 – 17 are presented for Examination.
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
Response to Arguments
Claim Rejections - 35 USC § 103
The Applicant has amended claim 1 to recites: “… wherein the three-dimensional biomechanical model is configured to simulate biomechanical interactions between the crystalline lens, zonular fibers, and ciliary muscle to model accommodation/disacommodative function or Dynamic Range of Focus (DRof) function from near to far and far to near…” and asserts that such limitations are non-obvious in view of the previously cited prior at.
The Examiner has considered the proposed amendment, however, it is not persuasive.
Ljubimova_2005 teaches:
Page 17/104 section 21. Human eye… “the crystalline lens and the cornea represent the main focusing system of a human eye… the curvature of the lens can be adjusted to “tune” the focus… this variable lens contribution is called accommodation and arises both from controlled changes in curvature and thickness along the lens’s polar axis, mediated by ciliary muscle contractions… nowadays it is universally accepted that accommodation is primarily achieved by alteration of the shape of the crystalline lens…”
Page 18/104 section 2.2 Components of the accommodative apparatus… “all the anatomical elements which are believed to participate directly or indirectly in the accommodative process are described more precisely in the current section. The component elements of the accommodation mechanism are: the crystalline lens, the zonular apparatus, the ciliary body, containing the ciliary muscles, the choroid and the vitreous, see Figure 2.2…”
Page 19/104 The zonule “… The zonule (suspensory ligament, zonules of zinn, zonular apparatus) is a supporting system of the lens. The zonule appears to attach and interlace with the lens capsule in rings on anterior, equatorial and posterior surfaces on one side and the elastic choroid structure on other. These three distinct groups of fibres deonted by the places of their attachments to the lens are called anterior (AF), central (AF) and posterior (PF) sets of fibres, respectively…”
Page 27/104 section 3.2 Studies of accommodation “… the present thesis deals with mechanical modelling of human eye accommodation. Construction of a numerical model of a biological system involves synthesis of disparate sets of geometrical and mechanical data…”
Page 33/104 Figure 3.5 (shown below) clearly illustrates the biomechanical relationships and interactions between the crystalline lens, zonular fibers (AF, PF), and ciliary muscle to model accommodation/disacommodative function
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Page 34/104: “… Conclusions 1) By author’s belief, the exploration of the validity of various hypothesis considering the mechanism of accommodation has proven, the Helmholtz theory of accommodation still stands with regard to the broad issues. With the addition of some up-to-date modifications and more accurate definitions concerning the supportive system of the lens, the classical theory explains specific experimental facts and does not contradict the basic laws of mechanics during all phases of the accommodation process. 2) New observations lead us to the consideration of a new analytical model, which should consist of the lens, zonular system and vitreous body, see Figure 3.6. The proposal of the present study is that an improved description of human eye accommodation can be obtained by such a model, which incorporates posteriorly sloped forces applied by the ciliary muscle, and the support of the lens, provided by the vitreous…”
Page 43/104 section 1.4 Modelling procedures: “… a numerical analysis bas been carried out using the commercial general-purpose finite element package ABAQUS… which is widely used in mechanical and civil engineering… which allowed the three-dimensional performance of the eye structure to be modelled… in the second model a posterior fibres set was added…”
Page 44/104: “… several meshes with different densities were created for the crystalline lens… the lens mesh… in the second model both lens and vitreous capsules were modelled… following Burd et al (2022) we assumed that the lens capsule is fully bonded with the cortex. Anterior, posterior and central sets of zonular fibres were modelled… the ligament of Wieger is represented in the model… the reference configuration of the main model is shown in Figure 4.4(a)… the process of disaccommodation can be performed… performing the process of disaccommodation by applying ciliary muscle forces to the ends of the zonular fibres…
The above citations clearly teach a biomechanical model configured to simulate biomechanical interactions between the crystalline lens, zonular fibers, and ciliary muscle to model accommodation/disacommodation function. Indeed, the author explicitly states that models should synthesize the interactions of the lens, zonular system, vitreous body, and forces applied by the ciliary muscles.
Figure 3.6 illustrates the “new theoretical model” and, as outlined above, this model includes the crystalline lens, zonular fibers, and forces applied by the ciliary muscles to model all phases of the accommodation process (i.e., both accommodation/disaccommodation).
Chapter 4, and section 4.4 in particular explicitly state to use ABAQUS to perform a three-dimensional biomechanical simulation and explicitly states that the model includes the crystalline lens, the zonular fibres, and the forces from the ciliary muscles.
Therefore, the Examiner finds that it would have been obvious to one of ordinary skill in the art to have “… wherein the three-dimensional biomechanical model is configured to simulate biomechanical interactions between the crystalline lens, zonular fibers, and ciliary muscle to model accommodation/disacommodative function or Dynamic Range of Focus (DRof) function from near to far and far to near…”
End Response to Arguments
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.
(1) Claims 1- 10, 12, 13, 14, 15, 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ljubimova_2005 (Numerical Modelling of the human eye accommodation, August 2005 Thesis Royal Institute of Technology Department of Mechanics SE-100 44 Stockholm, Sweden) in view of Taylor_2015 (US 2015/0269352 A1) in view of Ljubimova_2009 (Biomechanics of the Human Eye and Intraocular Pressure Measurement, Technical Reports from Royal Institute of Technology Department of Mechanics SE-100 44 Stockholm, Sweden) in view of Herekar_2019 (US 2019/0105519 with priority to provisional applications 61/237,840, 62/254,138, 61/305,996, 62/310,644 dated 10/6/2015, 11/11/2015, 3/9/2016 3/18/2016 respectively) in view of Zheng_2015 (Computer-Assisted Orthopedic Surgery: Current State and Future Perspectives, Frontiers in Surgery, 23 December 2015).
Claim 1. Ljubimova_2005 teaches “A method of three-dimensional (page 31 section 4.4 par 1: “… allowed the three-dimensional performance of the eye structure to be modelled…”) modeling for the treatment of accommodation of an eye (page 1 section 1.1 par 2: “… existing analytical frameworks are not enough for the prediction of occurred processes and selection of the best medical treatment… a science as ocular biomechanics came as a solution, combining the laws of physics and engineering concepts to describe motion of human eye segments… a systematic mathematical and biomechanical approach may help us to analyze and explain some visual processes and give an impulse for corresponding research in ophthalmology… investigation… are important both for clinical ophthalmologic practice and for the correction of general concepts of human eye. Conduction of such studies will provide an explanation for normal and pathological performance of intraocular structures, indicate perspective directions for treatment and diagnostics of some ocular diseases…”), the method comprising: determining, a first anatomic model of one or more structures of the accommodative mechanism of the eye (title: “numerical modelling of the human eye accommodation”; abstract: “this thesis addresses the biomechanics of the human eye accommodation…” page 35: “… clinic patients…”; section 2.2 par 1: “… all the anatomical elements which are believed to participate directly or indirectly in the accommodative process are described…”; chapter 3 par 1: “… anatomical connections, as well as events occurring during accommodation… the appropriate mechanical model can add a piece to that puzzle…”; par 24: “…the model is developed by bringing the anatomy and geometry of the accommodative apparatus together with mechanical properties of the lens, zonular system and vitreous body… our modeling procedure lead to an idealized model of the human eye at the particular age…”; page 28: “… all anatomical elements mentioned in the previous chapters were modelled…”; page 36: “… Finite element model of accommodation… our model predicts the objective accommodative amplitude… in our model the amplitude of lens equator displacement was derived… the computed variations of the pressure inside the lens were estimated in our analysis for the main model…”; par 39: “… the present model of accommodation with adopted assumptions captures at least several physiological aspects of accommodation…”; page 42: “… a new model that would take into account this feature is suggested for consideration…”) and biomechanical relationships between one or more lenticular and extralenticular structures, (page 11 chapter 3 par 1: “understanding the eye accommodation requires an exploration of the relationship between its structure and function… anatomical connections, as well as events occurring during accommodation… the appropriate mechanical model can add a piece to that puzzle…”; page 14: “… the integral relationship of the lens, zonules, and vitreous in the human eye was also demonstrated…”; page 15 section 3.2 par 1: “the present thesis deals with mechanical modeling of human eye accommodation. Construction of a numerical model of a biological system involves synthesis of disparate sets of geometrical and mechanical data…” Figure 3.5 illustrates a model framework showing the relationship between the lens, Ciliary muscle, Choriod, and sclera; page 62: “… we came to the conclusion that an improved theoretical model should consist of lens, zonular system and vitreous, Figure 1(b)…” Therefore the teaching of a model of “a biological system” where the relationship between lens, zonules, and vitrieous element so the human eye is integral along with illustrations of relationships between the lens, ciliary muscle, choroid, and sclera makes a model that determines the relationships between the structures of the eye obvious.), in the anterior and posterior [rotation], Wherein the one or more anterior structures associate with at least one of bruchs membrane, lens capsules, wiegart, ligament, ciliary muscle, lens, zonules, sclera, aqueous fluid, Schlemms canal, trabecular meshwork, and episcleral vessels (Page 62 – 68: “… model should consist of lens, zonular system and vitreous, Figure 1(b)… to model the accommodative lens… A numerical analysis has been carried out using the commercial general-purpose finite element package ABAQUS… which is widely used in mechanical and civil engineering. The eye was regard as being a body of revolution… axisymmetric boundary conditions were applied to the nodes… all materials were isotropic and purely elastic… meshing the interior of the lens… two-noded axi-membrane elements were used to model capsules of lens and vitreous… two meshes were created for the crystalline lens… when the eye was in fully accommodated state… all the stresses in the lens, capsules, vitreous and zonule were zero… established the contact between vitreous body and lens capsule with a friction coefficient… applying forces to the ends of the zonular fibers… the final deformed geometry should match the data reported… the ciliary body moves 0.4mm, the corresponding change in lens equator radius would be 0.3mm…. the simulation show that the central thickness of the crystalline lens increases with accommodation and paraxial anterior and posterior curvature become steeper…”; Figure 4 and 5 illustrates how the lens and the vitreous interact when the lens move into contact with the vitreous changing the location and shape of the lens and vitreous. Figure 6 illustrates how the lens mesh deforms during simulation. Page 35: “A finite element analysis is a valid tool in biomechanics…”; Page 24: “Our modeling procedure led to an idealized model of a human eye at the particular age… to study accommodation of a 29-years-old human eye…”; Page 28: “… all anatomical elements mentioned in the previous chapters were modeled…”; Figure 4.4 illustrates a cross section of a globe of the eye which illustrates that the biomechanical finite element model includes both the lenticular and extralenticular structures, in the anterior and posterior of the eye.
NOTE: Ljubimova_2005 explicitly teaches that the finite element model includes “all the anatomical elements mentioned in the previous chapters.” Figure 3.5, which is from a previous chapter illustrates the associations of anatomical elements and includes: the lens, ciliary muscle, sclera, choroid.
Additionally; page 64 states that the finite element model included setting parameters for component models included setting parameters for the lens, capsules, vitreous and zonule. Additionally; page 65 states that the stiffness of the modeled zonule fiberes was set to 1.5Nmm-2. Further; as cited above the ciliary body model in the finite element model moved 0.4mm in the simulation. Therefore; structures of the finite element model includes lens, lens capsules, ciliary muscle, zonules, and sclera)
determining a three-dimensional (page 31 section 4.4 par 1: “… allowed the three-dimensional performance of the eye structure to be modelled…”) biomechanical (abstract: “… biomechanics of the human eye accommodation…”; section 1.1: “… a systematic mathematical and biomechanical approach…”; section 4.1: “… finite element analysis is a vlid tool in biomechanics…”) model of the one or more lenticular and extralenticular structures of the eye using at least the first anatomic model (page 42: “… using an already established model of the young eye with reasonable behavior we can expand it to eyes of different ages. Such modeling exercise would involve modelling of age-related changes appearing in related eye structures…”; page 33 figure 4.4 illustrates the lens and extralenticular structures including the vitreous and zonal fibers. page 62 Figure 1(b); page 64: figure 3; page 66 Figure 4 illustrates the lens, the vitreous and choroid; page 67 Figure 5 NOTE: extralenticular structures are any which are not the lens) wherein the three-dimensional biomechanical model is configured to simulate biomechanical interactions between the crystalline lens, zonular fibers, and ciliary muscle to model accommodation/disacommodative function or Dynamic Range of Focus (DRof) function from near to far and far to near (Page 17/104 section 21. Human eye… “the crystalline lens and the cornea represent the main focusing system of a human eye… the curvature of the lens can be adjusted to “tune” the focus… this variable lens contribution is called accommodation and arises both from controlled changes in curvature and thickness along the lens’s polar axis, mediated by ciliary muscle contractions… nowadays it is universally accepted that accommodation is primarily achieved by alteration of the shape of the crystalline lens…” Page 18/104 section 2.2 Components of the accommodative apparatus… “all the anatomical elements which are believed to participate directly or indirectly in the accommodative process are described more precisely in the current section. The component elements of the accommodation mechanism are: the crystalline lens, the zonular apparatus, the ciliary body, containing the ciliary muscles, the choroid and the vitreous, see Figure 2.2…” Page 19/104 The zonule “… The zonule (suspensory ligament, zonules of zinn, zonular apparatus) is a supporting system of the lens. The zonule appears to attach and interlace with the lens capsule in rings on anterior, equatorial and posterior surfaces on one side and the elastic choroid structure on other. These three distinct groups of fibres deonted by the places of their attachments to the lens are called anterior (AF), central (AF) and posterior (PF) sets of fibres, respectively…” Page 27/104 section 3.2 Studies of accommodation “… the present thesis deals with mechanical modelling of human eye accommodation. Construction of a numerical model of a biological system involves synthesis of disparate sets of geometrical and mechanical data…” Page 33/104 Figure 3.5 (shown below) clearly illustrates the biomechanical relationships and interactions between the crystalline lens, zonular fibers (AF, PF), and ciliary muscle to model accommodation/disacommodative function
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Page 34/104: “… Conclusions 1) By author’s belief, the exploration of the validity of various hypothesis considering the mechanism of accommodation has proven, the Helmholtz theory of accommodation still stands with regard to the broad issues. With the addition of some up-to-date modifications and more accurate definitions concerning the supportive system of the lens, the classical theory explains specific experimental facts and does not contradict the basic laws of mechanics during all phases of the accommodation process. 2) New observations lead us to the consideration of a new analytical model, which should consist of the lens, zonular system and vitreous body, see Figure 3.6. The proposal of the present study is that an improved description of human eye accommodation can be obtained by such a model, which incorporates posteriorly sloped forces applied by the ciliary muscle, and the support of the lens, provided by the vitreous…” Page 43/104 section 1.4 Modelling procedures: “… a numerical analysis bas been carried out using the commercial general-purpose finite element package ABAQUS… which is widely used in mechanical and civil engineering… which allowed the three-dimensional performance of the eye structure to be modelled… in the second model a posterior fibres set was added…” Page 44/104: “… several meshes with different densities were created for the crystalline lens… the lens mesh… in the second model both lens and vitreous capsules were modelled… following Burd et al (2022) we assumed that the lens capsule is fully bonded with the cortex. Anterior, posterior and central sets of zonular fibres were modelled… the ligament of Wieger is represented in the model… the reference configuration of the main model is shown in Figure 4.4(a)… the process of disaccommodation can be performed… performing the process of disaccommodation by applying ciliary muscle forces to the ends of the zonular fibres…”
Figure 4.4; Figure 4.5
EXAMINER NOTE: The above citations clearly teach a biomechanical model configured to simulate biomechanical interactions between the crystalline lens, zonular fibers, and ciliary muscle to model accommodation/disacommodation function. Indeed, the author explicitly states that models should synthesize the interactions of the lens, zonular system, vitreous body, and forces applied by the ciliary muscles. Figure 3.6 illustrates the “new theoretical model” and, as outlined above, this model includes the crystalline lens, zonular fibers, and forces applied by the ciliary muscles to model all phases of the accommodation process (i.e., both accommodation/disaccommodation). Chapter 4, and section 4.4 in particular explicitly state to use ABAQUS to perform a three-dimensional biomechanical simulation and explicitly states that the model includes the crystalline lens, the zonular fibres, and the forces from the ciliary muscles.);
determining one or more parameters (page 81 Figure 4: geometric parameters of the model initial configuration. Configuration of the lens based on Burd…”; page 7: “… the lens curvature and axial thickness are controlled by the ciliary muscle. By changing these parameters of the lens, one can focus the eye on objects at different distances from it…”; page 17 “… a structural model is based on geometric and material parameters…”; page 18: “… displacement boundary conditions are applied around the equator, which means that the resultant of stretching forces is horizontal, see Figure 3.2…”; page 23 section 4.1: “a finite element analysis is a valid tool in biomechanics… biomechanical research… specification of the boundary conditions and operative forces… proper identification of model parameters… physical/physiological quantities…”) associated with a changed biomechanical state of the eye and related crystalline lens, lenses are young and fully capable of accommodation… the highest accommodative demands of 10 Diopters are assumed to correspond to a fully accommodated state, representing the initial configuration…”; page 26: “… geometric parameters used in description of the initial state of the model are summarized in Figure 4.1…”; page 28: “… at the reference model state it is adopted that all stresses in the lens, lens capsule and zonule are zero… at the beginning of the simulation…”; par 41: “… geometric information for accommodative demands of 10 Diopters are used to describe the reference state of the model…”; page 61: “… during accommodation…”; page 64 figure 3: “geometry of a fully-accommodated eye”; page 64: “… Figure 2… fully accommodated state (our reference configuration)…”; page 65: “… the finite element model at its initial state…”),wherein the one or more parameters include at least one of scleral, lens, lens capsule, wiegarts ligament, zonnules, trabecular meshwork, scleral spur, bruchs membrane, chorid, lens capsule, and lens stiffness and lens stiffness (page 62: “… we came to the conclusion that an improved theoretical model should consist of lens, zonular system and vitreous, Figure 1(b)…”; page 28 – 29: “… assuming a linear elastic behavior of the lens capsule. He reported a Poisson’s ratio of 0.47 for the capsule and that value is incorporated in the present numerical model… an elastic modulus of the lens capsule equal to 1.27 Nmm-2 and we adopt that value in our modelling exercise. The substance of the lens consists of cortex and nucleus, and their stiffnesses were deduced by Fisher… we proposed linear elasticity of these materials with Young’s moduli of 3.417 X 10-3 Nmm-2 and 0.5474X10-3Nmm-2, respectively…”);
and determining a second anatomic model incorporating biomechanical changes to the first anatomic model in response to the age-specific changed physiological state and material properties of the lenticular and extralenticular, geometry, biometry, anatomy, optical and physics of the eye (Page 62 – 68: “… model should consist of lens, zonular system and vitreous, Figure 1(b)… to model the accommodative lens… A numerical analysis has been carried out using the commercial general-purpose finite element package ABAQUS… which is widely used in mechanical and civil engineering. The eye was regard as being a body of revolution… axisymmetric boundary conditions were applied to the nodes… all materials were isotropic and purely elastic… meshing the interior of the lens… two-noded axi-membrane elements were used to model capsules of lens and vitreous… two meshes were created for the crystalline lens… when the eye was in fully accommodated state… all the stresses in the lens, capsules, vitreous and zonule were zero… established the contact between vitreous body and lens capsule with a friction coefficient… applying forces to the ends of the zonular fibers… the final deformed geometry should match the data reported… the ciliary body moves 0.4mm, the corresponding change in lens equator radius would be 0.3mm…. the simulation show that the central thickness of the crystalline lens increases with accommodation and paraxial anterior and posterior curvature become steeper…”; Figure 4 and 5 illustrates how the lens and the vitreous interact when the lens move into contact with the vitreous changing the location and shape of the lens and vitreous. Figure 6 illustrates how the lens mesh deforms during simulation. Page 35: “A finite element analysis is a valid tool in biomechanics…”; Page 24: “Our modeling procedure led to an idealized model of a human eye at the particular age… to study accommodation of a 29-years-old human eye…”; Page 28: “… all anatomical elements mentioned in the previous chapters were modeled…”; Figure 4.4 illustrates a cross section of a globe of the eye which illustrates that the biomechanical finite element model includes both the lenticular and extralenticular structures, in the anterior and posterior of the eye.
NOTE: the above citations teach to use a plurality of finite-element models for anatomical structures that include at least the lens, zonular system, and vitreous for predicting the shape (deformation) of the lens during accommodation of a 29-year-old human eye. The lens is a lenticular structure while all other structures including the vitreous are extralenticular structures. The figures clearly illustrate this “first anatomic model” and the changes that occur to its shape (i.e., deformation) as well as changes to the shape of the vitreous when in contact with the lens.
For example, Figure 4 illustrates a first anatomical model of the lens in (a) the vitreous is not compressed in (b) the vitreous is compressed. In figures 5, 6, 9 biomechanical changes to the shape of the lens is illustrated in response to accommodation and disaccomodation (i.e., changed physiological state). This is also illustrated in Figure 4.3 where pulling on the ciliary body changes the shape of the lens. Figure 4.4 also illustrates an anatomic model of the lens, the vitreous, and the zonal fibers. In Figure 4.4 (b) a change in the shape of the vitreous is illustrated.)
, using the three-dimensional (page 31 section 4.4 par 1: “… allowed the three-dimensional performance of the eye structure to be modelled…”) biomechanical model and the one or more parameters associated with the changed biomechanical state (page 35: “… during disaccommodation, outward tension is applied to the lens, which pulls it into a relatively flattened state…”; page 61: “… the unaccommodated state…”; page 65: “… unaccommodated state…”; page 67: “… unaccommodated state of lens…”;)
predicting one or more future conditions of the eye (chapter 4 section 4.1: “a finite element analysis is a valid tool in biomechanics” and that “its predictions can be considered to have clinical value” which “used correctly” and when the numerical study obeys several important demands; page 36 item 1: “our model predicts the objective accommodative amplitude” in the future; page 85, Figure 6 and Page 85: “… forces, predicted by the present analysis…”) based on the biomechanical model of the one or more lenticular and extralenticular structures of the eye using at least the first anatomic model (section 4.4 Modeling Procedures, Figure 4.4 illustrates a cross section of a globe of the eye which illustrates that the biomechanical finite element model includes both the lenticular (i.e., lens) and extralenticular structures (i.e., vitreous) , in the anterior and posterior of the eye.
NOTE: the above citations teach to use a plurality of finite-element models for anatomical structures that include at least the lens, zonular system, and vitreous for predicting the shape (deformation) of the lens during accommodation of a 29-year-old human eye. The lens is a lenticular structure while all other structures including the vitreous are extralenticular structures. The figures clearly illustrate this “first anatomic model” and the changes that occur to its shape (i.e., deformation) as well as changes to the shape of the vitreous when in contact with the lens.
For example, Figure 4 illustrates a first anatomical model of the lens in (a) the vitreous is not compressed in (b) the vitreous is compressed. In figures 5, 6, 9 biomechanical changes to the shape of the lens is illustrated in response to accommodation and disaccomodation (i.e., changed physiological state). This is also illustrated in Figure 4.3 where pulling on the ciliary body changes the shape of the lens. Figure 4.4 also illustrates an anatomic model of the lens, the vitreous, and the zonal fibers. In Figure 4.4 (b) a change in the shape of the vitreous is illustrated.
Predicting a change in shape is a prediction of a change in condition because the shape of an object is one aspect of its condition.)
Wherein the prediction includes simulating the progression of at least one ocular condition selected from presbyopia or other condition (page 14: “… simulated aging of the lens using mechanical model, and showed that accommodative loss with age (presbyopia) and other features…”; page 41: “… a new model can be useful tool for giving relevant clinical suggestions to a developing area in ophthalmology, such as surgical correction to presbyopia…”), using the first anatomic model integrated with dynamic biomechanical, physiological, variables (page 41: “… the present model of accommodation with adopted assumptions captures at least several physiological aspects of accommodation. We believe that the present study shows that the vitreous support is an important feature and its addition is consistent with mechanical laws for such structures…” NOTE: this citation explicitly states they captures several physiological aspects into the model which makes obvious physiological variables. Also, the above citation teaches the modeled vitreous is included in the model and is consistent with mechanical laws which makes obvious biomechanical variables. Page 23 section 4.1 par 1: “… a finite element analysis is a valid tool in biomechanics…”)
, thereby providing a predictive output that accounts for age-specific changes (page 42: “… using an already established model of the young eye with reasonable behavior we can expand it to eyes of different ages…”), anticipated treatment intervention, and patient-specific physiological responses (page 41: “… a new model can be useful tool for giving relevant clinical suggestions to a developing area in ophthalmology, such as surgical correction to presbyopia, a benefit of the finite element formulation is the possibility to relatively easily change properties and different configurations of the model.
Page 1 section 1.1 par 1: “… a better understanding of the human eye allows us to intervene more intelligently and purposefully as we attempt to correct or modify disorders of the eye brought about by trauma, disease or ageing…”) and determining, using a predictive model (page 42: “… using an already established model of the young eye with reasonable behavior we can expand it to eyes of different ages…”), treatment applications wherein the treatment (Page 36: “… our model predicts the objective accommodative amplitude…” Section 1.1: “… a better understanding of the human eye allows us to intervene more intelligently and purposefully as we attempt to correct or modify disorders of the eye brought on by trauma, disease or ageing… studies will provide an explanation for normal and pathological performance of intraocular structures, indicate perspective directions for treatment and diagnostics of some ocular diseases…” Section 5.1 page 41: “… model can be useful tool for giving relevant clinical suggestions to a developing area in ophthalmology, such as surgical correction to presbyopia…” Page 46 Paper 2: “… modeling exercise can be useful to obtain clinically relevant recommendations to presbyopia surgery by allowing easy adjustment of modelling parameters to simulate the eye of different ages…” Appendix Page 49: “… The presbyopia is a condition that occurs with growing age and results in the inability of the human eye to focus on objects up close. It is not a disease as such, but a condition that affects everyone at a certain age, that cannot be cured, but can be corrected with glasses or contact lenses…” NOTE: The above citations teach to use a predictive model to determine treatment for a range of ocular conditions. The range of ocular conditions include trauma, disease, or aging conditions and specifically teaches presbyopia which is an age-related condition but is not a disease condition per se.)
While Ljubimova_2005 clearly teaches a three-dimensional performance (page 31 section 4.4 par 1: “… allowed the three-dimensional performance of the eye structure to be modelled…”) which may properly imply a three-dimensional model; Ljubimova_2005 does not explicitly illustrate a three-dimensional model.
Also, While Lijubimova_2005 teaches “a finite element analysis is a valid tool in biomechanics” and that “its predictions can be considered to have clinical value” which “used correctly” and when the numerical study obeys several important demands (chapter 4 section 4.1) and that “our model predicts the objective accommodative amplitude” in the future (page 36 item 1) and because accommodative amplitude is a result of conditions of the tissues, it may properly be found that Lijubimova_2005 would have made obvious to one of ordinary skill in the art “predicting one or more future conditions of the tissue of the eye”; however, Lijubimova_2005 does not explicitly teach “conditions of the tissues”
While it may be properly found that one of ordinary skill in the art would infer that the rotation and circular slices of the finite element eye model imply a “globe”; Ljubimova_2005 does not explicitly illustrate a “globe.”
Further; Ljubimova_2005 does not teach “computer implemented” nor “using a processor” nor
“wherein the three-dimensional biomechanical model includes determining treatment regions having a plurality of specifically targeted three-dimensional treatment zones, wherein the plurality of targeted three-dimensional treatment zones include at least an inner zone 1 with dimensions starting from the anatomical limbus, a middle zone2 extending from zone 1, and an outer zone3 extending from zone 2
, and wherein each of the plurality of targeted three-dimensional treatment zones is specifically correlated with a subsurface three-three-dimensional anatomy including at least one of the iris, cornea, limbus membrane, lens capsule, wiegart, ligament, ciliary muscles, ciliary body, lens, zonules, sclera, aqueous fluid, Schlemms canal, trabecular meshwork, episcleral vessles and chorid, scleral spur, pars plana, ora serrata, and choroid; treatment zones can have a plurality of shapes, sizes and patterns”
nor “zonular apparatus, a ciliary muscle fibers”
nor “to apply a treatment to the eye, wherein applying treatment to the eye includes creating pores in one or more of the plurality of specifically targeted three-dimensional scleral treatment zones of the treatment region and”
nor predicting one or more future “conditions of the tissue” of the eye
nor “three dimensional”
nor using the first anatomic model integrated with dynamic biomechanical, physiological, “and treatment response” variables.
Nor “a customized sequence of” treatment applications “to the specially targeted three-dimensional treatment zones based on patient-specific parameters, including localized changes in tissue stiffness and elasticity,” wherein the treatment “sequence is dynamically adjusted in real-time during delivery of treatment based on intra-procedure measurements of localized biomechanical properties of ocular tissue, including stiffness, elasticity, or deformation, obtained after one or more prior treatment applications within the same treatment session, and wherein the biomechanical model is updated during treatment based on the intra-procedure measurements to predict and guide subsequent treatment applications.
Taylor_2015; however teaches “computer implemented” and “using a processor” (Figure 1; par 8: “… determining, using a processor, a first anatomic model…”; par 10: “… a computer system…”) and using the first anatomic model integrated with dynamic biomechanical, physiological, “and treatment response” variables (FIG. 5 block 507: “… model and/or predict change in geometry based on the calculated value…”; par 20: “… patient-specific anatomic models for simulating… physiological states… and/or treatment) are often performed based on the anatomic and geometric model… treatment may… cause… a geometry of a patient’s anatomy may change due to various conditions or treatments…”
Par 20: “… simulations and models… may further be applied to model possible treatments that may affect geometry… a geometric change to a model may be made… based on patient-specific model that reflect a second state… an anatomic and biomechanical model under which simulations are performed…”; par 24: “… treatment recommendations may be improved with modeling… then modified to incorporate a treatment plan…”; par 46: “… include predicting a change in geometry based on the values given…”; par 44: “… method 400 may include further modeling geometric changes based on post-treatment states… for example, deforming the mesh for an anatomic model… then, a simulation of step 409 may include simulation… treatment-related geometry… output may include a treatment recommendation, where several simulations may be run to simulate various treatment options…” NOTE: The above citation makes obvious to have treatment response variables such as the variables associated with the changes in geometry or post-operative state.)
Ljubimova_2005 and Taylor_2015 are analogous art because they are from the same field of endeavor called modeling. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Ljubimova_2005 and Taylor_2015. The rationale for doing so would have been that Ljubimova_2005 teaches to model and simulate accommodation and disaccommodation which are reversible states in the eye which depends on changes in the geometry of a patients anatomy (Figure 3.3, 3.4) and that vary according to the change in a patients age (age is a condition) and where the changes in the patient’s anatomy involves structures that have blood vessels (page 20: “… the unaccommodated state the lens is flattened by the passive tension of the zonular fibers which are pulled by the elastic choroid structure… it pulls the choroid structures, which causes the tension in the zonular fibers to reduce… under the influence of elastic forces from the lens capsule and choroid the anterior, posterior and central fibers are under stress state of dynamic equilibrium in all phases of accommodation…”; page 47: “… choroid which carries blood vessels… the sclera and the retina…”; page 79 Figure 2; page 8: “ the choroid is the elastic antagonist of the ciliary muscle. It lies between the retina and sclera and is composed of layers of blood vessels that nourish the back of the eye. The choroid connects with the ciliary body toward the front of the eye and is attached to edges of the optic nerve…”). Taylor_2015 teaches to model reversible physiological states for geometry of a patient’s anatomy that may change due to various conditions (par 20) and that modeling/simulating arterial blood flow may improve simulation results and that “changes in blood flow and pressure may cause changes in patient-specific geometric models and boundary conditions, since local vessel size may affect local pressure and smooth muscle tone and thus introduce changing geometry of the patient anatomy (par 20 – 22). Therefore it would have been obvious to combine Ljubimova_2005 and Taylor_2015 for the benefit of improving simulation results of the geometry dependent reversible state model taught by Ljubimova_2005 by incorporating geometry changes resulting from changes in blood flow and pressure in the Choroid to obtain the invention as specified in the claims.
Ljubimova_2005 and Taylor_2015 does not explicitly teach “wherein the three-dimensional biomechanical model includes determining a treatment region having a plurality of specifically targeted three-dimensional scleral treatment zones, wherein the plurality of targeted three-dimensional scleral treatment zones include at least an inner zone, a middle zone, and an outer zone, and wherein each of the plurality of specifically targeted three-dimensional sclearal treatment zones is specifically correlated with a subsurface three-three-dimensional anatomy and has a different shape and a different size;” nor “zonular apparatus, a ciliary muscle fibers” nor “to apply a treatment to the eye, wherein applying treatment to the eye includes creating pores in one or more of the plurality of specifically targeted three-dimensional scleral treatment zones of the treatment region and” nor predicting one or more future conditions “of the tissues” of the eye nor “three dimensional”
“three-dimensional model” nor “globe” nor “wherein the three-dimensional biomechanical model includes determining treatment regions having a plurality of specifically targeted three-dimensional treatment zones, wherein the plurality of targeted three-dimensional treatment zones include at least an inner zone 1 with dimensions starting from the anatomical limbus, a middle zone2 extending from zone 1, and an outer zone3 extending from zone 2, and wherein each of the plurality of targeted three-dimensional treatment zones is specifically correlated with a subsurface three-three-dimensional anatomy including at least one of the iris, cornea, limbus membrane, lens capsule, wiegart, ligament, ciliary muscles, ciliary body, lens, zonules, sclera, aqueous fluid, Schlemms canal, trabecular meshwork, episcleral vessles and chorid, scleral spur, pars plana, ora serrata, and choroid; treatment zones can have a plurality of shapes, sizes and patterns” nor “zonular apparatus, a ciliary muscle fibers” nor “to apply a treatment to the eye, wherein applying treatment to the eye includes creating pores in one or more of the plurality of specifically targeted three-dimensional scleral treatment zones of the treatment region and” nor predicting one or more future “conditions of the tissue” of the eye nor “three dimensional” nor “a customized sequence of” treatment applications “to the specially targeted three-dimensional treatment zones based on patient-specific parameters, including localized changes in tissue stiffness and elasticity,” wherein the treatment “sequence is dynamically adjusted in real-time during delivery of treatment based on intra-procedure measurements of localized biomechanical properties of ocular tissue, including stiffness, elasticity, or deformation, obtained after one or more prior treatment applications within the same treatment session, and wherein the biomechanical model is updated during treatment based on the intra-procedure measurements to predict and guide subsequent treatment applications.
Ljubimova_2009; however, does explicitly illustrate a three-dimensional model and Three dimensional (abstract: “This thesis… deals with the investigation of the relationship between predicted intraocular pressure… finite element models have been constructed… a three-dimensional model of the whole coreneoscleral envelope… the 3D model accounted for collagen microstructure and represented a hyperelastic fiber reinforced material… material model alone has a profound effect on predicted IOPG… the proposed procedures can be useful for suggesting the magnitude of corrections for corneal biomechanics… the present modelling exercise has the ability to reproduce the behavior of human cornea…”; Page 68: “… the present 3D model is a model of the whole eyeball and consists of cornea, limbus and sclera under the internal and external applianating pressures… three dimensional loading possibilities have been considered…” page 80 Figure 5.7: Reference configuration of the model. (1) cornea; (2) limbus area, where (2.1 is corneal limbus, (2.2) is scaleral limbus; (3) sclera); Page 119: “…in this chapter a 3D model of the whole eyeball, consisting of cornea, limbus and sclera is presented… its outcomes such as stress, strains and thickness within the corneal tissues were shown…”; Page 155: “… two finite element models have been developed: a 2D axisymmetric model of the cornea and a 3D model of the whole eyeball… “; Page 168: “… 3D Model In 3D the whole eyeball was modelled. It consisted of cornea, limbus and sclera with different material behavior, with incorporation of the fluid-filled cavity of the corneascleral envelope.; Page 173 section 8.1 par 1: “… Models in 2D and 3D are developed and a number of parametric simulations are conducted…”) and “globe” (page 80 figure 5.7 illustrates a globe which is comprised of three finite element models illustrated as (1) the cornea (2) the limbus and (3) sclera. Further Figure 5.7 illustrates that the limbus is comprised of two finite-element sub-models illustrated as (2.1) corneal limbus and (2.2) scleral limbus. This makes clear that a larger finite element model is comprised of a set of anatomical finite element models) and a customized sequence of treatment based on patient-specific parameters (Page 60: “a major strength of computer simulation is its ability to allow independent parametric analysis… numerical modeling based on the finite element method has been used to predict corneoscleral response for years. A finite element model can be customized to make it patient-specific by using clinically measured data and consider immediate change in patient corneal shape after the surgery…”)
Ljubimova_2005 and Taylor_2015 and Ljubimova_2009 are analogous art because they are from the same field of endeavor called modeling. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Ljubimova_2005 and Ljubimova_2009.
The rationale for doing so would have been that Ljubimova_2005 teaches a modeling procedure that uses ABAQUS which allowed the three-dimensional performance of the eye structure to be modeled using two-dimensional meshes of its cross-section. Ljubimova_2009 to use a 3D model to further account for collagen microstructures and represented a hyperelastic fiber reinforced material also using ABAQUS that resulted in a clear association between all considered parameters and measured IOPG wherein the proposed procedure can be useful tools for suggesting the magnitude of corrections for corneal biomechanics and clinical imperatives (page V abstract paragraphs 2 – 3) and illustrates a 3D model on page 80 figures 5.7. Therefore it would have been obvious to combine Ljubimova_2005 and Ljubimova_2009 for the benefit of taking into consideration additional structures and make a more realistic or complete model that provides suggestions for corrections and clinical imperatives to obtain the invention as specified in the claims.
while Ljubimova_2009 teaches that “the thickness of the adult sclear is not uniform. It is thickets at the posteriao pole… decreasing gradually… at the euator and is thinnest under recti muscles.. it increases again from insertion of extraocular muscles towards to limbus… where it blends with the cornea…” which clearly teaches that various zones of the scleara “has different shape and different sizes” with regard to depth. Ljubimova_2009; however, does not explicitly teach a treatment zone.
while Luubimova_2009 also teaches using a three-dimensional model to predict intraocular pressures and that the model is a useful tool for suggesting the magnitude of corrections for corneal biomechanics (abstract par 1, 2). “suggesting” the magnitude of corneal biomechanical corrections makes obvious to one of ordinary skill in the art the limitation of predicting one or more future conditions of the eye because the model suggests (predicts) the eyes condition in the future following a biomechanical correction.
Also while Ljubimova_2009 teaches that “the overall aim of the present study is to assess… material properties of the involved tissues…” (abstract par 1) which would imply to one of ordinary skill in the art that the predicted future conditions of the eye involve tissues of the eye and thereby make the limitation of “predicting one or more future conditions of the tissues of the eye” obvious; but Ljubimova_2009 does not explicitly teach predicting any particular eye tissue condition.
Ljubimova_2005 and Taylor_2015 and Ljubimova_2009 does not explicitly teach “wherein the three-dimensional biomechanical model includes determining treatment regions having a plurality of specifically targeted three-dimensional treatment zones, wherein the plurality of targeted three-dimensional treatment zones include at least an inner zone 1 with dimensions starting from the anatomical limbus, a middle zone2 extending from zone 1, and an outer zone3 extending from zone 2, and wherein each of the plurality of targeted three-dimensional treatment zones is specifically correlated with a subsurface three-three-dimensional anatomy including at least one of the iris, cornea, limbus membrane, lens capsule, wiegart, ligament, ciliary muscles, ciliary body, lens, zonules, sclera, aqueous fluid, Schlemms canal, trabecular meshwork, episcleral vessles and chorid, scleral spur, pars plana, ora serrata, and choroid; treatment zones can have a plurality of shapes, sizes and patterns” nor “zonular apparatus, a ciliary muscle fibers” nor “to apply a treatment to the eye, wherein applying treatment to the eye includes creating pores in one or more of the plurality of specifically targeted three-dimensional scleral treatment zones of the treatment region and” nor predicting one or more future “conditions of the tissue” of the eye nor “specially targeted three-dimensional treatment zones based on patient-specific parameters, including localized changes in tissue stiffness and elasticity, wherein the treatment sequence is dynamically adjusted in real-time during delivery of treatment based on intra-procedure measurements of localized biomechanical properties of ocular tissue, including stiffness, elasticity, or deformation, obtained after one or more prior treatment applications within the same treatment session, and wherein the biomechanical model is updated during treatment based on the intra-procedure measurements to predict and guide subsequent treatment applications.
Herekar_2019; however, makes obvious “wherein the three-dimensional biomechanical model includes determining a treatment region having a plurality of specifically targeted three-dimensional scleral treatment zones (Fig 2 illustrates an HIFU treatment transducer specifically targeted to a target location of the sclear; Fig 3 illustrates a sclera tripsy zone with a plurality of specifically targeted treatment pulse locations; par 22: “the processor and the transducer array are configured to focus the beam to a plurality of locations in a three dimensional pattern in the eye… to define a three dimensional treatment region…”; par 193: “… structures, which can be three dimensional…”),
wherein the plurality of targeted three-dimensional treatment zones (abstract state: “… the ultrasound beam can be focused and plused at each of a plurality of locations to provide a plurality of cavitation zones at each of the target regions…”. FIG. 2 also clearly illustrates and explicitly states “target location”. Paragraph 6 states: “… the system is configured to scan of a focused spot to target region of the eye with a plurality of pulses derived to a plurality of locations of the target region…. direct the pulse to target tissue structures…” Also page 27 item 25 states: “… focus the beam to a plurality of locations in a three dimensional pattern in the eye… focus the beam to a plurality of different locations… a plurality of different locations… to define a three dimensional treatment region…”. Paragraph 22: “… focus the beam to a plurality of locations in a three dimensional pattern in the eye… to define a three dimensional treatment region…” Paragraph 90: “… define a three dimensional tissue resection pattern…”) include at least an inner zone 1 with dimensions starting from the anatomical limbus, a middle zone2 extending from zone 1, and an outer zone3 extending from zone 2 (FIG. 24B illustrates a 3D treatment zone with various treatment focal points. FIG. 24C illustrates a 3D treatment zone with various adjacent treatment regions. The 3D space is illustrated as a cube and the treatment locations are inside the 3D space. Further, FIG. 24C illustrates three treatment regions. J is a first treatment region (i.e., zone1), G middle region that extends from the first region and I is an outer region that extends from the second region. Therefore; J makes obvious a zone 1, G makes obvious Zone 2 and I makes obvious Zone 3. NOTE: The above clearly illustrates that there may be multiple treatment zones. It also illustrates at least three treatment zones correlated with a subsurface three-dimensional anatomy. FIG. 24B and C teach the concept of treatment zones/regions. Herekar_2019 teaches that the treatment location/zone is specifically targeted because Herekar_2019 teaches to focus the treatment at a target location. This is illustrated in, for example, FIG. 2. It is also stated in the abstract. Indeed; Herekar_2019 teaches that any anatomical structure may be specifically targeted. For example, a capillary wall is focused on in FIG. 23.
Also, Herekar_2019 teaches that the treatment areas/zones/regions may have a variety of shapes that include circular rings as illustrated in 14E, 12B1, 12A1, FIG. 10A, as well as spherical cavitation areas, and cubes and that each of these treatment zones are chosen to treat particular targeted locations of the eye tissue. In fact, FIG. 12C clearly illustrates treatment zones starting at the limbus and going outward into the Sclera. This is also illustrated in FIG. 12D, and 15, 16.
Further; by the broadest reasonable interpretation a treatment zone is simply an area of treatment and it may simply be a single cavitation area. Therefore; three adjacent cavitation areas with one on or at the limbus would read on the claim limitation. Notice the FIG. 3 clearly illustrates focused treatment locations in a zone extending from the limbus to the Scleera. There are illustrated at least three cavitation areas adjacent to one another starting from the limbus.), and wherein each of the plurality of targeted three-dimensional treatment zones is specifically correlated with a subsurface three-three-dimensional anatomy including at least one of the iris, cornea, limbus membrane, lens capsule, wiegart, ligament, ciliary muscles, ciliary body, lens, zonules, sclera, aqueous fluid, Schlemms canal, trabecular meshwork, episcleral vessles and chorid, scleral spur, pars plana, ora serrata, and choroid (FIG. 3 explicitly illustrates a zone in the sclera where treatment pulses are illustrated to be targeted in the subsurface of the sclera. FIG. 6 also explicitly illustrates treatment areas targeted on the subsurface anterior and posterior region of the lens. FIG. 9B, 10B explicitly illustrates targeting a treatment zone that is in the subsurface of a cornea. The cornea is recited in the claim’s list of alternative anatomical structures. FIG. 12C explicitly illustrates targeting subsurface treatment zones in the Ora Serrata and Limbus anatomical structures. These structures are recited in the claim. FIG. 12D explicitly illustrates targeting treatment zones in the subsurface anatomical structures of the Limbus, Ora Serrata and Lens Capsule, and Sclera. FIG. 16 explicilty illustrates targeting treatment zones in the subsurface anatomical structure of the Schlemm’s canal. The Schlemm’s canal is recited in the claim. FIG. 18A explicitly illustrates targeting treatment zones in the subsurface anatomical structure of the lens capsule. The lens capsule is recited in the claim. FIG. 22C and D explicitly illustrate targeting treatment zones in the subsurface anatomical structure of the irirs. The iris is recited in the claim.); treatment zones can have a plurality of shapes, sizes and patterns” (Herekar_2019 teaches that the treatment areas/zones/regions may have a variety of shapes that include circular rings as illustrated in 14E, 12B1, 12A1, FIG. 10A, as well as spherical cavitation areas, and cubes and that each of these treatment zones are chosen to treat particular targeted locations of the eye tissue. In fact, FIG. 12C clearly illustrates treatment zones starting at the limbus and going outward into the Sclera. These treatment zones are also various shapes and sizes This is also illustrated in FIG. 12D, and 15, 16.) and determining one or more parameters associated with a changed biomechanical state of the eye and related lens “zonular apparatus” (par 250: “… FIG. 3. Treatment of the vitreous near the zonular insertion zone may improve accommodation by clearing thickened fibrous gel (also referred to herein an lacuae) and promoting forward movement. Treatment of the vitreous near the posterior pole may promote facile and stable shape changing of the lens during accommodation”; par 295: “… define a 3-D (three-dimensional) tissue resection patter. The HIFU may be configured to cleave collagen fibers treated may comprise for example collagen fibers of one or more of corneal, a limbus, a sclera, an iris, a lens capsule, a lens cortex, or zonulae. The pulse may be configured…” This teaches to make biomechanical changes to the state of the eye related to the lens and zonular apparatus by configuring a 3-D tissue resection patterns. par 347: “Table 3 describes various HIFU treatment parameters that the inventors have used…”; par 6: “… system can be used to identify target tissue structures on a display and input treatment parameters to treat the target tissue structures… such as the limbus, sclera and iris…”; par 222: “… the methods and system described herein may be operated with any combination of the parameters listed in Table 2…” These paragraphs teach to use parameters during treatment of the eye in order to change the biomechanical state of the eye.), a ciliary muscle fibers” (par 197: “… treatment located along the ciliary apex..”; par 201: “… tissue stiffness… or sclera tissue, may hinder movement of the ciliary apex… treatment….”; par 272: “… a treatment pulse for cyclo-sonocoagulation. The HIFU system described herein may be used in thermal mode to direct HIFU energy to the ciliary process to induce necrosis of ciliary apical cells… treat the ciliary processes…”; FIG. 15: “Ciliary processes/treatment zone”) and “to apply a treatment to the eye, wherein applying treatment to the eye includes creating pores in one or more of the plurality of specifically targeted three-dimensional scleral treatment zones of the treatment region and” (par 336: “The HIFU system described herein may be used to enhance drug delivery to the eye… micro-porate any of the tissues described herein in order to enhance porosity of the tissue…”; par 337: “… the average pore size…”; par 265: “FIG. 12C shows an embodiment of a treatment zone for presbyopia using scleral erosion… increase accommodation…”) and predicting one or more future conditions “of the tissues” of the eye (par 265: ‘… treatment zone for presbyopia using sclera erosion… scleral erosion using HIFU may result in softened pars plana, increased circumlental space… may further relieve presbyopia and increase accommodation…” NOTE: this teaches a change in the eye tissues that cause a change in accommodation. Ijubimova_2005 teaches to predict accommodation (page 36). Therefore the combination of references makes the prediction of future conditions of the eye tissue obvious).
Also, Herekar_2019 teaches “specially targeted three-dimensional treatment zones based on patient-specific parameters, including localized changes in tissue stiffness and elasticity, wherein the treatment sequence is dynamically adjusted in real-time during delivery of treatment (Par 32: “… a system to treat an eye comprises an ultrasound transducer to generate a HIFU beam… comprising a plurality of pulses… each pulse of the plurality of pulses is separated from a subsequent pulse of the plurality of pulses by a time with a range from about 1 microsecond to about 1000 microseconds…” Par 64: “… a method of treating an eye comprises generating a HIFU beam with an ultrasound transducer array… a pressure of the ultrasound beam comprises a peak negative acoustic pressure… in order to soften the tissue…” Par 192: “… the methods and systems disclosed herein provide improved methods and system for making tissue more elastic…” Par 194: “… the methods and system disclosed herein can provide high intensity focused ultrasound (HIFU) treatment to tissue so as to increase elasticity of the tissue…” Par 196: “the increased elasticity of the tissue can be provided at locations arranged in order to provide a therapeutic effect, such as presbyopia or glaucoma treatment…” Par 201: “the methods and systems disclosed herein may be used to treat presbyopia and/or glaucoma by reducing tissue stiffness in a target tissue using controlled cavitation-mediated ocular tissue erosion… treatment to reduce stiffness…” Par 312: “… the HIFU scanner may be further coupled to an imaging system… the imaging system may be used to capture one or more images of the eye before, during, or after treatment… the display may show images which allow the user to see the tissue treated and plan the treatment. Images shown on the display may be provided in real-time and can be used to prior to treatment to allow the user to align the tissue and/or select a treatment zone to target… the imaging apparatus may provide additional tissue feedback data in real-time, for example temperature or elasticity. The system as described herein may comprise an eye tracker as known to one in the art in order to generate real-time images of the eye in order to align or register the target treatment regions of the eye…” Par 315: “… The HIFU system described herein may allow for pre-treatment planning and/or treatment of a tissue in an image-guided manner. Treatment locations and patterns may for example be input by a user in response to an image shown on the display. The image may be obtained pre-operatively or in real-time prior to or during treatment. Targeted treatment zones may be selected by a user or operator in response to the image displayed…”
NOTE: The above citations teach that treatment locations and patterns may be dynamically changed by a user in real-time during treatment for a range of ocular conditions that include presbyopia and/or glaucoma and that the treatment parameters included changes in stiffness and elasticity for the targeted tissues.)
Ljubimova_2005 and Taylor_2015 and Ljubimova_2009 and Herekar_2019 are analogous art because they are from the same field of endeavor called medical treatments. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Ljubimova_2005 and Herekar_2019. The rationale for doing so would have been that Ljubimova_2005 teaches to model the accommodation of a human eye and Herekar_2019 teaches to perform treatments for accommodation of a human eye. Therefore it would have been obvious to combine Ljubimova_2005 and Herekar_2019 for the benefit of treating a human eye to obtain the invention as specified in the claims.
Ljubimova_2005 and Taylor_2015 and Ljubimova_2009 and Herekar_2019 does not explicitly teach “based on intra-procedure measurements of localized biomechanical properties of ocular tissue, including stiffness, elasticity, or deformation, obtained after one or more prior treatment applications within the same treatment session, and wherein the biomechanical model is updated during treatment based on the intra-procedure measurements to predict and guide subsequent treatment applications.”
Zheng_2015 makes obvious “based on intra-procedure measurements of localized biomechanical properties of(forces and moments), obtained after one or more prior treatment applications within the same treatment session, and wherein the biomechanical model is updated during treatment based on the intra-procedure measurements to predict and guide subsequent treatment applications” (abstract: “… two decades ago, computer-assisted orthopedic surgery (CAOS) has emerged… the aim of this paper is to present the basic elements of CAOS devices and the review state-of-the-art examples…”; page 2 – 3 section 2.1. Virtual Objects: “the VO in each CAOS system is defined as a sufficiently realistic representation… that allow the surgeon to plan the intended intervention… data may be acquired at two points in time: either pre-operatively or intra-operatively… limitations of pre-operative VOs were observed, which led to the introduction of intra-operative imaging modalities…” page 4: “… acquire a graphical representation of the patient’s anatomy by intra-operative digitization… the model is generated by the operator, the technique is, therefore, known as “surgeon-defined anatomy” (SDA). It is particularly useful when soft tissue structures, such as ligaments or cartilage boundaries, are to be considered…”; page 5: “… intra-operative ultrasonography… touch-based digitization done with a conventional probe…”; page 10 - 11: “… Biomechanical Modeling. Numerical models of human anatomical structures may help the surgeon during the planning, simulation, and intra-operative phases with the final goal to optimize the outcome… in addition, these models will not only be used pre-operatively, but need to function also in near real-time in the operating theater… developed a detailed volumetric finite element model… to simulate surgical correction… showed that with biomechanical modeling… presented the development of a biomechanical guidance system… the BGS aims to provide no only real-time feedback… but also… pressure… another approach is the combined use of intra-operative sensing devices with simplified biomechanical models. Corettet… introduced a device that intra-operatively measures knee joint forces and moments… the need for intra-operative force monitoring… available in recent years and is clinically used…” NOTE: the above teaches that intra-operative biomechanical modeling is used where intra-operative measurements are taken for the purpose of guiding optimal surgical outcomes and that data for models may be acquired either pre-operatively or intra-operatively. )
Ljubimova_2005 and Zheng_2015 are analogous art because they are from the same field of endeavor called biomechanical modeling for surgical procedures. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Ljubimova_2005 and Zheng_2015
The rationale for doing so would have been Ljubimova_2005 teaches to “address the biomechanics of the human eye accommodation” (abstract) where “a finite element analysis is a valid tool in biomechanics” (section 4.1) for modeling/simulating deformation (Figure 5; Page 68: “… the deformed mesh for mesh B (see Figure 2(b)…”; Figure 9 “deformed mesh with different depths of pit”; page 84: “… the calculated deformed positions of on the anterior surface… axial deformed coordinates… the deformed radius… deformed lens thickness…” Figure 6 “deformed lens meshes” page 85: “… deformed geometry…” section 4.3: “… finite element calculations are done by applying the outward tension… measured data is chosen… calculations to give the known deformed configuration…”) of ocular tissue (title: “numerical modeling of the human eye accommodation”) with the purpose of making “clinically relevant recommendations to presbyopia surgery by allowing easy adjustments of modeling parameters to simulate the eye of different ages” (page 46 6. Review of Papers).
Zheng_2015 teaches a known clinical method called Computer-Assisted Surgery where intra-operative measurements of tissue are used with intra-operative biomechanical models to make clinical recommendations in real-time for the purpose of improving surgical outcomes and calls such systems biomechanical guidance systems.
Therefore, it would have been obvious to combine the biomechanical model of ocular tissues of the human eye as taught by Ljubimova_2005 with intra-operative measurements of tissues that update the intra-operative biomechanical model for the purpose of making clinical recommendations/guidance during surgical procedures for the benefit of improved surgical outcomes to obtain the invention as specified in the claims.
Claims 2. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Further Ljubimova_2005 teaches “wherein the biomechanical state includes a baseline state (page 25: “… representing our initial configuration…” Figure 4.1 “initial state”; page 26: “… the initial state of the model…”; page 41: “… geometric information for accommodative demands of 10 Diopters are used to describe the reference state of the model…”), and age-related physiological state (page 41 table 5.2: “Mean age”; page 42: “… using an already established model of the young eye with reasonable behavior we can expand it to eyes of different ages. Such modelling exercise would involve modelling of age-related changes appearing in related eye structgures…”; page 43: “… models of eyes of different ages…”; page 46: “… allowing easy adjustments of modelling parameters to simulate the eyes of different ages…”; page 14: “… simulated aging of the lens using mechanical model, and showed that accommodative loss with age…”), a biomechanical functional state (page 35: “12 to 5.4 Diopters, depending on the thickness… lens power of 13.2 Diopters… 10 Diopters…” teaches a lens functioning at a particular Diopter state; page 36 Figure 4.6 teaches accommodative change according to functional Diopter state which is a functional state) and a biomechanical dysfunctional state (page 2 par 2: “… the detailed study of accommodation would add to our fundamental knowledge about refraction anomaly (e.g., spasm of accommodation), dysfunction caused by surgery on the accommodative apparatus (e.g., cataract surgery) and pathology of the accommodative system…” which teaches a motivation to study by modeling the dysfunctional state. Page 36 Figure 4.6 teaches a loss of functional accommodative change in terms of Diopter state which is a dysfunctional state. NOTE: functional state and dysfunctional state are opposite sides of the term and inversely related. As a dysfunctional state increases the corresponding functional state increases).
Claims 3 . Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Further Ljubimova_2005 teaches “wherein the one or more parameters are associated with biomechanical conditions optical conditions, boundary conditions, or a combination thereof” (page 63: “… boundary conditions were applied to the nodes located along the symmetry axis…”; page 66: “… to achieve this state we applied displacement boundary conditions…”; page 82: “… by applying displacement boundary conditions…”; page 18: “… boundary conditions are applied…”; chapter 4 section 4.1 “specification of the boundary conditions and operative forces…”).
Claim 4. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Further Ljubimova_2005 teaches “Performing a simulation using the biomechanical model in a plurality of states (page 35 Fig. 4.5; page 66 FIG. 4; Page 67 FIG. 5, page 68 FIG. 6, page 70 FIG. 9. NOTE: this illustrate the finite-element mesh biomechanical model in different shapes due to being an different states of accommodation/disaccomodation), wherein the one or more parameters associated with the changed biomechanical state of the patient are determined using the simulation” (Page 29: “… an inverse experiment was carried out…”; page 67: “… during the simulation we manually deduced unknown parameters… by ensuring that the final geometry matched the data for the unaccommodated state of lens…”; page 81: “… the Youngs modulus for vitreous humor was derived by inverse method during simulation…”; page 84: “… inverse methodology, was used to derive or estimate unknown datea, such as force, zonular stiffness and Young’s modulus… Numerical simulations were performed and the values of unknown parameters were deduced by ensuring that resulting configurations matched measured data in chosen respects…”).
Claims 5. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 4. Further Ljubimova_2005 teaches “wherein the simulation includes a simulation of dynamic range of focus including at least one of accommodation and disaccommodation of the eye, and hydrodynamic changes of the eye” (title: “numerical modelling of the human eye accommodation”; abstract: “this thesis addresses the biomechanics of the human eye accommodation…” page 35: “… clinic patients…”; section 2.2 par 1: “… all the anatomical elements which are believed to participate directly or indirectly in the accommodative process are described…”; chapter 3 par 1: “… anatomical connections, as well as events occurring during accommodation… the appropriate mechanical model can add a piece to that puzzle…”; par 24: “…the model is developed by brining the anatomy and geometry of the accommodative apparatus together with mechanical properties of the lens, zonular system and vitreous body… our modeling procedure lead to an idealized model of the human eye at the particular age…”; page 28: “… all anatomical elements mentioned in the previous chapters were modelled…”;
Page 35: “… Figure 4.5 during disaccommodation, outward tension is applied… the central anterior and posterior surface of the lens flatten…”
page 36: “… Finite element model of accommodation… our model predicts the objective accommodative amplitude… in our model the amplitude of lens equator displacement was derived… the computed variations of the pressure inside the lens were estimated in our analysis for the main model…”; par 39: “… the present model of accommodation with adopted assumptions captures at least several physiological aspects of accommodation…”; page 42: “… a new model that would take into account this feature is suggested for consideration…”; page 66 illustrates the finite-element mesh model for the vitreous. Change in the vitreous is a hydrodynamic change of the eye; page 67 Figure 5, “disaccommodation….”) and “wherein the simulation includes a simulation of accommodation mechanism (title: “numerical modelling of the human eye accommodation”; abstract: “this thesis addresses the biomechanics of the human eye accommodation…” page 35: “… clinic patients…”; section 2.2 par 1: “… all the anatomical elements which are believed to participate directly or indirectly in the accommodative process are described…”; chapter 3 par 1: “… anatomical connections, as well as events occurring during accommodation… the appropriate mechanical model can add a piece to that puzzle…”; par 24: “…the model is developed by brining the anatomy and geometry of the accommodative apparatus together with mechanical properties of the lens, zonular system and vitreous body… our modeling procedure lead to an idealized model of the human eye at the particular age…”; page 28: “… all anatomical elements mentioned in the previous chapters were modelled…”; page 36: “… Finite element model of accommodation… our model predicts the objective accommodative amplitude… in our model the amplitude of lens equator displacement was derived… the computed variations of the pressure inside the lens were estimated in our analysis for the main model…”; par 39: “… the present model of accommodation with adopted assumptions captures at least several physiological aspects of accommodation…”; page 42: “… a new model that would take into account this feature is suggested for consideration…”) and effects on central optical power” (page 9 section 2.3: “… optical power…”; page 20: “… thereby decreases, increases the refractive power of the eye…”; page 34: “… the optical power of the lens was determined using data within the important vision zone… optical power can be calculated, equation…”; page 35: “… numerical models described in the thesis so far relates to the optical power…”; page 37 Figure 4.7: “…opt. power (D)…”; chapter 6 par 2: “… values of total resulting optical power are obtained…”; page 67: “… the optical power was determined…”; page 68: “… the computed variations of optical power…”; page 69 Figure 7: “optical power (D)”; page 72: “… the computed variations in optical power… for two meshes…”).
Claims 6. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Further Ljubimova_2009 makes obvious “further comprising: At least one additional model in addition to the first anatomic model and the three-dimensional biomechanical model, the at least one additional model including one or more portions of the first anatomic model (Page 80 Figure 5.7 illustrates that an anatomical finite-element mesh model may be comprised of at least one additional model. The limbus sub-model illustrated as (2) comprises a corneal limbus (2.1) finite-element mesh model and a scleral limbus (2.2) finite-element mesh model.).
Additionally; Ljubimova_2009 page 66 Figure 4 illustrates a lens anatomic model and it is comprised of the lens finite-element mesh and also a second model illustrated as zonular fibers (on the right). Therefore; the lens model is comprised of two anatomic model portions.
Claim 7. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claims 1 from which claim 7 depend. Ljubimova_2009 teaches “wherein the biomechanical model includes at least one of measurement or properties of a scleral wall and choroid” (page 80 Figure 5.7 illustrates that the sclera is included in the model; page 77 section 5.3: “… 3D nonlinear model of the applanation tonometeric procedure, incorporating the coreoscleral shell…”; page 58: “… physiological stress for the corneoscleral coat should be between 8 and 22 kPa…” this is a property of the scleral wall that is included in the biomechanical model. page 90 table 5.5; page 121 table 6.5: “nonlinear scleral description is based on data reported by Woo…”; page 122 figure 6.18 displacement in the corneaoscleral envelope is a measure of the scleral wall).
Claims 8. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Taylor_2015 teaches “further comprising: performing a simulation using the second anatomic model; and outputting results of the simulation” (Fig 2 block 209, 211, 213).
Claim 9. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Herekar_2019 makes obvious “Wherein the outer zone includes a plurality of zones” ( FIG. 3 illustrates a sclera zone with a plurality of treatment pulses and each pulse may properly be considered a treatment zone; FIG. 12C and 12D also illustrates that there are multiple treatment zones; FIG 37 illustrates multiple “targeted treatment zones” par 145: “ FIG 24B shows a tissue treatment zone comprising multiple non-adjacent treatment focal points, par 146: “FIG 24C shows a tissue treatment zone comprising multiple adjacent treatment regions; These citations illustrate that a treatment zone is comprises of a plurality of smaller treatment zones which is a location such as where the focal point is targeted in the larger region.)
Claim 10. Ljubimova_2005 and Taylor_2015 and Ljumbimova_2009 and Herekar_2019 and Zheng_2015 teach all the limitations of claim 1. Herekar_2019 makes obvious “wherein the plurality of three-dimensional sclera treatment zones includes a depth” (par 197: “… the depth of the treatment can be controlled in accordance with the region being treated…”; par 198: “… program the treatment depth and location…”; par 234), width, length, (FIG 10A, 12A1, 12B1, FIG. 14E illustrate that a treatment zone can have a diameter. A diameter is the width of a circular treatment zone. FIG. 24C illustrate rectangular treatment areas in a rectangular treatment zone. The cube is illustrated with both width and length.) circumference ((FIG 10A, 12A1, 12B1, FIG. 14E illustrate that a treatment zone can be a circle. A circumference is the enclosed boundary of a curved geometric figure, especially a circle. FIG. 24B illustrates circular treatment areas A,B, C, E, F, D. These circular treatment zones have a circumference)
and pattern (FIG. 12D illustrates various patterns of the treatment zone in the Sclera. This figures also illustrates that the treatment zones are at various depths inside the sclera.).
Claim 12. Herekar_2019 makes obvious “Wherein the dimensions or boundaries of at least one of the specifically targeted three-dimensional treatment zones are dynamically adjusted in real-time during treatment based on intra-procedural measurements of localized biomechanical changes in the treated tissue” (Par 197: “… treatment pulses can be arranged in many ways within a region… the pulses can be overlapped to provide an overlapping treatment regions or zones having dimensions within a range from about 100 um to about 1 mm, and a plurality of spaced apart treatment regions can be provided… the depth of the treatment can be controlled in accordance with the region being treated…”; Par 201: “to treat presbyopia and/or glaucoma by reducing tissue stiffness in a target tissue using controlled cavitation-medicated ocular tissue erosion or fractionation… Tissue stiffness, for example rigidity in the corneal tissue and/or scleral tissue, may hinder movement… treatment to reduce stiffness may may include non-incisional and/or non-thermal methods, for example using ultrasound to induce cavitation in the tissue in order to focally disrupt, liquefy, or micro-porate (e.g., spongify) the tissue… a reduction in rigidity”; par 312: “provide additional tissue feedback data in real-time, for example temperature or elasticity”;
Claim 13. Herekar_2019 makes obvious “Wherein intra-procedure measurements of tissue stiffness or elasticity are iteratively acquired at successive treatment stages and used to dynamically adjust depth of pore creation within the treatment zone during delivery of treatment” (Par 201: “to treat presbyopia and/or glaucoma by reducing tissue stiffness in a target tissue using controlled cavitation-medicated ocular tissue erosion or fractionation… Tissue stiffness, for example rigidity in the corneal tissue and/or scleral tissue, may hinder movement… treatment to reduce stiffness may may include non-incisional and/or non-thermal methods, for example using ultrasound to induce cavitation in the tissue in order to focally disrupt, liquefy, or micro-porate (e.g., spongify) the tissue… a reduction in rigidity”; par 312: “provide additional tissue feedback data in real-time, for example temperature or elasticity”; par 324- 325: “in a seventh step, the treatment may viewed in real-time at the treatment region. in an eight step, the previous steps may be repeated for additional treatment regions or zones… one or ordinary skill in the art will recognize many variations based on the teachings described herein. The steps may be completed in a different order. Steps may be added or deleted. Some steps may comprise sub-steps. Many of the steps may be repeated as often as necessary to treat the tissues as desired…”
Claim 14. Ljubimova_2005 makes obvious “Wherein the biomechanical model predicts age-related future changes to the accommodative structures and adjusts the treatment sequence to account for anticipated age-specific changes in tissue stiffness and elasticity” (page 46 6. Review of Papers: “… the current modeling exercise can be used to obtain clinically relevant recommendations to presbyopia surgery by allowing easy adjustments of modeling parameters to simulate the eyes of different ages…”)
Claim 15. Herekar_2019 makes obvious “Wherein the intra-procedural measurements are obtained before, after, and during each of the multiple sequential treatment iterations within a single treatment session” (Par 312: “provide additional tissue feedback data in real-time, for example temperature or elasticity”; par 324 – 325: “in a seventh step, the treatment may viewed in real-time at the treatment region. in an eight step, the previous steps may be repeated for additional treatment regions or zones… one or ordinary skill in the art will recognize many variations based on the teachings described herein. The steps may be completed in a different order. Steps may be added or deleted. Some steps may comprise sub-steps. Many of the steps may be repeated as often as necessary to treat the tissues as desired…” ) Zheng_2015 makes obvious “and wherein the biomechanical model is updated after each iteration” (abstract: “… two decades ago, computer-assisted orthopedic surgery (CAOS) has emerged… the aim of this paper is to present the basic elements of CAOS devices and the review state-of-the-art examples…”; page 2 – 3 section 2.1. Virtual Objects: “the VO in each CAOS system is defined as a sufficiently realistic representation… that allow the surgeon to plan the intended intervention… data may be acquired at two points in time: either pre-operatively or intra-operatively… limitations of pre-operative VOs were observed, which led to the introduction of intra-operative imaging modalities…” page 4: “… acquire a graphical representation of the patient’s anatomy by intra-operative digitization… the model is generated by the operator, the technique is, therefore, known as “surgeon-defined anatomy” (SDA). It is particularly useful when soft tissue structures, such as ligaments or cartilage boundaries, are to be considered…”; page 5: “… intra-operative ultrasonography… touch-based digitization done with a conventional probe…”; page 10 - 11: “… Biomechanical Modeling. Numerical models of human anatomical structures may help the surgeon during the planning, simulation, and intra-operative phases with the final goal to optimize the outcome… in addition, these models will not only be used pre-operatively, but need to function also in near real-time in the operating theater… developed a detailed volumetric finite element model… to simulate surgical correction… showed that with biomechanical modeling… presented the development of a biomechanical guidance system… the BGS aims to provide no only real-time feedback… but also… pressure… another approach is the combined use of intra-operative sensing devices with simplified biomechanical models. Corettet… introduced a device that intra-operatively measures knee joint forces and moments… the need for intra-operative force monitoring… available in recent years and is clinically used…” NOTE: the above teaches that intra-operative biomechanical modeling is used where intra-operative measurements are taken for the purpose of guiding optimal surgical outcomes and that data for models may be acquired either pre-operatively or intra-operatively. )
Claim 16. Herekar_2019 makes obvious “Wherein energy delivery parameters for each treatment zone are dynamically modified in real-time based on zone-specific intra-procedural measurements of biomechanical properties” (par 301: “… the treatment zones may be regional, for example the treatment zones may comprise one or more layers of softening at depths of the lens. Softening of the lens may be used to adjust the modulus of the lens… to increase accommodation…”; par 293: “… tissue treatment zones comprising a plurality of adjacent treatment locations of the tissue…”; par 305: “… the numerical aperture, treatment pressure and position of the transducer array can be adjusted so as to provide a desired amount of energy…”).
Claim 17. Herekar_2019 makes obvious “Further comprising iterative calculating localized stiffness of ocular tissue based on volume fraction changes associated with biomechanical property measurements during successive stages of treatment” because Herekar_2019 explicitly teaches “to treat presbyopia and/or glaucoma by reducing tissue stiffness in a target tissue using controlled cavitation-medicated ocular tissue erosion or fractionation… Tissue stiffness, for example rigidity in the corneal tissue and/or scleral tissue, may hinder movement… treatment to reduce stiffness may may include non-incisional and/or non-thermal methods, for example using ultrasound to induce cavitation in the tissue in order to focally disrupt, liquefy, or micro-porate (e.g., spongify) the tissue… a reduction in rigidity (par 201) and to “provide additional tissue feedback data in real-time, for example temperature or elasticity” (par 312) and “in a seventh step, the treatment may viewed in real-time at the treatment region. in an eight step, the previous steps may be repeated for additional treatment regions or zones… one or ordinary skill in the art will recognize many variations based on the teachings described herein. The steps may be completed in a different order. Steps may be added or deleted. Some steps may comprise sub-steps. Many of the steps may be repeated as often as necessary to treat the tissues as desired…” (par 324 – 325)
Therefore, Herekar_2019 teaches to iteratively perform steps that include obtaining real-time tissue feedback data, such as elasticity during treatments that reduce tissue stiffness by micro-poration/spongification of the tissue to achieve a desired elasticity.
Therefore, Herekar_2019 makes obvious to those of ordinary skill in the art to obtain tissue stiffness of ocular tissue based on a volume fraction associated with a biomechanical property measurement because elasticity is a materials fundamental property to deform elastically while stiffness describes its resistance to elastic deformation under an applied force. Stiffness is directly proportional to the Young’s Modulus (i.e., elastic modulus) where a higher elastic modulus results in a stiffer material.
In other words, poration/spongification of the tissue changes the biomechanical property known as elasticity by tissue erosion/fractionalization (i.e., changing the volume of tissue in a region. NOTE: fractionalization means changing the fraction of tissue) and there is a proportional relation between elasticity and stiffness and Herakar_2019 teaches to obtain elasticity in real-time. Thus, those of ordinary skill in the art would understand how to calculate stiffness given elasticity.
Accordingly, the combination of prior art makes obvious “Further comprising iterative calculating localized stiffness of ocular tissue based on volume fraction changes associated with biomechanical property measurements during successive stages of treatment.”
(2) Claim 11 rejected under 35 U.S.C. 103 as being unpatentable over Ljubimova_2005 in view of Taylor_2015 in view of Ljubimova_2009 in view of Herekar_2019 in view of Zheng_2015 in view of Sigal_2014 (A method to estimate biomechanics and mechanical properties of Optic Nerve Head Tissues from Parameters Measurable Using Optical Coherence Tomography, IEEE transactions on medical Imaging, Vol. 33, No. 6 June 2014) in view of Norman_2010 (Dimensions of the Human Sclera: Thickness measurement and regional changes with axial length, Experimental Eye Research 90 (2010)).
Claim 11. While Ljubimova_2009 teaches to model stiffness changes with depth variations at page 70 section 5.2.1 which states “inhomogeneities in the stroma stiffness with depth variation” as illustrated in Figure 5.2 on page 69. While this clearly teaches to model depth variations through layered tissue using a finite element mesh, this is done for the stroma and not the sclera. Additionally, Ljubimova_2009, at page 56 does teaches “... obtaining accurate values for Young’s moduli of the cornea, sclera... relative moduli of the cornea, sclera and limbus provide an important guideline for how material properties of these tissues relate to each other...” which makes clear that the Young’s modulus of the sclera is important. Therefore; while teaching that Young’s modulus for the sclera is an important material property and also teaching to model the stiffness of the eye based on depth variation (i.e., depth variations) and that relative inhomogeneities (differences) in stiffness are based on relative differences in thickness of the material; this does not explicitly teach “further comprising calculating a new stiffness of a sclera in a treated region based on a volume fraction.”
Nevertheless; Sigal_2014 makes obvious “further comprising calculating a new stiffness of a sclera in a treated region based on a [depth] fraction” (page 1383: “... tissue’s behavior was governed by two parameters: a stiffness (Young’s modulus) and a compressibility (Poisson’s ratio)... stiffness is a parameter combining geometry and material properties, which has been useful for the study of the scleral shell [33]. As elsewhere, we computed the scleral structural stiffness as the scleral modulus multiplied by scleral thickness [34], [35]...”; page 1386: “... the ability to estimate... mechanical perperties in vivo would greatly enhance... the evaluation of potential treatments [49]...” NOTE: the above citations teach to calculate the mechanical property of stiffness of the sclera based on depth (i.e., thickness) of the sclera and that the ability of estimate mechanical properties such as the sclera would greatly enhance the evaluation of treatments that impact the stiffness of the sclera.
Ljubimova_2005 and Taylor_2015 and Ljubimova_2009 and Herekar_2019 and Zheng_2015 and Sigal_2014 are analogous art because they are from the same field of endeavor called medical treatments. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Ljubimova_2009 and Sigal_2014. The rationale for doing so would have been that Ljubimova_2009 teaches that Young’s modulus for the sclera is an important mechanical property to calculate and Sigal_2014 teaches to calculate stiffness by multiplying Young’s modulus by tissue thickness/depth to calculate the mechanical property of stiffness and that calculating material properties greatly enhances evaluation of potential treatments. Therefore, it would have been obvious to combine Ljubimova_2009 and Sigal_2014 for the benefit of estimating the effects of potential treatments of mechanical properties such as sclera stiffness to obtain the invention as specified in the claims.
Therefore; while both Ljubimova_2005 and Sigal_2014 teach that relative stiffness inhomogeneities is based on relative depth (i.e., depth fraction) and while both Ljubimova_2005 and Sigal_2014 teach to model the eye with a finite element (FE) model and this model has a grid of elements as illustrated by Ljubimova_2005 and while one of ordinary skill in the art would understand the relationship between these elements and volume; Ljubimova_2005 and Sigal_2014, do not explicitly teach to calculate the volume of the sclera using finite elements.
Nevertheless; Norman_2010 makes obvious scleral “volume” calculated from finite elements (introduction: “... the material properties of the sclera (effective stiffness) and the anatomical features of the sclera (thickness and globe size) (Sigal et al...”; page 279: “... Scleral volume was calculated by summing the volume of the individual elements comprising the 3-D corneoscleral shells...”; page 284: “... parameters discussed here are likely geometrically linked. Notably, scleral volume and thickness show similar correlations... exploring the relationship between IOP, scleral thickness and volume... may be informative...”
NOTE: the above teaches (1) to calculate volume based on summing up individual elements in the thickness and (2) that Scleral volume and thickness show similar correlations with the parameters discussed and even suggests to explore the relationship with volume.
Therefore; not only does Norman_2010 teach how to calculate volume it also teaches that volume is similarly correlated to the material property of stiffness like thickness and then teaches the exploration of scleral thickness and volume thereby providing a motivation for substituting volume for thickness in the calculation of scleral stiffness.
Ljubimova_2005 and Taylor_2015 and Ljubimova_2009 and Herekar_2019 and Zheng_2015 and Sigal_2014 and Norman_2010 are analogous art because they are from the same field of endeavor called medical treatments. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Sigal_2014 and Norman_2010. The rationale for doing so would have been that Sigal_2014 teaches to calculate scleral stiffness by multiplying Young’s modulus by depth and Norman_2010 teaches that depth and volume are similarly correlated with stiffness and teaches to explore this relationship. Therefore, it would have been obvious to combine Sigal_2014 and Norman_2010 for the benefit of calculating stiffness using a geometrically linked parameter of the material which, according to the prior art, is similarly correlated to stiffness as thickness to obtain the invention as specified in the claims.
Conclusion
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/BRIAN S COOK/Primary Examiner, Art Unit 2187