DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
The Amendment filed 10/22/2025 has been entered. Claims 1-2, 4, 9-10, and 14 were amended, and claims 3 and 11-12 were cancelled. Thus, claims 1-2, 4-10, and 13-16 are pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “a miniaturized optical coherence tomography device configured to generate cross-sectional images…determine a frequency domain…” in claim 2 lines 3-7 and claim 10 lines 3-10.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4-8, 10, and 13-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 and 10 limitation “a miniaturized optical coherence tomography device configured to generate cross-sectional images…determine a frequency domain…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claim 2, the limitation “greater acquisition speed and greater contrast” in line 8 is confusing, as the term “greater” implies a comparison but it is unclear as to what the claimed limitation is being compared against, thus the claim is indefinite.
Regarding claim 10, the limitation “improved acquisition speed and improved contrast” in line 11 is confusing, as the term “improved” implies a comparison (i.e. the Applicant’s invention would have to be compared to something else so as to be considered improved over that something else) but it is unclear as to what the claimed limitation is being compared against, thus the claim is indefinite. Moreover, the metes and bounds for considering the acquisition speed and contrast “improved” is not clear, and as such the claim is indefinite.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 9, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Linder et al. (US 8,721,572 B1) in view of Haddad et al. (US 4,261,364), Kelleher et al. (US 2015/0005750 A1), and Pazouki (US 2014/0107543 A1).
Regarding claim 1, Linder discloses a moldable warming device (eye treatment mask device to deliver heat and mechanical, including vibration, therapies to the eye) (Figs. 2-3, 10; abstract; col. 8, lines 53-55; col. 10, lines 24-26), comprising:
a heating element (temperature delivery module 320 to provide heating) (Fig. 3; col. 9, lines 10-14; col. 13, lines 28-35);
a harmonic resonance frequency stimulation vibration generator (RFSVG) (motor 360 of the mechanical massage module 340 to provide higher frequency vibration) (Fig. 3; col. 10, lines 24-26; col. 13, lines 45-49);
a coupling device (moisture module 310 links the user’s eye to the rest of the device; alternatively, the housing 342 for the holding the motor 360, rollers 344, and controller 350 of the mechanical massage module 340) (Fig. 3; abstract; col. 13, lines 24-25, 35-40);
a mask configured to hold the heating element, the harmonic RFSVG, and the coupling device for use in parallel utility (mask to hold the modules during use) (Fig. 2; col. 13, lines 1-6);
wherein the moldable warming device is configured to sequentially and alternately apply, using the heating element, therapeutic warmth and, using the harmonic RFSVG, tuned harmonic resonance frequency stimulation vibration (modules configurable to work sequentially or independently) (col. 6, lines 28-30) across the contour of the entire surface of the user's eyelid and periorbital structures to induce shear thinning and liquification of meibum contained within each Meibomian gland in all four eyelids to improve the lipid layer of the surface of the user's eye tear film (controller to control operating parameters of the temperature delivery module 320 and mechanical stimulation module with motor 360 to a user’s whole eye, including both eyelids 14, 14’ on each eye, to treat the meibomian glands; the temperature and mechanical stimulation modules work to heat the meibomian gland oil above melting point to thin it, decrease its viscosity, and help it flow again out from the depths of the meibomian glands, thereby stabilizing and improving the lipid layer of the tear film) (Figs. 3, 6A; abstract; col. 1, lines 45-51; col. 5, lines 1-6, 39-54; col. 14, lines 65-67; col. 15, lines 1-15).
Linder is silent on the a heating element being a disc.
However, Haddad teaches an ophthalmic heating device (Haddad; Fig. 1; col. 1, lines 9-21) wherein the heating element is a disc (housing 22 with heating coil 24 is a flat circular disc) (Haddad; Figs. 1-3; col. 2, lines 18-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder heating element to be a disc, as taught by Haddad, for the purpose of providing the heating element with a specific shape suitable for covering an eye during an eye heating procedure.
Linder does not disclose a sensor configured to determine tuning parameters of a harmonic resonance frequency stimulation vibration and heating profile of a user's individual eyelid and periorbital three- dimensional anatomy and surface topography; wherein the moldable warming device is configured apply therapeutic warmth and tuned harmonic resonance frequency stimulation vibration according to the determined tuning parameters; and wherein the RFSVG is configured to generate the tuned harmonic resonance frequency stimulation vibration comprising a superposition of two or more longitudinal vibrational waves across the contour of the entire surface of the user's eyelid and periorbital structures, wherein a primary axis of the first vibrational wave is in a superior-inferior direction parallel to a depth of the user's Meibomian glands, and a primary axis of the second vibrational wave is in a medial-lateral direction tangential into the depth of the user's Meibomian glands, to induce shear thinning and liquification of meibum contained within and out of the depth each Meibomian gland in all four eyelids to improve the lipid layer of the surface of the user's eye tear film.
However, Kelleher teaches a system to treat eyelids and Meibomian glands (Kelleher; abstract) including a sensor configured to determine tuning parameters of a harmonic resonance frequency stimulation vibration and heating profile of a user's individual eyelid and periorbital three-dimensional anatomy and surface topography (first safety sensor monitors temperature to ensure tissue is not damaged; force or pressure sensors 221 monitor force applied to eyelid; second safety sensors, such as contact sensors 238 to come into contact with the eyelid and provide an indication of force applied; third safety sensor monitors the energy transducers which can emit ultrasound or vibrational energy) (Kelleher; para. [0087]; paras. [0166-0169]; para. [0198]); wherein the moldable warming device is configured apply therapeutic warmth and tuned harmonic resonance frequency stimulation vibration according to the determined tuning parameters (controllers 212 modulate the output of the thermal management structures and the energy transducer module 120, which respectively output the temperature and vibration, based on the data from the sensors such that the device safely operates within predetermined parameters) (Kelleher; para. [0167]; para. [0198]; para. [0202]); and wherein the RFSVG is configured to generate the tuned harmonic resonance frequency stimulation vibration comprising two or more longitudinal vibrational waves across the contour of the entire surface of the user's eyelid and periorbital structures, wherein a primary axis of the first vibrational wave is in a superior-inferior direction parallel to a depth of the user's Meibomian glands, and a primary axis of the second vibrational wave is in a medial-lateral direction tangential into the depth of the user's Meibomian glands (eye treatment device 200 vibrates an eyelid in a side-to-side pattern orthogonal to the central ocular axis 30, i.e. a medial-lateral direction, and/or vibrates in a forward and backward direction parallel to the central ocular axis 30, i.e. a superior-inferior direction, and/or vibrates in an up-and-down direction orthogonal to the central ocular axis 30, i.e. an alternative superior-inferior direction; vibrations applied to the surfaces of the eyelids 12, 14 would propagate along and affect the entire eyelids, including into the depths of the meibomian glands 18 as best seen in Fig. 12) (Kelleher; Figs. 6, 12; para. [0174]). 3DM-#8059925Furthermore, Pazouki teaches an apparatus for providing massage to a user (Pazouki; para. [0001]) wherein the RFSVG is configured to generate the tuned harmonic resonance frequency stimulation vibration comprising a superposition of two or more longitudinal vibrational waves (one motor uses one vibrating component to generate multi-dimensional cyclical motions 212, 214, 216, or 610, 612 which are perpendicular to each other; thus, as only one motor with one vibrating component is generating these vibrations, the vibrations are therefore generated at the same time and are thus superpositioned on each other) (Pazouki; Figs. 2, 6A-6B; paras. [0021-0022]; paras. [0037-0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder mask to include a sensor configured to determine tuning parameters of a harmonic resonance frequency stimulation vibration and heating profile of a user's individual eyelid and periorbital three- dimensional anatomy and surface topography; wherein the moldable warming device is configured apply therapeutic warmth and tuned harmonic resonance frequency stimulation vibration according to the determined tuning parameters; and wherein the RFSVG is configured to generate the tuned harmonic resonance frequency stimulation vibration comprising two or more longitudinal vibrational waves across the contour of the entire surface of the user's eyelid and periorbital structures, wherein a primary axis of the first vibrational wave is in a superior-inferior direction parallel to a depth of the user's Meibomian glands, and a primary axis of the second vibrational wave is in a medial-lateral direction tangential into the depth of the user's Meibomian glands, as taught by Kelleher, for the purpose of ensuring user safety enabling a user to avoid tissue damage (Kelleher; para. [0104]; para. [0166]; para. [0198]), as well as to provide suitable vibration patterns to aid in expressing meibum (Kelleher; paras. [0174-0175]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Linder device such that the vibration comprises a superposition of the two or more Kelleher longitudinal vibrational waves, as taught by Pazouki, for the purpose of allowing several different vibration modes to occur simultaneously (Pazouki; abstract), thereby enhancing user stimulation and treatment.
With this modification, the modified Linder device would thus teach wherein the moldable warming device is configured to provide therapeutic warmth and tuned harmonic resonance frequency stimulation vibration according to the determined tuning parameters across the contour of the entire surface of the user’s eyelid and periorbital structures to induce shear thinning and liquification of meibum contained within and out of the depth of each Meibomian gland in all four eyelids to improve the lipid layer of the surface of the user's eye tear film (Kelleher teaches applying warmth and vibration according to the determined tuning parameters as claimed, and Pazouki teaches these vibrations can be superpositioned, i.e. simultaneously occur; Linder modules cover both eyelids of each eye as seen in Fig. 3, thus the Meibomian glands in all four eyelids would be affected by warmth and vibrations; Linder teaches such warmth and vibration across the surface of the eye to the meibomian glands on the eyelids works to heat the meibomian gland oil above melting point to thin it, decrease its viscosity, and help it flow again out from the depths of the meibomian glands, thereby stabilizing and improving the lipid layer of the tear film) (Linder, Fig. 3, abstract, col. 1 lines 45-51, col. 5 lines 1-6 and 39-54, col. 12 lines 59-61, col. 13 lines 10-16; Kelleher, para. [0167], para. [0198], para. [0202]; Pazouki, paras. [0021-0022], paras. [0037-0039]).
Regarding claim 9, Linder discloses a method for ophthalmic eyelid therapy (eye treatment device and method to provide therapies to the eye) (Figs. 2-3, 10; abstract; col. 8, lines 53-55; col. 10, lines 24-26), the method comprising the steps of:
applying a moldable warming device to a user's individual eyelid and periorbital three- dimensional anatomy and surface topography (eye treatment mask device to deliver heat therapies to the eyelid) (Figs. 2-3, 10; abstract; col. 8, lines 53-55), the moldable warming device comprising:
a heating element (temperature delivery module 320 to provide heating) (Fig. 3; col. 9, lines 10-14; col. 13, lines 28-35);
a harmonic resonance frequency stimulation vibration generator (RFSVG) (mechanical module with motor 360 to provide higher frequency vibration) (Fig. 3; col. 10, lines 24-26; col. 13, lines 45-49);
a coupling device (moisture module 310 links the user’s eye to the rest of the device; alternatively, the housing 342 for the holding the motor 360, rollers 344, and controller 350 of the mechanical massage module 340) (Fig. 3; abstract; col. 13, lines 24-25, 35-40);
a mask, wherein the mask is configured to hold the heating element, the harmonic RFSVG, and the coupling device for use in parallel utility (mask to hold the modules during use) (Fig. 2; col. 13, lines 1-4);
sequentially and alternately applying, using the heating element, thermal energy and, using the harmonic RFSVG, harmonic resonance frequency stimulation vibration (controller to control operating parameters of the temperature delivery module 320 and mechanical stimulation module with motor 360 to a user’s whole eye, including both eyelids 14, 14’ on each eye, to treat the meibomian glands; modules configurable to work sequentially or independently) (Figs. 3, 6A; abstract; col. 5, lines 1-6, 39-54; col. 6, lines 28-30; col. 14, lines 65-67; col. 15, lines 1-15);
and transferring the thermal energy and the harmonic resonance frequency stimulation vibration across the contour of the entire surface of the user's eyelid and periorbital structures (the temperature delivery module 320 transfers heat and the mechanical stimulation module with motor 360 transfers vibration to a user’s whole eye to treat the meibomian glands) (Figs. 3, 6A; abstract; col. 5, lines 1-6, 39-54; col. 14, lines 65-67; col. 15, lines 1-15);
and to induce shear thinning and liquification of meibum contained within each Meibomian gland in all four eyelids to improve the lipid layer of the surface of the user's eye tear film (a user’s whole eye, including both eyelids 14, 14’ on each eye, is heated and vibrated to treat the meibomian glands; the temperature and mechanical stimulation modules work to heat the meibomian gland oil above melting point to thin it, decrease its viscosity, and help it flow again out from the depths of the meibomian glands, thereby stabilizing and improving the lipid layer of the tear film) (Figs. 3, 6A; abstract; col. 1, lines 45-51; col. 5, lines 1-6, 39-54; col. 14, lines 65-67; col. 15, lines 1-15).
Linder is silent on the a heating element being a disc.
However, Haddad teaches an ophthalmic heating device (Haddad; Fig. 1; col. 1, lines 9-21) wherein the heating element is a disc (housing 22 with heating coil 24 is a flat circular disc) (Haddad; Figs. 1-3; col. 2, lines 18-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder heating element to be a disc, as taught by Haddad, for the purpose of providing the heating element with a specific shape suitable for covering an eye during a heating procedure.
Linder does not disclose and a sensor; determining, via the sensor, tuning parameters of a harmonic resonance frequency stimulation vibration and heating profile of the user's individual eyelid and periorbital three- dimensional anatomy and surface topography; applying thermal energy and harmonic resonance frequency stimulation vibration according to the determined heating profile of the user's individual eyelid and periorbital three-dimensional anatomy and surface topography and the tuning parameters; wherein the harmonic resonance frequency stimulation vibration comprises a superposition of two or more longitudinal vibrational waves across the contour of the entire surface of the user's eyelid and periorbital structures, wherein a primary axis of the first vibrational wave is in a superior-inferior direction parallel to a depth of the user's Meibomian glands, and a primary axis of the second vibrational wave is in a medial-lateral direction tangential into the depth of the user's Meibomian glands to induce shear thinning and liquification of meibum contained within and out of the depth of each Meibomian gland in all four eyelids to improve the lipid layer of the surface of the user's eye tear film.
However, Kelleher teaches a system to treat eyelids and Meibomian glands (Kelleher; abstract) including a sensor; determining, via the sensor, tuning parameters of a harmonic resonance frequency stimulation vibration and heating profile of the user's individual eyelid and periorbital three- dimensional anatomy and surface topography (first safety sensor monitors temperature to ensure tissue is not damaged; force or pressure sensors 221 monitor force applied to eyelid; second safety sensors, such as contact sensors 238 to come into contact with the eyelid and provide an indication of force applied; third safety sensor monitors the energy transducers which can emit ultrasound or vibrational energy) (Kelleher; para. [0087]; paras. [0166-0169]; para. [0198]); applying thermal energy and harmonic resonance frequency stimulation vibration according to the determined heating profile of the user's individual eyelid and periorbital three-dimensional anatomy and surface topography and the tuning parameters (controllers 212 modulate the output of the thermal management structures and the energy transducer module 120, which respectively output the temperature and vibration, based on the data from the sensors such that the device safely operates within predetermined parameters) (Kelleher; para. [0167]; para. [0198]; para. [0202]); wherein the harmonic resonance frequency stimulation vibration comprises two or more longitudinal vibrational waves across the contour of the entire surface of the user's eyelid and periorbital structures, wherein a primary axis of the first vibrational wave is in a superior-inferior direction parallel to a depth of the user's Meibomian glands, and a primary axis of the second vibrational wave is in a medial-lateral direction tangential into the depth of the user's Meibomian glands (eye treatment device 200 vibrates an eyelid in a side-to-side pattern orthogonal to the central ocular axis 30, i.e. a medial-lateral direction, and/or vibrates in a forward and backward direction parallel to the central ocular axis 30, i.e. a superior-inferior direction, and/or vibrates in an up-and-down direction orthogonal to the central ocular axis 30, i.e. an alternative superior-inferior direction; vibrations applied to the surfaces of the eyelids 12, 14 would propagate along and affect the entire eyelids, including into the depths of the meibomian glands 18 as best seen in Fig. 12) (Kelleher; Figs. 6, 12; para. [0174]). 3DM-#8059925Furthermore, Pazouki teaches an apparatus for providing massage to a user (Pazouki; para. [0001]) wherein the RFSVG is configured to generate the tuned harmonic resonance frequency stimulation vibration comprising a superposition of two or more longitudinal vibrational waves (one motor uses one vibrating component to generate multi-dimensional cyclical motions 212, 214, 216, or 610, 612 which are perpendicular to each other; thus, as only one motor with one vibrating component is generating these vibrations, the vibrations are therefore generated at the same time and are thus superpositioned on each other) (Pazouki; Figs. 2, 6A-6B; paras. [0021-0022]; paras. [0037-0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder mask to include a sensor; determining, via the sensor, tuning parameters of a harmonic resonance frequency stimulation vibration and heating profile of the user's individual eyelid and periorbital three- dimensional anatomy and surface topography; applying thermal energy and harmonic resonance frequency stimulation vibration according to the determined heating profile of the user's individual eyelid and periorbital three-dimensional anatomy and surface topography and the tuning parameters; wherein the harmonic resonance frequency stimulation vibration comprises two or more longitudinal vibrational waves across the contour of the entire surface of the user's eyelid and periorbital structures, wherein a primary axis of the first vibrational wave is in a superior-inferior direction parallel to a depth of the user's Meibomian glands, and a primary axis of the second vibrational wave is in a medial-lateral direction tangential into the depth of the user's Meibomian glands, as taught by Kelleher, for the purpose of ensuring user safety enabling a user to avoid tissue damage (Kelleher; para. [0104]; para. [0166]; para. [0198]), as well as to provide suitable vibration patterns to aid in expressing meibum (Kelleher; paras. [0174-0175]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Linder device such that the vibration comprises a superposition of the two or more Kelleher longitudinal vibrational waves, as taught by Pazouki, for the purpose of allowing several different vibration modes to occur simultaneously (Pazouki; abstract), thereby enhancing user stimulation and treatment.
With this modification, the modified Linder device would thus teach the harmonic resonance frequency stimulation vibration is configured to induce shear thinning and liquification of meibum contained within and out of the depth of each Meibomian gland in all four eyelids to improve the lipid layer of the surface of the user's eye tear film (Kelleher teaches applying vibration according to the determined tuning parameters as claimed, and Pazouki teaches these vibrations can be superpositioned, i.e. simultaneously occur; Linder modules cover both eyelids of each eye as seen in Fig. 3, thus the Meibomian glands in all four eyelids would be affected by vibrations; Linder teaches such vibration can be used across the surface of the eye to the meibomian glands on the eyelids to help the meibomian gland oil thin, decrease in viscosity, and flow again out from the depths of the meibomian glands, thereby stabilizing and improving the lipid layer of the tear film) (Linder, Fig. 3, abstract, col. 1 lines 45-51, col. 5 lines 1-6 and 39-54, col. 12 lines 59-61, col. 13 lines 10-16; Kelleher, para. [0167], para. [0198], para. [0202]; Pazouki, paras. [0021-0022], paras. [0037-0039]).
Regarding claim 15, the modified Linder teaches wherein the pair of eye pads are configured to provide cold compress for inflammation reduction (temperature applied can be cold to reduce inflammation) (Linder; col. 5, lines 48-50; col. 12, lines 55-60).
Regarding claim 16, the modified Linder teaches wherein the pair of eye pads further comprise a surface available to hold hydrogel sheets (moisture modules can include a strip with hydrogel) (Linder; Fig. 3; col. 6, lines 48-59), the hydrogel sheets containing one of moisture alone, impregnated anti-inflammatory agents including steroids, or therapeutic agents for treating conditions including demodex (hydrogel with greater than 75% water to moisturize; hydrogel may also have agents such as steroids or antidemodex) (Linder; col. 6, lines 48-62; Table 1 at bottom of col. 10 for Module #1).
Claims 2, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Haddad, Kelleher, and Pazouki as applied to claims 1 and 9 above, and further in view of Samec et al. (US 2016/0270656 A1).
Regarding claim 2, as best understood, the modified Linder teaches the invention as previously claimed, including a pair of removable and reusable eye pads (eyepieces 202 can be two separate eyepieces individually configured to contact an eye, and would be removable from each other and/or the user via the headband; as the eyepieces 202 are not specified to comprise a disposable material, the user would be able to reuse the eyepieces 202; moreover, as the device can have a memory to keep track of treatment protocols, it is implied that the device is meant to be used multiple times) (Linder; Figs. 2-3; col. 6, lines 28-38; col. 13, lines 1-16), but does not teach each eye pad comprising a miniaturized optical coherence tomography device configured to generate cross-sectional images with high axial resolution for tissue diagnosis, thereby imaging a user's retina, in real-time, including at the back of a user's eye; and determine a frequency-domain measurement of spectral interference which allows for greater acquisition speed and greater contrast in the resulting images of the periocular surface of the user's eyes.
However, Samec teaches a health system for patient diagnostics, monitoring, and/or therapy for the eyes (Samec; abstract) including each eye pad comprising a miniaturized optical coherence tomography device configured to generate cross-sectional images with high axial resolution for tissue diagnosis, thereby imaging a user's retina, in real-time, including at the back of a user's eye (the wearable device 2350 for eyes has an OCT system for providing imaging in real-time; light imaging is used to provide cross-sectional images of the eye tissues to micrometer resolution; the retina and/or various retinal layers can be imaged, including the macula which is a portion of the retina at the back of the eye) (Samec; Figs. 23A-23C; para. [1995]; para. [2000]; paras. [2011-2012]; para. [2015]); and determine a frequency-domain measurement of spectral interference which allows for greater acquisition speed and greater contrast in the resulting images of the periocular surface of the user's eyes (device 2350 configured as a Spectral (Fourier) Domain OCT to receive and measure reflected/backscattered multi-spectral light from the eye for more accurate imaging techniques; as Samec teaches determining the frequency-domain measurement of spectral interference as claimed, it would thus function to allow for greater acquisition speed and greater contrast in the resulting images as claimed) (Samec; Figs. 23A-23C; para. [2004]; para. [2019]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder eye pads to include a miniaturized optical coherence tomography device configured to generate cross-sectional images with high axial resolution for tissue diagnosis, thereby imaging a user's retina, in real-time, including at the back of a user's eye; and determine a frequency-domain measurement of spectral interference which allows for greater acquisition speed and greater contrast in the resulting images of the periocular surface of the user's eyes, as taught by Samec, for the purpose of providing the device with a superior in-vivo-wide-field micro-angiography imaging device (Samec; para. [2015]) and thereby enabling the user to determine if they have a health problem (Samec; para. [2026]).
Regarding claim 6, the modified Linder teaches the invention as previously claimed, but does not teach wherein each eye pad comprises a module insert configured to perform advanced diagnostic enabled imaging, the module insert comprising one of: a corneal staining pad, the corneal staining pad being one of a corneal fluorescein staining pad or a corneal rose bengal staining pad with illumination of selectable variable wavelengths, the corneal staining pad configured to detect dry eye syndrome, a tear interferometer configured to measure a tear meniscus in the user's eyes, a conjunctival redness measurement pad configured to diagnose and assess a level of conjunctival redness in the user's eyes, a tear breakup time measurement pad configured to measure tear breakup time in the user's eyes, a blink rate measurement pad configured to assess blink rate and completeness of blink cycle of the user's eyes for maintaining tear film stability and for sustaining tear film homeostasis, an intraocular cell and flare measurement pad configured to measure intraocular cell and flare in the user's eyes, and an intraocular pressure measurement pad configured to measure intraocular pressure in the user's eyes.
However, Samec teaches a health system for patient diagnostics, monitoring, and/or therapy for the eyes (Samec; abstract) wherein each eye pad comprises a module insert configured to perform advanced diagnostic enabled imaging, the module insert comprising one of: a corneal staining pad, the corneal staining pad being a corneal fluorescein staining pad with illumination of selectable variable wavelengths, the corneal staining pad configured to detect dry eye syndrome (optical source 2268 used to generate light, such a cobalt-blue light, in fluorescence ophthalmology, such that the degree of dryness can be detected by using fluorescein dye applied to the cornea to show green in de-epithelialized areas) (Samec; para. [1913]; para. [2127]), a conjunctival redness measurement pad configured to diagnose and assess a level of conjunctival redness in the user's eyes (camera and eye color sensor to detect the level of redness in an eye) (Samec; para. [2128]), a blink rate measurement pad configured to assess blink rate and completeness of blink cycle of the user's eyes for maintaining tear film stability and for sustaining tear film homeostasis (camera to detect a rate and degree of blinking for determining eye dryness or irritation) (Samec; para. [2128]), and an intraocular pressure measurement pad configured to measure intraocular pressure in the user's eyes (optical or ultrasonic measurement technology to measure intraocular pressure) (Samec; para. [1737]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder eye pads to include a module insert configured to perform advanced diagnostic enabled imaging, the module insert comprising one of: a corneal staining pad, the corneal staining pad being a corneal fluorescein staining pad with illumination of selectable variable wavelengths, the corneal staining pad configured to detect dry eye syndrome, a conjunctival redness measurement pad configured to diagnose and assess a level of conjunctival redness in the user's eyes, a blink rate measurement pad configured to assess blink rate and completeness of blink cycle of the user's eyes for maintaining tear film stability and for sustaining tear film homeostasis, and an intraocular pressure measurement pad configured to measure intraocular pressure in the user's eyes, as taught by Samec, for the purpose of enabling the device to diagnose a user with dry eyes and/or the presence of ocular hypertension (Samec; para. [1741]; para. [1913]; para. [2127]; para. [2128]).
Regarding claim 7, the modified Linder teaches wherein the pair of eye pads are configured to provide cold compress for inflammation reduction (temperature applied can be cold to reduce inflammation) (Linder; col. 5, lines 48-50; col. 12, lines 55-60).
Regarding claim 8, the modified Linder teaches wherein the pair of eye pads further comprise a surface available to hold hydrogel sheets (moisture modules can include a strip with hydrogel) (Linder; Fig. 3; col. 6, lines 48-59), the hydrogel sheets containing one of moisture alone, impregnated anti-inflammatory agents including steroids, therapeutic agents for treating conditions including demodex (hydrogel with greater than 75% water to moisturize; hydrogel may also have agents such as steroids or antidemodex) (Linder; col. 6, lines 48-62; Table 1 at bottom of col. 10 for Module #1).
Regarding claim 10, as best understood, the modified Linder teaches further comprising a pair of removable and reusable eye pads (eyepieces 202 can be two separate eyepieces individually configured to contact an eye, and would be removable from each other and/or the user via the headband; as the eyepieces 202 are not specified to comprise a disposable material, the user would be able to reuse the eyepieces 202; moreover, as the device can have a memory to keep track of treatment protocols, it is implied that the device is meant to be used multiple times) (Linder; Figs. 2-3; col. 6, lines 28-38; col. 13, lines 1-16), wherein each eye pad comprises a miniaturized optical coherence tomography device, the method further comprising, using the miniaturized optical coherence tomography device, generating cross-sectional images with high axial resolution for tissue diagnosis, thereby imaging a user's retina, in real-time, including at the back of a user's eye (the wearable device 2350 for eyes has an OCT system for providing imaging in real-time; light imaging is used to provide cross-sectional images of the eye tissues to micrometer resolution; the retina and/or various retinal layers can be imaged, including the macula which is a portion of the retina at the back of the eye) (Samec; Figs. 23A-23C; para. [1995]; para. [2000]; paras. [2011-2012]; para. [2015]); and determining a frequency-domain measurement of spectral interference which allows for improved acquisition speed and improved contrast in the resulting images of the periocular surface of the user's eyes (device 2350 configured as a Spectral (Fourier) Domain OCT to receive and measure reflected/backscattered multi-spectral light from the eye for more accurate imaging techniques; as Samec teaches determining the frequency-domain measurement of spectral interference as claimed, it would thus function to allow for improved acquisition speed and improved contrast in the resulting images as claimed) (Samec; Figs. 23A-23C; para. [2004]; para. [2019]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Haddad, Kelleher, Pazouki, and Samec as applied to claim 3 above, and further in view of Devine (US 2016/0220414 A1) and Aghara et al. (US 2017/0344107 A1).
Regarding claim 4, the modified Linder teaches the invention as previously claimed, but does not teach further comprising: feedback controlled mechanical gearing configured to locate a position for each eye pad based on the resulting images of the periocular surface of the user's eyes provided to an external computer-controlled software and algorithm for locating the position for each eye pad.
However, Devine teaches an eyelid heater (Devine; abstract) including a mechanism configured to locate a position for each eye pad (left and right eyelid heaters 900 are adjusted to fit the inter-pupil distance by using intermediate chassis portion 950 mated to respective pins; eyelid heaters 900 can thus be laterally adjusted in concert with each other) (Devine; para. [0047-0048]; para. [0055]). Moreover, Aghara teaches an apparatus for the user’s eyes where automatic adjustments are based on interpupillary distance (Aghara; Figs. 3A-3B; abstract) including feedback controlled mechanical gearing configured to locate the position for each eye pad based on the resulting images of the periocular surface of the user's eyes provided to an external computer-controlled software and algorithm for locating the position for each eye pad (motors 317A, 317B can be self-geared micro-motors or stepper motors used with extra gears to create movement of lenses 343A, 343B; lens are automatically adjusted or moved so that the lens are aligned with the pupils based on the measured interpupillary distance, determined by equipment such as a computing device 100 with detection/monitoring logic 201 and eye tracking sensors 241 and/or cameras which would image the surface of the eye) (Aghara; Fig. 3B; para. [0029]; para. [0049]; para. [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder device by including a mechanism configured to locate a position for each eye pad, as taught by Devine, for the purpose of ensuring the device fits various head shapes, epicanthal fold variations, and craniofacial orbital protrusions (Devine; para. [0055]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Linder device by substituting the Devine mechanism for a feedback controlled mechanical gearing configured to locate the position for each eye pad based on the resulting images of the periocular surface of the user's eyes provided to an external computer-controlled software and algorithm for locating the position for each eye pad, as taught by Aghara, for the purpose of allowing for the adjustment of the interpupillary distance between eye pads or lens to be performed automatically and dynamically (Aghara; abstract; para. [0013]), thereby improving the convenience of using the device.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Haddad, Kelleher, Pazouki, and Samec as applied to claim 2 above, and further in view of Fukuma et al. (US 2004/0032568 A1) and Shibata (US 6,045,432).
Regarding claim 5, the modified Linder teaches the invention as previously claimed, but does not teach further comprising: a plurality of manual adjustment wheels, each manual adjustment wheel configured to produce tactile feedback to the user of the moldable warming device allowing the user to manually adjust each eye pad to conform the pair of eye pads to the periocular surface of the user's eyelids.
However, Fukuma teaches an optometric apparatus (Fukuma; abstract) including a plurality of manual adjustment wheels, each manual adjustment wheel configured allow the user to manually adjust each eye pad to conform the pair of eye pads to the periocular surface of the user's eyelids (adjustment knob members 129A, 129B in retaining frame 128 are manipulated by a user to move the left-eye examination unit 113A and right-eye examination unit 113B towards and away from each other in accordance with interpupillary distance) (Fukuma; Fig. 9; para. [0125]). Moreover, Shibata teaches an eyeglass lens layout device (Shibata; abstract) wherein the manual adjustment wheel is configured to produce tactile feedback to the user (turning the dial 410, the operator can sense a click feeling) (Shibata; col. 7, lines 2-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Linder device by including a plurality of manual adjustment wheels, i.e. Fukuma adjustment knob members 129A, 129B, in a retaining frame 128, such that each manual adjustment wheel is configured to allow the user to manually adjust each eye pad to conform the pair of eye pads to the periocular surface of the user's eyelids, as taught by Fukuma, for the purpose of providing the device with a mechanism for adjusting the eye pads in accordance with the interpupillary distance (Fukuma; Fig. 9; para. [0125]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Linder device such that Fukuma adjustment knob members 129A, 129B are configured to produce tactile feedback to the user, as taught by Shibata, for the purpose of providing ease in achieving fine adjustments for a user (Shibata; col. 7, lines 19-20).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Haddad, Kelleher, Pazouki, and Samec as applied to claim 10 above, and further in view of Fukuma and Shibata.
Regarding claim 13, the modified Linder teaches the invention as previously claimed, but does not teach wherein the moldable warming device further comprises a plurality of manual adjustment wheels, the method further comprising: manually adjusting, using each manual adjustment wheel configured to produce tactile feedback to the user of the moldable warming device, each eye pad to conform the pair of eye pads to the periocular surface of the user's eyelids.
However