DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 27, 29-33, 35-39 and 42-52 are currently pending and under examination. Claims 28, 34, 40, and 41 are canceled. As per the amendments filed on 11/05/2025, claims 27, 29, 35, 42, 44, 48, and 50 are amended.
Response to Arguments
The Declaration under 37 CFR 1.132 filed 11/05/2025 is insufficient to overcome the rejections of claims 27, 29-33, 35-39, and 42-52 based upon prior art references (Tedford ‘087 (US PG Pub 2016/0067087 A1), Kelleher (US PG Pub 2015/0057701 A1),Tedford ‘086 (US PG Pub 2016/0067086 A1), Gerdt (US 6,235,046 B1), Johnson (US PG Pub 2017/0216088 A1), Robaina (US PG Pub 2018/0197624 A1)) under 35 USC § 103 as set forth in the last Office action because: for the reasons provided below in response to arguments, which repeat or include the points made in the Declaration.
Applicant’s arguments, see Remarks pages 9-10 (Priority Claim), filed 11/05/2025, with respect to the Examiner’s priority analysis. The Examiner notes the transmittal of the English translation of the certified foreign priority document. See the “Priority” section for the Examiner’s updated priority analysis.
Applicant’s arguments, see Remarks page 10 (Claim Objections), filed 11/05/2025, with respect to the objections of claims 33 and 48 have been fully considered and are persuasive. Therefore, the objections to claims 33 and 48 are withdrawn.
Applicant’s arguments, see Remarks page 10 (Claim Rejections under 35 U.S.C. § 112), filed 11/05/2025, with respect to the rejections of claims 40-44 and 50-52 under 35 U.S.C. § 112(b) have been fully considered and are persuasive (based on addressing the indefiniteness in claims 40, which is imported into claim 27, and 44). Therefore, the rejections of claims 40-44 and 50-52 are withdrawn.
Applicant’s arguments, see Remarks pages 12-21 (Claim Rejections under 35 U.S.C. § 103), filed 11/05/2025, with respect to the rejections of claims 27-52 under 35 U.S.C. § 103 have been fully considered. Note claims 28, 34, 40, and 41 have been canceled and incorporated into claim 27. Regarding amended claim 27, Applicant provides arguments about the incorporated limitations from claims 28 and 34:
In contrast, the prior art references cited by the Examiner each comprises a teaching which is in contradiction to this specific design objective. For example, Tedford '087 discloses an array 208 of multiple irradiation sources 210a, 210b, and 210c and thus does not specify the use of a specific irradiation axis. In particular, there is no teaching of the exclusive use of an irradiation axis aligned with a pupil of the patient disclosed in Tedford '087. Rather, as shown in FIG. 2A of Tedford '087, the array 208 of light sources 210a, 210b, and 210c simply form an irradiation matrix of irradiation sources, thus explicitly teaching away from a specific irradiation axis. FIG. 2A of Tedford '087 is shown below. Kelleher similarly shows two eccentric irradiation sources 120b and 120e, both of which are not aligned with a pupil of the patient at all, as can be seen from FIG. 6 of Kelleher shown below. Again, this is in technical contradiction to an irradiation source being aligned with a pupil of the patient and a diffuser in the irradiation axis. Thus, Applicant respectfully contends that arguments of the Examiner against these two dependent claims do not form a proper basis for demonstrating obviousness, since the teaching of both prior art references is in contradiction to independent claim 27 as currently amended.
Applicant further notes that one important aspect of success of the therapy lies in the effect of keeping the patient's eye in a fixed state looking straight forward. Otherwise, no irradiation of the relevant regions of the retina is possible. Usually, if the eyelid is closed, the so called Bell's phenomenon results in an upward looking of the eye, which is a protective reflex. This can be overcome by arranging the irradiation source to define an irradiation axis aligned with a pupil of the patient, since in such case the patient has a point to fixate his eye on. This result will never be obtained according to the arrangements shown in Tedford '087 and Kelleher, since both documents do not provide such a fixation point to look at for the patient. Rather, the array of irradiation sources of Tedford '087 is diffused and without a specific fixation point. The arrangement of the irradiation sources of Kelleher is described as one eccentric arrangement. (pages 12-13, 11/05/2025 Remarks)
This argument is not found persuasive. The limitation in question “wherein the irradiation source is fixed to the holding and positioning device and lies only in a treatment position defining an irradiation axis aligned with a pupil of the patient and the diffuser” is imported from claim 34. The Examiner is interpreting Applicant’s intention to claim the at least one light source is positioned in a central axis that aligns with a pupil in the forward-directed eye. However, this is interpreted as a more specific axis than the more general language in the limitation under consideration. The light sources in Tedford ‘087 irradiate light through a diffuser ([0098]) and the pupil ([0102]) in order to target a specific location on the retina. This would define an axis aligned with a diffuser and the pupil in keeping with the plain meaning of the limitation. Therefore, the argument is not found persuasive and the rejection of claim 27 is maintained based on the previously established grounds of rejection.
Regarding amended claim 27, Applicant provides arguments about the incorporated limitations from claims 40 and 41:
The features of canceled claims 40 and 41, now also added to independent claim 27, further define the limitations of providing information about the next treatment step and to start the treatment step after a user input which is requested by a control unit. This specific programming of the device using a control unit addresses an important issue, namely, to not surprise the patient with the irradiation and to risk a sudden irradiation through the open eye. This can be ensured even in multiple steps of a therapeutic treatment by requesting a user input for confirming the next step after each single step. Tedford '087 and Tedford '086, cited for this feature, do not provide such a function. Rather, Tedford '087 and Tedford '086 follow a different approach in that the state of the eye is monitored using a corresponding sensor and irradiation is stopped in case of an open eye state.
In rejecting claims under 35 U.S.C. § 103, it is incumbent upon the Examiner to establish a factual basis to support the legal conclusion of obviousness. See In re Fine, 837 F.2d 1071, 1073,5 USPQ2d 1596, 1598 (Fed. Cir. 1988). In so doing, the Examiner must make the factual determinations set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966), viz., (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; and (3) the level of ordinary skill in the art. "[T]he examiner bears the initial burden, on review of the prior art or on any other group, of presenting a prima facie case of unpatentability." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Furthermore, "Rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'/ Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) (quoting In re Kahn, 441 F.3d 977,988 (Fed. Cir. 2006)) […] Applicant therefore respectfully contends that the combination of Tedford '087, Kelleher, and Tedford '086 does not render independent claim 27 obvious, appears to apply a hindsight reconstruction, and is in contradiction to the regular understanding of the skilled person. (pages 14-15, 11/05/2025 Remarks)
This argument is not found persuasive. The imported limitations to be considered are:
• an input user interface;
• graphical output user interface for outputting graphical information;
• wherein the control unit is programmed to, in an information step, display to the patient information on a subsequent therapeutic treatment step via the graphical output user interface and perform the subsequent therapeutic treatment step after the information step,
wherein the irradiation duration and irradiation intensity correspond to a treatment mode input via the input user interface and/or an output via the graphical output user interface; and
• wherein the control unit is programmed to, between the information step and the subsequent therapeutic treatment step, in an input step request a user input via the input user interface, and start the subsequent therapeutic treatment step after receiving a predetermined user input.
The Examiner notes that Tedford ‘087 teaches a user interface 760 where the user interface is used to adjust the program ([0088-0089]), where settings would need to be communicated to the programmer. Tedford ‘086 teaches an explicit graphical interface/display as part of the user interface ([0061]), which would been seen as an obvious improvement of Tedford ‘087 for communicating information to the user. Tedford ‘087 teaches the interface can be used to alter the program ([0088-0089]), which was interpreted as providing information about how the device is programmed and executing that program. The specific irradiation duration and intensity are programmed and would be similarly communicated with the user interface via Tedford ‘087 ([0091]). The user can program the controller in response to therapeutic needs identified via the controller ([0094-0095] - alarms or warnings generated to facilitate the programmer changing settings). Applicant’s argument speaks to a specific intended use of the device which is not supported in the claim language. Therefore, the argument is not found persuasive and the rejection of claim 27 is maintained based on the previously established grounds of rejection.
Applicant also argues:
None of these references discloses an optical lens element comprising a diffuser adapted to distribute the irradiation from the irradiation source and further define that the irradiation source lies only in a treatment position defining an irradiation axis aligned with a pupil of the patient and the diffuser, i.e., in straight direction before the eye if the patient is looking straight forward. None of Tedford '087, Kelleher, or Tedford '086 teach that the irradiation source is in an irradiation axis with the pupil and the diffuser to achieve direct irradiation propagation without deflection in the direction of the retina along an axis. In addition, none of these references teach providing information about the next treatment step or starting the treatment step after a user input which is requested by a control unit. (page 15, 11/05/2025 Remarks)
This argument is not found persuasive. As previously discussed, the Examiner is interpreting Applicant’s intention to claim the at least one light source is positioned in a central axis that aligns with a pupil in the forward-directed eye. However, this is interpreted as a more specific axis than the more general language in the limitation under consideration. The light sources in Tedford ‘087 irradiate light through a diffuser ([0098]) and the pupil ([0102]) in order to target a specific location on the retina. This would define an axis aligned with a diffuser and the pupil in keeping with the plain meaning of the limitation. Additionally, the user can program the controller in response to therapeutic needs identified via the controller ([0094-0095]). Therefore, the argument is not found persuasive and the rejection of claim 27 is maintained based on the previously established grounds of rejection.
Regarding the rejection in view of Gerdt in claims 35-36, Applicant argues:
Thus, as in each of Tedford '087 and Kelleher, the lit ends 176 of Gerdt are eccentric irradiation sources, none of which are aligned with a pupil of the patient at all. In addition, none of these references teach providing information about the next treatment step or starting the treatment step after a user input which is requested by a control unit. Applicant therefore, respectfully contends that the combination of Tedford '087, Kelleher, and Gerdt, which Applicant does not concede is proper, does not render obvious independent claim 27, from which claims 35 and 36 depend. Nor is Applicant aware of any apparent reason why Tedford '087, Kelleher, or Gerdt should be so modified. Applicant, therefore, submits that independent claim 27 is not obvious in view of Tedford '087, Kelleher, and Gerdt, and is otherwise in allowable condition. (page 17, 11/05/2025 Remarks)
This argument is not found persuasive. As previously discussed, the Examiner is interpreting Applicant’s intention to claim the at least one light source is positioned in a central axis that aligns with a pupil in the forward-directed eye. However, this is interpreted as a more specific axis than the more general language in the limitation under consideration. The light sources in Tedford ‘087 irradiate light through a diffuser ([0098]) and the pupil ([0102]) in order to target a specific location on the retina. This would define an axis aligned with a diffuser and the pupil in keeping with the plain meaning of the limitation. Additionally, The user can program the controller in response to therapeutic needs identified via the controller ([0094-0095]). Therefore, the argument is not found persuasive and the rejections of claims 35-36 are maintained based on the previously established grounds of rejection.
Regarding the rejection in view of Johnson in claim 39, Applicant argues:
Johnson merely discloses a thermal eye pod assembly for use in heating and/or cooling at least one eye patch. In a heated state, Johnson pertains to a thermal eye pod assembly for use in heating said eye patch in order to treat a variety of different ailments, including, but not limited
to chalazions, styes, and dry eye syndrome; in a cooled state, Johnson pertains to a thermal eye
pod assembly for use in cooling said eye patch in order to be used to reduce post-operative swelling that is generally associated with a variety of different surgical procedures, blepharoplasty, or any other surgical procedures that are typically performed in a user's orbit
area. Johnson, [0004]. Thus, other than thermal convection, Johnson fails to disclose irradiation sources at all, much less irradiation sources which are aligned with a pupil of the patient. In addition, Johnson fails to teach providing information about the next treatment step or starting the treatment step after a user input which is requested by a control unit. (pages 17-18, 11/05/2025 Remarks)
This argument is not found persuasive. The limitation in question is “a base station comprising a receiving device for the holding and positioning device, the receiving device further comprising a heating or cooling device for heating or cooling the optical lens element.” Tedford ‘087 expresses a concern with the development of excessive temperatures and temperature regulation ([0144]). Johnson teaches a structural element capable of providing heating or cooling to an eyeglass structure which is placed over the face when in use ([0009], [0038]). The thermal eye-pod assembly is interpreted as being contained within a base unit distinct from the wearable frames containing the ocular components. In this manner a mechanism is provided by Johnson to use a receiving device for cooling or warming an element which can heat or cool elements on the eye frame.
As previously discussed, the Examiner is interpreting Applicant’s intention to claim the at least one light source is positioned in a central axis that aligns with a pupil in the forward-directed eye. However, this is interpreted as a more specific axis than the more general language in the limitation under consideration. The light sources in Tedford ‘087 irradiate light through a diffuser ([0098]) and the pupil ([0102]) in order to target a specific location on the retina. This would define an axis aligned with a diffuser and the pupil in keeping with the plain meaning of the limitation. Additionally, The user can program the controller in response to therapeutic needs identified via the controller ([0094-0095]). Therefore, the arguments are not found persuasive and the rejection of claim 39 is maintained based on the previously established grounds of rejection.
Regarding the rejection of claim 43 in view of Robaina, Applicant argues:
In response, Applicant notes that independent claim 27, from which claim 43 depends, is discussed above. Applicant respectfully contends that the disclosure of Robaina does not change the analysis of non-obviousness. Robaina merely discloses a wearable device that can present virtual content to the wearer for many applications in a healthcare setting. The wearer may be a patient or a healthcare provider (HCP). Such applications can include, but are not limited to, access, display, and modification of patient medical records and sharing patient medical records among authorized HCPs. Robaina, Abstract. The device of Robaina may be seen in FIG. 2A, presented below.
Thus, other than visual images, Johnson fails to disclose irradiation sources at all, much less irradiation sources which are aligned with a pupil of the patient. In addition, Johnson fails to teach providing information about the next treatment step or starting the treatment step after a user input which is requested by a control unit. Applicant therefore, respectfully contends that the combination of Tedford '087, Kelleher, Tedford '086, and Robaina, which Applicant does not concede is proper, does not render obvious independent claim 27, from which claim 43 depends. Nor is Applicant aware of any apparent reason why Tedford '087, Kelleher, Tedford '086, or Robaina should be so modified. Applicant, therefore, submits that independent claim 27 is not obvious in view of Tedford '087, Kelleher, Tedford '086, and Robaina, and is otherwise in allowable condition. (pages 19-20, 11/05/2025 Remarks)
This argument is not found persuasive. Tedford ‘087 teaches a camera or equivalent sensor can be used to identify features of the eye ([0045], [0110], [0112]). Robaina teaches a camera device which can be used to identify features in the eye ([0058]) where the camera is positioned ([0084]) on a wearable frame (Fig. 2A, [0047]). In addition to capturing features of the eye, the camera in Robaina is used to identify a user based on eye features ([0058]) in order to protect patient data ([0178]). This feature would be applicable to and obvious to incorporate into a framed device using a camera to assess eye features, such as the device in Tedford ’087.
As previously discussed, the Examiner is interpreting Applicant’s intention to claim the at least one light source is positioned in a central axis that aligns with a pupil in the forward-directed eye. However, this is interpreted as a more specific axis than the more general language in the limitation under consideration. The light sources in Tedford ‘087 irradiate light through a diffuser ([0098]) and the pupil ([0102]) in order to target a specific location on the retina. This would define an axis aligned with a diffuser and the pupil in keeping with the plain meaning of the limitation. Additionally, The user can program the controller in response to therapeutic needs identified via the controller ([0094-0095]). Therefore, the argument is not found persuasive and the rejection of claim 43 is maintained based on the previously established grounds of rejection.
Regarding claim 44, Applicant argues:
In response, Applicant notes that independent claim 27, from which claim 44 depends, is discussed above, as are all of the cited references Tedford '087 in view of Kelleher, Tedford '086, and Gerdt, none of which discloses irradiation sources which are aligned with a pupil of the patient at all. In addition, all references fail to teach the step of providing information about the next treatment step or starting the treatment step after a user input which is requested by a control unit.
Applicant therefore, respectfully contends that the combination of Tedford '087, Kelleher, Tedford '086, and Gerdt, which Applicant does not concede is proper, does not render obvious independent claim 27, from which claim 44 depends. Nor is Applicant aware of any apparent reason why Tedford '087, Kelleher, Tedford '086, or Gerdt should be so modified. Applicant, therefore, submits that independent claim 27 is not obvious in view of Tedford '087,Kelleher, Tedford '086, and Gerdt, and is otherwise in allowable condition. (pages 19-20, 11/05/2025 Remarks)
This argument is not found persuasive. As previously discussed, the Examiner is interpreting Applicant’s intention to claim the at least one light source is positioned in a central axis that aligns with a pupil in the forward-directed eye. However, this is interpreted as a more specific axis than the more general language in the limitation under consideration. The light sources in Tedford ‘087 irradiate light through a diffuser ([0098]) and the pupil ([0102]) in order to target a specific location on the retina. This would define an axis aligned with a diffuser and the pupil in keeping with the plain meaning of the limitation. Additionally, The user can program the controller in response to therapeutic needs identified via the controller ([0094-0095]). Therefore, the argument is not found persuasive and the rejection of claim 44 is maintained based on the previously established grounds of rejection.
Summary: The 35 U.S.C. § 103 rejections for claims 27, 29-33, 35-39 and 42-52 are maintained (see “Claim Rejections - 35 USC § 103”).
Priority
The instant application (filed on 10/13/2022) is a national stage of PCT/EP2021/059089 (filed on 04/07/2021), filed under 35 USC 371. Acknowledgment is made of applicant's claim for foreign priority based on DE10 2020 110 284.4, filed on 04/15/2020. Claims 27, 29-33, 35-39, and 42-52 are represented in the provided English translation of DE10 2020 110 284.4 and will receive the priority date of 04/15/2020. All prior art will be evaluated using this effective filing date.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 27, 29-33, 37-38, 42, and 45-52 are rejected under U.S.C 103 as being unpatentable over Tedford ‘087 (US PG Pub 2016/0067087 A1, see IDS filed on 10/13/2022) in view of Kelleher (US PG Pub 2015/0057701, see previously cited) and Tedford ‘086 (US PG Pub 2016/0067086, see previously cited).
Regarding Claim 27, Tedford ‘087 discloses a device for the therapeutic treatment of the retina of an eye of a patient ([0102]), comprising:
• at least one irradiation source which emits a therapeutically effective irradiation ([0012])
• a control unit for driving the irradiation source, the control unit being programmed to deliver the therapeutically effective irradiation ([0009] – “The controller can activate one or more light sources adapted to delivery light to the subject's ocular tissue”) with a predetermined irradiation duration and irradiation intensity from the irradiation source to the retina of the eye of the patient ([0091] – “Programmable Controller. To tailor one or more of the light energy emission, light energy intensity, light energy duration, frequency, area or sequence of application of light energy to a subject's ocular tissue, or other treatment parameters, at least some embodiments include a programmable controller”);
• a holding and positioning device for holding an optical lens element in a defined position and orientation in front of the eye of the patient (Figs 2A-6D show various embodiments of a holding and positioning device to hold the light sources in place [0068]; [0069] and [0074] – the light passes through one or more lens structures to direct light toward the eye);
• and the irradiation source cooperating with the optical lens element to deliver the therapeutically effective irradiation to the retina via the optical lens element ([0102] – “Light therapy may be administered through a closed eyelid, in which much of the light can be expected to scatter over a relatively broad area of the retina”; [0074] – “the light sources may be oriented toward the wearer's eye or may include at least one optical element (for example, a lens or reflector) that directs or redirects light towards the wearer's eye”)
• light can be administered through the closed eyelid ([0102]) after passing through an optical lens or reflector ([0074])
• an input user interface (user interface 760); and
• an output user interface for outputting information ([0088-0089] – the current settings are necessarily able to be interpreted by a programmer in order to be adjusted);
• wherein the optical lens element comprises a diffuser adapted to distribute the therapeutically effective irradiation from the irradiation source onto the irradiation-transmitting
concave surface ([0098] – “In at least some embodiments, the light source or the device includes one or more diffusers adapted to diffuse the light prior to reaching the eye or ocular tissue to advantageously homogenize the light beam”);
• wherein the irradiation source is fixed to the holding and positioning device and lies only in a treatment position defining an irradiation axis aligned with a pupil of the patient and the diffuser ([0102] – the light sources form an axis between the source and retina which passes through the pupil; where the light source is aligned to irradiate through the pupil: “In certain embodiments, the device includes the ability to target specific areas of the retina through the pupil”; [0098] - light passes through a diffuser before reaching the eye);
• wherein the control unit is programmed to, in an information step, display to the
patient information on a subsequent therapeutic treatment step via the output user interface ([0088-0089] – the current settings are necessarily able to be interpreted by a programmer in order to be adjusted); and
• perform the subsequent therapeutic treatment step after the information step, wherein the irradiation duration and irradiation intensity correspond to a treatment mode input via the input user interface and/or an output via the output user interface ([0091] – “To tailor one or more of the light energy emission, light energy intensity, light energy duration, frequency, area or sequence of application of light energy to a subject's ocular tissue, or other treatment parameters, at least some embodiments include a programmable controller (for example, internal controller 750 of FIG. 7) which may be coupled to the user interface 760 directly or through an external controller 750”);
• wherein the control unit is programmed to, between the information step and the subsequent therapeutic treatment step, in an input step request a user input via the input user interface, and start the subsequent therapeutic treatment step after receiving a predetermined user input ([0094] – there is a mechanism to adjust the treatment parameters in the user interface: “In at least some embodiments utilizing multiple light sources, the programmable controller can be programmed to activate a subset of the light sources to focus on a particular target region. In at least some embodiments, the programmable controller can be programmed to activate the light sources according to a predetermined treatment regimen, order, template, or sequence […] The treatment regimen can also be adjustable by a physician (e.g., via telemetry or a wireless or wired network interface”; [0095] – alarms or warnings generated to facilitate the programmer changing settings which are input into the device).
Tedford ‘087 does not disclose (1) the optical lens element having an irradiation-transmitting concave surface for resting on a closed eyelid of the patient and (2) a graphical interface for outputting information.
Kelleher, in the same field of endeavor of providing energy to the eye for treatment ([0101]), teaches a treatment device where an energy source 120 transmits to an energy waveguide module 130, where the waveguide modules transmits energy to the energy transmission surface 140 ([0092]), which is a concave surface ([0132] - to match the concavity of the closed eyelids) placed adjacent to the eyelids 12 and 14 (Fig 2C, [0099], [0135] – the energy transmission surface can come into contact with the eyelids). The energy transmission surface can be composed of lenses ([0096] – “For example, the energy transmission surface 140 may include one or more lenses configured to focus energy generated by the transducer module 120”). The energy transducer module can utilize a lens to direct energy at a specific angle for therapy ([0131] – “The energy transducer module 120 can include a lens 208 that can be used in conjunction with the LED emitter 207 or other electromagnetic energy source to direct the energy to the eyelid at a desired angle or in a desired pattern, at a desired intensity”). The energy transmission surface placed over the eyelids facilitates a function of allowing more uniform light distribution via addition of light-altering elements ([0158] – “Those skilled in the art may combine the two approaches, for example, by adding one or more prisms 280, shaping lenses 282, or other elements such as diffusers, gratings and the like, to the designs of FIGS. 5C-F, in order to optimize the uniformity of light distribution while keeping the size of the device as compact as possible”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device to pass energy through a lens to the closed eyelid by incorporating the energy transmission surface, containing a lens, placed over the closed eyelids in Kelleher. This would have been obvious because both Tedford ‘087 and Kelleher discuss lens elements to direct energy to the eye and Kelleher provides a solution/improvement for providing more coverage over the eyelid surface to prevent unintended distributions of light. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford ‘087 by incorporating the energy transmission surface, containing a lens, placed over the closed eyelids in Kelleher.
Tedford ‘086, in the same field of endeavor of providing energy to the eye for treatment ([0003]), teaches use of a programmable controller which can be adjusted via a user interface ([0080]). The user interface is described as a display with a screen for viewing graphical elements while programming ([0061] – “The optional user interface 108 can be built into the device and can be any suitable interface including, but not limited to, a touchscreen interface, a keyboard and display, or the like. Alternatively or additionally, the device 100 can include or permit a wired or wireless connection to an external user interface such, as for example, an external computer, a keyboard, a mouse or joystick, or the like. The user interface 108 is typically operated by the doctor or other practitioner [...] The user interface 108 may be used to input therapy parameters, patient information, operate the device 100, or any other suitable use”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device user interface by incorporating the graphical user interface in Tedford ‘086. This would have been obvious because both Tedford ‘087 and Tedford ‘086 discuss light therapy to the eyes controlled via a user interface and Tedford ‘086 provides a solution/improvement for providing a graphical display so the programmer can more readily interpret and adjust sensor and control parameters. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford ‘087 by incorporating the graphical user interface in Tedford ‘086.
Therefore, Claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 29, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the diffuser is designed as an integrating sphere or as a layer of a semitransparent material ([0100] – “The device can include diffusers such as, but are not limited to, holographic diffusers such as those available from Physical Optics Corp. of Torrance, Calif. and Display Optics PIN SN1333 from Reflexite Corp. of Avon, Conn” where this is interpreted as a reference to a semi-transparent holographic diffuser film layer).
Therefore, Claim 29 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 30, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses limitations to the irradiation profile in order to control temperature ([0144]). Tedford ‘087 does not disclose the optical lens element comprises a thermal heating or cooling device.
Kelleher, in the same field of endeavor of providing energy to the eye for treatment ([0101]), teaches a treatment device where an energy source 120 transmits to an energy waveguide module 130, where the waveguide modules transmits energy to the energy transmission surface 140 ([0092]), which is a concave surface ([0132] - to match the concavity of the closed eyelids) placed adjacent to the eyelids 12 and 14 (Fig 2C, [0099], [0135] – the energy transmission surface can come into contact with the eyelids). The energy transmission surface can be composed of lenses ([0096]). The energy transducer module can utilize a lens to direct energy at a specific angle for therapy ([0131]). The energy transmission surface may act as a heating element according to Kelleher:
In still other embodiments, tissue heating may be done as a result of a combination of conductive heating caused by preheating or active heating of energy transmission surface 140 and radiant heating of tissue and/or the scleral shield. The energy transmission surface 140 may incorporate an energy absorbing layer or pattern that may be pre-heated by light energy or other means, for example up to 42 degrees Celsius, prior to contact with the outer surface of the eyelid. Or, energy transmission surface may be made from a thermally-conductive material and may be heated by a heater that is thermally linked to energy transmission surface 140. In the case where surface 140 is made from a thermally-conductive material, the material may be transmissive to an energy source (such as light) coming from energy transducer module 120, or it may be solid, opaque or otherwise not transmissive to another form of energy other than conductive heating. In the case where surface 140 is opaque or non-transmissive, it may be made from a conductive metal such as copper or aluminum, in which case surface 140 may be heated by an energy transducer module 120 comprising any means of heating a thermal mass (such as a resistive heater), and then pushed against the eyelid to conductively heat the eyelids. [0137]
The energy transmission surface can be thermally managed by adding cooling elements to the energy transmission surface as well ([0168]). Kelleher teaches heat applied to the eyelid can be used to treat particular eye conditions ([0110]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device to pass energy through a lens to the closed eyelid by incorporating the energy transmission surface, containing a lens, placed over the eyelid with a heating or cooling element in Kelleher. This would have been obvious because both Tedford ‘087 and Kelleher discuss lens elements to direct energy to the eye and Kelleher provides a solution/improvement for providing more coverage over the eyelid surface to prevent unintended distributions of light and to provide regulated heat to the eyelid to treat certain conditions. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford ‘087 by incorporating the energy transmission surface, containing a lens, placed over the eyelid with a heating or cooling element in Kelleher.
Therefore, Claim 30 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 31, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses optical elements, such as lenses or reflectors, oriented toward the eye ([0074]) through the closed eyelid ([0102]). Tedford ‘087 does not disclose a set of contact surface elements, one of which is attachable to the concave surface of the optical lens element, the set comprising: a first contact surface element having a first refractive index; and a second contact surface element having a second refractive index different from the first refractive index.
Kelleher, in the same field of endeavor of providing energy to the eye for treatment ([0101]), teaches a treatment device where an energy source 120 transmits to an energy waveguide module 130, where the waveguide modules transmits energy to the energy transmission surface 140 ([0092]), which is a concave surface ([0132] - to match the concavity of the closed eyelids) placed adjacent to the eyelids 12 and 14 (Fig 2C, [0099], [0135] – the energy transmission surface can come into contact with the eyelids). The energy transmission surface can be composed of lenses ([0096]). The energy transducer module can utilize a lens to direct energy at a specific angle for therapy ([0131]).
Kelleher teaches the use of refractive elements as part of the energy transmission surface in order to direct light to a targeted region of the eye ([0151] – “FIG. 4D is a schematic side plan view of another embodiment of an eye treatment device 200. In this embodiment, the transmission of the light beam 211 may be administered without the aid of a reflector 210, if, for example, other components of the eye treatment device 200 can be used to control the direction and intensity of the light beam 211 such as a specially shaped lens 208, an additional lens element, a light pipe, a total internal reflective (TIR) element, a refractive element, a diffractive element, a mirror element, a diffuser, and the like, or a combination thereof. It may be desirable in this manner to control the focus and the intensity of the light energy”). Kelleher also teaches refractive elements, such as those in the previous sentence, with varying refraction properties can be used to direct light to a target or multiple targets ([0104] – “It will be appreciated that various desirable optical properties may be incorporated into image translator 155, such as image projection, angulation or magnification. Such properties may be achieved, for example, by curving the reflective surfaces 180, by shaping the surfaces of transmissive material 185 and/or by varying the index of refraction, by varying the density and distribution of fiber elements in a bundle, or by some combination thereof”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device to pass energy through a lens to the closed eyelid by incorporating the energy transmission surface, containing a lens and refractive elements, placed over the eyelid in Kelleher. This would have been obvious because both Tedford ‘087 and Kelleher discuss lens elements to direct energy to the eye and Kelleher provides a solution/improvement for providing more coverage over the eyelid surface to prevent unintended distributions of light while incorporating elements to focus light on desired locations throughout the eye. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Tedford ‘087 by incorporating the energy transmission surface, containing a lens and refractive elements, placed over the eyelid in Kelleher.
Therefore, Claim 31 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 32, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the holding and positioning device comprises a partial face mask which at least partially covers an eye area of a face of the patient (Figs 2A-6D show various embodiments of a holding and positioning device to hold the light sources [0068] in place; [0068] – the device partially covering the face over the eyes can be a mask: “Examples of other affixation elements include, but are not limited to, a headband, a helmet, a mask, or the like or any combination thereof”).
Therefore, Claim 32 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 33, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 32 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the partial face mask is held in a predetermined position on the patient's face by:
• a band passed around the head ([0068] – “Examples of other affixation elements include, but are not limited to, a headband, a helmet, a mask, or the like or any combination thereof”);
• at least one retaining element comprising a strap or spectacle temples passed around the ears ([0068] – “The earpieces 206 are one example of an affixation element of the frame 202 which is attached to the front piece 204 to hold the device 200 on the wearer”).
Tedford ‘087 does not disclose suction cups held in a predetermined position on the patient's face, but the suction cup limitation is interpreted as not being required (as evidenced by the “or” separating the three limitations).
Therefore, Claim 33 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 37, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses optical elements, such as lenses or reflectors, oriented toward the eye ([0074]) through the closed eyelid ([0102]). Tedford ‘087 does not disclose a concave surface is designed for superficial contact with the eye of the patient or the closed eyelid of the patient over a contact area of at least 1 cm2.
Kelleher, in the same field of endeavor of providing energy to the eye for treatment ([0101]), teaches a treatment device where an energy source 120 transmits to an energy waveguide module 130, where the waveguide modules transmits energy to the energy transmission surface 140 ([0092]), which is a concave surface ([0132] - to match the concavity of the closed eyelids) placed adjacent to the eyelids 12 and 14 (Fig 2C, [0099], [0135] – the energy transmission surface can come into contact with the eyelids). The energy transmission surface can be composed of lenses ([0096]). The energy transducer module can utilize a lens to direct energy at a specific angle for therapy ([0131]). While the dimensions of the energy transmission surface are not specified in Kelleher, Kelleher depicts the energy transmission surface 140 as covering most of the closed eyelids 12 and 14 (Fig 2C, Fig 5A) where the energy transmission surface is shaped to match the concavity of the closed eyelids ([0132]). Based on this disclosure, it seems reasonable that the closed eyelids covering the eye can be maximally covered by the energy transmission surface. Given eye and eyelid size can vary by individual, a covered closed eyelid is interpreted as necessarily being larger than 1 cm2 for at least some users to maintain the disclosed coverage over the closed eyelid.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device to pass energy through a lens to the closed eyelid by incorporating the energy transmission surface, containing a lens, placed over the closed eyelids in Kelleher. This would have been obvious because both Tedford ‘087 and Kelleher discuss lens elements to direct energy to the eye and Kelleher provides a solution/improvement for providing more coverage over the eyelid surface to prevent unintended distributions of light. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford ‘087 by incorporating the energy transmission surface, containing a lens, placed over the closed eyelids in Kelleher.
Therefore, Claim 37 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 38, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the lens element has an eyelid sensor in signal communication with the control unit for detecting the closed eyelid of the patient ([0111] – “In at least some embodiments, the device actively monitors the state of the patient's eyelid (e.g., open or closed) during therapy) and the control unit is adapted to activate the irradiation device only when the eyelid sensor transmits a signal signaling the closed eyelid of the patient ([0111] – “In at least some embodiments, the signal is used as an interlock in the logic circuit, temporarily stopping output of the device if a particular eyelid state is detected. In at least some embodiments, the signal is used by the logic circuit to increase or decrease the power output of the device … In at least some embodiments in which the therapy is nominally delivered through the closed eye, the logic circuit may halt therapy whenever an open-eye state is detected”).
Therefore, Claim 38 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 42, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the control unit is programmed to:
• receive user-related personal information via the input user interface ([0093] – a mechanism exists for identifying subjects to access a preprogrammed treatment for that particular subject);
• identify a user identity from a user identity data stored by the control unit on the basis of this user-related personal information ([0093] – a mechanism exists for identifying subjects to access a preprogrammed treatment for that particular subject); and
• perform a predetermined treatment step stored for that user identity in a treatment programmer data memory as a function of the user identity ([0093] – “In at least some embodiments, the programmable controller is preprogrammed (e.g., prior to implantation) with a desired set of treatment parameters for a given subject (e.g., patient)”).
Therefore, Claim 42 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 45, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses wireless communication with the wearable device as a control mechanism ([0089]). However, Tedford ‘087 does not disclose the control unit is provided in a smart tablet, laptop, or smartphone.
Kelleher, in the same field of endeavor of controlling irradiation of the light sources ([0115]), teaches the use of a smartphone as a controller device ([0225] – “In certain embodiments having a controller 212, the controller 212 can receive input instructions from a user (for example, through a user interface device 270, such as a button, switch, touch screen, voice commands, from another module or device, such as a smartphone) to emit light from the LED emitter 207”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wireless controller by incorporating the smartphone as the wireless controller in Kelleher. At the time, there would have been a recognized need to implement a specific type of wireless controller in Tedford ‘087. Given the limited options of types/classes for wireless controllers, the smartphone in Kelleher would have been a known option for controlling an irradiation device and obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the smartphone in Kelleher.
Therefore, Claim 45 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 46, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the holding and positioning device has a total weight and dimensions allowing the device to be held to the patient's head by the holding and positioning device alone (Figs 2A-6D show various embodiments of a holding and positioning device to hold the light sources [0068] in place; [0068] – the device partially covering the face over the eyes can be a mask: “Examples of other affixation elements include, but are not limited to, a headband, a helmet, a mask, or the like or any combination thereof”). Note the embodiments are meant to be worn on the head like normal headgear.
Therefore, Claim 46 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 47, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the irradiation device comprises two beam exit directions spaced apart from each other for simultaneous irradiation of both eyes of the patient ([0060] – “The device may be monocular, in that it is intended to expose only one eye to the light therapy, or it may be binocular, where the device may treat both eyes concurrently, sequentially, or in a specified sequence. Binocular devices are described herein in detail”).
Therefore, Claim 47 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 48, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the irradiation device further comprises:
• a first optical system comprising ([0060] – the eyes are provided therapy concurrently with separate systems for each eye):
a first optical filter unit ([0069] – “Each light source can optionally include one or more of a lens, diffuser, filter, or other optical elements associated with the light source”); and
• a second optical system spaced from the first optical system along an irradiation trajectory axis comprising ([0060] – the eyes are provided therapy concurrently with separate systems for each eye where each eye has an optical axis):
a second optical filter unit ([0069] – “Each light source can optionally include one or more of a lens, diffuser, filter, or other optical elements associated with the light source”).
Tedford ‘087 does not disclose a first opticallens, a first optical collimator, a second opticallens, or a second optical collimator, but these elements are interpreted as not being required (as evidenced by the “or” separating the limitations for each optical system).
Therefore, Claim 48 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 49, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the control unit is programmed to:
• store and control a treatment plan comprising at least a first and a second treatment operation for a user ([0091] – “the programmable controller can be used to transmit
light to specific target regions of the eye according to a therapeutic regimen. For example, the programmable controller can execute a treatment program that includes a set of activation times or periods during which each of the light sources is in an emitting state and a set of inactivation times or periods during which the light source is in a non-emitting state”), and to:
• control a first treatment procedure for the patient ([0091] – multiple distinct sets of procedures can be programmed);
• save the completion time of the first treatment procedure ([0164] – a real time clock is used for managing treatment times: “The total treatment time can be controlled by the programmable controller. The real time clock and the timers of the programmable controller can be used to control the timing of a particular therapeutic regimen and to allow for scheduled treatment (such as daily, twice a day, or every other day)”); and
• start a second treatment procedure on the condition that a minimum period of time has elapsed since the completion time of the first treatment procedure ([0164] – definite time limits govern light therapy where “the maximum treatment time of at least some embodiments can be limited by heating and by practical treatment times” and the second therapy could only be initiated when safety allows (such as limiting excessive heating in the tissue as measured by temperature sensors in [0096])).
Therefore, Claim 49 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 50, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the control unit is programmed ([0091] – programmable controller) to:
• receive a diagnostic data characterizing a body condition of the patient via the input user interface ([0096] – “The sensors can provide feedback regarding the parameters of the light treatment or the physiological parameters of the subject (e.g., patient)”; [0106] – “The signals provided by the interface from a user are indicative of parameters that may include, but are not limited to, individual subject characteristics (e.g., eye lid skin type, fat percentage)”);
• generate a therapy data after a treatment procedure which characterizes the treatment procedure carried out ([0093] – control unit is programmable based on treatment parameters which are accessible to the controller (via memory 752));
• send a data packet comprising the diagnostic data and the therapy data to a receiving device of an expert computer via a data transmission unit ([0094-0095] – the treatment can be adjusted by a physician via a telemetry unit where the communication interface sends data to the physician via the external telemetry unit);
• receive an instruction data from a transmitting device of the expert computer via the data transmission unit ([0094-0095] – the treatment can be adjusted by a physician via a telemetry unit where the communication interface receives data from the physician via the external telemetry unit); and
• control the irradiation device to perform a treatment procedure characterized by the instruction data ([0106] – “The interface of at least some embodiments provides
signals to the logic circuit, which the logic circuit uses to control the applied light. The interface can comprise a user interface or an interface to a sensor (for example, sensor 754 of FIG. 7) monitoring at least one parameter of the treatment. In at least some embodiments, the programmable controller is responsive to signals from the sensor to preferably adjust the
treatment parameters to optimize the measured response”).
Therefore, Claim 50 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 51, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 50 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the control unit is programmed to:
• receive the diagnostic data characterizing the body condition via the input user interface ([0096] – “The sensors can provide feedback regarding the parameters of the light treatment or the physiological parameters of the subject (e.g., patient)”; [0106] – “The signals provided by the interface from a user are indicative of parameters that may include, but are not limited to, individual subject characteristics (e.g., eye lid skin type, fat percentage)”);
• compare the diagnostic data with a predetermined body condition data stored in an electronic data memory of the control unit ([0106-0107] – feedback from sensors on the patient to optimize light therapy, for example: [0108] – “the logic circuit is responsive to the information from the temperature sensor to transmit a control signal to the light source driver so as to adjust the parameters of the applied light to maintain the skin or eyelid temperature below a predetermined level”);
• select a subsequent treatment procedure from a plurality of treatment procedures stored in the electronic data memory of the control unit on the basis of the correspondence with one of the stored body condition data exceeding or the falling below of a body condition defined by the body condition data ([0096] – “the programmable controller can automatically reprogram itself or recalibrate its treatment parameters in response to control signals received from feedback sensors,” such as the temperature controls in [0108]); and
• control the irradiation device to perform the selected treatment procedure ([0106] – “The interface of at least some embodiments provides signals to the logic circuit, which the logic circuit uses to control the applied light. The interface can comprise a user interface or an interface to a sensor (for example, sensor 754 of FIG. 7) monitoring at least one parameter of the treatment. In at least some embodiments, the programmable controller is responsive to signals from the sensor to preferably adjust the treatment parameters to optimize the measured response”).
Therefore, Claim 51 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Regarding Claim 52, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 50 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses the input user interface comprises a digital image capture device and the diagnostic data includes image capture data describing the image of a treated tissue ([0109] – the eye is imaged based on automated or user-directed instructions, where the visuals are used to determine information about the eye and establish specific treatment parameters).
Therefore, Claim 52 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086.
Claims 35-36 and 44 are rejected under U.S.C 103 as being unpatentable over Tedford ‘087 (US PG Pub 2016/0067087 A1, see IDS filed on 10/13/2022) in view of Kelleher (US PG Pub 2015/0057701, see previously cited), Tedford ‘086 (US PG Pub 2016/0067086, see previously cited), and Gerdt (US 6,235,046 B1, see IDS filed on 10/13/2022).
Regarding Claim 35, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses the light sources are embedded in the holding and positioning device (Figs 2A-6D show various embodiments of a holding and positioning device to hold the light sources [0068] in place). Tedford ‘087 discloses the use of light pipes to carry light from the light source to other locations ([0061]). Tedford ‘087 does not disclose a second irradiation source arranged at a distance from the holding and positioning device on an irradiation base device and wherein the therapeutically effective irradiation is guided from the irradiation base device to the holding and positioning device by a flexible irradiation guide.
Gerdt, in the same field of endeavor of applying light to a retina using eyewear (Fig. 16, Col 8, Lines 61-65), teaches the transmission of light to the eyewear via a light source not attached to the eyewear (Figure 16 – light is transmitted to the eyewear from a distance, Col 6, Lines 61-67 – “The disclosed device, when placed near the eye delivers light to the retina while enabling an unobstructed direct axis viewing area. Light is delivered to the light ring by a light transfer member, such as a fiber 65 optic bundle, or optical wave guide or guides, with the light being sourced by a variety of means such as light bulbs, light emitting diodes, arc lamps, and others”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device, with light sources in the eyewear positioned next to the eye, by incorporating distant light sources which transmit light via guides integrated into the eyewear in Gerdt. At the time, there would have been a recognized need to implement light emitting structures in the eyewear to be shined into the adjacent eyes. This could be accomplished by either having light sources on the eyewear itself or use light guides to transmit light to outputs on eyewear, making the light guide arrangement in Gerdt an obvious alternative to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the light guide arrangement in Gerdt.
Therefore, Claim 35 is obvious over Tedford ‘087 in view Kelleher, Tedford ‘087, and Gerdt.
Regarding Claim 36, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher, Tedford ‘086, and Gerdt, as indicated hereinabove. Tedford ‘087 discloses the light sources are embedded in the holding and positioning device (Figs 2A-6D show various embodiments of a holding and positioning device to hold the light sources in place [0068]). Tedford ‘087 discloses the use of light pipes to carry light from the light source to other locations ([0061]). Tedford ‘087 does not disclose the irradiation source is arranged at a distance from the holding and positioning device on an irradiation base device and the therapeutically effective irradiation is guided from the irradiation base device to the holding and positioning device by means of a flexible irradiation guide.
Gerdt, in the same field of endeavor of applying light to a retina using eyewear (Fig. 16, Col 8, Lines 61-65), teaches the transmission of light to the eyewear via a light source not attached to the eyewear (Figure 16 – light is transmitted to the eyewear from a distance, Col 6, Lines 61-67 – “The disclosed device, when placed near the eye delivers light to the retina while enabling an unobstructed direct axis viewing area. Light is delivered to the light ring by a light transfer member, such as a fiber 65 optic bundle, or optical wave guide or guides, with the light being sourced by a variety of means such as light bulbs, light emitting diodes, arc lamps, and others”). In Figure 16, the optical fibers (Col 9, Lines 3-9) are shown to curve in a flexible fashion.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device, with light sources in the eyewear positioned next to the eye, by incorporating distant light sources which transmit light via guides integrated into the eyewear in Gerdt. At the time, there would have been a recognized need to implement light emitting structures in the eyewear to be shined into the adjacent eyes. This could be accomplished by either having light sources on the eyewear itself or use light guides to transmit light to outputs on eyewear, making the light guide arrangement in Gerdt an obvious alternative to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the light guide arrangement in Gerdt.
Therefore, Claim 36 is obvious over Tedford ‘087 in view Kelleher, Tedford ‘087, and Gerdt.
Regarding Claim 44, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses light sources are embedded in the holding and positioning device (Figs 2A-6D show various embodiments of a holding and positioning device to hold the light sources in place [0068]) and a programmable user interface ([0088-0089]). Tedford ‘087 does not disclose the control unit and the graphical output user interface are arranged in the irradiation base device, and the irradiation base device further comprises an irradiation guide device for directing the therapeutically effective irradiation emitted from the irradiation source to the optical lens element held on the holding and positioning device in front of the patient's eye.
Tedford ‘086, in the same field of endeavor of providing energy to the eye for treatment ([0003]), teaches use of a programmable controller which can be adjusted via a user interface ([0080]). The user interface is described as a display with a screen for viewing graphical elements while programming ([0061]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device user interface by incorporating the graphical user interface in Tedford ‘086. This would have been obvious because both Tedford ‘087 and Tedford ‘086 discuss light therapy to the eyes controlled via a user interface and Tedford ‘086 provides a solution/improvement for providing a graphical display so the programmer can more readily interpret and adjust sensor and control parameters. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford ‘087 by incorporating the graphical user interface in Tedford ‘086.
Gerdt, in the same field of endeavor of applying light to a retina using eyewear (Fig. 16, Col 8, Lines 61-65), teaches the transmission of light to the eyewear via a light source not attached to the eyewear (Figure 16 – light is transmitted to the eyewear from a distance; Col 6, Lines 61-67 – “The disclosed device, when placed near the eye delivers light to the retina while enabling an unobstructed direct axis viewing area. Light is delivered to the light ring by a light transfer member, such as a fiber 65 optic bundle, or optical wave guide or guides, with the light being sourced by a variety of means such as light bulbs, light emitting diodes, arc lamps, and others”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable ophthalmic phototherapy device, with light sources in the eyewear positioned next to the eye, by incorporating distant light sources which transmit light via guides integrated into the eyewear in Gerdt. At the time, there would have been a recognized need to implement light emitting structures in the eyewear to be shined into the adjacent eyes. This could be accomplished by either having light sources on the eyewear itself or use light guides to transmit light to outputs on eyewear, making the light guide arrangement in Gerdt an obvious alternative to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the light guide arrangement in Gerdt.
While a user interface is not placed within the same base device as the optical source in the base device in Gerdt, the user interfaces in either Tedford ‘087 or Tedford ‘086 could be placed within the base device. This combination would be seen as an obvious design choice based on Tedford ‘087. Examples of case law supporting the obviousness of design choices are: (1) “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device” and “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)” (as seen in MPEP 2144.04, VI, C). Because a light source and user interface are disclosed in Tedford ‘087 and individually fulfill the same role as those elements would in combination, the design choice would be seen as obvious by one of ordinary skill in the art.
Therefore, Claim 44 is obvious over Tedford ‘087 in view of Kelleher, Tedford ‘086, and Gerdt.
Claim 39 is rejected under U.S.C 103 as being unpatentable over Tedford ‘087 (US PG Pub 2016/0067087 A1, see IDS filed on 10/13/2022) in view of Kelleher (US PG Pub 2015/0057701, see previously cited), Tedford ‘086 (US PG Pub 2016/0067086, see previously cited), and Johnson (US PG Pub 2017/0216088, see previously cited).
Regarding Claim 39, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 27 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 discloses limitations in the irradiation profile in order to control temperature ([0144]). Tedford ‘087 does not disclose a base station comprising a receiving device for the holding and positioning device, the receiving device further comprising a heating or cooling device for heating or cooling the optical lens element.
Johnson, in the same field of a wearable eye frame device for treatment of the eye ([0009]), teaches a thermal eye-pod assembly 100 containing heating/cooling source 73 ([0038]). The heat pump 73 inside assembly 100 is used to regulate the temperature of the ocular components placed over the eyes ([0040-0041]). The thermal eye-pod assembly is interpreted as being contained within a base unit distinct from the wearable frames containing the ocular components.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s wearable frames with ocular elements by incorporating the assembly containing a heating and cooling element within which elements of the wearable frames, or the frames themselves, can be placed in Johnson. This would have been obvious because both Tedford ‘087 and Johnson discuss wearable frames for treatment of eye conditions and Johnson provides a solution/improvement for pre-treating wearable frames with regulated temperatures before application to the head or face. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford ‘087 by incorporating the assembly containing a heating and cooling element within which elements of the wearable frames, or the frames themselves, can be placed in Johnson.
Therefore, Claim 39 is obvious over Tedford ‘087 in view of Kelleher, Tedford ‘087, and Johnson.
Claim 43 is rejected under U.S.C 103 as being unpatentable over Tedford ‘087 (US PG Pub 2016/0067087 A1, see IDS filed on 10/13/2022) in view of Kelleher (US PG Pub 2015/0057701, see previously cited), Tedford ‘086 (US PG Pub 2016/0067086, see previously cited), and Robaina (US PG Pub 2018/0197624, see previously cited).
Regarding Claim 43, the device for the therapeutic treatment of the retina of an eye of a patient according to claim 42 is obvious over Tedford ‘087 in view of Kelleher and Tedford ‘086, as indicated hereinabove. Tedford ‘087 further discloses wherein:
• the input user interface comprises a digital image capture unit ([0045] – “A camera or other sensor can be used to capture patient orbital features, including depth, size, skin color, or distances”), and
• the control unit is programmed to receive image data from the digital image capture unit ([0110] – “In at least some embodiments, the logic circuit is responsive to signals indicating the spatial position or orientation of the patient's eye (e.g., where the patient is looking). This may be accomplished through the use of one or more cameras (for example, camera 754 of FIG. 7) and associated software algorithms”; [0112] – features of the eye are measured).
However, Tedford ‘087 does not disclose to determine the user identity on the basis of image data describing an iris geometry of the patient on the basis of an iris recognition.
Robaina, in the same field of endeavor of measuring biometric data via a wearable device ([0084]), teaches the identification of user based on features from the eye ([0058] – “The cameras 24 and light sources 26 may be operatively coupled to the local processing module 260. Such cameras 24 may be configured to monitor one or more of the orientation, shape, and symmetry of pupils (including pupil sizes) or irises of the respective eyes, and/or tissues surrounding the eye, such as eyelids or eyebrows to conduct the various analyses disclosed herein. In some embodiments, imaging of the iris and/or retina of an eye may be used for secure identification of a user”) to prevent the unwanted proliferation of private patient data ([0178]). The cameras can be attached to the wearable system in an inward-facing direction to image the eyes ([0084]) where then wearable system includes frames worn on the head (Fig. 2A, [0047]).
17. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Tedford ‘087’s eyeglasses with inward facing cameras toward the eyes by incorporating the user identification feature via inward facing cameras to unlock medical records in Robaina. This would have been obvious because both Tedford and Robaina discuss wearable frames with cameras to monitor the eyes and Robaina provides a solution/improvement for identifying patients based on ocular features to increase security and provide information about specific patients. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Tedford by incorporating the user identification feature via inward facing cameras to unlock medical records in Robaina.
Therefore, Claim 43 is obvious over Tedford ‘087 in view of Kelleher, Tedford ‘086, and Robaina.
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796