DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 Amendment
2. Applicant’s Amendment filed September 10, 2025 (hereinafter “09/10/25 Amendment") has been entered, and fully considered. In the 09/10/25 Amendment, claims 1 & 16 were amended. No claims were cancelled, or newly added.
3. Claims 1-36 remain pending in the application.
4. The 09/10/25 Amendment has overcome the rejections under § 112(b) previously set forth in the Non-Final Office Action mailed 03/13/25 (“03/13/25 Action”).
5. NOTE: New claim objections and rejections under § 112(b) are set forth herein that were not previously set forth in the 03/13/25 Action. As such, this action constitutes a second Non-Final Action.
6. The prior rejection of independent claims 1 & 16 under § 103 has been updated to address the new claim limitations, and maintained.
Claim Objections
7. Claim 1 is objected to because of the following informalities:
In claim 1, lines 15-16, the recitation of “while conforming and retaining its shape to the underlying anatomy via the ductile layer” should instead recite --while conforming and retaining its shape to the underlying region via the ductile layer-- or --while conforming and retaining its shape to the anatomy of the underlying region of skin via the ductile layer-- to be consistent with the prior recitation at lines 5-6 of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-15 & 32 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 1 recites the limitation “the heating strip” in line 12. There is insufficient antecedent basis for this recitation in the claim.
11. Claims 2-15 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
12. Claim 14 recites the limitation “wherein the controller is programmed to heat the heating strip for at least 10 minutes” in lines 1-2. This recitation renders the claim indefinite, as the claimed range of “at least 10 minutes” is an open-ended range that does not have a clear, defined upper limit. See MPEP § 2173.05(c). It is noted that such a range also appears inconsistent with Applicant’s disclosed range which appears to have an upper limit of around 60 minutes [see, e.g., ¶[0076] of Applicant’s published Specification (U.S. 2021/0022914) (“Moreover, in any of the variations, the controller 40 and/or electronic device 42 may be programmed or initiated to heat up the assemblies 32, 34 to, e.g., 42.5° C.+/−1° to 2° C. Treatment time may be set to, e.g., 1 to 30 minutes or more such as 60 minutes…”)]. Clarification is required.
13. Claim 32 recites the limitation “heating the heating strip for at least 10 minutes” in line 2. This recitation renders the claim indefinite, as the claimed range of “at least 10 minutes” is an open-ended range that does not have a clear, defined upper limit. See MPEP § 2173.05(c). It is noted that such a range also appears inconsistent with Applicant’s disclosed range which appears to have an upper limit of around 60 minutes [see, e.g., ¶[0076] of Applicant’s published Specification (U.S. 2021/0022914) (“Moreover, in any of the variations, the controller 40 and/or electronic device 42 may be programmed or initiated to heat up the assemblies 32, 34 to, e.g., 42.5° C.+/−1° to 2° C. Treatment time may be set to, e.g., 1 to 30 minutes or more such as 60 minutes…”)]. Clarification is required.
Claim Rejections - 35 USC § 103
14. 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.
15. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
16. Claims 1-36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0106576 to Badawi et al. (“Badawi”) in view of U.S. 2014/0052198 to Mohn et al. (“Mohn”), and further in view of U.S. 2018/0071140 to Sheydin (“Sheydin”), and U.S. 2004/0044384 to Leber et al. (“Leber”).
17. Regarding claim 1, Badawi teaches a heating strip system, comprising:
a substrate layer [heating layer (36) - ¶’s [0096], [0097]; FIG. 3B (shown below)], having one or more heating elements incorporated [e.g., ¶[0097] (“The heating layer 36 may be configured to generate its heat energy… through any number various mechanisms such as mechanical, electrical, or chemical mechanisms”); see also ¶[0100] (“electrically resistive heating elements”)];
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a protective layer [insulative layer (38) - ¶[0038] (“an insulative layer 38 may be positioned atop the heating layer 36 for focusing, directing, or reflecting the heat towards the underlying skin surface as well as to protect the patient from contact with the heating layer 36 from other parts of the body”)]… where the heating strip [treatment strip (10); FIGS. 3A-3B] presents a flush and smooth surface [¶[0095]] which is configured to adhere to the underlying region of skin [see ¶[0018] (“the assembly for the treatment strip or strips may generally comprise one or more strips configured to adhere to an underlying region of skin”); see also ¶’s [0020], [0084], [0086]] and where the heating strip has a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction… [e.g., ¶[0090] (“… the treatment strips 10, 12 may apply, e.g., heat energy, to melt or liquefy any waxy or solid meibomian gland obstructions while the eyes remain unobstructed and are allowed to blink naturally. The treatment strips 10, 12 thus allow for the natural blinking…”); see also ¶’s [0018], [0020], [0024]];
a controller [controller (340) - ¶[0135]; FIG. 39] which is programmable for a treatment therapy [¶[0140]] and which is in communication with the substrate layer [e.g., via connecting cable (338) - ¶’s [0135]-[0136]; FIG. 39; NOTE: Badawi teaches, at ¶[0137], that any of the described treatment strips may be used with the controller; Badawi teaches that cable (338) provides power to the heating elements in the heating strip assemblies - ¶’s [0135]-[0136]; as such, when used with the treatment strip (10) illustrated in FIGS. 3A-3B, the cable (338) would be in communication with the substrate/heating layer (36) as the heating elements in treatment strip (10) are incorporated in heating layer (36) - ¶’s [0096], [0097], [0100]]… which is configured to receive the electrical energy and emit thermal energy [e.g., ¶’s [0096], [0097], [0100]] for conduction throughout the heating strip… such that the thermal energy is directed inwardly via the protective layer to the underlying region of skin [e.g., ¶[0096] (“insulative layer 38 may be positioned atop the heating layer 36 for focusing, directing, or reflecting the heat towards the underlying skin surface”)].
A. FLEXIBLE CONNECTOR
As noted above, Badawi teaches that the controller communicates with the substrate/heating layer (36) via a connecting cable.
Badawi further teaches an embodiment [FIG. 44 (provided below)] wherein flexible connectors (402A, 402B) extend from heating strips (400A, 400B), respectively, to a common junction (404), which may then be connected to coupler (410), which is connected to a cable (414) that communicates with a controller [see ¶[0161]; FIG. 44].
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Badawi appears silent, however, regarding the relationship between the flexible connectors and the substrate of the heating strips (400A, 400B). As such, Badawi does not appear to teach the following emphasized limitations:
a flexible connector formed from the substrate layer and configured to extend from the substrate layer; [and]
[the] controller… is in communication with the substrate layer via the flexible connector which is configured to transmit electrical energy to the substrate layer.
Mohn, in a similar field of endeavor, teaches a system comprising a console (20) [controller] that is likewise attached to a pad assembly (30) (for applying heat and electrical stimulation to a human or animal body - ¶[0001]) via a cable (40) [see ¶[0036]; FIG. 1].
The pad assembly (30) comprises a substrate (500) that comprises both:
a) a heating element (502) comprising a plurality of resistors (503); and
b) one or more flexible connectors [conductors (512a, 512b)] patterned on the substrate [i.e., the conductors (512a, 512b) are integral with the substrate (500) and are therefore “formed from the same substrate as the substrate layer” [see ¶’s [0039]-[0043]; FIG. 3].
FIG. 3 further depicts the one or more flexible connectors [conductors (512a, 512b)] “extending from” substrate (500) toward connector (507) which allows for electrical connection to cable (40) [¶[0042]; FIG. 3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Badawi (which already teaches the use of flexible connectors - ¶[0161]; FIG. 44) such that the substrate layer [heating layer (36) of strip (10)], which is in operative communication with controller (340) via a connecting cable (338), also include a flexible connector extending from the substrate layer and formed from the same substrate as the substrate layer, with the controller (340) in communication with the substrate layer via the flexible connector which is configured to transmit electrical energy to the substrate layer, since such a particular known connector mounting technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Mohn), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Badawi), and the results would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. DUCTILE LAYER
Badawi teaches that the treatment strips may incorporate various layers into the strips to effect various treatments [see, e.g., ¶[0028]], but doesn’t explicitly teach a ductile layer disposed between the substrate layer [heating layer (36)] and the protective layer [insulative layer (38)].
As such, the combination of Badawi and Mohn, as set forth above, does not teach the following emphasized limitations:
a ductile layer attached in proximity to the substrate layer [(36)] and configured to conform and retain a shape of the substrate layer to an anatomy of an underlying region of skin of an eyelid of a subject;
[the] protective layer [(38)] attached in proximity to the ductile layer and where the protective layer, ductile layer, and substrate layer each has a contour which is identical to one another; [and]
… where the heating strip has a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction while conforming and retaining the its shape to the underlying anatomy via the ductile layer.
… the substrate layer which is configured to receive the electrical energy and emit thermal energy for conduction throughout the heating strip via the ductile layer…; [and]
However, the use of a layer positioned between a substrate/heating layer and a protective/contact layer was well known in the art, before the effective filing date of the claimed invention, for the purpose of evenly distributing heat generated by the substrate/heating layer [it is noted that Applicant’s Specification (published as U.S. 2021/0022914) likewise describes the “ductile layer” as serving the same purpose at ¶[0093] (“the ductile layer 144 may conduct the heat emitted from the FPCBA layer 140 evenly over the entire heating strip assembly to facilitate the treatment of the underlying tissue surface…”)].
As one example, Sheydin, in a similar field of endeavor, teaches a multilayered heating structure for providing therapeutic benefits to a user [Abstract], including a heating layer (2) with integrated heating elements, a primary therapeutic layer (6) having an outer protective shell layer (14), and a heat-distribution layer (11) mounted between the heating layer (2) and the primary therapeutic layer (6) (and protective shell layer (14)) that evenly distributes the heat generated by the heating layer (2) across the primary therapeutic layer (6) [Sheydin, e.g., ¶’s [0016], [0020]; FIGS. 2-3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Badawi and Mohn to include a ductile layer (a heat distribution layer) attached in proximity to the substrate layer (36) and the protective layer (38) [e.g., as broadly as claimed, positioned between the substrate layer (36) and the protective layer (38)] so as to provide the benefit/advantage of evenly distributing the heat generated by the substrate/heating layer, as taught by Sheydin. Still further, such a particular known technique (incorporation of a heat distribution layer) was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Sheydin), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Badawi/Mohn), and the results (improved heat distribution via incorporation of a heat distribution layer) would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
As modified, the ductile layer (heat distribution layer) would comprise a portion of the overall structure of the heating treatment strip (10) of Badawi/Mohn, which Badawi already teaches is configured to conform to (and be retained on) an anatomy of an underlying region of skin of an eyelid of a subject [see, e.g., ¶’s [0002], [0028], [0085]-[0088], [0090], [0111]; FIGS. 2A-2B].
Further, as broadly as currently claimed, the protective layer (38), ductile layer, and substrate layer (36) would all comprise layers of the same device [i.e., treatment strip (10)] which would share the same contour [elongated layers with rounded edges configured similar to the protective layer (38) and the substrate layer (36) as shown in FIG. 3B of Badawi] in order to conform to the same overall general form or structure of the device [note, e.g., FIG. 3A of Badawi which shows an example of a contoured treatment strip (see ¶[0040]), and FIG. 3B which shows the cross-sectional side view (the layers) of the treatment strip of FIG. 3A (see ¶[0041]); each layer shares the same general form or structure]. The heating strip would have a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction while conforming and retaining its shape to the underlying anatomy [see, e.g., ¶’s [0002], [0028], [0085]-[0088], [0090], [0111]; FIGS. 2A-2B] via the ductile layer.
C. OPENINGS
The combination of Badawi, Mohn, & Sheydin does not teach:
where each layer defines an opening at each end and at a central portion away from a proximal edge and a distal edge such that each opening coincides with one another when each layer is aligned upon one another.
However, the provision of aligned openings in layers of a therapeutic heating device was well known in the art, before the effective filing date of the claimed invention, with such openings being used, for example, to allow for the passage of posts (fasteners) to enable the layers to be secured to one another.
As one example, Leber, in a similar field of endeavor, teaches a treatment pad comprising various protective or structural layers [¶[0031]], as well as thermal energy sources [¶[0049]]. Leber further teaches that the various layers of the device are aligned and include alignment holes (371) through which posts (392) extend to enable assembly [¶[0066]; FIG. 4].
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Annotated FIG. 4 of LEBER
With reference to annotated FIG. 4 of Leber (provided above), Leber depicts posts (392) at both an end portion and a central portion designed to extend through corresponding alignment holes (371) in the layers for assembly.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Badawi, Mohn, & Sheydin such that the layers (the protective layer, ductile layer, and substrate layer) each define an opening at an end portion and at a central portion which coincide with one another when each layer is aligned upon one another, since such a modification would allow for an assembly technique wherein layers of the device are aligned and include one or more alignment holes through which posts/fasteners extend to enable assembly of the layers. Such a known assembly technique (securing layers to one another via posts/fasteners extending through aligned openings in device layers) was clearly recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Leber), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Badawi, Mohn, & Sheydin), and the results (securing layers to one another) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, while Leber does not explicitly teach that each layer has 3 openings [i.e., an opening at each end and at a central portion away from a proximal edge and a distal edge], the selection of both the position (placement) and number of openings (for assembly purposes) including, e.g., openings at each end, and in a center portion, would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, since Applicant has not disclosed that the claimed number and position of openings solves any stated problem, or is for any particular purpose [see, e.g., Applicant’s published Specification (U.S. 2021/0022914) at ¶’s [0095]-[0096]]. Further, the claimed number and placement of openings provides no novel or unexpected result over the combination of Badawi, Mohn, Sheydin, & Leber.
18. Regarding claim 2, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] has a first periphery which is shaped to extend and follow a border of one or more meibomian glands contained within the underlying region of skin, and the heating strip further has a second periphery which is shaped to extend and follow a free margin of the eyelid [¶’s [0021], [0085]].
19. Regarding claim 3, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] is configured to adhere to an upper eyelid [¶’s [0084], [0085]; FIGS. 2A-2B].
20. Regarding claim 4, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches a second heating strip [(12) - ¶’s [0084]-[0086]; FIGS. 2A-2B, 3A] in communication with the controller [(340) - ¶[0137]] and configured to adhere to a lower eyelid of the subject [¶’s [0084]-[0086]; FIGS. 2A-2B, 3A].
21. Regarding claim 5, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] and second heating strip [(12)] are electrically coupled to one another via a coupler [see ¶’s [0135]-[0137]; FIG. 39; see also ¶[0161]].
22. Regarding claim 6, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] comprises a contact surface [contact region (30) - ¶[0095]; FIG. 3B] for placement against the underlying region of skin [¶[0095]].
23. Regarding claim 7, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the controller [(340)] is programmed to control one or more parameters of the heating strip [¶’s [0019], [0141], [0144]-[0148]].
24. Regarding claim 8, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the one or more parameters comprise a temperature [¶’s [0019], [0098], [0144], [0148]], treatment time [¶’s [0019], [0098], [0144], [0148]], frequency of treatment [¶[0148]], or thermal profile of the heating strip [¶’s [0096], [0098]].
25. Regarding claim 9, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the controller is programmed to heat the heating strip to a temperature of between 40º to 50º C [NOTE: Badawi teaches a temperature range of between 39ºC and 48ºC [see ¶[0019]], as well as about 20º to 55º C (or more) or between 40º to 50º C [see ¶[0097]].26. Regarding claim 10, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the controller is programmed to heat the heating strip to a temperature up to 45º C [NOTE: Badawi teaches a temperature range of between 39ºC and 48ºC [see ¶[0019]], as well as about 20º to 55º C (or more) or between 40º to 50º C [see ¶[0097]].27. Regarding claim 11, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the controller is programmed to heat the heating strip to a temperature of between 40.5º to 44.5º C [NOTE: Badawi teaches a temperature range of between 39ºC and 48ºC [see ¶[0019]], as well as about 20º to 55º C (or more) or between 40º to 50º C [see ¶[0097]].28. Regarding claim 12, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the controller is programmed to heat the heating strip to a temperature of between 41.5º to 43.5º C [NOTE: Badawi teaches a temperature range of between 39ºC and 48ºC [see ¶[0019]], as well as about 20º to 55º C (or more) or between 40º to 50º C [see ¶[0097]].29. Regarding claim 13, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches one or more temperature sensors incorporated into the heating strip for regulating a temperature of the heating strip [e.g., ¶[0098]].
30. Regarding claims 14-15, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the controller is programmed to heat the heating strip for:
at least 10 minutes [claim 14]; and
up to 15 minutes [claim 15].
Particularly, Badawi teaches that a variety of treatment times may be implemented including, e.g., from 1 minute to 60 minutes [see ¶[0019]], a period of time lasting, e.g., from 5 minutes up to 24 hours or even longer [¶[0097]], a treatment time of, e.g., 1 to 30 minutes or more such as 60 minutes [¶[0144]], as well as an exemplary potential treatment frequency of, e.g., up to six times per day for ten minutes or up to an hour or more for each treatment [see ¶[0092]].
31. Regarding claim 16, Badawi teaches a method of treating a subject, comprising:
conforming a heating strip [treatment strip (10); FIGS. 3A-3B] to an underlying region of skin of an eyelid of a subject… such that the heating strip [(10)] retains a shape of an anatomy of the underlying region of skin [see, e.g., ¶’s [0002], [0028], [0085]-[0088], [0090], [0111]; FIGS. 2A-2B], … a protective layer [insulative layer (38) - ¶[0038] (“an insulative layer 38 may be positioned atop the heating layer 36 for focusing, directing, or reflecting the heat towards the underlying skin surface as well as to protect the patient from contact with the heating layer 36 from other parts of the body”)]… and a substrate layer [heating layer (36) - ¶’s [0096], [0097]; FIG. 3B]…;
initiating a treatment [e.g., ¶’s [0140]-[0144]] with the heating strip [(10)] via a controller [controller (340) - ¶[0135]; FIG. 39] [NOTE: Badawi teaches, at ¶[0137], that any of the described treatment strips may be used with the controller] transmitting electrical energy to the substrate layer [heating layer (36) - ¶’s [0096], [0097]; FIG. 3B] of the heating strip [(10)] having one or more heating elements [e.g., ¶[0097] (“The heating layer 36 may be configured to generate its heat energy… through any number various mechanisms such as mechanical, electrical, or chemical mechanisms”); see also ¶[0100] (“electrically resistive heating elements”); Badawi further teaches that connecting cable (338) provides power to the heating elements in the heating strip assemblies - ¶’s [0135]-[0136]; as such, when used with the treatment strip (10) illustrated in FIGS. 3A-3B, the cable (338) would be in communication with the substrate/heating layer (36) as the heating elements in treatment strip (10) are incorporated in heating layer (36) - ¶’s [0096], [0097], [0100]]…; and
conducting thermal energy from the substrate layer [(36)] throughout the heating strip [(10)]… such that the thermal energy is directed inwardly via the protective layer [(38)] and into the underlying region of skin [e.g., ¶[0096] (“insulative layer 38 may be positioned atop the heating layer 36 for focusing, directing, or reflecting the heat towards the underlying skin surface”)].
A. FLEXIBLE CONNECTOR
As noted above, Badawi teaches that the controller communicates with the substrate/heating layer (36) via a connecting cable.
Badawi further teaches an embodiment [FIG. 44 (provided below)] wherein flexible connectors (402A, 402B) extend from heating strips (400A, 400B), respectively, to a common junction (404), which may then be connected to coupler (410), which is connected to a cable (414) that communicates with a controller [see ¶[0161]; FIG. 44].
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Badawi appears silent, however, regarding the relationship between the flexible connectors and the substrate of the heating strips (400A, 400B). As such, Badawi does not appear to teach the following emphasized limitations:
… initiating a treatment with the heating strip via a controller transmitting electrical energy to a substrate layer of the heating strip having one or more heating elements via a flexible connector formed from the substrate layer and configured to extend from the substrate layer.
Mohn, in a similar field of endeavor, teaches a system comprising a console (20) [controller] that is likewise attached to a pad assembly (30) (for applying heat and electrical stimulation to a human or animal body - ¶[0001]) via a cable (40) [see ¶[0036]; FIG. 1].
The pad assembly (30) comprises a substrate (500) that comprises both:
a) a heating element (502) comprising a plurality of resistors (503); and
b) one or more flexible connectors [conductors (512a, 512b)] patterned on the substrate [i.e., the conductors (512a, 512b) are integral with the substrate (500) and are therefore “formed from the same substrate as the substrate layer” [see ¶’s [0039]-[0043]; FIG. 3].
FIG. 3 further depicts the one or more flexible connectors [conductors (512a, 512b)] “extending from” substrate (500) toward connector (507) which allows for electrical connection to cable (40) [¶[0042]; FIG. 3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Badawi (which already teaches the use of flexible connectors - ¶[0161]; FIG. 44) such that the substrate layer [heating layer (36) of strip (10)], which is in operative communication with controller (340) via a connecting cable (338), also include a flexible connector extending from the substrate layer and formed from the same substrate as the substrate layer, with the controller (340) in communication with the substrate layer via the flexible connector which is configured to transmit electrical energy to the substrate layer, since such a particular known connector mounting technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Mohn), and one of ordinary skill in the art would have been capable of applying this known technique to the known method (of Badawi), and the results would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. DUCTILE LAYER
Badawi teaches that the treatment strips may incorporate various layers into the strips to effect various treatments [see, e.g., ¶[0028]].
Badawi does not, however, explicitly teach a ductile layer attached in proximity to the substrate layer [heating layer (36)]. As such, the combination of Badawi and Mohn, as set forth above, does not teach the following emphasized limitations:
conforming a heating strip to an underlying region of skin of an eyelid of a subject via a ductile layer which conforms and retains its shape within the heating strip such that the heating strip retains a shape of an anatomy of the underlying region of skin, wherein the ductile layer is positioned between a protective layer and a substrate layer and further presents a flush and smooth surface and where the protective layer, ductile layer, and substrate layer each has a contour which is identical to one another…; [and]
conducting thermal energy from the substrate layer [(36)] throughout the heating strip [(10)] via the ductile layer.
However, the use of a layer positioned between a substrate/heating layer and a protective/contact layer was well known in the art, before the effective filing date of the claimed invention, for the purpose of evenly distributing heat generated by the substrate/heating layer [it is noted that Applicant’s Specification (published as U.S. 2021/0022914) likewise describes the “ductile layer” as serving the same purpose at ¶[0093] (“the ductile layer 144 may conduct the heat emitted from the FPCBA layer 140 evenly over the entire heating strip assembly to facilitate the treatment of the underlying tissue surface…”)].
As one example, Sheydin, in a similar field of endeavor, teaches a multilayered heating structure for providing therapeutic benefits to a user [Abstract], including a heating layer (2) with integrated heating elements, a primary therapeutic layer (6) having an outer protective shell layer (14), and a heat-distribution layer (11) mounted between the heating layer (2) and the primary therapeutic layer (6) (and protective shell layer (14)) that evenly distributes the heat generated by the heating layer (2) across the primary therapeutic layer (6) [Sheydin, e.g., ¶’s [0016], [0020]; FIGS. 2-3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Badawi and Mohn to include a ductile layer (a heat distribution layer) within the heating strip so as to provide the benefit/advantage of evenly distributing the heat generated by the substrate/heating layer, as taught by Sheydin. Still further, such a particular known technique (incorporation of a heat distribution layer) was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Sheydin), and one of ordinary skill in the art would have been capable of applying this known technique to the known method (of Badawi/Mohn), and the results (improved heat distribution via incorporation of a heat distribution layer) would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
As modified, the ductile layer (heat distribution layer) would comprise a portion of the overall structure of the heating treatment strip (10) of Badawi/Mohn, which Badawi already teaches presents a flush and smooth surface [¶[0095]] and is configured to conform to (and be retained on) an anatomy of an underlying region of skin of an eyelid of a subject [see, e.g., ¶’s [0002], [0028], [0085]-[0088], [0090], [0111]; FIGS. 2A-2B].
Further, as broadly as currently claimed, the protective layer (38), ductile layer, and substrate layer (36) would all comprise layers of the same device [i.e., treatment strip (10)] which would share the same contour [elongated layers with rounded edges configured similar to the protective layer (38) and the substrate layer (36) as shown in FIG. 3B of Badawi] in order to conform to the same overall general form or structure of the device [note, e.g., FIG. 3A of Badawi which shows an example of a contoured treatment strip (see ¶[0040]), and FIG. 3B which shows the cross-sectional side view (the layers) of the treatment strip of FIG. 3A (see ¶[0041]); each layer shares the same general form or structure]. The heating strip would have a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction while conforming and retaining its shape to the underlying anatomy [see, e.g., ¶’s [0002], [0028], [0085]-[0088], [0090], [0111]; FIGS. 2A-2B] via the ductile layer.
C. OPENINGS
The combination of Badawi, Mohn, & Sheydin does not teach:
where each layer defines an opening at each end and at a central portion away from a proximal edge and a distal edge such that the openings coincide with one another when each layer is aligned upon one another.
However, the provision of aligned openings in layers of a therapeutic heating device was well known in the art, before the effective filing date of the claimed invention, with such openings being used, for example, to allow for the passage of posts (fasteners) to enable the layers to be secured to one another.
As one example, Leber, in a similar field of endeavor, teaches a treatment pad comprising various protective or structural layers [¶[0031]], as well as thermal energy sources [¶[0049]]. Leber further teaches that the various layers of the device are aligned and include alignment holes (371) through which posts (392) extend to enable assembly [¶[0066]; FIG. 4].
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Annotated FIG. 4 of LEBER
With reference to annotated FIG. 4 of Leber (provided above), Leber depicts posts (392) at both an end portion and a “central portion” designed to extend through corresponding alignment holes (371) in the layers for assembly.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Badawi, Mohn, & Sheydin such that the layers (the protective layer, ductile layer, and substrate layer) each define an opening at either end and at a central portion such that the openings coincide with one another when each layer is aligned upon one another, since such a modification would allow for an assembly technique wherein layers of the device are aligned and include one or more alignment holes through which posts/fasteners extend to enable assembly of the layers. Such a known technique (securing layers to one another via posts/fasteners extending through aligned openings in device layers) was clearly recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Leber), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Badawi, Mohn, & Sheydin), and the results (securing layers to one another) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, while Leber does not explicitly teach that each layer has 3 openings [i.e., an opening at each end and at a central portion away from a proximal edge and a distal edge], the selection of both the position (placement) and number of openings (for assembly purposes) including, e.g., openings at each end, and in a center portion, would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, since Applicant has not disclosed that the claimed number and position of openings solves any stated problem, or is for any particular purpose [see, e.g., Applicant’s published Specification (U.S. 2021/0022914) at ¶’s [0095]-[0096]]. Further, the claimed number and placement of openings provides no novel or unexpected result over the combination of Badawi, Mohn, Sheydin, & Leber.
32. Regarding claim 17, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] has a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction from the heating strip while covering one or more meibomian glands contained within the eyelid with the heating strip [e.g., ¶[0090] (“… the treatment strips 10, 12 may apply, e.g., heat energy, to melt or liquefy any waxy or solid meibomian gland obstructions while the eyes remain unobstructed and are allowed to blink naturally. The treatment strips 10, 12 thus allow for the natural blinking…”); see also ¶’s [0018], [0020], [0024]].
33. Regarding claim 18, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] has a first periphery which is shaped to extend and follow a border of the one or more meibomian glands contained within the eyelid and a second periphery which is shaped to extend and follow a free margin of the eyelid [¶’s [0021], [0085]].
34. Regarding claim 19, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein conforming the heating strip [(10)] comprises adhering the heating strip to an upper eyelid of the subject [¶’s [0084], [0085]; FIGS. 2A-2B].
35. Regarding claim 20, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 19 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches adhering a second strip [(12) - ¶’s [0084]-[0086]; FIGS. 2A-2B, 3A] to a lower eyelid of the subject such that one or more meibomian glands contained within the lower eyelid are covered by the second strip [¶’s [0084]-[0086]; FIGS. 2A-2B, 3A].
36. Regarding claim 21, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 20 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the heating strip [(10)] and the second strip [(12)] are electrically coupled to one another [see ¶’s [0135]-[0137]; FIG. 39; see also ¶[0161]].
37. Regarding claim 22, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein initiating the treatment comprises programming the heating strip via the controller attached to the substrate layer [¶’s [0019], [0141], [0144]-[0148]].
38. Regarding claim 23, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 22 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein programming the heating strip comprises controlling one or more parameters of the heating strip [¶’s [0019], [0141], [0144]-[0148]].
39. Regarding claim 24, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein controlling the one or more parameters comprises controlling a temperature [¶’s [0019], [0098], [0144], [0148]], treatment time [¶’s [0019], [0098], [0144], [0148]], frequency of treatment [¶[0148]], or thermal profile of the heating strip [¶’s [0096], [0098]].
40. Regarding claims 25-28, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein controlling the one or more parameters comprises heating the heating strip to:
a temperature of between 40º to 50º C [claim 25];
a temperature up to 45º C [claim 26];
a temperature of between 40.5º to 44.5º C [claim 27]; and
a temperature of between 41.5º to 43.5º C [claim 28].
Particularly, Badawi teaches a temperature range of between 39ºC and 48ºC [see ¶[0019]], as well as about 20º to 55º C (or more) or between 40º to 50º C [see ¶[0097]].
41. Regarding claim 29, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the method of treating comprises treating one or more conditions selected from the group consisting of dry eye [¶[0018]], evaporative dry eye, and Meibomian gland dysfunction [¶’s [0018], [0082]].
42. Regarding claim 30, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the method of treating comprises treating to improve one or more conditions selected from the group consisting of an ocular surface inflammation [¶[0083], [0092], [0093]], degraded tear quality, degraded lipid layer of tears, and shortened tear break up time [see also ¶[0143]].43. Regarding claim 31, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches monitoring a temperature of the heating strip via one or more temperature sensors incorporated into the heating strip [e.g., ¶[0098]].
44. Regarding claims 32-33, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein conducting thermal energy comprises heating the heating strip for:
at least 10 minutes [claim 32]; andup to 15 minutes [claim 33].
Particularly, Badawi teaches that a variety of treatment times may be implemented including, e.g., from 1 minute to 60 minutes [see ¶[0019]], a period of time lasting, e.g., from 5 minutes up to 24 hours or even longer [¶[0097]], a treatment time of, e.g., 1 to 30 minutes or more such as 60 minutes [¶[0144]], as well as an exemplary potential treatment frequency of, e.g., up to six times per day for ten minutes or up to an hour or more for each treatment [see ¶[0092]].
45. Regarding claim 34, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the method comprises treating the subject for a condition selected from the group consisting of meibomitis [¶[0124]], blepharitis [¶[0124]], ocular rosacea, acne [¶[0029]], arthralgia [¶[0029]], myalgia [¶[0029]], hordeolum [¶[0124]], styes [¶[0124]], chalazion [¶[0124]], and abcesses.
46. Regarding claim 35, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the method comprises treating the subject for a condition selected from the group consisting of conjunctivitis [¶’s [0083], [0124]], keratitis [¶’s [0083], [0124]], keratopathy [¶[0083]], iritis [¶[0083]], cyclitis [¶[0083]], glaucoma [¶[0083]], and cataract [¶[0083]].
47. Regarding claim 36, the combination of Badawi, Mohn, Sheydin, & Leber teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Badawi further teaches wherein the method comprises treating the subject for improving a comfort level for wearing a contact lens [¶[0124]].
Response to Arguments
48. As noted above, the 09/10/25 Amendment has overcome the rejections under § 112(b) previously set forth in the 03/13/25 Action.
49. The prior rejection of independent claims 1 & 16 under § 103 has been updated to address the new claim limitations, and maintained (for the reasons set forth in the body of the rejections above).
50. Finally, because new claim objections and rejections under § 112(b) are set forth herein that were not previously set forth in the 03/13/25 Action, this action constitutes a second Non-Final Action.
Conclusion
51. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794