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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 9, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement(s) filed on July 9, 2026 have/has been acknowledged and considered by the examiner. Initialed copies of supplied IDS(s) forms are included in this correspondence.
Response to Amendment
In general, Applicant’s remarks are not persuasive as Applicant appears to be attempting to define the server by what data it receives. For example, the claim recites “the remote server is configured to receive the image of the eye…”. If the server of the prior art is “configured to” receive data, it is certainly configured to receive an “image of an eye” since such image is nothing more than data. What data the server receives does not define the server (MPEP 2112.01; 2114.IV). Therefore, so long as the prior art server can receive data, it can receive an image of the eye.
Similarly, Applicant’s language “a display…configured to display an image of the eye…to a user for…” does not define the display. So long as the art’s display can display an image to a user, such limitation is met regardless of the image itself or how the user wants to assess the image (MPEP 2112.01; 2114.IV).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 29 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 29, the claim recites “the controller is further configured to determine one or more dimensions for the one or more heating strips based on the image…” which appears to be prohibited new matter. Examiner requests Applicant point out where in the originally filed specification support for such features exist.
As to claim 29, the claim recites “the controller is further configured to determine one or more dimensions for the one or more heating strips based on the image…” which is a computer implemented function without the necessary/sufficient algorithm (MPEP 2161.01.I).
Applicant's specification does not appear to contain any algorithm to compare the images and determine a condition of the eye/eyelid. As per MPEP 2161.01.I - When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 27, the claim recites “the image of the eye, ocular surface, tear, and/or eyelid” which lacks antecedent basis (MPEP 2173.05(e)). Prior to this, there is only “to image an eye and/or eyelid of the patient”.
Claim 29 is rejected as dependent upon claim 27.
As to claim 29, the claim recites “configured to determine one or more dimensions for the one or more heating strips based on the image…the one or more dimensions are sized to conform the one or more heating strips…” which is unclear regarding the relationship between determining the dimensions and the dimensions being sized. Are the dimensions being determined (calculated) and then determining if those dimensions are sized to conform the heating strips over the glands? Other? For purposes of compact prosecution so long as the art teaches determining the dimensions of the heating strips to conform for the eye, such limitation will be considered met.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5-6, 8-14, 27 are rejected under 35 U.S.C. 103 as being unpatentable over Badawi et al. (US 2016/0106576 - herein Badawi; of record).
As to claim 1, Badawi teaches a treatment system (Badawi Figs. 39-45) for determining a condition of a patient comprising
a controller having a housing configured for connection to one or more heating strips (Badawi Fig. 39 - 340, 338; para. [0137]; Fig. 40 - 350, 354; para. [0149]);
an imager incorporated into an external device which is in wireless communication with the controller and configured to image an eye or eyelid of the patient (Badawi Fig. 39 - 342; para. [0135] - smartphone (342); para. [0146] - device (342) may communicate wirelessly with additional controller);
wherein the controller is configured to receive the image of the eye and/or eyelid from the external device (Badawi Fig. 39 - 340, 342; para. [0132]-[0137] - electronic device 342 or controller 340 may leverage an integrated camera; controller may display visual information received from server/external device) and wirelessly transmit the image to a remote server (Badawi Fig. 39 - 340; para. [0145] - as disclosed, the controller (340) can include an imager, the controller includes a wireless connection and protocols to send necessary data to a remove server (i.e. is configured to transmit an image (e.g. data) to a remote server));
and wherein the remote server is configured to receive the image of the eye and/or the eyelid from the controller (Badawi para. [0143], [0145]), the image showing a condition of the eye or eyelid including physiological or disease markers (Badawi para. [0143]), and wherein the remote server is further configured to receive one or more selected images obtained previous to the image as treatment progresses (Badawi para. [0143]); and
a display along the housing configured to display the image of the eye or eyelid to a user for confirming the eye and/or eyelid is captured in the image (Badawi Fig. 39 - 340; para. [0145] - as discussed, controller (340) includes a display that is configured to display images (advertisements, educational media, etc.) and thus is necessarily “configured to” display an image of the eye/eyelid), the display further configured to provide an alert indicating whether the one or more heating strips are properly connected to the controller (Badawi Fig. 40 - 358; para. [0149]).
While Badawi teaches all the limitations as detailed above, Badawi does not specify the controller (340) and additional controller (350) include the same functions such that “a controller having a display configured to display the image of the eye” and “the display further configured to display…” the heating strip alert are the same controller in the same embodiment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to provide the displays on a the same controller since it has been held that making in one piece an article which has formerly been formed in multiple pieces involves only routine skill in the art. In re Larson 144 USPQ 347, 349, (CCPA 1965). As discussed by Badawi, a display providing an alert for connection of the heating strips allows for knowing the strips are properly connected (Badawi para. [0149]).
As to claim 2, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches a light for illuminating the eye and/or eyelid (Badawi para. [0143]).
As to claim 5, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is configured to wirelessly communicate with an external device to receive one or more images of the eye and/or eyelid (Badawi Fig. 39 - 340, 342; para. [0140]-[0145] - electronic device 342 or controller 340 may leverage an integrated camera...controller is in wireless communication with server, etc.).
As to claim 6, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is configured to track a condition of the eye and/or eyelid over time (Badawi para. [0143]).
As to claim 8, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is configured to analyze tear film analysis (Badawi para. [0143]).
As to claim 9, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is configured to analyze a condition of the eye and/or eyelid based on physiological data received from an imaging device comprising a camera in communication with the controller (Badawi para. [0143]).
As to claim 10, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is further configured to receive the image which includes an internal image of an inside of the eye and/or eyelid (Badawi para. [0143]).
As to claim 11, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is configured to monitor and induce a temperature in the one or more strips to provide a therapy (Badawi para [0019]).
As to claim 12, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the controller is programmable to maintain a set point above a threshold temperature and below a maximum temperature over a predetermined treatment period (Badawi para. [0097]).
As to claim 13, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the one or more strips are configured to emit thermal energy to an underlying region of the skin (Badawi para. [0097]), and wherein one or more strips are shaped to follow a location of one or more meibomian glands within the underlying region of the skin (Badawi Figs. 4-23).
As to claim 14, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches the one or more strips are configured to adhere to an underlying region of skin in proximity to one or both eyes of a subject such that one or more strips allow for the subject to blink naturally with minimal, or no restriction from the one or more strips (Badawi para. [0018]).
As to claim 27, Badawi teaches a treatment system (Badawi Figs. 39-45) for determining a condition of a patient comprising
a controller having a housing configured for connection to one or more heating strips (Badawi Fig. 39 - 340, 338; para. [0137]; Fig. 40 - 350, 354; para. [0149]);
an imager incorporated into an external device which is in wireless communication with the controller and configured to image an eye or eyelid of the patient (Badawi Fig. 39 - 342; para. [0135] - smartphone (342); para. [0146] - device (342) may communicate wirelessly with additional controller);
wherein the controller is configured to receive the image of the eye and/or eyelid from the external device (Badawi Fig. 39 - 340, 342; para. [0132]-[0137] - electronic device 342 or controller 340 may leverage an integrated camera; controller may display visual information received from server/external device) and wirelessly transmit the image to a remote server (Badawi Fig. 39 - 340; para. [0145] - as disclosed, the controller (340) can include an imager, the controller includes a wireless connection and protocols to send necessary data to a remove server (i.e. is configured to transmit an image (e.g. data) to a remote server)),
and wherein the remote server is configured to receive the image of the eye and/or the eyelid from the controller (Badawi para. [0143], [0145]), the image showing a condition of the eye or eyelid including physiological or disease markers (Badawi para. [0143]), and wherein the remote server is further configured to receive one or more selected images obtained previous to the image as treatment progresses (Badawi para. [0143]),
wherein the one or more heating strips have a length between 1mm and 50mm to conform over one or more meibomian glands contained within the eyelid (Badawi para. [0087]);
a display along the housing configured to display the image of the eye or eyelid to a user for confirming the eye and/or eyelid is captured in the image (Badawi Fig. 39 - 340; para. [0145] - as discussed, controller (340) includes a display that is configured to display images (advertisements, educational media, etc.) and thus is necessarily “configured to” display an image of the eye/eyelid), the display further configured to provide an alert indicating whether the one or more heating strips are properly connected to the controller (Badawi Fig. 40 - 358; para. [0149]).
While Badawi teaches all the limitations as detailed above, Badawi does not specify the controller (340) and additional controller (350) include the same functions such that “a controller having a display configured to display the image of the eye” and “the display further configured to display…” the heating strip alert are the same controller in the same embodiment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to provide the displays on a the same controller since it has been held that making in one piece an article which has formerly been formed in multiple pieces involves only routine skill in the art. In re Larson 144 USPQ 347, 349, (CCPA 1965). As discussed by Badawi, a display providing an alert for connection of the heating strips allows for knowing the strips are properly connected (Badawi para. [0149]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Badawi as applied to claim 27 above, and further in view of Ho et al. (US 2022/0304865 - Ho).
As to claim 29, Badawi teaches all the limitations of the instant invention as detailed above with respect to claim 27, and Badawi further teaches one or more dimensions are sized to conform the one or more heating strips over one or more meibomian glands within the eyelid (Badawi Fig. 3A - 10 ,12; para. [0087]; Figs. 4-39; para. [0166])
While Badawi teaches the heating strip (eye mask/patch(es)) can be custom made (Badawi para. [0087], [0166]), Badawi doesn’t specify determining dimensions for the strips based on an image.
In the same field of endeavor Ho teaches imaging an eye strip/patch/mask wearer and determining one or more dimensions from the image (Ho Figs. 1-6; Fig. 10 - 710, 740, 750; para. [0095]-[0097]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to provide the dimensions from an image since, as taught by Ho, such 3D scans allow for determining the individual user’s face and generating the corresponding contoured strip/mask/patch (Ho Figs. 1-6; Fig. 10 - 710, 740, 750; para. [0095]-[0097]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY W WILKES whose telephone number is (571)270-7540. The examiner can normally be reached M-F 8-4 (Pacific).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY W WILKES/Primary Examiner, Art Unit 2872 August 21, 2026
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