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.
Information Disclosure Statement
The information disclosure statement(s) filed on April 8, 2026; have/has been acknowledged and considered by the examiner. Initialed copies of supplied IDS(s) forms are included in this correspondence.
Specification
Applicant’s amendments to the specification have been entered. However, it is noted that Applicant had the incorrect paragraph numbers for the originally filed specification (as opposed to the printed publication 2021/0052216). Amendments to the specification filed November 26, 2025 included amendments to what Applicant wrote as para. [0074], [0138], [0148], [0168], however ONLY para. [0074] matched the originally filed specification of August 4, 2020. The text of the paragraphs [0138], [0148], [0168] filed on November 26, 2025 are not the text of the originally filed specification, but of Publication 2021/0052216. Examiner reminds Applicant that the paragraphs of a printed publication are not necessarily the same as those of an originally filed specification. Amendments should be made with respect to the originally filed specification, not the printed publication.
On November 26, 2025 Applicant made amendments to what Applicant wrote as para. [0168], however the text shown on the November 26, 2025 amendment does not match the text of the originally filed specification of para. [0168].
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Response to Amendment
USC 112(a) Issues
Applicant’s amendments to claims 4, 9 have resolved the new matter issues.
Applicant’s amendments to claim 1 and 27 have not resolved the computer algorithm issue. Applicant’s specification continues to lack the sufficient/necessary algorithm to analyze/process images to determine physiological or disease markers of the eye/eyelid.
USC 112(b) Issues
Applicant’s amendments to claim 9 have resolved the 112f+112b issue.
Applicant’s amendments claim 27 has resolved the subjective issue.
USC 103 Issues
Applicant’s amendments have overcome the outstanding rejection
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a) a visual or auditory indicator for providing an alert indicating (synonymous with means for visually/auditorily indicating…)…in claims 1, 27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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.
Claims 1-6, 8-14, 27 are 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 1, the claim recites “a remote server, and wherein the image is processed for determining a condition of the eye and/or eyelid including a physiological or disease marker based on the image and a comparison with one or more selected images obtained previous to 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).
Claims 2-6, 8-14 are rejected as dependent upon claim 1.
As to claim 27, the claim recites “a remote server, and wherein the image is processed for determining a condition of the eye, ocular surface, tear, and/or eyelid including a physiological or disease marker based on the image and a comparison with one or more selected images previously obtained” 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 1-6, 8-14, 27 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 claims 1, 27, the claim limitation “a visual or auditory indicator for providing an alert indicating…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Specifically, the disclosure fails to provide any structure for performing the visual or auditory indication(s). Applicant’s specification discusses the indicators are elements (358) however, no details on what the elements are or how they perform the function(s) of auditory or visual indication.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-6, 8-14 are rejected as dependent upon claim 1.
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 1-6, 8-14, 27 are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2013/0172829; of record) in view of Gravely et al. (US 2008/0081999 - Gravely; of record) and Badawi et al. (US 2016/0106576 - herein Badawi2).
As to claim 1, Badawi teaches a treatment system for determination of a patient (Badawi Fig. 39) comprising
a controller having a housing configured for connection to one or more heating stirps (Badawi Fig. 39 - 340, 338; para. [0127]);
an imager incorporated into an external device (Badawi Fig. 39 - 342; para. [0127] - smartphone; para. [0135]) which is in communication with the controller (Badawi Fig. 39; para. [0127] - external device (342) in communication with controller (340)) and configured to image an eye and/or eyelid (Badawi Fig. 39 - 342; para. [0127] - smartphone, thus necessarily configured to image an eye);
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 wherein the image is processed for determining a condition of the eye (Badawi Fig. 39 - 340; para. [0137] - 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/or eyelid including physiological or disease markers or progress (Badawi para. [0135]);
While Badawi states that both the controller (340) and external device (342) are configured to communicate wirelessly (Badawi para. [0127], [0137]), Badawi does not specify whether the controller (340) and external device (342) are in wireless communication with each other.
Additionally while Bawadi determines conditions of the eye/eyelid as treatment progresses (Bawadi para. [0135]) Bawadi doesn’t specify the server determines the physiological or disease markers based on image comparison with one or more selected images previously obtained.
Badawi doesn’t specify a visual or auditory indicator for providing an alert indicating whether the one or more heating strips are properly connected to the controller.
In the same field of endeavor Gravely teaches determining a condition of the eye and/or eyelid including physiological or disease markers (Gravely para. [0002], [0030]) based on an image (Gravely Fig. 6 - 90, 106; Fig. 10; Fig. 11 - 254; para. [0030]) and a comparison with one or more selected images obtained previous to the image (Gravely Fig. 6 - 78; Fig. 11 - 242; para. [0030]; Figs. 7-9; para. [0122]-[0127]) as treatment progresses (Gravely Fig. 6; Figs. 7-9; Fig. 11).
In the same field of endeavor Badawi2 teaches a treatment system with controller (Badawi2 Fig. 40 - 350) with connectable heat strips (Badawi2 Fig. 41B - 370A, B; para. [0151) with visual or auditory indicators providing an alert the heating strip(s) are properly connected to the controller (Badawi2 Fig. 40 - 458; para. [0149])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to provide wireless communication between the controller and external device since, as taught by Badawi, wireless communication is well known in the art for the purposes of transmitting data and other computer implemented functions (Badawi para. [0137], [0138]), to determine the condition based on image comparison since, as taught by Gravely, such image comparison allows for comparing before and after meibomian gland treatment (Gravely para. [0030], [0122]-[0123]), and to provide indicators for to indicate to the user the heat strips are properly connected (Badawi2 para. [0149]).
As to claim 2, Badawi in view of Gravely, Badawi2 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. [0135]).
As to claim 3, Badawi in view of Gravely, Badawi2 teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches a display along the housing (Badawi para. [0137]).
As to claim 4, Badawi in view of Gravely, Badawi2 teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Badawi further teaches a visual or auditory indicator is positioned along the housing (Badawi para. [0137]).
As to claim 5, Badawi in view of Gravely, Badawi2 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. [0132]-[0138] - electronic device 342 or controller 340 may leverage an integrated camera...controller is in wireless communication with server, etc.).
As to claim 6, Badawi in view of Gravely, Badawi2 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. [0135]).
As to claim 8, Badawi in view of Gravely, Badawi2 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. [0135]).
As to claim 9, Badawi in view of Gravely, Badawi2 teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Gravely 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 (Gravely Fig. 10 - 54, 208, 210).
As to claim 10, Badawi in view of Gravely, Badawi2 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. [0135]).
As to claim 11, Badawi in view of Gravely, Badawi2 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 [0033]).
As to claim 12, Badawi in view of Gravely, Badawi2 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. [0089]).
As to claim 13, Badawi in view of Gravely, Badawi2 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. [0089]), 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 in view of Gravely, Badawi2 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 for sizing one or more heating strips for a patient (Badawi Figs. 31, 32, 34, 39) comprising
a controller having a housing configured for connection to one or more heating stirps (Badawi Fig. 39 - 340, 338; para. [0127]);
an imager incorporated into an external device (Badawi Fig. 39 - 342; para. [0127] - smartphone; para. [0135]) which is in communication with the controller (Badawi Fig. 39; para. [0127] - external device (342) in communication with controller (340)) and configured to image an eye and/or eyelid (Badawi Fig. 39 - 342; para. [0127] - smartphone, thus necessarily configured to image an eye);
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]-[0135] - electronic device 342 or controller 340 may leverage an integrated camera...) and wirelessly transmit the image to a remote server, and wherein the image is processed for determining a condition of the eye (Badawi Fig. 39 - 340; para. [0137] - 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/or eyelid including physiological or disease markers or progress (Badawi para. [0135]) the one or more heating strips have a length between 1mm and 50mm (Badawi para. [0079]) to conform over meibomian glands contained within the eyelid (Badawi Figs. 31-32, 34; para. [0027], [0029], [0066], [0068], [0122]);
While Badawi states that both the controller (340) and external device (342) are configured to communicate wirelessly (Badawi para. [0127], [0137]), Badawi does not specify whether the controller (340) and external device (342) are in wirelessly communication with each other.
Additionally while Bawadi determines conditions of the eye/eyelid as treatment progresses (Bawadi para. [0135]) Bawadi doesn’t specify the server determines the physiological or disease markers based on image comparison with one or more selected images previously obtained.
Badawi doesn’t specify a visual or auditory indicator for providing an alert indicating whether the one or more heating strips are properly connected to the controller.
In the same field of endeavor Gravely teaches determining a condition of the eye and/or eyelid including physiological or disease markers (Gravely para. [0002], [0030]) based on an image (Gravely Fig. 6 - 90, 106; Fig. 10; Fig. 11 - 254; para. [0030]) and a comparison with one or more selected images obtained previous to the image (Gravely Fig. 6 - 78; Fig. 11 - 242; para. [0030]; Figs. 7-9; para. [0122]-[0127]) as treatment progresses (Gravely Fig. 6; Figs. 7-9; Fig. 11).
In the same field of endeavor Badawi2 teaches a treatment system with controller (Badawi2 Fig. 40 - 350) with connectable heat strips (Badawi2 Fig. 41B - 370A, B; para. [0151) with visual or auditory indicators providing an alert the heating strip(s) are properly connected to the controller (Badawi2 Fig. 40 - 458; para. [0149])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to provide wireless communication between the controller and external device since, as taught by Badawi, wireless communication is well known in the art for the purposes of transmitting data and other computer implemented functions (Badawi para. [0137], [0138]), to determine the condition based on image comparison since, as taught by Gravely, such image comparison allows for comparing before and after meibomian gland treatment (Gravely para. [0030], [0122]-[0123]), and to provide indicators for to indicate to the user the heat strips are properly connected (Badawi2 para. [0149]).
Conclusion
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZACHARY W WILKES/Primary Examiner, Art Unit 2872 May 29, 2026
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