DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed on 8/5/2026 has been entered. Claims 1-16 and 18-29 remain pending in the application. Claims 1-14 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 5/15/2026.
Applicants amendments to the specification have failed to overcome all of the drawing objections previously set forth in the Non-final Office Action mailed 5/15/2026. Specifically, the objection to the drawings for not including item 4332 mentioned in the description was not overcome. Item 4332 is mentioned on page 60 of the specification. Item 4332 however is not included in the drawings.
Applicants amendments to the abstract have overcome the abstract objections previously set forth in the Non-final Office Action mailed 5/15/2026.
Applicants amendments to the claims have failed to overcome all of the claim objections previously set forth in the Non-final Office Action mailed 5/15/2026. Specifically, the objection of “the maximum distance” in claim 22 was not overcome.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 5/15/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/22/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: item 4332. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 22 objected to because of the following informalities:
Line 6 recites “the maximum distance”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the maximum distance” in line 6 of claim 22 with “a maximum distance”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-16 and 18-28 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.
In regard to claim 15,
Line 6 recites “a surface of an eye”. Line 4 recites “an eye surface”. It is unclear if the surface of an eye is an additional surface to the eye surface of line 4, or it the surface of the eye in line 6 is the same surface as the eye surface of line 4. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “an eye surface” in line 4 with “a surface of an eye” AND replacing “a surface of an eye” in line 6 with “the surface of the eye”.
Line 22-23 recites “an eye of the patient”. Line 6 of claim 15 introduces an eye. It is unclear if the eye of line 22-23 is the same eye as line 6. It is also noted that line 25 refers to “the eye” and it is unclear which eye (the eye of line 22-23 or the eye of line 6) the eye refers to. For examination purposes Examiner construes the eye of line 22-23 and line 6 to be the same. Examiner suggests replacing “an eye of the patient” with “the eye of the patient”.
Allowable Subject Matter
Claims 15-16 and 18-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 15,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a method of treating a patient suffering from an ophthalmic condition using an ophthalmic device comprising a body comprising a drug and the body having: the retention portion being bordered by a portion of the anterior surface and having a height difference of at least 1 mm over at most a 1 mm distance, the height difference being a vertical difference between a first height and a parallel second height that are each coplanar with the imaginary central vertical cross sectional plane and that are each measured from the horizontal plane vertically to the anterior surface, the distance being measured horizontally from the first height to the second height in combination with the specific claimed method steps of claim 15.
Bawa (U.S. Patent no 5137728) a method of treating a patient suffering from an ophthalmic condition (column 1, line 45-58) using an ophthalmic device (see device of figure 2) comprising a body (see figure 2) comprising a drug (column 7, line 20-45 and column 8, line 3-column 8, line 30) and the body having: a posterior surface which is configured to face an eye surface when the ophthalmic device is worn (see figure 2; column 9, line 60-column 10, line 10); an anterior surface defining a height of the body above a surface of an eye (see figure 2), the posterior surface and the anterior surface joining at an edge (see figure 2), the edge comprising a leading edge that is configured to be a portion of the edge nearest an opening of an inferior eyelid when the ophthalmic device is worn (see figure 2; column 9, line 60-column 10, line 10), the body defining an imaginary central vertical cross sectional plane that intersects the leading edge and is perpendicular to a horizontal plane on which the ophthalmic device in a relaxed state rests (see figure 2); and a retention portion (see figure 2 wherein the body of the device between the posterior surface and the anterior surface form the retention portion) configured to reside between the inferior eyelid and the surface of the eye (column 9, line 60-column 10, line 10), the retention portion being bordered by a portion of the anterior surface (see figure 2), the method comprising a. applying the ophthalmic device to a bulbar conjunctiva of an eye of the patient beneath the inferior eyelid (column 9, line 60-column 10, line 10); and b. allowing the ophthalmic device to release a therapeutic amount of the drug to the surface of the eye while the ophthalmic device remains beneath the inferior eyelid (column 1, line 53-58, column 7, line 20-45 and column 8, line 3-column 8, line 30). Bawa fails to disclose the retention portion being bordered by a portion of the anterior surface having a height difference of at least 1 mm over at most a 1 mm distance, the height difference being a vertical difference between a first height and a parallel second height that are each coplanar with the imaginary central vertical cross sectional plane and that are each measured from the horizontal plane vertically to the anterior surface, the distance being measured horizontally from the first height to the second height.
Hussain (U.S. Patent no 3960150) a method of treating a patient suffering from an ophthalmic condition (column 2, line 53-54) using an ophthalmic device (column 2, line 55-57; see figure 5) comprising a body (see figure 5) comprising a drug (column 11, line 15-43) and the body having: a posterior surface (see figure 5) which is configured to face an eye surface when the ophthalmic device is worn (see figure 5); an anterior surface (see figure 5) defining a height of the body above a surface of an eye (see figure 5), the posterior surface and the anterior surface joining at an edge (see figure 5), the edge comprising a leading edge that is configured to be a portion of the edge nearest an opening of an inferior eyelid when the ophthalmic device is worn (see figure 5), the body defining an imaginary central vertical cross sectional plane that intersects the leading edge and is perpendicular to a horizontal plane on which the ophthalmic device in a relaxed state rests (see figure 5); and a retention portion (see figure 5 wherein the body of the device between the posterior surface and the anterior surface form the retention portion) configured to reside between the inferior eyelid and the surface of the eye (see figure 2), the retention portion being bordered by a portion of the anterior surface (see figure 5); the method comprising: a. applying the ophthalmic device to a bulbar conjunctiva of an eye of the patient beneath the inferior eyelid (see figure 2); and b. allowing the ophthalmic device to release a therapeutic amount of the drug to the surface of the eye while the ophthalmic device remains beneath the inferior eyelid (column 11, line 15-43). Hussain fails to disclose the retention portion being bordered by a portion of the anterior surface having a height difference of at least 1 mm over at most a 1 mm distance, the height difference being the vertical difference between a first height and a parallel second height that are each coplanar with the imaginary central vertical cross sectional plane and that are each measured from the horizontal plane vertically to the anterior surface, the distance being measured horizontally from the first height to the second height.
Badawi (U.S. PG publication 20130172829) a method of treating a patient suffering from an ophthalmic condition (paragraph [0002]) using an ophthalmic device (see figure 3A, item 12) comprising a body (see figure 3A) comprising a drug (paragraph [0018] and [0098]-[0101]) and the body having: a posterior surface which is configured to face an eye surface when the ophthalmic device is worn (see figure 3A and 2B); an anterior surface (see figure 3A) defining a height of the body above a surface of an eye (see figure 3A), the posterior surface and the anterior surface joining at an edge (see figure 3A), the edge comprising a leading edge that is configured to be a portion of the edge nearest an opening of an inferior eyelid when the ophthalmic device is worn (see figure 3A and 2), the body defining an imaginary central vertical cross sectional plane that intersects the leading edge and is perpendicular to a horizontal plane on which the ophthalmic device in a relaxed state rests (See figure 3A); and a retention portion (see figure 3A wherein the body of the device between the posterior surface and the anterior surface form the retention portion) configured to reside between the inferior eyelid and the surface of the eye (see figure 2 and 3A), the retention portion being bordered by a portion of the anterior surface (see figure 3A); the method comprising: a. applying the ophthalmic device to a bulbar conjunctiva of an eye of the patient beneath the inferior eyelid (see figure 2); and b. allowing the ophthalmic device to release a therapeutic amount of the drug to the surface of the eye while the ophthalmic device remains beneath the inferior eyelid (paragraph [0018] and [0098]-[0101]). Badawi fails to disclose the retention portion being bordered by a portion of the anterior surface having a height difference of at least 1 mm over at most a 1 mm distance, the height difference being the vertical difference between a first height and a parallel second height that are each coplanar with the imaginary central vertical cross sectional plane and that are each measured from the horizontal plane vertically to the anterior surface, the distance being measured horizontally from the first height to the second height.
Chow (U.S. PG publication 20070154522) a method of using an ophthalmic device (see figure 1) comprising a body (see figure 1) comprising a drug (paragraph [0040]-[0041]) and the body having: a posterior surface (see figure 1) which is configured to face an eye surface when the ophthalmic device is worn (see figure 1); an anterior surface (see figure 1) defining a height of the body above a surface of an eye (see figure 1), the posterior surface and the anterior surface joining at an edge (see figure 1), the edge comprising a leading edge that is configured to be a portion of the edge nearest an opening of an inferior eyelid when the ophthalmic device is worn (see figure 1), the body defining an imaginary central vertical cross sectional plane that intersects the leading edge and is perpendicular to a horizontal plane on which the ophthalmic device in a relaxed state rests (see figure 1); and a retention portion (see figure 1 wherein the body of the device between the posterior surface and the anterior surface form the retention portion) configured to reside between the inferior eyelid and the surface of the eye (see figure 1), the retention portion being bordered by a portion of the anterior surface (see figure 1); the method comprising: b. allowing the ophthalmic device to release a therapeutic amount of the drug to the surface of the eye (paragraph [0005] and [0040]-[0041]). Chow fails to disclose the retention portion being bordered by a portion of the anterior surface having a height difference of at least 1 mm over at most a 1 mm distance, the height difference being the vertical difference between a first height and a parallel second height that are each coplanar with the imaginary central vertical cross sectional plane and that are each measured from the horizontal plane vertically to the anterior surface, the distance being measured horizontally from the first height to the second height.
As disclosed in the instant application the specific claimed dimensions of the device provide an increased surface for interaction with the eyelid/s e.g. for retention of the device within the eyelid and/or when removing the device using pinch removal (see page 44, line 22-27 of the instant disclosure) and prevent rotation (see page 44, line 28-page 45, line 3 of the instant disclosure). Accordingly, claim 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 29 is allowed.
The following is an examiner’s statement of reasons for allowance:
In regard to claim 29,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a method of treating a patient suffering from an ophthalmic condition using an ophthalmic device, the ophthalmic device comprising the body further comprising a retention portion defined between the posterior and anterior surfaces, exhibiting a height difference of at least 1 mm over at most a 1 mm horizontal distance, the height difference being a vertical difference between first and second points on the anterior surface that are each coplanar with the imaginary central vertical cross-sectional plane and measured vertically from the horizontal plane. Claim 29 requires similar limitations as claim 15 and therefore is allowed for similar reasons as detailed above in claim 15.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 8/5/2026 have been fully considered but they are not persuasive. In regard to the drawings, Applicant argues that the specification has been amended to include the reference characters not mentioned in the description and found in the figures. The drawings were also objected to as item 4332 is mentioned on page 60 of the specification, but is not included in the drawings. The drawings were not amended to include item 4332. The specification was not amended to delete item 4332. Accordingly, the drawing objection still remains.
Applicant argues that the Applicant has amended claim 22 as suggested by the Examiner to state “a maximum distance”. Claim 22 however still states “the maximum distance”. Accordingly, the claim objection of “the maximum distance” in claim 22 still remains.
In regard to Applicant’s arguments regarding the rejoinder, the withdrawn claims do not require all limitations of an allowable claim. The allowable claims are drawn to a method and the withdrawn claims do not require all of the limitations of the allowable method. Additionally, the device claims do not disclose all of the features of the device in the method claims as argued by Applicant. For example, the device in the method claims require the body to contain a drug. A drug is not required in withdrawn claim 1. Furthermore, withdrawn claim 1 would need to include all limitations of the allowable method claim, not only the features of the device, in order to be rejoined.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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