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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/26/2024, 4/7/2025, 7/28/2025, 9/3/2025, 11/25/2025, 12/23/2025, and 7/8/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: item 602, 974, 934, 1076, 1078, 1134, 1234, 1276, 1214, 1278, 1302, 1304, 1503, 1792, 2116, 2436, 2504, 1548, 2534, 2563, 2562, 2636, 2780, 2734 (examiner notes item 2734a is included, but not 2734 in figure 27A), 2718 (examiner notes item 2718a and 2718b are included, but not 2718 in figure 27B), 5966, 6004, 6071, 6166, 6356, 6412, 6418, 6416, 6410, 6518, 6516, 6616, 7337, 7464, 7490, 7500, 7502, and 7504. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
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 (see figure 43). 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 31 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The abstract of the disclosure is objected to because:
Line 5 recites “at least 1mm”. Examiner suggests adding a space between “1” and “mm” to put the abstract in clearer form.
Line 5 recites “a 1mm distance”. Examiner suggests adding a space between “1” and “mm” to put the abstract in clearer form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 objected to because of the following informalities:
Line 7 recites “a retention portion”. Examiner suggests replacing “a retention portion” in line 7 of claim 1 with “and a retention portion” to put the claim in clearer grammatical form as the body comprises a posterior surface, an anterior surface, and a retention portion.
Line 9 recites “1mm”. Examiner suggests adding a space between “1” and “mm” to put the claim in clearer form.
Line 10 recites “1mm”. Examiner suggests adding a space between “1” and “mm” to put the claim in clearer form.
Line 13 recites “and second height”. As the second height has already been introduced, Examiner suggest replacing “and second height” in line 13 of claim 1 with “and the second height”.
Claim 6 objected to because of the following informalities:
Line 2 recites “1mm”. Examiner suggests adding a space between “1” and “mm” to put the claim in clearer form.
Line 2 recites “1mm2”. Examiner suggests adding a space between “1” and “mm2” to put the claim in clearer form.
Claim 14 objected to because of the following informalities:
Line 2 recites “1mm”. Examiner suggests adding a space between “1” and “mm” to put the claim in clearer form.
Claim 46 objected to because of the following informalities:
Line 2 recites “said device comprise”. This is grammatically incorrect. Examiner suggests replacing “said device comprise” in line 2 of claim 46 with “said device comprises”.
Line 2 recites “1mm”. Examiner suggests adding a space between “1” and “mm” to put the claim in clearer form.
Claim 50 objected to because of the following informalities:
Line 7 recites “c. a retention portion”. Examiner suggests replacing “c. a retention portion” in line 7 of claim 50 with “and c. a retention portion” to put the claim in clearer grammatical form as the body comprises a posterior surface, an anterior surface, and a retention portion.
Line 10 recites “1mm”. Examiner suggests adding a space between “1” and “mm” to put the claim in clearer form.
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 1-6, 14-16, 20, 22-24, 27, 30-31, 41, 46, 48, and 50 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.
In regard to claim 1,
Line 12-13 recites “with the posterior surface facing the horizontal plane to the anterior surface”. It is unclear what is meant by this. It is unclear what line 12-13 requires. For examination purposes Examiner construes “with the posterior surface facing the horizontal plane to the anterior surface” to be “with the posterior surface facing the horizontal plane”. Examiner suggests replacing “with the posterior surface facing the horizontal plane to the anterior surface” in line 12-13 of claim 1 with “with the posterior surface facing the horizontal plane”.
Examiner notes claims 2-6, 14-16, 20, 22-24, 27, 30-31, 41, 46, and 48 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 5,
Line 2 recites “its longitudinal axis”. It is unclear if “its longitudinal axis” refers to a longitudinal axis of the body or to a longitudinal axis of a different structure like the posterior surface, anterior surface, or retention portion. For examination purposes Examiner construes “its longitudinal axis” to be “a longitudinal axis of the body”. Examiner suggests replacing “its longitudinal axis” in line 2 of claim 5 with “a longitudinal axis of the body”.
Line 2 recites “its transversal axis”. It is unclear if “its transversal axis” refers to a transversal axis of the body or to a transversal axis of a different structure like the posterior surface, anterior surface, or retention portion. For examination purposes Examiner construes “its transversal axis” to be “a transversal axis of the body”. Examiner suggests replacing “its transversal axis” in line 2 of claim 5 with “a transversal axis of the body”.
In regard to claim 6,
Line 2 recites “1mm2”. It is unclear if “1mm2” is intended to be “1mm2” or if “1mm2” is intended to be “1mm”. For examination purposes Examiner construes “1mm2” to be “1 mm2”. Examiner suggests replacing “1mm2” in line 2 of claim 6 with “1 mm2”.
In regard to claim 15,
Line 2-4 recites “where said first portion degrades more rapidly than said second portion when said body is in residence on an eye surface”. It is unclear if a method step is being claimed due to the positive term “degrades”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “where said first portion degrades more rapidly than said second portion when said body is in residence on an eye surface” to be “where said first portion is configured to degrade more rapidly than said second portion when said body is in residence on an eye surface”. Examiner suggests replacing “where said first portion degrades more rapidly than said second portion when said body is in residence on an eye surface” in line 2-4 of claim 15 with “where said first portion is configured to degrade more rapidly than said second portion when said body is in residence on an eye surface”.
Examiner notes claim 16 is similarly rejected by virtue of its dependency on claim 15.
In regard to claim 20,
Line 2 recites “said eye surface”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “said eye surface” to be “an eye surface”. Examiners suggests replacing “said eye surface” in line 2 with “an eye surface”.
Line 3 recites “said eyelid”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “said eyelid” to be “an eyelid”. Examiners suggests replacing “said eyelid” in line 3 with “an eyelid”.
Line 1-3 recites “when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate”. It is unclear if a method step is being claimed as the device has not been claimed as being configured to be in residence on said eye surface. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes the device to not positively be required to be on said eye surface. Examiner suggests replacing “when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate” in line 1-3 of claim 20 with “said device is configured to be in residence on an eye surface with said anterior surface adjacent to an inner surface of an eyelid, and said retention portion held in position by a tarsal plate”.
In regard to claim 31,
Line 2 recites “an eye surface”. Claim 31 depends on claim 30 and claim 1. Claim 30 introduces an eye surface. It is unclear if the eye surface of claim 31 is a second eye surface or is intended to be the same eye surface as in claim 30. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “an eye surface” in line 2 of claim 31 with “the eye surface”.
In regard to claim 48,
Line 1-2 recites “wherein said retention portion prevents said device from sliding under an upper eyelid”. Examiner notes the retention portion is not claimed as being configured to be placed under an upper eyelid. It is unclear if a method claim is being claimed due to the positive term “prevents”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “wherein said retention portion prevents said device from sliding under an upper eyelid” to be “wherein said retention portion is configured to prevent said device from sliding under an upper eyelid”. Examiner suggests replacing “wherein said retention portion prevents said device from sliding under an upper eyelid” in line 1-2 of claim 48 with “wherein said retention portion is configured to prevent said device from sliding under an upper eyelid”.
In regard to claim 50,
Line 3-4 recites “a posterior surface which is adjacent to an eye surface when said ophthalmic device is worn”. It is unclear if a method step is being claimed as the device has not been claimed as being configured to be worn within an eye. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “a posterior surface which is adjacent to an eye surface when said ophthalmic device is worn” to be “a posterior surface which is configured to be adjacent to an eye surface when said ophthalmic device is worn”. Examiner suggests replacing “a posterior surface which is adjacent to an eye surface when said ophthalmic device is worn” with “a posterior surface which is configured to be adjacent to an eye surface when said ophthalmic device is worn”.
Line 5-6 recites “an anterior surface which is adjacent to an eyelid when said ophthalmic device is worn”. It is unclear if a method step is being claimed as the device has not been claimed as being configured to be worn within an eye. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “an anterior surface which is adjacent to an eyelid when said ophthalmic device is worn” to be “an anterior surface which is configured to be adjacent to an eyelid when said ophthalmic device is worn”. Examiner suggests relacing “an anterior surface which is adjacent to an eyelid when said ophthalmic device is worn” to be “an anterior surface which is configured to be adjacent to an eyelid when said ophthalmic device is worn”.
Line 7-8 recites “a retention portion defined by heights between said posterior surface and said anterior surface”. It is unclear what is meant by this. It is unclear if the retention portion is a portion between said posterior surface and said anterior surface. Appropriate correction is required. For examination purposes Examiners construes “a retention portion defined by heights between said posterior surface and said anterior surface” to be “a retention portion formed between said posterior surface and said anterior surface”.
Line 9-11 recites “wherein at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points on said posterior surface distanced from each other by at most 1 mm”. It is unclear what is meant by this. It is unclear how at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points on said posterior surface distanced from each other by at most 1 mm. If both points are measured from said posterior surface, it is unclear how at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm. For examination purposes Examiner construes “wherein at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points on said posterior surface distanced from each other by at most 1 mm” to be “wherein at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points distanced from each other by at most 1 mm”.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-4, 6, 20, 22-23, 30-31, 41, 46, 48 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunzler (U.S. PG publication 20060078592).
In regard to claim 1,
Kunzler discloses an ophthalmic device (see all of figure 1 and 2; paragraph [0002]) comprising:
a body (figure 2, item 6 and 10) comprising:
a posterior surface (see surface of item 10);
[AltContent: textbox (Posterior surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Anterior surface)]
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an anterior surface (see figure 2 above);
a retention portion (see figure 2 above wherein the retention portion is formed by the remaining portion of item 10 and 6 that are not the posterior surface or anterior surface) defined between a portion of the posterior surface and a portion of the anterior surface (see figure 2 above);
[AltContent: connector][AltContent: connector][AltContent: connector][AltContent: textbox (Second height)][AltContent: connector][AltContent: textbox (First height)]
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the retention portion having a height difference of at least 1mm over at most a 1mm distance (paragraph [0026]), the height difference being the difference between a first height (height of portion of item 10 only not including the posterior surface) and a second height (height of portion of item 10 and 6 excluding the posterior surface and the anterior surface) that are each measured vertically from a horizontal plane on which the device in a relaxed state rests and with the posterior surface facing the horizontal plane to the anterior surface (see figure 2), the first height and second height being perpendicular to the horizontal plane and the distance being measured horizontally from the first height to the second height (see figure 2).
In regard to claim 3,
Kunzler discloses the ophthalmic device according to claim 1, wherein said retention portion is made of a continuous material (see figure 2 where item 6 of the retention portion is made of a continuous material. It is noted that the claim does not require the retention portion to consist of a continuous material for example).
In regard to claim 4,
Kunzler discloses the ophthalmic device according to claim 1, wherein said body has an oval or round form (see figure 1).
In regard to claim 6,
Kunzler discloses the ophthalmic device according to claim 1, wherein said retention portion has a height of at least 1mm for an area of at least 1mm2 (paragraph [0026]).
In regard to claim 20,
Kunzler discloses the ophthalmic device according to claim 1, wherein, when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate (Examiner notes the ophthalmic device is not positively required to be in residence on said eye surface. The ophthalmic device is fully capable of when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate as supported by paragraph [0002], [0010], and [0025]).
In regard to claim 22,
Kunzler discloses the ophthalmic device according to claim 1, sized to be completely covered by an inferior eyelid when in residence on an eye surface (Examiner notes the ophthalmic device is not positively required to be in residence on said eye surface. The ophthalmic device is fully capable of being sized to be completely covered by an inferior eyelid when in residence on an eye surface as supported by paragraph [0002], [0010], and [0025]-[0026]).
In regard to claim 23,
Kunzler discloses the ophthalmic device according to claim 1, wherein said body is elongate (see figure 1 and 2).
In regard to claim 30,
Kunzler discloses the ophthalmic device according to claim 1, wherein said device is configured to move with respect to an eye surface, during wear (Examiner notes “wherein said device is configured to move with respect to an eye surface, during wear” is a functional limitation. The device is fully capable of the recited function due to its structure. It is noted that before item 10 is sutured for example, the device is capable of moving with respect to an eye surface, during wear).
In regard to claim 31,
Kunzler discloses the ophthalmic device according to claim 30, wherein said posterior surface has sufficiently low suction forces onto an eye surface to enable said movement (As noted above, the movement is not positively. Said posterior surface has sufficiently low suction forces onto an eye surface to enable said movement since the device can be moved).
In regard to claim 41,
Kunzler discloses the ophthalmic device according to claim 1, wherein said body comprises more than one layer (see item 10 and 6) with different material characteristics (Examiner notes the different layers are different materials and therefore would have different material characteristics; see paragraph [0025] and [0017]).
In regard to claim 46,
Kunzler discloses the ophthalmic device according to claim 1, wherein said device comprise a section comprising a length of at least 1mm where a height between said anterior surface and said posterior surface is constant (see figure 2; paragraph [0026]).
In regard to claim 48,
Kunzler discloses the ophthalmic device according to claim 1, wherein said retention portion prevents said device from sliding under an upper eyelid (It is noted that the device is not positively required to be within an eye. Item 10 of the retention portion is capable of preventing said device from sliding under an upper eyelid as supported by paragraph [0025]).
In regard to claim 50,
Kunzler discloses an ophthalmic device (see all of figure 1 and 2; paragraph [0002]), comprising:
A body (figure 2, item 6 and 10) comprising:
[AltContent: textbox (Posterior surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Anterior surface)]
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a. a posterior surface (see surface of item 10) which is adjacent to an eye surface when said ophthalmic device is worn (Examiner notes the ophthalmic device is not positively required to be worn. The posterior surface is fully capable of being adjacent to an eye surface when said ophthalmic device is worn a supported by paragraph [0002], [0010], and [0025]-[0026]);
b. an anterior surface (see figure 2 above) which is adjacent to an eyelid when said ophthalmic device is worn (Examiner notes the ophthalmic device is not positively required to be worn. The anterior surface is fully capable of being adjacent to an eyelid when said ophthalmic device is worn as supported by paragraph [0002], [0010], and [0025]-[0026]);
c. a retention portion (see figure 2 above wherein the retention portion is formed by the remaining portion of item 10 and 6 that are not the posterior surface or anterior surface) defined by heights between said posterior surface and said anterior surface (see figure 2);
[AltContent: connector][AltContent: connector][AltContent: connector][AltContent: textbox (Second height)][AltContent: connector][AltContent: textbox (First height)]
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wherein at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points on said posterior surface distanced from each other by at most 1 mm (paragraph [0026]; see figure 2).
Claims 1-3, 5-6, 20, 22-24, 30-31, 41, 46, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunzler (U.S. PG publication 20060067979). For clarity purposes Kunzler (U.S. PG publication 20060067979) will be referred to as Kunzler979.
In regard to claim 1,
Kunzler979 discloses an ophthalmic device (see all of figure 1; paragraph [0010]) comprising:
[AltContent: textbox (Body )][AltContent: connector][AltContent: rect]
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a body (see body labeled above) comprising:
a posterior surface (see surface of item 12 which forms a posterior surface);
an anterior surface (see surface of item 6 which forms an anterior surface);
a retention portion (remaining portion of the body located between the posterior surface and the anterior surface) defined between a portion of the posterior surface and a portion of the anterior surface (see figure 1);
[AltContent: textbox (Enlarged view of figure 1)][AltContent: connector][AltContent: textbox (First height)][AltContent: textbox (Second height)][AltContent: connector][AltContent: connector][AltContent: connector]
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the retention portion having a height difference of at least 1mm over at most a 1mm distance (paragraph [0027]; see enlarged view of figure 1 above), the height difference being the difference between a first height (see enlarged view of figure 1 above) and a second height (see enlarged view of figure 1 above) that are each measured vertically from a horizontal plane on which the device in a relaxed state rests (see enlarged view of figure 1 above) and with the posterior surface facing the horizontal plane to the anterior surface (see enlarged view of figure 1 above), the first height and second height being perpendicular to the horizontal plane and the distance being measured horizontally from the first height to the second height (see enlarged view of figure 1 above).
In regard to claim 2,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said body is not hollow (see figure 1).
In regard to claim 3,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said retention portion is made of a continuous material (see figure 1 wherein a part of the retention portion is made of a continuous material. It is noted that the claim does not require the retention portion to consist of a continuous material for example).
In regard to claim 5,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said body is symmetrical in its longitudinal axis and in its transversal axis (see figure 1).
In regard to claim 6,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said retention portion has a height of at least 1mm for an area of at least 1mm2 (paragraph [0027]).
In regard to claim 20,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein, when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate (Examiner notes the ophthalmic device is not positively required to be in residence on said eye surface. The ophthalmic device is fully capable of when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate as supported by paragraph [0002], [0010], and [0027]).
In regard to claim 22,
Kunzler979 discloses the ophthalmic device according to claim 1, sized to be completely covered by an inferior eyelid when in residence on an eye surface (Examiner notes the ophthalmic device is not positively required to be in residence on said eye surface. The ophthalmic device is fully capable of being sized to be completely covered by an inferior eyelid when in residence on an eye surface as supported by paragraph [0002], [0010], and [0027])).
In regard to claim 23,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said body is elongate (see figure 1).
In regard to claim 24,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said body is rotationally symmetrical around an axis connecting said anterior surface and said posterior surface (see figure 1).
In regard to claim 30,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said device is configured to move with respect to an eye surface, during wear (Examiner notes “wherein said device is configured to move with respect to an eye surface, during wear” is a functional limitation. The device is fully capable of the recited function due to its structure. It is noted that before item 10 is sutured for example, the device is capable of moving with respect to an eye surface, during wear).
In regard to claim 31,
Kunzler979 discloses the ophthalmic device according to claim 30, wherein said posterior surface has sufficiently low suction forces onto an eye surface to enable said movement (As noted above, the movement is not positively. Said posterior surface has sufficiently low suction forces onto an eye surface to enable said movement since the device can be moved).
In regard to claim 41,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said body comprises more than one layer (figure 1, item 6 and 4) with different material characteristics (paragraph [0017]-[0018]).
In regard to claim 46,
Kunzler979 discloses the ophthalmic device according to claim 1, wherein said device comprise a section comprising a length of at least 1mm where a height between said anterior surface and said posterior surface is constant (see figure 1 and paragraph [0027]).
In regard to claim 50,
Kunzler979 discloses an ophthalmic device (see all of figure 1 and paragraph [0010]), comprising:
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A body (see body labeled above) comprising:
a. a posterior surface (see surface of item 12 which forms a posterior surface) which is adjacent to an eye surface when said ophthalmic device is worn (Examiner notes the ophthalmic device is not positively required to be worn. The posterior surface is fully capable of being adjacent to an eye surface when said ophthalmic device is worn a supported by paragraph [0002], [0010], and [0027]);
b. an anterior surface (see surface of item 6 which forms an anterior surface) which is adjacent to an eyelid when said ophthalmic device is worn (Examiner notes the ophthalmic device is not positively required to be worn. The anterior surface is fully capable of being adjacent to an eyelid when said ophthalmic device is worn as supported by paragraph [0002], [0010], and [0027]);
c. a retention portion (remaining portion of the body located between the posterior surface and the anterior surface) defined by heights between said posterior surface and said anterior surface (See figure 1);
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wherein at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points on said posterior surface distanced from each other by at most 1 mm (paragraph [0027]; see figure 1).
Claims 1, 3-4, 6, 15-16, 20, 22-23, 30-31, 41, 46, 48 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsou (U.S. PG publication 20070026047).
In regard to claim 1,
Tsou discloses an ophthalmic device (see all of figure 4; paragraph [0002]) comprising:
a body (figure 4, item 6, 10, and 14) comprising:
a posterior surface (see surface of item 10);
[AltContent: arrow][AltContent: textbox (Posterior surface)][AltContent: arrow][AltContent: textbox (Anterior surface)]
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an anterior surface (see figure 4 above);
a retention portion (see figure 4 above wherein the retention portion is formed by the remaining portion of item 10, 14 and 6 that are not the posterior surface or anterior surface) defined between a portion of the posterior surface and a portion of the anterior surface (see figure 4 above);
[AltContent: textbox (First height)][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: textbox (Second height)]
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the retention portion having a height difference of at least 1mm over at most a 1mm distance (paragraph [0051]), the height difference being the difference between a first height (height of portion of item 10 only not including the posterior surface) and a second height (height of portion of item 10 and 6 excluding the posterior surface and the anterior surface) that are each measured vertically from a horizontal plane on which the device in a relaxed state rests and with the posterior surface facing the horizontal plane to the anterior surface (see figure 4), the first height and second height being perpendicular to the horizontal plane and the distance being measured horizontally from the first height to the second height (see figure 4).
In regard to claim 3,
Tsou discloses the ophthalmic device according to claim 1, wherein said retention portion is made of a continuous material (see figure 4 where item 6 of the retention portion is made of a continuous material. It is noted that the claim does not require the retention portion to consist of a continuous material for example).
In regard to claim 4,
Tsou discloses the ophthalmic device according to claim 1, wherein said body has an oval or round form (see figure 1).
In regard to claim 6,
Tsou discloses the ophthalmic device according to claim 1, wherein said retention portion has a height of at least 1mm for an area of at least 1mm2 (paragraph [0051]).
In regard to claim 15,
Tsou discloses the ophthalmic device according to claim 1, wherein said body comprises a first portion (figure 4, item 14) and a second portion (figure 4, item 6), where said first portion degrades more rapidly than said second portion when said body is in residence on an eye surface (Examiner notes the body is not positively required to be in residence on an eye surface. The first portion is fully capable of degrading more rapidly than the second portion due to the material properties of the first portion as supported by paragraph [0037], [0040]-[0041] and [0045]) .
In regard to claim 16,
Tsou discloses the ophthalmic device according to claim 15, wherein said second portion forms part or all of said retention portion (see figure 4 wherein said second portion forms part of said retention portion).
In regard to claim 20,
Tsou discloses the ophthalmic device according to claim 1, wherein, when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate (Examiner notes the ophthalmic device is not positively required to be in residence on said eye surface. The ophthalmic device is fully capable of when in residence on said eye surface, said anterior surface is adjacent to an inner surface of said eyelid, and said retention portion is held in position by a tarsal plate as supported by paragraph [0002], [0006], [0032], [0047] and [0051]).
In regard to claim 22,
Tsou discloses the ophthalmic device according to claim 1, sized to be completely covered by an inferior eyelid when in residence on an eye surface (Examiner notes the ophthalmic device is not positively required to be in residence on said eye surface. The ophthalmic device is fully capable of being sized to be completely covered by an inferior eyelid when in residence on an eye surface as supported by paragraph [0002], [0006], [0032], [0047] and [0051]).
In regard to claim 23,
Tsou discloses the ophthalmic device according to claim 1, wherein said body is elongate (see figure 4).
In regard to claim 30,
Tsou discloses the ophthalmic device according to claim 1, wherein said device is configured to move with respect to an eye surface, during wear (Examiner notes “wherein said device is configured to move with respect to an eye surface, during wear” is a functional limitation. The device is fully capable of the recited function due to its structure. It is noted that before item 10 is sutured for example, the device is capable of moving with respect to an eye surface, during wear).
In regard to claim 31,
Tsou discloses the ophthalmic device according to claim 30, wherein said posterior surface has sufficiently low suction forces onto an eye surface to enable said movement (As noted above, the movement is not positively. Said posterior surface has sufficiently low suction forces onto an eye surface to enable said movement since the device can be moved).
In regard to claim 41,
Tsou discloses the ophthalmic device according to claim 1, wherein said body comprises more than one layer (see item 14 and 6) with different material characteristics (Examiner notes the different layers are different materials and therefore would have different material characteristics; see paragraph [0037] and [0040]).
In regard to claim 46,
Tsou discloses the ophthalmic device according to claim 1, wherein said device comprise a section comprising a length of at least 1mm where a height between said anterior surface and said posterior surface is constant (see figure 4; paragraph [0051]).
In regard to claim 48,
Tsou discloses the ophthalmic device according to claim 1, wherein said retention portion prevents said device from sliding under an upper eyelid (It is noted that the device is not positively required to be within an eye. Item 10 of the retention portion is capable of preventing said device from sliding under an upper eyelid as supported by paragraph [0047]).
In regard to claim 50,
Tsou discloses an ophthalmic device (see all of figure 4; paragraph [0002]), comprising:
A body (figure 4, item 6, 10, and 14) comprising:
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a. a posterior surface (see surface of item 10) which is adjacent to an eye surface when said ophthalmic device is worn (Examiner notes the ophthalmic device is not positively required to be worn. The posterior surface is fully capable of being adjacent to an eye surface when said ophthalmic device is worn a supported by paragraph [0002], [0006], [0032], [0047] and [0051]);
b. an anterior surface (see figure 4 above) which is adjacent to an eyelid when said ophthalmic device is worn (Examiner notes the ophthalmic device is not positively required to be worn. The anterior surface is fully capable of being adjacent to an eyelid when said ophthalmic device is worn as supported by paragraph [0002], [0006], [0032], [0047] and [0051]);
c. a retention portion (see figure 4 above wherein the retention portion is formed by the remaining portion of item 10, 14 and 6 that are not the posterior surface or anterior surface) defined by heights between said posterior surface and said anterior surface (see figure 4);
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wherein at least some of said heights between said posterior surface and said anterior surface differ from each other by at least 1mm when measured from two points on said posterior surface distanced from each other by at most 1 mm (paragraph [0051]; see figure 4).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claims 14 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kunzler (U.S. PG publication 20060078592) further in view of De Carvalho (U.S. PG publication 20050113806).
In regard to claim 14,
Kunzler discloses the ophthalmic device according to claim 1.
Kunzler is silent as to wherein said retention portion has a slope of at least 45° for at least a length of 1mm along said anterior surface.
De Carvalho teaches wherein said retention portion has a slope for at least a length of 1mm along said anterior surface (see figure 15 and 13).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kunzler to include wherein said retention portion has a slope for at least a length of 1mm along said anterior surface, as taught by De Carvalho, for the purpose of better fitting the targeted tissue and improving volume capabilities (paragraph [0079]-[0080] and [0097] of De Carvalho).
Further, it would have been an obvious matter of design choice to modify Kunzler in view of De Carvalho to include wherein said retention portion has a slope of at least 45° for at least a length of 1mm along said anterior surface since applicant has not disclosed that having wherein said retention portion has a slope of at least 45° for at least a length of 1mm along said anterior surface solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein said retention portion has a slope of at least 45° for at least a length of 1mm along said anterior surface, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 27,
Kunzler discloses the ophthalmic device according to claim 1.
Kunzler is silent as to wherein said posterior surface is concave.
De Carvalho teaches wherein said posterior surface is concave (see figure 15).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kunzler to include wherein said posterior surface is concave, as taught by De Carvalho, for the purpose of better fitting the targeted tissue (paragraph [0071]-[0072] of De Carvalho).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Tsou (U.S. PG publication 20070026047) further in view of De Carvalho (U.S. PG publication 20050113806).
In regard to claim 27,
Tsou discloses the ophthalmic device according to claim 1.
Tsou is silent as to wherein said posterior surface is concave.
De Carvalho teaches wherein said posterior surface is concave (see figure 15).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsou to include wherein said posterior surface is concave, as taught by De Carvalho, for the purpose of better fitting the targeted tissue (paragraph [0071]-[0072] of De Carvalho).
Conclusion
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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