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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Acknowledgment is made of receipt of Information Disclosure Statement (PTO-1449) filed 06/21/2024. An initialed copy is attached to this Office Action.
Claim Objections
Claim 16 is objected to because of the following informalities: line 3 recites “the optical power” with no prior mention. To prevent antecedent basis issues, appropriate correction is required.
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 17-22, 25, 28 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 17, the term “at least essentially flat portion” is unclear. Due to the language “at least essentially” it is open to the interpretation that the portion has a curvature and is not completely flat. Furthermore, a flat surface of an optical zone would have a radius of curvature of zero or infinity. In the dependent claims and the specification, the flat portion comprises a radius of curvature larger than 20 mm. For the purpose of continuing examination, it is assumed that the “at least essentially flat portion” is a curved portion of the anterior surface of the anterior layer of the contact lens structure.
Claim 28 recites the limitation "the posterior surface" in line 2. There is insufficient antecedent basis for this limitation in the claim. For this reason, the distance “at centre of curvature of the posterior surface to the posterior layer” is unclear. For the purpose of continuing examination, it is assumed that the distance is between the posterior layer and the flat component at the center of the contact lens structure.
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 16, 23, 24, 26 and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lemoff et al. (USPG Pub No. 2018/0224671), hereinafter “Lemoff”.
Regarding claim 16, Lemoff discloses a contact lens structure (see Fig. 9, Paragraph 65) comprising: - an enclosure having an anterior layer (902) and a posterior layer (906) (see Fig. 9), wherein a back vertex power of the contact lens structure results from the optical power of at least the anterior layer and the posterior layer (Paragraph 63 – it is inherent for a back vertex power to be established with a contact lens where it is taught that a customization of the shape of the layers is to provide a desired refractive correction of a contact lens); and - an air chamber (948) fully located within the enclosure between the anterior layer and the posterior layer of the enclosure (see Fig. 9, Paragraph 65); wherein the contact lens structure further comprises a flat component (905) arranged at least partly within the air chamber (948) in an optical zone of the contact lens structure (see Fig. 9).
Regarding claim 23, Lemoff discloses wherein the flat component (605) extends over substantially the whole optical zone (see Fig. 6, Paragraph 59 – the multiple flat components span the optical zone).
Regarding claim 24, Lemoff discloses wherein the anterior layer has a thickness between 100 μm and 400 μm (Paragraph 38).
Regarding claim 26, Lemoff discloses further comprising a permeability zone, wherein the permeability zone is a portion of the anterior layer outside the optical zone (see Fig. 1, Paragraph 31).
Regarding claim 28, Lemoff discloses wherein the flat component is arranged with a distance at centre of curvature of the posterior surface to the posterior layer of between 20 and 200 μm (Paragraph 38 – teaches a core thickness sized to carry the flat component 1 of at least 0.1mm = 100 μm).
Regarding claim 29, Lemoff discloses wherein said distance is through the air chamber (948) (see Fig. 9).
Regarding claim 30, Lemoff discloses further comprising a component platform which comprises the flat component (905) and an annular component (944) arranged radially outside the flat component, and wherein at least one opening (612, 614, 616) is formed between the flat component (605) and the annular component, through which at least one opening oxygen is configured to reach the air chamber through the anterior layer (see Figs. 6, 9, Paragraph 65).
Claim Rejections - 35 USC § 103
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 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.
Claims 17-19, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (USPG Pub No. 2018/0224671) in view of Bruce et al. (USPG Pub No. 2021/0094251), hereinafter “Bruce”.
Regarding claim 17, Lemoff discloses wherein the anterior layer (902) comprises an anterior surface (see Fig. 9, Paragraphs 63, 67). Lemoff discloses the claimed invention, but does not specify which anterior surface comprises at least an essentially flat portion. Although the term “essentially flat portion” is interpreted as a curved portion2, Bruce is introduced to provide further teaching that a contact lens is capable of being a flat/planar, convex, concave or combined shape. In the same field of endeavor, Bruce discloses which anterior surface comprises at least an essentially flat portion (Paragraphs 34, 35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the contact lens structure of Lemoff with which anterior surface comprises at least an essentially flat portion of Bruce for the purpose of improving optical quality of the lens (Paragraph 5). Furthermore, such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art In re Dailey, 149 USPQ 47 (CCPA 1966).
Regarding claim 18, Lemoff further discloses wherein the flat portion extends over substantially the whole flat component (see Figs. 6, 9).
Regarding claim 19, Lemoff further discloses wherein the flat portion has a curvature with a radius larger than the radius of other parts of the anterior surface (see Figs. 6, 9). In addition, Paragraphs 33, 35, 103 of Bruce. In the steps taken to customize the configuration of a contact lens, a modification in the shape and size is generally recognized as being within the level of ordinary skill in the art In re Dailey, 149 USPQ 47 (CCPA 1966) and In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 22, Lemoff further discloses wherein the back vertex power of the contact lens structure is dependent on a curvature of the flat portion (Paragraphs 63, 67).
Regarding claim 25, Lemoff further discloses wherein the flat component (605, 905) is arranged adjacent to the flat portion (see Figs. 6, 9).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (USPG Pub No. 2018/0224671) in view of Bruce (USPG Pub No. 2021/0094251) as applied to claim 17 above, and further in view of Shimomura et al. (JP H11174388 A), hereinafter “Shimomura”.
Regarding claim 20, Lemoff and Bruce disclose the claimed invention, but do not specify wherein the radius of curvature of the flat portion is in absolute value larger than 20 mm. In the same field of endeavor, Shimomura discloses wherein the radius of curvature of the flat portion is in absolute value larger than 20 mm (Pg. 5, Paragraphs 10-12 of translation provided). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the contact lens structure of Lemoff and Bruce with wherein the radius of curvature of the flat portion is in absolute value larger than 20 mm of Shimomura for the purpose of providing a customized contact lens (Paragraphs 10-12). Furthermore, in the steps taken to customize the configuration of a contact lens, a modification in the shape and size is generally recognized as being within the level of ordinary skill in the art In re Dailey, 149 USPQ 47 (CCPA 1966) and In re Rose, 105 USPQ 237 (CCPA 1955). Lastly, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (USPG Pub No. 2018/0224671) in view of Bruce (USPG Pub No. 2021/0094251) as applied to claim 17 above, and further in view of Hough (USP No. 6,390,624).
Regarding claim 21, Lemoff discloses wherein the contact lens structure comprises a transition zone and/or a landing zone, wherein the transition zone and/or the landing zone are zones radially outside the optical zone, and wherein the flat portion of the anterior surface has a radius of curvature (see Figs. 6, 9). Lemoff and Bruce disclose the claimed invention, but do not specify larger than portions of the anterior surface at the transition zone and/or landing zone. In the same field of endeavor, Hough discloses larger than portions of the anterior surface at the transition zone and/or landing zone (Table 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the contact lens structure of Lemoff and Bruce with larger than portions of the anterior surface at the transition zone and/or landing zone of Hough for the purpose of providing a lens that corrects a vision defect while providing a normal lens-cornea relationship (Col. 4, Lines 43-46). Furthermore, in the steps taken to customize the configuration of a contact lens, a modification in the shape and size is generally recognized as being within the level of ordinary skill in the art In re Dailey, 149 USPQ 47 (CCPA 1966) and In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (USPG Pub No. 2018/0224671) in view of Chalberg (WO 2018/208724 A1).
Regarding claim 27, Lemoff discloses wherein the air chamber is dimensioned to cover a solid angle viewed from the centre of curvature of the posterior surface (see Fig. 9). Lemoff discloses the claimed invention, but does not specify a solid angle of between 0.5*π and 0.9*π. As the solid angle requirement is illustrated in Fig. 9, Chalberg is presented to provide further evidence that a solid angle is determined based on the customization of the contact lens. In the same field of endeavor, Chalberg discloses a solid angle of between degrees (Pg. 6, Paragraph 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the contact lens structure of Lemoff with a solid angle of between degrees of Chalberg for the purpose of placement in the visual field of the viewer (Pg. 6, Paragraph 2). In addition, in the steps taken to customize the configuration of a contact lens, a modification in the shape and size is generally recognized as being within the level of ordinary skill in the art In re Dailey, 149 USPQ 47 (CCPA 1966) and In re Rose, 105 USPQ 237 (CCPA 1955); it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art In re Aller, 105 USPQ 233 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the contact lens structure of Lemoff and Chalberg with between 0.5*π and 0.9*π for the purpose of placement in the visual field of the viewer (Pg. 6, Paragraph 2 of Chalberg).
Prior Art Citations
Fritsch et al. (USP No. 5,831,713), Etzkorn et al. (USPG Pub No. 2015/0362754), Perozziello et al. (USPG Pub No. 2018/0017811), Mirjalili et al. (USP No. 11,137,622) and Huang (WO 2024/086031 A1) are each being cited herein to show a contact lens structure relevant to the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHIDERE S SAHLE whose telephone number is (571)270-3329. The examiner can normally be reached Monday-Thursday 8:00 AM to 5:00 PM.
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/MAHIDERE S SAHLE/Primary Examiner, Art Unit 2872 6/26/2026
1 See 35 USC § 112 rejection above
2 See 35 USC § 112 rejection above
Prosecution Insights