DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 01/12/2024. Claims 1-20 are pending and examined below.
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.
Claim(s) 1-10, 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140107448 A1 (hereinafter referred to as “Liu”).
Regarding claim 1, Liu, a contact lens to detect biometric information (abstract; Figures 2A-B), teaches contact lens (paragraph [0057]) made of non-hydrophilized material (paragraphs [0067]), comprising at least one functional element (“bio-interactive electronics module 260 includes an analyte bio-sensor, for example, mounting such a bio-sensor on the substrate 230 to be close to the concave surface 226 allows the bio-sensor to sense analyte concentrations in tear film near the surface of the eye”; paragraph [0073]) disposed in correspondence with a rear surface of said lens and protruding with respect to said surface so as to be facing, during use, toward the eyeball (“The sensor can be arranged on the substrate to face inward, toward the corneal surface, so as to generate clinically relevant readings from near the surface of the cornea and/or from tear fluid interposed between the contact lens and the corneal surface”; paragraph [0035]; as shown in Figures 2A-B), being configured as a sensor suitable to detect the presence of one or more physiological parameters, or as a reservoir suitable to deliver, onto the corneal surface, one or more liquids for treating the eye (“Tear fluid contains a variety of inorganic electrolytes (e.g., Ca2+, Mg2+, Cl−), organic components (e.g., glucose, lactate, proteins, lipids, etc.), and so on that can be used to diagnose health states. The ophthalmic sensing platform can measure one or more of these components and provide a convenient non-invasive platform to diagnose or monitor health related problems. For example, the ophthalmic sensing platform can be configured to sense glucose and be used to measure glucose levels in diabetic patients”; paragraph [0037]).
Regarding claim 2, Liu teaches further comprising a circular shaped internal sector and an annular shaped external sector which extends annularly outside said internal sector, and said at least one functional element is disposed in said external sector (paragraphs [0067], [0073]; as shown in Figures 2A-B).
Regarding claim 3, Liu teaches further comprising a plurality of functional elements homogeneously distributed in correspondence with the rear surface of said sector intended to contact the eyeball, each being disposed longitudinally parallel to a respective radial directrix exiting from the center of said lens (paragraph [0072]).
Regarding claim 4, Liu teaches wherein said sector has a first radius of curvature smaller than a second radius of curvature of said sector (as shown in Figures 2A-B).
Regarding claim 5, Liu teaches further comprising a connection device for connecting said at least one functional element to a communication device, incorporated in the thickness of said lens so as to intersect said at least one functional element, and said connection device comprises an annular support element and a plurality of electrically conductive elements connected to said support element and to said communication device in order to communicate the data received from said sensors (paragraphs [0065], [0074]).
Regarding claim 6, Liu teaches wherein said sensor comprises at least one body protruding from the rear surface of said lens and an electrically conductive sensor element associated with said body (paragraphs [0072]-[0073]; Figures 2A-B).
Regarding claim 7, Liu teaches wherein said at least one body is configured as a protuberance made in one piece with the lens (paragraphs [0072]-[0073]; Figures 2A-B).
Regarding claim 8, Liu teaches wherein said sensor element is at least partly immersed in said at least one body (paragraphs [0070], [0072]-[0073]; Figures 2A-B).
Regarding claim 9, Liu teaches wherein said sensor comprises at least one electrically conductive terminal configured to be electrically connected to one of said plurality of electrically conductive elements of said connection device, said at least one terminal being partly immersed in said body and electrically connected to said sensor element (paragraphs [0070], [0072]-[0073]; Figures 2A-B).
Regarding claim 10, Liu teaches wherein said sensor comprises a plurality of terminals, the number of which is equal to the number of electrically conductive elements, wherein each one of said plurality of terminals is configured to be electrically connected to a respective electrically conductive element (paragraphs [0070], [0072]-[0073]; Figures 2A-B).
Regarding claim 15, Liu teaches further comprising a plurality of micro-protuberances, which protrude from the rear surface of said lens so as to be facing, during use, toward the eyeball and which are homogeneously distributed in a peripheral zone of said internal sector, according to a regular geometric pattern defined by a plurality of rows radiating from a central axis of said lens (paragraphs [0070]-[0073]; Figures 2A-B).
Regarding claim 16, Liu teaches further comprising a groove on an external surface (paragraphs [0070]-[0073]; Figures 2A-B).
Regarding claim 17, Liu teaches wherein said sensor comprises at least one body protruding from the rear surface of said lens and an electrically conductive sensor element associated with said body (paragraphs [0070]-[0073]; Figures 2A-B).
Regarding claim 18, Liu teaches wherein said groove is in correspondence with a space comprised between two parts of the body (paragraphs [0070]-[0073]; Figures 2A-B).
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.
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.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claim 1 above, and further in view of US 20190285911 A1 (hereinafter referred to as “Newman”).
Regarding claim 13, Liu does not explicitly teach wherein said reservoir comprises a body in which a containing space for the liquid to be delivered is made, provided with a lid equipped with a plurality of through holes, and/or in that said reservoir comprises a spongy matrix disposed inside said containing space and suitable to contain a liquid to be delivered.
However, Newman teaches wherein said reservoir comprises a body in which a containing space for the liquid to be delivered is made, provided with a lid equipped with a plurality of through holes, and/or in that said reservoir comprises a spongy matrix disposed inside said containing space and suitable to contain a liquid to be delivered (paragraph [0121]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu, to have a deliverable liquid therapeutic substance, as taught by Newman, because doing so provides a therapy for the patient.
Regarding claim 14, Liu, in view of Newman, teaches wherein said body is configured as a protuberance made in one piece with the lens (paragraphs [0122]-[0124]; as shown in Figures 2; as taught by Newman).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claim 16 and 18 above, and further in view of further rationale.
Regarding claims 19 and 20, Liu teaches a groove, but does not explicitly teach wherein said groove has a depth smaller than the thickness of the lens, wherein said groove has a width between 60 μm and 300 μm, and a depth between 5 μm and 60 μm. However, it would have been obvious to one having ordinary skill in the art at the time the invention effectively filed to have wherein said groove has a depth smaller than the thickness of the lens, wherein said groove has a width between 60 μm and 300 μm, and a depth between 5 μm and 60 μm, since 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.
Allowable Subject Matter
Claim 11, and claims dependent thereof, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 11, the prior art fails to teach or suggest “wherein said sensor comprises at least one removable joining member suitable to electrically connect said at least one terminal to said connection device” in combination with all of the limitations of the base claim and any intervening claims.
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791