DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
2. 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.
3. Claim 14 is 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.
a. Claim 14 recites the limitation "the haptics" in line 2. There is insufficient antecedent basis for this limitation in the claim, since claim 10 recites “at least one haptic” (which can be just one single haptic, and not two or more haptics).
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 1, 3-5, 7, 9, 10, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS).
Regarding independent claim 1, Mandell ‘538 teaches a method of implanting (Figures 5A, 5B; at least paragraphs [0377] and [0444]) an intraocular lens (IOL) into an eye of a subject (Figures 3A, 3B, 4A, 4B, and 24A-24D), comprising:
inserting an IOL comprising an IOL body (300) and at least one haptic (302) extending directly or indirectly from the IOL body into the capsular bag of the eye, and
positioning a dissolvable stretch ([0336]; [0422]; [0444]) ring (ring 100; ring 2401) comprising a biodegradable polymer on at least one haptic of the IOL ([0133]; [0141]; [0142]; [0444]; [0489]; [0501]; [0514]; [0530]).
Regarding claim 3, Mandell ‘538 teaches further comprising the step of removing an existing lens from the eye of the subject while leaving the capsular bag of the eye intact ([0378]; [0489]).
Regarding claim 4, Mandell ‘538 teaches wherein the IOL includes a plurality of haptics (302, 304).
Regarding claim 5, Mandell ‘538 teaches wherein the dissolvable stretch ring includes a plurality of positioning tabs configured to fit between the haptics of the IOL ([0333] – “In some embodiments, the ophthalmic article may comprise an internal structure (e.g., a hole) that is shaped to accommodate placement around a portion of an ocular device (e.g., portions of the ocular device with different shapes, sizes, and configurations). For example, the ophthalmic article may comprise an internal structure (e.g., a hole) that is shaped to accommodate placement around a haptic (e.g., haptics with different shapes, sizes, and configurations) of an IOL. In some embodiments, the portion of the ocular device (e.g., haptic of an IOL) may be uniformly flat along its outer surface. In other embodiments, the portion of the ocular device (e.g., haptic of an IOL) may comprise at least one indent or groove along its outer surface. The indent or groove may comprise a structure for receiving the circumference of the inner structure of the ophthalmic article. In other embodiments, the portion of the ocular device (e.g., haptic of an IOL) may comprise at least one protrusion along its outer surface. In any of the embodiments, a size and/or shape of the ophthalmic article may be designed, as described herein, so that the ophthalmic article may associate with the portion of the ocular device (e.g., haptic of an IOL)”; [0336] – “In some embodiments, the ophthalmic article may be configured to associate with the surface (e.g., an outward surface) of the portion of the ocular device (e.g., haptic of an IOL) through an indent, groove, narrowing, or protrusion along the surface of the portion of the ocular device. For example, the ophthalmic article may comprise an internal structure for securing around a notched region of the haptic of an IOL. In this case, the elastic annulus ophthalmic article can be applied to a notched haptic, such that it is first stretched to an inner circumference at least as large as the outer perimeter of the haptic distal to the notch. Next, the elastic annulus ophthalmic article may be advanced over the notch and allowed to constrict around the narrow portion of the haptic. In this case, friction is less relevant and the sides of the notch secure the ophthalmic article and may prevent dislocation of the ophthalmic article. The ophthalmic article can be hooked in the notch and can freely move or rotate within the notch. Alternatively, the ophthalmic article may be hooked in the notch with restricted movement or rotation within the notch. In another example, the ophthalmic article may be hooked in the notch so that it can compressively associate (e.g., attach) to a surface of the haptic within the notch”). In other words, some of the outer protrusions (e.g., “tabs”) around the ring of Mandell ‘538 are placed between haptics 302, 304 of IOL 300.
Regarding claim 7, Mandell ‘538 teaches wherein the dissolvable stretch ring degrades by 90% or more (e.g., completely gone or degraded) within about a month after implantation ([0133]; [0197]; [0379]).
Regarding claim 9, Mandell ‘538 teaches wherein the subject has been diagnosed as having one or more cataracts ([0378]; [0489]).
Regarding independent claim 10, Mandell ‘538 teaches an intraocular lens (IOL) arrangement, comprising:
an IOL comprising an IOL body (300) at least one haptic (302) extending directly or indirectly from the IOL body; and
a dissolvable stretch ([0336]; [0422]; [0444]) ring (ring 100; ring 2401) comprising a biodegradable polymer on at least one haptic of the IOL ([0133]; [0141]; [0142]; [0444]; [0489]; [0501]; [0514]; [0530]).
Regarding claim 13, Mandell ‘538 teaches wherein the IOL includes a plurality of haptics (302, 304).
Regarding claim 14, Mandell ‘538 teaches wherein the dissolvable stretch ring includes a plurality of positioning tabs configured to fit between the haptics of the IOL ([0333] – “In some embodiments, the ophthalmic article may comprise an internal structure (e.g., a hole) that is shaped to accommodate placement around a portion of an ocular device (e.g., portions of the ocular device with different shapes, sizes, and configurations). For example, the ophthalmic article may comprise an internal structure (e.g., a hole) that is shaped to accommodate placement around a haptic (e.g., haptics with different shapes, sizes, and configurations) of an IOL. In some embodiments, the portion of the ocular device (e.g., haptic of an IOL) may be uniformly flat along its outer surface. In other embodiments, the portion of the ocular device (e.g., haptic of an IOL) may comprise at least one indent or groove along its outer surface. The indent or groove may comprise a structure for receiving the circumference of the inner structure of the ophthalmic article. In other embodiments, the portion of the ocular device (e.g., haptic of an IOL) may comprise at least one protrusion along its outer surface. In any of the embodiments, a size and/or shape of the ophthalmic article may be designed, as described herein, so that the ophthalmic article may associate with the portion of the ocular device (e.g., haptic of an IOL)”; [0336] – “In some embodiments, the ophthalmic article may be configured to associate with the surface (e.g., an outward surface) of the portion of the ocular device (e.g., haptic of an IOL) through an indent, groove, narrowing, or protrusion along the surface of the portion of the ocular device. For example, the ophthalmic article may comprise an internal structure for securing around a notched region of the haptic of an IOL. In this case, the elastic annulus ophthalmic article can be applied to a notched haptic, such that it is first stretched to an inner circumference at least as large as the outer perimeter of the haptic distal to the notch. Next, the elastic annulus ophthalmic article may be advanced over the notch and allowed to constrict around the narrow portion of the haptic. In this case, friction is less relevant and the sides of the notch secure the ophthalmic article and may prevent dislocation of the ophthalmic article. The ophthalmic article can be hooked in the notch and can freely move or rotate within the notch. Alternatively, the ophthalmic article may be hooked in the notch with restricted movement or rotation within the notch. In another example, the ophthalmic article may be hooked in the notch so that it can compressively associate (e.g., attach) to a surface of the haptic within the notch”). In other words, some of the outer protrusions (e.g., “tabs”) around the ring of Mandell ‘538 are placed between haptics 302, 304 of IOL 300.
Regarding claim 16, Mandell ‘538 teaches wherein the dissolvable stretch ring comprises an ophthalmological drug (Abstract; [0141]; [0142]; [0223]).
6. Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS).
Regarding claim 2, Mandell ‘538 teaches the invention as claimed, except for particularly disclosing wherein the IOL is an accommodating intraocular lens. However, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have used Mandell ‘538 invention with an accommodating intraocular lens, since accommodating intraocular lens are already well-known in the art, and since Mandell ‘538 discloses his/her invention as applicable to any given ocular device ([0341]; [0342]).
7. Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS).
Regarding claim 6, Mandell ‘538 teaches the invention as claimed, including wherein the dissolvable stretch ring comprises a hyaluronic acid ([0135]; [0190]), except for particularly disclosing wherein the dissolvable stretch ring comprises a hyaluronic acid derivative. However, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have used a hyaluronic acid derivative with the invention of Mandell ‘538, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
8. Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS) in view of Neuhann (US 6,413,277
B1).
Regarding claim 8, Mandell ‘538 teaches the invention as claimed, including:
(i) “It is desirable for cataract surgeons to have flexibility to select IOLs of different sizes, shapes and refractive power for different clinical conditions. In various embodiments of the invention, the drug delivery article is manufactured and supplied separately from the IOL to allow physicians to use it with different types of IOLs. In other embodiments, the drug delivery article and IOL are manufactured and/or supplied to the surgeon as a single product” ([0342]), and
(ii) using an implantation device comprise a sleeve for holding the dissolvable stretch ring and a push rod positioned within the sleeve, wherein applying pressure to the push rod pushes the dissolvable stretch ring out of the implantation device (Figures 5A, 5B; and paragraph [0444]),
except for particularly disclosing wherein applying pressure to the push rod pushes the dissolvable stretch ring out of the implantation device and onto the at least one haptic of the IOL.
However, this is already well-known in the art. For example, Neuhann ‘277 teaches (Figures 3A-3F) a ring (20) positioned on at least one haptic (14 or 16) of an IOL (10/12) by delivering the ring using an implantation device (30) comprise a sleeve for holding the ring (Figures 3C-3E) and a push rod positioned within the sleeve (Figures 3C-3E), wherein applying pressure to the push rod pushes the ring out of the implantation device and onto the at least one haptic of the IOL (Figures 3C-3E), in order to attach the ring to the IOL (C3:L39-55).
Notice, the C-shaped (i.e., partial or open ring) of Figure 1A and the closed ring of Figure 2A (just like the ring of Mandell ‘538) of the instant application are obvious variants in the art. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the dissolvable stretch ring is positioned on the at least one haptic of the IOL by delivering the dissolvable stretch ring using an implantation device comprise a sleeve for holding the dissolvable stretch ring and a push rod positioned within the sleeve, wherein applying pressure to the push rod pushes the dissolvable stretch ring out of the implantation device and onto the at least one haptic of the IOL, as taught by Neuhann ‘277, with the invention of Mandell ‘538, in order to attach the ring to the IOL.
9. Claim 11 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS).
Regarding claim 11, Mandell ‘538 teaches the invention as claimed, except for particularly disclosing wherein the IOL is an accommodating intraocular lens. However, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have used Mandell ‘538 invention with an accommodating intraocular lens, since accommodating intraocular lens are already well-known in the art, and since Mandell ‘538 discloses his/her invention as applicable to any given ocular device ([0341]; [0342]).
10. Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS).
Regarding claim 12, Mandell ‘538 teaches the invention as claimed, except for particularly disclosing wherein the dissolvable stretch ring provides an outward force of about 0.6 to about 0.8 newtons.
Notice, other than “ring”, no particular structural features (e.g., diameter; thickness; contour; etc.) and no particular materials have been recited for the “dissolvable stretch ring”.
Although Mandell ‘538 does not specifically teach wherein the dissolvable stretch ring provides an outward force of about 0.6 to about 0.8 newtons, the reference teaches a ring as recited in claim 10, which appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the ring of Mandell ‘538 would have the instantly claimed outward force.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
11. Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Mandell (US PG Pub No. 2020/0405538 A1; cited in Applicant’s IDS).
Regarding claim 15, Mandell ‘538 teaches the invention as claimed, including wherein the dissolvable stretch ring comprises a hyaluronic acid ([0135]; [0190]), except for particularly disclosing wherein the dissolvable stretch ring comprises a hyaluronic acid derivative. However, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have used a hyaluronic acid derivative with the invention of Mandell ‘538, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO 0030566 A1
RU 2202987 C2
US PG Pub No. 2016/0220351 A1
US PG Pub No. 2020/0022840 A1
US PG Pub No. 2013/0302398 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774