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
Claims 1-4 are pending in the application. Claim 5 has been canceled. Claims 1 and 4 have been amended.
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.
Claim 4 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.
Claim 4 recites the limitation "the equator" in lines 4, 5, and 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (US 2012/0221102 A1) ("Tanaka").
Regarding claim 1, Tanaka discloses (Figures 1-12C) an insertion system to insert an intraocular lens (IOL) in a patient's eye comprising: a pusher (10) comprising a shaft (16); an introducer device comprising: a back sheath (14) having a longitudinally extending lumen sized and configured to slideably receive the shaft of the pusher (Figure 10; paragraph 0106); a tapering front sheath (Figure 5) having a proximal portion (48), an intermediate portion (50) with a top surface (see Figure 7 annotated below), and a distal portion (52) and comprising: a receptacle located at the proximal portion sized and configured to receive the IOL (Figure 12A); inner peripheral guide rails (70) beginning at a proximal end and terminating at a distal end and located at the intermediate portion of the front sheath below the top surface in fluid communication with the receptacle (Figure 5), the inner peripheral guide rails having an arcuate configuration (Figure 7, B-B) and comprising a first member separated by an inner lumen (54) from a second opposing member, the first and second member extending further into the inner lumen at the proximal end compared to the distal end of the inner peripheral rails (paragraph 0091); and a distal tip (58) lacking the inner peripheral guide rails (Figure 7, C-C).
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Regarding claim 2, Tanaka discloses (Figure 7) the front sheath tapers from a substantially rectangular configuration (at A-A) to a substantially conical or rounded configuration (at C-C).
Regarding claim 3, Tanaka discloses (Figures 5 and 7) the inner peripheral guide rails (70) do not extend into the receptable and the distal tip (paragraphs 0089-0094).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US 2012/0221102 A1) ("Tanaka") in view of Ellis (US 2020/0345481 A1).
Regarding claim 4, Tanaka discloses (Figures 1-12C) a kit comprising the insertion system of claim 1 (see rejection of claim 1 above) and an IOL (12) comprising a plurality of haptics (20a, 20b) connected circumferentially about the periphery of the IOL (Figures 3 and 4).
Tanaka fails to disclose the IOL comprising an anterior face located anterior to the equator and having a periphery; a posterior face located posterior to the equator and having a periphery; a side wall extending across the equator and extending from the anterior face to the posterior face; a chamber located between the anterior face and the posterior face and containing a material. However, Tanaka discloses that insertion system is used for doing insertion surgery of an intraocular lens of a one piece constitution (paragraphs 0035-0036).
In the same field of endeavor, Ellis teaches (Figures 1-3) an IOL with a one piece construction (paragraphs 0029, 0034, 0037) comprising an anterior face (14) located anterior to the equator (E) and having a periphery (20); a posterior face (26) located posterior to the equator (E) and having a periphery (28); a side wall (30) extending across the equator and extending from the anterior face to the posterior face (Figure 1); a chamber (32) located between the anterior face and the posterior face and containing a material (paragraphs 0032 and 0036); and a plurality of haptics (34a-34h) connected circumferentially about the periphery of the anterior face, the posterior face, or both (paragraph 0039).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the IOL taught by Ellis for the IOL disclosed by Tanaka. Tanaka discloses that the insertion system is used for doing insertion surgery of an intraocular lens of a one piece constitution (paragraphs 0035- 0036). The IOL taught by Ellis has a one piece constitution and provides a number of benefits. The IOL taught by Ellis is provided with a chamber that can comprise a soft solid, a gel, a viscoelastic material, a flowable fluid, or a gas, or other suitable material. Exemplary materials that can be contained within the interior of the chamber include a soft silicone, or other soft material subject to deformational change, air or other gas, silicone oil (of various refractive indices), an aqueous solution of saline or hyaluronic acid, a viscoelastic polymer, polyphenyl ether, or other optical fluid, solid or gases, or suitable combinations thereof. Adjusting the volume and/or type of material within the chamber allows an operator to adjust the power and range of accommodation of the IOL (Tanaka, paragraph 0036). The plurality of haptics connected circumferentially about the periphery of the anterior face, the posterior face, or both provide a net result where the anterior face can be pulled outward from several extension sites (such as, for example, eight extension sites as illustrated in Figure 3) and functionally result in relatively symmetric radial tension placed on the periphery of the anterior face of the shape-changing optic (Tanaka, paragraph 0039). Substitution of one known element (the IOL taught by Ellis) for another element (the IOL disclosed by Tanaka) providing the same function to yield predictable results (restoring the patient's vision) would have been obvious to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 8/7/26 have been fully considered but they are not persuasive.
Regarding claims 1-3, the Applicant has argued that the elements 70 disclosed by Tanaka are on the outer surface of the device and not on an inner surface, and certainly not below a top surface of an intermediate portion. The Examiner respectfully disagrees with these arguments.
Figure 7 has been annotated to show the Examiner’s interpretation (see below). Figure 7 shows that the elements 70 are located below the top surface of the intermediate portion of the front sheath. The elements 70 are located on an inner surface, as they are located within the lumen of the sheath.
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The Applicant has also argued that the recited inner peripheral guide rail geometry produces sequential folding of multiple haptic arms, thereby organizing the haptics into a controlled folded configuration prior to delivery from the introducer device.
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The device of Tanaka discloses all of the structural limitations of claim 1 as currently written.
For these reasons, the Examiner maintains that the claims are currently written fail to distinguish over the prior art of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.D.K/Examiner, Art Unit 3771
/BRIGID K BYRD/Examiner, Art Unit 3771
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