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 .
Detailed Action
This is in response to the amendment filed 05/19/2026.
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.
Claim(s) 1, 3, 5, 6-14, 17-19, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0008126 (Salahieh et al.) in view of U.S. Patent Publication Number 2011/0251685 (Chu)
Regarding claims 1, 3, 5, 6, 21-23 Salahieh et al. discloses as shown in Figures 3, 4, 27 an accommodating intraocular lens (AIOL) comprising: a base lens having— an accommodating lens (first lens 36, see paragraph [0151]); an optical axis passing through the accommodating lens; a haptic portion (support structure 31, see paragraph [0151]) positioned radially-outward from the accommodating lens with respect to the optical axis; a cavity (recess defined by support structure 31 or recess defined by threads on support structure 31) formed in the haptic portion and extending at least partially circumferentially about the optical axis; and a removable lens (second lens 33, see paragraph [0151]) configured to removably couple with the base lens, the removable lens having a lens portion (shown in Figure 3 at 33); and a tab (shown in Figure 3 at 37) extending radially-outward from the lens portion and configured to extend at least partially into the cavity when the removable lens is coupled to the base lens, wherein at least a portion of the tab is positioned posterior, wherein: the tab defines a length that terminates at an end configured to be received within the cavity, and the length of the tab, the lens portion, and the cavity are positioned along a plane extending perpendicular to the optical axis, wherein the cavity includes an opening that faces radially inwardly toward the optical axis and wherein, when the removable lens is coupled to the base lens, at least a portion of the tab extends through the opening and is received within the cavity, wherein: the accommodating lens includes a fluid-filled lens; the haptic portion of the base lens includes a haptic reservoir in fluid communication with the fluid-filled lens; and
the cavity is positioned radially inwardly from the haptic reservoir with respect to the optical axis. See paragraph [0195] and Figure 27.
Salahieh et al. fails to disclose a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker and at least partially hidden from view from an anterior-posterior perspective when the removable lens is coupled to the base lens.
Chu, from the same field of endeavor teaches a similar AIOL where a visual marker positioned anterior for the purpose of tracking the anterior of a portion of the AIOL, wherein the visual marker is opaque, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker; wherein the visual marker comprises a darkened and/or colored silicone structure. See paragraphs [0054], [0075], [0090].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the AIOL by including the visual marker taught Chu such that a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claims 7-10, the limitations are product by process.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
In this case, it is the position of the Office that the visual marker is formed in a mold separate from the base lens, the visual marker is partially cured and then co-molded with the base lens during manufacture, the visual marker is adhered to the base lens during manufacture, the visual marker is overmolded to the base lens during manufacture do not imply any structure not already disclosed by Tran.
Regarding claim 11, Salahieh et al. fails to disclose wherein the tab is coplanar with the lens portion of the removable lens.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the AIOL disclosed by Salahieh et al. by rearranging the location of the tab such that it was coplanar with the lens portion of the removable lens because it would only require a rearrangement of parts without changing how to the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claims 12, 13 Salahieh et al. discloses as shown in Figures 2A, 2B method of assembling an accommodating intraocular lens (AIOL), the method comprising: providing a base lens, the base lens having an accommodating lens (first lens 36, see paragraph [0151]); an optical axis passing through the accommodating lens; a haptic portion (support structure 31, see paragraph [0151]) positioned radially-outward from the accommodating lens with respect to the optical axis; a cavity (recess defined by support structure 31 or recess defined by threads on support structure 31) formed in the haptic portion and extending at least partially circumferentially about the optical axis; coupling a removable lens (second lens 33, see paragraph [0151]) to the base lens by inserting a tab (shown in Figure 3 at 37]) of the removable lens into the cavity such that the tab is positioned; and aligning a lens portion of the removable lens with the optical axis, wherein the removable lens is coupled to the base lens after the base lens is implanted in an eye of a patient.
Salahieh et al. fails to disclose a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker.
Chu, from the same field of endeavor teaches a similar AIOL where a visual marker positioned anterior for the purpose of tracking the anterior of a portion of the AIOL, wherein the visual marker is opaque, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker; wherein the visual marker comprises a darkened and/or colored silicone structure, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker, wherein the visual marker is opaque, adhering the visual marker to the base lens. See paragraphs [0054], [0075], [0090].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the AIOL by including the visual marker taught Chu such that a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 14, So modified Salahieh et al. in view of Chu are considered to disclose wherein the visual marker hides a portion of the tab when observed from a position anterior to the visual marker. See Figures 2A, 2B of Salahieh et al. and Figure 7A of Chu.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0008126 (Salahieh et al.) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2019/0076295 (Bashir).
Regarding claim 2, Salahieh et al. fails to disclose wherein the visual marker is a different color from at least a portion of base lens surrounding the visual marker.
Bashir, from the same field of endeavor teaches a similar AIOL as shown in Figure 3, where the visual marker is a different color from at least a portion of base lens surrounding the visual marker. See paragraph [0044].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the AIOL disclosed by Salahieh et al. by substituting the color of the visual marker or at least a portion of the base lens surrounding the visual marker such that they were different colors because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0008126 (Salahieh et al.) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2011/0153014 (Zhang et al.)
Regarding claim 4, Salahieh et al. fails to disclose wherein the visual marker is translucent.
Zhang et al., from the same field of endeavor teaches a similar AIOL as shown in Figure 3, wherein the visual marker is translucent. See paragraph [0042].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the AIOL disclosed by Salahieh et al. by substituting the color of the visual marker disclosed by Salahieh et al. for the translucent color taught by Zhang because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 15, 16, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0008126 (Salahieh et al.) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2008/0215008 (Nance al.)
Regarding claims 15, 16, Salahieh et al. fails to disclose overmolding the visual marker to the base lens, wherein the visual marker is overmolded to the base lens, comprising co-molding the visual marker with the base lens.
Nance et al., from a related field of endeavor teaches a similar method were the method includes the step of attaching maker, where the method includes the step includes overmolding a visual marker. See paragraph [0084].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Salahieh et al. by substituting the method of attaching the marker disclosed by Salahieh et al. for the method taught by Zhang such that it was overmolding the visual marker to the base lens, wherein the visual marker is overmolded to the base lens because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0008126 (Salahieh et al.) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2007/0203562 (Malewicz et al.)
Regarding claim 20 Salahieh et al. fails to disclose co-molding the visual marker with the base lens.
Malewicz et al., from a related field of endeavor teaches a similar method were the method includes the step of co-molding the visual marker with the base. See paragraph [0049].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Salahieh et al. by substituting the method of attaching the marker disclosed by Salahieh et al. for the method taught by Zhang such that it was co-molding the visual marker with the base because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1-23 have been considered but are largely moot in view of the new grounds of rejection.
The applicant argues Chu fails to teach or suggest a visual marker portioned anterior to a cavity such that at least a portion of the tab is positioned posterior to the visual marker.
In response, the Office respectfully disagrees. Chu, from the same field of endeavor teaches a similar AIOL where a visual marker positioned anterior for the purpose of tracking the anterior of a portion of the AIOL, wherein the visual marker is opaque, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker; wherein the visual marker comprises a darkened and/or colored silicone structure. See paragraphs [0054], [0075], [0090].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the AIOL by including the visual marker taught Chu such that a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Applicant does not dispute that Chu is from the same field of endeavor or that it teaches using a visual marker on haptic to track that location of the haptic. Applicant only argues that Chu is silent about placing the marker anterior to a cavity wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity.
However, applicant has not addressed the stated reasons that it would be obvious to put the marker taught by Chu in the lens disclosed by Salahieh et al., anterior to a cavity wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity, in order to track the anterior of the cavity.
Applicant argues that Chu’s disclosure of use of the marker to provide easily recognizable visual cues is incompatible with the claimed “wherein at least a portion of the tab is positioned posterior to the visual marker and at least partially hidden from view from an anterior-posterior perspective when the removable lens is coupled to the base lens”.
In response, the Office respectfully disagrees. Chu’s disclosure of use of the marker to provide easily recognizable visual cues would clearly be pertinent when prior to coupling the disclosed first and second lenses and Salahieh et al.
The applicant argues the only motivation to arrive at the claimed features comes from their specification. In response, the Office respectfully disagrees. The office’s rationale does not rely on the applicant’s specification at all. Rather, the Office’s rationale relies on the benefits explicitly disclosed by Chu and not disputed by the applicant (a visual marker used to identify a portion of the haptic).
The claimed marker is used for the same purpose as the one disclosed in Chu (providing a visual indication). It follows that incorporating the marker disclosed by Chu into the lens disclosed by Salahieh et al. at any location it could be viewed would be a predictable use of known components with a reasonable expectation of success (providing a visual indication of the hapatic). See KSR, 550 U.S. at 417; MPEP § 214
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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