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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-10 is/are pending. Claim(s) 9 is/are withdrawn.
Response to Arguments
Applicant’s arguments, filed 1/28/2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 1, 3-4, and 6 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 1/28/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-8 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive.
Applicant argues the prior art fails to teach the following limitations of claim 1:
(1) a 30-gauge cannula freely passes under the optic,
(2) irrigation flow is directed to the crystalline lens region,
(3) evacuation occurs at higher flow rates than irrigation alone, and
(4) the channel provides an uninterrupted path between the eye entry incision and the posterior region below the optic.
See Applicant's Response on 1/28/2026, herein "Response", page 6.
The Examiner notes the respective claimed language is as follows:
(1) "channel is wide enough to allow an irrigating cannula of at least 30-gauge to go through at least one open channel freely allowing for irrigation,"
(2) the crystalline lens is not found in claim 1,
(3) evacuation rate and relative evacuation rate are not found in claim 1, and
(4) the channel forming any uninterrupted path is not found in claim 1.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., each of Applicant’s (1)-(4) above) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues Currie's openings 18 are for fluid flow instead of irrigation (Response, page 7).
In response to applicant's argument that Currie's openings 18 are for fluid flow instead of irrigation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues there is no lumen, no cannula path, and no irrigation function (Response, page 7).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the lumen) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the cannula path, the Examiner notes that the opening #18 of Currie is a through hole and thus is a pathway through which a cannula can be placed.
In response to applicant's argument that Currie does not teach an irrigation function, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues the Currie's openings #18 do not extend into a posterior region below the optic (Response, page 7).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Currie's openings #18 do not extend into a posterior region below the optic) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that posterior side irrigation would not be possible using opening #18 of Currie (Response, page 7). The Examiner notes a cannula can be placed in the opening and irrigation fluid passed into the posterior space which would then be able to be pushed back through the remaining portions of the #18 the cannula is in or the other #18 the cannula is not in. Therefore, Applicant's arguments are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
With respect to claim 3, Applicant argues claim 3 would require Currie's channels #18 to be a single channel, which would render Currie unsatisfactory for its intended purpose by removing connections #16 (Response, page 9).
The Examiner notes no such modification was made in the rejection of record previously or currently. Rather, claim 3 requires the open channel be a "continuous circumferential channel". Currie's channel is a continuous opening that extends in the circumferential direction, thereby meeting the claimed requirement.
Applicant's arguments imply the claim requires the channel be annular or completely surround the optic. Such limitations are not claimed.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the channel be annular or completely surround the optic) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 102/103
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.
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.
Functional language and intended use language is presented in italicized font.
Claim(s) 1-8 and 10 is/are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Currie (US 2014/0277437 A1)as evidenced by Amon (US 2010/0070030 A1).
Regarding Claim 1, Currie teaches a plate haptic sulcus intraocular lens (IOL) or implantable contact lens (ICL) (e.g. Figures 1-2; [0321], the overall device length is 8 mm to 13 mm and the width is 5 mm to 13 mm; Amon teaches the diameter of a sulcus is 12.5 mm to 13.5 mm in [0003]; thus Currie’s device is envisioned to be of a size that can be used in a sulcus location) comprising an optic (e.g. Figure 2, #12), a haptic component (e.g. Figure 2, #s 16 and material having #s 22 therein), and at least one open channel (e.g. Figure 2, circumferential, elongated channels having radial dimensions “D”), wherein:
said at least one open channel is positioned outside the optic of the IOL or ICL (e.g. Figure 2) and far enough so as to not interfere with an optical correction an optical quality of the IOL or ICL (e.g. Figure 2, the entire open channel is radially outward of the optic and therefore is far enough from the optic to perform the claimed function);
said at least one open channel is placed in an incline, a slope and/or a vault connecting the optic of the IOL or ICL to the haptic (e.g. Figure 1); and
said at least one open channel, which is accessible to an eye entry incision (a tool can be placed through an incision and reach the IOL and its open channel), allows an irrigating fluid to evacuate trapped ophthalmic viscosurgical device (OVD) from said at least one open channel (as the channel is an opening, fluid is able to flow through it).
Currie discloses that the radial dimension of the channel is “D” (e.g. [0321], dimension D shown in Figure 2 is 0.2 mm to 2.0 mm; 30-gauge is 0.255 mm).
If not inherent that this size range would allow for a 30-guage device by being at least 30-guage in size, then Currie discloses the invention substantially as claimed but fails to teach said at least one open channel is wide enough to allow an irrigating cannula of at least 30-gauge to go through said at least one open channel freely allowing for irrigation to a posterior side of the optic of the IOL or ICL.
Currie is concerned with the same field of endeavor as the claimed invention, namely IOLs having channels radially outward from the optic.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Currie such that the size of the channel, “D”, is at least that of a 30 gauge cannula (≥ 0.255 mm) since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
The combined Currie device teaches: said at least one open channel is long enough to allow sideways sweeping movement of said irrigating cannula for irrigation and evacuation to occur (the Currie devices having a “D” of 0.256 mm to 2.0 mm each meet this requirement as they are larger than the required size of 30 gauge; additionally the Currie device is flexible, [0284], thus is able to allow for movement of the cannula that is exactly the same size as “D”).
Regarding Claim 2, at least two channels are present (e.g. Figure 2) to allow for irrigation from one or more channel and evacuation from two or more channels (as both channels are the same, both are able to allow for irrigation and evacuation).
Regarding Claim 3, said at least one open channel is a continuous circumferential channel (e.g. Figure 2) allowing for faster OVD evacuation (each channel allows for coverage of approximately half the space under the lens, which is faster than the case for holes such as those at #s 22 which require putting the cannula in multiple openings to cover the same circumferential area).
Regarding Claim 4, said at least one open channel comprises a variable width and a variable length as dictated by design of the IOL or ICL (e.g. [0321], the channels can be made at different sizes “D” and both length and width vary), and wherein said at least one open channel allows the irrigating cannula to freely pass through and sweep sideways to allow irrigation and evacuation (discussed supra for the combination in claim 1).
Regarding Claim 5, said irrigating cannula is marked to allow penetration to the posterior side of the IOL or ICL to prevent said irrigating cannula touching a crystalline lens (the irrigating cannula is only found in functional language of claim 1, thus the language of claim 5 is also part of that functional language; this limitation does not change the size required in claim 1 from the fixed size cannula; thus, when a cannula having the additional claim elements of claim 5 is used, it performs the required functions of claim 1).
Regarding Claim 6, said irrigating cannula is covered with a protective slippery silicone sleeve to protect against touching of a crystalline lens (the irrigating cannula is only found in functional language of claim 1, thus the language of claim 6 is also part of that functional language; this limitation does not change the size required in claim 1 from the fixed size cannula; thus, when a cannula having the additional claim elements of claim 6 is used, it performs the required functions of claim 1).
Regarding Claim 7, said irrigating cannula is angled as to allow the irrigating fluid to flow parallel to a crystalline lens, which will facilitate irrigation and/or evacuation (the irrigating cannula is only found in functional language of claim 1, thus the language of claim 7 is also part of that functional language; this limitation does not change the size required in claim 1 from the fixed size cannula; thus, when a cannula having the additional claim elements of claim 7 is used, it performs the required functions of claim 1).
Regarding Claim 8, said irrigating cannula comprises side port irrigation (the irrigating cannula is only found in functional language of claim 1, thus the language of claim 8 is also part of that functional language; this limitation does not change the size required in claim 1 from the fixed size cannula; thus, when a cannula having the additional claim elements of claim 8 is used, it performs the required functions of claim 1).
Regarding Claim 10, said protective slippery silicone sleeve is marked to allow safe distance penetration to the posterior side of the IOL or ICL (the irrigating cannula is only found in functional language of claim 1, thus the language of claim 10 is also part of that functional language; this limitation does not change the size required in claim 1 from the fixed size cannula; thus, when a cannula having the additional claim elements of claim 10 is used, it performs the required functions of claim 1).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/6/2026