DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 10/17/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 10/17/2025, have been fully considered. As argued by Applicant, “[c]laim 5 as amended is directed to a method for creating and identifying a landmark on the anterior lens capsule of the eye” comprising “identifying as the landmark a central region of anterior lens capsule tissue that is more darkly stained with Trypan Blue than surrounding anterior lens capsule tissue” (Applicant Arguments, Page 6).
The rejections of claims have been modified to address this new limitation.
Allowable Subject Matter
The following proposed independent claim would be ALLOWABLE:
“A method for creating and identifying a landmark on the anterior lens capsule of an eye during cataract surgery, the method comprising:
applying an ophthalmic solution comprising an isotonic and pH neutral aqueous solution of Trypan Blue at a concentration greater than 0.3% and less than or equal to 0.45% by weight to the anterior lens capsule of the eye for a period of less than or equal to ninety seconds to stain tissue of the anterior lens capsule with Trypan Blue;
rinsing the ophthalmic solution from the eye; and
after rinsing the ophthalmic solution from the eye, identifying as the landmark a central region of anterior lens capsule tissue that is more darkly stained with Trypan Blue than surrounding anterior lens capsule tissue stained with Trypan Blue;
wherein the central region of anterior lens capsule tissue that is more darkly stained than surrounding anterior lens capsule tissue stained with Trypan Blue has a diameter of about 2 mm to about 4 mm.”
The proposed claim would be ALLOWABLE for the following reasons:
Chang et al Part II (J Cataract Refract Surg 31:799-804, 2005; of record) is considered to be the closest prior art. As discussed below in the rejection of claims, Chang et al Part II render obvious a method comprising applying Trypan Blue at a concentration between 0.3% and 0.45% by weight to the anterior lens capsule of an eye for a period of less than or equal to ninety seconds to stain tissue of the anterior lens capsule of the eye and rinsing said solution from the eye, followed by “examin[ing] under a surgical microscope by [an] experienced cataract surgeon… to measure the effectiveness of the stain for visualizing the anterior capsule” (Page 800, Column 2) wherein a central region of anterior lens capsule that is more darkly stained with Trypan Blue than surrounding anterior lens capsule is clearly visible.
However, although Chang et al Part II further teach that purpose of the study was “[t]o investigate the efficacy of the various dyes for anterior capsule staining to facilitate capsulorhexis during cataract surgery” (Abstract), Chang et al Part II do not actually carry out a method comprising applying Trypan Blue at a concentration between 0.3% and 0.45% by weight to the anterior lens capsule to an eye during cataract surgery. Moreover, Chang et al Part II suggest using Trypan Blue at a concentration of 0.10% “for optimal enhancement of anterior capsule visibility for capsulorhexis” (Abstract).
While Center for Drug Evaluation and Research (NDA Application Number 21-670, 2003; of record) teach that “[t]he published clinical studies demonstrate that concentrations of trypan blue between 0.025% and 0.3%, inclusive, are 100% effective in staining the anterior capsule” (Page 12, Section 6.3), as further taught by Morales et al (Invest Ophthamol Vis Sci 51:6018-6029, 2010), noting that exposure to formulations comprising trypan blue “diluted at 1%, 0.25% and 0.025%” (Page 6019, Column 1) did not result in “significant differences” in acute toxicity (Page 6019, Column 2), “[i]t appears prudent to use the lowest possible dose of... dye, to minimize the risk of toxic effects” (Abstract).
Based on all of the foregoing, it is determined that it would not have been obvious to carry out the instantly claimed method comprising applying Trypan Blue at a concentration between greater than 0.3% and up to 0.45% by weight to the anterior lens capsule of an eye for a period of up to ninety seconds during cataract surgery. An ordinarily skilled artisan would have not have considered applying more than the upper limit of Trypan Blue identified by Center for Drug Evaluation and Research (for a period of up to ninety seconds) in staining the anterior capsule and, instead, would have been motivated to follow the guidance of Chang et al Part II and use Trypan Blue at a concentration of approximately 0.10% (Abstract) in order to “use the lowest possible dose of... dye, to minimize the risk of toxic effects” (as taught by Morales et al (Abstract)).
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.
Claims 5, 7-9 and 23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chang et al Part II (J Cataract Refract Surg 31:799-804, 2005; of record) as evidenced by Chang et al Part I (J Cataract Refract Surg 31:792-798, 2005; of record) and Sigma (Trypan Blue Solution 0.4%, available online at https://www.sigmaaldrich.com/US/en/coa/SIGMA/T8154/RNBM1133, accessed 6/28/2025; of record).
Claim 5 is drawn to a method for creating and identifying a landmark on the anterior lens capsule of the eye (more specifically, a human eye (claim 23)), the method comprising:
applying an ophthalmic solution comprising an isotonic and pH neutral aqueous solution of Trypan Blue at a concentration of between 0.25% and 0.45% by weight (more specifically, between 0.40% and 0.45% (claims 7-9)) to the anterior lens capsule for 90 seconds or less to stain tissue of the anterior lens capsule with Trypan Blue;
rinsing the ophthalmic solution from the eye; and
after rinsing the solution from the eye, identifying as the landmark a central region of anterior lens capsule tissue that is more darkly stained with Trypan Blue than surrounding anterior lens capsule tissue stained with Trypan Blue.
Chang et al Part II teach applying an ophthalmic solution comprising an isotonic and pH neutral aqueous solution of Trypan Blue1 at a concentration of 0.40% by weight to the anterior lens capsule of New Zealand white rabbits and “[e]ach lens was soaked… for 1 minute” (Page 800, Column 1; see also, Figure 1). Next, Chang et al Part II teach that “[t]he lenses were removed from the dye solutions and rinsed with BSS to wash out excess dye” and “[e]ach lens was examined under a surgical microscope by the same experienced cataract surgeon… to measure the effectiveness of the stain for visualizing the anterior capsule” (Page 800, Column 2). And, as taught by Chang et al Part II, the 0.40% by weight Trypan Blue solution provided “Intermediate visibility” of “Capsule Margin” (Page 800, Table 1 and Page 801, Table 2), as seen in Figure 1:
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wherein a central region of anterior lens capsule that is more darkly stained with Trypan Blue than surrounding anterior lens capsule is clearly visible, as indicated by arrow:
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Considering that Chang et al Part II teach that purpose of the study was “[t]o investigate the efficacy of the various dyes for anterior capsule staining to facilitate capsulorhexis during cataract surgery” (Abstract), a person of ordinary skill in the art would have found it prima facie obvious to extend the teachings of Chang et al Part II to a human eye.
Accordingly, based on all of the foregoing reasons, claims 5, 7-9 and 23 are rejected as prima facie obvious.
Claim 6 is rejected under 35 U.S.C. 103(a) as being unpatentable over Chang et al Part II (J Cataract Refract Surg 31:799-804, 2005; of record) as evidenced by Chang et al Part I (J Cataract Refract Surg 31:792-798, 2005; of record) and Sigma (Trypan Blue Solution 0.4%, available online at https://www.sigmaaldrich.com/US/en/coa/SIGMA/T8154/RNBM1133, accessed 6/28/2025; of record) as applied to claims 5, 7-9 and 23 above, as further evidenced by Auffarth et al (J Cataract Refract Surg 20:188-191, 1994, Abstract only; of record).
Claim 6 is drawn to the method of claim 5, wherein identifying the landmark comprises identifying a central region of anterior lens capsule tissue having a diameter of about 2 mm to about 4 mm that is more darkly stained than surrounding stained anterior lens capsule tissue.
As discussed above, Chang et al Part II teach the method of claim 5.
However, Chang et al Part II do not define the size of the central region identified as being more darkly stained than surrounding tissue.
Yet, as evidenced by Auffarth et al, “[t]he anterior lens capsule of young albino rabbits is very elastic” and “[m]ean capsulorhexis diameter was 4.9 mm + 0.9” (Abstract).
And, as further taught by Chang et al Part II, “dyes have been used to enhance contrast between the anterior capsule and the cortex during continuous curvilinear capsulorhexis” as well as “to ‘find’ the leading edge of a ‘lost’ capsulorhexis, to visualize the anterior capsule tear in cases of traumatic cataract, to facilitate capsulorhexis during phacoemulsification of corneal opacities, to facilitate removal of posterior capsule plaque after cataract surgery or assist in posterior CCC in children, and to assist in training surgeons in phacoemulsion techniques” (Page 799, Columns 1-2).
Accordingly, as further evidenced by Auffarth et al, it is asserted that the darkly stained central region of the New Zealand white rabbit’s anterior lens capsule identified by Chang et al Part II would have a diameter of about 2 mm to about 4 mm as claimed. And, it is further asserted that extending the teachings of Chang et al Part II to a human eye would similarly result in a darkly stained central region of anterior lens capsule tissue having a diameter of about 2 mm to about 4 mm as claimed.
Additionally, it is evident that the purpose of carrying out the procedure of Chang et al Part II would impact the specific region to be identified and, thus, it would have been prima facie obvious to determine the optimal size of the region investigated in order to best achieve the desired results.
Based on all of the foregoing, claim 6 is also rejected as prima facie obvious.
Claim 10 is rejected under 35 U.S.C. 103(a) as being unpatentable over Chang et al Part II (J Cataract Refract Surg 31:799-804, 2005; of record) as evidenced by Chang et al Part I (J Cataract Refract Surg 31:792-798, 2005; of record) and Sigma (Trypan Blue Solution 0.4%, available online at https://www.sigmaaldrich.com/US/en/coa/SIGMA/T8154/RNBM1133, accessed 6/28/2025; of record) as applied to claims 5, 7-9 and 23 above, in further view of Holland (“Laser Capsulotomy Brings Advantages to Cataract Surgery”, available online at https://crstodayeurope.com/articles/2015-oct/continuous-thermal-capsulotomy-a-simple-solution-for-a-longstanding-problem/, October 2015; of record).
Claim 10 is drawn to the method of claim 5, comprising identifying the landmark on the anterior lens capsule utilizing machine vision.
As discussed above, Chang et al Part II teach the method of claim 5 wherein “[e]ach lens was examined under a surgical microscope by the same experienced cataract surgeon… to measure the effectiveness of the stain for visualizing the anterior capsule” (Page 800, Column 2).
However, Chang et al Part II do not teach identifying the landmark on the anterior lens capsule utilizing machine vision.
Yet, as taught by Holland, discussing laser-assisted cataract surgery, “imaging incorporated into [the] system is capable of detecting important anatomic landmarks such as the anterior capsule in almost every eye” (Section entitled “Imaging”).
Accordingly, in further view of Holland, it would have been obvious to utilize machine vision to identify the landmark on the anterior lens capsule. It would have been obvious to do so in order to identify said landmarks with near certainty.
As such, claim 10 is rejected as prima facie obvious.
Conclusion
Any new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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 CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
1 Chang et al Part II describe preparation of the dye solutions “as described in the first part of the study”, referring to Chang et al Part I (Page 800, Column 1), wherein Chang et al Part I identify the solution as “TB (0.40% solution) (Sigma)” (Page 793, Column 1). And, as evidenced by Sigma, Trypan Blue solution 0.4% is an isotonic and pH neutral aqueous solution (Trypan Blue solution Certificate of Analysis).