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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-7, 9-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12138115B1. Although the claims at issue are not identical, they are not patentably distinct from each other because it would be obvious to one of ordinary skill in the art that the claimed invention of the US Patent No. 12138115B1would be similar or narrower in scope and, therefore, would comprise all the features of the claimed invention in the present application.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 8 and 19 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 5 of prior U.S. Patent No. 12138115B1. This is a statutory double patenting rejection.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dougherty et al., “Improving accuracy of phakic intraocular lens sizing using high-frequency ultrasound biomicroscopy”, J Cataract Refract Surg, Vol 37, January 2011 (applicant submitted prior art via the IDS) in view of Norrby (US 2007/0260157, November 8, 2007, applicant submitted prior art via the IDS).
Regarding claims 1 and 9, Dougherty discloses a method (and corresponding system) for operating a data processing system to provide an estimate of a vault value for an implantable collamer lens (ICL) to be inserted in a patient's eye (“To our knowledge, the literature contains no formal clinical studies using high-frequency UBM to measure intraocular structures preoperatively in an attempt to accurately predict postoperative vault. This was the purpose of our study. We also sought to develop and prospectively test a new sizing algorithm based on our findings.” page 14; also see “Visian Implantable Collamer Lens” in Methods section of Abstract on page 13), comprising:
capturing high-frequency ultrasound images of the patient's eye using an ultrasound imaging device (“Ultrasound Biomicroscopy Measurements Measurements were taken 1 to 3 months postoperatively using the high-frequency UBM system.” page 15; also see Figs. 1-5 and corresponding descriptions), including measuring a diameter of a plane passing through the ciliary body (CBID) (“The ciliary body distance was measured using the most prominent ciliary body present on the image.” page 16);
extracting anatomical measurements from the high-frequency ultrasound images including the diameter of the plane passing through the ciliary body (CBID) (“Using the above criteria, 6 frames were measured using calipers. The ATA distance was obtained using the iris root as the landmark. The STS measurement was obtained using the posterior aspect of the pigmented iris epithelium as the landmark. The ciliary body distance was measured using the most prominent ciliary body present on the image. The largest and smallest measurements were discarded, and the remaining 4 were averaged for the final number (Figure 4). The same imaging procedure and the criteria for frame selection were used for postoperative evaluation of vault. Measurements of vault were analyzed using the posterior surface of the pIOL and the anterior surface of the crystalline lens as landmarks (Figure 5). Measurements were averaged using the same method as preoperatively.” Page 16; also see Figs. 1-5 and corresponding descriptions);
receiving parameters specifying a power and a size for the ICL based on the anatomical measurements (see nomogram in Table 1, reproduced below, and corresponding description);
PNG
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500
630
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Greyscale
utilizing a calibrated model of a human eye which has been trained on a data set derived from measuring a plurality of different patients before and after ICL implant, to compute an estimated vault value based on the anatomical measurements and the parameters specifying the power and the size for the ICL (“To our knowledge, the literature contains no formal clinical studies using high-frequency UBM to measure intraocular structures preoperatively in an attempt to accurately predict postoperative vault. This was the purpose of our study.” page 14; also see pIOL size equation on page 15); and
implanting said ICL in said patient's eye when said estimated vault value is within a predetermined desired range (“Sizing recommendations using the nomogram were studied prospectively” page 13; also see “To our knowledge, the literature contains no formal clinical studies using high-frequency UBM to measure intraocular structures preoperatively in an attempt to accurately predict postoperative vault. This was the purpose of our study. We also sought to develop and prospectively test a new sizing algorithm based on our findings.” page 14; also see “As in the studies by Reinstein et al.1 and Dougherty, E we found a poor correlation between the WTW and STS values (r2 Z 0.35), despite good vault outcomes using our UBM nomogram, which relies almost exclusively on STS values. Between 36% and 69% of cases would have received a different length pIOL had 1 of the 2 nomograms based on WTW measurements been used. When the UBM STS differed by 0.5 mm or more from the WTW recommendations in 3 cases, Dougherty used a smaller pIOL recommended by UBM, resulting in acceptable vault in all 27 eyes in the study.” page 17).
Although Dougherty discloses providing said estimated vault value to a user of said data processing system (“As in the studies by Reinstein et al.1 and Dougherty, E we found a poor correlation between the WTW and STS values (r2 Z 0.35), despite good vault outcomes using our UBM nomogram, which relies almost exclusively on STS values. Between 36% and 69% of cases would have received a different length pIOL had 1 of the 2 nomograms based on WTW measurements been used. When the UBM STS differed by 0.5 mm or more from the WTW recommendations in 3 cases, Dougherty used a smaller pIOL recommended by UBM, resulting in acceptable vault in all 27 eyes in the study.” page 17), Dougherty fails to disclose displaying said estimated vault value to a user of said data processing system.
However, Norrby teaches, in the same field of endeavor, displaying said estimated vault value to a user of said data processing system (see display in the computer system 300 in Fig. 5 and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Dougherty with displaying said estimated vault value to a user of said data processing system as taught by Norrby in order to automate the implant selection procedure on a computerized system ([0043] of Norrby).
Dougherty also fails to disclose receiving a parameter specifying a different size for said IC when said estimated vault value is not within said desired range.
However, Norrby further teaches, in the same field of endeavor, receiving a parameter specifying a different size for said IC when said estimated vault value is not within said desired range (“In certain embodiments, a method comprises determining the optical quality of an eye following the implantation of an implantable IOL. The method may be based upon using the above described eye model with an aspheric IOL and a ray tracing routine, for example, in which a marginal ray and a paraxial ray are used to calculate the longitudinal spherical aberration (LSA). If an undesired high value of LSA is obtained from the method, another lens with another power and/or asphericity is selected and the method is repeated until a lens is found that provides a predetermined optical quality, as represented by a low LSA.” [0037]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Dougherty with receiving a parameter specifying a different size for said IC when said estimated vault value is not within said desired range as taught by Norrby in order to provide a predetermined optical quality ([0037] of Norrby).
Specifically regarding claim 9, although Dougherty suggests a data processing system (e.g., software on pages 16 and 18) Dougherty does not explicitly disclose a controller including data processing functions and a user interface in communication with the controller.
However, Norrby also teaches, in the same field of endeavor, a controller including data processing functions and a user interface in communication with the controller (see computer system in Fig. 5 and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Dougherty with a controller including data processing functions and a user interface in communication with the controller as taught by Norrby in order to automate the implant selection procedure on a computerized system ([0043] of Norrby).
Regarding claim 2, Dougherty further discloses said causing the data processing system to receive anatomical measurements of the patient's eye further comprising: the anatomical measurements further comprising sulcus-to-sulcus-lens-rise (STSL) (“A retrospective data analysis was performed using UBM measurements (VuMax-II) of preoperative sulcus-to-sulcus (STS) distance” page 13) and scotopic pupil diameter (SPD) (“The horizontal pink line represents the widest pupil diameter.” Figure 3 description, page 15).
Regarding claim 3, Dougherty further discloses said causing the data processing system to receive anatomical measurements of the patient's eye further comprising: wherein at least one of the anatomical measurements is ultrasound-based (“Ultrasound Biomicroscopy Measurements” section on pages 15-16).
Regarding claim 4, Dougherty further discloses said utilizing the calibrated model of the human eye to compute the estimated vault value further comprising: said calibrated model having been calibrated by training the model by fitting a data set derived by measuring a plurality of different patients before and after ICL implant (“Retrospective data were collected from patients of 4 ophthalmologists who used the VuMax-II high-frequency UBM system (Sonomed, Inc.) to directly measure the STS distance preoperatively and the vault postoperatively. A multiple regression analysis was performed on the resulting sizing equation, solving for the length of the pIOL in millimeters using the horizontal STS measurement in millimeters and the pIOL vault as 500 mm in millimeters as a constant for optimum vault” page 15), wherein the data set includes measurement of at least CBID (“Using the above criteria, 6 frames were measured using calipers. The ATA distance was obtained using the iris root as the landmark. The STS measurement was obtained using the posterior aspect of the pigmented iris epithelium as the landmark. The ciliary body distance was measured using the most prominent ciliary body present on the image.” Page 16).
Regarding claim 5, Dougherty further discloses wherein the data set further includes measurements of sulcus-to-sulcus-lens-rise (STSL) (“A retrospective data analysis was performed using UBM measurements (VuMax-II) of preoperative sulcus-to-sulcus (STS) distance” page 13) and scotopic pupil diameter (SPD) (“The horizontal pink line represents the widest pupil diameter.” Figure 3 description, page 15).
Regarding claim 6, Dougherty further discloses said utilizing the calibrated model of the human eye to compute the estimated vault value further comprising: said calibrated model having been calibrated by training the model to relate a vault value to a linear function of ICL power, ICL size, and at least one of CBID, STSL, and SPD (see linear equation in “Nomogram Development” section on page 15).
Regarding claim 7, Dougherty further discloses said utilizing the calibrated model of the human eye to compute the estimated vault value further comprising: said calibrated model having been calibrated by training the model to relate a vault value to a function of only CBID, STSL, ICL power, ICL size, and SPD (see linear equations in “Nomogram Development” section on page 15; also see “Ultrasound Biomicroscopy Measurements” section on pages 15-16).
Regarding claim 10, Dougherty modified by Norrby discloses the limitations of claim 9 as stated above but fails to disclose said controller further configured to: after outputting the estimated vault value to the user interface, receive from the user interface a different size for the ICL; and utilize the calibrated model of the human eye to compute an updated estimated vault value based at least on CBID, the power of the ICL, and the different size of the ICL; and output the updated estimated vault value to the user interface.
However, Norrby teaches, in the same field of endeavor, said controller further configured to: after outputting the estimated vault value to the user interface, receive from the user interface a different size for the ICL; and utilize the calibrated model of the human eye to compute an updated estimated vault value based at least on CBID, the power of the ICL, and the different size of the ICL; and output the updated estimated vault value to the user interface (“In certain embodiments, a method comprises determining the optical quality of an eye following the implantation of an implantable IOL. The method may be based upon using the above described eye model with an aspheric IOL and a ray tracing routine, for example, in which a marginal ray and a paraxial ray are used to calculate the longitudinal spherical aberration (LSA). If an undesired high value of LSA is obtained from the method, another lens with another power and/or asphericity is selected and the method is repeated until a lens is found that provides a predetermined optical quality, as represented by a low LSA.” [0037]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Dougherty with said controller further configured to: after outputting the estimated vault value to the user interface, receive from the user interface a different size for the ICL; and utilize the calibrated model of the human eye to compute an updated estimated vault value based at least on CBID, the power of the ICL, and the different size of the ICL; and output the updated estimated vault value to the user interface as taught by Norrby in order to provide a predetermined optical quality ([0037] of Norrby).
Regarding claim 11, Dougherty further discloses said controller further configured to: extract said plurality of anatomical measurements of said patient's eye from said image, wherein said plurality of anatomical measurements further includes sulcus-to-sulcus-lens-rise (STSL) (“A retrospective data analysis was performed using UBM measurements (VuMax-II) of preoperative sulcus-to-sulcus (STS) distance” page 13); utilize said calibrated model of said human eye to compute said estimated vault value, wherein said utilizing is based further on STSL (see equations in “Nomogram Development” section on page 15).
Regarding claim 12, Dougherty further discloses said controller further configured to: receive at least one additional anatomical measurement from the user interface (“The horizontal pink line represents the widest pupil diameter.” Figure 3 description, page 15), wherein said computing of said estimated vault value is based at least on STSL, CBID, the at least one additional anatomical measurement, and the parameters specifying the power and the size for the ICL (see equations in “Nomogram Development” section on page 15).
Regarding claim 13, Dougherty further discloses wherein said at least one additional anatomical measurement comprises scotopic pupil diameter (SPD) (“The horizontal pink line represents the widest pupil diameter.” Figure 3 description, page 15).
Regarding claim 14, Dougherty further discloses said controller further configured to: utilize said calibrated model of said human eye to compute said estimated vault value, wherein said computing of said estimated vault value is based only on CBID, STSL, ICL power, ICL size, and SPD (see linear equations in “Nomogram Development” section on page 15; also see “Ultrasound Biomicroscopy Measurements” section on pages 15-16).
Regarding claim 15, Dougherty further discloses further comprising: said calibrated model of said human eye having been calibrated by training the model by fitting a data set derived by measuring a plurality of different patients before and after ICL implant (“Retrospective data were collected from patients of 4 ophthalmologists who used the VuMax-II high-frequency UBM system (Sonomed, Inc.) to directly measure the STS distance preoperatively and the vault postoperatively. A multiple regression analysis was performed on the resulting sizing equation, solving for the length of the pIOL in millimeters using the horizontal STS measurement in millimeters and the pIOL vault as 500 mm in millimeters as a constant for optimum vault” page 15), wherein the data set includes measurements of at least CBID (“Using the above criteria, 6 frames were measured using calipers. The ATA distance was obtained using the iris root as the landmark. The STS measurement was obtained using the posterior aspect of the pigmented iris epithelium as the landmark. The ciliary body distance was measured using the most prominent ciliary body present on the image.” Page 16).
Regarding claim 16, Dougherty further discloses wherein the data set further includes measurements of sulcus-to-sulcus-lens-rise (STSL) (“A retrospective data analysis was performed using UBM measurements (VuMax-II) of preoperative sulcus-to-sulcus (STS) distance” page 13) and scotopic pupil diameter (SPD) (“The horizontal pink line represents the widest pupil diameter.” Figure 3 description, page 15).
Regarding claim 17, Dougherty further discloses said calibrated model having been calibrated by training the model to relate a vault value to a linear function of ICL power, ICL size, and at least one of CBID, STSL, and SPD (see linear equations in “Nomogram Development” section on page 15; also see “Ultrasound Biomicroscopy Measurements” section on pages 15-16).
Regarding claim 18, Dougherty further discloses said calibrated model having been calibrated by training the model to relate the vault value to a function of only CBID, STSL, ICL power, ICL size, and SPD (see linear equations in “Nomogram Development” section on page 15; also see “Ultrasound Biomicroscopy Measurements” section on pages 15-16).
Regarding claim 20, Dougherty modified by Norrby discloses the limitations of claim 9 as stated above. Dougherty further discloses receive input from a user for said parameters specifying at least the power and the size for the ICL (see nomogram in Table 1 and corresponding description); receive the estimated vault value from the controller; and provide the estimated vault value to the user to determine if said vault value is satisfactory for said patient's eye (“As in the studies by Reinstein et al.1 and Dougherty, E we found a poor correlation between the WTW and STS values (r2 Z 0.35), despite good vault outcomes using our UBM nomogram, which relies almost exclusively on STS values. Between 36% and 69% of cases would have received a different length pIOL had 1 of the 2 nomograms based on WTW measurements been used. When the UBM STS differed by 0.5 mm or more from the WTW recommendations in 3 cases, Dougherty used a smaller pIOL recommended by UBM, resulting in acceptable vault in all 27 eyes in the study.” page 17).
Norrby was previously relied on to teach the user interface and the controller. Norrby further teaches, in the same field of endeavor, the user interface in communication with the controller (see computer system in Fig. 5 and corresponding description).
Dougherty also fails to explicitly disclose displaying the estimated vault value to the user to determine if said vault value is satisfactory for said patient's eye.
However, Norrby further teaches, in the same field of endeavor, displaying the estimated vault value to the user to determine if said vault value is satisfactory for said patient's eye (see display in the computer system 300 in Fig. 5 and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Dougherty with the user interface in communication with the controller and displaying the estimated vault value to the user to determine if said vault value is satisfactory for said patient's eye as taught by Norrby in order to automate the implant selection procedure on a computerized system ([0043] of Norrby).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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/A.A./ Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/ Primary Examiner, Art Unit 3797
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