Detailed Action
1. Claims1-5 are pending in this Application.
Notice of Pre-AIA or AIA Status
2. 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
3. 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
4. Claims 1-5 provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, and 13-15 of copending application US No. 18/070,737, in view of Mazen Y, et al., ( hereafter Mazen ), “Single-Pass Microkeratome System for Eye Bank DSAEK Tissue Preparation: Is Stromal Bed Thickness Predictable and Reproducible?” pub. 2016.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
The subject matter claimed in the instant application is full disclosed in the referenced co-pending application and would be covered by any patent granted on the co-pending application since the referenced co-pending application and the instant application are claiming common subject matter. Specifically the instant application disclosed a device claims while the co-pending application disclosed the corresponding method claims. Further claimed invention in the cop-ending application is a border representation of the conflicting claims in the instant application. Therefore, the conflicting claims are not patentably distinct from each other because claims 1-5 of the instant application substantially recites the limitations of claims 1-2 and 13-15 of the co-pending application.
Current Application US No. 18/661246
Co-pending Application US No. 18/070,737
use an operator-specific nomogram to determine a predicted cut depth for a donor cornea, wherein the operator-specific nomogram is used to produce a corneal graft, wherein a predetermined value is determined based on a difference between the predicted cut depth and a desired cut depth, wherein the donor cornea is dried to cause a pre-cut thickness of the donor cornea to decrease, wherein, concurrently with drying the donor cornea, pre-cut thickness measurements are determined for the donor cornea, wherein, in response to the pre-cut thickness measurements indicating the pre-cut thickness of the donor cornea has decreased by the predetermined value, the donor cornea is cut to a post-cut thickness of less than or equal to 100 µm to produce the corneal graft, and wherein the donor cornea is cut with a single-pass rotational style microkeratome with a selected microkeratome head.
1. A system for producing a corneal graft, comprising
: an operator-specific nomogram configured to determine a predicted cut depth for a donor cornea, wherein a predetermined value is determined based on a difference between the predicted cut depth and a desired cut depth;
a measurement device configured to determine pre-cut thickness measurements for the donor cornea, wherein a pre-cut thickness of the donor cornea is decreased by drying the donor cornea, wherein concurrently with drying the donor cornea the measurement device determines the pre-cut thickness measurements for the donor cornea; and a single-pass rotational style microkeratome with a selected microkeratome head configured to cut the donor cornea, wherein the selected microkeratome head cuts the donor cornea to a post-cut thickness of less than or equal to 100 pm to produce the corneal graft in response to the pre-cut thickness measurements indicating the pre-cut thickness of the donor cornea has decreased by the predetermined value.
However it is noted that the co- pending application does not specifically teach “A non-transitory computer-readable storage medium comprising: instructions stored on the non-transitory computer-readable storage medium, the instructions, when executed by one or more processors, cause the one or more processors to”
On the other hand Mazen teaches A non-transitory computer-readable storage medium comprising instructions stored on the non-transitory computer-readable storage medium, the instructions, when executed by one or more processors, cause the one or more processors (page 95 right col., last two paragraphs, page 96 right col. Result section Statistical analysis related to Graft Thickness: Microkeratome Cutting Reliability was performed using SPSS software (IBM, NY). Kruskal-Wallis 1), computer simulation result are shown in Figs.1-3, )
The co-pending application and Mazen are combinable because all are directed to preparing and processing ultrathin graft (abstracts).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the technique of storing the SPSS software that case the computer to excite the procedure taught by Mazen in order to store and execute the procedure recited in the system claims of the co-pending application.
The suggestion/motivation for doing so would have been to transfer the invention in remote locations using internet or storing in removable computer readable media, thus maximize electronically transferability and portability of the invention taught by the co- pending application.
Claim2
Combination of claims 1 and 2
Claim 3
Combination of claims 1 and 13
Claim 4
Combination of claims 1 and14
Claim 5
Combination of claims 1 and15
Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
6. Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Romano V, et al. , (hereafter Romano), “Preparation of ultrathin grafts for Descemet-stripping endothelial keratoplasty with a single microkeratome pass”. J Cataract Refract Surg. pub. 2017, in view of Nahum Y, et al., ( hereafter Nahum), “Postoperative graft thickness obtained with single-pass microkeratome-assisted ultrathin Descemet stripping automated endothelial keratoplasty”. Cornea, pub. 2015, furthers in view of in view of Mazen Y, et al., ( hereafter Mazen ), “Single-Pass Microkeratome System for Eye Bank DSAEK Tissue Preparation: Is Stromal Bed Thickness Predictable and Reproducible?” pub. 2016
As to claim 1, Romano teaches use an operator-specific nomogram to determine a predicted cut depth for a donor cornea, wherein the operator-specific nomogram is used to produce a corneal graft (Table 1, Abstract,) TABLE 1 – “corneal thickness prior to cut”), cutting the donor cornea to a post-cut thickness of less than or equal to 100 µm to produce a corneal graft (ABSTRACT – “mean graft thickness was 83.2 µm +/- 14.9 (range 50 to 98 µm”; TABLE 1 – “graft thickness) wherein a predetermined value is determined based on a difference between the predicted cut depth and a desired cut depth(Table 1, page 13 right col., 1st and 2nd paragraphs, ., All the tissues were prepared successfully in a single attempt without perforation, and a graft thickness of less than 100 mm was achieved (Table 1). A mean of 15 minutes was required to prepare an ultrathin DSAEK graft (range 10 to 25 minutes). The mean posterior lamellar graft thickness measured immediately after the cut was 83.2 G 14.9 mm (range 50 to 98 mm), and the peripheral graft edge thickness was 106.8 G 10.9 mm (range 90 to 120 mm))
wherein the donor cornea is dried to cause a pre-cut thickness of the donor cornea to decrease, wherein, concurrently with drying the donor cornea, pre-cut thickness measurements are determined for the donor cornea(Abstract, PAGE 12 – page 14 right col., last paragraph, Using a simple method of controlling artificial anterior chamber pressure and drying the corneal surface, it was possible to thin the donor cornea at a rate of 11 mm a minute. The anterior corneal surface is continuously dried using a polyvinyl alcohol sponge, achieving a rate of corneal thinning of approximately 11 µm a minute. Corneal thick-ness is measured using high-resolution anterior segment optical coherence tomography (AS-OCT)” and PAGE 14 – “It is important to use a pachymeter or AS-OCT to measure corneal thickness and consider that 15 to 20 minutes are required for the preparation of tissue (corneal thinning, corneal cutting, and manual peripheral dissection ), wherein, in response to the pre-cut thickness measurements indicating the pre-cut thickness of the donor cornea has decreased by the predetermined value, the donor cornea is cut to a post-cut thickness of less than or equal to 100 µm to produce the corneal graft( Abstract, page 13 right col., 1st and 2nd paragraphs, When the donor cornea was between 500 mm and 510 mm, a single pass was made using a 350 mm microkeratome head followed by a peripheral dissection. The resulting mean graft thickness was 83.2 [Symbol font/0x6D]m[Symbol font/0xB1] 14.9 (SD) (range 50 to 98 [Symbol font/0x6D]m) with a mean peripheral graft edge thickness of 106.8 1[Symbol font/0xB1]0.9 [Symbol font/0x6D]m (range 90 to 120 [Symbol font/0x6D]m ). There were no surgical complications, and all grafts remained attached. This is a reliable method for preparing ultrathin donor corneal lenticules for DSAEK in the operating room or eye bank without using multiple microkeratome heads or risking double passes),
as discussed above Romano teaches the donor cornea cut, but fails to teach “A non-transitory computer-readable storage medium comprising: instructions stored on the non-transitory computer-readable storage medium, the instructions, when executed by one or more processors, cause the one or more processors to: the donor cornea is cut with a single-pass rotational style microkeratome with a selected microkeratome head.”
On the other hand Nahum the donor cornea is cut with a single-pass rotational style microkeratome with a selected microkeratome head(TABLE 1 – “microkeratome head”; PAGE 1362 – “We have recently started using a single-pass technique using a new linear microkeratome with disposable heads (350-450 µm) and developed a nomogram aimed at optimizing the final graft thickness below 100 µm”).
It would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of selecting a microkeratome head from a plurality of different microkeratome heads, as taught by Nahum into Romano.
The suggestion/motivation for doing so would have been allows user of Romano.
to optimizing the final graft thickness by adjusting the thickness below 100 µm.
However it is noted that the combination of Romano and Nahum does not specifically teach “A non-transitory computer-readable storage medium comprising: instructions stored on the non-transitory computer-readable storage medium, the instructions, when executed by one or more processors, cause the one or more processors to execute ”
On the other hand Mazen teaches A non-transitory computer-readable storage medium comprising instructions stored on the non-transitory computer-readable storage medium, the instructions, when executed by one or more processors, cause the one or more processors ( page95 right col., last two paragraphs, page 96 right col. Result section Statistical analysis related to Graft Thickness: Microkeratome Cutting Reliability was performed using SPSS software (IBM, NY). Kruskal-Wallis 1), computer simulation result are shown in Figs.1-3, )
Modified Romano and Mazen are combinable because all are directed to preparing and processing ultrathin graft (abstracts).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the technique of storing the SPSS software that case the computer to excite the procedure taught by Mazen in order to store and execute the process steps of modified Romano.
The suggestion/motivation for doing so would have been to transfer the process steps of modified Romano in remote locations using internet or storing in removable computer readable media, thus maximize electronically transferability and portability of the method taught by modified Romano
As claim 3, the combination of Romano and Mazen teaches executed by the one or more processors further cause the one or more processors (Mazen: this limitation discussed in claim 1 above )to: use the operator-specific nomogram to determine an amount of desired drying and decrease in the pre-cut thickness of the donor cornea (Romano: ABSTRACT;, PAGE 12, PAGE 14 Using a simple method of controlling artificial anterior chamber pressure and drying the corneal surface, an ultrathin DSAEK(micro100m)can be obtained( see ABSTRACT;, PAGE 12, PAGE 14). “The anterior corneal surface is continuously dried using a polyvinyl alcohol sponge, achieving a rate of corneal thinning of approximately 11 µm a minute. Corneal thick-ness is measured using high-resolution anterior segment optical coherence tomography (AS-OCT)”; TABLE 1 – “clamping and drying time”; “Various techniques have been proposed to achieve ultra-thin microkeratome-cut posterior lenticules. Air-drying or a THIN-C medium are used to reduce donor corneal thick-ness before a single microkeratome pass ( see page 14) )
As claim 4, the combination of Romano and Mazen teaches wherein the instructions, when executed by the one or more processors, further cause the one or more processors to: use the operator-specific nomogram to generate a predicted graft thickness (Mazen: this limitation discussed in claim 1 above)wherein the predicted graft thickness is the difference between the pre-cut thickness measurement and the average of the cut depths(Romano: “we evaluated a technique for predictable donor cornea thinning before the microkeratome cut using a simple method of controlling the pressure in the artificial anterior chamber and drying the anterior corneal surface. We now report the results obtained in the clinical application of this method for DSAEK graft preparation”, see page 14 left col. 2nd par., )
As to claim 5 Mazen teaches wherein the instructions, when executed by the one or more processors, further cause the one or more processors to: update the data for the operator-specific nomogram after each corneal graft is produced (page 96-97, Tissue Loss and Disqualification: There were a total of 7 failed procedures from 256 attempts (2.7%). These tissues were disqualified for transplantation secondary to perforations (n = 2), uneven cut n = 3), and thinness (n = 3). Four of the 7 failed procedures were during the 53 first attempts; the rate of tissue loss and disqualification dropped to 1.5% in the last 200 cuts. There was no difference in tissue characteristics among these failures.)
Allowable Subject Matter
7. Claim 2 is objected to as being dependent upon a rejected base claims, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and overcome the double patenting rejection set forth in this Office Action.
8. Regarding independent claim 2 no prior art is found to anticipate or render the flowing limitation obvious :
“wherein: the operator-specific nomogram uses data to generate the predicted cut depth, the data including a plurality of donor cornea cuts by an operator technician using the selected microkeratome head, the data for each of the plurality of donor cornea cuts of the donor cornea includes a pre-cut thickness measurement taken immediately before cutting and a post-cut thickness measurement of the corneal graft, the operator-specific nomogram generates the predicted cut depth based on an average of the cut depths for the plurality of donor cornea cuts, and a cut depth for each of the plurality of donor cornea cuts is the difference between the pre-cut thickness measurement of the donor cornea and the post-cut thickness measurement.”
Prior art of record but not applied in the rejection
“Technique for preparing ultrathin and nanothin Descemet stripping automated endothelial keratoplasty tissue”, published 2018, Cheung AY, et al., disclosed:
Methods: To prepare NT-DSAEK grafts, a pachymetry nomogram specific to each technician and individual microkeratome head was developed based on accumulated precut and postcut pachymetry data from previous DSAEK grafts. Mean graft thickness as well as precut and postcut endothelial cell counts (ECCs) of NT-DSAEK, UT-DSAEK, and Descemet membrane endothelial keratoplasty (DMEK) grafts between July 2015 and July 2017 were calculated and compared statistically. Endothelial cell loss was evaluated using calcein AM stains and ImageJ analysis. Postcut graft thickness and rates of perforation/tissue loss for NT-DSAEK grafts between May and July 2017 were calculated to determine overall graft preparation success rates.
Results: Mean postcut graft thickness for all grafts within the NT range was 41.0 ± 6.4 μm (range 26–50 μm). Mean ECC did not differ between NT-DSAEK, UT-DSAEK, and DMEK grafts (P = 0.759 and 0.633, respectively). The overall tissue loss rate from attempted NT-DSAEK was 4.8%. Excluding cases of perforation, the chance of achieving NT thickness was 60% and within the traditional UT range was 100%.
Conclusions: We propose the term “NT-DSAEK” for grafts ≤50 μm. The described nomogram allows for standardized creation of NT grafts with a low tissue loss rate. This technique is safe and does not result in significant ECC loss compared with UT-DSAEK and DMEK grafts. Further studies are necessary to corroborate the postsurgical results of NT grafts( see page 1).
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/MEKONEN T BEKELE/ Primary Examiner, Art Unit 2699