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 .
Claim Rejections - 35 USC § 101
Claims 39,40,41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 22-35 are for a method, and claims 36-41 are for an apparatus. Thus, the claims are for statutory subject matter.
Step 2A, prong 1
Claim 22 includes the step of calculating a three dimensional shape. This step is considered to be an abstract idea in the form of a mathematical concept that includes mathematical calculations; see at least ¶89 of applicant’s published application. Similarly, claims 39,40 also include the step of calculating three dimensional shape, and thus also include an abstract idea in the form of a mathematical concept.
Step 2A, prong 2
Claim 22 includes, other than the step of calculating, the step of augmenting the cornea with the corneal augmentation. This step is considered to integrate the abstract idea into a practical application by using the results of the abstract idea to provide a particular treatment for the patient. Thus, claims 22-35 are patent eligible.
Claim 39 includes the steps of claim 36 which are the result of practicing the abstract idea, and thus do not serve to use the abstract idea for a particular treatment or therapy. Thus, the steps of claim 36 do not serve to integrate the abstract idea of claim 39 into a practical application. The steps of claim 39, other than the abstract idea, include determining a measure, and creating a corneal map. These steps serve to provide data for use in the abstract idea and not to integrate the abstract idea into a practical application. Re claim 40, the step of generating a corneal map is considered to be data gathering, and does not serve to integrate the abstract idea into a practical application. Further, the step of causing the laser to produce the augmentation is merely applying the abstract idea, and not an integration of it into a practical application. There is no step of using the augmentation to improve the eyesight of the patient. Clam 41 merely describes various map shapes. As such, it does not include a step that integrates the abstract idea into a practical application.
Step 2B
Re claim 39, the elements of the claim, other than the abstract idea, include the corneal augmentation, which is the result of the abstract idea only. Further, the steps of determining a measure is considered to be data gathering for use with the abstract idea, and the step of creating a corneal map uses tomographic or topographic systems. Both of which are considered to be well understood, and routine in the art, whether considered individually, or as a whole. Claim 40 includes a processor, which is considered to be well understood and routine in the art. Further, the step of generating a corneal map, as mentioned, is well understood and routine in the art. Still further, the step of using a laser to produce the augmentation is routine. Lasers are frequently used to correct and shape the cornea or an implant, and as such are well understood and conventional. Claim 41 only includes details regarding the type of map, and not actual steps that are other than well understood and conventional in the art.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 22-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,406,531. Although the claims at issue are not identical, they are not patentably distinct from each other because at least one claim of the application is an obvious variant of at least one claim of the ‘531 patent. Claim 22 is an obvious broadening of patent claim 1. For claim 23, see patent claim 2. For claim 24, see patent 3. Claim 25 is considered to be an obvious broadening of patent claim 5. For claim 26, see patent claim 4. For claim 27, see patent claim 5. For claim 28, see patent claim 5. For claim 29, see patent claim 10. For claim 30, see patent claim 10. For claim 31, see patent claim 9. For claim 32, see patent claims 13,14. For claim 33, see patent claim 15. For claim 34, see patent claim 17. For claim 35, see patent claim 19. For claim 36, see patent claims 1,6. For claim 37, see patent claim 5. For claim 38, see patent claim 5. For claim 39, see patent claim 1. For claim 40, see patent claims 1,9. For claim 41, see patent claim 10.
Claim Rejections - 35 USC § 112
Claims 40,41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 40, line 9, it is unclear what is meant by the phrase ‘moveable stage’.
Claim Rejections - 35 USC § 103
Claim(s) 22,26,29,30,32,36,39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140).
22. (New) A method for amelioration of an abnormality of a cornea, the method
comprising:
determining a severity of the abnormality of the cornea; (see at least col. 8:10-20 of Chapoy which teaches that topographical measurements are made to determine the curvature of the cornea and any imperfections therein. This step inherently determines a severity of the abnormality since the user will see the severity by the measurements of the imperfections)
creating a corneal map of the cornea quantifying a deviation of the abnormality
from an optimal corneal shape; (at least col. 8:10-20 of Chapoy teaches using topography which is a mapping procedure)
calculating, using the corneal map and the severity, a three-dimensional shape of
a corneal augmentation to ameliorate the abnormality of the cornea; (Chapoy teaches that the augmentation, or arc, may vary in any way to address deficiencies in corneal shape, see at least col. 7:57-65. The augmentation has three dimensions, see at least col. 7:50-65. It is considered to have been obvious that the three dimensions of the augmentation of Chapoy be shaped depending upon the tomographic map so that the augmentation will achieve the proper results of correcting the corneal deficiency)
producing the corneal augmentation with the three-dimensional shape; (see at least col. 7:50-65 of Chapoy which teaches the rings can be altered to be the appropriate shape for the patient)
augmenting the cornea with the corneal augmentation. (see at least col. 8:57-65)
26. (New) The method of claim 22, wherein the three-dimensional shape is a sector
cut from a doughnut shape. (see at least col. 5:63-67 which teaches arc shape. The shape has a thickness, and thus is a sector of a doughnut shape)
29. (New) The method of claim 22, wherein the corneal map is an elevation map and
the three-dimensional shape has a plan projection that is one of a curve, a polygon, a
lenticule, a doughnut, a crescent or an arc. (see col. 8:20 of chapoy which teaches topography, and col. 5:65-67 which teaches an arc)
30. (New) The method of claim 29, wherein the plan projection is at least in part a best
fit to an iso-elevation line of the elevation map. (it would have been obvious to use a best fit to a iso-elevation line since it would allow for a more accurate sizing of the augmentation by conforming it to the actual contours of the cornea of the patient)
32. (New) The method of claim 22, wherein the corneal augmentation is an inlay and
augmenting the cornea further comprises creating an intra-stromal cavity using a
femtosecond laser, wherein the intra-stromal cavity is sized and shaped to accommodate
the inlay. (see at least col. 8:33 – col. 9:1.)
36. (New) A device for amelioration of an abnormality of a cornea, the device
comprising:
a corneal augmentation having a three-dimensional shape, (see at least col. 7:50-65 of Chapoy which teaches that the augmentation has a thickness, height, and width)
wherein the three-dimensional shape has a plan projection that is one of a curve,
a polygon, a lenticule, a doughnut, a crescent, or an arc, (see at least col. 7:50-65 of Chapoy which teaches an arc shape)
wherein the plan projection is at least in part a best fit to an iso-elevation line of an
elevation map. (as mentioned supra, Chapoy teaches using topography, which is an elevation map, see col. 8:10-21. Further, Chapoy teaches at least an arc shape for the augmentation; see at least col. 7:50-65. Chapoy is silent as to a best fit. It would have been obvious to use a best fit to an elevation line of the map since it would most closely follow the contours of the cornea, and thus provide a better correction of the patient’s cornea, in a predictable manner)
39. (New) The device of claim 36, wherein the three-dimensional shape is determined
by a method comprising:
determining a measure of severity of the abnormality of the cornea; (see at least col. 8:10-20 of Chapoy which teaches that topographical measurements are made to determine the curvature of the cornea and any imperfections therein. This step inherently determines a severity of the abnormality since the user will see the severity by the measurements of the imperfections)
creating a corneal map of the cornea quantifying a deviation of the
abnormality from an optimal corneal shape; (see at least col. 8:10-22 of Chapoy which teaches that a topography is made, which is a map of the various changes in elevation of the cornea over its surface)
calculating, using the corneal map and the measure of severity, the three-
dimensional shape of the corneal augmentation to ameliorate the abnormality of
the cornea. (Chapoy teaches that the augmentation, or arc, may vary in any way to address deficiencies in corneal shape, see at least col. 7:57-65. It is considered to have been obvious that the three dimensions of the augmentation of Chapoy be shaped depending upon the tomographic map so that the augmentation will achieve the proper results of correcting the corneal deficiency)
Claim(s) 40,41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140) and Winocur (4,984,883) and Dai et al (10,973,685).
40. (New) A system for amelioration of an abnormality of a cornea, the system
comprising:
at least one processor configured to:
generate a corneal map of a patient indicating a measure of severity of the
abnormality and a deviation between the abnormality and an optimal corneal
shape; (as mentioned supra, Chapoy teaches taking a topographical map of the cornea to determine the abnormality, see at least col. 8:10-22. Chapoy is silent as to a processor. Winocur teaches a processor used to generate a topographical map, see at least col. 5:57-61. It would have been obvious to use a processor to create the map since they are well known to efficiently process data and control digital devices)
calculate, using the corneal map, a three-dimensional shape of a corneal
augmentation to ameliorate the abnormality of the cornea; (Chapoy teaches that the augmentation, or arc, may vary in any way to address deficiencies in corneal shape, see at least col. 7:57-65. It is considered to have been obvious that the three dimensions of the augmentation of Chapoy be shaped depending upon the tomographic map so that the augmentation will achieve the proper results of correcting the corneal deficiency. To have a processor perform the calculations, as opposed to using a pencil and paper, would have been obvious since processors are well known in the art to perform calculations in an efficient manner.)
cause a laser and a moveable stage to produce the corneal augmentation
having the three-dimensional shape. (Chapoy is silent as to having a laser shape the augmentation. Dai teaches a laser that can use instructions that can cause the laser to shape cornea, see at least col. 4:1-65. It would have been obvious to use the laser of Dai to produce the corneal augmentations since lasers are well known in the art, and the laser system of Dai can follow instructions to efficiently produce the desired shape of the augmentation in a predictable manner. Further, as mentioned supra, the term ’moveable stage’ is unclear.)
41. (New) The system of claim 40, wherein the corneal map is an elevation map and
the three-dimensional shape has a plan projection that is one of a curve, a polygon, a
lenticule, a doughnut, a crescent or an arc, and wherein the plan projection is at least in
part a best fit to an iso-elevation line of the elevation map. (as mentioned supra, Chapoy teaches using topography, which is an elevation map, see col. 8:10-21. Further, Chapoy teaches at least an arc shape for the augmentation; see at least col. 7:50-65. Chapoy is silent as to a best fit. It would have been obvious to use a best fit to an elevation line of the map since it would most closely follow the contours of the cornea, and thus provide a better correction to the patient’s cornea, in a predictable manner)
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140) and Gesto et al (10,914,746).
24. (New) The method of claim 22, wherein the abnormality is keratoconus, the severity
is measured by a maximum keratometry (K-max), and the corneal map is obtained using
corneal tomography or corneal topography. (see at least col. 1:23-63 of Chapoy which teaches Keratoconus, and col. 8:20 teaches topography. Chapoy is silent as to K max. Gesto teaches Kmax, see at least col. 4:33. It would have been obvious to modify Chapoy with the Kmax of Gesto for the purpose of determining the maximum curvature power of the cornea)
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140) and Dai et al (10,973,685).
31. (New) The method of claim 22, wherein producing the three-dimensional shape
comprises generating, using a processor, a cutting file based on the corneal map and the
severity, wherein the cutting file contains instructions to form the corneal augmentation
using a femtosecond laser. (Chapoy teaches use of a femtosecond laser, see col 9:1. Chapoy is silent as to the processor and cutting file. Dai teaches instructions in memory (file) that uses a processor to instruct a laser to cut the cornea to the proper measurements. It would have been obvious to use such with the device of Chapoy since it would shape the augmentation in a efficient manner so that it fits in the patient’s cornea area)
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140) and Peyman (10,881,503)
35. (New) The method of claim 22, the method further comprising after augmentation,
reshaping the cornea with photorefractive keratectomy (PRK) surgery using an excimer
laser. (Chapoy is silent as to this feature. However, Peyman teaches reshaping the cornea using PRK and excimer laser, see at least col. 73:1-12. It would have been obvious to use such with the device of Chapoy since it would enable the cornea to be the proper shape in a predictable manner)
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140) and Silvestrini et al (5,300,118).
23. (New) The method of claim 22, wherein producing the corneal augmentation
comprises obtaining a corneal template from a source other than the cornea being treated,
wherein the corneal template is one of a corneal autograft, corneal allograft, a corneal
xenograft, and a manufactured corneal tissue. (Chapoy is silent as to this feature. Silvestrini teaches the common use of allograft corneal tissue. It would have been obvious to use such with the device of Chapoy to form the corneal template since allografts are well known in the art for their effective use in various eye implant procedures.)
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapoy et al (8,394,140) and Franssen et al (2014/0277430).
33. (New) The method of claim 22, wherein the corneal augmentation is an onlay
placed external to the cornea being treated and augmenting the cornea further comprises
removing, using a femtosecond laser, a contiguous region of epithelial tissue
corresponding in area to a plan projection of the corneal augmentation. (Chapoy is silent as to an onlay. Franssen teaches an insertion using an onlay procedure, in order to shape the cornea, see at least ¶31. It would have been obvious to use the onlay procedure of Franssen with the device of chapoy since it would yield predictable result such as the ability to shape the cornea in an alternative manner from that of using an inlay, which might be difficult for a certain patient. At least col. 9:1+ of Chapoy teaches use of a femtosecond laser that can be used to remove the epithelial tissue so that the onlay will better adhere to the patient’s cornea)
The following is a statement of reasons for the indication of allowable subject matter: the prior art does not fairly teach the subject of claims 25,27,28, 37,38 including the equation set forth, as well as the dimensions of the inner and outer radii of the augmentation. Additionally, the prior art does not fairly teach the chamfer of epithelial tissue as set forth in claim 34.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792