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 .
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
On page 9 of applicant remarks, applicant alleges the claimed invention is a practical application that improves surgical technology under Step 2A. However, Step 2A, Prong 1 per MPEP 2106.04(a). Each of Claims 1 to 20 recites at least one step or instruction for processing collected data for display, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a mathematical concept in MPEP 2106.04(a)(2)(I). While applicant has narrowed the scope of the claims they merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract), represent insignificant extra-solution activity or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed. For example, the machine learning model of dependent Claims 6, 7, 18, 19 and 20 does not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f).
Furthermore, Applicant argues on page 9-10 that the amended claims recite “significantly more” than an abstract idea are not persuasive. When considering MPEP 2106.04(d), because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., computing device as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 14 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Applicant’s arguments, with respect to Rejections Under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. Particularly, applicant’s argument on page 11 regarding the recited prior art not teaching: “the features including any of: alignment dots defined on the toric IOL, a perimeter of the toric IOL, and portions of haptics of the toric IOL”. Therefore, the Rejections Under 35 U.S.C. §§ 102 and 103 of claims 1-6, 9, and 13 has been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 to 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1 to 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1 to 20 recites at least one step or instruction for processing collected data for display, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a mathematical concept in MPEP 2106.04(a)(2)(I).
Specifically, Claim 1 recites a method for providing alignment guidance during ocular surgery comprising:
(a) receiving, by a computing device, from an ophthalmic imaging device during the ocular surgery, an input image of a patient's eye having a toric intraocular lens (IOL) within the patient's eye, the ophthalmic imaging device including at least one of an analog surgical microscope and a digital microscope (additional element);
(b) obtaining, by the computing device, a reference axis for the patient's eye, the reference axis indicating a desired orientation of a toric IOL axis of the toric IOL (observation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(c) processing, by the computing device, the input image to obtain a feature label indicating locations of features of the toric IOL represented in the input image, the features including any of: alignment dots defined on the toric IOL, a perimeter of the toric IOL, and portions of haptics of the toric IOL (evaluation or judgement, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(d) processing, by the computing device, the feature label to determine an orientation of the toric IOL axis (evaluation or judgement, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(e) calculating, by the computing device, an angle difference between the toric IOL axis and the reference axis (involves a mathematical concept in MPEP 2106.04(a)(2)(I) and/or a evaluation or judgement, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(f) generating, by the computing device, an output image including at least the input image and one indicator corresponding to the angle difference (additional element); and
(g) outputting the output image to a display device during the ocular surgery and as part of an output video feed of the ocular surgery (additional element).
Additionally, Claim 14 recites a system for providing alignment guidance during ocular surgery, the system comprising:
An ophthalmic imaging device, comprising at least one of an analog surgical microscope and a digital microscope (additional element);
a display device (additional element);
a computing device comprising one or more processing devices and one or more memory devices storing executable code that, when executed by the one or more processing devices, further cause the one or more processing devices to (additional element):
(a) receive from the ophthalmic device during the ocular surgery, an input image of a patient's eye having a toric intraocular lens (IOL) within the patient's eye (additional element);
(b) obtain a reference axis for the patient's eye, the reference axis indicating a desired orientation of a toric IOL axis of the toric IOL (observation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(c) process the input image using a machine learning model (additional element) to obtain a feature label indicating locations of features of the toric IOL represented in the input image, the features including any of: alignment dots defined on the toric IOL, a perimeter of the toric IOL, and portions of haptics of the toric IOL (evaluation or judgement, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(d) process the feature label to determine an orientation of the toric IOL axis (evaluation or judgement, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(e) calculate an angle difference between the toric IOL axis and the reference axis (involves a mathematical concept in MPEP 2106.04(a)(2)(I) and/or a evaluation or judgement, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
(f) generate an output image including at least the input image and one indicator corresponding to the angle difference (additional element); and
(g) output the output image to the display device during the ocular surgery and as part of an output video feed of the ocular surgery (additional element).
Further, dependent Claims 2 to 13 and 15 to 20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract), represent insignificant extra-solution activity or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed. For example, the machine learning model of dependent Claims 6, 7, 18, 19 and 20 does not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 and 14 (and their respective dependent Claims 2 to 13 and 15-20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 14), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of independent Claim 1 (and its respective dependent claims) include: a computing device; receiving, by a computing device, from an imaging device, an input image of a patient's eye having a toric intraocular lens (IOL) within the patient's eye; generate an output image including at least one indicator corresponding to the angle difference; and output the output image to the display device. The additional elements of independent Claim 14 (and its respective dependent claims) include: an imaging device, a display device and a computing device comprising one or more processing devices and one or more memory devices storing executable code (e.g., a machine learning model) that, when executed by the one or more processing devices to receive from the imaging device, an input image of a patient's eye having a toric intraocular lens (IOL) within the patient's eye, generate an output image including at least one indicator corresponding to the angle difference, and output the output image to the display device.
The imaging device, display device and computing device (e.g., processor, memory and/or machine learning model) are generically recited computer elements in independent Claims 1 and 14 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 14 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., computing device as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 14 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 14 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1 to 20 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
Independent Claim 1 (and its respective dependent claims) require the additional elements of: a computing device; receiving, by a computing device, from an imaging device, an input image of a patient's eye having a toric intraocular lens (IOL) within the patient's eye; generate an output image including at least one indicator corresponding to the angle difference; and output the output image to the display device. Further, independent Claim 14 (and its respective dependent claims) require the additional elements of an imaging device, a display device and a computing device comprising one or more processing devices and one or more memory devices storing executable code that, when executed by the one or more processing devices to receive from the imaging device, an input image of a patient's eye having a toric intraocular lens (IOL) within the patient's eye, generate an output image including at least one indicator corresponding to the angle difference, and output the output image to the display device.
The additional elements of an imaging device, a display device and a computing device (e.g., processor, memory and/or machine learning model) are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the imaging device 302 may be embodied as a digital three-dimensional microscope, such as the ALCON NGENUITY 1.5 (a digital three-dimensional digital marker microscope (DMM) with integrated image guidance) or ZEISS ARTEVO, or as an analog microscope with image guidance, such as the ALCON VERION DIGITAL MARKER or ZEISS CALISTO (paragraph 24). As known in the art, an imaging device 302 may be programmed with a treatment plan including pre-operative images of the patient's eye 100, which may include images of the sclera 104, iris 106 and possibly a portion of the retina 108 (paragraph 24). Additionally, the components of the system 300a in addition to the imaging device may be implemented using the computing capabilities of the imaging device 302 embodied as a digital microscope (paragraph 25). Alternatively, the additional components of the system 300a may be implemented by a separate computing device that receives images labeled with the reference axis from the imaging device 302. (paragraph 25). Further, the post processor 306 may determine the IOL axis from the label and determine an angular difference between the IOL axis and the reference axis (paragraph 30). The post processor 306 may generate an output image based on the image received from the imaging device 302 that has information superimposed thereon, such as lines representing the reference axis and the IOL axis and arrows, text, or other information indicating an amount of rotation needed to align the IOL axis with the reference axis (paragraph 30). Finally, the display device 308 may be implemented as a monitor in a room in which the implantation of the toric IOL 200 is being performed, a heads- up display worn by a surgeon performing the implantation, or another display device (paragraph 31).
Accordingly, in light of Applicant’s specification, the claimed terms imaging device, display device and computing device (e.g., processor, memory and/or machine learning model) are reasonably construed as a generic computing devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the imaging device, display device or computing device (e.g., processor, memory and/or machine learning model). This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. For example, paragraph 24 of Applicant’s specification discloses the imaging device to be commercially available digital microscopes. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1 to 20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and systems of Claims 1 to 20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 14 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1 to 20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 to 20 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6, 9, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimizu et al. US 20110292340 A1, herein referred to as Shizumi.
Re. Claim 1, Shizumi discloses a method for providing alignment guidance during ocular surgery comprising (Fig 1, ophthalmic apparatus 100, abstract):
(a) receiving, by a computing device (Fig 1, control unit 10 [0027]), from an imaging device (Fig 1, camera 20), an input image of a patient's eye having a toric intraocular lens (IOL) ([0023-0024]) within the patient's eye ([0027]);
(b) obtaining, by the computing device, a reference axis for the patient's eye ([0029-0030]), the reference axis indicating a desired orientation of a toric IOL axis of the toric IOL ([0038]);
(c) processing, by the computing device, the input image ([0027]) to obtain a feature label (Fig 3A-C display box 62) indicating locations of features of the toric IOL represented in the input image (Fig 3A-C, image 51), the features including any of: alignment dots (Fig 3A-C, not labeled [0050]R1 (length of the straight line shown in a dotted line) defined on the toric IOL (Fig 3A-C [0050]), a perimeter of the toric IOL (Fig 3A-C [0050]), and portions of haptics of the toric IOL ([0019], anticipates broader structure that can be used a haptic]);
(d) processing, by the computing device, the feature label to determine an orientation of the toric IOL axis ([0035]);
(e) calculating, by the computing device, an angle difference between the toric IOL axis ([0041]) and the reference axis ([0041]);
(f) generating, by the computing device, an output image (Fig 4B, image 70, [0016]) including at least one indicator (Fig 4B, angle 62a) corresponding to the angle difference (Fig 4B, angle 62a); and
(g) outputting the output image to a display device (Fig 4B, monitor 40).
Re. Claim 2, Shizumi discloses further comprising: (h) adjusting, by a surgeon, an orientation of the toric IOL; and (i) repeating (a) through (g) ([0036]).
Re. Claim 3, Shizumi discloses further comprising, following performing (h) and (i): determining, by the computing device (Fig 1, control unit 10), that the angle difference meets a predefined tolerance [0032]; and in response to determining that the angle difference (Fig 4B, angle 62a) meets the predefined tolerance [0035], outputting, by the computing device, on the display device (Fig 4B, monitor 40), an indicator indicating that no further rotation of the toric IOL is required ([0062], Fig 5, confirming theta and d (distance) on display box 82.
Re. Claim 4, Shizumi discloses wherein determining that the angle difference (Fig 4B, angle 62a) meets the predefined tolerance [0032] comprises determining that a refractive error (Abstract; configured to correct astigmatism, a type refractive error) resulting from the angle difference meets the predefined tolerance [0032].
Re. Claim 5, Shizumi discloses wherein (c) further comprises processing the input image ([0027]) to obtain one or more bounding boxes ([0040], dioptic power, axial angle) including the features and using the one or more bounding boxes to obtaining the feature label (Fig 3A-C, display box 62).
Re. Claim 6, Shizumi discloses wherein processing the feature label (Fig 3A-C display box 62) to determine the orientation of the toric IOL axis comprises generating line parameters describing a line passing through the alignment dots ([0040]; Fig 3A-C, not labeled; [0050] R1 (length of the straight line shown in a dotted line).
Re. Claim 9, Shizumi discloses wherein the at least one indicator is one or more digits representing the angle difference (Shizumi Fig 4B, angle 62a).
Re. claim 13, Shizumi discloses further comprising: matching, by the computing device (Shizumi Fig 1, control unit 10 [0027]), ocular anatomy represented in the input image to a treatment plan to determine an orientation of the patient's eye (Shizumi Fig 4B, 53); and determining, by the computing device (Shizumi Fig 1, control unit 10 [0027]), an orientation of the reference axis (Shizumi [0029-0030]) according to the treatment plan and the orientation of the patient's eye (Shizumi [0038] and [0041]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./ Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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