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 .
Election/Restrictions
Applicant’s election without traverse of Invention II, claims 10-18 in the reply filed on 5/19/2026 is acknowledged.
Information Disclosure Statement
As required by M.P.E.P. 609, the applicant’s submissions of the Information Disclosure Statement dated 3/05/2024 is acknowledged by the examiner and the cited references have been considered in the examination of the claims now pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-18 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.
As to claim 10, 13, 14, and 16, the claim recites “associated with” which is a subjective term (MPEP 2173.05(b). Specifically, what constitutes “associated” is entirely subjective to a practitioner of the invention and/or the subject themselves. Connected or linked to what? The metes and bounds are unclear since those of ordinary skill in the art would fail to understand what qualifies as an association or connection, and thus infringement becomes unclear (MPEP 2173.05; 2173).
Claims 11-18 inherit their indefiniteness from independent claim 10 respectively.
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.
Claim(s) 10-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 10, directed to a system for determining one or more intraocular lens (IOL) parameters:
Step 1: Claim 10 falls within the statutory category, the claim is directed to a machine (having a system with memory for storing and measuring ophthalmological data of patient). Therefore, step 1 is met by the claim.
Step 2A, prong one: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. The limitations are directed to a system for receiving data and providing mathematical calculations and storing a memory for measured data. Therefore, a computer is merely being used as a tool to perform an abstract idea and meets the prong one.
Step 2A, prong two: evaluating whether the claim as a whole integrates the judicial exception into a practical application. The limitations are directed to a system for receiving training data. The computer is merely used as a tool for receiving data and providing an output, this does not integrate the judicial exception into a practical application.
Step 2B: This part of eligibility analysis evaluates wherein the claim amounts to significantly more than the recited exception, wherein any additional element or combination of additional elements adds an inventive concept to the claim. The system uses data points and related results to determine parameters of an intraocular lens, therefore it does not provide additional elements other than instructions to implement an abstract idea. Therefore, it does not provide an inventive concept.
Additionally, the claim recites “generate a plurality of data points”, at a high degree of generality, amount no more than receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information). As set forth in MPEP 2106.05(d)(II), computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claim recites “a memory storing a machine learning model trained to emulate a finite elements analysis (FEA) model” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Dependent claims 11-18 are also rejected for the same reasons set forth above and because they also fail to recite an additional element that constitutes a practical application or significantly more.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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) 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salvati (20150092159).
Regarding claim 10, Salvati discloses a system ([0004], management systems for replacement of a human eye natural lens with a customized Biometric IntraOcular Lens (BIOLs)) for determining one or more intraocular lens (IOL) parameters for an IOL to be used in a cataract surgery procedure (Fig 2, [0063], system 200 for designing and implanting a BIOL), comprising: one or more ophthalmic imaging devices ([0005], pre-operative diagnostic devices include an anterior segment analyzer (ASA) and a Lens Prescription System (LPS) configured to generate a plurality of data points associated with measurements of a plurality of anatomical parameters for an eye to be treated ([0064], eye analysis module 202 is operable to provide biometric and functional information (e.g., curvature profiles, topographies, pachimetry, aberrometry, pupillometry, accommodation profiles, anterior chamber depth, axial length, etc.)); a memory storing a machine learning model trained to emulate a finite elements analysis (FEA) model ([0072], thick-lens optical model can be defined by a BIOL surface calculation using a boundary finite element model, with tessellated triangular elements), an IOL power calculator machine learning model (Fig 2, [0063], lens calculation and optimizing module 206), and a fused machine learning model ([0065], eye modeling module 204); and at least one processor coupled with the memory ([0150], instructions can be stored and transported on any computer-readable medium for use by or in connection with an instruction execution system, apparatus, or device, such as a computer-based system, processor-containing system), the at least one processor ([0150], computer based system) configured to: generate, using the machine learning model trained to emulate the FEA model, first predicted lens behavior based ([0067], manufacturing module 208 generates STL files), at least in part, on the plurality of data points associated with the measurements of the plurality of anatomical parameters and one or more IOL parameters for each of one or more IOLs ([0068], real time intra-operative analyzer 212); generate, using the IOL power calculator machine learning model, second predicted lens behavior based, at least in part, on at least a subset of the plurality of data points associated with the measurements of the plurality of anatomical parameters for the eye to be treated and the one or more IOL parameters for each of one or more IOLs ([0065], eye modeling module 204 calculates a final lens design for manufacturing. In accordance with one embodiment, the eye modeling module 204 receives raw data from the eye analysis module 202 and generates two distinct computational models: a geometric eye model and a functional eye model); and generate, using the fused machine learning model, recommendations including one or more IOL parameters for the IOL to be used in the cataract surgery based, at least in part, on the first and the second predicted lens behavior ([0067], manufacturing module 208 generates STL files based on information received from the eye modeling module 204 and the thick lens calculation and optimization module 206).
Regarding claim 11, Salvati discloses wherein the plurality of anatomical parameters comprises one or more crystalline lens feature dimensions of the eye ([0006], crystalline lens profiles can be generated).
Regarding claim 12, Salvati discloses wherein the one or more IOL parameters comprise at least one of: an IOL type, an IOL size, or an IOL power ([0137], total power of the eye and the IOL can be calculated).
Regarding claim 13, Salvati discloses wherein the at least one processor ([0150], computer based system) is further configured to: obtain an FEA model generated using a finite element method (FEM) based on a set of data points associated with anatomical parameters of at least one historical patient and least one set of one or more IOL parameters (Fig 2, [0067], manufacturing module 208 generates STL files based on information received from the eye modeling module 204 and the thick lens calculation and optimization module 206); use the FEA model to generate predicted lens behavior based, at least in part, on the set of data points associated with the anatomical parameters of the at least one historical patient and the at least one set of one or more IOL parameters ([0066], lens module 206 uses a thick-lens algorithm to optimize the optical surfaces of the BIOL); and adjust the FEA model based on a comparison of the predicted lens behavior to observed lens behavior for an IOL with the at least one set of IOL parameters implanted in the historical patient's eye with the set of data points associated with the anatomical parameters ([0067], STL files describe specifications of the BIOL for producing a final BIOL 210 using a 3-dimensional manufacturing system).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jochinsen (20180104100), Neal (7455407), Patel (20030214628), and Rubinstein (20030107706) are examples of a system for designing and implanting a customized intra-ocular lens (IOL).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharrief I Broome whose telephone number is (571)272-3454. The examiner can normally be reached Monday-Friday 8am-5pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Sharrief I. Broome
Primary Examiner
Art Unit 2872
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872
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