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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claims 2 and 12 recite the limitation “surgical tool is used for cataract surgery”, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
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 7-10 and 7-20 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.
Claim 7 recites the limitation "the anatomical structure" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the anatomical structure" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claims 1 and 11, recites a series of steps or acts, and a system to identify a sample. Thus, the claims are directed to a process and a product. which are ones of the statutory categories of invention.
STEP 2A PRONG ONE: The claim(s) recite(s) specific limitations/method steps of: a probe configured to be integrated into a surgical tool; a circuit coupled to the probe for obtaining a response signal when the probe contacts the sample.
This limitation recites a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A PRONG TWO: This judicial exception is not integrated into a practical application because the claim(s) recite the combination of additional elements/method steps of: a processor for classifying the sample in contact with the probe based on the response signal. Accordingly, this additional element/step does not integrate the abstract idea into a practical application because the claim limitations fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception
STEP 2B: The claim(s) does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, probe, circuit and a processor, but do(es) not include additional elements that are sufficient to amount to significantly more than the judicial exception because these structural elements are generically claimed to enable the collection of data by performing the basic functions of: (i) receiving, processing, and providing/displaying data, and (ii) automating mental tasks. The courts have recognized these functions to be well‐understood, routine, and conventional functions when claimed in a merely generic manner. Merely adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). As such, the recitation of these additional limitations in claims 2-10 and 12-20 does not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment and represent insignificant extra-solution activity. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as a sensor and use of a processor does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Thus, the claimed invention does not amount to significantly more than the Abstract Idea.
When viewed alone or in combination, the limitations of claims 1-20 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
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, 4, 7, 10, 11, 14, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hancock et al (US 2008/0234574).
As to claims 1 and 11, Hancock teaches a system and method for identifying a sample within a surgical site (apparatus for classifying and/or ablating tissue, abstract, par.163, fig.5), the system comprising:
a probe configured to be integrated into a surgical tool (probe 5 is adapted for insertion into a tissue 6, wherein probe 5 can be integrated with phase locked source of microwave radiation 1, and/or integrated with actuator 1130, par.163 and par.170, fig.5);
a circuit (directional coupler 200, par.171, fig.5) coupled to the probe for obtaining a response signal when the probe contacts the sample (when the apparatus is used to direct microwave radiation through the probe and into tissue 6 at the end of the probe 5, the tissue 6 will reflect a portion of the microwave radiation back through the probe towards the source 1. A directional coupler 200 diverts a portion of this signal to an input B of the detector 100. The reflected signal directed to the detector is indicated by reference numeral 210, the detector 100 also takes an input A from a reference signal 255, par.171, fig.5); and
a processor (detector 100 and classifier 150, par.170-172, fig.5) for classifying the sample in contact with the probe based on the response signal (detector 100 detects the magnitude and phase of both the reflected signal 210 and the reference signal 255. This information is then output to a tissue classifier 150 which classifies the tissue 6 as a particular tissue type (e.g. muscle, fat, cancerous tumor) and outputs the result to a display 160, which displays the tissue type, par.172).
As to claims 4 and 14, Hancock teaches the system and method, wherein the response signal represents an impedance of the sample (calculating a complex impedance (having both real and imaginary components) on the basis of the input reflected and reference signals, end of par.173, par.175, and tissue classifier 150 classifies the tissue by comparing the above-mentioned complex impedance value, par.176).
As to claims 7 and 17, Hancock teaches the system and method, wherein the probe is further configured to generate an input signal when the probe contacts the anatomical structure (probe 5 is adapted for insertion into the tissue, so that the tissue measured is at or surrounding the distal end 5a of the probe. That is, in use, there is physical contact between the probe and the tissue 6, par.163, tissue classifier 150 classifies the tissue 6 into one of a plurality of different tissue types (e.g. fat, muscle, cancerous tumor) and is also able to detect when the probe is in air and not in contact with tissue on the basis of the complex impedance value output, par.175, par.5).
As to claims 10 and 20, Hancock teaches the system and method, wherein the processor is configured to generate an impedance for one or more frequencies using the response signal and information regarding the input signal (source of microwave radiation is phased locked so that it outputs a single stable frequency, the source of microwave radiation outputs a frequency of between 13.75 GHz and 14.75 GHz, par.165, and a signal 630 having a frequency different to the frequency of the reference 255 and reflected 210 signals, the frequency of the signal 630 is chosen such that it mixes with the reflected signal 210 and reference signal 255 to produce a lower frequency signal which can be output to a digital signal processor 680, par.173).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2, 3, 12 and 13 is/are rejected under 35 U.S.C. 103 as being obvious over Hancock et al (US 2008/0234574), in view of Li et al (US 2011/0091084).
As to claims 2, 3, 12 and 13, Hancock teaches the claimed invention substantially above, but failed to explicitly teach wherein the surgical tool is used for cataract surgery, and the sample is human eye tissue, and wherein the human eye tissue is one of a cornea, an iris, a lens or vitreous tissue.
However, Li teaches an analogous for cataract diagnosis and detecting a region of interest in a picture of the lens (abstract) in the same field of endeavor, wherein sub-steps 210 to 215 identify angular (i.e. not radially-directed) opacity near the center of the pupil, which is likely to be due to PSC. In step 210, a local thresholding is performed with a tall rectangular element to obtain angular opacity (par.51), and step 215, we apply a spatial-filter to remove angular opacity near the rim of lens which may be due to cortical opacity. Spatial filtering is accomplished by eliminating opacity clusters with distances from the lens origin to the centroids being below a fixed ratio of the radius (par.52).
It would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to modify Hancock’s invention to detect different cataract/eye tissues, as taught by Li’s invention (par.6).
Claim(s) 5, 6, 15 and 16 is/are rejected under 35 U.S.C. 103 as being obvious over Hancock et al (US 2008/0234574), in view of Santamaria-Pang et al (US 2013/0051650).
As to claims 5, 6, 15 and 16, Hancock teaches the claimed invention substantially above, but failed to explicitly teach wherein the processor implements a machine learning algorithm for performing the classifying, and wherein the machine learning algorithm includes SVM.
However, Santamaria-Pang teaches a system in the same field of endeavor for classifying tissue (abstract, par.19) teaches an algorithm was performed for feature selection. Using the 18 features listed below, with the addition of preliminary clustering features as genes, chromosomes of features were mutated, crossed over, and then selected using an SVM as a fitness function (par.87), and methods for tissue classification may be applied, for example, to any tissue that is likely to vary in some manner as a result of its biological condition or history. For instance, the methods may be applied, for example, for a diagnosis of a condition by obtaining appropriate tissue samples from subjects with and without a particular condition or disease (par.92).
It would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to modify Hancock’s invention to classify different tissues using SVM, to accurately and precisely classify al types of different tissues, even healthy tissues, as taught by Santamaria-Pang’s invention (par.92).
Claim(s) 8, 9, 18 and 19 s/are rejected under 35 U.S.C. 103 as being obvious over Hancock et al (US 2008/0234574), in view of Kennedy et al (US 2006/0004300).
As to claims 8, 9, 18 and 19, Hancock teaches the claimed invention substantially above, but failed to explicitly teach wherein the input signal is an alternating current (AC) voltage signal, and wherein the AC voltage signal is a pseudorandom white noise signal.
However, Kennedy teaches a system to measure impedance in the same field of endeavor to determine different tissue types in a subject (abstract, par.39), wherein the pseudo-random voltage generator 15, delivers an analog command voltage 16 to the current source 17. The current source 17 is responsive to the received command voltage 16 to generate a pseudo-random "white noise" current 18 (par.115).
It would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to modify Hancock’s invention to use AC voltage signal to determine the variation in the impedance with the frequency of the applied signal, to accurately determine the tissue type, as taught by Kennedy’s invention (par.37).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791