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 § 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) 1, 4, 7, 10, 11, 14, 17 and 20 is/are rejected under 35 U.S.C. 103 as being obvious over Hancock et al (US 2008/0234574) in view of Gerbat et al (US 2022/0248977).
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).
Still regarding claims 1 and 11, Hancock teaches the invention substantially as claimed above but failed to explicitly teach probe 5 including a first conductor and a second conductor insulated from each other and configured to contact the sample such that the sample establishes an electrical conduction path between the first conductor and the second conductor, wherein the response signal represents electrical conduction through the sample between the first conductor and the second conductor.
However, Gerbat teaches an analogous probe system for contacting tissue (ablation catheter 2, abstract, par.70, fig.1-2) including a first conductor and a second conductor insulated from each other (tip electrode 10, ring electrodes 12, 14 and 16, par.70, each electrode is shown to have a respective wire (20, 22, 24, 26) connectible to electrical devices, Examiner respectfully notes that the electrodes are insulated from each other, par.70 and par.74, as best seen in fig.1) and configured to contact the sample such that the sample establishes an electrical conduction path between the first conductor and the second conductor, wherein the response signal represents electrical conduction through the sample between the first conductor and the second conductor (by touching the tissue with the electrodes an electrical path is generated between the electrodes to determine impedance and indicate tissue properties and/or type of tissue, par.121-127).
Since multi-electrode probes to measure impedance and classify/identify tissues are well-known in the art, it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to substitute probe 5 taught by Hancock’s invention with the probe taught by Gerbat’s invention and/or include multi electrodes to probe 5 taught by Hancock’s invention, as taught by Gerbat’s invention, for the same purpose of measuring impedance/electrical signal between the two electrodes to classify/identify tissues.
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(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) and Gerbat et al (US 2022/0248977), in view of Li et al (US 2011/0091084).
As to claims 2, 3, 12 and 13, Hancock/ Gerbat combination 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) and Gerbat et al (US 2022/0248977), in view of Santamaria-Pang et al (US 2013/0051650).
As to claims 5, 6, 15 and 16, Hancock/ Gerbat combination 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) and Gerbat et al (US 2022/0248977), in view of Kennedy et al (US 2006/0004300).
As to claims 8, 9, 18 and 19, Hancock/ Gerbat combination 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).
Response to Arguments
Applicant’s arguments with respect to 112, 101 and 102 rejections have been fully considered and are persuasive. The 112, 101 and 102 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure of Adler et al (US 2023/0346440) teaches a tissue probe/catheter 100 having two external electrodes 128 and 130 isolated from each other that determines electrical properties of the contacted tissue to identify type of tissue (par.17, par.69 and par.132).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
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