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 .
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 1-5, 7 and 11-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-10 are directed to a method (process) and claims 11-15 are directed to a system (machine) for monitoring a medical treatment of a tissue.
Step 2A, Prong One
Regarding claims 1 and 11, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “determining whether the correlation coefficient is greater than a second threshold; and when it is determined that the correlation coefficient is greater than the second threshold, determining that the photosensitizer is present in the tissue” (claim 1) and “determine whether the correlation coefficient is greater than a second threshold; and when it is determined that the correlation coefficient is greater than the second threshold, determine that the photosensitizer is present in the tissue” (claim 11) are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than looking at numbers on a piece of paper or screen and identifying one that is greater than the other.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claim 1 also recites “a biomedical laser device” and “a digital library of fluorescence data”; none of the claimed functions are being conducted or performed by these elements. Neither the “sensing” or “receiving” of claim 1 are performed by a particular structure, and these steps are not active steps being performed by the elements above. Therefore, the “biomedical laser device” and the “digital library of fluorescence data” are not part of the method claims to performing any of the limitations recited in the claims. Claim 2 also recites “at least one processor”. The “at least one processor” are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of “at least one processor”, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of determining/determine whether the correlation coefficient is greater than a second threshold; and when it is determined that the correlation coefficient is greater than the second threshold, determining/determine that the photosensitizer is present in the tissue.
Regarding dependent claims 2-5 and 7, the limitations of claim 1 further defines the limitations already indicated as being directed to the abstract idea.
With regards to claim 8, while there is a limitation of receiving sensor data, the receiving is not tied to a particular structure. Furthermore, the sensor measuring step is not an active step as written.
Regarding claim 12, this claim is directed to saving information to a computer memory, which is nothing more than a computer performing the generic function of saving information.
With regards to claim 13, the limitation of providing visual, audio, and haptic indications are nothing more than the abstract idea of organizing human activity ("managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions). See MPEP § 2106.04(a)(2)(Il).
Regarding claim 14, a biomedical device further comprising a processing is nothing more than a generic computer.
With regards to claim 15, temperatures for sensors, etc. are well known and routine in the art of physiological data gathering. See Majumder et al (“Wearable Sensors for Remote Health Monitoring”, Table 1).
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 13 requires a device associated with an “operator”, which would encompass a human subject based on par. 0072 of the published application of the specification.
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.
Claims 1-2, 4-6, 8, 11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al (U.S. 8,818,733). Jones discloses (col. 6, lines 49-63) receiving a fluorescence spectrum that is measured while the tissue is illuminated by laser light emitted by a biomedical laser device (col. 5, lines 13-45, e.g., “the slope is independent of incident intensity of the laser. This is because the intensity of the laser is factored out when calculating the photosensitizer content ratio.” Emphasis added); obtaining reference fluorescence data from a digital library of fluorescence data (col. 7, lines 18-30; “lookup table”), based at least on a type of a photosensitizer that is required to be present in the tissue for the medical treatment; determining a region of interest in the measured fluorescence spectrum, based on a reference fluorescence spectrum in the reference fluorescence data; determining whether a signal to noise ratio of the measured fluorescence spectrum in the region of interest is greater than a first threshold; when it is determined that the signal to noise ratio of the measured fluorescence spectrum in the region of interest is greater than the first threshold (“Emissions due to background noise may also be determined (308). In the porfimer sodium example, the intensity of the background emission may sampled at approximately 750 nm or other appropriate wavelength. For other photosensitizers, the background may be sampled at any relevant wavelength where fluorescence emission spectra levels out. The background may then be subtracted from each point (wavelength) in the autofluorescence region between 520 nm and 580 nm (or other relevant wavelength, depending upon the particular photosensitizer/excitation wavelength at issue) to obtain a background corrected autofluorescence (309). It is also subtracted from each point (wavelength) in the photosensitizer fluorescence region from 605 nm to 750 nm (or other relevant wavelength) to give the background-corrected photosensitizer fluorescence”, col. 6, lines 49-63); determining a correlation coefficient that is indicative of a correlation between the region of interest in the measured fluorescence spectrum and the reference fluorescence spectrum; determining whether the correlation coefficient is greater than a second threshold; and when it is determined that the correlation coefficient is greater than the second threshold, determining that the photosensitizer is present in the tissue (col. 8, lines 9-23, especially “the photosensitizer concentration may be compared to one or more threshold concentrations.”).
Regarding claim 2, Jones discloses (col. 4, lines 27-43) when it is determined that the photosensitizer is present in the tissue, the method further comprises providing an indication of the photosensitizer being present in the tissue, the indication being at least a visual indication (“The hand-held unit may further include the above-described optical and electrical processing, display, and/or analysis components. The hand-held unit may further incorporate one or more displays, and or one or more user input mechanisms, to enable communication with a user regarding detected results and/or suggestions for PDT therapy.”).
Regarding claim 4, Jones discloses (col. 8, lines 9-23) when it is determined that the signal to noise ratio of the measured fluorescence spectrum in the region of interest is lesser than or equal to the first threshold, the method further comprises determining that the photosensitizer is absent in the tissue.
Regarding claim 5, Jones discloses (col. 8, lines 9-23) when it is determined that the correlation coefficient is lesser than or equal to the second threshold, the method further comprises determining that the photosensitizer is absent in the tissue (“if the photosensitizer concentration is less than a third threshold concentration, the light dose (intensity and/or duration) may be adjusted to improve the effects of the PDT when delivered. The one or more threshold concentrations may be the same or different.”).
Regarding claim 6, Jones discloses (col. 8, lines 9-23) when it is determined that the photosensitizer is absent in the tissue, the method further comprises generating a control signal for a machine to administer the photosensitizer in the tissue (“if the photosensitizer concentration is less than a third threshold concentration, the light dose (intensity and/or duration) may be adjusted to improve the effects of the PDT when delivered. The one or more threshold concentrations may be the same or different.”).
Regarding claim 8, Joes discloses (col. 2, lines 48-54) receiving sensor data that is measured by at least one sensor arranged in proximity of the tissue, the sensor data comprising at least an oxygen saturation of the tissue.
Regarding claim 11, Jones discloses (Figure 1) a system comprising at least one processor (42) configured to: (col. 6, lines 49-63) receive a fluorescence spectrum that is measured while the tissue is illuminated by laser light emitted by a biomedical laser device (col. 5, lines 13-45, e.g., “the slope is independent of incident intensity of the laser. This is because the intensity of the laser is factored out when calculating the photosensitizer content ratio.” Emphasis added); obtain reference fluorescence data from a digital library of fluorescence data (col. 7, lines 18-30, “lookup table”), based at least on a type of a photosensitizer that is required to be present in the tissue for the medical treatment; determine a region of interest in the measured fluorescence spectrum, based on a reference fluorescence spectrum in the reference fluorescence data; determine whether a signal to noise ratio of the measured fluorescence spectrum in the region of interest is greater than a first threshold (“Emissions due to background noise may also be determined (308). In the porfimer sodium example, the intensity of the background emission may sampled at approximately 750 nm or other appropriate wavelength. For other photosensitizers, the background may be sampled at any relevant wavelength where fluorescence emission spectra levels out. The background may then be subtracted from each point (wavelength) in the autofluorescence region between 520 nm and 580 nm (or other relevant wavelength, depending upon the particular photosensitizer/excitation wavelength at issue) to obtain a background corrected autofluorescence (309). It is also subtracted from each point (wavelength) in the photosensitizer fluorescence region from 605 nm to 750 nm (or other relevant wavelength) to give the background-corrected photosensitizer fluorescence”, col. 6, lines 49-63); when it is determined that the signal to noise ratio of the measured fluorescence spectrum in the region of interest is greater than the first threshold, determine a correlation coefficient that is indicative of a correlation between the region of interest in the measured fluorescence spectrum and the reference fluorescence spectrum; determine whether the correlation coefficient is greater than a second threshold; and when it is determined that the correlation coefficient is greater than the second threshold, determine that the photosensitizer is present in the tissue (col. 8, lines 9-23, especially “the photosensitizer concentration may be compared to one or more threshold concentrations.”).
Regarding claim 13, Jones discloses (col. 4, lines 27-43) the at least one processor is communicably coupled to one or more of the biomedical laser device (Figure 1; 2,4 “light source”) and a device associated with an operator of the biomedical laser device (“user interface” 48), and wherein when it is determined that the photosensitizer is present in the tissue, the at least one processor is further configured to provide an indication of the photosensitizer being present in the tissue on the biomedical laser device and/or the device associated with an operator of the biomedical laser device, the indication being at least a visual indication.
Regarding claim 14, Jones discloses (Figure 1) the biomedical laser device (10) comprises the at least one processor (42).
Regarding claim 15, Jones discloses (col. 2, lines 48-61) at least one sensor communicably coupled to the at least one processor, the at least one sensor comprising at least an oxygen saturation sensor (6), the at least one sensor being arranged in proximity of the tissue (12), and wherein the at least one processor is further configured to receive sensor data that is measured by the at least one sensor, the sensor data comprising at least an oxygen saturation of the tissue, wherein the at least one processor obtains the reference fluorescence data from the digital library of fluorescence data, based also on the sensor data (“lookup table”, col. 5, lines 46-59).
Conclusion
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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