DETAILED ACTION
This Office action is in response to the Application filed on March 1, 2024, which is a national stage application under 35 U.S.C. §371 of International Application No. PCT/US2022/019812, filed on March 10, 2022, which claims foreign priority to PCT/US2022/019812, filed on September 2, 2021. Claims 3-4, 6, 10, 12-13, and 59-60 have been amended and claims 16-58 and 61-62 have been cancelled a via preliminary amendment. An action on the merits follows. Claims 1-15 and 59-60 are pending on the application.
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 .
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 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.
Drawings
Figure(s) 1-28B contain portions that are missing or blurry, and therefore are not electronically reproducible. See 37 CFR 1.84(I). Replacement drawing sheets in compliance with 37 CFR 1.84 and 1.121(d) containing figures that are of sufficient quality to be electronically reproduced are required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-15 and 59-60 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 1 recites the limitation “generating a diagnostic, prognostic, or theranostic for a disease state from three or more imaging modalities obtained from a biopsy sample from a subject… comparing a plurality of cross-modal features to identify a correlation between at least one cross-modal feature parameter” in lines 1-4 of the claim. However, it is not clear if the claimed “plurality of cross-modal features” recited in line 3 of the claim encompass embodiments corresponding to “cross-modal features” of the claimed “biopsy sample from a subject” previously recited in line 2 of the claim, or if the claimed “plurality of cross-modal features” recited in line 3 of the claim embodiments to “cross-modal features” that do not correspond to the claimed “biopsy sample from a subject” previously recited in line 2 of the claim, for example. Additionally, it is not clear if the claimed “at least one cross-modal feature parameter” recited in lines 3-4 of the claim encompass embodiments corresponding to at least one of the claimed “plurality of cross-modal features” previously recited in line 3 of the claim, or if the claimed “at least one cross-modal feature parameter” recited in lines 3-4 of the claim encompass embodiments corresponding to another “at least one cross-modal feature parameter” different from at least one of the claimed “plurality of cross-modal features” previously recited in line 3 of the claim, for example. Therefore, the metes and bounds of the claim are not clearly set forth and the examiner cannot clearly determine which elements are encompassed by the claim language, which renders the claim indefinite.
Claim 1 further recites the limitation “the three or more spatially resolved data sets… the spatially aligned three or more spatially resolved data sets” in lines 6-7 of the claim. There is insufficient antecedent basis for the claimed “the three or more spatially resolved data sets” and “the spatially aligned three or more spatially resolved data sets” limitation recited in lines 6-7 the claim. Therefore, the lack of antecedent basis makes the scope of the claim indeterminate.
Claim 1 further recites the limitation “extracting the cross-modal feature from the aligned feature image… wherein each cross-modal feature comprises a cross-modal feature parameter, and wherein the three or more spatially resolved data sets are outputs by the corresponding imaging modality selected from the group consisting of the three or more imaging modalities” in lines 8-9 of the claim. However, it is not clear if the claimed “the cross-modal feature” recited in line 8 of the claim encompass embodiments corresponding to the claimed “at least one cross-modal feature parameter” previously recited in lines 3-4 of the claim, or if the claimed “the cross-modal feature” recited in line 8 of the claim encompass embodiments corresponding to another “cross-modal feature” different from the claimed “at least one cross-modal feature parameter” previously recited in lines 3-4 of the claim, for example, because the claimed “cross-modal features” term recited in line 3 of the claim, and the claimed “cross-modal feature parameter” term recited in lines 3-4 of the claim, respectively, are not clearly defined, or differentiated, by the claims. Additionally, it is not clear if the claimed “a cross-modal feature parameter” recited in line 9 of the claim encompass embodiments corresponding to the claimed “cross-modal feature parameter” previously recited in lines 3-4 of the claim, or if the claimed “a cross-modal feature parameter” recited in line 9 of the claim encompass embodiments corresponding to another “cross-modal feature parameter” different from the claimed “cross-modal feature parameter” previously recited in lines 3-4 of the claim, for example. Therefore, the metes and bounds of the claim are not clearly set forth and the examiner cannot clearly determine which elements are encompassed by the claim language, which renders the claim indefinite.
Claim 1 further recites the limitation “the three or more spatially resolved data sets are outputs by the corresponding imaging modality selected from the group consisting of the three or more imaging modalities” in lines 9-11 of the claim. There is insufficient antecedent basis for the claimed “the corresponding imaging modality” limitation recited in line 10 of the claim. Therefore, the lack of antecedent basis makes the scope of the claim indeterminate.
Claims 2-15 and 59-60 are rejected by virtue of being dependent upon rejected base claim 1.
Claim 2 recites the limitation “at least one of the three or more spatially resolved data sets comprise data on abundance and spatial distribution of cells” in lines 1-2 of the claim. However, it is not clear if the claimed “data on abundance and spatial distribution of cells” recited in line 2 of claim 2 encompass embodiments corresponding to “cells” of the claimed “biopsy sample from a subject” previously recited in line 2 of claim 1, or if the claimed “data on abundance and spatial distribution of cells” recited in line 2 of claim 2 encompass embodiments corresponding to other “cells” different from “cells” of the claimed “biopsy sample from a subject” previously recited in line 2 of claim 1, for example. Therefore, the metes and bounds of the claim are not clearly set forth and the examiner cannot clearly determine which elements are encompassed by the claim language, which renders the claim indefinite.
Claim 3 recites the limitation “at least one of the three or more spatially resolved data sets comprise data on abundance and spatial distribution of tissue structures” in lines 1-2 of the claim. However, it is not clear if the claimed “data on abundance and spatial distribution of tissue structures” recited in line 2 of claim 3 encompass embodiments corresponding to “tissue structures” of the claimed “biopsy sample from a subject” previously recited in line 2 of claim 1, or if the claimed “data on abundance and spatial distribution of tissue structures” recited in line 2 of claim 3 encompass embodiments corresponding to other “tissue structures” different from “tissue structures” of the claimed “biopsy sample from a subject” previously recited in line 2 of claim 1, for example. Therefore, the metes and bounds of the claim are not clearly set forth and the examiner cannot clearly determine which elements are encompassed by the claim language, which renders the claim indefinite.
Claim 4 recites the limitation “at least one of the three or more spatially resolved data sets comprise data on abundance and spatial distribution of one or more molecular analytes” in lines 1-3 of the claim. However, it is not clear if the claimed “data on abundance and spatial distribution of one or more molecular analytes” recited in line 2-3 of claim 4 encompass embodiments corresponding to “molecular analytes” of the claimed “biopsy sample from a subject” previously recited in line 2 of claim 1, or if the claimed “data on abundance and spatial distribution of one or more molecular analytes” recited in lines 2-3 of claim 4 encompass embodiments corresponding to other “molecular analytes” different from “molecular analytes” of the claimed “biopsy sample from a subject” previously recited in line 2 of claim 1, for example. Therefore, the metes and bounds of the claim are not clearly set forth and the examiner cannot clearly determine which elements are encompassed by the claim language, which renders the claim indefinite.
Conclusion
The prior art made of record cited in PTO-892 and not relied upon is considered pertinent to Applicant’s disclosure.
US 2011/0280455 A1 (Alexandrov et al.) discloses “invention relates to the spatially resolved determination of the nature and state of a tissue from spatially resolved mass spectra of a tissue section… the quality of spatially resolved tissue states is improved by a method involving the following steps… (a) acquisition of spatially resolved mass spectra of a tissue section or parts of a tissue section… (b) generation of at least two mass images from the spatially resolved mass spectra, the mass images comprising the ion current signals of predetermined mass intervals… (c) smoothing of the mass images using a smoothing algorithm with smoothing parameters, and… (d) calculation of a status image from the smoothed mass images by means of a classification algorithm derived from mathematical statistics… For an evaluation, several of the spatially resolved mass spectra of a tissue section can be used as input data; mass spectra of partial regions may be selected on account of additionally available information, e.g. from light-optical images of the tissue section, and thus different types of tissue or regions of diseased and healthy tissue may be taken into account. The selection of mass intervals in the spatially resolved mass spectra, with which an iterative optimization process is started, can be done in different ways… a status image (50) is calculated from spatially resolved mass spectra (20) of a tissue section (1)… the tissue section (1) is prepared on a sample support (2), and spatially resolved mass spectra S(x,y,m) (20) of the tissue section (1) are acquired… ions (5) generated by the individual MALDI processes are analyzed in a time-of-flight mass spectrometer (not shown) with axial ion injection so that a spatially resolved mass spectrum… from summed individual spectra is assigned to every pixel… Another way of viewing all the spatially resolved mass spectra S(x,y,m) (20) consists in dividing the mass spectra into mass intervals so that the signals in one mass interval m, produce a two-dimensional mass image… and the spatially resolved mass spectra S(x,y,m) (20) are composed of a large number of mass images… mass images are selected from the spatially resolved mass spectra” in Par. [0001-34], for example.
US 2019/0307390 A1 (Bawendi et al.) discloses “detecting disease states… determining a progression state for a patient may be useful for monitoring disease states in patients to determine if treatment and/or therapy is necessary. For example, based on a progression state of a patient, the likelihood of disease presence, disease severity, possible treatments and/or medications, as well as follow up frequency (e.g., every three months, six months, etc.) may be determined. Further, due to the relatively noninvasive nature and specificity of the disclosed methods, the methods described herein may decrease the risk of associated errors in disease diagnosis or prognosis (e.g., sample-error), decrease the need for invasive procedures, and improve both pre-clinical testing and in-treatment options for patients… a progression state of a patient may be used to either provide a determination of a stage or extent of an identified disease state and/or may be used to recommend a course of treatment (e.g., to a medical practitioner). For example, a controller of a device may make the comparison between the detected autofluorescence signals to the stored autofluorescence intensity thresholds and/or area thresholds to determine both a particular disease state and progression state. The controller may then output the identified disease state and/or progression state along with a recommended course of treatment… depending on the particular disease state and progression state, recommended courses of treatment may include treatment options, recommending biopsy or other diagnostic procedures, frequency of monitoring (e.g. monitor every 3 months, 6 months, etc.), and/or any other appropriate treatment option - detection of lipopigments by NIR/SWIR autofluorescence in stained and unstained tissue. Most healthy tissue has very little autofluorescence in the NIR and SWIR wavelength ranges. Lipopigments (e.g., lipofuscin and/or ceroid), however, can emit NIR- and SWIR-light, resulting in elevated NIR/SWIR autofluorescence signals under particular disease conditions, providing disease-correlated contrasted images. For example, FIGS. 6A and 6B show spatially-resolved emission detection via microscopy of cirrhotic liver tissue for wavelengths corresponding to the Cy5 channel and NIR/SWIR channel shown in FIG. 8 which shows a diagram of the excitation and emission wavelengths for each microscope filter cube setting. In FIG. 8, for each channel, the excitation wavelengths are represented by the band on the left and the emission wavelengths are represented by the band on the right. Comparatively, FIGS. 7A and 7B show spatially-resolved emission detection via microscopy of formaldehyde-fixed, paraffin-embedded cirrhotic liver tissue with a Sudan Black B stain, which quenched visible wavelength emission of lipofuscin/ceroid through absorption” in Par. [0003-105], for example.
US 2004/0057609 A1 (Weinberg et al.) discloses “a system for determining a biopsy location in a body part. The system includes a first device configured to obtain digital physiological image data about the body part, a second device configured to obtain second image data about the body part, a monitor configured to display the second image data, a signal processing module that includes an analog-to-digital converter configured to digitize the second image data, a memory configured to store the digital physiological image data and the digitized second image data, and a correlator coupled to the memory and configured to correlate the digital physiological image data with the digitized second image data and to produce a combined image as a result of the correlation. A determination of a biopsy location is made on the basis of the combined image, or on the basis of features derived from the two images. The first device may include a positron emission tomography scanner machine. The second device may include one of the group consisting of a digital x-ray machine, an x-ray mammography machine, an x-ray cranial axial tomography machine, a magnetic resonance imaging machine, and an ultrasound machine. The system may also include a localization device configured to select a preferred subset of the second image data based on the digital physiological image data obtained from the first device. The localization device may include a computer mouse. The first device may be configured to use a predetermined spatial coordinate system. The correlator may include a transformer configured to transform at least one of the digital physiological image data and the digitized second image data into the predetermined spatial coordinate system… method and apparatus for obtaining x-ray or image sets for correlation with a physiological imaging set… invention allows a device used for physiological imaging (hereinafter referred to as a "first device") to "grab" images from any of a variety of other devices (hereinafter referred to a "second device")… An example of a first device is a positron emission tomography ("PET") scanner machine. Examples of second devices include digital x-ray machines, x-ray mammography machines, x-ray cranial axial tomography (CT) machines, magnetic resonance imaging (MRI) machines, ultrasound machines, or any other medical imaging device that provides an image to a computer monitor… a method for determining a biopsy location in a body part according to a preferred embodiment of the present invention. At the first step 205, image data about the body part is obtained using a first device. Preferably, the image data is digital and contains physiological information about the body part. The first device may be a positron emission tomography scanner machine. At the second step 210, second image data about the body part is obtained using a second device. Preferably, the second image data is anatomical image data that is transmittable to a video monitor. The second device may be one of a digital x-ray machine, an x-ray mammography machine, an x-ray cranial axial tomography machine, a magnetic resonance imaging machine, and an ultrasound machine… data from the second image may be processed with feature extraction software in order to generate locations of features of interest that are then superimposed on the first image data display” in Par. [0007-18], for example.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO M RIVERA-MARTINEZ whose telephone number is (571) 272-4979. The examiner can normally be reached on 9 am to 5 pm.
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/GUILLERMO M RIVERA-MARTINEZ/ Primary Examiner, Art Unit 2677