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 .
Response to Arguments
Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as expounded below.
Claim Rejections - 35 USC § 103
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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wolf et al. (US 2014/0330341; hereinafter “Wolf”) in view of Pless et al. (US 2006/0129204; hereinafter “Pless”).
Regarding claim 1, Wolf discloses a system, comprising: a spinal cord stimulation (SCS) system configured to deliver spinal cord neuromodulation including deliver a test SCS (e.g. ¶¶ 73); an infrared imaging system configured for taking thermal images of at least a portion of a patient; and an SCS suitability analyzer configured to: create thermographic imaging comparison data by comparing an infrared imaging response to the test SCS to an infrared imaging baseline before the test SCS is delivered (e.g. ¶¶ 155 – Fig. 26, #2637; #2642); and analyze the infrared imaging comparison data for an indicator of a significant perfusion response to the test SCS to determine whether the patient is a suitable candidate for SCS (e.g. ¶¶ 162-165).
Wolf fails to expressly disclose using a thermographic imaging system/imaging as claimed. The examiner notes that thermographic imaging is a type of infrared imaging/technology. In the same field of endeavor, Pless discloses the interchangeable use of thermographic imaging and analysis to more effectively visualize blood flow in different aspects of the body, to help with further analysis, therapy, and procedures (e.g. ¶¶ 104-107). It would have been obvious to use the known technique of thermographic imaging, to perform the SCS analysis in Wolf, to improve the device in the same way by allowing another data point for assessing spinal blood flow in the region to determine the SCS suitability.
Regarding claim 6, Wolf teaches a method, comprising: capturing a thermographic imaging baseline, using a thermal imaging system, before delivering a test spinal cord stimulation (SCS) (e.g. Fig. 26, #2637); delivering the test SCS using an SCS system, capturing a thermographic imaging response to the test SCS using the thermographic imaging system, and using an SCS suitability analyzer to: create thermographic imaging comparison data by comparing the thermographic imaging response to the thermographic imaging baseline (e.g. ¶¶ 155 – Fig. 26, #2642); analyze the thermographic imaging comparison data for a perfusion response and determine if a patient is a suitable candidate for SCS based on the analyzed thermographic imaging comparison data (e.g. ¶¶ 162-165).
Wolf fails to expressly disclose using a thermographic imaging system/imaging as claimed. The examiner notes that thermographic imaging is a type of infrared imaging/technology. In the same field of endeavor, Pless discloses the interchangeable use of thermographic imaging and analysis to more effectively visualize blood flow in different aspects of the body, to help with further analysis, therapy, and procedures (e.g. ¶¶ 104-107). It would have been obvious to use the known technique of thermographic imaging, to perform the SCS analysis in Wolf, to improve the device in the same way by allowing another data point for assessing spinal blood flow in the region to determine the SCS suitability.
Regarding claim 7, Wolf discloses the SCS system includes a programmer and a neuromodulator configured to deliver SCS including the test SCS; and the programmer of the SCS system includes the SCS suitability analyzer (e.g. ¶¶ 155-165).
Regarding claims 2 and 8, Wolf discloses the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, and the thermographic imaging system includes the SCS suitability analyzer (e.g. ¶¶ 143-144).
Regarding claims 3 and 9, Wolf discloses the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, and the SCS suitability analyzer includes a cloud-based analyzer implemented by one or more remote processing systems, wherein the thermographic imaging system is configured to: capture and create digital image files for both the thermographic imaging baseline and the thermographic imaging response; and send the digital image files to the cloud-based analyzer (e.g. ¶¶ 129-130).
Regarding claims 4 and 10, Wolf discloses the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging; the SCS suitability analyzer includes a cloud-based SCS suitability analyzer implemented by one or more remote processing systems; the SCS system includes a programmer and a neuromodulator configured to deliver SCS including the test SCS; and the programmer includes a digital camera to capture thermographic imaging displayed on the display screen of the thermographic imaging system, wherein the programmer is configured to use the digital camera create digital image files for both the thermographic imaging baseline and the thermographic imaging response, and configured to send the digital image files to the cloud-based SCS suitability analyzer (e.g. ¶¶ 129-130).
Regarding claims 5 and 11, Wolf discloses the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, the system further comprising a digital camera to capture thermographic imaging displayed on the display screen of the thermographic imaging system, wherein the digital camera is used to capture and create digital image files for both the thermographic imaging baseline and the thermographic imaging response when displayed on the display screen, and the SCS suitability analyzer is configured to use the digital image files to compare the thermographic imaging response to the test SCS (e.g. ¶¶ 143-144, 172, etc.).
Regarding claim 12, Wolf discloses a personal device includes the digital camera (e.g. ¶¶ 172, 196, etc.).
Regarding claim 13, Wolf discloses the personal device includes a phone or a tablet, and the personal device includes a downloadable app, wherein the method includes using the downloadable app to create and analyze the thermographic imaging comparison data from the digital image files, or using the downloadable app to send the digital image files to a cloud-based SCS suitability analyzer implemented by one or more remote processing systems (e.g. ¶¶ 172, 196, etc.).
Regarding claim 14, Wolf discloses the SCS suitability analyzer is used to create and analyze the thermographic imaging comparison data for a determined region of interest (ROI) (e.g. ¶¶ 96-99).
Regarding claim 15, Wolf discloses the ROI is automatically determined by automatically determining out-of-norm areas in the thermographic imaging baseline (e.g. ¶¶ 99-100).
Regarding claim 16, Wolf discloses the ROI is determined using user input identifying the determined ROI, and the user input includes: a user selection of one or more of pre-defined regions; or a user-defined ROI (e.g. ¶¶ 96-99).
Regarding claim 17, Wolf discloses programming neuromodulation using real-time thermographic imaging feedback (e.g. Abstract – “Electrode pulse characteristics are adjusted in real time, based on the set of measured optical intensities…”).
Regarding claim 18, Wolf discloses using the SCS suitability analyzer to: store pre-SCS thermographic data corresponding the thermographic imaging baseline and SCS-response thermographic data corresponding to the thermographic imaging response; identify one or more pre-SCS statistical values for the pre-SCS thermographic data and one or more SCS-response statistical value(s) for the SCS-response thermographic data; determine one or more differences between the pre-SCS thermographic data and the SCS-response thermographic data; and compare the one or more differences to one or more threshold values to determine if the patient is suitable for SCS (e.g. ¶¶ 201-202).
Regarding claim 19, Wolf discloses using the SCS suitability analyzer to: store pre-SCS thermographic data corresponding the thermographic imaging baseline and SCS-response thermographic data corresponding to the thermographic imaging response; fit the pre-SCS thermographic data to a first distribution curve and fit the SCS-response thermographic data to a second distribution curve; identify a first set of one or more distribution parameter(s) for the first distribution curve and a second set of the one or more distribution parameters for the second distribution curve; determine one or more differences between corresponding one or more distribution parameters in the first set and the second set; and compare the one or more differences to one or more threshold values to determine if the patient is suitable for SCS (e.g. ¶¶ 171, 207, etc.).
Regarding claim 20, Wolf discloses the first distribution curve and the second distribution curves are gamma distributions, and the one or more distribution parameters include a shape parameter (k) and a scale parameter (Θ) (e.g. ¶¶ 150).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796