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 .
Drawings
The drawings were received on 5/3/2024. These drawings are accepted.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Logic module in claims 1, 14, 15, 16, 20 and 31
Sub-logic module in claim 9
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 4, 10, 14-15, 17-18, 20, 22-23, 26 and 32-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piron et al. (US20160015471, hereinafter “Piron”)
Claim 1. Piron teaches A medical imaging and optical identifier system, comprising:
an optical identifier camera configured to generate an identifier image of a medical device ([0134] “images obtained by an additional camera may be processed to identify a medical instrument based on a known instrument shape, or based on known markings or features that may be imaged, for example the templates (2040 and 2030) located on medical instruments (2020 and 2040 respectively) as shown in FIG. 20.”) or a packaging of the medical device; ([0128] “one or two-dimensional barcodes may be employed to provide detectable information identifying a medical instrument.” Is understood to be the same as the claimed packaging of the medical device in light of instant specifications [0075])
an imaging probe configured to send and receive a signal for providing a medical image of a target location; ([0153] “collecting a multi-spectral detector images at a selected location.” Is understood to be the same as the claimed send and receive a signal for providing a medical image of a target location in light of instant specifications [0091])
a console configured to display one or both of the identifier image and the medical image; ([0170] “GUI has adapted to this multimodal imaging by displaying both the visible and hyperspectral imaging simultaneously side by side as opposed to just the single view depicted in FIG. 6A. …allow the user to view a hyperspectral spectrum at a specific point on the display of the hyperspectral image if the user chose to do so.”) and
one or more logic modules stored within a non-transitory storage medium, the one or more logic modules, when executed by one or more processors, perform operations ([0192] “executing sequences of instructions contained in a memory, such as ROM, … non-volatile memory,”) including:
parsing the identifier image to extract one or more identifier markers; ([0128] “identification data may correlate the graphical symbol, or a code or other information extractable from the graphical symbol, with the identities of various medical instruments.”)
analyzing the one or more identifier markers to determine an identity of the medical device; ([0128]“information extractable from the graphical symbol, with the identities of various medical instruments.” And [0133] “two-dimensional barcodes for instrument identification.” And [0134] “identify a medical instrument based on a known instrument shape, or based on known markings”) and
modifying a parameter of the medical image based on the identity of the medical device. ([0137] “Referring again to FIG. 3, after having identified a medical instrument in step 200, customized configuration parameters are obtained for adaptively configuring one or more devices that are employed during a medical procedure.”)
Claim 4. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein the one or more identifier markers includes one or more of a boundary of the medical device, ([0134] “images obtained by an additional camera may be processed to identify a medical instrument based on a known instrument shape”) a boundary of the packaging, a boundary of a portion of the medical device, a boundary of a portion of the packaging.
Claim 10. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein the identity of the medical device includes one or more of a model, batch number, serial number, ([0163] “In some embodiments, the medical instrument may be identified beyond its name or type. For example, in one embodiment, the instrument may be uniquely identified. In other words, a resection device would not simply be identified as a generic “resection device”, but would be identified with a unique identifier that is only associated with the specific instrument that is used, such as an instrument identifier that includes a serial or inventory number associated with the resection device.”) product code, product name, and product description.
Claim 14. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein the imaging probe is an ultrasound probe ([0152] “modalities other than optical, for instance ultrasound,”) configured to emit ultrasound signals and detect reflected ultrasound signals, ([0153] “ultrasound array positioned in the access port is employed to collect the emitted ultrasound signal.”) and wherein the one or more logic modules is configured to retrieve information from the ultrasound probe to provide the medical image. ([0220] “tools being utilized such as the ultrasound used to scan under the surface of the dura and in addition the introducer which is inserted into the port and used to penetrate the brain to provide access to the tumor in a non-traumatic manner.” And [0228] “intraoperative ultrasound imaging,”)
Claim 15. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein the imaging probe is an electromagnetic probe configured to emit electromagnetic signals and detect reflected electromagnetic signals, and wherein the one or more logic modules is configured to retrieve information from the electromagnetic probe to provide the medical image. ([0046] “optical imaging device employed during the medical procedure;” and [0227] “optical imaging may be performed to determine one or more context measures associated with the present state of the medical procedure. For example, optical imaging may be employed using one or more spectral regions including ultraviolet, visible, and infrared.” is understood to be the same as the claimed electromagnetic signal/probe in light of instant specifications [0092])
Claim 17. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein modifying the parameter of the medical image further includes modifying one or more of ([0147] “adaptively provide configuration parameters associated with one or more of, but not limited to,”) frequency, ([0147] “imaging frame rate”) gain, ([0147] “gain”) depth, ([0148] “depth of field”) focus, ([0156] “focus”) dynamic range, ([0229] “dynamic range”) persistence, one or more filters, ([0148] “filter wavelength”) zoom, ([0147] “digital zoom (ROI)”) pan, time gain compensation (“TGC”), color doppler and power doppler.
Claim 18. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein modifying the parameter of the medical image further includes modifying one or more icons superimposed on the medical image. ( [0169] “Examples of configuration parameters for configuring a user interface include… displayed icons… for overlay of images from two or more imaging modalities,” and [0154] “images of different types which can be combined into an overlaid representation and displayed to the operator.”)
Claim 20. Piron teaches The medical imaging and optical identifier system according to claim 1, further including the optical identifier camera configured to generate an identifier image of a patient or a technician, and the one or more logic modules configured to analyze the one or more identifier markers to determine a characteristic or an identity of the patient or the technician. ([0164] “a medical instrument may be identified as being associated with a specific operator…biometric sensors may be integrated into the surgical tool or acquired via a separate device either attached to the surgeon continuously or separate (e.g. the surgeon activates his/her identity at a computer console). Example biometric identification techniques are: iris scan, fingerprint scan, voice identification, and cardiac patterns.” is understood to be the same as the claimed identifier markers to determine characteristic or an identify of the patient or technician in light of instant specifications [0057] and [0100])
Claim 22. Piron teaches The medical imaging and optical identifier system according to claim 20, wherein determine the identity the patient or the technician includes running one of a facial recognition or a fingerprint recognition analysis to extract the one or more identifier markers and compare the one or more identifier markers with a medical records database. ([0164] “a medical instrument may be identified as being associated with a specific operator.” And [0124] “The identification data may be provided in the form of a database,”)
Claim 23. Piron teaches A method of placing a medical device, comprising:
generating an identifier image of one or both of the medical device ([0134] “images obtained by an additional camera may be processed to identify a medical instrument based on a known instrument shape, or based on known markings or features that may be imaged, for example the templates (2040 and 2030) located on medical instruments (2020 and 2040 respectively) as shown in FIG. 20.”) and a packaging of the medical device ([0128] “one or two-dimensional barcodes may be employed to provide detectable information identifying a medical instrument.” Is understood to be the same as the claimed packaging of the medical device in light of instant specifications [0075])
using an optical identifier camera; ([0134] “images obtained by an additional camera may be processed to identify a medical instrument based on a known instrument shape” and [0140] “system includes an optical system 250 including camera 255,”)
parsing the identifier image to extract one or more identifier markers; ([0128] “identification data may correlate the graphical symbol, or a code or other information extractable from the graphical symbol, with the identities of various medical instruments.”)
analyzing the one or more identifier markers to determine an identity of the medical device; ([0128]“information extractable from the graphical symbol, with the identities of various medical instruments.” And [0133] “two-dimensional barcodes for instrument identification.” And [0134] “identify a medical instrument based on a known instrument shape, or based on known markings”)
querying the medical device identity with one or more relational databases ([0185] “Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.”) to retrieve a predetermined medical imaging parameter; ([0185] “data storage device 442 includes identification data 450 for identifying one or more medical instruments 460 and configuration data 452 that associates customized configuration parameters with one or more medical instruments 460.”)
imaging a target location using a probe of a medical imaging system to generate a medical image; ([0153] “collecting a multi-spectral detector images at a selected location.” Is understood to be the same as the claimed send and receive a signal for providing a medical image of a target location in light of instant specifications [0091])
modifying a medical imaging parameter of the medical imaging system to the predetermined medical imaging parameter; ([0137] “Referring again to FIG. 3, after having identified a medical instrument in step 200, customized configuration parameters are obtained for adaptively configuring one or more devices that are employed during a medical procedure.”)
and
placing the medical device at the target location. ([0104] “track the position and/or orientation of an access port or other component that is attached to, or inserted into, a patient or subject.” And [0118] “so that the position and orientation of the instrument can be determined.”)
Claim 26. The method herein has been executed and performed by the system of claim 4 and is likewise rejected
Claim 32. The method herein has been executed and performed by the system of claim 10 and is likewise rejected
Claim 33. Piron teaches The method according to claim 23, wherein the medical imaging system is one of an ultrasound medical imaging system, ([0152] “modalities other than optical, for instance ultrasound,”) electromagnetic medical imaging system, ([0046] “optical imaging device employed during the medical procedure;” and [0227] “optical imaging may be performed to determine one or more context measures associated with the present state of the medical procedure. For example, optical imaging may be employed using one or more spectral regions including ultraviolet, visible, and infrared.” is understood to be the same as the claimed electromagnetic signal/probe in light of instant specifications [0092]) fluoroscopic imaging system, or a magnetic imaging system.
Claim 34. Piron teaches The method according to claim 23, wherein modifying a parameter of the medical imaging system further includes modifying an icon superimposed on the medical image ( [0169] “Examples of configuration parameters for configuring a user interface include… displayed icons… for overlay of images from two or more imaging modalities,” and [0154] “images of different types which can be combined into an overlaid representation and displayed to the operator.”) of the target location. ([0153] “image could be overlaid on video images to provide different perspectives of exposed tissue regions.”)
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3, 5-6, 8-9, 24-25, 27-28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US20160015471, hereinafter “Piron”) and in view of Degen et al (US20240005653, hereinafter “Degen”)
Claim 2. Piron teaches The medical imaging and optical identifier system according to claim 1,
Piron does not explicitly teach wherein parsing the identifier image to extract the one or more identifier markers further includes parsing the identifier image into pixels and assigning a numerical value to each pixel and analyzing the numerical values to detect one or more edges within the identifier image.
Degen teaches wherein parsing the identifier image ([0091] “machine vision tool that identifies targeted image conditions, whether objects, portions of regions of interest, or image-derived features.”) to extract the one or more identifier markers further ([0091] “barcode detection”) includes parsing the identifier image into pixels and assigning a numerical value to each pixel and analyzing the numerical values to detect one or more edges within the identifier image. ([0091] “the polarity of the target edge (e.g., whether the target edge is formed of a transition from left to right of dark pixels to light pixels or of light pixels to dark pixels),”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have barcode detection by conducting edge detection as taught by Degen to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been so because (Degen et al [0094] “auto-configuration techniques herein allow for multiple different tool configuration parameters to be set and for multiple different values for a single tool configuration parameter to set.”)
Claim 3. Piron and Degen teach The medical imaging and optical identifier system according to claim 2,
Piron does not explicitly teach wherein parsing the identifier image to extract the one or more identifier markers further includes analyzing the one or more edges detected within the identifier image to detect one or more boundaries within the identifier image.
Degen teaches wherein parsing the identifier image to extract the one or more identifier markers further includes analyzing the one or more edges detected within the identifier image to detect one or more boundaries within the identifier image. ([0091] “shape of the edge (e.g., linear or curvilinear).” Is understood to be the same as the claimed boundaries in light of instant specifications [0065])
Claim 5. Piron and Degen teach The medical imaging and optical identifier system according to claim 3,
Piron teaches wherein analyzing the one or more identifier markers to determine the identity of the medical device further includes comparing one or more of a shape and a dimension of the one or more boundaries within the identifier image with a labeled dataset ([0124] “pre-selected identification data, where the pre-selected identification data associates the identities of a plurality of medical instruments with various measures. The identification data may be provided in the form of a database, look-up table, or other data structure that may be accessed by control and processing unit 400 to identify the medical instrument.” ) including a plurality of boundaries and associated medical device identities. ([0126] “a medical instrument may be identified based on marker geometry (e.g. using passive optical systems). For example, a medical instrument may be identified by the size and/or shape of the fiducial markers. In such a case, the identification data may correlate the geometry of the fiducial markers with the identities of various medical instruments.” And [0134] “identify a medical instrument based on a known instrument shape, or based on known markings or features that may be imaged,”)
Claim 6. Piron teaches The medical imaging and optical identifier system according to claim 1,
Piron does not explicitly teach wherein parsing the identifier image to extract the one or more identifier markers further includes parsing the identifier image into pixels an assigning a numerical value to each pixel and analyzing the numerical values to detect one or more colors within the identifier image.
Degen teaches wherein parsing the identifier image ([0091] “machine vision tool that identifies targeted image conditions, whether objects, portions of regions of interest, or image-derived features.”) to extract the one or more identifier markers further ([0091] “barcode detection”) includes parsing the identifier image into pixels an assigning a numerical value to each pixel and analyzing the numerical values to detect one or more colors within the identifier image. ([0091] “the polarity of the target edge (e.g., whether the target edge is formed of a transition from left to right of dark pixels to light pixels or of light pixels to dark pixels),”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have barcode detection by conducting color detection within the image as taught by Degen to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been so because (Degen et al [0094] “auto-configuration techniques herein allow for multiple different tool configuration parameters to be set and for multiple different values for a single tool configuration parameter to set.”)
Claim 8. Piron and Degen teach The medical imaging and optical identifier system according to claim 2, wherein parsing the identifier image to extract the one or more identifier markers further includes analyzing the one or more edges detected within the identifier image
Piron teaches to detect one or more alphanumeric symbols within the identifier image. ([0162] “medical instrument may be indirectly identified with a textual, numeric, …or alphanumeric instrument identifier that is associated with its identity.” and [0128] “glyphs, … or textual markers may be employed to identify a medical instrument.”)
Claim 9. Piron and Degen teach The medical imaging and optical identifier system according to claim 8, wherein analyzing the one or more identifier markers to determine the identity of the medical device further includes
Piron teaches running a text recognition sub-logic module including comparing the one or more alphanumeric symbols within the identifier image with a labeled dataset ([0124] “pre-selected identification data, where the pre-selected identification data associates the identities of a plurality of medical instruments with various measures. The identification data may be provided in the form of a database, look-up table, or other data structure that may be accessed by control and processing unit 400 to identify the medical instrument.” ) including a plurality of alphanumeric symbols associated with medical device identities. ([0162] “medical instrument may be indirectly identified with a textual, numeric, …or alphanumeric instrument identifier that is associated with its identity.” and [0128] “glyphs, … or textual markers may be employed to identify a medical instrument.”)
Claim 24. The method herein has been executed and performed by the system of claim 2 and is likewise rejected
Claim 25. The method herein has been executed and performed by the system of claim 3 and is likewise rejected
Claim 27. The method herein has been executed and performed by the system of claim 5 and is likewise rejected
Claim 28. The method herein has been executed and performed by the system of claim 6 and is likewise rejected
Claim 30. The method herein has been executed and performed by the system of claim 8 and is likewise rejected
Claim 31. The method herein has been executed and performed by the system of claim 9 and is likewise rejected
Claims 7 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US20160015471, hereinafter “Piron”) and in view of Degen et al (US20240005653, hereinafter “Degen”) and in view of Jacobs et al (US20150164606, hereinafter “Jacobs”)
Claim 7. Piron and Degen teach The medical imaging and optical identifier system according to claim 6, wherein analyzing the one or more identifier markers to determine the identity of the medical device further includes
Piron and Degen do not explicitly teach comparing the one or more colors within the identifier image with a labeled dataset including a plurality of colors and associated medical device identities.
Jacobs teaches comparing the one or more colors within the identifier image ([0047] “Analysis of visible-light images” is understood to be the same as color) with a labeled dataset ([0063] “identify a matching object from the listing in the digital data store.”) including a plurality of colors and associated medical device identities. ([0047] “can allow the sensing device 116 or digital data processor 118 to read identification information that is encoded in markings formed on an outer surface of an instrument 104 or array 114.”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination of Piron and Degen to have comparing colors within the image with a labeled dataset including colors and associated medical device identities as taught by Jacobs to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been to (Jacobs [0025] “allow for more accurate tracking of the object by the surgical navigation system”)
Claim 29. The method herein has been executed and performed by the system of claim 7 and is likewise rejected
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US20160015471, hereinafter “Piron”) and in view of Aysin et al (US20190362841, hereinafter “Aysin”)
Claim 11. Piron teaches The medical imaging and optical identifier system according to claim 1, wherein determining the identity of the medical device further includes
Piron does not explicitly teach training a machine learning model using a predetermined labeled dataset having a plurality of images, each image of the plurality of images includes one or more labeled identifier markers.
Aysin teaches training a machine learning model using a predetermined labeled dataset having a plurality of images, ([0038] “correctly identified images may be used to fine tune the trained convolutional neural network 313.”) each image of the plurality of images includes one or more labeled identifier markers. ([0038] “The ‘correct’ label may be further confirmed, prior to being used to retrain the trained convolutional neural network 313… a device specific identifier 326 as shown in FIG. 3 may be passed to the data management application, and this device specific identifier 326 may be used to confirm the device type of the identified medical device 108A.” and [0024] “The production identifier includes current production information for the specific medical device 108 such as lot serial number, expiration date, and the like.”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have training a machine learning model using labeled dataset of images having labeled identifier markers as taught by Aysin to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been so because it (Aysin [0016] “reduces an amount of processing time along with reducing a potential of human error, thereby increasing and improving processing speed and accuracy of the systems described herein.”)
Claim 12. Piron teaches The medical imaging and optical identifier system according to claim 1,
Piron does not explicitly teach wherein determining the identity of the medical device further includes providing a GUI to request an input confirming the identity of the medical device is correct.
Aysin teaches wherein determining the identity of the medical device further includes providing a GUI to request an input ([0040] “The machine readable instructions further may include instructions to display an option for a user to accept or reject the name of the identified medical device 108A.”) confirming the identity of the medical device is correct. ([0038] “The ‘correct’ label may be applied to an image after a user manually confirms a predicted device type as predicted by the trained convolutional neural network 313.”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have a GUI requesting input confirming the identity of the medical device is correct as taught by Aysin to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been so because it (Aysin [0016] “reduces an amount of processing time along with reducing a potential of human error, thereby increasing and improving processing speed and accuracy of the systems described herein.”)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US20160015471, hereinafter “Piron”) and in view of Wolf et al (US20200268457, hereinafter “Wolf”)
Claim 16. Piron teaches The medical imaging and optical identifier system according to claim 1,
Piron does not explicitly teach wherein the imaging probe is a fluoroscopic imaging probe configured to emit radiation and detect reflected radiation signals, and wherein the one or more logic modules is configured to retrieve information from the fluoroscopic imaging probe to provide the medical image.
Wolf teaches wherein the imaging probe is a fluoroscopic imaging probe configured to emit radiation and detect reflected radiation signals, and wherein the one or more logic modules is configured to retrieve information from the fluoroscopic imaging probe to provide the medical image. ([0421] “capture the surgical footage by converting visible light, x-ray light (e.g., via fluoroscopy), infrared light, or ultraviolet light to images, a sequence of images, videos, and the like.”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have fluoroscopic imaging probe to provide the medical image as taught by Wolf to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been so because it (Wolf [0313] “enables the sending and receiving of information between the components of system”)
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US20160015471, hereinafter “Piron”) and in view of Gluncic et al (US20140328517, hereinafter “Gluncic”)
Claim 19. Piron teaches The medical imaging and optical identifier system according to claim 1,
Piron does not explicitly teach wherein the medical image of the medical device is an image of the medical device disposed subcutaneously.
Gluncic teaches wherein the medical image of the medical device is an image of the medical device disposed subcutaneously. (Abstract “detects and identifies implanted medical devices ("IMDs") and/or retained surgical foreign objects ("RSFOs") from diagnostic medical images”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have a medical image of a medical device disposed under the skin as taught by Gluncic to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been so because it (Gluncic [0005] “accurate and timely identification of IMDs”)
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US20160015471, hereinafter “Piron”) and in view of Srinivasa Naidu (US20210353260 , hereinafter “Srinivasa Naidu”)
Claim 21. Piron teaches The medical imaging and optical identifier system according to claim 20,
Piron does not explicitly teach wherein the characteristic of the patient or the technician includes age, gender, weight, height.
Srinivasa Naidu teaches wherein the characteristic of the patient or the technician includes age, gender, weight, height.([0053] “patient ID and/or other patient identifying information (e.g., height, weight, BMI, name, date of birth, age, sex, medical record ID, etc.) may be provided to the system”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Piron to have patient age, gender, weight, height included in the system as taught by Srinivasa Naidu to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been because it provides (Srinivasa Naidu [0025] “improved image quality by the selection of the correct preset and thus applying the appropriate imaging parameter settings.”)
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Dein et al US20090317002 teaches shape recognition to identify surgical instruments
Frushour et al US20180250093 teaches a medical instrument identifier by reading a barcode during a medical procedure
Fryman et al US20220037011 teaches identifying a medical instrument by reading a barcode and updating the settings on the medical device
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/OWAIS I MEMON/Examiner, Art Unit 2663
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