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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims 1 and 11 recite capturing images of an environment surrounding the capture device, obtaining auxiliary data associated with at least one of at least one image of environment during a period of time and audio recorded in the environment during the period of time, determining based on images and auxiliary data a location of a medical device within an environment and updating based on location database including special relationship. The limitations recite mental process of evaluation since a the devices and processors are recited at such a high level of generality that apart of obtaining the images the user can see the images and auxiliary data. The limitation of updating based on location of medical device within the environment a database including a spatial relationship of the medical device is a mental process of judgement.
This judicial exception is not integrated into a practical application because the processors are recited at a high level of recitation that are merely used as tools to perform an abstract idea. MPEP 2106.05(f).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements as disclosed do not integrate the judicial exception into a practical application as they are mere insignificant extra solution activity in combination of generic computer functions being implemented with generic computer elements in a high level of generality to perform the disclosed abstract idea.
Claims 2 and 12 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 2 and 12 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “the medical device is not visible in at least a portion of the plurality of images”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 3 and 13 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 3 and 13 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “medical device includes a catheter, and wherein the auxiliary data includes at least one of: a tubing type of the catheter, a size of the catheter, a shape of the catheter, and a location of a catheter insertion site of the catheter on a patient”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 4 and 14 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 4 and 14 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “the auxiliary data is associated with the audio recorded in the environment during the period of time”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 5 and 15 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 5 and 15 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “he audio includes a predetermined signal associated with the medical device”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 6 and 16 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 6 and 16 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “the medical device includes an infusion pump”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 7 and 17 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 7 and 17 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “comprising: determining, with the one or more processors, based on the plurality of images and the auxiliary data, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices, wherein the plurality of medical devices includes the medical device and the at least one other medical device, wherein the medical device and the at least one other medical device are configured to emit a predetermined audible signal when connected; and determining, with the one or more processors, based on the plurality of locations of the plurality of medical devices within the environment over the period of time and the plurality of types of the plurality of medical devices, at least one connection between two or more medical devices of the plurality of medical devices; and updating, with the one or more processors, based on the at least one connection determined between the two or more medical devices, the database”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 8 and 18 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 8 and 18 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “the audio includes the predetermined audible signal associated with connection of the medical device and the at least one other medical device”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 9 and 19 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 9 and 19 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “wherein the medical device includes at least one of: a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, a central venous catheter (CVC), a needleless connector, a catheter dressing, a disinfectant cap, a disinfectant swab, an IV tubing set, an extension set, a Y connector, a stopcock, an infusion pump, a flush syringe, a medication delivery syringe, a caregiver glove, an IV fluid bag, a medication dispensing cabinet, an ultrasound device, a sharps collector, or any combination thereof”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claims 10 and 20 is dependent on claims 1 and 11 and includes all the limitations of claims 1 and 11. Therefore, claims 10 and 20 recites the same abstract idea of claims 1 and 11. The claim recites the additional limitation of “wherein the one or more image capture devices includes at least one of the following: a plurality of image capture devices, an infrared (IR) camera, a pan, tilt, and zoom (PTZ) camera including a variable field-of- view (FOV) and an automatic zoom function, a master and slave camera system including a static camera and a dynamic camera, a camera including a filter configured to filter a predetermined wavelength of light, a LiDAR sensor, or any combination thereof”, which is merely elaborating on the abstract idea, by further specifying an additional element recited at a high-level of generality, therefore, does not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US 2015/0209510 A1).
With respect to Claim 1, Burkholz’510 shows a method comprising:
capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices (paragraph [0047] data collection devices for obtaining information about the medical procedure being performed, include one or more image capture devices 12, such as digital cameras, for image or video capture, paragraph [0025] series of images un real time to determine if movable portions of a fluid delivery apparatus has advanced to an end-of-use position, figures 2 and 4);
obtaining, with one or more processors, from a data source other than the one or more image capture devices, auxiliary data associated with at least one of: at least one image of the environment during the period of time and audio recorded in the environment during the period of time (paragraphs [0088], [0090], and [0099] shows visualization based on anatomical positioning is enhanced based on readings obtained using various external imaging devices, such as ultrasound, infrared imaging, magnetic resonance imaging (MRI), or combinations thereof);
determining, with the one or more processors, based on the plurality of images and the auxiliary data, a location of a medical device within the environment over the period of time (paragraph [0019] program identifies the one or more identification tags in the image captured by processing the image to locate a positional marker on the fluid delivery apparatus and then locating the one or more identification tags based on the location on the image of the positional marker, paragraphs [0089]-[0090] also using the images and information from an ultra sound ); and
updating, with the one or more processors, based on the location of the medical device within the environment over the period of time, a database including a spatial relationship of the medical device and at least one other medical device (paragraph [0024] program may verify that the infusion set is correctly connected by identifying connection points between portions of the infusion set on an image of the infusion set captured by the at least one imaging sensor and processes a portion of the image including the connection points to determine whether a sufficient connection exists, paragraph [0068] the image processing functionality may identify various connection points of the infusion set 44, fluid containers 46, and catheter 50. The system 10c would then confirm that the elements are connected correctly).
With respect to Claim 2, Burkholz’510 shows the method of claim 1, wherein the medical device is not visible in at least a portion of the plurality of images (paragraph figure 7 and paragraph [0025]).
With respect to Claim 3, Burkholz’510 shows the method of claim 1, wherein the medical device includes a catheter (paragraph [0018]), and wherein the auxiliary data includes at least one of: a tubing type of the catheter, a size of the catheter, a shape of the catheter, and a location of a catheter insertion site of the catheter on a patient (paragraphs [0067], [0088]-[0089], [0100] and figure 4 showing location of insertion of the catheter 50).
With respect to Claim 4, Burkholz’510 shows the method of claim 1, wherein the auxiliary data is associated with the audio recorded in the environment during the period of time (paragraphs [0089]-[0092] also using the images and information from an ultra sound ).
With respect to Claim 5, Burkholz’510 shows the method of claim 4, wherein the audio includes a predetermined signal associated with the medical device (paragraph [0045] wearable electronic device 18 may beep or vibrate to signal to the technician that a problem was identified).
With respect to Claim 6, Burkholz’510 shows the method of claim 5, wherein the medical device includes an infusion pump (paragraphs [0006] and [0023] infusion device figure 4).
With respect to Claim 7, Burkholz’510 shows the method of claim 4, further comprising: determining, with the one or more processors, based on the plurality of images and the auxiliary data, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices, wherein the plurality of medical devices includes the medical device and the at least one other medical device, wherein the medical device and the at least one other medical device are configured to emit a predetermined audible signal when connected (paragraphs [0045], [0068] and [0070] communicate the technician important information using audio alert, system 10c may alert the technician to check the connection before beginning the fluid delivery); and determining, with the one or more processors, based on the plurality of locations of the plurality of medical devices within the environment over the period of time and the plurality of types of the plurality of medical devices, at least one connection between two or more medical devices of the plurality of medical devices (paragraph [0024] determining connection with alert to the user); and updating, with the one or more processors, based on the at least one connection determined between the two or more medical devices, the database (paragraph [0049] updating patient data stored in the data storage location).
With respect to Claim 8, Burkholz’510 shows the method of claim 7, wherein the audio includes the predetermined audible signal associated with connection of the medical device and the at least one other medical device (paragraphs [0045], [0068] and [0070] communicate the technician important information using audio alert, system 10c may alert the technician to check the connection before beginning the fluid delivery).
With respect to Claim 9, Burkholz’510 shows the method of claim 1, wherein the medical device includes at least one of: a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, a central venous catheter (CVC), a needleless connector, a catheter dressing, a disinfectant cap, a disinfectant swab, an IV tubing set, an extension set, a Y connector, a stopcock, an infusion pump, a flush syringe, a medication delivery syringe, a caregiver glove, an IV fluid bag, a medication dispensing cabinet, an ultrasound device, a sharps collector, or any combination thereof (figure 4, paragraphs [0053] and [0067] fluid delivery apparatus 28, such as an infusion set 44, including various fluid containers 46, namely intravenous therapy (IV) bags, associated tubing 48, and a catheter 50 extending into the vein of a patient).
With respect to Claim 10, Burkholz’510 shows the method of claim 1, wherein the one or more image capture devices includes at least one of the following: a plurality of image capture devices, an infrared (IR) camera, a pan, tilt, and zoom (PTZ) camera including a variable field-of- view (FOV) and an automatic zoom function, a master and slave camera system including a static camera and a dynamic camera, a camera including a filter configured to filter a predetermined wavelength of light, a LiDAR sensor, or any combination thereof (paragraph [0047] digital camera or video camera).
With respect to Claim 11, rejection analogous to those presented for claim 1, are applicable.
With respect to Claim 12, rejection analogous to those presented for claim 2, are applicable.
With respect to Claim 13, rejection analogous to those presented for claim 3, are applicable.
With respect to Claim 14, rejection analogous to those presented for claim 4, are applicable.
With respect to Claim 15, rejection analogous to those presented for claim 5, are applicable.
With respect to Claim 16, rejection analogous to those presented for claim 6, are applicable.
With respect to Claim 17, rejection analogous to those presented for claim 7, are applicable.
With respect to Claim 18, rejection analogous to those presented for claim 8, are applicable.
With respect to Claim 19, rejection analogous to those presented for claim 9, are applicable.
With respect to Claim 20, rejection analogous to those presented for claim 10, are applicable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kohring (US 2012/0302875 A1): paragraph [0046] and figure 8 the algorithm uses anatomical clues in the images obtained from the video camera 24 to determine whether or not the catheter 10 has entered the ventricle 12.
Sugano et al. (US 2020/0337798 A1): paragraph [0130]-[0131] and figures 3 and 10 panoramic image stored in the storage unit is an image that is obtained by merging a plurality of images generated by performing imaging in directions different from each other and in which a panoramic angle in a horizontal direction reaches 360 degrees, the medical safety system according to any one of (1-1) to (1-6), wherein the storage unit stores, in association with image data of the panoramic image, sound data recorded while the panoramic image is imaged, and a beep identification unit is included, the beep identification unit being configured to, by performing sound recognition processing for the sound data, detect a beep contained in the sound data and identify a hardware device that sounded the detected beep.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRIANA CRUZ whose telephone number is (571)270-3246. The examiner can normally be reached 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Akwasi M. Sarpong can be reached at (571) 270-3438. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRIANA CRUZ/Primary Examiner, Art Unit 2681