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 .
Election/Restrictions
Applicant's election with traverse of species election in the reply filed on 6/16/2026 is acknowledged. The traversal is on the ground(s), yet, in an effort to provide compact prosecution, since the identified species claims are determined to be no longer a burden, they are claims 1-20 hereby fully examined on their merits.
Therefore, the restriction requirement is withdrawn.
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 “determining… a first identifier” (along with other determining steps), “updating, … a database”.
The limitation of “determining”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a processor” language, “determining… identifier” in the context of this claim encompasses the user manually identifying a glove with an identifier and its location over time. Similarly, the limitation of “updating”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “a processor” language, “updating…database” in the context of this claim encompasses the user thinking or with a pen and paper to keep records of the events and update accordingly. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform the limitation of “determining… a first identifier” (along with other determining steps), “updating, … a database”. The processor in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ““determining”, and “updating” such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 using a processor to perform “determining” steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
The depending claims also recite similar abstract ideas (e.g.,” determining”, “providing”, “automatically controlling” etc.) without 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.
Therefore, the claims are not patent eligible.
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, 8-9, 11 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amanatullah (US 20200253683 A1).
Regarding claims 1 and 11, Amanatullah teaches a method and a system (“method for tracking objects within a surgical space during a surgery” abst) 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 (“detect and track objects in a live feed of images of a surgical space during a surgery…the computer system can detect and track a constellation of objects moving within the surgical space—including into and out of a sterile field—such as surgical textiles, gloves,” [0011]);
determining, with one or more processors, based on the plurality of images, a first identifier element associated with a medical device and a second identifier element associated with a glove of a caregiver (“computer system can then annotate the current constellation of objects with types of these objects. In one example, the computer system: detects quick-response (or “QR) codes or barcodes applied to an inventory table, an operating table, surgical gloves, surgical gowns, surgical face masks, surgical instruments, surgical drapes, surgical sponges, surgical towels, etc. depicted in the image; queries a QR or bar code database to identify types of objects associated with these QR codes or barcodes; and populates the current object constellation with locations of these object types” [0027]), wherein the first identifier element encapsulates a first identifier associated with the medical device (e.g., QR or bar code [0027]), and
wherein the second identifier element encapsulates a second identifier associated with the glove of the caregiver (e.g., QR or bar code [0027]);
determining, with the one or more processors, based on the first identifier element in the plurality of images, the medical device and a location of the medical device within the environment over the period of time (“system can therefore generate an object constellation representing 3D (or 2D) locations of objects throughout the surgical space within a time interval” [0032]);
determining, with the one or more processors, based on the second identifier element in the plurality of images, the glove of the caregiver and a location of the glove of the caregiver within the environment over the period of time (“system can therefore generate an object constellation representing 3D (or 2D) locations of objects throughout the surgical space within a time interval” [0032]);
determining, with the one or more processors, based on the location of the medical device within the environment over the period of time and the location of the glove of the caregiver within the environment over the period of time and the location, at least one event associated with the medical device (“, the computer system can detect hands of surgical staff by: isolating blue and white regions in the image; implementing object recognition to identify each instance of a hand in a white surgical glove; and/or implementing object recognition to identify each instance of a blue sterile drape grasped by a hand in a white surgical glove” [0030]); and
updating, with the one or more processors, based on the at least one determined event, a database including events associated with the environment (“computer system can then implement methods and techniques described below to reassess the contamination, injury, and retention risks of a particular object based on locations and scores of other objects in the surgical space and to update these contamination, injury, and retention scores for the object accordingly for the current time interval” [0034]).
Regarding claims 8 and 18, Amanatullah teaches wherein the second identifier element includes a predetermined color of the glove of the caregiver (“computer system can detect and track a constellation of objects moving within the surgical space—including into and out of a sterile field—such as surgical textiles, gloves” [0011]; “the computer system can also a stream of images from a camera that includes a color (e.g., RGB) camera, a 3D stereoscopic color camera, and/or a 2D or 3D depth sensor and can return 2D or 3D color images” [0019]).
Regarding claims 9 and 19, Amanatullah teaches wherein the first identifier element includes at least one of: a colored pattern, a reflective pattern, a fluorescent pattern, a LED pattern, a barcode, a fiducial marker, a hologram marker, or any combination thereof (“the computer system: detects quick-response (or “QR) codes or barcodes” [0027]).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7, 10, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Amanatullah in view of Brand et al (US20220118240).
Regarding claims 7 and 17, Amanatullah teaches wherein the at least one event includes the medical device (“computer system can detect and track a constellation of objects moving within the surgical space—including into and out of a sterile field—such as surgical textiles, gloves, surgical needles, tool drivers, retractors, cutting tools, scrubbed surgical staff, nonsterile surgical staff, and a patient moving relative to an operating table, a back table, a floor, and other fixed infrastructure in the surgical space” [0011]).
Amanatullah does not teach the specifics of the medical device including a catheter dressing and a catheter dressing change event.
However, in the same field of endeavor, Brand teaches a system including a needleless connector including a fluid flow path; one or more force sensors connected to the needleless connector; and one or more processors programmed and/or configured to: receive, from the force sensor, a force signal; and determine, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device [0006].
[0198] trace a lumen from a patient to a particular medication source device to which the lumen is connected; connections between lumens and medication source devices to be removed if the patient is moved (e.g., to a new room, to a new floor, to surgery, to the bathroom, etc.) with the same type of visual indicator on a lumen/medication source device pair used to more easily reattach the correct medication source device channel to the correct (e.g., the same as before) lumen; tracking compliance to best practice protocols, for example, by determining if hub scrubbing has occurred and if hub scrubbing occurred effectively (e.g., sufficient pressure, sufficient time scrubbing, etc.) and/or if a device has been flushed, maintained, and/or the like; providing reminders and prescriptive help for protocol adherence, and/or the like.
[0199] In some non-limiting embodiments or aspects, medication source system 102 identifies a lumen by determining and providing, based on the medical data, one or more alerts or reminders associated with the lumen and/or the same type of visual output associated with the lumen, such as a reminder to flush the lumen and/or a needleless connector 214 thereof, a reminder to remove or replace a lumen
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with medical device including a catheter dressing and a catheter dressing change event as taught by because it ensures proper catheter maintenance ([0004] of Brand).
Regarding claims 10 and 20, Amanatullah teaches all the limitations of the claims except for fluid flow and alert.
However, in the same field of endeavor, Brand teaches a system including a needleless connector including a fluid flow path; one or more force sensors connected to the needleless connector; and one or more processors programmed and/or configured to: receive, from the force sensor, a force signal; and determine, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device [0006]. Smart device 104 may determine an occlusion event and provide an alert and/or automatically flush a lumen associated with the occlusion in response to detection of the occlusion event [0184].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with fluid flow and alert as taught by because it ensures proper catheter maintenance ([0004] of Brand).
Conclusion
Claims 2-6 and 12-16 are free from prior art, yet claims 1-20 are found patent ineligible due to the 35 USC 101 abstract ideas nature of the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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