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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 7, 11, 16, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dein, US 20090317002 A1 .
1. 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, (see Dein, ¶ 57 "comparison of an image obtained prior to the addition of the new sharp object with an image obtained after the addition of the new sharp object implies the capture of the plurality of images over a period of time with the camera);
determining, with one or more processors, based on the plurality of images, a state of a package containing a medical device over the period of time, (see Dein, ¶ 94, FIGS. 4A and 4B disclose hand-held scanners designed to detect the surgical sharp objects to be counted whether they are presented in their original packaging or have been removed from the packaging);
determining, with the one or more processors, based on the state of the package over the period of time, whether the medical device is removed from the package, (see Dein, ¶ 94, FIGS. 4A and 4B disclose hand-held scanners designed to detect the surgical sharp objects to be counted whether they are presented in their original packaging or have been removed from the packaging); and
updating, with the one or more processors, based on a determination that the medical device is removed from the package, a database including medical devices in the environment, (see Dein, ¶ 51, 94. The system can maintain a data set, e.g., database, of the number of times a particular measurement of size or other characteristic (e.g., whether they are presented in their original packaging or have been removed from the packaging) was associated with a particular surgical item).
6. The method of claim 1, wherein the package is associated with a first identifier element, wherein the medical device is associated with a second identifier element different than the first identifier element, and wherein the state of the package is determined based on a location of the first identifier element with respect to a location of the second identifier element, (see Dein, ¶ 93, “FIG. 3C depicts a disposable scalpel blade 350 shown already removed from its packaging (and thus removed from any associated barcode information).
7. The method of claim 1, further comprising: determining, based on the plurality of images, a location of a glove of a caregiver within the environment over the period of time with respect to a location of the package, wherein the state of the package is determined based on the location of the glove of the caregiver within the environment over the period of time with respect to the location of the package, (see Dein, ¶ 94 “a sterile hand-held device 480 may be used by the scrub nurse to count the needle 470 already added to the field, but not yet added to the count. A sterile case 460 enclosing the hand-held scanner 400 maintains the sterility of the field.”).
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.
Claim(s) 2-5, 8, 9, 12-15, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dein in view of Cowan et al., AU 2016315632 A1.
2. The method of claim 1, wherein the package includes a removable first layer covering a second layer, wherein the first layer including a first color, wherein the second layer includes a second color different than the first color, and wherein removal of the first layer from the package reveals the second layer, (see Cowan, ¶ 120).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the features of Dein and Cowan because of the following findings of fact:
F. Known Work in One Field of Endeavor May Prompt Variations of It for Use in Either the Same Field or a Different One Based on Design Incentives or Other Market Forces if the Variations Are Predictable to One of Ordinary Skill in the Art
(1) the scope and content of the prior art in the same field of endeavor as that of the applicant’s invention include a similar or analogous device (method, or product), i.e. A61 MEDICAL OR VETERINARY SCIENCE; HYGIENE;
(2) there were design incentives or market forces which would have prompted adaptation of the known device (method, or product), (see Cowan, ¶ 7 “enhancing safety by preventing air injections as well as facilitating improved workflow by preventing technicians from mixing up the fluid types”);
(3) the differences between the claimed invention and the prior art were encompassed in known variations or in a principle known in the prior art;
(4) one of ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to one of ordinary skill in the art.
This rationale is applied to any other relevant 103 rejections below by reference.
3. The method of claim 2, wherein the first layer is at least partially transparent, (see Cowan, ¶ 122).
4. The method of claim 1, wherein a color of the package is configured to change when exposed to air, (see Cowan, ¶ 122).
5. The method of claim 1, wherein a portion of the package is transparent such that the medical device contained within the package is visible through the transparent portion of the package, (see Cowan, ¶ 122).
8. The method of claim 1, wherein the package includes a removable first layer covering a second layer, wherein the removable first layer includes a first identifier element, wherein the second layer includes a second identifier element, wherein the removable first layer is at least partially transparent, and wherein determining the state of the package further includes: determining, based on the plurality of images, a distance between the first identifier element and the second identifier element; and determining, based on the distance between the first identifier element and the second identifier element, whether the package is faulty; and in response to determining that the package is faulty, providing, to a user device, an alert associated with the faulty package, (see Cowan, ¶ 230, “The system can also send a signal to alert the operator of the type of fluid via any other method of visual, auditory, or sensory cues. For instance, once it has been determined by image recognition techniques that a syringe 12 contains contrast, visual cues (LEDs, laser light, graphics, text) and/or auditory cues (alarms, bells, whistles, other sounds) alerts the operator to the fact that a particular syringe 12 contains contrast.”).
9. The method of claim 1, further comprising: determining, with the one or more processors, based on the plurality of images, 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; 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, the plurality of types of the plurality of medical devices, and the state of the package over the period of time, at least one event of the following events: (i) a reuse of the medical device including a connection of the medical device to two or more medical devices in the environment over the period of time, (ii) a replacement of the medical device with a new medical device of a same type as the medical device in the environment including the disconnection of the medical device from the at least one of the patient and the another medical device and a connection of the new medical device of the same type to the at least one of the patient and the another medical device, and (iii) a replacement of the medical device with different medical device of a different type than the medical device in the environment including the disconnection of the medical device from the t least one of the patient and the another medical device and a connection of the different medical device of the different type to the at least one of the patient and the another medical device, (see Cowan, ¶ 140, 168, 183)(replacement); ¶184 (reuse).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dein in view of Cowan, and further in view of Minerath et al, US 20070144929 A1.
10. The method of claim 1, wherein the medical device includes a disinfectant swab or wipe, (see Minerath, ¶ 61).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the features of Dein and Cowan with Minerath because of the following findings of fact:
F. Known Work in One Field of Endeavor May Prompt Variations of It for Use in Either the Same Field or a Different One Based on Design Incentives or Other Market Forces if the Variations Are Predictable to One of Ordinary Skill in the Art
(1) the scope and content of the prior art in the same field of endeavor as that of the applicant’s invention include a similar or analogous device (method, or product), i.e. A61 MEDICAL OR VETERINARY SCIENCE; HYGIENE;
(2) there were design incentives or market forces which would have prompted adaptation of the known device (method, or product), (see Minerath, ¶ 20, “As used herein, the term "professional care products" includes protective garments, such as surgical drapes, gowns, and sterile wraps, protective gloves, skin care products, topical antimicrobials, patient care compositions, and the like”);
(3) the differences between the claimed invention and the prior art were encompassed in known variations or in a principle known in the prior art;
(4) one of ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to one of ordinary skill in the art.
This rationale is applied to any other relevant 103 rejections below by reference.
As per claims 11, 12-20, these claims contain the same or similar features as claims as claims 1-10 rejected above, and therefore the remaining claims are rejected on the same grounds as those detailed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20090177249 A1, US 20220254482 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL S GLASS whose telephone number is (571)272-7285. The examiner can normally be reached M-F, 9-5.
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/RUSSELL S GLASS/Primary Examiner, Art Unit 3627
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