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 .
The present Office Action is in response to the Request for Continued Examination dated 22 December 2025.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 December 2025 has been entered.
DETAILED ACTION
In the RCE filed 22 December 2025:
Claims 1,13 and 22 are amended
Claims 1-22 are pending
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 22 December 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 12, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method and non-transitory computer program product, which are within a statutory category.
Step 2A1
The limitations of:
Claims 1, 12 and 22 (Claim 1 being representative)
catalogue components of the surgical instrument;
determine that the package has been opened;
and in response to determining that the package has been opened:
determine a waste classification of a component of the surgical instrument;
determine a disposal procedure for the component of the surgical instrument based on the waste classification;
and generate a control signal configured to cause a change in a color indicate the disposal procedure at an end of the surgical procedure.
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to properly classify and dispose of a surgical instrument in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “cataloguing, determining and generating” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a method implemented by a processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a processor and non-transitory computer program product that implements the identified abstract idea. The processor and non-transitory computer program product are not described by the applicant and is recited at a high-level of generality (i.e., a generic server performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional elements of a manufacturer-sealed sterile surgical package containing a surgical instrument and light emitting diode (LED). The manufacturer-sealed sterile surgical package containing a surgical instrument and light emitting diode (LED) merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claims do 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 elements of using a processor and non-transitory computer program product to perform the noted steps amounts 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 (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a manufacturer-sealed sterile surgical package containing a surgical instrument and light emitting diode (LED) were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claims are not patent eligible.
Claims 2-11, and 13-21 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 13 merely describe(s) measuring accuracy of the disposal, which further defines the abstract idea.
Claim(s) 3, 15 merely describe(s) adjusting disposal procedure, which further defines the abstract idea.
Claim(s) 4, 16 merely describe(s) adjusting disposal procedure, which further defines the abstract idea.
Claim(s) 5, 17 merely describe(s) adjusting disposal procedure, which further defines the abstract idea.
Claim(s) 6, 18 merely describe(s) a return address, which further defines the abstract idea.
Claim(s) 7, 19 merely describe(s) instructions, which further defines the abstract idea.
Claim(s) 8, 20 merely describe(s) a display, which further defines the abstract idea.
Claim(s) 2 also includes the additional element of “a display” which is analyzed the same as the “a manufacturer-sealed sterile surgical package” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 9 merely describe(s) using e-ink label, which further defines the abstract idea.
Claim(s) 10, 21 merely describe(s) color matching to bins, which further defines the abstract idea.
Claim(s) 11 merely describe(s)…, which further defines the abstract idea.
Claim(s) 2 also includes the additional element of “a remote device” which is analyzed the same as the “a manufacturer-sealed sterile surgical package” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 14 merely describe(s)…, which further defines the abstract idea.
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.
The Examiner notes that the rejection will reference the translated documents (attached) corresponding to any foreign documents recited in the rejection.
Claims 1, 12, 22 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari et al (US Publication No. 20220246288) in view of Hickle et al (US Publication No. 20080061153) in view of RISHIWAL et al (Foreign Publication AU-2020103095-A4) in view of Ito et al (US Publication No. 20080217414).
Regarding Claim 1
Yavari teaches a manufacturer-sealed sterile surgical package containing a surgical instrument configured to be used in a surgical procedure, wherein the manufacturer-sealed sterile surgical package comprises a processor configured to:
catalogue components of the surgical instrument [Yavari at Para. 0088 teaches a container 50 configured to hold an individual sponge, a plurality of sponges, a bundle 30 or plurality of bundles 30 and may comprise a similar master tag 52 configured to identify the contents of the container 50. For example, the container master tag 52 may identify the contents of the container 50, such as the number of sponges, or number of bundles 30 included in the container 50, as well as any additional equipment or medical instruments included in the container 50.];
Yavari does not teach determine that the manufacturer-sealed sterile surgical package has been opened;
and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determine a waste classification of a component of the surgical instrument;
determine a disposal procedure for the component of the surgical instrument based on the waste classification;
and generate a control signal configured to cause a change in a color of a light-emitting diode (LED) on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure.
Hickle teaches determine that the manufacturer-sealed sterile surgical package has been opened [Hickle at Para. 0049 teaches FIG. 4 depicts a medical kit containing, for example, medical supplies and/or components necessary for a particular procedure or surgery. The kit has a peel-away cover 40. The peel-away cover has an RFID tag 42 attached to it. The RFID tag could be in the form of a label (as shown) or in a non-label format. When cover 40 is peeled away prior to a procedure, breakable conductive loop 44 is broken indicating to a RFID reader and/or writer which kit has been opened and should be written to as being used];
and generate a control signal configured to cause a change in a color of a … [ … ] … on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure [Hickle at Para. 0060 teaches Similarly, upon removal of the medical supply or component from the capital equipment unit after its use, the magnetic strip may also contact a read/write head so that its encoded data is altered or its serial number is logged to indicate that the particular medical supply or component has been used; Hickle at Para. 0061 teaches other use-indicating mechanisms may be employed according to the present invention. For example, physical indicators such as thermochromatic ink that changes color on heating or “scratch-and-sniff” coatings may be used in certain situations and on certain items to be tagged. Further, alternative electronic data transfer mechanisms, such as Bluetooth for example, could be used in tagging systems and methods of the present invention (interpret to combine with disposal procedure of RISHIWAL, cited hereinbelow)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine components of Yavari with the tag of Hickle with the motivation to improve the efficiency of manufacturing, distribution, warehousing, restocking of medical supplies and components, and reduction of waste.
Yavari/Hickle do not teach and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determine a waste classification of a component of the surgical instrument;
determine a disposal procedure for the component of the surgical instrument based on the waste classification;
[ … ] … light-emitting diode (LED) … [ … ]
RISHIWAL teaches and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determine a waste classification of a component of the surgical instrument; determine a disposal procedure for the component of the surgical instrument based on the waste classification [RISHIWAL at Page 4 Para 3 teaches the tracking subsystem may also include active and/or passive tag technology to track kits and/or items in each of the kits. The retrieval subsystem includes retrieval equipment, routines and protocols. The retrieval equipment, routines and protocols may be designed and authorized to handle various classifications of medical waste. The disposal subsystem includes disposal equipment, routines and protocols for disposing of any type of medical wastes. The disposal subsystem may also be designed and authorized to handle various classifications of medical waste];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari/Hickle with the classification of RISHIWAL with the motivation to improve medical waste management.
Yavari/Hickle/RISHIWAL do not teach [ … ]… light-emitting diode (LED) … [ … ]
Ito teaches [ … ] … light-emitting diode (LED) [Ito at Para. 0020 teaches as shown in FIG. 1, the RFID label 11 includes a base plate 12 as a base member having flexibility; an antenna 13 mounted on the base plate 12; an IC (Integrated Circuit) chip 14; and a thin film LED (Light Emitting Diode) 15 as a thin film LED element]… [ … ]
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of an LED of Ito with teaching of Hickle since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the LED of Ito of the secondary reference(s) for the indicators of the primary reference. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Regarding Claim 12
Yavari teaches a method, performed by a manufacturer-sealed sterile surgical package, the method comprising:
cataloguing components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used in a surgical procedure [Yavari at Para. 0088 (see Claim 1 for explanation); Yavari at Para. 0089 teaches a first method 400 of managing an inventory of surgical articles used during a surgical procedure is illustrated.];
Yavari does not teach determining that the manufacturer-sealed sterile surgical package has been opened;
and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determining a waste classification of a component of the surgical instrument;
determining a disposal procedure for the component of the surgical instrument based on the waste classification;
and generating a control signal configured to cause a change in a color of a light-emitting diode (LED) on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure.
Hickle teaches determining that the manufacturer-sealed sterile surgical package has been opened [Hickle at Para. 0049 (see Claim 1 for explanation)];
and generating a control signal configured to cause a change in a color of a … [ … ] … on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure [Hickle at Para. 0060, 0061 (see Claim 1 for explanation)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine components of Yavari with the tag of Hickle with the motivation to improve the efficiency of manufacturing, distribution, warehousing, restocking of medical supplies and components, and reduction of waste.
Yavari/Hickle do not teach and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determining a waste classification of a component of the surgical instrument; determining a disposal procedure for the component of the surgical instrument based on the waste classification;
[ … ] … light-emitting diode (LED) … [ … ]
RISHIWAL and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
teaches determining a waste classification of a component of the surgical instrument; determining a disposal procedure for the component of the surgical instrument based on the waste classification [RISHIWAL at Page 4 Para 3 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle with the classification of RISHIWAL with the motivation to improve medical waste management.
Yavari/Hickle/RISHIWAL do not teach [ … ]… light-emitting diode (LED) … [ … ]
Ito teaches [ … ] … light-emitting diode (LED) [Ito at Para. 0020 (see Claim 1 for explanation)] … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL with the LED of Ito with the motivation to more reliable flexible display.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of an LED of Ito with teaching of Hickle since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the LED of Ito of the secondary reference(s) for the indicators of the primary reference. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Regarding Claim 22
Yavari teaches a non-transitory computer program product storing instructions which, when executed by a processor forming part of a manufacturer-sealed sterile surgical package, cause the processor to:
catalogue components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used in a surgical procedure [Yavari at Para. 0088 (see Claim 1 for explanation); Yavari at Para. 0089 (see Claim 1 for explanation)];
Yavari does not teach determine that the manufacturer-sealed sterile surgical package has been opened;
and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determine a waste classification of a component of the surgical instrument;
determine a disposal procedure for the component of the surgical instrument based on the waste classification;
and generate a control signal configured to cause a change in a color of a light-emitting diode (LED) on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure.
Hickle teaches determine that the manufacturer-sealed sterile surgical package has been opened [Hickle at Para. 0049 (see Claim 1 for explanation)];
and generate a control signal configured to cause a change in a color of a … [ … ] … on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure [Hickle at Para. 0060, 0061 (see Claim 1 for explanation)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine components of Yavari with the tag of Hickle with the motivation to improve the efficiency of manufacturing, distribution, warehousing, restocking of medical supplies and components, and reduction of waste.
Yavari/Hickle do not teach and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determine a waste classification of a component of the surgical instrument; determine a disposal procedure for the component of the surgical instrument based on the waste classification ;
[ … ] … light-emitting diode (LED) … [ … ]
RISHIWAL teaches and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determining a waste classification of a component of the surgical instrument; determining a disposal procedure for the component of the surgical instrument based on the waste classification [RISHIWAL at Page 4 Para 3 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle with the classification of RISHIWAL with the motivation to improve medical waste management.
Yavari/Hickle/RISHIWAL do not teach [ … ]… light-emitting diode (LED) … [ … ]
Ito teaches [ … ] … light-emitting diode (LED) [Ito at Para. 0020 (see Claim 1 for explanation)] … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL with the LED of Ito with the motivation to more reliable flexible display.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of an LED of Ito with teaching of Hickle since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the LED of Ito of the secondary reference(s) for the indicators of the primary reference. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claim 2, 13 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of Collar et al (US Publication No. 20150302157).
Regarding Claim 2
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the processor is further configured to:
track the disposal procedure for the component of the surgical instrument;
determine an accuracy level of the disposal procedure;
and provide the accuracy level.
Collar teaches wherein the processor is further configured to:
track the disposal procedure for the component of the surgical instrument;
determine an accuracy level of the disposal procedure; and provide the accuracy level [Collar at Para. 0013 teaches accordingly, the inventive method may be used to track, as waste, those surgical cartridges entering the sterile field of the operating room, but not used. Advantageously, the inventive method provides medical professionals with a way of analyzing the number and type of surgical sutures not used during surgery. Furthermore, the inventive method provides ways by which the use, and waste, of a particular type of surgical suture may be correlated with other surgery or operating-room variables such as surgeon name, surgery type, surgery duration, surgery start time, and other such variables (counting and tracking waste interpreted as accuracy level); Collar at Para. 0102 teaches as discussed above, FIG. 6 shows one version of a display that includes options for counting surgical sutures. In the representative version illustrated in FIG. 6, a user may use the touch screen of the electronic device to select, for example, the in-count counting option (i.e., “New Suture,” denominated as 608); the out-count counting option (i.e., the “Used/Styrofoam Pad,” denominated as 610); or the waste counting option (i.e., “Waste Suture,” denominated as 612)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the accuracy of Collar with the motivation to reduce costs.
Regarding Claim 13
Claim(s) 13 is/are analogous to Claim(s) 2, thus Claim(s) 13 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 2.
Claim 3, 10, 15, 21 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of Mallett et al (US Publication No. 20100219238).
Regarding Claim 3
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the processor is further configured to:
receive data characterizing available disposal options at a healthcare site hosting the surgical procedure;
adjust the disposal procedure based on the received data;
and provide the adjusted disposal procedure.
Mallet teaches wherein the processor is further configured to:
receive data characterizing available disposal options at a healthcare site hosting the surgical procedure [Mallett at Para. 0268 teaches in some embodiments, as discussed above, determination of the waste categories themselves can depend on a number of factors, including RCRA hazardous waste definitions, state and federal EPA regulations, OSHA regulations, and any institution-specific regulations. For example, RCRA definitions generally include a P list, a U list and four characteristics of hazardous waste: ignitability, corrosivity, toxicity and reactivity. Materials exhibiting each of these characteristics typically call for different handling, treatment and/or disposal. Thus, in some cases waste categories can be defined based on groups of materials that require the same or similar handling, treatment, or disposal. However, in some cases, two materials that may be handled and/or treated in a similar manner might react adversely if they are combined with one another. Thus, in further embodiments, determination of the waste categories can also depend on the combinability of materials exhibiting one or more of the above characteristics];
adjust the disposal procedure based on the received data [Mallett at Para. 0036 teaches the system and method may also comprise a waste item identification device configured to determine a qualitative parameter of a waste item. In one embodiment, the system also comprises a database comprising waste item classification information. The system and method may also comprise a control system programmed to compare the qualitative parameter of the waste item to information contained in the database, assign the waste item to a waste category, determine the preferred container in which the waste item should be placed based on the assigned waste category, determine if said preferred container is capable of accepting the waste item and direct a user to perform an alternative disposal action if the preferred container is not capable of accepting the waste item];
and provide the adjusted disposal procedure [Mallett at Para. 0036].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the disposal procedures of Mallett with the motivation to reduce hospital worker exposure to hazardous materials in the workplace.
Regarding Claim 10
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the color of the LED corresponds to a color of one or more disposal bins located within an operating room hosting the surgical procedure.
Mallet teaches wherein the color of the LED corresponds to a color of one or more disposal bins located within an operating room hosting the surgical procedure [Mallet at Para. 0309 teaches in one embodiment, the containers are manufactured using common tooling techniques known in the art and injection moldings that are made with a single color (e.g., white). Container types may be distinguished for human recognition using color coded labels. In other embodiments, specialized tooling is used. In yet another embodiment, containers are manufactured with one or more special distinguishing characteristics, including color, size, shape, material, codes, etc.].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the color indicator of Mallett with the motivation to reduce hospital worker exposure to hazardous materials in the workplace.
Regarding Claim 15
Claim(s) 15 is/are analogous to Claim(s) 3, thus Claim(s) 15 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 3.
Regarding Claim 21
Claim(s) 21 is/are analogous to Claim(s) 10, thus Claim(s) 21 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 10.
Claim 4, 16 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of Mallett et al (US Publication No. 20100219238) in view of Khajavi et al. (US Publication No. 20160022361).
Regarding Claim 4
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the processor is further configured to:
receive data characterizing a geopolitical location of a healthcare site hosting the surgical procedure;
adjust the disposal procedure based on the received data;
and provide the adjusted disposal procedure.
Mallet teaches receive data characterizing a geopolitical location of a healthcare site hosting the surgical procedure [Mallet at Para. 0268 (see Claim 3 for explanation; State and federal EPA regulations interpreted as geopolitical location)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the disposal procedures of Mallett with the motivation to reduce hospital worker exposure to hazardous materials in the workplace.
Yavari/Hickle/RISHIWAL/Ito/Mallet do not teach adjust the disposal procedure based on the received data;
and provide the adjusted disposal procedure.
Khajavi teaches adjust the disposal procedure based on the received data [Khajavi at Para. 0025 teaches in one embodiment, the method of sorting waste comprise determining whether the waste item belongs to a waste category by comparing information obtained from the barcode to regulations governing the disposal of medical waste. Such regulations (including laws, rules, or guidelines) may be found in a database];
and provide the adjusted disposal procedure [Khajavi at Para. 0025].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito, Mallet with the adjustments of Khajavi with the motivation to improve tactical decisions prior to surgery [Khajabi at Para. 0131].
Regarding Claim 16
Claim(s) 16 is/are analogous to Claim(s) 4, thus Claim(s) 16 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 4.
Claim 5-6, 17-18 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of Dickerson et al (US Publication No. 20170284860).
Regarding Claim 5
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the processor is further configured to:
receive data characterizing a performance error of the surgical instrument;
adjust the disposal procedure based on the received data;
and provide the adjusted disposal procedure.
Dickerson wherein the processor is further configured to:
receive data characterizing a performance error of the surgical instrument [Dickerson at Para. 0054 teaches If it is determined that surgical instrument (250) may not be safely used or reconditioned based upon usage history (block 900), diagnostic and reconditioning device (270) will report that reconditioning of surgical instrument (250) is not possible (block 920). For example, if an ultrasonic surgical instrument (200) has been used beyond its normal life by a user, perhaps by keeping the ultrasonic surgical instrument (200) disconnected from a generator (112) except for very brief periods when ultrasonic surgical instrument (200) is being actively used to cut tissue, in order to prevent a device lockout based upon total time connected to a generator (112), the device usage history may indicate over six hours of activation time. If such an ultrasonic surgical instrument (200) has only been tested or certified for safe use of up to three hours of activation time, it may be determined that the device usage history is unacceptable (block 900)];
adjust the disposal procedure based on the received data [Dickerson at Para. 0060 teaches a user may be notified via a display on diagnostic and reconditioning device (270) and/or via a display on surgical instrument (250), indicating that surgical instrument (250) has no remaining life and that surgical instrument (250) should be discarded or returned to the manufacturer];
and provide the adjusted disposal procedure [Dickerson at Para. 0060].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the performance error of Dickerson with the motivation to improve the reusability of surgical instruments.
Regarding Claim 6
Yavari/Hickle/RISHIWAL/Ito/Dickerson teach the manufacturer-sealed sterile surgical package of claim 5,
Yavari/Hickle/RISHIWAL/Ito/Dickerson further teach wherein the adjusted disposal procedure includes a return address for the surgical instrument [Dickerson at Para. 0060 (see Claim 5 for explanation; returned to manufacturer interpreted as including return address)].
Regarding Claim 17
Claim(s) 17 is/are analogous to Claim(s) 5, thus Claim(s) 17 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 5.
Regarding Claim 18
Claim(s) 18 is/are analogous to Claim(s) 6, thus Claim(s) 18 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 6.
Claim 7, 19 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of BIRKBECK et al (Foreign Publication CN-112912029-A).
Regarding Claim 7
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the disposal procedure includes instructions for at least one of:
disassembly, compartmentalization, or separation of the catalogued components of the surgical instrument.
BIRKBECK teaches wherein the disposal procedure includes instructions for at least one of:
disassembly, compartmentalization, or separation of the catalogued components of the surgical instrument [BIRKBECK at Page 14 Para 4 teaches the features indicating the order of assembly and/or disassembly may correspond to surgical technical documentation describing the assembly and/or disassembly of the instrument for the user (interpreted as instructions for disassembly)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the disassembly of BIRKBECK with the motivation to provide a more robust and stable tray to be able to protect and handle the surgical instruments during handling of the tray.
Regarding Claim 19
Claim(s) 19 is/are analogous to Claim(s) 7, thus Claim(s) 19 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 7.
Claim 8-9, 20 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of Mahmood et al (US Publication No. 20220374807).
Regarding Claim 8
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the disposal procedure is provided via a display located on the manufacturer-sealed sterile surgical package.
Mahmood teaches wherein the disposal procedure is provided via a display located on the manufacturer-sealed sterile surgical package [Mahmood at Para. 0043 teaches Turning now to FIG. 1A, illustrated is an example, non-limiting diagram 100A of smart label device(s) 198 in accordance with one or more embodiments described herein. In an aspect, smart label device(s) 198 can represent a device comprising a digital display capable of affixing or adhering to a package, material, specimen, sample or item (referred to as any of the foregoing throughout the disclosure) (interpret to combine with manufacturer-sealed sterile surgical package of Hickle)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the display of Mahmood with the motivation to improve supply chain efficiencies critical to transit of biological materials.
Regarding Claim 9
Yavari/Hickle/RISHIWAL/Ito/Mahmood teach the manufacturer-sealed sterile surgical package of claim 8,
Yavari/Hickle/RISHIWAL/Ito/Mahmood further teach wherein the display comprises at least one e-ink label [Mahmood at Para. 0044 teaches in a non-limiting embodiment, smart label device(s) 198 can be configured with an electronic ink (e-ink) programmable display having low power requirements to display content].
Regarding Claim 20
Claim(s) 20 is/are analogous to Claim(s) 8, thus Claim(s) 20 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 8.
Claim 11 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito as applied to claim 1, 12, 22 above, and further in view of Kobayashi et al (US Publication No. 20070083286).
Regarding Claim 11
Yavari/Hickle/RISHIWAL/Ito teach the manufacturer-sealed sterile surgical package of claim 1,
Yavari/Hickle/RISHIWAL/Ito do not teach wherein the processor is further configured to transmit the disposal procedure to a remote display device in electronic communication with the manufacturer-sealed sterile surgical package.
Kobayashi teaches wherein the processor is further configured to transmit the disposal procedure to a remote display device in electronic communication with the manufacturer-sealed sterile surgical package [Kobayashi at Para. 0260 teaches a step for displaying the result of the determination step on the image display device (interpret to combine with package of Hickle)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito with the display device of Kobayashi with the motivation to improve reliability of medical instruments.
Claim 14 rejected under 35 U.S.C. 103(a) as being unpatentable over Yavari, Hickle, RISHIWAL, Ito, Collar as applied to claim 13 above, and further in view of Mallett et al (US Publication No. 20100219238).
Regarding Claim 14
Yavari/Hickle/RISHIWAL/Ito teach the method of claim 13,
Yavari/Hickle/RISHIWAL/Ito do not teach further comprising transmitting data characterizing at least one warning message when the accuracy level falls below a predetermined threshold.
Mallet teaches further comprising transmitting data characterizing at least one warning message when the accuracy level falls below a predetermined threshold [Mallett at Para. 0041 teaches in one embodiment, the control system is further configured to notify a user of the assigned waste category. In another embodiment, the control system is configured to notify a user of the assigned waste category by indicating an appropriate container into which the item should be deposited; Mallett at Para. 0158 teaches the system will notify the disposer that the waste item was unrecognized. In another embodiment, the sorting system may also notify a database or database personnel that the waste item is unrecognized, thus facilitating a database upgrade to include that waste item for future disposals (unrecognized interpreted as accuracy levels below a predetermined threshold)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Yavari, Hickle, RISHIWAL, Ito, Collar with the threshold of Mallett with the motivation to reduce hospital worker exposure to hazardous materials in the workplace.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-22, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
Under Step 2A, Prong Two, amended claim 1 is not directed to an abstract idea for the additional reason that it mirrors the claim the Office itself declared patent-eligible in Example 45, claim 2 of the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG). Amended claim 1 follows the identical Office-approved pattern. Like Example 45 claim 2, amended claim 1 recites a meaningful limitation: generating a control signal configured to cause a change in a color of a light-emitting diode on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure so that the speed and accuracy of waste disposal decision making can be improved. Thus, just as Example 45 claim 2 employs the calculated cure percentage to control the injection molding apparatus, amended claim 1 employs the determined waste disposal method to control the LED on the packaging. The technical result is analogous: a physical action is triggered at the calculated moment, preventing defects in the former case and reducing disposal errors and decision making time in the latter, thereby improving the performance of the respective technical process beyond what manual or non-predictive systems could achieve. Accordingly, amended claim 1 is not directed to an abstract idea.
Regarding (a), the Examiner respectfully disagrees. The claim recites generating a control signal. The control signal is not being transmitted to the LED. Therefore, it is not actually controlling the LED to perform a function and fails this test for a practical application.
Rejection under 35 U.S.C. § 102/103
Regarding the rejection of Claims 1-22, the Examiner has considered the Applicant’s arguments; however, these arguments are moot given the new grounds of rejection as afforded by the present RCE.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Aquino et al (US Publication No. 10716641) discloses Method and apparatus to account for transponder tagged objects used during clinical procedures, employing a trocar
Dye et al (US Publication No. 20110313894) discloses methods and systems of making and using custom surgical packs having radio frequency identification (RFID) tags capable of detecting use of the surgical packs to coordinate manufacturing and inventory control.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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