DETAILED ACTION
Status of Claims
This action is in reply to the Request for Continued Examination filed on 12/23/2025.
Claims 1, 10 and 20 have been amended.
Claims 1-20 are currently pending and have been examined.
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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered.
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.
Step 1:
Claims 1-9 are directed to a system (i.e., a machine), claims 10-19 are directed to a method (i.e., a process), and claim 20 is directed to non-transitory computer readable medium (i.e., a manufacture). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claim 8 includes limitations that recite an abstract idea. Note that independent claim 8 is the system claim, while claim 1 covers a method claim and claim 12 covers the matching computer readable medium.
Specifically, independent claim 1 recites:
A surgical system, comprising:
a manufacturer-sealed, sterile surgical package containing a surgical instrument;
a sterility indicator disposed on the manufacturer-sealed sterile surgical package, the sterility indicator comprising a first portion and a second portion, wherein the sterility indicator is readable based on the first portion and the second portion being readable, wherein the first portion comprises anon-radiation- sensitive ink and the second portion comprising a radiation-sensitive ink, and wherein the second portion is configured to be readable based on the radiation-sensitive ink being exposed to radiation
at least one data processor disposed in the surgical package; and
memory disposed in the surgical package and storing instructions configured to, prior to breach of the manufacturer-sealed sterile surgical package, cause the at least one data processor to perform operations comprising:
sense, by an environmental sensor disposed in the surgical package, an environmental parameter associated with the surgical package;
receive, from a remote server, data characterizing a geo-political location of at least one of the surgical package and the surgical instrument,
determine, based on the environmental parameter and the received data, whether an operative capability of the surgical instrument is non-compliant with a geo-political location threshold associated with the geo-political location of at least one of the surgical package and the surgical instrument, and
transmit a control signal, based on one or more of the received data or the determination of whether the whether the manufacturer-sealed sterile surgical package has been sterilized to at least one of the surgical package or the surgical instrument to alter one or more aspects of the surgical package or the surgical instrument.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain methods of organizing human activity” because characterizing a geo-political location of a manufactured-sealed sterile surgical package and surgical instrument, determining environmental parameters associated with the geo-political location, using non-radiation-sensitive and radiation-sensitive ink and transmitting sterilization information of the manufactured-sealed surgical package and surgical instrument are a part of a medical workflow, following manufacturer guidelines for packaging surgical instruments and performing healthcare administrative duties, which are managing human behavior/interactions between people. The foregoing underlined limitations also relate to claims 10 and 20 (similarly to claim 1).
Accordingly, the claim describes at least one abstract idea.
In relation to claims 5, 7-9, 11, 14 and 16-18, these claims merely recite specific kinds of input/output data, such as: claim 5 - aspects include a capacity to collect medical data and data related to surgical procedures, claims 7 and 16 - aspects include one or more operations of the surgical instrument usable during a surgical procedure, claims 8 and 18 – the geo-political location is a customs checkpoint , claims 9 and 14 – aspects include a capacity to deliver one or more controlled substances, wherein the one or more controlled substances are prohibited or controlled in the geo-political location, claim 11 – the manufacturer-sealed sterile surgical package includes a display configured to present visual information and claim 17 - aspects include a capacity to deliver one or more controlled substances, wherein the one or more controlled substances are prohibited or controlled in the geo-political location.
In relation to claims 2-4, 6, 12-13, 15 and 19, these claims merely recite determining steps such as: claim 2 - the manufacturer-sealed sterile surgical package includes a display configured to present visual information, claims 3 and 12 - present one or more messages indicating non-compliance with one or more regulations of the geo-political location, claims 4 and 13 - presented messages is based upon the geo-political location, claim 6 - disable one or more functions of the manufacturer-sealed, sterile surgical package, the one or more functions being non-compliant with one or more regulations of the geo-political location, claim 15 - the instructions disable one or more functions of the surgical package, the one or more functions being non-compliant with one or more regulations of the geo-political location and claim 19 - the instructions are transmitted prior to crossing a geo-political border into the geo-political location.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 10 and 20, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations as human activities, but for the recitation of generic computer components. That is, other than reciting a surgical system, at least one processor, memory, a remote server, and a tangible, non-transitory computer program product to perform the limitations, nothing in the claim elements precludes the steps from practically being performed by humans. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care environment as human activities, 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 claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the surgical system, least one processor, memory, remote server, and tangible, non-transitory computer program product are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
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 the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claim 8, regarding the additional limitations of the surgical system, least one processor, memory, remote server, and tangible, non-transitory computer program product, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations, “sense, by an environmental sensor disposed in the surgical package, an environmental parameter associated with the surgical package,” the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)) and are mere instructions to apply the above-noted at least one abstract idea (Id.).
Thus, representative independent claim 1 and analogous independent claims 10 and 20 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
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, 7, 10, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kippenhan (US 2010/0217620 A1).
Claim 1:
Kippenhan discloses A surgical system, comprising:
a manufacturer-sealed, sterile surgical package containing a surgical instrument (See sterilization indicators and labels manufactured for surgical instruments in P0003, P0009, P0022, P0145 and P0149.);
a sterility indicator disposed on the manufacturer-sealed sterile surgical package, the sterility indicator comprising a first portion and a second portion, wherein the sterility indicator is readable based on the first portion and the second portion being readable, wherein the first portion comprises a non-radiation- sensitive ink and the second portion comprising a radiation-sensitive ink, and wherein the second portion is configured to be readable based on the radiation-sensitive ink being exposed to radiation (See Fig. 1, Fig. 2, P0061-P0062 where the variety of sterilization processes are non-radiation and ink color change after sterilization mentioned in P0078, P0085, P0087. See Fig. 17, P0119-P0122 where radiation is an energy source reflected form the sterilization indicator and Fig. 32-33 a sterilization indicator before and after a sterilization cycle mentioned in P0064-P0066.);
at least one data processor disposed in the surgical package (See Fig. 3, Fig. 4, Fig. 18 personal computer mentioned in P0147-P0149.); and
memory disposed in the surgical package and storing instructions configured to, prior to breach of the manufacturer-sealed sterile surgical package, cause the at least one data processor to perform operations (Taught in P0137-P0138 as previously loaded sterilization indicator data stored in non-volatile memory. Also, see Scan Chemical Indicator Bar Code Prior to Placement in Pack 74 (P0129, P0160) shown in Fig. 25.) comprising:
sense, by an environmental sensor disposed in the surgical package, an environmental parameter associated with the surgical package (Taught as photosensors in P0124-P0125, printer density and Hall sensors in P0175-P0176. Also, see ability to indicate sterilization environment in P0079, P0085, P0088, P0091.);
receive, from a remote server, data characterizing a geo-political location of at least one of the surgical package and the surgical instrument (See exemplary geo-political standards and state laws (P0005-P0006), U.S. sterilization assurance practices (P0011-P0012) for comparison, where the steam vacuum is indicated for a Bowie-Dick pack at exemplary graphical interface screen as a server shown in Fig. 24, P0159. Also, see remote locations P0022, P0149.),
determine, based on the environmental parameter or the received data, whether an operative capability of the surgical instrument is non-compliant with a geo-political location threshold associated with the geo-political location of at least one of the surgical package and the surgical instrument (See P0011 the Bowie-Dick pack indicate failure of the vacuum portion of a steam sterilization cycle, Fig. 20, P0137 where 92 from the indicator 70 may be compared against stored standards 91 data from that type of sterilization indicator, and thresholding 93 may be accomplished by comparing for best matches with the stored standards 91. Also, see assigned sterilant exposure value pass/fail threshold in P0141 and threshold values correspond suitable color and “accept” cycle of the sterilization in P0228-P0231.);
transmit a control signal, based on one or more of the received data or the determination of whether the whether the manufacturer-sealed sterile surgical package has been sterilized to at least one of the surgical package or the surgical instrument to alter one or more aspects of the surgical package or the surgical instrument (See Fig. 4, P0148-P0149 electronic communication for monitoring and tracking. Also, see communicated aspects of the surgical package in Fig. 21, Fig. 24, [P0159] some test packs for ethylene oxide sterilizers require an aeration period prior to disposal. The system according to the present invention may be designed to communicate proper disposal procedures to the user and [P0167] FIG. 26 is an example of a computer screen that issues a warning and provides further instructions to a user. This may be presented to a user if an attempt is made to send an article from a failed sterilization cycle to the operating room for use in a surgical procedure.).
Claim 10:
Kippenhan discloses A method, comprising:
sensing, by an environmental sensor disposed in the surgical package, an environmental parameter associated with the surgical package (Taught as photosensors in P0124-P0125, printer density and Hall sensors in P0175-P0176. Also, see ability to indicate sterilization environment in P0079, P0085, P0088, P0091.);
receiving, by a surgical system and from a remote server, data characterizing a geo-political location of the surgical system, the surgical system including a manufacturer-sealed, sterile surgical package, a surgical instrument contained within the manufacturer-sealed, sterile surgical package (See exemplary geo-political standards and state laws (P0005-P0006), U.S. sterilization assurance practices (P0011-P0012) for comparison, where the steam vacuum is indicated for a Bowie-Dick pack at exemplary graphical interface screen as a server shown in Fig. 24, P0159. Also, see remote locations P0022, P0149.), and a sterility indicator disposed on the manufacturer-sealed sterile surgical package, the sterility indicator comprising a first portion and a second portion, wherein the sterility indicator is readable based on the first portion and the second portion being readable, wherein the first portion comprises anon-radiation-sensitive ink and the second portion comprising a radiation-sensitive ink, and wherein the second portion is configured to be readable based on the radiation-sensitive ink being exposed to radiation (See Fig. 1, Fig. 2, P0061-P0062 where the variety of sterilization processes are non-radiation and ink color change after sterilization mentioned in P0078, P0085, P0087. See Fig. 17, P0119-P0122 where radiation is an energy source reflected form the sterilization indicator and Fig. 32-33 a sterilization indicator before and after a sterilization cycle mentioned in P0064-P0066.);
determining, based on the environmental parameter or the received data, whether an operative capability of the surgical instrument is non-compliant with a geo-political location threshold associated with the geo-political location of at least one of the surgical package and the surgical instrument (See P0011 the Bowie-Dick pack indicate failure of the vacuum portion of a steam sterilization cycle, Fig. 20, P0137 where 92 from the indicator 70 may be compared against stored standards 91 data from that type of sterilization indicator, and thresholding 93 may be accomplished by comparing for best matches with the stored standards 91. Also, see assigned sterilant exposure value pass/fail threshold in P0141 and threshold values correspond suitable color and “accept” cycle of the sterilization in P0228-P0231.); and
transmitting a control signal, based on one or more of the received data or the determination of whether the whether the manufacturer-sealed sterile surgical package has been sterilized to at least one of the surgical package or the surgical instrument to alter one or more aspects of the surgical package or the surgical instrument (See Fig. 4, P0148-P0149 electronic communication for monitoring and tracking. Also, see communicated aspects of the surgical package in Fig. 21, Fig. 24, [P0159] some test packs for ethylene oxide sterilizers require an aeration period prior to disposal. The system according to the present invention may be designed to communicate proper disposal procedures to the user and [P0167] FIG. 26 is an example of a computer screen that issues a warning and provides further instructions to a user. This may be presented to a user if an attempt is made to send an article from a failed sterilization cycle to the operating room for use in a surgical procedure.).
Claim 20:
Kippenhan discloses A non-transitory computer program product storing instructions which, when executed by at least one data processor forming part of at least one computing system, cause the at least one data processor to implement operations (See Fig. 17-18, P0119-P0122 processor and storage medium in P0025.) comprising:
sensing, by an environmental sensor disposed in the surgical package, an environmental parameter associated with the surgical package (Taught as photosensors in P0124-P0125, printer density and Hall sensors in P0175-P0176. Also, see ability to indicate sterilization environment in P0079, P0085, P0088, P0091.);
receiving, by a surgical system and from a remote server, data characterizing a geo-political location of the surgical system, the surgical system including a manufacturer-sealed, sterile surgical package, a surgical instrument contained within the manufacturer-sealed, sterile surgical package (See exemplary geo-political standards and state laws (P0005-P0006), U.S. sterilization assurance practices (P0011-P0012) for comparison, where the steam vacuum is indicated for a Bowie-Dick pack at exemplary graphical interface screen as a server shown in Fig. 24, P0159. Also, see remote locations P0022, P0149.), and a sterility indicator disposed on the manufacturer-sealed sterile surgical package, the sterility indicator comprising a first portion and a second portion, wherein the sterility indicator is readable based on the first portion and the second portion being readable, wherein the first portion comprises anon-radiation-sensitive ink and the second portion comprising a radiation-sensitive ink, and wherein the second portion is configured to be readable based on the radiation-sensitive ink being exposed to radiation (See Fig. 1, Fig. 2, P0061-P0062 where the variety of sterilization processes are non-radiation and ink color change after sterilization mentioned in P0078, P0085, P0087. See Fig. 17, P0119-P0122 where radiation is an energy source reflected form the sterilization indicator and Fig. 32-33 a sterilization indicator before and after a sterilization cycle mentioned in P0064-P0066.);
determining, based on the environmental parameter or the received data, whether an operative capability of the surgical instrument is non-compliant with a geo-political location threshold associated with the geo-political location of at least one of the surgical package and the surgical instrument (See P0011 the Bowie-Dick pack indicate failure of the vacuum portion of a steam sterilization cycle, Fig. 20, P0137 where 92 from the indicator 70 may be compared against stored standards 91 data from that type of sterilization indicator, and thresholding 93 may be accomplished by comparing for best matches with the stored standards 91. Also, see assigned sterilant exposure value pass/fail threshold in P0141 and threshold values correspond suitable color and “accept” cycle of the sterilization in P0228-P0231.); and
transmitting a control signal, based on one or more of the received data or the determination of whether the whether the manufacturer-sealed sterile surgical package has been sterilized, to at least one of the surgical package or the surgical instrument to alter one or more aspects of the surgical package or the surgical instrument (See Fig. 4, P0148-P0149 electronic communication for monitoring and tracking. Also, see communicated aspects of the surgical package in Fig. 21, Fig. 24, [P0159] some test packs for ethylene oxide sterilizers require an aeration period prior to disposal. The system according to the present invention may be designed to communicate proper disposal procedures to the user and [P0167] FIG. 26 is an example of a computer screen that issues a warning and provides further instructions to a user. This may be presented to a user if an attempt is made to send an article from a failed sterilization cycle to the operating room for use in a surgical procedure.).
Regarding claims 7 and 16, Kippenhan discloses the surgical system of claim 1, the method of claim 10 and wherein the one or more aspects include one or more operations of the surgical instrument usable during a surgical procedure (See Fig. sterilization history for surgical instruments in P0179.).
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 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, 11-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of Nyez (US 2010/0108761 A1).
Regarding claims 2 and 11, Kippenhan discloses the surgical system of claim 1 and the method of claim 11 mentioned above, and Kippenhan does not explicitly teach when the manufacturer-sealed sterile surgical package includes a display configured to present visual information. Nyez teaches wherein the manufacturer-sealed sterile surgical package includes a display configured to present visual information (See Fig. 3, P0017-P0018 and [P0044] the user then is prompted to enter more information, such as the cleaning and sterilizing date of each surgical instrument, whether the process was completed, and other remarks about the instrument.).
Therefore, it would have been obvious to one of ordinary skill in the art of surgical tray management before the effective filing date of the claimed invention to modify the system, method and software of Kippenhan to include the manufacturer-sealed sterile surgical package includes a display configured to present visual information as taught by Nyez to identify and inventory the medical surgical instruments to facilitate, repair, and replace them mentioned in Nyez’ P0001 and P0003.
Regarding claims 3 and 12, although Kippenhan and Nyez teach the surgical system of claim 2 and the method of claim 11 mentioned above, Kippenhan further discloses wherein the display is configured to present one or more messages indicating non-compliance with one or more regulations of the geo-political location (See exemplary geo-political standards and state laws (P0005-P0006), U.S. sterilization assurance practices (P0011-P0012) for comparison, where the steam vacuum is indicated for a Bowie-Dick pack at exemplary graphical interface screen shown in Fig. 24, P0159. Also, see Fig. 26 Warning P0162-P0163, and [P0167] an example of a computer screen that issues a warning and provides further instructions to a user. This may be presented to a user if an attempt is made to send an article from a failed sterilization cycle to the operating room for use in a surgical procedure.).
Regarding claims 5 and 14, Kippenhan discloses the surgical system of claim 1 and the method of claim 10 mentioned above, and Kippenhan does not explicitly teach a capacity to collect medical data and data related to surgical procedures. Nyez teaches wherein the one or more aspects include a capacity to collect medical data and data related to surgical procedures (See Fig. 6, P0047 where the table lists names of the surgical instruments such as Eye Bolt, Screw Kit and Fig. 5 Bone Saw Handle would be used for Orthopedic surgery.).
Therefore, it would have been obvious to one of ordinary skill in the art of surgical tray management before the effective filing date of the claimed invention to modify the system, method and software of Kippenhan to include the capacity to collect medical data and data related to surgical procedures as taught by Nyez to identify and inventory the medical surgical instruments to facilitate, repair, and replace them mentioned in Nyez’ P0001 and P0003.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of Nyez (US 2010/0108761 A1) further in view of Halvorsen (US 2021/0019581 A1).
Regarding claims 4 and 13, although Kippenhan and Nyez teach the surgical system of claim 3 and the method of claim 12 mentioned above, Kippenhan and Nyez do not explicitly teach geo-political-location based language of message. Halvorsen teaches wherein a language of the one or more presented messages is based upon the geo-political location (See P0008-P0009 where language is based on geographic location. Also, see P0019, P0059-P0060.).
Therefore, it would have been obvious to one of ordinary skill in the art of labelling medical supplies before the effective filing date of the claimed invention to modify the system of Kippenhan and Nyez to include the geo-political-location based language of message as taught by Halvorsen when proper translations, printing and shipping of specific labels for specific jurisdictions must be coordinated and performed as mentioned in Halvorsen’s P0003.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of Djachiachvili (US 2010/0118138 A1).
Regarding claim 6, although Kippenhan discloses the surgical system of claim 1 mentioned above, Kippenhan does not explicitly teach disabling functions of the manufacturer-sealed, sterile surgical package for being non-compliant. Djachiachvili teaches wherein the instructions are configured to disable one or more functions of the manufacturer-sealed, sterile surgical package, the one or more functions being non-compliant with one or more regulations of the geo-political location (See Fig. 3, removing rejected package and automatically separate defective product in [P0021-P0022] When defect has being detected by the image processing module 260, a fault condition can be generated by a PLC 280. The fault condition (a signal) from the PLC can be used to identify the compromised package so that it can be removed or marked for rejection. As an example, the PLC 280 can send a signal downstream to the frame unload station to identify (mark) fault or to automatically separate defective product from the good product.).
Therefore, it would have been obvious to one of ordinary skill in the art of sealed sterilized packaging before the effective filing date of the claimed invention to modify the system of Kippenhan to include disabling functions of the manufacturer-sealed, sterile surgical package for being non-compliant as taught by Djachiachvili to avoid micro objects such as human hair, dust and injection molding debris from becoming embedded between sealing surfaces of sterile surgical instruments as mentioned in Djachiachvili’s P0003.
Regarding claim 15, although Kippenhan discloses the surgical method of claim 10 mentioned above, Kippenhan does not explicitly teach disabling functions of the manufacturer-sealed, sterile surgical package for being non-compliant. Djachiachvili teaches wherein the instructions disable one or more functions of the surgical package, the one or more functions being non-compliant with one or more regulations of the geo- political location (See Fig. 3, removing rejected package and automatically separate defective product in [P0021-P0022] When defect has being detected by the image processing module 260, a fault condition can be generated by a PLC 280. The fault condition (a signal) from the PLC can be used to identify the compromised package so that it can be removed or marked for rejection. As an example, the PLC 280 can send a signal downstream to the frame unload station to identify (mark) fault or to automatically separate defective product from the good product.).
Therefore, it would have been obvious to one of ordinary skill in the art of sealed sterilized packaging before the effective filing date of the claimed invention to modify the system of Kippenhan to include disabling functions of the manufacturer-sealed, sterile surgical package for being non-compliant as taught by Djachiachvili to avoid micro objects such as human hair, dust and injection molding debris from becoming embedded between sealing surfaces of sterile surgical instruments as mentioned in Djachiachvili’s P0003.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of Kim (US 2015/0278758 A1).
Regarding claim 8, although Kippenhan discloses the surgical system of claim 1 mentioned above, Kippenhan does not explicitly teach a customs checkpoint. Kim teaches wherein the geo-political location is a customs checkpoint (See customed information (PP0018, P0100, Fig. 4A) using customs module 430 when checking status of a package (P0068, P0118) including dental supplies shown in Fig. 4C.).
Therefore, it would have been obvious to one of ordinary skill in the art of package delivery management before the effective filing date of the claimed invention to modify the system Kippenhan to include a customs checkpoint as taught by Kim as a standard to comply with Customs and Boarder Patrol for safely sending international packages.
Claims 9 and 17 rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of McKinzie (US 11,481,739 B1).
Regarding claim 9, although Kippenhan discloses the surgical system of claim 1 and the method of claim 10 mentioned above, Kippenhan does not explicitly teach a capacity to deliver controlled substances prohibited or controlled in the geo-political location. McKinzie teaches wherein the one or more aspects include a capacity to deliver one or more controlled substances, wherein the one or more controlled substances are prohibited or controlled in the geo-political location (See Abstract, column 4, lines 5-20 where the kiosk distributes or disposes control substances such as opioids from various locations.).
Therefore, it would have been obvious to one of ordinary skill in the art of kiosk medication management before the effective filing date of the claimed invention to modify the system of Kippenhan to a capacity to deliver controlled substances prohibited or controlled in the geo-political location as taught by Kim as an incentive to easily and safely dispose the controlled substances and opioids that patients are no longer taking as mentioned in McKinzie’s column 8, lines 43-59.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of McKinzie (US 11,481,739 B1) further in view of Kim (US 2015/0278758 A1).
Regarding claim 18, although Kippenhan and McKinzie teach the methos of claim 10 mentioned above, Kippenhan and McKinzie do not explicitly teach a customs checkpoint. Kim teaches wherein the geo-political location is a customs checkpoint (See customed information (PP0018, P0100, Fig. 4A) using customs module 430 when checking status of a package (P0068, P0118) including dental supplies shown in Fig. 4C.).
Therefore, it would have been obvious to one of ordinary skill in the art of package delivery management before the effective filing date of the claimed invention to modify the method Kippenhan and McKinzie to include a customs checkpoint as taught by Kim as a standard to comply with Customs and Boarder Patrol for safely sending international packages.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kippenhan (US 2010/0217620 A1) in view of McKinzie (US 11,481,739 B1) further in view of Hurwitz (US 2010/0311385 A1).
Regarding claim 19, although Kippenhan and McKinzie teach the method of claim 17 mentioned above, Kippenhan and McKinzie do not explicitly teach transmit instructions prior to crossing a geo-political border into the geo-political location. Hurwitz teaches wherein the instructions are transmitted prior to crossing a geo-political border into the geo-political location (See Fig. 2, medical instrument has satellite communication where an emergency medicine physician can provide instructions to the caregiver on sight in P0063-P0065 and geo-fencing used for predefined messages transmitted to a person that needs to be contained in a particular area.).
Therefore, it would have been obvious to one of ordinary skill in the art of generating medical alerts before the effective filing date of the claimed invention to modify the method of Kippenhan and McKinzie to include teach transmit instructions prior to crossing a geo-political border into the geo-political location as taught by Hurwitz to allow for multimedia communications on a non-multimedia rationalized satellite network as mentioned in Hurwitz’ P0039.
Response to Arguments
Regarding the prior art rejections, Applicant’s arguments have been fully considered, but are now moot in view of the new grounds of rejection. The Examiner has entered new rejections under 35 USC § 102, 103 and applied new art and art already of record.
Applicant argues that amended claims 1, 10, and 20 reflect a specific improvement to the technical field of surgical packaging and sterility verification as set forth in the specification, and integrate the judicial exception into a practical application., e.g. see pgs. 8-9 of Remarks – Examiner disagrees.
The claim reciting “a sterility indicator disposed on the manufacturer-sealed sterile surgical package, the sterility indicator comprising a first portion and a second portion, wherein the sterility indicator is readable based on the first portion and the second portion being readable, wherein the first portion comprises a non-radiation-sensitive ink and the second portion comprising a radiation-sensitive ink, and wherein the second portion is configured to be readable based on the radiation-sensitive ink being exposed to radiation” is an additional element and not an improvement in the surgical packaging and sterility verification fields. Designing a surgical packaging seal with portions to indicate ink gamma radiation or color change is a problem that has already been solved. As discussed supra, the claimed invention does not provide a physical improvement to the computer. The claimed invention also does to improve any other technical field, see, e.g., Diamond v. Diehr. The claimed invention may improve the abstract idea, but an improved abstract idea is still an abstract idea.
Applicant’s arguments, see page, filed 12/23/2025 with respect to the 112 rejection, have been fully considered and are persuasive. Determining environmental parameter or received data is done by scanning according to paragraph 274 of Applicant’s specification. The 112 rejection of claims 1-20 has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. (See Patel US 8115182 B1)
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/T.S.W./Examiner, Art Unit 3687 03/30/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687