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 .
Response to Arguments
In response to Applicant’s arguments to the objection of figures 12-13 and 24. Examiner respectfully disagrees. The drawings are objected to under 37 CFR 1.83(a) because figure 12-13 and 24 fails to have proper labels for all the rectangular boxes as required by 37 CFR 1.83(a), and as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended.
In response to Applicant’s arguments regarding the rejection of claims 1-2, 4-14 and 16-18 under 35 U.S.C. 101 as directed to non-statutory subject matter. Examiner respectfully disagrees. Claim 1 is directed to idea of itself (abstract idea) without significantly more for the following reason(s): Claim 1 recites an electronic management system comprising a processor configured to receive a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determine a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generate a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging. Thus, the claim is directed to a method, which is one of the statutory categories of the invention. the claimed of receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging, are directed to abstract idea for the reason that these steps are processes found by the courts to be abstract ideas in that related to a mental process grouping “collecting information, analyzing the data of the collection and displaying the analyzed data,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); That is, nothing in the claim element precludes the steps from practically being performed in the mind. The claim recites the step of receiving data, determining and analyzing the received data, and displaying the analyzed data, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping. Accordingly, the claim recites an abstract idea. Further, the Judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – “electronic management system,” and “graphical display,” which merely serve to tie the abstract idea to a particular technological environment (automated or computer-based operating environment) via generic computing hardware, software/instructions, which is not sufficient to amount to a practical application, as noted in the 2019 PEG. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Furthermore, these additional elements fail to integrate the abstract idea into a practical application because they fail to provide an improvement to the functioning of a computer or to any other technology or technical field, fail to apply the exception with a particular machine, fail to effect a transformation of a particular article to a different state or thing, and fail to apply/use the abstract idea in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. Moreover, limitations that are “not” indicative of integration into a practical application include adding the words “apply it”, or mere instructions to implement an abstract idea on a computer (See MPEP 2106.05(f)). Accordingly, the 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, and there is still no improvement to a technology or using the judicial in some “meaning way beyond linking the use of the judicial exception to a particular technological environment.”. Treating claim 1 as a whole, the claim limitations do not show inventive concept in applying the judicial exception (e.g., The collection, and determination of data may be accurately identified without relying on an electronic management system, which improves the accuracy of collecting, determining and displaying the data. From the claim scope, the claim fail to address this improvement because merely acquiring the features of receiving data, determining and analyzing the received data, and displaying the analyzed data is not enough to tie the claim towards the technical improvement. Thus, claim 1 as a whole is not significantly more than the abstract idea itself and is ineligible. Furthermore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites the step of receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging, which is an act of receiving data, determining and analyzing the received data, and displaying the analyzed data, that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, and merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking) component cannot provide an inventive concept. The claim is not patent eligible.
Applicant’s arguments with respect to claim(s) 1-2, 4-14 and 16-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because figure 12-13 and 24 fails to have proper labels for all the rectangular boxes as required by 37 CFR 1.83(a), and as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2, 4-14 and 16-18 are rejected under 35 U.S.C. 101 as directed to non-statutory subject matter. Claims 1-2, 4-14 and 16-18 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.
Regarding claims 1:
Claim 1 is directed to idea of itself (abstract idea) without significantly more for the following reason(s):
Step 1: Claim 1 recites an electronic management system comprising a processor configured to receive a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determine a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generate a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging. Thus, the claim is directed to a method, which is one of the statutory categories of the invention.
Step 2A prong 1, the claimed of receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging, are directed to abstract idea for the reason that these steps are processes found by the courts to be abstract ideas in that related to a mental process grouping “collecting information, analyzing the data of the collection and displaying the analyzed data,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); That is, nothing in the claim element precludes the steps from practically being performed in the mind. The claim recites the step of receiving data, determining and analyzing the received data, and displaying the analyzed data, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping. Accordingly, the claim recites an abstract idea.
Step 2A prong 2, The Judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – “electronic management system,” and “graphical display,” which merely serve to tie the abstract idea to a particular technological environment (automated or computer-based operating environment) via generic computing hardware, software/instructions, which is not sufficient to amount to a practical application, as noted in the 2019 PEG. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Furthermore, these additional elements fail to integrate the abstract idea into a practical application because they fail to provide an improvement to the functioning of a computer or to any other technology or technical field, fail to apply the exception with a particular machine, fail to effect a transformation of a particular article to a different state or thing, and fail to apply/use the abstract idea in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. Moreover, limitations that are “not” indicative of integration into a practical application include adding the words “apply it”, or mere instructions to implement an abstract idea on a computer (See MPEP 2106.05(f)). Accordingly, the 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, and there is still no improvement to a technology or using the judicial in some “meaning way beyond linking the use of the judicial exception to a particular technological environment.”. Treating claim 1 as a whole, the claim limitations do not show inventive concept in applying the judicial exception (e.g., The collection, and determination of data may be accurately identified without relying on an electronic management system, which improves the accuracy of collecting, determining and displaying the data. From the claim scope, the claim fail to address this improvement because merely acquiring the features of receiving data, determining and analyzing the received data, and displaying the analyzed data is not enough to tie the claim towards the technical improvement. Thus, claim 1 as a whole is not significantly more than the abstract idea itself and is ineligible.
Step 2B, The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites the step of receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging, which is an act of receiving data, determining and analyzing the received data, and displaying the analyzed data, that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, and merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking) component cannot provide an inventive concept. The claim is not patent eligible.
Regarding dependent claims 2-8.
Dependent claims 2 and 4-8, The Judicial exception is not integrated into a practical application and said claims does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims are not patent eligible.
Regarding claim 9 and 18:
Claims 9 and 18 are directed to idea of itself (abstract idea) without significantly more for the following reason(s):
Step 1: Claims 9 and 18 recites series of steps to receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging. Thus, the claim is directed to a method, which is one of the statutory categories of the invention.
Step 2A prong 1, the claimed of receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging, are directed to abstract idea for the reason that these steps are processes found by the courts to be abstract ideas in that related to a mental process grouping “collecting informations, analyzing the data of the collection and displaying the analyzed data,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); That is, nothing in the claim element precludes the steps from practically being performed in the mind. The claim recites the step of receiving data, determining and analyzing the received data, and displaying the analyzed data, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping. Accordingly, the claim recites an abstract idea.
Step 2A prong 2, The Judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – “electronic management system,” and “graphical display,” which merely serve to tie the abstract idea to a particular technological environment (automated or computer-based operating environment) via generic computing hardware, software/instructions, which is not sufficient to amount to a practical application, as noted in the 2019 PEG. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Furthermore, these additional elements fail to integrate the abstract idea into a practical application because they fail to provide an improvement to the functioning of a computer or to any other technology or technical field, fail to apply the exception with a particular machine, fail to effect a transformation of a particular article to a different state or thing, and fail to apply/use the abstract idea in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. Moreover, limitations that are “not” indicative of integration into a practical application include adding the words “apply it”, or mere instructions to implement an abstract idea on a computer (See MPEP 2106.05(f)). Accordingly, the 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, and there is still no improvement to a technology or using the judicial in some “meaning way beyond linking the use of the judicial exception to a particular technological environment.”. Treating claim 1 as a whole, the claim limitations do not show inventive concept in applying the judicial exception (e.g., The collection, and determination of data may be accurately identified without relying on an electronic management system, which improves the accuracy of collecting, determining and displaying the data. From the claim scope, the claim fail to address this improvement because merely acquiring the features of receiving data, determining and analyzing the received data, and displaying the analyzed data is not enough to tie the claim towards the technical improvement. Thus, claim 1 as a whole is not significantly more than the abstract idea itself and is ineligible.
Step 2B, The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites the step of receiving a list of secondary packagings, wherein each of the secondary surgical packagings has a surgical implement disposed therein that is compatible with a surgical device disposed in the primary surgical packaging, wherein the list of secondary surgical packagings is stored on the primary surgical packaging; determining a secondary surgical packaging in electronic communication with the electronic management system from the list of secondary surgical packagings; and generating a control signal configured to display data characterizing the determined secondary surgical packaging or the surgical implement disposed therein on a graphical display disposed on the primary surgical packaging, which is an act of receiving data, determining and analyzing the received data, and displaying the analyzed data, that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, and merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking) component cannot provide an inventive concept. The claim is not patent eligible.
Regarding dependent claims 10-14 and 16-17.
Dependent claims 10-17, The Judicial exception is not integrated into a practical application and said claims does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the determined compatible secondary surgical packaging" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is rejected as stated above because due to their dependency from claim 16. Claim 17 is also indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 4-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 4-8 recites “The primary surgical packaging of claim 1….” In line 1, are improper dependent claims because it does not include all the limitations of the independent claim such as “The electronic management system of claim 1…”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 6 is rejected as stated above because due to their dependency from claim 5. Claim 6 is also improper dependent claim.
Claim 8 is rejected as stated above because due to their dependency from claim 7. Claim 8 is also improper dependent claim.
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.
1. Claim(s) 1-2, 7, 9-11, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald et al. (US2022/0096825A1) hereafter McDonald in view of Shelton, IV et al. (US2020/0405441A1) hereafter Shelton.
Regarding claim 1, McDonald discloses an electronic management system in electronic communication with a primary surgical packaging, the electronic management system comprising a processor configured to:
receive a list of secondary packagings (fig 9:910; par[0127], [0129]: Prior to or after the electrode member 110 of the trackable electrode device 100 is connected to the electrical signal interface 250 of the medical device 200, the medical device 200 uses the RF reader 270 to receive, from the RF tag 120 of the trackable electrode device 100, tag identification data representing a tag ID (Step 910). The tag ID is associated with the electrode member 110.), wherein each of the secondary packagings has an implement disposed therein that is compatible with a device disposed in the primary packaging (par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables), wherein the list of secondary packagings is stored on the primary packaging (par[0130]: the medical device 200 may be configured to determine the control signal based on a predefined algorithm, e.g., by executing a computer program pre-stored on the medical device 200, and based on pre-stored data in the medical device 200. The pre-stored data represent the compatibilities between the devices ID and the tag IDs, e.g., as compatibility tables. The offline medical device 200 has the tag ID pre-stored, and this can be updated sporadically, e.g., in a software update.);
determine secondary packaging in electronic communication with the electronic management system from the list of secondary packagings (par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables); and
generate a control signal configured to display data characterizing the determineda display of the medical device. The terminal computing device 500 may send the control signal to the medical device 200, to instruct the medical device 200 to use or not use the electrode member 110 according to the control signal. Alternatively, the terminal computing device 500 may output the control signal in any other suitable manner. For example, the terminal computing device 500 may display a control message on a screen of the terminal computing device 500 to inform a user of the medial device 200, the control message indicating whether and/or how the electrode member 110 should be used with the medical device 200).
McDonald does not explicitly the primary surgical packaging comprising: primary and secondary surgical packagings.
Shelton discloses the primary surgical packaging comprising: primary and secondary surgical packagings (par[0302], [0304], [0311], [0313]: During various surgical procedures, surgical instruments comprising at least one replaceable component are used. It is important that such replaceable components be replaced with functional and/or compatible components. Various identification systems described in greater detail herein verify, among other things, a component's compatibility with the surgical instrument and/or verify an operating status of the component. For instance, the identification system can serve to, for example, ensure that the packaging containing the replaceable component has not been destroyed and/or tampered with, alert a clinician if a component is compatible or incompatible with the surgical instrument prior to opening the product packaging, and/or alert the clinician if a recall exists for a particular manufacturing batch or type of the replaceable component. The scanner decodes bars of the barcode which generally represent a series of numbers. The decoded information is sent to a computer, or a controller, which interprets what has been read. This information can contain data regarding, for example, the manufacturer of the replaceable component, a type or model of the replaceable component, and/or compatibility information of the replaceable component for use with a surgical instrument. The packaging 25000 comprises various identification systems that facilitate a surgical instrument and/or a clinician in selecting a staple cartridge 25100 that is compatible with a particular surgical instrument and/or a particular surgical procedure. In addition to the name 25012 of the contents of the packaging 25000 being displayed on the first layer 25010, the packaging 25000 comprises a serial number 25016 that can, for example, provide more detailed information that a clinician can utilize before deciding whether to open the packaging 25000. For example, the serial number 25016 may comprise alphanumeric symbols that are specific and/or unique to a surgical system. Each alphanumeric symbol can represent a component of a compatible assembled surgical system.).
One of ordinary skill in the art would be aware of both the McDonald and the Shelton references since both pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the compatibility feature as disclosed by Shelton to achieve predictable results and gain the functionality of providing an enhanced patient safety through reduced infection risk and improved outcomes from more precise procedures, increased efficiency and time savings for surgical staff, and consistent performance from high-quality, durable, or custom-fit tools.
Regarding claim 2, McDonald in view of Shelton discloses the primary surgical packaging of claim 1, wherein the secondary surgical packaging is determined based on a surgical procedure in which the surgical device is configured to be used (McDonald par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables.).
Regarding claim 7, McDonald in view of Shelton discloses the system wherein the electronic management system is further configured to:
provide, based on the determined compatible secondary packaging, operational information for the primary packaging and compatible secondary packaging (Shelton par[0311], [0313], [0315]: The packaging 25000 comprises various identification systems that facilitate a surgical instrument and/or a clinician in selecting a staple cartridge 25100 that is compatible with a particular surgical instrument and/or a particular surgical procedure. The packaging 25000 comprises a serial number 25016 that can, for example, provide more detailed information that a clinician can utilize before deciding whether to open the packaging 25000. For example, the serial number 25016 may comprise alphanumeric symbols that are specific and/or unique to a surgical system. Each alphanumeric symbol can represent a component of a compatible assembled surgical system. For example, the alphanumeric symbols can represent a staple cartridge, an end effector, a shaft assembly, a surgical instrument, etc. The serial number 25016 can represent additional factors such as, manufacturing lot, date of manufacture, etc. The RFID system 25200 comprises an RFID tag 25210 and an insulator 25220. The RFID tag 25210 comprises a chip, such as a microchip, for example, that stores information about the packaging 25000 and/or the contents of the packaging 25000. In various instances, the chip comprises a basic identification number. Such a basic identification can be assigned to the chip that can communicate the chip's existence to an RFID scanner. In various instances, the chip comprises additional information such as, for example, manufacturing data, shipping data, and/or compatibility data.).
Regarding claim 9, McDonald discloses a method, performed by an electronic management system in electronic communication with a primary surgical packaging, the method comprising:
receiving a list of secondary packagings (fig 9:910; par[0127], [0129]: Prior to or after the electrode member 110 of the trackable electrode device 100 is connected to the electrical signal interface 250 of the medical device 200, the medical device 200 uses the RF reader 270 to receive, from the RF tag 120 of the trackable electrode device 100, tag identification data representing a tag ID (Step 910). The tag ID is associated with the electrode member 110.), wherein each of the secondary packagings has an implement disposed therein that is compatible with a device disposed in the primary packaging (par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables), wherein the list of secondary packagings is stored on the primary packaging (par[0130]: the medical device 200 may be configured to determine the control signal based on a predefined algorithm, e.g., by executing a computer program pre-stored on the medical device 200, and based on pre-stored data in the medical device 200. The pre-stored data represent the compatibilities between the devices ID and the tag IDs, e.g., as compatibility tables. The offline medical device 200 has the tag ID pre-stored, and this can be updated sporadically, e.g., in a software update.);
determining secondary packaging in electronic communication with the electronic management system from the list of secondary packagings (par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables); and
generating a control signal configured to display data characterizing the determineda display of the medical device. The terminal computing device 500 may send the control signal to the medical device 200, to instruct the medical device 200 to use or not use the electrode member 110 according to the control signal. Alternatively, the terminal computing device 500 may output the control signal in any other suitable manner. For example, the terminal computing device 500 may display a control message on a screen of the terminal computing device 500 to inform a user of the medial device 200, the control message indicating whether and/or how the electrode member 110 should be used with the medical device 200).
McDonald does not explicitly the primary surgical packaging comprising: primary and secondary surgical packagings.
Shelton discloses the primary surgical packaging comprising: primary and secondary surgical packagings (par[0302], [0304], [0311], [0313]: During various surgical procedures, surgical instruments comprising at least one replaceable component are used. It is important that such replaceable components be replaced with functional and/or compatible components. Various identification systems described in greater detail herein verify, among other things, a component's compatibility with the surgical instrument and/or verify an operating status of the component. For instance, the identification system can serve to, for example, ensure that the packaging containing the replaceable component has not been destroyed and/or tampered with, alert a clinician if a component is compatible or incompatible with the surgical instrument prior to opening the product packaging, and/or alert the clinician if a recall exists for a particular manufacturing batch or type of the replaceable component. The scanner decodes bars of the barcode which generally represent a series of numbers. The decoded information is sent to a computer, or a controller, which interprets what has been read. This information can contain data regarding, for example, the manufacturer of the replaceable component, a type or model of the replaceable component, and/or compatibility information of the replaceable component for use with a surgical instrument. The packaging 25000 comprises various identification systems that facilitate a surgical instrument and/or a clinician in selecting a staple cartridge 25100 that is compatible with a particular surgical instrument and/or a particular surgical procedure. In addition to the name 25012 of the contents of the packaging 25000 being displayed on the first layer 25010, the packaging 25000 comprises a serial number 25016 that can, for example, provide more detailed information that a clinician can utilize before deciding whether to open the packaging 25000. For example, the serial number 25016 may comprise alphanumeric symbols that are specific and/or unique to a surgical system. Each alphanumeric symbol can represent a component of a compatible assembled surgical system.).
One of ordinary skill in the art would be aware of both the McDonald and the Shelton references since both pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the compatibility feature as disclosed by Shelton to achieve predictable results and gain the functionality of providing an enhanced patient safety through reduced infection risk and improved outcomes from more precise procedures, increased efficiency and time savings for surgical staff, and consistent performance from high-quality, durable, or custom-fit tools.
Regarding claim 10, McDonald in view of Shelton discloses the method wherein the secondary surgical packaging is determined based on a surgical procedure in which the surgical device is configured to be used (McDonald par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables.).
Regarding claim 11, McDonald in view of Shelton discloses the method wherein the determined secondary surgical packaging is provided on the graphical display of the primary surgical packaging (McDonald par[0083], [0139]: the external medical device may notify a user that the trackable electrode device 100 the user is attempting to use is not compatible or not fully compatible with the medical device, e.g., by triggering an alarm or displaying a warning message on a display of the medical device. The terminal computing device 500 may send the control signal to the medical device 200, to instruct the medical device 200 to use or not use the electrode member 110 according to the control signal. Alternatively, the terminal computing device 500 may output the control signal in any other suitable manner. For example, the terminal computing device 500 may display a control message on a screen of the terminal computing device 500 to inform a user of the medial device 200, the control message indicating whether and/or how the electrode member 110 should be used with the medical device 200).
Regarding claim 16, McDonald in view of Shelton discloses the method further comprising:
providing, based on the determined compatible secondary surgical packaging, operational information for the primary surgical packaging and the secondary surgical packaging (Shelton par[0311], [0313], [0315]: The packaging 25000 comprises various identification systems that facilitate a surgical instrument and/or a clinician in selecting a staple cartridge 25100 that is compatible with a particular surgical instrument and/or a particular surgical procedure. The packaging 25000 comprises a serial number 25016 that can, for example, provide more detailed information that a clinician can utilize before deciding whether to open the packaging 25000. For example, the serial number 25016 may comprise alphanumeric symbols that are specific and/or unique to a surgical system. Each alphanumeric symbol can represent a component of a compatible assembled surgical system. For example, the alphanumeric symbols can represent a staple cartridge, an end effector, a shaft assembly, a surgical instrument, etc. The serial number 25016 can represent additional factors such as, manufacturing lot, date of manufacture, etc. The RFID system 25200 comprises an RFID tag 25210 and an insulator 25220. The RFID tag 25210 comprises a chip, such as a microchip, for example, that stores information about the packaging 25000 and/or the contents of the packaging 25000. In various instances, the chip comprises a basic identification number. Such a basic identification can be assigned to the chip that can communicate the chip's existence to an RFID scanner. In various instances, the chip comprises additional information such as, for example, manufacturing data, shipping data, and/or compatibility data.).
Regarding claim 18, McDonald discloses a non-transitory computer program product storing instructions which, when executed by at least one data processor forming part of an electronic management system in electronic communication with a primary surgical packaging (fig 7(A):300; par[0123]: The medical device 200 may be in data communication with a server 300, via a communication network 400. The server 300 may take any suitable form, e.g., a cloud server, or a dedicated server. The server 300 may be a local server in a hospital, or a cloud-based server accessed by secure Internet connections.), cause the at least one data processor to implement operations comprising:
receiving a list of secondary packagings (fig 9:910; par[0127], [0129]: Prior to or after the electrode member 110 of the trackable electrode device 100 is connected to the electrical signal interface 250 of the medical device 200, the medical device 200 uses the RF reader 270 to receive, from the RF tag 120 of the trackable electrode device 100, tag identification data representing a tag ID (Step 910). The tag ID is associated with the electrode member 110.), wherein each of the secondary packagings has an implement disposed therein that is compatible with a device disposed in the primary packaging (par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables), wherein the list of secondary packagings is stored on the primary packaging (par[0130]: the medical device 200 may be configured to determine the control signal based on a predefined algorithm, e.g., by executing a computer program pre-stored on the medical device 200, and based on pre-stored data in the medical device 200. The pre-stored data represent the compatibilities between the devices ID and the tag IDs, e.g., as compatibility tables. The offline medical device 200 has the tag ID pre-stored, and this can be updated sporadically, e.g., in a software update.);
determining secondary packaging in electronic communication with the electronic management system from the list of secondary packagings (par[0129]: Based on the received tag ID and the obtained device ID, at Step 930 the medical device 200 obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server 300. The medical device 200 may send both the tag ID and the device ID to the server 300 via the communication network 400. Based on the combination of the tag ID and the device ID, the server 300 determines a control signal indicating the compatibility between the medical device 200 and the trackable electrode device 100, and sends the control signal back to the medical device 200. The server 300 determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables); and
generating a control signal configured to display data characterizing the determinedsurgical packaging (par[0083], [0139]: the external medical device may notify a user that the trackable electrode device 100 the user is attempting to use is not compatible or not fully compatible with the medical device, e.g., by triggering an alarm or displaying a warning message on a display of the medical device. The terminal computing device 500 may send the control signal to the medical device 200, to instruct the medical device 200 to use or not use the electrode member 110 according to the control signal. Alternatively, the terminal computing device 500 may output the control signal in any other suitable manner. For example, the terminal computing device 500 may display a control message on a screen of the terminal computing device 500 to inform a user of the medial device 200, the control message indicating whether and/or how the electrode member 110 should be used with the medical device 200).
McDonald does not explicitly the primary surgical packaging comprising: primary and secondary surgical packagings.
Shelton discloses the primary surgical packaging comprising: primary and secondary surgical packagings (par[0302], [0304], [0311], [0313]: During various surgical procedures, surgical instruments comprising at least one replaceable component are used. It is important that such replaceable components be replaced with functional and/or compatible components. Various identification systems described in greater detail herein verify, among other things, a component's compatibility with the surgical instrument and/or verify an operating status of the component. For instance, the identification system can serve to, for example, ensure that the packaging containing the replaceable component has not been destroyed and/or tampered with, alert a clinician if a component is compatible or incompatible with the surgical instrument prior to opening the product packaging, and/or alert the clinician if a recall exists for a particular manufacturing batch or type of the replaceable component. The scanner decodes bars of the barcode which generally represent a series of numbers. The decoded information is sent to a computer, or a controller, which interprets what has been read. This information can contain data regarding, for example, the manufacturer of the replaceable component, a type or model of the replaceable component, and/or compatibility information of the replaceable component for use with a surgical instrument. The packaging 25000 comprises various identification systems that facilitate a surgical instrument and/or a clinician in selecting a staple cartridge 25100 that is compatible with a particular surgical instrument and/or a particular surgical procedure. In addition to the name 25012 of the contents of the packaging 25000 being displayed on the first layer 25010, the packaging 25000 comprises a serial number 25016 that can, for example, provide more detailed information that a clinician can utilize before deciding whether to open the packaging 25000. For example, the serial number 25016 may comprise alphanumeric symbols that are specific and/or unique to a surgical system. Each alphanumeric symbol can represent a component of a compatible assembled surgical system.).
One of ordinary skill in the art would be aware of both the McDonald and the Shelton references since both pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the compatibility feature as disclosed by Shelton to achieve predictable results and gain the functionality of providing an enhanced patient safety through reduced infection risk and improved outcomes from more precise procedures, increased efficiency and time savings for surgical staff, and consistent performance from high-quality, durable, or custom-fit tools.
2. Claim(s) 4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald in view of Shelton, and further in view of Jaynes (US2015/0169829A1).
Regarding claim 4, McDonald in view of Shelton does not explicitly disclose the primary surgical packaging wherein the graphical display comprises at least one e-ink label.
Jaynes discloses the primary surgical packaging wherein the graphical display comprises at least one e-ink label (fig 5:550; par[0040]: The illustrated embodiment depicts a bin 500 that has a base 510 including a cavity for receiving an article therein, and a lid 520. The lid 520, which may not be present in some embodiments, may be hinged proximate an edge of the lid, such as at hinge 530. The bin 500 may also include a label 540 with a digital display 550, such as an electronic-ink display. The bin 500 of the illustrated embodiment may receive an article therein with the lid in an open position and the lid may be closed to seal the contents.).
One of ordinary skill in the art would be aware of the McDonald, Shelton and Jaynes references since all pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the e-link labeling feature as disclosed by Jaynes to achieve predictable results and gain the functionality of providing a Low power consumption, high readability, versatility, remote and dynamic updates that enables dynamic pricing, allows businesses to synchronize in-store and online promotions, and reduces pricing errors.
Regarding claim 12, McDonald in view of Shelton does not explicitly disclose the method wherein the graphical display comprises at least one e-ink label.
Jaynes discloses the method wherein the graphical display comprises at least one e-ink label (fig 5:550; par[0040]: The illustrated embodiment depicts a bin 500 that has a base 510 including a cavity for receiving an article therein, and a lid 520. The lid 520, which may not be present in some embodiments, may be hinged proximate an edge of the lid, such as at hinge 530. The bin 500 may also include a label 540 with a digital display 550, such as an electronic-ink display. The bin 500 of the illustrated embodiment may receive an article therein with the lid in an open position and the lid may be closed to seal the contents.).
One of ordinary skill in the art would be aware of the McDonald, Shelton and Jaynes references since all pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the e-link labeling feature as disclosed by Jaynes to achieve predictable results and gain the functionality of providing a Low power consumption, high readability, versatility, remote and dynamic updates that enables dynamic pricing, allows businesses to synchronize in-store and online promotions, and reduces pricing errors.
3. Claim(s) 5-6 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald in view of Shelton, and further in view of Leung et al. (US2023/0128550A1) hereafter Leung.
Regarding claim 5, McDonald in view of Shelton does not explicitly disclose the primary surgical packaging wherein the compatible secondary packaging includes a second graphical display disposed on the compatible secondary packaging.
Leung discloses the primary surgical packaging wherein the compatible secondary packaging includes a second graphical display disposed on the compatible secondary packaging (Leung fig 10:1012, 1014&1016, par[0097]: FIG. 10 shows an illustrative example of items and packages that are hierarchically aggregated and tracked using electronic tracking labels. An item 1011, which may represent a unit of sale, for example, is placed into a package 1021, possibly with other items. (In some cases, a package may contain only a single item.) Electronic tracking label 1012 is placed on item 1011, and similar electronic tracking labels 1014 and 1016 are placed on other items that are packed into package 1021).
One of ordinary skill in the art would be aware of the McDonald, Shelton and Leung references since all pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the display feature as disclosed by Leung to achieve predictable results and gain the functionality of providing a smart authentication, dynamic information, clutter reduction, enhanced engagement and logistical efficiency.
Regarding claim 6, McDonald in view of Shelton and Leung discloses the primary surgical packaging wherein the processor is further configured to:
receive data characterizing a list of compatible primary packagings stored on the secondary packaging (Leung fig 10:1031; par[0100], [0101]: Package 1021 is placed on pallet 1031, with two other packages, technically package 1021 is a primary packaging that is stored on the secondary packaging 1031. The pallet serves as a higher-level package. It may also have an electronic tracking label 1032, with unique identifier 1033. The pallet-level tracking label may communicate with the tracking label of each of the package labels on the pallet (and these package labels may in turn communicate with the labels of their contained items). In this situation the pallet 1031 is a package that contains items that are themselves packages. A package may be any type of item that may contain one or more other items, where the contained items may also be other packages. Containment may be any type of inclusion or association; for example, the pallet 1031 “contains” package 1021 even though the package is not “inside” the pallet but is rather on the pallet (and likely secured to the pallet with wrap or straps). Containment may represent any association between an aggregating device and its aggregated unit(s). FIG. 10 also shows a third level of “packaging” where pallet 1031 is placed into a cargo container 1041, along with other items, including potentially other pallets or packages. Container 1041 has an electronic tracking label 1042, with unique identifier 1043; the container label 1042 communicates with electronic tracking labels of the packages, pallets, or other items in the container. Packaging and aggregation may continue to include any number of levels; for example, container 1041 may be placed onto a ship or truck, and the vessel or vehicle may be considered as a “package”);
determine a compatible primary packaging in electronic communication with the electronic management system from a list of compatible primary packagings stored on the secondary packaging (Leung fig 10:332a; par[0102], [0103]: The containment relationship between packages and their contained items (which may in turn be other packages) may be represented in the tracking database(s) 332a maintained by or accessible to central server(s) 331. FIG. 10 shows an illustrative containment table 1050 that maps item label identifiers to the identifiers of the labels of their containing package. For example, the hierarchy of packaging in FIG. 10 is represented in table 1050 with item identifier 1013 technically equivalent to a secondary packaging contained in package identifier 1023, which is contained in package (pallet) identifier 1033, which is contained in package (container) identifier 1043.); and
provide data characterizing the determined compatible primary packaging on the second graphical display of the secondary packaging (Leung par[0102]: FIG. 10, each package label communicates with its directly contained labels. For example, pallet electronic label 1032 communicates with package electronic label 1022. In one or more embodiments, labels may also communicate directly with the indirect contents, rather than communicating strictly hierarchically. For example, pallet label 1032 may communicate directly with item labels 1012, 1014, and 1016 in package 1021, without necessarily passing through the package label 1022.).
Regarding claim 13, McDonald in view of Shelton does not explicitly disclose the method wherein the compatible secondary packaging includes a second graphical display disposed on the compatible secondary packaging.
Leung discloses the method wherein the compatible secondary packaging includes a second graphical display disposed on the compatible secondary packaging (Leung fig 10:1012, 1014&1016, par[0097]: FIG. 10 shows an illustrative example of items and packages that are hierarchically aggregated and tracked using electronic tracking labels. An item 1011, which may represent a unit of sale, for example, is placed into a package 1021, possibly with other items. (In some cases, a package may contain only a single item.) Electronic tracking label 1012 is placed on item 1011, and similar electronic tracking labels 1014 and 1016 are placed on other items that are packed into package 1021).
One of ordinary skill in the art would be aware of the McDonald, Shelton and Leung references since all pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the display feature as disclosed by Leung to achieve predictable results and gain the functionality of providing a smart authentication, dynamic information, clutter reduction, enhanced engagement and logistical efficiency.
Regarding claim 14, McDonald in view of Shelton and Leung discloses the method further comprising:
receiving data characterizing a list of compatible primary packagings stored on the secondary packaging (Leung fig 10:1031; par[0100], [0101]: Package 1021 is placed on pallet 1031, with two other packages, technically package 1021 is a primary packaging that is stored on the secondary packaging 1031. The pallet serves as a higher-level package. It may also have an electronic tracking label 1032, with unique identifier 1033. The pallet-level tracking label may communicate with the tracking label of each of the package labels on the pallet (and these package labels may in turn communicate with the labels of their contained items). In this situation the pallet 1031 is a package that contains items that are themselves packages. A package may be any type of item that may contain one or more other items, where the contained items may also be other packages. Containment may be any type of inclusion or association; for example, the pallet 1031 “contains” package 1021 even though the package is not “inside” the pallet but is rather on the pallet (and likely secured to the pallet with wrap or straps). Containment may represent any association between an aggregating device and its aggregated unit(s). FIG. 10 also shows a third level of “packaging” where pallet 1031 is placed into a cargo container 1041, along with other items, including potentially other pallets or packages. Container 1041 has an electronic tracking label 1042, with unique identifier 1043; the container label 1042 communicates with electronic tracking labels of the packages, pallets, or other items in the container. Packaging and aggregation may continue to include any number of levels; for example, container 1041 may be placed onto a ship or truck, and the vessel or vehicle may be considered as a “package”);
determining a compatible primary packaging in electronic communication with the electronic management system from a list of compatible primary packagings stored on the secondary packaging (Leung fig 10:332a; par[0102], [0103]: The containment relationship between packages and their contained items (which may in turn be other packages) may be represented in the tracking database(s) 332a maintained by or accessible to central server(s) 331. FIG. 10 shows an illustrative containment table 1050 that maps item label identifiers to the identifiers of the labels of their containing package. For example, the hierarchy of packaging in FIG. 10 is represented in table 1050 with item identifier 1013 technically equivalent to a secondary packaging contained in package identifier 1023, which is contained in package (pallet) identifier 1033, which is contained in package (container) identifier 1043.); and
providing data characterizing the determined compatible primary packaging on the second graphical display of the secondary packaging (Leung par[0102]: FIG. 10, each package label communicates with its directly contained labels. For example, pallet electronic label 1032 communicates with package electronic label 1022. In one or more embodiments, labels may also communicate directly with the indirect contents, rather than communicating strictly hierarchically. For example, pallet label 1032 may communicate directly with item labels 1012, 1014, and 1016 in package 1021, without necessarily passing through the package label 1022.).
3. Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Shelton, and further in view of Gravelle et al. (US2020/0279217A1) hereafter Gravelle.
Regarding claim 8, McDonald in view of Shelton does not explicitly disclose the primary surgical packaging wherein the operational information includes at least one of product compatibility information or operational instructions.
Gravelle discloses the primary surgical packaging wherein the operational information includes at least one of product compatibility information (fig 3E:328; par[0113]: on the mobile data storage devices 226 of the storage bins 224a and 224b that hold vendor inventory, a product information table 328 is populated from fields of the vendor's product table(s) 303 of one or more vendors whose products are contained in one or more compartments of that storage bin. Each record in the product information tables 328 of the storage bins 224a and 224b thus contains a respective vendor and/or global Product_ID from the contents table 327, and a copy of all or some fields from the corresponding product record in the vendor's product table 303 of that vendor, for example, including the handling data, the customization data, and the environmental data that will be used to guide handing and customization within one or more of the facilities, and environmental placement within both the facilities and the transport vehicles.) or operational instructions (par[0093]: the product handling data comprise flags, codes, or instructions relating to: product packing requirements such as placement of heavy or leak-prone items at the bottom of a multi-item order, placement of light or fragile items at the top of a multi-order item, grouping or separation of items by product category, etc.; and packaging requirements concerning selection and application of particular packaging types for a particular product, such as wrapping of products in tissue, bubble wrap, gift wrap, or other wrapping material, placement of products in bags, boxes or other containers, and selection from among differently branded, stylized, sized, or gauged wrapping materials, bags, boxes or containers, etc. Other examples of product handling data comprise flags, codes, or instructions relating to storage and/or handing of volatile, flammable or otherwise hazardous items requiring particular routing to, or processing or handling in, specially equipped facilities, facility zones, facility workstations, or transport vehicles; and flags, codes or instructions for allergenically-safe handling of food items to avoid cross-contamination).
One of ordinary skill in the art would be aware of the McDonald, Shelton and Gravelle references since all pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the operational information feature as disclosed by Gravelle to achieve predictable results and gain the functionality of providing equipment that is compatible with the storage bins for performing various supply chain activities and inventory exchanges between the entities, handle and transport the smart, standardized storage bins having a single form factor and structure for interfacing with standard, compliant robotics and transport vehicles throughout the supply chain ecosystem.
Regarding claim 17, McDonald in view of Shelton does not explicitly disclose the method wherein the operational information includes at least one of product compatibility information and operational instructions.
Gravelle discloses the method wherein the operational information includes at least one of product compatibility information (fig 3E:328; par[0113]: on the mobile data storage devices 226 of the storage bins 224a and 224b that hold vendor inventory, a product information table 328 is populated from fields of the vendor's product table(s) 303 of one or more vendors whose products are contained in one or more compartments of that storage bin. Each record in the product information tables 328 of the storage bins 224a and 224b thus contains a respective vendor and/or global Product_ID from the contents table 327, and a copy of all or some fields from the corresponding product record in the vendor's product table 303 of that vendor, for example, including the handling data, the customization data, and the environmental data that will be used to guide handing and customization within one or more of the facilities, and environmental placement within both the facilities and the transport vehicles.) and operational instructions (par[0093]: the product handling data comprise flags, codes, or instructions relating to: product packing requirements such as placement of heavy or leak-prone items at the bottom of a multi-item order, placement of light or fragile items at the top of a multi-order item, grouping or separation of items by product category, etc.; and packaging requirements concerning selection and application of particular packaging types for a particular product, such as wrapping of products in tissue, bubble wrap, gift wrap, or other wrapping material, placement of products in bags, boxes or other containers, and selection from among differently branded, stylized, sized, or gauged wrapping materials, bags, boxes or containers, etc. Other examples of product handling data comprise flags, codes, or instructions relating to storage and/or handing of volatile, flammable or otherwise hazardous items requiring particular routing to, or processing or handling in, specially equipped facilities, facility zones, facility workstations, or transport vehicles; and flags, codes or instructions for allergenically-safe handling of food items to avoid cross-contamination).
One of ordinary skill in the art would be aware of the McDonald, Shelton and Gravelle references since all pertain to the field of packaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have improved the system of McDonald with the operational information feature as disclosed by Gravelle to achieve predictable results and gain the functionality of providing equipment that is compatible with the storage bins for performing various supply chain activities and inventory exchanges between the entities, handle and transport the smart, standardized storage bins having a single form factor and structure for interfacing with standard, compliant robotics and transport vehicles throughout the supply chain ecosystem.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINE BENLAGSIR whose telephone number is (571)270-5165. The examiner can normally be reached (571)270-5165.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steven Lim can be reached at (571) 270-1210. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMINE BENLAGSIR/Primary Examiner, Art Unit 2688
Prosecution Insights