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 .
Claims 1-20 are pending.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-10 are drawn to a method for managing a digital display associated with a medicinal product, which is within the four statutory categories (i.e. process). Claims 11-20 are drawn to a non-transitory medium for managing a digital display associated with a medicinal product which is within the four statutory categories (i.e. manufacture).
Step 2A | Prong One
Claims 1-10 (Group I) recites a computer-implemented method of managing a digital display label associated with medicinal product, the method comprising:
receiving, from a medicinal supply management system (MPEP § 2106.05(f), apply it), a label image to be displayed on the digital display label associated with the medicinal product;
identifying a unique identifier of the digital display label affixed to the medicinal product;
establiShing a connection with the digital display label identified by the unique identifier (MPEP § 2106.05(g), insignificant extra-solution activity);
transmitting the label image to the digital display label for presentation; and
receiving a receipt confirmation from the digital display label.
The bolded limitations, given the broadest reasonable interpretation, cover a a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationShips or interactions between people. Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 11-20 is identical as the abstract idea for Claims 1-10 (Group I), because the only difference is they are directed towards different statutory categories.
Dependent Claims 2-10 and 12-20 include other limitations, for example Claims 2 and 12 recite wherein the label presents information on a formulation of the medicinal product, Claims 3 and 13 recite wherein the label presents information on a protocol for administration of the medicinal product, Claims 4 and 14 recite wherein identifying the unique identifier of the digital display label comprises scanning an electronic signature of the digital display label indicating the unique identifier of the digital display label, Claims 5 and 15 recite wherein scanning the electronic signature comprises receiving the electronic signature with one of: Bluetooth technology, radio frequency identification (RFID) technology, Zigbee, or near-field communication (NFC) technology (MPEP § 2106.05(h), generally linking), Claims 6 and 16 recite wherein identifying the unique identifier of the digital display label comprises: receiving an image of a QR code or a barcode; and identifying the unique identifier of the digital display label through image analysis of the image of the QR code or the barcode, Claims 7 and 17 recite
wherein establiShing the connection with the digital display label comprises establiShing a wireless connection between a client device and the digital display label (MPEP § 2106.05(g), insignificant extra-solution activity), wherein transmitting the label image to the digital display label (MPEP § 2106.05(f), apply it) for presentation comprises transmitting the label image to the client display (MPEP § 2106.05(f), apply it) for transmission to the digital display label via the wireless connection, and wherein receiving the receipt confirmation from the digital display label comprises receiving the receipt confirmation via the client device (MPEP § 2106.05(f), apply it), Claims 8 and 18 recite further comprising, at a subsequent time: receiving, from the medicinal supply management system (MPEP § 2106.05(f), apply it), an updated version of the label image; transmitting, to a client device (MPEP § 2106.05(f), apply it), a notification indicating presence of the updated version of the label image; identifying, via the client device (MPEP § 2106.05(f), apply it), the unique identifier of the digital display label affixed to the medicinal product; establiShing, via the client device (MPEP § 2106.05(f), apply it), subsequent connection with the digital display label identified by the unique identifier (MPEP § 2106.05(g), insignificant extra-solution activity); transmitting, via the client device, the updated version of the label image to the digital display label for presentation, Claims 9 and 19 recite receiving, via the connection to the digital display label (MPEP § 2106.05(h), generally linking), a request to view a protocol associated with the medicinal product; identifying, in a table, the protocol associated with the unique identifier of the digital display label affixed to the medicinal product; and transmitting the protocol to the digital display label for presentation, Claims 10 and 20 recite receiving, via the connection to the digital display label (MPEP § 2106.05(h), generally linking), data captured by one or more sensors coupled to the medicinal product; and storing the data captured by the one or more sensors in conjunction with the unique identifier for the digital display label (MPEP § 2106.05(g), insignificant extra-solution activity), but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 11.
Step 2A | Prong Two
Furthermore, Claims 1-20 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a non-transitory computer-readable storage medium, medicinal supply management system, client device, and digital display label which amounts to merely invoking a computer or other machinery as a tool to perform the abstract idea, e.g. see paragraphs [0053], [01058-0059] and [120] of the present Specification, see MPEP 2106.05(f);
add insignificant extra-solution activity to the abstract idea – for example, the recitation of the recitation of storing data and establiShing a wireless connection (for example, using Bluetooth®), which amounts to an insignificant application, see MPEP 2106.05(g); and
generally link the abstract idea to a particular technological environment or field of use – for example, the recitation of Bluetooth technology, radio frequency identification (RFID) technology, Zigbee, or near-field communication (NFC) technology, which amounts to limiting the abstract idea to the field of wireless communication, see MPEP 2106.05(h))
Step 2B
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0053], [01058-0059] and [120] of the Specification discloses that the additional elements (i.e. a non-transitory computer-readable storage medium, medicinal supply management system, client device, and digital display label) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. storing data, connecting wirelessly) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of sensor and instruction data on a database and/or electronic memory.
The following State of the Art Publication that demonstrates the well-understood, routine, and conventional nature of the additional elements:
establiShing a connection with the digital display label identified by the unique identifier of claims 1, 7, 11 and 17, e.g. see Rössl (U.S.Pub. No. 2024/0241210 A1) [0048] discusses using standardized communication methods or protocol, such as WLAN, ZigBee, or Bluetooth for electronic shelf labels.
Dependent Claims 2-10 and 12-20 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than electronic recordkeeping (e.g. the storing feature of dependent Claims 10 and 20). The other additional elements, such as the client device, are recited at an “apply it” level and do not result in significantly more than the abstract idea itself.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7, 9-17 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shi U.S. Pub. No. 2023/0186866 A1 in view of Burgess (U.S. Pub. No. 2022/0051792 A1).
Regarding claim 1, Shi discloses a computer-implemented method of managing a digital display label associated with medicinal product, the method comprising:
receiving, from a medicinal supply management system, a label image to be displayed on the digital display label associated with the medicinal product (Paragraphs [0050] and [0073-0075] discuss receiving an image to be displayed on the electronic ink display screen, which can be an electronic shelf label and being used a pharmacy, construed as including labels associated with medicinal products.);
identifying a unique identifier of the digital display label (Paragraph [0049] discusses the electronic ink display apparatus being able to be paired wirelessly using Bluetooth, which requires each device to a have a unique identifier.);
establishing a connection with the digital display label identified by the unique identifier (Paragraph [0049] discusses the electronic ink display apparatus being able to be paired wirelessly using Bluetooth, which requires each device to a have a unique identifier, construed as establishing a connecting with the digital display label.);
transmitting the label image to the digital display label for presentation (Paragraphs [0073-0075] discuss the display control apparatus obtaining the image to be displayed and sending to the electronic ink display apparatus/electronic shelf tag.);
but Shi does not appear to explicitly disclose:
wherein the electronic shelf label is affixed to the medicinal product; and
receiving a receipt confirmation from the digital display label.
Burgess teaches:
wherein the electronic shelf label is affixed to the medicinal product (Paragraphs [0044-0045] and [0082] discuss that the electronic tag, construed as a digital display label, is affixed to the IV administration line, construed as being affixed to the medicinal product and the signal exchanges are used to verify that the correct devices are receiving the information.); and
receiving a receipt confirmation from the digital display label (Paragraphs [0044-0045] and [0082] discuss that the electronic tag exchanges signals which are used to verify that the correct devices are receiving the information, construed as including a receipt confirmation.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to be affixed to a medicinal product and confirm receipt, as taught by Burgess, in order to “correctly associate an IV container with an IV set (Burgess, [0007]).”
Regarding claim 2, Shi does not appear to explicitly disclose wherein the label presents information on a formulation of the medicinal product.
Burgess teaches wherein the label presents information on a formulation of the medicinal product (Paragraph [0068] discusses that the electronic tag displays information about the medical fluid contained in the IV container. See also Figure 4D showing the electronic tag displaying information about the IV fluid.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to be include formulation of the medicinal product, as taught by Burgess, in order to “display pertinent information relating to the infusion process (Burgess, [0007]).”
Regarding claim 3, Shi does not appear to explicitly disclose wherein the label presents information on a protocol for administration of the medicinal product.
Burgess teaches wherein the label presents information on a protocol for administration of the medicinal product (Paragraph [0068] discusses that the electronic tag displays information about the medical fluid contained in the IV container and information about the infusion rate of the medical fluid. Starting time and intended usage period. Figure 4D shows the information on the electronic label.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to include information on a protocol for administration, as taught by Burgess, in order to “display pertinent information relating to the infusion process (Burgess, [0007]).”
Regarding claim 4, Shi discloses wherein identifying the unique identifier of the digital display label comprises:
scanning an electronic signature of the digital display label indicating the unique identifier of the digital display label (Paragraph [0066] discusses the devices pairing using Bluetooth.).
Regarding claim 5, Shi discloses wherein scanning the electronic signature comprises receiving the electronic signature with one of: Bluetooth technology, radio frequency identification (RFID) technology, Zigbee, or near-field communication (NFC) technology (Paragraph [0066] discusses the devices pairing using Bluetooth to wirelessly communicate to exchange information.).
Regarding claim 6, Shi does not appear to explicitly disclose wherein identifying the unique identifier of the digital display label comprises:
receiving an image of a QR code or a barcode; and
identifying the unique identifier of the digital display label through image analysis of the image of the QR code or the barcode.
Burgess teaches wherein identifying the unique identifier of the digital display label comprises:
receiving an image of a QR code or a barcode (Paragraphs [0034] and [0070] discuss scanning a machine-readable code, such as a barcode or a quick read code on the electronic tag.); and
identifying the unique identifier of the digital display label through image analysis of the image of the QR code or the barcode (Paragraphs [0070], [0079] and [0085] discuss using the scanned code to identify the electronic tag.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to include receiving an image of a QR code or barcode to identify the electronic shelf tag, as taught by Burgess, in order to “determine that they are correctly attached to the same infusion IV set (Burgess, [0085]).”
Regarding claim 7, Shi discloses:
wherein establishing the connection with the digital display label comprises establishing a wireless connection between a client device and the digital display label (Paragraph [0049] discusses the electronic ink display apparatus being able to be paired wirelessly using Bluetooth, which requires each device to a have a unique identifier, construed as establishing a connecting with the digital display label to a communication opposite-end device, construed a client device.),
wherein transmitting the label image to the digital display label for presentation comprises transmitting the label image to the client device for transmission to the digital display label via the wireless connection (Paragraphs [0073-0075] discuss the display control apparatus obtaining the image to be displayed and sending to the electronic ink display apparatus/electronic shelf tag.),
but Shi does not appear to explicitly disclose:
wherein receiving the receipt confirmation from the digital display label comprises receiving the receipt confirmation via the client device.
Burgess teaches wherein receiving the receipt confirmation from the digital display label comprises receiving the receipt confirmation via the client device (Paragraphs [0032] and [0044-0045] and [0082] discuss that the electronic tag exchanges signals which are used to verify that the correct devices are receiving the information including device terminals that may include personal computers, tablets or smartphones, construed as including a receipt confirmation.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to confirm receipt, as taught by Burgess, in order to “correctly associate an IV container with an IV set (Burgess, [0007]).”
Regarding claim 9, Shi does not appear to explicitly disclose:
receiving, via the connection to the digital display label, a request to view a protocol associated with the medicinal product;
identifying, in a table, the protocol associated with the unique identifier of the digital display label affixed to the medicinal product; and
transmitting the protocol to the digital display label for presentation.
Burgess teaches:
receiving, via the connection to the digital display label, a request to view a protocol associated with the medicinal product (Paragraph [0048] discusses receiving information about the infusion rate based on profiles of the drugs and IV fluids.);
identifying, in a table, the protocol associated with the unique identifier of the digital display label affixed to the medicinal product (Paragraph [0048] discusses using drug and IV fluid libraries for the profiles that can provide additional information about the drug or IV fluid to help a clinician select on the programming module or infusion pump.); and
transmitting the protocol to the digital display label for presentation (Paragraph [0048] discusses the electronic tag receiving the data for display on the electronic tag.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to include protocol, as taught by Burgess, in order to “help reduce IV medication errors, improve the overall quality of patient care, track and measure system performance and help increase compliance with national safety standards (Burgess, [0048]).”
Regarding claim 10, Shi does not appear to explicitly disclose:
receiving, via the connection to the digital display label, data captured by one or more sensors coupled to the medicinal product; and
storing the data captured by the one or more sensors in conjunction with the unique identifier for the digital display label
Burgess teaches:
receiving, via the connection to the digital display label, data captured by one or more sensors coupled to the medicinal product (Paragraphs [0045] and [0058] discuss the electronic tag including sensors.); and
storing the data captured by the one or more sensors in conjunction with the unique identifier for the digital display label (Paragraphs [0042] and [0070 discuss storing data associated with various part of the electronic tag for tracking and recording steps in the infusion process.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the electronic shelf tag of Shi to include sensors, as taught by Burgess, so that “once the sensor on the electronic tag senses that the electronic tag has been attached to a tubing of the IV set , the display provides an updated message containing a subsequent instruction for associating the electronic tag with a particular IV container (Burgess, [0072]).”
2025Attorney Docket No. 317EP.001US01
Claim 11 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 12 recites substantially similar limitations as those already addressed in claim 2, and, as such, is rejected for similar reasons as given above.
Claim 13 recites substantially similar limitations as those already addressed in claim 3, and, as such, is rejected for similar reasons as given above.
Claim 14 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
Claim 15 recites substantially similar limitations as those already addressed in claim 5, and, as such, is rejected for similar reasons as given above.
Claim 16 recites substantially similar limitations as those already addressed in claim 6, and, as such, is rejected for similar reasons as given above.
Claim 17 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Claim 19 recites substantially similar limitations as those already addressed in claim 9, and, as such, is rejected for similar reasons as given above.
Claim 20 recites substantially similar limitations as those already addressed in claim 10, and, as such, is rejected for similar reasons as given above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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