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, 3-4, 6, 9-16 and 20 have been amended. Claims 2, 5 and 17 have been cancelled. Claims 7-8 were previously cancelled. Claims 21 and 22 are new. Claims 1, 3-4, 6, 9-16 and 18-22 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 ends with the word “and.” As this appear to be a typographical error, the claim will be construed as ending with “by the user interface (201/202/203) of the scanning subsystem (200)” without the word “and” at the end.
Appropriate correction is required.
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.
Claim 2 is 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 2 recites the limitation " by the asset tracking system.” There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “by the asset tracking system” will be interpreted as “by the asset tracking subsystem” consistent with claim 1.
Appropriate correction is required.
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, 3-4, 6, 9-16 and 18-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 3-4, 6, 9-10 and 21 are drawn to a method for preparing and managing medical devices and supplies for use in a medical procedure, which is within the four statutory categories (i.e. process). Claims 11-16, 18-20 and 22 are drawn to a system for preparing and managing medical devices and supplies for use in a medical procedure, which is within the four statutory categories (i.e. machine).
Claims 1, 3-4, 6, 9-10 and 21 (Group I) recite a method for preparing and tracking medical devices and supplies used in a medical procedure, comprising:
storing information on medical devices and supplies in a computer-readable identification database (MPEP § 2106.05(f), apply it, MPEP § 2106.05(g), insignificant extra-solution activity), wherein the computer-readable identification database comprises:
a first dataset of standard identification information from governing agencies, wherein the standard identification information comprises unique device identifiers (UDI) from global unique device identification database (GUDID) and product recall information,
a second dataset of product identification information from vendors and suppliers, wherein the product identification information comprises device identifiers from multiple vendors and suppliers, and information for the same medical device or supply from different vendors and suppliers are structured and organized, and
a third dataset of user-input identification information on the medical devices and supplies, wherein the user-input identification information are device identifiers with customized attributes for medical devices and supplies used in medical procedures that are created and curated by local clinical users on-site,
wherein the computer-readable identification database comprises harmonized and curated device identifiers from the first, second, and third datasets with images and recognition features corresponding to the medical devices and supplies, the computer-readable identification database is in direct communication with a first non-transitory medium of an asset tracking subsystem and being periodically replicated and updated, and the first non-transitory medium is in direct communication with a scanning subsystem,
storing information on the medical devices and supplies specific to patients and healthcare practitioners associated with a healthcare facility in a computer-readable operational database (MPEP § 2106.05(f), apply it, MPEP § 2106.05(g), insignificant extra-solution activity) in the asset tracking subsystem, wherein the computer-readable operational database comprises transactional information on the medical devices and supplies and inventory specific to the healthcare facility for tracking workflow of medical procedures and is in direct communication respectively with the first non-transitory medium, a computer algorithm, and a second non-transitory medium in the asset tracking subsystem, and the second non-transitory medium is in direct communication with electronic records,
automatically retrieving a list of medical procedures to be performed in the healthcare facility by the second non-transitory medium based on information from the computer-readable operational database and electronic records, and displaying this list of medical procedures to allow a clinical user to select a medical procedure in the list of medical procedures to be performed through a user interface (MPEP § 2106.05(f), apply it) on the scanning subsystem, wherein the scanning subsystem is connected to the asset tracking subsystem over a web protocol-based interface,
upon selection of the medical procedure by the clinical user, the scanning subsystem automatically switching into a scanning mode to allow one or more users to scan medical devices or supplies to be used for the selected medical procedure and automatically sending scanned images and recognition features of the medical devices and supplies by the scanning subsystem to the asset-tracking system,
automatically retrieving information on the medical devices and supplies to be used for the selected medical procedure by the first non-transitory medium (MPEP § 2106.05(f), apply it) via direct communication with the computer-readable identification and operational databases, wherein the retrieved information comprise the device identifiers from the government agencies, vendors and suppliers, and local users with images and recognition features and any product recall information corresponding to the medical devices and supplies from the computer-readable identification database and transactional information on the medical devices and supplies specific to patients and healthcare practitioners involved in the selected medical procedure from the computer-readable operational database based on the computing algorithm that matches the selected type of medical procedure with type of product information stored in the computer-readable identification and operational databases,
sending the retrieved information to the user interface (201/202/203) of the scanning subsystem and displaying the retrieved information on the medical devices and supplies to one or more users through the user interface (MPEP § 2106.05(f), apply it),
providing digital access to the multiple users through the user interface, wherein the multiple users are located either locally or in the healthcare facility or remotely,
allowing the multiple users to verify the medical devices and supplied based on the retrieved information and input any changes to the medical devices and supplies in real time through the user interface (MPEP § 2106.05(f), apply it),
upon receiving verification and changes from the multiple users from the scanning subsystem by the asset tracking subsystem via the web protocol-based interface (MPEP § 2106.05(f), apply it), automatically updating the computer-readable operational database and the electronic records by the second non-transitory medium (MPEP § 2106.05(f), apply it) in the asset tracking subsystem in real time and carrying out the medical procedure using the verified medical devices and supplies, and
during and after the medical procedure, automatically updating the electronic records, the computer-readable operational database, and the computer-readable identification database on use and disposal of the medical devices and supplies by the asset tracking subsystem in real time based on the recognition features of the medical devices and supplies captured during and after the medical procedure by the user interface.
Claim 11 further includes the additional elements of a first non-transitory computer-readable medium storing instruction that, when executed, causing one or more computing devices to perform steps (MPEP § 2106.05(f), apply it), a second non-transitory computer-readable medium, storing instruction that, when executed, causing one or more computing devices to perform steps (MPEP § 2106.05(f), apply it), a tangible, non-transitory storage medium (MPEP § 2106.05(f), apply it) storing one or more datasets related to product and inventory information on medical devices and supplies associated with the healthcare facility (MPEP § 2106.05(g), insignificant extra-solution activity); a third non-transitory computer-readable medium storing instruction that, when executing, causing one or more computing devices to perform steps (MPEP § 2106.05(f), apply it), providing a user interface (MPEP § 2106.05(f), apply it), a tangible, non-transitory storage medium (MPEP § 2106.05(f), apply it) storing two or more datasets (MPEP § 2106.05(g), insignificant extra-solution activity).
The bolded limitations, given the broadest reasonable interpretation, cover 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. The claims are directed towards tracking inventory of medical supplies and devices in order to “optimize the workflow of medical procedures, particularly, to identify and track the use and disposition of medical assets such as surgical supplies and medical devices used in medical procedures in healthcare facilities (Specification, [0001]).”. Any limitations not identified above as part of the method of organizing human activity are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 3-4, 6, 9-10, 12-16 and 18-22 include other limitations, for example claim 3 recites scanning to obtain an image or one or more recognition features on a medical device or supply, identifying the medical device or supply based on the image or recognition features by the asset tracking subsystem and the computer-readable identification database, wherein the scanned image or one or more recognition features are automatically matched with the image or recognition features of the medical device or supply in the computer-readable identification database, automatically retrieving, by one or more computing devices without user input, a list of medical procedures associated with the identified medical device or supply from the computer-readable identification database and operational database by the first non-transitory medium and the computer algorithm, wherein the computer algorithm automatically matches the type of identified medical device or supply with the type of medical procedures to be performed to form the list of the medical procedure, displaying on the user interface the list of medical procedures, and allowing a user to select a medical procedure to be performed from the list of the medical procedures, claim 4 recites organizing in the user interface, by one or more computing devices without user input, of the medical devices and supplies selected for the medical procedure into one or more groups based on their related use, and tracking, by one or more computing devices without user input, the use and disposal of the one or more groups of the medical devices and supplies and updating the electronic records and the computer-readable identification and operational databases based on the use and disposal of the one or more groups of the medical devices and supplies, claim 6 recites automatically alerting a user to replenish medical devices and supplies based on supply chain applications and available supplies and updated asset utilization from the updated electronic records and the computer readable operational database, claim 9 recites wherein the medical devices and supplies selected for the medical procedure comprise one or more implantable medical devices, and the retrieved information on the one or more implantable medical devices comprise patient-specific information, medical practitioner-specific information, procedure-specific information, or a combination thereof from the computer-readable operational database, claim 10 recites wherein the medical procedure comprises removal of one or more explantable medical devices from a patient, and the explantable medical devices are being tracked during and after the medical procedure and updated on the electronic records associated with the patient in the computer-readable operational database and the electronic records in real time, claim 21 recites upon selection of the list of medical procedure by the clinical user via the user interface, automatically retrieving a collection of medical devices and supplies associated with the selected medical procedure by the first non-transitory medium and the computer algorithm, wherein the computer algorithm automatically matches the type of the selected medical procedure with the type of medical devices or supplies from the computer- readable operation and identification databases to form the collection of medical devices and supplies, displaying on the user interface the collection of medical devices and supplies, and allowing a user to select the medical devices and supplies from the collection of medical devices and supplies before the verification step, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1. Dependent claims 12-16 18-20 and 22 recite similar abstract ideas as those recited in claims 3-4, 6, 9-10 and 21.
Furthermore, Claims 1, 3-4, 6, 9-16 and 18-22 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 computing device, database, user interface, an non-transitory computer readable mediums, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0025-0026], [0030], [0037], [0050] of the present Specification, see MPEP 2106.05(f).
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 [0025-0026], [0030], [0037], [0050] of the Specification discloses that the additional elements (i.e. computing devices, non-transitory storage mediums, user interface) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions 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 medical device and supply data on a database and/or electronic memory.
Dependent Claims 3-4, 6, 9-10, 12-16 and 18-22 include other limitations, but none of these functions are deemed significantly more than the abstract idea because there are not additional elements recited in the aforementioned dependent claims beyond those found in independent claims 1 and 11.
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, 3-4, 6, 9-16 and 18-22 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered. Examiner notes the Declaration 12/30/2025 has been considered and is addressed in the below response to arguments.
Claim Objections
The previous objections have been withdrawn in view of the claim amendments.
Claim Rejections – 35 U.S.C. § 112
The previous section 112 rejections have been withdrawn in view of the amendments.
Claim Rejections – 35 U.S.C. § 101
Applicant argues that the claims recite patent eligible subject matter as the claims are not abstract because the “invention is in a specialized technical field within healthcare and does not involve any agreements in the form of contracts, legal obligations, nor does it involve any advertising, marketing, sales activities or behavior, or business relations (Remarks, page 22).” The instant disclosure states that the “present invention relates to methods and systems to optimize the workflow of medical procedures, particularly, to identify and track the use and disposition of medical assets such as surgical supplies and medical devices used in medical procedures in healthcare facilities ([0001]).” Tracking inventory of surgical supplies and medical devices is for business purposes, which is abstract. The instant specification further states that “the present invention provides a method and system that can be used in various clinical settings to automatically identify parts and consumable medical devices and supplies during clinical workflows and track and manage their disposition in required systems using various optimization methods [0006]).”
The mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential) is not sufficient to show an improvement in computer functionality.
Applicant attempts to compare the instant claims to Example 42. However, Example 42 was eligible because the claims resulted in a technical solution to a technical problem. There is no such problem present in the instant application as alleged by Applicant or Declarant.
Applicant further asserts that the combination of elements integrate any abstract idea into a practical application (Remarks, pages 25-27), however, Applicant cites to portions of the abstract idea in doing so. The storing of data is an additional element, however, the other limitations argued are considered part of the abstract idea (such as alerting a user) or are not even claimed (such as standardizing the format of data).
The claims are automating a manual process. The number of people involved is irrelevant. The claims automate a manual process, which is following rules and instructions and organizing human behavior (even if its just one person’s behavior).
Applicant, citing the Declaration dated 12/30/25, asserts that the claimed invention “is in the technical field of preparing medical devices and supplies for medical procedures in healthcare facilities, which requires identifying and assembling thousands of different surgical tools, from simple scissors to complex robotic instruments and endoscopes for a medical procedure based on the knowledge and understanding of microbiology (to prevent healthcare-associated infections), anatomy, and the chemical interactions of various disinfectants as well as maintaining detailed electronic records and performing regular quality assurance tests to ensure medical devices and supplies are functioning correctly for the medical procedure.” Examiner maintains that this is not technical as it is related to the business providing healthcare. The devices recited in the claims, which are considered the additional elements, are not improved as a result of the claimed invention. The instant disclosure repeatedly cites to business reasons for the claimed invention being helpful, including “real time billing and logging inventory ([0071]),” “real time billing inventory management ([0072]),” and “real time, product utilization and [to] facilitate strategic resource allocation ([0073]),” all of which are business reasons, not technical ones as alleged in the affidavit. The specification even states “[s]ome operation rooms and procedures still rely on pencil and paper to record the use and disposition of the medical devices and supplies; and due to lack of prompt information sharing, there is a vast amount of information discrepancy among different departments within the healthcare facility and between the internal departments and outside healthcare facility.” The Declaration and its assertion of a technical solution to a technical problem does not have any nexus to the claimed invention or the disclosure as its fails to acknowledge any technical aspects. Examiner notes that although the technical problem does not have to be explicitly stated in the claims or the disclosure, it has to be apparent that the claim results in a technical improvement. See MPEP § 2106.04(d)(1). It is not apparent here because there is no technical problem present, so even if there was a technical solution, it would not be enough to result in a practical application.
Applicant argues “the claimed invention provides a technical solution to the technical problem in the examples of storing information in the identification database, operational database, computer algorithm, and grouping function (Remarks, page 30).” Storing data is well-understood, routine and conventional activity as indicated in MPEP 2106.05(II) and the above rejection. There is not a technical problem regarding the storing of data.
Applicants arguments and Declarant’s assertions repeatedly support Examiner’s position that the claims are directed towards organizing human activity. Applicant states that “in smaller sized healthcare facilities, certified professionals may not be available or affordable, and often the medical practitioners rely on nurse practitioners to prepare the medical devices and supplies for a medical procedure; many aspects of medical device and supply preparation remain highly manual and dependent on human memory, visual inspection, and paper or semi-digital checklists, making the process inherently error-prone.” This is a business problem, not a technical one as asserted. The claimed invention results in an improvement to the abstract idea rather than a technical one.
Applicant incorrectly asserts that the “findings in the Examiner's action further support that the additional elements of the claimed invention in combination are not conventional, well-known, or routinely conducted” when referencing the lack of an art rejection (Remarks, page 32).
Even if the abstract idea is novel and non-obvious, Examiner notes that lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101) and patentability over the art (under 35 U.S.C. 102 and/or 103) is further discussed in MPEP § 2106.05(d). See MPEP § 2106.05.
Applicant, citing to the USPTO Memorandum on August 4th, 2025, argues that the Examiner oversimplified the claimed invention as “the additional elements in combination in the claimed invention as set forth in the amended claim 1 provide detailed steps of carrying out the method of preparing and tracking medical devices and supplies with particularities, including the detailed structures and inter-communications (interfaces) of the asset tracking and scanning subsystems, the computer-readable identification and operational databases, the computer algorithm based on the logic and databases, and their connection with the electronic records outside the system and users through user interfaces” and that these “additional elements are not just directed to a desired outcome or an idea of a solution but concrete steps to carry out and achieve the purpose of the claimed invention (Remarks, pages 33-34).” Examiner did not oversimplify the claims as the abstract idea was taken directly from the claim language. Every limitation is considered and addressed. Applicant argues that portions of the abstract idea are not well-understood routine and conventional, which is not persuasive because the additional elements identified by the Examiner were either recited at an “apply it” or are explicitly listed in the MPEP as being well-understood, routine and conventional (the storing of data).
Applicant asserts “as the additional elements in the claimed invention are implemented through the computer, and at the same time, they are more than just a general purpose computer but requires the claimed specific software, computer algorithm, databases, interfaces (communication), and architecture or structure.” MPEP 2106.05(a)(II) states that a commonplace business method being applied on a general purpose computer may not be sufficient to show an improvement to technology, as is the case here. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions). If applicant amends a claim to add a generic computer or generic computer components and asserts that the claim recites significantly more because the generic computer is 'specially programmed' (as in Alappat, now considered superseded) or is a 'particular machine' (as in Bilski), the examiner should look at whether the added elements integrate the exception into a practical application or provide significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008). See MPEP § 2106.05(b)(I).
Applicant argues that claim 11 and its dependents are eligible for the same reason as claim 1 and its dependents. Examiner maintains the rejection for the same reasons as asserted above with respect to claim 1 and its dependents.
The claims remain rejected as being directed towards an abstract idea without a practical application or significantly more.
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