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 Amendment
Amendment received on 09/10/2025 is acknowledged and entered. Claims 2 have been canceled. Claims 1-13, 15, 20 and 23 have been amended. Claims 1-23 are currently pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2025 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claims 1, 13 and 23 are objected to, because
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 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In determining whether a claim falls within an excluded category, the Examiner is guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)); Bilski v. Kappos, 561 U.S. 593, 611 (2010); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019); the October 2019 Update of the 2019 Revised Guidance (Oct. 17, 2019); 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (July 17, 2024), and the USPTO’s Paten Subject Matter Eligibility Memorandums of August 4, 2025 and December 5, 2025.
Step 1
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability (i.e., laws of nature, natural phenomena, and abstract ideas). Alice Corp. v. CLS Bank Int'l, 573 U. S. ____ (2014).
The broadest reasonable interpretation of claim 1 encompasses a computer system (e.g., hardware such as a processor) that implements the recited operations. If assuming that the system comprises a device or set of devices, then the system is directed to a machine, which is a statutory category of invention.
Claim 13 is directed to a statutory category, because a series of steps for updating a historical record satisfies the requirements of a process (a series of acts).
Claim 23 is directed to a statutory category, because a non-transitory computer program product storing computer-readable instructions satisfies the requirements of a product. (Step 1: Yes).
(Step 1: Yes).
Next, the claim is analyzed to determine whether it is directed to a judicial exception.
Step 2A – Prong 1
For the purposes of examination, Examiner assumes that the method of claim 13 is performed by a processor.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of updating a historical record of a surgical system. The claim recites:
13. A method, performed by amanufacturer-sealed sterile surgical packaging containing a surgical instrument, wherein the manufacturer-sealed sterile surgical packaging comprises a radio frequency identification tag, and wherein the method comprises:
updating a historical record of the manufacturer-sealed sterile surgical packaging
based on at least one of regulatory information associated with a current location of the manufacturer-sealed sterile surgical packaging or a supply-chain progression of the manufacturer-sealed sterile surgical packaging;
determining handling instructions for the manufacturer-sealed sterile surgical packaging based on at least one of the regulatory information associated with the current location of the manufacturer-sealed sterile surgical packaging or the supply-
-chain progression of the manufacturer-sealed sterile surgical packaging; and
outputting, via the radio frequency identification tag, handling instructions for the manufacturer-sealed sterile surgical packaging.
The limitations of updating a historical record; determining handling instructions, and outputting the handling instructions, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity but for the recitation of generic computer components. (Note: Examiner’s language (e.g. “receiving location-related data”; “updating a historical record”; etc.) is an abbreviated reference to the detailed claim steps and is not an oversimplification of the claim language; the Examiner employing such shortcuts (that refer to more specific steps) when attempting to explain the rejection). That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind, and/or performed as organized human activity. Aside from the general technological environment (addressed below), it covers purely mental concepts and/or certain methods of organizing human activity processes, and the mere nominal recitation of a generic network appliance (e.g. an interface for inputting or outputting data, or generic network-based storage devices and displays) does not take the claim limitation out of the mental processes and/or certain methods of organizing human activity grouping.
Specifically, generating/updating data based on the received information - said functions could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., mental comparison regarding a sample or test subject to a control or target data in Ambry, Myriad CAFC, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (Grams)). In Grams, the recited functions require obtaining data or patient information (from sensors), and analyze that data to ascertain the existence and identity of an abnormality or estimated responses, and possible causes thereof. While said functions are performed by a computer, they are in essence a mathematical algorithm, in that they represent "[a] procedure for solving a given type of mathematical problem." Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). Moreover, the Federal Circuit has held, “without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Here, the claimed subject matter is directed to the abstract idea of manipulating existing information (e.g., “received location-related data”) to generate additional information (e.g., “handling instructions”). See id. Further, “analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, [are] essentially mental processes within the abstract-idea category.” Elec. Power, 830 F.3d at 1354; see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016). “[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
It is similar to other abstract ideas held to be non-statutory by the courts. See, also, CAFC Appeal No. 14-1773 - Increasing patient compliance with medical care instructions; Univ. of Utah Research Found. v. Ambry Genetics Corp. Also known as In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litigation; Mayo Collaborative Svcs. v. Prometheus Labs. 566 U.S. __, 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012), - Optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders; Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363 (Fed. Cir. 2015)—tailoring sales information presented to a user based on, e.g., user data and time data; and TLI Communications LLC v. AV Automotive LLC 823 F.3d 607, 118 U.S.P.Q.2d 1744 (Fed. Cir. 2016) - recording, transmitting and administering digital images.
As per receiving, storing and outputting data limitations, it has been held that “As many cases make clear, even if a process of collecting and analyzing information is ‘limited to particular content’ or a particular ‘source,’ that limitation does not make the collection and analysis other than abstract.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1168 (Fed. Cir. 2018) (citation omitted); see also In re Jobin, 811 F. App’x 633, 637 (Fed. Cir. 2020) (claims to collecting, organizing, grouping, and storing data using techniques such as conducting a survey or crowdsourcing recited a method of organizing human activity, which is a hallmark of abstract ideas).
All these cases describe the significant aspects of the claimed invention, albeit at another level of abstraction. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed. Cir. 2016) ("An abstract idea can generally be described at different levels of abstraction. As the Board has done, the claimed abstract idea could be described as generating menus on a computer, or generating a second menu from a first menu and sending the second menu to another location. It could be described in other ways, including, as indicated in the specification, taking orders from restaurant customers on a computer.").
Therefore, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes).
Step 2A – Prong 2
In Prong Two, the Examiner determines whether claim 13, as a whole, recites additional elements that integrate the judicial exception into a practical application of the exception, i.e., whether the additional elements apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the judicial exception. See Guidance, 84 Fed. Reg. at 54-55. If the additional elements do not integrate the judicial exception into a practical application, then the claim is directed to the judicial exception. See id., 84 Fed. Reg. at 54. “An additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” is indicative of integrating a judicial exception into a practical application. See Guidance, 84 Fed. Reg. at 55.
The Examiner determined that this judicial exception is not integrated into a practical application, because there are no meaningful limitations that transform the exception into a patent eligible application. In particular, the claim recites additional elements – using a processor to perform the steps of updating a historical record; determining handling instructions, and outputting the handling instructions. However, the processor in each step is recited (or implied) at a high level of generality, i.e., as a generic processor performing a generic computer functions of processing data, including receiving, storing, comparing, and outputting data. This generic processor limitation is nor more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). The processor that performs the recited steps merely automates these steps which can be done mentally or manually. Thus, while the additional elements have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." The claim only manipulates abstract data elements into another form, and does not set forth improvements to another technological field or the functioning of the computer itself and, instead, uses computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above.
Further, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, - their collective functions merely provide conventional computer implementation. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
The recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, comparing, storing and outputting data.
As per receiving, storing and/or outputting data limitations, these recitations amount to mere data gathering and/or outputting, is insignificant post-solution or extra-solution component and represents nominal recitation of technology. Insignificant "post-solution” or “extra-solution" activity means activity that is not central to the purpose of the method invented by the applicant. However, “(c) Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility”. See Bilski, 138 S. Ct. at 3230 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, ___ (1978)). Thus, claim drafting strategies that attempt to circumvent the basic exceptions to § 101 using, for example, highly stylized language, hollow field-of-use limitations, or the recitation of token post-solution activity should not be credited. See Bilski, 130 S. Ct. at 3230.
Thus, the claim as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these 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. Therefore, the claim is directed to an abstract idea. (Step 2A – Prong 2: No).
Step 2B
If a claim has been determined to be directed to a judicial exception under revised Step 2A, examiners should then evaluate the additional elements individually and in combination under Step 2B to determine whether the provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself).
The Examiner determined that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the steps of updating a historical record; determining handling instructions, and outputting the handling instructions amount to no more than mere instructions to apply the exception using a generic computer component. The claim is now re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field.
The claimed method would require a processor and memory in order to perform basic computer functions of receiving information, storing the information in a database, retrieving information from the database, comparing data, and outputting said information. These components are not explicitly recited and therefore must be
construed at the highest level of generality. Based on the Specification, the invention utilizes conventional communication networks, and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity. Specifically, regarding the recited functions, MPEP 2106.05(d)(II) defines said functions as routine and conventional, or as insignificant extra-solution activity:
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) (“The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.”); collecting and comparing known information in Classen 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
iii. Electronic recordkeeping, Alice Corp., 134 S. Ct. at 2359, 110 USPQ2d at 1984 (creating and maintaining “shadow accounts”); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
vi. A web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Thus, the background of the current application does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Also, the claim does not involve a non-conventional and non-generic arrangement of known, conventional pieces, as asserted, by receiving information from an external source of data. The receiving of data from an external source over a network, such as via the Internet, can fairly be characterized as insignificant extra-solution activity that does not receive patentable weight. See Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Similar to Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014): “And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular asserted inventive technology for performing those functions. They are therefore directed to an abstract idea. As such, the additional elements, considered individually and in combination with the other claim elements, do not make the claim as a whole significantly more than the abstract idea itself. Accordingly, a conclusion that the recited steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further, similar to Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016) (Power Group), claim’ invocation of computers, networks, and displays does not transform the claimed subject matter into patent-eligible applications. Claim 13 does not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and display functions on a set of generic computer components and display devices. Nothing in the claim, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Analogous to Power Group, claim 13 does not even require a new source or type of information, or new techniques for analyzing it. As a result, the claim does not require an arguably inventive set of components or methods, such as measurement devices or techniques that would generate new data. The claim does not invoke any assertedly inventive programming. Merely requiring the selection and manipulation of information - to provide a “humanly comprehensible” amount of information useful for users - by itself does not transform the otherwise-abstract processes of information collection and analysis into patent eligible subject matter. Merely obtaining and selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Therefore, the recited steps represent implementing the abstract idea on a generic computer, or “reciting a commonplace business method aimed at processing business information despite being applied on a general purpose computer” Versata, p. 53; Ultramerical, pp. 11-12.
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s) or the network elements. There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. Applicant did not invent a new type of computer; Applicant like everyone else programs their computer to perform functions. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does neither. The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, storing, comparing and transmitting data—see the Specification as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. “However, it is not apparent how appellant’s programmed digital computer can produce any synergistic result. Instead, the computer will simply do the job it is instructed to do. Where is there any surprising or unexpected result? The unlikelihood of any such result is merely one more reason why patents should not be granted in situations where the only novelty is in the programming of general purpose digital computers”. See Sakraida v. Ag. Pro, Inc., 425 U.S. 273 [ 96 S.Ct. 1532, 47 L.Ed.2d 784], 189 USPQ 449 (1976) and A P Tea Co. V. Supermarket Corp., 340 U.S. 147 [ 71 S.Ct. 127, 95 L.Ed. 162], 87 USPQ 303 (1950).
Moreover, there is no transformation recited in the claim as understood in view of 35 USC 101. The steps of updating a historical record; determining handling instructions, and outputting the handling instructions merely represent abstract ideas which cannot meet the transformation test because they are not physical objects or substances. Bilski, 545 F.3d at 963. Said steps are nothing more than mere manipulation or reorganization of data, which does not satisfy the transformation prong. It is further noted that the underlying idea of the recited steps could be performed via pen and paper or in a person's mind. Moreover, “We agree with the district court that the claimed process manipulates data to organize it in a logical way such that additional fraud tests may be performed. The mere manipulation or reorganization of data, however, does not satisfy the transformation prong.” and “Abele made clear that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium. Thus, merely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test”. CyberSource, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because, when considered separately and in combination, the claim elements do not add significantly more to the exception. Considered separately and as an ordered combination, the claim elements do not provide an improvement to another technology or technical field; do not provide an improvement to the functioning of the computer itself; do not apply the judicial exception by use of a particular machine; do not effect a transformation or reduce a particular article to a different state or thing; and do not add a specific limitation other than what is well-understood, routine and conventional in the operation of a generic computer. None of the hardware recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). As per “updating, with a surgical system, a historical record … based on at least one of a current geo-political location and a supply-chain progression of the surgical system” recitations, these limitations do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment, that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). Limiting the claims to the particular technological environment is, without more, insufficient to transform the claim into patent-eligible applications of the abstract idea at their core.
Accordingly, claim 13 is not directed to significantly more than the exception itself, and is not eligible subject matter under § 101. (Step 2B: No).
Further, although the Examiner takes the steps recited in the independent claim as exemplary, the Examiner points out that limitations recited in dependent claims 14-22 further narrow the abstract idea but do not make the claims any less abstract. Dependent claims 14-22 each merely add further details of the abstract steps recited in claim 13 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. These claims "add nothing of practical significance to the underlying idea," and thus do not transform the claimed abstract idea into patentable subject matter. Ultramercial, 772 F.3d at 716. Therefore, dependent claims 14-22 are also directed to non-statutory subject matter.
Because Applicant’s apparatus claims 1-12 and computer-readable storage product claim 23 add nothing of substance to the underlying abstract idea, they too are patent ineligi-ble under §101.
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 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 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bauss et al. (US 2019/0217018 A1) (IDS of 6/25/2024) in view of Mahmood (US 2022/0374807 A1.
Claims 1, 13 and 23. Bauss et al. (Bauss) discloses a method, performed by a manufacturer-sealed sterile surgical packaging containing a surgical instrument, wherein the manufacturer-sealed sterile surgical packaging comprises a radio frequency identification tag, Fig. 13; [0006] – [0009]; [0003]; [0009]; [0064], and wherein the method comprises:
updating a historical record of the manufacturer-sealed sterile surgical packaging
based on at least one of a current location of the manufacturer-sealed sterile surgical packaging or a supply-chain progression of the manufacturer-sealed sterile surgical packaging; [0037]; [0044]; [0061]; [0063]-[0064]; [0067]-[0070]
While Bauss discloses tracking the supply-chain progression of the surgical system [0045]; [0061]; [0064], Bauss does not specifically teach: determining handling instructions for the manufacturer-sealed sterile surgical packaging based on at least one of the regulatory information associated with the current location of the manufacturer-sealed sterile surgical packaging or the supply-chain progression of the manufacturer-sealed sterile surgical packaging; and outputting, via the radio frequency identification tag, handling instructions for the manufacturer-sealed sterile surgical packaging, which is disclosed in Mahmood. [0030]; [0034]; [0043]; [0052]; [0055]; [0056]; [0057]; [0065]; [0071]; [0074]; [0075]; [0081]; [0084]; [0085]; [0086]; [0091]. Mahmood further teaches update a historical record of the surgical package and/or the surgical instrument based on at least one of a current location and a supply-chain progression of the surgical system. [0074]; [0075]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bauss to include the recited limitations, as disclosed in Mahmood, because it would advantageously allow to mitigate issues related to regulatory compliance associated with labeling medical packages, and tracking personal patient information during handling said packages, as specifically stated in Mahmood. [0007]
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bauss to include the recited limitations, as disclosed in Mahmood, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Claims 2 and 14. The method of claim 13, wherein the handling instructions include information characterizing at least one of historic states, future states, and operational information. Bauss; [0064]; Mahmood; [0057]; [0065]; [0071]; [0074]; [0075]; [0085]; [0086]. Same rationale as applied to claims 1 and 13.
Claims 3 and 15. The method of claim 14, wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information, and environmental information experienced by the manufacturer-sealed sterile surgical packaging. Bauss; [0037]; [0044]; [0061]
Claims 4 and 16. The method of claim 14, wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedures information. Bauss; [0064]; Mahmood; [0057]; [0065]; [0071]; [0074]; [0075]; [0085]; [0086]. Same rationale as applied to claims 1 and 13.
Claims 5 and 17. The method of claim 14, wherein the operational information includes at least one of product compatibility information, expected lifecycle information, and operational instructions. Bauss; [0064]
Claims 6 and 18. The method of claim 13, further comprising providing, based on an on-demand user request, at least a portion of the historical record. Bauss; [0064]
Claims 7 and 19. The method of claim 18, wherein the on-demand user request is authenticated prior to providing the at least a portion of the historical record.
Mahmood; [0010]; [0011] Same rationale as applied to claims 1 and 13.
Claims 8 and 20. The method of claim 13, wherein the handling instructions are provided via a display located on the manufacturer-sealed sterile surgical packaging.
Bauss; [0064]; Mahmood; [0057]; [0065]; [0071]; [0074]; [0075]; [0085]; [0086]. Same rationale as applied to claims 1 and 13.
Claims 9 and 21. The method of claim 13, wherein the handling instructions include a list of one or more surgical items for a surgical procedure involving the surgical instrument. Mahmood; [0057]; [0065]; [0071]; [0074]; [0075]; [0085]; [0086]. Same rationale as applied to claims 1 and 13.
Claim 10. The manufacturer-sealed sterile surgical packaging of claim 1, wherein the handling instructions are transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging. Mahmood; [0057]; [0065]; [0071]; [0074]; [0075]; [0085]; [0086]. Same rationale as applied to claims 1 and 13.
Claim 11. The manufacturer-sealed sterile surgical packaging of claim 1, wherein the handling instructions are displayed on at least one display disposed on the manufacturer-sealed sterile surgical packaging. Bauss; Fig. 13.
Claim 12. The manufacturer-sealed sterile surgical packaging of claim 11, wherein the at least one display comprises at least one e-ink label. Mahmood; [0045]; [0046] Same rationale as applied to claims 1 and 13.
Claim 22. The method of claim 21, further comprising transmitting at least one message indicating the absence of at least one of the one or more surgical items. Bauss in view of Mahmood discloses a surgical system configured to transmit messages related to a surgical package. As per the nature of the messages itself (i.e. indication of the absence of at least one of the one or more surgical items) does not create a patentable distinction because the data itself is non-functional descriptive material (i.e. the data itself does not change the actual process being performed; In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 403-04 (Fed. Cir. 1983). In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). Accordingly, the content of the message is a distinction of non-function descriptive material, and therefore obvious.
Response to Arguments
Applicant's arguments filed 09/10/2025 have been fully considered but they are not persuasive.
Applicant argues that the present claims cannot be performed in the human mind, and therefore does not recite a mental process. For example, claim 1 recites a manufacturer-sealed sterile surgical package and a method performed thereby. Furthermore, the claims as amended recite that the handling information is transmitted via a radio frequency identification tag.
The Examiner respectfully disagrees, and maintains that claim limitations, as currently recited in the amended claims, are directed to a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity but for the recitation of generic computer components. And the mental processes remain unpatentable even when automated to reduce the burden on the user of what once could have been done with pen and paper. CyberSource Corp. at 1375 (“That purely mental processes can be unpatentable, even when performed by a computer, was precisely the holding of the Supreme Court in Gottschalkv. Benson, [409 U.S. 63 (1972)].”).
For example, regarding the updating and determining steps, - in Content Extraction & Transmission LLC v. Wells Fargo Bank, National Ass’n, Nos. 13-1588,-1589, 14-1112, -1687 (Fed. Cir. Dec. 23, 2014) the Federal Circuit affirmed that such limitations - parsing and extracting the data - were generally directed to “the abstract idea of 1) collecting data, 2) recognizing certain data within the collected data set, and 3) storing that recognized data in a memory.” The Court explained that ”[t]he concept of data collection, recognition, and storage is undisputedly well-known,” and noted that “humans have always performed these functions.” Id. The Court then rejected CET’s argument that the claims were patent eligible because they required hardware to perform functions that humans cannot, such as processing and recognizing the stream of bits output by the scanner. Comparing the asserted claims to “the computer-implemented claims in Alice,” the Court concluded that the claims were “drawn to the basic concept of data recognition and storage,” even though they recited a scanner. Id. at 8. Mental processes, (e.g., parsing and extracting data) as recited in claim 1, remain unpatentable even when automated to reduce the burden on the user of what once could have been done with pen and paper. CyberSource Corp. at 1375 (“That purely mental processes can be unpatentable, even when performed by a computer, was precisely the holding of the Supreme Court in Gottschalkv. Benson, [409 U.S. 63 (1972)].”).
Even accepting Applicant’s argument regarding the hardware used, it also is insufficient, without more, to establish patent eligibility that “[t]he human mind is not equipped to execute the claimed method”. Although “a method that can be performed by human thought alone is merely an abstract idea and is not patent-eligible under § 101,” CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1373 (Fed. Cir. 2011), it does not automatically follow that methods requiring physical components, i.e., methods that arguably cannot be performed entirely in the human mind, are, therefore, not directed to abstract ideas. See, e.g., In re TLI Commc'ns LLC Patent Litig., 823 F.3d
607, 611 (Fed. Cir. 2016) (“[N]ot every claim that recites concrete, tangible components escapes the reach of the abstract-idea inquiry.”); FairWarning IP, LLC v. Latric Sys., Inc., 839 F.3d 1089, 1098 (Fed. Cir. 2016) (“[T]he inability for the human mind to perform each claim step does not alone confer patentability.”).
Applicant further argues that even if one assumes that the claims recite a judicial exception, they still recite a practical application, because amended claim 1 covers an improvement to surgical technology. For example, the specification explains that tracking and providing handling instructions … improves the chances of the surgical instrument complying with relevant regulations.’, and can improve performance and efficiency.
The Examiner respectfully disagrees. Further, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, - their collective functions merely provide conventional computer implementation. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. Applicant did not invent a new type of computer; Applicant like everyone else programs their computer to perform functions. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does not represent improvement in technology. The claimed invention merely utilizes conventional computing and network elements for transmitting and storing data. Thus, the current application’ solution to the problem of providing handling instructions is not technological, but “business solution”, or “entrepreneurial. Accordingly, claim 1 does not provide a specific means or method that improves the relevant technology, but, instead, is directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery.
Applicant further argues that Bauss does not disclose “determine[ing] handling instructions for the manufacturer-sealed sterile surgical packaging based on at least one of the regulatory information associated with the current location of the manufacturer-sealed sterile surgical packaging or the supply-chain progression of the manufacturer-sealed sterile surgical packaging” either.
The Examiner notes that the recited limitations are disclosed in Mahmood at [0030]; [0034]; [0043]; [0052]; [0055]; [0056]; [0065]; [0081]; [0084]; [0086]; [0091].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
The prior art search has been conducted, with no significant prior art found.
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 extension fee 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.
/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 12/12/2025
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