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 .
Status of Claims
This action is in reply to the amendment filed on 11/10/25.
Claims 1, 21, 25 have been amended and are hereby entered.
Claim 18 has been canceled.
Claims 2, 9, 10, 14, 16, 20, 22 were previously canceled.
Claims 1, 3-8, 11-13, 15, 17, 19, 21, 23-25 are currently pending and have been examined.
This action is made final.
Foreign Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. BR 10 2021 005819-6, filed on 03/25/21, and parent Application No. BR 10 2020 0021049 1, filed on 10/14/2020. Accordingly, a priority date of 10/14/2020 has been given to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8, 11-13, 15, 17, 19, 21, 23-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended recitations of “if a negative confirmation (7B) is provided, an indication to repeat the collection step which resulted in the negative confirmation is displayed on the screen of the first device” within Claims 1, 21, 25 appear to constitute new matter. In particular, Applicant does not point to, nor was Examiner able to find support for this newly added language within the specification as originally filed. As such, Applicant is respectfully requested to clarify the above issues and to specifically point out support for the newly added limitations in the originally filed spec and claims.
The specification discloses, at para. [0137] as published, “Furthermore, and in reference to FIG. 7, after each of the collection steps has been performed, a confirmation step can be displayed to the user, so that, with a positive confirmation 7A (the step was properly performed), the next collection step will be displayed on the first device 10. If the operator indicates a negative confirmation 7B (the step was not correctly performed), said step must be performed again”. Figure 7 shows an image of a mobile device with “FIRST COLLECTION” and “5ml tube purple cap” and icons 7A and 7B, respectively indicating a thumbs up or thumbs down for positive or negative confirmation. The specification and drawings do not appear to disclose that an indication to repeat the collection step resulting in the negative confirmation is displayed on the screen; indication of a thumbs up or down is not the same as “indicating” that a collection step must be performed again.
Dependent Claims 3-8, 11-13, 15, 17, 19, 23, 24 are subsequently rejected as they inherit the deficiencies of their respective parent claims.
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, 3-8, 11-13, 15, 17, 19, 21, 23-25 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1, 3-8, 11-13, 15, 17, 19, 25 are drawn to a method, Claim 21 is drawn to a system, Claim 23 is drawn to a non-transitory computer-readable medium, and Claim 24 is drawn to a computer readable memory (interpreted as non-transitory per [0024] specification), each of which are within the four statutory categories. Claims 1, 3-8, 11-13, 15, 17, 19, 21, 23-25 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recite implementing the steps of:
performing a dispatch reading (LD) of a set of medical technology products, the medical technology products comprising a plurality of medical technology products each being provided with a product identifier code (2), the product identifier code comprising at least one of: a medical technology product description data (DDESCR), a medical technology product batch data, or a medical technology product expiration date (DExr), wherein the dispatch reading (LD) is held at a point of origin, wherein the point of origin is configured as a manufacturer of the set of medical technology products
performing a receipt reading (LR) of the set of medical technology product, wherein the receipt reading (LR) is held at a destination point, wherein the destination point is a health care setting of a network of health care settings, wherein the network of health care settings comprises a plurality of health care settings,
in a health care settings of the network of the heath care settings, linking the product identifier code of each medical technology product to a patient's identifier code (C),
generating a plurality of indicators (Io,IG) from the step of linking the product identifier code (2) of each medical technology product to a patient's identifier code (4), wherein the indicators are associated with an operator of the health care setting and a manager of the network of the health care settings, wherein the indicator to the operator of the health care setting (Io) is displayed in a first environment (10) and, the indicator to the manager of the network of the health care settings is displayed in a second environment (20) (Examiner prospectively notes that “first environment” and “second environment” are included in the scope of the abstract idea, as the broadest reasonable interpretation is understood to be a first paper form which displays an indicator to the operator, and a second paper form which displays an indicator to the manager);
providing access to the second environment (20) so the manager of the network of the health care settings can visualize the indicator to the manager of the network of the health care settings, wherein the indicator to the manager of the network of the health care settings is updated in real time based on the step of linking the product identifier code (2) of each medical technology product to a patient's identifier code (4), wherein the step of linking the product identifier code of each medical technology product to a patient's identifier code (C) further comprises the step of reading the product identifier code (B) of each medical technology product, wherein the step of reading the product identifier code (B) of each medical technology product further comprises the step of comparing the medical technology product expiration date with a current date (BI), wherein the step of comparing the medical technology product expiration date (DExr) with a current date (DCURRENT) results in a status of compliance or a status of non-compliance, so that: if a status of non- compliance is obtained, the method further comprises the steps of:
displaying an error message in the first environment (10), and displaying a warning to the manager of the network of the health care settings in the second environment (20), and wherein the step of linking the product identifier code of each medical technology product to a patient's identifier code (C) further comprises the steps of:
generating a plurality of sets of consolidated data (Dc) at each health care setting that each includes a combination of information contained in the product identifier code (2) and the patient's identifier code (4), along with information on a place and date when the link between the product and the patient's identifier code was generated and on the collection step conducted at that time, and
generating a collection sequence (Sc) to the health care setting operator and displaying the collection sequence (Sc) in the first environment, wherein the collection sequence has a plurality of collection steps, wherein in each collection step, a test data (DTEST) and the medical technology product description data (DDESCR) are displayed in the first environment, and
displaying a confirmation step in the first environment after each collection step has been performed, wherein, in response to the confirmation step, the user may provide a positive confirmation (7A) or a negative confirmation (7B), wherein if the positive confirmation (7A) is provided, the next collection step of the collection sequence (Sc) is displayed in the first environment, and if a negative confirmation (7B) is provided, an indication to repeat the collection step which resulted in the negative confirmation should be performed again is displayed in the first environment,
based on the plurality of sets of the generated consolidated data (Dc), correlating a plurality of medical technology products with a plurality of patients and generating, in the first environment, an indication of all links between the plurality of medical technology products and the plurality of patients performed on a specific day or period,
based on the plurality of sets of the generated consolidated data (Dc),generating and displaying a test panel (PE) to the health care setting manager in a second area of the second environment, wherein the test panel (PE) correlates data: referring to a health care setting unit where the link was generated, referring to a test performed (DTEST). and referring to a number of tests performed for a given health care setting unit (NTEST), considering the specific day or period, and wherein generation and display of the test panel (PE) enables management of replenishment and stock of each of the plurality of medical technology products.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Performing a dispatch reading and receipt reading of medical technology products, e.g., viewing and hand- recording a product identifier code; linking the product identifier code to a patient’s identifier code within health care settings; generating indicators to display to an operator and a manager, wherein the indicator may be updated based on linking each product identifier code to a patient’s code; comparing each product expiration date with a current date to determine a status of compliance or non-compliance, and displaying an error/warning when a non-compliance status occurs; combining different data types to create consolidated data; providing a collection sequence to the operator to follow; displaying a confirmation step which requires a negative or positive confirmation, and subsequently displaying a next collection step in response to a positive confirmation or providing instructions to repeat a collection step in response to a negative collection; using the consolidated data to correlate a plurality of medical technology products and generating an indication of links between the plurality of products and patients performed on a particular day/period, are all personal behaviors that may be performed by healthcare providers or clinical laboratory technicians. Regarding limitations pertaining to recitation of “link(s)” and “linking”, the broadest reasonable interpretation in the context of the claim, e.g., of “linking” a product code to a patient identifier code, or, generating an “indication of links” between plurality of products, etc. is understood to be recording the various data (patient/product codes) in a spreadsheet or list format to indicate which product code is associated with a particular patient code. Examiner interprets “indication of links” to be providing all of the various linked data in spreadsheet or table format. Recording data in a spreadsheet/table format to show associations between different types of data is a personal behavior that could be performed by a healthcare provider or laboratory technician.
Claims 21, 23, 24 and 25 recites the same or substantially similar limitations as Claim 1. Examiner prospectively notes that Claim 25 recites “during handling of the medical products” prior to the limitation pertaining to performing a dispatch reading of the set of medical technology products, and submits that this would be within the scope of the abstract idea as it is merely defining a time when the steps of the abstract idea are performed. Claims 21, 23, 24 and 25 recite an abstract idea under the same analysis as Claim 1.
Claims 1, 21, 23-25 are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
providing remote access as the means by which the manager of the network of the healthcare settings can visualize the indicator (Claims 1, 21, 23-25)
a first device comprising an optical instrument / optical instrument of a first device as implementing the step of reading the product identifier code of each medical technology product and comparing the medical technology product expiration date with a current date (Claim 21) and as implementing the steps of linking the product identifier code of each medical technology product to a patient’s identifier code and reading the product identifier code (Claim 25)
a screen of the first device as implementing the steps of displaying various information, including the collection sequence, a confirmation message, a next step of collection sequence, instructions to repeat a collection step resulting in a negative confirmation, an error message, an indication of links between the plurality of medical technology products and patients performed on a specific day or period (Claims 1, 21, 23-25)
a non-transitory computer-readable medium, the readable medium being characterized in that it stores instructions, which instructions when executed by a processor as implementing the steps of the abstract idea (Claim 23)
computer readable memory containing instructions as implementing the steps of the abstract idea (Claim 24)
a processor as implementing the steps of linking the product identifier code (2) of each medical technology product to a patient's identifier code (4), wherein said linking is done in the health care setting of the network of the health care settings, and generating a plurality of indicators (Io, IG) from the link between the product identifier code (2) of each medical technology product and the patient's identifier code (Claims 21) and as implementing the steps of generate a plurality of indicators (Io, IG), wherein the indicators are associated with an operator of the health care setting and a manager of the network of the health care settings, wherein the indicator to the operator of the health care setting (Io) is displayed in a first environment (10) and, the indicator to the manager of the network of the health care settings is displayed in a second environment (20), wherein the second environment (20) can be remotely accessed by the manager of the network of the health care settings, so the manager of the network of the health care settings can visualize the indicator to the manager of the network of the health care settings, wherein the indicator to the manager of the network of the health care settings is updated in real time based on the linking of the product identifier code (2) of each medical technology product to a patient's identifier code (4) and comparing the medical technology product expiration date with a current date (B1) (Claim 25)
a screen of the second device as implementing the steps of providing access to a manager of the network of healthcare settings, displaying a warning message to the manager, and displaying a test panel to the health care setting manager
The broad recitation of general purpose computing elements such as a first device and non-transitory CRM only amount to mere instructions to implement the abstract idea using computing components as tools. Per [0094], the “first device” and “second device” are understood to be a cell phone functioning in its ordinary capacity to implement the steps of the abstract idea. Regarding recitation of “remote” access, this merely amounts to using computers to apply the abstract idea, e.g., paras. [0103] teaches on transmitting data between electronic devices through a “network protocol or any protocol that allows one to send/receive data”. No particulars of the remote access or networks are provided; as such, these elements are given their broadest reasonable interpretation as general purpose computing elements functioning in their ordinary capacity to implement the steps of the abstract idea. Regarding the non-transitory CRM, per specification [0024], this is understood to be a general purpose computing element functioning in its ordinary capacity to implement the steps of the abstract idea. Regarding the computer readable memory containing instructions, per paras. [0194], [0210], this is understood to be a general purpose computing element functioning in its ordinary capacity to implement the steps of the abstract idea. Regarding the optical instrument, per [0195], this is understood to be the camera of the first device, which is understood to be a cell phone per [0144], which is understood to amount to a cell phone functioning in its ordinary capacity to read an identifier code using its camera. Regarding the processor, per paras. [0151], [0197], this is understood to be a general purpose computer processor functioning in its ordinary capacity to implement the steps of the abstract idea.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Claims 1, 21, 23-25 additionally recite:
distributing the plurality of medical technology products to the plurality of health care settings of the network of health care settings
automatically and periodically transmitting the plurality of sets of the generated consolidated data (Dc), along with an indication of correlations based thereon, from each one of the first devices to the manager of the network of the health care settings in the second device (20).
As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the function of distributing the plurality of medical products to the plurality of healthcare settings is only nominally or tangentially related to the abstract idea (as set forth in Step 2A Prong 1). The function of automatically and periodically transmitting the plurality of sets of the generated consolidated data (Dc), along with an indication of correlations based thereon, from each one of the first devices to the manager of the network of the health care settings in the second device (20), only amounts to insignificant extra-solution activity in the form of post-solution activity, as it is merely outputting (transmitting) data after performance of the abstract idea.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Claims 1, 21, 23-25, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1, 21, 23-25 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the step of distributing the plurality of medical technology products to the plurality of health care settings of the network of health care settings only amounts to insignificant extra-solution activity as it is only tangentially or nominally related to the process of tracking medical products through their lifecycle. (This step has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field of computerized healthcare. See C. below.)
Likewise, as explained above, the step of automatically and periodically transmitting the plurality of sets of the generated consolidated data (Dc), along with an indication of correlations based thereon, from each one of the first devices to the manager of the network of the health care settings in the second device (20) only amounts to insignificant extra-solution activity in the form of insignificant application, as it only amounts to outputting a result after performance of the abstract idea.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity the elements in Section B
above constitute well-understood, routine and conventional activity.
As discussed above, the step of distributing the plurality of medical technology products to the plurality of health care settings of the network of health care settings only amounts to insignificant extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. As evidenced by the prior art of record, distributing medical technology products to a plurality of healthcare settings is a well-understood, routine, and conventional element in the field of computerized healthcare (see US Publication 20200098457A1 at Paras. [0035], [0046], [0794]), see US Publication 20150161558A1 at Para. [0025], see US Publication 20080217391A1 at paras. [0144], [0168]). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The step of automatically and periodically transmitting the plurality of sets of the generated consolidated data (Dc), along with an indication of correlations based thereon, from each one of the first devices to the manager of the network of the health care settings in the second device (20), only amounts to transmitting/receiving data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, Claims 3-8, 11, 13, 17 recite limitations which further narrow the scope of the independent claims. Claims 11, 12, 15, 19 further recites limitations that are certain methods of organizing human activity and/or are certain methods of organizing human activity. Recitation of general purpose computing elements in these claims only amounts to mere instructions to apply the abstract idea. MPEP 2106.05(f).
Dependent claims 3-8, 11-13, 15, 17, 19 have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of their respective independent claims. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Regarding recitation of “control panel” in Claim 19, this is understood to amount to using a general purpose computing device to implement the steps of the abstract idea and display information, e.g., graphical indicator correlating a time period, links generated and medical technology product. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 3-8, 11-13, 15, 17, 19 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claims 1, 21, 23-25 above. As discussed above with respect to independent claims and integration of the abstract idea into a practical application, recitation of these additional elements only amounts to invoking computing elements operating in their ordinary capacities as tools to perform the abstract idea. 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.
Dependent claims 3-8, 11-13, 15, 17, 19 when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1, 3-8, 11-13, 15, 17, 19, 21, 23-25 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
Claim Objections
The objections to claims 1, 21, 25 are withdrawn in view of Applicant’s amendments to the claims.
112(a) Rejections
Applicant does not provide specific arguments regarding the 112(a) rejection of Claims 1, 21 and 25, but rather remarks that the amendments fully address and overcome all the claim written description and indefiniteness issues (page 13). This is not persuasive; Examiner respectfully disagrees. Regarding the limitation “if a negative confirmation (7B) is provided, an indication to repeat the collection step which resulted in the negative confirmation is displayed on the screen of the first device (10)”, Examiner submits that the specification as originally filed fails to provide adequate disclosure of displaying, on the screen, “an indication to repeat the collection step which resulted in the negative confirmation”. The specification discloses, at para. [0137] as published, “Furthermore, and in reference to FIG. 7, after each of the collection steps has been performed, a confirmation step can be displayed to the user, so that, with a positive confirmation 7A (the step was properly performed), the next collection step will be displayed on the first device 10. If the operator indicates a negative confirmation 7B (the step was not correctly performed), said step must be performed again”. Figure 7 shows an image of a mobile device with “FIRST COLLECTION” and “5ml tube purple cap” and icons 7A and 7B, respectively indicating a thumbs up or thumbs down for positive or negative confirmation. The specification and drawings do not appear to disclose that an indication to repeat the collection step resulting in the negative confirmation is displayed on the screen; Examiner submits that indication of a thumbs up or down is not the same as “indicating” that a collection step must be performed again. The specification only discloses that the operator can indicate a negative confirmation, it does not disclose anything that happens subsequent to receipt of the negative confirmation, e.g. the screen displaying an indication to repeat the step again.
The 112(a) rejections of Claims 1, 21, 25 and corresponding dependent claims are maintained.
112(b) Rejections
The 112(b) rejections of Claims 1, 21, 25 and corresponding dependent claims are withdrawn in view of applicant’s amendments to the claims.
101 Rejections
Applicant’s remarks have been fully considered but are not persuasive. Regarding remarks at page 14-15, Examiner respectfully disagrees. MPEP 2106.04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). As shown above in the main 101 analysis section, Examiner has provided a detailed breakdown of which limitations fall within the scope of the abstract idea and explained how the steps are directed to certain methods of organizing human activities, specifically managing personal behavior of hospital staff or clinical laboratory technicians in tracking inventory samples. Applicant remarks, at page 14, “The improved techniques are not directed to management of personal behavior or relationships, including "Commercial or Legal Interactions (Including Agreements in the form of Contracts; Legal Obligations; Advertising, Marketing, or Sales Activities or Behaviors; Business relations)" as defined by the Manual of Patent Examining Procedure ("MPEP"), § 2106 and, even if they are, they are directly applied to improve the consolidation of data to achieve simultaneous and/or real-time validation of multiple tests using medical technological products disposed at different locations, with restrictions upon advancement to subsequent collection steps if a negative confirmation is indicated, but also to generate a test panel report that correlates specific data to enable efficient, effective, and accurate management of product replenishment and stock. Unintentional repetition is also avoided due to the elimination of redundant events and/or key collisions (i.e., two records trying to use the same unique identifier).”. Examiner respectfully submits that any purported improvements may improvements to the abstract idea itself, e.g., “consolidation of data to achieve simultaneous/real-time validation of multiple tests” is abstract, as is displaying a test report correlating specific data to enable efficient and effective management of product replenishment and stock. Please see MPEP 2106.05(a) which states, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” Generating and displaying data that is time period scoped may provide an improvement to the abstract idea but is not a technological improvement per MPEP 2106.05(a) as the improvement is not provided by the additional elements. Examiner respectfully submits that by limiting data to be generated/displayed to a particular time period, the amount of data parsing, memory usage and CPU usage is necessarily reduced. Applicant has not provided, nor can Examiner find evidence of, how any of the additional elements identified above in main 101 analysis section are providing an improvement over prior art systems. The additional elements are all understood to be general purpose computing components functioning in their ordinary capacities to implement the steps of the abstract idea.
Regarding remarks at page 15 and “the claimed configuration is not merely focused on product distribution but also tracking of the products from the manufacturer throughout, an element that is simply not well-understood, routine, or conventional”, Examiner submits that features cited by Applicant are within the scope of the abstract idea and not additional elements. The well-understood, routine or conventional analysis only applies to additional elements. This argument is not persuasive.
Regarding remark that the claimed configuration cannot be performed “by a person”, Examiner respectfully submits that for an abstract idea to be classified as Certain Methods of Organizing Human Activity, there is no requirement that the claims steps must be performed by “a person”, e.g., one singular person. One sub-grouping of Certain Methods of Organizing Human Activity is “managing personal behavior or relationships or interactions between people”, e.g., plural persons. Examiner submits that multiple people across multiple sides could perform the claimed steps. This argument is not persuasive.
Regarding remarks at bottom of page 15-16 pertaining to multiple health units in a network, as discussed above, Examiner submits that certain methods of organizing human activity including managing personal behavior or relationships or interactions between people is not limited to the activity of a single person. Regarding health units HS1-HS7, merely positioning the healthcare facilities (e.g., health “units”) in different locations from each other does not preclude the claims from being directed to certain methods of organizing human activity, as the steps of tracking products at each individual site could be performed by a respective individual at that site. This argument is not persuasive.
Regarding distribution of the products, e.g., the figure presented at bottom of page 16, Examiner submits that the link between products and patients being carried out simultaneously in different locations falls within the scope of the abstract idea, e.g., each individual site records the patients and products that are associated within that site. Applicant has not identified any additional elements to amount to “significantly more”, and as such, these remarks are not persuasive.
Regarding remarks at page 17 directed to USPTO’s 2024 Guidance and McRO, Examiner respectfully disagrees that the instant claims are analogous. McRO was determined to be eligible because the claims allowed a computer to perform 3-D lip-syncing animation using a new morph weight algorithm that allowed the computer to perform animation tasks that only a human could previously perform. In McRO, the claimed invention recited a very specific set of rules that allowed a computer to perform animation in a manner that was previously only performable by human animators. The very fact that the animation could not be previously performed by computers and that the rules applied by the claimed invention solved this problem was the reason the claimed invention in McRO was found to be not directed to an abstract idea. Here, there is no evidence on record that establishes that the claimed invention was only previously performable by humans in the manner of McRO. Examiner respectfully submits that unlike McRO, the instant claims do not recite a set of rules; nor do the claims recite utilizing a range data structure that provides an improvement to data storage and transmission. This argument is not persuasive.
Regarding remarks at bottom of page 18 continuing to page 19, regarding Step 2A Prong 1/MPEP 2106.04(a)(2)(II) and amended claim language, as stated above, the instant invention may provide an improvement to the abstract idea itself (e.g., tracking of hospital supplies) but is not a technological improvement per MPEP 2106.05(a) as discussed above, as the additional elements do not provide the improvement. Examiner respectfully submits that the features of the claim to which Applicant cites have all been identified as being within the scope of the abstract idea. The additional elements (e.g., a screen of a second device) are only recited at a high level of generality and amount to mere instructions to apply the abstract idea as discussed above with respect to Claim 1. This argument is not persuasive.
Regarding the list of examples of certain methods of organizing human activity cited at page 19-20, Applicant remarks “Claim 1 is not directed to any of the above”. The examples presented are merely that – non-limiting examples; and are not an all-inclusive list. This argument is not persuasive. Please see above remarks regarding characterization of the abstract idea as certain methods of organizing human activity.
Regarding remarks at page 20 directed to Step 2A Prong 2 and improvement of the functioning of a computer or improving another technology or technical field, Examiner respectfully disagrees with Applicant’s position that the combination of additional elements integrate the judicial exception into a practical application. Applicant remarks, “The claimed configuration includes several features that integrate any alleged judicial exception into a practical application, such as by improving the functioning of a computer” and cites to amended Claim 1. Applicant has identified limitations in their entirety and has not distinguished the additional elements from the abstract idea. Examiner submits that “features” that provide improvements are not sufficient to provide a technological improvement, unless the “features” are additional elements. As shown above in 101 section, the additional elements are recited at a high level of generality and are understood to be general purpose computing elements functioning in their ordinary capacity to implement steps of the abstract idea, which is not sufficient to provide a technological improvement. Regarding the amended imitations presented by Applicant at page 21, e.g., “generating and displaying a test panel…”, this falls within the scope of the abstract idea, as it amounts to data processing/analysis and display/output that could be performed by a person. The only additional elements in the limitations cited by Applicant here appear to be “screen of second first device”, which only amounts to using an electronic device screen to display information (“Apply it”, MPEP 2106.05(f)); and is not sufficient to integrate the judicial exception into a practical application. Examiner submits that “consolidation of data” and “simultaneous and/or real-time validation of multiple tests using medical technological products disposed at different locations” are within the scope of the abstract idea and as such, do not integrate the judicial exception into a practical application. This argument is not persuasive.
Applicant further remarks, at page 21, “Moreover, the claims are primarily focused on structure for correlating data and making tangible decisions based thereon; thus, not an attempt to claim any raw judicial exception. These improvements are, for example, leveraged to address a technical challenge unique to validation of multiple tests using medical technological products disposed at different locations- increasing the efficiency with which the stored data can be accessed and transferred while also enabling real-time replenishment of stocked products without delay.” However, Applicant has not cited to any evidence in specification of improvements to data storage structures; any improvements appear to be directed to the abstract idea itself. Regarding specification citations provided at pages 22-25, Examiner respectfully disagrees that these provide evidence of a technological improvement to data storage structures or efficiency of stored data access/transfer. For example, para. [0102] only pertains to data processing, e.g. generation of “consolidated data”. Using a processor to read the consolidated data ([0103]) only amounts to mere instructions to apply the abstract idea on a general purpose computing device, e.g., using the processor to read data. Examiner is unable to find evidence of improvements to data structures or stored data access/transfer in any of the cited paragraphs. Regarding remark at page 25, “As explained in the Specification as filed and as discussed above, the improved techniques recited allow for simultaneous validation of multiple tests using medical technological products disposed at different locations with improved accuracy and efficiencies”, Examiner respectfully submits that Applicant appears to be arguing a particular interpretation of the intended use of claims, as the instant claims do not appear to be directed to simultaneous validation of multiple tests; nor does the specification appear to disclose this as an improvement. Regarding “multiple” instances or sets of data being generated, Examiner submits that this falls within the scope of the abstract idea. Moreover, Applicant has not demonstrated how the claimed system actually improves accuracy and efficiencies. Regarding remark, “a tangible improvement to any computer utilizing the data storage and display techniques of claim I instead of other processing techniques”, Examiner respectfully disagrees. Applicant has not provided, nor can Examiner find, evidence in the specification how the claimed invention provides improvements to a computer itself, including storage or display techniques.
Examiner prospectively notes the following paragraphs from the background of instant specification:
[0007] However, the current state of the art does not disclose an effective means to track collection tubes used in hospital settings.
[0008] More specifically, the state of the art does not disclose any means to manage the large amount of collection tubes used in hospital settings, so that, in some instances, expired collection tubes are still kept in use, because there is no way to manage, control and track the use of said tubes in hospital settings.
[0009] The present invention describes a methodology and system capable of managing and tracking collection tubes (or any other medical technology product) used in health care settings.
As described the specification, it appears that the inventive concept and improvement are to managing and tracking collection tubes, and not to data storage structures or computer functioning. As previously stated, improvements to managing and tracking collection tubes in healthcare settings may provide an improvement to the abstract idea itself – e.g., an improved way of managing and tracking collection tubes – but are not technological improvements per MPEP 2106.05(a). These arguments are not persuasive.
Regarding remarks to McRO at bottom of page 21, Examiner respectfully disagrees that the instant claims are analogous. McRO was determined to be eligible because the claims allowed a computer to perform 3-D lip-syncing animation using a new morph weight algorithm that allowed the computer to perform animation tasks that only a human could previously perform. In McRO, the claimed invention recited a very specific set of rules that allowed a computer to perform animation in a manner that was previously only performable by human animators. The very fact that the animation could not be previously performed by computers and that the rules applied by the claimed invention solved this problem was the reason the claimed invention in McRO was found to be not directed to an abstract idea. Here, there is no evidence on record that establishes that the claimed invention was only previously performable by humans in the manner of McRO. Applicant further remarks, “As was the case with respect to McRO, the claimed set of rules that create and otherwise utilize a utility range data structure provides an improvement in the field of data storage and transmission and are thus sufficient for integrating an alleged abstract idea into a practical application”. Examiner respectfully submits that unlike McRO, the instant claims do not recite a set of rules; nor do the claims recite utilizing a range data structure that provides an improvement to data storage and transmission. This argument is not persuasive.
Regarding remarks directed to Step 2B at page 26, Examiner respectfully disagrees. The additional elements have been identified in the 101 analysis section above. Applicant has not provided evidence of, nor can Examiner find evidence of, how any of the identified additional elements are being implemented in an unconventional manner. The additional elements amount to general purpose computing devices being used in their ordinary capacity to implement the steps of the abstract idea. Applicant remarks that the claimed invention provides “non-routine results in the field of focus” but has not elaborated on this matter or provided evidence from the specification to support this statement. Therefore, this argument is not persuasive.
For all of the above reasons, Applicant’s arguments are not persuasive and the rejections of Claims 1, 3-8, 11-13, 15, 17, 19, 21, 23-25 under 35 USC 101 are maintained.
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20120041770A1, teaching on systems, methods and apparatus for provisioning and tracking medical supplies for medical procedures
US Publication 20190198161A1, teaching on a medical inventory management and data integration system using computer-readable codes
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 date of this final action.
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