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 05/06/26.
Claims 1, 3, 5-7, 9-11, 13-15 have been amended and are hereby entered.
Claims 2, 4, 8, 12, 16 have been canceled.
Claims 1, 3, 5-7, 9-11, 13-15 are currently pending and have been examined.
This action is made final.
IDS
The information disclosure statement (IDS) submitted on 03/30/26 has been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Foreign Priority/Continuity
Status of this application as a 371 of PCT/KR2021/015194, filed 10/27/21, claiming priority to KR10-2021-0144050, filed 10/26/21, is acknowledged. A certified copy has been received on 04/26/24. Accordingly, a priority date of 10/26/21 has been given to this application.
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, 5-7, 9-11, 13-15 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, 5-7 are drawn to a server, and Claims 9, 10, 11, 13-15 are drawn to a method, both of which are within the four statutory categories. Claims 9, 10, 11, 13-15 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
analyze each of the plurality of measurement images included in the clinic sperm data to assess, for each measurement image, state information of sperm including at least one of a number of sperm, sperm motility, sperm viability, or sperm morphology, generate first state information of the sperm by averaging the assessed state information from the plurality of measurement images, and analyze the at least one measurement image included in the personal sperm data to assess second state information of the sperm
determine, based on the first state information, a sperm state of the user as one of a normal state, an abnormal state, and a care state, when the sperm state is the care state, determine a first care-state level from among a plurality of preset care-state levels, and determine, based on the second state information assessed from the at least one measurement image included in the personal sperm data received after determination of the first care-state level, whether the sperm state of the user has changed such that the care-state level changes from the first care-state level to a second care-state level
generate first health management information corresponding to the first-care state level when the sperm state of the user is determined as the care state based on the first state information and generate second health management information corresponding to the second care-state level when the sperm state is determined to have changed from the first care- state level to the second care-state level based on the second state information
encrypting the clinic sperm data, the personal sperm data, and health management information
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Analyzing sperm measurement images to asses state information, determining a sperm state, determining a first care-state level, determining whether the sperm state has changed over time, generating health management information for the user, and encrypting the different types of data are personal behaviors that may be performed by healthcare providers working in reproductive health/fertility fields.
Claim 9 recites implementing the steps of:
analyzing each of the plurality of measurement images included in the clinic sperm data to assess, for each measurement image, state information of sperm including at least one of a number of sperm, sperm motility, sperm viability, or sperm morphology;
generating first state information of the sperm by averaging the assessed state information from the plurality of measurement images;
analyzing the at least one measurement image included in the personal sperm data to assess second state information of the sperm; determining, based on the first state information, a sperm state of the user as one of a normal state, an abnormal state, and a care state;
when the sperm state is the care state, determining a first care-state level from among a plurality of preset care-state levels;
determining, based on the second state information assessed from the at least one measurement image included in the personal sperm data received after determination of the first care-state level, whether the sperm state of the user has changed such that the care-state level changes from the first care-state level to a second care-state level;
generating first health management information corresponding to the first care-state level when the sperm state of the user is determined as the care state based on the first state information;
generating second health management information corresponding to the second care-state level when the sperm state is determined to have changed from the first care-state level to the second care-state level based on the second state information
encrypting the clinic sperm data, the personal sperm data, and health management information
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Analyzing sperm measurement images to asses state information, determining a sperm state, determining a first care-state level, determining whether the sperm state has changed over time, generating health management information for the user, and encrypting the different types of data are personal behaviors that may be performed by healthcare providers working in reproductive health/fertility fields.
The above claims 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:
a body fluid management server as implementing the abstract idea (Claim 1)
a body fluid analysis unit as implementing the steps of analyze each of the plurality of measurement images included in the clinic sperm data to assess, for each measurement image, state information of sperm including at least one of a number of sperm, sperm motility, sperm viability, or sperm morphology, generate first state information of the sperm by averaging the assessed state information from the plurality of measurement images, and analyze the at least one measurement image included in the personal sperm data to assess second state information of the sperm (Claim 1)
a body fluid state determination unit as implementing the step of determine, based on the first state information, a sperm state of the user as one of a normal state, an abnormal state, and a care state, when the sperm state is the care state, determine a first care-state level from among a plurality of preset care-state levels, and determine, based on the second state information assessed from the at least one measurement image included in the personal sperm data received after determination of the first care-state level, whether the sperm state of the user has changed such that the care-state level changes from the first care-state level to a second care-state level (Claim 1)
a health management information generation unit as implementing the step of generate first health management information corresponding to the first-care state level when the sperm state of the user is determined as the care state based on the first state information; and generate second health management information corresponding to the second care-state level when the sperm state is determined to have changed from the first care- state level to the second care-state level based on the second state information (Claim 1)
a body fluid management server which is connected to a user terminal in communication with a personal sperm measurement apparatus and a clinic terminal in communication with a clinic sperm measurement apparatus as implementing the steps of the abstract idea (Claim 9)
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding the body fluid management server, para. [061] discloses that the server is comprised of various units. Fig. 2 provides an architectural drawing. The “communication” with the terminals (interpreted as general purpose computing devices; see below) is understood to be the internet per [1]. No further structure/description of the server is provided; as such, this element is given its broadest reasonable interpretation as a general purpose server computer functioning in its ordinary capacity.
Regarding the various functional units (e.g., body fluid analysis unit, body fluid state determination unit, health management information generation unit, blockchain unit), the specification discloses at [61] that these are units included in server 100; see also Fig. 2. No structural description of the actual individual units are provided. Therefore, the units are given the broadest reasonable interpretation as software/hardware components installed and executing on a general purpose computer server functioning in its ordinary capacity.
Regarding the user terminal and clinic terminal, para. [57] discloses that the user terminal may be a smartphone or a computer and para. [138] discloses that a clinic administrator’s terminal may be a “smartphone or computer” and a clinic terminal may be a “computer or server”. No further structure/description of these computing terminals is provided; as such, this element is given its broadest reasonable interpretation as a general purpose computing element functioning in its ordinary capacity.
Regarding generating a “block” to be transmitted to a blockchain, the specification does not describe any particulars or inventive features of the blockchain or block encryption/generation process; limitations pertaining to generating a block by encrypting the clinic sperm data, personal sperm data and health management information only amount to mere instructions to apply the abstract idea using computers, e.g., using a block/blockchain to maintain data electronically; the step of generating the block is understood to be performed by general purpose computing devices (server/user terminals).
B. Insignificant extra-solution activity MPEP 2106.05(g)
The independent claims additionally recite:
receive, from a clinic terminal in communication with a clinic sperm measurement apparatus, clinic sperm data including a plurality of measurement images of sperm of a user and receive, from a user terminal in communication with a personal sperm measurement apparatus, personal sperm data including at least one measurement image of the sperm of the user (via an interface unit) (Claim 1)
receiving, from the clinic terminal, clinic sperm data including a plurality of measurement images of sperm of a user; and receiving, from the user terminal, personal sperm data including at least one measurement image of the sperm of the user (Claim 9)
These elements only amounts to insignificant extra-solution activity in the form of mere data gathering. The above steps only serve as a step to collect data necessary to perform the steps of the abstract idea.
The independent claims additionally recite:
a measurement data storage unit configured to store, for each user, for each user's clinic sperm data the clinic sperm data and the personal sperm data (Claim 1)
a health management information storage unit configured to store, for each user, the first health management information and the second health management information (Claim 1)
storing, for each user, the clinic sperm data and the personal sperm data (Claim 9)
storing, for each user, the first health management information and the second health management information (Claim 9)
These elements only amounts to insignificant extra-solution activity. 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 various functions of storing different types of data (e.g., personal sperm data, clinic sperm data, health management information, etc.) are only tangentially related to the respective abstract idea of analyzing sperm measurement images to asses state information, determining a sperm state, determining a first care-state level, determining whether the sperm state has changed over time, generating health management information for the user, and encrypting the different types of data, and accordingly constitutes insignificant extra-solution activity.
The independent claims additionally recite:
transmit the generated block to blockchain nodes associated with the user for sharing information (Claim 1)
transmitting, by a blockchain unit, the generated block to blockchain nodes associated with the user for sharing information (Claim 9)
These steps only amounts to insignificant application of the abstract idea, as it only amounts to outputting the results 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.
The above claims, 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 and 9 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).
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.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the additional elements identified in Step 2A Prong 2 above only amount to insignificant extra-solution activity 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:
The step of receive, from a clinic terminal in communication with a clinic sperm measurement apparatus, clinic sperm data including a plurality of measurement images of sperm of a user and receive, from a user terminal in communication with a personal sperm measurement apparatus, personal sperm data including at least one measurement image of the sperm of the user (via an interface unit) and receiving, from the clinic terminal, clinic sperm data including a plurality of measurement images of sperm of a user; and receiving, from the user terminal, personal sperm data including at least one measurement image of the sperm of the user, only amount to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional activity when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
The steps pertaining to storing each user's clinic sperm data and personal sperm data, and storing the health management information only amount to storing/retrieving data in memory, which has been held to be well-understood, routine and conventional activity when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
The steps of transmit the generated block to blockchain nodes associated with the user for sharing information and transmitting, by a blockchain unit, the generated block to blockchain nodes associated with the user for sharing information only amount to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional activity 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:
Claims 3 and 11 recite limitations pertaining to receiving biometric information of the user and determining a final state based on the sperm state information and the biometric information of the user and determine, based on the first state information and the biometric information of the user, whether the sperm state of the user is the care state and, when the sperm state is the care state, determine the first care-state level from among the plurality of preset care state levels, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare provider could receive biometric information of a user and use the biometric information along with sperm state information to make a determination, e.g., this only amounts to receiving data and performing making a determination. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the abstract idea.
Claims 5 and 13 recite limitations pertaining to inquiring the user about personal information regarding at least one of an existing disease, a dietary habit, an alcohol consumption status, and a smoking status, receive a response from the user, and assess the user's characteristics based on the received personal information, and retrieve sperm data corresponding to specific characteristics in response to a request from an external organization or company, and provide the retrieved data to the external organization or company, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare provider could as a user for personal information such as dietary habit, alcohol consumption or smoking status, and subsequently provide this information to an external organization who is requesting sperm data exhibiting the specific individual’s characteristics based on the personal information, e.g., this only amounts to asking for information and providing the data to a requesting party. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the abstract idea.
Claims 6 and 14 recite limitations pertaining to providing a reward to a user who has provided the personal sperm data or a user whose sperm data is provided to the external organization or company, which is also certain methods of organizing human activity including managing personal behaviors, as personnel working for a healthcare organization or external company/organization (e.g., a research institution) could provide a reward to a user for sharing their personal sperm data. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the abstract idea.
Claims 7 and 15 recite limitations pertaining to suggesting insurance enrollment or an insurance claim to the user when the sperm state determined has changed from the care state to the normal state, from the care state to the abnormal state, or when a care state level decreases or increases to a predetermined level, and provide information on the sperm state of the user to an insurance company in response to receiving consent from the user, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare provider could as suggest an insurance enrollment/claim when a user’s sperm state or care state changes, and subsequently provide the user’s sperm state information to the insurance company when a positive response from the user is received, e.g., this only amounts to making a recommendation to a user when particular conditions are met and facilitating sharing of information between parties. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the abstract idea.
The dependent claims 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 claim 1 or claim 9 respectively. 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). 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, 5-7, 10, 11, 13-15 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claims 1 and 9 above. As discussed above with respect to Claims 1 and 9 and integration of the abstract idea into a practical application, recitation of these additional elements only amounts to invoking computers as a tool 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, 5-7, 10-11, 13-15, 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, 5-7, 9-11, 13-15 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 Claim 1 and corresponding dependent claims are withdrawn in view of Applicant’s amendments to Claim 1. The objections to Claim 8 are moot as this claim has been canceled by Applicant.
Rejections under 35 USC 101
Applicant’s remarks have been fully considered but are not persuasive. Regarding remarks at page 10 pertaining to the claimed steps being performed “entirely by a server and its functional units, not a human”, Examiner submits that as discussed above in 101 section, the computing components are understood to be general purpose computing elements/devices (e.g., a general purpose computer server) functioning in its ordinary capacity, which only amounts to mere instructions to apply the abstract idea on a computer. Beyond the limitations which recite the abstract idea, recitation of the various computing components (server, functional units) only amounts to 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). This argument is not persuasive.
Regarding remarks directed to Step 2A Prong 2 and integration into a practical application, Examiner respectfully disagrees with Applicant’s position. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP 2106.05(a)(I). The technological environment of Applicant’s claim is a general-purpose computer server (see e.g., Spec. Para. [0061]). Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the server that results from the implementation of Applicant’s claim. Because there is no improvement to the function of the computer, a practical application is not present.
MPEP 2106.04(d)(1) further states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer (see Spec. Para. [0061]) and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine). While Applicant’s claimed invention recites the additional element(s) discussed above in 101 section, these additional elements merely implement the steps of the abstract idea, and there is no indication that these additional elements operate in a manner different than they normally operate. Operating a computing device such as a server in the manner it normally operates is insufficient to improve another technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present.
Further, with regard to integration of a judicial exception into a practical application, please see 2106.04(d)(II) which states, “The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h)”, and 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.” 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 identified above are understood to be general purpose computing components functioning in their normal operating capacity, which is not sufficient to integrate the judicial exception into a practical application. Examiner submits that any purported improvements stem from the abstract idea itself (e.g., an improved way of monitoring sperm quality changes), which is not sufficient to integrate the judicial exception into a practical application. Therefore, this argument is not persuasive.
Regarding remarks at page 11 pertaining to the blockchain unit, Examiner submits that as discussed above in 101 section, no particulars of the block chain have been provided. This is understood to be a known means of storing data electronically and therefore only amounts to mere instructions to implement the abstract idea on a computer. See preceding paragraphs with respect to “technical improvement and specific practical application”. This argument is not persuasive.
Regarding remarks directed to Example 42 at page 11, Examiner respectfully disagrees that the instant application and claims are analogous. Regarding Example 42, Examiner submits that this claim was found eligible at the Step 2A Prong 2 analysis because the Applicant described particular problems caused by the environment to which the claim is confined (computers); see Background which discloses physically separate medical providers recording patient notes in their own local patient records and storing these records in a non-standard format selected by whichever hardware/ platform is in use in the medical provider’s office, which causes problems if healthcare providers need to share updated information about a patient’s condition. Applicant then presents a solution to the existing system which “collects, converts and consolidates patient information” into a “standardized format” and generates messages to notify HCP’s or patients when that information is updated. As such, the claims were found to recite a combination of additional elements that recite a specific improvement over prior art systems to provide a solution to the problem disclosed by the specification. Applicant’s specification does not appear to disclose analogous problems caused by the technological environment of the claim (a computer/computing system) to which the additional elements provide a specific improvement. Examiner notes that para. [0005] discusses, with respect to current sperm monitoring methods, the problem, “this method used by fertility clinics only assesses the sperm state during the patient's clinic visits, making it impossible to frequently monitor changes in sperm state and provide immediate prescriptions”; as presented, this is not a problem caused by the computing system/server itself. As such, this argument is not persuasive.
Regarding remarks directed to “ordered combination”, Applicant has not cited to evidence in specification, nor can Examiner find evidence, that the ordered combination of additional elements provides significantly more than the judicial exception. Recitation of general purpose computing elements only amounts to mere instructions to implement the abstract idea. This argument is not persuasive.
For all of the above reasons, Applicant’s arguments are not persuasive. The rejections of Claims 1, 3, 5-7, 9-11, 13-15 under 35 USC 101 are maintained.
Rejections under 35 USC 103
Applicant’s remarks have been considered and are persuasive in view of Applicant’s amendments to the claims. The closest prior art is understood to be the art of record, but fails to expressly teach on all of the limitations of the independent claims as amended. A search of publicly available prior art fails to yield a reference or combination of references that would make the claimed combination obvious when considered as a whole. The rejections of all pending claims under 35 USC 103 are withdrawn.
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 20200205790 A1, teaching on a method and system for determining the quality of a semen sample by analyzing images
US Publication 20180368815A1, teaching on a body fluid state diagnostic system and state diagnostic method
US Publication 20200374125A1, teaching on securely transmitting health data using a blockchain
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST, and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
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