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
In the reply filed on 12 June 2026, the following changes have been made: amendments to claims 1-2, 8, and 20.
Claims 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a machine (claims 1-7) and process (claims 8-20).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 1 recites steps of
a spectrometer sensor which analyzes a sample of human milk using a near infrared sensor and emitter to identify macronutrients and micronutrients in the sample of human milk, and
an artificial intelligence server including a processor or several processors and an artificial intelligence engine which:
receives spectrometer data generated by the spectrometer which
includes an identification of macronutrients and micronutrients in the sample of human milk;
analyzes the spectrometer data to identify concentrations of macronutrients and or micronutrients in the sample of human milk;
compares the concentrations of macronutrients and or micronutrients in the sample of human milk from the analyzed spectrometer data with nutritional guidelines for a particular infant;
compares the concentrations of macronutrients and or micronutrients in the sample of human milk from the analyzed spectrometer data with feeding protocols obtained from historical clinical data about one or more infants with similar clinical profiles to the particular infant;
identifies one or more disease risk scores based on clinical data specific to the particular infant; and
provides to a device a nutritional recommendation for optimal personalized milk fortification based on the comparison of the macronutrients and or micronutrients in the sample of human milk with chosen nutritional guidelines, and with feeding protocols obtained from historical clinical data about one or more infants with similar clinical profiles for the particular infant, and optionally disease risk scores.
Claims 8 and 20 recite similar limitations as claim 1 but for the recitation of generic computer components.
These steps directed to providing optimal personalized milk fortification, as drafted, under the broadest reasonable interpretation, includes performance of the limitations in the mind but for recitation of generic computer components. That is, nothing in the claim element precludes the italicized portions from practically being performed in the mind through performing determinations, including observations and evaluations, on milk nutrition and one or more disease risk scores. This could be analogized to collecting information, analyzing it, and displaying certain results of the collection and analysis. If a claim limitation, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it falls within the “Mental Process” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements non-italicized portions identified above for claims 1, 8, and 20, do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as by
a spectrometer sensor […] using a near infrared sensor and emitter; an artificial intelligence server including a processor or several processors and an artificial intelligence engine; generated by the spectrometer; and, to a device amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receives spectrometer data amounts to mere data gathering since it does not add meaningful limitations to the receiving action performed, see MPEP 2106.05(g))
Each of the above additional element(s) therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity, and also add insignificant extra-solution activity to the abstract idea. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as by a spectrometer sensor […] using a near infrared sensor and emitter; generated by the spectrometer; and, to a device, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f); an artificial intelligence server including a processor or several processors and an artificial intelligence engine, e.g., requiring the use of software to tailor information and provide it to the user on a generic computer, Intellectual Ventures I LLC v. Capital One Bank., MPEP 2106.05(f).
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as receives spectrometer data, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i).
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 generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-7 and 9-19 reciting particular aspects of customizing a regularly scheduled feeding fortification of milk for infants such as
[Claim 2] one or more of a spectrograph sensor and an electrochemical
sensor;
[Claim 3] wherein the optimized nutrition recommendation is specific to the particular infant and the particular infant has a birthweight less than 5 pounds, 8 ounces;
[Claim 4] wherein the clinical data may include disease risk score information about the particular infant;
[Claim 5] wherein the clinical data include a risk score of the particular infant to contract a disease;
[Claim 6] wherein the optimized nutritional recommendation reflects the one or more disease risk scores;
[Claim 7] wherein the one or more disease risk scores include clinical data information about the pre-birth period, at-birth period, or post-birth period of the particular infant;
[Claim 9] receiving, by the artificial intelligence server that includes one or more processors, an indication that the optimized nutritional recommendation for milk fortification has been manually adjusted;
[Claim 10] wherein based on the manual adjustment, the artificial intelligence server that includes one or more processors, updates the optimized nutritional recommendation for milk fortification for subsequent recommendations for the particular infant;
[Claim 11] receiving, by the artificial intelligence server that includes one or more processors, feeding feedback;
[Claim 12] wherein the feeding feedback indicates an amount of milk effectively consumed by the particular infant;
[Claim 13] wherein the feeding feedback is correlated by the artificial intelligence server with growth of the infant over a period of time;
[Claim 14] wherein the artificial intelligence server suggests the presence of an ailment or disease in the particular infant based on the feeding feedback;
[Claim 15] wherein the artificial intelligence server uses both the clinical data specific to the particular infant and feeding feedback to determine a risk score for the likelihood of developing diseases or conditions which may be affected by nutrition, including but not limited to growth faltering, bronchopulmonary dysplasia, necrotizing enterocolitis, and sepsis, for a particular infant;
[Claim 16] wherein the optimized nutrition recommendation for milk fortification provided to a device is generated using machine learning;
[Claim 17] wherein the artificial intelligence server that includes one or more processors further updates the optimized nutrition recommendation for milk fortification based on outcomes of other infants and based on at least one shared clinical data point between the other infants and the particular infant;
[Claim 18] wherein the artificial intelligence server that includes one or more processors transmits the optimized nutritional recommendation for milk fortification to the device for graphical or textual display on the device;
and,
[Claim 19] wherein the processor provides a timestamp for feeding feedback which is correlated, by the artificial intelligence server which includes one or more processors, with infant growth, and wherein the correlation is provided graphically or textually to a device;
these italicized portions covers performance of the limitations in the mind but for recitation of generic computer components since they merely describe types of data and determinations that can be performed by humans).
Step 2A Prong 2
Dependent claims 2, 9-11, and 13-19 recites additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claim 2 (one or more of a spectrograph sensor and an electrochemical sensor), claim 9 (by the artificial intelligence server that includes one or more processors), claim 10 (the artificial intelligence server that includes one or more processors), claim 11 (by the artificial intelligence server that includes one or more processors), claim 13 (by the artificial intelligence server), claim 14 (wherein the artificial intelligence server suggests the presence of an ailment or disease in the particular infant), claim 15 (wherein the artificial intelligence server uses both the clinical data specific to the particular infant and feeding feedback), claim 16 (provided to a device […] using machine learning), claim 17 (wherein the artificial intelligence server that includes one or more processors further updates the optimized nutrition recommendation for milk fortification), claim 18 (wherein the artificial intelligence server that includes one or more […] to the device for graphical or textual display on the device) and claim 19 (the processor provides […] by the artificial intelligence server which includes one or more processors) amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f); add insignificant extra-solution activity to the abstract idea such as claim 9 (receiving, […] , an indication that the optimized nutritional recommendation for milk fortification has been manually adjusted), claim 11(receiving […] feeding feedback), claim 18 (transmits the optimized nutritional recommendation for milk fortification), and claim 19 (and wherein the correlation is provided graphically or textually to a device) amounts to mere data gathering and output since it does not add meaningful limitations to the receiving, transmitting, and providing performed, see MPEP 2106.05(g))). 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.
Step 2B
Dependent claims 2, 9-11, 13-17, and 19 recites additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f). Also, see [0023] which provides examples of computer devices, [0029] which provides examples of memory devices, and [0029] disclosing examples of processing devices. Dependent claims 9, 11, and 18-19 amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i). There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation.
Response to Arguments
The arguments filed on 12 June 2026 have been considered, but are not fully persuasive.
Regarding the USC 101 rejection, applicant argues that the claims are not drawn to an abstract idea and that humans lack the ability to provide a chemical analysis of the constitutional makeup of milk e.g., the relative amount of fat, carbohydrates, and protein in a particular sample of human milk. Applicant asserts that a "spectrometer" based analysis of milk to identify constituent elements of the milk is not a process that can be performed by the human mind, and thus there is no basis to assert that claim 1 is drawn to a mental process. The argument is also made that compared to manual techniques disclosed in the specification, the systems and method are proactive and not reactive. Applicant submits that claim 1 recites patent-eligible subject matter as at least a practical application of an abstract idea, including a "spectrometer sensor" and an "artificial intelligence engine" to both "identify macronutrients and micronutrients" in a "human milk sample" and determine a "concentration" of the identified "macronutrients and micronutrients" in the human milk sample. Applicant also states that claims 8 and 20, while of a different scope from claim 1, recite elements similar to those of claim 1 and are likewise drawn to eligible subject matter.
Examiner disagrees with the applicant’s arguments. Examiner again asserts, similar to previous arguments, that applicant is asserting on record or operating under the assumption that the claims are performing unrecited limitations that humans cannot perform. While the claims recite a spectrometer sensor, it is clear that there is no recitation of a chemical analysis being performed. That is, there is no delineation of the chemical analysis steps that determine the constitutional makeup of milk e.g., the relative amount of fat, carbohydrates, and protein in a particular sample of human milk as argued by the applicant on the present record. There is also no indication that the spectrometer, artificial intelligence server including a processor or several processors, and device are doing anything specific other that generic computer functions. The MPEP makes it clear that claims can recite an abstract idea even if they are claimed as being performed on a computer. The courts have also found claims requiring a generic computer or nominally reciting a generic computer may still recite abstract idea even though the claim limitations are not performed entirely by a human. The limitations identified as abstract in the present application are very outcome-based or result-focused and don’t give much technical detail that goes beyond what a human can do. As can be seen, there is nothing in the claim that tells the examiner how the asserted chemical analysis is being performed to a sample of milk beyond what a human can do. Given the mismatch between the applicant’s arguments and what is actually claimed, examiner still cannot be expected to believe that humans could not determine characteristics such as viscosity, smell, color, etc. Examiner points out the applicant didn’t invent the concept of sensor detection or even the concept of performing analysis and comparison through sensors and an artificial intelligence server to now generically claim it and then call it non-generic. Applicant’s claim limitations are still very outcome-based or result-focused. The computer components recited in the present claims are recited at a high level of generality. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1984 (2014). See also OIP Techs. v. Amazon.com, 788 F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94 (Fed. Cir. 2015) ("Just as Diehr could not save the claims in Alice, which were directed to ‘implement[ing] the abstract idea of intermediated settlement on a generic computer’, it cannot save OIP's claims directed to implementing the abstract idea of price optimization on a generic computer.") (citations omitted). Even if the claims nominally recite computer components that are rooted in technology, there is no recitation of how the computer components are specifically programmed to distinguish from generic computer processes.
Examiner further adds that the specification provides a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art. The MPEP provides that improvements to the functioning of a computer or to any other technology or technical field can signal eligibility, see MPEP 2106.05(a), and provides examples of improvements to computer functionality, MPEP 2106.05(a)(I), and improvements to any other technology of technical field, MPEP 2106.05(a)(I). “In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool”. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification' s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691. Unlike Enfish, the instant claimed invention appears to improve upon a judicial exception rather than a problem in the software arts. Rather than improving a computer's algorithm (i.e., solving a technically based problem), the claimed invention purports to solve the non-technological problem of the AAP & ESPGHAN guidelines failing to address nutritional needs that an infant may have due to the infant's clinical data, and the non-technological problem of analyzing a large quantity of data to accurately identifying risk factors such as growth faltering and other diseases which may be affected by nutrition ([0003] & [0005] of the specification) through generically applying computer components as a tool to customize a personalized fortification of human milk to feed to infants and to further identify risk scores for the onset of diseases based on the infant's clinical data. The applicant’s main/glaring issue is that specification does not show or describe a deficiency in technology. Applicant’s own specification [0003]-[0005] literally admits that previously the invention could be performed by doctors in developing a feeding protocol for a preterm infant with a certain amount of monitoring, waiting, and checking. Applicant is simply using computers in place of humans to improve upon the judicial exception. All the applicant is doing is applying known technology for their intended benefit(s) to a new data environment and calling it an improvement (see Customedia Techs., LLC v. Dish Network Corp., Case No.18-2239 (Fed. Cir. Mar. 6, 2020).
The examiner asserts the following facts which the applicant has not been able to dispute:
1) the invention does NOT involve a novel algorithm or data structure that significantly improves the computer's functionality,
2) the invention does NOT involve a new hardware component or configuration that works with the computer to achieve a specific technical benefit, and
3) the computer is NOT used in a completely new way demonstrating a significant technical advancement.
Improvement to monitoring and managing medical and/or clinical events associated with the patient is not an improvement to computer technology. Thus, examiner does not see how the present claims improve the functioning of a computer or provide improvements to any other technology or technical field. The claimed invention appears similar to the example of improvements that are insufficient to show an improvement in computer-functionality such as arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly, Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019). See MPEP 2106.05(a)(I)(viii). The asserted benefits from the applicant’s invention seem to come as a result of the use of general-purpose computers. The broad claims are lacking concrete limitations to integrate the abstract idea into a practical application. Examiner points out that the claimed limitations have no indication in the specification that the operations recited invoke any inventive programming, require any specialized computer hardware or other inventive computer components, i.e., a particular machine, or that the claimed invention is implemented using other than generic computer components to perform generic computer functions. See DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (fed Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent-eligible.”). Most importantly, in DDR Holdings, the claims at issue specified how interactions with the Internet were manipulated to yield a desired result—a result that overrode the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. On the other hand, with the applicant’s claims, examiner points out there is nothing that tells the examiner how exactly the receiving, analyzing, comparing, identification, and providing limitations are actually performed through use of computer(s)/sensor(s). This further supports the examiner’s assertion that the present invention does not integrate the abstract idea into a practical application. To show an involvement of a computer assists in improving technology, the claims must recite details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology (MPEP 2106.05(a)(II)). In Finjan, Inc. v. Blue Coat Systems the courts found that the claims were “directed to a non-abstract improvement in computer functionality…” (MPEP 2106.04(d)). The present invention does not meet the condition set forth by the courts and thus is not a patent eligible invention. Claims 8 and 20 are also not drawn to patent eligible subject matter. The remaining dependent claims are still rejected under USC 101. Therefore, the USC 101 rejection has been strongly maintained.
Regarding the USC 103 rejection, while the references of record are understood to be the closest prior art, the scope of the claim(s) has been clarified to describe a particular manner in which a spectrometer sensor uses a near infrared sensor and emitter; and, compares the concentrations of macronutrients and or micronutrients in the sample of human milk from the analyzed spectrometer data with feeding protocols obtained from historical clinical data about one or more infants with similar clinical profiles to the particular infant. This goes beyond any teachings or suggestions in the art. Therefore, the USC 103 rejection has been withdrawn.
Prior Art Cited but Not Relied Upon
Sánchez, C., Franco, L., Regal, P., Lamas, A., Cepeda, A., & Fente, C. (2021). Breast milk: A source of functional compounds with potential application in nutrition and therapy. Nutrients, 13(3), 1026.
This reference is relevant because it investigates the contribution of these variants to disease susceptibility and phenotype in the Scottish early-onset IBD population.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
ASFAND M SHEIKH/Quality Assurance Specialist, Technology Center 3600 Any inquiry concerning this communication or earlier communications from the examiner should be directed to WINSTON FURTADO whose telephone number is (571)272-5349. The examiner can normally be reached Monday-Friday 8:00 AM to 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WINSTON R FURTADO/Primary Examiner, Art Unit 3687
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