DETAILED ACTION
Notice to Applicant
This communication is in response to the application submitted August 21, 2024. A Restriction Requirement was mailed August 20, 2025 with regard to claims 1 – 28, restricting the claims as follows: Group I (claims 1 – 10), Group II (claims 11 – 22), and Group III (claims 23 – 28). The Applicant elected Group II. Claims 11 – 22 are pending.
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 .
Claim Objections
Claim 12 is objected to because of the following informalities: the term “interprets” wherein the decoder interprets the interprets internal learned representation” is in duplicate. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11 – 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 11 –22 are drawn to a method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 11 recites providing intravenous nutrients to a premature baby including obtaining an electronic health record of the premature baby and selecting a nutrient bag comprising a mix of nutrients to supplement the health of the individual based on a recommendation.
Independent claim 19 recited obtaining health information about an individual and providing a dietary recommendation for the individual.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which relates to identifying neonatal risk, especially in preterm births (paragraph 3). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address providing a nutrient bag including a mix of nutrients to supplement the health of the preterm infant (paragraph 18). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 11: “electronic”, “machine learning model”
Claim 12: “the machine learning model comprises a multitask neural network, wherein the neural network comprises an encoder, a hidden state, and a decoder, wherein the encoder reads an input, wherein the hidden state represents an internal learned representation of the input, and wherein the decoder interprets the interprets internal learned representation and reconstructs the input”
Claim 13: “bottleneck layer”
Claim 22: “database”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 12 – 18 and 20 – 22 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (U.S. Patent Number 11,935,642 B2) in view of Jacob et al., herein after Jacob (U.S. Publication Number 2013/0191150 A1).
Claim 11. Neumann discloses a method for providing intravenous nutrients to a premature baby (column 19, lines 14 – 17 discloses an "intravenous line" is a component that allows for nourishment to be received by an infant as a function of a parenteral feeding mechanism), comprising:
selecting a nutrient bag comprising a mix of nutrients to supplement the health of the individual (column 11, line 67 through column 12, line 2 discloses a "nourishment demand" is requirement and/or necessary amount of nutrients required for an infant to receive; column 11, lines 42 – 46 discloses an "aliment" is a source of nourishment that may be provided to an infant such that the infant may absorb the nutrients from the source and may include formula, breastmilk, dissolved foods, nutrient mixtures, and the like) based on a recommendation by a machine learning model (Figure 1; column 6, lines 36 – 38 discloses a computing device that produces a neonatal profile as a function of a neonatal goal and neonatal recommendation using a neonatal machine learning model, where the "neonatal machine-learning model" is a machine-learning model to produce a neonatal profile output given neonatal functional goals and neonatal recommendations as inputs; column 14, line 58 through column 15, line 15 discloses computing device generates a nourishment program as a function of aliment, where a "nourishment program" is a program consisting of one or more aliments that are to be administered to an infant over a given time period).
Neumann fails to explicitly teach the following limitations met by Jacob as cited:
obtaining or having obtained electronic health records (EHR) for an individual, wherein the EHR comprise details about the individual's health, and the individual is a premature baby (paragraph 77 discloses the infant patient’s medical records would transfer to the subsequent hospital and the procedures for scheduling examinations, recording findings and determining whether follow-up evaluations within the hospital or NICU are necessary or desirable, indicating the infants medical records have been obtained; paragraph 79 discloses after entry of a premature baby into the NICU various vital statistics will be taken. This patient data may be obtained and entered into the system, either directly or via sharing with a database or electronic medical records system already utilized by the NICU).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Neumann to further include schedule examinations that are necessary and follow-up with a patient after he or she has been discharged from a NICU and facilitates the accurate communication of patient data between the NICU and the pediatric ophthalmologist as disclosed by Jacob.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Neumann in this way to transfer the data relating to the premature patient to an alternate provider, and the data that is transferred is selectively monitored and recorded (Jacob: paragraph 32).
Claim(s) 12 – 13 and 16 – 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (U.S. Patent Number 11,935,642 B2) in view of Jacob et al., herein after Jacob (U.S. Publication Number 2013/0191150 A1) further in view of Hsu et al., herein after Hsu (U.S. Publication Number 2021/0158967 A1).
Claim 12. Neumann and Jacob teach the method of claim 11. Neumann teaches a method wherein the machine learning model comprises a multitask neural network (Figure 5; column 21, lines 41 – 44 discloses a machine-learning model may be generated by creating an artificial neural network, such as a convolutional neural network comprising an input layer of nodes, one or more intermediate layers, and an output layer of nodes).
Neumann and Jacob fail to explicitly teach the following limitations met by Hsu as cited:
wherein the neural network comprises an encoder, a hidden state, and a decoder, wherein the encoder reads an input, wherein the hidden state represents an internal learned representation of the input, and wherein the decoder interprets the interprets internal learned representation and reconstructs the input (paragraph 83 discloses the architecture of auto-encoder has an input layer (dimension is n), a hidden layer (dimension is m) and an output layer. The training part is divided into two parts: encoding (input layer to hidden layer) and decoding (hidden layer to output layer)).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Neumann and Jacob to further include the prediction of potential health risks by training artificial neural networks using biological analysis data as disclosed by Hsu.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Neumann and Jacob in this way to improve the accuracy of prediction, reduce the time spent in a large number of biomedical testing and gene sample extraction, and to be able to screen key genes more rapidly (Hsu: paragraph 3).
Claim 13. Neumann, Jacob, and Hsu teach the method of claim 12. Neumann teaches a method wherein the nutrient bag is one bag of a set of nutrient bags (column 11, lines 42 – 46 discloses an "aliment" is a source of nourishment that may be provided to an infant such that the infant may absorb the nutrients from the source and may include formula, breastmilk, dissolved foods, nutrient mixtures, and the like).
Neumann and Jacob fail to explicitly teach the following limitations met by Hsu as cited:
wherein each bag in the set of nutrient bags is comprised of a composition of nutrients generated by clustering from a bottleneck layer (paragraph 60, table 2 discloses a bottleneck layer of an autoencoder).
The motivation to combine the teachings of Neumann and Jacob is disclosed in the rejection of claim 12, and incorporated herein.
Claim 16. Neumann, Jacob, and Hsu teach the method of claim 13. Neumann teaches a method wherein the nutrient bag improves respiratory health (column 5, lines 41 – 52 discloses a "neonatal functional goal" is an intended function of a neonatal bundle. The neonatal functional goal may include an intended goal of improving function of a respiratory system to include enhancing and/or raising a breathing rate of an infant; column 11, lines 42 – 46 discloses an "aliment" is a source of nourishment that may be provided to an infant such that the infant may absorb the nutrients from the source and may include formula, breastmilk, dissolved foods, nutrient mixtures, and the like).
Claim 17. Neumann, Jacob, and Hsu teach the method of claim 13. Neumann teaches a method wherein the nutrient bag improves gastrointestinal health (column 19, lines 5 – 33 discloses the Nourishment delivery component may include a gastronomy tube. As used in this disclosure a "gastronomy tube" is a component that allows for nourishment to be received by an infant as a function of a feeding tube).
Claim 18. Neumann, Jacob, and Hsu teach the method of claim 13. Neumann teaches a method wherein the nutrient bag improves eye health (column 11, line 67 through column 12, line 2 discloses a "nourishment demand" is requirement and/or necessary amount of nutrients required for an infant to receive; column 11, lines 42 – 46 discloses an "aliment" is a source of nourishment that may be provided to an infant such that the infant may absorb the nutrients from the source and may include formula, breastmilk, dissolved foods, nutrient mixtures, and the like. Although Neumann does not explicitly disclose eye health, it is obvious the nutrient bag can be modified regarding the health topic).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (U.S. Patent Number 11,935,642 B2) in view of Jacob et al., herein after Jacob (U.S. Publication Number 2013/0191150 A1) further in view of Hsu et al., herein after Hsu (U.S. Publication Number 2021/0158967 A1) in view of Hoath et al., herein after Hoath (U.S. Patent Number 6,333,041 B1).
Claim 14. Neumann, Jacob, and Hsu teach the method of claim 13.
Neumann, Jacob, and Hsu fail to explicitly teach the following limitations met by Hoath as cited:
wherein the nutrient bag improves wound healing (column 2, lines 40 – 63 discloses a composition of vernix and a medicament, where the vernix may be natural or synthetic and the medicament may be a nutrient. An effective amount of a vernix/nutrient composition in a pharmaceutically acceptable carrier is applied either parenterally or enterally, indicating a medication/nutrient delivered via IV which indicates the use of a bag).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Neumann, Jacob, and Hsu to further include therapeutic or prophylactic, natural or synthetic vernix film for enhanced growth and maturation of skin and other tissue. as disclosed by Hoath.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Neumann, Jacob, and Hsu in this way to provide a clinically useful vernix formulation and for a composition which can provide therapeutic treatment (Hoath: column 2, lines 35 – 37).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (U.S. Patent Number 11,935,642 B2) in view of Jacob et al., herein after Jacob (U.S. Publication Number 2013/0191150 A1) further in view of Hsu et al., herein after Hsu (U.S. Publication Number 2021/0158967 A1) in view of Lambers et al., herein after Lambers (U.S. Publication Number 2018/0332881 A1).
Claim 15. Neumann, Jacob, and Hsu teach the method of claim 13.
Neumann, Jacob, and Hsu fail to explicitly teach the following limitations met by Lambers as cited:
wherein the nutrient bag improves neurocognitive development (paragraph 59 discloses supplementing preterm infant formulas or nutritional composition for preterm infants with butyrate may help promote or accelerate myelination in preterm infants, thereby accelerating neuronal development which is critical in the preterm infant population. Additionally, accelerated myelination will provide additional neurological benefits such as improved cognition, memory function, learning capacity, social interaction skills, visual acuity, motor skills, language skills, and reduced anxiety).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Neumann, Jacob, and Hsu to further include preterm infant formula or nutritional compositions suitable for administration to a preterm infant containing dietary butyrate and uses thereof as disclosed by Lambers.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Neumann, Jacob, and Hsu in this way provide a preterm infant formula or nutritional composition formulated for administration to a preterm infant that provides butyrate yet does not have diminished organoleptic properties and stability issues. The incorporation of the dietary butyrate compounds disclosed herein into the preterm nutritional compositions will provide butyrate while allowing the (Lambers: paragraph 5).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19 – 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumann (U.S. Patent Number 11,935,642 B2).
Claim 19. Neumann teaches a method for nutritional support, comprising:
obtaining health information about an individual (column 5, lines 17 – 52 discloses "neonatal profile" is a profile of the health status of an infant (individual), wherein a health status is a relative level of wellness and illness of the infant).
providing a dietary recommendation for the individual (column 17, lines 4 – 25 discloses "diet phase" is a developmental phase associated with dietary milestones that an infant may or may not progress through, where dietary phase may include one or more capabilities to ingest varying aliment types and/or nutrients. The diet phase may include developing from a parenteral administration of nutrients to breast milk).
The motivation to combine the teachings of Neumann and Jacob is discussed in the rejection of claim 11, and incorporated herein.
Claim 20. Neumann teaches the method of claim 19. Neumann teaches a method wherein providing a dietary recommendation comprises providing a food recommendation (column 15, lines 12 – 15 discloses a nourishment program may recommend one or more diet programs such as paleo, keto, vegan, vegetarian, and the like thereof to the mother that is breastfeeding the infant).
Claim 21. Neumann teaches the method of claim 20. Neumann teaches a method wherein the food recommendation includes at least one baby food recommendation (column 11, lines 42 – 46 discloses an "aliment" is a source of nourishment that may be provided to an infant such that the infant may absorb the nutrients from the source and may include formula, breastmilk, dissolved foods, nutrient mixtures, and the like).
Claim 22. Neumann teaches the method of claim 19. Neumann teaches a method wherein providing a dietary recommendation comprises interfacing with a database of foods and nutritional information (column 6, lines 1 – 31 discloses a "neonatal database" which is a database of recommendations associated with the health status of an infant).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peri et al. (U.S. Publication Number 2021/0118574 A1) discloses a maternal and infant health intelligence and cognitive insights system and score to predict the risk of maternal mortality by detecting disease early and identifying possible risks in mothers, fetuses, and infants across pre, peri, and post-natal stages of pregnancy.
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682