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 .
DETAILED ACTION
Response to Election/Restriction filed on December 1, 2025 is acknowledged. Claims 9-12 were newly added and claims 8-12 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse Group 2, claim 8-12, drawn to a method of treating in the reply filed December 1, 2025.
The restriction is deemed proper and is made FINAL in this office action.
Claims 8-12 are examined on the merits of this office action.
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 8 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, Claims 8, 10 does not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on MPEP2106.03-MPEP2106.05.
Claim Interpretation
Claim 8 claims “A method for providing nutritional support for a patient in an undernutrition state using a nutritional formulation, wherein the nutritional formulation comprises 0 to 3.5 g of a protein or an amino acid per 100 kcal”.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see MPEP
2106.03)?
Yes, claim 8 is directed to a process and therefore falls within the statutory category of patent eligible subject matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea
(see 2106.04)?
Yes. Claim 8 is directed to an abstract idea, namely dietary guidance and nutritional management, which constitutes a method of organizing human activity and or a mental process involving the selection and use of a nutrition based on nutritional parameters. Claim 8 recites a method for “providing nutritional support” using a nutritional formulation defined solely by its protein or amino acid content per calorie, without reciting any affirmative action that applies the formulation to the patient. The claim is drafted in a result oriented manner and is analogous to “a method of providing food”, consistent with the example in MPEP 2106.04(b) of a “method of providing an apple”. Claim 10 is directed to the same abstract idea as claim 8.
As the product is found in nature, consideration is given to whether it is integrated into a practical application or contains other elements that provide a marked difference as compared to the natural counterpart.
Accordingly, claim 8 is directed to a judicial exception.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application? (see MPEP 2106.04 (d)) NO. This judicial exception is not integrated into a practical application because claim 8 (and also claim 10) do not affirmatively recite an action that effects a particular treatment of a patient or otherwise applies the abstract idea in a concrete manner. Specifically, claim 8 does not recite administering the nutritional formulation to the patient; does not recite a specifical medical intervention or treatment step; merely recites achieving a desired result (“providing nutritional support”). Accordingly, claim 8 (and dependent claim 10) are not integrated into a practical application. Claim 10 does not affirmatively recite administering the formulation to a patient. Instead, the claim merely further limits the composition of the nutritional formulation by adding sugar. Defining a formulation by its intended route of administration, without reciting an active method step of administration, does not constitute a medical treatment or otherwise apply the idea in a concrete manner.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see MPEP 2106.05))?
No. Claim 8 does not recite additional elements that amount to significantly more than the judicial exception. The use of protein or amino acids for nutritional support and the selection of nutritional quantities are well understood, routine and conventional activities in the field of nutrition. When considered as a whole, Claim 8 does not amount to significantly more than the abstract idea itself. Claim 10 does not recite additional elements that amount to significantly more than the judicial exception. The inclusion of sugar in a nutritional formulation represents conventional nutritional component and does not transform the abstract idea into patent eligible subject matter.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in MPEP 2106. In sum, when the relevant considerations are analyzed, they weigh against eligibility.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, Claims 8 and 10 not qualify as eligible subject matter. *Please note that amendment of claim 8 to include an active method step of administering (i.e. “the method comprising administering intravenously to the patient…” or “the method comprising administering enterally to the patient…) would overcome the rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 10, 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “a method for providing nutritional support for a patient in an undernutrition state using a nutritional formulation, wherein the nutritional formulation comprises 0 to 3.5 g of a protein or an amino acid per 100 kcal.”
The claim merely recites use of a nutritional formulation without positively reciting any active method steps that define how the nutritional support is provided. As set forth in MPEP §2173.05(q), attempts to claim a process without setting forth affirmative steps involved in the process raise an issue of indefiniteness under 35 U.S.C. §112(b). Here, the claim is drafted in a result-oriented manner that fails to delineate the boundaries of the claimed method with reasonable certainty.
Accordingly, Claim 8 fails to inform those skilled in the art of the scope of the invention with reasonable certainty and is therefore indefinite.
Claim 10 claims “The method according to claim 8, wherein the intravenous nutritional infusion formulation further comprises a sugar”. There is lack of antecedent basis for the limitation of “the intravenous nutritional infusion” given claim 8 (claim from which claim 10 depends on) does no recite intravenous nutritional infusion.
Claim 12 claims “The method according to claim 11, wherein the intravenous nutritional infusion formulation further comprises a saccharide”. There is lack of antecedent basis for the limitation of “the intravenous nutritional infusion” given claim 11 and claim 8 (claims from which claim 12 depends on) does no recite intravenous nutritional infusion. Furthermore, claim 11 also claims enteral administration not intravenous administration, and thus there is confusion as to which form of administration is required of claim 12.
For purposes of prior art analysis, claims 10 and 12 are interpreted under their broadest reasonable interpretation consistent with claim dependency. The inconsistent phrase of “the intravenous nutritional infusion formulation” is interpreted as describing the formulation, not as imposing an intravenous administration step. The method steps remain controlled by the parent claims (claim 8 for claim 10; claim 11 for claim 12). Claim 10 is being interpreted as a method of using a nutritional formulation further comprising a sugar. Claim 12 is interpreted as a method of enterally administering a nutritional formulation further comprising a saccharide.
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) 8, 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Somekawa (US20110288012 A1, cited in Applicant’s IDS).
*Please note that claim 8 is interpreted under its plain language as reciting a method of providing nutritional support using a nutritional formulation defined by its protein/amino acid content. Claim 8 does not recite a specific route of administration. For purposes of the prior art analysis under 35 U.S.C. § 102, the term “undernutrition state” as recited in claim 8 is interpreted according to its ordinary and customary meaning in the clinical nutrition art, as informed by the specification. As described in the specification (see, e.g., paragraphs [0022]–[0034]), an “undernutrition state” refers to a clinically recognized condition of malnutrition, including patients meeting established diagnostic criteria such as low body mass index, significant unintentional weight loss, prolonged inadequate nutritional intake, and/or associated electrolyte abnormalities, and includes conditions such as marasmus, kwashiorkor, and marasmus-kwashiorkor. Accordingly, the term encompasses patients requiring therapeutic nutritional intervention, including intravenous nutritional administration, and is not limited to any single diagnostic threshold unless expressly recited in the claim.
Somekawa teaches a method for preventing or improving malnutrition associated with renal disease by administering an effective amount of a nutritional composition to a subject in need thereof (see claims 20-23, abstract). Somekawa further teaches that the nutritional composition comprises free amino acids, and histidine and/or soybean protein or a hydrolysate thereof (see claims 1-7, paragraphs 0068-0071). The total amount of protein and peptide is not more than 3.5 g per 100 kcal of the composition (claims 6-7, paragraph 0070, tables 1 and 3). Thus, Somekawa anticipates claim 8 by teaching providing nutritional support to a patient with malnutrition and using a nutritional formulation comprising 0-3.5 gram of protein or amino acid per 100 kcal.
*Please note that claims 10 and 12 are indefinite under 35 U.S.C. 112 (b) because it is unclear whether the nutritional formulation is administered intravenously or via enteral administration (see above rejection). For purposes of prior art analysis, claims 10 and 12 are interpreted under their broadest reasonable interpretation consistent with claim dependency. The inconsistent phrase of “the intravenous nutritional infusion formulation” is interpreted as describing the formulation, not as imposing an intravenous administration step. The method steps remain controlled by the parent claims (claim 8 for claim 10; claim 11 for claim 12). Claim 10 is being interpreted as a method of using a nutritional formulation further comprising a sugar. Claim 12 is interpreted as a method of enterally administering a nutritional formulation further comprising a saccharide.
Regarding claim 10, Somekawa teaches that the nutritional composition comprises carbohydrates, including dextrin and sucrose, i.e. sugars (paragraph 0111, Tables 1 and 3). Accordingly, Somekawa anticipates claim 10 by disclosing a nutritional formulation used in a method of treating malnutrition that further comprises a sugar as required by instant claim 10.
Regarding claim 11, Somekawa teaches enteral administration of the nutritional formulation including ingestion of jelly drinks and acidic drinks prepared as nutritional compositions (see paragraphs 0109-0111; tables 1-3). Thus, Somekawa anticipates claim 11 by enteral administration of the formulation.
Regarding claim 12, Somekawa teaches that enterally administered nutritional composition comprises saccharides, including dextrin and sucrose (see paragraph 0111, tables 1 and 3). Accordingly, Somekawa anticipates instant claim 12 by disclosing the nutritional formulation comprising a saccharide.
Claim(s) 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wassner (The American Journal of Clinical Nutrition 32: JULY 1979, pp. 1497-1504).
*Please note that claim 8 is interpreted under its plain language as reciting a method of providing nutritional support using a nutritional formulation defined by its protein/amino acid content. Claim 8 does not recite a specific route of administration. For purposes of the prior art analysis under 35 U.S.C. § 102, the term “undernutrition state” as recited in claim 8 is interpreted according to its ordinary and customary meaning in the clinical nutrition art, as informed by the specification. As described in the specification (see, e.g., paragraphs [0022]–[0034]), an “undernutrition state” refers to a clinically recognized condition of malnutrition, including patients meeting established diagnostic criteria such as low body mass index, significant unintentional weight loss, prolonged inadequate nutritional intake, and/or associated electrolyte abnormalities, and includes conditions such as marasmus, kwashiorkor, and marasmus-kwashiorkor. Accordingly, the term encompasses patients requiring therapeutic nutritional intervention, including intravenous nutritional administration, and is not limited to any single diagnostic threshold unless expressly recited in the claim.
Regarding claim 8, Wassner teaches a method of treating malnutrition in protein depleted patients by intravenous administration of a nutritional formulation (parenteral administration). Wassner expressly teaches that the intravenous nutrition solutions contain 2 grams of amino acids per 100 kcal of total solution (see Methods section, page 1498), wherein the amino acids serve as the sole nitrogen source during the intravenous nutrition therapy. The claimed limitation requiring less than 3.5 gram of protein per 100 kcal is met because 2 grams per 100 kcal falls within the claimed range.
Regarding claim 9, Wassner teaches intravenous nutrition therapy wherein amino acids are administered intravenously to malnourished patients (see abstract and Methods, page 1498).
Regarding claim 10, Wassner teaches IV administration in malnourished patients in which glucose provides the remaining calories of the infusion (see abstract, Methods).
Conclusion
No claims are allowed.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654