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 .
Claims Status
Applicants’ election with traverse of the composition of claims 1 and 20 in the reply filed on 06/02/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious search burden as the species are linked to a common inventive concept for an enteral formulation. This is not found persuasive because each of the different species of the claims requires a different field of search that employs different search queries. A search for a saline solution having isobutyric acid may not necessarily yield ones with the further additive of gluconate. Thus, each of the different species requires different search queries and there is search burden for each of the different species presented. Each of the species requires a different field of search such that where it is necessary to search for one of the inventions in a manner that is not likely to result in finding pertinent art to the other inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/02/2026. Claims 1 and 20 are under current examination.
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 05/02/2024 and 05/08/2024 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Rejections - 35 USC § 112-indefinite
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 1 and 20 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 1 recites the presence of sodium acetate however the claim further recites acetate to 23.27% wt. It is unclear if the acetate to 23.27% by weight in claim 1 requires the acetate to be present or not as the claim recites to 23.27 without a lower limit of acetate and the claim earlier recites sodium acetate. Claim 20 is rejected as being dependent from claim 1 as claim 20 does not rectify the deficiency to the acetate concentration. Thus, the metes and bounds of claim 1 are unclear.
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 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more.
The claims recite laws of nature and natural phenomena. These judicial expectations are not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 1 and 20 are directed to a saline electrolyte solution with the intended use of administering enteral infusion wherein the saline solution comprises sodium chloride, potassium chloride, sodium acetate, sodium phosphate, calcium chloride, magnesium sulfate and water and gluconate in the specified weight ranges.
Regarding the preamble which indicates “for enteral administration” this is interpreted as being an intended use of the claimed composition which does not confer any structural difference to the compositional limitations of the clamed product. A review of the instant specification does not indicate that the intended use requires any particular formulation to achieve the desired outcome of being for enteral administration. Thus, it is reasonable to conclude that the intended use does not confer any particular structural or composition limitation on the instant claims, See MPEP 2111.02.
Patent Eligibility Analysis The 2019 Patent Eligibility Guidance requires that one must answer a series of questions to determine if the claimed invention is directed to a statutory category of invention (i.e. Question #1), whether the claims recite a judicial exception (i.e. Question #2A-Prong I), whether any additional elements recited in the claim language direct the claimed invention to a practical application of any JE recited in the claims (i.e. Question #2A-Prong II), and whether any additional elements recited in the claim language cause the claims to read on something significantly more than just the judicial exception itself (i.e. Question #2B). See MPEP 2106.03-2106.05. Product of Nature Definition When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972,1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Question #1: Is the claim to a process, machine, manufacture or composition of matter? The instant claims are directed to a product that is a composition of matter. The answer to Question #1 is therefore “Yes”, the instant claims are directed to a statutory category of invention. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One).
Question #2a-Prong I: Does the claim recite an abstract idea, law of nature or natural phenomenon? YES
The instant claims are directed to a natural product. In addition, there is nothing in the language of the claims that would indicate that the claimed natural components to sodium chloride, potassium chloride, sodium acetate, sodium phosphate, calcium chloride, magnesium sulfate, and gluconate in water are in any way “markedly different” from their natural counterparts. There is nothing in the disclosure that indicates the recited concentrations of each naturally occurring ingredient result in a markedly different characteristic when combined in the recited concentrations.
Therefore, it is reasonable to conclude that the instant claims having ingredients which are naturally occurring does not significantly affect the characteristics of any of the natural products. The natural components in the instant claims are not ‘markedly different’ from their natural counterparts. The answer to Question 2A-Prong 1 is therefore “Yes”, the instant claims recite products of nature, which are judicial exceptions. The claims are directed to a judicial exception such as a natural phenomenon (e.g., product of nature) as the only compositional requirement set forth in the instant claims is that the composition comprises a combination of naturally occurring ingredients.
MPEP 2106.04(c) recites: “When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").”
Question #2A-Prong II: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO
The instant claims recite additional elements to the judicial exceptions. The additional elements are the preamble of the claim, which indicates that the claimed saline electrolyte composition is “for enteral infusion”. As indicated above, this limitation is merely an intended use limitation and does not convey any discernable structural or compositional limitation to the claimed product.
Question #2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO
The instant claims recite additional elements to the judicial exceptions of the claimed compositions and product combinations. The first additional element is the preamble of the claim, which indicates that the claimed composition is for administering via enteral infusion. As indicated above, this limitation is merely an intended use limitation and does not convey any discernable structural or compositional limitation to the claimed product. Furthermore, there is no indication that the claimed concentrations of each naturally occurring component amount to significantly more than the judicial exception. As noted by Cleveland Clinic, the human body requires electrolytes including magnesium, potassium, sodium, calcium, chlorine, phosphate. According to Vivere, acetate is naturally found in the body and is also a key component in many foods. As evidenced by Science Direct, sulfate is a component of major structural molecules found in the body and is also a component of mucus, see page 130 and table 10.2. There is no indication that each of the naturally occurring components claimed provide for significantly more than the judicial exception.
Therefore, combining the naturally occurring ingredients claimed would not provide significantly more than the judicial exception.
Accordingly, claims are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C § 101.
Conclusion
Currently claims 1 and 20 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
Prosecution Insights