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 . 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.
Information Disclosure Statement
The information disclosure statement filed 29 Aug, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. There were several citations for which no corresponding document could be found in the application data file. Thus, they were not considered. Note that there was one document in the application data file that was illegible. It was not possible to correlate the document with a citation, so it was not considered. Note that when documents are loaded onto the USPTO server, there is usually some loss of resolution. While the document applicants uploaded may have been legible, the copy with the application is not.
Election/Restrictions
Applicant’s election without traverse of group I and a formulation with sodium, a caloric sweetener, and one or more of Ala and Asp in the reply filed on 1 July, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants elected a formulation with sodium, a caloric sweetener, and one or more of Ala and Asp. A search was conducted for this invention, and a reference was found that anticipated it. As a result, claim 1 was examined and claims 7, 8, and 10-27 have been withdrawn from consideration. Applicants have implied that claims 7, 8, 10, and 22-27 read on the election, but those claims all describe non-elected features. Thus, they are properly withdrawn.
Claims Status
Claims 1, 7, 8, 10, and 22-27 are pending.
Claims 1 and 8 have been amended.
Claims 22-27 are new.
Claims 7, 8, 10, and 22-27 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 July, 2026.
Examiner’s Note
While the anticipation rejection of this office action relies on free amino acids, it is clear from applicant’s disclosure that the amino acids of the claims can be in the form of protein and complexes, note claim 12, for example.
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.
Claim 1 is rejected under 35 U.S.C. 101 because it reads on a judicial exception (natural phenomenon).
The Supreme Court has given a 2 part test for eligibility under this statute:
1) Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
The claim is drawn to a formulation, a composition of matter, passing the first test.
2a) Every component of the formulation occurs naturally. For example, whole milk has 98 mg sodium per cup (Pima heart and vascular (2021) https://www.pimaheartandvascular.com/wp-content/uploads/2021/04/Sodium-Content-of-common-foods.pdf), lactose (a caloric sweetener) levels of around 4% (Tirlan farmlife blog, post of 2 Sept, 2016, 2nd page, 1st through 3d paragraphs), and roughly a mg/100 mL of Ala and ¾ mg/100 mL of Asp (free amino acids)(Landi et al, Foods (2021) 10 2431, table 2, 6th page, bottom of page). As these compounds all exist naturally, the judicial exception of a natural phenomenon applies.
2b) As natural products containing all three components of applicant’s invention occur naturally, there can be nothing beyond the natural product. Thus, the claim lacks patent eligibility.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1 is 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.
There are a number of issues with the claim. First, the claim requires a faster or longer lasting hydration. This leads to two issues. First, faster or longer compared to what? Tap water? Gatorade? Sea water? Second, the test is not defined. This could be feelings of thirst, sweat osmolarity, plasma osmolarity, or some other measurement.
Second, it is not clear what is meant by a caloric sweetener. Any organic compound, when burned in a bomb calorimeter, will produce energy measured in calories.
Claim Rejections - 35 USC § 102
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) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ozselek et al (Bull. Clin. Psychopharmcol. (2012) 22(Suppl. 1) S127), with evidentiary support from the USCF web page on blood testing (2015), Sterns (N. Engl. J. Med. (2015) 372 p55-65) and Guemes et al (Arch. Dis. Child (2016) 101 p569-574).
Ozelek et al discus a case of autovampirism (title). The patient felt a compulsion to drink blood, his own and others (abstract, 2nd paragraph). As evidenced by the USCF web page, blood in adults has a free Ala content of 125-564 µmol/L and Asp levels between 1 and 7 µmol/L (3d page, section “normal results”, continues to 4th page). As evidenced by Sterns, plasma sodium concentrations are typically between 135-142 mmol/L (abstract). As evidenced by Guemes et al, blood glucose levels are typically between 3.5-5.5 mmol/L in adults (abstract). In other words, the patient of Ozelek et al was consuming a material with sodium, Ala, Asp, and glucose (a caloric sweetener). It is reasonable to assume that there is a formulation that provides inferior hydration, such as sea water or dry formulations, so Ozelek et al anticipates claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
first rejection
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 18/870,139 in view of Xu et al (US 8,993,032, cited by applicants).
Competing claim 1 describes a composition for fast and long lasting hydration, comprising an active ingredient. Competing claim 5 specifies that the active ingredient is a mixture of sodium salts (sodium electrolyte).
The difference between the competing claims and the examined claims is that the competing claims do not discuss an amino acid and a sweetener.
Xu et al discuss hydration drinks (abstract). These can have a sweetener selected from a Markush group comprising Ala (column 11, line 64) and sucrose (column 12, line 11).
Therefore, it would be obvious to add the alanine and sucrose of Xu et al to the formulation of the competing claims, to provide a sweeter, more palatable formulation. As both the competing claims and Xu et al are using the formulations for the same purpose, an artisan in this field would attempt this addition with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
second rejection
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -3, 26, and 27 of copending Application No. 19/512,215 in view of Silk et al (Clin. Sci Mol. Med. (1975) 49 p401-408).
Competing claim 1 describes an oral composition comprising a nutritive sweetener (interpreted as a caloric sweetener) and an active ingredient, while claims 2-3 specify the active ingredient to include electrolytes, specifically, sodium electrolytes. Competing claims 26 and 27 specify that the formulation is for hydration.
The difference between the competing claims and the examined claims is that the competing claims do not specify an amino acid.
Silk et al teach that Ala stimulates absorption of water and sodium from orally administered solutions (abstract).
Therefore, it would be obvious to add Ala to the formulation of the competing claims, to improve uptake of water and sodium. As Silk et al clearly show that this amino acid will assist with this, an artisan in this field would attempt this modification with a reasonable expectation of success.
third rejection
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 18/848,338 (US 20250204556) in view of Xu et al (US 8,993,032, cited by applicants).
Competing claim 1 describes an enhanced water composition. Competing claim 9 specifies that the comprise an electrolyte selected from a Markush group that includes sodium salts (sodium electrolyte).
The difference between the competing claims and the examined claims is that the competing claims do not discuss an amino acid and a sweetener.
Xu et al discuss hydration drinks (abstract). These can have a sweetener selected from a Markush group comprising Ala (column 11, line 64) and sucrose (column 12, line 11).
Therefore, it would be obvious to add the alanine and sucrose of Xu et al to the formulation of the competing claims, to provide a sweeter, more palatable formulation. As both the competing claims and Xu et al are using the formulations for the same purpose, an artisan in this field would attempt this addition with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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