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 .
Priority
The present application claims priority to the applications EP21203855.8 and PCT/EP2022/078764, with effective filing dates of 21 October 2021 and 17 October 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction Requirement filed, 30 June 2026.
Applicant’s election with traverse of Group III (claim 11) and species of carbohydrates in the reply filed on 30 June 2026 is acknowledged. The traversal is on the ground(s) that each independent claim has been amended to require that the amino acids are free amino acids and/or salts thereof.
However, this is not persuasive, because while Bevec (US 2010/0204110) no longer teaches a composition wherein threonine, serine, proline, leucine, and cysteine are free amino acids and/or salts thereof, a composition comprising threonine, serine, proline, leucine, and cysteine as free amino acids and/or salts thereof is not a special technical feature as it does not make a contribution over the prior art in view of Hofman (U.S. Patent No. 9,066,537, issued 30 June 2015). Hofman teaches an enteral composition having threonine, serine, proline, leucine, and cysteine as free amino acids (Table 2; column 9, lines 45-65). As such, in view of the above teachings a composition comprising threonine, serine, proline, leucine, and cysteine as free amino acids and/or salts thereof is not a special technical feature.
Claims 1-10, 12, and 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group (Group II: claims 1, 3, 5-10, and 12; Group II: claims 2, 4, and 16-22), there being no allowable generic or linking claim.
Claim 11 is under examination in the instant office action.
Information Disclosure Statement
The Information Disclosure Statements filed 19 Apr 2024 and the references cited therein have been considered, unless indicated otherwise.
Claim Interpretation
For clarity, the Examiner notes that claim 11 recites “an enteral nutritional composition comprising each of threonine, serine, proline, leucine, and cysteine, as free amino acids and/or salts thereof, in an amount of about 1.5 g/1000 kcal or more.” In light of Applicant’s specification, the Examiner interprets claim 11 to specify each of the recited amino acid components is present in the composition in the ratio of 1.5 g per 1000 kcal or are present in a higher ratio (e.g. 2 g per 1000 kcal of threonine; page 4, lines 13-30). The Examiner also notes that Applicant defined “about” to be ± 10% (see the specification, page 7, lines 13-15).
Specification
1. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “Compositions of free threonine, serine, proline, leucine, and cysteine and uses thereof.”
Drawings
2. The drawings are objected to under 37 CFR 1.83(a) because they fail to show discernible features as described in the specification for Figures 3D, 4A, 4B, 5, and 6 as the legend for the amino substrate and control/placebo are depicted as black or gray lines with no differentiation between the two. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim 11 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hofman (U.S. Patent No. 9,066,537, issued 30 June 2015) as evidenced by Flink (“What is Pea Protein, Exactly?” Abbot’s Food & Home¸ 2026, < abbots.com/our-journal/what-is-pea-protein-exactly-benefits-uses-pea>, accessed 12 Aug 2026).
Hofman teaches pea-based protein mixtures and the use thereof in a liquid nutritional composition for providing long-term complete enteral nutrition to patients in need thereof (abstract). Hofman teaches that patients may not be able to obtain the necessary nutrition by ingesting food through the mouth due to a variety of reasons (column 1, lines 28-31). Hofman teaches that the state of being fed by nutritional supplements and/or by a feeding tube is called enteral feeding, which is a part of enteral nutrition (column 1, lines 39-43). Hofman teaches that enteral nutrition contains a protein fraction, which at least meets and preferably exceeds the WHO amino acid profile recommendations for complete nutrition and that with advances in medicine resulting in increased life expectancy and better disease treatment, a large number of patients would benefit from such enteral nutrition designed to provide long-term enteral nutrition (column 1, lines 48-54). Hofman teaches that enteral nutrition should be easily digestible and not lead to upper gastrointestinal conditions or complications, such as intestinal discomfort, reflux, aspiration pneumonia, high gastric residual volume, vomiting, nausea, bloating, or delayed gastric emptying (column 1, lines 54-59). Hofman teaches that pea-based protein mixtures are well-tolerated, easy to administer, low viscosity, low density, pH neutral, good shelf stability, and suitable for heat treatment without substantial change in structure (column 2, lines 12-26). Hofman teaches the pea-based protein mixture has an amino acid profile with 9.8 g leucine, 1.4 g cysteine (which is within 10% of 1.5g), 5.6 g threonine, 6.5 g proline, and 5.9 g serine (Table 2, column 9, lines 45-65). Hofman teaches that pea-based protein mixture is preferably administered in a range of 1000 to 2500 kcal per daily dosage but depends upon the weight of the patient (column 11, lines 45-47), which has carbohydrates as evidenced by Flink. Flink teaches that pea protein has carbohydrates (page 1, paragraph 3).
Regarding claim 11, Hofman teaches a pea-based protein mixture, which has carbohydrates as evidenced by Flink. Flink teaches that pea protein has carbohydrates (page 1, paragraph 3). Hofman teaches that the pea-based protein mixture has an amino acid profile with 9.8 g leucine, 1.4 g cysteine, 5.6 g threonine, 6.5 g proline, and 5.9 g serine (Table 2, column 9, lines 45-65) and that that pea-based protein mixture is preferably administered in a range of 1000 to 2500 kcal per daily dosage but depends upon the weight of the patient (column 11, lines 45-47).
4. Claim11 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Whippie (US Patent No. 8,383,680, issued 26 Feb 2013).
Whippie teaches nutritional compositions for treating patients having impaired gastro-intestinal tract function (abstract). Whippie teaches that a traditional form of nutritional support has involved enterally administering whole protein liquid formula to a patient to remedy protein deficiency but that some patients requiring nutritional support have a compromised absorptive capacity and thus cannot tolerate whole protein liquid formulae (column 1, lines 46-52). Whippie teaches administering an enteral nutritional composition that has 13.0 g leucine, 5.0 g proline, 7.0 g threonine, 6.0 g serine, and 3.0 g cysteine (all shown as g/100 g total amino acids), which has an energy density of 1.0 kcal/mL (column 8, lines 10-11; column 9, lines 1-30). Additionally, Whippie teaches that the protein equivalent of the nutritional composition is 20% of the kcal and that the nutritional composition also comprises carbohydrates (70% of the kcal; column 9, lines 1-30). Whippie teaches that the free amino acids provide 20% of the total energy of the composition are 5 g/100 kcal of the total energy of the composition, which is optimal for adults and older children (10+ years old) for moderate tissue repair needs without imposing an undue nitrogen burden on renal function (column 5, lines 40-47). Additionally, Whippie teaches the composition also contains mineral and vitamins as required, which are measured in per 1000 kcal (e.g. magnesium and beta-carotene; column 7, lines 13-14; column 7, lines 34-35; column 7, lines 47-48). Accordingly, Whippie teaches in a 1000 kcal enteral composition, having an energy density value of 1.0 kcal/mL, there is 20% protein (free amino acids), which is 50 g of amino acid per the 1000 kcal of the composition (5 g/ 100 kcal; column 5 ,lines 40-47; column 9, lines 1-30). Of the 50 g free amino acids, Whippie teaches that there is 6.5 g leucine, 2.5 g proline, 3.5 g threonine, 3.0 g serine, and 1.5 g cysteine (column 9, lines 1-30). Calculation shown below for leucine:
13
g
c
y
s
t
e
i
n
e
100
g
t
o
t
a
l
a
m
i
n
o
a
c
i
d
s
=
x
g
c
y
s
t
e
i
n
e
50
g
t
o
t
a
l
a
m
i
n
o
a
c
i
d
s
, and thus, x = 6.5 g leucine.
Regarding claim 11, Whippie teaches an enteral nutritional composition having 6.5 g leucine, 2.5 g proline, 3.5 g threonine, 3.0 g serine, and 1.5 g cysteine as free amino acids per 1000 kcal (column 9, lines 1-30).
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.
5. Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 3-8 of copending Application No. 19/103,982 in view of Hofman (U.S. Patent No. 9,066,537, issued 30 June 2015) as evidenced by Flink (“What is Pea Protein, Exactly?” Abbot’s Food & Home¸2026, < abbots.com/our-journal/what-is-pea-protein-exactly-benefits-uses-pea>, accessed 12 Aug 2026).
This is a provisional nonstatutory double patenting rejection.
19/103,982 claims a nutritional blend composition A comprising at least three ingredients selected from the group consisting of vitamin B1, vitamin B2, vitamin B6, zinc, iron, copper, histidine, isoleucine, lysine, leucine, vitamin A, folate, magnesium, phosphorus, potassium, selenium, 3’-SL, alanine, cysteine, glutamic acid, phenylalanine, proline, serine, threonine, tyrosine, and valine (claim 1). ‘982 also claims that the leucine is in a daily amount ranging from about 0.6-4 g, cysteine is in a daily amount ranging from about 0.07-0.4 g, proline is in a daily amount ranging from about 0.6-3 g, serine is in a daily amount ranging from about 0.4-2 g, and threonine is in a daily amount ranging from about 0.3-2 g (claim 5).
Regarding claim 11, 982 fails to claim that the nutritional composition is an enteral composition, wherein each of threonine, serine, proline, leucine, and cysteine are present in an amount of 1.5g/1000 kcal or more.
Hofman teaches pea-based protein mixtures and the use thereof in a liquid nutritional composition for providing long-term complete enteral nutrition to patients in need thereof (abstract). Hofman teaches that patients may not be able to obtain the necessary nutrition by ingesting food through the mouth due to a variety of reasons (column 1, lines 28-31). Hofman teaches that the state of being fed by nutritional supplements and/or by a feeding tube is called enteral feeding, which is a part of enteral nutrition (column 1, lines 39-43). Hofman teaches that enteral nutrition contains a protein fraction, which at least meets and preferably exceeds the WHO amino acid profile recommendations for complete nutrition and that with advances in medicine resulting in increased life expectancy and better disease treatment, a large number of patients would benefit from such enteral nutrition designed to provide long-term enteral nutrition (column 1, lines 48-54). Hofman teaches that enteral nutrition should be easily digestible and not lead to upper gastrointestinal conditions or complications, such as intestinal discomfort, reflux, aspiration pneumonia, high gastric residual volume, vomiting, nausea, bloating, or delayed gastric emptying (column 1, lines 54-59). Hofman teaches that pea-based protein mixtures are well-tolerated, easy to administer, low viscosity, low density, pH neutral, good shelf stability, and suitable for heat treatment without substantial change in structure (column 2, lines 12-26). Hofman teaches the pea-based protein mixture has an amino acid profile with 9.8 g leucine, 1.4 g cysteine, 5.6 g threonine, 6.5 g proline, and 5.9 g serine (Table 2, column 9, lines 45-65) and that that pea-based protein mixture is preferably administered in a range of 1000 to 2500 kcal per daily dosage but depends upon the weight of the patient (column 11, lines 45-47), which has carbohydrates as evidenced by Flink. Flink teaches that pea protein has carbohydrates (page 1, paragraph 3).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to modify the composition of ‘982 with the composition of Hofman to create an enteral nutritional composition that is easily digestible, not lead to upper gastrointestinal conditions or complications, and is well-tolerated, easy to administer, low viscosity, low density, pH neutral, good shelf stability, and suitable for heat treatment without substantial change in structure. One or ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘982 claims a nutritional blend composition A comprising at least three ingredients selected from the group consisting of vitamin B1, vitamin B2, vitamin B6, zinc, iron, copper, histidine, isoleucine, lysine, leucine, vitamin A, folate, magnesium, phosphorus, potassium, selenium, 3’-SL, alanine, cysteine, glutamic acid, phenylalanine, proline, serine, threonine, tyrosine, and valine,
-‘982 also claims that the leucine is in a daily amount ranging from about 0.6-4 g, cysteine is in a daily amount ranging from about 0.07-0.4 g, proline is in a daily amount ranging from about 0.6-3 g, serine is in a daily amount ranging from about 0.4-2 g, and threonine is in a daily amount ranging from about 0.3-2 g,
-Hofman teaches pea-based protein mixtures and the use thereof in a liquid nutritional composition for providing long-term complete enteral nutrition to patients in need thereof,
-Hofman teaches that patients may not be able to obtain the necessary nutrition by ingesting food through the mouth due to a variety of reasons,
-Hofman teaches that the state of being fed by nutritional supplements and/or by a feeding tube is called enteral feeding, which is a part of enteral nutrition,
-Hofman teaches that enteral nutrition contains a protein fraction, which at least meets and preferably exceeds the WHO amino acid profile recommendations for complete nutrition and that with advances in medicine resulting in increased life expectancy and better disease treatment, a large number of patients would benefit from such enteral nutrition designed to provide long-term enteral nutrition,
-Hofman teaches that enteral nutrition should be easily digestible and not lead to upper gastrointestinal conditions or complications, such as intestinal discomfort, reflux, aspiration pneumonia, high gastric residual volume, vomiting, nausea, bloating, or delayed gastric emptying,
-Hofman teaches that pea-based protein mixtures are well-tolerated, easy to administer, low viscosity, low density, pH neutral, good shelf stability, and suitable for heat treatment without substantial change in structure, and
-Hofman teaches the pea-based protein mixture has an amino acid profile with 9.8 g leucine, 1.4 g cysteine, 5.6 g threonine, 6.5 g proline, and 5.9 g serine and that that pea-based protein mixture is preferably administered in a range of 1000 to 2500 kcal per daily dosage but depends upon the weight of the patient, which has carbohydrates as evidenced by Flink. Flink teaches that pea protein has carbohydrates.
Accordingly, the combination of ‘982 and Hofman as evidenced by Flink teaches an enteral nutritional composition comprising threonine, serine, proline, leucine, and cysteine, as free amino acids and/or salts thereof, in an amount of about 1.5 g/1000 kcal or more.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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, James Alstrum-Acevedo can be reached at 571-272-5548. 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.
/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights