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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 07/24/2026, claims 1-9, 11, and 16-23 are amended, claim 13 is canceled, and claims 24-25 are newly added. Currently, claims 1-9, 11, and 16-25 are pending in the instant application.
Claim Objections - Withdrawn
Objections to claims 3-9, 11, and 16-23:
In light of Applicant’s amendment to the claims, the objections are hereby withdrawn. The indicated claims have been amended for grammatical clarity.
Claim Rejections - 35 USC § 112 – Withdrawn
Rejections of claims 8 and 21:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. Each of claims 8 and 21 now recite the inclusion of protein and no longer provide improper antecedence.
Claim Rejections - 35 USC § 112 Second Paragraph – Maintained
Claims 4 and 17 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.
Rejection of claims 4 and 17:
Applicant’s amendments to the claims are not sufficient to overcome the rejections. The rejections are hereby maintained. Claim 4 has been amended to recite wherein the composition of claim 1 is administered in an amount effective to improve muscle mass and/or strength. Claim 17 has been amended to recite wherein the composition of claim 2 is administered in an amount effective to improve muscle mass and/or strength. While the claims at hand are no longer directed towards an intended use of the compositions, they remain indefinite because a person of ordinary skill in the art would still not reasonably be able to understand the metes and bounds of the claims. The parent claims of claims 4 and 17 are directed towards a method of preventing or reducing a glutamine or arginine deficiency and preventing or reducing muscle loss, respectively. A person of ordinary skill in the art would not reasonably be able to identify an “amount effective” to achieve the improved muscle mass or strength from either the recitation of the claims or the disclosure.
Claim Rejections - 35 USC § 112 Second Paragraph – New grounds of Rejection
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 24 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.
Claim 24 is indefinite for reciting the units “g/kg/day”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. Claim 1 is drawn to a method of reducing glutamine and/or arginine deficiency by administering an amino acid composition. The instant claim appears to be attempting to further limit the contents of said amino acid composition by use of the term “present”, however, the units “g/kg/day” appear to be drawn to a dosing amount. Accordingly, the instant claim does not align with the limitations of the parent claim.
Claim Rejections - 35 USC § 103 – Withdrawn
Rejections of claims 1-9, 11, and 16-23:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. Independent claims 1 and 2 are now drawn to the administration of compositions comprising threonine, serine, proline, leucine, and cysteine, but not glutamine and/or arginine. The teachings of Smith (previously referenced) are drawn to compositions of amino acids which include both glutamine and arginine. However, the claims at hand now provide new grounds for rejection which will be discussed herein.
Claim Rejections - 35 USC § 103 – New Grounds of Rejection
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9, 11, and 16-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janow in view of Morris.
Claim 1 recites a method for use in preventing and/or reducing glutamine deficiency and/or arginine deficiency in a subject, the method comprising administering to the subject an amino acid composition comprising each of threonine, serine, proline, leucine, and cysteine as a free amino acid, or salt thereof, wherein the amino acid composition does not comprise glutamine and/or arginine as a free amino acid or salt thereof.
Janow teaches compositions comprising rice protein isolate, further comprising amino acids, and methods of use thereof for achieving muscle maintenance and decreased muscle loss. Janow provides an exemplary rice protein isolate having the following amino acid constitution (specification [0119]):
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As can be seen above, threonine, serine, proline, leucine, and cysteine are present in the rice protein isolate at amounts of 35 mg/g, 49 mg/g, 45 mg/g, 80 mg/g, and 21 mg/g, respectively, and the formulation does not contain glutamine.
While Janow teaches a composition comprising the recited amino acids while not comprising arginine and/or glutamine, Janow does not explicitly teach the use of said composition for treating an arginine and/or glutamine deficiency. However, it would be obvious for a person of ordinary skill in the art to utilize the composition of Janow to treat such a condition because Morris teaches that such conditions may be reversed using amino acid supplementation, and there would be a reasonable expectation of success in such treatment.
Morris provides an overview of glutamine deficiency, arginine deficiency, related diseases, and methods of treating each. Morris indicates that glutamine and arginine are considered as conditionally essential amino acids Where a person having a poor clinical outcome due to an amino acid deficiency, Morris indicates that such conditions may be reversed using amino acid supplementation. Examples of such situations being the use of arginine supplementation wherein arginine deficiency is associated with trauma or sickle cell disease (SCD) (page 36)1.
Given that Morris teaches the treatment of arginine deficiency and related conditions by amino acid supplementation (such as with arginine), and Janow teaches amino acid compositions comprising arginine, it would have been prima facie obvious at the time of invention for a person of ordinary skill in the art to be able to utilize the composition of Janow for the treatment of glutamine and/or arginine deficiency.
Claim 2 recites a method of preventing and/or reducing muscle loss in a subject, wherein the subject is at risk of or has a glutamine deficiency and/or an arginine deficiency, the method comprising administering to the subject an amino acid composition comprising each of threonine, serine, proline, leucine, and cysteine as a free amino acid, or salt thereof, wherein the amino acid composition does not comprise glutamine and/or arginine as a free amino acid or salt thereof.
As iterated in the rejection of claim 1, Janow teaches compositions comprising the recited amino acids while not comprising arginine and/or glutamine, and methods of use of said compositions for muscle growth, muscle maintenance, and decreased muscle loss.
Janow does not explicitly teach the use of their compositions for preventing and/or reducing muscle loss in subjects having glutamine and/or arginine deficiency. However, it would be obvious to apply the compositions of Janow to subjects having glutamine and/or arginine deficiency because Morris teaches the administration of amino acids to subjects having such deficiencies, and there would be a reasonable expectation of success in treatment.
Morris provides an overview of glutamine deficiency, arginine deficiency, related diseases, and methods of treating each. Morris indicates that glutamine and arginine are considered as conditionally essential amino acids Where a person having a poor clinical outcome due to an amino acid deficiency, Morris indicates that such conditions may be reversed using amino acid supplementation. Examples of such situations being the use of arginine supplementation wherein arginine deficiency is associated with trauma or sickle cell disease (SCD) (page 36)2. Morris further indicates that critical illness is also associated with muscle catabolism wherein muscle is degraded and used as a source of protein in situations wherein amino acid supply is reduced or where amino acid demand is increased (page 36)3.
Given the teachings of Janow and Morris, it would have been prima facie obvious for a person of ordinary skill in the art to administer the composition of Janow to a subject having an arginine and/or glutamine deficiency, because there would have been a reasonable expectation of success in maintaining muscle or decreasing muscle loss in such a subject.
Claim 3 further limits the method of claim 1 wherein the subject is a critically ill patient and has a condition selected from the group consisting of: sepsis, acute respiratory failure, trauma, surgery, shock, pancreatitis, severe burns, mucositis, inflammatory bowel disease, distorted gut barrier, intestinal mucosal lesions, and short-bowel syndrome.
Morris teaches that supplementation with glutamine or arginine may be useful for treating arginine deficiency associated with trauma in critically ill patients.
Claim 4 further limits the method of claim 1 wherein the amino acid composition is administered in an amount effective to improve muscle mass and/or strength.
As iterated previously, the teachings of Janow are directed to achieving muscle growth by administering an effective amount of amino acid composition.
Claim 5 further limits the method of claim 1 therein the amino acid composition is administered by enteral administration.
Compositions of Janow are indicated as being formulated for oral ingestion which is considered an enteral form of administration.
Claim 6 further limits the method of claim 1 wherein the amino acid composition is in a form selected from the group consisting of a nutritional composition, supplement, and fortifier.
The compositions of Janow are considered as supplements (Abstract)4.
Claim 7 further limits the method of claim 1 wherein the subject is administered each of threonine, serine, proline, leucine, and cysteine in an amount of about 0.02 g/kg/day or more.
Janow teaches compositions comprising rice protein isolate, further comprising amino acids, and methods of use thereof for achieving muscle maintenance and decreased muscle loss. Janow provides an exemplary rice protein isolate having the following amino acid constitution (specification [0119]):
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As can be seen above, threonine, serine, proline, leucine, and cysteine are present in the rice protein isolate at amounts of 35 mg/g, 49 mg/g, 45 mg/g, 80 mg/g, and 21 mg/g, respectively. According to Janow, the above rice protein isolate was administered to subjects in an amount of 48g, wherein the subjects had an initial baseline body weight of about 60 kg (specification [0123]). Accordingly, for each of the aforementioned amino acids, the amount administered would be greater than 0.02 g/kg/day.
Claim 8 further limits the method of claim 1 wherein the composition comprises protein and the subject is administered each of threonine, serine, proline, leucine, and cysteine in an amount of about 1% or more as a percentage of total protein.
Per Janow Table 2, the rice protein isolate composition comprises about 3.5% threonine, 4.9% serine, 4.5% proline, 8% leucine, and 2.1% cysteine as a percentage of total protein.
Claim 9 further limits the method of claim 1 wherein the amino acid composition comprises each of threonine, serine, proline, leucine, and cysteine in an amount of about 0.5 mg/1000kcal.
Janow indicates that the rice protein isolate of Table 2 is the result of an amino acid profile analysis of commercially available Growing Naturals Rice Protein Isolate wherein said isolate is accompanied by the following nutrition label (Figure 1A):
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As can be seen from the label above, a serving of 34 g is equivalent to about 120 Calories (kcal). When applied to the analyzed values of Table 2, the amounts of threonine, serine, proline, leucine, and cysteine are each greater than 0.5 mg/1000 kcal.
Claim 11 further limits the method of claim 1 wherein the amino acid composition comprises:
from about 1 g/1000kcal to about 20 g/1000kcal, from about 2 g/1000kcal to about 15 g/1000kcal, or from about 3 g/1000kcal to about 10 g/1000kcal threonine;
from about 1 g/1000kcal to about 16 g/1000kcal, from about 2 g/1000kcal to about 12 g/1000kcal, or from about 3 g/1000kcal to about 8 g/1000kcal serine;
from about 0.5 g/1000kcal to about 16 g/1000kcal, from about 1 g/1000kcal to about 12 g/1000kcal, or from about 1.5 g/1000kcal to about 8 g/1000kcal proline;
from about 1 g/1000kcal to about 20 g/1000kcal, from about 1.5 g/1000kcal to about 16 g/1000kcal, or from about 2 g/1000kcal to about 12 g/1000kcal leucine; and/or
from about 1 g/1000kcal to about 10 g/1000kcal, from about 1.5 g/1000kcal to about 7.5 g/1000kcal, or from about 2 g/1000kcal to about 5 g/1000kcal cysteine
As iterated in the rejection of claim 9, Janow provides that the rice protein isolate composition contains about 120 kcal per 34g. The equivalent weight of composition per 1000 kcal would be about 283.3 g. Accordingly, per Janow’s Table 2, a 283.3 g (1000 kcal) of the rice protein isolate composition would comprise about 9.92 g threonine, 13.88 g serine, 12.75 g proline, and 5.95 g cysteine.
Claim 16 further limits the method of claim 2 wherein the subject is a critically ill patient and has a condition selected from the group consisting of: sepsis, acute respiratory failure, trauma, surgery, shock, pancreatitis, severe burns, mucositis, inflammatory bowel disease, distorted gut barrier, intestinal mucosal lesions, and short-bowel syndrome.
Morris teaches that supplementation with glutamine or arginine may be useful for treating arginine deficiency associated with trauma in critically ill patients.
Claim 17 further limits the method of claim 2 wherein the amino acid composition is administered in an amount effective to improve muscle mass and/or strength.
As iterated previously, the teachings of Janow are directed to achieving muscle growth by administering an effective amount of amino acid composition.
Claim 18 further limits the method of claim 2 wherein the amino acid composition is administered by enteral administration.
Compositions of Janow are indicated as being formulated for oral ingestion which is considered an enteral form of administration.
Claim 19 further limits the method of claim 2 wherein the amino acid composition is in a form selected from the group consisting of a nutritional composition, supplement, and fortifier.
The compositions of Janow are considered as supplements.
Claim 20 further limits the method of claim 2 wherein the subject is administered each of threonine, serine, proline, leucine, and cysteine in an amount of about 0.02 g/kg/day or more.
Janow teaches compositions comprising rice protein isolate, further comprising amino acids, and methods of use thereof for achieving muscle maintenance and decreased muscle loss. Janow provides an exemplary rice protein isolate having the following amino acid constitution (specification [0119]):
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As can be seen above, threonine, serine, proline, leucine, and cysteine are present in the rice protein isolate at amounts of 35 mg/g, 49 mg/g, 45 mg/g, 80 mg/g, and 21 mg/g, respectively. According to Janow, the above rice protein isolate was administered to subjects in an amount of 48g, wherein the subjects had an initial baseline body weight of about 60 kg (specification [0123]). Accordingly, for each of the aforementioned amino acids, the amount would be greater than 0.02 g/kg/day.
Claim 21 further limits the method of claim 2 wherein the composition comprises protein and the subject is administered each of threonine, serine, proline, leucine, and cysteine in an amount of about 1% or more as a percentage of total protein.
Per Janow Table 2, the rice protein isolate composition comprises about 3.5% threonine, 4.9% serine, 4.5% proline, 8% leucine, and 2.1% cysteine as a percentage of total protein.
Claim 22 further limits the method of claim 2 wherein the amino acid composition comprises each of threonine, serine, proline, leucine, and cysteine in an amount of about 0.5 mg/1000kcal or more.
Per Janow Fig. 1A (see rejection of claim 9), a serving of 34 g is equivalent to about 120 Calories (kcal). When applied to the analyzed values of Table 2, the amounts of threonine, serine, proline, leucine, and cysteine are each greater than 0.5 mg/1000 kcal.
Claim 23 further limits the method of claim 2 wherein the amino acid composition comprises:
from about 1 g/1000kcal to about 20 g/1000kcal, from about 2 g/1000kcal to about 15 g/1000kcal, or from about 3 g/1000kcal to about 10 g/1000kcal threonine;
from about 1 g/1000kcal to about 16 g/1000kcal, from about 2 g/1000kcal to about 12 g/1000kcal, or from about 3 g/1000kcal to about 8 g/1000kcal serine;
from about 0.5 g/1000kcal to about 16 g/1000kcal, from about 1 g/1000kcal to about 12 g/1000kcal, or from about 1.5 g/1000kcal to about 8 g/1000kcal proline;
from about 1 g/1000kcal to about 20 g/1000kcal, from about 1.5 g/1000kcal to about 16 g/1000kcal, or from about 2 g/1000kcal to about 12 g/1000kcal leucine; and/or
from about 1 g/1000kcal to about 10 g/1000kcal, from about 1.5 g/1000kcal to about 7.5 g/1000kcal, or from about 2 g/1000kcal to about 5 g/1000kcal cysteine
As iterated in the rejection of claim 22, Janow provides that the rice protein isolate composition contains about 120 kcal per 34g. The equivalent weight of composition per 1000 kcal would be about 283.3 g. Accordingly, per Janow’s Table 2, a 283.3 g (1000 kcal) of the rice protein isolate composition would comprise about 9.92 g threonine, 13.88 g serine, 12.75 g proline, and 5.95 g cysteine.
Claim 25 further limits the method of claim 1 wherein the composition comprises protein and the subject is administered:
threonine in an amount from 5-16% total protein
serine in an amount from 4-16% total protein
proline in an amount from 1-16% total protein
leucine in an amount from 3-18% total protein
cysteine in an amount from 2-10% protein
Per Table 2 of Janow, the subjects were administered composition having threonine in an amount of 3.5% of total protein, serine in an amount of 4.9% of total protein, proline in an amount of 4.5% of total protein, leucine in an amount of 8% of total protein, and cysteine in an amount of 2.1% of total protein.
Conclusion
Claims 1-9, 11, and 16-25 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “A nutrition deficiency is only present if the biological processes that depend on the nutrient are compromised and if this compromise leads to abnormal physiologic responses that are causative of poor clinical outcomes. Based on the principles of causality, the poor out-comes linked to the deficiency should ultimately be reversed by therapeutic replacement of that amino acid.117 Accumulating data support the notion of an arginine deficiency syndrome that may benefit from supplementation in trauma47,117 and in SCD8that meets these criteria of causality. For example, pulmonaryhypertension90 and leg ulcers118–121 are SCD-related clinical phenotypes of arginine deficiency that are reversed with arginine supplementation.”
2 “A nutrition deficiency is only present if the biological processes that depend on the nutrient are compromised and if this compromise leads to abnormal physiologic responses that are causative of poor clinical outcomes. Based on the principles of causality, the poor out-comes linked to the deficiency should ultimately be reversed by therapeutic replacement of that amino acid.117 Accumulating data support the notion of an arginine deficiency syndrome that may benefit from supplementation in trauma47,117 and in SCD8that meets these criteria of causality. For example, pulmonaryhypertension90 and leg ulcers118–121 are SCD-related clinical phenotypes of arginine deficiency that are reversed with arginine supplementation.”
3 “Critical illness is associated with an adaptive metabolic stress response that is characterized by muscle catabolism. A reduced supply of amino acids from the diet or increased demand for amino acids from catabolic disease will contribute to increased protein degradation from muscle, which is the largest reservoir of protein, to ensure bodily functions.”
4 “Some embodiments relate to nutritional Supplements comprising rice protein isolate.”
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