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
The preliminary amendment filed 05/12/2023, cancelled claims 1-15 and added claims 16-36.
Claims 16-36 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See, for example, [0054] of the instant specification.
Claim Objections
Claim 16 is objected to because of the following informalities:
-in part (C), deoxycarnitine and gamma-butyrobetaine are synonyms. As such, one of these terms should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a) a method of increasing kidney health by administering 12.35 and 24.7 g serine, 2.55 and 5.1 g of N-acetylcysteine, 3.73 and 7.46 g L-carnitine tartrate, and 1 and 2 g nicotinamide riboside chloride, and a method of treating renal failure by administering a composition comprising lysine, glycine, serine, cysteine, carnitine, niacinamide (i.e., nicotinamide) does not reasonably provide enablement for a method of treating or preventing hyperuricemia, gout, and/or renal impairment in a subject comprising administering:
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. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
Independent claim 16 recites the following:
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, which encompasses a great number of possible combinations since each of the four categories can comprise one of the recited compounds or up to all of the recited compounds, and the method encompasses administration of a combination of a single compound of A)-D), or all of the compounds in A)-D).
As such, the breadth of the claims is great.
Level of Skill in Art
The level of skill in the art is a clinician or an artisan with a PhD.
State of the Prior Art
US 5,728,678 to Trimbo (published 1998, PTO-892) teaches a composition for providing nutrition to a patient suffering from or at risk of renal failure and a method for providing nutrition to a patient suffering from or at risk of renal failure comprising administering to the patient the following composition:
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(Cols. 7-10, claims 1-23), and Trimbo teaches the composition as having the following amino acid profile:
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(Cols. 7-8, claim 5).
Thus, Trimbo teaches a composition comprising lysine, glycine, serine, carnitine niacinamide (i.e., nicotinamide), and cysteine for the treatment of renal failure.
EP 3677263 to Oshima (IDS of 05/12/2023), teaches a combination of glycine and tryptophan for decreasing uric acid levels (abstract), which may be beneficial in treating gout and hyperuricemia ([0027]).
Sochman (Prevention of contrast agent-induced renal impairment in patients with chronic renal insufficiency and heart disease by high-dose intravenous N-acetylcysteine: a pilot ministudy, Kardiologia Polska, IDS of 05/12/2023) teaches that a high intravenous dose of N-acetylcysteine prevents contrast agent-induced renal impairment (abstract).
WO 2018/117954 to Mardinoglu (IDS of 05/12/2023) teaches administering the instantly claimed combination of A)-D) for the treatment of liver disease, type 2 diabetes, obesity, insulin resistance and dyslipidemia (abstract).
Thus, the prior art teaches specific combinations of instant A)-D) or single agents of instant A)-D) for the treatment of renal failure, gout, hyperuricemia, or contrast-induced renal impairment, and the prior art teaches the instantly claimed composition for the treatment of liver disease, type 2 diabetes, obesity, insulin resistance and dyslipidemia.
Predictability in the Art
Lin (Kidney Health and Care: Current Status, Challenges, and Developments, Jn of Personalized Med, PTO-892) teaches that it is unclear whether the existing chronic kidney disease (CKD) care systems are optimal for improving patient prognosis and outcomes and that even under the general care principles, there are still significant gaps in our understanding of the causes of CKD, prevention or care resources, and care burdens between countries and worldwide (abstract).
Lin further teaches that the care and management of CKD patients is more challenging than for other common chronic diseases (pg. 2, 1st full paragraph).
Breyer (The Next Generation of Therapeutics for Chronic Kidney Disease, Nat. Reve. Drug Discov., PTO-892) teaches that at present there is no cure for most forms of chronic kidney disease, and that although steroids and other immunosuppressive measurements can halt or reverse some diseases of the kidney, they have not shown benefit in kidney disease in patients with diabetes and hypertension (pg. 2, last full paragraph).
Breyer teaches that while angiotensin converting enzyme inhibition/receptor blockade therapy slows the progression of renal disease, it does not halt disease progression (pg. 3).
Breyer teaches that while renin inhibition blocks the renin angiotensin system, there are significant safety concerns (pg. 5).
Breyer teaches that blockage of endothelin A is associated with renal protection when used in combination with existing therapies, but that it increases fluid retention and heart failure (pg. 7).
And Breyer teaches several other possible treatments and new pathways for treating kidney disease on pgs. 7-12, and states “While these pathways may therefore represent new and potentially attractive therapeutic targets, at present, further studies are needed to better differentiate the profibrotic and regenerative activities” (pg. 12).
Breyer ends by stating that drug development for CKD has lagged behind other therapeutic areas and that systemic engagement of the pharmaceutical industry has been lacking, partly due to lack of success, operational difficulties, and long duration outcome trials.
In view of the teachings of Lin and Breyer, treating kidney disease in general, and specifically with pharmacological agents, is unpredictable.
Working Examples
The instant specification provides two examples beginning on pg. 14. The first example begins by stating, “The main aim of the study was to establish metabolic improvements in NAFLD subjects by dietary supplementation with N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside, and serine,” wherein NAFLD is non-alcoholic fatty liver disease, and the L-carnitine tartrate is outside the scope of the instantly claimed method since the instant claim only recite “carnitine.”
Subjects received the following amounts of these substances in the following dosage regimen:
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(pgs. 16-17, Specification).
Regarding the results, the Specifications states the following:
- “an analysis of the results of the biochemical tests showed significantly reducing serum uric acid levels” ([0065]);
-“Before taking the mixture of the four substances, the average uric acid serum level in the (to be) treated group was 6.9mg/dl, which is above the lower limit that commonly defines hyperuricemia (i.e. 6,8 mg/dl). After taking said mixture, the average uric acid serum level was well below 6,8mg/dl” ([0068]); and
-“In the art, serum creatine is considered to be an indicator of kidney health. Elevated serum creatine levels have been associated with renal impairment. . .Figure 4A shows significantly reduced serum creatinine levels in the treat group after 70 days, hence indicating improved kidney health” ([0069]).
The second example measures the creatinine and uric acid fold change in rats that are administered a high fat diet, and serine, N-acetylcysteine, L-carnitine tartrate, and/or nicotinamide.
However, the instant examples provide no correlation between measuring these levels and treating or preventing hyperuricemia, gout, and/or renal impairment.
And the instant examples are limited to a single compound from each of categories A)-D).
Direction and Guidance
In view of the state of the prior art, the unpredictability of the prior art, and the two narrow working examples that show no method of treating or preventing any type of kidney disorder, the instant specification lacks sufficient direction and guidance to use the invention as instantly claimed.
Quantity of Experimentation
In view of the great number of combinations of A)-D) and the vast number of patient populations encompassed by treating or preventing hyperuricemia, gout, and/or renal impairment, the amount of experimentation would be astronomical, amounting to invention and not development; it is an undue amount of experimentation.
Thus, while being enabling for a) a method of increasing kidney health by administering 12.35 and 24.7 g serine, 2.55 and 5.1 g of N-acetylcysteine, 3.73 and 7.46 g L-carnitine tartrate, and 1 and 2 g nicotinamide riboside chloride, and a method of treating renal failure by administering a composition comprising lysine, glycine, serine, cysteine, carnitine, niacinamide (i.e., nicotinamide), the specification does not reasonably provide enablement for a method of treating or preventing hyperuricemia, gout, and/or renal impairment in a subject comprising administering:
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.
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-20, 22-25, and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,728,678 to Trimbo (published 1998, PTO-892), as evidenced by PubChem (Nicotinamide, PTO-892).
Trimbo teaches a composition for providing nutrition to a patient suffering from or at risk of renal failure and a method for providing nutrition to a patient suffering from or at risk of renal failure comprising administering to the patient the following composition:
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(Cols. 7-10, claims 1-23).
Trimbo teaches the composition as having the following amino acid profile:
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(Cols. 7-10, claims 5, 11, 20-21).
Trimbo exemplifies a composition comprising lysine, glycine, serine, carnitine niacinamide (i.e., nicotinamide) (Col. 6, lines 50-65). As evidenced by PubChem, niacinamide is nicotinamide.
Regarding claim 16, while Trimbo exemplifies a composition comprising serine, glycine, carnitine, lysine, and niacinamide, it differs from that of instant claim 16, in that it does not contain “B).”
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add cysteine, to the exemplified composition of Trimbo, to arrive at instant claim 16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Trimbo teaches cysteine as part of the amino acid profile of the protein source in its compositions, and
-Trimbo teaches cysteine as part of the preferred amino acids with serine, glycine, lysine, which are in the exemplified composition (Col. 4, lines 15-40).
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at an optimal amino acid combination to treat renal failure.
Regarding claim 17, since A)-D) are in a single composition, they are administered simultaneously.
Regarding claim 18, Trimbo teaches administering the composition to a subject.
Regarding claims 19 and 30-32, Trimbo teaches 7.1-8.6 mole % glycine (A), 3-3.5 mole % serine (A), and 0.6 to 1.1 mole % cysteine (B), meeting the instantly claimed ratio.
Regarding claims 20, Trimbo teaches 7.1-8.6 mole % glycine (A), 3-3.5 mole % serine (A), and 5.5 to 6.6 mole % lysine (C), meeting the instantly claimed ratio.
Further regarding claims 19-20 and 30-32, in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists (MPEP 2144.05).
The optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences. It has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 22, Trimbo teaches serine and glycine.
Regarding claim 23, Trimbo teaches cystine.
Regarding claim 24, Trimbo teaches carnitine.
Regarding claim 25, Trimbo teaches nicotinamide (i.e., niacinamide).
Regarding claim 29, Trimbo teaches L-serine.
Regarding claim 33, Trimbo does not teach a molar ratio of A) to C) of between 30:1 and 3:1.
Trimbo teaches that the administration of the composition may be varied to refine the responsiveness of the renal failure patient in the particular clinical circumstances at hand, such as progress and extent of renal failure, the presence of complications or disease states, and whether or not dialysis is concurrent. These factors and the degree of dietary protein restriction, if any, are balanced to arrive at optimal maintenance (Col. 6, lines 26-44).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the molar ratio of A) to C), to arrive at instant claim 33. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Trimbo teaches that its composition may be varied to refine the responsiveness of the renal failure patient in the particular clinical circumstance, such as progress and extent of renal failure, the presence of complications or disease states, whether or not dialysis is concurrent, and the degree of dietary protein restriction, to arrive at optimal maintenance, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)).
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at an optimized method of treating kidney failure.
Claims 21, 27-28, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,728,678 to Trimbo (published 1998, PTO-892), as applied to claims 16-20, 22-25, and 29-33 above, and further in view of US 2020/0069624 to Reiner (published 03/2020, PTO-892) and Maurer (Dose Predictions for Drug Design, Jn of Medicinal Chem, published 01/2020, PTO-892).
Trimbo is applied as discussed above and incorporated herein.
Regarding claims 21, 27-28, and 34-36, while Trimbo teaches a method of treating renal failure by administering a composition comprising serine, glycine, cysteine, carnitine, lysine, and niacinamide, it differs from that of instant claims 21, 27-28, and 34-36, in that it does not teach an amount of niacinamide, and thus a molar ratio of A) to D), and does not teach mmol/kg/day or mmol/day dosages.
As discussed above, Trimbo teaches that the administration of its compositions are varied to refine the responsiveness of the renal failure patient in the particular clinical circumstances at hand, such as progress and extent of renal failure, the presence of complications or disease states, and whether or not dialysis is concurrent. These factors and the degree of dietary protein restriction, if any, are balanced to arrive at optimal maintenance (Col. 6, lines 26=44).
Reiner teaches methods and formulations useful for supplementing individuals with inborn errors of metabolism with special dietary needs for amino acids. Reiner specifically teaches patients with chronic kidney disease ([0060]; pg. 17, claims 2-3, 7, 12).
Specifically exemplified is a composition comprising 5.25g lysine, 2.5417g serine, 1.5g cystine, 0.0833g carnitine, 0.0348238g nicotinamide (pgs. [0151]).
Reiner teaches that daily regiments of amino acids balanced in relative amounts to meet the physiological needs of the subject typically comprise from 0.8 to 1.35 g/kg/day. Reiner teaches that subjects can be divided into three weight and energy categories ([0065]). Reiner further teaches embodiments with different combinations of amino acids in different ratios ([0066]-[0084], [0124]).
Maurer teaches that the efficacious dose of a drug is the most holistic metric reflecting its therapeutic potential. Maurer teaches that dose predications can be made early in drug discovery to enable drug design, and teaches that dose predictions can identify critical drug properties for a viable dose regimen and provide clinically relevant context to lead to optimization (abstract).
Maurer teaches that in order to be useful to drug design, dose predications must be quantitatively linked to drug properties, and that such dose predications should be grounded in a quantifiable and clinically relevant goal, such as achieving a predefined level of efficacy (pg. 6424, Key Concepts and Considerations).
Maurer teaches that once careful consideration has been given to the clinical goal and estimation/translation of key parameters characterizing the primary pharmacology, the next step is to incorporate this information into an approach to predict dose. While the specifics of any given dose prediction will vary greatly according to the nature of the molecular target, molecular mechanism of action, and pharmacological response of interest, dose predictions can commonly be classified as empirical, PK, or PK/PD in nature (pg. 6426, Col. 2).
Maurer teaches empirical dose predications as using a simple scaling, such as body surface area, to scale the dose showing efficacy in an animal species to a dose that should be effective in man. Maurer teaches the PK approach as dose predictions based on achieving a certain drug exposure. This is based on achieving some ratio of unbound drug concentration at the site of action relative to the most relevant measure of potency or explicitly calculating the level of pharmacological activity from the drug concentration, potency, and intrinsic activity (pg. 6426, Col. 2). Maurer teaches the PK/PD approach as the most useful and accurate approach since it can be tailored to the particular details of a program, including the molecular mechanism of action, PK profile, biological context, and clinical goal (pgs. 6429-6430, PK/PD Approach).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the molar ratios of A)-D), the mmol/kg/day, and the mmol/day dosages of serine, glycine, cysteine, carnitine, lysine, and niacinamide, to arrive at instant claims 21, 27-28, and 34-36. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Reiner teaches amino acids compositions comprising the same active ingredients as those taught by Trimbo, for the treatment of chronic kidney disease,
-Reiner teaches mmol/kg/day and mmol/day dosages that fall within the instantly claimed amounts and ratios,
-Reiner teaches that its daily regimens of amino acids are balanced in relative amounts to meet the physiological needs of the subject and typically comprise from 0.8 to 1.35 g/kg/day.
-Reiner teaches that subjects can be divided into three weight and energy categories ([0065]), and teaches embodiments with different combinations of amino acids in different ratios ([0066]-[0084], [0124]),
-Trimbo teaches that its composition may be varied to refine the responsiveness of the renal failure patient in the particular clinical circumstance, such as progress and extent of renal failure, the presence of complications or disease states, whether or not dialysis is concurrent, and the degree of dietary protein restriction, to arrive at optimal maintenance,
-Maurer teaches that it is known in the art to optimize drug dose for optimal therapeutic effect, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)).
As such, an ordinary skilled artisan would have been motivated to make such a modification, to predictably arrive at an optimized amount of A)-D) that is therapeutically effective to treat renal failure.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over US 5,728,678 to Trimbo (published 1998, PTO-892), as applied to claims 16-20, 22-25, and 29-33 above, and further in view of US 2020/0069624 to Reiner (published 03/2020, PTO-892) and Mountainside Medical Equipment (Nutrition Delivery Methods, published 2019, PTO-892).
Trimbo is applied as discussed above and incorporated herein.
Regarding claim 26, while Trimbo teaches a method of treating renal failure by administering a composition comprising serine, glycine, cysteine, carnitine, lysine, and niacinamide, it differs from that of instant claim 26, in that it does not teach oral administration.
Reiner is applied as discussed above and incorporated herein. Reiner additionally teaches its nutritional amino acid supplement as orally administered ([0019]; pg. 17, claims 1, 3, 7, 8).
Mountainside teaches that various nutrition delivery methods are available and can be tailored to patients’ needs and changes in condition, wherein the three primary nutrition delivery methods include oral, enteral, and total parenteral nutrition. Each nutritional delivery model accommodates a level of patient need from moderate to severe (1st paragraph).
Oral nutrition delivery is the method that is most familiar. Supplements are integrated into the meal plan to make them more palatable (2nd paragraph).
Enteral feeding is a nutritional delivery method that utilizes a small feeding tube when patients have difficulty chewing or swallowing. This method requires regular x-rays to verify that the tube is positioned correctly (3rd paragraph).
Adequate nutrition delivery is imperative to the successful healing of a patient and is often challenged by conditions that weaken their muscles, immune system and even result in depression. By offering a variety of methods, health care providers are able to increase the change of successful treatment (last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the enteral administration of Trimbo with oral administration, to arrive at instant claim 26. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Reiner teaches amino acids compositions comprising the same active ingredients as those taught by Trimbo, for the treatment of chronic kidney disease, and Reiner teaches its compositions as orally administered,
-Mountainside teaches oral or enteral administration as known in the art to deliver nutritional compositions, and
-Mountainside teaches that adequate nutrition delivery is imperative to the successful healing of a patient and is often challenged by conditions that weaken their muscles, immune system and even result in depression, and that by offering a variety of methods, health care providers are able to increase the chance of successful treatment.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a method of administration that is optimized for the patient and that increases the chance of successful treatment.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622