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 05/16/20222, amended claims 1-13 and added claims 14-16.
Claims 1-16 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Objections
Claim 16 is objected to because of the following informalities:
-In claim 16, the quotation marks around “inflamm-aging” should be removed. This disorder is defined on pg. 3 of the instant specification, “a scenario where there is a sustained, long-term and progressive increase in the proinflammatory status of an aging individual and is linked to increased disability and mortality.”
Appropriate correction is required.
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.
Claims 9, 13, and 16 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.
-In claim 9, the phrase “detrimental pathophysiological change” renders the claim indefinite, as the adjective “detrimental” is a relative term. The term “detrimental” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
It is not clear what differentiates a “detrimental pathophysiological change” from a pathophysiological change that is not detrimental. It is further not clear what measures are relied upon to determine “detrimental pathophysiological change” in reference to inflammation.
As such, this phrase is indefinite.
-Claim 13, line 3, recites the limitation "the inflammation in cultured cells.” There is insufficient antecedent basis for this limitation in the claim.
-Claim 16 is indefinite because it is not clear if “development and progression” is applicable to each member of the Markush group or if “development and progression” is just referencing cardiovascular disease and insulin resistance.
Claim 16 is interpreted as a method for treating inflammation by treating or preventing detrimental pathophysiological changes in the subject, by administering a composition comprising at least one keto acid and/or salt thereof, wherein the detrimental pathophysiological changes are development and progression of cardiovascular disease, development and progression of insulin resistance, development and progression of type-2-diabetes, development and progression metabolic syndrome, development and progression hypertension, development and progression inflamm-aging, and development and progression post-exercise recovery.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In view of compact prosecution, for the purpose of applying prior art, claim 10 is interpreted as method for the treatment of inflammation in subjects with sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease.
-Claim 13 depends from claim 1, wherein claim 1 recites a method for reducing inflammation comprising administering, to a subject in need thereof, a composition comprising at least one keto acid and/or salt thereof. However, claim 1 does not recite a cell culture medium or cultured cells. In claim 1, inflammation is reduced in a subject in need thereof, and a keto acid is administered to the subject; inflammation is not reduced in cultured cells and cultured cells are not contacted with a keto acid.
As such, claim 13 does not further limit claim 1 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 9, 10-12 and 16 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 method of treating inflammation by decreasing the development and progression of a detrimental pathophysiological change in any subject, and for a method of treating inflammation in sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease, does not reasonably provide enablement for a method of treating inflammation by preventing the development and progression of a detrimental pathophysiological change in a subject or a method for treating inflammation that that prevents sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease, in a subject.
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
Claim 9 is directed toward a method for treating inflammation by treating or preventing any detrimental pathophysiological change in any subject with inflammation subject.
Claim 10 is directed toward a method for treating inflammation that that treats or prevents sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease, in a subject.
Claim 11 is directed toward a composition comprising at least one keto acid and/or salt thereof, in an amount effective for prevention and/or treatment of inflammation.
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
MayoClinic (Parkinson’s Disease, PTO-892) teaches that since the cause of Parkinson’s disease is not known, there are no proven ways to prevent it, though there are some factors that may help protect against it, such as increased exercise, increased caffeine, and some medicines (pg. 6).
Cleveland Clinic (Crohn’s disease, PTO-892) teaches that there is no cure for Crohn’s disease, though symptoms can be managed and complications can be prevented (pg. 9).
WO 02/074301 to Fink (published 2002, IDS of 05/16/2022) teaches a method of treating a patient having a cytokine mediated inflammatory condition comprising administering an effective amount of a composition comprising an alpha-ketoalkanoic acid, or a salt, ester, or amide thereof, in a pharmaceutically acceptable carrier, wherein Crohn’s disease, ulcerative colitis, rheumatoid arthritis, asthma, sepsis, septic shock, and psoriasis as the inflammatory conditions (pgs. 32-33, claims 25-27;pgs. 29-30, claims 1-8).
Thus, while the prior art teaches that it is known to treat inflammatory symptoms in diseases characterized by inflammation, the prior art does not teach that treat inflammation prevents diseases.
Predictability in the Art
In view of the above teachings, while treating diseases that are characterized by inflammation is known in the art, and while controlling inflammation is taught as beneficial in such diseases, preventing diseases by treating inflammation is not predictable in the art.
Working Examples
The instant specification provides a single example of the effects of calcium salts of keto leucine, keto isoleucine, and keto valine in a 2:1:1 ratio (i.e., BCKA) on the secretion of cytokines, TNF-alpha, IL-1beta, and IL-6.
The working examples are directed to the treatment of zero diseases.
Direction and Guidance
In view of the single example directed toward an in vitro assay, that does not treat any disease, the instant specification does not provide direction or guidance in a method of preventing detrimental pathophysiological changes due to inflammation, or a method of preventing sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease.
Quantity of Experimentation
The amount of experimentation required to determine which keto acids and combinations thereof, and salt forms thereof, in which amounts, are effective to prevent detrimental pathophysiological changes due to inflammation, and prevent sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease, would be astronomical. Such experimentation amounts to invention and not development.
As such, while being enabling for a method of treating inflammation by decreasing the development and progression of a detrimental pathophysiological change in any subject, and for a method of treating inflammation in sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease, the specification does not reasonably provide enablement for a method of treating inflammation by preventing the development and progression of a detrimental pathophysiological change in a subject or a method for treating inflammation that that prevents sarcopenia, multiple sclerosis, rheumatoid arthritis, renal disease, liver disease, psoriasis, psoriatic arthritis, colitis ulcerosa, Crohn’s disease, myasthenia gravis, autoimmune polyglandular syndrome type II, Hashimoto’s thyroiditis, type-1 diabetes, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, Parkinson’s disease, an allergy, asthma, or an infectious disease, in a subject.
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 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.
Claims 1, 4-5, 7-12, and 14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 02/074301 to Fink (published 2002, IDS of 05/16/2022).
Regarding claims 1 and 11, Fink teaches a method of treating a patient having a cytokine mediated inflammatory condition comprising administering an effective amount of a composition comprising an alpha-ketoalkanoic acid, or a salt, ester, or amide thereof, in a pharmaceutically acceptable carrier, (pgs. 29-30, claims 1-8).
Fink teaches alpha-keto-butyrate, alpha-keto-pentanoate, alpha-keto-3-methyl butyrate, alpha-keto-4-methyl-pentoate, alpha-keto-hexanoate, pyruvic acid, ethyl pyruvate, and more as the alpha-ketoalkanoic acid (pg. 30-31, claims 9-10, 14).
Regarding claims 4-5, and 14, calcium, magnesium, and others are taught as the salts (pg. 30, claim 11).
Regarding claims 1, 4-5, 7, 14, Fink exemplifies composition comprising ethyl pyruvate and calcium chloride
Regarding claim 8, Fink teaches its methods as mediated by tumor necrosis factor and interleukin 1beta (pgs. 29-30, claims 5-7), and exemplifies its methods as attenuating serum levels of TNF (pg. 23, Example III; pgs. 25-27, Examples VI, VII).
Regarding claims 9-10, Fink teaches Crohn’s disease, ulcerative colitis, rheumatoid arthritis, asthma, sepsis, septic shock, and psoriasis as the inflammatory conditions that are treated (pgs. 32-33, claims 25-27).
Regarding claim 12, Fink exemplifies a therapeutic solution comprising ethyl pyruvate that is administered in a single dose (pgs. 23-24, Example III).
Claims 1-2, 4-6, 8-12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 4,100,160 to Walser (published 1978, PTO-892).
Regarding claims 1-2, 4, 5-6, 9-12, 14-16, Walser exemplifies a mixture for oral or parenteral administration that is effective in restoring nitrogen balance to patients who lose tissue protein, comprising administering a sodium or calcium salt of alpha-keto-acid analog of valine, a sodium or calcium salt of leucine, and a sodium or calcium salt of isoleucine, to patients with cancer, chronic infections, burns, surgery, trauma, diabetes, renal disease, or other conditions characterized by tissue wastage (Col. 19, line 29 to Col. 20, line 40).
Regarding claims 1 and 8, while Walser does not explicitly teach “reducing inflammation” or “reducing and/or inhibiting release of one or more inflammatory factors selected from the group consisting of interleukin 1beta (IL-1beta), interleukin 6 (IL-6) and tumor necrosis factor alpha (TNF-alpha),” it teaches administering the same composition (one comprising at least one keto acid and/or salt thereof), in therapeutically effective amounts (the instant specification does not teach any in-vivo effective amounts of the compounds; as such, any therapeutic amount of the compounds is determined to be an amount effective to treat inflammation), to the same patient population (patients with inflammatory conditions, such as cancer, diabetes, surgery, chronic infection, etc.). As such, the methods of Walser are expected to reduce inflammation reducing, and reduce and/or inhibiting release of one or more inflammatory factors selected from the group consisting of interleukin 1beta (IL-1beta), interleukin 6 (IL-6) and tumor necrosis factor alpha (TNF-alpha). See MPEP 2112.02.
Further regarding claim 1, Applicant is reminded that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02.
Further regarding claim 8, MPEP 2111.04 states that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a composition comprising at least one keto acid or salt thereof subject in need of reduced inflammation.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 9 and 16, Walser teaches treatment of diabetes, which meets the limitation of “development and progression of insulin resistance.”
Regarding claim 10, Walser specifically teaches treating patients with chronic infections, i.e., and infectious disease.
Regarding claim 12, Walser teaches its pharmaceutical mixtures in oral administration forms.
Claim 15 is interpreted as a product-by-process claim. Product-by-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show a nonobvious difference. Thus, the teachings of a sodium or calcium salt of alpha-keto-acid analog of valine, a sodium or calcium salt of leucine, and a sodium or calcium salt of isoleucine, of Walser, meets these limitations.
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 1-6, 8-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,100,160 to Walser (published 1978, PTO-892) in view of US 2021/0290544 to Jarecki (effectively filed 07/31/2018, PTO-892).
Walser is applied to claims 1-2, 4-6, 8-12 and 14-16, as discussed above, and incorporated herein.
Walser teaches its mixtures as preventing nitrogen loss and treating protein depletion to maintain tissue protein (Col. 19, line 26-Col. 20, line 59).
Walser teaches alpha-keto-acid analog of valine, a sodium or calcium salt of leucine, and a sodium or calcium salt of isoleucine in a ratio of 2.9:4:2.1, which is a ratio of keto leucine to keto valine to keto isoleucine of 1.38:1:1 (Col. 19, line 29 to Col. 20, line 40).
Regarding claim 3, while Walser teaches a mixture comprising alpha-keto-acid analog of valine, a sodium or calcium salt of leucine, and a sodium or calcium salt of isoleucine for the treatment of nitrogen loss and protein depletion in inflammatory disorders, it differs from that of instant claim 2 in that it does not teach a ratio of keto leucine to keto valine to keto isoleucine of 2:1:1.
Walser further teaches that the “The administered compounds are given in an amount equal at least to from one to one and a half times the minimal daily amount of the corresponding amino acid ordinarily required by the individual undergoing treatment. The respective mixtures of the compounds which form the several preferred embodiments of the invention. . .may be administered in four identical daily doses. Of course, the dosage of individual components of the invention can be modified if analysis of the user’s blood for the corresponding amino acids reveals an abnormal balance” (Col. 6, lines 33-45).
Jarecki teaches a mixture comprising keto leucine, keto isoleucine, and keto valine in an approximate ratio of 2:1:1 (pg. 8, claims 9-14).
Jarecki teaches the mixture in the form of a foodstuff, food supplement, or pharmaceutical product (pg. 8, claim 16).
Jarecki teaches its mixtures for the use in promoting wellbeing after sporting activities, in increasing muscle synthesis and efficiency of the muscle, and in permanently lowering the nitrogen burden of metabolism ([0012], [0-45]-[0046]).
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 ratio of keto leucine, keto valine, and keto isoleucine in Walser, to approximately 2:1:1, to arrive at instant claim 3. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Walser teaches a ratio of keto leucine to keto valine to keto isoleucine of 1.38:1:1,
-Walser further teaches that the amounts can be modified,
-Jarecki teaches pharmaceutical formulations comprising a mixture of keto leucine, keto isoleucine, and keto valine in an approximate ratio of 2:1:1,
-Walser and Jarecki are both directed toward building muscle tissue by affecting nitrogen metabolism (Walser, Col. 3, lines 50-59; Col. 14, lines 34-51; Col. 20, lines 46-59; Jarecki-abstract; [0006]-[00012]; [0044]; [0046]), 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 a ratio of keto leucine, keto isoleucine, and keto valine, with optimal therapeutic effect in building muscle in inflammatory disorders, such as diabetes, renal disease, or chronic infection.
Note: In view of the common assignee between the instant Applicant and US 2021/0290544 to Jarecki, the above rejection may possibly be overcome by a 102(b)(2) Exception. As such, in view of compact prosecution, the below rejection is also applied.
Claims 1-6, 8-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,100,160 to Walser (published 1978, PTO-892).
Walser is applied to claims 1-2, 4-6, 8-12 and 14-16, as discussed above, and incorporated herein.
Walser teaches its mixtures as preventing nitrogen loss and treating protein depletion to maintain tissue protein (Col. 19, line 26-Col. 20, line 59).
Walser teaches alpha-keto-acid analog of valine, a sodium or calcium salt of leucine, and a sodium or calcium salt of isoleucine in a ratio of 2.9:4:2.1, which is a ratio of keto leucine to keto valine to keto isoleucine of 1.38:1:1.
Regarding claim 3, while Walser teaches a mixtures comprising alpha-keto-acid analog of valine, a sodium or calcium salt of leucine, and a sodium or calcium salt of isoleucine for the treatment of nitrogen loss and protein depletion in inflammatory disorders, it differs from that of instant claim 2 in that it does not teach a ratio of keto leucine to keto valine to keto isoleucine of 2:1:1.
Walser further teaches that the “The administered compounds are given in an amount equal at least to from one to one and a half times the minimal daily amount of the corresponding amino acid ordinarily required by the individual undergoing treatment. The respective mixtures of the compounds which form the several preferred embodiments of the invention. . .may be administered in four identical daily doses. Of course, the dosage of individual components of the invention can be modified if analysis of the user’s blood for the corresponding amino acids reveals an abnormal balance” (Col. 6, lines 33-45).
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 ratio of keto leucine, keto valine, and keto isoleucine, to approximately 2:1:1, to arrive at instant claim 3. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Walser teaches is a ratio of keto leucine to keto valine to keto isoleucine of 1.38:1:1,
-Walser further teaches that the amounts can be modified, 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 ordinarily skilled artisan would have been motivated to make such a modification, to predictably arrive at a ratio of keto leucine, keto isoleucine, and keto valine, with optimal therapeutic effect in preventing nitrogen loss and treating protein depletion to maintain tissue protein in diseases, such as cancer, chronic infections, burns, surgery, trauma, diabetes, renal disease, or other conditions characterized by tissue wastage.
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.
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