DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06 January 2026 has been entered.
Formal Matters
Applicant’s arguments in the reply filed on 06 January 2026 are acknowledged and have been fully considered due to the entered request for continued examination. Claims 1-20 are pending. Claims 1-11 are under consideration in the instant office action. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claims.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 26 November 2025 are noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. A signed copy is attached.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejection Maintained
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Novak et al. (US 2018/0055879, newly cited) in view of Kramer et al. (US Patent No. 8,466,187, IDS reference, 02/15/24).
Note: Claims are examined with respect to the elected species of potassium nitrate as source of nitrate and citric acid as the type of acid.
Applicant Claims
Applicant claims a composition for human consumption comprising: elemental calcium; and a source of nitrate anion (NO3-) (potassium nitrate, elected species); wherein the composition is in a unit dosage form selected from one or more of the group consisting of: a capsule. a tablet. a pill, and a combination thereof.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Novak et al. teach in another embodiment, the composition comprises an effective therapeutic amount of at least one light isotope selected from the group consisting of K-39, Mg-24, Zn-64, Rb-85, Si-28, Ca-40 (which the examiner notes is elemental calcium), Cu-63, Fe-54, Cr-52, Ni-58, Mo-92, Se-74, Br-79, and Cl-35 either in elemental form or in the form of a pharmaceutically acceptable salt, compound, chelate, or complex, wherein the composition is enriched for the at least one light isotope relative to the natural abundance of the isotope. In preferred embodiments, the composition is suitable for various routes of administration, such as topical or oral administration or administration by injection. In certain embodiments, the composition further comprises at least one additional ingredient suitable to the form of the composition, including carriers and excipients such as diluents, solvents (such as water), binders, lubricants, coloring agents, and preservatives, which are conventional and known to the person of ordinary skill in the art. The composition preferably is formulated for a specific route of administration such as, but not limited to, injection (e.g. intravenous, intraperitoneal, or subcutaenous injection), topical administration and oral administration, and other parenteral routes not mentioned above (e.g. via suppository). Other conventional routes of administration may also be used as appropriate to the condition being treated. Specific exemplary forms of the composition include a topical solution, spray, lotion, salve, ointment, gel, cream, soap, shampoo, patch, powder and foam, and an oral tablet, capsule, syrup, suspension, lozenge, gum, spray, and solution, and a solution or other composition suitable for intravenous, intraperitoneal, subcutaneous, or other route of administration by injection. In one embodiment, the light isotope is packaged in liposomes, which in turn are dissolved or suspended in an appropriate liquid and packaged in capsules that are administered orally. In other embodiments, oral compositions of the invention may be formulated for immediate, delayed, or sustained release and may also be formulated for enteric release. Topical compositions of the invention may include at least one absorption-enhancing agent such as DMSO (see paragraph 0031). In alternative embodiments, any of the above compositions can comprise as a therapeutic agent at least one light isotope selected from any subgroup selected from the group consisting of K-39, Mg-24, Zn-64, Rb-85, Si-28, Ca-40, Cu-63, Fe-54, Cr-52, Ni-58, Mo-92, Se-74, Br-79, and Cl-35, each independently either in elemental form or in the form of a pharmaceutically acceptable salt, compound, chelate, or complex, wherein the composition is enriched for the at least one light isotope relative to the natural abundance of the isotope (see paragraph 0034). In certain embodiments, the preferred dosage of any of the light isotopes is proportional to various authoritative daily ingestion guidance’s (e.g. recommended dietary allowance (USRDA), adequate intake (AI), recommended dietary intake (RDI)) of the corresponding element. The light isotope dosage is preferably between about ½ and about 30 times the guidance amount of the corresponding element, more preferably between about 1 and about 10 times the guidance amount, even more preferably between about 1 and about 3 times the guidance amount. Generally, the low end of the dose range to be administered daily is about ½ the guidance daily amount, whereas the high end is as follows: total daily oral doses can be as high as about 30 times the guidance daily amount, total daily doses administered by intraperitoneal injection can be as high as about 20 times the guidance daily amount, and total daily doses administered intravenously can be as high as about 7 times the guidance daily amount (paragraph 0230). Thus, in preferred embodiments, a single dose of a composition of the invention for daily administration would be formulated to comprise a quantity within these ranges, such as about ½, about 1, about 3, about 5, about 10, and about 20 times the guidance amount. These amounts generally are for oral intake or topical application. In some embodiments, the preferred intravenous dosage is lower, such as from about 1/10 to about ½ the guidance amount. Doses at the low end of these ranges are appropriate for anyone with a heightened sensitivity to a specific element or class of elements (e.g., those with kidney problems). For zinc, the guidance amount ranges from 2 mg in infants to 8-11 mg (depending on sex) for ages 9 and up. Guidance amounts for some of the elements used in the compositions of the invention are presented below based on information obtained from https://ods.od.nih.gov/factsheets/list-all/ and https://health.gov/dietaryguidelines/2015/guidelines/appendix-7/, summarized below. Daily dosages discussed throughout this application may be subdivided into fractional dosages and the fractional dosages administered the appropriate number of times per day to provide the total daily dosage amount (e.g. ½ the daily dose administered twice daily, ⅓ the daily dose administered three times daily, etc.) (paragraph 0231). Novak et al. in terms of recommended amounts teach as follows:
PNG
media_image1.png
672
442
media_image1.png
Greyscale
PNG
media_image2.png
438
446
media_image2.png
Greyscale
Referring to FIG. 1, a pharmaceutical composition of the present invention is generally shown at 10. The pharmaceutical composition 10 is used for improving health, cure abnormalities and degenerative disease; achieve anti-aging effect of therapy and therapeutic effect on mammals, such as, for example, a human 12 (paragraph 0239).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Novak et al. do not teach the inclusion of potassium nitrate and its amounts and the inclusion of citric acid. These deficiencies are cured by the teachings of Kramer et al.
Kramer et al. teach methods for increasing athletic performance, distribution of various Amino Acids to muscles, and solubility of various Amino Acids in a human or animal by administering an amino acid composition that includes: at least one constituent selected from the group consisting of a nitrate, a nitrite, and both; and at least one constituent amino acid selected from the group consisting of Arginine, Agmatine, Beta Alanine, Citrulline, Creatine, Glutamine, L-Histidine, Isoleucine, Leucine, Norvaline, Ornithine, Valine, Aspartic Acid, Cysteine, Glycine, Lysine, Methionine, Proline, Tyrosine, and Phenylalanine (see abstract). As used herein, “Nitrate” is a term used in its broadest sense and may refer to an Nitrate in its many different chemical forms including a salt of Nitric Acid, a single administration Nitrate, its physiologically active salts or esters, its combinations with its various salts, its tautomeric, polymeric and/or isomeric forms, its analog forms, and/or its derivative forms. Nitrate comprises, by way of non-limiting example, many different chemical forms including dinitrate and trinitrate. Nitrates may be salts, or mixed salts, of Nitric Acid (HNO3) and comprise one Nitrogen atom and three Oxygen atoms (NO3). For the exemplary purposes of this disclosure, Nitrate may comprise salts of Nitrate such as sodium nitrate, potassium nitrate, barium nitrate, calcium nitrate, and the like (column 7, lines 3-8). Composition 5 (Tablets Containing Arginine and Potassium Nitrate for Blood Pressure support). Per tablet: Arginine 250-700 mg. Potassium Nitrate 50-500 mg. Corn Starch till the desired volume for the tablet machine is obtained.
Empirical studies indicate that Nitrates are useful for their vasolidating effects. Nitrates exert their vasodilating effect through their reduction to Nitrites. In vivo, Nitrates are reduced to Nitrites and, in the blood vessels' epithelial cells, Nitrite reacts with a thiol donor (mainly glutathione) to yield Nitric Oxide (column 17, lines 29-32).
Implementations of an Amino Acid Compound or Composition may include diluents, or any inert substances added to increase the bulk of the Amino Acid Compound to make a tablet a practical size for compression. Diluents may include, for example, calcium phosphate, calcium sulfate, lactose, mannitol, magnesium stearate, potassium chloride, and citric acid, among other organic and inorganic materials (column 15, lines 63-67 and column 16, lines 1-2).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Novak et al. by incorporating potassium nitrate and citric acid because Kramer et al. teach methods for increasing athletic performance, distribution of various Amino Acids to muscles, and solubility of various Amino Acids in a human or animal by administering an amino acid composition that includes: at least one constituent selected from the group consisting of a nitrate, a nitrite, and both; and at least one constituent amino acid selected from the group consisting of Arginine, Agmatine, Beta Alanine, Citrulline, Creatine, Glutamine, L-Histidine, Isoleucine, Leucine, Norvaline, Ornithine, Valine, Aspartic Acid, Cysteine, Glycine, Lysine, Methionine, Proline, Tyrosine, and Phenylalanine (see abstract). As used herein, “Nitrate” is a term used in its broadest sense and may refer to an Nitrate in its many different chemical forms including a salt of Nitric Acid, a single administration Nitrate, its physiologically active salts or esters, its combinations with its various salts, its tautomeric, polymeric and/or isomeric forms, its analog forms, and/or its derivative forms. Nitrate comprises, by way of non-limiting example, many different chemical forms including dinitrate and trinitrate. Nitrates may be salts, or mixed salts, of Nitric Acid (HNO3) and comprise one Nitrogen atom and three Oxygen atoms (NO3). For the exemplary purposes of this disclosure, Nitrate may comprise salts of Nitrate such as sodium nitrate, potassium nitrate, barium nitrate, calcium nitrate, and the like (column 7, lines 3-8). Composition 5 (Tablets Containing Arginine and Potassium Nitrate for Blood Pressure support). Per tablet: Arginine 250-700 mg. Potassium Nitrate 50-500 mg. Corn Starch till the desired volume for the tablet machine is obtained. Empirical studies indicate that Nitrates are useful for their vasolidating effects. Nitrates exert their vasodilating effect through their reduction to Nitrites. In vivo, Nitrates are reduced to Nitrites and, in the blood vessels' epithelial cells, Nitrite reacts with a thiol donor (mainly glutathione) to yield Nitric Oxide (column 17, lines 29-32). Implementations of an Amino Acid Compound or Composition may include diluents, or any inert substances added to increase the bulk of the Amino Acid Compound to make a tablet a practical size for compression. Diluents may include, for example, calcium phosphate, calcium sulfate, lactose, mannitol, magnesium stearate, potassium chloride, and citric acid, among other organic and inorganic materials (column 15, lines 63-67 and column 16, lines 1-2). One of ordinary skill in the art would have been motivated to do so because Kramer et al. teach that empirical studies indicate that Nitrates are useful for their vasolidating effects. Nitrates exert their vasodilating effect through their reduction to Nitrites. In vivo, Nitrates are reduced to Nitrites and, in the blood vessels' epithelial cells, Nitrite reacts with a thiol donor (mainly glutathione) to yield Nitric Oxide (column 17, lines 29-32). One of ordinary skill in the art would have been motivated to include citric acid because implementations of an Amino Acid Compound or Composition may include diluents, or any inert substances added to increase the bulk of the Amino Acid Compound to make a tablet a practical size for compression. Diluents may include, for example, calcium phosphate, calcium sulfate, lactose, mannitol, magnesium stearate, potassium chloride, and citric acid, among other organic and inorganic materials (column 15, lines 63-67 and column 16, lines 1-2). It should be noticed that both Novak et al. and Kramer et al. teach that in the preparation of their solid dosage forms the inclusion of diluents. Substituting one dilute with another is prima facie obvious as they all are functionally equivalent. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) Furthermore, in the case where the claimed ranges for amounts of actives and ingredients “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, one of ordinary skill in the art would have had a reasonable expectation of success upon combination of the Novak et al. and Kramer et al. because both references teach dietary supplement compositions in solid dosage forms containing various ingredients with different health benefits for humans.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Novak et al. (US 2018/0055879, newly cited) in view of Kramer et al. (US Patent No. 8,466,187, IDS reference, 02/15/24) as applied to claims 1-2 and 7-11 above, and further in view of Schramm et al. (US2006/0188607, newly cited).
Applicant Claims
Applicant claims a composition for human consumption. Dependent claims 2-3 recite the amount of elemental calcium and potassium nitrate in the composition.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Novak et al. and Kramer et al. is described above in detail and are incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Novak et al. and Kramer et al. do not teach the amount of elemental calcium as recited in claims 2-3. These deficiencies are cured by the teachings of Schramm et al.
Schramm et al. teach oral dosage compositions, and methods of making thereof, which contain an edible oil, preferably containing an omega-3 fatty acid, and admixed therein one or more water soluble vitamins and/or minerals, for example vitamins B6, B9, and/or B12. The present invention also provides a method of making the composition comprising mixing the edible oil and one or more water-soluble vitamins and/or minerals to form a suspension or emulsion of the water-soluble vitamins and/or minerals in the edible oil. The mixture can be inserted into capsules, gelcaps, or caplets for oral consumption. An additional aspect of the invention is that the edible oil can coat particles of the water-soluble vitamins and/or minerals, which may preferably provide the vitamins and/or minerals improved absorption in the body due to increased resistance to degradation in the acidic environment of the stomach (see abstract). The term “minerals” as used herein means minerals that are edible, and includes those in an elemental, salt or other form. Examples of minerals include, but are not limited to, calcium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, potassium, phosphorous, selenium and zinc, in an elemental form, or in the form of carbonates, oxides, phosphates, silicates, sulfates, sulfides or other forms. Many minerals are inorganic compounds that are necessary for life and good nutrition, such as calcium, copper, iron, magnesium, potassium and zinc (paragraph 0111). Set forth hereinbelow are the approximate preferred ranges of the daily quantities of the various vitamins and minerals that may generally be used in one composition of the invention (or divided between more than one composition of the invention for consumption during a one-day period) for mammals, including pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant (from about one quantity to about another quantity), as well as more preferred ranges, and the most preferred quantities for pregnant and lactating women (paragraph 0162). Schramm et al. teach regarding suggested preferred amounts of ingredients as follows:
PNG
media_image3.png
552
448
media_image3.png
Greyscale
The examiner notes that the most preferred range of calcium covers 200 mg to 2000 mg as shown above.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Novak et al. and Kramer et al. by incorporating elemental calcium in the composition in amounts as recited in claim 2-3 because Schramm et al. teach oral dosage compositions, and methods of making thereof, which contain an edible oil, preferably containing an omega-3 fatty acid, and admixed therein one or more water soluble vitamins and/or minerals, for example vitamins B6, B9, and/or B12. The present invention also provides a method of making the composition comprising mixing the edible oil and one or more water-soluble vitamins and/or minerals to form a suspension or emulsion of the water-soluble vitamins and/or minerals in the edible oil. The mixture can be inserted into capsules, gelcaps, or caplets for oral consumption. An additional aspect of the invention is that the edible oil can coat particles of the water-soluble vitamins and/or minerals, which may preferably provide the vitamins and/or minerals improved absorption in the body due to increased resistance to degradation in the acidic environment of the stomach (see abstract). The term “minerals” as used herein means minerals that are edible, and includes those in an elemental, salt or other form. Examples of minerals include, but are not limited to, calcium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, potassium, phosphorous, selenium and zinc, in an elemental form, or in the form of carbonates, oxides, phosphates, silicates, sulfates, sulfides or other forms. Many minerals are inorganic compounds that are necessary for life and good nutrition, such as calcium, copper, iron, magnesium, potassium and zinc (paragraph 0111). One of ordinary skill in the art would have been motivated to utilize elemental calcium in amounts as recited in claims 3-4 because Schramm et al. teach that set forth hereinbelow are the approximate preferred ranges of the daily quantities of the various vitamins and minerals that may generally be used in one composition of the invention (or divided between more than one composition of the invention for consumption during a one-day period) for mammals, including pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant (from about one quantity to about another quantity), as well as more preferred ranges, and the most preferred quantities for pregnant and lactating women (paragraph 0162). Schramm et al. teach regarding suggested preferred amounts of ingredients as follows:
PNG
media_image3.png
552
448
media_image3.png
Greyscale
The examiner notes that the most preferred range of calcium covers 200 mg to 2000 mg as shown above. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.)Furthermore, in the case where the claimed ranges for amounts of ingredients such as elemental calcium “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, an ordinary skilled artisan would have had a reasonable expectation of success upon combination of the Novak et al., Kramer et al., and Schramm et al. because all of references teach dietary supplement based oral compositions.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Novak et al. (US 2018/0055879, newly cited) in view of Kramer et al. (US Patent No. 8,466,187, IDS reference, 02/15/24) as applied to claims 1-2 and 7-11 above, and further in view of Dennis et al. (EP0454396, newly cited) and Hughes et al. (WO2018071988, newly cited).
Applicant Claims
Applicant claims a composition for human consumption. Dependent claims 5-6 recite the amount of citric acid in the composition.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Novak et al. and Kramer et al. is described above in detail and are incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Novak et al. and Kramer et al. do not teach the amount of citric acid as recited. These deficiencies are cured by the teachings of Dennis et al. and Hughes et al.
Dennis et al. teach an improved tablet composition for drugs or active ingredients prone to poor tabletting properties is disclosed. The improved composition comprises a premixture, consisting essentially of between about 85 and 99.9 percent by weight of the active ingredient and between about 0.1 and 15 percent by weight of citric acid, and one or more other formulation ingredients added to the premixture. The present invention also involves the process for making such compositions and products therefrom (see abstract). It is known that certain pharmacologically active ingredients are extremely difficult to manufacture in tablet form due to the physical nature of the active compound itself. For example, many drugs which when utilized in free base form, i.e., not in salt form, e.g. atenolol, nadolol, salbutamol, chlordiazepoxide, temazepam, diazepam, sulpiride, d-sotalol, d-L-sotalol and the like, are prone to many undesirable tabletting problems including poor compression and dissolution properties, high lubricant requirement, formation of soft granules and "sticking" which refers to the film-forming adherence phenomenon wherein the compound adheres to tablet punches and other manufacturing apparatus. These problems can result in soft tablets of high friability and tablets of inelegant appearance due to loss of material to punch surfaces. Attempting to reduce the compression problems by increasing compression forces in the tablet press can result in high disintegration times and slow drug release which may compromise bioavailability. In all instances so far discussed high ejection forces are needed to remove tablets from dies which can result in inelegant product and machine wear (paragraph 0001). Increasing the level of certain excipient materials to compensate for these phenomena is not without difficulties. For example, increasing the level of hydrophobic tablet lubricants to reduce ejection forces and adhesion, e.g. magnesium stearate, decreases the attainable tablet hardness which in turn can result in poor handling properties and a decrease in the rate of drug release. Attempts to counter the decreased hardness with higher compression forces have given way to retardation of the tablet disintegration. Higher ratios of lubricant-to-drug can be provided without adversely affecting tablet hardness by proportionally increasing the levels of all of the other ingredients, except the drug itself. However, this results in a substantial increase in tablet size which is not at all desirable as this might compromise patient compliance (paragraph 0002). In accordance with the present invention, large improvements in the handling/manufacturing of drugs, prone to compression, lubrication, sticking and adherence problems, into tablet form is provided. Not only does the present composition and process substantially eliminate these problems, but a smaller, more elegant dosage form having significantly enhanced disintegration and dissolution times is also provided (paragraph 0011). In trying to overcome the undesirable tabletting problems, it was found that a 4:1 ratio of drug to citric acid provided some alleviation of the problems as compared to formulations with no citric acid. However, the present compositions unexpectedly provide less adherence, improved compression, reduced ejection forces and more rapid disintegration and dissolution with less citric acid resulting in smaller tablet size. Further, the present composition allows for tablet sizes much smaller than those practicable for non-citric acid compositions which must employ larger proportions of all excipients so as to "swamp" the adherence problem, and to reduce problems of flow, compression, wetting, disintegration and dissolution. This may be of particular benefit for high dose drugs or in case of long term medications or in elderly patients where larger tablets could produce problems of patient compliance (paragraph 0013).
Hughes et al. teach a preparation comprising an active ingredient, a suspension base and an effervescent agent wherein the active ingredient comprises one or more B vitamins (see claim 1). A preparation according to claim 2 wherein the thickening/viscosity component comprises one or more of: Xanthum gum, carboxymethyl cellulose, a hydratable methyl cellulose, sodium carboxyl methyl cellulose, sodium methyl cellulose, microcrystalline cellulose group, other gums such as guar gum, pectin, or other hydrocolloids, agar, carrageenan (see claim 5). A composition comprising: 0.1-100mg optionally 1 to 80mg, optionally 10 to 50mg, optionally 12 to 25mg, optionally 10 to 20mg L-methylfolate a physiologically acceptable salt, ester or derivative thereof; 10 to 1000 mg optionally 20 to 800mg optionally 40 to 400mg optionally 80 to 300mg, optionally 120 to 200mg flavour additive which is optionally a natural flavour additive and optionally pink grapefruit flavour or the like; 80 to 8000 mg optionally 200 to 4000 mg optionally 400 to 2000 mg, optionally 600 to 1000mg optionally 750 to 900mg inulin which is optionally instant inulin-fibriline; 3 to 300 mg optionally 10 to 200mg, optionally 15 to 100mg, optionally 25 to 50mg, optionally 25 to 35 mg sucralose; 80 to 8000 mg optionally 200 to 4000 mg optionally 400 to 2000 mg, optionally 600 to 1000mg optionally 750 to 900mg glucose syrup which is optionally glucose solids-rice; 40 to 5000 mg optionally 80 to 3000mg, optionally 100 to 1000mg, optionally 200 to 800 mg, optionally 400 to 600mg sodium carbonate; 150 to 15,000 mg optionally 300 to 10,000mg, optionally 500 to 5000mg, optionally 1000 to 2000 mg, optionally 1200 to 1700 mg citric acid anhydrous; 1 to 200 mg optionally 1 to 100 mg optionally 1 to 50 mg, optionally 1 to 30 mg, optionally 10 to 22 mg natural colour; 1 to 200 mg optionally 1 to 100 mg optionally 1 to 50 mg, optionally 1 to 30 mg, optionally 10 to 22 mg xanthan gum 200 mesh; 40 to 5000 mg optionally 80 to 3000mg, optionally 100 to 1000mg, optionally 200 to 800 mg, optionally 450 to 650mg sodium bicarbonate (see claims 10-12). A supplement as used herein may be a powder, tablet, capsule or take some other form. The skilled addressee will appreciate that a product according to the invention may contain other ingredients not listed herein (see page 8, lines 8-11).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Novak et al. and Kramer et al. by incorporating citric acid in the composition in amounts as recited because Dennis et al. teach an improved tablet composition for drugs or active ingredients prone to poor tabletting properties is disclosed. The improved composition comprises a premixture, consisting essentially of between about 85 and 99.9 percent by weight of the active ingredient and between about 0.1 and 15 percent by weight of citric acid, and one or more other formulation ingredients added to the premixture. The present invention also involves the process for making such compositions and products therefrom (see abstract). It is known that certain pharmacologically active ingredients are extremely difficult to manufacture in tablet form due to the physical nature of the active compound itself. For example, many drugs which when utilized in free base form, i.e., not in salt form, e.g. atenolol, nadolol, salbutamol, chlordiazepoxide, temazepam, diazepam, sulpiride, d-sotalol, d-L-sotalol and the like, are prone to many undesirable tabletting problems including poor compression and dissolution properties, high lubricant requirement, formation of soft granules and "sticking" which refers to the film-forming adherence phenomenon wherein the compound adheres to tablet punches and other manufacturing apparatus. These problems can result in soft tablets of high friability and tablets of inelegant appearance due to loss of material to punch surfaces. Attempting to reduce the compression problems by increasing compression forces in the tablet press can result in high disintegration times and slow drug release which may compromise bioavailability. In all instances so far discussed high ejection forces are needed to remove tablets from dies which can result in inelegant product and machine wear (paragraph 0001). Increasing the level of certain excipient materials to compensate for these phenomena is not without difficulties. For example, increasing the level of hydrophobic tablet lubricants to reduce ejection forces and adhesion, e.g. magnesium stearate, decreases the attainable tablet hardness which in turn can result in poor handling properties and a decrease in the rate of drug release. Attempts to counter the decreased hardness with higher compression forces have given way to retardation of the tablet disintegration. Higher ratios of lubricant-to-drug can be provided without adversely affecting tablet hardness by proportionally increasing the levels of all of the other ingredients, except the drug itself. However, this results in a substantial increase in tablet size which is not at all desirable as this might compromise patient compliance (paragraph 0002). One of ordinary skill in the art would have been motivated to include citric acid in the composition in amounts as recited during tablet preparation because Dennis et al. teach in accordance with the present invention, large improvements in the handling/manufacturing of drugs, prone to compression, lubrication, sticking and adherence problems, into tablet form is provided. Not only does the present composition and process substantially eliminate these problems, but a smaller, more elegant dosage form having significantly enhanced disintegration and dissolution times is also provided (paragraph 0011). In trying to overcome the undesirable tabletting problems, it was found that a 4:1 ratio of drug to citric acid provided some alleviation of the problems as compared to formulations with no citric acid. However, the present compositions unexpectedly provide less adherence, improved compression, reduced ejection forces and more rapid disintegration and dissolution with less citric acid resulting in smaller tablet size. Further, the present composition allows for tablet sizes much smaller than those practicable for non-citric acid compositions which must employ larger proportions of all excipients so as to "swamp" the adherence problem, and to reduce problems of flow, compression, wetting, disintegration and dissolution. This may be of particular benefit for high dose drugs or in case of long term medications or in elderly patients where larger tablets could produce problems of patient compliance (paragraph 0013). One of ordinary skill in the art would have been motivated to include citric acid in amounts as recited because Hughes et al. teach a preparation comprising an active ingredient, a suspension base and an effervescent agent wherein the active ingredient comprises one or more B vitamins (see claim 1). A preparation according to claim 2 wherein the thickening/viscosity component comprises one or more of: Xanthum gum, carboxymethyl cellulose, a hydratable methyl cellulose, sodium carboxyl methyl cellulose, sodium methyl cellulose, microcrystalline cellulose group, other gums such as guar gum, pectin, or other hydrocolloids, agar, carrageenan (see claim 5). A composition comprising: 0.1-100mg optionally 1 to 80mg, optionally 10 to 50mg, optionally 12 to 25mg, optionally 10 to 20mg L-methylfolate a physiologically acceptable salt, ester or derivative thereof; 10 to 1000 mg optionally 20 to 800mg optionally 40 to 400mg optionally 80 to 300mg, optionally 120 to 200mg flavour additive which is optionally a natural flavour additive and optionally pink grapefruit flavour or the like; 80 to 8000 mg optionally 200 to 4000 mg optionally 400 to 2000 mg, optionally 600 to 1000mg optionally 750 to 900mg inulin which is optionally instant inulin-fibriline; 3 to 300 mg optionally 10 to 200mg, optionally 15 to 100mg, optionally 25 to 50mg, optionally 25 to 35 mg sucralose; 80 to 8000 mg optionally 200 to 4000 mg optionally 400 to 2000 mg, optionally 600 to 1000mg optionally 750 to 900mg glucose syrup which is optionally glucose solids-rice; 40 to 5000 mg optionally 80 to 3000mg, optionally 100 to 1000mg, optionally 200 to 800 mg, optionally 400 to 600mg sodium carbonate; 150 to 15,000 mg optionally 300 to 10,000mg, optionally 500 to 5000mg, optionally 1000 to 2000 mg, optionally 1200 to 1700 mg citric acid anhydrous; 1 to 200 mg optionally 1 to 100 mg optionally 1 to 50 mg, optionally 1 to 30 mg, optionally 10 to 22 mg natural colour; 1 to 200 mg optionally 1 to 100 mg optionally 1 to 50 mg, optionally 1 to 30 mg, optionally 10 to 22 mg xanthan gum 200 mesh; 40 to 5000 mg optionally 80 to 3000mg, optionally 100 to 1000mg, optionally 200 to 800 mg, optionally 450 to 650mg sodium bicarbonate (see claims 10-12). A supplement as used herein may be a powder, tablet, capsule or take some other form. The skilled addressee will appreciate that a product according to the invention may contain other ingredients not listed herein (see page 8, lines 8-11). Furthermore, in the case where the claimed ranges for amounts of ingredients such as citric acid “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, an ordinary skilled artisan would have had a reasonable expectation of success upon combination of the Novak et al., Kramer et al., Dennis et al., and Hughes et al. because all references teach tablet based pharmaceutical compositions.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06 January 2026 have been fully considered but they are not persuasive.
Applicant argue claim terms must be construed in view of the specification. The specification expressly acts as its own lexicographer for "elemental metal," defining it as "the neutral-charged state of a metal element.. in its elemental form and not in a salt form or charged form," and further clarifying that "elemental metals and salts of the same metal are different constituents" and that "a composition that consists of magnesium citrate is not a composition that comprises elemental magnesium." The disclosure then enumerates "elemental magnesium, elemental calcium, elemental lithium, elemental zinc, and elemental iron" as exemplary elemental metals. Appl.[0016]. Conventional elemental calcium is an isotopic mixture. In ordinary chemical usage, "elemental calcium" refers to calcium metal having the naturally occurring isotopic distribution, not an isotopically purified nuclide. Standard isotope data confirms that natural calcium contains multiple isotopes, predominantly 40Ca (about 96.94%), but also ⁴²Ca (about 0.647%), ⁴³Ca (about 0.135%), ⁴⁴Ca (about 2.086%), ⁴⁶Ca (about 0.004%), and ⁴⁸Ca (about 0.187%). Accordingly, Novak's disclosure of "calcium-40" (or any stated isotopic purity/enrichment threshold) would not be understood by a person of ordinary skill in the art to refer to the claimed limitation of "elemental calcium".
The above assertions are not found persuasive because the teachings of Novak et al. is consistent with the description Applicant disclosed in the original disclosure. A teaching of Ca-40 in elemental form unequivocally met the description provided in the specification. Novak et al. teach in another embodiment, the composition comprises an effective therapeutic amount of at least one light isotope selected from the group consisting of K-39, Mg-24, Zn-64, Rb-85, Si-28, Ca-40 (which the examiner notes is elemental calcium), Cu-63, Fe-54, Cr-52, Ni-58, Mo-92, Se-74, Br-79, and Cl-35 either in elemental form or in the form of a pharmaceutically acceptable salt, compound, chelate, or complex, wherein the composition is enriched for the at least one light isotope relative to the natural abundance of the isotope. In preferred embodiments, the composition is suitable for various routes of administration, such as topical or oral administration or administration by injection. In certain embodiments, the composition further comprises at least one additional ingredient suitable to the form of the composition, including carriers and excipients such as diluents, solvents (such as water), binders, lubricants, coloring agents, and preservatives, which are conventional and known to the person of ordinary skill in the art. The composition preferably is formulated for a specific route of administration such as, but not limited to, injection (e.g. intravenous, intraperitoneal, or subcutaenous injection), topical administration and oral administration, and other parenteral routes not mentioned above (e.g. via suppository). Other conventional routes of administration may also be used as appropriate to the condition being treated. Specific exemplary forms of the composition include a topical solution, spray, lotion, salve, ointment, gel, cream, soap, shampoo, patch, powder and foam, and an oral tablet, capsule, syrup, suspension, lozenge, gum, spray, and solution, and a solution or other composition suitable for intravenous, intraperitoneal, subcutaneous, or other route of administration by injection. In one embodiment, the light isotope is packaged in liposomes, which in turn are dissolved or suspended in an appropriate liquid and packaged in capsules that are administered orally. In other embodiments, oral compositions of the invention may be formulated for immediate, delayed, or sustained release and may also be formulated for enteric release. Topical compositions of the invention may include at least one absorption-enhancing agent such as DMSO (see paragraph 0031). In alternative embodiments, any of the above compositions can comprise as a therapeutic agent at least one light isotope selected from any subgroup selected from the group consisting of K-39, Mg-24, Zn-64, Rb-85, Si-28, Ca-40, Cu-63, Fe-54, Cr-52, Ni-58, Mo-92, Se-74, Br-79, and Cl-35, each independently either in elemental form or in the form of a pharmaceutically acceptable salt, compound, chelate, or complex, wherein the composition is enriched for the at least one light isotope relative to the natural abundance of the isotope (see paragraph 0034). In certain embodiments, the preferred dosage of any of the light isotopes is proportional to various authoritative daily ingestion guidance’s (e.g. recommended dietary allowance (USRDA), adequate intake (AI), recommended dietary intake (RDI)) of the corresponding element. The light isotope dosage is preferably between about ½ and about 30 times the guidance amount of the corresponding element, more preferably between about 1 and about 10 times the guidance amount, even more preferably between about 1 and about 3 times the guidance amount. Generally, the low end of the dose range to be administered daily is about ½ the guidance daily amount, whereas the high end is as follows: total daily oral doses can be as high as about 30 times the guidance daily amount, total daily doses administered by intraperitoneal injection can be as high as about 20 times the guidance daily amount, and total daily doses administered intravenously can be as high as about 7 times the guidance daily amount (paragraph 0230). Thus, in preferred embodiments, a single dose of a composition of the invention for daily administration would be formulated to comprise a quantity within these ranges, such as about ½, about 1, about 3, about 5, about 10, and about 20 times the guidance amount. These amounts generally are for oral intake or topical application. In some embodiments, the preferred intravenous dosage is lower, such as from about 1/10 to about ½ the guidance amount. Doses at the low end of these ranges are appropriate for anyone with a heightened sensitivity to a specific element or class of elements (e.g., those with kidney problems). For zinc, the guidance amount ranges from 2 mg in infants to 8-11 mg (depending on sex) for ages 9 and up. Guidance amounts for some of the elements used in the compositions of the invention are presented below based on information obtained from https://ods.od.nih.gov/factsheets/list-all/ and https://health.gov/dietaryguidelines/2015/guidelines/appendix-7/, summarized below. Daily dosages discussed throughout this application may be subdivided into fractional dosages and the fractional dosages administered the appropriate number of times per day to provide the total daily dosage amount (e.g. ½ the daily dose administered twice daily, ⅓ the daily dose administered three times daily, etc.) (paragraph 0231). Novak et al. in terms of recommended amounts teach as follows:
PNG
media_image1.png
672
442
media_image1.png
Greyscale
PNG
media_image2.png
438
446
media_image2.png
Greyscale
Referring to FIG. 1, a pharmaceutical composition of the present invention is generally shown at 10. The pharmaceutical composition 10 is used for improving health, cure abnormalities and degenerative disease; achieve anti-aging effect of therapy and therapeutic effect on mammals, such as, for example, a human 12 (paragraph 0239).
Furthermore, it must be very clear Applicant uses the transitional phrase “comprising” in reciting the components of the composition. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps."); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to "a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades" encompasses razors with more than three blades because the transitional phrase "comprising" in the preamble and the phrase "group of" are presumptively open-ended. "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended." Id. In contrast, the court noted the phrase "group consisting of" is a closed term, which is often used in claim drafting to signal a "Markush group" that is by its nature closed. Id. The court also emphasized that reference to "first," "second," and "third" blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group. Id. Arguendo if other isotopes of calcium in elemental form are included it is permissible. However, Novak et al. clearly teach the inclusion of the most common form of elemental calcium which is Ca-40 which reads on Applicant’s claim.
Applicant further argues Under In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004), prior art is only analogous if it is from the same field of endeavor or if it is "reasonably pertinent" to the particular problem the inventor faced. Here, the problem addressed by the present Application is how to achieve rapid blood pressure reduction under nitrate constraints using a specific elemental metal-nitrate-acid reaction system. Novak, by contrast, is directed to long-term modulation of isotope ratios in essential elements to treat degenerative disease and effect "anti-aging" outcomes. Therefore, Novak is not from the same field of endeavor and is not reasonably pertinent to Applicant's specific technical problem. Novak is non-analogous art under In re Bigio and should not be used as the primary teaching for the "elemental calcium" limitation.
The above assertions are not found persuasive because in response to applicant's argument that Novak et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, there is nothing nonanalogous between Novak et a. and Kramer as they both are drawn to compositions in solid dosage forms containing various ingredients with different health benefits for humans.
Applicant further argues Kramer does not teach elemental metals.
The above assertions are not found persuasive because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection is based on the combination teachings of Novak et al. and Kramer. Novak clearly teach the inclusion of calcium in elemental form as described above. Kramer is included in the rejection to obviate why one of ordinary skill in the art would have been motivated to add potassium nitrate in the composition of Novak et al.
Applicant further argues Schramm Addresses a Different Problem and Formulation (Omega-3/B-Vitamin Oil Suspensions), Not the Problem of Safely Co-Formulating Elemental Calcium and Nitrate in a Unit Dose and Schramm does not teach elemental metals.
The above assertions are not found persuasive because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection is based on the combination teachings of Novak et al. Kramer, and Schramm. Novak clearly teach the inclusion of calcium in elemental form as described above. Kramer is included in the rejection to obviate why one of ordinary skill in the art would have been motivated to add potassium nitrate in the composition of Novak et al. Schramm is included to render obvious the amount of elemental calcium. There is nothing nonanalogues about the references.
Applicant further argues the specification and Applicant's prior response provide exactly such evidence. Experiment 10 describes a capsule containing 100 mg elemental calcium, 250 mg magnesium nitrate hexahydrate (providing 60.5 mg nitrate), and 600 mg anhydrous citric acid, administered to a normotensive subject. This composition produced a "rapid and pronounced decrease of systolic blood pressure," with an overall decrease in diastolic pressure and sustained reduction in mean blood pressure over 60 minutes. Appl. [0051]. Crucially, this outcome is unexpected in view of the art, which taught that calcium supplementation at even 1.5 g/day, and modest nitrate doses, are having "no notable effects on blood pressure" in adults with high-normal blood pressure. Id.
The above assertions are not found persuasive because Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). Applicant’s claim is broader in terms of types of ingredients and amounts of ingredients in comparison to example 10. Furthermore, Example 10 is not also drawn to the elected species in terms of the nitrate type (potassium nitrate).
Applicant argues preferred ranges in Schramm is an improper hindsight reconstruction.
The above assertions are not found persuasive because in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant then argues Dennis addresses a different problem and Hughes uses citric acid as an effervescent acid for B-vitamin beverages not as a gastric pH-control agent in a nitrate -calcium unit dosage form.
The above assertions are not found persuasive for Dennis to be combinable with the other references Dennis does not have to solve the same problem as Applicant’s problem. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGABU KASSA whose telephone number is (571)270-5867. The examiner can normally be reached on 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIGABU KASSA/
Primary Examiner, Art Unit 1619