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 .
Formal Matters
Applicant’s arguments in the reply filed on 28 July 2026 are acknowledged and have been fully considered. Claims 1-20 are pending. Claims 1-11 are under consideration in the instant office action. Claims 12-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking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. Applicant’s arguments did not overcome the rejections under 35 U.S.C. 103 for reasons set forth in the previous Office action and herein below.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 26 January 2026 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Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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 remain rejected under 35 U.S.C. 103 as being unpatentable over Novak et al. (US 2018/0055879, previously 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:
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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, previously 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, previously 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:
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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:
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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, previously 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, previously cited) and Hughes et al. (WO2018071988, previously 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 28 July 2026 have been fully considered but they are not persuasive.
Applicant argues that paragraph [0016] defines “elemental calcium” as zero-valent calcium metal (Ca⁰) in the neutral, uncharged state, not a salt, chelate, oxide, carbonate, or isotopically enriched compound, and that this lexicography controls under Phillips and Vitronics.
The above assertions are not found persuasive because the lexicography is accepted for what it says: elemental calcium is the neutral metal, not a salt or charged form. It does not exclude an isotopically enriched metal. Isotopic composition and oxidation state are different properties. A Ca-40 atom in the zero-valent metallic state is still elemental calcium. The claims use “comprising” and do not require natural isotopic abundance. Applicant’s statement that “no … isotopically enriched compound can satisfy this limitation” adds a limitation that is not in paragraph [0016] and is not in the claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ““no … isotopically enriched compound”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that Novak’s Ca-40 is an isotopically enriched therapeutic material, that the phrase “elemental form or … salt, compound, chelate, or complex” is disjunctive and states no preference for reactive zero-valent metal, and that a Ca-40 citrate salt is not Ca⁰.
The above assertions are not found persuasive because the disjunctive phrasing is the teaching, not a defect. Novak states that the light isotope, expressly including Ca-40, is present “either in elemental form or in the form of a pharmaceutically acceptable salt, compound, chelate, or complex,” and repeats that each isotope is independently “either in elemental form or” in salt, chelate, or complex form (paragraphs 0031 and 0034). “Elemental form” is used in opposition to salt, chelate, and complex, which is the same distinction Applicant draws. A Ca-40 citrate salt is a salt embodiment. It is not the elemental-form embodiment. Oral tablets, capsules, powders, and lozenges are expressly disclosed for those compositions (paragraph 0031). Enrichment relative to natural abundance does not convert an elemental-form disclosure into a salt disclosure. The claimed composition does not exclude enrichment.
Applicant argues that Ca⁰ reacts with acid to generate local protons and to reduce nitrate, that this in-situ chemistry is shown by Exhibit A and by Lundberg, Weitzberg, and Gladwin (2008) and Koch et al. (2017), and that calcium salts cannot participate in that redox chemistry. Applicant argues that using Novak for elemental calcium is hindsight under In re Lee.
The above assertions are not found persuasive because claims 1–11 do not recite a reaction, local acidification, nitrite, nitric oxide, or a blood-pressure result. Those features cannot be imported to distinguish the composition. The cited reviews describe the known acid-dependent nitrate–nitrite–NO pathway. They do not teach away from co-formulating calcium and a nitrate salt. Novak is not used for that mechanism. Novak is used for elemental-form calcium in an oral unit dose. Kramer is used for potassium nitrate and for citric acid. The combination does not depend on Applicant’s disclosure of a redox pathway. 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 argues that Novak is non-analogous under In re Bigio. Applicant defines the field as acute dietary-supplement potentiation of nitrate by a zero-valent metal, and Novak’s field as long-term isotopic anti-aging therapy, and argues that a formulator would have no reason to consult Novak. Applicant argues that calling both references solid oral compositions with health benefits is too broad under In re Clay.
The above assertions are not found persuasive because the claims under examination are composition claims, not the withdrawn methods of reducing blood pressure within 5 minutes. The field of endeavor is oral compositions for human consumption containing calcium and other nutritional or therapeutic ingredients. Novak is in that field: oral tablets and capsules of calcium for improving health in a human (paragraphs 0031 and 0239). A reference in the same field of endeavor is analogous regardless of the problem addressed. Even on the second prong, selecting an orally administrable form and amount of calcium is reasonably pertinent to formulating the claimed calcium-containing unit dose. In re Clay does not require that the fields share a mechanism of action.
Applicant argues that the motivation is an impermissible in globo statement that both references are oral supplements, contrary to KSR and In re Lee, and that no reason is given to consult an isotopic reference when designing an acute nitrate supplement.
The above assertions are not found persuasive because the motivation is not merely that both references are supplements. Kramer teaches that nitrates are useful for vasodilation through reduction to nitrite and nitric oxide, and teaches tablets containing 50–500 mg potassium nitrate for blood-pressure support (column 7, lines 3–8; column 17, lines 29–32; Composition 5). Novak teaches an oral tablet or capsule already adapted to deliver calcium, including calcium in elemental form, together with conventional carriers and excipients (paragraphs 0031, 0034, and 0230–0231). A person of ordinary skill would have added Kramer’s potassium nitrate to Novak’s oral calcium composition to obtain the vasodilating and blood-pressure-support effect Kramer expressly attributes to nitrate. That is an articulated reason with rational underpinning.
Applicant argues that adding potassium nitrate would alter Novak’s intended isotopic use, and that replacing Kramer’s amino acid with elemental metal would make each reference unsatisfactory for its intended purpose, under In re Gordon.
The above assertions are not found persuasive because Gordon applies where the proposed modification renders the prior art inoperable for its disclosed purpose, as in turning a filter upside down. Adding a nitrate salt to an open oral composition does not destroy isotopic enrichment, and Novak already contemplates additional ingredients and excipients. The rejection also does not require deleting arginine from Kramer. The claimed composition uses “comprising” and can contain arginine, starch, and other unrecited ingredients.
Applicant argues that there is no reasonable expectation of success because Weinberger et al. (1993) found no significant blood-pressure change with 1.5 g/day calcium carbonate, so a skilled artisan would not have expected 100 mg of calcium plus a sub-ADI nitrate dose to lower systolic pressure by 14% in 30 minutes.
The above assertions are not found persuasive because success for these claims is making the claimed composition, not achieving a blood-pressure result. Both references teach dietary supplement compositions in solid oral dosage forms, so the expectation of producing a tablet or capsule containing calcium and potassium nitrate is reasonable. Weinberger concerns calcium carbonate, a salt, and reports no significant blood-pressure effect. It does not teach away from elemental calcium, and it does not address nitrate. A reference that is silent on a result the claims do not require is not a teaching away.
Applicant argues that Experiment 10 unexpectedly produced up to a 14% systolic decrease within 30 minutes from 100 mg elemental calcium, 60.5 mg nitrate from magnesium nitrate hexahydrate, and 600 mg citric acid, whereas calcium salts at 1.5 g/day and sub-ADI nitrate would have been expected to do nothing. Applicant argues that the counterion is inert and that In re Clemens permits mechanism-based extrapolation from magnesium nitrate to the elected potassium nitrate.
The above assertions are not found persuasive because unexpected results must be commensurate in scope with the claims. In re Clemens, 622 F.2d 1029, 1036 (CCPA 1980); In re Peterson, 315 F.3d 1325, 1329–31 (Fed. Cir. 2003); In re Grasselli, 713 F.2d 731, 741 (Fed. Cir. 1983). Claims 1 and 10 cover potassium, sodium, magnesium, and proline nitrate, calcium from 1 mg to 800 mg or with no amount limit, nitrate anion from 30 mg to 2000 mg or with no amount limit, and compositions with or without acid. One capsule, one subject, one nitrate salt, and one set of amounts does not cover that scope. Clemens does not hold that a proposed mechanism substitutes for comparative data across the claim. Experiment 10 also uses magnesium nitrate, not the elected potassium nitrate. No comparison with potassium nitrate alone, elemental calcium alone, or the closest prior-art tablet of Kramer is reported. The argument is therefore not persuasive evidence of nonobviousness.
Applicant argues that Kramer’s Composition 5 has arginine, 50–500 mg potassium nitrate, and corn starch, but no calcium and no citric acid, and that picking citric acid from a diluent list for gastric pH maintenance is hindsight. Applicant argues that citric acid is not a bulk diluent but maintains the acidity required for the Ca⁰–nitrate reaction.
The above assertions are not found persuasive because composition 5 is relied on for potassium nitrate in a tablet, not for citric acid. Citric acid is expressly listed among diluents used to make a tablet a practical size, together with calcium phosphate, calcium sulfate, lactose, mannitol, magnesium stearate, and potassium chloride (column 15, line 63, through column 16, line 2). Selecting a disclosed diluent for its disclosed tableting use does not require Applicant’s gastric-redox disclosure. Claims 2 and 11 require only that an acid, specifically citric acid, be present. They do not require a gastric pH-maintenance function. The intended use of an ingredient does not patentably distinguish a composition claim that recites the ingredient.
Applicant argues that Schramm’s oil coating is meant to protect minerals from gastric acid and is therefore the antithesis of a composition that must react in acid, so a formulator would avoid Schramm.
The above assertions are not found persuasive because Schramm is not relied on for an oil-coated particle or for a gastric reaction. Schramm is relied on for the amount of calcium suitable in one oral composition: a more preferred range of 0.2–2.0 g, which is 200–2000 mg (paragraph 0162). Novak already teaches oral administration of calcium in elemental form. The oil coating is an optional aspect of Schramm (“can coat”) and is not required by the claims. Combining teachings does not require bodily incorporation of every feature of each reference.
Applicant argues that Schramm’s 200–2000 mg calcium range is a nutritional RDA for prenatal and lactating women, serves a different purpose from reactive-chemistry dosing, and therefore does not support range-overlap obviousness under Woodruff. Applicant argues that the claimed amounts reflect safety and acidity constraints, not routine optimization.
The above assertions are not found persuasive because the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case exists. In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). Woodruff does not hold that a different purpose automatically rebuts that case. Claims 3 and 4 recite amounts, not a purpose. Schramm’s more preferred 200–2000 mg overlaps 1–800 mg and 5–400 mg. Novak’s guidance amounts for calcium, about 700 mg to 1300 mg depending on age, also overlap claim 3 and sit above, but are the same order as, claim 4, and Novak teaches doses from about one-half to about 30 times guidance (paragraphs 0230–0231). Applicant has not shown that the claimed endpoints are critical. In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Applicant argues that Dennis’s 0.1–15 wt% citric acid does not map to claims 5 and 6, because a 500 mg tablet would contain only about 0.5–75 mg citric acid, and that Dennis is directed to tableting mechanics rather than gastric pH.
The above assertions are not found persuasive because Dennis is relied on for the known use of citric acid at 0.1–15 wt% in a tablet premixture to improve compression, sticking, and disintegration. The milligram overlap for claim 6 is carried by Hughes, not by assuming a 500 mg Dennis tablet. A different purpose does not defeat the combination. The prior art need not suggest the combination for Applicant’s reason. 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).
Applicant argues that Hughes is an effervescent B-vitamin system that is dissolved in water before ingestion, that paragraph [0035] says pre-dissolution loses potency, and that combining Hughes with elemental calcium would cause premature reaction. Applicant argues that Hughes uses citric acid as an effervescent agent, not as a gastric pH agent, so the range overlap is improper.
The above assertions are not found persuasive because Hughes expressly teaches a supplement that “may be a powder, tablet, capsule or take some other form,” and teaches citric acid anhydrous at 150–15,000 mg, including 300–10,000 mg, 500–5,000 mg, 1,000–2,000 mg, and 1,200–1,700 mg (claims 10–12; page 8, lines 8–11). Those amounts overlap 50–20,000 mg and 300–1,000 mg. The claims do not exclude carbonate or bicarbonate, and they do not require that the composition avoid contact with water before ingestion. Paragraph [0035] is not a claim limitation. Applying Hughes’s citric acid amount to a tablet or capsule does not require adopting pre-dissolution. In re Gordon is not applicable. The function Applicant assigns to citric acid is not claimed.
Therefore, the rejections of claims 1–11 are maintained. The claims are open “comprising” composition claims to elemental calcium plus a nitrate source in a capsule, tablet, or pill. They do not require a gastric redox mechanism, a blood-pressure result, natural isotopic abundance, or exclusion of oil, carbonate, or other excipients. Those limitations are being read in from the specification and from withdrawn method claims. Novak expressly teaches Ca-40 in elemental form, as distinct from a salt, chelate, or complex, in an oral tablet or capsule. Kramer teaches potassium nitrate at 50–500 mg per tablet for blood-pressure support, and citric acid as a tablet diluent. Schramm and Hughes supply overlapping calcium and citric acid amounts.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619