DETAILED ACTION
Status of the Claims
Claims 1 and 62-65 are pending in the instant application and are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The U.S. effective filing date has been determined to be 07/28/2023, the filing date of the U.S. Provisional Application No. 63/529,441.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 62-65 are rejected under 35 U.S.C. 103 as being unpatentable over NOVAK (US 2016/0151415; published June, 2016) in view of VECTOR (US 11,433,095; published 09/06/2022; filed 03/26/2021); TEMNIKOV (US 2018/0296596; published October, 2018); WARRELL (US 4,529,593; published July, 1985) and CARRINGTON (US 2020/0000136 A1; published January, 2020).
Applicants Claims
Applicant claims a method to restore homeostasis in a subject in need thereof, comprising administering to said a pharmaceutical composition comprising an essential chemical element and additive chemical elements, each additive chemical element specific to said essential chemical element in specific quantity wherein for each isotope of said additive chemical element the number of protons in each of the additive chemical element is equal to number of neutrons in the corresponding isotope of the essential chemical element; wherein the essential chemical element is Fe; and the additive chemical elements are Ni, Zn, Ga and Ge, and the dose is 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, and 7.2 mcg Ge, or the dose is a multiple thereof, wherein the multiple is the same for each element (claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
NOVAK teaches “A pharmaceutical composition of the present invention is used for improving health, cure abnormalities and degenerative disease; achieve anti-aging effect of therapy and therapeutic effect on mammals. The pharmaceutical composition includes a pharmaceutical carrier and an isotope selective ingredient including at least one of a chemical element and a chemical compound containing the chemical element whereby isotope distribution in the at least one of the chemical element and the chemical compound containing the chemical element is different from natural distribution of at least one of isotopes wherein the part of selected isotope of the chemical element ranges from 0 to 100%. A method of the present invention uses the inventive pharmaceutical composition to improve health, cure abnormalities and degenerative disease and achieve therapeutic effect on mammals.” (abstract, see whole document). And that: “The present invention relates to a pharmaceutical composition for improving health, cure abnormalities and degenerative disease; achieve anti-aging effect of therapy and therapeutic effect on mammals and method of administering the same.” ([0002]).
NOVAK teaches that: “It is not enough to think in terms of homeostasis. It is essential to understand that homeostasis starts from elementary particles and goes up to the levels higher than individual mind or intellect and not limited by the currently agreed borders of life science.” ([0015]). And that: “The pharmaceutical composition includes a pharmaceutical carrier and an isotope selective ingredient including at least one of a chemical element and a chemical compound containing the chemical element whereby isotope distribution in the at least one of the chemical element and the chemical compound containing the chemical element is different from natural distribution of at least one of isotopes wherein the part of selected isotope of the chemical element ranges from 0 to 100%. The selected isotopes include at least one of K-39; Mg-24; Zn-64; Rb-85; Si-26 and combination thereof. The selected isotopes also include at least one of Ca-40; Cu-63; Fe-54; Cr-52; Ni-58; Mo-92; Ag-107; Br-79; Cl-35 and combination thereof.” [emphasis added]([0017]). And further that: “The pharmaceutical composition includes combination of at least two of the isotopes wherein one of the isotopes is lighter in weight than the other of the isotopes to achieve therapeutic effect. The light isotopes of the pharmaceutical composition are K-39; Mg-24; Zn-64; Rb-85; Si-26; Ca-40; Cu-63; Fe-54; Cr-52; Ni-58; Mo-92; Ag-107; Br-79; Cl-35. The chemical compounds of the pharmaceutical composition include the isotopes such as at least one of oxides, sulfates, citrates gluconate, and a chelate containing a ligand bonded to a central metal atom at least two points. The chemical elements and chemical compounds are food supplements.” (instant claim 1, Fe, Ni, and Zn)[emphasis added]([0018]).
Regarding the limitations of claims 23-26, NOVAK clearly teaches that: “The method begins with preparing the pharmaceutical carrier and the isotope selective ingredient including at least one of the chemical element and the chemical compound containing the chemical element whereby isotope distribution in the at least one of the chemical element and the chemical compound containing the chemical element is different from natural distribution of at least one of isotopes wherein the part of selected isotope of the chemical element ranges from 0 to 100%.” ([0019]), thereby encompassing natural isotope distribution (selected isotope of the chemical element ranges from 0%)(instant claims 62, 64) to fully enriched (selected isotope of the chemical element ranges to 100%), thereby encompassing “90% of the lightest isotope” (or “at least 80% of its lightest isotope) including Fe-54 which is the lightest isotope of Fe (instant claims 62-65).
NOVAK teaches that: “The person skilled in the art can provide shifting the balance in favor of youth and health with right combination of light isotopes in optimal doses. In general, isotope compositions and doses are always case specific. For the purpose of diseases and aging prevention, daily intake doses are sufficient. For therapeutic treatment much higher doses like triple daily intake are more suitable.” ([0021])(instant claims 1, 21, and 41 – dose).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of NOVAK is that NOVAK does not expressly teach the inclusion of gallium (Ga) or germanium (Ge).
VECTOR teaches foods to promote better health and/or to maintain homeostasis and method of production thereof (title, see whole document). VECTOR teaches that: “Daily consumption of isotope-selective food is the best way for promoting health and/or maintaining youthful homeostasis i.e. stability of human organism with simultaneous prevention from degenerative and infectious diseases.” (col. 4, lines 13-16). VECTOR teaches that “In one aspect, this disclosure provides a method of producing a food product of a plant comprising growing the plant in fertilizer or compost comprising essential chemical elements enriched for lightest stable isotope or isotopes thereof; or foliar feeding the plant a solution comprising essential chemical elements enriched for lightest stable isotope or isotopes thereof, or growing the plant in hydroponics in a solution comprising essential chemical elements enriched for lightest stable isotope or isotopes thereof. In some embodiments, a food product of a plant is a vegetable or a fruit. In some embodiments, the fertilizer, compost, or solution fed to the plants (in which the plants are grown) comprises 64Zne.” (col. 4, lines 24-36).
VECTOR teaches that: “In another aspect, this disclosure provides fertilizer or compost comprising essential chemical elements enriched for lightest stable isotope or isotopes thereof. In some embodiments, the essential chemical elements are enriched for lightest stable isotope or isotopes thereof at higher than 85%, 90%, 95% or 99%. In some embodiments, the essential chemical element(s) is(are) one or more of H, C, N, O, Zn, Fe, Mg, Si, Se, Rb, K, and Ca.” and including 64-Zn, 54-Fe, 58-Ni, 70-Ge (col. 5, lines 25-40)(instant claims 63-65).
VECTOR teaches that: “Homeostasis is the state of steady internal, physical, and chemical conditions maintained by living systems. Homeostasis is brought about by a natural resistance to change when already in the optimal conditions, and equilibrium is maintained by many regulatory mechanisms. Homeostasis is any self-regulating process by which biological systems tend to maintain stability while adjusting to conditions that are optimal for survival. The stability attained is actually a dynamic equilibrium, in which continuous change occurs yet relatively uniform conditions prevail.” (col. 7, lines 21-30).
VECTOR teaches that: “Isotope-induced changes in the symmetry of biomolecules can be caused not only by such basic elements as hydrogen, carbon, oxygen, and nitrogen but also by essential chemical elements. Isotope-induced chirality and its amplification in asymmetric autocatalysis could go in both directions. It means that reverse isotope selective autocatalytic reactions may lead to the isotope separation in live cells. If true, isotope separation effect could be the most critical feature which defines the fate of live cells and makes all the difference between normal and pathology affected cells and tissues, young and senescent cells, and at the end-between life and death Isotope composition of biomolecules should be a decisive factor for stability/homeostasis in both healthy/young organism and efficient pathogens (whether it is bacteria or virus).” (col. 11, lines 1-18).
VECTOR teaches that: “According to this model, pathology cannot progress absent heavy isotopes. To fight diseases, the "isotope ratios" can be changed of essential chemical elements in favor of atoms that have an equal number of protons and neutrons or minimum excess of neutrons over protons. The ideal therapeutic composition should include a mixture of the lightest isotopes of essential chemical elements in the amounts proportional to the correspondent daily consumption dose.” (col. 14, lines 36-43).
TEMNIKOV teaches that: “the cumulative divergence of the body's isotope relative abundances from the natural relative abundance causes a decrease in the functionality of various proteins and other molecules in the body, leading to a decline in health with age.” And that: “The present inventors believe such a decline can be countered by restoring the body's original isotope relative abundances, or by moving the isotope relative abundances in that direction. Similarly, pathogenic infectious bacteria can be suppressed by treating them with light isotopes of the elements listed above, which can alter the chirality of the autocatalytic products of such bacteria, resulting in their death or suppressed growth. Thus, treatment with light isotopes can have the dual result of improving the body's ability to fight off a bacterial infection and simultaneously killing or suppressing the growth of infective bacteria. Further, the quantity of light isotope that is effective may be proportional to the quantity of the corresponding element that is present in the body. Where the body contains a relatively large quantity of the element, a correspondingly relatively large amount of the element's light isotope will be required to provide an effective dosage amount. On the other hand, where the body contains a relatively small quantity of the element, a correspondingly relatively small amount of the element's light isotope will be required to provide an effective dosage amount.” ([0005]-[0006]). TEMNIKOV teaches zinc, iron, nickel and germanium play important roles in autocatalytic reactions in the body of an animal, such as a human or other mammal. ([0005]).
TEMNIKOV teaches that: “In certain embodiments, the preferred dosage of any of the light isotopes is proportional to various authoritative daily ingestion guidance (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 20 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. 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.” [emphasis added]([0046]). TEMNIKOV teaches the daily guidance amount for the element isotope Iron (Fe-54) is: Birth to 6 months 0.27 mg, 7-12 months 11 mg, 1-3 years 7 mg, 4-8 years 10 mg, 9-13 years 8 mg, 14-18 years males: 11 mg, females: 15 mg, 19-50 years males: 8 mg, females: 18 mg, Adults 51 years and older 8 mg” And Zinc (Zn-64) is: Birth to 6 months 2 mg, 7 months-3 years 3 mg, Children 4-8 years 5 mg, Children 9-13 years 8 mg, 14-18 years (boys) 11 mg 14-18 years (girls) 9 mg, Adults (men) 11 mg, Adults (women) 8 mg.” (p. 6, col. 1, Table).
WARRELL teaches use of gallium salts to treat disorders of calcium homeostasis (title, see whole document), and particularly that: “The present invention comprises a method of preventing or treating a disorder associated with accelerated loss of calcium from bone in a human individual comprising administering to the individual a pharmaceutically acceptable gallium compound.” (abstract).
CARRINGTON teaches healthful supplement food (title, see whole document), including that: “The supplement foods described herein have no negative side effects and can optimize health of animals, including humans, who receive them.” ([0004]). CARRINGTON teaches their compositions include: “Multi-Minerals”: The supplement foods described herein can include small amounts of minerals or salts thereof. Examples of such minerals can include […] gallium, germanium […] iron […] nickel […] zinc […], or any combination thereof.” ([0017]). The examiner notes that the minerals in CARRINGTON would have had natural abundances (instant claim 62)(MPEP §2144.01). And that: “The amounts of minerals in the supplement food can vary. For example, the minerals in a single serving of the supplement food can range from about 0.01 µg/Kg to about 100 mg/Kg, […] or any intervening amount.” ([0016]). The examiner notes that for 60 Kg adult the range would be 0.6 mcg to 6,000 mg, therefore encompassing the claimed range, or multiple thereof. MPEP §2144.05(I) - In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising chemical elements to a human body enriched in the lightest isotopes, as suggested by NOVAK and VECTOR, in order to establish, maintain or restore homeostatic as suggested by VECTOR, the chemical elements including iron (Fe), zinc (Zn) and nickel, as taught by NOVAK, and including germanium (Ge), as taught by VECTOR and TEMNIKOV, and further including gallium (Ga), as suggested by CARRINGTON to restore bone homeostasis, as suggested by WARRELL, the treatment aimed at restoring homeostasis taught by NOVAK/VECTOR comprise the composition comprising an essential element and a non-essential element as taught by NOVAK/VECTOR as suggested by TEMNIKOV to lower the patient’s heavy isotopes relative to light isotopes to improved the patients health (“the cumulative divergence of the body's isotope relative abundances from the natural relative abundance causes a decrease in the functionality of various proteins and other molecules in the body, leading to a decline in health with age.” ([0005]), “a decline can be countered by restoring the body's original isotope relative abundances, or by moving the isotope relative abundances in that direction” ([0006])).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to produce a mineral supplement including known mineral elements therein. 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 claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Response to Arguments:
Applicant's arguments filed 04/14/2026 have been fully considered but they are persuasive regarding the previously cited combination of references. Particularly, Applicant argues, regarding the previously cited combination of references, that: “The cited references do not disclose the following elements of the claimed invention.” And particularly that: “The disclosure of the cited references do not disclose or suggest that for the essential chemical element Fe, the additive chemical elements are Ni, Zn, Ga and Ge: and the dose is 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, and 7.2 mcg Ge, or the dose is a multiple thereof, wherein the multiple is the same multiplier for each element.” (p. 5). However, upon further consideration, a new ground(s) of rejection is made in view of NOVAK (US 2016/0151415; published June, 2016) in view of VECTOR (US 11,433,095; published 09/06/2022; filed 03/26/2021); TEMNIKOV (US 2018/0296596; published October, 2018); WARRELL (US 4,529,593; published July, 1985) and CARRINGTON (US 2020/0000136 A1; published January, 2020).
Conclusion
Claims 1 and 62-65 are pending and have been examined on the merits. Claims 1 and 62-65 are rejected under 35 U.S.C. 103. No claims allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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/IVAN A GREENE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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