DETAILED ACTION
Status of the Claims
Claims 1, 62-65, and 74 are pending in the instant application and are being examined on the merits in the instant application.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/25/2025 has been entered.
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All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.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 § 112(a)
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, 62-65 and 74 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter Rejection.
Scope of the Claimed Invention:
Applicant claims a method to restore homeostasis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising an essential chemical element and one or more 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; and wherein a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element; wherein the essential chemical element is Fe; and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, or a dose that is a multiple thereof, wherein the multiple is the same for each element (claim 1).
Applicant claims a method to restore homeostatis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising an essential chemical element and one or more 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; and wherein a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element; wherein the essential chemical element is Fe, which is enriched to 90% isotope of Fe-54; and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe-54, 2.31 mg Ni, 0.23 mg Zn, 26 mg, Ga and 2.6 mg. Ge, or a dose that is a multiple thereof, wherein the multiple is the same multiplier for each element (instant claim 74).
The “one or more additive chemicals” taken with the specific dose are considered new matter as the Specification indicates the combination is required.
Disclosure of the Instant Application:
Applicants arguments indicate that: “These amendments are supported in the Specification throughout.”
The instant Specification discloses that: “In some embodiments, the pharmaceutical composition comprises the essential chemical element Fe and additive chemical elements Ni, Zn, Ga and Ge, and a therapeutic dose equal to or multiple of a sum of: 20 mg Fe+ 0.15 mg Ni+ 2.36 mg Zn+ 50 mcg Ga+ 7.2 mcg
Ge.” (p. 67, [00475])1, corresponding to the dose amounts in instant claim 1.
The instant Specification discloses that: “In some embodiments, the pharmaceutical composition comprises the essential chemical element Fe enriched to 90% isotope Fe-54 and additive chemical elements Ni, Zn, Ga and Ge, and a therapeutic dose equal to or multiple of a sum of: 20 mg Fe-54 + 2.31 mg Ni+ 0.23 mg Zn+ 26 mg Ga+ 2.6 mg Ge.” (p. 68, [00481]), corresponding to the dose amounts in instant claim 74.
Discussion:
The both claims 1 and 74 recite “administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising an essential chemical element and one or more additive chemical elements, each additive chemical element specific to said essential chemical element in specific quantity” and further a specific dose. The claims introduce new matter because the “one or more additive chemical” does not require each of the species “Ni, Zn, Ga and Ge, and a therapeutic dose equal to or multiple of a sum of: 20 mg Fe+ 0.15 mg Ni+ 2.36 mg Zn+ 50 mcg Ga+ 7.2 mcg Ge.” corresponding to Fe in claim 1, and similarly in claim 74. The support for the Specific doses is for Fe taken with each of the additive elements. The inclusion of “one or more additive chemical elements” in claims 1 and 74 taken with the specific corresponding doses of additive chemical elements is considered to introduce new matter because the Specification requires each of the additive chemical elements “each additive chemical element specific to said essential chemical element in specific quantity”. As such, the claims are properly rejected as failing to comply with the written description requirement.
Claim Rejections - 35 USC § 112(b)
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, 62-65 and 74 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 has been amended to recite “administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising an essential chemical element and one or more 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; and wherein a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element; wherein the essential chemical element is Fe; and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, or a dose that is a multiple thereof, wherein the multiple is the same for each element (claim 1). It is unclear what the required “dose” to be administered is because the claim variously recites “a therapeutically effective amount” which is being regarded as “a dose”, and recites “a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element” and again recites “and a dose of 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, or a dose that is a multiple thereof, wherein the multiple is the same for each element”. Therefore, it is unclear what dose of the essential chemical element and one or more additive chemical elements are required by the claims. Furthermore, it appears to be a broad and narrow scope (MPEP §2173.05(c)(I)) of “a dose” in recited in the claim where the broadest is “a therapeutically effective amount” and the narrowest is “a dose of 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, or a dose that is a multiple thereof” with “a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element” being unclear because “the daily consumption dose” in unclear in the context of the claim because, for example, a subjects diet may include the recited elements (Fe, Ni, Zn, Ga and/or Ge). Appropriate clarification is required. Claim 74 includes the same language as is therefore rejected for the same reasoning. Claims 62-65 are rejected as depending from a rejected claim, as detailed above, and doing nothing to clarify the parent claim. Appropriate clarification is required.
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, 62-65 and 74 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); De Ninno et al.2 (“Electromagnetic homeostasis and the role of low-amplitude electromagnetic fields on life organization,” 2017, Taylor & Francis; Electromagnetic Biology and Medicine, Vol. 36, No. 2, pp. 115-122); Averill et al.3 (“General Chemistry Principles, Patterns, and Applications,” July 2020; retrieved on 11-SEP-2024, 718-pages) and XI (US 2018/0110802; published April, 2018).
Applicants Claims
Applicant claims a method to restore homeostasis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising an essential chemical element and one or more 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; and wherein a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element; wherein the essential chemical element is Fe; and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, or a dose that is a multiple thereof, wherein the multiple is the same for each element (claim 1).
Applicant claims a method to restore homeostatis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising an essential chemical element and one or more 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; and wherein a dose of each of said additive chemical element is chosen by calculating as a product between ratio of the daily consumption dose of the additive chemical element that compensates for the magnetic component of the lightest isotope of the essential chemical element to the abundance of said isotope in nature and the abundance of each isotope of said essential chemical element; wherein the essential chemical element is Fe, which is enriched to 90% isotope of Fe-54; and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe-54, 2.31 mg Ni, 0.23 mg Zn, 26 mg, Ga and 2.6 mg. Ge, or a dose that is a multiple thereof, wherein the multiple is the same multiplier for each element (instant claim 74).
Elected Species:
Applicants have elected the following species in the reply filed 02/03/2025: (a) a species of administering is intraperitoneal administration; (b) a species of “a pharmaceutical composition comprising various essential chemical elements and additive chemical elements specific to each essential chemical element in specific quantities” is “the essential chemical element” Fe (iron) and “additive chemical element” Zn (zinc).
Claim Interpretation: Claims 1, 21 and 41 each recite “the abundance of said isotope in nature” which is being interpreted as synonymous with “natural abundance” (instant Specification, Table 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.” [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 6-65 and 73).
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 choosing the essential chemical element and additive chemical element such than the number of protons in the additive chemical element is equal to number of neutrons in the corresponding isotopes of the essential chemical element (instant claim 22).
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).
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).
VECTOR does not explicitly teach wherein the homeostasis comprises homeostasis between electric and magnetic components of differential and integral characteristics of electromagnetic field, or the composition comprising additive chemical elements specific to each essential chemical element in specific quantities. However, VECTOR does teach the role of electromagnetic fields and improper levels of heavy isotope compositions in cells, tissues, and/or biological molecules (i.e., proteins and DNA) as well as their influence on cellular functions and/or pathological conditions (col. 10, line 48 through col. 13; col. 14, line 49 through col. 15, line 17)
Regarding the dose, the instant Specification discloses that: “The Use of Natural Iron as a Component of the Therapeutic Composition” has a dose of “20 mg dose of Fe” and “Zn 2.36 mg to compensate ‘magnetic’ Zn in Fe-56.” (p. 97, Example 1, p. 99, paragraphs [00510], [00511] and [00513]). And “The Use of Enriched Lightest Iron Isotope Fe-54 as the Component of a Therapeutic Compound” has a dose of 20 mg of Fe-54 and “Zn 0.23 mg to compensate ‘magnetic’ Zn in Fe-56” (Example 2, paragraphs [00517], [00524], [00525] and [00527]).
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 that: “In certain embodiments, the preferred dosage of any of the light isotopes is proportional to various authoritative daily ingestion guidances (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.” ([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).
De Ninno et al. teaches a role for elements comprised by biological molecules and/or cells influencing electromagnetic homeostasis which can impact the health status of an organism or functions Within the organism (see whole document). De Ninno et al. teaches that: "Electromagnetic homeostasis is a rather new concept and involves the entire set of electromagnetic parameters of the constituent elements of biological molecules.” (p. 115, col. 2, last paragraph. And that: “If we admit that electromagnetism plays a role in the physiology of the cells, we have also to conclude that any alteration of the electromagnetic pattern inside the living organisms could induce a modification of the physiological processes.” (p. 116, col. 1, 2nd paragraph). And further that: “The electromagnetic homeostasis can then be associated with the optimal functionality of cells, protein metabolism and DNA duplication and with the maintenance of the health of the whole organism. External perturbations could thus affect cellular function and the overall health status therefore implying major medical effect.” (p. 116, col. 1, 3rd paragraph).
Averill et al. teaches elements that are essential or suggested to be essential for humans (p. 69, Figure 1.26). Note, Figure 1.26 depicts Br as nonessential for humans and that the following elements are essential or suggested to be essential for humans: H, C, N, O, F, Na, Mg, Si, P, S, Cl, K, Ca, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Se, Mo, Sn, and I.
XI teaches “A mineral water comprising a composition of a blend of minerals and trace rare earth elements is provided, […]. The water is conducive to good health and can relieve the symptoms of some chronic diseases.” (title, abstract, see whole document). XI teaches that “The use of rare earth elements provides certain health benefits.” ([0041]). XI teaches that: “The present invention is directed to a mineral water comprising a health promoting composition of a blend of minerals and trace rare earth elements.” ([0005]). And including gallium (Ga) “from 0.2 to 0.8 micrograms of Gallium” ([0005], Table 1).
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 therapeutically effective amount of a composition comprising chemical elements essential for the 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/ De Ninno et al., and further it would have been obvious during routine experimentation to optimize the quantity and/or concentrations of two or more compounds in a pharmaceutical to obtain greatest impact and/or desired results, it would have been obvious to one of ordinary skill in the art that the degenerative 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/Averill et al./XI in specific quantities which would have been able to influence electromagnetic homeostasis as taught by De Ninno et al., so that the degenerative disease is treated in part by altering electromagnetic homeostasis, the does being “between about ½ and about 20 times the guidance amount of the corresponding element” as suggested by TEMNIKOV, in order 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. 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 12/04/2025 have been fully considered but they are not persuasive.
Applicant agues that: “The combined disclosure of the cited references do not disclose or suggest at least: "wherein the essential chemical element is Fe, and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe, 0.15 mg Ni, 2.36 mg Zn, 50 mcg Ga, and 7.2 mcg Ge, or a dose that is a multiple thereof, wherein the multiple is the same multiplier for each element," as required by claim 1 and claims dependent therefrom (claims 62-65).” And further that: “The combined disclosure of the cited references do not disclose or suggest at least: "wherein the essential chemical element is Fe, which is enriched to 90% isotope Fe-54; and the additive chemical elements are Ni, Zn, Ga and Ge, and a dose of 20 mg Fe-54, 2.31 mg Ni, 0.23 mg Zn, 26 mg Ga, and 2.6 mg Ge, or a dose that is a multiple thereof, wherein the multiple is the same multiplier for each element," as required by claim 74.” (p. 9, last two paragraphs).
In response the examiner argues that NOVAK clearly teaches compositions including Fe in natural abundance or enriched in the lightest isotope which is Fe-54, wherein the enrichment encompasses 80% and 90% Fe-54 (instant claims 1, 62-65 and 74), and in combination with “one or more additive chemical elements” selected from Ni, Zn, Ga and Ge as detailed above.
Conclusion
Claims 1, 62-65 and 74 are pending and have been examined on the merits. Claims 1, 62-65 and 74 are rejected under 35 U.S.C. 112(a)(New Matter); claims 1, 62-65 and 74 are rejected under 35 U.S.C. 112(b); and claims 1, 62-65 and 74 are rejected under 35 U.S.C. 103. No claims allowed at this time.
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
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 The citation is to the Clean-Copy of the Specification filed 12/04/2025.
2 Of record as cited on the IDS dated 01/21/2025 (non-patent literature citation No. 1).
3 Of record as cited on the IDS dated 01/21/2025 (non-patent literature citation No. 3).