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 .
Status of the Claims
Claims 1-18 are pending and currently under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received and placed in the file.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 12/02/2024 and 11/07/2025 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 2-18 are objected to because of the following informalities:
Dependent claims 2-18 are objected to because they recite the indefinite article “A” rather than the definite article “The” at the beginning of the claim. Amending the claim to replace the “A” with the definite article “The” would be remedial.
Claim 8 is objected to because the claim recites “potassium gluconate” as a duplicate limitation in lines 2 and 4. Amending the claim to delete one of the recited “potassium gluconate” would be remedial.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a multi-ionic composition comprising mineral and/or organic salts, including at least one lithium, magnesium and potassium salt”. This language renders the claim indefinite because it is not clear whether the claim requires lithium, magnesium, and potassium salt, or requires only one of the three salts present in the multi-ionic composition. The examiner suggests amending the claim to “a multi-ionic composition comprising mineral and/or organic salts, including a lithium, a magnesium, and a potassium salt”.
Claims depending from rejected claims have also been rejected because they incorporate
all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness
concerns outlined above.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fechner et al. (US20050064193A1, Published 03/24/2005).
Applicant’s Invention
The Applicants claims are drawn to a method of oral or parenteral treatment or prevention of inflammation, comprising: providing a multi-ionic composition comprising mineral and/or organic salts, including at least one lithium, magnesium and potassium salt, characterized by the following molar ratios: lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40]; and administering the multi-ionic composition to a subject for oral or parenteral treatment or prevention of inflammation.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-2 and 5, Fechner teaches the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]). Fechner also teaches in claim 1, that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). Fechner continues to teach the antimicrobial, anti-inflammatory and disinfecting glass powder for use in the field of dental medicine (i.e., oral) as an anti-inflammatory additive for avoidance of gum bleeding (claim 22).
Regarding claims 14 and 15 wherein the multi-ionic composition is administered to the subject to reduce the release of TNF-α and/or IL-1β and/or IL-18 and wherein the multi-ionic composition is administered to the subject to reduce the activation of Caspase, Fechner teaches the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]). Fechner also teaches in claim 1, that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). Although Fechner does not explicitly teach reducing the release of TNF-α and/or IL-1β and/or IL-18 and wherein reducing the activation of Caspase, such property must necessarily be present. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Fechner does not disclose a single embodiment or example where every limitation recited in the instant claims are taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art because
Fechner teaches all of the claimed elements. It would have been prima facie obvious at the time
of filing to have a method of oral or parenteral treatment or prevention of inflammation, comprising: providing a multi-ionic composition comprising mineral and/or organic salts, including at least one lithium, magnesium and potassium salt, characterized by the following molar ratios: lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40]; and administering the multi-ionic composition to a subject for oral or parenteral treatment or prevention of inflammation because Fechner teaches these elements as components of their invention.
With regards to the limitation wherein the at least one lithium, magnesium and potassium salt, are characterized by the following molar ratios: lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40] and wherein lithium is present at a concentration between 0.01 and 100 mmol/kg, it would have been obvious to optimize the molar ratios of lithium, magnesium, and potassium, as well as the concentration of lithium in Fechner’s anti-inflammatory dental medicine. One would have understood in view of Fechner that that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). It would have been obvious to optimize the molar ratios of lithium, magnesium, and potassium, as well as the concentration of lithium in Fechner’s anti-inflammatory dental medicine because Fechner teaches wherein the composition comprises 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (claim 1), therefore, one of ordinary skill in the art can use the teachings of Fechner as a starting point using routine experimentation for the desired results of molar ratios of lithium, magnesium, and potassium, as well as the concentration of lithium. Where 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, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments
and adaptations, within the skill of the competent worker.” (MPEP 716.07).
With regards to having a multi-ionic composition comprising mineral and/or salts, including at least one lithium, magnesium, and potassium salt, it would have been obvious to one of ordinary skill to have all three in Fechner’s anti-inflammatory dental medicine. Fechner teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). Fechner further teaches that that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (claim 1). Therefore, it would have been obvious to have lithium, magnesium, and potassium in one composition in Fechner’s anti-inflammatory dental medicine because Fechner teaches that the composition can have 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (claim 1) present in an anti-inflammatory composition.
Claims 3-4, 6-8, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fechner et al. (US20050064193A1, Published 03/24/2005) as applied to claims 1-2, 5, and 14-15 above in view of Dehaan et al (US20170304564A1, Published 10/26/2017).
Applicant’s Invention
Fechner renders obvious all the limitations of instant claim 1. Applicants claim 3 further adds the limitation wherein the lithium salt is a mineral salt, optionally selected from lithium chloride, lithium hydroxide or lithium carbonate. Applicants claim 4 further adds the limitation wherein the lithium salt is an organic salt, optionally selected from lithium citrate, lithium gluconate or lithium orotate. Applicants claim 6 further adds the limitation wherein the magnesium salt is an organic salt, optionally selected from magnesium bisglycinate, magnesium malate, magnesium glycerophosphate, magnesium stearate, magnesium ascorbate, magnesium taurate, magnesium citrate, magnesium gluconate or magnesium taurinate. Applicants claim 7 further adds the limitation wherein the potassium salt is a mineral salt, optionally selected from potassium chloride, potassium bromide, potassium iodide, potassium phosphate, potassium carbonate, potassium hydroxide, potassium silicate. Applicants claim 8 further adds the limitation wherein the potassium salt is an organic salt, optionally selected from potassium gluconate, potassium citrate, potassium malate, potassium glycerophosphate, potassium lactate, potassium pidolate, potassium aspartate or potassium gluconate. Applicants claim 17 further adds the limitation wherein the multi-ionic composition further comprising at least one additive selected from stabilizers, emulsifiers, preservatives, antioxidant and/or gelling agents. Applicants claim 18 further adds the limitation wherein the multi-ionic composition further comprising one or more other mineral or organic salt, optionally selected from such as a salt of zinc, manganese, copper and/or silicon.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 3-4, 6-8, and 17-18, Fechner teaches the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]). Fechner also teaches in claim 1, that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). Fechner continues to teach the antimicrobial, anti-inflammatory and disinfecting glass powder for use in the field of dental medicine (i.e., oral) as an anti-inflammatory additive for avoidance of gum bleeding (claim 22).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Fechner does not teach wherein the lithium salt is a mineral salt, optionally selected from lithium chloride, lithium hydroxide or lithium carbonate; wherein the lithium salt is an organic salt, optionally selected from lithium citrate, lithium gluconate or lithium orotate; wherein the magnesium salt is an organic salt, optionally selected from magnesium bisglycinate, magnesium malate, magnesium glycerophosphate, magnesium stearate, magnesium ascorbate, magnesium taurate, magnesium citrate, magnesium gluconate or magnesium taurinate; wherein the potassium salt is a mineral salt, optionally selected from potassium chloride, potassium bromide, potassium iodide, potassium phosphate, potassium carbonate, potassium hydroxide, potassium silicate; wherein the potassium salt is an organic salt, optionally selected from potassium gluconate, potassium citrate, potassium malate, potassium glycerophosphate, potassium lactate, potassium pidolate, potassium aspartate or potassium gluconate. Fechner further does not teach wherein the multi-ionic composition further comprising at least one additive selected from stabilizers, emulsifiers, preservatives, antioxidant and/or gelling agents; and wherein the multi-ionic composition further comprising one or more other mineral or organic salt, optionally selected from such as a salt of zinc, manganese, copper and/or silicon. However, these deficiencies are cured by Dehaan et al.
In the analogous art of method for the treatment or prevention of inflammation, Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract).
Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Deehan continues to teach that suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]). Dehaan further teaches that the respirable dry powders and dry particles described herein contain one or more metal cation salts, which can be monovalent metal cation salts, divalent metal cation salts, or combinations thereof (paragraph [0064), wherein suitable lithium salts include lithium chloride, and lithium carbonate (i.e., mineral salt), lithium citrate, lithium gluconate, and lithium orotate (i.e., organic salts) (paragraph [0068]). Suitable magnesium salts include magnesium malate, magnesium stearate, magnesium taurate, magnesium citrate, and magnesium gluconate (i.e., organic salts) (paragraph [0071]). Deehan continues to teach suitable potassium salts include potassium chloride, potassium bromide, potassium iodide, potassium phosphate (i.e., mineral salts), potassium gluconate, potassium citrate, and potassium malate (i.e., organic salts) (paragraph [0067]). Deehan also teaches therapeutic agents such as Biperiden for Parkinson’s disease and Mesalamine for Irritable Bowel Syndrome (paragraph [0177]). Deehan further teaches excipients (i.e., additives) such as maltodextrin which can act as an amorphous phase stabilizer (paragraph [0257]). Deehan also teaches if desired, the formulations, dry powders or dry particles may comprise a salt other than a monovalent or divalent metal cation salt such as one or more non-toxic salts of the elements zinc, manganese, copper and silicon (paragraph [0077]).
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 at the time of filing to use mineral and/or organic salts of lithium, magnesium, and potassium in Fechner’s anti-inflammatory dental medicine. Fechner teaches the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]). Fechner also teaches in claim 1, that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). One would have understood in view of Dehaan, an invention wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agents that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Deehan continues to teach that suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]). Dehaan further teaches that the respirable dry powders and dry particles described herein contain one or more metal cation salts, which can be monovalent metal cation salts, divalent metal cation salts, or combinations thereof (paragraph [0064), wherein suitable lithium salts include lithium chloride, and lithium carbonate (i.e., mineral salt), lithium citrate, lithium gluconate, and lithium orotate (i.e., organic salts) (paragraph [0068]). Suitable magnesium salts include magnesium malate, magnesium stearate, magnesium taurate, magnesium citrate, and magnesium gluconate (i.e., organic salts) (paragraph [0071]). Deehan continues to teach suitable potassium salts include potassium chloride, potassium bromide, potassium iodide, potassium phosphate (i.e., mineral salts), potassium gluconate, potassium citrate, and potassium malate (i.e., organic salts) (paragraph [0067]). It would have been obvious
use mineral and/or organic salts of lithium, magnesium, and potassium in Fechner’s anti-inflammatory dental medicine because Fechner teaches the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass powder which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]) and Deehan teaches an invention wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract), wherein the invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Dehaan further teaches that the respirable dry powders and dry particles described herein contain one or more metal cation salts, which can be monovalent metal cation salts, divalent metal cation salts, or combinations thereof (paragraph [0064), such as mineral and/or organic salts of lithium, magnesium, and potassium. Therefore, mineral and/or organic salts of lithium, magnesium, and potassium are suitable in a composition for the purpose of treating or preventing inflammation. See MPEP 244.07.
Claims 1-10, 12, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dehaan et al (US20170304564A1, Published 10/26/2017) in view of Fechner et al. (US20050064193A1, Published 03/24/2005).
Applicant’s Invention
The Applicants claims are drawn to a method of oral or parenteral treatment or prevention of inflammation, comprising: providing a multi-ionic composition comprising mineral and/or organic salts, including at least one lithium, magnesium and potassium salt, characterized by the following molar ratios: lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40]; and administering the multi-ionic composition to a subject for oral or parenteral treatment or prevention of inflammation.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 9, Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Dehaan continues to teach that suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]). Dehaan further teaches that the respirable dry powders and dry particles described herein contain one or more metal cation salts, which can be monovalent metal cation salts, divalent metal cation salts, or combinations thereof, such as potassium salts, magnesium salts, and lithium salts (paragraph [0064)]. Dehaan also teaches that the dry powders can be used as a oral dosage form for the delivery of an therapeutic agent, which is designed to provide a rapid delivery of the therapeutic agent, a sustained delivery of the therapeutic agent, or at an in between rate (paragraph [0272]).
Regarding claims 3 and 4, Dehaan teaches wherein suitable lithium salts include lithium chloride, and lithium carbonate (i.e., mineral salt), lithium citrate, lithium gluconate, and lithium orotate (i.e., organic salts) (paragraph [0068]).
Regarding claims 5 and 6, Dehaan teaches suitable magnesium salts include Magnesium chloride, magnesium hydroxide, magnesium oxide, magnesium carbonate (i.e., mineral salts) magnesium malate, magnesium stearate, magnesium taurate, magnesium citrate, and magnesium gluconate (i.e., organic salts) (paragraph [0071]).
Regarding claims 7 and 8, Dehaan teaches suitable potassium salts include potassium chloride, potassium bromide, potassium iodide, potassium phosphate (i.e., mineral salts), potassium gluconate, potassium citrate, and potassium malate (i.e., organic salts) (paragraph [0067]).
Regarding claims 10 and 12, Dehaan teaches therapeutic agents such as Biperiden for Parkinson’s disease and Mesalamine for Irritable Bowel Syndrome (paragraph [0177]).
Regarding claims 14 and 15, wherein the multi-ionic composition is administered to the subject to reduce the release of TNF-α and/or IL-1β and/or IL-18 and wherein the multi-ionic composition is administered to the subject to reduce the activation of Caspase, Dehaan teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Dehaan further teaches that the respirable dry powders and dry particles described herein contain one or more metal cation salts, which can be monovalent metal cation salts, divalent metal cation salts, or combinations thereof, such as potassium salts, magnesium salts, and lithium salts (paragraph [0064)]. Although Dehaan does not explicitly teach reducing the release of TNF-α and/or IL-1β and/or IL-18 and wherein reducing the activation of Caspase, such property must necessarily be present. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Regarding claim 17, Dehaan teaches excipients (i.e., additives) such as maltodextrin which can act as an amorphous phase stabilizer (paragraph [0257]).
Regarding claim 18, Dehaan teaches if desired, the formulations, dry powders or dry particles may comprise a salt other than a monovalent or divalent metal cation salt such as one or more non-toxic salts of the elements zinc, manganese, copper and silicon (paragraph [0077]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Dehaan does not teach a multi-ionic composition comprising mineral and/or organic salts, including at least one lithium, magnesium and potassium salt, characterized by the following molar ratios: lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40]; wherein lithium is present at a concentration between 0.01 and 100 mmol/kg. However, these deficiencies are cured by Fechner et al.
Fechner teaches the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]). Fechner also teaches in claim 1, that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). Fechner continues to teach the antimicrobial, anti-inflammatory and disinfecting glass powder for use in the field of dental medicine (i.e., oral) as an anti-inflammatory additive for avoidance of gum bleeding (claim 22).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of filing to have
molar ratios of lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40]; and lithium at a concentration between 0.01 and 100 mmol/kg in Dehaan’s dry powders that contain a therapeutic agent. Dehaan teaches the invention provides a method for the treatment or prevention of inflammation (paragraph [0299]), wherein suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]). Dehaan further teaches that the respirable dry powders and dry particles described herein contain one or more metal cation salts, which can be monovalent metal cation salts, divalent metal cation salts, or combinations thereof, such as potassium salts, magnesium salts, and lithium salts (paragraph [0064)]. One would have understood in view of Fechner that the object of the present invention is to make available an antimicrobial, anti-inflammatory and disinfecting glass which itself has an antimicrobial and anti-inflammatory effect and which benefits synergistically from the addition of iodide (paragraph [0009]). Fechner also teaches in claim 1, that the glass contains 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1). Fechner further teaches in example 5, a composition with 4% magnesium oxide, and 0.05% of potassium oxide (paragraph [0036]). It would have been obvious to have the molar ratios of lithium 1- magnesium [0.13-0.34] – potassium [1.20-2.40]; and lithium at a concentration between 0.01 and 100 mmol/kg in Dehaan’s dry powders that contain a therapeutic agent because Fechner teaches the particular three ingredients, 0-40 wt% of potassium oxide, 0-40 wt% of lithium oxide, 0-10 wt% of magnesium oxide (i.e., mineral salt) (claim 1), therefore it would be obvious to modify Dehaan’s composition to comprise the specifically lithium, potassium, and magnesium. It also would have been obvious to optimize molar ratios lithium, magnesium, and potassium, as well as the concentration of lithium using the teachings of Fechner as a starting point for routine experimentation to achieve the desired results. Where 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, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments
and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dehaan et al (US20170304564A1, Published 10/26/2017) in view of Fechner et al. (US20050064193A1, Published 03/24/2005) as applied to claims 1-10, 12, 14-15, and 17-18 above, further in view of Moore (News Medical Life sciences, Published 02/06/2020).
Applicant’s Invention
Dehaan renders obvious all the limitations of instant claim 1. Applicants claim 11 further adds the limitation wherein the condition is chronic neuroinflammation.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 11, Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Dehaan continues to teach that suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Dehaan does not teach the condition is chronic neuroinflammation. However, this deficiency is cured by Moore.
Moore teaches that Neuroinflammation refers to the process whereby the brain’s innate immune system is triggered following an inflammatory challenge such as those posed by injury, infection, exposure to a toxin, neurodegenerative disease, or aging (abstract). Moore also teaches neuroinflammation arises in slightly different ways depending on its cause. Below these types of neuroinflammation are discussed, and their specific pathways detailed such as injury, Peripheral immune response, Infection, Aging, Neurodegenerative disease and Psychiatric disease, wherein these pathways all trigger inflammatory signals, resulting in neuroinflammation (whole document).
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 at the time of filing to use Dehaan’s dry powders that contain a therapeutic agent for the condition of chronic neuroinflammation. Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). One would have understood in view of Moore that Neuroinflammation refers to the process whereby the brain’s innate immune system is triggered following an inflammatory challenge such as those posed by injury, infection, exposure to a toxin, neurodegenerative disease, or aging (abstract). Moore also teaches neuroinflammation arises in slightly different ways depending on its cause. Below these types of neuroinflammation are discussed, and their specific pathways detailed such as injury, Peripheral immune response, Infection, Aging, Neurodegenerative disease and Psychiatric disease, wherein these pathways all trigger inflammatory signals, resulting in neuroinflammation (whole document). It would have been obvious use Dehaan’s dry powders that contain a therapeutic agent for the condition of chronic neuroinflammation because Dehaan teaches invention provides a method for the treatment or prevention of inflammation (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]) and Moore teaches that Neuroinflammation refers to the process whereby the brain’s innate immune system is triggered following an inflammatory challenge such as those posed by injury, infection, exposure to a toxin, neurodegenerative disease, or aging (abstract). Moore also teaches neuroinflammation and their specific pathways detailed such as injury, Peripheral immune response, Infection, Aging, Neurodegenerative disease and Psychiatric disease, wherein these pathways all trigger inflammatory signals, resulting in neuroinflammation (whole document). Therefore, it would have been obvious to treat or prevent chronic neuroinflammation which is a condition caused by inflammation by using Deehan’s composition which is taught to treat or prevent inflammation.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dehaan et al (US20170304564A1, Published 10/26/2017) in view of Fechner et al. (US20050064193A1, Published 03/24/2005) as applied to claims 1-10, 12, 14-15, and 17-18 above, further in view Kelly et al. (AHA/ASA Journals, Published 06/24/2021).
Applicant’s Invention
Dehaan renders obvious all the limitations of instant claim 1. Applicants claim 13 further adds the limitation wherein the multi-ionic composition is administered to the subject for treating or preventing a condition selected form stroke, infraction, sepsis, burns, systemic inflammatory response syndrome, covid, trauma or postoperative inflammation.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 13, Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Dehaan continues to teach that suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Dehaan does not teach wherein the multi-ionic composition is administered to the subject for treating or preventing a condition selected from stroke, infraction, sepsis, burns, systemic inflammatory response syndrome, covid, trauma or postoperative inflammation. However, this deficiency is cured by Kelly.
Kelly teaches new therapeutic approaches are required for secondary prevention of residual vascular risk after stroke. Diverse sources of evidence support a causal role for inflammation in the pathogenesis of stroke. Randomized controlled trials of anti-inflammatory agents have reported benefit for secondary prevention in patients with coronary disease (abstract). Kelly also teaches Data from experimental studies indicates that inflammation is central in all stages of the initiation, progression, erosion, and rupture of atherosclerotic plaque leading to thrombo-embolic events (i.e., stroke) (Laboratory studies section). Kelly further teaches Evidence suggests that inflammation is important in other stroke subtypes by at least 3 mechanisms. Inflammation is known to contribute to a prothrombotic state, regardless of stroke subtype (Inflammation in Small Vessel, Cardio-Embolic, and Cryptogenic Stroke section).
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 at the time of filing to use Dehaan’s dry powders that contain a therapeutic agent for the condition of chronic neuroinflammation. Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). One would have understood in view of Kelly that new therapeutic approaches are required for secondary prevention of residual vascular risk after stroke. Diverse sources of evidence support a causal role for inflammation in the pathogenesis of stroke. Randomized controlled trials of anti-inflammatory agents have reported benefit for secondary prevention in patients with coronary disease (abstract). Kelly also teaches data from experimental studies indicates that inflammation is central in all stages of the initiation, progression, erosion, and rupture of atherosclerotic plaque leading to thrombo-embolic events (i.e., stroke) (Laboratory studies section). Kelly further teaches Evidence suggests that inflammation is important in other stroke subtypes by at least 3 mechanisms. Inflammation is known to contribute to a prothrombotic state, regardless of stroke subtype (Inflammation in Small Vessel, Cardio-Embolic, and Cryptogenic Stroke section). It would have been obvious use Dehaan’s dry powders that contain a therapeutic agent for the condition of chronic neuroinflammation because Dehaan teaches invention provides a method for the treatment or prevention of inflammation (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]) and Kelly teaches new therapeutic approaches are required for secondary prevention of residual vascular risk after stroke. Diverse sources of evidence support a causal role for inflammation in the pathogenesis of stroke. Randomized controlled trials of anti-inflammatory agents have reported benefit for secondary prevention in patients with coronary disease (abstract). Kelly also teaches Data from experimental studies indicates that inflammation is central in all stages of the initiation, progression, erosion, and rupture of atherosclerotic plaque leading to thrombo-embolic events (i.e., stroke) (Laboratory studies section). Therefore, it would have been obvious to treat or prevent stroke which is a condition associated with inflammation by using Deehan’s composition which is taught to treat or prevent inflammation.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dehaan et al (US20170304564A1, Published 10/26/2017) in view of Fechner et al. (US20050064193A1, Published 03/24/2005) as applied to claims 1-10, 12, 14-15, and 17-18 above, further in view of Jones t al. (J Biomed Sci, Published 06/11/2021).
Applicant’s Invention
Dehaan renders obvious all the limitations of instant claim 1. Applicants claim 16 further adds the limitation wherein the multi-ionic composition is administered to the subject for orally treating or preventing a bipolar disorder.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 13, Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). Dehaan continues to teach that suitable therapeutic agents include anti-inflammatory agents (paragraph [0100]). Dehaan also teaches that the dry powders can be used as an oral dosage form for the delivery of an therapeutic agent, which is designed to provide a rapid delivery of the therapeutic agent, a sustained delivery of the therapeutic agent, or at an in between rate (paragraph [0272]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Dehaan does not teach wherein the multi-ionic composition is administered to the subject for orally treating or preventing a bipolar disorder. However, this deficiency is cured by Jones.
Jones teaches Epidemiological evidence shows BD (bipolar disorder) is associated with increased rates of inflammatory comorbidities including numerous autoimmune conditions, hypersensitivity reactions (asthma, seasonal allergies), and cardiometabolic diseases. Patients with BD demonstrate both central and peripheral elevations in proinflammatory elements (cytokines, chemokines, prostaglandins, acute-phase reactants, oxidative/nitrosive species), increased inflammatory gene expression, as well as aberrant cellular (T-cell, monocyte, microglial) and complement activation (Intracellular signaling and inflammation section). Jones also teaches Importantly; numerous studies have shown anti-inflammatory agents to be most beneficial in BD patients with elevated baseline inflammatory markers (Intracellular signaling and inflammation section).
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 at the time of filing to use Dehaan’s dry powders that contain a therapeutic agent for the condition of chronic neuroinflammation. Dehaan teaches the invention related to dry powders that contain a therapeutic agent, wherein the dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (abstract). Dehaan also teaches invention provides a method for the treatment or prevention of inflammation such as rheumatoid arthritis, Crohn’s disease, ulcerative Colitis (i.e., chronic inflammation) (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]). One would have understood in view of Jones that epidemiological evidence shows BD (bipolar disorder) is associated with increased rates of inflammatory comorbidities including numerous autoimmune conditions, hypersensitivity reactions (asthma, seasonal allergies), and cardiometabolic diseases. Patients with BD demonstrate both central and peripheral elevations in proinflammatory elements (cytokines, chemokines, prostaglandins, acute-phase reactants, oxidative/nitrosive species), increased inflammatory gene expression, as well as aberrant cellular (T-cell, monocyte, microglial) and complement activation (Intracellular signaling and inflammation section). Jones also teaches Importantly; numerous studies have shown anti-inflammatory agents to be most beneficial in BD patients with elevated baseline inflammatory markers (Intracellular signaling and inflammation section). It would have been obvious use Dehaan’s dry powders that contain a therapeutic agent for the condition of chronic neuroinflammation because Dehaan teaches invention provides a method for the treatment or prevention of inflammation (paragraph [0299]), wherein an effective amount of therapeutic agent is used to achieve the desired therapeutic or prophylactic effect such as reduce total inflammatory cell count or modulate the profile of inflammatory cell counts (paragraph [0061]) and Jones teaches epidemiological evidence shows BD (bipolar disorder) is associated with increased rates of inflammatory comorbidities including numerous autoimmune conditions, hypersensitivity reactions (asthma, seasonal allergies), and cardiometabolic diseases. Patients with BD demonstrate both central and peripheral elevations in proinflammatory elements (cytokines, chemokines, prostaglandins, acute-phase reactants, oxidative/nitrosive species), increased inflammatory gene expression, as well as aberrant cellular (T-cell, monocyte, microglial) and complement activation (Intracellular signaling and inflammation section).
Therefore, it would have been obvious to treat or prevent bipolar disorder which is a condition associated with inflammation by using Deehan’s composition which is taught to treat or prevent inflammation.
Conclusion
No claims are allowed.
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AFUA BAMFOAA BOATENG Examiner, Art Unit 1617
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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