FINAL 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 Claims
Claims 1-86 and 100-101 are cancelled.
Claims 102 and 110 are withdrawn from consideration.
Claims 87-99 and 103-109 are presented for examination herein.
Rejections Maintained
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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 87-99, 103 and 105-109 are rejected under 35 U.S.C. 103 as being unpatentable over KENNEDY (WO 2009/058857 A1, publication date of 07 May 2009, cited in IDS filed 06/01/2023) in view of SMITH (“Lyme Disease and the Orthopaedic Implications of Lyme Arthritis”, Journal of American Academy of Orthopaedic Surgeons, 19(2), 91-100, 2011) as evidenced by the instant specification.
Kennedy is primarily directed towards a composition able to treat including animal diseases and includes a therapeutically effective amount of an encapsulated ionic mineral complex, a pharmaceutically acceptable carrier and may include other inert ingredients (abstract).
Regarding claims 87, 95-96, 99, 103, 107 and 109, Kennedy discloses a formulation that provides delivery system for moving mineral ions to the target disease area in including animals using highly bioavailable cations through the complex ligand system (page 2, lines 4-6). Kennedy discloses that the composition and delivery mechanism is used to treat a myriad of human disease conditions including pain (page 2, lines 16-17). Kennedy discloses a composition that includes a therapeutically effective amount of an ionic mineral complex and a pharmaceutically acceptable carrier. The ionic mineral complex is an ionic mineral cation ligand bonded to a plurality of ammonia molecules enabling transport of said ionic mineral complex through a biological system to a target cell affected by a disease. The cation is at least one of from a group that includes zinc, copper and magnesium (page 3, lines 4-10). Kennedy discloses that the composition which includes an ionic mineral complex is produced from a method that includes adding ammonium hydrogen sulfate (e.g., formed by sulfuric acid and ammonium sulfate (page 13 of Kennedy)), at least one mineral composition (e.g., zinc, copper and magnesium) and distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration (page 3, lines 12-15). Kennedy discloses that the composition can be administered orally (e.g., systemically) (page 21, lines 1-3). As evidenced by the instant specification, mineral cation hexa-aqua complex and ionic salt composition is prepared by including diluting ammonia hydrogen sulfate (e.g., hydrogen cations, ammonium, hydrogen sulfate) with water to form a mixture, adding minerals (e.g., copper, zinc, and magnesium) to the mixture and agitating the mixture which comprises the ammonium hydrogen sulfate, sulfuric acid, water and the mineral salt (e.g., copper, zinc, and magnesium) (paragraph [0043] of the instant specification). Thus, the composition of Kennedy that includes a pharmaceutically acceptable carrier and a therapeutically effective amount of an ionic mineral complex of including zinc, copper and magnesium (e.g., composition comprising hexaaquacopper (II) ions, hexaaquazinc (II) ions, hexaaquamagnesium (II) ions, hydrogen cations, ammonium, hydrogen sulfate, and water), which is produced by the identical method as the instantly claimed composition necessarily has the same characteristics, e.g., is a composition that comprises the minerals including copper, zinc and magnesium that are present as hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions, respectively, and includes hydrogen cations, ammonium, hydrogen sulfate and water, especially in the absence of evidence to the contrary.
Regarding claims 88-93 and 108, Kennedy discloses making one gallon of mineral complexes (including combinations of more than one which includes zinc, copper and magnesium) with 98 ounces of water (e.g., [98/128 (total)]x100~76.56%), 14 ounces of ammonium hydrogen sulfate (e.g., [14/128]x100~10.94%) and 16 ounces of the one or combination of minerals including zinc, copper and magnesium (e.g., [16/128]x100~12.5%) (page 18, lines 1-7). Kennedy discloses that the concentration of the minerals can be adjusted to produce a more concentrated formulation and the exemplary composition has a reduced amount of mineral content (page 17, lines 25-29). The instant specification defines “about” as referring “to a quantity, level, value, number, frequency, percentage, dimension, size, amount, weight or length that varies by as much as 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% to a reference quantity, level, value, number, frequency, percentage, dimension, size, amount, weight or length” (paragraph [0159]). The amount of mineral including zinc, copper and magnesium (e.g., in the form of hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions, respectively), amount of ammonium hydrogen sulfate (e.g., produced from one mole of sulfuric acid and one mole of ammonium sulfate; which is present as hydrogen cations, ammonium, hydrogen sulfate after agitation of all the ingredients (e.g., composition made by the same ingredients and by the same method as the instantly claimed composition as evidenced by the instant specification at paragraph [0043])) and the amount of water, are art-recognized result-effective variables, e.g., provides therapeutically effective amount of minerals including zinc, copper and magnesium, which a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It is prima facie obvious for one of ordinary skill in the art to determine the optimum amount of mineral including zinc, copper and magnesium (e.g., in the form of hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions, respectively), amount of ammonium hydrogen sulfate (e.g., produced from one mole of sulfuric acid and one mole of ammonium sulfate; which is present as hydrogen cations, ammonium, hydrogen sulfate after agitation of all the ingredients (e.g., composition made by the same ingredients and by the same method as the instantly claimed composition as evidenced by the instant specification at paragraph [0043])) and the amount of water in order to obtained a composition with a desired therapeutically effective amount of minerals including zinc, copper and magnesium (e.g., in the form of hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions, respectively, since they are in the same composition that is made by the same method as the instantly claimed composition (paragraph [0043] of the instant specification)), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Regarding claims 94 and 105-106, Kennedy discloses that the composition can be used to mitigate including arthritis (page 11, lines11-16). Kennedy discloses that zinc and including copper can be used for actions against diseases where swelling and irritation occur (page 28, lines 16-20). Kennedy discloses that the composition can be used to treat pain and inflammation (page 29, lines 9-12).
Regarding claims 97-98, Kennedy discloses that the composition can be administered by topical administration (e.g., locally) (page 21, lines 1-3).
Kennedy does not specifically teach administration to a subject in need of treating Lyme Disease. The deficiency is made up for by the teachings of Smith.
Smith is primarily directed towards Lyme hich is a common clinical manifestation of Lyme disease (abstract).
Regarding claims 87, 94 and 105-107, Smith teaches that children infected with B burgdorferi are more likely than adults to develop arthritis (e.g., secondary disorder) as an initial manifestation of Lyme disease (page 2, second paragraph). Smith teaches that Lyme disease is caused by the spirochete B burgdorferi, which is carried in the gut of the Ixodes tick (page 2, third paragraph). Smith teaches that B burgdorferi is injected into the skin following the bite of an infected tick. Tick saliva, which is injected into the skin along with the spirochete, disrupts local immune mechanisms. The spirochetes multiply and expand within the dermis, and the characteristic erythema migrans rash is caused by the host inflammatory response (page 2, fourth paragraph). Smith teaches that arthritis is the most distinguishing feature of late-stage Lyme disease (page 3, fourth paragraph). Smith teaches that CDC defines Lyme arthritis as “recurrent, brief attacks (weeks or months) of objective joint swelling in one or a few joints, sometimes followed by chronic arthritis in one or a few joints” (page 4, third paragraph).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising a therapeutically effective amount of an ionic mineral complex of including zinc, copper and magnesium (e.g., hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions) and a pharmaceutically acceptable carrier; wherein the ionic mineral complex is produced by a method that includes adding including 14 ounces of ammonium hydrogen sulfate (e.g., formed by sulfuric acid and ammonium sulfate), 16 ounces of at least one mineral composition (e.g., zinc, copper and magnesium) and 98 ounces of distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration. The person of ordinary skill in the art would have been motivated to make those modifications to treat Lyme disease because the composition and method of Kennedy is able to treat including arthritis, pain, immune response, swelling and inflammation, which are symptoms that may be experienced by a subject with Lyme disease. The person of ordinary skill in the art would have reasonably expected success because Kennedy discloses a formulation that provides delivery system for moving mineral ions to the target disease area in including animals using highly bioavailable cations through the complex ligand system (page 2, lines 4-6). Kennedy discloses that the composition and delivery mechanism is used to treat a myriad of human disease conditions including pain (page 2, lines 16-17). Kennedy discloses a composition that includes a therapeutically effective amount of an ionic mineral complex and a pharmaceutically acceptable carrier. The ionic mineral complex is an ionic mineral cation ligand bonded to a plurality of ammonia molecules enabling transport of said ionic mineral complex through a biological system to a target cell affected by a disease. The cation is at least one of from a group that includes zinc, copper and magnesium (page 3, lines 4-10; page 18, lines 9-11). Kennedy discloses that the composition which includes an ionic mineral complex is produced from a method that includes adding ammonium hydrogen sulfate (e.g., formed by sulfuric acid and ammonium sulfate (page 13 of Kennedy)), at least one mineral composition (e.g., zinc, copper and magnesium) and distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration (page 3, lines 12-15). As evidenced by the instant specification, mineral cation hexa-aqua complex and ionic salt composition is prepared by including diluting ammonia hydrogen sulfate (e.g., hydrogen cations, ammonium, hydrogen sulfate) with water to form a mixture, adding minerals (e.g., copper, zinc, and magnesium) to the mixture and agitating the mixture which comprises the ammonium hydrogen sulfate, sulfuric acid, water and the mineral salt (e.g., copper, zinc, and magnesium) (paragraph [0043] of the instant specification). Kennedy discloses that the composition can be used to mitigate including arthritis (page 11, lines11-16). Kennedy discloses that the minerals maintain and boost the immune system (page 23, fourth paragraph). Kennedy discloses that zinc and including copper can be used for actions against diseases where swelling and irritation occur (page 28, lines 16-20). Kennedy discloses that the composition can be used to treat pain and inflammation (page 29, lines 9-12). Smith teaches that children infected with B burgdorferi are more likely than adults to develop arthritis (e.g., secondary disorder) as an initial manifestation of Lyme disease (page 2, second paragraph). Smith teaches that Lyme disease is caused by the spirochete B burgdorferi, which is carried in the gut of the Ixodes tick (page 2, third paragraph). Smith teaches that B burgdorferi is injected into the skin following the bite of an infected tick. Tick saliva, which is injected into the skin along with the spirochete, disrupts local immune mechanisms. The spirochetes multiply and expand within the dermis, and the characteristic erythema migrans rash is caused by the host inflammatory response (page 2, fourth paragraph). Smith teaches that arthritis is the most distinguishing feature of late-stage Lyme disease (page 3, fourth paragraph). Smith teaches that CDC defines Lyme arthritis as “recurrent, brief attacks (weeks or months) of objective joint swelling in one or a few joints, sometimes followed by chronic arthritis in one or a few joints” (page 4, third paragraph).
Claim 104 is rejected under 35 U.S.C. 103 as being unpatentable over Kennedy in view of Smith as evidenced by the instant specification as applied to claims 87-99, 103, and 105-109 above, and further in view of GERHART (US 2015/0224077 A1, publication date of 13 August 2015).
Regarding claim 104, the method of claim 87 is described above in section 7.
Regarding claim 104, Kennedy discloses that composition can be administered by including inhalation (page 23, second paragraph).
Kennedy and Smith do not specifically teach administration by a nebulizer. The deficiency is made up for by the teachings of Gerhart.
Gerhart is primarily directed towards methods for treatment of systemic disorders including Lyme disease (abstract and paragraph [0006]).
Regarding claim 104, Gerhart teaches a method for treatment of including Lyme disease (paragraph [0006]). Gerhart teaches administration of a composition by including high efficiency nebulizer (paragraph [0007]). Gerhart teaches that administration with a high efficiency nebulizer provides one or more advantages including (1) an enhanced pharmacokinetic profile as compared to administration of an oral solution or an inhalation formulation with a conventional inhalation device, (2) an enhanced therapeutic effect as compared to administration of an oral solution or an inhalation formulation with a conventional inhalation device; (3) an enhanced lung deposition (deposited lung dose) as compared with a conventional inhalation device; (4) reduced administration times, periods, and/or volumes as compared to administration with a conventional inhalation device; (5) a reduction in adverse side effects associated with oral formulations of a mast cell stabilizer, such as gastrointestinal irritation, or associated with conventional inhalation devices, such as cough; and (6) a longer duration of therapeutic effect as compared to administration of an oral solution or an inhaled formulation with a conventional inhalation device (paragraph [0160]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising a therapeutically effective amount of an ionic mineral complex of including zinc, copper and magnesium (e.g., hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions) and a pharmaceutically acceptable carrier; wherein the ionic mineral complex is produced by a method that includes adding including 14 ounces of ammonium hydrogen sulfate (e.g., formed by sulfuric acid and ammonium sulfate and produces ammonium, hydrogen sulfate and hydrogen cation), 16 ounces of at least one mineral composition (e.g., zinc, copper and magnesium) and 98 ounces of distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration. The person of ordinary skill in the art would have been motivated to make those modifications to obtain a method with advantages by administering the composition using a high efficiency nebulizer, wherein the advantages include: (1) an enhanced pharmacokinetic profile as compared to administration of an oral solution or an inhalation formulation with a conventional inhalation device, (2) an enhanced therapeutic effect as compared to administration of an oral solution or an inhalation formulation with a conventional inhalation device; (3) an enhanced lung deposition (deposited lung dose) as compared with a conventional inhalation device; (4) reduced administration times, periods, and/or volumes as compared to administration with a conventional inhalation device; (5) a reduction in adverse side effects associated with oral formulations of a mast cell stabilizer, such as gastrointestinal irritation, or associated with conventional inhalation devices, such as cough; and (6) a longer duration of therapeutic effect as compared to administration of an oral solution or an inhaled formulation with a conventional inhalation device. The person of ordinary skill in the art would have reasonably expected success because Kennedy discloses that composition can be administered by including inhalation (page 23, second paragraph). Gerhart teaches that administration with a high efficiency nebulizer provides one or more advantages including (1) an enhanced pharmacokinetic profile as compared to administration of an oral solution or an inhalation formulation with a conventional inhalation device, (2) an enhanced therapeutic effect as compared to administration of an oral solution or an inhalation formulation with a conventional inhalation device; (3) an enhanced lung deposition (deposited lung dose) as compared with a conventional inhalation device; (4) reduced administration times, periods, and/or volumes as compared to administration with a conventional inhalation device; (5) a reduction in adverse side effects associated with oral formulations of a mast cell stabilizer, such as gastrointestinal irritation, or associated with conventional inhalation devices, such as cough; and (6) a longer duration of therapeutic effect as compared to administration of an oral solution or an inhaled formulation with a conventional inhalation device (paragraph [0160]).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues on page 3 that Kennedy and Smith do not teach or suggest a composition comprising hexaaquacopper, hexaaquazinc, and hexaaquamagnesium ions. Applicant argues that Kennedy’s composition is an “ionic mineral complex...ligand-bonded to a plurality of ammonia molecules” and describes ammine complexes formed in a system prepared from ammonium hydrogen sulfate, a mineral source and water; and that Kennedy emphasizes the ammonia-ligand delivery system for the cations. Applicant argues that, in contrast, the composition of the instant claims requires hexaaqua complexes that are species in which the coordinating ligands are six water molecules, not ammonia. Applicant argues that ammine complexes and hexaaqua complexes are chemically and functionally distinct species, including water ligands bind less strongly to the metal center and exchange more rapidly, ammine complexes are unstable in acidic media, and hexaaqua complexes are stable in acidic aqueous environments. Applicant argues that Kennedy’s ammonia-ligated complexes are not the hexaaqua complexes required by claims 87 and 107, and there is not teaching, suggestion, or necessity that would convert Kennedy’s ammonia-ligand coordination architecture into the water-ligand coordination recited in the instant claims.
Applicant's arguments filed on 02 April 2026 have been fully considered but they are not persuasive. In response, Kennedy discloses a composition that comprises a therapeutically effective amount of an ionic mineral complex and a pharmaceutically acceptable carrier. The ionic mineral complex is an ionic mineral cation ligand bonded to a plurality of ammonia molecules enabling transport of said ionic mineral complex through a biological system to a target cell affected by a disease. The cation is at least one of from a group that includes zinc, copper and magnesium (page 3, lines 4-10). Kennedy discloses that the composition which includes an ionic mineral complex is produced from a method that includes adding ammonium hydrogen sulfate (e.g., formed by sulfuric acid and ammonium sulfate (page 13 of Kennedy)), at least one mineral composition (e.g., zinc, copper and magnesium) and distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration (page 3, lines 12-15). As evidenced by the instant specification, mineral cation hexa-aqua complex and ionic salt composition is prepared by including diluting ammonia hydrogen sulfate with water to form a mixture, adding minerals (e.g., copper, zinc, and magnesium) to the mixture and agitating the mixture which comprises the ammonium hydrogen sulfate, sulfuric acid, water and the mineral salt (e.g., copper, zinc, and magnesium) (paragraph [0043] of the instant specification). Thus, the composition of Kennedy that includes a pharmaceutically acceptable carrier and a therapeutically effective amount of an ionic mineral complex of including zinc, copper and magnesium (e.g., composition comprising hexaaquacopper (II) ions, hexaaquazinc (II) ions, hexaaquamagnesium (II) ions, hydrogen cations, ammonium, hydrogen sulfate, and water), which is produced by the identical method as the disclosed method of the instantly claimed composition, necessarily has the same characteristics, e.g., is a composition that comprises the minerals including copper, zinc and magnesium that are present as hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions, respectively, and includes hydrogen cations, ammonium, hydrogen sulfate and water, especially in the absence of evidence to the contrary. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Applicant argues on page 4 that Kennedy’s composition is produced with a reaction that occurs under conditions of high heat so that free ammonia (NH3) becomes available to coordinate to the mineral cations. Applicant argues that the composition of the instant application is produced by a different method and points to instant paragraph [0044] and to the specific disclosure of “a) mixing ammonium sulfate with distilled water; and b) mixing sulfuric acid with the mixture comprising ammonium sulfate and distilled water, wherein the components of said mixture are added at a rate that does not result in an exothermic reaction in excess of 300°C during either a) or b)”. Applicant argues on page 5 that the key differences between the method of making the instantly claimed composition to the method of making the composition of Kennedy is, first, the instant method creates a strongly acidic environment that eliminates free ammonia which Kennedy’s ammine complexes depends on which is generated under high heat. Applicant argues that, by contrast, the instant method requires adding sulfuric acid, which creates a strongly acidic medium, and that under acidic conditions the ammonia is protonated to ammonium (NH4+), which is non-ligating and cannot form amine complexes but instead form hexaaqua complexes. Applicant argues that Kennedy’s ammonia-ligated complexes and the instant applications hexaaqua complexes are chemically distinct products that cannot arise under the same reaction conditions. Applicant argues that, secondly, Kennedy’s process employs high heat to decompose ammonium hydrogen sulfate and liberate NH3, in contrast, the instant method prohibits an exothermic reaction during steps (a) and (b), which prevents the thermal conditions necessary for NH3 formation and cannot form Kennedy’s ammine complexes.
In response, Kennedy’s method desires preventing exothermic reaction (e.g., high heat) because Kennedy teaches that the method of producing the composition includes adding ingredients of ammonium hydrogen sulfate (e.g., formed from ammonium sulfate and sulfuric acid), at least one mineral composition and distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration, wherein the agitating is a slow agitation process performed at a speed able to reduce exothermic interaction between the ingredients (page 3, lines 12-17; page 18, lines 1-3). Kennedy discloses that the resulting solution has a very low pH because of the ligand bonded mineral ions (Table 2; page 16, lines 21-22). Therefore, Kennedy’s process desires preventing exothermic reaction (e.g., high heat) and produces an acidic composition, which is identical method as the disclosed method of the instantly claimed composition, and necessarily has the same characteristics, e.g., is a composition that comprises the minerals including copper, zinc and magnesium that are present as hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions, respectively, and includes hydrogen cations, ammonium, hydrogen sulfate and water, especially in the absence of evidence to the contrary.
Applicant argues on page 6 that there is no motivation to treat Lyme disease with Kennedy’s mineral-ammine compositions and there is no reasonable expectation of success. Applicant argues that Kennedy is directed to treatment of arthritis and other inflammatory disorders and does not address an infectious disease caused by Borrelia burgdorferi. Applicant argues that Smith only describes the clinical manifestations of Lyme disease and notes that arthritis can appear in later stages of infection but does not teach or suggest that arthritis treatment are appropriate therapies for Lyme disease, nor does Smith suggest using any metal-ion compositions for an infectious spirochetal condition. Applicant argues that the fact that Lyme disease may present with arthritis is not a teaching that any treatment effective for arthritis would be effective for treating Lyme disease itself.
In response, Kennedy discloses that the ionic mineral complexes have anti-microbial properties (paragraph bridging pages 7 and 8). Kennedy discloses that the composition can be used to mitigate including arthritis (page 11, lines 11-16). Kennedy discloses that zinc and including copper can be used for actions against diseases where swelling and irritation occur (page 28, lines 16-20). Kennedy discloses that the composition can be used to treat pain and inflammation (page 29, lines 9-12). Smith teaches that children infected with B burgdorferi (e.g., bacteria) are more likely than adults to develop arthritis (e.g., secondary disorder) as an initial manifestation of Lyme disease (page 2, second paragraph). Smith teaches that arthritis is the most distinguishing feature of late-stage Lyme disease (page 3, fourth paragraph). Smith teaches that CDC defines Lyme arthritis as “recurrent, brief attacks (weeks or months) of objective joint swelling in one or a few joints, sometimes followed by chronic arthritis in one or a few joints” (page 4, third paragraph). Therefore, in light of the disclosure of Kennedy and the teachings of Smith, the person of ordinary skill in the art would have been motivated to administer the composition of Kennedy (a composition comprising a therapeutically effective amount of an ionic mineral complex of including zinc, copper and magnesium (e.g., hexaaquacopper ions, hexaaquazinc ions and hexaaquamagnesium ions) and a pharmaceutically acceptable carrier; wherein the ionic mineral complex is produced by a method that includes adding including 14 ounces of ammonium hydrogen sulfate (e.g., formed by sulfuric acid and ammonium sulfate), 16 ounces of at least one mineral composition (e.g., zinc, copper and magnesium) and 98 ounces of distilled water to a mixture, agitating said mixture and diluting said mixture to a desired concentration) to a person with Lyme disease and expected the administration to be able to treat a Lyme disease which is caused by a bacteria infection, can experience arthritis, experience swelling and inflammation, which the composition of Kennedy can provide.
Thus, for the reasons of record and for the reasons presented above claims 87-99 and 103-109 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
THIS ACTION IS MADE FINAL.
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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