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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 13, 2025 has been entered.
Election/Restrictions
To summarize the current election, the application elected group I and the species where the condition or disease is gout, the lithium agent is lithium carbonate, the administration route is topical, and no additional anti-gout or pain management agent is administered. Dimethyl sulfoxide has pain management and anti-gout properties (e.g., pain and inflammation relief), nevertheless its required presence is not considered to remove it from the scope of compositions applied in the elected method (see discussion of Hershner et al. below in Claim Rejections - 35 USC § 103 section for further detail).
Claims 4, 10-14, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
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.
Claim 5 is 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.
The claim recites that the gout is one or more types selected from a listing that includes acute gout and chronic gout as well as moderate gout and severe gout. The condition of gout cannot be both chronic and acute nor can it be both moderate and severe. In addition, the scope of the claim is not clearly narrower than the parent given that all types of gout can be categorized as acute or chronic.
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, 3 ,5, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hershler et al. (US Patent No. 3,549,770) in view of Sandborn (US Patent No. 4,652,557), Drizen et al. (previously cited), and the Japanese Pharmacopoeia XIV (2001 – henceforth JP-XIV).
Hershler et al. teach that dimethyl sulfoxide (DMSO) is known to have an array of medicinal properties including as an anti-inflammatory agent and pain reliever (see abstract). They teach topical application of pure DMSO or in diluted form with water (see column 27 lines 36-40 and column 28 lines 10-15). They further teach treating inflammation and other symptoms in a gouty arthritis affected toe in multiple patients by topically applying the DMSO (see column 25 line 51-column 41;instant claims 1 and 3). The treatment reduced both inflammation and pain. A patient with recurrent bouts of the condition was treated (see column 25 line 66-column 26 line 12; instant claim 5). The presence of lithium carbonate is not detailed.
Sandborn teaches the utility of DMSO as an ant-inflammatory and pain relieving active that also of its added benefit of aiding in the transdermal delivery of other pharmaceutical actives (see column 1 lines 14-22 and column 2 lines 13-18). The detail a drug, such as diclofenac, included with the DMSO to produce a composition where they collectively treat inflammation and pain (column 2 lines 32-33 and column 3 lines 48-49). Sandborn also teaches that the additional drug compound is dissolved in the composition and to include solubilization aids to enhance this process (see column 35-39).
Drizen et al. teach a method of topically administering a drug in a polymer gel carrier to a mammal in order to treat pain (see abstract, column 3 lines 3-15, 36-45, and claim 1; instant claim 1). The envisioned drugs include diclofenac and metal salts, where lithium carbonate is named amongst two envisioned options (see claims 2 and 9). They further teach application to a knee, back, ankle, hand, foot, or neck to treat pain in these locations as well as teach treating acute or chronic conditions (see column 2 lines 58-62 and claim 16; instant claim 3).
The JP-XIV teaches that lithium carbonate is sparingly soluble in water but is soluble in dilute acetic acid (acetic acid and water).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add lithium carbonate to the composition topically applied by Hershler et al. to treat gouty arthritis. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g., the added effect of a second compound that acts against inflammation and/or pain). The modification would have been obvious in light of Drizen et al. who teach diclofenac and lithium carbonate as alternate pain relievers and in light of Sandborn who teach the recognized utility of adding compounds like diclofenac to topical DMSO for pain and/or inflammation. It further would have been obvious to include water diluted acetic acid to the composition to dissolve the lithium carbonate in light of the JP-XIV because it is known to achieve this dissolution that is for the incorporated drugs as detailed by Sanborn. The result is a composition consisting of lithium carbonate, water, acetic acid, and DMSO topically applied to treat a recurrent gout. Therefore claims 1, 3 ,5, and 21-23 are obvious over Hershler et al. in view of Sandborn, Drizen et al., and the JP-XIV
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Drizen et al. in view of Shudo et al. (previously cited) and Horrobin (previously cited).
Drizen et al. teach a method of topically administering a drug in a polymer gel carrier to a mammal in order to treat pain (see abstract, column 3 lines 3-15, 36-45, and claim 1; instant claim 1). They highlight that the benefit of their composition is its ability to deliver its drug through the skin (column 3 lines 37-51). The envisioned drugs include diclofenac and metal salts, where lithium carbonate is named amongst two envisioned options (see claims 2 and 9; instant claims 7-8). They further teach application to a knee, back, ankle, hand, foot, or neck to treat pain in these locations as well as teach treating acute or chronic conditions (see column 2 lines 58-62 and claim 16; instant claim 3). Drizen et al. exemplify that administration of the compositions of the invention to the spine and neck decreased pain (intensity of gout flare) that was present in these locations prior to application (see example 2 and column 13 line 45-column 14 line 7; instant claim 6). Treating pain explicitly due to gout and the presence of DMSO are not detailed.
Shudo et al. teach treating pain from a variety of conditions via the application of a topical pain relieving composition (see abstract). Pain from joint inflammation as well as gout and pseudo gout are envisioned conditions to treat via topical application to the site (see paragraphs 35, 42, and 44).
Horrobin teaches a topical lithium gel composition, where lithium carbonate is an envisioned active (see column 2 lines 50-56 and example 7, claim 1and claim 3). The composition is also envisioned to include a skin penetration assistant agent, where dimethylsulfoxide is one of two envisioned options (see column 2 lines 61-64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the lithium carbonate containing composition of Drizen et al. to a knee, back, ankle, hand, foot or neck experiencing pain from gout because Shudo et al. teach gout as a cause of pain in these locations and that such pain was known to be treated topically. Treating pain from gout in a knee, back, ankle, hand, foot or neck is a way to treat gout in these locations (see instant claim 1). Since Drizen et al. teach treating acute and chronic conditions, their modified method also renders obvious treating acute and chronic gout via treating their pain. It also would have been obvious to add DMSO to the composition administered in the method of Drizen et al. in view of Shudo et al. in light of Horrobin. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3, and 5 are obvious over Drizen et al. in view of Shudo et al. and Horrobin.
Response to Arguments
Applicant's arguments filed August 13, 2025 have been fully considered, but are not persuasive.
The applicant argues that Drizen et al. teach away from including a penetration aid. While the paragraph of Drizen et al. the applicant cites appears to direct away from achieving skin penetration, the whole point of the composition of Drizen et al. is repeatedly discussed as producing and encouraging skin penetration of their actives (see column 3 lines 36-51, column 6 lines 14-19, column 9 lines 8-11, column 10 lines 36-47). Therefore Drizen et al. remains a viable collection of teachings discussing transdermal deliver of its active compounds for pain treatment and the recognition of lithium as a compound with this property that can be delivered topically for this purpose. The inclusion of components that aid in achieving the transdermal delivery of their actives remains an obvious modification to further facilitate their stated goal.
The applicant also argues that there would not have been a reasonable expectation of treating gout with a combination of lithium carbonate and DMSO. Hershler et al. refutes this contention with their example showing that DMSO treats gout. Further, lithium had already been discussed as treating excessive uric acid and gouty diathesis via lithiated water (see GB 189708779). Thus there would have been a reasonable expectation of success for the claimed composition treating gout. The applicant also argues that treating pain due to gout is not treating gout itself. To the contrary, gout is identified by a number of symptoms including pain and inflammation. Treating a symptom of a condition is treating the condition. While not a curative, an action that yields symptom alleviation is a treatment. The applicant themselves support this interpretation given that 1) they tout treating inflammation caused by gout as treating gout on page 7 of the remarks and 2) the specification examples 1-5 also highlights pain treatment in gout affected tissue as treating gout.
Further, the applicant offers the results of a published study as evidence of the claimed composition unexpectedly treating gout via treating its inflammation. The document provided does not identify the components in the tested lithium carbonate formulation. Thus their connection to the claimed compositions is not clear. The remarks state that the composition in the study is that of instant example A. However, such elaboration on the published study cannot be provided by arguments of counsel, but are properly placed for consideration as evidence in an affidavit or declaration under 37 CFR 1.132 (see MPEP 716). It is noted that, an average of the inflammation values in each of the assessed locations shows the DMSO treatment yielding a degree of improvement as compared to no treatment. The lithium carbonate formulation improves further on this level of improvement. However, there is no indication that the difference is unexpected or significantly better due to a difference between the claimed composition and the cited prior art (see MPEP 716.02(a)).
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615