Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2003-02-18
2004-10-19
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S443000, C424S686000, C424S690000, C424S692000, C514S865000
Reexamination Certificate
active
06805875
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to topical compositions and treatments of a skin condition commonly known as “diaper rash” and more particularly, acidic-type diaper rash and other skin irritations caused by acidic bodily secretions, usually resulting from teething, antibiotic dosages, bacterial infections, and an acidic diet.
A skin condition commonly known as diaper rash is prevalent among infants everywhere. This invention focuses on a specific type of diaper rash and skin irritation, the type associated with acidic bodily secretions generated by teething, antibiotic dosages, bacterial infections, and an acidic diet.
A prior art reference was found in U.S. Pat. No. 5,972,321 issued to Kligerman, which discusses a compound, calcium glycerophosphate, which potentially is a remedy for acidic diaper rashes, although the claims section of said prior art omits the acidic diaper rash discussion. The present invention solves the acidic rash symptoms without the use of calcium glycerophosphate. Calcium glycerophosphate is not necessary to treat the symptoms of infant acidic diaper rash. Moreover, calcium glycerophosphate was developed and is being marketed as a food additive for reducing acid in the digestive tract. The present invention was specifically formulated for the treatment of acidic diaper rash, taking into account all factors necessary to make said treatment effective and safe.
Another prior art reference was found in U.S. Pat. No. 6,506,392 issued to Siamon which lists ingredients including sodium bicarbonate, sodium carbonate, and tisodium phosphate. The prior art does not address the present invention's goals of adjusting the pH of the skin. Moreover, some members of the class of alkali metals that the composition is comprised of is disclosed in the patent document to be harmful to the user if used internally or ingested, making this prior art composition unsuitable for infant skincare and diapering use. Furthermore, the percentages of the acid trisodium phosphate in U.S. Pat. No. 6,506,392 issued to Siamon does not fulfill the goals of the present invention, which is to raise the pH of the solution, not lower it.
Prior art related to diaper rash occasionally addresses buffered skin creams which attempt to stabilize pH as in U.S. Pat. No. 5,362,488 issued to Sibley and U.S. Pat. No. 5,436,007 issued to Hartung. This prior art establishes a desired pH range for said cream in a range of 4.5-6.0.
The present invention's active ingredients more closely resemble antacid formulations for the digestive tract as in U.S. Pat. No. 5,914,135 issued to Dubek and in U.S. Pat. No. 6,066,342 issued to Gurol. However, the present invention and its uniquely formulated composition is exclusively related to alleviating diaper rash and skin irritations caused by acidic secretions.
Other prior art related to diaper rash as in U.S. Pat. No. 5,091,193 issued to Enjolias and U.S. Pat. Nos. 5,618,529 and 5,194,261 issued to Pichierri disclose a barrier type cream in which the stated purpose is to protect the infant's skin from moisture resulting from bodily secretions, or an antibacterial element such as Nystatin, as in U.S. Pat. No. 5,762,945 issued to Ashley which prevents the growth of bacteria which contributes to infant diaper rash.
Consequently, a need has been felt for providing a composition and method for treating acidic diaper rash which can raise the pH of the skin sufficient to eliminate redness and irritation, yet gentle enough for an infant's delicate skin.
Moreover, the present invention is unique and innovative due to its composition and method and its difference in approach to the prior art in solving the problem of diaper rash and skin irritations caused by acidic secretions.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide an innovative and effective composition and method for treating acidic-type diaper rashes and skin irritations.
It is yet another object of the present invention to provide another formulation and method besides barrier creams to treat acidic type diaper rash and skin irritations by effectively raising the pH of the skin, thus offsetting the acid burn which results from gastric imbalances caused by teething, antibiotic dosages, bacterial infections, and/or an acidic diet.
It is a feature of the present invention to provide a novel use for the formulation in the form of a cream, lotion, spray, dusting powder, bath salts and/or effervescent molded tablet, and/or a composition for a disposable diaper's interior liner, all of which increase the pH of the skin to the degree that redness and irritation is alleviated.
Advantages of the present invention are that it is easily applied, the ingredients are readily available and inexpensive to manufacture, the active ingredients have been proven to be safe over years of uses in other applications (i.e., the digestive tract), and the composition is effective by itself or in combination with other conventional treatments.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
It has now been discovered, a topical composition of a combination of pH-raising ingredients such as sodium hydrogen carbonate (bicarbonate of soda), magnesium hydroxide, calcium carbonate, aluminum hydroxide and mixtures thereof. This active ingredient(s) would function in a preparation of an anhydrous base ointment, polysorbate 80, a pharmaceutically acceptable diluent, and butylated hydroxy toluene. pH is adjusted with the addition of glacial acetic acid. The high pH ingredients sodium hydrogen carbonate and/or magnesium hydroxide, calcium carbonate, and/or aluminum hydroxide could also be combined with AQUAPHOR™ Beiersdorf to yield a similar composition. This composition can provide relief from the symptoms of diaper rash or skin irritations caused by acidic secretions resulting from teething, antibiotic dosages, bacterial infections, and/or an acidic diet.
REFERENCES:
patent: 4764505 (1988-08-01), Fujinuma et al.
patent: 5362488 (1994-11-01), Sibley et al.
patent: 5618529 (1997-04-01), Pichierri
patent: 5652274 (1997-07-01), Martin
patent: 5762945 (1998-06-01), Ashley
patent: 5972321 (1999-10-01), Kligerman et al.
patent: 6066673 (2000-05-01), McIver et al.
patent: 6296862 (2001-10-01), Paul et al.
patent: 6506392 (2003-01-01), Siamon
patent: 2002/0136755 (2002-09-01), Tyrell et al.
patent: 8702742 (1987-12-01), None
Bartels Jennifer F.
Goldberg Joshua
Juneau Todd
Lamm Marina
Nath & Associates
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