(12) United States Patent (10) Patent No.: US 9,668,948 B2 Klingman (45) Date of Patent: *Jun
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USOO9668948B2 (12) United States Patent (10) Patent No.: US 9,668,948 B2 Klingman (45) Date of Patent: *Jun. 6, 2017 (54) PRODUCTS AND METHODS FOR A 6LX 9/70 (2006.01) REDUCING MALODOR FROM THE A61O 15/00 (2006.01) PUDENDUM A6IR 8/49 (2006.01) (52) U.S. Cl. (71) Applicant: Shannon Elizabeth Klingman, Chaska, CPC ............ A61K 8/0208 (2013.01); A61K 8/365 MN (US) (2013.01); A61K 9/0034 (2013.01); A61 K 9/7007 (2013.01); A61O 15/00 (2013.01); (72) Inventor: Shannon Elizabeth Klingman, Chaska, A61 K 8/4953 (2013.01) MN (US) (58) Field of Classification Search None (*) Notice: Subject to any disclaimer, the term of this See application file for complete search history. patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. (56) References Cited This patent is Subject to a terminal dis- U.S. PATENT DOCUMENTS claimer. 2008/0050398 A1* 2, 2008 Bockmuehl ........ A61K 38/1709 (21) Appl. No.: 15/015, 197 424,190.1 (22) Filed: Feb. 4, 2016 OTHER PUBLICATIONS (65) Prior Publication Data K. Ara et al., “Foot odor due to microbial metabolism and its control.” Canadian Journal of Microbiology, Apr. 2006:52 (4):357 US 2016/O151257 A1 Jun. 2, 2016 64, abstract only from Pubmed: https://www.ncbi.nlm.nih.gov/ pubmed/16699586. Related U.S. Application Data (Continued) (63) Continuation-in-part of application No. 14/613,420, filed on Feb. 4, 2015, which is a continuation of Primary Examiner Ernst N Arnold application No. 12/875,123, filed on Sep. 2, 2010, Assistant Examiner — Kyung Sook Chang now abandoned, application No. 15/015,197, filed on (74) Attorney, Agent, or Firm — Jeffrey D. Lindsay Feb. 4, 2016, which is a continuation-in-part of application No. 14/604,733, filed on Jan. 25, 2015, (57) ABSTRACT now. Pat No. 9,566,223, which is a continuation of Products and methods are disclosed for reducing the pro application No. 127823,834, filed on Jun. 25, 2010, duction of unwanted odors from the pudendum. The prod now Pat. No. 8,992,898, application No. 15/015,197, ucts include an acidifying composition comprising one or filed on Feb. 4, 2016, which is a continuation of more carboxylic acids such as mandelic acid or salts thereof (Continued) and Xanthine compounds such as caffeine or salts thereof. The methods include application of the products to the (51) Int. Cl. pudendum in any of a variety of ways to effectively reduce A6 IK 8/02 (2006.01) unwanted odors. A6 IK 8/365 (2006.01) A6 IK 9/00 (2006.01) 19 Claims, 7 Drawing Sheets US 9,668,948 B2 Page 2 Related U.S. Application Data application No. 12/875,123, filed on Sep. 2, 2010, now abandoned. (60) Provisional application No. 61/309,831, filed on Mar. 2, 2010, provisional application No. 61/289.992, filed on Dec. 23, 2009, provisional application No. 61/325,317, filed on Apr. 17, 2010. (56) References Cited OTHER PUBLICATIONS A. Zech et al., “The quantitative distribution of percutaneously applied caffeine in the human skin.” Archives of Dermatology Research, Nov. 1979, 266(3): 277-283. URL: https://www.ncbi.nlm. nih.gov/pubmed/526050. S. Trauer et al., “Permeation of topically applied caffeine through human skin—a comparison of in vivo and in vitro data, British Journal of Clinical Pharmacology, Aug. 2009; 68(2): 181-186: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2767280/. * cited by examiner U.S. Patent Jun. 6, 2017 Sheet 1 of 7 US 9,668,948 B2 24 FIG. 1C U.S. Patent Jun. 6, 2017 Sheet 2 of 7 US 9,668,948 B2 FIG. 2 U.S. Patent Jun. 6, 2017 Sheet 3 of 7 US 9,668,948 B2 FIG. 3 U.S. Patent Jun. 6, 2017 Sheet 4 of 7 US 9,668,948 B2 FIG. 4 U.S. Patent Jun. 6, 2017 Sheet S of 7 US 9,668,948 B2 g - 3. s 8. th ess - i. ES, --- 0 S S g e FIG 5A { S. - 8 s as 3.3 als s \ s t Gs-s { --- ---0 U.S. Patent Jun. 6, 2017 Sheet 6 of 7 S. 3. r 3. s s 3. s s -- - s --" -- : --- 1 : s m , aw' is 3. s S. 8. - i. FIG.^ 6As ES te a -------- t s S w -F=- H ==- s 2. S. & s S. X is FIG. 6B U.S. Patent Jun. 6, 2017 Sheet 7 Of 7 US 9,668,948 B2 it Stasia: Ei e FIG 7A Stasia fe: setta US 9,668,948 B2 1. 2 PRODUCTS AND METHODS FOR with reactions from bacteria, but the historic focus on REDUCING MALODOR FROM THE bacteria in the vagina and the assumption that vaginitis or PUDENDUM more specifically, bacterial vaginosis, is the cause of the odor may have misled many in seeking for solutions that CLAIM TO PRIORITY treat bacteria in the vagina. We have found that for many women, the source of the This application claims priority to U.S. patent application odor is more commonly from the pudendum (including the Ser. No. 14/613,420, “Products and Methods for Reducing intergluteal folds and external genitalia), where anaerobic Malodor from the Pudendum,” filed Feb. 4, 2015 by Shan bacteria from the lower gastrointestinal (GI) tract or other non Klingman, which claims priority to U.S. patent appli 10 Sources can be found. These anaerobic bacteria may be cation Ser. No. 12/875,123, “Products and Methods for especially present on the external skin around the perianal Reducing Malodor from the Pudendum, filed Sep. 2, 2010 anatomy. by Shannon Klingman, which in turn claims priority to both The new recognition that vaginal bacteria are not cause of U.S. patent application Ser. No. 61/309,831, “Products and fishy odor in many women is of special significance, and Methods for Reducing Malodor from the Pudendum, filed 15 Mar. 2, 2010 by Shannon Klingman, and U.S. patent appli helps explain why antibiotic treatments and other standard cation Ser. No. 61/289.992, “Products and Methods for treatments have fared so poorly in treating many cases of Reducing Malodor from the Pudendum,” filed Dec. 23, 2009 fishy odor, and why may women presenting symptoms of by Shannon Klingman; and also claims priority to U.S. fishy odor do not actually have bacterial vaginosis when patent application Ser. No. 14/604.733, “Antiperspirants and thorough testing is conducted (see, for example, N. K. Lowe Deodorants, filed Jan. 25, 2015, which in turn claims et al., “Accuracy of the Clinical Diagnosis of Vaginitis priority to U.S. patent application Ser. No. 12/823,834, Compared With a DNA Probe Laboratory Standard.” “Antiperspirants and Deodorants, filed Jun. 25, 2010, Obstetrics & Gynecology, vol. 113, no. 1, January 2009, pp which claims priority to U.S. patent application Ser. No. 89-95, abstract available online at http://journals.lww.com/ 61/325,317, “Improved Antiperspirant,” filed Apr. 17, 2010; 25 greenjournal/Abstract/2009/01000/ all of which are hereby incorporated by reference in their Accuracy of the Clinical Diagnosis of Vaginitis. 15.aspx entireties for all purposes. and Hope K. Haefner, “Conquering Resistant Vulvovagini tis.” 2007, presentation available online at http://www.yel BACKGROUND lowdocuments.com/12180308-advancements-in-benign 30 Vulvar-and). It also points to the long unmet need for Field of the Invention improved means of reducing or preventing fishy odor by This invention pertains to products and methods for better controlling the activity of anaerobic bacteria on the personal care and odor control, particularly for reducing or pudendum, particularly those interacting with or feeding on preventing unwanted odor from the pudendum. nitrogen compounds in body fluids such as semen, blood, Description of Related Art 35 urine, and feces. Fishy odors from the pudendal region or genitalia of the It is believed that a particularly significant discovery is the female body have long been a source of annoyance and recognition that the Source of a fishy odor for many women embarrassment to adult and teenaged women. Women seek is not bacteria in the vagina, nor bacteria coming from the ing help from physicians are frequently given antibiotics vagina, but anaerobic bacteria from non-vaginal sources Such as metronidazole, based on the long-standing belief 40 Such as the gastrointestinal tract. An understanding of this that vaginal bacteria are the cause of the problem. Indeed, a discovery can be enhanced in part by consideration of a rare fishy odor is commonly considered to be a symptom for metabolic disorder, trimethylaminuria, a disorder occurring bacterial vaginosis (see, for example, "Bacterial Vaginosis.” when humans have an impaired version of the enzyme Wikipedia, http://en.wikipedia.org/wiki/Bacterial vagino flavin-containing monooxygenase 3 (FMO3), which con sis, accessed Nov. 17, 2009). Others seeking relief have tried 45 verts trimethylamine to trimethylamine N-oxide during the a variety of products such as douches which may provide metabolism of some nitrogen-containing compounds such as only short-term decrease in the odor (if the vagina was the choline or phosphocholine. With impaired FMO3 activity, actual source of the odor). In spite of many medications and trimethylamine concentrations become elevated and strong feminine hygiene products, there has been a long-standing fishy odor can be generated by the sweat and other body unmet need in this area, fueled by lack of understanding 50 fluids of a person, making life difficult and painful. Foods about the causes and the nature of the problem, especially rich in choline are especially problematic for those with the assumption that fishy odor only arises from the vagina trimethylaminuria, since it leads to production of large due to bacterial imbalance or infectious cause Such as amounts of trimethylamine.