DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Applicant’s amendments in the response filed on 10/28/2025 has been considered by the Examiner. Currently, claims 3, 9-12, and 14-28 are pending, claims 1-2, 4-8, and 13 are canceled, claim 12 has been amended, and claims 15-28 are newly added.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 3 and 9-11, 12, and 14-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cole (US Pub No. 2007/0021809) as further evidenced by Liu (CN101780145A) and Wang (CN 102861016A).
Regarding claim 12, Cole teaches a method of curing a yeast infection in a vagina of a patient (10, Figs 1-15. Para. [0004] Cole teaches a device and therapeutic method that provides cooling or warming to a user's vagina or vulva as a therapeutic benefit to and relief from maladies in these areas. The most common vaginal infections are bacterial vaginosis, trichomoniasis and vaginal yeast infection or candidiasis), the steps of:
(a) providing a device comprising a cooling or freezable filler material, wherein the device has no active energy source (Para. [0076] Inner core 48, Fig.10 is adapted to hold ice, cold water or a combination of ice and water in projection cavity 40, Fig.10-11);
(b) cooling or freezing the device (The device can be placed in a cold environment such as a refrigerator or freezer prior to use...or the filler can be placed in a refrigerator or freezer to achieve a desired temperature prior to be inserted in the cavity 40. Par. [0085] and Par. [0108], lines 5-7. Because projection 12 are cool or warm, the therapeutic benefits of this cool or warm contact will be felt by the user both within the vagina and in the vulva area);
(c) inserting the cooled device into the vagina of the patient suffering from a vaginal yeast infection (the projection 12 in operation will be inserted into the user's vagina; [0058]);
(d) allowing the device to remain in the vagina [for a period of time] thereby cooling adjacent tissues (The present invention is a device and therapeutic method that provides topical cooling or heating to a user's vagina or vulva as a therapeutic benefit to and relief from maladies of these areas [0014] the cooling provides maximum benefit and relief to the user [0070]… Vaginitis is often caused by infections. The most common vaginal infections are bacterial vaginosis, trichomoniasis and vaginal yeast infection or candidiasis. Symptoms of vaginitis, particularly with trichomoniasis and vaginal yeast infection, include irritation and itching of the female genital area including itching, burning and irritation of the vagina [0004] It is an object of the invention in one embodiment to provide a method of treating vaginitis) to alleviate symptoms of the patient [0004];
(e) removing the device from the vagina (If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10 [0109]) and;
repeating steps (b) through (e) causing at least one effect upon the infecting yeast of the vaginal yeast infection, curing vulvovaginal candidiasis of the patient free of drugs ([0109] If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10. Where the device 10 is reusable, the device 10 may be recooled or rewarmed and thereafter reused; [0109] The device is configured to treat vaginitis and symptoms of inflammation or irritation [0004] vaginal yeast infection or candidiasis);
While Cole does not specifically recite dormancy, changed morphology, cessation of growth, disruption of a biofilm created by the yeast, and any combination thereof, it is the position of the Examiner that the sufficiency of the time depends on the desired therapeutic benefit and since Cole provides for a therapeutic benefit and relief it would read on the claim language. Furthermore, it would have been obvious for the device of Cole to provide for dormancy, cessation of growth, or disruption of a biofilm since cooling in the art is known to reduce bacteria growth and Cole treats vaginitis [0004] and symptoms of inflammation or irritation to a women's genitals [0002]. In addition, Cole provides for a temperature range of 15°F to about 50°F and the disclosed invention provides “Biofilms start to break down at less than 30°C.”(Page 5). Therefore, it is the position of the Examiner that Cole’s device would be capable of providing for a disruption of a biofilm.
While Cole provides the device is reusable and may be recooled [0109], it is silent about specifically teaching repeating the steps at least 3 times at intervals of at least 4 hours,
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to reuse the device at least three times at intervals of at least 4 hours until relief of the condition is achieved because Cole provides that if the device eventually ceases to be cool or warm enough to provide the desired therapeutic effect, the user may remove and recool the device.
Cole is silent about specifically teaching wherein steps (b) through (e) are repeated are repeated at least 1 time past relief of the symptoms.
However, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to further repeat the steps for cooling to ensure the symptoms are relieved and to further cool beyond symptom relief when the symptoms reappear at another time. Furthermore, Cole provides vaginitis is associated with more than one symptom (e.g. itching, burning, and irritation of the vagina) [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to repeat the cooling steps such that symptom A is treated and the user continues the cooling steps past relief of system A until symptoms B, C, etc. are relieved.
Further evidence by Liu provides for a thermal therapy device and further teaches “using this heat therapy remedy stone health care product 1 of the present invention for heat treatment, each day for 2 times, each time for 40, 14 days after symptom relief….” [0047]. Further evidence by Wang provides for a micanozole suppository whereby the medicine is inserted in the vaginal for 7 days…or each day every morning for 3 days…after 2 to 3 days the symptoms are alleviated or eliminated [0006].
Therefore, it is well known in the art to apply the method steps past symptom relief to ensure treatment and prevent recurrence of symptoms.
Regarding claim 3, Cole teaches the limitations of claim 12 as previously rejected above. Cole teaches wherein the yeast is genus Candida (vaginal yeast infection or candidiasis).
Regarding claims 9-11 Cole teaches the limitations of claim 12 as previously rejected above. Cole teaches wherein a temperature of the vaginal tissue goes below 30°C, 26°C and 22°C during each period of time (It is believed that this temperature range extends from about 15°F to about 50°F with a temperature of about 25°F believed to be most preferred. [0101] Cole teaches such temperature produces optimum relief).
Regarding claim 14, Cole as further evidenced by Liu and Wang teaches the limitations of claim 12 wherein the filler material comprises a freezable liquid (Para. [0076] Inner core 48, Fig.10 is adapted to hold ice, cold water or a combination of ice and water in projection cavity 40, Fig.10-11).
Regarding claim 15, Cole teaches a method of curing a yeast infection in a vagina of a patient (10, Figs 1-15. Para. [0004] Cole teaches a device and therapeutic method that provides cooling or warming to a user's vagina or vulva as a therapeutic benefit to and relief from maladies in these areas. The most common vaginal infections are bacterial vaginosis, trichomoniasis and vaginal yeast infection or candidiasis), the steps of:
(a) providing a device comprising a shell comprising a cooling or freezable filler material, wherein the device has no active energy source (Para. [0076] projection outer surface 20 made of a hard smooth plastic …also has a projection cavity which holds inner core 48, Fig.10 . Inner core is adapted to hold ice, cold water or a combination of ice and water in projection cavity 40, Fig.10-11);
(b) cooling or freezing the device (The device can be placed in a cold environment such as a refrigerator or freezer prior to use...or the filler can be placed in a refrigerator or freezer to achieve a desired temperature prior to be inserted in the cavity 40. Par. [0085] and Par. [0108], lines 5-7. Because projection 12 are cool or warm, the therapeutic benefits of this cool or warm contact will be felt by the user both within the vagina and in the vulva area);
(c) inserting the cooled device into the vagina of the patient suffering from a vaginal yeast infection (the projection 12 in operation will be inserted into the user's vagina; [0058]);
(d) cooling adjacent tissues by allowing the device to remain in the vagina [for a period of time] alleviating symptoms of the patient (The present invention is a device and therapeutic method that provides topical cooling or heating to a user's vagina or vulva as a therapeutic benefit to and relief from maladies of these areas [0014] the cooling provides maximum benefit and relief to the user [0070]… Vaginitis is often caused by infections. The most common vaginal infections are bacterial vaginosis, trichomoniasis and vaginal yeast infection or candidiasis. Symptoms of vaginitis, particularly with trichomoniasis and vaginal yeast infection, include irritation and itching of the female genital area including itching, burning and irritation of the vagina [0004] It is an object of the invention in one embodiment to provide a method of treating vaginitis) to alleviate symptoms of the patient [0004];
(e) removing the device from the vagina (If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10 [0109]) and;
repeating steps (b) through (e) causing at least one effect upon the infecting yeast of the vaginal yeast infection, curing vulvovaginal candidiasis of the patient ([0109] If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10. Where the device 10 is reusable, the device 10 may be recooled or rewarmed and thereafter reused; [0109] The device is configured to treat vaginitis and symptoms of inflammation or irritation [0004] vaginal yeast infection or candidiasis);
While Cole does not specifically recite dormancy, changed morphology, cessation of growth, disruption of a biofilm created by the yeast, and any combination thereof, it is the position of the Examiner that the sufficiency of the time depends on the desired therapeutic benefit and since Cole provides for a therapeutic benefit and relief it would read on the claim language. Furthermore, it would have been obvious for the device of Cole to provide for dormancy, cessation of growth, or disruption of a biofilm since cooling in the art is known to reduce bacteria growth and Cole treats vaginitis [0004] and symptoms of inflammation or irritation to a women's genitals [0002]. In addition, Cole provides for a temperature range of 15°F to about 50°F and the disclosed invention provides “Biofilms start to break down at less than 30°C.”(Page 5). Therefore, it is the position of the Examiner that Cole’s device would be capable of providing for a disruption of a biofilm.
While Cole provides the device is reusable and may be recooled [0109], it is silent about specifically teaching repeating the steps at least 3 times at intervals of at least 4 hours,
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to reuse the device at least three times at intervals of at least 4 hours until relief of the condition is achieved because Cole provides that if the device eventually ceases to be cool or warm enough to provide the desired therapeutic effect, the user may remove and recool the device.
Cole is silent about specifically teaching wherein steps (b) through (e) are repeated are repeated at least 1 time past relief of the symptoms.
However, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to further repeat the steps for cooling to ensure the symptoms are relieved and to further cool beyond symptom relief when the symptoms reappear at another time. Furthermore, Cole provides vaginitis is associated with more than one symptom (e.g. itching, burning, and irritation of the vagina) [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to repeat the cooling steps such that symptom A is treated and the user continues the cooling steps past relief of system A until symptoms B, C, etc. are relieved.
Further evidence by Liu provides for a thermal therapy device and further teaches “using this heat therapy remedy stone health care product 1 of the present invention for heat treatment, each day for 2 times, each time for 40, 14 days after symptom relief….” [0047]. Further evidence by Wang provides for a micanozole suppository whereby the medicine is inserted in the vaginal for 7 days…or each day every morning for 3 days…after 2 to 3 days the symptoms are alleviated or eliminated [0006].
Therefore, it is well known in the art to apply the method steps past symptom relief to ensure treatment and prevent recurrence of symptoms.
Claim 16 recites the same limitations of claim 3 as previously rejected above.
Claim 17 recites the same limitations of claim 9 as previously rejected above.
Claim 18 recites the same limitations of claim 10 as previously rejected above.
Claim 19 recites the same limitations of claim 11 as previously rejected above.
Regarding claim 20, the combination teaches wherein steps (b) through (e ) are repeated at least 1 time past symptom relief when the patient is exhibiting no further symptoms (see claim rejection 15).
Claim 21 recites the same limitations of claim 14 as previously rejected above.
Regarding claim 22, Cole teaches a method of curing a yeast infection in a vagina of a patient (10, Figs 1-15. Para. [0004] Cole teaches a device and therapeutic method that provides cooling or warming to a user's vagina or vulva as a therapeutic benefit to and relief from maladies in these areas. The most common vaginal infections are bacterial vaginosis, trichomoniasis and vaginal yeast infection or candidiasis), the steps of:
(a) providing a device comprising a shell comprising a cooling or freezable filler material, wherein the device has no active energy source (Para. [0076] projection outer surface 20 made of a hard smooth plastic …also has a projection cavity which holds inner core 48, Fig.10 . Inner core is adapted to hold ice, cold water or a combination of ice and water in projection cavity 40, Fig.10-11);
(b) cooling or freezing the device (The device can be placed in a cold environment such as a refrigerator or freezer prior to use...or the filler can be placed in a refrigerator or freezer to achieve a desired temperature prior to be inserted in the cavity 40. Par. [0085] and Par. [0108], lines 5-7. Because projection 12 are cool or warm, the therapeutic benefits of this cool or warm contact will be felt by the user both within the vagina and in the vulva area);
(c) inserting the cooled device into the vagina of the patient suffering from a vaginal yeast infection (the projection 12 in operation will be inserted into the user's vagina; [0058]);
(d) cooling adjacent tissues by allowing the device to remain in the vagina [for a period of time] alleviating symptoms of the patient (The present invention is a device and therapeutic method that provides topical cooling or heating to a user's vagina or vulva as a therapeutic benefit to and relief from maladies of these areas [0014] the cooling provides maximum benefit and relief to the user [0070]… Vaginitis is often caused by infections. The most common vaginal infections are bacterial vaginosis, trichomoniasis and vaginal yeast infection or candidiasis. Symptoms of vaginitis, particularly with trichomoniasis and vaginal yeast infection, include irritation and itching of the female genital area including itching, burning and irritation of the vagina [0004] It is an object of the invention in one embodiment to provide a method of treating vaginitis) to alleviate symptoms of the patient [0004];
(e) removing the device from the vagina (If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10 [0109]) and;
repeating steps (b) through (e) causing at least one effect upon the infecting yeast of the vaginal yeast infection, resulting in a drug-free cure of vulvovaginal candidiasis of the patient ([0109] If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10. Where the device 10 is reusable, the device 10 may be recooled or rewarmed and thereafter reused; [0109] The device is configured to treat vaginitis and symptoms of inflammation or irritation [0004] vaginal yeast infection or candidiasis);
While Cole does not specifically recite dormancy, changed morphology, cessation of growth, disruption of a biofilm created by the yeast, and any combination thereof, it is the position of the Examiner that the sufficiency of the time depends on the desired therapeutic benefit and since Cole provides for a therapeutic benefit and relief it would read on the claim language. Furthermore, it would have been obvious for the device of Cole to provide for dormancy, cessation of growth, or disruption of a biofilm since cooling in the art is known to reduce bacteria growth and Cole treats vaginitis [0004] and symptoms of inflammation or irritation to a women's genitals [0002]. In addition, Cole provides for a temperature range of 15°F to about 50°F and the disclosed invention provides “Biofilms start to break down at less than 30°C.”(Page 5). Therefore, it is the position of the Examiner that Cole’s device would be capable of providing for a disruption of a biofilm.
While Cole provides the device is reusable and may be recooled [0109], it is silent about specifically teaching repeating the steps at least 3 times at intervals of at least 4 hours,
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to reuse the device at least three times at intervals of at least 4 hours until relief of the condition is achieved because Cole provides that if the device eventually ceases to be cool or warm enough to provide the desired therapeutic effect, the user may remove and recool the device.
Cole is silent about specifically teaching wherein steps (b) through (e) are repeated are repeated at least 1 time past relief of the symptoms.
However, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to further repeat the steps for cooling to ensure the symptoms are relieved and to further cool beyond symptom relief when the symptoms reappear at another time. Furthermore, Cole provides vaginitis is associated with more than one symptom (e.g. itching, burning, and irritation of the vagina) [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to repeat the cooling steps such that symptom A is treated and the user continues the cooling steps past relief of system A until symptoms B, C, etc. are relieved.
Further evidence by Liu provides for a thermal therapy device and further teaches “using this heat therapy remedy stone health care product 1 of the present invention for heat treatment, each day for 2 times, each time for 40, 14 days after symptom relief….” [0047]. Further evidence by Wang provides for a micanozole suppository whereby the medicine is inserted in the vaginal for 7 days…or each day every morning for 3 days…after 2 to 3 days the symptoms are alleviated or eliminated [0006].
Therefore, it is well known in the art to apply the method steps past symptom relief to ensure treatment and prevent recurrence of symptoms.
Claim 23 recites the same limitations of claim 3 as previously rejected above.
Claim 24 recites the same limitations of claim 9 as previously rejected above.
Claim 25 recites the same limitations of claim 10 as previously rejected above.
Claim 26 recites the same limitations of claim 11 as previously rejected above.
Claim 27 recites the same limitations of claim 20 as previously rejected above.
Claim 28 recites the same limitations of claim 14 as previously rejected above.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered, but they are not persuasive.
Applicant recites on page 8 of the remarks “Cole…fails to disclose anything regarding curing vulvovaginal candidiasis and fails to provide any teaching that the device in Cole actually does cure vulvovaginal candidiasis. Instead, it appears that Cole teaches a device that will help relieve the symptoms associated with vaginitis. The claim recites both symptom relief and curing. Cole cannot disclose both limitations - it only discloses symptom relief. As further evidence in paragraph 13 of Cole, it describes its device as an easy and accessible device for treatment of maladies of the vagina. In other words, it appears that Cole is describing itself as an over the counter device or stated another way a device that is not subject to FDA approval. Unlike the device covered by claim 12, because it is used to cure vulvovaginal candidiasis.”
The Examiner respectfully disagrees. Cole provides the temperature range of 15°F to about 50°F provides for optimum relief [0101]. The Examiner previously found pertinent art by Podella (7,476,529) that recites cooling less than 25°C disrupts the cellular structure of some of the plurality of yeast cells (Claim 36). The Examiner concludes that the temperature ranges in Cole are sufficient to provide for the claimed effect upon the infecting yeast. Furthermore, according to MPEP 2107.03 (IV), “An assertion that the claimed invention is useful in treating a symptom of an incurable disease may be considered credible by a person of ordinary skill in the art on the basis of a fairly modest amount of evidence or support. In contrast, an assertion that the claimed invention will be useful in "curing" the disease may require a significantly greater amount of evidentiary support to be considered credible by a person of ordinary skill in the art. In re Sichert, 566 F.2d 1154, 196 USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980).”
Applicant recites on page 9 of the remarks, “Wang is directed to using jatrorrhizine to treat candida albicans infectious diseases, which is a drug. Obviously utilizing a drug cannot be in the same field of endeavor as a method of curing vulvovaginal candidiasis of the patient free of drugs. As such one must determine if Wang is reasonably pertinent to the particular problem faced by the inventor…. Further, both the problem addressed by Wang and Wang’s solution to the problem are very different than that addressed by Applicant …It is not only unrelated but it is the exact problem that the applicant was trying to solve—not using a drug.”
The Examiner respectfully disagrees. According to the MPEP 2141.01, ‘A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art.’ In this case, Wang is related to the same field of endeavor since it discusses treating the same type of yeast as the disclosed invention. While the Examiner acknowledges Wang uses a drug to treat the infection, it is well known in the art that such yeast infection can be recurrent and one of ordinary skill would be interested in treating past symptom relief.
Conclusion
An updated search revealed the following pertinent reference:
Regarding the claimed limitation of repeating the treatment past symptom relief, (Ringdahl, Erika N., published 2000, https://www.aafp.org/pubs/afp/issues/2000/0601/p3306.html) recites recurrences of the claimed yeast infection are possible in the absence of any maintenance therapy months after treatment. While Ringdahl’s treatment is not drugfree, it teaches the nature of the infection is such that a recurrence is very likely past symptom relief. Therefore, one of ordinary skill in the art would be motivated to treat past symptom with the claimed method.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794
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