DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/21/2025 has been entered.
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 02/21/2025 has been considered by the Examiner. Currently claims 3, 9-14 are pending, claims 1-2, and 4-8 are canceled, claim 12 has been amended, and claim 14 is newly added. A complete action on the merits of claims 3, and 9-14 follows below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/21/2025 has been considered by the examiner.
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 9-14 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);
(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) to cause at least one effect upon the infecting yeast of the vaginal yeast infection, resulting in a drug-free cure of vulvovaginal candidiasis ([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 the steps of the method are repeated at least 1 time past symptom relief.
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 therapy 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 13, Cole as further evidenced by Liu and Wang teaches the limitations of claim 12 wherein the steps of the method are repeated at least one time past symptom relief when the patient is exhibiting no further symptoms (see claim rejection 12).
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).
Response to Arguments
Applicant's arguments filed 02/21/2025 have been fully considered, but they are not persuasive.
Applicant recites on page 5 of the Remarks, ‘The Office Action goes on to argue that Cole provides for a temperature range of 15°F to about 50°F and that the disclosed invention provides that “Biofilms start to break down at less than 30°C” to support modification of Cole. However, as acknowledged in the Office Action only the present application discloses that Biofilms start to break down at less than 30°C. This is totally absent from Cole. Due to the lack of this concept being disclosed in Cole and the fact that this is only present on the record in Applicant’s specification, it logically follows that this concept has been improperly gleaned from Applicant’s own specification and that the modification of Cole is an exercise of impermissible hindsight.”
The Examiner respectfully disagrees. Cole specifically provides 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 [0004] and further provides the temperature range of 15°F to about 50°F provides for optimum relief [0101]. Furthermore, dependent claims 9-11 specifically disclose temperature ranges wherein a temperature of vaginal tissue goes below during each period of time (i.e. below 30°C, 26°C, and 22°C respectively). Therefore, the cooling temperatures taught in Cole read on the temperature ranges in the claims and one can conclude that such temperature ranges have an effect upon the infecting yeast of the vaginal yeast infection. Furthermore, in an updated search the Examiner 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.
Applicant recites on pages 6 and 7 of the remarks that Liu isn’t from the same field of endeavor and is not reasonably pertinent because it does not address the same problem addressed by the claimed invention and serves a different purpose than the method of curing a yeast infection in a vagina of a patient…A heated medicinal stone is under no circumstance in the same filed of endeavor as the present system and method utilizing a cooling device cure a yeast infection in a vagina of the patient…The closes comparison is that the medicinal stone in Liu was used to treat menstrual pain.” Similarly with respect to Wang Applicant recites “Wang isn’t reasonably related to the problem faced by the inventor ..a drug-free method of curing a yeast infection in a vagina of the patient.”
The Examiner respectfully disagrees. In the rejection the Examiner relies on Cole to teach that vaginitis is associated with multiple symptoms and it would obvious to repeat cooling until all symptoms are relived. Cole also provides for effective temperature ranges to address candidiasis and vaginitis. The Examiner applies evidentiary reference by Liu (which uses a thermal therapy device to apply thermal therapy to a patient therefore it is in the same field of endeavor) to teach it is well known to one of ordinary skill in the art to use the thermal therapy device more than once during the day as well as days after symptom relief. Similarly, Wang provides for a method of treating yeast infection in a vagina of a patient (therefore it is reasonably pertinent to the particular problem faced by the inventor) and further provides reusing its device days after symptoms are alleviated. The Examiner applies these two evidentiary references to conclude it is well known in the art to apply the device of Cole past symptom relief to prevent recurrence of vaginitis symptoms.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M. Hoffman can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794