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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/21/2025 has been considered by the examiner.
Claim Status
Applicant’s amendments in the response filed on 02/21/2025 has been considered by the Examiner. Currently, claims 1-7 and 10 are pending, claims 1 and 5 have been amended, claim 10 is newly added. In addition, claims 8-9 are canceled and the Examiner withdraws the previously filed 112(b) rejection.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/21/2025 has been considered by the examiner.
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.
Claims 2 and 7 are 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.
Claim 2 recites “wherein the filler is at least one of a gas, a liquid and a solid.” However, claim 1 requires the filler to comprise a frozen material.
Claim 7 recites “a removable plug”. It is unclear if the limitation is one of or in addition to “a removable plug” recited in claim 1.
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 1-3 and 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sarson (1,729,296) in view of Singleton (Patent No. 4,240,436).
Regarding claim 1, Sarson teaches a device to treat an overgrowth of yeast in a vagina comprising a shell, a first end, a second end and a chamber within the shell (Col. 1 line 1 For the treatment of the inner female genitals Sarson teaches a device comprising a bladder b that is inserted into the vagina, cock f is opening and water is forced from bladder a into bladder b), wherein the chamber is sealed with a removable plug (screw stopper d);
wherein the second end is rounded (bladder b), and the first end comprises a removal means (intermediate element c, cock f, mouthpiece e, bladder a);
wherein the chamber is configured to house a filler (water; Col. 1 line 6);
wherein the shell comprises a malleable unfreezable material (bladder b is made of extensible rubber or rubber skin so that it can be inflated; Col. 1 lines 47-58);
wherein the filler comprises a material that is refreezable (cold water is used to treat inflammations Col 2 lines 68-70);
wherein, when the filler is frozen and the shell is inserted into a body cavity, the shell cools the vagina to a temperature that prevents a replication of yeast and provides relief to symptoms associated within an overgrowth of yeast (the device of Sarson is inserted into the vagina for a period of time to provide cooling to relieve inflammation Col. 2 lines 68-70).
Sarson is silent about specifically teaching the refreezable material is frozen, Singleton teaches a device within the same field of invention (perineal ice pack comprises raised surface portions being adapted for partial insertion into both said vaginal and rectal openings; Claim 1 wherein the device contains a cold temperature storage means such as water or a chemical slurry which is a mixture of 10% isopropyl alcohol and water which creates a semi-pliable slurry at a temperature of 20 degrees Fahrenheit; Col. 3 lines 35 -40).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the filler such that it includes a slurry since it has a freezing point between zero and 32 degrees Fahrenheit and provides for the appropriate therapy. One of ordinary skill in the art can replace water with slurry since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
While Sarson is silent about specifically teaching wherein the device is reusable after each use it would have been obvious to one of ordinary skill in the art at the time the invention was made to reuse the device since it has been held that a recitation with respect to the manner in which a claimed apparatus is intendent to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2D 1647 (1987).
Regarding claim 2, Sarson in view of Singleton teaches the limitations of claim 1 and wherein the filler is at least one of a gas, a liquid and a solid (chemical slurry which is a mixture of 10% isopropyl alcohol and water).
Regarding claim 3, Sarson teaches the limitations of claim 1 and wherein the filler is at least one of saline, distilled water, and a gel (chemical slurry which is a mixture of 10% isopropyl alcohol and water).
Regarding claim 7, Sarson teaches the limitations of claim 1 further comprising a removable plug adapted to seal an opening of the chamber (screw cap d).
Claims 4-5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sarson (1,729,296) in view of Singleton (Patent No. 4,240,436) and in further view of Ponder (Patent No. 5,539,934).
Regarding claims 4, Sarson in view of Singleton teaches the limitations of claim 1. While the chamber of Sarson includes a first compartment (bladder b), it does not teach a second compartment.
However, Ponder teaches a device within the same field of invention (cooling apparatus), wherein the device includes a first and second compartment (annular chamber of the bladder further comprising water, and a waterproof membrane 13 containing at least one capsule comprising a salt capable of producing an endothermic reaction with the water and a water soluble coating encapsulating the salt).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device in Sarson to include an additional compartment for the purposes of including salt tablets such that when the compartment breaks and mixes with the water in the first compartment, it extends a cooling effect (Claim 1; Col. 2 lines 37-39).
Regarding claim 5, Sarson in view of Singleton and Ponder teaches the limitations of claim 4. Ponder provides wherein the first compartment is filled with a first compound (annular chamber includes water ) and the second compartment is filled with a second compound (waterproof membrane 13 includes capsules 14), wherein the first compartment and second compartment are separated by breakable walls, wherein the walls are broken, the compounds mix to create a cooling gel (membrane 13 is capable of being ruptured or broken when deformed by an external force ; Col. 2 line 39…Claim 1 the annular chamber of the bladder further comprising water, at least one capsule and a waterproof membrane, said at least one capsule comprising a salt capable of producing an endothermic reaction with the water and a water soluble coating encapsulating the salt and thereby extending a cooling effect).
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sarson (1,729,296) in view of Singleton (Patent No. 4,240,436) and in further view of Jacobson (Pub. No. 2004/0176827).
Regarding claim 6, Sarson in view of Singleton teaches the limitations of claim 1. Sarson does not teach wherein the removal means comprises a string attached to the shell, wherein pulling on the string removes the device from the vagina.
However, Jacobson teaches a device within the same field of invention (thermal therapy applicator) wherein the device comprises a string Fig. 5.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a string on the proximal end of the device in Sarson since Jacobson provides the string may be used instead of the handle to allow removal of the device from the body cavity [0026].
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sarson (1,729,296) in view of Singleton (Patent No. 4,240,436), Jacobson (Pub. No. 2004/0176827), and in further view of Fleshman (2010/0174209).
Regarding claim 10, Sarson teaches a device to treat an overgrowth of yeast in a vagina comprising:
a shell comprising a first end, a second end and a chamber within the shell (Col. 1 line 1 For the treatment of the inner female genitals Sarson teaches a device comprising a bladder b that is inserted into the vagina, cock f is opening and water is forced from bladder a into bladder b), wherein the chamber is sealed with a removable plug (screw stopper d) and wherein the shell comprises a malleable unfreezable material (bladder b is made of extensible rubber or rubber skin so that it can be inflated; Col. 1 lines 47-58);
a filler housed in the chamber (water; Col. 1 line 6), wherein the filler comprises a material that is refreezable (cold water is used to treat inflammations Col 2 lines 68-70);
wherein, when the filler is frozen and the shell is inserted into a body cavity, the shell cools the vagina to a temperature that prevents a replication of yeast and provides relief to symptoms associated within an overgrowth of yeast (the device of Sarson is inserted into the vagina for a period of time to provide cooling to relieve inflammation Col. 2 lines 68-70).
Sarson is silent about specifically teaching the refreezable material is frozen, Singleton teaches a device within the same field of invention (perineal ice pack comprises raised surface portions being adapted for partial insertion into both said vaginal and rectal openings; Claim 1 wherein the device contains a cold temperature storage means such as water or a chemical slurry which is a mixture of 10% isopropyl alcohol and water which creates a semi-pliable slurry at a temperature of 20 degrees Fahrenheit; Col. 3 lines 35 -40).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the filler such that it includes a slurry since it has a freezing point between zero and 32 degrees Fahrenheit and provides for the appropriate therapy. One of ordinary skill in the art can replace water with slurry since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
While Sarson is silent about specifically teaching wherein the device is reusable after each use it would have been obvious to one of ordinary skill in the art at the time the invention was made to reuse the device since it has been held that a recitation with respect to the manner in which a claimed apparatus is intendent to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2D 1647 (1987).
Sarson does not teach a removal loop formed in the first end.
However, Jacobson teaches a device within the same field of invention (thermal therapy applicator) wherein the device comprises a removal element (string Fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a string on the proximal end of the device in Sarson since Jacobson provides the string may be used instead of the handle to allow removal of the device from the body cavity [0026].
The combination does not provide wherein the removal element (string) is a loop. However, Fleshman teaches a medical device that has a removal element in the shape of a loop (grasping end 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the removal element (string) such that it has a shape of a loop since Fleshman teaches the loop is an easy to grasp handle design [0035].
Response to Remarks
Applicant’s arguments in the response filed on 02/21/2025 has been considered by the Examiner. Applicant’s remarks regarding the Harris reference were persuasive; therefore, the Examiner withdraws the rejection under 35 U.S.C 102(a)(1). Applicant’s amendments necessitate a new grounds of rejection over Sarson (1,729,296) in view of Singleton (Patent No. 4,240,436) for claim 1.
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.
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794