DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant’s arguments with respect to claim(s) 7-9 and 20-25 have been considered but are moot because the new ground of rejection were necessitated by Applicant’s amendments and do not apply to the current rejection.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7-9 and 20-25 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2014/0058326 A1 to Cull (Cull).
Regarding claim 7, Cull discloses a method of preventing preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement, or cervical incompetence or premature rupture of membranes in a pregnant woman (non-chemically, para [0013], treats pathogens known to cause bacterial vaginosis, para [0055]- which may otherwise lead to preterm birth, para [0010] and [0014]; see also para [0002-0004] and [0020]), the method comprising supplying a device (Fig. 1) comprising a shell (shell 10, Figs. 1-2; para [0039]) and a freezable or cooling filler contained within a chamber within the shell (filler 20 within chamber 12 of the shell 10, Fig. 1; para [0039]; filler is a freezable or cooling filler, para [0050]), freezing the device until the filler is frozen or rendered cooler (can be rendered frozen or sufficiently cold in a freezer or other cooling apparatus, para [0053]); applying the device to a vagina (placed in a body cavity such as a vagina, para [0053]) to treat an infection that can contribute to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes free of use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes (treats pathogens known to cause bacterial vaginosis, para [0055]- which may otherwise lead to preterm birth, para [0010] and [0014]; see also para [0002-0004]), wherein the pathogen is associated with a microbial condition of the vagina comprising vaginal candidiasis or bacterial vaginosis (treats pathogens known to cause bacterial vaginosis, para [0055]), refreezing the device ([0060]) and repeating the applying and refreezing steps during pregnancy (The device of Cull is applied for less than about 1 hour or until no additional cooling sensation is noticed or experienced and that a new or re-frozen/cooled device would be inserted at that time. The repetitive process could be continued until the used does not experience and itching or discomfort, possibly requiring episodes of treatment every 4-6 hours, depending on the severity of the symptoms and length of time needed to cure the infection as discussed in para [0060]).
Regarding claim 8, Cull discloses the method of claim 7 as well as wherein the chamber comprises a first and a second compartment separated by a breakable barrier (chamber 20 has compartments 14/15 separated by breakable wall 16, para [0039]; Fig. 1).
Regarding claim 9, Cull discloses the method of claim 8 as well as wherein the first compartment contains a first solution and the second compartment contains a second solution (each compartment contains an ingredient in liquid form, para [0053]); wherein the solutions combine when the breakable barrier is broken (when breakable wall 16 is broken, the contents mix and chemically react, para [0053-0054]; see also para [0024] and [0039]).
Regarding claim 20, Cull discloses a method (non-chemically, para [0013], treats pathogens known to cause bacterial vaginosis, para [0055]- which may otherwise lead to preterm birth, para [0010] and [0014]; see also para [0002-0004] and [0020]) comprising providing a device (Fig. 1) comprising a shell (shell 10, Figs. 1-2; para [0039]) and a freezable or cooling filler contained within a chamber within the shell (filler 20 within chamber 12 of the shell 10, Fig. 1; para [0039]; filler is a freezable or cooling filler, para [0050]), causing the device to cool until the filler is frozen or rendered cooler (can be rendered frozen or sufficiently cold in a freezer or other cooling apparatus, para [0053]), applying the device to a vagina (placed in a body cavity such as a vagina, para [0053]) to treat a pathogen free if use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes free of use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes (non-chemically, para [0013], treats pathogens known to cause bacterial vaginosis, para [0055]- which may otherwise lead to preterm birth, para [0010] and [0014]; see also para [0002-0004]), wherein the pathogen is associated with a microbial condition of the vagina comprising vaginal candidiasis or bacterial vaginosis (treats pathogens known to cause bacterial vaginosis, para [0055]).
Regarding claim 21, Cull discloses the method of claim 20 as well as refreezing the device ([0060]).
Regarding claim 22, Cull discloses the method of claim 21 as well as repeating the applying and freezing steps during pregnancy (The device of Cull is applied for less than about 1 hour or until no additional cooling sensation is noticed or experienced and that a new or re-frozen/cooled device would be inserted at that time. The repetitive process could be continued until the used does not experience and itching or discomfort, possibly requiring episodes of treatment every 4-6 hours, depending on the severity of the symptoms and length of time needed to cure the infection as discussed in para [0060]).
Regarding claim 23, Cull discloses the method of claim 20 as well as wherein the chamber comprises a first and a second compartment separated by a breakable barrier (chamber 20 has compartments 14/15 separated by breakable wall 16, para [0039]; Fig. 1).
Regarding claim 24, Cull discloses the method of claim 23 as well as wherein the first compartment contains a first solution and the second compartment contains a second solution (each compartment contains an ingredient in liquid form, para [0053]); wherein the solutions combine when the breakable barrier is broken (when breakable wall 16 is broken, the contents mix and chemically react, para [0053-0054]; see also para [0024] and [0039]).
Regarding claim 25, Cull discloses a method (non-chemically, para [0013], treats pathogens known to cause bacterial vaginosis, para [0055]- which may otherwise lead to preterm birth, para [0010] and [0014]; see also para [0002-0004] and [0020]) comprising providing a device (Fig. 1) comprising a shell (shell 10, Figs. 1-2; para [0039]), wherein the chamber comprises a first and a second compartment separated by a breakable barrier (chamber 20 has compartments 14/15 separated by breakable wall 16, para [0039]; Fig. 1) and wherein the first compartment contains a first solution and the second compartment contains a second solution (each compartment contains an ingredient in liquid form, para [0053]), breaking the breakable barrier and combining the first and second solutions and causing the device to cool (when breakable wall 16 is broken, the contents mix and chemically react, para [0053-0054]; see also para [0024] and [0039] and applying the device to a vagina (placed in a body cavity such as a vagina, para [0053]) to treat a pathogen free if use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes free of use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes (non-chemically, para [0013], treats pathogens known to cause bacterial vaginosis, para [0055]- which may otherwise lead to preterm birth, para [0010] and [0014]; see also para [0002-0004]), wherein the pathogen is associated with a microbial condition of the vagina comprising vaginal candidiasis or bacterial vaginosis (treats pathogens known to cause bacterial vaginosis, para [0055]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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