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 .
Election/Restrictions
Applicant’s election without traverse of Group II: Claims 28-31, 33, 34, 36-42, 44-45, and 51 and new claims 71-84 have been added for consideration in the reply filed on 02/24/2026 is acknowledged.
Claims 1-8, 18, 20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/26/206.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 28, 37, 73-74, 76-77 and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosen et al. (WO-2014127270 A1).
With respect to claim 28, Rosen et al. discloses a method of inserting [0008, the method comprises inserting an intravaginal device into a user's vagina], the device comprising a stabilizing body and an occluding body] a vaginal pessary [000147] comprising: cooling a shape memory material of the vaginal pessary to reduce a temperature of one or more core elements [000116, shape memory element 1702] of the vaginal pessary [000116] and inserting the cooled vaginal pessary into a position upon a surface of a vaginal wall of a body such that the temperature of the vaginal pessary increases to a body temperature wherein the core elements change configuration in response to the increase in temperature and thereby immobilize the vaginal pessary relative to the vaginal wall [000116].
With respect to claim 37, Rosen et al. discloses determining a temperature of the one or more core elements of the vaginal pessary [000179, the intra-vaginal device has one or more incorporated smart functions. The smart functions can include one or more sensors configured to allow for capabilities such as monitoring, notification of device status, and real time stabilization. Many of the functions can be controlled using an online interface, an attachable user interface, a computer, a tablet, a smart phone, and the like. In some embodiments, some or all functions can be locked or limited by a physician].
With respect to claim 73, Rosen et al. discloses processing sensor data with a processor configured to set a value for an operating parameter of a sensor on the vaginal pessary [000179].
With respect to claim 74, Rosen et al. discloses communicating a condition of the vaginal pessary to a mobile communication device with the processor [000179].
With respect to claim 76, Rosen et al. discloses the body temperature is in a range from 36.4 and 37.2 degrees C [000116, Once in place, allowing the device to expand or come to body temperature can cause it to recover the original shape].
With respect to claim 77, Rosen et al. discloses sensing a condition of the vaginal pessary with a sensor that includes at least one of a pressure sensor [000180]- [000181].
With respect to claim 80, Rosen et al. discloses a method treating a patient with a vaginal pessary [0008, the method comprises inserting an intravaginal device into a user's vagina] comprising: introducing a vaginal pessary into a patient [000147], the vaginal pessary comprising a shape memory material having a first configuration at a first temperature and a second configuration at a second temperature, the second temperature conforming to a body temperature of a patient [000116], the vaginal pessary including an outer wall surface to contact a vaginal wall of the patient wherein the first configuration has a first radius for insertion and removal and the second configuration has a second radius larger than the first radius such that the outer wall surface engages the vaginal wall at the body temperature [000116, “the frame 1700 comprising an internal shape memory element 1702. The shape memory element 1702 can be formed into a particular shape (e.g., a large shape) and then mechanically compressed or cooled to change the shape (e.g., reduce the size of the shape), as shown in FIG. 17B. Once in place, allowing the device to expand or come to body temperature can cause it to recover the original shape”].
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 30-31, 39, 71, 75 and 82-83 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al. as applied to claim 28 above, and further in view of Bartning et al. U.S. Publication No. (2008/0033231 A1).
With respect to claim 30, Rosen et al. substantially discloses the invention as claimed except the one or more core elements of the vaginal pessary comprises a set of nitinol core elements.
Bartning et al. however, teaches a method for treating urinary incontinence includes the steps of inserting into the woman's vagina a first disposable device, removing the first disposable device, and inserting a second disposable device substantially identical to the first disposable device (abstract) comprising a pessary (10) and [0048] made of Nitinol wire 20 and comprises alternating sinusoidal struts 2, 3 that intersect and form a strut angle .theta. [0028].
In view of the teachings of Bartning et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vaginal pessary of Rosen et al. by incorporating the one or more core elements of the vaginal pessary comprises a set of nitinol core elements which is a shape memory is the ability of a material to remember its original shape, either after mechanical deformation, which is a one-way effect, or by cooling and heating which is a two-way effect [0039] of Bartning et al.
With respect to claim 31, the combination of Rosen et al/Bartning et al. substantially discloses the invention as claimed. Bartning et al. further teaches the set of nitinol core elements comprise a continuous spiral of helical elements (20, as shown in fig.4).
With respect to claim 39, the combination of Rosen et al/Bartning et al. substantially discloses the invention as claimed. Bartning et al. further teaches a drug from the vaginal pessary to treat a condition of the patient [0048, in addition, the pessary 10 may be loaded with various pharmacological compounds and additives, such as hormones and/or alpha-adrenoceptor agonists, urethra selective stimulators, prostaglandins, anticholinergics, hormones, nicotine, cytostatics, tranquilizers, local anaesthetics and other compounds, such as pharmacologically active alpha-[tertiary-aminomethyl]-benzenemethanol derivatives].
With respect to claim 71, the combination of Rosen et al/Bartning et al. substantially discloses the invention as claimed. Bartning et al. further teaches delivering a therapeutic agent to the patient [0048].
With respect to claim 75, the combination of Rosen et al/Bartning et al. substantially discloses the invention as claimed. Bartning et al. further teaches the drug comprises at least on of estradiol, an antibiotic, and estrogen [0048].
With respect to claim 82, the combination of Rosen et al/Bartning et al. substantially discloses the invention as claimed. Bartning et al. further teaches delivering a drug into the patient wherein a drug dispenser on the vaginal pessary comprises a container that can be inserted into a reservoir of the pessary, the container having a cavity to contain a drug to be dispensed into the patient [0049, “Methods of associating drugs, hormones or other pharmacological compounds with an object for drug administration to the body are well known to those skilled in the art, as for example, described in U.S. Pat. No. 5,188,835 and German Patent No. 198 29 713, both incorporated in their entirety by reference herein. In still a further embodiment, topical medications, ointments or creams can be associated with pessary 10 by infusion (injection), coating or absorption into the pores of a sponge-like material of the medication of the pessary 10 and slowly released, within a day or two, into the vaginal cavity. This embodiment of the invention may be used for treating dryness, irritation, or other local conditions. The ointment, cream, etc., can be replenished into the pessary on an as needed basis”].
With respect to claim 83, the combination of Rosen et al/Bartning et al. substantially discloses the invention as claimed. Bartning et al. further teaches the shape memory material comprises nitinol [0038].
Claim(s) 36, 38, 51, 72, 78 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al.
With respect to claim 36, Rosen et al. substantially discloses the invention as claimed except the vaginal pessary comprises a hemi- cylindrical shape. Rosen et al., however, teaches in [000157, FIG. 39A illustrates an embodiment of a tool 3900 comprising a soft body 3902 configured to increase in diameter when tensioned by the user. In this embodiment, the body or the body's shell, is at least partly incompressible, conserving volume. The body 3902 can comprise a cylindrical shape]. Furthermore, Rosen et al. teaches in [000153, “Intra-vaginal devices disclosed herein may be provided in multiple sizes and/or shapes. In some embodiments, adjustable intra-vaginal devices are provided. In both cases, a particular device, size, or shape must be selected for particular patient anatomy. A tool that allows for measurement of patient anatomy may allow for increased comfort and efficiency during patient fitting. As sizing is commonly done by hand, such a tool may also standardize communications between different clinicians for patient care or instructional purposes. The tool can include a portion for pressing against the rectovaginal septum. The tool can be configured to measure a lateral width of the vaginal cavity simultaneous to creating a protrusion of the posterior vaginal wall into the rectal space”].
In view of the alternative embodiment of Rosen et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vaginal pessary of Rosen et al. such that the vaginal pessary comprises a hemi-cylindrical shape in order to conform to the anatomy of the vaginal wall, as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
With respect to claim 38, Rosen et al. substantially discloses the invention as claimed but did not explicitly discloses sensing the temperature and determining if the sensed temperature is above a threshold temperature; and removing the applicator from the vaginal pessary. Rosen et al. however teaches in [000179, “In some embodiments, the intra-vaginal device has one or more incorporated smart functions. The smart functions can include one or more sensors configured to allow for capabilities such as monitoring, notification of device status, and real time stabilization. Many of the functions can be controlled using an online interface, an attachable user interface, a computer, a tablet, a smart phone, and the like. In some embodiments, some or all functions can be locked or limited by a physician”] and [000182, “In some embodiments, the device incorporates sensors to monitor patient position and activity. For example, the device can incorporate position sensors, accelerometers, force transducers, or torsion transducers. Such sensors can gather information about patient position and activity for more efficacious treatment of the patient or to gather information to improve programming for the general population. Such sensors can allow the device or system to trigger specific events based on patient activity”], therefore, it would have been well within the skill of an ordinary artisan to programmed the sensor to sense the temperature and determining if the sensed temperature is above a threshold temperature; and removing the applicator from the vaginal pessary in order to prevent the heated phase from being uncomfortable for the patient.
With respect to claim 51, Rosen et al. substantially discloses the invention as claimed but did not explicitly discloses determining that the temperature of the one or more core elements of the vaginal pessary have reached a threshold temperature; and removing the applicator from the vaginal pessary. Rosen et al. however teaches in [000179, “In some embodiments, the intra-vaginal device has one or more incorporated smart functions. The smart functions can include one or more sensors configured to allow for capabilities such as monitoring, notification of device status, and real time stabilization. Many of the functions can be controlled using an online interface, an attachable user interface, a computer, a tablet, a smart phone, and the like. In some embodiments, some or all functions can be locked or limited by a physician”] and [000182, “In some embodiments, the device incorporates sensors to monitor patient position and activity. For example, the device can incorporate position sensors, accelerometers, force transducers, or torsion transducers. Such sensors can gather information about patient position and activity for more efficacious treatment of the patient or to gather information to improve programming for the general population. Such sensors can allow the device or system to trigger specific events based on patient activity”], therefore, it would have been well within the skill of an ordinary artisan to programmed the sensor to determine that the temperature of the one or more core elements of the vaginal pessary have reached a threshold temperature; and removing the applicator from the vaginal pessary in order to prevent the heated phase from being uncomfortable to the patient.
With respect to claim 72, Rosen et al. substantially discloses the invention as claimed but did not explicitly disclose a sensor detects a condition of the patient in response to delivery of the therapeutic agent. Rosen et al. however teaches in [000179, “In some embodiments, the intra-vaginal device has one or more incorporated smart functions. The smart functions can include one or more sensors configured to allow for capabilities such as monitoring, notification of device status, and real time stabilization. Many of the functions can be controlled using an online interface, an attachable user interface, a computer, a tablet, a smart phone, and the like. In some embodiments, some or all functions can be locked or limited by a physician”] and [000182, “In some embodiments, the device incorporates sensors to monitor patient position and activity. For example, the device can incorporate position sensors, accelerometers, force transducers, or torsion transducers. Such sensors can gather information about patient position and activity for more efficacious treatment of the patient or to gather information to improve programming for the general population. Such sensors can allow the device or system to trigger specific events based on patient activity”], therefore, it would have been well within the skill of an ordinary artisan to programmed the sensor to detects a condition of the patient in response to delivery of the therapeutic agent in order to monitor the general health condition of the patient.
With respect to claim 78, Rosen et al. substantially discloses the invention as claimed except the vaginal pessary comprises a ring or a cylinder having a radius that is not joined along a portion such that opposing sides can expand from a smaller radius to a larger radius upon warming to the body temperature.
Rosen et al., however, teaches in [000157, FIG. 39A illustrates an embodiment of a tool 3900 comprising a soft body 3902 configured to increase in diameter when tensioned by the user. In this embodiment, the body or the body's shell, is at least partly incompressible, conserving volume. The body 3902 can comprise a cylindrical shape]. Furthermore, Rosen et al. teaches in [000153, “Intra-vaginal devices disclosed herein may be provided in multiple sizes and/or shapes. In some embodiments, adjustable intra-vaginal devices are provided. In both cases, a particular device, size, or shape must be selected for particular patient anatomy. A tool that allows for measurement of patient anatomy may allow for increased comfort and efficiency during patient fitting. As sizing is commonly done by hand, such a tool may also standardize communications between different clinicians for patient care or instructional purposes. The tool can include a portion for pressing against the rectovaginal septum. The tool can be configured to measure a lateral width of the vaginal cavity simultaneous to creating a protrusion of the posterior vaginal wall into the rectal space”].
In view of the alternative embodiment of Rosen et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vaginal pessary of Rosen et al. such that the vaginal pessary comprises a cylinder having a radius that is not joined along a portion such that opposing sides can expand from a smaller radius to a larger radius upon warming to the body temperature in order to conform to the anatomy of the vaginal wall, as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
With respect to claim 84, Rosen et al. substantially discloses the invention as claimed but did not explicitly disclose the shape memory material comprises a frame having a hemi-cylindrical shape. Rosen et al., however, teaches in [000157, FIG. 39A illustrates an embodiment of a tool 3900 comprising a soft body 3902 configured to increase in diameter when tensioned by the user. In this embodiment, the body or the body's shell, is at least partly incompressible, conserving volume. The body 3902 can comprise a cylindrical shape]. Furthermore, Rosen et al. teaches in [000153, “Intra-vaginal devices disclosed herein may be provided in multiple sizes and/or shapes. In some embodiments, adjustable intra-vaginal devices are provided. In both cases, a particular device, size, or shape must be selected for particular patient anatomy. A tool that allows for measurement of patient anatomy may allow for increased comfort and efficiency during patient fitting. As sizing is commonly done by hand, such a tool may also standardize communications between different clinicians for patient care or instructional purposes. The tool can include a portion for pressing against the rectovaginal septum. The tool can be configured to measure a lateral width of the vaginal cavity simultaneous to creating a protrusion of the posterior vaginal wall into the rectal space”].
In view of the alternative embodiment of Rosen et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vaginal pessary of Rosen et al. such that the vaginal pessary comprises a hemi-cylindrical shape in order to conform to the anatomy of the vaginal wall, as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 33 and 79 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al. as applied to claim 28 above, and further in view of Race (WO-2008115906 A1).
With respect to claim 33, Rosen et al. substantially discloses the invention as claimed except causing a notification element on an applicator to display a notification responsive to the determining that the temperature of the one or more core elements of the vaginal pessary have reached the threshold temperature.
Race however, teaches a drug delivery devices which deliver a drug and monitor patient compliance with drug delivery instructions are provided (abstract); comprising electronics module may comprising one or more sensors for monitoring and recording a physiological parameter or parameters in the patient. Examples of commercially available sensors which can be used in the present invention include, but are not limited to, thermocouples, thermistors, RTDs, pH sensors, and conductivity sensors. In this embodiment, the microprocessor has integrated into it one or more sensors and associated electronics that enable other parameters such as the ambient temperature to be monitored. In a preferred embodiment the microprocessor and associated sensor or sensors measure physiological parameters of the patient such as body temperature, pH, electrical conductivity, and/or other physical parameters. Preferably, the sensors are capable of measuring physiological parameters of the patient indirectly through the drug product or portions of the delivery device without requiring direct contact with the patient. Even more preferred is use of sensors capable of measuring physiological parameters of the patient and collecting physiological samples that can be used to determine the site of drug delivery [Page 3], 2nd paragraph] and a vaginal applicator appropriate for dispensing microbicides, antifungal creams, gels, or other vaginal products, equipped with a microprocessor and sensors to monitor temperature [Page 3], 6th paragraph].
In view of the teachings of Race, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the applicator of Rosen et al. by incorporating a notification element on an applicator to display a notification responsive to the determining that the temperature of the one or more core elements of the vaginal pessary have reached the threshold temperature in order for monitoring and recording a physiological parameter or parameters in the patient.
With respect to claim 79, Rosen et al. substantially discloses the invention as claimed except the applicator comprises a sensor for measuring a condition of the vaginal pessary.
Race however, teaches a drug delivery devices which deliver a drug and monitor patient compliance with drug delivery instructions are provided (abstract); comprising electronics module may comprising one or more sensors for monitoring and recording a physiological parameter or parameters in the patient. Examples of commercially available sensors which can be used in the present invention include, but are not limited to, thermocouples, thermistors, RTDs, pH sensors, and conductivity sensors. In this embodiment, the microprocessor has integrated into it one or more sensors and associated electronics that enable other parameters such as the ambient temperature to be monitored. In a preferred embodiment the microprocessor and associated sensor or sensors measure physiological parameters of the patient such as body temperature, pH, electrical conductivity, and/or other physical parameters. Preferably, the sensors are capable of measuring physiological parameters of the patient indirectly through the drug product or portions of the delivery device without requiring direct contact with the patient. Even more preferred is use of sensors capable of measuring physiological parameters of the patient and collecting physiological samples that can be used to determine the site of drug delivery [Page 3], 2nd paragraph] and a vaginal applicator appropriate for dispensing microbicides, antifungal creams, gels, or other vaginal products, equipped with a microprocessor and sensors to monitor temperature [Page 3], 6th paragraph].
In view of the teachings of Race, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the applicator of Rosen et al. by incorporating a sensor for measuring a condition of the vaginal pessary in order for monitoring and recording a physiological parameter or parameters in the patient.
Allowable Subject Matter
Claims 29, 34, 40-42, 44-45 and 81 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to Rosen et al. fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claims 29, 34, 40-42, 44-45 and 81 which recite features not taught or suggested by the prior art drawn to Rosen et al., in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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