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 .
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.
Claims 3-5, and 35-53 are rejected under 35 U.S.C. 103 as being unpatentable over Rockweiler et al. (US 20160346568 A1) in view of Marchitto (US 20040229295 A1) in further view of Zhang (US 20180008837 A1).
Regarding claim 3, Rockweiler discloses a light irradiating vaginal dilating device (device 60, Fig 4; [0052]), comprising a vaginal insertion shaft (1000, Annotated Fig 1) to affect gradual vaginal dilation (Fig 4; distal portion of device 60 had a shape that increase in diameter longitudinally until it reaches a constant diameter portion), and a source of a pulsed light ([0006]: pulse laser) having a selected wavelength (light emitted by device 60 pulse laser has a certain wavelength), selected pulse rate (pulse laser emit light-based energy at a selected rate) and selected duty cycle (at least one duty cycle of pulse laser since it operates in discrete on/off periods) ([0052]); the device (60) is capable of being inserted in the vagina (6) of an adult human female ([0007]; Fig 4).
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Rockweiler is silent regarding to provide for intravaginal trans-membrane interstitial delivery of a biologically active composition; a shaft with longitudinally, continuously and progressively increasing diameter from a distal end to a proximal end.
Marchitto teaches a light irradiating vaginal device (device; [0036]) to provide for intravaginal trans-membrane interstitial delivery of a biologically active composition ([0036]: “including bioactive molecules”) ([0094]; laser energy including light for the purpose of drug delivery across vaginal membranes ; [0099]; [0072]: “the electrode of the patch may be replaced by a laser, multiple lasers, or optical fibers which conduct and transmit light at a desired wavelength, pulse length, pulse energy, pulse number and pulse repetition rate to ablate or alter the tissue directly beneath the patch”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler with a biologically active composition delivered across the vaginal membranes using laser energy as taught by Marchitto for the purpose of activating delivery of pharmaceuticals and biomaterials ([0036]).
Rockweiler/Marchitto are silent regarding a shaft with longitudinally, continuously and progressively increasing diameter from a distal end to a proximal end.
Zhang teaches a light irradiating vaginal dilating device (device 200, Fig 2) comprising a vaginal insertion shaft (elongated portion 235, Fig 2A) with longitudinally, continuously and progressively increasing diameter from a distal (2000, Annotated Fig 2) end to a proximal end (2001, Annotated Fig 2) (Fig 2; [0051];[0082]).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto with similar tapered shaped shaft as taught by Zhang for the purpose of substantially conform to a diameter of a patient's vaginal cavity for comfort ([0051]; [0052]: “An advantage of the present invention is the wearability, comfort, safety and conformability to the treated vaginal cavity area”).
Regarding claim 4, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler discloses comprising an inflatable dilating sheath to effect progressive dilation ([0052]: “The insertable portion of the device may be inflatable, flexible and/or compressible for ease of insertion and for ensuring sufficient contact with the vaginal wall (made, e.g., of a biocompatible polymer like silicone or polyurethane”) without causing tissue ischemia (device 60 increases blood flow to internal vaginal tissue to treat vaginal atrophy; therefore it does not cause tissue ischemia (abstract).
Regarding claim 5, Rockweiler/Marchitto/Zhang discloses the device of claim 4. Rockweiler discloses which is capable of providing increasing dilation pulsatile pressure (pulsatile pressure by inflation of the device 60; [0052]) within an atrophied vagina (6, Device 60 is used to treat vaginal atrophy) to affect dilation and increase tissue flexibility and compliance (when inflated device 60 affects dilation, increasing tissue flexibility and compliance; [0007]: “In particular, the invention provides methods and devices for increasing blood flow, lubrication, elasticity and resilience of the vagina and surrounding tissue”).
Regarding claim 35, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler discloses further comprising a handle area (area 1001, Annotated Fig 1) connected to proximal end (1002, Annotated Fig 1) of the vaginal insertion shaft (1000, Annotated Fig 1).
Regarding claim 36, Rockweiler/Marchitto/Zhang discloses the device of claim 35. Rockweiler is silent wherein the handle area is angled away from the vaginal insertion shaft.
Zhang teaches wherein a handle area (rim 230, Fig 2A); the handle area (230) is angled away from the vaginal insertion shaft (235) ( handle area of rim 230 is angled from shaft 235, Fig 2A; [0082]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar handle area as taught by Zhang for the purpose of making the device easier to handle and extract ([0082]).
Regarding claim 37, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler is silent wherein the selected wavelength of the pulsed light is from about 600 nm to about 1100 nm.
Zhang teaches wherein the selected wavelength of the pulsed light is from about 600 nm to about 1100 nm ([0073]: from 650nm-700nm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar range as taught by Zhang for the purpose of to promote healing ([0073]).
Regarding claim 38, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler is silent wherein the selected wavelength of the pulsed light is from about 600 nm to about 700 nm.
Zhang teaches wherein the selected wavelength of the pulsed light is from about 600 nm to about 700 nm ([0073]: from 650nm-700nm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar range as taught by Zhang for the purpose of to promote healing ([0073]).
Regarding claim 39, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler is silent wherein the pulsed light is a pulsed incoherent light selected from the group consisting of: fluorescent light, ultraviolet light, visible light, near-infrared light, mid-infrared light, LED (light emitting diode) light, laser diode light, organic electroluminescent material (OLED) light, and halogen light.
Zhang teaches wherein the pulsed light is a pulsed incoherent light selected from the group consisting of: fluorescent light, ultraviolet light, visible light, near-infrared light, mid-infrared light, LED (light emitting diode) light, laser diode light, organic electroluminescent material (OLED) light, and halogen light ([0011]; [0072] LED is incoherent).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar LED as taught by Zhang for the purpose of providing vaginal therapy ([0030];[0072]).
Regarding claim 40, Rockweiler/Marchitto/Zhang discloses the device of claim 39. Rockweiler is silent wherein the pulsed incoherent light is LED light or OLED light, having a peak emission wavelength of 660 nm ± 12 nm.
Zhang teaches wherein the pulsed incoherent light is LED light or OLED light, having a peak emission wavelength of 660 nm ± 12 nm ([0072]-[0073]: 650 nm is a red peak emission wavelength).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar LED preak emission as taught by Zhang for the purpose of to promote healing ([0073]).
Regarding claim 41, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler/Marchitto/Zhang are silent wherein the selected pulse rate is between about 1.7 cycles per second (cps) and about 2000 cps, or between about 24 cps and about 8000 cps.
The examiner notes that the pulse rate is a result effective variable, dependent on the desired therapeutic benefit. Further, the pulse rate range in the instant specification is lacking specific criticality ([0142]-[0143], in the instant specification). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the selected pulse rate to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 42, Rockweiler/Marchitto/Zhang discloses the device of claim 3. Rockweiler discloses wherein the selected duty cycle has a discrete ON time and a discrete OFF time, and wherein the discrete ON time is between about 10% and about 75% ([0043]; claim 2; duty cycle of 20%).
Regarding claim 43, Rockweiler discloses a light irradiating vaginal dilating device (device 60, Fig 4; [0052]), comprising a longitudinally progressively increasing diameter to affect gradual vaginal dilation (Fig 4; distal portion of device 60 had a shape that increase in diameter longitudinally until it reaches a constant diameter portion), and a source of a pulsed light ([0006]: pulse laser) having a selected wavelength (light emitted by device 60 pulse laser has a certain wavelength), selected pulse rate and selected duty cycle (at least one duty cycle of pulse laser since it operates in discrete on/off periods) ([0052]).
Rockweiler is silent wherein to provide for intravaginal trans-membrane interstitial delivery of a biologically active composition, when the device is capable of being inserted in the vagina of human female, wherein the selected wavelength of the pulsed light is from about 600 nm to about 1100 nm.
Marchitto teaches a light irradiating vaginal device (device; [0036]) to provide for intravaginal trans-membrane interstitial delivery of a biologically active composition ([0036]: “including bioactive molecules”) ([0094]; laser energy including light for the purpose of drug delivery across vaginal membranes ; [0099]; [0072]: “the electrode of the patch may be replaced by a laser, multiple lasers, or optical fibers which conduct and transmit light at a desired wavelength, pulse length, pulse energy, pulse number and pulse repetition rate to ablate or alter the tissue directly beneath the patch”); Marchitto further teaches a wavelength of the pulsed light ([0116]; from about 200 nm to about 20,000 nm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler with a biologically active composition delivered across the vaginal membranes using laser energy at a similar range as taught by Marchitto for the purpose of activating delivery of pharmaceuticals and biomaterials ([0036]).
Rockweiler/Marchitto are silent wherein the selected wavelength of the pulsed light is from about 600 nm to about 1100 nm.
Zhang teaches a light irradiating vaginal dilating device (device 200, Fig 2) wherein the selected wavelength of the pulsed light is from about 600 nm to about 1100 nm ([0073]: from 650nm-700nm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto with similar range as taught by Zhang for the purpose of to promote healing ([0073]).
Regarding claim 44, Rockweiler/Marchitto/Zhang discloses the device of claim 43. Rockweiler is silent wherein the selected wavelength of the pulsed light is from about 600 nm to about 700 nm.
Zhang teaches wherein the selected wavelength of the pulsed light is from about 600 nm to about 700 nm ([0073]: from 650nm-700nm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar range as taught by Zhang for the purpose of to promote healing ([0073]).
Regarding claim 45, Rockweiler/Marchitto/Zhang discloses the device of claim 43. Rockweiler is silent wherein the pulsed light is a pulsed incoherent light selected from the group consisting of: fluorescent light, ultraviolet light, visible light, near-infrared light, mid-infrared light, LED (light emitting diode) light, laser diode light, organic electroluminescent material (OLED) light, and halogen light.
Zhang teaches wherein the pulsed light is a pulsed incoherent light selected from the group consisting of: fluorescent light, ultraviolet light, visible light, near-infrared light, mid-infrared light, LED (light emitting diode) light, laser diode light, organic electroluminescent material (OLED) light, and halogen light([0011]; [0072] LED is incoherent).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang to include similar LED as taught by Zhang for the purpose of providing vaginal therapy ([0030];[0072]).
Regarding claim 46, Rockweiler/Marchitto/Zhang discloses the device of claim 45. Rockweiler is silent wherein the pulsed incoherent light is LED light or OLED light, having a peak emission wavelength of 660 nm ± 12 nm.
Zhang teaches wherein the pulsed incoherent light is LED light or OLED light, having a peak emission wavelength of 660 nm ± 12 nm ([0072]-[0073]: 650 nm is a red peak emission wavelength).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar LED preak emission as taught by Zhang for the purpose of to promote healing ([0073]).
Regarding claim 47, Rockweiler/Marchitto/Zhang discloses the device of claim 43. Rockweiler/Marchitto/Zhang is silent wherein the selected pulse rate is between about 1.7 cycles per second (cps) and about 2000 cps, or between about 24 cps and about 8000 cps.
The examiner notes that the pulse rate is a result effective variable, dependent on the desired therapeutic benefit. Further, the pulse rate range in the instant specification is lacking specific criticality ([0142]-[0143], in the instant specification). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the selected pulse rate to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 48, Rockweiler/Marchitto/Zhang discloses the device of claim 43. Rockweiler discloses wherein the selected duty cycle has a discrete ON time and a discreet OFF time, and wherein the discrete ON time is between about 10% and about 75% ([0043]; claim 2; at a duty cycle of 20%)
Regarding claim 49, Rockweiler/Marchitto/Zhang discloses the device of claim 43. Rockweiler discloses wherein the device comprises a vaginal insertion shaft (1000, Annotated 1). Rockweiler is silent wherein the shaft has a longitudinally, continuously and progressively increasing diameter from a distal end to a proximal end to affect gradual vaginal dilation.
Zhang teaches a light irradiating vaginal dilating device (device 200, Fig 2) comprising a vaginal insertion shaft (elongated portion 235, Fig 2A) with longitudinally, continuously and progressively increasing diameter from a distal (2000, Annotated Fig 2) end to a proximal end (2001, Annotated Fig 2) (Fig 2; [0051];[0082]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto with similar tapered shaped shaft as taught by Zhang for the purpose of substantially conform to a diameter of a patient's vaginal cavity for comfort ([0051]; [0052]: “An advantage of the present invention is the wearability, comfort, safety and conformability to the treated vaginal cavity area”).
Regarding claim 50, Rockweiler/Marchitto/Zhang discloses the device of claim 49. Rockweiler discloses comprising an inflatable dilating sheath to effect progressive dilation ([0052]: “The insertable portion of the device may be inflatable, flexible and/or compressible for ease of insertion and for ensuring sufficient contact with the vaginal wall (made, e.g., of a biocompatible polymer like silicone or polyurethane”) without causing tissue ischemia (device 60 increases blood flow to internal vaginal tissue to treat vaginal atrophy; therefore it does not cause tissue ischemia (abstract).
Regarding claim 51, Rockweiler/Marchitto/Zhang discloses the device of claim 50. Rockweiler discloses which is capable of providing increasing dilation pulsatile pressure (pulsatile pressure by inflation of the device 60; [0052]) within an atrophied vagina (6, Device 60 is used to treat vaginal atrophy) to affect dilation and increase tissue flexibility and compliance (when inflated device 60 affects dilation, increasing tissue flexibility and compliance; [0007]: “In particular, the invention provides methods and devices for increasing blood flow, lubrication, elasticity and resilience of the vagina and surrounding tissue”).
Regarding claim 52, Rockweiler/Marchitto/Zhang the device of claim 43. Rockweiler discloses further comprising a handle area (area 1001, Annotated Fig 1) connected to proximal end (1002, Annotated Fig 1) of the vaginal insertion shaft (1000, Annotated Fig 1).
Regarding claim 53, Rockweiler/Marchitto/Zhang discloses the device of claim 52. Rockweiler is silent wherein the handle area is angled away from the vaginal insertion shaft.
Zhang teaches wherein a handle area (rim 230, Fig 2A); the handle area (230) is angled away from the vaginal insertion shaft (235) ( handle area of rim 230 is angled from shaft 235, Fig 2A; [0082]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Rockweiler/Marchitto/Zhang with similar handle area as taught by Zhang for the purpose of making the device easier to handle and extract ([0082]).
Response to Arguments
Applicant’s arguments with respect to claims 3-5, and 35-53 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783