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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/29/2024 has been entered.
Response to Amendments
The Amendment filed 1/29/2024 has been entered. Claims 19, 33, and 40 were amended, and claims 1-18, 20, 22-25, and 37 were canceled. Thus, claims 19, 21, 26-36, and 38-41 are pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation are: “pumping means configured to pump” in claim 33 line 6, “heating means configured to maintain a desired temperature” in claim 33 line 8, and “means for controlling” in claim 40 lines 3-4.
Because these claim limitation are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the Applicant’s specification paras. [0016-0017], the “pumping means configured to pump” in claim 33 line 5 is being interpreted as a syringe, an inflation pump, or an equivalent structure. According to the Applicant’s specification paras. [0012] and [0062], the “heating means configured to maintain a desired temperature” in claim 33 line 7 is being interpreted as a low voltage heating element, a heater, or an equivalent structure. According to the Applicant’s specification paras. [0052] and [0065], the “means for controlling” in claim 40 line 3 is being interpreted as a controller system or an equivalent structure.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 19, 21, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Eshel et al. (US 2021/0059856 A1) in view of Shipley (US 3,496,942), Borkon (US 2010/0082057 A1), and Shantha (US 5,195,965).
Regarding claim 19, Eshel discloses a method for treating Vaginal Relaxation Syndrome (VRS) or Atrophic Vaginitis in a patient in need thereof (device and method for treating disorders associated with vaginal tissues; vaginal rejuvenation treatments for restoring and restructuring vaginal tissue in females with stretched vaginal walls or excess vaginal laxity) (abstract; para. [0006]; para. [0023]), the method comprising the steps of:
a) inserting a dilation balloon into the patient's vagina (balloon 12 inserted into the vaginal cavity) (Figs. 1-9; para. [0064]); and
b) stretching and relaxing the vagina's vaginal wall with the dilation balloon, comprising:
i) mechanically inducing stress in the vaginal wall via inflation and deflation of the dilation balloon, thereby stretching and relaxing the vaginal wall (balloon 12 is inflated until it applies pressure to the vaginal walls; there is periodic inflation/deflation of balloon 12 while inside the vaginal cavity, thereby stretching and relaxing the vaginal walls) (Figs. 1-9; para. [0064]); and/or
ii) heating the vaginal wall by adding a heated fluid to the dilation balloon's interior and replenishing the heated fluid to maintain a desired temperature of the heated fluid, thereby uniformly heating the vaginal wall (heated water circulated through the balloon 12 via pump 52 while in the vaginal cavity, thereby uniformly heating the vaginal walls; water is heated to maintain a uniform temperature) (Figs. 1-9; para. [0040]; para. [0062]; para. [0064]);
whereby mechanical energy and/or heat energy stimulate vaginal tissue cell function, activate collagen and elastin remodeling, and/or enhance capillary blood flow to the vaginal wall, thereby treating the patient's VRS or Atrophic Vaginitis (the inflation/deflation and heating treatments are for the vaginal rejuvenation treatment to restore and restructure vaginal tissue in females with stretched vaginal walls or excess vaginal laxity, i.e. treating VRS; as the inflation/deflation and heating occurs in the vaginal cavity walls as claimed, the stimulation of tissue cell function, activating collagen and elastin remodeling, and enhancing blood flow would inherently occur as claimed) (Figs. 1-9; abstract; para. [0006]; para. [0023]; para. [0064]).
Eshel does not disclose wherein the dilation balloon is deflated and empty when inserted into the vagina.
However, Shipley teaches an expandable bladder expanded by fluid pressure for insertion into a body cavity (Shipley; Figs. 1-3; abstract) wherein the dilation balloon is deflated and empty when inserted into the vagina (bladder has a deflated condition for ease of inserting the apparatus into a body cavity) (Shipley; Figs. 1-3; col. 4, lines 24-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method such that the dilation balloon is deflated and empty when inserted into the vagina, as taught by Shipley, for the purpose of improving the ease with which the balloon can be inserted into a patient (Shipley; col. 4, lines 24-32), thereby helping to minimize patient discomfort.
Eshel does not disclose a single inflation and deflation of the dilation balloon comprising leaving the dilation balloon in place for a period of time ranging from 1-15 minutes followed by removing the dilation balloon from the vagina.
However, Borkon teaches a method for vaginal dilation (Borkon; abstract) including a single inflation of the dilation balloon comprising leaving the dilation balloon in place for a period of time ranging from 1-15 minutes followed by removing the dilation balloon from the vagina (the holding time, or the time in which an expanded balloon is left in place in the vagina before removing it, is initially 5-15 minutes) (Borkon; paras. [0041-0043]). Moreover, Shantha teaches a method for heating the interior surface of a body orifice such as the vagina (Shantha; abstract; col. 4, lines 50-56) including a single deflation of the dilation balloon (after the inflated balloon has been held in the vagina for a treatment, the balloon is deflated to prepare for removal from the vagina) (Shantha; col. 8, lines 42-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method of mechanically inducing stress to include a single inflation of the dilation balloon comprising leaving the dilation balloon in place for a period of time ranging from 1-15 minutes followed by removing the dilation balloon from the vagina, as taught by Borkon, for the purpose of helping to ensure minimal pain is produced during the initial phase of a treatment regimen (Borkon; paras. [0042-0043]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Eshel method of mechanically inducing stress to include a single deflation of the dilation balloon, as taught by Shantha, for the purpose of performing a necessary step to withdraw the balloon from the vagina which allows for the balloon to be withdrawn more easily (Shantha; col. 8, lines 42-59).
Regarding claim 21, the modified Eshel teaches wherein the heated fluid of step (b)(ii) is water and is pumped into the balloon by an inflation pump (heated water is circulated/pumped in the balloon 12 by a syringe through port 38 and the extracorporeal unit 50 with pump 52) (Eshel; Fig. 1; para. [0064]).
Regarding claim 27, the modified Eshel teaches wherein the dilation balloon is inflated with an inflation syringe using water (balloon 12 is inflated by water with a syringe through port 38) (Eshel; Fig. 1; para. [0051]; para. [0064]).
Regarding claim 28, the modified Eshel teaches wherein the dilation balloon is inflated with an inflation pump capable of providing a continuous stream of heated inflation fluid (heated water is continuously circulated/pumped in the balloon 12 with the extracorporeal unit 50 and the pump 52) (Eshel; Fig. 1; para. [0042]; para. [0064]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Eshel in view of Shipley, Borkon, and Shantha as applied to claim 19 above, and further in view of Niver (US 10,660,670 B1) and Juravic et al. (US 2018/0193619 A1).
Regarding claim 26, the modified Eshel teaches the invention as previously claimed, including wherein a catheter is attached to the dilation balloon, wherein the catheter comprises a diameter ranging from 10 mm to 40 mm (support member 18 with inflow conduit 22 is attached to the balloon 12; inflow conduit 22 is 2-12 mm in diameter) (Eshel; Figs. 1-9; para. [0049]), but does not teach wherein the catheter is flexible and wherein the dilation balloon comprises a diameter ranging from 1 cm to 4 cm.
However, Niver teaches a cervical dilator (Niver; abstract) wherein the catheter is flexible (shaft 304 which delivers fluid to a balloon is formed of a flexible polymer) (Niver; Figs. 3-6; col. 5, lines 6-21).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method such that the catheter is flexible, as taught by Niver, for the purpose of ensuring device can be easily guided through a patient’s anatomy (Niver; Figs. 3-6; col. 5, lines 6-21).
However, Juravic teaches a vaginal dilation device (Juravic; abstract) wherein the dilation device comprises a diameter ranging from 1 cm to 4 cm (diameter of spine region, defined by spines 102, in the expanded configuration is approximately 2-4 cm) (Juravic; Fig. 1B; para. [0012]; para. [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method such that the dilation device, in this case the Eshel balloon, comprises a diameter ranging from 1 cm to 4 cm, as taught by Juravic, for the purpose of providing the device with a specific suitable diameter size for vaginal dilation when the device is in an expanded configuration which one of ordinary skill in the art could reasonably expect to perform similarly well.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Eshel in view of Shipley, Borkon, and Shantha as applied to claim 19 above, and further in view of Cionata et al. (US 2004/0267340 A1).
Regarding claim 29, the modified Eshel teaches the invention as previously claimed, including creating cycles of inflation and deflation of the dilation balloon while the dilation balloon is inserted in the patient's vagina (periodic inflation/deflation of balloon 12 inside the vaginal cavity) (Eshel; para. [0064]), but does not teach wherein the inflation pump is configured to control the inflation and deflation of the dilation balloon according to a preprogrammed cycle.
However, Cionata teaches a method, systems, and computer program products for catheter assemblies with a balloon (Cionata; abstract) wherein the inflation pump is configured to control the inflation and deflation of the dilation balloon according to a preprogrammed cycle (controller with computer program code for activating the pump and the pressure adjustment device used to circulate the heated fluid to operate the system at a desired operating pressures at a desired time by controlling volume of fluid used in the treatment balloon) (Cionata; Fig. 17; para. [0017]; para. [0117]; para. [0120]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method’s inflation pump to be configured to control the inflation and deflation of the dilation balloon according to a preprogrammed cycle, as taught by Cionata, for the purpose of providing the device with a means for automatically controlling the pressure over the course of treatment (Cionata; para. [0010]), thereby ensuring the device is more convenient to use.
Regarding claim 30, the modified Eshel teaches wherein the inflation pump is also configured to heat and maintain the temperature of the inflation fluid (extracorporeal unit 50 has a controller 402 operating the heat exchanger 54 and pump 52, wherein the controller 402 monitors and modifies if necessary the fluid temperature) (Eshel; Fig. 1; para. [0053]).
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Eshel in view of Shipley, Borkon, and Shantha as applied to claim 19 above, and further in view of Hamadi et al. (US 5,662,699).
Regarding claim 31, the modified Eshel teaches the invention as previously claimed, but does not teach wherein the dilation balloon further comprises one or more electrodes on the dilation balloon's surface and step (b) further comprises providing electrical stimulation to the vaginal wall to cause vaginal tube muscle contractions, whereby electrical stimulation stimulates vaginal tissue cell function, activates collagen and elastin remodeling, and/or enhances blood flow to the vaginal wall, thereby treating the patient's VRS or Atrophic Vaginitis.
However, Hamedi teaches a method and apparatus for stimulating muscles in a body cavity such as the vagina (Hamedi; abstract; col. 4, lines 31-39) wherein the dilation balloon further comprises one or more electrodes on the dilation balloon's surface (sheath 14 with frame 50 made of an elastomer is expanded by air pressure; electrodes 32, 34, 36, 38 on the surface of sheath 14) (Hamedi; Figs. 1-4; col. 5, lines 66-67; col. 6, lines 1-10) and step (b) further comprises providing electrical stimulation to the vaginal wall to cause vaginal tube muscle contractions, whereby electrical stimulation stimulates vaginal tissue cell function, thereby treating the patient's VRS or Atrophic Vaginitis (electrical energy used to stimulate muscles near a body cavity, such as the vagina; electrical stimulation causes contraction of those muscles; as the vagina muscle cell tissues are being stimulated as claimed, the method would be able to treat VRS or Atrophic Vaginitis as claimed) (Hamedi; abstract; col. 1, lines 16-25; col. 4, lines 31-39).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method to include wherein the dilation balloon further comprises one or more electrodes on the dilation balloon's surface and step (b) further comprises providing electrical stimulation to the vaginal wall to cause vaginal tube muscle contractions, whereby electrical stimulation stimulates vaginal tissue cell function, activates collagen and elastin remodeling, and/or enhances blood flow to the vaginal wall, thereby treating the patient's VRS or Atrophic Vaginitis, as taught by Hamedi, for the purpose of enabling the method to additionally treat conditions such as urinary incontinence in women (Hamedi; col. 4, lines 31-39).
Regarding claim 32, the modified Eshel teaches wherein the electrical stimulation is pulsed (electrodes 32, 34, 36, 38 connected to pulse generator 92, which forms a train of electrical pulses) (Hamedi; Fig. 17; col. 7, lines 50-67).
Claims 33, 35-36, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Eshel in view of Shipley, Niver, Borkon, Shantha, and Cionata.
Regarding claim 33, Eshel discloses a vaginal remodeling system (device and method for treating disorders associated with vaginal tissues; vaginal rejuvenation treatments for restoring and restructuring vaginal tissue in females with stretched vaginal walls or excess vaginal laxity) (abstract; para. [0006]; para. [0023]) comprising:
a) a dilation balloon configured to be inserted into a vagina of any size (balloon 12 inserted into the vaginal cavity) (Figs. 1-9; para. [0064]);
b) a catheter attached to and in fluid communication with the dilation balloon (support member 18 with inflow conduit 22 provides the fluid to the attached balloon 12) (Eshel; Figs. 1-9; para. [0049]; para. [0057]);
c) pumping means configured to pump a fluid into and out of the dilation balloon via the catheter (water is circulated/pumped in the balloon 12 via the support member 18 by a syringe through port 38 and the extracorporeal unit 50 with pump 52) (Fig. 1; para. [0049]; para. [0064]);
d) heating means configured to maintain a desired temperature for the fluid (water is heated by the heat exchanger 54, and the temperature of the water is monitored and modified if necessary) (Figs. 1-9; para. [0053]; para. [0064]); and
e) a programmable electronic controller system (controller 402 operates heat exchanger 54 and pump 52 with preset rate for fluid circulation) (Fig. 1; para. [0053]) for;
i) controlling the pumping means to control inflation of the dilation balloon (controller 402 operates pump 52; pump 52 circulates fluid to have the balloon 12 inflated) (Figs. 1-9; para. [0053]; para. [0064]); and
ii) controlling the heating means to maintain a desired temperature of the fluid (controller 402 operates heat exchanger 54; water is heated to maintain a uniform temperature) (Figs. 1-9; para. [0040]; para. [0053]).
Eshel does not disclose wherein the dilation balloon is configured to be inserted in to the vagina when the dilation balloon is deflated and empty.
However, Shipley teaches an expandable bladder expanded by fluid pressure for insertion into a body cavity (Shipley; Figs. 1-3; abstract) wherein the dilation balloon is configured to be inserted in to the vagina when the dilation balloon id deflated and empty (bladder has a deflated condition for ease of inserting the apparatus into a body cavity) (Shipley; Figs. 1-3; col. 4, lines 24-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method such that the dilation balloon is configured to be inserted in to the vagina when the dilation balloon id deflated and empty, as taught by Shipley, for the purpose of improving the ease with which the balloon can be inserted into a patient (Shipley; col. 4, lines 24-32), thereby helping to minimize patient discomfort.
Eshel does not disclose the catheter is flexible.
However, Niver teaches a cervical dilator (Niver; abstract) wherein the catheter is flexible (shaft 304 which delivers fluid to a balloon is formed of a flexible polymer) (Niver; Figs. 3-6; col. 5, lines 6-21).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel device such that the catheter is flexible, as taught by Niver, for the purpose of ensuring device can be easily guided through a patient’s anatomy (Niver; Figs. 3-6; col. 5, lines 6-21).
Eshel does not disclose a single inflation and deflation of the dilation balloon wherein, once the dilation balloon is inflated, the dilation balloon is left in place for a period of time ranging from 1-15 minutes followed by removing the dilation balloon from the vagina.
However, Borkon teaches a method for vaginal dilation (Borkon; abstract) including a single inflation of the dilation balloon wherein, once the dilation balloon is inflated, the dilation balloon is left in place for a period of time ranging from 1-15 minutes followed by removing the dilation balloon from the vagina (the holding time, or the time in which an expanded balloon is left in place in the vagina before removing it, is initially 5-15 minutes) (Borkon; paras. [0041-0043]). Moreover, Shantha teaches a method for heating the interior surface of a body orifice such as the vagina (Shantha; abstract; col. 4, lines 50-56) including a single deflation of the dilation balloon (after the inflated balloon has been held in the vagina for a treatment, the balloon is deflated to prepare for removal from the vagina) (Shantha; col. 8, lines 42-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method of mechanically inducing stress to include a single inflation of the dilation balloon wherein, once the dilation balloon is inflated, the dilation balloon is left in place for a period of time ranging from 1-15 minutes followed by removing the dilation balloon from the vagina, as taught by Borkon, for the purpose of helping to ensure minimal pain is produced during the initial phase of a treatment regimen (Borkon; paras. [0042-0043]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Eshel method of mechanically inducing stress to include a single deflation of the dilation balloon, as taught by Shantha, for the purpose of performing a necessary step to withdraw the balloon from the vagina which allows for the balloon to be withdrawn more easily (Shantha; col. 8, lines 42-59).
Eshel does not disclose the programmable electronic controller system is for controlling the pumping means to control inflation and deflation of the dilation balloon.
However, Cionata teaches a method, systems, and computer program products for catheter assemblies with a balloon (Cionata; abstract) wherein the programmable electronic controller system is for controlling the pumping means to control inflation and deflation of the dilation balloon (controller with computer program code for activating the pump and the pressure adjustment device used to circulate the heated fluid to operate the system at a desired operating pressures at a desired time by controlling volume of fluid used in the treatment balloon) (Cionata; Fig. 17; para. [0017]; para. [0117]; para. [0120]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method’s programmable electronic controller system such that it is for controlling the pumping means to control inflation and deflation of the dilation balloon, as taught by Cionata, for the purpose of providing the device with a means for automatically controlling the pressure over the course of treatment (Cionata; para. [0010]), thereby ensuring the device is more convenient to use.
Regarding claim 35, the modified Eshel teaches wherein the fluid comprises water and the pumping means comprises an inflation syringe (balloon 12 is inflated by water with a syringe through port 38) (Eshel; Fig. 1; para. [0051]; para. [0064]).
Regarding claim 36, the modified Eshel teaches wherein the fluid comprises water and the pumping means comprises an inflation pump (water is circulated/pumped in the balloon 12 by the pump 52) (Eshel; Fig. 1; para. [0064]).
Regarding claim 38, the modified Eshel teaches wherein the inflation pump further comprises the heating means (extracorporeal unit 50 with pump 54 also has the heat exchanger 54) (Eshel; Fig. 1; para. [0053]).
Regarding claim 39, the modified Eshel teaches wherein the inflation pump is capable of providing a continuous stream of heated inflation fluid (heated water is continuously circulated/pumped in the balloon 12 the pump 52) (Eshel; Fig. 1; para. [0042]; para. [0064]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Eshel in view of Shipley, Niver, Borkon, Shantha, and Cionata as applied to claim 33 above, and further in view of Juravic.
Regarding claim 34, the modified Eshel teaches the invention as previously claimed, including wherein the catheter comprises a diameter ranging from 10 mm to 40 mm (support member 18 with inflow conduit 22 is attached to the balloon 12; inflow conduit 22 is 2-12 mm in diameter) (Eshel; Figs. 1-9; para. [0049]), but does not teach wherein the dilation balloon comprises a diameter ranging from 1 cm to 4 cm.
However, Juravic teaches a vaginal dilation device (Juravic; abstract) wherein the dilation device comprises a diameter ranging from 1 cm to 4 cm (diameter of spine region, defined by spines 102, in the expanded configuration is approximately 2-4 cm) (Juravic; Fig. 1B; para. [0012]; para. [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel device such that the dilation device, in this case the Eshel balloon, comprises a diameter ranging from 1 cm to 4 cm, as taught by Juravic, for the purpose of providing the device with a specific suitable diameter size for vaginal dilation when the device is in an expanded configuration which one of ordinary skill in the art could reasonably expect to perform similarly well.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Eshel in view of Shipley, Niver, Borkon, Shantha, and Cionata as applied to claim 33 above, and further in view of Hamedi.
Regarding claim 40, the modified Eshel teaches the invention as previously claimed, but does not teach further comprising one or more electrodes on the dilation balloon's surface configured to provide electrical stimulation to the vaginal wall to cause vaginal tube muscle contractions and means for controlling the one or more electrodes, whereby electrical stimulation stimulates vaginal tissue cell function, activates collagen and elastin remodeling, and/or enhances capillary blood flow to the vaginal wall, thereby treating the patient's VRS or Atrophic Vaginitis.
However, Hamedi teaches a method and apparatus for stimulating muscles in a body cavity such as the vagina (Hamedi; abstract; col. 4, lines 31-39) including one or more electrodes on the dilation balloon's surface (sheath 14 with frame 50 made of an elastomer is expanded by air pressure; electrodes 32, 34, 36, 38 on the surface of sheath 14) (Hamedi; Figs. 1-4; col. 5, lines 66-67; col. 6, lines 1-10) configured to provide electrical stimulation to the vaginal wall to cause vaginal tube muscle contractions and means for controlling the one or more electrodes, whereby electrical stimulation stimulates vaginal tissue cell function, thereby treating the patient's VRS or Atrophic Vaginitis (pulse generator is used to produce a pattern of electrical pulses to the electrodes 32, 34, 36, 38; this electrical energy is used to stimulate muscles near a body cavity, such as the vagina; electrical stimulation causes contraction of those muscles; as the vagina muscle cell tissues are being stimulated as claimed, the method would be able to treat VRS or Atrophic Vaginitis as claimed) (Hamedi; Figs, 1-4, 17; abstract; col. 1, lines 16-25; col. 4, lines 31-39; col. 7, lines 50-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Eshel method to include wherein the dilation balloon further comprises one or more electrodes on the dilation balloon's surface and step (b) further comprises providing electrical stimulation to the vaginal wall to cause vaginal tube muscle contractions, whereby electrical stimulation stimulates vaginal tissue cell function, activates collagen and elastin remodeling, and/or enhances capillary blood flow to the vaginal wall, thereby treating the patient's VRS or Atrophic Vaginitis, as taught by Hamedi, for the purpose of enabling the method to additionally treat conditions such as urinary incontinence in women (Hamedi; col. 4, lines 31-39).
Regarding claim 41, the modified Eshel teaches wherein the electrical stimulation is pulsed (electrodes 32, 34, 36, 38 connected to pulse generator 92, which forms a train of electrical pulses) (Hamedi; Fig. 17; col. 7, lines 50-67).
Response to Arguments
Applicant's arguments filed 1/29/2024 have been fully considered but they are not persuasive.
On page 6 in the “Claim Rejections - 35 USC 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(d) rejection of the previous office action. The Examiner agrees, and has thus withdrawn that rejection.
Applicant’s arguments on pages 6-7 in the “Claim Rejections - 35 USC 103” section of the Applicant’s remarks with respect to the independent claims have been considered but are moot in view of new ground of rejection with new additional Borkon and Shantha references being used in the current rejection as discussed above.
Conclusion
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785