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 .
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive. Applicant argues Juravic et al. (US 2013/0253376 A1) fails to disclose expanding a diameter of the expansion device by a series of preset dilation increments, the preset dilation increments in the series being each about a 2.0 mm or less increment to the diameter and being spaced in time by a time delay small enough to provide a substantially linear dilation of the lower birth canal and expanding from the incremented diameter by another preset dilation increment in the series of preset dilation increments.
Applicant points to Fig. 15 of Juravic which discloses a stepwise method of therapeutic expansion that has about 0.5 cm per increment, or about 5.0 mm, and are spaced apart in time about 500 seconds (over 8 minutes) between each expansion step. Thus, the method of Juravic lacks the small, less than 2 mm preset dilation increments that are spaced in time by a time delay small enough to prove a substantially linear dilation of the birth canal. However, the particulars of Fig. 15 refer to one example of the method of dilating vaginal tissue ([0140]). Fig. 18 on the other hand, along with paragraphs [0240]-[0243] refer to an additional method of dilating vaginal tissue during labor. In Fig. 18, the method of dilating vaginal tissue is done at a constant rate i.e., dilating at a preset increment spaced in time by a time delay small enough to provide a substantially linear dilation (see for example, Fig. 18; [0240]).
Juravic discloses a constant rate dilation scheme in paragraph [0243] in which “the trigger assembly can be configured to expand the device by a preset dilation increment (e.g., approximately 0.5 cm) with every "click" or actuation of the trigger. The user can then actuate the trigger assembly after a pre-determined period of time (e.g., every 10 minutes) to dilate the device at a constant rate.” Juravic goes on to disclose “It should be understood that in other embodiments, the preset dilation increment can be any amount (e.g., 0-1 cm per actuation, 0-2 cm per actuation, 0-3 cm per actuation, 0-4 cm per actuation, etc) and the pre-determined period of time can be any period of time (e.g., anywhere from 0-2 hours or even longer).” Accordingly, Juravic encompasses the range of preset dilation increments being about a 2.0 mm or less increment and a time delay of minutes. Such a constat rate dilation scheme would inherently produce a substantially linear dilation.
Applicant argues that the cited method of Juravic lacks the claimed “expanding from the incremented diameter by another preset dilation increment in the series of preset dilation increments” because, as shown in Fig. 15, after each expansion the Force (lb) applied is reduced to zero, indicating that the expansion device is no longer in contact with the patient, thus, the method begins expansion each time from a collapsed configuration. However, as discussed above, the method of Fig. 15 is not being used in the rejection. Instead, a method similar to that shown in Fig. 18 is applied to the rejection. As shown in Fig. 18, in a constant rate dilation method, the device is not removed between dilation increments as the force does not drop to zero. Instead, after a small period of time i.e. seconds, another preset dilation increment is applied to tissue. Thus, Juravic does disclose expanding from the incremented diameter by another preset dilation increment in the series of preset dilation increments.
Lastly, applicant argues the method of Juravic described at [0243] is disclosing the method of Fig. 15 and that Juravic is not disclosing a method that expands the device by increments of 4.0 cm per actuation. The examiner respectfully disagrees. Paragraph [0243] explicitly discloses a device “suitable for use in a constant rate dilation scheme” which is described by Fig. 18, while Fig. 15 discloses a method of stepwise dilation. With respect to applicant’s argument that this method expands the diameter of the collapsed device with 0.0 cm of expansion only, applicant is again directed to Fig. 18 in which the device is not removed after ever “click” of the trigger or expansion of a preset dilation increment.
Accordingly, applicant’s arguments over Juravic are not found persuasive and the application is not found in condition for allowance at this time.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the force applied to the lower birth canal of the human patient decreases from the applied force” in lines 16-17 which should read “the applied force to the lower birth canal of the human patient decreases”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “and expansion device” in lines 1-2 which should read “and the expansion device”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “the preset dilation increment” in lines 1-2 which should read “the preset dilation increments” for consistency purposes. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites “the preset dilation increment” in line 1 which should read “the preset dilation increments” for consistency purposes. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: Claim 17 recites “a selected diameter” in line 2 which should read “the selected diameter”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10-12 recite the limitation "the time duration" in line 1, respectively. There is insufficient antecedent basis for this limitation in the claim.
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) 1-3, 5-6, 8-14, 16-17 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juravic et al. (US 2013/0253376 A1).
Regarding claim 1, Juravic discloses a method of dilating vaginal tissue of a human patient using an expansion device (vaginal dilation device 1900 that can include pads 1902, handle 1906, arms (not shown), expansion mechanism 1908 central rod 1924, diameter gauge 1918, and any of the features described and shown in the other figures, such as Figs. 14a-14, which are included for reference; [0241]; Figs. 19a-19b) to prepare the human patient’s birth canal for a second stage of labor (Figs. 14a-14c), comprising inserting the expansion device (1900) into the human patient’s vagina during a first stage of labor (see for example, Fig. 14a; [0231]); expanding a diameter of the expansion device by a series of preset dilation increments (preset dilation increment; [0243]), the preset dilation increments in the series being each about a 2.0 mm or less increment to the diameter (the preset dilation increment can be any amount e.g., 0-1 cm per actuation, which encompasses and anticipates 2.0 mm or less; [0243]) and being spaced in time by a time delay (pre-determined period of time; [0243]) small enough to provide a substantially linear dilation of the lower birth canal (as the pre-determined period of time can be any period of time e.g., 0-2 hours and encompasses seconds to minutes as shown in Fig. 18 to provide a substantially linear dilation; [0243]), as the expansion device applies a force to the lower birth canal of the human patient (Fig. 18; [0243]); wherein after each respective preset dilation increment in the series of preset dilation increments, pausing expansion after increasing the diameter of the expansion device by the respective preset dilation increment for the time delay (after each click or actuation of the trigger to actuate the preset dilation increment, the user waits a pre-determined period of time; [0243]) to allow tissue of the human patient’s vagina to expand such that the force applied to the lower birth canal of the human patient decreases from the applied force ([0243]; Fig. 18); expanding from the incremented diameter by another preset dilation increment in the series of preset dilation increments (by then actuating the trigger assembly after a pre-determined period of time; [0243]), and repeating until the expansion device reaches a diameter selected to have a therapeutic effect of reducing likelihood of injury to the human patient during a passage of a baby through the birth canal of the human patient ([0243]).
Regarding claim 2, Juravic discloses wherein the expansion device (1900) includes expansion arms (pads 1902 similar to pads 1402) arranged to move radially outward to increase the diameter of the expansion device (see for example, Figs. 14a-14c).
Regarding claim 3, Juravic discloses monitoring a dilation condition of the human patient’s cervix (measuring a force applied by the vaginal dilation service to the vagina; Fig. 18) and inserting the expansion device prior to full cervical dilation (see for example, Figs. 14a, 15-16).
Regarding claim 5, Juravic discloses monitoring data from a force sensor measuring the applied force to the lower birth canal of the human patient (a force sensor measures the force applied by the pads to the lower birth canal; [0021]) and a diameter sensor on the expansion device (the vaginal dilation device further comprises a diameter sensor configured to indicate a dilation diameter of the vagina; [0020]).
Regarding claim 6, Juravic discloses monitoring data from a force sensor measuring the applied force to the lower birth canal of the human patient and stopping expansion if the measured force is greater than a set force threshold (measuring a force applied by the vaginal dilation device to the vagina, dilating the vagina with the vaginal dilation device, and pausing or stopping dilation of the vagina with the vaginal dilation device when the force applied by the vaginal dilation device to the vagina increases to a first force threshold at failure; Fig. 18).
Regarding claim 8, Juravic discloses providing the expansion device with a controller (trigger) to automatically expand the diameter of the expansion device by the preset dilation increment (as a single click of the trigger automatically expands the dive to the preset dilation increment; [0243]); pause expansion after reaching the preset dilation increment (expansion is paused by a pre-determined period of time); again expand the diameter of the expansion device from the incremented diameter by the preset dilation increment (as the trigger assembly is actuated after a pre-determined period of time; [0243]); and repeat the pausing expansion and again expanding until the expansion device reaches the diameter selected to have the therapeutic effect of reducing likelihood of injury to the human patient during a passage of a baby through the birth canal of the human patient ([0243]).
Regarding claim 9, Juravic discloses allowing selection of different therapeutic durations (time durations) for expansion to the diameter selected to have the therapeutic effect of reducing likelihood of injury to the human patient during a passage of a baby through the birth canal of the human patient (for example, 0-2 hours or even longer; [0243]).
Regarding claim 10, Juravic discloses wherein the time duration is about 20 to 120 minutes (0-2 hours; [0243]).
Regarding claim 11, Juravic discloses wherein the time duration is about 30 to 60 minutes (0-2 hours; [0243]).
Regarding claim 12, Juravic discloses wherein the time duration is about 30 minutes (0-2 hours; [0243]) and expansion device is expanded from about 40 mm to about 80 mm during the 30 minutes time duration (as the expansion device can be preset to dilate 0-4 cm i.e. 0-40 mm within the pre-determined period of time; [0243]).
Regarding claim 13, Juravic discloses selecting the preset dilation increments prior to insertion of the expansion device into the human patient (because the dilation increments are “preset” they are set prior to use i.e. prior to insertion into the body; [0243]).
Regarding claim 14, Juravic discloses wherein the preset dilation increment is about .5 – 2.0 mm (preset dilation increments can be any amount e.g. 0-2 cm; [0243]).
Regarding claim 16, Juravic discloses collecting diameter and therapy duration data (via a diameter sensor configured to indicate a dilation diameter of the vagina; [0020]; Fig. 18).
Regarding claim 17, Juravic discloses selecting a preset time period between a beginning of a first expansion to a selected diameter of the expansion device and a beginning of a consecutive-in-time second expansion of the expansion device (as the pre-determined period of time can be anywhere from 0-2 hours and the expansion device can be preset to dilate 0-4 cm i.e. 0-40 mm within the pre-determined period of time; [0243]).
Regarding claim 20, Juravic discloses providing a regional anesthetic before insertion of the expansion device (in order to reduce or eliminate any discomfort, the device can be used under epidural analgesia or local anesthesia on the vagina; [0239]).
Regarding claim 21, Juravic discloses wherein the expansion device provides a linearly increasing force against a tissue wall of the lower birth canal to cause a linear increase in a diameter of the lower birth canal (Fig. 18).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juravic et al. (US 2013/0253376 A1) in view of Ekman-Ordeberg et al. (US 2015/0057226 A1).
Regarding claim 4, Juravic discloses the outer diameter of the pads of the expansion device in the expanded configuration is approximately 8-10 cm ([0017]) such that the dilating step comprising dilating the patient’s vagina to approximately 7-10 cm ([0081]) with a target dilation diameter of 10 cm ([0163]), but fails to explicitly disclose inserting the expansion device into the human patient’s vagina prior to full cervical dilation includes inserting the expansion device at or greater than about 6 cm of cervical dilation.
However, Ekman-Ordeberg teaches a woman can enter into labor arrest at different stages of labor. Early stage labor arrest is often due to impaired cervical dilation and in late phase of the labor i.e. when the woman is dilated 5-6 cm due to impaired or insufficient myometrial contractions of the uterus ([0016]). Thus, Ekman-Ordeberg teaches there is a need for dilation assistance at or greater than 6 cm of cervical dilation and Juravic teaches target dilation for the cervix is 10 cm ([0163]).
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 method of Juravic such that the expansion device is inserted at or greater than about 6 cm of cervical dilation in light of the teachings of Ekman-Ordeberg in order to increase the diameter of the lower birth canal prior to reaching a target cervical dilation of 10 cm.
Claim(s) 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juravic et al. (US 2013/0253376 A1).
Regarding claim 7, Juravic discloses the expansion fails to explicitly disclose re-initiating expansion if the measured force falls below the set force threshold and having the re-initiated expansion deliver a constant force to the lower birth canal for a remainder of a therapeutic expansion.
However, Juravic discloses a different method of dilation for re-initiating expansion if the measured force falls below the set force threshold (resuming dilation of the vagina when the force applied by the vaginal dilation device to the vagina decreases to a second force threshold, which below the first force threshold as indicated in Fig. 15; [0234]) and a method of delivering a constant force to the lower birth canal for a therapeutic expansion (Fig. 16).
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 method of Juravic to re-initiate expansion if the measured force falls below the set force threshold and deliver a constant force to the lower birth canal for a remainder of a therapeutic expansion in light of the teachings of Juravic in order to safely continue dilating the lower birth canal with minimal pain and discomfort to the patient. Juravic teaches it was known to use both constant rate and constant force dilation methods therefore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methos with no change in their respective functions, and the combination would have yielded the predictable result of dilating the lower birth canal.
Regarding claim 19, Juravic fails to explicitly disclose wherein inserting the expansion device into the human patient’s vagina includes inserting the expansion device to extend across the lower 3-4 cm of the human patient’s vagina.
However, Juravic teaches inserting the expansion device (1400) into the human patient’s vagina (Figs. 14a-14c), wherein each pad of the expansion device is shaped and configured to conform to a vagina ([0082]; Figs. 14a-14c).
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 expansion device of Juravic so that the pads are sized to extend across the lower 3-4 cm of the human patient’s vagina since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Juravic would not operate differently with the claimed length since the expansion device of Juravic is intended to be shaped and configured to conform to the patient’s vagina, which would include the lower 3-4 cm thereof. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the expansion device “may” be within the claimed range ([0018]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juravic et al. (US 2013/0253376 A1) in view of Barakat et al. (US 2022/0192707 A1).
Regarding claim 18, Juravic discloses collecting force (via a force sensor disposed on the device and configured to measure a force applied against the pads; [0013]), diameter (via a diameter sensor configured to indicate a dilation diameter of the vagina; [0020]) and therapy duration data (as the controller may determine that the tissue has relaxed enough that it is time to begin dilating the vaginal tissue to a larger diameter; [0234]), and that expansion of the pelvic floor and perineal tissues can happen in a matter of seconds to minutes ([0008]), but fails to explicitly disclose the data is collected about every 1 to 2 seconds once the expansion device is inserted in the human patient’s vagina.
Barakat teaches controller systems in which at least force data collected from a sensor can be acquired at least 100 times per second ([0012]). Thus, the capability of collecting data from sensors rapidly, at least every 1 to 2 seconds was known in the prior art and Juravic teaches rapid dilation can happen in a matter of seconds ([0008]); therefore, there is a need to collect data in a matter of seconds.
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 method of Juravic to collect the force, diameter and therapy duration data about every 1 to 2 seconds once the expansion device is inserted in the human patient’s vagina in light of the teachings of Barakat and Juravic to effectively measure data in real time as the patient’s vaginal tissue is dilated and provide useful feedback to the user.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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