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 Objections
Claims 1, 10, 17-18 and 25 are objected to because of the following informalities:
In claim 1, line 11, the phrase “the expandable cuff and/or positioning balloon” should read “the expandable cuff and/or the positioning balloon”.
In claim 1, line 13, the phrase “the expandable cuff and/or positioning balloon” should read “the expandable cuff and/or the positioning balloon”.
In claim 10, lines 2-3, the phrase “the expandable cuff and/or positioning balloon” should read “the expandable cuff and/or the positioning balloon”.
In claim 17, line 7, the phrase “closing the valve” should read “closing the first valve”.
In claim 18, line 2, the phrase “extends” should read “extend”.
In claim 25, line 2, the phrase “the cuff and/or positioning balloon” should read “the cuff and/or the positioning balloon”.
Appropriate correction is required.
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) 1-2, 4-12, 15-17, 19-27 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yosowitz (US 3741216).
Regarding claim 1, Yosowitz discloses (see abstract; col. 1 line 1-col. 4 line 3; figs. 1-7) a method (col. 3 lines 37-49) comprising:
positioning a cervix of a patient within an internal passageway of a cervical control system (cervix pulled through central opening, col. 3 lines 37-49), the cervical control system comprising:
an expandable cuff (33, col. 2 lines 50-67; fig. 3) configured to surround at least a portion of a cervix of a patient (when cervix is pulled through central opening);
an expandable positioning balloon (34) disposed at an exterior surface of the cervical control system (fig. 3), wherein the positioning balloon surrounds a portion of a circumference of the exterior surface (figs. 3 and 6), wherein the expandable positioning balloon is configured to adjust an angle of orientation of the cervix when expanded (when 34 is expanded to engage tissue, considered to adjust the angle of orientation of the cervix when engaged, col. 3 lines 37-49); and
an inflation media conduit (at least conduit 46, col. 3 lines 9-22; fig. 7) comprising a first end configured to be in fluid communication with the expandable cuff and/or positioning balloon (end connected to membranes) and a second end (end connected to source of fluid) opposite the first end configured to receive an inflation media (via source of fluid), wherein the expandable cuff and/or positioning balloon are configured to expand when inflation media is added to the second end of the inflation media conduit (via inflation);
adding inflation media to the second end of the inflation media conduit thereby expanding at least the positioning balloon and adjusting the angle of orientation of the cervix (via inflation, col. 3 lines 37-49).
Regarding claim 2, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein the second end of the inflation media conduit is in fluid communication with a valve (valves 37 and 38), the method further comprising: opening the valve to add inflation media to the inflation media conduit (via source of fluid) and closing the valve to hold inflation media within the inflation media conduit (considered to be held within conduit when tubing is tied or closed, col. 3 lines 37-49).
Regarding claim 4, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein adding the inflation media expands the expandable cuff, thereby compressing the cervix and exerting traction thereon (via engagement of cervix when inflated, col. 3 lines 37-49).
Regarding claim 5, Yosowitz discloses the method of claim 4. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the expandable cuff to adjust a degree of traction applied to the cervix (volume of inflation media considered to be adjusted when membranes are inflated, considered to adjust a degree of traction applied to the cervix when membranes are inflated and engage the tissue of the cervix, therefore adjusting how much traction is applied via engagement, col. 3 lines 37-49).
Regarding claim 6, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein adding the inflation media expands the expandable cuff (col. 3 lines 37-49), thereby compressing the cervix and stopping a flow of amniotic fluid from the cervix (neck is closed, considered to stop a flow of amniotic fluid, since device is used for closing an incontinent cervix during the second trimester, col. 1 lines 4-19 and 42-55).
Regarding claim 7, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein adding the inflation media expands the expandable cuff (col. 3 lines 37-49), the method further comprising: adjusting a volume of inflation media in the expandable cuff to treat premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM) (volume of inflation media considered to be adjusted when membranes are inflated, considered to treat premature rupture of membranes or preterm premature rupture of membranes by closing the cervix, which applicant describes in para. [00034] of the instant spec. as a sufficient treatment for PROM and PPROM, col. 1 lines 1-55 and col. 3 lines 37-49).
Regarding claim 8, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein adding the inflation media expands the expandable cuff (col. 3 lines 37-49), the method further comprising: adjusting a volume of inflation media in the expandable cuff to treat short cervix (volume of inflation media considered to be adjusted when membranes are inflated, considered to treat short cervix by applying the device closing the cervix, which para. [000208] of the instant specification describes as an example of cervical insufficiency, also encompassing incompetent cervix, which Yosowitz discloses as the device being used to treat).
Regarding claim 9, Yosowitz discloses the method of claim 1. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the positioning balloon to adjust the angle of orientation of the cervix (volume of inflation media considered to be adjusted when membranes are inflated, angle of orientation of cervix considered to be adjusted when neck of cervix is closed, col. 1 lines 42-55).
Regarding claim 10, Yosowitz discloses the method of claim 1. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the expandable cuff and/or positioning balloon to prevent onset of labor and delivery of a fetus (volume of inflation media considered to be adjusted when membranes are inflated, considered to prevent onset of labor by closing neck of cervix to hold products of conception during the second trimester, which would prevent early labor, col. 1 lines 1-55).
Regarding claim 11, Yosowitz discloses the method of claim 1. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the positioning balloon to anchor the cervical control system within the patient’s vagina (volume of inflation media considered to be adjusted when membranes are inflated, which fixes the cuff in place, such that cuff is considered to be anchored within the vagina due to the cuff closing the neck of the cervix, col. 1 lines 1-55 and col. 3 lines 37-49).
Regarding claim 12, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein the cervical control system is placed responsively to the patient being associated with a risk factor for pre-term labor (provided for treating cervical incompetence, which encompasses reducing complications with the cervix closing, considered to encompass use of the device with a patient associated with a risk factor for pre-term labor, col. 1 lines 1-55).
Regarding claim 15, Yosowitz discloses the method of claim 1. Yosowitz further discloses wherein a degree of expansion or contraction of the expandable cuff and/or the expandable positioning balloon is responsive to at least one of a clinical need (inflation of membrane encompasses expansion, considered to be responsive to a clinical need due to device being used for closing an incontinent cervix), an orientation of the cervix, an orientation of the patient’s uterus, a degree of dilation of the cervix, a length of the cervix, a degree of softness of the cervix, a level of amniotic fluid present in the patient’s uterus, and an indication of a status of the patient’s amniotic sac membrane.
Regarding claim 16, Yosowitz discloses (see abstract; col. 1 line 1-col. 4 line 3; figs. 1-7) a method (col. 3 lines 37-49) comprising:
positioning a cervix of a patient within an internal passageway of a cervical control system (cervix pulled through central opening, col. 3 lines 37-49), the cervical control system comprising:
a cuff (33, col. 2 lines 50-67; fig. 3) comprising:
an exterior surface defining an internal passageway configured to accept insertion of a cervix of a patient therein (depicted in figs. 3-4 and 6);
an interior surface (interior surface of 33); and
a first inner chamber disposed between the inner surface and the exterior surface (chamber formed by 33);
an expandable positioning balloon (34) disposed on an exterior surface of the cervical control system (figs. 3 and 6) and including a second inner chamber (chamber formed by 34);
a first inflation media conduit (conduit 46, col. 3 lines 9-22; fig. 7), the first inflation media conduit comprising:
a first end in fluid communication with the first inner chamber (end connected to inner chamber, fig. 7); and
a second end configured to receive inflation media (end connected to source of fluid); and
a second inflation media conduit (second conduit 46, each chamber includes respective conduit, claim 8), the second inflation media conduit comprising:
a first end in fluid communication with the second inner chamber (end connected to inner chamber, fig. 7); and
a second end configured to receive inflation media (end connected to source of fluid),
adding inflation media to the second end of the first inflation media conduit, thereby expanding the cuff (chambers of membranes are inflated, col. 3 lines 37-49); and
adding inflation media to the second end of the second inflation media conduit, thereby expanding the expandable positioning balloon (chambers of membranes are inflated, col. 3 lines 37-49).
Regarding claim 17, Yosowitz discloses the method of claim 16. Yosowitz further discloses wherein the second end of the first inflation media conduit is in fluid communication with a first valve (37, col. 3 lines 9-19) and the second end of the second inflation media conduit is in fluid communication with a second valve (38), the method further comprising: opening the first valve to add inflation media to the first inflation media conduit (via source of fluid); closing the valve to hold inflation media within the first inflation media conduit (considered to be held within conduit when tubing is tied or closed, col. 3 lines 37-49); opening the second valve to add inflation media to the second inflation media conduit (via source of fluid); closing the second valve to hold inflation media within the second inflation media conduit (considered to be held within conduit when tubing is tied or closed, col. 3 lines 37-49).
Regarding claim 19, Yosowitz discloses the method of claim 16. Yosowitz further discloses wherein the expansion of the cuff compresses the cervix and exerts traction thereon (via engagement of cervix when inflated, col. 3 lines 37-49.
Regarding claim 20, Yosowitz discloses the method of claim 19. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the cuff to adjust a degree of traction applied to the cervix (volume of inflation media considered to be adjusted when membranes are inflated, considered to adjust a degree of traction applied to the cervix when membranes are inflated and engage the tissue of the cervix, therefore adjusting how much traction is applied via engagement, col. 3 lines 37-49).
Regarding claim 21, Yosowitz discloses the method of claim 16. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the cuff to stop a flow of amniotic fluid from the cervix (volume of inflation media considered to be adjusted when membranes are inflated, neck is closed which is considered to stop a flow of amniotic fluid, since the cuff is used for closing an incontinent cervix during the second trimester, col. 1 lines 4-19 and 42-55).
Regarding claim 22, Yosowitz discloses the method of claim 16. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the cuff to treat premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM) (volume of inflation media considered to be adjusted when membranes are inflated, considered to treat premature rupture of membranes or preterm premature rupture of membranes by closing the cervix, which applicant describes in para. [00034] of the instant spec. as a sufficient treatment for PROM and PPROM, col. 1 lines 1-55 and col. 3 lines 37-49).
Regarding claim 23, Yosowitz discloses the method of claim 16. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the cuff to treat short cervix (volume of inflation media considered to be adjusted when membranes are inflated, considered to treat short cervix by applying the device closing the cervix, which para. [000208] of the instant specification describes as an example of cervical insufficiency, also encompassing incompetent cervix, which Yosowitz discloses as the device being used to treat).
Regarding claim 24, Yosowitz discloses the method of claim 16. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the positioning balloon to adjust the angle of orientation of the cervix (volume of inflation media considered to be adjusted when membranes are inflated, angle of orientation of cervix considered to be adjusted when neck of cervix is closed, col. 1 lines 42-55).
Regarding claim 25, Yosowitz discloses the method of claim 16. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the cuff and/or positioning balloon to prevent onset of labor and delivery of a fetus (volume of inflation media considered to be adjusted when membranes are inflated, considered to prevent onset of labor by closing neck of cervix to hold products of conception during the second trimester, which would prevent early labor, col. 1 lines 1-55).
Regarding claim 26, Yosowitz discloses the method of claim 16. Yosowitz further discloses further comprising: adjusting a volume of inflation media in the positioning balloon to anchor the cervical control system within the patient’s vagina (volume of inflation media considered to be adjusted when membranes are inflated, which fixes the cuff in place, such that cuff is considered to be anchored within the vagina due to the cuff closing the neck of the cervix, col. 1 lines 1-55 and col. 3 lines 37-49).
Regarding claim 27, Yosowitz discloses the method of claim 16. Yosowitz further discloses wherein the cervical control system is placed responsively to the patient being associated with a risk factor for pre-term labor (provided for treating cervical incompetence, which encompasses reducing complications with the cervix closing, considered to encompass use of the device with a patient associated with a risk factor for pre-term labor, col. 1 lines 1-55).
Regarding claim 30, Yosowitz discloses the method of claim 16. Yosowitz further discloses wherein a degree of expansion or contraction of the cuff and/or the expandable positioning balloon is responsive to at least one of a clinical need (inflation of membrane encompasses expansion, considered to be responsive to a clinical need due to device being used for closing an incontinent cervix), an orientation of the cervix, an orientation of the patient’s uterus, a degree of dilation of the cervix, a length of the cervix, a degree of softness of the cervix, a level of amniotic fluid present in the patient’s uterus, and an indication of a status of the patient’s amniotic sac membrane.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yosowitz in view of Kelley (US 2019/0321215 A1).
Regarding claim 3, Yosowitz discloses the method of claim 1.
Yosowitz further discloses wherein the cervical control system further comprises a tube (tubings, col. 3 lines 9-19), a first end of the tube being in fluid communication with the second end of the inflation media conduit (considered to be connected to conduit 46) and a second opposing end of the tube being configured to receive an inflation media (via source of fluid), the method further comprising adding inflation media to the second end of the tube for communication to the inflation media conduit (via source of fluid providing inflation).
However, Yosowitz fails to explicitly disclose the tube being sufficiently long that it extends through the patient’s vaginal canal and exits the introitus when the cervical control system is in position within the patient, the method further comprising: accessing the second end of the tube outside the patient’s body.
Kelley teaches (paras. [0059]-[0060] and [0067]-[0075]; figs. 6-9a), in the same field of endeavor, a method comprising a cervical control system (600) and a tube (610), the tube being sufficiently long that it extends through a patient’s vaginal canal and exits the introitus when the cervical control system is in position within the patient (depicted in fig. 9a), the method further comprising accessing the second end of the tube outside the patient’s body (via 910, para. [0072]), for the purpose of allowing the clinician and/or patient to use the expansion device to deliver fluid to the system (para. [0072]).
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 tubing of Yosowitz to be sufficiently long such that it extends through the patient’s vaginal canal and exits the introitus such that the second end of the tube is outside the patient’s body, in order to allow the clinician and/or patient to use the source of fluid to deliver fluid to the cuff from outside the body, based on the teachings of Kelley (para. [0072]).
Claim(s) 13 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Yosowitz in view of Ichim (US 2017/0087344 A1).
Regarding claim 13, Yosowitz discloses the method of claim 1.
However, Yosowitz fails to disclose wherein the cervical control system is placed responsively to the patient being diagnosed with a short cervix.
Ichim teaches (para. [0285]; fig. 2), in the same field of endeavor, a method comprising a cervical control system (cervical ring) placed responsively to a patient being diagnosed with a short cervix (para. [0285]), for the purpose of completely covering the cervix to treat the subject (para. [0285]).
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 Yosowitz to include placement of the system responsively to a patient being diagnosed with a short cervix, in order to properly treat the patient by closing the neck of the cervix, providing complete covering of the cervix for proper treatment, based on the teachings of Ichim (para. [0285]).
Regarding claim 28, Yosowitz discloses the method of claim 16.
However, Yosowitz fails to disclose wherein the cervical control system is placed responsively to the patient being diagnosed with a short cervix.
Ichim teaches (para. [0285]; fig. 2), in the same field of endeavor, a method comprising a cervical control system (cervical ring) placed responsively to a patient being diagnosed with a short cervix (para. [0285]), for the purpose of completely covering the cervix to treat the subject (para. [0285]).
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 Yosowitz to include placement of the system responsively to a patient being diagnosed with a short cervix, in order to properly treat the patient by closing the neck of the cervix, providing complete covering of the cervix for proper treatment, based on the teachings of Ichim (para. [0285]).
Claim(s) 14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Yosowitz in view of Crafton (US 2021/0177645 A1).
Regarding claim 14, Yosowitz discloses the method of claim 1.
However, Yosowitz fails to explicitly disclose wherein the cervical control system is placed responsively to the patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).
Crafton teaches (para. [0035]; fig. 2), in the same field of endeavor, a method comprising a cervical control system (10) placed responsively to a patient diagnosed with PROM or PPROM (paras. [0008], [0034]-[0035] and [0063]), for the purpose of providing an effective treatment for PPROM by sealing off the amniotic sac, decreasing the risk of infection so pregnancy could be sustained longer, and decreasing the amount of effective contractions to therefore decrease the likelihood of PPROM leading to preterm labor and delivery (para. [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the cuff of Yosowitz responsively to a patient diagnosed with PROM or PPROM, in order to provide an effective treatment for PPROM by sealing off the amniotic sac, decreasing the risk of infection so pregnancy could be sustained longer, and decreasing the amount of effective contractions to therefore decrease the likelihood of PPROM leading to preterm labor and delivery by closing the neck of the cervix, based on the teachings of Crafton (para. [0063]).
Regarding claim 29, Yosowitz discloses the method of claim 16.
However, Yosowitz fails to explicitly disclose wherein the cervical control system is placed responsively to the patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).
Crafton teaches (para. [0035]; fig. 2), in the same field of endeavor, a method comprising a cervical control system (10) placed responsively to a patient diagnosed with PROM or PPROM (paras. [0008], [0034]-[0035] and [0063]), for the purpose of providing an effective treatment for PPROM by sealing off the amniotic sac, decreasing the risk of infection so pregnancy could be sustained longer, and decreasing the amount of effective contractions to therefore decrease the likelihood of PPROM leading to preterm labor and delivery (para. [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the cuff of Yosowitz responsively to a patient diagnosed with PROM or PPROM, in order to provide an effective treatment for PPROM by sealing off the amniotic sac, decreasing the risk of infection so pregnancy could be sustained longer, and decreasing the amount of effective contractions to therefore decrease the likelihood of PPROM leading to preterm labor and delivery by closing the neck of the cervix, based on the teachings of Crafton (para. [0063]).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yosowitz in view of Petros (US 2022/0313947 A1).
Regarding claim 18, Yosowitz discloses the method of claim 16.
However, Yosowitz fails to disclose wherein the cervical control system further comprises a bi-lumen tube that is sufficiently long to extends through the patient’s vaginal canal and exit the introitus when the cervical control system is in position within the patient, wherein a first end of a first lumen of the bi-lumen tube is in fluid communication with the second end of the first inflation media conduit and a second opposing end of the first lumen is configured to receive an inflation media, further wherein a first end of a second lumen of the bi-lumen tube is in fluid communication with the second end of the second inflation media conduit and a second opposing end of the second lumen is configured to receive an inflation media, the method further comprising: accessing the second end of the first and second lumens of the bi-lumen tube outside the patient’s body; and adding inflation media to the second end of the first and second lumens of the bi-lumen tube for communication to the respective first and second inflation media conduits.
Petros teaches (para. [0063]; fig. 10a), in the same field of endeavor, a method comprising a system (1000) comprising a bi-lumen tube (1031 which includes lumens of 1030 and 1030’) that is sufficiently long to extend through a patient’s vaginal canal and exit the introitus when the system is in position within the patient (portions remains external to allow for manipulation, considered to extend through vaginal cavity to outside of patient’s body, para. [0046]), wherein a first end of a first lumen of the bi-lumen tube is in fluid communication with a first inflatable portion (1025) and a second opposing end of the first lumen is configured to receive an inflation media (via valved luer locks, para. [0063]), further wherein a first end of a second lumen of the bi-lumen tube is in fluid communication with a second inflatable portion (1025’) and a second opposing end of the second lumen is configured to receive an inflation media (via valved luer locks), the method further comprising: accessing the second end of the first and second lumens of the bi-lumen tube outside the patient’s body (considered to be accessed external to the patient, para. [0046]); and adding inflation media to the second end of the first and second lumens of the bi-lumen tube for communication to the respective first and second inflatable portions (conduits feed inflatable portions, considered to add inflation media to the conduits), for the purpose of providing independent inflation of the balloons, allowing the balloons to be inflated to different degrees and provide more precise mechanical support for respective ligaments and asynchronous expansion of the vagina (para. [0043]).
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 tubing of Yosowitz to be bi-lumen tubing connected to the respective conduits of the chambers, in order to provide independent inflation of the chambers, allowing the chambers to be inflated to different degrees and provide more precise mechanical support for respective expansion of the tissue that each chamber is engaged with, based on the teachings of Petros (para. [0043]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8550088 B1 to Booher, Sr., disclosing a cervical stabilization device.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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