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 § 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 29-30 and 32-35 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.
Claim 29 recites “a bladder comprising a base coupled to the conduit and defining a first volume in fluid communication with the inflation pathway.” The text appears to recite the base defining a first volume. However, the specification indicates the first volume being defined by the bladder, not its base.
Claim 32 recites “a collar coupled to the conduit with the outer body and fixedly coupled to the collar.” The collar cannot be coupled to itself. Further clarification is required.
Claim Rejections - 35 USC § 102
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, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freed [US 2010/0228239 A1].
Re. claim 1, Freed discloses a device [10, Figs. 1-6] for treating a uterus [Par. 0002], the device comprising:
a conduit defining a suction pathway [410, Fig. 4; Par. 0033] and an inflation pathway [26, Par. 0021];
a bladder [“inflatable member” 30] coupled to the conduit [Fig. 1] and defining a first volume [Annotated Fig. 5, below] in fluid communication with the inflation pathway [Par. 0021];
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and an expandable outer body [“outer layer” 50] at least partially disposed over the bladder [Par. 0021, Fig. 5] and defining suction ports [“openings at the layer 50,” Par. 0039], wherein a second volume defined between the bladder and the outer body[Annotated Fig. 5] is in fluid communication with the suction ports of the outer body and the suction pathway of the conduit [Par. 0039],
wherein the conduit defines a suction port [the proximal end of 410, where 410 connects to 420] external to the bladder [Fig. 2] and in fluid communication with the suction pathway [as defined].
Re. claim 14, Freed discloses the bladder comprises a base coupled to the conduit, and wherein the bladder is not otherwise coupled to the conduit [Annotated Fig. 4, below] and configured to expand omnidirectionally [Figs. 6B-D].
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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.
Claim(s) 4-6, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed.
Re. claim 4, Freed discloses the bladder
Re. claim 5, Freed discloses the spacing features are projections integrally formed with the respective body [Fig. 5]. Therefore, the above-modified Freed teaches this limitation as claimed.
Re. claim 6, Freed discloses a strut [402 Fig. 4, par. 0032, in the embodiment where they are not formed integrally but are secured to the surface using an adhesive] coupled to the bladder operation of the device and therefore is an obvious matter of design choice. See MPEP 2144.04.VI.C.
Re. claim 6, Freed discloses the strut is oriented longitudinally along an inner surface of the outer body [Figs. 4-5, as modified with respect to claim 6 above]
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of McGloughlin et al. [US 20040030352 A1, hereinafter “McGloughlin”].
Re. claim 12, Freed discloses the bladder is formed from a conformable material [Par. 0025] configured to expand with inflation fluid being directed through the inflation pathway and into the first volume [Figs. 6A-D], and wherein the outer body is formed from a McGloughlin teaches, in a device for treating a uterus, an inflatable member made of a resilient material [Par. 0013]. forming the bladder and outer layer to be a resilient material would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows the device to be inflated/expandable to “selectable sizes,” [McGloughlin Par. 0013]. Note that because both the bladder and outer layer have to change size/shape, it would have been obvious to form both of a resilient material.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of Claren [US 2005/0049627 A1] and McGloughlin.
Re. claim 13, Freed discloses the bladder is formed from a flexible material [Par. 0025] configured to expand
Regarding the bladder, Claren teaches, in a device for treating a uterus, a balloon made from a flexible non-resilient material configured to unfurl with inflation fluid [Par. 0014]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Freed such that the balloon is made of a flexible non-resilient material because “[a]n advantage of using a non-resilient material is that the pressure that can be observed in the cuff will be equal to the working pressure of the balloon and the complete device,” [Claren Par. 0047].
Regarding the outer layer, McGloughlin teaches an inflatable member made of a resilient material [Par. 0013]. Forming the outer layer to be a resilient material would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows the device to be inflated/expandable to “selectable sizes,” [McGloughlin Par. 0013].
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of Rangaswamy [US Pat. 4552557].
Re. claim 29, as best understood, Freed discloses a device [10, Figs. 1-6] for treating a uterus [Par. 0002], the device comprising:
a conduit defining a suction pathway [410, Fig. 4; Par. 0033] and an inflation pathway [26, Par. 0021];
a bladder [“inflatable member” 30] comprising a base coupled to the conduit [Fig. 1] and the bladder defining a first volume [Annotated Fig. 5, below] in fluid communication with the inflation pathway [Par. 0021];
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and an expandable outer body [“outer layer” 50] at least partially disposed over the bladder [Par. 0021, Fig. 5] and defining suction ports [“openings at the layer 50,” Par. 0039], wherein a second volume defined between the bladder and the outer body[Annotated Fig. 5] is in fluid communication with the suction ports of the outer body and the suction pathway of the conduit [Par. 0039],
wherein the conduit defines a suction port [the proximal end of 410, where 410 connects to 420] positioned proximal to the bladder [Fig. 2] and in fluid communication with the suction pathway [as defined].
Freed fails to disclose an inflation port distal to the base of the bladder. However, Rangaswamy teaches, in a device for treating a uterus [Abstract], an inflation port [5, Fig. 3] positioned distal to the suction port [10] and distal to the base of the bladder [Annotated Fig. 3]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Freed by configuring the bladder, bladder base, and inflation port so that the inflation port extends into the bladder, distal to the base of the bladder, as taught by Rangaswamy, because this configuration allows for a device which is easily inserted into the uterine cavity [Col. 5 lines 9-13].
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Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of Rangaswamy, as applied to claim 29, and further in view of Isch et al. [US 2019/0069929 A1, hereinafter “Isch”].
Re. claim 30, the modified Freed is silent regarding the additional suction port distal to the bladder. However, Isch teaches, in a device for treating a uterus [Abstract], the conduit defines a suction port [24] proximal to the bladder [14] another suction port [26, Fig. 1] positioned distal to the bladder [14]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Freed such that there is at least one suction port proximal to the bladder and another suction port distal to the bladder, as taught by Isch, because “Distal drainage ports 26 provide a path for blood present at the top of the uterus to drain. It has been observed that hemorrhaging is more present at the top of the uterus than at the bottom, so the distal drainage ports 26 provide a path for the drainage of the blood, even after the balloon 14 has been inflated, which could otherwise block the blood from flowing down out of the uterus. The proximal drainage ports 24 provide a path for drainage of blood that is present at the bottom of the uterus.” [Isch Par. 0080].
Claim(s) 20, 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of Belfort et al. [US 20080215031 A1, hereinafter “Belfort”].
Re. claim 20, Freed fails to teach the second inflation pathway and expandable cervical seal.
However, Belfort teaches, in a device for treating a uterus [Abstract], an expandable cervical seal [150, Fig. 5] coupled to the conduit and defining a third volume in fluid communication with the second inflation pathway [“second inflation lumen,” Par. 0043].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Freed by adding an expandable cervical seal defining a third volume in fluid communication with a second inflation pathway as taught by Belfort because this ensures that both the uterus and a portion of the vaginal canal can be tamponaded [Par. 0011], preventing the material from falling through the cervix and allowing it to be collected.
Re. claim 31, Freed discloses a device [10, Figs. 1-6] for treating a uterus [Par. 0002], the device comprising:
a conduit defining a suction pathway [410, Fig. 4; Par. 0033] and a “first” inflation pathway [26, Par. 0021],
a bladder [“inflatable member” 30] coupled to the conduit [Fig. 1] and defining a first volume [Annotated Fig. 5, below] in fluid communication with the first inflation pathway [Par. 0021];
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and an expandable outer body [“outer layer” 50] at least partially disposed over the bladder [Par. 0021, Fig. 5] and defining suction ports [“openings at the layer 50,” Par. 0039], wherein a second volume defined between the bladder and the outer body [Annotated Fig. 5] is in fluid communication with the suction ports of the outer body and the suction pathway of the conduit [Par. 0039].
Freed fails to teach the second inflation pathway and expandable cervical seal.
However, Belfort teaches, in a device for treating a uterus [Abstract], an expandable cervical seal [150, Fig. 5] coupled to the conduit and defining a third volume in fluid communication with the second inflation pathway [“second inflation lumen,” Par. 0043].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Freed by adding an expandable cervical seal defining a third volume in fluid communication with a second inflation pathway as taught by Belfort because this ensures that both the uterus and a portion of the vaginal canal can be tamponaded [Par. 0011], preventing the material from falling through the cervix and allowing it to be collected.
Re. claim 32, as best understood, Belfort teaches a collar[130] coupled to the conduit [Fig. 5]
Regarding the collar forming the barrier, this amounts to a simple rearrangement of parts which does not modify the mode of operation of the device and therefore is an obvious matter of design choice. See MPEP 2144.04.VI.C.
Re. claim 33, Belfort further teaches the conduit further defines a second inflation port [inherently. See Belfort Par. 0017 and Fig. 6g. Because the conduit 150 contains two inflation lumens, 40 and 42, there is inherently a second inflation port where the second inflation lumen connects to the inflating source]. Given the above teachings of Freed-Belfort containing the second inflation lumen, the second inflation port would also have been obvious to allow the device to operate as intended to inflate the second volume.
Regarding the second inflation lumen being positioned proximal to the barrier, given the above teachings, such a modification would have been obvious to one of ordinary skill because the inflation source is proximal to the second volume which is proximal to the barrier.
Re. claim 34, Belfort teaches the cervical seal is formed from a sidewall comprising an outer surface opposite an inner surface to define a thickness therebetween [Fig. 4], and wherein the thickness of the sidewall varies between opposing ends of the cervical seal [Par. 0041]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Freed-Belfort such that a thickness of the sidewall of the cervical seal varies, as taught by Belfort, in order to limit the expansibility of the balloon in certain areas and cause expansion in other areas [Belfort Par. 0041]
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of Belfort, as applied to claim 32, and further in view of Buster et al. [US 20140378756 A1, hereinafter “Buster”]
Re. claim 35, Belfort teaches the suction pathway and the first and second inflation pathways are partitioned channels within the conduit [Fig. 6g], wherein the conduit has a constant outer diameter [Par. 0038] but fails to teach the cross-sectional area of the suction pathway being larger than that of the first or second inflation pathway.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Freed such that the conduit has a constant outer diameter and where the first and second inflation pathways are partitioned channels within the conduit as taught by Belfort in order to prevent inflation of the conduit and to simplify the structure of the device with only one conduit body.
Regarding the relative cross sections, Buster teaches wherein an effective cross-sectional area of the suction pathway [46, Fig. 3a] is greater than an effective cross-sectional area of the first inflation pathway [76, Fig. 3a]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Freed such that the effective cross-sectional area of the suction pathway is greater than the first and second inflation pathways as taught by Buster because this allows material to pass through more readily (suction lines would remove blood possibly uterine material, while the inflation lines only need to carry the inflation fluid).
Allowable Subject Matter
Claims 7 and 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Re. claim 7, the closest prior art of record fails to teach the strut defines bores aligned with the suction ports of the outer body, and wherein the bores are disposed within the channel.
Re. claim 15, the closest prior art of record fails to teach the device further comprises a distal cap movably disposed over the distal end portion, and wherein the bladder is coupled to the distal cap.
Nor would there have been an obvious motivation to modify the above references to teach such.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 3 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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