DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 55-61, 63-65, 67-72 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chin et al (US 6361543).
Regarding claim 55, Chin discloses a tissue separation assembly, comprising: a tube (903, figures 20-23); and an inflatable bladder (901) releasably attached and fluidly coupled with the tube, the inflatable bladder arranged to be inserted by the tube between tissue masses inside a body (C:31, L:63-67; C:32 L:1-5), the inflatable bladder comprising a first outer surface and a second outer surface facing away from the first outer surface, the first (927) and second outer surfaces (917) arranged to be spaced from each other (left and right sides are spaced from each other by 935) to separate the tissue masses as the inflatable bladder is inflated inside the body (figure 27); wherein the inflatable bladder is configured to be inserted into the body in a rolled state in which a first lateral portion of the inflatable bladder is rolled inwardly with respect to the first outer surface toward a center of the inflatable bladder, and a second lateral portion of the inflatable bladder opposite the first lateral portion is rolled inwardly with respect to the second outer surface toward the center of the inflatable bladder (figure 26), and the inflatable bladder is configured to unroll inside the body as the inflatable bladder is inflated to separate the tissue masses.
Regarding claim 56, Chin discloses all of the limitations set forth in claim 55, wherein the inflatable bladder in the rolled state is deflated, and each of the first and second lateral portions are rolled along a respective axis substantially parallel with respect to a longitudinal axis of the tube (figure 26).
Regarding 57, Chin discloses all of the limitations set forth in claim 55, wherein each of the first and second lateral portions are configured to be rolled in opposite directions (rolled in left and right directions) and along similar distances of the inflatable bladder such that the lateral portions are arranged, with the inflatable bladder in the rolled state, substantially anti-asymmetrically (the limitation ‘substantially anti-asymmetrically’ is sufficiently broad to encompass the configuration in figure 26).
Regarding 58, Chin discloses all of the limitations set forth in claim 55, wherein the inflatable bladder is configured to unroll as the inflatable bladder is inflated between the tissue masses until a predetermined form of the inflatable bladder is achieved (inflated figure 27).
Regarding 59, Chin discloses all of the limitations set forth in claim 55, wherein the inflatable bladder is configured to be inflated by fluid flowed into the inflatable bladder through the tube (906, 904, 905, C:30, L:60-67).
Regarding 60, Chin discloses all of the limitations set forth in claim 59, wherein the inflatable bladder is configured to unroll such that the inflatable bladder separates tissue inside the body in at least one of a lateral direction of the inflatable bladder or a vertical direction of the inflatable bladder (figure 27).
Regarding 61, Chin discloses all of the limitations set forth in claim 55, wherein at least one of the first outer surface or second outer surface comprises a coefficient of friction such that the at least one of the first outer surface or second outer surface is arranged to slide along tissue as the inflatable bladder is unrolled (C:31, L:60-67, C:32, L:1-10).
Regarding 63, Chin discloses all of the limitations set forth in claim 55, wherein the inflatable bladder is configured to be disposed, in the rolled state, inside a packaging sheath (933)arranged to deliver the inflatable bladder inside the body in the rolled state, the inflatable bladder configured to be pushed out of the packaging sheath inside the body to allow the inflatable bladder to unroll as the inflatable bladder is inflated (figure 26).
Regarding 64, Chin discloses a method of separating tissue masses, the method comprising: rolling an inflatable bladder (C:31, L:49-60), the inflatable bladder comprising a first lateral portion (917), a second lateral portion (927) opposite the first lateral portion, a first outer surface (bottom surface of 917), and a second outer surface (bottom surface of 927) facing away from the first outer surface, the rolling comprising: rolling the first lateral portion inwardly with respect to the first outer surface and toward a center of the inflatable bladder, and rolling the second lateral portion of the inflatable bladder inwardly with respect to the second outer surface and toward the center of the inflatable bladder (figure 29), inserting, with the inflatable bladder rolled, the inflatable bladder between tissue masses of a body; and inflating the inflatable bladder inside the body to at least partially unroll the inflatable bladder, separating the tissue masses with the inflatable bladder (figure 27).
Regarding 65, Chin discloses all of the limitations set forth in claim 64, wherein the inflatable bladder is releasably and fluidly coupled with a tube, and the inserting comprises inserting the inflatable bladder with the tube and inflating the inflatable bladder with the tube (C:31, L:1-15).
Regarding 67, Chin discloses all of the limitations set forth in claim 65, wherein the rolling comprises rolling the inflatable bladder in a deflated state and rolling each of the first and second lateral portions along a respective axis substantially parallel with respect to a longitudinal axis of the tube (C:32, L:1-20).
Regarding 68, Chin discloses all of the limitations set forth in claim 64, wherein the rolling comprises rolling each of the first and second lateral portions in opposite directions (left and right directions) and along similar distances such that the lateral portions are arranged, with the inflatable bladder in a rolled state, substantially anti- asymmetrically (the limitation ‘substantially anti-asymmetrically’ is sufficiently broad to encompass the configuration in figure 29).
Regarding 69, Chin discloses all of the limitations set forth in claim 64, wherein the inflating comprises inflating the inflatable bladder inside the body to at least partially unroll the inflatable bladder, separating tissue inside the body in at least one of a lateral direction of the inflatable bladder or a vertical direction of the inflatable bladder (figure 27).
Regarding 70, Chin discloses all of the limitations set forth in claim 64, further comprising: disposing, with the inflatable bladder rolled, the inflatable bladder inside a packaging sheath (903); delivering, with the inflatable bladder rolled inside the packaging sheath, the inflatable bladder at a target location inside the body; and pushing the inflatable bladder out of the packaging sheath inside the body to allow the inflatable bladder to unroll as the inflatable bladder is inflated (C:31, L:28-67, C:21, L:1-50).
Regarding 71, Chin discloses a tissue separation device, comprising: an inflatable bladder (901) comprising a port (905) and configured: to be inserted into a body in a compact, deflated state, to be inflated to a substantially planar form in a manner which dissects between tissues of the body (figure 27), and to be implanted between said tissues; an introducer tube (903) comprising an inflation lumen (906), detachably connected or connectable to said bladder such that said inflation lumen is in direct communication with said port, and configured for guiding said bladder in said deflated state to an anatomic target location in the body and inflating said bladder via said port; and an external restrictor (932, 935) configured for restricting lateral displacement of said inflatable bladder in a direction toward said external restrictor (figure 26).
Regarding 72, Chin discloses all of the limitations set forth in claim 71, wherein the compact, deflated state comprises a rolled state in which a first lateral portion of the inflatable bladder is rolled inwardly with respect to a first outer surface of the inflatable bladder and toward a center of the inflatable bladder, and a second lateral portion of the inflatable bladder opposite the first lateral portion is rolled inwardly with respect to a second outer surface of the inflatable bladder and toward the center of the inflatable bladder (figures 26, 29), and the inflatable bladder is configured to unroll inside the body as the inflatable bladder is inflated to dissect the tissues of the body (figure 27).
Claims 55, 62 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chin et al (US 5720762).
Regarding claim 55, Bass discloses a tissue separation assembly, comprising: a tube (48); and an inflatable bladder (50) releasably attached and fluidly coupled with the tube, the inflatable bladder arranged to be inserted by the tube between tissue masses inside a body (figure 5), the inflatable bladder comprising a first outer surface and a second outer surface facing away from the first outer surface, the first (under surface of 60 left of 54 in figure 6B) and second outer surfaces (under surface of 60 right of 54 in figure 6B) arranged to be spaced from each other (left and right sides are spaced from each other by 54) to separate the tissue masses as the inflatable bladder is inflated inside the body (figure 5); wherein the inflatable bladder is configured to be inserted into the body in a rolled state in which a first lateral portion of the inflatable bladder is rolled inwardly with respect to the first outer surface toward a center of the inflatable bladder, and a second lateral portion of the inflatable bladder opposite the first lateral portion is rolled inwardly with respect to the second outer surface toward the center of the inflatable bladder (figure 11C), and the inflatable bladder is configured to unroll inside the body as the inflatable bladder is inflated to separate the tissue masses (figures 4-5) .
Regarding 62, Chin discloses all of the limitations set forth in claim 55, wherein the inflatable bladder defines, in an inflated state, a length of between 1 and 20 centimeters, a width of between 1 and 20 centimeters, and a thickness of between 1 and 10 centimeters (C:21, L:45-60).
Allowable Subject Matter
Claim 66 is 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding 66, Chin discloses all of the limitations set forth in claim 65, but does not disclose the step of withdrawing the tube from the body, leaving the inflatable bladder in place inside the body. Chin does not teach or suggest leaving the inflatable bladder in place inside the body and any modification would teach away from the disclosed purpose of the device of Chin. Therefore, since there is no teaching, suggestion, or motivation to produce the claimed invention, claim 66 has not been rejected over the body of prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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