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 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 31-37 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 31 refers to “a first tubular member” and “a second tubular member.” These limitations are indefinite as it is unclear which component is considered the “first tubular member” and “second tubular member.” Under one interpretation, the first tubular member is 120 while the second tubular member is 130. Under another interpretation, the first tubular member is 130 while the second tubular member is 140 or 150. Claim 31 goes on to require the method step of “causing relative sliding movement between the first tubular member and a second tubular member . . . the implant going from being retained in the constrained configuration within the first lumen to being partially exposed outside of the first lumen.” Because the delivery device includes multiple lumens which slide relative to one another (e.g., fig. 2A, 2B, para. 40) it is unclear which lumen constitutes the “first tubular member” and “second tubular member.” Likewise with the limitation “imaging a distal portion of the implant that is exposed outside of the first lumen,” it is unclear which lumen the implant is exposed outside of. Because there are multiple reasonable interpretations for the limitations, the claim is indefinite.
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.
Claims 31-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et al. (Pub. No.: US 2010/0130815).
Gross et al. (hereinafter, Gross) discloses a method for delivering an implant into a prostatic urethra of a patient (abstract), the implant being self-expandable (e.g., para. 718, fig. 3) from a constrained configuration towards an at-rest configuration, the method comprising:
inserting a first tubular member 24, and an imaging device (e.g., para. 716) into the prostatic urethra of the patient (e.g., fig. 3, para. 716),
the first tubular member having a distal end and proximal end and defining a first lumen extending from the proximal end to the distal end of the first tubular member (e.g., fig. 3);
causing relative sliding movement between the first tubular member 24 and a second tubular member 25 having a distal end and a proximal end and defining a second lumen (e.g., para. 717) extending from the proximal end to the distal end of the second tubular member,
the implant going from being retained in the constrained configuration within the first lumen (e.g., fig. 2) to being partially exposed outside of the first lumen (e.g., fig. 3);
imaging a portion of the implant that is exposed outside of the first lumen (para. 729);
causing relative movement between the first tubular member and the distal portion of the implant to expose the entire extent of the implant (fig. 3); and
deploying the implant within the prostatic urethra (fig. 4-5).
For claim 32, Gross discloses the method of claim 31, wherein the causing relative movement includes withdrawing the first tubular member 24 relative to the implant (e.g., fig. 6).
For claim 33, Gross discloses the method of claim 31, wherein the causing relative movement includes withdrawing the first tubular member and the imaging device relative to the implant (e.g., fig. 6, para. 742).
For claim 34, Gross discloses the method of claim 31, further comprising selectively deflecting the first tubular member within the urethra of the patient (e.g., fig. 3-4, relative position of outer sheath 24 to the urethra).
For claim 35, Gross discloses the method of claim 31, further comprising selectively deflecting the first tubular member and the second tubular member together in the urethra of the patient (e.g., fig. 3-4).
For claim 36, Gross discloses the method of claim 31, wherein during the inserting, the implant is radially constrained between the first tubular member and the second tubular member (e.g., fig. 2, 3) and is selectively inhibited from axial movement relative to the second tubular member (e.g., para. 794).
For claim 37, Gross discloses the method of claim 31, further comprising moving a safety catch 127 to enable the implant to be transitioned from the constrained configuration to an at-rest configuration (e.g., para. 799).
For claim 38, Gross discloses a method of deploying an expandable (e.g., para. 718, fig. 3) implant within a patient's urethra (abstract), the method comprising:
inserting into the urethra a shaft 24 defining a lumen with an implant 120 positioned therein and disposed in a delivery configuration (e.g., fig. 2) in which the implant is radially constrained and retained within the lumen of the shaft (e.g., fig. 2, 3)
advancing a distal end of the shaft distally relative to the urethra towards the patient's bladder neck (e.g., fig. 3);
transitioning the implant from the delivery configuration into a partially-delivered configuration (fig. 3, para. 726) in which the implant is (1) partially-uncovered from the shaft but still (2) radially constrained and retained within the shaft (fig. 3, the implant is advanced through the shaft 24 and thus must have a position in which part of the implant has emerged from the shaft while the remainder of the implant is within the shaft);
positioning the implant at a target site within the urethra at a longitudinal position in the urethra proximal to the bladder neck (e.g., fig. 3); and
deploying the implant at the target site by transitioning the implant from the partially-delivered configuration to a deployed configuration in which the implant is fully exposed and released from the shaft (e.g., fig. 4-6).
For claim 39, Gross discloses the method of claim 38, wherein the deploying the includes withdrawing the shaft relative to the implant (e.g., fig. 6).
For claim 40, Gross discloses the method of claim 38, further comprising moving a safety catch 129 to enable the implant to be transitioned from the partially-delivered configuration to the deployed configuration (e.g., para. 742).
For claim 41, Gross discloses the method of claim 38, further comprising holding the implant substantially stationary relative to the urethra when transitioning the implant from the partially-delivered configuration to the deployed configuration (e.g., para. 742).
For claim 42, Gross discloses the method of claim 38, further comprising allowing the implant to expand radially when deploying the implant (fig. 3, para. 726).
For claim 43, Gross discloses the method of claim 38, wherein the implant is retained by engagement with a retainer 127 that remains covered by the shaft in the partially-delivered configuration but that is exposed during the deploying to release the implant (fig. 5, exposed in slot 130).
For claim 44, Gross discloses the method of claim 38, further comprising moving an imaging device 70 proximally relative to the implant (e.g., para. 742).
For claim 45, Gross discloses the method of claim 44, wherein the moving the imaging device is performed concurrently with the transitioning the implant from the delivery configuration into the partially-delivered configuration (e.g., para. 729).
For claim 46, Gross discloses the method of claim 38, wherein the transitioning the implant from the partially- delivered configuration to the deployed configuration includes further retracting the shaft proximally relative to the implant to an extent sufficient to release the implant from the shaft (e.g., fig. 6).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774