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 6/2/2026 have been fully considered but they are not persuasive.
Applicant argues that Gross discloses an implant configured to be corkscrewed into a prostate and thus lacks the method step of “deploying the implant within the prostatic urethra.” This is not persuasive as Gross discloses implant 2000 is implanted within the urethra (para. 850).
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.
Claims 31-46 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (Pub. No.: US 2010/0130815).
Gross et al. (hereinafter, Gross) discloses a method for delivering an implant 2000 (para. 850, abstract; not disclosed in combination with delivery device) into a prostatic urethra of a patient (abstract), the implant being self-expandable (e.g., para. 850) 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 2000 within the prostatic urethra (fig. 19B).
As provided in italicized text above, Gross discloses implant 2000 implanted within the prostatic urethra (fig. 19B, para. 850), however, Gross does not specify the delivery mechanism for this implant. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the delivery devices disclosed in Gross as the delivery device for implant 2000 also disclosed in Gross as an obvious expedient to deliver the intra-urethral implant to the body. This modification would have occurred using known methods and would have yielded predictable results.
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. 850) implant 2000 within a patient's urethra (para. 850, abstract, not disclosed in combination with delivery device), 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).
As provided in italicized text above, Gross discloses implant 2000 implanted within the prostatic urethra (fig. 19B, para. 850), however, Gross does not specify the delivery mechanism for this implant. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the delivery devices disclosed in Gross as the delivery device for implant 2000 also disclosed in Gross as an obvious expedient to deliver the intra-urethral implant to the body. This modification would have occurred using known methods and would have yielded predictable results.
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
THIS ACTION IS MADE FINAL. 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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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