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
Claim 12 is objected to because of the following informalities: Claim 12 recites “the wall of said anchor garage”, which lacks antecedent basis and should instead recite – a wall of said anchor garage –. Appropriate correction is required.
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 20 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.
Regarding claims 20, the phrase “may be” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
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) 1-8 and 11-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2021/0145576 A1 to Becerra et al. (Becerra).
Regarding claim 1
Becerra teaches systems, apparatuses, and methods disclosed herein are provided for a motorized implant delivery system (abstract).
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Becerra meets the limitations of an anchor delivery and deployment device (10) comprising: an anchor garage (rail assembly; 20) configured to deliver an anchor (distal anchors; 80 of implant; 70 are construed to be an anchor delivered by the rail assembly/garage; 20) therein; an atraumatic shield (inner retention member; 40) movable with respect to said anchor garage (paragraph 0112 discloses that the rail assembly; 20 slides over the inner shaft assembly; 18, which includes inner retention member/atraumatic shield; 40); and a biasing element configured to bias the atraumatic shield into a position with respect to said anchor garage (connector; 526 is coupled to adaptor 516f for moving the inner retention member/atraumatic shield; 40 via drive rod 518f that is actuated by motor; 500, as disclosed in paragraphs 0134-0135 – at least drive rod; 518f is construed to be a biasing element that maintains position of the inner retention member/atraumatic shield; 40 with respect to rail assembly/anchor garage; 20 as claimed).
Regarding claim 2
Becerra teaches the anchor delivery and deployment device of claim 1, further comprising an indicator of the relative positions of said anchor garage (20) and said atraumatic shield (40) (paragraph 0236 discloses an indicator; 850 may be provided to the user when the apparatus has contacted a surface or has improperly deployed an implant; further, paragraph 0161 discloses that the sensor may comprise a position sensor utilized to determine the movement and/or position of one or more of the assemblies, which includes the anchor garage/rail assembly 20 relative to the inner retention member/atraumatic shield 40).
Regarding claim 3
Becerra teaches the anchor delivery and deployment device of claim 2, wherein said indicator is a visual indicator (paragraph 0153 discloses that the output of the indicator may include lights; 568 that illuminate).
Regarding claim 4
Becerra teaches the anchor delivery and deployment device of claim 2, wherein said indicator includes at least one radiopaque marker (paragraph 0117 discloses a radiopaque marker to provide for visibility under fluoroscopy).
Regarding claim 5
Becerra teaches the anchor delivery and deployment device of claim 2, wherein said indicator generates a signal indicating the relative positions of said anchor garage and said atraumatic shield (paragraph 0161 discloses a sensor may be utilized to sense a condition of the delivery apparatus, such as a position sensor to determine the movement and/or position of one or more of the assemblies, thereby causing the motor to perform a desired movement based on the signal from the position sensor).
Regarding claim 6
Becerra teaches the anchor delivery and deployment device of claim 2, wherein said indicator indicates that said anchor delivery and deployment device has contacted tissue (paragraph 0164 discloses a contact sensor configured to sense a spatial relationship between the delivery apparatus and a surface of the patient’s body and may provide a signal when the shaft contacts a portion of the body, which includes an inner wall of blood vessel as disclosed in paragraph 0165).
Regarding claim 7
Becerra teaches the anchor delivery and deployment device of claim 1, further comprising a limit stop positioned to limit relative movement between said atraumatic shield and said anchor garage (paragraph 0164 discloses that if contact is sensed with a surface, the processor may actuate the delivery apparatus to move away from the surface or stop operation of the motor – the processor is construed to be a limit stop).
Regarding claim 8
Becerra teaches the anchor delivery and deployment device of claim 7, wherein said limit stop is positioned and configured to limit proximal retraction of said atraumatic shield with respect to said anchor garage (the proximity sensor 582 senses proximity to a surface (e.g. an inner wall of blood vessel), and in such case, the processor may provide output that operates the motor to retract from the surface as disclosed in paragraph 0172).
Regarding claim 11
Becerra teaches the anchor delivery and deployment device of claim 1, wherein said biasing element comprises a plurality of elongated beams proximal to said atraumatic shield and biased into an elongated configuration along said anchor garage to bias said atraumatic shield toward the distal end of said anchor garage (drive shafts 518a-g are construed to be a plurality of elongated beams proximal to said shield 40 that are biased into an elongated configuration along the garage 20 to bias the shield 40 toward the distal end of the garage 20 as shown in fig. 2B).
Regarding claim 12
Becerra teaches the anchor delivery and deployment device of claim 11, wherein said beams are formed from the wall of said anchor garage (the drive shaft extends through a lumen within the garage 20 as shown in fig. 2B and is therefore construed to be formed from the wall of the garage 20).
Regarding claim 13
Becerra meets the limitations of an anchor delivery and deployment system (10) comprising: an anchor (distal anchor portion 80 of implant 70); an anchor garage (rail assembly; 20) configured to deliver said anchor therein (distal anchors; 80 of implant; 70 are construed to be an anchor delivered by the rail assembly/garage; 20); an atraumatic shield (inner retention member; 40) movable with respect to said anchor garage (paragraph 0112 discloses that the rail assembly; 20 slides over the inner shaft assembly; 18, which includes inner retention member/atraumatic shield; 40); and a biasing element configured to bias the atraumatic shield into a position with respect to said anchor garage (connector; 526 is coupled to adaptor 516f for moving the inner retention member/atraumatic shield; 40 via drive rod 518f that is actuated by motor; 500, as disclosed in paragraphs 0134-0135 – at least drive rod; 518f is construed to be a biasing element that maintains position of the inner retention member/atraumatic shield; 40 with respect to rail assembly/anchor garage; 20 as claimed).
Regarding claim 14
Becerra also teaches the anchor delivery and deployment system of claim 13, further comprising a tubular delivery element (outer sheath; 22) configured to deliver said anchor (70), said anchor garage (20), and said atraumatic shield (40) transluminally through a patient’s body to a target site (figs. 29-30 show delivery of the implant as claimed).
Regarding claim 15
Becerra teaches the anchor delivery and deployment system of claim 13, further comprising an indicator configured to indicate the relative positions of said anchor garage and said atraumatic shield (paragraph 0153 discloses an indicator provided by an output device to indicate a condition of the delivery apparatus or of the patient, which includes relative positions of the assemblies including the anchor garage 20 and the shield 40).
Regarding claim 16
Becerra teaches the anchor delivery and deployment system of claim 13, further comprising a limit stop positioned to limit relative movement of said atraumatic shield with respect to said anchor garage (paragraph 0164 discloses that if contact is sensed with a surface, the processor may actuate the delivery apparatus to move away from the surface or stop operation of the motor – the processor is construed to be a limit stop that is capable of limiting relative movement of the shield 40 with respect to the garage 20).
Regarding claim 17
Becerra also meets the limitations of a method of delivering and deploying an anchor to a target site within a patient’s body, said method comprising: delivering an anchor (70) within an anchor garage (20) to a target site (paragraph 0007 discloses a motorized implant delivery system used to delivery an implant such as a replacement heart valve or an implant for repair of a heart valve to a desired location within the body); contacting an atraumatic shield (40) positioned with respect to the anchor garage (20) with tissue at the target site to cause the atraumatic shield to retract proximally with respect to the anchor garage (paragraph 0190 discloses retraction of the capsule to expose shield 40 thus beginning the expansion of the proximal end of the implant 70); deploying the anchor into the target site (paragraph 0191 discloses expansion and release of the implant as claimed); proximally retracting the anchor garage from the target site to allow a biasing element to bias the atraumatic shield distally with respect to the anchor garage (drive shafts 518a-g are construed to be biasing elements that bias the shield 40 distally with respect to the garage 20 as disclosed in paragraph 0135); and retracting the anchor garage and atraumatic shield from the target site (paragraph 0191 discloses withdrawing proximally the outer, mid, and inner assemblies relative to the rail/garage back to their original position via the motor after release of the implant).
Regarding claim 18
Becerra teaches the method of claim 17, further comprising causing an indicator positioned with respect to the atraumatic shield and the anchor garage to indicate the relative position of the atraumatic shield and the anchor garage (paragraph 0161 discloses a sensor may be utilized to sense a condition of the delivery apparatus, such as a position sensor/indicator to indicate the movement and/or position of one or more of the assemblies, thereby causing the motor to perform a desired movement based on the signal from the position sensor).
Regarding claim 19
Becerra teaches the method of claim 17, further comprising distally advancing the anchor garage and the atraumatic shield against tissue to cause proximal retraction of the atraumatic shield with respect to the anchor garage until the atraumatic shield is inhibited from further proximal movement by encountering a limit stop (paragraph 0164 discloses that if contact is sensed with a surface, the processor may actuate the delivery apparatus to move away from the surface or stop operation of the motor – the processor is construed to be a limit stop that is encountered to inhibit the shield 40 from further proximal movement when contact is sensed with a surface).
Regarding claim 20
Becerra teaches the method of claim 17, further comprising allowing the biasing element to bias the atraumatic shield distally with respect to the anchor garage (the drive rod biases the shield 40 distally with respect to the anchor garage 20, as shown in fig. 2B), and to return the biasing element to a configuration in which the anchor garage, the atraumatic shield, and the biasing element may be retracted into a delivery device for withdrawal from the patient (the contact and/or proximity sensor(s) causes the processor to actuate the delivery apparatus to move away from the surface in a way that the drive rod may be retracted for withdrawal).
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) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Becerra.
Regarding claim 9
Becerra teaches the anchor delivery and deployment device of claim 1, wherein said biasing element biases said atraumatic shield over the distal end of said anchor garage (connector; 526 is coupled to adaptor 516f for moving the inner retention member/atraumatic shield; 40 via drive rod 518f that is actuated by motor; 500, as disclosed in paragraphs 0134-0135 – at least drive rod; 518f is construed to be a biasing element that biases the inner retention member/atraumatic shield; 40 over the distal end of the rail assembly/anchor garage; 20 as claimed, particularly since the term “over” is defined as: across a barrier; forward beyond an edge – fig. 2B shows that the shield 40 is across and forward beyond the barrier/edge defined by the distal end of the anchor garage 20).
Becerra also discloses that the rail assembly/anchor garage (20) is utilized for steering/deflecting the distal end of the elongate shaft (12), thereby allowing the implant to be more easily and accurately positioned in a patient’s body (paragraph 0090). The distal end of the anchor garage (20) is planar (fig. 30), which would be capable of causing trauma to relatively softer surrounding tissue. Further, Becerra teaches that the rail assembly can include a rail shaft (132) made up of a rail proximal shaft (134) and a rail hypotube (136) attached to the distal end of the shaft (134) and having a rail tip at its distal end for abutting a proximal end of the inner retention member (40) (fig. 6B). However, Becerra does not teach that the distal end of said anchor garage is sharp to penetrate tissue.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor garage such that the rail tip is sharp to penetrate tissue as the anchor is deployed, for example, in order to maintain position of the device during deployment, and particularly since there is no evidence of record that establishes that changing the shape of the distal rail tip of the anchor garage would result in a difference in function of the Becerra device. The Examiner notes that the term “sharp” is a relative term of degree that does not require a particular shape of the distal end, wherein a wide variety of shapes of the garage distal end being formed of a stiffer material than the patient’s tissue would be capable of penetrating tissue with sufficient force. Further, a person having ordinary skill in the art, being faced with modifying the shape of the distal rail tip Becerra device, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed sharp tip. Lastly, applicant has not disclosed that the claimed shape solves any stated problem, indicating that the distal end of the anchor garage “may” have a sharp, needle tip, and offering other acceptable ranges (e.g., may be blunt, specification at para. [0032]) and therefore there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal rail tip of Becerra to be sharp to penetrate tissue as an obvious matter of design choice within the skill of the art.
Regarding claim 10
Becerra teaches the anchor delivery and deployment device of claim 9, further comprising a limit stop positioned to limit advancement of said sharp distal end of said anchor garage out of said atraumatic shield (the proximity sensor 582 senses proximity to a surface (e.g. an inner wall of blood vessel), and in such case, the processor/limit stop may provide output that operates the motor to retract from the surface as disclosed in paragraph 0172).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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