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 .
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 11/18/2024 is acknowledged. Claims 16-20 have been withdrawn from further consideration and claims 1-15 are pending.
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, 10, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt (US PGPub 2015/0051611).
Regarding Claim 1, Schmidt teaches a medical system, comprising:
a driver (102; Figure 17A; Paragraph 0078) configured to impart a torque on an implantable medical device within an anatomical volume defined by a body of a patient, the driver including a head section (108; Figure 17A; Paragraph 0078),
wherein the driver (102) comprises a lumen (118; Figure 17A; Paragraph 0080) extending through at least a portion of the head section (112), the lumen (118) extending to a lumen opening defined by the head section (112; Figure 17A; Paragraph 0080), and
wherein the head section (112) or a protrusion (114) thereof is configured to insert within a device recess (82A or 82B) or a device slot (82A or 82B; Figure 17B; Paragraph 0081) of the implantable medical device (12; Figure 17B); and
a snare (80; Figure 17B; Paragraph 0080) configured to slidably translate within the lumen (118; Figure 17B) and through the lumen opening to engage the implantable medical device (12; Figure 17B),
wherein the snare (80) is configured to cause the head section (112) to exert a contact force on the implantable medical device (12) when the snare (80) engages the implantable medical device (12) and imparts a force on the implantable medical device (12; As seen in Figure 17B; the snare maintains the head section onto the implantable medical device and imparts a compressive force), and
wherein the head section (112) is configured to transfer the torque from a driver body (106) of the driver (102) to the implantable medical device (12) when the snare (80) causes the contact force and the protrusion (114) inserts within the device recess or the device slot (82a/82b; Figures 17A-17B; Paragraph 0078).
Regarding Claim 2, Schmidt teaches the medical system of claim 1, wherein the lumen (118) defines a longitudinal axis (Figure 17A), and wherein the head section (112) defines a head perimeter surrounding the longitudinal axis (Figure 17A), and wherein the protrusion (114) defines at least a portion of the head perimeter (Figure 17A).
Regarding Claim 3, Schmidt teaches the medical system of claim 2, wherein the snare (80) is configured to cause the head section (112) to exert the contact force as the head section (112) rotates about the longitudinal axis (as seen in Figures 17B and 17C, the snare exerts a compressive contact force between the driver head and the implantable medical device 12).
Regarding Claim 4, Schmidt teaches the medical system of claim 1, wherein the protrusion (114; Figure 17A) is configured to transmit the torque to a retrieval structure (82) defined by the implantable medical device (12; Paragraph 0079).
Regarding Claim 5, Schmidt teaches the medical system of claim 1 , wherein the snare (80) is configured to at least one of:
cause the head section to increase the contact force when the snare increases the force exerted on the implantable medical device (Paragraph 0071), or
cause the head section to decrease the contact force when the snare decreases the force exerted on the implantable medical device (Paragraph 0071 states that the tether is used (Paragraph 0071).
Regarding Claim 6, Schmidt teaches the medical system of claim 1, wherein when the driver body imparts a torque on the head section and the head section imparts the contact force on the implantable medical device, the head section is configured to at least one of substantially roll or slip around a structure perimeter of the implantable medical device to cause the protrusion to insert within the device recess or the device slot, wherein the head section exhibits a relative rotation with respect to the implantable medical device when the head section substantially rolls or slips around the structure perimeter (See Figures 16A-17B; It’s the Examiners position that this limitation is an intended use. There is a configuration where the snare is attached to the implantable device and the head section is contacting the implantable medical device but misaligned, and by rotating the driver body, the head section will roll across the implantable medical device until the protrusions (114) enter slot (82) as seen in Figure 17B.)
Regarding Claim 7, Schmidt teaches the medical system of claim 1 wherein the protrusion (114) is configured to at least one of:
impart a head-transmitted force on the device recess when the protrusion inserts into the device recess and the head section transfers the torque from the driver body to the implantable medical device (Paragraph 0079), or
impart the head-transmitted force on the device slot when the protrusion inserts into the device slot and the head section transfers the torque from the driver body to the implantable medical device (Paragraph 0079).
Regarding Claim 8, Schmidt teaches the medical system of claim 7, wherein the head section (112) is configured to exert the head-transmitted force in a direction substantially perpendicular to a longitudinal axis of the lumen when the driver delivers the torque in a rotational direction around the longitudinal axis of the lumen (see Figure 17 where the lugs 114 impart a torque moment about the longitudinal axis and thus the force is tangential to the longitudinal axis).
Regarding Claim 10, Schmidt teaches the medical system of claim 1, further comprising the implantable medical device (10; Figure 16A; Paragraph 0072),
wherein the implantable medical device (10) includes a retrieval structure (30) defining at least one of the device recess or the device slot (82; Figure 16A),
wherein the retrieval structure (30) defines a device axis and a structure perimeter surrounding the device axis (Figure 16A), and
wherein the at least one of device recess or the device slot (82) defines at least a portion of the structure perimeter (30; Figure 16A).
Regarding Claim 14, Schmidt teaches the medical system of claim 1, wherein the driver (102) includes a driver body (106) supporting the head section (112; Figure 17A).
Regarding Claim 15, Schmidt teaches the medical system of claim 1, wherein the lumen (118) extends through at least a portion of the driver body (106; Paragraph 0080).
Claim Rejections - 35 USC § 103
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 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US PGPub 2015/0051611) as applied to claim 1 above, and further in view of Soltis (US PGPub 2018/0207430)
Regarding Claim 9, Schmidt teaches the medical system of claim 1, wherein the head section (112) defines a head perimeter and the protrusion (114) is on the perimeter (Figures 17A-18C) but fails to disclose wherein at least a portion of the head perimeter defines a polygonal curve, and wherein the protrusion defines at least a portion of the polygonal curve.
Soltis teaches a medical system comprising a driver comprising a head section (318a; Figure 11E) that is configured to engage with an implantable medical evice (10; Figure 11E), wherein the head perimeter (322a; Figure 11D) defines a polygonal curve (Figure 11D) and wherein the protrusion (320a; Figure 11C and 11E) defines at least a portion of the polygonal curve (see Figure 11C).
It would have been obvious to one of ordinary skill in the art to change the perimeter shape of Schmidt to be a polygonal curve, as taught by Soltis, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Alternatively, it is the Examiner' s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the head section taught by Schmidt with the head section as taught by Soltis, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the head section of Soltis would be sufficient to provide torque to implant the medical device.
Allowable Subject Matter
Claims 11-13 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.
Regarding Claim 11, the prior art of record fails to disclose the medical system of claim 10,
wherein the retrieval structure defines the device recess and the slot,
wherein the slot defines a first minimum radial displacement from the device axis and the device recess defines a second minimum radial displacement from the device axis, and
wherein the first minimum radial displacement is less than the second minimum radial displacement.
Regarding Claim 12, the prior art of record fails to disclose the medical system of claim 10,
wherein the retrieval structure defines the device recess and the slot,
wherein the head section defines a first maximum radial displacement from the device axis when the protrusion inserts into the device recess and defines a second maximum radial displacement when the protrusion inserts into the slot, and
wherein the second maximum radial displacement is less than the first maximum radial displacement.
Regarding Claim 13, the prior art of record fails to disclose the medical system of claim 10, wherein the retrieval structure defines a first slot and a second slot on the structure perimeter, and wherein the retrieval structure defines at least one device recess between the first slot and the second slot on the structure perimeter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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