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 (claims 1-19) in the reply filed on 5/5/2026 is acknowledged.
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/5/2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN202221015511, filed on 3/21/2022.
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 1-2, 4, 6, 9, 11, 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190009057 Li et al. (hereinafter Li).
Regarding claim 1, Li discloses an implant detaching mechanism (10, Fig. 2) configured to detach an implant (110) from an implant holder (211), comprising:
a catheter having an inner shaft (200), a catheter shaft (300), a capsule (distal portion of sleeve 300), and a handle (the catheter will necessarily have a proximal end outside of the body and is thus considered the handle in order to manipulate the catheter);
the implant holder is attached to the inner shaft (as seen in Fig. 2), the implant holder having at least one pin (paragraph 89-94, in the embodiment in Fig. 16, thin strips (second locking pieces 215c) are provided with protruding distal end sections (216c) which are regarded as pins) on its peripheral surface (it is considered that the inner side of the second locking pieces (215c) is a peripheral surface of the implant holder) that is configured to engage an implant to the implant holder;
wherein the catheter shaft is movable in the longitudinal direction (paragraph 66) and a capsule (distal portion of sleeve 300) is attached to the distal end of the catheter shaft (300), wherein the capsule is configured to cover and uncover, upon movement of the catheter shaft, the implant holder and, at least partially, the implant when the implant is engaged to the implant holder (paragraph 73, Fig. 6); and
a thin strip (second locking piece 215, 215c), elastic in nature (paragraph 69, Fig. 6), that is attached to the implant holder (211) and located between the peripheral surface of the implant holder (paragraph 74, the limiting part 400 also may be fixed with the delivery cable 200 to form a whole) and the implant when the implant is engaged to the implant holder (Fig. 8, the peripheral surface of the limiting part is considered to match the peripheral surface of the implant holder);
wherein, on the capsule being moved to cover the implant holder, a force is applied on the thin strip and the implant when the implant is engaged to the implant holder (Fig. 6, paragraph 73, 75);
wherein, on the capsule being moved to uncover the implant holder, release of potential energy stored in the thin strip is configured to cause detachment of the implant, when the implant is engaged to the implant holder, from the pin (Fig. 9-10, paragraph 75).
Regarding claim 2, Li discloses the limitations in claim 1, and further discloses wherein the thin strip in the implant holder is attached towards proximal side of the implant holder at a first end of the thin strip and a second, opposing, end of the thin strip is free (as seen with second locking pieces 215, 215c in Fig. 4, 16).
Regarding claim 4, Li discloses the limitations in claim 1, and further discloses wherein the thin strip in the implant holder has at least a length long enough: 1) to reach the closest peripheral surface of the pin, 2) to reach the center point of the pin, 3) to reach the farthest peripheral surface of the pin, or 4) to surpass the pin (because the pins 216c are supported by the thin strips 215c, the thin strips are able to reach the closest peripheral surface of the pin).
Regarding claim 6, Li discloses the limitations in claim 1, and further discloses wherein the implant holder has a plurality of pins attached to the implant holder at equal distance in circumferential direction (as seen with the two pins 216c in Fig. 16).
Regarding claim 9, Li discloses the limitations in claim 1, and further discloses wherein the thin strip in the implant holder has at least a step-change in the curvature along its length or along its circumference (as seen with the curved thin strips 215c in Fig. 16).
Regarding claim 11, Li discloses the limitations in claim 1, and further discloses wherein the implant holder has a plurality of thin strips attached to the implant holder, wherein the plurality of thin strips are disposed parallel to each other (as seen with the plurality of thin strips 215c parallel to each other in Fig. 16).
Regarding claim 15, Li discloses the limitations of claim 1, and further discloses wherein the implant is selected from a stent, a valve, a mesh, a balloon, a patch, a drug-containing matrix, a shunt, a vena cava filter, a vascular graft, a stent graft, and/or a combination thereof (paragraph 62, “The interventional medical device 110 mentioned in this text may be any one medical device for the interventional therapy, such as a heart defect occluder, a valve repair device, a vascular plug, a vascular filter and a lung volume reduction device”).
Regarding claim 16, Li discloses the limitations of claim 1, and further discloses wherein the pin on the implant holder has a cross-sectional shape selected from rectangular, circular, D-shaped, oval, hexagonal, pentagonal, octagonal, triangular configuration, and/or a combination thereof (the pin 216c has a rectangular cross sectional shape as seen in Fig. 16).
Regarding claims 17-18, Li discloses the limitations of claim 1, and further discloses wherein the implant holder is made of a biocompatible material selected from a group of polymers, metals, alloys, non-metals, biodegradable materials, bioresorbable materials, and/or a combination of thereof (claim 17) and wherein the biocompatible material selected from stainless steel, nitinol, cobalt-chromium, polyamide, polypropylene, Acrylonitrile butadiene styrene, and/or a combination thereof (claim 18) (paragraph 68, “made of common metal materials for interventional medical devices, such as stainless steel or a cobalt-chromium alloy”, a material suitable for interventional medical devices is implicitly biocompatible).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 5702419 Berry et al. (hereinafter Berry).
Regarding claim 3, Li discloses the limitations in claim 1, and further discloses wherein the thin strip in the implant holder is attached towards a proximal side of the implant holder at a first end of the thin strip (as seen with second locking pieces 215, 215c in Fig. 4, 16).
Li is silent on a second end of the thin strip is attached towards distal side of the implant holder, wherein a length of the thin strip is higher than a distance between the attached ends to the thin strip into a curved configuration.
However, Berry teaches a device for delivering an implant (stent 10, Fig. 1, abstract) having an implant holder (40) that has thin strips 42 wherein one side of the thin strips are attached at a proximal side of the implant holder and a second side of the thin strip is attached at a distal side of the implant holder (Fig. 1, 9a-b, 10b-c, col. 8 line 39-58) and the thin strip is higher than a distance between the attached ends to the thin strip into a curved configuration (as seen in Fig. 1, 9a-b, 10b-c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Berry in order to provide an expansive force on the implant to further secure the implant to the implant holder prior to final deployment.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20060089627 Burnett et al. (hereinafter Burnett).
Regarding claim 8, Li discloses the limitations in claim 1.
Li is silent on wherein the thin strip in the implant holder has at least a step-change reduction in the thickness along its length or along its circumference.
However, Burnett teaches a device for delivering a medical device in a patient’s body (abstract, paragraph 2, 8) that has a medical device holder (82, Fig. 4, paragraph 47) with thin strips (medical device holder 82 opens at perforations 88 to create the thin strips) wherein the thin strips have at least a step-change reduction in the thickness along its length (paragraph 47, as seen in Fig. 4, step change 84 has a reduction in thickness along the length of the thin strip).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Burnett in order to allow a user to feel the abutment of the catheter to know that the catheter has advanced to the desired location as disclosed by Burnett (paragraph 47).
Claims 5, 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20150366665 Lombardi et al. (hereinafter Lombardi).
Regarding claim 5, Li discloses the limitations in claim 1.
Li is silent on wherein the thin strip in the implant holder has an eyelet or an elongated slot on its peripheral surface that is configured to accommodate an overlapping portion of the pin on compression due to the movement of the capsule.
However, Lombardi teaches a device for delivering an implant (abstract, paragraph 1) that comprises an implant holder (30, Fig. 3-4) with thin strips (52) having an eyelet or an elongated slot (62) configured to accommodate a pin (42) upon compression due to movement of a capsule (paragraph 64, 107-108, a sheath (capsule) surrounds an implant (valve) around the implant holder causing it to compress down onto the thin strips compressing the thin strips and the pins project through the eyelets of the thin strips).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Lombardi to further secure the implant to the implant holder.
Regarding claim 12, Li discloses the limitations in claim 1, and further discloses wherein the implant holder is attached to the inner shaft (as seen in Fig. 2),
Li is silent on wherein the inner shaft has at least one slot extending longitudinally or circumferentially.
However, Lombardi teaches a device for delivering an implant (abstract, paragraph 1) comprising an inner shaft (40, Fig. 5) having at least one slot (66) extending longitudinally to accommodate thin strips (52) (Fig. 5, paragraph 107, 110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Lombardi in order to ensure the thin strips can compress fully and to secure them to prevent lateral translation.
Regarding claim 13, the combination of Li and Lombardi teaches the limitations in claim 12, and the combination further teaches wherein the implant holder is attached to the inner shaft (Li: as seen in Fig. 2) wherein shape of the slot is rectangular, circular, helical, oval, or irregularly shaped configuration (Lombardi: shape of the slot 66 is rectangular as seen in Fig. 5).
Regarding claim 14, the combination of Li and Lombardi teaches the limitations in claim 12, and the combination further teaches wherein the implant holder is attached to the inner shaft (Li: as seen in Fig. 2) wherein at least one edge of the thin strip is accommodated in the slot (as seen in Fig. 3-4, paragraph 107, 110).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20070135826 Zaver et al. (hereinafter Zaver).
Regarding claim 19, Li discloses the limitations of claim 1.
Li is silent on wherein the implant holder has at least one radiopaque marker on its peripheral surface.
However, Zaver teaches a device for delivering an implant (100, Fig. 17a) in a body (abstract, paragraph 8) that has an implant holder (200, Fig. 17a) and the implant holder has at least one radiopaque marker (204, Fig. 17a, paragraph 177) on its peripheral surface.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Zaver in order to assist in the deployment of the implant to the proper location in the body.
Allowable Subject Matter
Claims 7 and 10 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. The following is a statement of reasons for the indication of allowable subject matter: No prior art references alone or in combination with other references teaches each and every limitation of the independent claims. The closest art of record is Li.
Regarding claim 7, Li discloses the limitations in claim 1. However, Li is silent on wherein the implant holder has a plurality of pins attached to the implant holder at unequal distance in circumferential direction.
Regarding claim 10, Li discloses the limitations in claim 1. However, Li is silent on wherein the thin strip includes at least one second thin strip attached to the thin strip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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