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 § 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 1-5, 11, 15 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by U.S. Patent Publication 2013/0131717 to Glimsdale.
As to claim 1-5, Glimsdale discloses a method for occluding a Left Atrial Appendage (LAA) (paragraph 5, 20, figure 18), the method comprising providing an occluder (100, figure 2) that has, when in a radially compressed condition (figure 2), (i) a disc (180) at a proximal end of the occluder, (ii) a lobe (185) at a distal end of the occluder, the lobe including a proximal surface that transitions into a middle portion at a first transition (see Annotated Figure I below) and a distal portion that transitions into the middle portion at a second transition (see Annotated Figure I below), (iii) a connecting member (see Annotated Figure I below) that connects the disc to the lobe, and (iv) a plurality of stabilizing wires (200) coupled to the lobe at the middle portion, each stabilizing wire having a hook portion (210) extending radially outward from the lobe and pointing toward the disc (figure 2), while the occluder is in a reduced delivery configuration within a delivery catheter (paragraph 54), advancing the occluder toward the LAA (paragraph 54-56), deploying the lobe of the occluder from the delivery catheter so that the lobe self-expands into the LAA (paragraph 55, 56, 45, 68) and so that the lobe has a deployed configuration (paragraph 55,56) in which radial compression causing the proximal surface of the lobe and the distal surface of the lobe to bow outwardly in a longitudinal a direction, while the middle portion resists bowing radially inwardly from the applied radial compression (paragraph 55). Th device is limited to return to the complete expanded state by the tissue opening diameter. Therefore the tissue will apply a radial compression to the device which would prevent the device to completely return to the expanded state. Even though the claim is a method claim, the recitation with respect to middle portion resists bowing radially inwardly from the applied radial compression is a functional recitation. Glimsdale does recite the claimed structure of the device with respect tot the first and second transitions of the lobe, the proximal, distal and middle surface of the lobe, and that the device does have a radial compression when the device is implanted in the LAA. Therefore, since Glimsdale discloses the claimed structure of the device and radial compression, Glimsdale will be able to read on “radial compression causing the proximal surface of the lobe and the distal surface of the lobe to bow outwardly in a longitudinal direction, while the middle portion resists bowing radially inwardly from the applied radial compression”.
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As to claim 2, Glimsdale discloses in the radially uncompressed condition, the middle portion is linear between the first transition and the second transition (figure 2).
As to claim 3, Glimsdale discloses in the radially uncompressed condition, the hook portion has a first angle with respect to the longitudinal direction (figure 2).
As to claim 4, Glimsdale discloses tin the radially uncompressed condition, the hook portion maintains the first angle with respect to the longitudinal a direction (paragraph 67, 68, after the device is deployed, and assumes the heat set shape, the hooks penetrate the wall of LAA to secure the device in place, once in place, the angle can be maintained).
As to claim 5, Glimsdale discloses after deploying the lobe from the occluder from the delivery catheter, the hook portions of the plurality of stabilization wires engage with the tissue of the LAA to help retain the occluder within the LAA (paragraph 68).
As to claims 11, 15, Glimsdale discloses the first and second transitions are curved (figure 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11, 15, 19, 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2018/0193027 to Wang in view of U.S. Patent Publication 2013/0131717 to Glimsdale.
As to claim 1, Wang discloses a method for occluding a left atrial appendage (LAA) (paragraph 113), the method comprising providing an occluder (100, figure 1-3b) that has, when in a radially compressed condition (figure 1-3b), (i) a disc (110, figure 1, 2) at a proximal end of the occluder, (ii) a lobe (120, figure 1,3b) at a distal end of the occluder, the lobe including a proximal surface (top portion of 120 as seen in figure 3a) that transitions into a middle portion (outside lateral portion of 122) at a first transition (125) and a distal portion (bottom portion of 120 as seen in figure 3a) that transitions into the middle portion at a second transition (124), (iii) a connecting member (126/114) that connects the disc to the lobe, and (iv) a plurality of stabilizing wires (wires that form barbs 127, figure 1, 3a, paragraph 119) coupled to the lobe at the middle portion, each stabilizing wire having a hook portion (tip of 127, paragraph 126, 130, the end part that “tilts up” and the barbs “hook” the inner wall of the LAA) extending radially outward from the lobe and pointing toward the disc (figure 1, 3a), while the occluder is in a reduced delivery configuration within a delivery catheter (paragraph 130), advancing the occluder toward the LAA (paragraph 130), deploying the lobe of the occluder from the delivery catheter so that the lobe self-expands into the LAA (paragraph 130, 114, 118, the device is made from nickel-titanium wires, which is a shape memory device which will self-expand) and so that the lobe has a deployed configuration (paragraph 130) in which radial compression causing the proximal surface of the lobe and the distal surface of the lobe to bow outwardly in a longitudinal a direction, while the middle portion resists bowing radially inwardly from the applied radial compression (paragraph 131). The device applies uniform pressure to the inner wall of the LAA. If pressure is applied to the LAA, that means an equal and opposite pressure, from the tissue, is applied to the device. The equal and opposite force can be the radial compression. Therefore, radial compression is applied to the device. Even though the claim is a method claim, the recitation with respect to middle portion resists bowing radially inwardly from the applied radial compression is a functional recitation. Wang does recite the claimed structure of the device with respect to the first and second transitions of the lobe, the proximal, distal and middle surface of the lobe, and that the device does have a radial compression when the device is implanted in the LAA. Therefore, since Wang discloses the claimed structure of the device and radial compression, Wang will be able to read on “radial compression causing the proximal surface of the lobe and the distal surface of the lobe to bow outwardly in a longitudinal direction, while the middle portion resists bowing radially inwardly from the applied radial compression”.
If it would not be known that the device of Wang will self-expand into the LAA since it is made of a shape memory material, Glimsdale teaches a similar device and method (occluder device and method, paragraph 7) having a device self expands as it is delivered into the LAA (paragraph 54, 55, 71, 49) based on using a similar shape memory alloy in order to set a desired shape of the device as it is delivered to occlude the LAA. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device in the method of Wang self-expand in order for obtain a desired shape configured to occlude the LAA.
As to claim 2, with the device of Wang, and Glimsdale above, Wang discloses in the radially uncompressed configuration, the middle portion is linear between the first transition and the second transition (figure 1, 3a). There is a linear section which connects the two transition section (figure 3a).
As to claim 3, with the device of Wang, and Glimsdale above, Wang discloses in the radially uncompressed condition, the hook portion has a first angle with respect to the longitudinal direction (figure 3a).
As to claim 4, with the device of Wang, and Glimsdale above, Wang discloses in the radially uncompressed condition, the hook portion maintains the first angle with respect to the longitudinal a direction (paragraph 130, after the device is deployed, and assumes the heat set shape, the hooks hook the wall of LAA to secure the device in place, once in place, the angle can be maintained).
As to claim 5, with the device of Wang, and Glimsdale above, Wang discloses after deploying the lobe from the occluder from the delivery catheter, the hook portions of the plurality of stabilization wires engage with the tissue of the LAA to help retain the occluder within the LAA (paragraph 130).
As to claim 6, with the device of Wang, and Glimsdale above, Wang discloses deploying the disc from the delivery catheter after deploying the lobe from the delivery catheter (paragraph 130).
As to claim 7, with the device of Wang, and Glimsdale above, Wang discloses deploying the disc from the delivery catheter includes allowing the disc to self-expand into a deployed configuration (paragraph 114, 130). Glimsdale will also teach the self-expansion (paragraph 49, 54)
As to claim 8, with the device of Wang, and Glimsdale above, Wang discloses the disc is in the deployed configuration, the disc abuts a wall of the heart surrounding an opening of the LAA (Figure 10).
As to claim 9, with the device of Wang, and Glimsdale above, Wang discloses when the disc is in the deployed configuration, the disc has a diameter that is larger than an opening of the opening of the LAA (figure 10).
As to claim 10, with the device of Wang, and Glimsdale above, Wang discloses disconnecting a delivery cable (the connection part of the transport device, paragraph 130, similar to the embodiment as seen in figure 21a ) from the disc after the disc is in the deployed configuration to fully deploy the occluder (paragraph 130). Glimsdale can also further teach/provide evidence on the delivery cable (410, figure 15b).
As to claims 11, 15, with the device of Wang, and Glimsdale above, Wang discloses the first and second transitions are curved (figure 3a).
As to claim 19, with the device of Wang, and Glimsdale above, Wang discloses the first transition is blunt (figure 3a). Paragraph 28 of the application discloses blunt is non-rounded. The second transition is more rounded than the first transition of Wang as seen in figure 3a. Therefore the first transition can be considered to be “blunt”.
As to claim 20, with the device of Wang and Glimsdale above, Wang discloses the first transition is approximately 90 degrees (figure 1). If it would not be known that first transition is approximately 90 degrees, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Wang as modified by Glimsdale to have a first transition be approximately 90 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wang would not operate differently with the claimed first transition and since the first transition would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that it is known in the art for a first transition be 90 degrees (paragraph 28) and that the first transition can be relatively blunt (paragraph 32).
Claims 12-14, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0131717 to Glimsdale.
As to claim 12-14, 16-18, Glimsdale discloses the method above but is silent about the specific ranges of the radius of curvature of the first and second transitions. Glimsdale does disclose the device is used in the LAA (paragraph 45) as well as another abnormalities in the heart as well as selecting a volume to conform to the curvature of the LAA (paragraph 65). Therefore, the radius of curvature of the first and second transitions can be a result effective variable in that changing the radius of the curvature will change how the device will conform the LAA. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Glimsdale to have first and second transitions have a radius of curvature be between 0.001 inches and 0.150 inches, (0.025 inches and 0.150 inches / 0.075 inches and 0.150 inches) as it involves only adjusting the dimensions of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Glimsdale by making the radius of curvature of the first and second transitions be between 0.001 inches and 0.150 inches (0.025 inches and 0.150 inches / 0.075 inches and 0.150 inches) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Claims 19, 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2013/0131717 to Glimsdale.
As to claim 19, 20, Glimsdale discloses the first transition is blunt approximately 90 degrees (figure 2). The application states that a device can be blunt if it is substantially 90 degrees (paragraph 32). It would seem that the first transition of Glimsdale will be approximately 90 degrees (figure 2). If it would not be known that first transition is approximately 90 degrees, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Wang as modified by Glimsdale to have a first transition be approximately 90 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wang would not operate differently with the claimed first transition and since the first transition would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that it is known in the art for a first transition be 90 degrees (paragraph 28) and that the first transition can be relatively blunt (paragraph 32).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-16 of U.S. Patent No. No. 12,108,946 in view of U.S. Patent Publication 2013/0131717 to Glimsdale.
As to the instant application’s claim 1, the reference patent claims a method for occluding a left atrial appendage ("LAA") (claim 12), the method comprising: providing an occluder (claim 12, “medical device”) that has, when in a radially uncompressed condition, (i) a disc (claim 12) at a proximal end of the occluder, (ii) a lobe (claim 12) at a distal end of the occluder, the lobe including a proximal surface (claim 12) that transitions into a middle portion (claim 12) at a first transition (claim 12, one of the curved transitions) and a distal portion that transitions into the middle portion at a second transition (claim 12, other curved transitions), (iii) a connecting member (claim 12) that connects the disc to the lobe, and (iv) a plurality of stabilizing wires (claim 12) coupled to the lobe at the middle portion, each stabilizing wire having a hook portion (claim 12) extending radially outward from the lobe; while the occluder is in a reduced delivery condition within a delivery catheter (claim 12), advancing the occluder toward the LAA; deploying the lobe of the occluder from the delivery catheter (claim 12), and so that the lobe has a deployed condition in which radial compression is applied to the lobe by tissue of the LAA (claim 12), the radial compression causing the proximal surface of the lobe and the distal surface of the lobe to bow outwardly in a longitudinal direction, while the middle portion resists bowing radially inwardly from the applied radial compression (claim 12) but is silent about the occluder self-expands into the LAA and the hook is pointing toward the disc.
Glimsdale teaches a similar device and method (occluder device and method, paragraph 7) having a device self expands as it is delivered into the LAA (paragraph 54, 55, 71, 49) based on using a similar shape memory alloy in order to set a desired shape of the device as it is delivered to occlude the LAA. Glimsdale also teaches a hook portion of a stabilizing wire extending radially outward from a lobe toward a disc (figure 2, paragraph 67, 68) for the purpose of helping to retain the device in the LAA. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device in the method of reference self-expand and have the hook portion pointing toward the disc in order for obtain a desired shape configured to occlude the LAA and retain the device in the LAA.
As to the instant application’s claim 2, see teaching reference figure 2. The shape is able to help conform the device to the LAA which will help retain the device in the LAA. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the middle portion of the claimed reference patent to have a linear middle portion in order to conform the claimed device to the LAA which will help retain the claimed device in the LAA
As to the instant application’s claim 3, see reference patent claim 12 (the radial extension angle).
As to the instant application’s claim 4, see reference patent claim 12.
As to the instant application claim 5, see teaching reference (paragraph 67,68).
As to the instant application’s claim 11-18, see reference patent claim 12.
Claims 6-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-16 of U.S. Patent No. No. 12,108,946 in view of U.S. Patent Publication 2013/0131717 to Glimsdale as applied to claims 1-5, 11-18 above and further in view of U.S. Patent Publication 2018/0193027 to Wang.
As to claim instant application’s 6, the reference patent as modified by Glimsdale claims the method above but is silent about the deploying the disc from the delivery catheter after deploying the lobe from the delivery catheter.
Wang teaches a similar device and method (LAA occluder, abstract) having a method step of deploying a disc from a delivery catheter after deploying a lobe from the delivery catheter (paragraph 130) in order to proper occlude the LAA first and then seal the opening of the LAA. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the claimed method of the reference patent deploy the disc after deploying the lobe in order to proper occlude the LAA first and then seal the opening of the LAA.
As to the instant application’s claim 7, see teaching reference Glimsdale (paragraph 67,68).
As to the instant application’s claim 8, see reference patent (claim 14).
As to the instant application’s claim 9, see reference patent (claim 15). The disc will have a diameter, and is outside the opening, contacting tissue surrounding the opening, so the disc will have a larger diameter.
As to the instant application’s claim 10, see reference patent (claim 12).
Conclusion
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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