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
Newly amended claim 24 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 24 is newly amended to include “the connecting unit connects the anchoring unit to the cover membrane, the anchoring unit is positioned between the supporting rod and the cover membrane, the cover membrane at a position of the anchoring unit protrudes in a direction facing away from an axis of the medical device, the cover membrane abuts closely against the surface of the anchoring member to form a protrusion structure.” Examiner notes applicant points to paragraph 118 describing figure 25 in the response to provide support for this language including the protrusion structure. Figure 25 is directed toward a non-elected species R. This protruding structure comprises the connecting unit attached to the cover membrane creating the protrusion structure, instead of connecting to the supporting rod 12 (as shown in elected species figs. 1, 2). Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 24 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-23 and 26 have been considered but are moot because the new ground of rejection over Chen et al. US 2019/0021741 in view of Lubock et al. US 2015/0133989, as discussed below. Claims 41-50 are newly added.
Claim Rejections - 35 USC § 112
Claims 23, 26 and 44 are 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.
Claim 23 discloses “the second end bends radially inward” in lines 1-2. This language is indefinite as the second end bending radially inward was also disclosed in claim 21, line 13. It is unclear as to whether this is the same or different radially inward bend.
Claim 26 discloses the limitation "a plug" in line 2-3. This language is indefinite as it is unclear whether the plug is the same plug or a different plug as claimed in claim 21, line 10.
Claim 26 discloses the limitation "the edge" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the cover membrane" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 21-23, 26, 41-43, 45, 46 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 2019/0021741 in view of Lubock et al. US 2015/0133989.
Regarding claims 21, 22 and 41, Chen et al. discloses a medical device, comprising: a fixing part (see annotated figure 2 below) configured to fix the medical device at a predetermined position (left atrial appendage closure apparatus, paragraph 0001), and the fixing part is provided with at least one anchoring member 104 (figure 2) so as to anchor the medical device at the predetermined position (paragraphs 0067, 0077; 104 anchoring pin to secure within the left atrial appendage); and a sealing part 106 connected to the fixing part and spaced apart from the fixing part along an axial direction of the medical device (sealing part 106, see annotated figure 2 below); wherein the sealing part has a shape selected from a disc shape, a cylindrical shape, and a plug shape (figure 2, plate or disc shape); wherein the fixing part comprises a plug 109 and a plurality of supporting rods 102 (figure 2), wherein each supporting rod has a first end connected to the plug 109 of the fixing part and extends radially outward from a central end portion before turning toward the sealing part (see annotated figure 2 below), wherein each supporting rod further comprises a second end that bends radially inward (see annotated figure 2 below, paragraph 0066, distal ends of supporting rods inwardly curved shape), and wherein each anchoring member is located between the first end and the second end of the supporting rod (figure 2, anchoring pins 104 between first and second ends).
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Chen et al. fails to explicitly disclose the anchor to abut against a target cavity after the medical device is implanted at the predetermined position, the anchoring member comprising a connecting unit and at least one anchoring unit, the connecting unit connects the anchoring unit to the supporting rod, wherein each anchoring member comprises a protrusion having a shape selected from hemispherical, drop-shaped, or disc-shaped.
Lubock et al. teaches a medical device comprising a fixing part provided with an anchoring member (for example, paragraph 0098, figures 7C-7K show a variety of anchoring shapes and configurations) configured to pierce or to abut against a target cavity after the medical device is implanted to as to anchor the medical device at the predetermined position (paragraph 0098, for example, retention members 14a having atraumatic tips configured to interface with the tissue or vascular walls without puncturing the tissue or vascular walls), the anchoring member comprising a connecting unit and at least one anchoring unit (for example, see figure 7E below, or various shapes may be realized, paragraph 0098), the connecting unit connects the anchoring unit to the supporting rod (for example, figure 7B, paragraph 0097, anchoring unit connected to supporting rod 18 of fixing part), wherein each anchoring member comprises a protrusion 14a having a shape selected from hemispherical, drop-shaped, or disc-shaped (for example, figure 7E, anchoring unit may comprise a spherical or drop shape or any other suitable shapes and/or configurations for atraumatic anchoring, paragraph 0098).
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Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify Chen et al. with an anchoring member comprising an anchoring unit or protrusion and a connecting unit to connect the anchoring unit to the supporting rod, as taught by Lubock et al. to provide atraumatic tips connected to a connecting unit and having a suitable shape at the end configured to interface with tissue and anchoring into a desire location without having to puncture tissue walls. It would have been an obvious matter of design choice to modify the anchoring unit to be hemispherical, drop-shaped, or disc-shaped for atraumatic anchoring, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 23, Chen et al. discloses wherein the second end bends radially inward (figure 2) and terminates in a spherical portion (figure 2, paragraph 0063, 0079, second end segment bends inward and ends in a round ball head or spherical bead 111).
Regarding claim 26, Chen et al. discloses wherein the sealing part 106 comprises a mesh tube formed (paragraph 0065, 0071, 0079, mesh sealing plate is a hollow woven structure to receive membrane 108 inside), and ends of the wires are closed and fixed by a plug at a distal end of the sealing part (paragraph 0065, 0071, distal end fixed within plug 109), and wherein the mesh tube is heat set to have the shape selected from a disc shape, a cylindrical shape, and a plug shape (figure 2, plate or disc shape; paragraph 0079, woven mesh structure forming the sealing part 106 is finalized to the plate shape by thermal treatment, ends of the plate fixed with the steel sleeve and fastener), and at least one layer of film is provided inside the sealing part (paragraph 0065, 0071, membrane 108 inside), the edge of which is fixed to the mesh at the edge of the sealing part (figure 2, membrane 108 edge fixed within the mesh structure 106 as it is inside the mesh structure). Examiner further notes the “sealing part comprising a mesh tube formed by weaving a plurality of wires…the mesh tube is heat set…” to have the selected shape is a product by process limitation. It is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2 Chen et al. discloses the resulting product comprising a sealing part being woven wires having the claimed shape selected from a disc shape, a cylindrical shape, and a plug shape.
Regarding claims 42 and 43, Chen et al. discloses a medical device essentially as claimed, wherein the supporting rod 102 has a medial side close to an axis of the medical device and a lateral side facing away from the axis (lateral side facing outward from the device, figure 2); wherein the anchoring member 104 is positioned on the lateral side of the supporting rod (figure 2) and extends obliquely outward relative to the supporting rod at an angle of 20-60 degrees (figures 2, paragraph 0016, angle between anchor and supporting rod being 20-45 degrees), but fails to disclose wherein each anchoring member comprises a protrusion, wherein the protrusion is positioned on the lateral side of the supporting rod and extends obliquely outward relative to the supporting rod, wherein each anchoring member further comprises a connecting member having a first end connected to the supporting rod and a second end connected to the protrusion, wherein the connecting member has a length of 0.5-2 mm, and wherein the protrusion has a maximum diameter of 1.5 mm to 2.5 mm, wherein the connecting member has an opening angle of 20-60 degrees relative to the axis of the medical device.
Lubock et al. teaches a medical device comprising a fixing part provided with an anchoring member (for example, paragraph 0098, figures 7C-7K show a variety of anchoring shapes and configurations) configured to abut against a target cavity after the medical device is implanted to as to anchor the medical device at the predetermined position (paragraph 0098, retention members 14a having atraumatic tips configured to interface with the tissue or vascular walls without puncturing the tissue or vascular walls), the anchoring member comprising a connecting unit and at least one anchoring unit (for example, figure 7E, or various shapes may be realized, paragraph 0098), wherein each anchoring member comprises a protrusion (for example, figure 7E, protrusion 14a), wherein the supporting rod has a medial side close to an axis of the medical device and a lateral side facing away from the axis; wherein the protrusion is positioned on the lateral side of the supporting rod and extends obliquely outward relative to the supporting rod (figure 7B shows an embodiment having the anchor protruding outward at an angle, paragraph 0097, retention member 14 may be angled toward a proximal end, but may bend or conform to anatomy), wherein each anchoring member further comprises a connecting member having a first end connected to the supporting rod and a second end connected to the protrusion (for example, figures 7A, 7B, paragraph 0097, anchoring unit connected to supporting rod 18 of fixing part), wherein the protrusion members may be about .025 mm to .5 mm in length (paragraph 0099), but fails to explicitly disclose wherein the connecting member has a length of 0.5-2 mm, and wherein the protrusion has a maximum diameter of 1.5 mm to 2.5 mm, or wherein the connecting member has an opening angle of 20-60 degrees relative to the axis of the medical device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lubock et al. with the connecting member having a length of 0.5-2 mm, the protrusion having a maximum diameter of 1.5 mm to 2.5 mm, and the connecting member has an opening angle of 20-60 degrees relative to the axis of the medical device 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 Li et al. in combination with Lubock et al. would not operate differently with the connecting member having a length of 0.5-2 mm, the protrusion having a maximum diameter of 1.5 mm to 2.5 mm, and the connecting member has an opening angle of 20-60 degrees relative to the axis of the medical device and the device would function successfully with the claimed ranges.
Regarding claim 45, Chen et al. discloses an anchoring member essentially as claimed above, but fails to disclose the anchoring member comprising a protrusion, and the protrusion is formed from a soft material selected from silicone or threads.
Lubock et al. discloses an anchoring member (for example, figures 7C-7K) wherein each anchoring member comprises a protrusion (for example, figure 7E, protrusion 14a), and the protrusion is formed from a soft material selected from silicone or threads (paragraph 0102, retention members may be any suitable material such as for example, PLA silicone).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing of the invention to modify Li et al. to have an anchoring member protrusion being made from a soft material selected from silicone or threads, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 46, Chen et al. in combination discloses wherein each supporting rod comprises a plurality of anchoring members (paragraph 0016, at least supporting rod has more than one anchor pin), with gaps formed between adjacent anchoring members on the supporting rod (for example, as shown in a similar embodiment figure 11, two sets of anchors 336 on each support rod 331 with a gap therebetween each anchor).
Regarding claim 50, Chen et al. discloses wherein the second end of the supporting rod is a free end suspended in air (figure 2, free end 111).
Claim(s) 44 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 2019/0021741 in view of Lubock et al. US 2015/0133989 and further in view of Melanson et al. US 10,722,240.
Regarding claim 44, Chen et al. in combination discloses the anchor member and a cover member (Chen et al., figure 3, anchor member 104 and a cover member 103), but fails to explicitly disclose wherein each anchoring member is arranged on a cover membrane by hot melting, entanglement or bonding.
Melanson et al. teaches a medical device for occluding a left atrial appendage (paragraph 0001) comprising a plurality of anchoring members 3090, 3094 (figure 88E) and a cover 3150 (figure 88E), wherein each anchoring members is arranged on the cover member (figure 88E, column 63 lines, 31-40; anchors 3090 may extend through the cover 3151 material), the cover member may be arranged over various portions of the device and may extend over the anchoring members as required, the cover being attached with penetrating anchors, the cover may be attached to various components with mechanical attachments, fasteners, adhesives, chemical bonds or other suitable techniques or combinations (column 57, lines 39-64).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Chen et al. with the anchoring member arranged on the cover member and attached by various means such as attachments, fasteners, adhesives, chemical bonds or other suitable techniques, as taught by Melanson et al. as known in the art for attaching a cover member to various components, such as anchoring elements, of the device.
Examiner further notes the “anchoring member is arranged on the cover membrane by hot melting, entanglement or bonding” is a product by process limitation. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Regarding claim 47, Chen et al. in combination discloses the medical device essentially as claimed as discussed above wherein the supporting rod comprises a plurality of anchoring members positioned at different horizontal planes (for example, figure 11, two rows of anchors 336 placed on struts 331 and extending circumferentially around the device), but fails to explicitly disclose wherein each anchoring member comprises a protrusion; and wherein the protrusions of the plurality of anchoring members are positioned at different horizontal planes, and wherein the protrusions extend from the supporting rod at different distances from the supporting rod and at different angles relative to the supporting rod.
Lubock et al. teaches a medical device comprising a fixing part provided with a plurality of anchoring members (for example, paragraph 0098, figures 7A show a plurality of anchoring members around the device, 7C-7K show a variety of anchoring shapes), wherein each anchoring member comprises a protrusion 14a (for example, figure 7E, anchoring unit may comprise a spherical or drop shape or any other suitable shapes and/or configurations for atraumatic anchoring, paragraph 0098).
Melanson et al. discloses a left atrial appendage closure device (column 1, lines 19-23) wherein the plurality of anchoring members are positioned at different horizontal planes (for example, figures 87A-90B, 98, rows of anchors 3090 and 3094), and wherein the anchors extend from the supporting rod at different distances from the supporting rod (column 70, lines 32-56, anchors may be of different lengths) and at different angles relative to the supporting rod (column 88, lines 24-43; anchors 3090 and 3094 may be inclined at the same or different angles) to provide an anchor configuration that will provide a number of anchors in the configuration as desired to increase stability of the device and ensure engagement with the LAA tissue (column 71, lines 28 – column 72, lines 16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Chen et al. with a plurality of anchoring members having a protrusion, as taught by Lubock et al. to provide atraumatic tips having a suitable shape at the end configured to interface with tissue and anchoring into a desire location without having to puncture tissue walls, and the plurality of anchoring members in different horizontal planes, and wherein the anchors extend from the supporting rod at different distances from the supporting and at different angles relative to the supporting rod, as taught by Melanson et al. as known in the art to provide the anchoring members configuration as desired to increase stability of the device and ensure engagement with the LAA tissue.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 2019/0021741 in view of Lubock et al. US 2015/0133989 and further in view of Campbell et al. US 2012/0172927.
Regarding claim 48, Chen et al. in combination disclose the device essentially as claimed as discussed above, but fails to disclose wherein each anchoring member comprises a protrusion, and wherein a contact surface of the protrusion configured to contact an atrial appendage wall comprises a biocompatible coating that smooths the contact surface.
Lubock et al. teaches a medical device comprising a fixing part provided with a plurality of anchoring members (for example, paragraph 0098, figures 7A show a plurality of anchoring members around the device, 7C-7K show a variety of anchoring shapes), wherein each anchoring member comprises a protrusion 14a (for example, figure 7E, anchoring unit may comprise a spherical or drop shape or any other suitable shapes and/or configurations for atraumatic anchoring, paragraph 0098).
Campbell et al. teaches a left atrial occlusion device (for example, figure 1, paragraph 0002) wherein each anchoring member 106 comprises a protrusion (for example, figures 5A-5C, 25; paragraph 0054; anchors or barbs configured to contact the left atrial appendage), and wherein a contact surface of the protrusion configured to contact an atrial appendage wall comprises a biocompatible coating that smooths the contact surface (paragraph 0105; barbs are coated/covered with a material which minimizes friction).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Chen et al. with a plurality of anchoring members having a protrusion, as taught by Lubock et al. to provide atraumatic tips having a suitable shape at the end configured to interface with tissue and anchoring into a desire location without having to puncture tissue walls, and the contact surface of the protrusion configured to contact an atrial appendage wall comprises a biocompatible coating, as taught by Campbell et al. to provide a surface that reduces friction and smooths the contact surface.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. US 2019/0021741 in view of Lubock et al. US 2015/0133989 and further in view of Bridgeman et al. US 2011/0054515.
Regarding claim 49, Chen et al. discloses the fixing part comprises a cover membrane (for example, figure 3, cover 103), but fails to disclose the cover membrane is made of a metal material.
Bridgeman et al. discloses a device for occluding the left atrial appendage (paragraph 0003) comprising a cover membrane 19 over a fixing part or frame 10 (figure 13), the cover membrane may be any suitable biocompatible material such as polyester, ptfe, silicone, urethane, metal fibers or other polymers (paragraph 0041).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cover membrane is made of a metal material or metal fibers since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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