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 .
Response to Amendment
The amendment filed January 2, 2026 has been entered.
Claims 1-20 are currently pending.
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tischler et al. (US 2014/0135817, hereafter “Tischler”).
Regarding claim 1, Tischler discloses the invention substantially as claimed including a medical implant (200; Figs 5-12), comprising: an expandable framework (210) having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub (212) and a distal hub (214), wherein the expandable framework includes a distal shoulder region extending from the distal hub to a distal shoulder region end point (para [0046]); and
a membrane (230) disposed along an outer surface of the expandable framework, wherein the membrane extends along the outer surface of the expandable framework from the proximal hub to a membrane end point (para [0062]), and wherein the expandable framework includes a plurality of straight struts extending between the membrane end point and the distal shoulder region end point (see annotated Fig 11 below);
[AltContent: textbox (Distal Shoulder Region end point)][AltContent: arrow][AltContent: textbox (Membrane end point)][AltContent: arrow][AltContent: connector][AltContent: arrow][AltContent: textbox (At least one straight strut)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Proximal Hub)][AltContent: textbox (Distal Shoulder Region)][AltContent: textbox (Proximal Shoulder Region)][AltContent: textbox (Distal Hub)][AltContent: arrow][AltContent: arrow]
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Tischler teaches each straight strut of the plurality of straight struts forms at least a portion of a four-sided cell. Tischler fails to teach the cell may be a six-sided cell as claimed. Tischler discloses an example prior art device including a similar expandable framework (110) with a plurality of struts and a membrane (120) disposed along a portion thereof (Figs 3-3A; para [0042]) and teaches the struts of the framework form “elongated generally diamond-shaped wire portions” comprising a six-sided cell (cells in row 116). 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 Tischler such that each straight strut of the plurality of straight struts formed at least a portion of a six-sided cell as such a cell shape is known to be effective in a similar expandable framework and since substitution of one known element (four-sided cell in an expandable framework) for another element (six-sided cell in an expandable framework) providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Regarding claims 2 and 13, wherein the expandable framework further includes a proximal shoulder region, wherein the proximal shoulder region includes a first grouping of cells adjacent to the proximal hub and defining a first row (220), and wherein a first cell in the first row of cells includes a first strut segment and a second strut segment joined at a first distal node (distal end of diamond) (Figs 5, 11; para [0056]).
Regarding claim 3, wherein the first row (220) of cells extends circumferentially around the central longitudinal axis of the expandable framework (Figs 5, 11; para [0056]).
Regarding claims 4 and 14, wherein the expandable framework further includes a second grouping of cells defining a second row (222) adjacent to the first row (Figs 5, 11; para [0056]).
Regarding claims 5 and 15, wherein the width of at least one cell of the second grouping of cells (222) is different than the width of the cells defining the first grouping of cells (220) (Figs 5, 11; para [0056]).
Regarding claim 6, wherein the width of at least one cell of the second grouping of cells (222) is wider than the width of the cells defining the first grouping of cells (220) (Figs 5, 11; para [0056]).
Regarding claim 7, wherein the expandable framework further includes a plurality of fixation members (250) disposed thereon (para [0047]).
Regarding claims 8 and 16, wherein the expandable framework and the plurality of fixation members are formed from a unitary tubular member (para [0054]; Fig 10A).
Regarding claims 9 and 18, wherein at least a portion of the plurality of fixation members (250) extend through an aperture formed in the membrane (230) (para [0062]).
Regarding claims 10 and 19, wherein the plurality of struts extending between the proximal hub and the distal hub define an interior volume of the expandable framework, and wherein the proximal hub (212) is located outside the interior volume of the expandable framework and the distal hub (214) is located within the interior volume of the expandable framework (Figs 6, 11; para [0046, 0048, 0053]).
Regarding claim 11, wherein the expandable framework is configured to shift between a first unexpanded configuration and an expanded configuration, and wherein when in the expanded configuration, the distal hub is positioned proximal of a distalmost extent of the expandable framework (Figs 6, 11; para [0046, 0048, 0053]).
Regarding claim 12, Tischler discloses the invention substantially as claimed including an occlusive implant (200; Figs 5-12), comprising: an expandable framework (210) configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable framework includes a plurality of strut members circumferentially spaced around a longitudinal axis, the plurality of strut members being joined at a proximal hub (212) and a distal hub (214), and wherein the expandable framework includes a distal shoulder region extending from the distal hub to a distal shoulder region end point (para [0046]; see annotated Fig 11 above);
a membrane (230) disposed along an outer surface of the expandable framework, wherein the membrane extends along the outer surface of the expandable framework from the proximal hub to a membrane end point (para [0062]), and wherein the expandable framework includes a plurality of straight struts extending between the membrane end point and the distal shoulder region end point (see annotated Fig 11 above); and
a plurality of fixation members (250) disposed along the expandable framework (para [0047]).
Tischler teaches each straight strut of the plurality of straight struts forms at least a portion of a four-sided cell. Tischler fails to teach the cell may be a six-sided cell as claimed. Tischler discloses an example prior art device including a similar expandable framework (110) with a plurality of struts and a membrane (120) disposed along a portion thereof (Figs 3-3A; para [0042]) and teaches the struts of the framework form “elongated generally diamond-shaped wire portions” comprising a six-sided cell (cells in row 116). 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 Tischler such that each straight strut of the plurality of straight struts formed at least a portion of a six-sided cell as such a cell shape is known to be effective in a similar expandable framework and since substitution of one known element (four-sided cell in an expandable framework) for another element (six-sided cell in an expandable framework) providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Regarding claim 17, wherein the membrane (230) extends circumferentially around the outer surface of the expandable framework (para [0062]).
Regarding claim 20, Tischler discloses the invention substantially as claimed including a method for occluding a left atrial appendage of a patient (Figs 7-9, 12; para [0049-0052]), the method comprising:
positioning an occlusive implant (200) adjacent the left atrial appendage (para [0049]), the occlusive implant including;
an expandable framework (210) having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub (212) and a distal hub (214), wherein the expandable framework includes a distal shoulder region extending from the distal hub to a distal shoulder region end point (para [0046]; see annotated Fig 11 above); and
a membrane (230) disposed along an outer surface of the expandable framework, wherein the membrane extends along the outer surface of the expandable framework from the proximal hub to a membrane end point (para [0062]), and wherein the expandable framework includes a plurality of straight strut extending between the membrane end point and the distal shoulder region end point (see annotated Fig 11 above); and
expanding the occlusive implant within the left atrial appendage such that the membrane extends across an ostium of the left atrial appendage (Fig 12; para [0052, 0063]).
Tischler teaches each straight strut of the plurality of straight struts forms at least a portion of a four-sided cell. Tischler fails to teach the cell may be a six-sided cell as claimed. Tischler discloses an example prior art device including a similar expandable framework (110) with a plurality of struts and a membrane (120) disposed along a portion thereof (Figs 3-3A; para [0042]) and teaches the struts of the framework form “elongated generally diamond-shaped wire portions” comprising a six-sided cell (cells in row 116). 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 Tischler such that each straight strut of the plurality of straight struts formed at least a portion of a six-sided cell as such a cell shape is known to be effective in a similar expandable framework and since substitution of one known element (four-sided cell in an expandable framework) for another element (six-sided cell in an expandable framework) providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Response to Arguments
Applicant’s arguments, see amendment, filed January 2, 2026, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102(a)(1) as being anticipated by Tischler (US 2014/0135817) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tischler (US 2014/0135817) under 35 U.S.C. 103.
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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