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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 2, 2026 has been entered.
Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-9 and 12-19 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 7 recites “wherein the expandable framework further includes a plurality of fixation members disposed thereon”. However, claim 1 was amended to introduce a first fixation member and a second fixation member. Thus, it is unclear if claim 7 is introducing additional fixation members or if claim 7 is referring to the first and second fixation members already introduced in claim 1. Claims 8-9 are rejected due to their dependency on claim 7.
Claim 12 recites “a plurality of fixation members disposed along the expandable framework” in line 13, then goes on to introduce “a first fixation member” and “a second fixation member” in lines 16-22. Thus, it is unclear if liens 16-22 are introducing additional fixation members or if lines 16-22 are further defining plurality of fixation members of line 13. The Examiner suggests amending line 13 to recite “a plurality of fixation members disposed along the expandable framework including at least a first fixation member and a second fixation member”. Claims 13-19 are rejected due to their dependency on claim 12.
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”) in view of Bosma et al. (US 6,443,972, hereinafter “Bosma”).
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).
Tischler teaches the support frame may include a plurality of fixation members (250) to secure the implant to the tissue wall, which may be arranged in first (252) and second (254) rows forming a staggered pattern about the circumference of the framework, wherein “additional rows or other alternate arrangements of the plurality of anchors 250 are also possible” (Figs 5, 11 and para [0047]). However, Tischler fails to specifically teach the positioning of the first and second fixation members on first and second struts, as claimed. Bosma discloses a similar medical implant comprising an expandable framework (22) having a plurality of struts (24), wherein the struts form a portion of a six-sided cell (Fig 8), wherein a first straight strut of the plurality of straight struts includes a first fixation member (26,27) positioned along a length thereof including along a distal end region of the first straight strut; a second straight strut of the plurality of straight struts positioned circumferentially adjacent to the first straight strut includes a second fixation member (26,27) positioned along a length thereof including along a proximal end region of the second straight strut; wherein the first fixation member is longitudinally offset from the second fixation member (see annotated Fig 8 below) (col 6, ln 13-47).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Tischler to include additional hooking elements or fixation members such that a first straight strut of the plurality of straight struts includes at least a first fixation member and a second straight strut of the plurality of straight struts positioned circumferentially adjacent to the first straight strut includes at least a second fixation member, wherein the first fixation member is longitudinally offset from the second fixation member, as taught by Bosma, for the purpose of enhancing the effectiveness of the fixation members and since Tischler recognizes “additional rows or other alternate arrangements of the plurality of anchors 250 are also possible” (para [0047]).
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]). Alternatively, the plurality of fixation members may be interpreted as the first fixation member and the second fixation member defined in claim 1.
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).
Tischler teaches the support frame may include a plurality of fixation members (250) to secure the implant to the tissue wall, which may be arranged in first (252) and second (254) rows forming a staggered pattern about the circumference of the framework, wherein “additional rows or other alternate arrangements of the plurality of anchors 250 are also possible” (Figs 5, 11 and para [0047]). However, Tischler fails to specifically teach the positioning of the first and second fixation members on first and second struts, as claimed. Bosma discloses a similar medical implant comprising an expandable framework (22) having a plurality of struts (24), wherein the struts form a portion of a six-sided cell (Fig 8), wherein a first straight strut of the plurality of straight struts includes a first fixation member (26,27) positioned along a length thereof including along a distal end region of the first straight strut; a second straight strut of the plurality of straight struts positioned circumferentially adjacent to the first straight strut includes a second fixation member (26,27) positioned along a length thereof including along a proximal end region of the second straight strut; wherein the first fixation member is longitudinally offset from the second fixation member (see annotated Fig 8 above) (col 6, ln 13-47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Tischler to include additional hooking elements or fixation members such that a first straight strut of the plurality of straight struts includes at least a first fixation member and a second straight strut of the plurality of straight struts positioned circumferentially adjacent to the first straight strut includes at least a second fixation member, wherein the first fixation member is longitudinally offset from the second fixation member, as taught by Bosma, for the purpose of enhancing the effectiveness of the fixation members and since Tischler recognizes “additional rows or other alternate arrangements of the plurality of anchors 250 are also possible” (para [0047]).
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).
Tischler teaches the support frame may include a plurality of fixation members (250) to secure the implant to the tissue wall, which may be arranged in first (252) and second (254) rows forming a staggered pattern about the circumference of the framework, wherein “additional rows or other alternate arrangements of the plurality of anchors 250 are also possible” (Figs 5, 11 and para [0047]). However, Tischler fails to specifically teach the positioning of the first and second fixation members on first and second struts, as claimed. Bosma discloses a similar medical implant comprising an expandable framework (22) having a plurality of struts (24), wherein the struts form a portion of a six-sided cell (Fig 8), wherein a first straight strut of the plurality of straight struts includes a first fixation member (26,27) positioned along a length thereof including along a distal end region of the first straight strut; a second straight strut of the plurality of straight struts positioned circumferentially adjacent to the first straight strut includes a second fixation member (26,27) positioned along a length thereof including along a proximal end region of the second straight strut; wherein the first fixation member is longitudinally offset from the second fixation member (see annotated Fig 8 above) (col 6, ln 13-47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Tischler to include additional hooking elements or fixation members such that a first straight strut of the plurality of straight struts includes at least a first fixation member and a second straight strut of the plurality of straight struts positioned circumferentially adjacent to the first straight strut includes at least a second fixation member, wherein the first fixation member is longitudinally offset from the second fixation member, as taught by Bosma, for the purpose of enhancing the effectiveness of the fixation members and since Tischler recognizes “additional rows or other alternate arrangements of the plurality of anchors 250 are also possible” (para [0047]).
Response to Arguments
Applicant’s arguments, see amendment, filed July 2, 2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 103 as being unpatentable over 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 Bosma (US 6,443,972).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Clark (US 2014/0188157), Miles (US 2013/0178889), Young (US 2009/0171442) and Shank (US 6231581), additionally discloses a medical implant comprising an expandable framework with a plurality of straight struts having a plurality of fixation members.
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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