DETAILED ACTION
Receipt is acknowledged of Applicant’s Response, dated 8 September 2025, which papers have been made of record.
Claims 1-20 are currently presented for examination, of which claims 19-20 have been withdrawn from consideration.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18, in the reply filed on 8 September 2025 is acknowledged.
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 1-18 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 1 recites the pronoun “its” at lines 9 and 10. It is difficult to determine to which previously presented claim element the pronoun refers. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
Each of claims 2-14 depends from claim 1, and therefore is rejected for at least the reasons presented above with respect to claim 1. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
Claim 6 recites the pronoun “its” at line 2. It is difficult to determine to which previously presented claim element the pronoun refers. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
Claim 10 recites the pronoun “its” at line 3. It is difficult to determine to which previously presented claim element the pronoun refers. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
Claim 13 recites the pronoun “its” at line 2. It is difficult to determine to which previously presented claim element the pronoun refers. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
Claim 15 recites the pronoun “its” at lines 9 and 10. It is difficult to determine to which previously presented claim element the pronoun refers. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
Each of claims 16-18 depends from claim 15, and therefore is rejected for at least the reasons presented above with respect to claim 1. Applicant could overcome this rejection by reciting the claimed element in full each time it is to be referenced.
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 1-4, 7, 11, and 14-18
Claims 1-4, 7, 11, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication 2014/0277562 to Seddon et al. (hereinafter “Seddon”).
Regarding claim 1, Seddon discloses a method of manufacturing a medical implant (stent 10; see paragraph [0033]) for occluding a left atrial appendage (suitable for heart; see paragraph [0003]), comprising: cutting an expandable scaffold (body of stent 10; see Fig. ) in a first configuration (see Fig. 1A); wherein the expandable scaffold includes a plurality of struts (struts 26) having ends (see Fig. 3A; struts shown interconnected at terminal ends and paragraph [0018] at portions 22) joined together at intersection points (at 24a, 24b) and a plurality of anchor members (28; see Figs. 1A, 1B, 1C, 1D) extending from the plurality of struts such that each anchor member extends from a medial portion (see Figs. 1A, 1B, 1C, 1D at portions including anchors 28) of a strut (select a strut 26) of the plurality of struts (26); forming the expandable scaffold into a second configuration (bent configuration shown in Figs. 3A, 3B, 3C, 3D); wherein forming the expandable scaffold into the second configuration includes bending each anchor member (28) along its bending axis (twisting, which is understood to be bending about a longitudinal axis through 30a, 30b in Fig. 3A; see paragraph [0051]), the bending axis being oriented parallel to a longitudinal axis of its respective strut (26; longitudinal axis through geometric center of the struts having anchor portions 28 understood to be offset form centerline of strut body at 36a, 36b shown in Fig. 1A) of the plurality of struts (26); and heat setting the expandable scaffold in the second configuration (see paragraphs [0038] and [0052]; heat setting after bending/twisting).
Regarding claim 2, Seddon discloses the limitations of claim 1, and further Seddon discloses that the expandable scaffold is cut with a laser (see paragraph [0046]).
Regarding claim 3, Seddon discloses the limitations of claim 1, and further Seddon discloses that the first configuration is radially collapsed configuration (see Fig. 1A) and the second configuration is a radially expanded configuration (bent configuration shown in Figs. 3A, 3B, 3C, 3D).
Regarding claim 4, Seddon discloses the limitations of claim 1, and further Seddon discloses that each anchor member (28) extends radially outward from the plurality of struts (26) after bending (see Figs. 3A, 3B, 3C, 3D).
Regarding claim 7, Seddon discloses the limitations of claim 1, and further Seddon discloses that the expandable scaffold (body of stent 10) is formed from a unitary tubular member (tube of stent material is cut; see paragraph [0046]).
Regarding claim 11, Seddon discloses the limitations of claim 1, and further Seddon discloses that the expandable scaffold (body of stent 10) is formed from a flat sheet of material (see paragraph [0046]; stent formed from flat sheet which is rolled).
Regarding claim 14, Seddon discloses the limitations of claim 1, and further Seddon discloses forming the flat sheet of material into a tubular member (see paragraph [0046]; stent formed from flat sheet which is rolled).
Regarding claim 15, Seddon discloses a method of manufacturing a medical implant (stent 10; see paragraph [0033]) for occluding a left atrial appendage (suitable for heart; see paragraph [0003]), comprising: cutting an expandable scaffold (body of stent 10; see Fig. ) in a first configuration (see Fig. 1A); wherein the expandable scaffold includes a plurality of struts (struts 26) having ends (see Fig. 3A; struts shown interconnected at terminal ends and paragraph [0018] at portions 22) joined together at intersection points (at 24a, 24b) and a plurality of anchor members (28; see Figs. 1A, 1B, 1C, 1D) extending from the plurality of struts such that each anchor member extends from a medial portion (see Figs. 1A, 1B, 1C, 1D at portions including anchors 28) of a strut (select a strut 26) of the plurality of struts (26); forming the expandable scaffold into a second configuration (bent configuration shown in Figs. 3A, 3B, 3C, 3D); wherein forming the expandable scaffold into the second configuration includes bending each anchor member (28) along its bending axis (twisting, which is understood to be bending about the longitudinal axis; see paragraph [0051]), the bending axis being oriented parallel to a longitudinal axis (longitudinal axis through geometric center of the struts having anchor portions 28 understood to be offset form centerline of strut body at 36a, 36b shown in Fig. 1A) of its respective strut (26) of the plurality of struts (26); heat setting the expandable scaffold in the second configuration (see paragraphs [0038] and [0052]; heat setting after bending/twisting); and securing an occlusive element (cover 50) to the expandable scaffold (see paragraph [0039] and paragraphs [0053]-[0055]; cover may be applied to stent to produce covered stent).
Regarding claim 16, Seddon discloses the limitations of claim 15, and further Seddon discloses that at least some of the plurality of anchor members extend through the occlusive element (50) in the second configuration (see paragraph [0028]; in some embodiments the anchor 28 protrudes from the cover 50).
Regarding claim 17, Seddon discloses the limitations of claim 15, and further Seddon discloses that the occlusive element (50) is disposed along an exterior surface (see paragraph [0039]; there are embodiments where the outer surface 12 of the prosthesis is formed by the cover) of the expandable scaffold (body of stent 10).
Regarding claim 18, Seddon discloses the limitations of claim 15, and further Seddon discloses that the occlusive element (50) covers at least 30% of the expandable scaffold in the second configuration (see paragraph [0039]; fully covered stent configuration has a cover 50 which extends from a first end to a second end of the stent; reasonably understood to exceed 30% of the scaffold).
Allowable Subject Matter
Claims 5-6, 8-10, and 12-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the prior art made of record does not explicitly disclose or fairly teach that “forming the expandable scaffold into the second configuration includes preventing the plurality of struts from twisting,” in combination with the remaining limitations of the claim. The examiner notes that Seddon teaches that the anchors (28) are bent by twisting (see paragraph [0051]) but does not describe any structure which prevents other parts of the stent from also twisting.
Regarding claim 8, the prior art of record does not explicitly disclose or fairly teach that “bending each anchor member includes: inserting a punch into an interior of the expandable scaffold; and moving the punch radially outward relative to the plurality of struts,” in combination with the remaining limitations of the claim.
Regarding claim 10, the prior art of record does not explicitly disclose or fairly teach that “bending each anchor member includes: inserting a die into an interior of the expandable scaffold; and positioning its respective strut over a groove formed in the die; and urging the respective strut into the groove with a punch,” in combination with the remaining limitations of the claim.
Regarding claim 12, the prior art of record does not explicitly disclose or fairly teach that “bending each anchor member includes moving a punch through the expandable scaffold without moving the plurality of struts,” in combination with the remaining limitations of the claim.
Regarding claim 13, the prior art of record does not explicitly disclose or fairly teach that “bending each anchor member includes: inserting a die into an interior of the expandable scaffold; and positioning its respective strut over a groove formed in the die; and urging the respective strut into the groove with a punch,” in combination with the remaining limitations of the claim.
Conclusion
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/DARRELL C FORD/Examiner, Art Unit 3726