DETAILED ACTION
The following is a non-final office action is response to communications received on 06/30/2023. Claims 1-4 & 6-21 are currently pending and addressed below.
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
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 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.
Claim(s) 1-4 & 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macaulay et al. (US 9,192,751).
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Regarding Claim 1, Macaulay teaches a delivery sheath (1), comprising:
an insertion body (10), the insertion body comprising an outer elastic (Col 3: lines 13-15) layer (300), an inner elastic layer (200), a stent-like frame (100) between the inner elastic layer and outer elastic layer (Fig 1), and an adhesive between the inner elastic layer and the stent-like frame (Col 3: lines 15-18 teaches wherein 100 is laminated between 200 and 300. “Laminate” is defined in Merriam-Webster Dictionary as to unite layers by an adhesive), wherein the stent-like frame is configured to locally radially expand (Fig 12) in a section (50) thereof proportional to local surface lengthening of the section thereof, wherein the stent-like frame comprises a plurality of circumferential links (shown), a plurality of nodes (shown as the connection point or area between circumferential and longitudinal links), and a plurality of longitudinal links (shown), wherein the stent-like frame comprises a plurality of ring-like elements loops (112), with each ring-like element extending about a circumference of the stent-like frame (Fig 5), each ring-like element comprising circumferential links alternating with nodes and extending circumferentially about the ring-like element (Figs 3 & 5), and wherein adjacent ring-like elements are secured to each other via longitudinal links extending longitudinally between and connecting the nodes of the adjacent ring-like elements (Figs 3 & 5), wherein in an unexpanded configuration (Figs 7 & 8) of a portion of the stent-like frame (100) the longitudinal links (shown) and circumferential links (shown) in that portion of the stent-like frame have more-curved shapes (in cross section), and in an expanded configuration (Fig 9) of a portion of the stent-like frame the longitudinal links and circumferential links in that portion of the stent-like frame have less-curved shapes (as the stent-like frame has expanded and has less curvature in cross section); and
a hub (15 in Fig 15).
Regarding Claim 2, Macaulay teaches wherein the stent-like frame (100) is configured to maintain a constant overall linear (Fig 3 shows constant shows square pattern resulting in radial expansion without lengthening) length during local surface lengthening or local expansion of the stent-like frame.
Regarding Claim 3, Macaulay teaches wherein the stent-like frame (100) is configured to locally radially expand responsive to local surface lengthening of the stent-like frame (Fig 3 and 12).
Regarding Claim 4, Macaulay teaches wherein the stent-like frame is configured to locally lengthen responsive to local radially expansion of the stent-like frame (Figs 6 & 12).
Regarding Claim 6, Macaulay teaches wherein expansion of the stent-like frame (100) causes one or more of the circumferential links (shown in Fig 5) to at least partially straighten (radially), which causes one or more of the nodes to at least partially rotate (radially), which causes one or more of the longitudinal links to at least partially straighten (as the links are curved, expansion would cause at least some straightening).
Regarding Claim 7, Macaulay teaches wherein lengthening of the stent-like frame (100) causes one or more of the longitudinal links (shown) to at least partially straighten (to some extent the longitudinal links of Figs 5 & 6 would straighten if lengthened), which causes one or more of the nodes to at least partially rotate (radially), which causes one or more of the circumferential links (shown) to at least partially straighten (radially).
Regarding Claim 8, Macaulay teaches wherein the stent-like frame (100) comprises a memory material (Col 4: lines 19-21), and wherein the stent-like frame is adapted to locally radially expand responsive to outward pressure (Fig 12), and is further adapted to return to an unexpanded state responsive to removal of the outward pressure (Fig 12) (Col 5: lines 42-62).
Allowable Subject Matter
Claims 9-21 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, which is the most pertinent art found, fails to teach and/or fairly suggest the instant invention.
Regarding Claim 9, Macaulay (US 9,192,751) discloses the invention substantially as claimed. Macaulay teaches a delivery sheath (1), comprising: an insertion body (10), the insertion body comprising an outer elastic (Col 3: lines 13-15) layer (300), an inner lining layer (200), and a stent-like frame (100) between the outer elastic layer and the inner lining layer (Fig 1), wherein the stent-like frame comprises a plurality of ring-like elements (112) and a plurality of longitudinally-extending links (shown), each ring-like element comprising a plurality of circumferentially-extending links alternating with a plurality of nodes (Figs 3 & 5), a longitudinally-extending link of the plurality of longitudinally-extending links extending between two nodes of two adjacent ring-like elements (Figs 3 & 5), and a node (shown as the connection point or area between circumferential and longitudinal links) of a portion of the stent-like frame in an expanded state (Fig 9) being rotated (radially) relative to the node of the portion in an unexpanded state (Fig 8) to locally radially expand the stent-like frame responsive to local surface lengthening of the stent-like frame (Fig 12); and a hub (15 in Fig 15).
However, the prior art either individually or in combination, does not teach or render obvious wherein each of the plurality of longitudinally-extending links comprising a thinner center portion and a plurality of wider end portions.
Regarding Claim 16, Macaulay (US 9,192,751) discloses the invention substantially as claimed. Macaulay teaches a delivery sheath (1), comprising: an insertion body (10), the insertion body comprising an outer elastic (Col 3: lines 13-15) layer (300), an inner lining layer (200), and a stent-like frame (100) between the outer elastic layer and the inner lining layer (Fig 1), wherein the stent-like frame comprises a plurality of ring-like elements (112) and a plurality of longitudinally-extending links (shown), each ring-like element comprising a plurality of circumferentially-extending links alternating with a plurality of nodes (Figs 3 & 5), a longitudinally-extending link of the plurality of longitudinally-extending links extending between two nodes of two adjacent ring-like elements (Figs 3 & 5), and a node (shown as the connection point or area between circumferential and longitudinal links) of a portion of the stent-like frame in an expanded state (Fig 9) being rotated (radially) relative to the node of the portion in an unexpanded state (Fig 8) to locally radially expand the stent-like frame responsive to local surface lengthening of the stent-like frame (Fig 12); and a hub (15 in Fig 15).
However, the prior art either individually or in combination, does not teach or render obvious wherein each of the plurality of circumferentially-extending links comprising a thinner center portion and a plurality of wider end portions.
Duerig et al. (US 6,190,406) teaches an intravascular stent comprising circumferential-extending links and/or longitudinally-extending links comprising a thinner center portion (shown) and a plurality of wider end portions (shown). Said thinner and wider portion orientation configured to better distribute strain, and prevent metal to metal contact when bent and minimize opening size between struts, loops and bridges (Col 5: lines 56-59).
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In the examiner’s opinion, it would not have been obvious to a person of ordinary skill in the art to construct the circumferential-extending links and/or longitudinally-extending links, as taught by Macaulay, with the thinner and wider strut portion orientation, as taught by Duerig, as Macaulay is an introducer sheath with a sinusoidal strut pattern intended to expand radially to allow passage of a medical device, while Duerig is a stent configured to expand both radially and longitudinally with a traditional strut and bridge orientation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774