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 .
Benefit
The application claims benefit to US Provisional 63/523,017 (filed 23 June 2023).
Formal Matters
Claims 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 September 2024 has considered by the examiner. A signed copy is attached.
Rejections Withdrawn
The rejection of claims 1 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onushko et al,. US 20190083075 (21 March 2019) is withdrawn in light of Applicant’s amendments. However, new rejections are set forth below, necessitated by amendment.
Rejections over now-cancelled claim 10 are moot in light of the cancellation of the claim. To the extent that subject matter of claim 10 has been incorporated into other claims, modified rejections apply as set forth below.
Response to Arguments
Regarding the rejection of claims 1 and 5-9, Applicant argues that the Onushko does not teach the amendments to claim 1 (Remarks, numbered p. 6). Applicant’s amendments are persuasive. The rejection is withdrawn. However, Applicant’s amendments also require a modified rejection, necessitated by amendment.
Regarding the rejection of claims 2-4 and 10-20, Applicant argues that claim 10 has been cancelled and claim 15 has been amended to include features of claim 10. Applicant argues that neither Onushko nor Min, either alone or in combination teach the amendments to claim 15 (Remarks, numbered p. 7). Applicant also argues that the designation reference number 600 designating the purse string sutures as teaching the emphasized features of amended claim 15. Applicant argues that there is no teaching or suggestion that these purse string sutures comprise a cinch suture that “restricts the radial expansion of the radially expandable frame to a first radially expanded orientation” as recited in claim 15. Applicant argues that claims 2-4 and 11-20 depend directly or indirectly from one of claims 1 or 15 that are in condition for allowance (Remarks, numbered p. 7).
Applicant’s arguments have been fully considered, but they are not persuasive. The modified rejections over amended claims 1 and 15 are set forth below over Onushko in view of Min. Regarding applicant’s argument as to the purse string sutures 600 of Min (FIG 6A, ¶37) cinch structure of Min, although Min does not textually recite the function of the structures to restrict the radial expansion of the radially expandable frame to a first radially expanded orientation, the cinch structures perform the functions for which they were designed. Applicant is reminded that the recitation of an element that is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946).
Further, ¶37 of Min also teaches that “the attachment anchors 118 can be sutures that are tied or otherwise coupled with the purse string sutures 600 placed in the LAA 108.” Accordingly, there is a teaching, suggestion, and motivation in Min that the purse string sutures are functionally placed to hold the LAA 108 in place. The placement of purse string sutures, which are expressly made for the purpose of cinching tissue, would be functionally able to restrict further radially expansion of the radially expandable frame and limit it to a first radially expanded orientation when it was placed in the LAA. One of ordinary skill in the art would reasonably understand that once the occlude was placed, it would need to be secured in the LAA and not permitted to further expand beyond the opening of the LAA.
Applicants’ attention is also drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure, such as the purse string sutures 600 of Min, is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use.
It is also noted that the phrase “suture lattice” does not appear in the disclosure as that term is now claimed. However, the examiner recognizes that mere rephrasing of a passage does not constitute new matter (MPEP 2163.07 and 608.01(o)). The examiner has given Applicant consideration for being their own lexicographer in the amended and newly added claim. However, there must still be originally filed support even if alternative comparable language (synonyms) are used. The phrases “first and second lattice of sutures” is recited throughout the specification and the amended phrase “suture lattice” is considered to be a mere rephrasing of the terms.
New and Modified Claim Rejections – Necessitated by Amendment
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.
Claims 1-9 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Onushko et al,. US 20190083075 (21 March 2019) in view of Min et al., US 20190175191 (13 June 2019).
Regarding amended independent claim 1, Onushko teaches an occlusion apparatus (FIGs 1, 3, 10) comprising: a radially expandable frame (12; ¶65) extending along a frame axis from a first axial end (annotated FIG 3) to a second axial end (annotated FIG 3), the first axial end defining a first opening (annotated FIG 3), and the first axial end comprising a plurality of attachment locations that are circumferentially spaced about the first opening (FIGs 1, annotated 3, anchor members 16); and
a first lattice (FIGs 1, 3; covering 14, ¶62) extending across the first opening (annotated FIG 3), and each peripheral portion of a plurality of portions (a plurality of anchor members 16; ¶65) of an outer periphery of the first lattice (FIGs 1, 3, covering 14, ¶62).
Onuskho does not teach sutures that threaded through a corresponding attachment location of the plurality of attachment locations to attach the first suture lattice to the first axial end.
Min teaches a left atrial appendage (LAA) occlusion device (morphology-specific occluder (MSO) 102, ¶19) comprising attachment anchors (118) that can be sutures (¶26) that are tied or otherwise coupled with the purse string sutures 600 placed in LAA 108 (¶26). The attachment anchors 118 can hold the MSO device 102 in place and within the LAA 108.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Onushko and Min, given that the prior art included each element claimed, although not necessarily in a single reference. Onushko and Min both teach left atrial appendage (LAA) occlusion devices.
Although, Onushko discloses the claimed base LAA occlusion device comprising a radially expandable frame and a first structure extending across the first opening, does not teach sutures that can be threaded through a corresponding attachment location of the plurality of attachment locations to attach the first suture lattice to the first axial end. Instead, Onushko teaches a plurality of anchor members on the outer periphery of the structure that can be used to anchor the occlusion device to the LAA.
Min specifically addresses attachment anchors as sutures. Because Onushko teaches the base device comprising a lattice (occlusive member 14 covering at least a portion of the expandable framework 12, ¶63) and teaches a plurality of portions of the outer periphery (covering 14) comprising a plurality of attachment locations (anchor members 16), a person of ordinary skill in the art, seeking to improve fastening architecture would reasonably consult Min’s suture solution. Min’s suture anchors can be incorporated alongside Onushko’s covering 14 where the anchors are sutures, as taught by Min, using known assembly methods without redesigning Onushko’s core device structure.
Because the references address the same engineering problem (securing radially expandable devices in an left atrial appendage) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing sutures as the anchors), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The term “sutures” is interpreted in the broadest reasonable interpretation given the definition provided in the Specification at ¶34 where “sutures refer to surgical sutures but can also include other sutures such as filaments, wires, strings, or strands of polymer, metal, or any suitable material”.
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Compare annotated FIGs 3 of Onushko to visualize the first and second axial ends.
Regarding claim 2, Onushko modified by Min teaches the occlusion apparatus (FIGs 1, 3; 10) of claim 1, as set forth above, for the reasons set forth above.
Onushko does not teach further comprising support material filling an interior area of the radially expandable frame to facilitate maintenance of the radially expandable frame in a radially expanded orientation, wherein the first suture lattice inhibits the support material from exiting the interior area through the first opening.
Min teaches a left atrial appendage (LAA) occlusion device (102; morphology-specific occluder (MSO), ¶19) comprising support material filling (fill including gels, ¶5) an interior area of the radially expandable frame (¶23; claim 1) wherein the first suture lattice (walls of the MSO device 102 comprising ribs; ¶23) inhibits the support material (fill including gels, ¶5) from exiting the interior area through the first opening (MSO monolithically integrated with valve 112; ¶24).
Onushko and Min both teach left atrial appendage (LAA) occlusion devices and they both teach a continuing need for improved medical devices to control thrombus formation within the left atrial appendage of patients (Min at ¶3 and Onushko ¶2). Although, Onushko discloses the claimed base occlusion apparatus 110 comprising a radially expandable frame), Onushko does not teach that the interior of the frame is filled with a support material. Instead, Onushko teaches an exterior support material and seal structure (FIG 4, ¶73). Min specifically addresses the need to provide closure of the left atrial appendage to seal the LSAA and reduce the risk of clot formation (¶3) by providing a scaffold structure (MSO 102) and then filling the interior of 102 with a support material (including gels, ¶¶5, 36). The filler of Min is taught as being enclosed within the MSO structure, inside a balloon with a monolithically integrated valve 112 (¶24). Additionally, Min teaches that the MSO device comprises walls of nitinol ribs (¶23). Because Onushko’s occlusion framework comprises a radially expandable frame (112) extending along a frame axis from a first axial end to a second axial end (FIG 4; ¶73), it provides an exterior framework structure like the ribs of Min’s MSO 102 (¶24). A person of ordinary skill in the art, seeking to provide greater structural support for the occlusion device and to reduce the risk of clot formation, as taught by Min at ¶3 and Onushko at ¶2, in the lattice frame of Onushko’s architecture would reasonably consult Min’s interior fill solution. Min’s MSO 102 interior fill solution can be incorporated alongside Onushko’s lattice framework (an otherwise empty expanded frame with the same type of anchoring mechanisms, similar to the walled rib structure of Min’s MSO 102) using known assembly methods without redesigning Onushko’s core device. Because the references address the same engineering problem (the need to establish stable, radially expandable occlusion devices in structurally distinct anatomical spaces while reducing the risk of clot formation) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding Min’s gel-filled structure comprising a valve to the interior of the rib-like lattice framework of Onushko in order to provide improved device support and reduce the risk of clot formation), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding amended claim 3, Onushko modified by Min teaches the occlusion apparatus of claim 2, as set forth above, for the reasons set forth above.
Onushko teaches the apparatus further comprising a second suture lattice (annotated FIG 3, above; occlusive member 14, extending across the hole near 12 in FIG 3; ¶63) extending across a second opening defined by the second axial end of the radially expandable frame (annotated FIG 3, above), wherein the second suture lattice inhibits the support material from exiting the interior area through the second opening (¶¶63-64).
Regarding claim 4, Onushko modified by Min teaches the occlusion apparatus of claim 2, as set forth above, for the reasons set forth above.
Onushko teaches related embodiment FIG 5, wherein the support material (230) comprises gel (hydrogel material, ¶81). Additionally, Min teaches wherein the support material (inflation fluid) comprises a polymeric gel (¶5; claim 5).
Regarding claim 5, Onushko teaches the occlusion apparatus of claim 1, as set forth above, for the reasons set forth above.
Onushko teaches wherein the first suture lattice (14) defines a central first lattice opening that is substantially concentric with the frame axis (FIGs 1, 3).
Regarding claim 6, Onushko teaches the occlusion apparatus of claim 1, as set forth above, for the reasons set forth above.
Onushko teaches wherein the radially expandable frame comprises a frustoconical shape (FIGs 1, 3).
Regarding claim 7, Onushko teaches the occlusion apparatus of claim 1, as set forth above, for the reasons set forth above.
Onushko wherein the radially expandable frame comprises a plurality of protrusions extending away from the frame axis and an exterior of the radially expandable frame (FIGs 1, 3; 16, ¶67).
Regarding claim 8, Onushko teaches the occlusion apparatus of claim 7, as set forth above, for the reasons set forth above.
Onushko teaches wherein the plurality of protrusions each comprise a hook (FIGs 1, 3; 16, ¶67).
Regarding claim 9, Onushko teaches the occlusion apparatus of claim 8, as set forth above, for the reasons set forth above.
Onushko teaches wherein each protrusion (16) of a first set of the plurality of protrusions comprises a distal end extending in a direction towards the first axial end (FIGs 1, 3; 16, ¶67).
Regarding new claim 21, Onushko modified by Min teaches the occlusion apparatus of claim 1, as set forth above, for the reasons set forth above.
Onushko teaches wherein first lattice (FIGs 1, 3; covering 14, ¶62) defines an outer peripheral array of polygonal lattice openings (annotated FIG 3; expandable framework 12).
Onushko does not teach wherein one corner of each polygonal lattice opening of the plurality of polygonal openings is associated with one attachment location of the plurality of attachment locations.
However, Onushko teaches that the expandable framework includes a plurality of anchor members extending radially outward from the expandable framework (¶12). Onushko teaches wherein the expandable framework and the plurality of anchor members are formed from a unitary tubular member (¶13). Onushko teaches a portion of the plurality of anchor members extend through an aperture formed in the occlusive member (¶14). A plurality of anchor members disposed along the expandable framework (¶16).
Min teaches a left atrial appendage (LAA) occlusion device (morphology-specific occluder (MSO) 102, ¶19) comprising “attachment anchors (118) that can be sutures” (¶26) “that are tied or otherwise coupled with the purse string sutures 600 placed in LAA 108” (¶26). Min also teaches that attachment anchors 118 can hold the MSO device 102 in place and within the LAA 108.
The term “sutures” is interpreted in the broadest reasonable interpretation given the definition provided in the Specification at ¶34 where “sutures refer to surgical sutures but can also include other sutures such as filaments, wires, strings, or strands of polymer, metal, or any suitable material”.
In its broadest reasonable interpretation polygons are a genus of shapes including triangles, quadrilaterals, hexagons, pentagons, octagons, etc. They are defined in the Specification at ¶44-48 as shapes comprising three or more sides.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Onushko and Min, given that the prior art included each element claimed, although not necessarily in a single reference. Onushko and Min both teach left atrial appendage (LAA) occlusion devices.
Although, Onushko discloses the claimed base LAA occlusion device comprising a radially expandable frame and a first structure extending across the first opening, does not teach sutures that can be threaded through a corresponding attachment location of the plurality of attachment locations to attach the first suture lattice to the first axial end. Instead, Onushko teaches a plurality of anchor members on the outer periphery of the structure that can be used to anchor the occlusion device to the LAA. Onushko teaches that the expandable framework includes a plurality of anchor members extending radially outward from the expandable framework (¶12). Onushko teaches wherein the expandable framework and the plurality of anchor members are formed from a unitary tubular member (¶13). Onushko teaches a portion of the plurality of anchor members extend through an aperture formed in the occlusive member (¶14). A plurality of anchor members disposed along the expandable framework (¶16). Accordingly, the anchor members are taught as being disbursed throughout the expandable framework in locations that may form various shapes of more than three sides depending on how they are viewed and the angle of viewing.
Min specifically addresses attachment anchors as sutures. Because Onushko teaches the base device comprising a lattice (occlusive member 14 covering at least a portion of the expandable framework 12, ¶63) and teaches a plurality of portions of the outer periphery (covering 14) comprising a plurality of attachment locations (anchor members 16), a person of ordinary skill in the art, seeking to improve fastening architecture would reasonably consult Min’s suture solution. Min’s suture anchors can be incorporated alongside Onushko’s covering 14 where the anchors are sutures, as taught by Min, using known assembly methods without redesigning Onushko’s core device structure.
Because the references address the same engineering problem (securing radially expandable devices in an left atrial appendage) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing sutures as the anchors), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, because suture structures are functions of a surgeon securing a suture, the patterns of suturing may vary as a result of the individual end-user surgeon. Accordingly,
the claimed wherein the first suture lattice defines an outer peripheral array of polygonal lattice openings, wherein one corner of each polygonal lattice opening of the plurality of polygonal openings is associated with one attachment location of the plurality of attachment locations is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that suture structure can be optimized depending on the end-effect desired for the use case and the surgeon making the stitches. The shape of the sutures can be optimized by a person of ordinary skill in the art without undue experimentation. As such, adjusting the sutures to any particular three-sided shape in order to secure the covering to the LAA would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Additionally, 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. See MPEP 2144.04. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding amended now independent claim 15, Onushko teaches a method (claim 18) of deploying an occlusion apparatus (FIGs 1, 3, 10) comprising a radially expandable frame (expandable framework 12; ¶65) extending along a frame axis from a first axial end (annotated FIG 3) to a second axial end (annotated FIG 3), and a first suture lattice (FIG 1, plurality of anchor members 16, ¶65) extending across a first opening defined by the first axial end of the radially expandable frame (FIGs 1, 3; 12, ¶65),
the radially expandable frame (FIGs 1, 3; 12, ¶65) positioned in a radially collapsed orientation (¶70) within an interior area of a capsule (part of the occlusion implant delivery system 20, ¶70) of a delivery device (catheter 24; ¶70),
the method (claim 18) comprising:
retracting the capsule (part of the occlusion implant delivery system 20, ¶70) in a proximal direction relative to the radially expandable frame such that the radially expandable frame (12) is positioned outside of the capsule (part of the occlusion implant delivery system 20, ¶70); radially expanding the radially expandable frame from the radially collapsed orientation to a radially expanded orientation (¶70),
Onushko does not expressly teach wherein after retracting the capsule in the proximal direction such that the radially expandable frame is positioned outside of the capsule, a cinch suture restricts the radial expansion of the radially expandable frame to a first radially expanded orientation; and filling an interior area of the radially expandable frame with a support material to facilitate maintenance of the radially expandable frame in the radially expanded orientation, wherein the first lattice of sutures inhibits the support material from exiting the interior area through the first opening.
Min teaches a left atrial appendage (LAA) occlusion device (morphology-specific occluder (MSO) 102, ¶19) comprising a radially expandable frame (¶23; claim 1). Min teaches deployment of the occluder 102 (“FIG 6B illustrates the retraction of the catheter 104. As the catheter 104 is retracted, the MSO device 102 is deployed into and remains within the LAA 108” ¶37). Min teaches retracting the capsule in the proximal direction such that the radially expandable frame is positioned outside of the capsule (FIG 6D, ¶37). Min teaches a cinch suture (FIG 6A, purse string sutures 600, ¶37) restricts the radial expansion of the radially expandable frame to a first radially expanded orientation.
Min also teaches a left atrial appendage (LAA) occlusion device (102; morphology-specific occluder (MSO), ¶19) comprising support material filling (fill including gels, ¶5) an interior area of the radially expandable frame (¶23; claim 1) wherein the first lattice of sutures (walls of the MSO device 102 comprising ribs; ¶23) inhibits the support material (fill including gels, ¶5) from exiting the interior area through the first opening (MSO monolithically integrated with valve 112; ¶24).
Onushko and Min both teach left atrial appendage (LAA) occlusion devices. Although, Onushko discloses the claimed base occlusion apparatus 110 comprising a radially expandable frame), Onushko does not teach that the interior of the frame is filled with a support material. Instead, Onushko teaches an exterior support material and seal structure (FIG 4, ¶73). Min specifically addresses the need to provide closure of the left atrial appendage to seal the LSAA and reduce the risk of clot formation (¶3) by providing a scaffold structure (MSO 102) and then filling the interior of 102 with a support material (including gels, ¶¶5, 36). The filler of Min is taught as being enclosed within the MSO structure, inside a balloon with a monolithically integrated valve 112 (¶24). Additionally, Min teaches that the MSO device comprises walls of nitinol ribs (¶23). Because Onushko’s occlusion framework comprises a radially expandable frame (112) extending along a frame axis from a first axial end to a second axial end (FIG 4; ¶73), it provides an exterior framework structure like the ribs of Min’s MSO 102 (¶24). A person of ordinary skill in the art, seeking to provide greater structural support for the occlusion device and to reduce the risk of clot formation, as taught by Min, in the lattice frame of Onushko’s architecture would reasonably consult Min’s interior fill solution. Min’s MSO 102 interior fill solution can be incorporated alongside Onushko’s lattice framework (an otherwise empty expanded frame with the same type of anchoring mechanisms, similar to the walled rib structure of Min’s MSO 102) using known assembly methods without redesigning Onushko’s core device. Because the references address the same engineering problem (the need to establish stable, radially expandable occlusion devices in structurally distinct anatomical spaces while reducing the risk of clot formation) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding Min’s gel-filled structure comprising a valve to the interior of the rib-like lattice framework of Onushko in order to provide improved device support and reduce the risk of clot formation), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The term “sutures” is interpreted in the broadest reasonable interpretation given the definition provided in the Specification at ¶34 where “sutures refer to surgical sutures but can also include other sutures such as filaments, wires, strings, or strands of polymer, metal, or any suitable material”.
Regarding claim 11, Onushko modified by Min teaches the method of claim 15, as set forth above, for the reasons set forth above.
Min teaches wherein the delivery device (104) further comprises an injection device (syringe, ¶36) comprising an injection tube (122, ¶24) extending through the first opening of the radially expandable frame with a distal end of the injection tube (122) positioned within the interior area of the radially expandable frame (¶24), wherein filling the interior area of the radially expandable frame comprises passing the support material through the injection tube (¶37; FIGs 6A-6D).
Regarding claim 12, Onushko modified by Min teaches the method of claim 11, as set forth above, for the reasons set forth above.
Min teaches wherein the injection tube (122) further extends through a central first suture lattice opening (¶37; FIGs 6A-6B) of the suture lattice (purse string sutures, 600) when passing support material through the injection tube (¶37).
Regarding claim 13, Onushko modified by Min teaches the method of claim 12, as set forth above, for the reasons set forth above.
Min teaches wherein, after filling the interior area of the radially expandable frame with the support material (¶37, FIG 6B/C), the injection tube is retracted until the distal end of the injection tube is positioned outside of the interior area of the radially expandable frame (¶37; FIGs 6B/C-6D), and after positioning the distal end of the injection tube outside of the interior area of the distal frame (¶37; FIG 6A), the central first lattice opening contracts to a reduced size to inhibit support material from exiting the interior area through the central first suture lattice opening (¶37; FIGs 6D).
Regarding claim 14, Onushko modified by Min teaches the method of claim 15, as set forth above, for the reasons set forth above.
Min teaches wherein filling the interior area of the radially expandable frame with the support material occurs after radially expanding the radially expandable frame (¶37; FIGs 6A-6D).
Regarding claim 16, Onushko modified by Min teaches the method of claim 15, as set forth above, for the reasons set forth above.
Min teaches wherein, after achieving the first radially expanded orientation, further comprising adjusting the cinch suture (¶37, purse string suture 600) to further radially expand the radially expandable frame to a second radially expandable orientation (¶37, FIGs 6A-6D).
Regarding claim 17, Onushko modified by Min teaches the method of claim 16, as set forth above, for the reasons set forth above.
Min teaches wherein a cinch device (¶37, purse string suture 600) is releasably secured to a portion of the cinch suture (¶37, attachment anchors 118) at a secured location (¶37; FIGs 6A-6D) and adjusting the cinch suture comprises distally extending the cinch device (¶37, attachment anchors 118 can be coupled to purse string suture 600).
Regarding claim 18, Onushko modified by Min teaches the method of claim 15, as set forth above, for the reasons set forth above.
Min teaches wherein filling the interior area of the radially expandable frame with a support material further radially expands the radially expandable frame to a final radially expandable orientation (¶37; FIGs 6B-6D).
Regarding claim 19, Onushko modified by Min teaches the method of claim 18, as set forth above, for the reasons set forth above.
Min teaches wherein after filling the interior area of the radially expandable frame with the support material (¶37, FIG 6D), further comprising releasing a tension in the cinch suture (¶37, purse string suture 600).
Regarding claim 20, Onushko modified by Min teaches the method of claim 15, as set forth above. Min teaches wherein the support material comprises gel (fill including gels, ¶5).
New Claim Rejection – Necessitated by Amendment
Claim Rejections - 35 USC § 112
Claims 1-9 and 21 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 limitation "each peripheral suture portion of a plurality of peripheral suture portions" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. The phrase “each peripheral suture portion” is recited before the “a plurality of peripheral suture portions”. Accordingly, the phrase “each peripheral suture portion” lacks antecedent basis.
Claims 2-9 and 21 are rejected as being dependent on a rejected claim.
Claim 21 is 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.
The suture lattice recited in claim 21 appears to be the product of an end-user constructing the sutures in a particular structure, rather than the structure of the device itself.
See MPEP 2173.05(p)(II). The examiner has considered whether the recited suture structure is a result of user-involved functions (suturing) or is a part of the structure of the claimed apparatus. The examiner has determined, in the broadest reasonable interpretation of the claims, that the recited suture structure of claim 21 is broadly drawn to end-user involved processes (e.g. the suture structure is woven by a surgeon as the end-user and the process by which the sutures are woven is a process by which at least a three-sided structure is weaved). The functional language is tied to the structure of the end-product of the suturing, even though the device structure is missing. The intermediate steps of suturing is not directed to the product, but rather to the users, and is dependent on the users (surgeon/suturers) which would create confusion as to when direct infringement occurs. See, Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005).
Where claimed and prior art products/apparatus (including systems) are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Accordingly, as long as the prior art teaches the claimed structural components, the claims are anticipated and/or rendered obvious by the prior art. See, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See also, MPEP 2111, MPEP 2113, MPEP 2173, and MPEP 2112.01.
Conclusion
No claim is allowed.
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 CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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