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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No.2021-128641, filed on 05/08/2021.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the limitation “An in-vivo indwelling stent that extends in an axial direction”, is directed to a non-statutory subject matter. Specifically, the phrase “in vivo indwelling stent” implies the living animal is part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean " a stent, configured for in-vivo indwelling, that extends in an axial direction ".
Claim Objections
Claim 3 objected to because of the following informalities: using the words “an other” instead of the grammatically correct “another”. Appropriate correction is required.
Claim 19 objected to because of the following informalities: Extra spacing and commas. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 Cam et al. US 20120290067 A1, herein referred to as Cam, in view of Kitaoka et al. EP 2322121 A1, herein referred to as Kitaoka, as motivated by Kealey et al. US 20200000612 A1, herein referred to as Kealey.
Regarding claim 1, Cam discloses an in-vivo indwelling stent (the instant application defines “in-vivo indwelling stent” as “used for treating various diseases caused by stenosis or occlusion of a blood vessel or other lumens in a living body” see [0003]; See [0002] Cam teaches treating blood occluding in a vessel; Stent 66k) that extends in an axial direction (Fig 6K),
has a central portion in the axial direction (Fig 6K) and is expandable from a contracted state to an expanded state ([0004], [0041]),
the in-vivo indwelling stent comprising: a plurality of annular bodies (Annotated Fig 6K below) each of which is constituted by a linear body that is in an annular shape (Fig 6k),
and connection portions that connect the annular bodies that are adjacent to each other (Annotated Fig 6K below),
a plurality of the annular bodies located on at least the central part of the stent including a first pattern annular body (Annotated Fig 6K below) and
a second pattern annular body (Annotated Fig 6K below) that are alternately arranged in the axial direction of the stent (Fig 6K),
the first pattern annular body having an endless zigzag linear shape including a plurality of one-end-side apexes (Fig 6k; 74), a plurality of other-end-side apexes (Annotated Fig 6k below),
that connect the plurality of one-end-side apexes and the plurality of other-end-side apexes (Annotated Fig 6k below) and that protrude in a first circumferential direction (Fig 6k; [0086] teaches multiple apexes 131, 133, 132 and 134),
the second pattern annular body having an endless zigzag linear shape including a plurality of one-end-side apexes (Fig 6k), a plurality of other-end-side apexes ([0086] teaches multiple apexes 131, 133, 132 and 134),
that connect the plurality of one-end-side apexes of the second pattern annular body and the plurality of other-end-side apexes of the second pattern annular body and that protrude in a second circumferential direction opposite to the first circumferential direction (Fig 6k; [0086] teaches multiple apexes 131, 133, 132 and 134,
and 80% or more of the one-end-side apexes and the other-end-side apexes of the first and second pattern annular bodies that are adjacent to each other are connected by the connection portions (Fig 6k).
But does not explicitly disclose a plurality of curved linear bodies plurality of curved linear bodies that connect the plurality of one-end-side apexes and the plurality of other-end-side apexes and that protrude in a first circumferential direction, and a plurality of curved linear bodies that connect the plurality of one-end-side apexes of the second pattern annular body and the plurality of other-end-side apexes of the second pattern annular body and that protrude in a second circumferential direction opposite to the first circumferential direction.
But Kitaoka teaches a plurality of curved linear bodies that connect the plurality of one-end-side apexes and the plurality of other-end-side apexes and that protrude in a first circumferential direction (Kitaoka Fig 4, curved strut 5), and a plurality of curved linear bodies that connect the plurality of one-end-side apexes of the second pattern annular body and the plurality of other-end-side apexes of the second pattern annular body and that protrude in a second circumferential direction opposite to the first circumferential direction (Kitaoka Fig 4, curved strut 5).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Cam to incorporate a plurality of curved linear bodies plurality of curved linear bodies that connect the plurality of one-end-side apexes and the plurality of other-end-side apexes and that protrude in a first circumferential direction, and a plurality of curved linear bodies that connect the plurality of one-end-side apexes of the second pattern annular body and the plurality of other-end-side apexes of the second pattern annular body and that protrude in a second circumferential direction opposite to the first circumferential direction, as taught and suggest by Kealey in order to allow omni-directional expansion of the stent (Kealey [0069]).
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Regarding claim 2, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the connection portions adjacent to each other in a circumferential direction of the stent are inclined in a common direction (Cam Annotated Fig 6K), and the connection portions adjacent to each other in the axial direction of the stent are inclined in different directions (cam Annotated Fig 6k).
Regarding claim 3, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the stent has one end and an other end at opposite axial ends of the stent (Cam Fig 6k), the stent including one end annular body at the one end of the stent and an other-end annular body at the other end of the stent (Cam Fig 6k), the stent including plural first pattern annular bodies (Cam Annotated Fig 6k above) and plural second pattern annular bodies (Cam Annotated Fig 6k above, all of the one-end-side apexes and the other-end-side apexes of the first and second pattern annular bodies being connected to the connection portions or adjacent annular bodies except for the apexes located at both axial ends of the stent, the stent having no other-end-side apex that is a free end except for the other-end annular body (Cam Annotated Fig 6k above).
Regarding claim 4, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches apex of each of the annular bodies has curved outer edges that are gently connected to the end of the connection portion without having a distinct bent portion (Cam Fig 6k).
Regarding claim 5, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches comprising at least two first pattern annular bodies each of which is the first pattern annular body (Cam Annotated Fig 6k above), wherein a number of the second pattern annular bodies is N - 1 or more and N + 1 or less when a number of the first pattern annular bodies is N (Kitaoka Col 6, lines 41-49; Fig 4; Teaches annular body numbers within defined ranged).
Regarding claim 6, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the connection portions include a first pattern connection portion (Kitaoka Fig 4, curved strut 5) and a second pattern connection portion (Kitaoka Fig 4, curved strut 5; Kitoaka teaches a plurality of this strut see Col 9, lines 32-57),
the first pattern annular body includes two curved linear bodies of the plurality of curved linear bodies extending from one of the one-end-side apexes to two different other-end-side apexes of the plurality of other-end-side apexes (Cam Fig 6k),
the second pattern annular body includes two curved linear bodies of the plurality of curved linear bodies extending from one of the one-end-side apexes to two different other-end-side apexes of the plurality of other-end-side apexes (Cam Fig 6k), the first pattern connection portion extends to another end side and in the second circumferential direction, and connects the other-end-side apexes of the first pattern annular body and the one-end-side apexes of the second pattern annular body (Cam Fig 6k),
and the second pattern connection portion extends to the other end side and in the first circumferential direction, and connects the other-end-side apexes of the second pattern annular body and the one-end-side apexes of the first pattern annular body (Cam Fig 6k).
Regarding claim 7, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein each of the curved linear bodies of the first pattern annular body and each of the curved linear bodies of the second pattern annular body have a substantially arc shape (Kitoaka Col 10, lines 52-58).
Regarding claim 8, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the connection parts each include a central part (Kitoaka Fig 5), the central parts of the connection portions being curved and protruding outward of the stent when the stent is expanded (Kitoak Col 16, 20-28).
Regarding claim 9, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the one-end-side apexes and the other-end-side apexes of the first and second pattern annular bodies and the connection portions are connected with continuity (Cam Fig 6k).
Regarding claim 10, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches the stent being substantially cylindrical in shape (Cam [0042]), being compressed in a central axis direction when inserted in a living body (Cam [0004]), and being expandable outward to be restored to a shape before compression (Cam [0004]).
Regarding claim 11, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches an vivo indwelling stent extending in an axial direction and having a substantially tubular shape (the instant application defines “in-vivo indwelling stent” as “used for treating various diseases caused by stenosis or occlusion of a blood vessel or other lumens in a living body” see [0003]; See [0002] Cam teaches treating blood occluding in a vessel; Stent 66k),
the stent comprising: a plurality of wavy linear bodies (Annotated Fig 6K above, annular bodies shown are wavy and linear) extending in the axial direction from one end side to another end side and arranged in a circumferential direction of the stent (Cam Fig 6k);
a plurality of connection portions (Kitoaka Fig 4, 5) connecting the wavy linear bodies adjacent to each other (Kitoaka Fig 4),
the plurality of connection portions extending in a predetermined long axis direction (Cam Fig 6k; [0086] teaches multiple apexes 131, 133, 132 and 134);
the wavy linear bodies including a plurality of first linear curved portions having central parts (Kitoaka Fig 3, strut 4) that protrude in a first circumferential direction of the stent and a plurality of second linear curved portions (Annotated Kitoaka Fig 3, strut 4 below; Kitoaka teaches plurality of all struts shown) having central parts that protrude in a second circumferential direction opposite to the first circumferential direction (Kitoaka Annotated Fig 3 below),
the first linear curved portions and the second linear curved portions being alternately arranged in the axial direction of the stent (Kitoaka Annotated Fig 3 below);
the connection portions including a first pattern curved connection portion located between the first linear curved portions of the wavy linear bodies that are adjacent to each other in the circumferential direction (Kitoaka Fig 4),
the first pattern curved connection portion connecting (Kitoaka Annotated Fig 3 below, strut 5, connecting on both sides) a portion on the one end side with respect to the central part of the first linear curved portion that is one of the first linear curved portions and that is located on the first circumferential direction side (Cam Fig 6k),
and a portion near the central part and on the other end side of the other first linear curved portion (Kitoaka Annotated Fig 3 below; connecting on both sides),
and a second pattern curved connection portion located between the second linear curved portions of the wavy linear bodies that are adjacent to each other in the circumferential direction (Kitoaka Fig 3),
the second pattern curved connection portion connecting a portion on the one end side with respect to the central part of the second linear curved portion that is one of the second linear curved portions and that is located on the second circumferential direction side (Kitoaka Fig 3),
and a portion near the central part and on the other end side of the other second linear curved portion (Annotated Fig 6k above);
a plurality of the first pattern curved connection portions being arranged in the circumferential direction of the stent with central parts of the first pattern curved connection portions protruding in the first circumferential direction (Kitoaka Fig 3),
and a plurality of the second pattern curved connection portions being arranged in the circumferential direction of the stent with central parts of the second pattern curved connection portions protruding in the second circumferential direction (Kitoaka Fig 4).
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Regarding claim 12, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 11 teaches wherein the first pattern curved connection portion and the second pattern curved connection portion have a substantially arc shape (Cam Fig 6k).
Regarding claim 13, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 11 teaches wherein the wavy linear bodies are substantially sinusoidal (Cam Fig 6k).
Regarding claim 14, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 11 teaches wherein the stent includes the first pattern curved connection portions in all regions between the first linear curved portions (Cam Fig 6k), and includes the second pattern curved connection portions in all regions between the second linear curved portions (Cam Fig 6k).
Regarding claim 15, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches an in-vivo indwelling stent (the instant application defines “in-vivo indwelling stent” as “used for treating various diseases caused by stenosis or occlusion of a blood vessel or other lumens in a living body” see [0003]; See [0002] Cam teaches treating blood occluding in a vessel; Stent 66k) extending in an axial direction and having a substantially tubular shape (Cam Fig 6K; Cam [0042]), the stent comprising:
a plurality of first pattern annular portions (Cam Annotated Fig 6K above) arranged in a circumferential direction of the stent (Cam Fig 6k),
each of the first pattern annular portions including a plurality of S-shaped curved (Kitoaka teaches curved see Fig 3) linear bodies extending in the axial direction of the stent (Cam Annotated Fig 6k above);
a plurality of second pattern annular portions arranged in the circumferential direction of the stent (Cam Annotated Fig 6k above),
each of the second pattern annular portions including a plurality of inverted S-shaped curved linear bodies extending in the axial direction of the stent (Cam Annotated Fig 6k above),
the first pattern annular portions and the second pattern annular portions being alternately arranged in the axial direction of the stent (Cam Fig 6k);
the first pattern annular portions and the second pattern annular portions that are adjacent to each other in the axial direction including an overlapping portion in which an end of the S-shaped curved linear body and an end of the inverted S-shaped curved linear body overlap each other in the circumferential direction between ends of the first pattern annular portion and the second pattern annular portion (Cam Fig 6k),
the first pattern annular portion and the second pattern annular portion adjacent to each other in the axial direction being connected to each other in the overlapping portion (Cam Annotated Fig 6k, see connections labeled);
and in the overlapping portion, one end of the inverted S-shaped curved linear body is connected to a portion (Kitoaka Fig 4, 5) located on one end side with a predetermined length from the other end of the S-shaped curved linear body adjacent to the inverted S-shaped curved linear body on one end side in the axial direction of the stent (Cam Fig 6k),
the other end of the inverted S-shaped curved linear body is connected to a portion (Kitoaka Fig 4, 5) located on the other end side with a predetermined length from one end of the S-shaped curved linear body adjacent to the inverted S-shaped curved linear body on the other end side in the axial direction of the stent (Cam Fig 6k [0046]),
one end of the S-shaped curved linear body is connected to a portion (Kitoaka Fig 4, 5) located on one end side with a predetermined length from the other end of the inverted S-shaped curved linear body adjacent to the S-shaped curved linear body on one end side in the axial direction of the stent (Cam Fig 6k [0046]),
and the other end of the S-shaped curved linear body is connected to a portion (Kitoaka Fig 4, 5) located on the other end side with a predetermined length from one end of the inverted S-shaped curved linear body adjacent to the S-shaped curved linear body on the other end side in the axial direction of the stent (Cam Fig 6k).
Regarding claim 16, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 15 teaches wherein the ends of all the S-shaped curved linear bodies located in a central part of the stent are connected to two of the inverted S-shaped curved linear bodies, and the ends of all the inverted S-shaped curved linear bodies located in the central part of the stent are connected to two of the S-shaped curved linear bodies.
Regarding claim 17, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 15 teaches wherein the S-shaped curved linear bodies and the inverted S-shaped curved linear bodies have substantially symmetrical shapes (Cam Fig 6k).
Regarding claim 18, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 15 teaches wherein a number of the S-shaped curved linear bodies constituting each of the first pattern annular portions and a number of the inverted S-shaped curved linear bodies constituting each of the second pattern annular portions are equal to each other (Cam Fig 6k).
Regarding claim 19, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 15 teaches wherein a number of the second pattern annular portions is N - 1 or more and N + 1 or less when a number of the first pattern annular portions is N (Kitaoka Col 6, lines 41-49; Fig 4; Teaches annular body numbers within defined ranged).
Regarding claim 20, Cam/Kitaoka/Kealey discloses the invention substantially as claimed and as discussed above with respect to claim 19 teaches A stent delivery system comprising: a sheath; the stent according to Claim 19 accommodated in a distal portion of the sheath (Kitoka Fig 13, sheath 202; Col 19 lines 35-53); and a shaft (Kitoaka Fig 13, shaft 204) that is slidably insertable through the sheath for releasing the stent from a distal end of the sheath (Kitoaka Col 19 lines 35-53).
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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