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 .
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.
Election/Restrictions
Applicant’s election without traverse of Species C, drawn to Claims 21-23 and 25-30 in the reply filed on 07/07/2026 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 26 and 27 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.
Regarding Claim 26, it is unclear how the connection part has no third film part form thereon when the claim it depends from, claim 21, has the limitation “the second cylindrical body, the connection part, and the bent portion having a third film part made of silicone formed thereon”. Further clarification is required.
Regarding Claim 27, it is unclear how “the connection part has no third film part formed thereon” when the claim it depends from, claim 21, has the limitation “the second cylindrical body, the connection part, and the bent portion having a third film part made of silicone formed thereon”. Further clarification is required.
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 21-23, 25-27, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200315821 A1 (hereafter --Myung--).
Myung discloses an anti-migration stent having a first stent (10) configured to expand a lesion area narrowed or blocked in a lumen of a body and to have a first cylindrical body formed in a hollow cylindrical shape by weaving or crossing wires made of a super elastic shape memory alloy (see Abstract) in a mesh shape so that multiple first space parts are formed between the wires (see annotated first space parts and crossing wires in Figure 14A below), a first film part made of polytetrafluoroethylene (PTFE) formed on an inner surface of the first cylindrical body (see Figure 14C below, the “first film part” being the portion on the inner surfaces of the wires, see paragraph [0106]) with the first film part formed in a spiral shape to have predetermined intervals defined therein (see paragraph [0106]), and a second film part made of polytetrafluoroethylene (PTFE) formed on an outer surface of the first cylindrical body (see Figure 14C below, the “second film part” being the portion on the outer surfaces of the wires), with the second film part being formed in the same spiral shape as the shape of the first film part so as to have predetermined intervals defined therein (see paragraph [0106]) and being bonded to the first film part (see Figure 14C below) the anti-migration stent comprising:
a second stent having multiple second space parts formed by weaving or crossing the wires (see annotated second space parts and crossing wires in Figure 14A below) made of a super elastic shape memory alloy in a mesh shape (see Abstract) with the second stent being shorter in length than the first stent and fitted over and connected to one side of the first stent from the outside so that the second stent is held in the lumen in which the lesion area has occurred (see Figure 14A below), wherein the second stent is composed of a second cylindrical body formed in a hollow cylindrical shape (see second stent in Figure 14A below), a connection part formed to be inclined at one side of the second cylindrical body so as to be connected to the first stent (see annotated connection part in Figure 14A below), and a bent portion formed at an angle between the second cylindrical body and the connection part (see annotated bent portion in Figure 14A below), with the second cylindrical body, the connection part, and the bent portion having a third film part made of silicone formed thereon (see paragraph [0106], see also third film part 24 in Figure 14A), wherein a protruding part is formed to protrude on one side of the first cylindrical body located at a side opposite to the second stent (see annotated protruding part in Figure 14A below), and wherein the protruding part has no first and second film parts formed thereon (see Figure 14A below).
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Regarding Claim 22, Myung discloses the anti-migration stent of claim 21, wherein a first space part of one end of the first stent and a second space part of the connection part are sewn and connected to each other with a connecting thread (see annotated connecting thread, connection part, and second space parts in Figure 14A above, see also paragraph [0045]).
Regarding Claim 23, Myung discloses the anti-migration stent of claim 21, wherein one end of the first stent and the connection part are integrally formed and connected to each other (see annotated first stent and connection part in Figure 14A above).
Regarding Claim 25, Myung discloses anti-migration stent of claim 21, wherein one side of the first cylindrical body overlapping with the connection part has no first and second film parts formed thereon (see paragraph [0106] denoting that the first and second film parts, being component 12, can be on only a “portion” of the first stent).
Regarding Claim 26, Myung discloses the anti-migration stent of claim 21, wherein the connection part has no third film part formed thereon (see Figure 14A showing that only a portion of the second stent can be covered by the “third film part”, see also paragraph [0106] denoting that membranes 12 and 24 made of silicon or Polytetrafluoroethylene (PTFE) at a “predetermined portion” or at positions with predetermined gaps on inner and outer stent 10 and 20, so only some of the spaces 11 and 21 are covered).
Regarding Claim 27, Myung discloses the anti-migration stent of claim 21, wherein one side of the first cylindrical body overlapping with the connection part has no first and second film parts formed thereon (see paragraph [0106] denoting that the first and second film parts, being component 12, can be on a portion of the first stent), and the connection part has no third film part formed thereon (see Figure 14A above showing that only a portion of the second stent can be covered by the “third film part”, see also paragraph [0106] denoting that membranes 12 and 24 made of silicon or Polytetrafluoroethylene (PTFE) at a “predetermined portion or at positions with predetermined gaps” on inner and outer stent 10 and 20, so only some of the spaces 11 and 21 are covered).
Regarding Claim 30, Myung discloses the anti-migration stent of claim 21, wherein the first stent protrudes by a predetermined length L from the connection part and is connected to the connection part (see annotated first stent and connection part in Figure 14A above).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 28 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200315821 A1 (hereafter --Myung --), in view of US 20150127087 A1 (hereafter --Kim--).
Regarding Claim 28, Myung discloses the anti-migration stent of claim 21.
Myung fails to disclose wherein a first space part at one side of the first cylindrical body overlapping with the second stent is greater in size than a first space part of a remaining part of the first cylindrical body which does not overlap with the second stent.
Kim discloses a stent with a cylindrical body for implantation into a patient (see stent in Figure 8 below, see also Abstract). Kim teaches wherein a first space part at one side of the first cylindrical body is greater in size than a first space part of a remaining part of the first cylindrical body (see annotated Figure 8 below).
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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 invention, for a first space part at one side of the first cylindrical body overlapping with the second stent is greater in size than a first space part of a remaining part of the first cylindrical body which does not overlap with the second stent, since it is taught by Kim that it is well known in the art to have differing sized “space parts”, or spaces between stent filaments, in the same stent to vary the mechanical properties according to a particular purpose. Such a modification would have involved a mere change in the size of components. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200315821 A1 (hereafter --Myung --), in view of US 20200214833 A1 (hereafter --Birmingham--).
Regarding Claim 29, Myung discloses the anti-migration stent of claim 21.
Birmingham discloses a first stent with a cylindrical body with first space parts and a second stent with a cylindrical body with second space parts for implantation into a patient (see stent in Figure 10 below, see also Abstract). Birmingham teaches wherein each of the second space parts is greater in size than each of the first space parts (see annotated Figure 10 below).
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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 invention, for the second space parts to be greater in size than each of the first space parts, since it is known in the art to have different sized “space parts” in an outer stent compared to the “space parts” of an inner stent as taught by Birmingham, and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20190167455 A1: This reference discloses an anti-migration stent having a first stent (1) configured to expand a lesion area narrowed or blocked in a lumen of a body and to have a first cylindrical body formed in a hollow cylindrical shape by weaving or crossing wires made of a super elastic shape memory alloy (see paragraph [0029]) in a mesh shape so that multiple first space parts are formed between the wires (see annotated first space parts and crossing wires in Figure 13 below), a first film part made of polytetrafluoroethylene (PTFE) formed on an inner surface of the first cylindrical body (see paragraph [0031] denoting that the cylindrical stent 1 is configured to have a membrane part 11 made of silicon or PTFE provided thereon so as to cover all diamond-shaped parts 12 of an entirety of the cylindrical stent 1, see also Figure 1), and a second film part made of polytetrafluoroethylene (PTFE) formed on an outer surface of the first cylindrical body (see paragraph [0031] denoting that the cylindrical stent 1 is configured to have a membrane part 11 made of silicon or PTFE provided thereon so as to cover all diamond-shaped parts 12 of an entirety of the cylindrical stent 1), the anti-migration stent comprising: a second stent (2) having multiple second space parts formed by weaving or crossing the wires (see annotated second space parts and crossing wires in Figure 13 below) made of a super elastic shape memory alloy in a mesh shape (see paragraph [0029]), with the second stent being shorter in length than the first stent and fitted over and connected to one side of the first stent from the outside so that the second stent is held in the lumen in which the lesion area has occurred (see Figure 13 below, see also Figure 6), wherein the second stent is composed of a second cylindrical body formed in a hollow cylindrical shape (see second stent 2 in Figure 13 below), a connection part formed to be inclined at one side of the second cylindrical body so as to be connected to the first stent (see annotated connection part in Figure 13 below, see also paragraph [0045]), and a bent portion formed at an angle between the second cylindrical body and the connection part (see annotated bent portion in Figure 13 below), with the second cylindrical body, the connection part, and the bent portion having a third film part made of silicone formed thereon (see Figure 10, see also paragraph [0031] denoting that the second stent can have a membrane 11, being the third film part, around the entirety of the second stent), wherein a protruding part is formed to protrude on one side of the first cylindrical body located at a side opposite to the second stent (see annotated protruding part 4 in Figure 4 below), and wherein the protruding part has no first and second film parts formed thereon (see Figure 13 below, see also Figure 12, see also paragraph [0044]).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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