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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/5/2025 has been entered.
Status of Claims
Claims 1-6 and 8-21 are pending and currently under consideration for patentability.
Claims 1, 2, 13, and 21 have been amended.
Claim 7 remains canceled without prejudice or disclaimer.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive.
The applicant argues that the combination fails to teach:
(1) the extension portion is independent of the stent body, and is an internally hollow arc- shaped tube connected to the proximal end of the stent body; and
(2) the extension portion has two ends, where the fixed end is fixedly connected with the edge of the proximal end of the stent body and the free end in a free state; and a partial region of the extension portion that occupies 1/3 of a total length of the arc-shaped tube is fixedly connected with the stent body along a spiral direction of the extension portion from the fixed end of the extension portion.
In response to argument (1) that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., internally hollow tubes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to argument (2) it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have explicitly a partial region of the extension portion at least occupying 1/3 of a total length of the arc-shaped tube in order to fit the particular procedure being done since this claimed dimension of the total length is not critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see page 3, paragraphs= 1 of applicants specification), the Federal Circuit held that, 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Li is not being modified by Binmoeller, Binmoeller needs to be modified by Li, so there is not destroying the intended use of Li.
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.
Claim(s) 1-13, 15, 16, 18-19 and 21is/are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller (US 20180289463 A1) in view of Li (CN 106880429 B).
Regarding Claim 1, Binmoeller teaches a medical drainage stent (medical drainage stent)(figures 13A-16D), comprising:
a stent body (170), and a proximal portion and a distal portion that are located at two ends of the stent body configured to connect a first region and a second region in a juxtaposing manner (paragraph [0027]), the stent body being fixed between the first region and the second region to provide a drainage channel (paragraph [0032]),
wherein the proximal portion of the stent has N extension portions (flange structure 171)(figure 15A-15C), a fixed end of the extension portion being fixedly connected with an edge of a proximal end (downstream flange/ proximal edge, paragraph [0019])) of the stent body (170) (annotated figure 15B).
structures of the N extension portions (171) at least partially protrude from the stent body in a radial direction (figure 15B) so that the proximal portion of the stent is fixed on the first region, wherein N (N =2) is a positive integer.
An alternative embodiment of Binmoeller teaches the other end of the extension portion being a free end in a free state, the other end is a free end in a free state; (distal end is free until flange is deployed (paragraph [0031-32]). It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to combine the embodiments Binmoeller to include a free end portion so that stent may be easily inserted.
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Binmoeller fails to teach wherein the extension portion is an arc-shaped tube extending spirally along the edge of the proximal end of the stent body; the fixed end of the arc-shaped tube is fixed at the edge of the proximal end of the stent body; the other end is a free end in a free state; and a partial region of the extension portion at least occupying 1/3 of a total length of the arc-shaped tube is fixedly connected with the edge of the proximal end of the stent body along a spiral direction of the extension portion from the fixed end of the extension portion.
Li teaches a spiral vascular bracket wherein the extension portion is an arc-shaped tube extending spirally along the edge of the proximal end of the stent body (abstract)(figure 2); the fixed end of the arc-shaped tube is fixed at the edge of the proximal end of the stent body (“the spiral vascular bracket two ends of helix 1 for curve 1 asmoothly connecting to integrally form a closed state”); the other end is a free end in a free state (open spiral ends, figure 2 and 3)(claim 1); the arc-shaped tube is fixedly connected with the edge of the proximal end of the stent body along a spiral direction of the extension portion from the fixed end of the extension portion (open spiral ends, figure 2 and 3). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the stent of Binmoeller to have the extension portion is an arc-shaped tube extending spirally along the edge of the proximal end of the stent body; the fixed end of the arc-shaped tube is fixed at the edge of the proximal end of the stent body; the other end is a free end in a free state; and a partial region of the extension portion at least occupying 1/3 of a total length of the arc-shaped tube is fixedly connected with the edge of the proximal end of the stent body along a spiral direction of the extension portion from the fixed end of the extension portion, similar to Binmoeller so that the stent is both flexible and supported.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have explicitly a partial region of the extension portion at least occupying 1/3 of a total length of the arc-shaped tube in order to fit the particular procedure being done since this claimed dimension of the total length is not critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see page 3, paragraphs= 1 of applicants specification), the Federal Circuit held that, 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 2, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 1. Binmoeller further teaches wherein a structure of the arc-shaped tube partially protrudes from the stent body in the radial direction (171), so that the proximal portion of the stent is fixed on the first region (figure 15B)(paragraph [0083]).
Regarding Claim 3, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 1. Binmoeller further teaches wherein the extension portion extends outward along a radial direction of the stent body figure 15B)(paragraph [0083]), the fixed end thereof is fixed at the edge of the proximal end of the stent body (downstream flange), and the other end is a free end in a free state (distal end is free until flange is deployed (paragraph [0031-32])).
Regarding Claim 4, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 1. Binmoeller further teaches wherein all the extension portions are evenly arranged at the edge of the proximal end of the stent body (figure 15B), and an included angle between two adjacent extension portions is 360/N degrees, wherein N is a positive integer from 2 to 4 (right angles are 90 degrees. (360/4)) (paragraph [0080])
Regarding Claim 5, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 2. Binmoeller further teaches wherein all the extension portions are evenly arranged at the edge of the proximal end of the stent body (figure 15B), and an included angle between two adjacent extension portions is 360/N degrees, wherein N is a positive integer from 2 to 4 (right angles are 90 degrees. (360/4)) (paragraph [0080])
Regarding Claim 6, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 3. Binmoeller further teaches wherein all the extension portions are evenly arranged at the edge of the proximal end of the stent body (figure 15B), and an included angle between two adjacent extension portions is 360/N degrees, wherein N is a positive integer from 2 to 4 (right angles are 90 degrees. (360/4)) (paragraph [0080])
Regarding Claim 8, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 2. Binmoeller further teaches wherein the free end of the extension portion is provided with a fixing structure for fixedly connecting the free end to the first region (paragraph [0037]), wherein the fixing structure and the free end are fixedly or not fixedly connected (distal end is free until flange is deployed (paragraph [0031-32])) and supporting force of the fixing structure is greater than that of the extension portion (paragraph [0051: pullout force can be greater than 9.8N)]) (paragraph [0004: down steam flange structure have a force of about 2.49 N]).
Regarding Claim 9, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 3. Binmoeller further teaches wherein the free end of the extension portion is provided with a fixing structure for fixedly connecting the free end to the first region (paragraph [0037]), wherein the fixing structure and the free end are fixedly or not fixedly connected (distal end is free until flange is deployed (paragraph [0031-32])) and supporting force of the fixing structure is greater than that of the extension portion (paragraph [0051: pullout force can be greater than 9.8N)]) (paragraph [0004: down steam flange structure have a force of about 2.49 N]).
Regarding Claim 10, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 1. Binmoeller further teaches a retrieval loop provided at the proximal portion and/or the distal portion of the stent (paragraph [0033]). The claim language only requires the prior art to disclose one of the claim structures, therefore “the developing member provided on the stent to display a position of the stent under rays” is not required.
Regarding Claim 11, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 2. Binmoeller further teaches a retrieval loop provided at the proximal portion and/or the distal portion of the stent (paragraph [0033]). The claim language only requires the prior art to disclose one of the claim structures, therefore “the developing member provided on the stent to display a position of the stent under rays” is not required.
Regarding Claim 12, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 3. Binmoeller further teaches a retrieval loop provided at the proximal portion and/or the distal portion of the stent (paragraph [0033]). The claim language only requires the prior art to disclose one of the claim structures, therefore “the developing member provided on the stent to display a position of the stent under rays” is not required.
Regarding Claim 13, Binmoeller teaches a medical drainage stent (medical drainage stent)(figures 13A-16D), comprising:
a stent body (170), and a proximal portion and a distal portion that are located at two ends of the stent body configured to connect a first region and a second region in a juxtaposing manner (paragraph [0027]), the stent body being fixed between the first region and the second region to provide a drainage channel (paragraph [0032]),
wherein the stent body has a flexible portion (172) whose supporting force is smaller than that of the proximal portion and the distal portion (paragraph [0039]); and
the flexible portion is able to form a recess with a reduced inner diameter after being pressed (paragraph [0039]), so that structures of the proximal portion and the distal portion of the stent partially protrude from the stent body(paragraph [0039]), and that the proximal portion of the stent is fixed on the first region, and the distal portion is fixed on the second region (paragraph [0053]).
The primary embodiment of Binmoeller fails to teach wherein the flexible portion is able to form a recess with a reduced inner diameter after being pressed, so that structures of the proximal portion and the distal portion of the stent partially protrude from the stent body, and that the proximal portion of the stent is fixed on the first tissue wall, and the distal portion is fixed on the second tissue wall. It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to combine the embodiments Binmoeller to create flanges at the desired location depending on the procedure.
Binmoeller fails to teach wherein the extension portion is an arc-shaped tube extending spirally along the edge of the proximal end of the stent body; the fixed end of the arc-shaped tube is fixed at the edge of the proximal end of the stent body; the other end is a free end in a free state; and a partial region of the extension portion at least occupying 1/3 of a total length of the arc-shaped tube is fixedly connected with the edge of the proximal end of the stent body along a spiral direction of the extension portion from the fixed end of the extension portion.
In the same field of endeavor, Li teaches an anti-displacement anesthetic catheter wherein the extension portion is an arc-shaped tube (airbag 2) extending spirally along the edge of the proximal end of the stent body(1) (figures 1-3); the fixed end of the arc-shaped tube is fixed at the edge of the proximal end of the stent body (1) (page 3); the arc-shaped tube is fixedly connected with the edge of the proximal end of the stent body along a spiral direction of the extension portion from the fixed end of the extension portion (figure 3)(page 3). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have the extension loop down the stent similar to Li to prevent displacement of the catheter (as motivated by Li, page 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have explicitly a partial region of the extension portion at least occupying 1/3 of a total length of the arc-shaped tube in order to fit the particular procedure being done since this claimed dimension of the total length is not critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see page 3, paragraphs= 1 of applicants specification), the Federal Circuit held that, 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 15, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 13. Binmoeller further teaches wherein the flexible portion (172) covers a part of a region of the stent body (figures 15A-15B)(paragraph [0083]), and supporting force of the remaining region of the stent body is greater than that of the flexible portion (paragraph [0039]).
Regarding Claim 16, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 13. Binmoeller further teaches wherein the proximal portion and the distal portion of the stent have fixing structures (flange structure 171)(figure 15A-15C) protruding from the stent body (170) (paragraph [0083]).
Regarding Claim 18, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 15. Binmoeller further teaches wherein the proximal portion and the distal portion of the stent have fixing structures (flange structure 171)(figure 15A-15C) protruding from the stent body (170) (paragraph [0083]).
Regarding Claim 19, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 13. Binmoeller further teaches a retrieval loop provided at the proximal portion and/or the distal portion of the stent (paragraph [0033]). The claim language only requires the prior art to disclose one of the claim structures, therefore “the developing member provided on the stent to display a position of the stent under rays” is not required.
Regarding Claim 21, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 14. The combination further teaches wherein the free end of the extension portion is provided with a fixing structure for fixedly connecting the free end to the first region, wherein the fixing structure and the free end are fixedly or not fixedly connected, and a supporting force of the fixing structure is greater than that of the extension portion (paragraph [0051-0052]).
Claim(s) 14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller (US 20180289463 A1) in view of Li (CN 106880429 B) in view of Amplantz (US-9039724-B2).
Regarding Claim 14, the combination of Binmoeller in view of Li teaches the medical drainage stent according to claim 13. Binmoeller fails to teach wherein the stent body has more than two flexible portions that extend along an axial direction of the stent body, and the flexible portions are distributed at equal intervals in a circumferential direction of the stent body. Amplantz teaches wherein the stent body has more than two flexible portions that extend along an axial direction of the stent body, and the flexible portions are distributed at equal intervals in a circumferential direction of the stent body (A has sections 412a, 412b, 412c). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the stent body of Binmoeller to include flexible portions distributed at even intervals similar to that disclosed by Amplantz so that the user may choose exactly where to place the flanges for optimal use.
Regarding Claim 17, the combination of Binmoeller in view of Amplantz teaches the medical drainage stent according to claim 14. Binmoeller further teaches wherein the proximal portion and the distal portion of the stent have fixing structures (flange structure 171)(figure 15A-15C) protruding from the stent body (170) (paragraph [0083]).
Regarding Claim 20, the combination of Binmoeller in view of Amplantz teaches the medical drainage stent according to claim 14. Binmoeller further teaches a retrieval loop provided at the proximal portion and/or the distal portion of the stent (paragraph [0033]). The claim language only requires the prior art to disclose one of the claim structures, therefore “the developing member provided on the stent to display a position of the stent under rays” is not required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/ Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781