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.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CN on 01/07/2022. It is noted, however, that applicant has not filed an English translation certified copy of the CN 202210011816.9 application as required by 37 CFR 1.55.
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 1-5 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140277561 A1 (hereafter --Jordan--).
Regarding Claim 1, Jordan discloses a degradable bile and pancreatic duct stent (100) for dilating the narrowed lumen of a lesion, the duct stent comprising:
- a guiding part configured to have a guide passage through which a guide wire passes and a fluid flows (see annotated guiding part and guide passage in Figure 4A below); and
- a stent main body spirally distributed around the guiding part along the longitudinal direction of the guiding part (see annotated stent main body and guiding part in Figure 4A below);
- wherein the stent main body is configured to form a spiral fluid channel relative to the lumen (see annotated stent main body and spiral fluid channel in Figure 4A below), and the guide passage of the guiding part is in communication with the spiral fluid channel (see annotated guiding part and spiral fluid channel in Figure 4A below, the two being “in communication” through the openings in the “guiding part” body).
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Regarding Claim 2, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 1, wherein the guiding part comprises at least one first spiral element, the first spiral element being is spring-shaped and defines the guide passage, wherein a plurality of the first spiral elements define the guide passage in parallel with each other (see annotated plurality of first spiral elements in Figure 4A above, the spiral elements being individual filaments of the braided struts that spread spirally from one longitudinal end to the other longitudinal end).
Regarding Claim 3, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 1, wherein the stent main body comprises at least one group of spiral structures, wherein a plurality of groups of the spiral structures are distributed parallel with each other around the guiding part (see annotated group of spiral structures in Figure 4A below, in which they are parallel with one another along the longitudinal direction of the stent).
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Regarding Claim 4, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 1, wherein the guiding part comprises: a first portion, the first portion comprising at least two groups of straight elements arranged parallel with each other (see annotated straight elements in Figure 4A below, the “straight elements” being the straight sides from the side lateral angle to the stent); a second portion, the second portion being configured in a ring shape and arranged at an end of the first portion to define the guide passage together with the first portion (see annotated guide passage in Figure 4A above, see also second portion being round (ring shape) in Figure 4A below, see also end of first portion in Figure 4A below); and the stent main body comprises at least one group of spiral structures (see annotated spiral structures in Figure 4A above), wherein a plurality of groups of the spiral structures are distributed parallel with each other around the guiding part (see annotated spiral structures in Figure 4A below) along the first portion (see annotated first portion in Figure 4A below) to confine the guide wire within the guide passage (see paragraph [0030]).
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Regarding Claim 5, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 1, wherein the guiding part is constructed as a porous structural element with said guide passage (see annotated guiding part in Figure 4A above, the braided structure of Jordan being a porous tube defining a guidewire passage).
Regarding Claim 6, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 1, wherein the stent main body comprises two groups of spiral structures spirally extending around the guiding part, and each group of the spiral structures comprises at least one second spiral element (see annotated second spiral elements (one being the “fourth element”, the second being the “second element”) in Figure 4A below).
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Regarding Claim 7, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 6, wherein the spiral structure comprises two second spiral elements arranged in parallel (see annotated second spiral elements (one being the “fourth element”, the other being the “second spiral element”) in Figure 4A above).
Regarding Claim 8, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 6, wherein the spiral structure comprises three spirally arranged second spiral elements (see annotated spiral structures in Figure 4A above, the second, third, and fourth elements being the “three spirally arranged second spiral elements”).
Regarding Claim 9, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 1, wherein the stent main body and the guiding part are made of different materials (see paragraph [0031] denoting that the stent main body (component 204) is made of polyethylene material, and see also paragraph [0035] denoting that component 202, being the guiding part, can be made of nitinol) [and/or the stent main body and the guiding part have different material degradation rates.]
Regarding Claim 10, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 9.
The claimed phrase ““wherein the degradable bile and pancreatic duct stent is made by 3D printing technology” is being treated as a product by process limitation; that is the degradable bile and pancreatic duct stent is made by 3D printing technology. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Jordan is silent as to the process used to make the stent, it appears that the stent would be the same as that claimed.
Regarding Claim 11, Jordan discloses the degradable bile and pancreatic duct stent (100) according to claim 2, wherein the stent main body comprises at least one group of spiral structures, wherein a plurality of groups of the spiral structures are distributed parallel with each other around the guiding part (see annotated spiral structures and groups of spiral structures in Figure 4A above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20190053921 A1: This reference discloses a stent with a spiral structure.
US 20080195189 A1: This reference discloses a stent for implantation into the body of a patient, having a guiding part being the body of the stent (see Abstract). Asgari teaches herein the guiding part is constructed as a porous structural element with said guide passage (see paragraph [0063]).
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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