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 .
Election/Restrictions
Applicant’s election without traverse of group I directed towards a biliary stent in the reply filed on 8/17/2026 is acknowledged. Accordingly, non-elected claims 18-20 are withdrawn from consideration.
Claim Objections
Claim(s) 3, 7, 13 is/are objected to because of the following informalities:
In regard to claim 3, “with adjacent creases” should be “with the creases adjacent one another” or similar since the creases are the same creases as recited in claim 1 for consistent antecedent basis throughout.
In regard to claim 7, “wherein each wing” should be “wherein each of the wings” for consistent antecedent basis throughout.
In regard to claim 13, “with adjacent creases” should be “with the creases adjacent one another” or similar since the creases are the same creases as recited in claim 1 for consistent antecedent basis throughout.
Appropriate correction is required.
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.
Claim(s) 4-5, 14-17 is/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.
In regard to claim 4, “the first proximal position” lacks proper antecedent basis. It appears that this phrase should have read “the first contracted position”.
In regard to claim 5, “the second distal position” lacks proper antecedent basis. It appears this limitation should have read the second expanded position”.
In regard to claim 14, “the first proximal position” lacks proper antecedent basis. It appears that this phrase should have read “the first contracted position”.
In regard to claim 15, “the second distal position” lacks proper antecedent basis. It appears this limitation should have read the second expanded position”.
In regard to claim 16, “the first proximal position” lacks proper antecedent basis. It appears that this phrase should have read “the first contracted position”.
In regard to claim 17, “the second distal position” lacks proper antecedent basis. It appears this limitation should have read the second expanded position”.
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.
Claim(s) 1-3 and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franano (EP2806825B1).
In regard to claim 1, Franani discloses a biliary stent [0051: bile duct or other biological conduit] comprising a plurality (defined as two or more) of lobes (ridge lines 3602; [0157]) alternating radially with a plurality of creases (pleats 3600);
wherein each of the plurality of lobes 3602 has a first contracted position biased inwards from the creases such that the biliary stent has a first cross-sectional diameter; (fig 43A-B; contracted position is in the right in the figures)
and wherein each of the plurality of lobes 3602 has a second expanded position (position on the far left in figs 43A-B) biased outwards from the creases 3600 such that the biliary stent has a second cross-sectional diameter larger than the first cross-sectional diameter. (fig 43A-B)
In regard to claim 2, Franani discloses the biliary stent of claim 1, and further discloses the plurality of lobes 3602 are the same length such that the stent is symmetrical (see figure 43A; stent is symmetrical).
In regard to claim 3, Franani meets the claim limitations as discussed in the rejection of claim 1, and further discloses each of the lobes 3602 forms a convex curve with adjacent creases (interpreted as best understood as the same creases as claim 1) when in the second expanded position (Figure 43B, partially expanded and fully expanded both show creases in figure 43A, B; the claim does not require the second expanded position to be fully expanded) such that adjacent lobes 3602 form side walls of channels exterior to the stent upon expansion of the biliary stent. (see channels, concave exterior channels in the partially expanded views in figures 43A-B)
In regard to claim 5, Franani discloses the biliary stent of claim 1, and further discloses the stent in the second distal position (interpreted as best understood to be referring to the second expanded position) has a cross-sectional diameter of between 2 mm and 10 mm. [0079: expanded diameter of about 2mm to about 10mm]
In regard to claim 6, Franani discloses the biliary stent of claim 1, and further discloses the stent has an axial length of between 2 mm and 20 mm. [0079: expanded length of about 2mm to about 20mm]
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franano (EP2806825B1).
In regard to claim 4, Franani meets the claim limitations as discussed in the rejection of claim 1, but remains silent to the cross-sectional diameter of the stent in the first proximal position (interpreted as best understood to be referring to the first contracted position).
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the stent in the first proximal position (interpreted as best understood to refer to the contracted position) have a cross-sectional diameter of between 1 mm and 5 mm in order to meet the size limitations of the vessel the stent is being inserted into and catheter being used to deliver the stent. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boston (JP200524487A).
In regard to claim 7, Boston teaches a biliary stent delivery device, comprising:
a shaft 18 sized for insertion into a bile duct of a patient (bile ducts, in paragraph 3 of the description in the translation);
and one or more wings 52 at the distal end of the shaft, wherein each wing shifts between a first proximal orientation pointed towards a proximal end of the shaft and a second distal orientation pointed towards the distal end of the shaft. (figs 12-13; open and closed orientations)
Claim(s) 9, 11, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boston (JP2005524487A) in view of Kang (WO2015199289A1).
In regard to claim 9, Boston teaches a medical system for delivering a biliary stent, comprising:
a biliary stent delivery device (paragraph 3 of description in the translation: bile ducts) having a shaft 18 sized for insertion into a bile duct of a patient (capable of since collapsible and example of bile duct stent is given) and one or more wings 52 at the distal end of the shaft 18, wherein each wing 52 shifts between a first proximal orientation pointed towards a proximal end of the shaft and a second distal orientation pointed towards the distal end of the shaft (figs 13-14, open and closed orientations; flexible material);
and a biliary stent 24.
However, Boston does not teach the stent as claimed.
Kang teaches a biliary stent (description paragraph 2) comprising a plurality (defined as two or more) of lobes 230 alternating radially with a plurality of creases (see creases between folds, fig 11),
wherein each of the plurality of lobes 230 has a first contracted position biased inwards from the creases such that the biliary stent has a first cross-sectional diameter, and wherein each of the plurality of lobes has a second expanded position biased outwards from the creases such that the biliary stent has a second cross-sectional diameter larger than the first cross-sectional diameter. (easily compressed or expanded; pg 3 of translation, paragraph 16)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent formation of Kang in place of the stent of Boston because the stent of Kang prevents necrosis and side effects (translation page 2, p 1, 9: allows fluid to flow into and out of the stent at the same time while flexing to reduce friction).
In regard to claim 11, Boston meets the claim limitations as discussed in the rejection of claim 9, but does not teach the stent as claimed.
Kang further teaches the plurality of lobes 230 of the biliary stent are the same length such that the stent is symmetrical. (see figure 11)
In regard to claim 13, Boston meets the claim limitations as discussed in the rejection of claim 9, but does not teach the stent as claimed.
Kang further teaches each of the lobes 230 of the biliary stent forms a convex curve with adjacent creases when in the second expanded position such that adjacent lobes form side walls of channels exterior to the stent. (see fig 12, creases between convex curves of lobs)
In regard to claim 14, Boston in view of Kang meets the claim limitations as discussed in the rejection of claim 9.
However, the combination of references remains silent to the stent diameter.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, require no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the stent in the first proximal position (interpreted as best understood to refer to the first contracted position) has a cross-sectional diameter of between 1 mm and 5 mm for the particular application and anatomy. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regard to claim 15, Boston in view of Kang meets the claim limitations as discussed in the rejection of claim 9, but the combination does not teach the diameter of the stent.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, require no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the stent in the first proximal position (interpreted as best understood to refer to the second expanded position) has a cross-sectional diameter of between 2 mm and 10 mm for the particular application and anatomy. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regard to claim 16, Boston meets the claim limitations as discussed in the rejection of claim 9, but does not teach the cross sectional diameter of the wings.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, require no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the wings have a cross-sectional diameter in the first proximal orientation (interpreted as the first contracted orientation) of 2.3 to 4.2mm for the particular application and anatomy. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regard to claim 17, Boston meets the claim limitations as discussed in the rejection of claim 9, but does not teach the cross sectional diameter of the wings.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, require no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the wings have a cross-sectional diameter in the second distal orientation (interpreted as the second expanded orientation) of 2.3 to 4.2mm for the particular application and anatomy. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boston (JP2005524487A) in view of Kang (WO2015199289A1) and further in view of Franano (EP2806825B1).
In regard to claim 12, Boston meets the claim limitations as discussed in the rejection of claim 9, but does not teach the stent is comprised of biocompatible plastic.
Franano teaches the biliary stent [0198: bile ducts] is comprised of biocompatible plastic. [0056: materials include plastics; biocompatible]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the plastic material of Frananao for the stent of Boston in view of Kang through functional equivalents since both are biocompatible stent materials used for a bile duct stent. MPEP 2144.0406II
Allowable Subject Matter
Claim(s) 8 and 10 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claim 8, Boston (JP200524487A) meets all of the claimed limitations except “the expandable stent positioned proximally to the one or more wings such that, when the shaft is retracted through the loaded stent, the wings shift from the first proximal orientation to the second distal orientation to press outward on the stent, expanding the stent” in combination with the other claimed limitations.
In regard to claim 10, Boston (JP2005524487A) in view of Kang (WO2015199289A1) meet all of the claimed limitations except “when the shaft is retracted through the loaded stent, the wings shift from the first proximal orientation to the second distal orientation to press outward on the stent, expanding the stent from the first contracted position into the second expanded position” in combination with the other claimed limitations.
Conclusion
Boston (JP200524487A) also anticipates claim 7 in claims 12-13 with wings 52 flipping between a proximal and distal orientation.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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