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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 21-41 is/are pending. Claim(s) 1-20 is/are canceled.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 12/5/2025 is acknowledged.
All claims previously drawn to the non-elected Group I have been canceled. Therefore, there are no withdrawn claims at this time.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21, line 19 recites “the first and second”, which should be “the first and the second”.
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.
Claims 21-41 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.
Claim 21, lines 14-15 recite “a vessel wall”. It is unclear if this is the same vessel wall introduced earlier in the claim. For purposes of examination the Examiner considers the two instance of “a vessel wall” to be “a first vessel wall” and “a second vessel wall”, respectively.
The term "under" in each of claim 21, line 15 and claim 33, line 2 is a relative term which renders the claim indefinite. The term "under" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “under”. Therefore, this term is indefinite.
Claim 21, line 20 and claim 33, lines 2-3 each recites “the collapsed configuration”. As two collapsed configurations were introduced earlier in the claim, it is unclear which one is being referred back to. For purposes of examination the Examiner considers this language to be “the first and the second stents are in their respective collapsed configurations”.
Claim 24, line 1 recites “of two catheter shaft channels”. It is unclear if this is the same or different feature as that introduced in claim 22. For purposes of examination the Examiner considers this language to be “of the two catheter shaft channels”.
Claim 41, line 3 recites “of stent and expandable member”. It is unclear if the stent is one of those introduced earlier in the claims and if the expandable member is one of those introduced earlier in the claims. For purposes of examination the Examiner considers this language to be “the first stent, the second stent, the first expandable member, and the second expandable member”.
Claim(s) 22-23, 25-32, and 34-40 are rejected as dependent from a rejected claim.
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) 21 and 32-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bourang (US 2014/0100647 A1).
Regarding Claim 21, Bourang teaches a method of treating a bifurcated vessel (e.g. [0009]), said method comprising:
providing a first delivery catheter (e.g. Figure 1, #130) and a second delivery catheter (e.g. Figure 1B, #102), wherein the first delivery catheter comprises a first elongate shaft (e.g. Figure 1B, #132), a first expandable member (e.g. Figure 1B, #140), and a first stent (e.g. Figure 1B, #142) disposed over the first expandable member (e.g. Figure 1B), the first stent having a collapsed configuration and an expanded configuration (e.g. [0013]), in the collapsed configuration the first stent being crimped on the first expandable member with the first expandable member in an uninflated delivery configuration (e.g. [0013], [0110]), and in the expanded configuration the first stent being expanded radially by expansion of the first expandable member from the delivery configuration so as to support a vessel wall (e.g. [0013]), and the second delivery catheter comprises a second elongate shaft (e.g. Figure 1B, #104), a second expandable member (e.g. Figure 1B, #106), and a second stent (e.g. Figure 1B, #108) disposed over the second expandable member (e.g. Figure 1B), the second stent having a collapsed configuration and an expanded configuration (e.g. [0011]), in the collapsed configuration the second stent being crimped on the second expandable member with the second expandable member in an uninflated delivery configuration (e.g. [0011], [0109]), and in the expanded configuration the second stent being expanded radially by expansion of the second expandable member from the delivery configuration so as to support a vessel wall (e.g. [0010]), and wherein a portion of the first elongate shaft is disposed under the second stent (e.g. Figure 1B) and the first elongate shaft exits a side hole in the second stent (e.g. Figure 1B, side hole #120), the first expandable member being distal to the second expandable member (e.g. Figure 1B, where distal is toward the end with label #138);
advancing both the first delivery catheter and the second delivery catheter through a main branch vessel having a lesion to a bifurcation in the main branch vessel while the first and second stents are in the collapsed configuration (e.g. [0175]-[0177], Figure 38C), the bifurcation comprising a side branch vessel having a lesion and extending from the main branch vessel (e.g. [0175]), wherein the first stent is advanced into the side branch (e.g. Figure 38D), distal to the side branch lesion (e.g. Figure 38D); and
providing a twist resolution pocket disposed on the first delivery catheter or the second delivery catheter (e.g. Figure 1B, #124; [0110]), wherein the twist resolution pocket is positioned and configured such that when the first delivery catheter and the second delivery catheter are pushed against a carina of the bifurcation during said advancement, twisting in the first delivery catheter or the second delivery catheter is pushed back proximally through the first delivery catheter or the second delivery catheter and away from the bifurcation (e.g. [0110], #124 keeps the two catheter shafts parallel and prevents tangling during delivery; as twisting is tangling, #124 performs in the manner claimed).
Regarding Claim 32, a cross-sectional profile of a region of the first elongate shaft or a region of the second elongate shaft pushed against the carina includes an asymmetric or oval shape (e.g. [0102], non-uniform crimping forms an asymmetric shape).
Regarding Claim 33, further comprising: proximally retracting the first elongate shaft under a portion of the second stent in the collapsed configuration until a proximal end of the first stent is aligned with the side hole in the second stent (e.g. Figures 38D to 38E; [0178]); radially expanding the first expandable member (e.g. between Figures 38E and 38F), thereby simultaneously expanding the first stent into engagement with the lesion in the side branch vessel and expanding a proximal portion of the second stent in the main branch vessel from the collapsed configuration (e.g. [0179]); and radially expanding the second expandable member (e.g. Figures 38E-38H, [0179]-[0180], thereby further expanding the proximal portion of the second stent and expanding a distal portion of the second stent into engagement with a wall of the main branch vessel (e.g. Figures 38G-38H).
Regarding Claim 34, the advancing comprises advancing both the first and the second delivery catheters until a resistance to further advancement is felt by an operator (e.g. [0177]).
Regarding Claim 35, the resistance is provided by separation of the first elongate shaft from the second elongate shaft as both shafts are advanced against a wall formed between the main branch and the side branch (e.g. [0177]).
Regarding Claim 36, the first expandable member comprises a balloon (e.g. [0110]), and the expanding of the first expandable member comprises inflating the balloon (e.g. [0110]).
Regarding Claim 37, further comprising contracting the first expandable member after expansion thereof and prior to the expansion of the second expandable member (e.g. [0180]).
Regarding Claim 38, the expanding of the first stent comprises differentially expanding the first stent so that a proximal region of the expanded first stent has a larger diameter than a distal region of the expanded first stent (e.g. Figure 38A, the proximal end of the first stent has a larger diameter that the opposing distal end (having the diameter of the side branch) as it fills the size of the side hole in the second stent, which is wider than the branch vessel).
Regarding Claim 39, the second expandable member comprises a balloon (e.g. [0109]), and the expanding of the second expandable member comprises inflating the balloon (e.g. [0109]).
Regarding Claim 40, the expanding of the second expandable member comprises expanding at least a portion of the second stent into engagement with the main branch lesion (e.g. Figures 38G to 38H).
Regarding Claim 41, a therapeutic agent is disposed on one or more of the stents, on one or more of the expandable members, on both stent and expandable member, or in any combination or permutation of stent and expandable member (e.g. [0018]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 26 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourang (US 2014/0100647 A1) as discussed supra, alone.
Regarding Claim 26, Bourang teaches the twist resolution pocket is any length that extends between a proximal portion of the balloons and a distal portion of the catheter connectors and particularly 5 cm to 10 cm long (50 mm to 100 mm) (e.g. [0108]).
Bourang discloses the invention substantially as claimed but fails to teach a length of the twist resolution pocket is in a range of 5-60 mm.
Bourang are concerned with the same field of endeavor as the claimed invention, namely methods using a delivery system for delivering multiple stents to a bifurcated vessel location.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bourang such that the twist resolution pocket is 5 mm to 60 mm long since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Regarding Claim 29-30, Bourang teaches the twist resolution pocket is placed 1 cm to 30 cm (10 mm to 300 mm) from the second expandable member (mother balloon in Bourang) (e.g. [0108]). As the twist resolution pocket is fixed to the second elongate shaft, it’s relative position is the same when manufactured as it is during delivery. Thus, pocket-to-bifurcation distance is the distance disclosed because during delivery the second expandable member is at the bifurcation (positioning seen in e.g. Figures 38D-38H).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Bourang such that the method further comprises positioning the twist resolution pocket at a pocket-to-bifurcation distance in a range of 30-100 mm (for claim 29) and 30-50 mm (for claim 30) when the first delivery catheter and the second delivery catheter are advanced distally and pushed against the carina of the bifurcation since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Claims 22-25 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourang (US 2014/0100647 A1) as discussed supra and further in view of Hilaire, et al (Hilaire) (US 2005/0085845 A1).
Regarding Claim 22, Bourang discloses the invention substantially as claimed but fails to teach the twist resolution pocket includes two catheter shaft channels including a first catheter shaft channel to receive the first elongate shaft of the first delivery catheter, and a second catheter shaft channel to receive the second elongate shaft of the second delivery catheter.
Hilaire teaches a linking device having first and second catheter channels to hold the catheters in a side-by-side manner (e.g. Figures 15-16, [0072]).
Hilaire and Bourang are concerned with the same field of endeavor as the claimed invention, namely stent methods using delivery systems having two catheters for delivery to a bifurcation.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Bourang such that the twist resolution pocket has two respective catheter shafts as taught by Hilaire in order to have a fixed relative position between the first and second catheters (e.g. Hilaire, [0072]).
Regarding Claim 23, the twist resolution pocket is fixed on the first elongate shaft or the second elongate shaft (e.g. Bourang, Figure 1B).
Regarding Claim 24, at least one of two catheter shaft channels of the twist resolution pocket slidably receives the first elongate shaft or the second elongate shaft (e.g. Hilaire, [0074], the catheters are slidable relative to the twist resolution pocket; Bourang, Figure 1B, as the catheters are within the channels (of the combined device) they were slid in place).
Regarding Claim 25, the first catheter shaft channel of the twist resolution pocket slidably receives the first elongate shaft of the first delivery catheter, and the second catheter shaft channel of the twist resolution pocket slidably receives the second elongate shaft of the second delivery catheter (e.g. Bourang, Figure 1B, as the catheters are within their respective channels (of the combined device) they were slid in place).
Regarding Claim 31, a cross-sectional profile of the twist resolution pocket, or a cross-sectional profile of at least one of the two catheter shaft channels, includes an asymmetric or oval shape (e.g. Bourang, Figure 1B, the cross-section through the shown channel is elongated (oval) and thus in the combination, each channel is elongated as shown, as the combination was to include a second channel).
Claims 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourang (US 2014/0100647 A1) in view of Hilaire, et al (Hilaire) (US 2005/0085845 A1) as discussed supra and further in view of Quiachon, et al (Quiachon) (US 2004/0153143).
Regarding Claim 27, the combination of Bourang and Hilaire discloses the invention substantially as claimed but fails to teach a length of the first catheter shaft channel of the twist resolution pocket is in a range of 5-60 mm, and an outer diameter of the first catheter shaft channel is in a range of 0.040-0.050 mm.
Bourang teaches the twist resolution pocket is any length that extends between a proximal portion of the balloons and a distal portion of the catheter connectors and particularly 5 cm to 10 cm long (50 mm to 100 mm) (e.g. [0108])
Quiachon teaches catheter shaft diameters suitable for use in the vascular system having diameters ranging from 0.035 to 0.1 inches (0.889-2.54 mm) (e.g. [0078]).
Bourang and Quiachon are concerned with the same field of endeavor as the claimed invention, namely methods using a delivery system using at least one catheter for stent graft delivery in the vascular system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Bourang and Hilaire such that the first shaft channel of the twist resolution pocket is 5 mm to 60 mm long since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bourang such that an outer diameter of the first catheter shaft channel is in a range of 0.040-0.050 mm a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (MPEP 2144.05(I)).
Regarding Claim 28, the combination of Bourang and Hilaire discloses the invention substantially as claimed but fails to teach a length of the second catheter shaft channel of the twist resolution pocket is in a range of 5-60 mm, and an outer diameter of the second catheter shaft channel is in a range of 0.030-0.040 mm.
Bourang teaches the twist resolution pocket is any length that extends between a proximal portion of the balloons and a distal portion of the catheter connectors and particularly 5 cm to 10 cm long (50 mm to 100 mm) (e.g. [0108])
Quiachon teaches catheter shaft diameters suitable for use in the vascular system having diameters ranging from 0.035 to 0.1 inches (0.889-2.54 mm) (e.g. [0078]).
Bourang and Quiachon are concerned with the same field of endeavor as the claimed invention, namely methods using a delivery system using at least one catheter for stent graft delivery in the vascular system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Bourang and Hilaire such that the second shaft channel of the twist resolution pocket is 5 mm to 60 mm long since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bourang such that an outer diameter of the second catheter shaft channel is in a range of 0.040-0.050 mm a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (MPEP 2144.05(I)).
Relevant Prior Art
US 7,476,243 B2 to Eidenschink teaches a torquing system having multiple, parallel channels for different components of the delivery system (e.g. Figure 15B; column 9, lines 23-45).
US 2008/0009933 A1 to Ta, et al teaches a method of stent delivery to a bifurcated location using a catheter assembly (e.g. abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 12/23/2025