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 .
Claim Objections
Claim(s) 7, 20 is/are objected to because of the following informalities:
Within claim 7, line 3 (and claim 7, line 6; and claim 20, line 3; and claim 20, line 5): “the expansible mesh structure” should be replaced with --the expansible knitted mesh structure-- (in order to maintain consistent claim terminology).
Appropriate correction is required.
Applicant is advised that should claim 4 be found allowable, claim5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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) 1-24 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.
Within claim 1, lines 13-14: Applicant claims, “to an extent such that the stent assembly applies a chronic radial force to a wall of the body lumen”; the aforementioned claim requirement is an incomplete claim clause on it’s own, it is therefore unclear what it modifies – the expansible stent? And if it is the expansible stent, is it configured to an extent such that the stent assembly applies a chronic radial force to a wall of the body lumen? OR is Applicant trying to claim the application of the chronic radial force (which is a method of used/ after implantation) which would not be within the scope of the claim (as determined by the preamble) which is to a method of selecting a stent assembly alone. (Please note: for the purposes of examination, Examiner is assuming the aforementioned claim requirement should be read as --the expansible stent configured to an extent such that the stent assembly is configured to apply a chronic radial force to a wall of the body lumen--.) Claim(s) 2-15, which depend from claim 1, inherit all the problems associated with claim 1.
Within claim 1, line 15: Applicant claims, “a chronic radial force”; it is unclear, and therefore indefinite, if this is the same as OR different from the chronic radial force in claim 1, line 14.
Claim 4 recites the limitation "the expanded diameter" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Within claim 4, lines 1-3: Applicant claims, “the stent assembly is configured to […], but instead adapts upon deployment in a body lumen”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the “is configured to” does not appear to modify the “instead adapts” clause; in which case, the “instead adapts” clause is positively reciting the adapting upon deployment (which is a method of used/ after implantation) which would not be within the scope of the claim (as determined by the preamble) which is to a method of selecting a stent assembly alone.
Within claim 4, line 3: Applicant claims, “a body lumen”; it is unclear, and therefore indefinite, if this is the same OR different from the body lumen (within claim 1, line 2).
Within claim 4, line 4: Applicant claims, “a non-uniform diameter body lumen”; it is unclear and therefore indefinite, if this is the same OR different from the body lumen (within claim 1, line 2). Please note: for the purposes of examination, Examiner is assuming the aforementioned claim requirement should be read as --a non-uniform diameter of the body lumen--.
Claim 7 recites the limitation "the initial diameter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the one or more expanded diameters " in line 3. There is insufficient antecedent basis for this limitation in the claim.
Within claim 10, lines 1-2: Applicant claims, “the porous structure controls a local pressure exerted by the expansible stent on a body lumen wall in which the stent assembly is implanted”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim clause is positively reciting the interaction between the stent assembly and the body lumen (which is a method of used/ after implantation) which would not be within the scope of the claim (as determined by the preamble) which is to a method of selecting a stent assembly alone.
Within claim 10, line 2: Applicant claims, “a body lumen”; it is unclear, and therefore indefinite, if this is the same as OR different from the wall of the body lumen (within claim 1, line 14).
Within claim 11, line 2: Applicant claims, “a radial force”; it is unclear, and therefore indefinite, if this is the same as OR different from the chronic radial force (within claim 1, line 15).
Within claim 16, lines 6-7: Applicant claims, “to an extent such that the stent assembly applies a chronic radial force to a wall of the body lumen”; the aforementioned claim requirement is an incomplete claim clause on it’s own, it is therefore unclear what it modifies – the expansible stent? And if it is the expansible stent, is it configured to an extent such that the stent assembly applies a chronic radial force to a wall of the body lumen? OR is Applicant trying to claim the application of the chronic radial force (which is a method of used/ after implantation) which would not be within the scope of the claim (as determined by the preamble) which is to a method of selecting a stent assembly alone. (Please note: for the purposes of examination, Examiner is assuming the aforementioned claim requirement should be read as --the expansible stent configured to an extent such that the stent assembly is configured to apply a chronic radial force to a wall of the body lumen--.) Claim(s) 17-24, which depend from claim 16, inherit all the problems associated with claim 16.
Within claim 16, line 8: Applicant claims, “a chronic radial force”; it is unclear, and therefore indefinite, if this is the same as OR different from the chronic radial force in claim 16, line 6.
Claim 20 recites the limitation "the initial diameter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the one or more expanded diameters " in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 8-16, 18, 21-24 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Dickerson et al. (US 2015/0374486 A1).
With respect to claim 1:
Dickerson et al. discloses a method of selecting a stent assembly (device 100, as seen in figs. 8-9 and 11) for stenting, which comprises:
estimating a base reference diameter associated with a portion of a body lumen (anatomy/ passages 116/ 118) in which a stent assembly (device 100) will be placed (in order for device to be tailored to the anatomy/ passages 116/ 118 of an individual patient the geometry/ diameter of said anatomy must be estimated) (paragraph [0138, 0160]);
determining, based on the estimated base reference diameter, a target expanded stent diameter of the stent assembly (device 100) which is to be placed in the portion of the body lumen (anatomy/ passages 116/ 118) (in order for device 100 to correspond to the anatomical shape of the native anatomy a determination must be made on the size/ shape of the device 100 which will at least partially correspond thereto) (paragraph [0138, 0160]); and
select the stent assembly (device 100) for stenting the portion of the body lumen (anatomy/ passages 116/ 118) based on the target expanded stent diameter (paragraph [0138]),
wherein the stent assembly (device 100) comprises:
a porous structure (first mesh 142 along the entire length of device 100), comprising an expansible mesh structure (paragraphs [0151, 0180]); and
an expansible stent (second mesh 144 along the entire length of device 100) (paragraph [0151]), having a tubular shape, operatively associated with the porous structure (first mesh 142) and configured to expand in any body lumen having a diameter in a range between a first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) and a second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm), smaller than the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) by more than 2 millimeters (has high conformability/ adaptability within a range (1-12 mm) of expanded diameters) (paragraphs [0156, 0180]), to an extent such that the stent assembly (device 100) applies a chronic radial force (outward radial force/ radial strength) to a wall of the body lumen (anatomy/ passages 116/ 118) (device 100 maintains consistent/ (i.e. chronic) radial force otherwise the device 100 could migrate within the vessel),
wherein the stent assembly (device 100) is configured to apply a chronic radial force (outward radial force/ radial strength) of less than about 0.33 N/mm (0.1-0.3 N/mm) (paragraphs [0134, 0181]), when expanded to any diameter within the range (the outward radial force/ radial strength will be within this range for the intended/ expanded diameters of 1-12 mm of the device 100).
With respect to claim 2:
Wherein the portion of the body lumen (anatomy/ passages 116/ 118) defines varying body lumen diameters (has a taper) and wherein determining the target expanded stent diameter (in order for device 100 to correspond to the anatomical shape of the native anatomy a determination must be made on the size/ shape of the device 100 which will at least partially correspond thereto) comprises determining two different target diameters within the range (the end portions of the device 100 must taper to match thereto and would be within the expanded diameter range of 1-12 mm) (paragraphs [0013, 0160, 0164]).
With respect to claim 4:
Wherein the stent assembly (device 100) is configured to act (is capable of acting) as either a straight stent or a tapered stent and is not designed for a pre-determined tapering of the expanded diameter (adaptable/ conformable to the native anatomy) (paragraphs [0145, 0156, 0189]), but instead adapts upon deployment in a body lumen (anatomy/ passages 116/ 118) to the diameter of the body lumen (anatomy/ passages 116/ 118) even across a non-uniform-diameter body lumen (anatomy/ passages 116/ 118) within the range between the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) and the second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm) (paragraphs [0178, 0189]).
With respect to claim 5:
Wherein the stent assembly (device 100) is configured to act (is capable of acting) as either a straight stent or a tapered stent and is not designed for a pre-determined tapering of the expanded diameter (adaptable/ conformable to the native anatomy) (paragraphs [0145, 0156, 0189]), but instead adapts upon deployment in a body lumen (anatomy/ passages 116/ 118) to the diameter of the body lumen (anatomy/ passages 116/ 118) even across a non-uniform-diameter body lumen (anatomy/ passages 116/ 118) (paragraphs [0178, 0189]).
With respect to claim 8:
Wherein the porous structure (first mesh 142) is constructed from one or more fibers of metal (filaments of metal alloy) (paragraphs [0170-0172]).
With respect to claim 9:
Wherein the porous structure (first mesh 142) is constructed from one or more polymer fibers (filaments of polymer) (paragraphs [0170-0172]).
With respect to claim 10:
Wherein the porous structure (first mesh 142) is configured to controls a local pressure exerted by the expansible stent (second mesh 144) on a body lumen wall in which the stent assembly (device 100) is implanted (the two meshes maybe in overlapping relationship with each other, as such meshes will have an effect on each other, in terms of diameter and radial strength, which will then be applied to the body lumen wall in which they are implanted) (paragraph [0151]).
With respect to claim 11:
Wherein when the stent assembly (device 100) is expanded to a diameter of at least 5.5 millimeters (diameter between 1-12 mm) (paragraph [0178]), the stent assembly (device 100) applies a radial force which is greater than about 0.20 N/mm (0.1-0.3 N/mm) (paragraph [0181]).
With respect to claim 12:
Wherein the expansible stent (second mesh 144 along the entire length of device 100) comprises a self-expandable stent (is self-expanding) (paragraphs [0142, 0167]).
With respect to claim 13:
Wherein the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) is 10 millimeters, and the second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm) is 5 millimeters (paragraph [0178]).
With respect to claim 14:
Wherein the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) is 9 millimeters, and the second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm) is 5.5 millimeters (paragraph [0178]).
With respect to claim 15:
Wherein the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) is 7 millimeters, and the second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm) is 4 millimeters (paragraph [0178]).
With respect to claim 16:
Dickerson et al. discloses a method of stenting, which comprises:
providing a plurality of identical stent assemblies (there inherently are a plurality of kits (each having devices 100) in order to treat a plurality of CLI patients, each kit would include identical components) (paragraphs [0210, 0250]), comprising:
an expansible stent, (second mesh 144 along the entire length of device 100) (paragraph [0151]), having a tubular shape, configured to expand in any body lumen having a diameter in a range between a first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) and a second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm), smaller than the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) by more than 2 millimeters (has high conformability/ adaptability within a range (1-12 mm) of expanded diameters) (paragraphs [0156, 0180]), to an extent such that the stent assembly (device 100) applies a chronic radial force (outward radial force/ radial strength) to a wall of the body lumen (anatomy/ passages 116/ 118) (device 100 maintains consistent/ (i.e. chronic) radial force otherwise the device 100 could migrate within the vessel),
wherein the stent assembly (device 100) is configured to apply a chronic radial force (outward radial force/ radial strength) of less than about 0.33 N/mm (0.1-0.3 N/mm) (paragraphs [0134, 0181]), when expanded to any diameter within the range (the outward radial force/ radial strength will be within this range for the intended/ expanded diameters of 1-12 mm of the device 100);
implanting a first one of the identical stent assemblies (a first device 100) in a first patient (a first of the plurality of patients) in a body lumen having a diameter of the first deployed diameter (paragraph [0009, 0240, 0250]); and
implanting a second one of the identical stent assemblies (a second device 100) in a second patient (a second of the plurality of patents) in a body lumen having a diameter of the second deployed diameter (paragraph [0009, 0240, 0250]).
With respect to claim 18:
Wherein the plurality of identical stent assemblies (devices 100) further comprises a porous structure (first mesh 142 along the entire length of device 100), comprising an expansible mesh structure, surrounding the expansible stent (second mesh 144 along the entire length of device 100) (one of the meshes overlaps/ surrounds the other), having the tubular shape (paragraph [0151]).
With respect to claim 21:
Wherein the porous structure (first mesh 142) is constructed from one or more fibers of metal (filaments of metal alloy) (paragraphs [0170-0172]).
With respect to claim22:
Wherein the porous structure (first mesh 142) is constructed from one or more polymer fibers (filaments of polymer) (paragraphs [0170-0172]).
With respect to claim 23:
Wherein the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) is 10 millimeters, and the second deployed diameter (the smaller half of diameters within the acceptable range of 1-12 mm) is 5 millimeters (paragraph [0178]).
With respect to claim 24:
Wherein the first deployed diameter (the larger half of diameters within the acceptable range of 1-12 mm) is 9 millimeters, and the second deployed diameter is 5.5 millimeters (the smaller half of diameters within the acceptable range of 1-12 mm) (paragraph [0178]).
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) 3, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al. (US 2015/0374486 A1) in view of Sirhan et al. (US 2002/0114823 A1).
Dickenson et al. discloses the invention substantially as claimed, as discussed above. However, Dickenson et al. is silent concerning the radial force when the stent assembly is expanded to the first deployed diameter vs the radial force when expanded to the second deployed diameter (as required by claim(s) 3 and 17).
Sirhan et al. teaches a stent that is usable over a wide range of diameters, and while in all those different diameters the radial force stays relatively constant (see fig. 3). Sirhan et al. further links a large radial force plateau with being capable of use with a wide range of diameters (paragraph [0038]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the radial force of the stent assembly (device 100), as disclosed by Dickerson et al., with a relatively constant (including at least 50%) across the entire range of expandable diameters, as taught by Sirhan et al., as Sirhan et al. teaches these two features to be directly related to each other (large radial force plateaus are related to the ability of the stent to be used in a wide range of diameters).
Allowable Subject Matter
Claim(s) 6-7, 19-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim(s) 6 and 19:
A method (as required by claim 1 or 16) including a stent assembly in which the stent assembly comprises: a porous/ expansible mesh structure AND an expansible stent associated with the porous/ expansible mesh structure; wherein the stent is assembly is configured to apply a chronic radial force (the stent assembly thus cannot be made from a degradable material, as the material degrades the force applied thereby will not remain “chronic”) of less than about 0.33 N/mm over a range of diameters (the range diameters varying by at least 2 mm); wherein the porous/ expansible mesh structure is made from the specific claimed structure (knitted from fibers with a diameter of ~7-~40 μm).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
Prosecution Insights