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.
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 21 recites the limitation "the second structural element". There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-10 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Nae (20230191093) in view of Shannon (20050113909) and further in view of Kovach (20140277374).
With regards to claim 1, Nae discloses an implantable medical device (200) comprising: a frame including a first structural element (210) having a first side and a second side opposite the first side (FIG 2B) and a membrane ([140], the encapsulant), but fails to disclose that the membrane is bias wrapped, comprising at least a first helically wrapped film and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle, each of the first helically wrapped film and the second helically wrapped film arranged on the first side of the first structural element, wherein the first helically wrapped film has a first plurality of fibrils having an arcuate shape extending along the first side of the first structural element, wherein the arcuate shape of the first plurality of fibrils extend for a majority of the first structural element side.
Shannon discloses an implantable medical device (10) comprising a frame including a first structural element having a first side and a second side opposite the first side (14). Shannon teaches a bias-wrapped membrane (16), comprising at least a first helically wrapped film (17, FIG 4d) and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle (FIG 4e, [0067]), each of the first helically wrapped film (FIG 4d) and the second helically wrapped film (FIG 4e) arranged on the first side of the first structural element (FIG 4d, e). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nae’s medical device to include a bias-wrapped membrane, comprising at least a first helically wrapped film and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle, each of the first helically wrapped film and the second helically wrapped film arranged on the first side of the first structural element, as taught by Shannon, in order to provide reinforcement and additional burst strength ([0014]).
Nae as modified by Shannon fails to discloses wherein the first helically wrapped film has a first plurality of fibrils having an arcuate shape extending along the first side of the first structural element, wherein the arcuate shape of the first plurality of fibrils extend for a majority of the first structural element side. Kovach discloses a stent-graft (FIG 1) with an ePTFE film ([0033]). Kovach teaches that the film has a first plurality of fibrils having an arcuate shape extending along the first side of the first structural element ([0058], “bent configuration”), wherein the arcuate shape of the first plurality of fibrils extend for a majority of the first structural element side (FIG 5). Kovach teaches that this type of coating material is particular useful for stent-grafts to aid in retaining an increased diameter ([0010]). Since Shannon is directed towards an expandable stent, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to have further modified Shannon’s medical device to include that the first helically wrapped film has a first plurality of fibrils having an arcuate shape extending along the first side of the first structural element, wherein the arcuate shape of the first plurality of fibrils extend for a majority of the first structural element side, as taught by Kovach, in order to allow for flexibility with applied force (abstract). It has also been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
With regards to claim 2, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 1, wherein the frame includes a second structural element (220) having a first side and a second side opposite the first side (FIG 2B), wherein the second structural element has a circumference smaller than a circumference of the first frame element (FIG 2B), wherein the first plurality of fibrils of the first helically wrapped film extend along the first side of the second structural element (Shannon FIG 4e).
With regards to claim 3, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 2, wherein the second helically wrapped film extends along the second side of the first structural element and the second structural element (Shannon FIG 4e), and wherein the second helically wrapped film includes a second plurality of fibrils along the second side of the first structural element with an arcuate shape and the second plurality of fibrils extend along the second side of the second structural element (Shannon FIG 4e, the film extends along the whole structure).
With regards to claim 4, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 3, wherein the frame includes a third structural element (211) that extends at an acute angle relative to a longitudinal axis of the frame ([0201]), wherein the first plurality of fibrils extends along the third structural element side at an acute angle in a helical configuration (if the third structural element is extending at an angle, the fibril associated with it will be extending at the same angle).
There is no evidence of record that establishes that an angle ranging from 15 to 85 degrees would result in a difference in the function of Nae’s implantable device. A person having ordinary skill in the art, being faced with modifying Nae’s implantable device, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended. Therefore, there appears to be no criticality places on the range as claimed such that it produces an unexpected result, and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the third structural element of Nae to have an angle between 15 to 85 degrees as an obvious matter of design choice within the skill of the art. Additionally, it is understood that the third element is capable of moving through a range of angles when moving from a compressed, linear configuration to an expanded configuration.
With regards to claim 5, Shannon as modified by Kovach discloses the implantable medical device of claim 1, wherein at least a portion of the first helically wrapped film of the bias-wrapped membrane is coupled to at least part of the second helically wrapped film of the bias-wrapped membrane (Shannon FIG 4e).
With regards to claim 6, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 1, wherein the entirety of the device is coupled to at least a portion of the bias-wrapped membrane along at least one of the first side and second side of the first structural element (Shannon FIG 4e), wherein the first structural element is coupled to at least a portion of the bias-wrapped membrane along at least one of the first side and second side of the first structural element (Shannon FIG 4e) and wherein the second structural element is coupled to at least a portion of the bias- wrapped membrane along at least one of the first side and second side of the second structural element Shannon FIG 4e).
With regards to claim 7, Shannon as modified by Kovach discloses the implantable medical device of claim 1, wherein the first plurality of fibrils are configured to slide relative to adjacent arcuate fibrils (Kovach [0010]).
With regards to claim 8, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 1, wherein the first structural element is a flange (FIG 2B) and wherein a sensor is coupled to or integral with the flange such that the flange is operable to engage the sensor and tissue for operable engagement between the sensor and the tissue ([0209]).
With regards to claim 9, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 1, wherein the first structural element is a flange (FIG 2B), wherein the implantable medical device comprises an occluder coupled to or integral with the flange (the structure of FIG 2B is a septal occluder) such that the flange is configured to anchor the occluder to tissue (abstract, the shunt is for placement at an atrial septum).
With regards to claim 10, Nae discloses an implantable medical device (200) comprising: a frame including a first frame element having a first circumference (210) and a second frame element (220) having a second circumference (FIG 2B), the first frame element having a first side and a second side opposite the first side (FIG 2B) and a membrane ([140], the encapsulant), but fails to disclose that the membrane is bias wrapped, comprising at least a first helically wrapped film and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle, wherein the bias-wrapped membrane is arranged on the first side of the first frame element and wherein the bias- wrapped membrane has a first plurality of fibrils arranged in an arcuate shape along the first side of the first frame element and a second plurality of fibrils arranged in an arcuate shape along the first side of the second frame element; and wherein the bias-wrapped membrane has a third plurality of fibrils arranged between the first and second plurality of fibrils, wherein the third plurality of fibrils have a pitch angle.
Shannon discloses an implantable medical device (10) comprising a frame including a first structural element having a first side and a second side opposite the first side (14). Shannon teaches a bias-wrapped membrane (16), comprising at least a first helically wrapped film (17, FIG 4d) and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle (FIG 4e, [0067]), wherein the bias-wrapped membrane is arranged on the first side of the first frame element (FIG 4d, e). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nae’s medical device to include a bias-wrapped membrane, comprising at least a first helically wrapped film and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle, wherein the bias-wrapped membrane is arranged on the first side of the first frame element arranged on the first side of the first structural element, as taught by Shannon, in order to provide reinforcement and additional burst strength ([0014]).
Nae as modified by Shannon fails to disclose wherein the bias- wrapped membrane has a first plurality of fibrils arranged in an arcuate shape along the first side of the first frame element and a second plurality of fibrils arranged in an arcuate shape along the first side of the second frame element; and wherein the bias-wrapped membrane has a third plurality of fibrils arranged between the first and second plurality of fibrils, wherein the third plurality of fibrils have a pitch angle. Kovach discloses a stent-graft (FIG 1) with an ePTFE film ([0033]). Kovach teaches the film has a plurality of fibrils having an arcuate shape extending along the structural element ([0058], “bent configuration”), wherein the arcuate shape of the first plurality of fibrils extend for a majority of the structural elements (FIG 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shannon’s medical device to include that the bias- wrapped membrane has a first plurality of fibrils arranged in an arcuate shape along the first side of the first frame element and a second plurality of fibrils arranged in an arcuate shape along the first side of the second frame element; and wherein the bias-wrapped membrane has a third plurality of fibrils arranged between the first and second plurality of fibrils, wherein the third plurality of fibrils have a pitch angle, as taught by Kovach, in order to in order to allow for flexibility with applied force (abstract).
With regards to claim 20, Nae discloses an implantable medical device (200) comprising: a frame (FIG 2B) including a flat flange element, the flat flange (210) having a first side and a second side opposite the first side (FIG 2B), and a membrane coupled to at least a portion of the frame ([140], the encapsulant), but fails to disclose that the membrane is comprising at least a first helically wrapped film and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle, each of the first helically wrapped film and the second helically wrapped film arranged on the first side of the flat flange, and wherein the first helically wrapped film has a first plurality of fibrils having an arcuate shape extending along the first side of the flat flange such that the bias-wrapped film defines an arcuate shape along the first side of the flat flange.
Shannon discloses an implantable medical device (10) with a frame having a first side and a second side opposite the first side (14). Shannon teaches a bias-wrapped membrane (16) coupled to at least a portion of the frame (FIG 4d), comprising at least a first helically wrapped film (14, FIG 4d) and a second helically wrapped film (FIG 4e) at least partially overlapping the first helically wrapped film at an angle (FIG 4e, [0067]), each of the first helically wrapped film and the second helically wrapped film arranged on the first side of the frame (FIG 4d, e). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nae’s medical device to include a bias-wrapped membrane coupled to at least a portion of the frame, comprising at least a first helically wrapped film and a second helically wrapped film at least partially overlapping the first helically wrapped film at an angle, each of the first helically wrapped film and the second helically wrapped film arranged on the first side of the flat flange, as taught by Shannon, in order to provide reinforcement and additional burst strength ([0014]).
Nae as modified by Shannon fail to disclose wherein the first helically wrapped film has a first plurality of fibrils having an arcuate shape extending along the first side of the flat flange such that the bias-wrapped film defines an arcuate shape along the first side of the flat flange. Kovach discloses a stent-graft (FIG 1) with an ePTFE film ([0033]). Kovach teaches the film has a plurality of fibrils having an arcuate shape extending along the structural element ([0058], “bent configuration”), wherein the arcuate shape of the first plurality of fibrils extend for a majority of the structural elements (FIG 5). Kovach teaches that this type of coating material is particular useful for stent-grafts to aid in retaining an increased diameter ([0010]). Since Shannon is directed towards an expandable stent, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to have further modified Nae’s medical device to include wherein the first helically wrapped film has a first plurality of fibrils having an arcuate shape extending along the first side of the flat flange such that the bias-wrapped film defines an arcuate shape along the first side of the flat flange, as taught by Kovach, in order to in order to allow for flexibility with applied force (abstract). It has also been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
With regards to claim 21, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 20, wherein the second helically wrapped film extends along the second side of the first structural element (modified Nae 210), wherein the second helically wrapped film extends along a second structural element (modified Nae 220), and wherein the second helically wrapped film includes a second plurality of fibrils along the second side of the first structural element with an arcuate shape (Kovach FIG 5) and the second plurality of fibrils extend along the second side of the second structural element (Shannon FIG 4e).
With regards to claim 22, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 21, wherein the frame includes a third structural element (211) that extends at an acute angle relative to a longitudinal axis of the frame ([0201]), wherein the first plurality of fibrils extends along the third structural element side at an acute angle in a helical configuration (if the third structural element is extending at an angle, the fibril associated with it will be extending at the same angle).
There is no evidence of record that establishes that an angle ranging from 15 to 85 degrees would result in a difference in the function of Nae’s implantable device. A person having ordinary skill in the art, being faced with modifying Nae’s implantable device, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended. Therefore, there appears to be no criticality places on the range as claimed such that it produces an unexpected result, and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the third structural element of Nae to have an angle between 15 to 85 degrees as an obvious matter of design choice within the skill of the art.
With regards to claim 23, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 20, wherein at least a portion of the first helically wrapped film of the bias-wrapped membrane is coupled to at least part of the second helically wrapped film of the bias-wrapped membrane (Shannon FIG 4e).
With regards to claim 24, Nae as modified by Shannon and Kovach discloses the implantable medical device of claim 20, wherein the first structural element (210) is coupled to at least a portion of the bias-wrapped membrane along at least one of the first side and second side of the first structural element (Shannon FIG 4d) and wherein the second structural element is coupled to at least a portion of the bias-wrapped membrane along at least one of the first side and second side of the second structural element (Shannon discloses the entirety of the device coupled to at least a portion of the bias-wrapped membrane, FIG 4e).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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