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 .
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot. Limitations that were previously indicated as having allowable subject matter are no longer considered allowable in view of a newly applied reference Khosravi (US 5925063). As such this action is NONFINAL. Although applicant incorporated a claim considered to have allowable subject matter into the independent claim, the claim was presented in the alternative and not limited only to the allowed subject matter. Additionally the dependent claims are replete with 112(b) issues as they were not amended in light of the amendment to claim 1.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference numbers 100, 101, 102, 104, 106, 108, 110 in Figs. 4A-5B
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The terminology of original claims 7, 10 and 11 are not found in the specification. There is no disclosure of a tunnel graft is bifurcated and
each tunnel graft further including first stent and a second stent
where each of the tunnel graft lumens includes a first stent at the proximal end and a second stent at the distal end
wherein at least one of the filters is between the proximal and the first stent and the second stent of the respective tunnel graft.
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 1-3, 6-14 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.
Claims 2, 3 and 6 recite “the filter”, however claim 1 from which it depends, recites “at least one filter”. It is unclear if the recitation in claim 2 is meant to limit the previously recited “at least one filter” to just a single filter.
Claim 1 recites “the filter” in line 2 of section e). There is a lack of antecedent basis in the claim. The previous recitation in line 1 of section e) is “at least one filter” thus it is unclear if the second recitation is intended to narrowly claim 1 filter or meant to refer back to the first recitation. Claims 2, 3, 6 also recite “the filter” for which there is lack of antecedent basis.
Claim 7 is rejected for the following reasons: Initially, claim 1 sets forth “a tunnel graft having a proximal end and a distal end and “the tunnel graft includes a first stent at a proximal end of the graft and a second stent distal to the first stent”. Claim 7 recites “the tunnel graft is bifurcated, each tunnel graft”. It is unclear if the limitation each tunnel graft in line 2 is incorporating the previously recited tunnel graft in line 1 as well as in claim 1. Thus, it is unclear what structure is being claimed since the same term “tunnel graft” is used to define the whole structure as well as parts of the structure.
Further the claim goes on to recite “each tunnel graft having a proximal and a distal end and each tunnel graft further comprising a first stent and a second stent”. However, the initial tunnel graft of claim 1 already includes the tunnel graft having a first and second stent. The terminology “further comprising” conveys that the claim is introducing additional first and second stents to the previously recited first and second stents of claim 1. However, using the same terminology implies that perhaps the stents in claim 7 might have antecedent basis in the stents in claim 1. It is unclear as to whether 2 additional stents in each tunnel graft are required in addition to the previous 2 stents in the tunnel graft of claim 1. As such, it is unclear how many stents are required within the metes and bounds of the claim.
Claim 9 recites “at least one of the filters spans each tunnel graft lumen”. It is unclear if one filter is spanning more than one tunnel graft or if there is meant to be a one filter to one tunnel graft assignment. Further, claim 1 from which claim 9 depends, recites “at least one filter spans the tunnel graft between the first stent and the second stent”. Thus, it is unclear if claim 9 is claiming structure that is redundant of claim 1 of further defining additional structure.
Claim 9 appears to introduce at least a second filter to the at least one filter in claim 1. Claim 9 goes on to recite “the at least two filters span each tunnel graft lumen”. However, the claim 1 recites at least one filter spanning the aperture or the tunnel graft. If the filter of claim 1 spans the aperture, it is unclear how the two filters of claim 9, which includes the one in claim 1, spans each tunnel graft lumen. That is, the claim appears to require a filter spanning the aperture and the tunnel lumen.
Claim 10 introduces “a first stent” and “a second stent, however these structures were previously recited in claim 1 and claim 7. It is unclear if there is meant to be antecedent basis or if there is mean to be additional structure claimed.
Claim 10 recites the distal end. It is unclear which distal end is being referenced as previous recitations include distal end of the tunnel graft, distal end of the tunnel graft lumen, distal end of the wall aperture and distal end of the tubular aortic component.
Claim 11 recites “the filters is between the proximal and the first stent and the second stent” It is unclear what “the proximal” is referring to as previous recitations include proximal end of the tunnel graft, proximal end of the tunnel graft lumen, proximal end of the wall aperture and proximal end of the tubular aortic component.
Claim 8 is rejected due to its dependency of claim 7.
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.
Claims 1-3, 6-8 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille et al. (9,592,112) in view of Yassour et al. (6,673,089).
Arbefeuille et al. disclose the invention substantially as claimed. Arbefeuille et al. disclose, in figures 1A-3B and col. 6, line 6 to col. 7, line 62 and col. 8 lines 25-56; an aortic graft assembly, comprising:
a) a tubular aortic component (12) that defines a tunnel lumen and includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture (20) that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end;
b) a tunnel graft (28) connected to the wall of the tubular aortic component and extending from the wall aperture and within the tunnel lumen of the tubular aortic component toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end (92) and a distal end (94), and defining a tunnel graft lumen that extends between the distal end and the proximal end of the tunnel graft lumen, the distal end being at or proximal to the wall aperture of the tubular aortic component (see Fig. 2B), wherein the tunnel graft includes a first stent (88) at a proximal end of the tunnel graft and a second stent (90) distal to the first stent;
c) a proximal stent (34) that supports the proximal end of the tubular aortic component (see Fig.1A-1C) ; and
d) a distal stent (36) that supports the distal end of the tubular aortic component (see Figs. 1A-1C);
However, Arbefeuille et al. do not explicitly disclose at least one filter spanning at least one of the aperture and the tunnel graft; wherein the filter includes at least on of nylon, nitinol, and polyester.
Yassour et al. teach, in figures 1A, 2B, and 2C and col. 5, line 12 to col. 6, line 25 and col. 8, lines 5-17; at least one filter (24) spanning an aperture of a tubular component (22) (claim 1); wherein the filter includes nitinol or a polymeric material (claim 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Yassour et al., to modify the aortic graft assembly of Arbefeuille et al., so that at least one filter spans the aperture; wherein the filter includes nitinol or a polymeric material. Such modifications would allow filtering of embolic material and free flow of blood through the aortic component.
NOTE that the claim 1 only requires the filter to span the aperture OR to span the tunnel graft. Since the prior art addresses the filter spanning the aperture, it need not address the limitation of the filter spanning the tunnel graft, wherein the filter spans the tunnel graft between the first and second stent.
Claim 2: Arbefeuille et al. in view of Yassour et al. do not explicitly disclose that the filter has a mesh size of between about 90 microns and about 100 microns. Nevertheless, Yassour et al. teach, in col. 7, lines 20-28 and col. 8, lines 13-16; that the mesh size of a filter should be able to prevent passage of particles of a size in the range of 200-400 microns. One can infer that the mesh size of this device would range from below 200 to below 400 microns to meet this criterion. The mesh size is therefore considered a result effective variable in that changing the size of the mesh changes the ability to filter different sizes of particulate. Therefore, 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 device of Arebefeuille et al. by making mesh size between about 90 microns and about 100 microns as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 6: the filter spans the aperture (as taught by Yassour above)
Claim 7: Arbefeuille discloses wherein the tunnel graft is bifurcated (100, 102 Figs. 7A-8B) but does not explicitly disclose that each tunnel graft further includes a first stent and a second stent. However, Aberfeuile does disclose that a single tunnel graft has a first and second stent (55, 90 Fig 2b) and further that the tunnel graft optionally includes additional stents (98 see Fig. 3B). Based on the teachings of Arbefeuille, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a fist and a second stent in each of the tunnel grafts, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further doing so would have had reasonable expectation of success since it would provide support to each tunnel and prevent it from collapsing during use.
Claim 8: Alberfeuille wherein the distal end of each tunnel graft lumen is proximal to the proximal end of the aperture (see Figs. 7A-8B).
Claim 12: Alberfeuille where the tunnel graft includes at least three stents (88, 98, 90 Fig. 3B) between the proximal end and the distal end of the tunnel graft
NOTE that the claim 1 only requires the filter to span the aperture OR to span the tunnel graft. Since the prior art addresses the filter spanning the aperture, it need not address the limitation of the filter spanning the tunnel graft, wherein the filter spans the tunnel graft between the first and second stent.
Claim 13: Alberfeuille discloses wherein the proximal end (22) of the wall aperture includes an arch that lies in a first plane extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis (see Fig.1B).
Claim 14: Alberfeuille discloses that the length of the proximal end of the wall aperture in a first plane is greater than the diameter of the tunnel graft lumen in a second plane extending orthogonally to a major longitudinal axis at a point proximal to the proximal end of the wall aperture (C 7: L19-29).
Claims 1-3, 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille et al. (9,592,112) in view of Khosravi (5,925,063).
Arbefeuille et al. disclose the invention substantially as claimed. Arbefeuille et al. disclose, in figures 1A-3B and col. 6, line 6 to col. 7, line 62 and col. 8 lines 25-56; an aortic graft assembly, comprising:
a) a tubular aortic component (12) that defines a tunnel lumen and includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture (20) that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end;
b) a tunnel graft (28) connected to the wall of the tubular aortic component and extending from the wall aperture and within the tunnel lumen of the tubular aortic component toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end (92) and a distal end (94), and defining a tunnel graft lumen that extends between the distal end and the proximal end of the tunnel graft lumen, the distal end being at or proximal to the wall aperture of the tubular aortic component (see Fig. 2B), wherein the tunnel graft includes a first stent (88) at a proximal end of the tunnel graft and a second stent (90) distal to the first stent;
c) a proximal stent (34) that supports the proximal end of the tubular aortic component (see Fig.1A-1C) ; and
d) a distal stent (36) that supports the distal end of the tubular aortic component (see Figs. 1A-1C);
However, Arbefeuille et al. do not explicitly disclose at least one filter spanning at least one of the aperture and the tunnel graft; wherein the filter spans the tunnel graft between the first stent and the second stent.
Khosravi discloses a stent having a filter (flaps 28 which may be constructed of fine mesh material) such that it performs as a blood filter and provides the advantage of capturing frangible material liberated during surgical procedures (C4: L51-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Khosravi, to modify the aortic graft assembly of Arbefeuille et al., to include filters that span the tunnels of the graft assembly. Such modifications would allow filtering of embolic material and free flow of blood through the aortic component.
NOTE that the claim 1 only requires the filter to span the aperture OR to span the tunnel graft. Since the prior art addresses the filter spanning tunnel graft, it need not address the limitation spanning the aperture.
Regarding the filter spanning the tunnel graft between the first and second stent, Khosravi does not provide any guidance as to the location of the filter membrane within the lumen of the stent. However, one of ordinary skill would have would have had only a finite number of options to choose from regarding the placement of the filter; inculding distal of the stents, in between the stents, or proximal of the stents. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have found it "obvious to try" to any of the recited potential options since there are only a finite number of identified solutions that would have a reasonable expectation of success (i.e preventing unwanted particulate from entering the blood stream). KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim 2: Arbefeuille et al. in view of Khosravi does not explicitly disclose that the filter has a mesh size of between about 90 microns and about 100 microns. However it is well known to one of ordinary skill that that changing the size of the mesh would change the sizes of particulate that can be captured. Changing the mesh size is beneficial depending on where the body the device is placed and what type of particulate needs to be captured. Thus, the mesh size is considered a result effective variable. Therefore, 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 device of Arebefeuille et al. by making mesh size between about 90 microns and about 100 microns as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 3: The filter includes nitinol. (C4:L59)
Claim 7: Arbefeuille discloses wherein the tunnel graft is bifurcated (100, 102 Figs. 7A-8B) but does not explicitly disclose that each tunnel graft further includes a first stent and a second stent. However, Aberfeuile does disclose that a single tunnel graft has a first and second stent (55, 90 Fig 2b) and further that the tunnel graft optionally includes additional stents (98 see Fig. 3B). Based on the teachings of Arbefeuille, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a fist and a second stent in each of the tunnel grafts, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further doing so would have had reasonable expectation of success since it would provide support to each tunnel and prevent it from collapsing during use.
Claim 8: Alberfeuille discloses wherein the distal end of each tunnel graft lumen is proximal to the proximal end of the aperture (see Figs. 7A-8B).
Claim 9: As noted above Khosravi the teaches the use of a filter within the lumens. Regarding including at least two filters, at least one of the filters spans each each tunnel graft lumen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a second filter within the second lumen since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further doing so would have had reasonable expectation of success of effective filtering to prevent particulate matter to enter the blood stream
Claim 11: see claim 1 above with respect to the location of the filter within the tunnel grafts relative to the stents.
Claim 12: Alberfeuille discloses where the tunnel graft includes at least three stents (88, 98, 90 Fig. 3B) between the proximal end and the distal end of the tunnel graft. With respect to the location of the filter within the tunnel grafts relative to the stents see claim 1 above.
Claim 13: Alberfeuille discloses wherein the proximal end (22) of the wall aperture includes an arch that lies in a first plane extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis (see Fig.1B).
Claim 14: Alberfeuille discloses that the length of the proximal end of the wall aperture in a first plane is greater than the diameter of the tunnel graft lumen in a second plane extending orthogonally to a major longitudinal axis at a point proximal to the proximal end of the wall aperture (C 7: L19-29).
Conclusion
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/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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