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 .
Drawings
The replacement drawings were received on 4/3/26. These drawings are acceptable to address and correct figures that caused objections.
Specification
The amendment to the specification filed 4/3/26 has been entered because it corrected informalities or inconsistencies in the disclosure.
Claim Objections
Claim 4 is objected to because of the following informalities: line 10 the recitation “portion of the and up to the nominal …..” is grammatically improper. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 4/3/26 have been fully considered but they are not persuasive. Applicant contends Robison ‘505 does not disclose or show the recitation of “combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen” but seems to present no evidence. It must be noted that the feature is a function dependent upon the patient variables of which Applicant cannot claim as this is a product claim and not a method of using. Thus, since Robison discloses the first and second elongated segments have the capability to expand, they are fully capable of achieving the claimed function of “combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen” and Robison clearly discloses the two segments expand to the intraluminal cross-section of the lumen, see paragraphs 44-46.
Additionally a similar argument was made for the rejection over Dereume (WO ‘912) of not discussing the function of “combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen” but seems to present no evidence. It must be noted that the feature is a function dependent upon the patient variables of which Applicant cannot claim. Thus, since Dereume discloses (page 22, lines 16,17) the first and second elongated segments have the capability to expand, they are fully capable of achieving the claimed function of “combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen” and Robison clearly discloses the two segments expand to the intraluminal cross-section of the lumen, see page 23 lines 22-26.
In addition the same argument was made against the rejection over Bolduc (Pub ‘132) of not discussing the function of “combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen” but seems to present no evidence. It must be noted that the feature is a function dependent upon the patient variables of which Applicant cannot claim positively in a product claim. Further the recitation at issue is just a function to be able to be placed in an occlusion of which when the apparatus is compressed it can be expanded to the occluded dimension and then further to the lumen vessel dimension which is greater than the occluded dimension. Thus, since Bolduc discloses (paragraphs 36,48) the first and second elongated segments have the capability to expand, they are fully capable of achieving the claimed function of “combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen” and Bolduc clearly can be said per the doc teachings the two segments expand to the intraluminal cross-section of the lumen.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3,16,17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robison (2013/0211505). Fig. 2 shows a device having a support structure and a covering material (paragraph 25), the device operable to be delivered to an at least partially occluded lumen (intended use) including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising: a first elongated segment having 220 two opposing ends and defining a first primary lumen extending therebetween, the first elongated segment 220b operable to be positioned at least partially in the first bifurcated portion of the at least partially occluded region of the lumen (intended use); and a second elongated segment 230a having two opposing ends and defining a second primary lumen extending therebetween, the second elongated segment 230b operable to be positioned at least partially in the second bifurcated portion of the at least partially occluded region of the lumen (intended use); wherein a combined cross section of the first elongated segment and second elongated segment includes a combined cross section that is equal to or greater than the occluded intraluminal cross section and up to the nominal intraluminal cross section of the lumen (paragraphs 44-461), the first and second elongated segments having a radial wall strength (paragraph 65) sufficient to resist inward radial force (arbitrary value) exerted by the at least partially occluded region of the lumen (intended use) to resist collapse of the first and second primary lumens. Regarding claims 2,3 Robison discloses (paragraph 53) the first and second elongated segments are self-expandable and balloon expandable. With respect to claim 16, Robison discloses (paragraphs 47,53) the radial wall strength of the first and second elongated segments is sufficient to expand the first and second elongated segments to a predetermined diameter and resist the inward radial force to resist collapse of the first and second primary lumens from the predetermined diameter (paragraph 37). Regarding claim 17, Robison further discloses (paragraph 86) the first and second elongated segments are configured to expand and substantially conform to the occluded intraluminal cross section of the lumen.
Claim(s) 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dereume et al. (WO 97/17912). Fig. 25 shows a device having a support structure and a covering material (see abstract), the device operable to be delivered to an at least partially occluded region of a lumen having an occluded intraluminal cross section that is smaller than a nominal intraluminal cross section of the lumen, the at least partially occluded region of the lumen including a non-bifurcated portion (page 25, lines 14-17), a first bifurcated portion, and a second bifurcated portion, the device comprising: a primary elongated segment 101 having two opposing ends and defining a primary lumen defined by element 121 extending therebetween wherein a cross section of the primary elongated segment is equal to or greater than the occluded intraluminal cross section of the non- bifurcated portion of the and up to the nominal intraluminal cross section of the lumen (which is just an intended use of function or ability to expand an occluded region) with Dereume disclosing expansion via balloon (page 18) one can expand to the arbitrary dimensions; a first elongated segment 108 having two opposing ends and defining a first secondary lumen extending therebetween, the first elongated segment operable to be positioned at least partially in the first bifurcated portion of the partially occluded region of the lumen; and a second elongated segment 115 having two opposing ends and defining a second primary lumen extending therebetween, the second elongated segment operable to be positioned at least partially in the second bifurcated portion of the partially occluded region of the lumen. Regarding claims 5,6 Dereume et al. disclose (page 5, lines 19,20,37) the primary, first and second elongated segments are self-expandable and balloon expandable.
Claim(s) 7,8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolduc et al. (2005/0021132). Fig. 4 shows a device having a support structure 38 and a covering material 36 (see Fig. 2A), the device operable to be delivered to an at least partially occluded region of a lumen (intended use) having an occluded intraluminal cross section that is smaller than a nominal intraluminal cross section of the lumen, the at least partially occluded region of the lumen including a non-bifurcated portion (upper part of stent graft below stent 40), a first bifurcated portion, and a second bifurcated portion, the device comprising: a body including a primary portion 12, a first branch 20, and a second branch 18, the primary portion defining a primary lumen, the primary portion defined between a first open end and a flow divider 16 and having a primary portion length, the first branch defining a first branch lumen, the first branch extending from the primary portion at the flow divider to a first branch open end, the first branch having a first branch length, and the second branch defining a second branch lumen, the second branch extending from the primary portion at the flow divider to a second branch open end, the second branch having a second branch length. Bolduc et al. disclose the body having a radial wall strength (paragraph 36) sufficient to resist inward radial force exerted by the at least partially occluded region of the lumen (an intended use) to resist collapse of the primary, first branch and the second branch lumens. Regarding claim 8, Bolduc et al. disclose (paragraph 35) the body is self-expandable.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (2005/0021132) in view of Dereume et al. (WO 97/17912). Bolduc et al. is explained supra. However, Bolduc et al did not explicitly disclose the stent or support structure have a body which is balloon expandable. Dereume et al. teach (page 5, lines 19,20) the body of the device is balloon expandable. It would have been obvious to one of ordinary skill in the art to alternatively use a balloon expandable body as taught by Dereume et al. with the device of Bolduc et al. such that it provides the user with controlled deployment via the use of a balloon expandable materials for the body.
Claim(s) 10,14,15 are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (2005/0021132) in view of Cragg et al. (2011/0130819). Bolduc et al. is explained supra. However, Bolduc et al did not explicitly disclose the body of the device has a length of approximately 2.5 to 5.5 centimeters. Cragg et al. teach (paragraph 38) the body of the device has a length of approximately 2.5 to 5.5 centimeters. It would have been obvious to one of ordinary skill in the art to provide length within the range
approximately 2.5 to 5.5 centimeters for the body as taught by Cragg et al. with the
device of Bolduc et al. such that it provides the appropriate length to cover the area of
treatment sufficiently and support the diseased or problem area. Finding the optimal
length only involves routine skill in the art. With respect to claim 14, Bolduc et al.
disclose (paragraph 34) there can be a first elongated segment having two opposing
ends and defining a lumen extending therebetween, the first elongated segment
operable to be positioned at least partially in the first branch lumen. Figs. 7A,B show the
two branch lumens 18,20. Fig. 4 shows the first elongated element 26 to insert in the
branch lumen. However, Bolduc did not explicitly state a second elongated segment
having two opposing ends and defining a lumen extending therebetween, the second
elongated segment operable to be positioned at least partially in the second branch
lumen. Cragg teaches (Fig. 13C) there are two elongated segments 1362a,1362b with
lumens and are inserted into first and second branch lumens. It would have been
obvious to one of ordinary skill in the art to utilize two elongate segments as taught by
Cragg et al. with the device of Bolduc et al. as the surgeon is able to deliver
components of a modular system accordingly and provide appropriately selected lengths and seal each accordingly, see Cragg paragraph 113. Regarding claim 15, Bolduc shows (Fig. 1) a branch 26 that is with a length that is about 1:1 with the body (length extends from proximal end 14 to distal end 24) of the device. Bolduc did not explicitly show the two branches with both being separate, however Cragg teaches two
elongated separate branches (Fig. 13C). Thus, Cragg teaches two separate branches
and are individually delivered in branch lumens of a main body graft device. It would
have been obvious to one of ordinary skill in the art to use two branch elements as taught by Cragg with the main body device of Bolduc and provide lengths that are about 1:1 for both relative to the main body SO one can provide stable anchoring and balance across the length of the device for an established supportive structure to allow flow of blood therethrough as it restores stability across the diseased region of placement.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (2005/0021132) in view of Cragg et al. (2011/0130819) as applied to claim 10 above, and further in view of Greenberg et al. (2014/0180394). Bolduc et al. as modified with Cragg et al. is explained supra. However, Bolduc et al. in view of Cragg et al. did not explicitly disclose the first and second branch lengths are approximately 2 to 7 centimeters. Greenberg et al. teach (paragraph 57) the first and second branch lengths are approximately 2 to 7 centimeters. It would have been obvious to one of ordinary skill in the art to provide lengths within the range approximately 2.5 to 5.5 centimeters for the first and second branches as taught by Greenberg et al. with the device of Bolduc et al. as modified by Cragg et al. such that it provides the appropriate length to extend into a branch vessel and establish a supported flow channel. Finding the optimal length only involves routine skill in the art.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (2005/0021132) in view of Lu (CN 107693163). Bolduc et al. is explained supra. However, Bolduc et al did not explicitly disclose the body of the device has a diameter from 8 to 24 millimeters. Lu teaches (paragraph 38) the body of the device can have a diameter of 10-20 millimeters. It would have been obvious to one of ordinary skill in the art to provide a diameter of 10-20 millimeters for the body as taught by Lu in the device of Bolduc et al. such that it provides the appropriate dimensions such that the diameter matches a vessel wall and provides the sufficient lumen dimension as needed. Finding the optimal diameter only involves routine skill in the art.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (2005/0021132) in view of Melissano (WO 2016/075615). Bolduc et al. is explained supra. However, Bolduc et al did not explicitly disclose the first and second branch dimension diameters. Melissano teaches (page 7 lines 21,22) a bifurcated prosthesis that can have branches disposed therein can have a diameter of 10 millimeters. It would have been obvious to one of ordinary skill in the art to select a diameter of 10 millimeters for a first and second branch as taught by Melissano in the device of Bolduc et al. such that it provides the appropriate dimensions such that the diameter matches a vessel dimension in which a branch is used to communicate with the vessel and match a channel diameter provided within the main body for a branch element. Finding the optimal diameter only involves routine skill in the art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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