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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/3/25 and 2/23/36 has been entered.
Claim Rejections - 35 USC § 103
3. 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.
4. Claim(s) 1-7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vonesh et al. (US 6,673,102) in view of Kariniemi et al. (US 2010/0106235).
5. Regarding to claim 1, Vonesh et al. discloses a method of forming a kink resistant graft [as described in column 5 lines 46-48, column 7 lines 39-41 and column 13 lines 25-26 in Vonesh et al.] comprising: wrapping a film (a first wrapping of a film to form cover 18, as described in column 7 lines 65-column 9 line 4 and column 18 lines 3-17 and can be seen from Figure 1 in Vonesh et al.) to form an inner graft layer (an inner layer of the film of first segment 14 that is slit and helically wrapped in approximately 6 layers, as described in column 7 lines 65-column 9 line 4 and column 18 lines 3-17 and can be seen from Figure 1 in Vonesh et al.) forming a tube with a central lumen extending from a first end of the tube to a second end of the tube [as can be seen from Figure 1 in Vonesh et al.]; scrunching (scrunching, as described in column 9 lines 5-11) the inner graft layer (inner layer film that is slit and helically wrapped in approximately 6 layers) to form corrugations including at least one of folds and creases in the inner graft layer [as described in column 9 lines 5-11 and can be seen from Figure 1 in Vonesh et al. Note that the prior art discloses a step of “scrunching” which is defined as causing to draw together and crumple (Merriam Webster Online Dictionary). “Crumple” is defined as causing a wrinkle or crease (Merriam Webster Online Dictionary). The prior art of record therefore is interpreted as disclosing “creases”], the corrugations providing a stored length of the corrugated inner graft layer [as described in column 9 lines 5-27 and column 13 lines 19-column 14 line 40]; wrapping an outer graft layer (additional layer wrapped over the construction in approximately 5 overlapping layers, as described in column 9 lines 35-40 and column 18 lines 31-55) and over the corrugated inner graft layer to cover the corrugated inner graft layer [as described in column 9 lines 35-40 and column 18 lines 31-55]; and bonding the outer graft layer to the corrugated inner graft layer to form the kink resistant graft [as described in column 9 lines 43-55 and column 9 lines 35-40 and column 18 lines 31-55].
Vonesh et al. discloses having a stored length where a maximum length of the covered segment should be 20% or more of the normal deployed length of the covered segment [as described in column 9 lines 5-27 and column 13 lines 19-column 14 line 40]. However, Vonesh et al. does not explicitly disclose the stored length of the inner graft layer being at least twenty-five percent. However, it would have been obvious to one of ordinary skill in the art to try a stored length of at least 25% to achieve a predictable solution with a reasonable expectation of success.
Vonesh discloses a step of scrunching the inner graft layer to form corrugations. However, Vonesh does not explicitly disclose the corrugations being formed along a surface of the inner graft layer. Kariniemi et al. however discloses a step of forming corrugations on an inner graft layer (inner layer 12 having corrugations 36, as described in paragraph 0051 and can be seen from Figure 10 in Kariniemi et al.]. Therefore, 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 inner graft layer in Vonesh to include corrugations along a surface of the inner graft layer, as taught by Kariniemi et al., as a simple substitution of one known element for another to obtain predictable results.
6. Regarding to Claim 2, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, further comprising securing a stent (second element 16, as described in column 5 lines 46-48 and can be seen from Figure 1 in Vonesh et al.) to the graft adjacent the first end of the tube [as described in column 5 lines 46-48 and can be seen from Figure 1 in Vonesh et al.].
7. Regarding to Claim 3, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, wherein the wrapping the film to form the inner graft layer forming the tube includes wrapping more than one layer of the film to form the tube [as described in column 7 lines 65-column 9 line 4 and column 18 lines 3-17 and can be seen from Figure 1 in Vonesh et al.].
8. Regarding to Claim 4, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, further comprising, after the wrapping the film to form the inner graft layer forming the tube and before the scrunching the inner graft layer to form the corrugations in the inner graft layer, heating the wrapped film to set the film in the tube [as described in column 8 lines 10- column 9 line 9 in Vonesh et al.].
9. Regarding to Claim 5, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, further comprising, after the wrapping the outer graft layer over the corrugated inner graft layer to cover the corrugated inner graft layer, bonding the wrapped outer graft layer to the corrugated inner graft layer [as described in column 9 lines 43-55 and column 9 lines 35-40 and column 18 lines 31-55].
10. Regarding to Claim 6, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, wherein the kink resistant graft is configured to resist kinking while experiencing a 90 degree bend with an internal fluid pressure in that the kink resistant graft is configured to maintain cross-sectional area at the apex of the 90 degree bend while experiencing the internal fluid pressure [as described in column 7 lines 39-41 and column 14 lines 30-40 and can be seen from Figure 5 in Vonesh et al.]. However, the combination of Vonesh et al. and Kariniemi et al. does not explicitly disclose having an internal fluid pressure of at least 100 mmHg and being configured to maintain at least 60% of its cross-sectional area at an apex. However, it would have been obvious to one of ordinary skill in the art to try various pressures and dimensions, such as having an internal fluid pressure of at least 100 mmHg and being configured to maintain at least 60% cross-sectional area, to achieve a predictable solution with a reasonable expectation of success.
11. Regarding to Claim 7, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, wherein the kink resistant graft having a wall thickness [as can be seen from Figure 1 in Vonesh et al.]. However, the combination of Vonesh et al. and Kariniemi et al. does not explicitly disclose having a wall thickness of no greater than 0.20 nm. However, it would have been obvious to one of ordinary skill in the art to try various dimensions, such various wall thicknesses, to achieve a predictable solution with a reasonable expectation of success.
12. Regarding to Claim 16, Vonesh et al. modified by Kariniemi et al. discloses the method of claim 1, wherein scrunching the inner graft (inner layer film that is slit and helically wrapped in approximately 6 layers) to form corrugations on the inner graft layer (inner layer film that is slit and helically wrapped in approximately 6 layers) comprises forming one or more of folds, creases, undulations or crinkles [as described in column 9 lines 5-11 and can be seen from Figure 1 in Vonesh et al. Note that the prior art discloses a step of “scrunching” which is defined as causing to draw together and crumple (Merriam Webster Online Dictionary). “Crumple” is defined as causing a wrinkle or crease (Merriam Webster Online Dictionary). The prior art of record therefore is interpreted as disclosing “creases”].
Response to Arguments
13. Applicant's arguments filed 12/3/25 have been fully considered but they are not persuasive. Applicant argues the rejection under 103. Applicant argues that it would have not been obvious to modify the device of Vonesh to include corrugations providing a stored length of the corrugated inner graft layer of at least twenty-five percent. Applicant argues that the prior art of Vonesh focuses on providing luminal surface without compromising the luminal surface and modifying the prior art of Vonesh would change the dynamics of the inner layer and specifically the luminal surface. From a review of column 7 lines 39-41 the prior art of Vonesh. Vonesh does disclose “the cover allowing bending of segment 14 without kinking or compromising the luminal surface of the device”. However, applicant’s arguments are directed to speculating that the proposed modification would compromise the apparatus disclosed by Vonesh rather than facts. Arguments by applicant cannot take the place of evidence. There is no evidence that the proposed modification under 103 compromises the apparatus disclosed by Vonesh. The prior art of Vonesh discloses corrugations. Kariniemi further discloses corrugations formed along a surface of the inner graft layer. Furthermore, it would have been obvious to one or ordinary skill in the art to include having a stored length of twenty-five percent, as previously rejected and rejected again above under 103. Applicant has failed to amend the claims to add sufficient structure to overcome the prior art of record.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/NIRVANA DEONAUTH/Primary Examiner, Art Unit 3726