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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/8/26 and 6/18/26 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) and Lunn (US 5,476,506).
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.
However, the combination of Vonesh modified by Kariniemi et al. does not explicitly disclose a step of coupling at least one stent to a portion of the kink resistant graft such that a middle portion of the kink resistant graft is free from any stent. Lunn, however, discloses coupling stents (36, 38, Figure 4 in Lunn) to a portion of a graft (10) such that a middle portion of the graft (10) is free from any stent [as can be seen from Figure 4 in Lunn]. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a step of coupling at least one stent on a portion of a graft such that a middle portion of the graft is free from any stent, as taught by Lunn, to enable secure anchoring of the ends of the graft in a blood vessel to prevent migration of the graft relative to the blood vessel [as described on column 4 lines 26-32 and can be seen from Figure 4 in Lunn].
6. Regarding to Claim 2, the combination of Vonesh et al., Kariniemi et al., and Lunn 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, the combination of Vonesh et al., Kariniemi et al., and Lunn 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, the combination of Vonesh et al., Kariniemi et al., and Lunn 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, the combination of Vonesh et al., Kariniemi et al., and Lunn 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, the combination of Vonesh et al., Kariniemi et al., and Lunn 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., Kariniemi et al., and Lunn 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, the combination of Vonesh et al., Kariniemi et al., and Lunn 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., Kariniemi et al., and Lunn 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, the combination of Vonesh et al., Kariniemi et al., and Lunn 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 with respect to claim(s) 1-7 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/NIRVANA DEONAUTH/Primary Examiner, Art Unit 3726
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