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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 AF submission filed on 1/14/26 has been entered.
Drawings
The amendment submitted on 1/14/26 has resulted in overcoming the drawing objection and is thus withdrawn.
Response to Amendment
Applicant's request for reconsideration of the 112 (a) rejection of the last Office action is persuasive in view of the amendment of 1/14/26 and, therefore, the 112 (a) rejection is withdrawn.
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) 1,5-9,11,13-16,23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (WO 2006/014592) in view of Armstrong et al. (2017/0216062). Osborne et al. disclose (abstract) a stent-graft apparatus. Osborne et al. also disclose (paragraph 44) a membrane comprising of a first set of fibers and a second set of fibers, wherein the first set of fiber and the second set of fibers combine to form a membrane material. Fig. 2 shows each fiber of the first set of fibers is undulating and is formed of a first material having a first stiffness, each fiber of the second set of fibers has differing undulations from the fibers of the first set and is formed of a second material having a second stiffness that is different from the first stiffness (see paragraph 45 and in Fig. 2 different size or diameter of filaments). In addition Fig. 1 shows a pile weave that clearly illustrates fibers that have a first undulation and a second fiber that has different undulations. It can be construed that the membrane material being configured to exhibit a nonlinear stretch behavior that produces a Windkessel effect due to non- uniform weaving, paragraph 33. It is also noted that Osborne stated (paragraph 3) that membranes of grafts are evaluated for compliance and thus it can be construed the membrane is configured to exhibit a first level of compliance (paragraph 22) in response to pressures in a range of 40 mmHg to 200 mmHg. Osborne also disclose (paragraphs 9-11) a scaffold coupled to the membrane. Figs. 3-5 show the scaffold comprising one or more struts. It is also noted that Osborne et al. disclose that the membrane is configured to exhibit a second level of compliance (paragraph 38) or high degree of flexibility. However, Osborne was silent as to "compliance" in response to pressures above 200 mmHg, such that the first level of compliance being greater than the second level of compliance. It must be noted that since Osborne discloses the same materials for the membrane, but also same arrangement (first and second set of fibers with differing undulation and stiffness) as recite and using the same arrangement, it can be said that the properties would be expected to be the same. The prior art teachings are at the same level as the claim, thus, it is reasonable to conclude that the membrane would possess a nonlinear stretch behavior because it is structured by the same arrangement. However, Osborne is silent as to the nonlinear stretch behavior of the membrane Armstrong et al. teach (paragraph 89) that a stent-graft is provided with the membrane resulting in a nonlinear stretch response. It would have been obvious to one of ordinary skill in the art to utilize the properties of composite membranes to provide a nonlinear stretch as taught by Armstrong et al. with the stent graft of Osborne et al. such that it mimics the natural blood vessel or responds to change in pressure, see Armstrong, paragraph 89. Thus it can be construed the membrane of Pham and alternatively modified with Armstrong is configured to exhibit a first level of compliance in response to pressures in a range of 40 mmHg to 200 mmHg and the membrane is configured to exhibit a second level of compliance in response to pressures above 200 mmHg, the first level of compliance being greater than the second level of compliance. Regarding claim 5, it is noted Osborne states (paragraphs 67,86) the stent-graft can be used in a vessel, thus the scaffold is configured to exert a pressure against a wall of an adjacent blood vessel following implantation of the stent- graft into a lumen of the adjacent blood vessel. Therefore, it can be construed the pressure exerted by the scaffold against the wall of the adjacent blood vessel is less than a threshold pressure since the prior art structure is the same construction as claimed and must possess the same capabilities. Regarding claim 6, Applicant is reminded because the Patent & Trademark Office does not have the testing facilities to provide factual evidence needed to establish that the claimed invention or subject matter is unobvious, the examiner properly shifts the burden to Applicants to show that unobvious differences exist, Ex parte Phillips, 28 USPQ 1302 (Bd Pat App & Inter, 4/27/93). If the prior art has the same materials and arrangement it must inherently possess the same capabilities. Since the scaffold is configured to exert a pressure (placed in vessel to support a lumen) it must provide a force inherently that can fall in a range of 0 Pascal to 50 Pascal against pressures above the threshold pressure result in increased stress in the wall of the adjacent blood vessel following implantation of the stent-graft into the lumen of the adjacent blood vessel. Regarding claim 7, it is noted that Osborne discloses (paragraph 9) the membrane comprise at least one of a woven material or a non-woven material. Regarding claim 8, please note the claim recites arbitrary values and just a placeholder value in reciting the first set of fibers comprises a first plurality of nanofibers; and the second set of fibers each comprise a second plurality of nanofibers. Thus, it can be said at the low end range Osborne does disclose (paragraph 43) what can be considered nanofibers for the different sets of fibers used. With respect to claim 9, Osborne et al. disclose (paragraph 45) an orientation of one or more nanofibers of at least one of first plurality of nanofibers and the second plurality of nanofibers provides one or more mechanical properties in a range corresponding to a range for the one or more mechanical properties for human vascular tissue. Regarding claim 11, it can be construed that the membrane of Osborne is configured to exhibit a greater ability to stretch when subjected to pressures in a range of 40 mmHg to 120 mmHg than when subjected to pressures greater than 120 mmHg because it designed (paragraph 22) to have good tensile strength in the range of 40 mmHg to 120 mmHg, but would be risked to break over 120 mmHg, paragraph 23. Again Applicant is reminded because the Patent & Trademark Office does not have the testing facilities to provide factual evidence needed to establish that the claimed invention or subject matter is unobvious, the examiner properly shifts the burden to Applicants to show that unobvious differences exist, Ex parte Phillips, 28 USPQ 1302 (Bd Pat App & Inter, 4/27/93). If the prior art has the same materials and arrangement it must inherently possess the same capabilities. Regarding claim 13, Osborne discloses (paragraphs 7,8,89,90) the membrane comprise a polymer. With respect to claim 14, Osborne discloses (paragraph 11) that the membrane material can be polyurethane. With respect to claim 15, Osborne et al. disclose (paragraph 20) the membrane is manufactured by at least one of weaving or knitting methods. With respect to claim 16, Osborne does not explicitly disclose the scaffold material. However, Armstrong teaches (paragraph 102) that a stent or scaffold support can be constructed of nitinol. It would have been obvious to one of ordinary skill in the art to select a material based on its property such as nitinol for the scaffold as taught by Armstrong and use in the stent-graft of Osborne to provide the desired scaffold property. Regarding claim 21, since Osborne discloses different materials are used for fiber, they inherently have different stiffness with one being greater than the other. It must be noted that claim 1 just recites an arbitrary first set of fiber and a second set of fibers, thus if there are different stiffness materials, it meets the scope of the claim since the claim fails to establish any distinction in what, where or how the first and second set of fibers are constructed to require any clarity as to what is the first or second fiber type. Regarding claim 23, it is noted that Osborne discloses (paragraph 3) that compliance is critical and should be similar to a tissue site in which the graft or membrane is placed. It is further noted that Osborne discloses (paragraph 35) that the stretch or compliance capability of the membrane material can be optimized. Since the values of stretch properties for the material is a finite number of possibilities, it can be said it would be obvious to one of ordinary skill in the art to find the optimal values such that the ratio of compliance of the membrane material in the longitudinal direction to compliance of the membrane material in the circumferential direction is between 0.5 and 2 because it is a result dependent variable it only involves routine skill in the art. With respect to claim 24, Osborne et al. disclose (paragraphs 11,31) that the fibers of at least one of the first set of fibers or the second set of fibers is treated using thermal, mechanical, or hygroscopic techniques to generate a complex stress state in the fibers of the at least one of the first set of fibers or the second set of fibers. Regarding claim 25, Osborne disclose (paragraph 9) the membrane material can be provided with a permeability of 65 ml/min-cm². With respect to claim 26, Osborne et al. did not explicitly state the scaffold is embedded in the membrane. Armstrong et al. teach (paragraph 98) that a stent is embedded in a covering or membrane. It would have been obvious to one of ordinary skill in the art to embed the scaffold in the membrane as taught by Armstrong et al. with the stent graft of Osborne et al. such that it assures the scaffold remains affixed to the membrane for the desired period of time for treatment and within the site of implantation.
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (WO 2006/014592) in view of Armstrong et al. (2017/0216062) as applied to claim 1 above, and further in view of Mangiardi (2017/0312102). Osborne et al. in view of Armstrong et al. is explained supra. However, Osborne et al. as modified by Armstrong did not explicitly disclose the stent scaffold is biodegradable and comprises at least one of biodegradable magnesium or a biodegradable magnesium alloy. Mangiardi is in the field of covered stent devices, see abstract. Mangiardi teaches (paragraphs 15,22) that the scaffold's biodegradable material can be one such as a metal. Additionally, Mangiardi further teaches (paragraphs 22-25) the metal can be one of a biodegradable magnesium or a biodegradable magnesium alloy. It would have been obvious to one of ordinary skill in the art to modify the biodegradable material used for the scaffold and use a magnesium metal for the degradable scaffold as taught by Mangiardi in the stent graft of Osborne et al. as modified with Armstrong such that it would provide improved in vivo supporting device that degrades over time in a controlled manner without interfering with the normal circulation of body fluid, paragraph 4. Regarding claim 19, Osborne as modified with Armstrong did not detail a strut dimension. Mangiardi teaches (paragraph 22) the thickness of struts for a stent can be within the range of 200 µm to 1000 µm. It would have been obvious to one of ordinary skill in the art to select a thickness for the stent struts and be within the range of 200 µm to 1000 µm as taught by Mangiardi in the stent graft of Osborne et al. as modified by Armstrong et al. in order to provide the appropriate supportive stability based on the desired patient parameters needed and improving the in vivo support in controlled fashion due to the degradable profile and maintaining fluid flow parameters, paragraph 4 of Mangiardi.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (WO 2006/014592) in view of Armstrong et al. (2017/0216062) as applied to claim 1 above, and further in view of Kitaoka et al. (2011/0196475). Osborne et al. in view of Armstrong et al. is explained supra. However, Osborne as modified by Armstrong did not disclose one or more of the struts of the scaffold strut have an amplitude in a range of 2mm to 6 mm. Kitaoka et al. teach (abstract) stents with struts having amplitudes due to wave shaped struts. Kitaoka et al. further teaches (para. 60) the amplitude of one or more struts in the range of 2mm to 6mm. It would have been obvious to one of ordinary skill in the art to use a stent with struts having wave shaped pattern to provide an amplitude between 2-6 mm as taught by Kitaoka et al. with the stent graft of Osborne et al. as modified with Armstrong et al. such that the amplitude selected for the waves of the struts in the pattern of the stent improve flexibility and smoothly bendable, see paragraph 17.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (WO 2006/014592) in view of Armstrong et al. (2017/0216062) as applied to claim 1 above, and further in view of Dong (6939372). Osborne et al. in view of Armstrong et al. is explained supra. However, Osborne as modified by Armstrong did not disclose the membrane material is configured to exhibit greater compliance along a longitudinal direction of the stent-graft than along a circumferential direction of the stent-graft. Dong teaches (abstract) that a stent-graft with a membrane configured to exhibit greater compliance along a longitudinal direction of the stent-graft than along a circumferential direction of the stent-graft. Itis also noted that Dong teaches (col. 13, lines 18-22,25-28) that the stretchability aspect relates to providing the compliance of the membrane. It would have been obvious to one of ordinary skill in the art to configure the membrane to exhibit greater compliance along a longitudinal direction of the stent-graft than along a circumferential direction of the stent- graft as taught by Dong for the stent-graft of Osborne et al. as modified with Armstrong et al. such that the appropriate functionality is provided in the vessel site and a compliant device is attained for that lumen in order to maintain proper flow while accommodating pressure changes, see Dong (col. 2, lines 31-33).
Response to Arguments
Applicant's arguments filed 1/14/26 have been fully considered but they are not persuasive. Applicant comments that Osborne does not suggest or teach a membrane with a “first set of fibers and a second set of fibers ….each fiber of the second set of fibers has differing undulations from the fibers of the first set and is formed from a second material having a second stiffness that is lower than the first stiffness” since the reference does not state the limitation. However, while a reference may be silent, it must be considered in its entirety, including drawings and suggested modifications.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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