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 .
Response to Amendment
Applicant’s amendment and remarks, filed 02/23/2026 in reply to the non-final Office action (“non-final action”), are noted with appreciation. No claims have been added, canceled, or amended.
Claims 1-20 remain pending.
Response to Arguments
Applicant’s arguments, set forth in the remarks, have been fully considered.
Abstract
The objection to the abstract of the disclosure set forth in the non-final action is withdrawn in view of the amendment.
Specification
The objection to the disclosure set-forth in the non-final action is withdrawn in view of the amendment.
Title
The objection to the title of the invention set forth in the non-final action is withdrawn in view of the amendment.
Claim Rejections – 35 USC § 103
The rejection(s) under this heading in the non-final action are maintained because Applicant’s arguments are not persuasive.
I. The Primary Examiner’s prima facie case is supported by articulated reasoning with a rational underpinning.
‘‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418, 82 USPQ2d at 1396 (quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)). Moreover, “[o]bviousness can be established by . . . modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so . . . . A motivation to combine may be found explicitly or implicitly in . . . the background knowledge, creativity, and common sense of the person of ordinary skill.” MPEP § 2143.01. An “objective reason” is sufficiently non-conclusory to meet the burden under KSR requiring “some articulated reasoning with some rational underpinning.” See MPEP § 2143.01(IV).
In the non-final action, the Primary Examiner’s position that it would have been obvious to the artisan to dry the liquid ECM hydrogel material to form the ECM is not conclusory because it clearly articulates an objective reason with rational underpinning derived from the background knowledge or common sense of one of ordinary sill in the art. Namely, that a dried hydrogel results in a dried stent, which facilitates handling, packaging, transport, etc., of the stent. Non-final action at ¶ 21. Consequently, the Primary Examiner has met his burden under the law and Applicant’s assertion that the prima facie case is “conclusory” or “merely speculative and unsupported by any evidence” is not persuasive.
As Applicant has not explained any of the other instances of alleged “select[ing] disparate teachings from three references without establishing why one skilled in the art would combine them in the specific manner claimed,” Remarks at 12, nor specifically traversed the objective reasons with rational underpinnings clearly set forth by the Primary Examiner at ¶¶ 18 – 21 or any other part of the non-final action, the balance of Applicant’s arguments is not persuasive.
II. Geckil does not teach away from drying the ECM hydrogel.
A teaching away either criticizes, discredits, or otherwise discourages the proposed modification or demonstrates that the proposed modification would have rendered the prior art unsatisfactory for its intended purpose. MPEP § 2143.01(I) and (V).
Here, Geckil teaches that ECM hydrogels are capable of absorbing a large amount of water or biological fluid. Geckil at p. 3, l. 10 et seq. There is nothing in this teaching that criticizes, discredits, or otherwise discourages one of ordinary skill in the art from drying the ECM hydrogel to facilitate further processing. Moreover, there is no hint (nor, from a functional standpoint, does it logically follow) that a dehydrated ECM hydrogel could not or would not be capable of rehydrating in the presence of water or biological fluid, thereby rendering it unsatisfactory for its intended purpose. Consequently, Applicant’s argument that Geckil teaches away from drying the ECM hydrogel is not persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-9, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over us 2006/0228389 A1 in view of US 8,916,227 B2 and Geckil et al., Engineering hydrogels as extracellular matrix mimics, Nanomedicine (Lond). 2010 April; 5(3): 469-484.
Independent Claim 1
US 389 teaches a process for the manufacture of an implantable biomedical device [0017]. The process comprises:
applying a polymeric covering (e.g., segmented polyurethane) to a metallic
stent surface and micropatterning the polymeric coating’s external surface [0023],
the micropattern having a plurality of parallel, elongate grooves (i.e., voids) separated by plateau regions (i.e., protrusions) therebetween [0018]; and
applying an extracellular matrix material (ECM) over at least a portion of the polymeric in the grooves (i.e., within the plurality of the voids) [0021].
US 389 does not explicitly teach: (i) that the stent is “an elongated tubular body having a scaffolding forming a plurality of cells; (ii) that the ECM is a liquid hydrogel; and (iii) drying the ECM hydrogel to form the ECM.
With respect to (i), US 389 teaches that the stent can be a vascular stent and that such “stents are commonly fabricated from metallic materials such as stainless steel, nickel-titanium alloys (e.g., nitinol), cobalt chromium alloys, etc.” [0023]. US 8,916,227 B2 teaches that a stent, such as a vascular stent, is a tube (i.e., elongated tubular body) composed of a mesh network formed by solid struts and cut-out interstices (i.e., cells), “[t]herefore, an endoprosthesis has a plurality of scaffolding elements (e.g., struts, rings, helices, wires and intersection points), which together form the endoprosthesis, as well as a plurality of interstices between said solid elements such as intersection points and struts . . . . [T]he struts meet at intersection points, such that the interstices are defined by the surrounding struts and intersection points” [4:25-61]. Moreover, US 227 teaches that the entire surface of the mesh-like scaffolding can be coated with a polymeric coating [5:19-51].
Based on the teaching of US 227 that such elongated, tubular bodies having scaffolding forming a plurality of cells are known in the art as vascular stents and that it is further known to coat them with a polymeric coating, 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 process of US 389 so as to utilize, as the vascular stent, a vascular stent such as the one taught by US 227. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully forming a polymer-coated stent.
With respect to (ii), Geckil et al. teach the use of engineered hydrogel scaffolds as ECM mimics [beginning at the bottom of p. 2]. Such hydrogels have advantageous tissue-engineering properties, such as ease of adjusting physico-chemcial and mechanical properties to levels that are desirable for tissue scaffolds [top of p. 3]. Consequently, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize, as the ECM material in the process of US 389, a liquid ECM hydrogel such as that taught by Geckil. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully providing a specifically-tailored environment to particular cell adhesion, such as the smooth muscle cells taught by US 389.
With respect to (iii), it is the Primary Examiner’s position that it would have been obvious to the artisan to dry the liquid ECM hydrogel material to form the ECM in order to facilitate handling, packaging, transport, etc., of the stent. The dried ECM rehydrating once implanted in the body.
Independent Claim 9
US 389, US 227, and Geckil et al. are applied herein again as with respect to independent claim 1 above. Independent claim 9 differs from independent claim 1 in that it specifies that the pattern is on the outer surface of the polymeric covering. US 389 teaches patterning the polymeric coating with an excimer laser [0023], which necessarily must be focused on the outer surface of the polymeric coating to form the pattern. The laser-formed voids and protrusions read on the claimed “outer surface including a plurality of voids.” Moreover, the ECM material in US 389 contacts the outer surface of the polymer covering and rests in the voids.
Independent Claim 15
US 389, US 227, and Geckil et al. are applied herein again as with respect to independent claim 1 above. Independent claim 15 differs from independent claim 1 in that is recites and additional step of “generating a liquid extracellular matrix hydrogel.” As noted above, it would have been obvious to use a liquid ECM hydrogel to coat the stent in the process of US 389. It is the Primary Examiner’s position that, in order to provide the liquid ECM hydrogel, it is necessary to first generate it.
Claims 5 & 13
The combined teaching of US 389, US 227, and Geckil et al. is detailed above. US 389 additionally teaches that the stent (elongated tubular body) can be made of a biodegradable, polymeric material, instead of metal [0019]. The Primary Examiner interprets biodegradable as bioabsorbable in the context of US 389 because the device is implantable in the human body. If the biodegradable material were not also bioabsorbable, it would leave that material to remain and possibly migrate in unexpected ways within the recipient’s body.
None of the cited prior art teaches that the polymeric coating in which the micropattern is formed is bioabsorbable.
US 389 teaches that the micropattern directs the direction of growth of tissue, in particular, vascular smooth muscle cells (VSMC) [0018]. After the stent has served its purpose and sufficient VSMC has grown as desired, it would then be desirable to have the foreign body eliminated from the body. Consequently, it would have been obvious to one of ordinary skill in the art to modify the process of US 389, US 227, and Geckil et al. so as to, in addition to making the stent itself out of bioabsorbable material, to additionally make the micropatterned polymeric coating out of bioabsorbable material as well to allow for this elimination.
Claims 6-8
The combined teaching of US 389, US 227, and Geckil et al. is detailed above. As noted, US 389 teaches ECM in the grooves but not on the plateaus [0021]. This reads on claim 8’s recitation of “wherein the extracellular matrix material fills the plurality of voids such that a height of the extracellular matrix material is less than the plurality of protrusions.”
US 389 teaches that it is possible to additionally apply a composition that resists cell adhesion to the plateaus or without any cell adhesion resistant material between the grooves [0021]. This, combined with the teaching that the stent, pattern, and ECM is used to guide VSMC growth, would have suggested to one of ordinary skill in the art that VSMC growth is determined by the presence of ECM and, if a greater degree of VSMC growth is desired, then a greater volume of ECM in the micropattern (i.e., including up to the top of the grooves such that the ECM forms a generally planar surface equal with the plateaus or covering the entire surface of the patterned stent-ECM structure, as recited in claims 6 and 7, respectively) can be applied to the micropatterned stent.
Consequently, it would have been obvious to one of ordinary skill in the art, depending on the amount and orientation of VSCM grown on the stent, to have completely filled the micropatterned grooves or completely covered the micropattern with ECM. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully forming a desired amount and orientation of VSCM.
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over us 2006/0228389 A1 in view of US 8,916,227 B2 and Geckil et al., Engineering hydrogels as extracellular matrix mimics, Nanomedicine (Lond). 2010 April; 5(3): 469-484, as applied to claims 1 and 9, respectively, further in view of CA 2607413 C.
The combined teaching of US 389, US 227, and Geckil et al. is detailed above.
None of the cited prior art teaches that the polymeric covering is applied to the stent by spray coating, electrospinning, dip coating, or injection molding.
CA 413 teaches a process for the application of a polymeric coating to a lattice-like or mesh-like metallic endoprosthesis (i.e., stent) [8:31-35 and 9:11-12]. The polymers can be applied by spray coating, electrospinning, and/or dip coating [10:4-6].
Because US 389, US 227, and Geckil et al. place no limitation on the method of application of the polymeric material, it would have been obvious to one of ordinary skill in the art to utilize any known means in the prior art for doing so. Insofar as CA 413 teaches that spraying, electrospinning, and dipping are all known in the art for this purpose, it would have been obvious to one of ordinary skill in the art to utilize one or all of these methods to apply the polymeric coating to the scaffolded stent motivated by the desire and expectation of successfully forming the polymeric coating thereon.
Claim(s) 3, 4, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over us 2006/0228389 A1 in view of US 8,916,227 B2 and Geckil et al., Engineering hydrogels as extracellular matrix mimics, Nanomedicine (Lond). 2010 April; 5(3): 469-484, as applied to claims 1 and 9, respectively, further in view of US 2009/0180965 A1.
The combined teaching of US 389, US 227, and Geckil et al. is detailed above.
None of the cited prior art teaches that the liquid ECM hydrogel is applied by either dip coating or spray coating.
US 965 teaches that it is known to apply a liquid ECM material to a stent by spray coating or dip coating [0064-0065].
Because US 389, US 227, and Geckil et al. place no limitation on the method of application of the liquid ECM hydrogel, it would have been obvious to one of ordinary skill in the art to utilize any known means in the prior art for doing so. Insofar as US 965 teaches that spraying and dipping are both known in the art for the purpose of applying liquid hydrogel material, it would have been obvious to one of ordinary skill in the art to utilize one or all of these methods to apply the liquid ECM hydrogel coating to the scaffolded stent motivated by the desire and expectation of successfully forming the liquid ECM hydrogel coating thereon.
Claim(s) 14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over us 2006/0228389 A1 in view of US 8,916,227 B2 and Geckil et al., Engineering hydrogels as extracellular matrix mimics, Nanomedicine (Lond). 2010 April; 5(3): 469-484, as applied to claims 1 and 15, respectively, further in view of US 2013/0268063 A1.
The combined teaching of US 389, US 227, and Geckil et al. is detailed above. Specifically, US 389 teaches micropatterning the polymer using, e.g., an excimer laser.
None of the cited prior art teaches the formation of the micropatterned polymer according to claims 14 and 16-20.
US 063 teaches a process for forming a stent having a micropatterned coating wherein:
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Here, the molding disclosed reads on the claimed formation of the polymer and micropattern as a monolithic structure as recited in claims 14 and 17. Moreover, the micropattern is clearly formed into the outer surface of the polymeric covering as illustrated in Fig. 2 (i.e., the pattern of voids and plateaus point away from the underlying stent), as required by claims 15 and 18:
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Moreover, the polymeric coating has an inner portion (layer) that is closer to the stent and through which it is adhered to the stent, and an outer portion (layer) that contains the micropattern. These portions are “separate” in that they are distinguishable from one-another and serve different purposes (adhesion vs. pattern) and satisfy the limitations of claims 16 and 19. The claims do not require (i) that the “inner layer” and “outer layer” be formed separately in distinct steps (which would not result in a “monolithic” structure) or (ii) have a strict, distinct transition between the two. Finally, it is the Primary Examiner’s position that the injection of polymeric material into the mold necessarily results in the filling of the plurality of cells in the stent, as required by claim 20, which serves to anchor the polymer on the stent without the use of the adhesive, which is the goal of this embodiment in US 063.
Consequently, it would have been obvious to one of ordinary skill in the art to modify the process of US 389, US 227, and Geckil et al. so as to form the micropatterned polymeric coating on the stent according to the process of US 063. Firstly, since US 389 places no limitation on the particular method utilized for forming the patterned polymer, it would have been obvious to one of ordinary skill in the art to use any known method for doing so. Secondly, one of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully forming the patterned polymeric coating by a process that advantageously uses simpler equipment than the example of an excimer laser in US 389. See MPEP § 2144(II).
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM P FLETCHER III whose telephone number is (571)272-1419. The examiner can normally be reached Monday-Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WILLIAM PHILLIP FLETCHER III
Primary Examiner
Art Unit 1759
/WILLIAM P FLETCHER III/Primary Examiner, Art Unit 1759
11 May 2011
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