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 .
Priority
The instant application is the national stage entry of PCT/US2021/024728 filed 29 March 2021. Acknowledgment is made of the Applicant’s claim of domestic priority to provisional US application 63/005,927 filed 6 April 2020.
Status of the Claims
Claims 1-24, 33, and 35 are pending.
Claim 24 is withdrawn.
Claims 1-23, 33, and 35 are rejected.
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.
Claims 1, 10-11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 2004/0078079).
Foley teaches implants that can be inserted into a spinal disc space [0005]. The implant material can be porous [0062], resorbable, and made from shape-memory alloys [0106]. In addition, radiographic markers may be located on the body (imaging technique using x-rays) [0106].
Foley does not teach the implant as comprising all the above properties at once.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of properties of the implant (porous, bioresorbable, shape-memory) from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.” The resulting implant composition comprising visualization markers on the device renders obvious instant claim 1.
Regarding claim 10, the use of shape memory would necessarily provide the property that is claimed. Similarly, regarding claim 11, the selection of resorbable material for making the implant of Foley would necessarily provide the required resorption. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Accordingly, claims 1, 10-11, and 16-17 are rejected as being obvious in view of the prior art.
Claims 1-23, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US 2008/0312733) in view of Ganatra et al. (US 2015/0118152) in view of Majercak (US 2015/0374517) in view of Sarac (US 2010/0300045) in view of Mackiewicz et al. (US 2005/0060025).
Jordan teaches a stent made from shape memory polymer [0002] wherein the stent can comprise a plurality of helically wound elongate members (i.e. fibers) [0011] and can further include radiopaque markers [0060]. The shape memory polymer may be biodegradable or bioabsorbable [0011]. Regarding the shape memory polymer, the polymer can have hard and soft segments and can comprise polymers such as polyhyaluronic acid or poly(b-hydroxybutyrate) [0058]. The polymer can also further comprise hydrogels [0058]. The stent of Jordan can further comprise a therapeutic agent such as an antineoplastic agent [0076].
Jordan does not teach the modulus of elasticity. Jordan does not teach suture eyelets. Jordan does not teach wherein the visualization markers comprise a locking feature.
Ganatra teaches methods of making medical implants wherein the starting polymer can be P4HB and wherein the Young’s modulus is greater than 35 MPa and an elongation to break of less than 1,100% [0002, 0015].
Majercak teaches marker bands formed from radiopaque material may be positioned at various locations on the struts of an implantation device [0034]. Marker may be attached to the stent by any means including stitches [0041]. In addition, to attach the stent to a graft, sutures may be used [0035]. The sutures may be bioresorbable and made of shape memory material [0044].
Sarac teaches that “oriented polymer” is synonymous with “shape memory” polymers and further teaches that polyhydroxybutyrate is an example thereof useful for producing stents [0029-0030].
Mackiewicz teaches implantable medical devices comprising marker holders designed to hold a radiopaque marker (abstract). The marker holder is made from a self-expanding material with shape memory effect, wherein the marker holder can be deformed to accept the marker and then brought back to the original temperature in order to lock the radiopaque material in place [0012].
It would have been prima facie obvious to prepare the bioresorbable, shape memory stent of Jordan comprising radiopaque markers wherein the stent comprises poly(b-hydroxybutyrate). Since Jordan is silent as to a separate material for forming the radiopaque markers, it would have been obvious to use a resorbable material taught by the reference. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of stents and radiopaque markers from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.” As a result, it would have been obvious to prepare a stent of Jordan that does not lose shape (shape memory) but is bioresorbable wherein the stent is made of poly(b-hydroxybutyrate), further comprises an anti-neoplastic agent, and comprises a plurality of radiopaque markers which can be incorporated anywhere along the stent, reading on instant claims 1, 5, 7, 13-17, 19-20, 23, and 35.
Regarding claim 10, the use of shape memory would necessarily provide the property that is claimed. Similarly, regarding claim 11, the selection of resorbable material for making the implant would necessarily provide the required resorption. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Since Jordan is silent as to the modulus of elasticity, it would have been obvious to look to Ganatra which teaches using P4HB (poly(b-hydroxybutyrate)) to make medical implants and further teaches a desirable Young’s modulus of greater than 35 MPa and elongation to break of less than 1,100%. Thus, it would have been obvious to apply these desired properties to the implant composition of Jordan. Regarding the range, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I).
The skilled artisan would have looked to Majercak which teaches that the markers can be placed anywhere along the stent including attached by stitches (sutures). In addition, the stent as a whole can be attached to the graft by sutures. Although suture eyelets are not taught, it would be obvious that the sutures of Majercak would need an eyelet portion of the stent in order to secure the stitches to the graft and/or the markers to the stent, addressing instant claim 12.
Regarding claim 6, the claim is towards an intended use of the composition, does not impart a structural difference over the prior art, and is thus given minimal patentable weight (see MPEP 2111.02 (II)).
Regarding claim 9, as can be seen on Fig. 5A of Jordan, the stent comprises a longitudinal access and the elongated fibers form a unit cell pattern on the outer surface. Moreover, the markers can be placed at any point on the stent, thus addressing instant claim 9.
Regarding claims 21-22, said claims are towards a product-by-process limitation of the claimed composition and are given minimal patentable weight. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." (see MPEP 2113 (I)).
Regarding claim 33, the stent of Jordan can be packaged as a kit wherein the markers are not attached based on the teachings of Mackiewicz, wherein the radiopaque markers are added by manipulating the shape memory of the marker holders and thus locking in the markers. Moreover, Majercak teaches marker bands formed from radiopaque material may be positioned at various locations on the struts of an implantation device and may be attached by a stitch (suture) therefore it would have been obvious to provide the stent, markers, and sutures in a kit to be assembled at a later time, addressing instant claim 33.
The resulting bioresorbable stent renders obvious instant claims 1-23, 33, and 35.
Response to Arguments
Applicant's arguments filed 21 October 2025 have been fully considered but they are not persuasive. The Applicant argues against Scanlon and Asgari.
In response, said references have been withdrawn from the above rejection and arguments against are considered moot.
The Applicant argues that Majercak fails to teach a resorbable porous scaffold having shape memory.
In response, Majercak is applied for its teachings of marker bands formed from radiopaque material. Alternative references are provided to teach a resorbable porous scaffold having shape memory.
Conclusion
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613