DETAILED ACTION
The following is a non-final office action is response to communications received on 04/21/2023. Claims 1-20 are currently pending and addressed below.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 & 13-18 of U.S. Patent No. 10,314,726. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claim 1, patent claim 1 recites the same limitations.
Regarding Claims 2, 4 & 20, patent claim 4 recite the same limitations.
Regarding Claim 3, patent claim 3 recites the same limitations.
Regarding Claim 5, patent claim 5 recites the same limitations.
Regarding Claim 6-12, patent claims 6-8 recite the same limitations.
Regarding Claim 13, patent claim 9 recites the same limitations.
Regarding Claim 14, patent claim 13 recites the same limitations.
Regarding Claim 15, patent claim 14 recites the same limitations.
Regarding Claim 16, patent claim 15 recites the same limitations.
Regarding Claim 17, patent claim 16 recites the same limitations.
Regarding Claim 18, patent claim 17 recites the same limitations.
Regarding Claim 19, patent claim 18 recites the same limitations.
Claims 1, 3, 5 & 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8 & 12 of U.S. Patent No. 11,660,215. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claim 1, patent claim 1 recites the same limitations.
Regarding Claim 3, patent claims 2 & 6 recite the same limitations.
Regarding Claim 5, patent claim 8 recites the same limitations.
Regarding Claim 13, patent claim 12 recites the same limitations.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-10, 12, 18 & 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jantzen et al. (US 8,764,813). Please refer to the annotated figure below in consideration of rejection of claims 1, 3, 5-10 & 12:
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Regarding Claim 1, Jantzen teaches a medical stent (Fig 3b) comprising: a tubular support structure (outlined in red) including a plurality of struts (shown), the plurality of struts defining a plurality of cells disposed between the plurality of struts; and a polymeric (Col 8: lines 15-38) coating (140, 240) disposed over the tubular support structure defining a plurality of closed cells (shown) that are completely covered by the polymeric coating, and a plurality of open cells (shown) that are open to allow fluid flow or tissue ingrowth therethrough; wherein the polymeric coating extends over and laterally beyond each of the plurality of struts and partially into each of the plurality of open cells (Fig 3b).
Regarding Claims 3 & 5, only the product will be examined. (Even 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 (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)); see MPEP 2113). To the extent that the process steps further define the structure of the device, they have been considered. In the instant case, none of the process steps recited in claim 3 further define or add any structural limitations to the component.
Regarding Claim 6, Jantzen teaches wherein the plurality of closed cells are located in at least a first region of the tubular support structure, and the plurality of open cells are located in at least a second region of the tubular support structure.
Regarding Claim 7, Jantzen teaches wherein the plurality of closed cells are located in at least first (shown) and second (shown) regions of the tubular support structure, and the plurality of open cells are located in at least third (shown) and fourth (shown) regions of the tubular support structure, wherein the third region is disposed between the first and second regions (as shown).
Regarding Claim 8, Jantzen teaches wherein the fourth region is adjacent the second region (as shown).
Regarding Claim 9, Jantzen teaches wherein the stent further comprises a fifth region of closed cells disposed adjacent the fourth region (as shown).
Regarding Claim 10, Jantzen teaches wherein the tubular support structure is a woven, braided or knitted structure (Col 5: lines 46-48).
Regarding Claim 12, Jantzen teaches wherein each of the plurality of closed cells is adjacent to at least one of the plurality of open cells (Fig 3b).
Please refer to the figure below in consideration of the rejection of claims 18 & 19:
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Regarding Claim 18, Jantzen teaches a medical stent (Fig 3b) comprising: a tubular support structure including a plurality of struts (shown), the plurality of struts defining a plurality of cells (shown) disposed between the plurality of struts, each of the cells extending from an outer surface of the tubular support structure to an inner surface of the tubular support structure; and a polymeric (Col 8: lines 15-38) coating (140, 240) coated onto the plurality of struts of the tubular support structure such that some of the plurality of cells are closed (shown) by the polymeric coating and some of the plurality of cells remain open (shown) to fluid flow or tissue ingrowth therethrough; wherein at least some of the plurality of struts coated with the polymeric coating extend between adjacent open cells (as shown).
Regarding Claim 19, Jantzen teaches wherein the polymeric coating extends laterally beyond (as shown) the plurality of struts coated with the polymeric coating and partially into the open cells.
Claim Rejections - 35 USC § 103
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jantzen et al. (US 8,764,813) in view of Ryan (US 2011/0319980).
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Regarding Claim 13, as set forth supra, Jantzen discloses the invention substantially as claimed. Further, Jantzen teaches wherein the polymeric coating material (140, 240) may be made from any biodegradable or non-biodegradable polymer material (Col 8: lines 9-11). However, Jantzen does not specifically disclose wherein the polymeric coating comprises polyurethane or silicone.
Ryan teaches a stent with a framework defining both covered and uncovered stent cells (Fig 1) in the same field of endeavor to impart the desired stent performance [0021]. Said covering material comprising at least silicone or polyurethane [0027].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the polymeric coating, as taught by Jantzen, from either polyurethane or silicone, as taught by Ryan, in order to effectively mask the desired cells while providing the desired stent performance. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774