The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of Patent No. 10517710 and claim 1 of Patent No. 11654009. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of the present application are anticipated by claims 1 and 5 of Patent No. 10517710 and claim 1 of Patent No. 11654009.
Claim 1 is anticipated by claim 1 of Patent No. 11654009 and claim 1 of Patent No. 11654009 because it is broader, it includes identical language except for the limitations “wherein the plurality of elongated members comprise a first plurality of elongated members and a second plurality of elongated members, wherein the first plurality of elongated members form an inner layer of the body to define the lumen, and the second plurality of elongated members form an outer layer of the body that surrounds the inner layer and each of the plurality of elongated members extend in a helical pattern to define a surface of the body and the lumen; the first plurality of elongated members extend around and along the lumen in a clockwise helical pattern; and the second plurality of elongated members extend around and along the lumen in a counterclockwise helical pattern”, such that the reference claims fall within the broader scope of the examined claim. MPEP 804(II)(B)(2).
Claim Objections
Claim 21 is objected to because of the following informalities: “the distal end of the body and the distal end of the body” should be changed to “the distal end of the body and the proximal end of the body”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-7, 9 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacGregor (US 5,015,253).
Regarding claim 1, MacGregor discloses a stent 21 (Fig. 2), comprising: a body extending between a distal end and a proximal end (opposing ends of stent 21; Fig. 2), the body defined by a plurality of elongated members 22 (see Fig. 3, multiple members 22 make up layer 31, and multiple other member make up layer 32), each elongated member 22 extending between a distal end that is coterminous with the distal end of the body and a proximal end that is coterminous with the proximal end of the body (Fig. 2 discloses the strands 22 ending at the distal and proximal ends); wherein each of the plurality of elongated members are arranged so as to define a lumen extending along the length of the respective plurality of elongated members, the lumen extending between the distal and proximal ends of the body so as to form a lumen length (Col. 4, ln 36, 65 and Fig. 5 discloses a hollow lumen); wherein each of the plurality of elongated members are attached to adjacent elongated members at the distal end and proximal end forming gaps between adjacent elongated members (the spacing formed between intersecting strands connecting at points 34) to permit drainage of a fluid from within the lumen through the gaps to an environment external the stent along the entire lumen length (see Fig. 3, the structure of the stent is fully capable of performing the intended use of allowing drainage of fluid from within the lumen to an environment external the stent by draining between the spacing created by intersecting strands).
Regarding claims 2 and 5, MacGregor discloses each of the plurality of elongated members extend in a helical pattern to define a surface of the body and the lumen; and the first plurality of elongated members extend around and along the lumen in a clockwise helical pattern; and the second plurality of elongated members extend around and along the lumen in a counterclockwise helical pattern (Col. 4, ln 53-54, double-helical).
Regarding claim 3, MacGregor discloses wherein: each of the plurality of elongated members extend between the distal and proximal ends such that each of the plurality of elongate members extends multiple revolutions between the distal and proximal ends of the body (as shown in Fig. 3).
Regarding claim 4, MacGregor discloses the plurality of elongated members comprise a first plurality of elongated members (see Fig. 3, multiple members that make up inner layer 31) and a second plurality of elongated members (see Fig. 3, multiple members that make up outer layer 32), wherein the first plurality of elongated members form an inner layer of the body to define the lumen, and the second plurality of elongated members form an outer layer of the body that surrounds the inner layer (underlying and overlying layers 31 and 32; col. 4, lin. 45-54).
Regarding claim 6, MacGregor discloses: the first plurality of elongated members and the second plurality of elongated members each extend at a pitch that is the same magnitude (Fig. 3 discloses the spacing between the helical spiraling is the same), while the pitch of the first plurality of elongate members and the pitch of the second plurality of elongate members extend in opposite directions (col. 4, lin. 47-48 disclose different pitch angles and lin. 51 discloses opposite direction).
Regarding claim 7, MacGregor discloses the lumen is configured so as to allow the passage of a wire guide therethrough (the hollow lumen is capable of performing this intended use; Fig. 5).
Regarding claim 9, MacGregor discloses the plurality of elongated members comprise a biocompatible metal (col. 4, lin. 11-15).
Regarding claim 22, MacGregor discloses wherein each of the plurality of elongated members are arranged so as to define a fixed outside diameter of the body (the stent has a fixed diameter once it is expanded to hold the body lumen 43 open; Fig. 2).
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over MacGregor (US 5,015,253) in view of Hixon et al. (2008/0004578) “Hixon”.
MacGregor discloses the claimed invention of claim 1 including the body comprises a distal end portion that extends to the distal end and a proximal end portion that extends to the proximal end (Fig. 2); except for wherein one or both of the distal and proximal end portions are biased into a shape other than straight and further comprising: a wire guide movably disposed within the lumen. However, Hixon teaches a similar stent 120 (Fig. 2) comprising one or both of the distal and proximal end portions are biased into a shape other than straight (curled ends 138 and 138’; Fig. 2) and further comprising: a wire guide movably disposed within the lumen (par. 0002 discloses sliding the stent on the guidewire). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention was made to modify the stent in MacGregor to include wherein one or both of the distal and proximal end portions are biased into a shape other than straight and further comprising: a wire guide movably disposed within the lumen, as taught and suggested by Hixon, for the purpose of accurate placement of the ureteral stent at the desired implantation site to minimize corrective surgery.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over MacGregor (US 5,015,253) in view of Farzin-Nia (6818076).
MacGregor discloses the claimed invention of claim 1 including plurality of elongated members comprise a first plurality of elongated members and a second plurality of elongated members, wherein the first plurality of elongated members form an inner layer to surround and form the lumen, and the second plurality of elongated members form an outer layer that surrounds the inner layer ( see claim 4 above); except for the first plurality of elongated members and the second plurality of elongated members each comprise nine elongated members. However, Farzon-Nia teaches a plurality of elongated member 10 having two or more strands (col. 2, lin. 31-37). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify elongated members each comprise nine elongated members, since these are result effective variables that contribute to the overall mechanical properties of the elongated member, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art and modifying elongated members each comprise nine elongated members would allow for the stent to best withstand the forces at the implantation site and not collapse. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality that elongated members each comprise nine elongated members, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 12, MacGregor discloses each of the plurality of elongated members extend in a helical pattern to define a surface of the body and the lumen; and the first plurality of elongated members extend around and along the lumen in a clockwise helical pattern; and the second plurality of elongated members extend around and along the lumen in a counterclockwise helical pattern (Col. 4, ln 53-54, double-helical).
Regarding claim 13, MacGregor discloses the lumen is configured so as to allow the passage of a wire guide therethrough (the hollow lumen is capable of performing this intended use; Fig. 5).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over MacGregor (US 5,015,253) in view of Hollett (2013/0053766).
MacGregor discloses the claimed invention of claim 1; except for the distal end of the body and the distal end of the body are polished so as to ease advancement of the stent. However, Hollett teaches a similar stent wherein the distal end of the body and the proximal end of the body are polished so as to ease advancement of the stent (par. 0052 discloses electropolishing the stent to provide improved guidewire handling and steering). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention was made to modify the stent in MacGregor to include the distal end of the body and the distal end of the body are polished so as to ease advancement of the stent, as taught and suggested by Hollett, for the purpose of providing ease of handling and steering.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “the gaps between the adjacent elongated members extend continuously from the distal end of the body to the proximal end of the body” as set forth in claim 20, which has not been found anticipated by or obvious over prior art. The closest prior art of record of MacGregor fails to disclose a continuous gap between adjacent elongated members.
Conclusion
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774