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 .
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of Chen U.S. Patent No. 12,133,652. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the clamps overlap (see chart below).
Claims of 18/888812
Claims of US 12,133,652
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Claims 1-3 and 5-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5 and 7-12 of Chen U.S. Patent No. 11,819,216. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the clamps overlap (see chart below).
Claims of 18/888812
Claims of US 11,819,216
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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) 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaolian et al. US 2006/0206140 in view of Jayaraman US 2005/0187564.
Regarding claims 14-17, Shaolian et al. discloses an embolic device for placement in a body lumen (paragraph 0014, providing an embolic coil for treatment of an aneurysm), the embolic device comprising: an elongated member 2 having a first configuration when at room temperature (paragraph 0074, shape memory responds to temperature different from a nominal ambient temperature), the elongated member being configured to form a second configuration in response to temperature (paragraph 0014, 0015, embolic coil changes shape in response to being heated to a predetermined temperature), the second configuration having a second configuration that is different from the first configuration (paragraph 0015, changes shape in response to temperature; figures 3A-3C); wherein the elongated member comprises a first segment 4, a second segment (figure 3A, segment between 4 and 4’), and a third segment 4’, the second segment extending from an end of the first segment to an end of the third segment (figure 3A, segment between 4 and 4’); wherein the first segment and the third segment are configured to change their respective shapes in response to the temperature (figure 3C); wherein the first segment has a first length, the second segment has a second length that is an entire length of the second segment, and the third segment has a third length (figure 3A-3C); wherein an entirety of the first segment has a first material property (paragraph 0081, section 4 has a shape memory property which transitions to austenite phase), an entirety of the second segment has a second material property that is different from the first material property (paragraph 0081, middle segment remains in martensite phase), and an entirety of the third segment has a third material property that is different from the second material property (paragraph 0081, section 4’ shape memory property transitions to austenite phase), the first material property is the same as the third material property (paragraph 0084, comprise the same shape memory material).
Shaolian et al. fails to disclose the elongated member being configured to form a second configuration in response to body temperature, or wherein the second length of the second segment is shorter than the first length of the first segment, and is also shorter than the third length of the third segment, wherein the second length of the second segment is less than 50% of the first length of the first segment, and is also less than 50% of the third length of the third segment.
However, Shaolian et al. discloses wherein the zones having shape memory segments may have more or less zones of the same or of differing lengths (paragraph 0082), the shape memory segments 4, 4’ may be part of or substantially all of the embolic coil, resulting in a second segment being than the length of the first or third segments. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have the second length of the second segment to be shorter than the first length of the first segment and also shorter than the third length of the third segment, and wherein the second length of the second segment is less than 50% of the first length of the first segment, and is also less than 50% of the third length of the third segment, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Jayaraman teaches an occlusive coil or embolic device for placement within a body lumen (paragraph 0004), the device being made of a shape memory material that may transition in shape in response to body temperature (paragraph 0032), the device comprising an elongate member having a first configuration when in room temperature (wire remains straight during delivery through the catheter, paragraph 0093), the elongated member being configured to form a second configuration in response to body temperature (paragraph 0093, 0102, the wire may assume the predetermined shape upon warming to the higher temperature) suitable for conforming to the space of the malformation or defect where the device is introduced into the body, including various shapes such as circular forms, rectangular forms, coiled forms having loops or any other configuration suitable for treating the lumen or malformation (paragraph 0017, 0093, 0094).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Shaolian et al., with a first configuration when in room temperature and forming a second configuration in response to body temperature, as taught by Jayaraman, and known in the art, to enable insertion of the elongated member into the catheter for delivery, and then elongate member reverting back to a predetermined shape once placed within the target body lumen and upon warming to body temperature which activates the change of shape.
Regarding claim 18, Shaolian et al. discloses wherein the first segment is martensitic when at room temperature (for example, figure 1A, 3A, paragraph 0072, 0077, segments at room temperature prior to activation).
Regarding claim 19, Shaolian et al. discloses wherein the second segment does not change phase between room temperature and the body temperature (segment remains in same phase, while the shape memory segments 4 and 4’ are activated, paragraph 0081).
Claims 20 and 21, Shaolian et al. discloses wherein the first segment is configured to form a first part of a loop or a first loop, and the third segment is configured to form a second part of the loop or second loop (may form dimension and different configurations including curvilinear, square, rectangle, triangle, spherical, figure 8 or a combination, paragraph 0070). Examiner notes that “a figure 8” configuration forms a first and second loop or a plurality of loops. The first second and third segments will be a part of at least one of the loops as it forms the shape of the coil. Additionally, the shape memory members 4 and 4’, or first and third segments, may be a part of or include any portion of the embolic device (paragraph 0072). Therefore, the first segment is configured to form a first part of a loop or a first loop, and the third segment is configured to form a second part of the loop or second loop, when the shape memory members are placed in that configuration on the elongate member.
Allowable Subject Matter
Claims 1-13 are rejected on the ground of nonstatutory double patenting as presented above, but would be allowable if a proper terminal disclaimer is filed and 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:
Shaolian et al. US 2006/0206140 discloses an embolic device having an elongated member having a first configuration and a second configuration in response to temperature, comprising a first, second and third segment, the first and third segments are configured to change their respective shapes in response to the temperature.
However, Shaolian et al. and the prior art of record or at large fails to disclose in combination with the claim language, an embolic device having a first, second and third segment, the first and third segments configured to change their respective shapes in response to body temperature, wherein the first segment is martensitic when the first segment is at the room temperature, and austenitic when the first segment is at the body temperature. Shaolian et al. and the prior art of record or at large fails to disclose an embolic device having a first, second and third segment, the first segment is martensitic when at room temperature and is austenitic when at body temperature, and the second segment is martensitic when the second segment is at the room temperature and is also martensitic when at body temperature. Shaolian et al. requires a temperature higher than body temperature to activate the phase change, and would not be obvious to one in the art to modify to phase, explicitly martensitic or austenitic, at a lower temperature.
Jayaraman US 2005/0187564 an occlusive coil or embolic device for placement within a body lumen (paragraph 0004), the device being made of a shape memory material that may transition in shape in response to body temperature (paragraph 0032).
However, Jayaraman fails to disclose wherein the first segment is martensitic when the first segment is at the room temperature, and austenitic when the first segment is at the body temperature, the first segment is martensitic when at room temperature and is austenitic when at body temperature, and the second segment is martensitic when the second segment is at the room temperature and is also martensitic when at body temperature, wherein the second segment comprises an irreversible martensitic segment, or the first segment is martensitic at room temperature and austenitic at body temperature, the second segment is martensitic at room temperature and martensitic at body temperature.
Jones et al. US 2008/0087508 discloses an occlusion device transitioning shape at body temperature (paragraph 0035), and the tubular element may be martensite or austenite (paragraph 0030), but does not explicitly teach a first, second or third segment, the second segment being between the first and third segment, or explicitly the element or segments are austenitic at body temperature and martensitic or any specific material phase at room temperature. Examiner notes a mere disclosure that a device changes shape when reaching body temperature does not necessarily mean that the device is austentic when at body temperature. This is because it is possible for a device to change shape without going through material phase change.
Conclusion
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771