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
In light of Applicant’s amendment, claim(s) 1 and 5 is/are amended. Claims 1-15 are now pending examination.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 5 and 11 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues the rejection fails to teach a three-layered elongate braid member, as Sarge and Huitema describe two-layer wires. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Sarge teaches a core of platinum and a layer over the core akin to Applicant’s “intermediate layer” made of nitinol. It is noted in the rejection that Sarge does not teach a third, i.e., outer layer, however, Huitema is relied upon to remedy this. Huitema teaches an inner nitinol layer and an outer titanium layer, akin to Applicant’s “outer layer”. Thus, since the inner layer of Huitema and the outer layer of Sarge both comprise nitinol, combining both inventions would lead to an innermost layer being the platinum core of Sarge, a middle layer, being the nitinol layer of both Sarge and Huitema and an outer layer as the titanium layer of Huitema. Thus, the combination of Sarge and Huitema teaches a three-layered wire as claimed and the rejection is maintained.
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.
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) 1-2, 4, 6, 8-11, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarge et al (US 20170035437 A1) (noted on IDS) in view of Huitema (US 6638297 B1) (previously of record), as evidenced by DeVries et al. (US 20050055045 A1).
Regarding claim 1, Sarge discloses a vaso-occlusive treatment system, comprising:
a delivery assembly (102) (Figure 1; Paragraph 0101); and
a vaso-occlusive device (1400) detachably coupled to the delivery assembly by a
delivery assembly junction (115) (Paragraph 0104), the vaso-occlusive device comprising a braid (1401) formed out of one or more elongate braid members (1300) (Figure 13B, 14; Paragraph 0145),
wherein each elongate braid members comprise a core (1302) (Figure 13B; Paragraph 0145),
an intermediate layer (1301) at least partially surrounding the core (Figure 13B; Paragraph 0145), and,
wherein the core comprises a core metallic material (platinum) (Paragraph 0145),
wherein the intermediate layer comprises an intermediate layer metallic material (nitinol) (Paragraph 0145),
wherein each of the core and the intermediate layer has a respective radiopacity and a respective stiffness (it is known for platinum and nitinol to have a respective radiopacity and respective stiffness) (Paragraph 0145), and
wherein the core has a greater radiopacity and a higher stiffness than the intermediate layer (Paragraph 0145) (DeVries teaches an inner core member 28 being formed of a material having super elastic characteristics such as Nitinol and an outer member 26 formed of a relatively stiff material such as platinum (Paragraph 0035), thus indicating Platinum is stiffer than nitinol.).
Sarge fails to explicitly disclose an outer layer at least partially surrounding the intermediate layer wherein the outer layer comprises an outer layer metallic material, wherein the outer layers has a respective radiopacity and a respective stiffness.
However, Huitema is directed to an implantable wire (2) (Figure 2-3) and teaches the wire comprising nitinol inner layer (30) coated with a titanium metal outer layer (40) (Figure 3; Col 4, line 47-54).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sarge to coat the nitinol with a titanium outer layer, as taught by Huitema, as both references and the claimed invention are directed to implantable wire devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sarge with the teachings of Huitema by incorporating a titanium metal coating on the nitinol in order to improve yield strength of the wire (Huitema Col 4, line 47-54).
Regarding claim 2, Sarge further discloses wherein the core metallic material comprises platinum (Paragraph 0145).
Regarding claim 4, Sarge further discloses wherein the intermediate layer metallic material comprises Nitinol (Paragraph 0145).
Regarding claim 6, Sarge as modified by Huitema further teaches wherein the outer layer metallic material comprises titanium (Huitema Col 4, line 47-54).
Regarding claim 8, Sarge further discloses wherein the core comprises a radiopaque metallic material (platinum) (Paragraph 0145).
Regarding claim 9, Sarge further discloses wherein the intermediate layer comprises a superelastic metallic material (nitinol) (nitinol is a superelastic material) (Paragraph 0145).
Regarding claim 10, the combination of Sarge and Huitema further teaches wherein the outer layer comprises an oxidation resistant metallic material (titanium is an oxidation resistant metallic material) (Huitema Col 4, line 47-54).
Regarding claim 11, the combination of Sarge and Huitema teaches wherein the core has a higher radiopacity than the each of the intermediate layer and the outer layer (platinum has a higher radiopacity than nitinol and titanium), wherein the intermediate layer has a lower stiffness than each of the core and the outer layer (nitinol has a lower stiffness than platinum and titanium), and wherein the outer layer has a higher resistance to oxidation than each of the core and the intermediate layer (titanium is more oxidation resistant than platinum and nitinol) (the combination uses an inner core of platinum, intermediate layer of nitinol, and outer layer of titanium, corresponding to the same materials as the present invention, which according to Applicant’s specification, the materials would have all the claimed properties).
Regarding claim 13, the combination of Sarge and Huitema teaches wherein the outer layer is configured to minimize impact on a flexibility or a stiffness of the elongate braid member (like the present invention, the outer layer comprises titanium this is fully capable of minimizing impact on a flexibility or a stiffness of the elongate braid member).
Regarding claim 14, the combination of Sarge and Huitema further teaches wherein the outer layer comprises a biocompatible material (titanium is a biocompatible material) (Huitema Col 4, line 47-54).
Regarding claim 15, the claimed phrase “wherein the elongate braid member is formed by co-extrusion, plating, coating, or Physical Vapor Deposition” is being treated as a product by process limitation; that is, the phrase will be examined as “the elongate braid member is formed”, which is taught by Sarge (Paragraph 0145-146). As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
“[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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarge in view of Huitema and further in view of Tieu et al. (US 20090163780 A1) (previously of record).
Regarding claim 3, Sarge as modified by discloses the vaso-occlusive treatment system of claim 1, but fails to explicitly disclose wherein the core metallic material comprises pure platinum.
However, Tieu is directed to a wire implant and teaches a bimetallic wire comprising a Nitinol outer layer and an inner core of pure reference grade platinum (Paragraph 0044).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sarge and Huitema such that the platinum core comprises pure platinum, as taught by Tieu, as both references and the claimed invention are directed to wire implants. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sarge and Huitema with the teachings of Tieu by incorporating pure platinum in order to have high radiopacity and resist permanent deformation (Tieu Paragraph 0044) as Sarge is silent to the grade of platinum employed in the platinum core.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarge in view of Huitema and further in view of Ferrera (US 20040243168 A1) (previously of record).
As best understood in view of the 112(b) issues above, regarding claim 5, Sarge as modified by Huitema teaches the vaso-occlusive treatment system of claim 1, but fails to explicitly disclose wherein the intermediate layer metallic material comprises pure Nitinol.
However, Ferrera is directed to a vaso-occlusive device and teaches a layer comprising pure nitinol (Paragraph 0076; 0078).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sarge such that the nitinol is pure nitinol, as taught by Ferrera, as both references and the claimed invention are directed to vaso-occlusive devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sarge with the teachings of Ferrera by incorporating wherein the nitinol is pure nitinol in order to be stretch resistant and resilient, and Sarge is silent to the quality of nitinol employed.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarge in view of Huitema and further in view of Burgio (US 4462401 A) (previously of record).
Regarding claim 7, Sarge as modified by Huitema teaches the vaso-occlusive treatment system of claim 1, but fails to explicitly disclose wherein the outer layer metallic material comprises pure titanium.
However, Burgio is directed to an implantable wire and teaches using wires commercially pure titanium (Col 5, line 34-35).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sarge as modified by Huitema such that the titanium is pure titanium, as taught by Burgio, as both references and the claimed invention are directed to implantable wires. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sarge as modified by Huitema with the teachings of Burgio by incorporating wherein the titanium is pure titanium in order to provide increased biocompatibility whereas Huitema is silent to the purity of the titanium.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarge in view of Stinson (US 20010044629 A1) (previously of record).
Regarding claim 12, Sarge as modified by Huitema teaches the vaso-occlusive treatment system of claim 1, but fails to explicitly disclose wherein the outer layer has a thickness between 0.001 to 20 micrometers.
However, Stinson is directed to an occlusive device and teaches the thickness of a layer of the coating 70 on a filament 16 preferably ranges from about 100 angstroms to about 20 microns, which encompasses the claimed range of between 0.001 to 20 micrometers (Paragraph 0075).
There are a number of choices available to a person of ordinary skill in the art for thicknesses of layers on wires. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10321915 B2 in view of Sarge as evidenced by Devries and further in view of Huitema.
Regarding claim 1, US 10321915 B2 discloses a vaso-occlusive treatment system (Col 29, line 31), comprising:
a delivery assembly (Col 29 line 32); and
a vaso-occlusive device detachably coupled to the delivery assembly by a delivery assembly junction (Col 29 line 33-34), the vaso-occlusive device comprising a braid formed out of one or more elongate braid members (Col 29 line 36),
wherein each elongate braid members comprise a core (Col 29 line 37-38),
an intermediate layer (extremal layer) at least partially surrounding the core (Col 39 line 38), and,
wherein the core comprises a core metallic material (Col 29 line 37-38),
wherein the intermediate layer comprises an intermediate layer metallic material (Col 29 line 38-39),
wherein each of the core and the intermediate layer has a respective radiopacity and a respective stiffness (it would be inherent for two materials to have respective radiopacity and stiffness), and
wherein the core has a greater radiopacity (Col 29 line 40-43).
US 10321915 B2 fails to explicitly disclose the core has a higher stiffness than the intermediate layer and an outer layer at least partially surrounding the intermediate layer wherein the outer layer comprises an outer layer metallic material, wherein the outer layers has a respective radiopacity and a respective stiffness.
However, Sarge teaches a core comprising platinum and an intermediate layer comprising nitinol, wherein the core has a greater radiopacity and a higher stiffness than the intermediate layer (Paragraph 0145) (DeVries teaches an inner core member 28 being formed of a material having super elastic characteristics such as Nitinol and an outer member 26 formed of a relatively stiff material such as platinum (Paragraph 0035), thus indicating Platinum is stiffer than nitinol.).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 10321915 B2 with the teachings of Sarge by incorporating a platinum core and nitinol intermediate layer in order to increase radiopacity while maintaining shape-memory properties of Nitinol (Sarge Paragraph 0145).
Further, Huitema directed to an implantable wire (2) (Figure 2-3) and teaches the wire comprising nitinol inner layer (30) coated with a titanium metal outer layer (40) (Figure 3; Col 4, line 47-54).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify US 10321915 B2 to coat the nitinol with a titanium outer layer, as taught by Huitema, as both references and the claimed invention are directed to implantable wire devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 10321915 B2 with the teachings of Huitema by incorporating a titanium metal coating on the nitinol in order to improve yield strength of the wire (Huitema Col 4, line 47-54).
Regarding claims 2-15, see rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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