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 .
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 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 of this title, 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 1 and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Steingisser (US Pub No. 2013/0103047) in view of Legaspi (US Pub No. 2009/0287187) and further in view of Aoba (US Pub No. 2009/0312829).
Regarding claim 1, Steingisser discloses (Figures 1A-6) a tool (200) facilitating deployment of an implantable medical device (100), the tool comprising: a pull wire (225); a handle assembly (210) including a first control member (211) and a second control member (212), wherein the first control member operably connected to the pull wire (Figure 2B) (Paragraphs 0017 and 0020), wherein actuation of the first control member by a user actuates the pull wire (Paragraphs 0017 and 0020); and an elongate assembly (230) (Figures 3A-3B), wherein a distal-most portion of the elongate assembly is configured to receive the implantable medical device (clearly shown in Figures 3A-3B) and defines a distal opening (opening of 230 as shown in Figures 3A-3B) configured for deployment of the implantable medical device out from the distal-most portion (clearly shown in Figures 4A-4C) (Paragraph 0017), wherein the elongate assembly comprises a segment (see annotated figure below) proximal from the distal-most portion, and a tether assembly (280, 285) (Figure 6) comprising a tether (280) extending proximally from an end of the implantable medical device (Paragraph 0029), and a proximal member (285) wherein a proximal portion of the tether is coupled to the proximal member (clearly shown in Figure 6) (Paragraph 0029).
Steingisser fails to disclose the segment configured to cause the elongate assembly to bend in a first direction and a second direction in response to actuation of the pull wire.
Legaspi, in the same field of endeavor, teaches (Figures 3A-4C) a deflectable guide catheter (2) that includes a pull wire (10) and a segment (18) that is defined by a composite sidewall (Figure 3E), wherein when the pull wire (10) is actuated (Paragraphs 0040 and 0056) the composite sidewall causes the segment of the catheter to bend in a first direction and a second direction (Paragraph 0043) [Segment 18 is able to bend in two or more directions and two or more planes from its straight configuration (Paragraph 0043)]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the segment of Steingisser with the segment of Legaspi so that the segment is defined by a composite sidewall allowing the elongate assembly to bend in a first direction and a second direction in response to actuation of the pull wire, in order to provide an improved steering mechanism that permits navigation around tight bends and other hard-to-reach places and also, to provide an improved steering mechanism that reduces creases that may impair components to pass through the deployment tube (Legaspi, Paragraphs 0002 and 0040).
Steingisser also fails to disclose the proximal member received in a proximal end of the handle assembly, the proximal member comprising a tether anchor and a knob coupled to the tether anchor, the knob configured to facilitate proximal movement of the proximal member relative to the handle assembly, and wherein the proximal portion of the tether is coupled to the tether anchor.
Aoba, in the analogous art of medical device deployment devices that uses a tether, teaches (Figures 1-16) a deployment device (Figure 1) that includes a tether (40) extending proximally from an end of an implant (1) (Figure 2), a proximal member (42) received in a proximal end of the handle assembly (14) (clearly shown in Figure 1), the proximal member comprising a tether anchor (see annotated figure below) and a knob (see annotated figure below) coupled to the tether anchor (Figures 1 and 12), the knob configured to facilitate proximal movement of the tether relative to the handle assembly (Figures 1 and 12) (Paragraphs 0066 and 0078), and wherein the proximal portion of the tether is coupled to the tether anchor (clearly shown in Figures 1 and 12) (Paragraphs 0066 and 0078).
Since Steingisser discloses in Paragraph 0029 that the proximal member 285 may be secured in a feature of the handle 210 similar to the proximal member 42 of Aoba as shown in Figure 1 and also, both Steingisser and Aoba are directed towards a proximal member that is secured to a tether in order to manually pull the tether for manipulating an implant, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the proximal member of Steingisser with the proximal member of Aoba that includes a tether anchor and a knob coupled to the tether anchor, in order to achieve a predictable result of pulling the proximal member in order to pull the tether for manipulating the implant (MPEP 2143). [Steingisser modified by Aoba as a whole would result in the proximal member to be received in a proximal end of the handle assembly, the proximal member comprising a tether anchor and a knob coupled to the tether anchor, the knob configured to facilitate proximal movement of the proximal member relative to the handle assembly, and wherein the proximal portion of the tether is coupled to the tether anchor]
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Regarding claim 4, Steingisser modified by Legaspi and Aoba further discloses wherein the distal-most portion of the elongate assembly comprises a radiopaque marker (Steingisser, Paragraph 0020).
Regarding claim 5, Steingisser modified by Legaspi and Aoba further discloses wherein the distal-most portion of the elongate assembly is configured to receive the entire implantable medical device (clearly shown in Figure 3A of Steingisser).
Regarding claim 6, Steingisser modified by Legaspi and Aoba further discloses wherein the elongate assembly comprises an elongate outer assembly (Steingisser, 230) and an inner elongate assembly (Steingisser, 220) configured to be moveably disposed within the outer elongate assembly (Steingisser, Figures 3A-3B) (Paragraph 0018).
Regarding claim 7, Steingisser modified by Legaspi and Aoba further discloses wherein the inner elongate assembly is configured to be detachably connected to the implantable medical device (Steingisser, Figures 4A-4C) (Paragraph 0018), wherein relative movement of the inner elongate assembly and the outer elongate assembly deploys the implantable medical device out from the distal-most portion of the outer elongate assembly (Steingisser, Figures 4A-4C) (Paragraph 0018).
Regarding claim 8, Steingisser modified by Legaspi and Aoba further discloses wherein a distal end of elongate inner assembly comprises a distal member (Steingisser, 252) (Figures 3A-3B) configured to attach the elongate inner assembly to a proximal end of the implantable medical device (clearly shown in Figure 3A of Steingisser).
Regarding claims 9 and 10, Steingisser modified by Legaspi and Aoba further discloses wherein the pull wire (Steingisser, 225) extends within the elongate inner assembly (Steingisser, Paragraph 0017) and wherein the pull wire extends from the first control member to a location adjacent to a distal end of the elongate inner assembly (Steingisser, Paragraph 0017).
Regarding claim 11, Steingisser modified by Legaspi and Aoba further discloses wherein the elongate assembly comprises a deployment tube (Steingisser, 230) and an inner elongate member (Steingisser, 250) extending within the deployment tube (Steingisser, Figure 3A).
Regarding claim 12, Steingisser modified by Legaspi and Aoba further discloses wherein the inner elongate member is configured to be moveably disposed within the deployment tube (Steingisser, Paragraph 0020).
Regarding claim 13, Steingisser modified by Legaspi and Aoba further discloses wherein the elongate assembly further comprises an outer sheath (Steingisser, 275) (Figures 4A-4C).
Regarding claim 14, Steingisser modified by Legaspi and Aoba further discloses wherein the outer sheath extends from the handle assembly to a distal end of the outer sheath (clearly shown in Figures 4A-4C of Steingisser), the distal end of the outer sheath being spaced proximally from a proximal end of the distal-most portion of the elongate assembly (clearly shown in Figures 4A-4C of Steingisser).
Regarding claim 15, Steingisser modified by Legaspi and Aoba further discloses wherein the tether (Steingisser, 280) comprises a first strand and a second strand that extend alongside each other to the proximal end of the implantable medical device (clearly shown in Figure 6 of Steingisser).
Regarding claim 16, Steingisser modified by Legaspi and Aoba further discloses wherein a proximal facing portion of the handle comprises a proximal opening (opening where the proximal member 42 is inserted as shown in Figures 1 and 12 of Aoba), and wherein the proximal member is received in the proximal opening (clearly shown in Figure 1 of Aoba).
Regarding claim 17, Steingisser modified by Legaspi and Aoba further discloses wherein the knob is positioned proximal of and adjacent to the proximal opening (clearly shown in Figure 1 of Aoba).
Regarding claim 18, Steingisser modified by Legaspi and Aoba further discloses a rotatable release control (Steingisser, 260) positioned on the handle (Figures 2A and 6), the release control configured to be rotated to release the tether (Paragraphs 0017 and 0029).
Regarding claim 19, Steingisser modified by Legaspi and Aoba further discloses wherein the first direction and second direction are in different planes (Legaspi, Paragraph 0043).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Steingisser (US Pub No. 2013/0103047) in view of Legaspi (US Pub No. 2009/0287187) and Aoba (US Pub No. 2009/0312829) as applied to claim 1 above, and further in view of Jorgensen (US Pub No. 2009/0171159).
Regarding claim 2, Steingisser modified by Legaspi and Aoba discloses the invention of claim 1 above including a second segment (Legaspi, 18) (Figures 3B-3C) at a second longitudinal position, the second segment configured to be bent in the second direction (Legaspi, Paragraph 0043) [Second segment 18 is able to bend in two or more directions and two or more planes from its straight configuration (Paragraph 0043)] but fails to disclose a first segment at a first longitudinal position, the first segment defining a preformed curvature in the first direction.
Jorgensen, in the same field of endeavor, teaches (Figures 3-5A) a medical device that includes a tube (122) (Figure 5A) having a segment (see annotated figure below) at a longitudinal position, wherein the segment defines a preformed curvature in the first direction (clearly shown in Figure 5A) (Paragraphs 0083-0084 and 0091). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the deployment tube of Steingisser modified by Legaspi and Aoba to have included a first segment at a first longitudinal position, the first segment defining a preformed curvature in the first direction as taught by Jorgensen, in order to provide enhanced access to the site of the procedure (Jorgensen, Paragraph 0091). [Steingisser modified by Legaspi, Aoba and Jorgensen will result in the first segment having the preformed curvature to be located just proximal to the second segment of the deployment tube]
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Regarding claim 3, Steingisser modified by Legaspi, Aoba and Jorgensen further discloses wherein the first longitudinal position is proximal of the second longitudinal position [Steingisser modified by Legaspi, Aoba and Jorgensen will result in the first segment having the preformed curvature (first longitudinal position) to be located just proximal to the second segment (second longitudinal position) of the deployment tube].
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-11, 15-20 and 23 of U.S. Patent No. 12,214,206. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
19/043,992
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Claims
Patent 12,214,206
1, 20, 23
2
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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