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 .
Priority
This application is a continuation of US Application no. 17/178,099, now US Patent no. 12,076,555, filed 17 February 2021, which is a continuation of US Application no. 16/256,473, now US Patent no. 10,953,223, filed 24 January 2019, which is a continuation of US Application no. 15/844,367, now US Patent no. 10,232,170, filed 15 December 2017, which is a continuation of US Application no. 14/707,246, now US Patent no. 9,872,981, filed 8 May 2015, which claims the benefit of domestic priority from US Provisional Application no. 61/990,998 filed9 May 2014.
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 (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 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) 29-31, 34, and 37-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garai et al. (US Publication no. 2012/0323253 – disclosed by Applicant) in view of Reddy et al. (US Publication no. 2009/0259272 – disclosed by Applicant).
In regard to claim 29, Garai et al. disclose an electrical sensing/stimulation apparatus for positioning at least one electrode within body tissue, the electrical sensing/stimulation apparatus comprising:
an elongate lead body having a longitudinal axis and an inner lumen (figure 1, para 20);
at least one sensing/stimulation electrode coupled to the elongate lead body (para 20-21, electrode array 150);
a displacement member coupled to the elongate lead body and adapted to move or bias the at least one electrode towards a prescribed direction by a user (para 21, 27, element 170 biases the elongated electrode towards the intraventricular septum);
a tissue attachment mechanism (element 160) adapted to affix a distal segment of the elongate lead body to body tissue, the tissue attachment mechanism having a retracted configuration and a deployed configuration, wherein in the retracted configuration the tissue attachment mechanism is positioned substantially within the inner lumen of the elongate lead body, and in the deployed configuration the tissue attachment mechanism extends from the longitudinal axis of the elongate lead body to engage body tissue (para 20, 21 and figure 1-3; figure 3 shows at least one internal lumen wherein in the retracted configuration the tissue attachment mechanism is positioned (para 23); figures 1 and 2 show the attachment mechanisms in the deployed configuration wherein the attachment mechanism extends from the longitudinal axis of the elongated lead body to engage the tissue).
Garai et al. describes the invention as claimed except a shaping wire configured for placement within the inner lumen of the elongate lead body to provide a predetermined shape to the elongate lead body. Reddy et al. describes an implantable lead with an inner lumen 26 configured for receiving a stylet. The stylet lumen 26 enables the use of a stiffening stylet wire 46 to deliver the lead 14 to the desired location. In one embodiment, the stylet lumen 26 may be configured to receive a locking stylet which allows the lead 14 to be more easily extracted if needed. In an alternative embodiment, the stylet lumen 26 may be sized to accommodate a torque tube design, rather than a traditional stylet wire (see paragraph 25). The stylet wire 46 may have a predetermined shape such a wire ribbon in order to provide more efficient torque transfer to the lead (para 33).
Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify Garai et al. to include a shape wire since Reddy et al. explicity teaches that the stiffening wire is a known implement for aiding in lead placement and facilitating torqueability of the lead to enhance placement.
In regard to claim 30, the stiffening stylet wire 46 of Reddy et al. is configured to axially translated within inner lumen 26.
In regard to claim 31, the stiffening stylet wire 46 of Reddy et al. is configured to be removeable from inner lumen 26 (para 44).
In regard to claim 34, Reddy et al. describes a similar device that includes a torque member (26) within the inner lumen and adapted to torque the elongate lead body (para 25 and 33). The torque member may be a torque tube design sized to be accommodated in the lumen (para 25). The torque tube is designed to transfer a torque force applied to a proximal end of an implantable lead to the distal end, which in turn enables fixation of the lead at a target location.
In regard to claim 37, in Garai et al., the displacement member comprises an expandable member having a collapsed configuration and an expanded configuration (para 21 and 47-49, displacement mechanism 170 is depicted as expanded in figure 2).
In regard to claim 38, in Garai et al., the expandable member is adapted to deploy out of a lateral side of the elongate lead body (para 21 and 47-49, displacement mechanism 170 is depicted in figure as expanded from the side of the lead body).
In regard to claim 39, in Garai et al., the expandable member in the collapsed configuration has an outer perimeter greater than an outer circumference of the elongate lead body (para 47-49).
In regard to claim 40, figure 16a of Garai et al. depicts the expandable members of the attachment mechanism. However, Garai et al. does not teach that the expandable members are at least partially folded onto itself in the retracted configuration. This feature is considered to comprise an element of design and thus dictated by choice.
In regard to claim 41, in Garai et al., the inflatable volume comprising the expandable member of the displacement mechanism 170 may be E-Shaped (para 48). The other shapes are considered choices in design.
In regard to claims 42 and 43, the displacement mechanism 170 includes a contrast marker to aid in visualization of displacement mechanism expansion and retraction (para 49). In view that the contrast marker aids in visualization that the displacement member has been expanded, the contrast marker is considered expandable with the expandable element. Additionally, the contrast marker is considered to be an equivalent to the radiopaque marker.
In regard to claims 44 and 45, the shape of the contrast marker attached to the displacement mechanism 170 would resemble the shape of the displacement mechanism when in the collapsed and/or expanded configurations. The shape is considered to be a matter of design.
In regard to claim 46, Garai et al. disclose an electrical sensing/stimulation apparatus for positioning at least one electrode within body tissue, the electrical sensing/stimulation apparatus comprising:
an elongate lead body having a longitudinal axis and an inner lumen (figure 1, para 20);
at least one sensing/stimulation electrode coupled to the elongate lead body (para 20-21, electrode array 150);
a displacement member coupled to the elongate lead body and adapted to move or bias the at least one electrode towards a prescribed direction by a user (para 21, 27, element 170 biases the elongated electrode towards the intraventricular septum);
a tissue attachment mechanism (element 160) adapted to affix a distal segment of the elongate lead body to body tissue, the tissue attachment mechanism having a retracted configuration and a deployed configuration, wherein in the retracted configuration the tissue attachment mechanism is positioned substantially within the inner lumen of the elongate lead body, and in the deployed configuration the tissue attachment mechanism extends from the longitudinal axis of the elongate lead body to engage body tissue (para 20, 21 and figure 1-3; figure 3 shows at least one internal lumen wherein in the retracted configuration the tissue attachment mechanism is positioned (para 23); figures 1 and 2 show the attachment mechanisms in the deployed configuration wherein the attachment mechanism extends from the longitudinal axis of the elongated lead body to engage the tissue).
Garai et al. describes the invention as claimed except for a torque member within the inner lumen of the elongate lead body adapted to torque the elongate lead body. Reddy et al. describes a similar device that includes a torque member (26) within the inner lumen and adapted to torque the elongate lead body (para 25 and 33). The torque member may be a torque tube design sized to be accommodated in the lumen (para 25). The torque tube is designed to transfer a torque force applied to a proximal end of an implantable lead to the distal end, which in turn enables fixation of the lead at a target location. Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the elongate lead of Garai et al. to include a torque member since Reddy et al. teaches that the torque member for an implantable lead is known for assisting in the transfer or torque from a proximal end to a distal end of the lead to enable fixation of the lead to the target tissue. The modification is considered to comprise the application of a known element/technique in the art to a known device in order to yield a predictable result.
In regard to claim 47, in Reddy et al., the torque member is fixedly attached to the elongate lead body (para 25 and 33)
In regard to claim 48, in Reddy et al., the torque member comprises a hypotube (para 25).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garai et al. (US Publication no. 2012/0323253 – disclosed by Applicant) in view of Reddy et al. (US Publication no. 2009/0259272 – disclosed by Applicant), further in view of Mann et al. (US Publication no. 2006/0149324).
In regard to claim 32, Garai et al. in view of Reddy et al. substantially describe the invention as claimed except that the shaping wire is fixed within the inner lumen. Reddy et al. supplies the shaping wire as a stylet. Mann et al. describe a lead with a stiffening stylet fixed within the central lumen of the lead (para 130). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the stylet to be fixed within the inner lumen since this feature is explicitly taught by Tockman et al.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garai et al. (US Publication no. 2012/0323253 – disclosed by Applicant) in view of Reddy et al. (US Publication no. 2009/0259272 – disclosed by Applicant), further in view of Tockman et al. (US Patent no. 7,280,876).
In regard to claim 33, Garai et al. in view of Reddy et al. substantially describe the invention as claimed except that the elongate lead body is rotatable about the shaping wire. Reddy et al. supplies the shaping wire as a stylet. Tockman et al. teach that stylets can rotate within a lumen of a lead (col 1 lines 54-58). Therefore, it is considered to have been obvious to one of ordinary skill in the art to enable the lead to be rotatable about the shaping wire since this feature is explicitly taught by Tockman et al.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garai et al. (US Publication no. 2012/0323253 – disclosed by Applicant) in view of Reddy et al. (US Publication no. 2009/0259272 – disclosed by Applicant), further in view of Ollivier (US Publication no. 2010/0004662).
In regard to claim 35, Garai et al. in view of Reddy et al. substantially describe the invention as claimed except that the shaping wire is curved. Reddy et al. supplies the shaping wire as a stylet. Ollivier describes stylets that are supplied with preformed curvatures (para 30, 39, and 40). Therefore, it is considered to have been obvious to one of ordinary skill in the art to impart a preformed curve on teh shaping wire since this feature is explicitly taught by Ollivier.
Allowable Subject Matter
Claims 36 and 49 are 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 prior art does not teach that the tissue attachment members extend from a common port.
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 29-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 9,872,981. Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention is considered to be an obvious combination of elements claimed in the ‘981 patent.
For instance, present claim 29 is considered a combination of previously claimed elements of claim 1 in view of claims 30, 33-34 of the ‘981 patent, wherein claim 1 of the ‘981 presents all the limitations of present claim 29, and when modified in view of claims 30, 33-34 of the ‘981 patent includes the shaping wire limitation. Therefore, present claim 29 is considered an obvious combination of previously claimed elements of the ’981 patent.
Additionally, present claim 46 is considered a combination of previously claimed elements of claim 1 in view of claims 30-32 of the ‘981 patent, wherein claim 1 of the ‘981 presents all the limitations of present claim 46, and when modified in view of claims 30-32 of the ‘981 patent includes the torque member limitations. Therefore, present claim 46 is considered an obvious combination of previously claimed elements of the ’981 patent.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 11 June 2026
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