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, 6-8, 11, 16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-28 of U.S. Patent No. 10,850,108. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 27 anticipates all the components recited in the claims of this application.
Regarding claims 1 and 11 of this application: the “tubular body” is anticipated by the “tubular catheter” recited in claim 18 of ‘108. The anchor needle is recited in claim 27 of ‘108. The “lead lumen” is anticipated by the understanding of a “tubular catheter” defining a lumen, and the “exit port” is anticipated by “an opening defined in the side of the tubular body” in claim 18 of ‘108.
Regarding claims 6-8: claim 18 of ‘108 recites a fixation ring and deflection member coupled to the fixation ring.
Further regarding claim 11: the “pacing lead” is recited in claim 18 of ‘108 as extending through the side opening, which corresponds with the exit port of this application, and line 1 of claim 18 of ‘108 states the lead is for pacing.
Regarding claim 16 of this application: claim 18 of ‘108 recites the step of anchoring a distal tip near an implantation site (establishing a pivotable fixation between a right atrium and a distal termination). Claim 27 recites an anchor needle extending distally of the distal tip is recited in claim 27 of ‘108. Claim 18 recites a “lead lumen” is anticipated by the understanding of a “tubular catheter” defining a lumen, and the “exit port” is anticipated by “an opening defined in the side of the tubular body” in claim 18 of ‘108. The step of “pivoting the lead delivery catheter” is anticipated by pivoting the distal termination” of claim 18. Claim 18 states the lead extends from the “opening”, corresponding with the exit port, wherein it is considered obvious to recite the step of advancing the lead through the lumen and port in order to achieve extending the lead through the port.
Regarding claim 18: the step of “further comprising deflecting the lead delivery catheter” is anticipated by the limitation in claim 18 of ‘108 “wherein the deflection member is displaceable … to deflect the distal end laterally.”
Claims 1, 2, 6-9, 11, 12, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,004,775. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘775 patent anticipate all the components recited in the claims of this application.
Regarding claims 1 and 11 of this application: claims 1and 7 of the ‘775 patent recite an “extension” that is absent from the claims of this application. Writing the claims to be broader in scope is considered to be an obvious modification.
Regarding claims 6-8: claims 2-5 and 8-11 of ‘775 recite a fixation ring and deflection member coupled to the fixation ring.
Claims 9 corresponds with claim 6 or 12.
Further regarding claim 11: the “pacing lead” is recited in claim 17 of ‘775.
Regarding claim 16 of this application is anticipated by claim 18 of ‘775, wherein claim 13 recites the steps of anchoring a distal tip near an implantation site, pivoting the catheter and advancing the lead. Claim 18 recites an anchor needle.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 16 recites “the extension” in line
Claim 16 recites the limitation "the extension" in line 8. There is insufficient antecedent basis for this limitation in the claim. dependent claims 17-20 are indefinite for the same reason. For the purpose of expediting prosecution the claim is being read as “pivoting the lead delivery catheter to direct the exit port to the implantation site.”
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.
Claim(s) 1-4 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 6,723,069 (Weldon et al.).
Weldon discloses a catheter in Figures 11-16 that comprises a tubular body (56/70) extending along a longitudinal axis from a proximal end to a distal end, an anchor needle (64/84) having a needle tip extendable distal to the distal tip to anchor in tissue (26) (see Fig. 13 and 16), and a lead lumen extending through the tubular body to an exit port (see opening through which member 66 or 92 extends in Fig. 13 and 16; column 7, line 44 to column 8).
The language “actively pivotally anchor in tissue near an implantation site” is a functional recitation that is not given full patentable weight, wherein the prior art is not required to disclose this function. Additionally the prior art is not required to disclose delivery of a lead, since the lead is not positively recited as part of the claimed invention. The capability of the Weldon device to have a lead disposed on the lumen and pivotally maneuvered meets the functional requirements.
Regarding claim 2, the axis of the needle (64/84) is coaxial with the longitudinal axis of the tubular body.
Regarding claim 3: the claim does not explicitly state a direction or element from which the needle is retractable. The ability of the needle to be retracted from tissue meets the broad requirement.
Regarding claim 4, the anchor needle is helical (see “corkscrew” in column 7, line 54).
Regarding claim 9, the distal tip tapers in diameter.
Regarding claim 10, the blunt shape of the distal end of the catheter meets the broad requirement of “bullnose”.
Claim(s) 1-3 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent App. Pub. No. 2008/0091196 (Deal).
Deal discloses a catheter that comprises a tubular body (214) extending along a longitudinal axis from a proximal end (200) to a distal end, an anchor needle (240) having a needle tip (240A) extendable distal to the distal tip [0019], and a lead lumen extending through the tubular body to an exit port (242) [0019], wherein the guidewire lumen (234) is capable of receiving a lead.
The language “actively pivotally anchor in tissue near an implantation site” is a functional recitation that is not given full patentable weight, wherein the prior art is not required to disclose this function. Additionally the prior art is not required to disclose delivery of a lead, since the lead is not positively recited as part of the claimed invention. The capability of the Deal device to have a lead disposed on the lumen and pivotally maneuvered meets the functional requirements.
Regarding claim 2, the axis of the needle (240) is coaxial with the longitudinal axis of the tubular body (214).
Regarding claim 3: Deal explains the needle is retractable [0019]; [0024].
Regarding claim 9, the distal tip tapers in diameter.
Regarding claim 10, the blunt rounded shape of the distal end of the catheter (214) meets the broad requirement of “bullnose” (see especially Figure 2B-C).
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) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of US 7,713,285 (Stone et al.).
Weldon teaches the anchor is a hook or corkscrew (col 7, lines 50-55) but fails to disclose a threaded anchor. Stone teaches that it is well known in the art for an anchoring structure of an implantable device (10) to comprise a threaded surface (16) (Fig. 1-5; column 3, line 63 to column 4). It would have been obvious before the effective filing date of the claimed invention to configure the anchor of Weldon as a threaded structure, as taught by Stone, as the modification merely involves a substitution of one known anchoring structure for another that obtains a predictable result.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Deal in view of USPAP 2013/0281925 (Benscotter et al.).
Deal discloses a deflection member (250/350) for deflect the catheter laterally [0020-0021], but fails to disclose that the distal end of the is coupled to a fixation ring. Benscotter discloses a steering mechanism for a catheter that comprises a fixation ring (34) mounted to a catheter body (22) and a deflection member (24) coupled to the ring and configured to move in a proximal/distal direction to deflect the catheter tip (See Figure 1; [0025]). Benscotter teaches that it is well known in the art to incorporate a steering mechanism with a catheter used to perform procedures within tortuous vasculature and/or requiring precise navigation ([0004-0005]). One of ordinary skill in the art one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the deflection member of the Deal device to include a fixation ring taught by Benscotter, as the modification merely involves a combination of known guiding catheters according to known methods that obtains a predictable result of a catheter having a distal tip steering mechanism for more easily navigating through tortuous vessels.
Claim(s) 11-13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Deal in view of USPAP 2006/0247750 (Seifert et al.).
Deal fails to disclose a pacing lead placed within the lumen and configured to advance through the exit port. Seifert discloses a catheter used for lead delivery, wherein a lead (20) extends through a lumen (114) and is advanced through an exit port (134) (Fig. 6; [0048 – 0055]). It would have been obvious before the effective filing date of the claimed invention to combine a pacing lead taught by Seifert with the catheter of Deal, as the modification merely involves a substitution of one known medical device delivered through a catheter lumen for another that obtains a predictable result of delivering a pacing lead.
Regarding claim 12, the axis of the needle (240) is coaxial with the longitudinal axis of the tubular body (214).
Regarding claim 13: Deal explains the needle is retractable [0019]; [0024].
Claim(s) 11-14, 16, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of USPAP 2006/0247750 (Seifert et al.).
Weldon fails to disclose a pacing lead placed within the lumen and configured to advance through the exit port, but Weldon does teach the device (52) in the lumen may be any catheter or medical device (column 7, lines 24-25). Seifert discloses a catheter used for lead delivery, wherein a lead (20) extends through a lumen (114) and is advanced through an exit port (134) (Fig. 6; [0048 – 0055]). It would have been obvious before the effective filing date of the claimed invention to combine a pacing lead taught by Seifert with the catheter of Deal, as the modification merely involves a substitution of one known medical device delivered through a catheter lumen for another that obtains a predictable result of delivering a pacing lead.
Regarding claim 12, the axis of the needle (64/84) is coaxial with the longitudinal axis of the tubular body.
Regarding claim 13: the claim does not explicitly state a direction or element from which the needle is retractable. The ability of the needle to be retracted from tissue meets the broad requirement.
Regarding claim 14, the anchor needle is helical (see “corkscrew” in column 7, line 54).
In regards to claim 16, Weldon discloses the step of anchoring a distal tip of the catheter to tissue with a helical needle and extending a medical device through an exit port to a treatment site. Weldon fails to disclose a pacing lead placed within the lumen and configured to advance through the exit port, but Weldon does teach the device (52) in the lumen may be any catheter or medical device (column 7, lines 24-25). Seifert discloses a catheter used for lead delivery, wherein a lead (20) extends through a lumen (114) and is advanced through an exit port (134) (Fig. 6; [0048 – 0055]). It would have been obvious before the effective filing date of the claimed invention to use the catheter of Deal to deliver the pacing lead taught by Seifert, as the modification merely involves a combination of a known medical device with a catheter to that obtains a predictable result of delivering a pacing lead to an implantation site.
It would have been further obvious to perform a step of pivoting the catheter, about at least some axis, such as rotating the catheter about the longitudinal axis, in order to align the exit port with a desired site of anchoring the pacing lead.
In regards to claim 17, the claim does not explicitly state a direction or element from which the needle is retractable. The ability of the needle of modified Weldon to be retracted from tissue meets the broad requirement.
In regards to claims 19 and 20, Seifert teaches the pacing lead comprises a sensing electrode [0038], wherein the target tissue is sensed by the electrode during a method of use. The claims do not necessarily require that the location of target tissue is based on the sensing of the electrode. It would have been further obvious to control the electrode to sense a parameter of the target tissue before/during the step of implanting the pacing lead.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of Seifert, as applied to claim 11 above, and further in view of US 7,713,285 (Stone et al.).
Weldon teaches the anchor is a hook or corkscrew (col 7, lines 50-55) but fails to disclose a threaded anchor. Stone teaches that it is well known in the art for an anchoring structure of an implantable device (10) to comprise a threaded surface (16) (Fig. 1-5; column 3, line 63 to column 4). It would have been obvious before the effective filing date of the claimed invention to configure the anchor of Weldon as a threaded structure, as taught by Stone, as the modification merely involves a substitution of one known anchoring structure for another that obtains a predictable result.
Conclusion
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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