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 § 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.
Claims 1, 3, 5, 7-11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickley US 2003/0216693 A1.
Regarding claim 1, Mickley discloses a catheter system (catheter 600, P0065-0066 and shown in Fig. 7) comprising: a catheter (elongate shaft 636 forming helical member 684, P0066) having a straight section (straight section is the section proximal to the helical member 684) and a flexible portion (helical member 684, P0066, biased to expand in diameter and therefore flexible, P0066); a shaping member (barrel 662, P0065) defined by a helical shape (helical member 678, P0065) for imparting, when engaging the flexible portion, a plurality of turns on the flexible portion (plurality of turns, see annotated Fig. 7 below), the shaping member, when engaging the flexible portion, providing the plurality of turns with sufficient rigidity to permit traction with tissue (tissue including the heart P0036, wherein the distal end is disposed within the heart P0037) by allowing tissue to be lodged between the plurality of turns (a distal end of the elongate shaft 636 may be advanced into a target tissue by rotating elongate shaft 636 P0066); and a pathway (the invention relates to devices for delivering therapeutic or diagnostic agents P0013, via the injection lumen which is labeled 140/240/340/540 in various embodiments) extending through the catheter for transporting fluids to and from the tissue (the injection lumen is fully capable of transporting fluids to and from the tissue).
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Regarding claim 3, Mickley discloses the catheter of claim 1, wherein each of the plurality of turns are spaced apart from one another (see annotated Fig. 7 above showing spacing between turns).
Regarding claim 5, Mickley discloses the catheter of claim 1, wherein a diameter of the plurality of turns is larger than a diameter of the straight section (Fig. 7 showing the helically shaped section distal to the proximal section of the catheter that forms the straight section).
Regarding claim 7, Mickley discloses the catheter of claim 1, wherein the straight section is configured to be advanced into the tissue (catheter advanced into lumen of the blood vessel to the heart, P0036) in a substantially linear direction to create a linear pathway upon complete insertion and the flexible portion is configured to be inserted into the tissue in a rotational direction to create a pathway corresponding to the plurality of turns upon complete insertion (a distal end of the elongate shaft 636 may be advanced into a target tissue by rotating elongate shaft 636, P0066).
Regarding claim 8, Mickley discloses the catheter of claim 1, wherein the shaping member has a length extending between a first end and a second end, the shaping member having a helical shape along its entire length (see annotated Fig. 7 above).
Regarding claim 9, Mickley discloses the catheter of claim 1, wherein the shaping member is arranged adjacent a proximal section of the catheter (see annotated Fig. 7 above).
Regarding claim 10, Mickley discloses the catheter of claim 1, wherein the shaping member is a jacket (jacket defined as an outer covering, see attached definition of jacket) that covers an outer surface of the flexible portion of the catheter (Fig. 7).
Regarding claim 11, Mickley discloses a catheter system (catheter 600, P0065-0066 and shown in Fig. 7) comprising: a catheter (elongate shaft 636 forming helical member 684, P0066) having a straight section (straight section is the section proximal to the helical member 684) and a flexible portion (helical member 684, P0066, biased to expand in diameter and therefore flexible, P0066); a shaping member (barrel 662, P0065) for imparting, when directly arranged onto the flexible portion, a plurality of turns on the flexible portion (plurality of turns, see annotated Fig. 7 below), the plurality of turns, in the presence of the shaping member, are provided with sufficient rigidity to permit the flexible portion to be inserted into tissue (tissue including the heart P0036, wherein the distal end is disposed within the heart P0037) in a rotational direction (a distal end of the elongate shaft 636 may be advanced into a target tissue by rotating elongate shaft 636 P0066); and a pathway (the invention relates to devices for delivering therapeutic or diagnostic agents P0013, via the injection lumen which is labeled in some embodiments as 140/240/340/540) extending through the straight section and flexible portion of the catheter for transporting fluids to and from the tissue (the injection lumen is fully capable of transporting fluids to and from the tissue).
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Regarding claim 13, Mickley discloses the catheter system of claim 11, wherein each of the plurality of turns are spaced apart from one another (Fig. 7).
Regarding claim 15, Mickley discloses the catheter of claim 11, wherein a diameter of the plurality of turns is larger than a diameter of the straight section (Fig. 7).
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 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.
Claims 2, 4, 6, 12, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley.
Regarding claim 2, Mickley discloses the catheter of claim 1.
The embodiment of Fig. 7 does not explicitly teach the catheter further comprising a hub section positioned proximal to the flexible portion for providing coupling with a medical instrument, wherein the hub section is substantially aligned with the straight section.
However, other embodiments of Mickley teach the catheter further comprising a hub section (hub 144 of Fig. 1, P0031) positioned proximal to the flexible portion for providing coupling with a medical instrument (fluid source 34 P0038, shown in Fig. 2), wherein the hub section is substantially aligned with the straight section (Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter with a hub for the purpose of coupling the catheter to a fluid source.
Regarding claim 4, Mickley discloses the catheter of claim 1.
Mickley does not teach wherein a pitch between the plurality of turns is about two millimeters to about four millimeters.
However, at the time the invention was made, it would have been a matter of obvious design choice for the pitch between the plurality of turns to be about two to four millimeters. Applicant has not disclosed that having this configuration serves an advantage of particular purpose or solves a stated problem. Furthermore, one or ordinary skill would expect Mickley’s helical section and applicant’s helical section to perform equally well with the claimed pitch or the pitch of Mickley because both devices are disclosed for use for anchoring in an anatomical structure. Therefore, it would have been obvious to modify the helical section of Mickley as specified because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Mickley.
Regarding claim 6, Mickley discloses the catheter of claim 5.
Mickley does not explicitly teach wherein the diameter of the plurality of turns is about two times to about six times the diameter of the straight section. However, as can be seen in Fig. 7, Mickley shows that the diameter of the plurality of turns is greater than the diameter of the straight section. Therefore, it would have been obvious to one of ordinary skill in the art to form the device of Mickley wherein the diameter of the plurality of turns is about two times to about six times the diameter of the straight section because Mickley shows an example wherein this appears to be the relationship between the diameter of the straight section and the plurality of turns.
Regarding claim 12, Mickley discloses the catheter system of claim 11.
The embodiment of Fig. 7 does not explicitly teach the catheter further comprising a hub section positioned proximal to the flexible portion for providing coupling with a medical instrument, wherein the hub section is substantially aligned with the straight section.
However, other embodiments of Mickley teach the catheter further comprising a hub section (hub 144 of Fig. 1, P0031) positioned proximal to the flexible portion for providing coupling with a medical instrument (fluid source 34 P0038, shown in Fig. 2), wherein the hub section is substantially aligned with the straight section (Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter with a hub for the purpose of coupling the catheter to a fluid source.
Regarding claim 14, Mickley discloses the catheter system of claim 11.
Mickley does not teach wherein a pitch between the plurality of turns is about two millimeters to about four millimeters.
However, at the time the invention was made, it would have been a matter of obvious design choice for the pitch between the plurality of turns to be about two to four millimeters. Applicant has not disclosed that having this configuration serves an advantage of particular purpose or solves a stated problem. Furthermore, one or ordinary skill would expect Mickley’s helical section and applicant’s helical section to perform equally well with the claimed pitch or the pitch of Mickley because both devices are disclosed for use for anchoring in an anatomical structure. Therefore, it would have been obvious to modify the helical section of Mickley as specified because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Mickley.
Regarding claim 16, Mickley discloses the catheter of claim 15.
Mickley does not explicitly teach wherein the diameter of the plurality of turns is about two times to about six times the diameter of the straight section. However, as can be seen in Fig. 7, Mickley shows that the diameter of the plurality of turns is greater than the diameter of the straight section. Therefore, it would have been obvious to one of ordinary skill in the art to form the device of Mickley wherein the diameter of the plurality of turns is about two times to about six times the diameter of the straight section because Mickley shows an example wherein this appears to be the relationship between the diameter of the straight section and the plurality of turns.
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 and 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7-9 of U.S. Patent No. 12,029,868. Although the claims at issue are not identical, they are not patentably distinct from each other because patent 12,029,868 discloses a catheter system comprising (c 10 ln 39-51): a catheter having a straight section and a flexible portion (c 10 ln 40); a shaping member (c 10 ln 43) defined by a helical shape (with a helical section, c 10 ln 43) for imparting, when engaging the flexible portion, a plurality of turns on the flexible portion (c 10 ln 43-45), the shaping member, when engaging the flexible portion, providing the plurality of turns with sufficient rigidity to permit traction with tissue by allowing tissue to be lodged between the plurality of turns (c 10 ln 45-49); and a pathway extending through the catheter for transporting fluids to and from the tissue (c 10 ln 50-51).
Claim 1 of this application is anticipated by claim 5 of the patent as both claims are drawn to the same structural limitations of the catheter system as claimed. The difference between the scope of claim 1 of this application and claim 5 of the patent is that claim 1 of this application is a broader claim as it does not recite and claim the specifics of the straight section of the catheter comprising a pointed tip for piercing through tissues. However, one of ordinary skill in the art would recognize that claim 1 of this application is anticipated by claim 5 of the patent.
Additionally, claim 1 is unpatentable over claim 1 of the patent for similar reason in that claim 1 of the pending application is a broader claim as it does not recite and claim “an insertion needle removably inserted through the pathway for piercing through tissues”.
Claim
12,029,868
Citation
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.D./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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