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 CON of 18/481,580 10/05/2023 PAT 12295834
18/481,580 is a CON of 17/002,284 08/25/2020 PAT 11786364
17/002,284 is a CON of 15/974,099 05/08/2018 PAT 10758341
15/974,099 is a DIV of 15/040,772 02/10/2016 PAT 10039637
15/040,772 has PRO 62/115,010 02/11/2015 is acknowledged.
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 1-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,295,834, respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader claims of the instant application are anticipated by the narrower claims of the Patent.
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 1-14 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.
Claims 1 recites the limitation "the distal end of the elongated shaft" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is the same or different from a distal portion of the elongated shaft in line 7.
Claim 8 recites the limitation " the distal end of the elongated shaft " in lines 13-14. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is the same or different from a distal portion of the elongated shaft in line 7.
Claim 1 recites “a first steering mechanism” and claim 8 recites “a first actuation mechanism”. It is unclear what the “first steering mechanism” or the “ first actuation mechanism” is since there is no support in the written specification of what structure this first steering mechanism or first actuation mechanism is referring to.
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) 1-4, 7-11, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0184095 to Spence et al. (Spence).
Spence teaches:
Claims 1 and 8: A delivery apparatus for a medical device implant, comprising:
an outer catheter (introducing sheath, Fig. 1);
a delivery catheter (10, Fig. 1) comprising a second steering mechanism/actuation mechanism (para. 0089, last sentence);
wherein the outer catheter comprises an axially extending shaft and a first lumen (where catheter 10 extending through, Fig. 1) extending co-axially through the axially extending shaft;
wherein the delivery catheter comprises an elongate shaft (10, Fig. 1) having a flexible section (deflectable tip 10a, Fig. 1, bending for steering is flexible) extending along a distal portion of the elongate shaft;
wherein the flexible section of the elongate shaft can be positioned or adjusted between a delivery configuration (straight within the introducer sheath) and an activated configuration via the second steering mechanism (after extending out of introducer sheath, Fig. 1);
wherein the second steering mechanism of the delivery catheter comprises a pull wire (26, Fig. 5A);
wherein the elongate shaft (10, Fig. 1) comprises an axially extending second lumen (where 12 is extending through, Fig. 1), and the pull wire (26, Fig. 5A) extends co-axially through the second lumen of the elongate shaft.
wherein a distal end of the pull wire (26) is fixedly secured or attached to the distal end of the elongate shaft (Fig. 5B);
wherein in the activated configuration, the delivery catheter forms a helically curved portion (Fig. 1); wherein the helically curved portion comprises a proximal section that curves radially away from the elongate shaft in a plane that is substantially perpendicular to the elongate shaft (Fig. 1 reproduced with annotation below).
Claims 2 and 9: The elongate shaft (10, Fig. 5A) further comprises a relatively more rigid section (straight section) located adjacent and proximal to the flexible section (bent section, Fig. 5A).
Claims 3 and 10: The second lumen (where 12 is extending through, Fig. 1) is centrally disposed.
Claims 4 and 11: In the delivery configuration (within the introducer sheath before being push out of the introducer sheath, Fig. 1), the flexible section is substantially straight.
Claims 7 and 14: The elongate shaft (10, Fig. 5A) comprises a plurality of axial sections, the plurality of axial sections comprising a relatively more rigid section (straight section, Fig. 5A) located adjacent and proximal to the flexible section (the bent section, Fig. 5A) extending along the distal portion of the elongate shaft.
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Spence fails to teach:
Claim 1: An outer catheter comprising a first steering mechanism/actuation mechanism.
The helically curved portion comprises a distal tip portion that is angled downwardly away from the plane of the proximal section.
Spence fails to disclose the first steering mechanism/actuation mechanism for the outer catheter. However, Spence does teach steering mechanism for the delivery catheter 10. It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ a steering mechanism for the outer catheter as a well-known device and function for steering the outer catheter as this device and function is already taught for steering for the delivery catheter.
Spencer also fails to specifically disclose the helically curved portion comprises a distal tip portion that is angled downwardly away from the plane of the proximal section. However, Spencer teaches that the when the pull wire 26 is pulled, the delivery catheter tip 10a deflects and deforms into various shapes as desired or needed in the procedure (para. 0078). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was filed to deflect and deform the flexible tip to angled downwardly away from the plane of the proximal section as claimed in order to enhance surgical procedure.
Claim(s) 5, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spencer in view of US 2010/0331776 to Salahieh et al. (Salahieh).
Spencer teaches:
The delivery apparatus of claims 1 and 8 (see rejection of claims 1 and 8 above).
Spencer fails to teach:
The distal end of the pull wire is attached with an adhesive to the distal end of the elongate shaft.
Salahieh teaches:
Steerable medical delivery devices comprises pull wires (708, Fig. 29A) secured to the distal end of the catheter by adhesive (para. 0122).
Spencer is silence of how the distal end of the pull wire 26 is attached to the distal end of the delivery catheter and fails to disclose that the attachment is by adhesive. However, Salahieh teaches this limitation. It would have been obvious to one or ordinary skill in the art at the time of the invention was filed to employ adhesive for attaching the distal end of the pull wire to the distal end of the delivery catheter as taught by Salahieh as it is a known method for attaching pull wire to catheter.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spencer in view of US 2015/0157455 to Hoang et al. (Hoang).
Spencer teaches:
The delivery apparatus of claims 1 and 8 (see rejection of claims 1 and 8 above).
Spencer fails to teach:
The distal end of the pull wire is attached with welding to the distal end of the elongate shaft.
Hoang teaches:
In the same field as endeavor comprises pull wire (162, Fig. 28A) secure to the distal segment (126, Fig. 28A) of outer catheter (104, Fig. 24) by welding (para. 0084).
Spencer is silence of how the distal end of the pull wire 26 is attached to the distal end of the delivery catheter and fails to disclose that the attachment is by welding. However, Hoang teaches this limitation. It would have been obvious to one or ordinary skill in the art at the time of the invention was filed to employ welding as a technique for attaching the distal end of the pull wire to the distal end of the delivery catheter as taught by Hoang as it is a known method for attaching pull wire to catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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