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 . Claims 1-20 are currently pending.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-20 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 13 recites in lines 9-10 “the tapered portion configured with a taper in width with a proximal end with width WIP generally equal to the width WP and a distal end with width WID generally equal to the width WD”, where it is entirely unclear what the WP and WD widths are referencing.
Claims 1 and 13 disclose a distal electrode assembly and an elongated body with no detail as to their structural relationship. The same issue arises between the proximal stem portion and the plurality of spines.
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 1-8 and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1, 7-14 of U.S. Patent No. 12,161,472. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the claimed elements are explicitly included while the ‘472 is more specific on other aspects of the device. ‘216 discloses the elongate body, stem portion, plurality of splines with the dimensions and indented portion, while the dependent claims are near identical.
Claims 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. ‘216 (as mentioned above) in view of WU et al. US Publication 2016/0374582 (at figure 5, where the language does not say that each spine includes two different preformed curvatures, as in different spines could have different curvatures). If the intended interpretation is taken, it is still taught by Fang US Publication 2013/0253504 (Figure 13b). Therefore, it would have been obvious to utilize the different curvatures (of either Wu or Fang) with the device of ‘216 as predictable results would have ensued (curing a spine to fit within a part of a human anatomy as desired).
Claims 12 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. ‘216 (as mentioned above) in view of Diep et al. US Publication 2014/0194716 (hereinafter Diep). ‘216 details the base device but is silent on the enlarged distal end of the spline. Diep teaches such a feature (Figure 9). It would have been obvious to the skilled artisan before the effective filing date to utilize the enlarged distal end as taught by Diep with the device of ‘216 in order to aid in anchoring the spine to the distal end of the device with the increased surface area while maintaining an overall flexible spine (thinner more proximal portion).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claims 10-11 and 18-19 are allowable (allowed in parent application, now US Patent 11,058,315) which includes the same subject matter and would not fall within the scope of double patenting. For claims 18-19 specifically, the above 112 rejections must also be overcome.
For claim 1, it should also be noted that the spine’s structural design is taught by Kordis US 8,346,339, however the free end of the distal part of the spine is what prevents its use in a rejection as Kordis related to a basket electrode assembly where the skilled artisan would not have been inclined to keep that spine shaping when altering the design to include free ends. Many references detail that spines in a basket or free ended are known equivalents, it would have been unreasonable to alter the shape of the spine as claimed.
Claim 13 overcomes the closest prior art of record as the tapers found in references such as Solis US Patent 7,155,270 (Figure 9) and Diep (as mentioned above; Figures 8-9) are continuous from the proximal to the distal end of the spine. The claim specifically details that the proximal end (before the taper closer to the stem) has a uniform width, while the distal end (distal of the taper) also includes a uniform width, where ultimately the taper only exists for a portion of the spine, not along its entire length.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights