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 .
A complete action on the merits of pending claims 1-10 appears herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/23/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive.
Applicant argues “Wood does not describe a structure including a cannula shaft that includes an electrically conductive shaft portion and an electrode shaft that includes an electrically conductive shaft portion. As noted in paragraph [0019] of Wood, a cannula shaft can include an exposed portion, but there is no electrode shaft that includes an electrically conductive shaft disclosed in Wood.”
Examiner respectfully disagrees and contends that Wood, as further discussed in the rejection to claim 1 below, teaches a cannula shaft (Fig. 1: the shaft of cannula (18)) that includes an electrically conductive shaft portion (Par. [0030]: Cannula (18) can be made from surgical steel) and an electrode shaft that includes an electrically conductive shaft portion. (Par. [0019]: The shaft of needle (24) functions as a cauterization electrode) Furthermore, the exposed portion of electrode (32), as shown in Fig. 4A, would comprise an electrically conductive shaft portion.
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.
Claim 1 is rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 10,588,687. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 10,588,687 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(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) 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood (US 2003/0093007 A1).
Regarding claim 1, Wood teaches a system (Fig. 1) including a cannula (Fig. 1, Char. 18: cannula) and an electrode, (Par. [0019]: Fig. 1: the exposed portion of needle (16)//Fig. 1 and 4A-C, the exposed portion of distal end (32) of cannula (18)) wherein the cannula is configured to introduce a biopsy needle into bodily tissue, (Par. [0019]) the cannula is configured to introduce the electrode into the bodily tissue, (Par. [0019]//Fig. 4A-C) the cannula shaft includes an electrically conductive shaft portion, (Par. [0030]: Cannula (18) can be made from surgical steel) the electrode shaft includes an electrically conductive shaft portion, (Fig. 1, Char. 24: distal end//Fig. 1 and 4A-C, Char. 32: distal end) the combination of the cannula and electrode is configured to operate with an electrosurgical generator (Par. [0030]: energy generator) to ablate tissue around a tract through the tissue formed by prior introduction of the biopsy needle through the cannula and around the cannula distal end. (Fig. 4A-C; and Par. [0048])
Regarding claim 2, Wood further teaches the cannula shaft includes an electrically insulated portion at its proximal end, (Fig. 1, and Par. [0021]) the cannula shaft that includes the electrically conductive portion at its distal end around which tissue is ablated. (Fig. 1 and Par. [0030] and [0035]: At least the exposed distal end of cannula (18) is connected to an Rf generator and delivers energy to tissue)
Regarding claims 3 and 4, Wood further teaches the biopsy needle includes the electrode; (Fig. 1, and Par. [0022] and [0046]) and wherein the electrode and the biopsy needle protrude into the tissue beyond the cannula by the same length when each of the electrode and the biopsy needle are introduced by the cannula. (Fig. 1 and 4A: The exposed portion of needle (16) is a part of needle (16))
Regarding claim 5, Wood further teaches the electrode is monopolar and cannula conductive shaft portion is energized by the electrode when the electrode is introduced into the tissue via the cannula. (Par. [0019] and Par. [0046])
Regarding claim 6, Wood further teaches the electrode is bipolar and cannula conductive shaft portion is energized by one of the electrodes contacts when the electrode when the electrode introduced into the tissue via the cannula. (Par. [0019] and Par. [0046])
Regarding claim 7, Wood further teaches the electrode is bipolar electrode. (Par. [0019] and Par. [0046])
Regarding claim 8, Wood further teaches the distal contact of the electrode has smaller surface area than does the proximal contact of the electrode. (Fig. 3A: sharpened point (28a) is smaller than the exposed shaft portion of needle (16))
Regarding claim 10, Wood further teaches a stylet, (Par. [0025]: Stylet (16) in Fig. 1 can be removed and replaced with blunt tipped stylet) wherein the cannula includes the electrode, (Par. [0019]) the cannula is configured to introduce the stylet into bodily tissue, (Fig. 4A, Par. [0019] and Par. [0046]) and tissue is ablated around the stylet (Par. [0025]: The blunt tipped stylet is capable of conducting RF energy treating tissue in contact with/adjacent to said blunt tipped stylet).
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.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 2003/0093007 A1), as applied to claim 2 above.
Regarding claim 9, Wood, as applied to claim 2 above, teaches the electrode is a bipolar electrode, (Par. [0019] and Par. [0046]) wherein the distal contact of the electrode has smaller surface area than does the proximal contact of the electrode, (Fig. 3A: sharpened point (28a) is smaller than the exposed shaft portion of needle (16))
Wood further teaches the cannula shaft conductive portion can be configured in a plurality of sizes depending on the user’s preference, including reducing the surface area of the exposed portion of canula (18). (Par. [0036])
Wood, as applied to claim 2 above, is silent regarding the cannula shaft conductive portion having smaller surface area than the distal contact of the electrode.
However, absent a statement of criticality and unexpected results, it would have been an obvious matter of design choice to configure the exposed portion of cannula (18) to have a smaller surface area than sharpened point (28a), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM 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, Joanne Rodden can be reached at 3032974276. 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.
/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights