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 .
Drawings
The drawings are objected to because it appears “131A” in Fig. 3E should be “131B”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “tracking system” in claims 24, 26, 30, 38, and 40 with specification support in published paragraph [0035].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 30, 34, and 40 are objected to because of the following informalities:
In claim 30, line 9, ‘treatment’ should be removed.
In claims 34 and 40, it appears the temperature sensor should only be set forth as being disposed “adjacent” to the balun instead of “on” the balun.
Appropriate correction is required.
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.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Rossetto et al (US Pub 2008/0294162 -cited by applicant) in view of Hill et al (US Pub 2016/0128669 -cited by applicant) and Brannan (US Pub 2016/0051327 -cited by applicant).
Re claims 21, 22, 26, 30-32, 34, 36-38, 40: Rossetto discloses a probe, comprising:
an antenna extending distally from a handle and configured for delivering microwave energy to tissue, the antenna include a coaxial cable [0021, 0022, Figure 1; see the needle/antenna portion as the probe that has its proximal end inside a handle for delivering microwave energy from generator G via transmission conduit/coaxial cable].
Rossetto discloses all features except an EM tracking sensor configured to provide probe location information, wherein a location of the probe is determined in part based on a material of a tracking wire. However, Hill teaches of a treatment probe with a tracking system including a EM tracking sensor disposed on the treatment probe and configured to communicate with a tracking system via a tracking sensor wire, the tracking sensor wire configured to transmit a location signal from the tracking sensor to the tracking system for determining a location of the treatment probe, the tracking sensor wire extending through the handle assembly and through at least one of the first cable or the second cable to electrically couple to the tracking system, wherein a location of the probe is determined in part based on a material of a tracking wire [0065, Figure 1; see the EM sensor 137 that communicates with tracking system 100, wherein the sensor may be internal to the probe thereby extending through the handle assembly for electrical coupling, wherein the actual location is inherently dependent upon the particular material of the wire]. It would have been obvious to the skilled artisan to modify Rossetto, to include the tracking sensor as taught by Hill, in order to facilitate a procedure by determining exactly where the probe is located in a patient’s body [0022 of Hill].
Rossetto/Hill discloses all features including that temperature of the probe is determined [0067 of Hill] but does not disclose a temperature sensor to sense a temperature of the antenna, a jacket coaxially surrounding the outer conductor to define a lumen configured to receive a fluid, or the antenna including an outer conductor and a balun. Rossetto/Hill also does not disclose the tracking system determines the location of the probe based in part on the temperature of the antenna. However, Brannan teaches of a system and method for ablation using a treatment probe including a temperature sensor disposed within the antenna, wherein the temperature is used to determine the location of the probe [0088, 0091, Fig 2B; see temperature sensor 148 disposed within the antenna of the probe 100 with connection to the source 170 to provide a temperature signal through the connector 101, wherein the temperature is used to create a map that determines location]. Further, Brannan teaches of a jacket coaxially surrounding the outer conductor to define a lumen configured to receive a fluid and the antenna including an outer conductor and a balun [0049, 0088, Fig 2A; see the outer cooling jacket 110; see the temperature sensor 148 on outer conductor 130 and located adjacent balun short 142]. It would have been obvious to the skilled artisan to modify Rossetto/Hill, to incorporate the temperature sensor and jacket as taught by Brannan, as such ensures a desired temperature is maintained.
Re claims 23, 39: Rossetto discloses a first cable having a distal end disposed within the handle and a proximal end opposite the distal end configured to electrically couple the antenna to an electrosurgical generator.
Re claim 24: Rossetto (and Brannon) disclose all features except for a tracking sensor includes a wire configured to transmit a signal from the tracking sensor to a tracking system, the wire extending through the handle and through the first cable to electrically couple the tracking sensor to the tracking system. However, Hill teaches a tracking sensor includes a wire configured to transmit a signal from the tracking sensor to a tracking system, the wire extending through the handle and through the first cable to electrically couple the tracking sensor to the tracking system [0028, 0065, Figure 1; see the EM sensor 137 on the outer surface of the probe and its communication with tracking system 100, wherein the sensor may be internal to the probe thereby extending through the handle for electrical coupling]. It would have been obvious to the skilled artisan to modify Rossetto, to include the tracking sensor as taught by Hill, in order to facilitate a procedure by determining exactly where the probe is located in a patient’s body.
Re claim 25: Rossetto discloses the proximal end of the first cable is releasably coupled to a distal end of a second cable, the second cable having a proximal end opposite the distal end of the second cable for coupling to the electrosurgical generator [see first cable 109 and second cable 105 for coupling to the generator G].
Re claims 27-29, 33, 35: Rossetto/Hill disclose all features except a temperature sensor wire coupled to the temperature sensor and extending through the antenna and the handle, an inner tube coaxially surrounded by the jacket, or the temperature sensor is disposed between the inner tube and the outer conductor/coaxial cable. However, Brannon teaches a temperature sensor wire coupled to the temperature sensor and extending through the antenna and the handle, an inner tube coaxially surrounded by the jacket, and the temperature sensor is disposed between the inner tube and the outer conductor [0049, 0088, Figs 2A and 2B; see the temperature sensor connected to source 170 by extending through the handle along with the cooling jacket 108 and inflow tube 108]. It would have been obvious to the skilled artisan to modify Rossetto/Hill, to incorporate the temperature sensor and jacket as taught by Brannan, as such ensures a desired temperature is maintained.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,874,327 in view of Brannan (US Pub 2016/0051327 -cited by applicant). US 10874327 features a system including a treatment probe with an antenna and an energy source, a tracking sensor to track a location of the probe, a tracking system, a first cable to provide energy to the antenna, a second cable to connect the disposable cable to the energy source, and a balun surrounding an outer conductor. 10874327 does not disclose a temperature sensor with a temperature sensor wire. However, Brannan teaches that a temperature sensor disposed within the antenna and connected to the connector assembly by a temperature sensor wire extending through the antenna, the handle assembly, the first cable, and into the connector assembly, the temperature sensor wire configured to transmit a sensed temperature signal from the temperature sensor to the connector assembly [0088, Fig 2B; see temperature sensor 148 disposed within the antenna of the probe 100 with connection to the source 170 to provide a temperature signal through the connector (the unlabeled transition connector shown in Fig 1)]. It would have been obvious to the skilled artisan to modify the claims of 10874327, to incorporate the cables and temperature sensor as taught by Brannan, as such facilitates operation during a treatment via cable coupling and also to ensure a desired temperature is maintained.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,121,341. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘341 features a system including a probe with a microwave antenna, a cooling jacket coaxially surrounding an outer conductor, an inflow tube, a first and second cable, a tracking sensor to communicate with a tracking system with a tracking sensor wire, and a temperature sensor, wherein the system determines a location of the probe based at least in part on the sensed temperature signal and a material forming the tracking sensor wire. While the instant claims are broader (for example, instant claims do not require that the probe position be based on both a temperature signal and a tracking sensor wire material, it would have been obvious to conclude that the instant claims are an obvious variant.
Conclusion
This is a CON of applicant's earlier Application No. 17/124,687. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797