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 .
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.
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Claims 16-35 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12207891 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 16, the prior patent teaches a system for displaying a temperature profile of an ablation zone ([claim 1] system for visualizing a projected ablation zone)
one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of displaying a target for placing an ablation antenna for delivery of ablation energy to a patient ([claim 1] one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of displaying, on an image of an anatomical structure within a patient, a target for placing an ablation antenna for delivery of ablation energy to the patient at the target)
displaying a first circle surrounding the target displaying a second circle surrounding the first circle and corresponding to a bound of an ablation zone that would result from delivery of the ablation energy to the patient ([claim 1] displaying a projected ablation zone surrounding the target, the projected ablation zone corresponding to an ablation zone that would result from delivery of the ablation energy to the patient via the ablation antenna)
and displaying, in an area between the first and second circles, at least one color representing a temperature profile resulting from delivery of the ablation energy to the patient ([claim 1] displaying a lower bound of the projected ablation zone surrounding the target, the lower bound corresponding to the ablation zone that would result from delivery of the ablation energy to the patient at a first power setting and displaying an upper bound of the projected ablation zone surrounding the lower bound and the target, the upper bound corresponding to the ablation zone that would result from delivery of the ablation energy to the patient at a second power setting greater than the first power setting)
Regarding claim 17, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying the target on an image of an anatomical structure within the patient ([claim 2] instructions which, when executed by the one or more processors, cause performance of simultaneously displaying the lower and upper bounds on the image of the anatomical structure)
Regarding claim 18, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying the first circle in a first color and the second circle in a second color different than the first color ([claim 9] instructions which, when executed by the one or more processors, cause performance of displaying the target in a first color and displaying the lower and upper bounds in a second color different than the first color)
Regarding claim 19, the prior patent teaches instructions which, when executed by the one or more processors cause performance of displaying the ablation antenna disposed within the first and second circles ([claim 4] instructions which, when executed by the one or more processors, cause performance of displaying a middle bound of the projected ablation zone surrounded by the upper bound, the middle bound corresponding to the ablation zone that would result from delivery of ablation energy to the patient at a third power setting greater than the first power setting and less than the second power setting)
Regarding claim 20, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying the first and second circles simultaneously on an image of an anatomical structure ([claim 5] instructions which, when executed by the one or more processors, cause performance of displaying the lower, middle, and upper bounds simultaneously on the image of the anatomical structure)
Regarding claim 21, the prior patent teaches the at least one color includes at least one of yellow, green, or blue ([0063] the circle 904 may be filled in with a range of colors (e.g., yellow, green, blue))
Regarding claim 22, the prior patent teaches the first circle is the color green ([0063] the at least one color includes at least one of yellow, green, or blue)
Regarding claim 23, the prior patent teaches the second circle is the color red ([0063] a circle 904 of a second color (e.g., red))
Regarding claim 24, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying at least one movable point configured to be manipulated to change a size of the second circle ([claim 7] instructions which, when executed by the one or more processors, cause performance of displaying at least one movable point configured to be manipulated via input at the display of the image of the anatomical structure to change at least one of a size or a shape of the projected ablation zone)
Regarding claim 25, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of delivering the ablation energy to the patient at about 45 watts ([claim 10] the first power setting corresponds to delivery of the ablation energy to the patient at about 45 watts)
Regarding claim 26, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of delivering the ablation energy to the patient at about 75 watts ([claim 6] the third power setting corresponds to delivery of the ablation energy to the patient at about 75 watts)
Regarding claim 27, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of delivering the ablation energy to the patient at about 100 watts ([claim 11] the second power setting corresponds to delivery of the ablation energy to the patient at about 100 watts)
Regarding claim 28, the prior patent teaches one or more non-transitory processor readable media storing instructions which, when executed by one or more processors, cause performance of displaying a target for placing an ablation antenna for delivery of ablation energy to a patient ([claim 12] one or more non-transitory processor readable media storing instructions which, when executed by one or more processors, cause performance of displaying a target for placing an ablation antenna for delivery of ablation energy to a patient at the target)
displaying an outer circle surrounding the target and corresponding to a bound of an ablation zone that would result from delivery of the ablation energy to the patient ([claim 12] displaying a projected ablation zone surrounding the target, the projected ablation zone corresponding to an ablation zone that would result from delivery of the ablation energy to the patient via the ablation antenna)
and displaying, in an area between the outer circle and the target, at least one color representing a temperature profile resulting from delivery of the ablation energy to the patient ([claim 12] displaying a first bound of the projected ablation zone surrounding the target, the first bound corresponding to the ablation zone that would result from delivery of the ablation energy to the patient at a first power setting and displaying a second bound of the projected ablation zone surrounding the first bound and the target, the second bound corresponding to the ablation zone that would result from delivery of the ablation energy to the patient at a second power setting greater than the first power setting)
Regarding claim 29, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying an inner circle surrounding the target and surrounded by the outer circle, wherein the at least one color is displayed in an area between the outer circle and the inner circle ([claim 13] instructions which, when executed by the one or more processors, cause performance of displaying a third bound of the projected ablation zone surrounding the target and the first bound, the third bound corresponding to the ablation zone that would result from delivery of the ablation energy to the patient at a third power setting greater than the first power setting)
Regarding claim 30, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying the outer circle in a first color and the inner circle in a second color different than the first color ([claim 9] instructions which, when executed by the one or more processors, cause performance of displaying the target in a first color and displaying the lower and upper bounds in a second color different than the first color)
Regarding claim 31, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying at least one movable point configured to be manipulated to change a size of the outer circle ([claim 16] instructions which, when executed by the one or more processors, cause performance of displaying at least one movable point configured to be manipulated via input at the display of the image of the anatomical structure to change at least one of a size or a shape of the projected ablation zone)
Regarding claim 32, the prior patent teaches instructions which, when executed by the one or more processors, cause performance of displaying the target on an image of an anatomical structure within the patient ([claim 14] instructions which, when executed by the one or more processors, cause performance of simultaneously displaying the first, second, and third bounds)
Regarding claim 33, the prior patent teaches the at least one color includes at least one of yellow, green, or blue ([0063] the at least one color includes at least one of yellow, green, or blue)
Regarding claim 30, the prior patent teaches the third power setting corresponds to delivery of the ablation energy to the patient at about 75 watts ([claim 15] the third power setting corresponds to delivery of the ablation energy to the patient at about 75 watts)
Regarding claim 35, the prior patent teaches a processor-implemented method ([claim 20] a system comprising one or more processors)
for displaying a temperature profile of an ablation zone, the processor-implemented method comprising: displaying on an image of an anatomical structure within a patient; a target for placing an ablation antenna for delivery of ablation energy to a patient ([claim 20] one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of displaying a projected ablation zone surrounding a target within a patient, the projected ablation zone corresponding to an ablation zone that would result from delivery of ablation energy to the patient)
a first circle surrounding the target; a second circle surrounding the first circle and corresponding to a bound of an ablation zone that would result from delivery of the ablation energy to the patient ([claim 20] displaying a first bound of the projected ablation zone, the first bound corresponding to the ablation zone that would result from delivery of the ablation energy to the patient at a first power setting)
wherein the first circle is a first color and the second circle is a second color different than the first color ([claim 9] first color and displaying the lower and upper bounds in a second color different than the first color)
and a plurality of colors in an area between the first and second circles, the plurality of colors representing a temperature profile resulting from delivery of the ablation energy to the patient ([0065] A temperature profile may be represented by a range of colors 1020 (e.g., red, orange, yellow, green, blue))
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 25-27, and 34 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.
The term “about” in claims 21, 25, 26, 30, 33, and 34 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Due to the term “about” it is impossible to determine the exact wattage of the features outlined in the claims.
Claim Rejections - 35 USC § 102
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.
(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) 16-21, 23, 24, 28-33, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brannan (US 20180008341 A1).
Regarding claim 16, Brannan teaches a system for displaying a temperature profile of an ablation zone ([0004] a method of generating a representation of an active heating zone on a display in real time during an ablation procedure)
one or more processors; and one or more processor-readable media storing instructions ([0029] The memory 202 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by the processor 204 and which controls the operation of the processing unit 100)
displaying a target for placing an ablation antenna for delivery of ablation energy to a patient ([0004] navigating an ablation device in proximity to target tissue, delivering electrosurgical energy to the target tissue via the ablation device; [0006] The ablation device may be a microwave antenna configured to deliver microwave energy to tissue)
displaying a first circle surrounding the target ([0042] the representation of the active heating zone “HZ” may be depicted as a generally circular shape, as shown in FIG. 3)
displaying a second circle surrounding the first circle and corresponding to a bound of an ablation zone that would result from delivery of the ablation energy to the patient ([0042] representation of the active heating zone “HZ” overlaid on the surgical site “S” on the display 110 provides the clinician with a visualization of where in the surgical site “S” tissue is being ablated)
and displaying, in an area between the first and second circles, at least one color representing a temperature profile resulting from delivery of the ablation energy to the patient ([0046] In some embodiments, the representation of the active heating zone “HZ” on the display 110 may include color coded temperature gradients that are indicative of differences in potential temperature rise across various locations of the active heating zone generated by the ablation probe 130, the differential in potential temperature rise with time within the active heating zone generated by the ablation probe 130, and/or at what time rate of change the temperature is changing at particular locations of the active heating zone generated by the ablation probe 130)
Regarding claim 17, Brannan teaches displaying the target on an image of an anatomical structure within the patient ([0055] clinician is able to verify that the ablation probe 130 is correctly positioned relative to the target tissue through visual confirmation via the representation of the active heating zone “HZ” on the display 110)
Regarding claim 18, Brannan teaches displaying the first circle in a first color and the second circle in a second color different than the first color ([0045] a positive Doppler phase shift may be represented by a first color (e.g., red) on the display 110 and a negative Doppler phase shift may be represented by a second color (e.g., blue) on the display 110. In this way, the representation of the active heating zone “HZ” on the display 110 may be color coded to depict positive and negative Doppler phase shifts)
Regarding claim 19, Brannan teaches displaying the ablation antenna disposed within the first and second circles ([0007] verifying a position of the ablation device within the surgical site based on the representation of the active heating zone. The method may include adjusting a position of the ablation device within the surgical site based on the verified position of the ablation device).
Regarding claim 20, Brannan teaches displaying the first and second circles simultaneously on an image of an anatomical structure ([0042] This representation of the active heating zone “HZ” overlaid on the surgical site “S” on the display 110 provides the clinician with a visualization of where in the surgical site “S” tissue is being ablated).
Regarding claim 21, Brannan teaches the at least one color includes at least one of yellow, green, or blue ([0045] second color (e.g., blue))
Regarding claim 23, Brannan teaches the second circle is the color red ([0045] a first color (e.g., red))
Regarding claim 24, Brannan teaches displaying at least one movable point configured to be manipulated to change a size of the second circle ([0047] processing unit 100 may provide feedback to the clinician to sweep, rotate, pivot, move, or otherwise manipulate the ultrasound probe 142 to eliminate the gaps thereby creating a complete visualization of the surgical site “S” on the display 110).
Regarding claim 28, Brannan teaches one or more non-transitory processor readable media storing instructions ([0029] The memory 202 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by the processor 204 and which controls the operation of the processing unit 100)
displaying a target for placing an ablation antenna for delivery of ablation energy to a patient ([0004] navigating an ablation device in proximity to target tissue, delivering electrosurgical energy to the target tissue via the ablation device; [0006] The ablation device may be a microwave antenna configured to deliver microwave energy to tissue)
displaying an outer circle surrounding the target and corresponding to a bound of an ablation zone that would result from delivery of the ablation energy to the patient ([0042] the representation of the active heating zone “HZ” may be depicted as a generally circular shape, as shown in FIG. 3…representation of the active heating zone “HZ” overlaid on the surgical site “S” on the display 110 provides the clinician with a visualization of where in the surgical site “S” tissue is being ablated)
and displaying, in an area between the outer circle and the target, at least one color representing a temperature profile resulting from delivery of the ablation energy to the patient ([0046] In some embodiments, the representation of the active heating zone “HZ” on the display 110 may include color coded temperature gradients that are indicative of differences in potential temperature rise across various locations of the active heating zone generated by the ablation probe 130, the differential in potential temperature rise with time within the active heating zone generated by the ablation probe 130, and/or at what time rate of change the temperature is changing at particular locations of the active heating zone generated by the ablation probe 130)
Regarding claim 29, Brannan teaches displaying an inner circle surrounding the target and surrounded by the outer circle, wherein the at least one color is displayed in an area between the outer circle and the inner circle ([0042] This representation of the active heating zone “HZ” overlaid on the surgical site “S” on the display 110 provides the clinician with a visualization of where in the surgical site “S” tissue is being ablated).
Regarding claim 30, Brannan teaches displaying the outer circle in a first color and the inner circle in a second color different than the first color ([0045] a positive Doppler phase shift may be represented by a first color (e.g., red) on the display 110 and a negative Doppler phase shift may be represented by a second color (e.g., blue) on the display 110. In this way, the representation of the active heating zone “HZ” on the display 110 may be color coded to depict positive and negative Doppler phase shifts).
Regarding claim 31, Brannan teaches displaying at least one movable point configured to be manipulated to change a size of the outer circle ([0047] processing unit 100 may provide feedback to the clinician to sweep, rotate, pivot, move, or otherwise manipulate the ultrasound probe 142 to eliminate the gaps thereby creating a complete visualization of the surgical site “S” on the display 110).
Regarding claim 32, Brannan teaches displaying the target on an image of an anatomical structure within the patient ([0055] clinician is able to verify that the ablation probe 130 is correctly positioned relative to the target tissue through visual confirmation via the representation of the active heating zone “HZ” on the display 110)
Regarding claim 33, Brannan teaches the at least one color includes at least one of yellow, green, or blue ([0045] second color (e.g., blue)).
Regarding claim 35, Brannan teaches a processor-implemented method for displaying a temperature profile of an ablation zone ([0004] a method of generating a representation of an active heating zone on a display in real time during an ablation procedure; [0029] The memory 202 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by the processor 204 and which controls the operation of the processing unit 100)
displaying on an image of an anatomical structure within a patient a target for placing an ablation antenna for delivery of ablation energy to a patient ([0004] navigating an ablation device in proximity to target tissue, delivering electrosurgical energy to the target tissue via the ablation device; [0006] The ablation device may be a microwave antenna configured to deliver microwave energy to tissue)
a first circle surrounding the target; a second circle surrounding the first circle and corresponding to a bound of an ablation zone that would result from delivery of the ablation energy to the patient ([0042] the representation of the active heating zone “HZ” may be depicted as a generally circular shape, as shown in FIG. 3…representation of the active heating zone “HZ” overlaid on the surgical site “S” on the display 110 provides the clinician with a visualization of where in the surgical site “S” tissue is being ablated)
wherein the first circle is a first color and the second circle is a second color different than the first color; and a plurality of colors in an area between the first and second circles, the plurality of colors representing a temperature profile resulting from delivery of the ablation energy to the patient ([0046] In some embodiments, the representation of the active heating zone “HZ” on the display 110 may include color coded temperature gradients that are indicative of differences in potential temperature rise across various locations of the active heating zone generated by the ablation probe 130, the differential in potential temperature rise with time within the active heating zone generated by the ablation probe 130, and/or at what time rate of change the temperature is changing at particular locations of the active heating zone generated by the ablation probe 130).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan as applied to claim 16 above, and further in view of
Regarding claim 22, Brannan fails to teach the first circle is the color green.
However, Bharadwaj teaches the first circle is the color green ([0094] the treatment zone marker 308 may be presented in a bright green color)
Brannan and Bharadwaj are considered analogous because both disclose visualizations of planned surgical procedures. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to display a marker in the color green so that the marker may be presented in a visually distinct or contrasting color as compared to the rest of the 3D model (Bharadwaj [0094])
Claim(s) 26, 27, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan as applied to claims 16 and 28 above, and further in view of Curley (US 20200015880 A1).
Regarding claim 26, Brannan fails to teach delivering the ablation energy to the patient at about 75 watts.
However, Curley teaches delivering the ablation energy to the patient at about 75 watts ([0074] ablative energy power (e.g., from about 0 W to about 100 W)).
Brannan and Curley are considered analogous because both deal with ablation procedures. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to deliver the ablation energy anywhere between a range from 0-100 watts in order to impart less energy into the tissue and reduce heating therein (Curley [0074]).
Regarding claim 27, Brannan fails to teach delivering the ablation energy to the patient at about 100 watts.
However, Curley teaches delivering the ablation energy to the patient at about 100 watts ([0074] ablative energy power (e.g., from about 0 W to about 100 W)).
Brannan and Curley are considered analogous because both deal with ablation procedures. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to deliver the ablation energy anywhere between a range from 0-100 watts in order to impart less energy into the tissue and reduce heating therein (Curley [0074]).
Regarding claim 34, Brannan fails to teach delivering the ablation energy to the patient at one of about 45 watts, about 75 watts, or about 100 watts.
However, Curley teaches delivering the ablation energy to the patient at one of about 45 watts, about 75 watts, or about 100 watts ([0074] ablative energy power (e.g., from about 0 W to about 100 W)).
Brannan and Curley are considered analogous because both deal with ablation procedures. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to deliver the ablation energy anywhere between a range from 0-100 watts in order to impart less energy into the tissue and reduce heating therein (Curley [0074]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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