DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 15/483925, 14/137393 & 61/745476 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the benefit date of 12/21/2012.
Specification
The abstract of the disclosure is objected to because: delete the “4893-0640-0085” at the bottom of the paragraph. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the predetermined signal properties” to -the plurality of pre-determined signal properties- in ll. 19. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “.” to “;” at the end of ll. 3. Appropriate correction is required.
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 1-12 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 1 recites the limitation “perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database” in ll. 19-20. It is unclear how the signal property can be compared against both the pre-determined signal properties and the plurality of ablation levels. It is suggested to amend “perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database” to -perform a comparison between: the signal property and the plurality of pre-determined signal properties respectively associated with the plurality of ablation levels-. The claim will be interpreted in this manner.
Claim 1 recites the limitation “perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database; determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels” in ll. 19-22. It is unclear how the determination is made if the signal property is not first determined to match with, or even associate with, a specific one of the signal properties, which, in turn, is then matched with, or associated with, a respective one of the plurality of ablation levels (in this case, the “first ablation level”). It is suggested to amend “perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database; determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels” to -perform a comparison between: the signal property and the pre-determined signal properties; determine, based on the comparison, the wall of the blood vessel to have a respective signal property of the plurality of pre-determined signal properties, the respective signal property respectively associated with a first ablation level of the plurality of ablation levels-. The claim will be interpreted in this manner.
Claims 2-12 depend from claim 1 and are thus also rejected.
Claim 4 recites the limitation "the determination" in ll. 1-2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend “based on the determination of the wall of the blood vessel to have the first ablation level” to -based on the first ablation level-. The claim will be interpreted in this manner.
Claim 8 recites the limitation "the determination" in ll. 2. There is insufficient antecedent basis for this limitation in the claim. Claim 8 also recites “a first ablation level” in ll. 2 when claim 1, upon which claim 8 depends, recites “a first ablation level”. It is unclear if the “a first ablation level” of claim 8 is the same as or different from the “a first ablation level” in claim 1. It is suggested to amend “based on the determination that the wall of the blood vessel to have the first ablation level” to -based on the first ablation level-. The claim will be interpreted in this manner.
Claim 10 recites the limitation “the processor is configured to control…the ablative element to stop ablation of the blood vessel” in ll. 2-3; however, claim 1, upon which claim 10 depends, recites the limitation “control, if the first ablation level for the wall of the blood vessel is not therapeutically effective, the ablative element to direct a second ablative energy”. It is unclear how “ablation” relates to the “second ablative energy” delivered in claim 1. It is suggested to amend “the processor is configured to control…the ablative element to stop ablation of the blood vessel” to -the processor is configured to control…the ablative element to stop any further ablation, including direction of the second ablative energy-. The claim will be interpreted in this manner.
Claim Interpretation
Claim 5 recites the limitation “wherein the wall of the blood vessel comprises a plurality of tissue components” which recites further structure of “the blood vessel” which is not positively recited in claim 1. Thus, for purposes of examination, the limitation of claim 5 recited above is further functional language and is not regarded as providing any further structure to the apparatus either implicitly or explicitly.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1 & 3-11 are is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Balbierz et al. (2006/0241577).
Concerning claim 1, as illustrated in at least Figs. 30-31, Balbierz et al. disclose an apparatus (apparatus to diagnose a tumor, accurately position an energy delivery device, visually monitor and confirm complete ablation of the tumor, the apparatus capable of being used in a blood vessel; [0041]), comprising:
a database configured to store a plurality of pre-determined signal properties and a plurality of ablation levels such that the plurality of pre-determined signal properties is respectively associated with the plurality of ablation levels (software module 19a comprises database of profiles 19db/19dp of tissue identification and/or tissue differentiation, including metabolite concentrations that are predictive or otherwise indicative of abnormal tissue (ablation level: none), necrosed (ablation level: adequate) tissue, or injured tissue; [0062], [0064], [0069]); and
a processor configured for communication with the database, an intravascular catheter comprising an ablative element and an imaging apparatus, and a display (single controller 329 comprises controller 338/microprocessor 350 that governs power level and duration of energy delivered to apparatus 10 comprising catheter 12, optical measurement device 19, and display 336 to achieve and maintain power levels appropriate to achieve desired treatment objectives and clinical endpoints and, in tandem, analyze spectral profile 19s and perform tissue biopsy identification and ablation monitoring functions including endpoint determination; [0043], [0057], [0075], [0105], [0106], [0108]), wherein the processor is configured to:
control the ablative element to direct a first ablative energy toward a blood vessel while the intravascular catheter is positioned within the blood vessel and the ablative element is adjacent to a wall of the blood vessel (electrode 18e can be positioned to heat, necrose or ablate a selected target tissue volume, and is capable of being used in a blood vessel; [0088]);
control the imaging apparatus to emit imaging energy toward the blood vessel while the intravascular catheter is positioned within the blood vessel and the imaging apparatus is adjacent to the wall of the blood vessel (array 22a including members 22m that can be configured to perform tissue identification, differentiation, ablation monitoring and mapping of tissue masses and structures, where such information is obtained by probing the target tissue volume 5sv with an incident beam 22ib; [0048], [0062]);
receive a signal representative of reflections of the imaging energy from the blood vessel (light detecting member 22md, configured to detect returning light 22rb resulting from various optical tissue interactions (including scatter, reflectance or absorbance) of incident beam 22ib by tissue 5; [0048]);
determine a signal property of the signal (optical tissue interactions of incident beam 22ib on target tissue site 5' result in a distinct spectral profile 19s that serves as a fingerprint of the tissue type and/or tissue condition; [0062]);
perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database (tissue types will have a signature profile 19s that can be readily identified and matched to a database of profiles; [0062]);
determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels (software module 19a matches spectral profile 19s to the database of profiles 19db/19dp of tissue identification and/or tissue differentiation, including metabolite concentrations, to determine abnormal tissue (ablation level: none), necrosed tissue (ablation level: adequate), or injured tissue; [0062], [0064], [0069]); and
control, if the first ablation level for the wall of the blood vessel is not therapeutically effective, the ablative element to direct a second ablative energy toward the blood vessel to cause a second ablation level of the plurality of ablation levels for the wall of the blood vessel (sensor array 22a can be utilized to detect incomplete ablation volumes such that an appropriate feedback signal is received and then regulates an amount of energy delivered to electrodes 18e; [0077], [0095]).
The Examiner notes that the “a first ablative energy” is not related to “a first ablation level of the plurality of ablation levels”.
Concerning claim 3, Balbierz et al. disclose the processor is configured to output an image of the blood vessel based on the reflections of the imaging energy ([0058], [0071]).
Concerning claim 4, Balbierz et al. disclose the processor (329) is configured to output a score based on the determination of the wall of the blood vessel to have the first ablation level ([0063]).
Concerning claim 5, Balbierz et al. disclose the wall of the blood vessel comprises a plurality of tissue components, wherein the processor is configured to identify a tissue component of the plurality of tissue components ([0062], [0064], [0069]).
Concerning claim 6, Balbierz et al. disclose wherein, to determine the wall of the blood vessel to have the first ablation level, the processor (329) is configured to determine the tissue component to have the first ablation level (none); wherein, to control the ablative element (18) to direct the second ablative energy toward the blood vessel to cause the second ablation level for the wall of the blood vessel, the processor (329) is configured to control the ablative element (18) to direct the second ablative energy toward the blood vessel to cause the second ablation level for the tissue component ([0077], [0095]).
Concerning claim 7, Balbierz et al. disclose the plurality of pre-determined signal properties and the plurality of ablation levels stored in the database (19db) are associated with the tissue component ([0062], [0064], [0069]).
Concerning claim 8, Balbierz et al. disclose the processor is configured to generate a treatment plan for ablation (5av) of the blood vessel ([0076]).
Concerning claim 9, Balbierz et al. disclose the processor (329) is configured to modify the treatment plan based on the determination that the wall of the blood vessel to have a first ablation level (none or adequate) of the plurality of ablation levels ([0077], [0095]).
Concerning claim 10, Balbierz et al. disclose the processor (329) is configured to control, if the first ablation level for the wall of the blood vessel is therapeutically effective (adequate), the ablative element (18) to stop ablation of the blood vessel ([0077], [0095]).
Concerning claim 11, Balbierz et al. disclose the intravascular catheter (10: 12) ([0043]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Balbierz et al. (2006/0241577), as applied to claim 1.
Concerning claim 12, Balbierz et al. disclose, wherein the intravascular catheter (10: 12) is sized to be positioned within a renal blood vessel ([0078], [0082]). In the alternative, Balbierz et al. teach that the shaft can be of varying diameters to achieve a shaft that facilitates mechanical performance ([0078]). Thus, it would have been obvious to one having ordinary skill in the art at the time the invention the invention was made to modify the invention of Balbierz et al. such that the intravascular catheter is sized to be positioned within a renal blood vessel and thus is of whatever desired or expedient size, 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).
Claim 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Balbierz et al. (2006/0241577) in view of Sliwa et al. (2010/0168572).
Concerning claim 2, Balbierz et al. fail to disclose the imaging apparatus configured to emit ultrasound energy and the signals are representative of the reflections of the emitted ultrasound energy. However, Sliwa et al. disclose a system for ablating and characterizing tissue components of a scanned object in a patient comprising a catheter including an ablative element directing ablative energy toward an anatomical wall scanned object while the ablative element is positioned adjacent the anatomical wall and emitting ultrasound energy from an imaging apparatus at two different frequencies toward the scanned object while the imaging apparatus is positioned adjacent to the anatomical wall, receiving emitting ultrasound energy from the scanned object, and determining one or more signal properties of the scanned object from the signals representative of the reflections of the emitted ultrasound energy. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Balbierz et al. such that the imaging apparatus is configured to emit ultrasound energy and the signals are representative of the reflections of the emitted ultrasound energy in order to provide the same benefit/effect of optical spectral feedback taught by Balbierz et al. as ultrasonic imaging reflections at two different frequencies provide the feedback of spectral fingerprints that can be used in monitoring ablation and providing feedback as taught by Sliwa et al. ([0018-0020], [0061-0062], [0064-0065], [0067-0068])
Claim(s) 1-2 & 8-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Koblish et al. (2014/0081262, having support in provisional 61/703344) in view of Johnson et al. (2003/0109871).
Concerning claim 1, as illustrated in at least Figs. 1-2 & 4, Koblish et al. disclose an apparatus (system 100; [0038]), comprising:
a processor configured for communication with, an intravascular catheter comprising an ablative element and an imaging apparatus, and a display (control unit 220 comprises communicating components of user interface 270, including display 271, catheter interface 280, ablation subsystem 240 and ultrasound subsystem 250; [0045-0052]), wherein the processor is configured to:
control the ablative element to direct a first ablative energy toward a blood vessel while the intravascular catheter is positioned within the blood vessel and the ablative element is adjacent to a wall of the blood vessel (ablation therapy can be delivered (430) to one or more of a plurality of areas with catheter 110, the areas capable of being a blood vessel; [0038], [0076]);
control the imaging apparatus to emit imaging energy toward the blood vessel while the intravascular catheter is positioned within the blood vessel and the imaging apparatus is adjacent to the wall of the blood vessel (each area to which ablation therapy is delivered (430) can be scanned 440 with an ultrasound transducer; [0077]);
receive a signal representative of reflections of the imaging energy from the blood vessel (information collected in the scan (440) can include, among other things, the level of ultrasound energy reflected from the area of cardiac tissue; [0077]);
determine a signal property of the signal (for each scanned (440) area of cardiac tissue, ultrasound information collected from the area can be associated (450) with the area, where such associations (450) can include an indication of the degree to which the area of tissue was lesioned by the delivery (430) of the ablation therapy, an indication of the level of ultrasound energy reflected from the area of cardiac tissue determining that a particular portion of an ultrasound signal, indicative of the degree of lesioning, was sensed as reflected from the area of cardiac tissue; [0078]);
perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels; determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels (based on the catheter 310 being moved to a particular area of cardiac tissue, ultrasound information collected from that particular area of cardiac tissue can be retrieved from memory and displayed, the ultrasound information may be displayed as a chart or other representation to indicate the degree to which the area of tissue was lesioned; [0074]); and
control, if the first ablation level for the wall of the blood vessel is not therapeutically effective, the ablative element to direct a second ablative energy toward the blood vessel to cause a second ablation level of the plurality of ablation levels for the wall of the blood vessel (decision (490) can be made regarding whether further ablation is needed, where ablation therapy may be redelivered (430) to one or more areas based on the indication, as guided by the selective display 480 of ultrasound information indicating the degree of lesioning; [0080]).
While Koblish et al. disclose making a decision to determine if further ablation is needed using signal properties relatively associated with ablation levels ([0074], [0080]), Koblish et al. fail to specifically disclose a database configured to store a plurality of pre-determined signal properties and a plurality of ablation levels such that the plurality of pre-determined signal properties is respectively associated with the plurality of ablation levels, the processor configured to communicate with the database and make the comparison to determine if further ablation is needed based on information stored in the database. However, Johnson et al. disclose comparing post-ablation data points to a database with baseline measurements to provide indication if a complete ablation and/or clinical endpoint is reached. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Koblish et al. to further comprise a database configured to store a plurality of pre-determined signal properties and a plurality of ablation levels such that the plurality of pre-determined signal properties is respectively associated with the plurality of ablation levels, the processor configured to communicate with the database and make the comparison to determine if further ablation is needed based on information stored in the database in order to provide the benefit of making comparisons to baseline conditions as taught by Johnson et al. ([0005], [0069], [0071], 0073]).
Concerning claim 2, Koblish et al. disclose the imaging apparatus configured to emit ultrasound energy and the signals are representative of the reflections of the emitted ultrasound energy ([0077]).
Concerning claim 8, Koblish et al. disclose the processor (220) is configured to generate a treatment plan (490) for ablation of the blood vessel ([0080-0081]).
Concerning claim 9, Koblish et al. disclose the processor (220) is configured to modify the treatment plan (stop ablation or further ablate; 490) based on the determination that the wall of the blood vessel to have a first ablation level of the plurality of ablation levels ([0080-0081]).
Concerning claim 10, Koblish et al. disclose the processor (220) is configured to control, if the first ablation level for the wall of the blood vessel is therapeutically effective, the ablative element (240) to stop ablation of the blood vessel ([0080-0081]).
Concerning claim 11, Koblish et al. disclose the intravascular catheter (110) ([0034]).
Concerning claim 12, Koblish et al. in view of Johnson et al. fail to specifically disclose, wherein the intravascular catheter is sized to be positioned within a renal blood vessel. However, Koblish et al. disclose the catheter can be introduced through a vessel (303) ([0054]). Thus, it would have been obvious to one having ordinary skill in the art at the time the invention the invention was made to modify the invention of Koblish et al. in view of Johnson et al. such that the intravascular catheter is sized to be positioned within a renal blood vessel and thus is of whatever desired or expedient size, 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).
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 & 3-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 9,615,878 in view of Balbierz et al. (2006/0241577). Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose an apparatus (system), comprising: a database configured to store a plurality of pre-determined signal properties and a plurality of ablation levels such that the plurality of pre-determined signal properties is respectively associated with the plurality of ablation levels (a characterization application comprising: a signal analyzer configured to analyze the imaging data and determining one or more signal properties from the reflected signals; and a correlation processor configured to associate the one or more signal properties to pre-determined tissue signal properties of different tissue components and a plurality of ablation levels based on a pattern recognition technique, wherein the pre-determined tissue signal properties are embodied in a database, the correlation processor further configured to identify a tissue component and an ablation level of the tissue of interest based on the pattern recognition technique, wherein the tissue component is identified as one of the different tissue components and the ablation level is identified as one of the plurality of ablation levels, wherein the signal analyzer is further configured to analyze the imaging data to determine the one or more signal properties associated with each of the more than one type of imaging modality, and the correlation processor is further configured to identify the tissue component and the ablation level of the tissue of interest based on associating the one or more signal properties to the pre-determined tissue signal properties of the different tissue components and the plurality of ablation levels for each of the more than one type of imaging modality). The U.S. Patent fails to disclose a processor configured for communication with the database, an intravascular catheter comprising an ablative element and an imaging apparatus, and a display, wherein the processor is configured to: control the ablative element to direct a first ablative energy toward a blood vessel while the intravascular catheter is positioned within the blood vessel and the ablative element is adjacent to a wall of the blood vessel; control the imaging apparatus to emit imaging energy toward the blood vessel while the intravascular catheter is positioned within the blood vessel and the imaging apparatus is adjacent to the wall of the blood vessel; receive a signal representative of reflections of the imaging energy from the blood vessel; determine a signal property of the signal; perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database; determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels; and control, if the first ablation level for the wall of the blood vessel is not therapeutically effective, the ablative element to direct a second ablative energy toward the blood vessel to cause a second ablation level of the plurality of ablation levels for the wall of the blood vessel. However, Balbierz et al. disclose a system comprising a database (19db) and a processor configured for communication with the database, an intravascular catheter comprising an ablative element and an imaging apparatus, and a display (single controller 329 comprises controller 338/microprocessor 350 that governs power level and duration of energy delivered to apparatus 10 comprising catheter 12, optical measurement device 19, and display 336 to achieve and maintain power levels appropriate to achieve desired treatment objectives and clinical endpoints and, in tandem, analyze spectral profile 19s and perform tissue biopsy identification and ablation monitoring functions including endpoint determination; [0043], [0057], [0075], [0105], [0106], [0108]), wherein the processor is configured to: control the ablative element to direct a first ablative energy toward a blood vessel while the intravascular catheter is positioned within the blood vessel and the ablative element is adjacent to a wall of the blood vessel (electrode 18e can be positioned to heat, necrose or ablate a selected target tissue volume 5’; [0088]); control the imaging apparatus to emit imaging energy toward the blood vessel while the intravascular catheter is positioned within the blood vessel and the imaging apparatus is adjacent to the wall of the blood vessel (array 22a including members 22m can be configured to perform tissue identification, differentiation, ablation monitoring and mapping of tissue masses and structures, where such information is obtained by probing the target tissue volume 5sv with an incident beam 22ib; [0048], [0062]); receive a signal representative of reflections of the imaging energy from the blood vessel (light detecting member 22md, configured to detect returning light 22rb resulting from various optical tissue interactions (including scatter, reflectance or absorbance) of incident beam 22ib by tissue 5; [0048]); determine a signal property of the signal (optical tissue interactions of incident beam 22ib on target tissue site 5' result in a distinct spectral profile 19s that serves as a fingerprint of the tissue type and/or tissue condition such as necrosis or thermal injury; [0062]); perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database (tissue types will have a signature profile 19s that can be readily identified and matched to a database of profiles; [0062]); determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels (software module 19a matches spectral profile 19s to the database of profiles 19db/19dp of tissue identification and/or tissue differentiation, including metabolite concentrations, to determine abnormal tissue (ablation level of none), necrosed tissue (adequate), or injured tissue; [0062], [0064], [0069]); and control, if the first ablation level for the wall of the blood vessel is not therapeutically effective, the ablative element to direct a second ablative energy toward the blood vessel to cause a second ablation level of the plurality of ablation levels for the wall of the blood vessel (sensor array 22a can be utilized to detect incomplete ablation volumes such that an appropriate feedback signal is received and then regulates an amount of energy delivered to electrodes 18e; [0077], [0095]). At the time of the invention, it would have been obvious to modify the invention of the U.S. Patent to further comprise the missing claimed limitations in order to provide the benefit of performing an adequate/full ablation treatment of target tissue as taught by Balbierz et al. ([0077])
Claims 1 & 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,596,469. Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose an apparatus (system), comprising: an apparatus (apparatus to optically biopsy a tissue and use the information to diagnose a tumor, accurately position an energy delivery device, visually monitor and confirm complete ablation of the tumor, the apparatus capable of being used in a blood vessel; [0041]), comprising: a database configured to store a plurality of pre-determined signal properties and a plurality of ablation levels such that the plurality of pre-determined signal properties is respectively associated with the plurality of ablation levels (pre-determined signal properties comprise classification conditions stored in a data structure); and a processor configured for communication with the database, an intravascular catheter comprising an ablative element and an imaging apparatus, and a display (an imaging apparatus configured to emit imaging energy toward an object while the imaging apparatus is positioned adjacent to an anatomical wall of the object; and an ablative element configured to direct ablative energy toward the anatomical wall while the ablative element is positioned adjacent to the anatomical wall; and a processor in communication with the catheter), wherein the processor is configured to: control the ablative element to direct a first ablative energy toward a blood vessel while the intravascular catheter is positioned within the blood vessel and the ablative element is adjacent to a wall of the blood vessel (control the ablative element to direct a first ablative energy toward the anatomical wall); control the imaging apparatus to emit imaging energy toward the blood vessel while the intravascular catheter is positioned within the blood vessel and the imaging apparatus is adjacent to the wall of the blood vessel (control the imaging apparatus to emit the imaging energy toward the object); receive a signal representative of reflections of the imaging energy from the blood vessel (receive signals representative of reflections of the emitted imaging energy from the object); determine a signal property of the signal (determine one or more signal properties of the object from the signals representative of the reflections of the emitted imaging energy); perform a comparison between: the signal property; and the pre-determined signal properties and the plurality of ablation levels stored in the database (associate the one or more signal properties to pre-determined signal properties of a tissue component and a plurality of ablation levels for the tissue component); determine, based on the comparison, the wall of the blood vessel to have a first ablation level of the plurality of ablation levels (identify, based on the associating, the tissue component of the anatomical wall and an ablation level of the tissue component resulting from the first ablative energy, wherein the anatomical wall comprises a wall of a blood vessel, wherein the ablation level is identified as a first ablation level of the plurality of ablation levels); and control, if the first ablation level for the wall of the blood vessel is not therapeutically effective, the ablative element to direct a second ablative energy toward the blood vessel to cause a second ablation level of the plurality of ablation levels for the wall of the blood vessel (determine, based on the identifying, if ablation of the tissue component resulting from the first ablative energy is therapeutically effective; and control the ablative element to direct, when the ablation is not therapeutically effective, a second ablative energy toward the anatomical wall to cause at least a second ablation level of the plurality of ablation levels for the tissue component). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Keidar (2004/0147920) teach an apparatus comprising a controller configured to receive ultrasound signals representative of reflections of imaging energy from tissue and determine a signal property of the signal, perform a comparison between the signal property and a pre-determined signal property associated with a stored ablation level, and adjust ablation ([0075-0077]; Fig. 3-4). Keidar et al. fail to disclose a database configured to store a plurality of pre-determined signal properties and a plurality of ablation levels such that the plurality of pre-determined signal properties is respectively associated with the plurality of ablation levels.
Lee et al. (2012/0053577) disclose a processor configured for the creation of a database of information (e.g., required energy levels, duration of treatment for a tissue region based on particular patient characteristics) pertaining to ablation treatments for a particular tissue region based upon previous treatments with similar or dissimilar patient characteristics. Lee et al. fail to disclose the processor limitations.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794