DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed February 26, 2026 (hereinafter “02/26/26 Amendment") has been entered, and fully considered. In the 02/26/26 Amendment, claims 12, 13, 15, 16, & 19 were amended, claims 2-4, 7-11, & 20 were cancelled (claims 1, 5, & 6 were previously cancelled), and claims 24-31 were newly added. Therefore, claims 12-19 & 21-31 are now pending in the application.
3. The 02/26/26 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the Non-Final Office Action mailed 08/26/25 (“08/26/25 Action”).
4. New claim objections, and rejections under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
5. The prior rejection(s) of independent claims 12 & 16 have been updated to address the new claim limitations, and maintained.
6. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Objections
7. Claims 13, 15, & 16 are objected to because of the following informalities:
a. In claim 13, lines 1-2, the recitation of “further comprising the control unit for controlling the energy source” should instead recite --wherein the control unit is further configured to control the energy source--.
b. In claim 15, lines 1-2, the recitation of “wherein means for measuring a temperature are temperature measuring elements” should instead recite --further comprising temperature measuring elements-- since the recitation of “means for measuring” does not invoke § 112(f) [see “Claim Interpretation” section below], and is therefore redundant.
c. In claim 16, lines 3-4, the recitation of “in said at least a portion of a tissue” should instead recite --in said portion of said tissue site--.
Appropriate correction is required.
Claim Interpretation
8. 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.
9. Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
10. Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in this Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
11. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
12. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
13. CLAIM 15
14. The limitation of “means for measuring a temperature” in claim 15 has NOT been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it includes structural modifiers that further describe the term “means,” with the structural modifiers each denoting a type of structural device with a generally understood meaning in the mechanical arts:
“wherein means for measuring a temperature are temperature measuring elements arranged in a sleeve…”
15. For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
16. 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.
17. Claims 13 & 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
18. Claim 13 recites the limitation “said measured temperature” in line 2. There is insufficient antecedent basis for this recitation in the claim.
19. Claim 14 recites the limitation “said measured temperature” in lines 2-3. There is insufficient antecedent basis for this recitation in the claim.
Claim Rejections - 35 USC § 103
20. 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.
21. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
22. Claims 12, 13, 16-18, 21, 22, 23, 27, & 29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,418,337 to Torchia et al. (“Torchia”) in view of a publication to Köcher et al., entitled "Internal structuring of silica glass fibers: Requirements for scattered light applicators for the usability in medicine" Photonics & Lasers in Medicine, vol. 5, no. 1, 2016, pp. 57-67, https://doi.org/10.1515/plm-2015-0014 (previously published online October 13, 2015) (hereinafter “Köcher”), and further in view of U.S. Patent Application Publication No. 2009/0326420 to Moonen et al. (“Moonen”).
23. Regarding claim 12, Torchia teaches a system for performing thermotherapy on at least a portion of a tissue site, said system comprising:
an energy source [laser - Abstract; FIG. 1] for heating said tissue site [col. 2, ll. 59-65; col. 6, ll. 35-41];
a heating probe comprising a fibre [optical fiber (20) - col. 6, ll. 35-37 (“optical fiber 20 which transmits heat energy in the form of light”); col. 7, ll. 30-40; FIG. 2], and an energy emitting area [tip - see col. 6, ll. 39-41 (“a tip 21 (FIG. 2) at which the energy escapes into the relevant part of the patient”)], wherein said energy emitting area is a light emitting area [col. 6, ll. 35-41]…;
said heating probe [(20)] is connectable to said energy source [laser - Abstract; FIG. 1];
a magnetic resonance imaging device [MRI system - e.g., Abstract, col. 11, ll. 12-14] for obtaining a temperature… of a treatment area [as broadly as claimed, Torchia teaches using the MRI system to obtain temperature measurements in boundary zone (90) which defines the external perimeter of the tumour, and is therefore broadly considered an “area” associated with treatment - see col. 10, ll. 54-60; col. 11, ll. 12-35; FIG. 8; NOTE: independent claim 12 does not currently define “treatment area;” absent any limitations clearly defining the “treatment area” that would prevent such an interpretation, the boundary or periphery of the tumor is properly considered to be a part of the “treatment area,” as currently claimed]; [and]
a control unit [control system] configured to control the heating probe [col. 2, ll. 30-40; col. 3, ll. 14-31; col. 6, ll. 35-50] based on the temperature… and provide a warning or shut down the heating probe should a threshold temperature be reached in the treatment area [e.g., col. 11, ll. 32-33 (“Heating at a localised area defined by the beam is therefore continued until the heat at the boundary layer 90 is raised to the predetermined coagulation temperature of the order of 55 to 65.degree. C. Once the boundary layer reaches this temperature, heating at that zone is discontinued…”); claim 6 (“using a measure of the temperature at that part of the peripheral surface of the volume in the first zone as the determining factor as to when to halt heating by the probe to the first zone”); claim 14; col. 3, ll. 14-31] to minimize thermal tissue damage [e.g., col. 12, ll. 24-30] comprising vaporization and/or carbonization in the treatment area [under the interpretation of “treatment area” set forth above to include boundary zone (90), Torchia clearly teaches temperature control to minimize thermal damage in this area (see, e.g., col. 2, ll. 30-40; col. 3, ll. 14-31; col. 6, ll. 35-50; col. 10, ll. 54-60; col. 11, ll. 12-35; col. 12, ll. 24-30; & FIG. 8); Moreover, it is additionally noted that shutting down the heating probe based on measurements at the boundary zone (90) to reduce temperature and minimize thermal damage at this location will also have the effect of reducing temperature within the tumor (due to the probe being switched off), which will result in minimizing thermal damage in this location as well. Stated another way, temperature monitoring/control at the boundary zone will keep the temperatures lower (in the tumor and at the boundary zone) than what might otherwise be experienced without any temperature monitoring/control at all. In this regard, Torchia teaches “minimizing” thermal damage since the claims do not further quantify/define what is required to “minimize” thermal damage and, as such, any decrease in thermal damage, no matter how small, will be less than what would be experienced without temperature monitoring/control].
A. Micro-Modifications
Torchia does not however, teach, the following emphasized claim limitations:
wherein said energy emitting area is a light emitting area which is at least partially a diffuser; [and]
wherein said light emitting area comprises at least a core and a cladding, and said diffuser is a structured writing comprised of micro-modifications being microdots and/or refractive index modifications burnt into at least said core of said fibre.
Köcher, in a similar field of endeavor, relates to diffuser fibers used in the fields of laser-induced thermotherapy (LITT) and photodynamic therapy [see pg. 57, “Background;” & pg. 58 “Introduction”].
More particularly, Köcher teaches a flexible diffuser fiber having a light-emitting area comprising at least a core and a cladding [see pg. 59, “2.2 Fiber processing;” and FIG. 2].
Köcher further teaches that the diffuser is a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre [see pg. 57, “Materials and Methods” (“scattering microdots were induced linearly into the core of an optical silica fiber through a multiple photon process using a femtosecond laser”); pg. 59, first full paragraph; pg. 60, “2.3 Testing process;” pg. 61, & “3.1 Feasibility of the manufacturing process”; NOTE: those skilled in the art will readily appreciate that the use of a laser to create the microdot micro-modifications in the core of the fiber (see pg. 59, “2.2 Fiber processing,” and FIG. 3) reads on the limitation of the diffuser being a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre].
Köcher additionally teaches that the diffuser fiber provides the benefits of a nearly homogeneous radiation profile with less forward emission, and increased flexibility [see pg. 57, “Background,” “Results,” & “Conclusion;” & pg. 66, “5 Outlook” & “6 Conclusion”].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Torchia to utilize the fibre of Köcher wherein said energy emitting area is a light emitting area which is at least partially a diffuser, and wherein said light emitting area comprises at least a core and a cladding, and said diffuser is a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre, since such a modification would provide the benefits of a fibre having a nearly homogeneous radiation profile with less forward emission, and increased flexibility, as expressly taught by Köcher.
B. Temperature “Map”
As noted above, Torchia teaches a magnetic resonance imaging device [MRI system] to obtain temperature measurements in the treatment area [which includes boundary zone (90)].
The combination of Torchia & Köcher (as set forth above) does not explicitly teach obtaining a temperature “map,” and therefore fails to teach the following emphasized claim limitations:
a magnetic resonance imaging device for obtaining a temperature map of a treatment area;
a control unit configured to control the heating probe based on the temperature map and provide a warning or shut down the heating probe should a threshold temperature be reached in the treatment area to minimize thermal tissue damage, such as vaporization and/or carbonisation.
Moonen, in a similar field of endeavor, teaches a device for the heat treatment of a target region of a biological tissue [Abstract], and further teaches that an MRI imaging apparatus may be used to simultaneously provide 3D anatomical maps and temperature maps of the patient region of interest [see ¶[0073]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia & Köcher such that the temperature data obtained by the MRI system of Torchia, and used by the control unit of Torchia to control the heating probe, also be displayed on a temperature map, as taught by Moonen, so that a practitioner is able to quickly and easily view acquired temperature data in a convenient and meaningful format in order to be well informed during a procedure.
24. Regarding claim 13, the combination of Torchia, Köcher, & Moonen teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches the control unit [control system] for controlling the energy source [e.g., col. 2, ll. 32-40; col. 3, ll. 23-28] so that said measured temperature is kept at a target temperature between 40°C to 60°C [Torchia teaches a target temperature on the order of 55° to 65° C (col. 1, ll. 6-15; col. 11, ll. 30-32) which overlaps with Applicant’s claimed range of “between 40°C to 60°C.”]. It has been held that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
25. Regarding claim 16, Torchia teaches a method of performing thermotherapy [e.g., col. 2, ll. 5-22] on at least a portion of a tissue site [e.g., col. 5, ll. 45-46; col. 10, ll. 51-61], said method comprising:
arranging a heating probe comprising a fibre [optical fiber (20) - col. 6, ll. 35-37 (“optical fiber 20 which transmits heat energy in the form of light”); col. 7, ll. 30-40; FIG. 2] and an energy emitting area [tip - see col. 6, ll. 39-41 (“a tip 21 (FIG. 2) at which the energy escapes into the relevant part of the patient”)] in said at least a portion of a tissue, and wherein said energy emitting area is a light emitting area [col. 6, ll. 35-41]…,
emitting energy from said energy emitting area of said heating probe [(20)] for heating said portion of said tissue site for controlling said thermotherapy [e.g., col. 6, ll. 35-50].
obtaining a temperature… of a treatment area using a magnetic resonance imaging device [MRI system - e.g., Abstract, col. 11, ll. 12-14] [NOTE: as broadly as claimed, Torchia teaches using the MRI system to obtain temperature measurements in boundary zone (90) which defines the external perimeter of the tumour, and is therefore broadly considered an “area” associated with treatment - see col. 10, ll. 54-60; col. 11, ll. 12-35; FIG. 8; independent claim 16 does not currently define “treatment area;” absent any limitations clearly defining the “treatment area” that would prevent such an interpretation, the boundary or periphery of the tumor is properly considered to be a part of the “treatment area,” as currently claimed]; and
controlling the heating probe [col. 2, ll. 30-40; col. 3, ll. 14-31; col. 6, ll. 35-50] based on the temperature… and providing a warning or shuttinq down the heating probe should a threshold temperature be reached in the treatment area [e.g., col. 11, ll. 32-33 (“Heating at a localised area defined by the beam is therefore continued until the heat at the boundary layer 90 is raised to the predetermined coagulation temperature of the order of 55 to 65.degree. C. Once the boundary layer reaches this temperature, heating at that zone is discontinued…”); claim 6 (“using a measure of the temperature at that part of the peripheral surface of the volume in the first zone as the determining factor as to when to halt heating by the probe to the first zone”); claim 14; col. 3, ll. 14-31] to minimize thermal tissue damage [e.g., col. 12, ll. 24-30] comprising vaporization and/or carbonisation in the treatment area [under the interpretation of “treatment area” set forth above to include boundary zone (90), Torchia clearly teaches temperature control to minimize thermal damage in this area (see, e.g., col. 2, ll. 30-40; col. 3, ll. 14-31; col. 6, ll. 35-50; col. 10, ll. 54-60; col. 11, ll. 12-35; col. 12, ll. 24-30; & FIG. 8); Moreover, it is additionally noted that shutting down the heating probe based on measurements at the boundary zone (90) to reduce temperature and minimize thermal damage at this location will also have the effect of reducing temperature within the tumor (due to the probe being switched off), which will result in minimizing thermal damage in this location as well. Stated another way, temperature monitoring/control at the boundary zone will keep the temperatures lower (in the tumor and at the boundary zone) than what might otherwise be experienced without any temperature monitoring/control at all. In this regard, Torchia teaches “minimizing” thermal damage since the claims do not further quantify/define what is required to “minimize” thermal damage and, as such, any decrease in thermal damage, no matter how small, will be less than what would be experienced without temperature monitoring/control].
A. Micro-Modifications
Torchia does not however, teach, the following emphasized claim limitations:
wherein said energy emitting area is a light emitting area which is at least partially a diffuser; [and]
wherein said light emitting area comprises at least a core and a cladding, and said diffuser is a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre.
Köcher, in a similar field of endeavor, relates to diffuser fibers used in the fields of laser-induced thermotherapy (LITT) and photodynamic therapy [see pg. 57, “Background;” & pg. 58 “Introduction”].
More particularly, Köcher teaches a flexible diffuser fiber having a light-emitting area comprising at least a core and a cladding [see pg. 59, “2.2 Fiber processing;” and FIG. 2].
Köcher further teaches that the diffuser is a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre [see pg. 57, “Materials and Methods” (“scattering microdots were induced linearly into the core of an optical silica fiber through a multiple photon process using a femtosecond laser”); pg. 59, first full paragraph; pg. 60, “2.3 Testing process;” pg. 61, & “3.1 Feasibility of the manufacturing process”; NOTE: those skilled in the art will readily appreciate that the use of a laser to create the microdot micro-modifications in the core of the fiber (see pg. 59, “2.2 Fiber processing,” and FIG. 3) reads on the limitation of the diffuser being a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre].
Köcher additionally teaches that the diffuser fiber provides the benefits of a nearly homogeneous radiation profile with less forward emission, and increased flexibility [see pg. 57, “Background,” “Results,” & “Conclusion;” & pg. 66, “5 Outlook” & “6 Conclusion”].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Torchia to utilize the fibre of Köcher wherein said energy emitting area is a light emitting area which is at least partially a diffuser, and wherein said light emitting area comprises at least a core and a cladding, and said diffuser is a structured writing comprised of micro-modifications being microdots burnt into at least said core of said fibre, since such a modification would provide the benefits of a fibre having a nearly homogeneous radiation profile with less forward emission, and increased flexibility, as expressly taught by Köcher.
B. Temperature “Map”
As noted in detail above, Torchia teaches a magnetic resonance imaging device [MRI system] to obtain temperature measurements in the treatment area [which includes boundary zone (90)].
The combination of Torchia & Köcher (as set forth above) does not explicitly teach obtaining a temperature “map,” and therefore fails to teach the following emphasized claim limitations:
obtaining a temperature map of a treatment area using a magnetic resonance imaging device; and
controlling the heating probe based on the temperature map…
Moonen, in a similar field of endeavor, teaches a device for the heat treatment of a target region of a biological tissue [Abstract], and further teaches that an MRI imaging apparatus may be used to simultaneously provide 3D anatomical maps and temperature maps of the patient region of interest [see ¶[0073]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia & Köcher such that the temperature data obtained by the MRI system of Torchia, and used by the control unit of Torchia to control the heating probe, also be displayed on a temperature map, as taught by Moonen, so that a practitioner is able to quickly and easily view acquired temperature data in a convenient and meaningful format in order to be well informed during a procedure.
26. Regarding claim 17, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches measuring a temperature in said portion of said tissue site using a temperature measuring element [MRI imaging system - e.g., Abstract (“A magnetic resonance imaging system is arranged to generate a series of output signals over a period of time representative of temperature in the part as the temperature of the part changes during that time”); & col. 11, ll. 12-14].
27. Regarding claim 18, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches wherein said measured temperature is used for controlling said emitted energy from said heating probe [e.g., col. 2, ll. 30-40; col. 3, ll. 18-31; col. 6, ll. 35-50].
28. Regarding claim 21, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, & Moonen further teaches wherein said diffuser is a radial fibre [NOTE: Torchia was modified in the rejection of claim 12 (above) to utilize the diffuser fibre of Köcher, which is a radial fibre (note the cross-section in FIG. 2(B) of Köcher, at pg. 59)].
29. Regarding claim 22, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Moonen further teaches wherein said diffuser is a radial fibre [NOTE: Torchia was modified in the rejection of claim 16 (above) to utilize the diffuser fibre of Köcher, which is a radial fibre (note the cross-section in FIG. 2(B) of Köcher, at pg. 59)].
30. Regarding claim 23, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches:
a sleeve [cannula (31) - col. 6, line 65 - col. 7, line 6; FIG. 2]; and
wherein said heating probe [(20)] is arrangeable in said sleeve [(31)], and said sleeve [(31)] is configured to be slid along said heating probe in a distal and/or proximal direction for positioning of said energy emitting area in said portion of said tissue site for controlling said thermotherapy [col. 2, line 66 - col. 3, line 2 (“there is provided a cannula through which the fiber is inserted, the cannula having an end which is moved to a position immediately adjacent but outside the part to be heated”); col. 6, line 65 - col. 7, line 1 (“rigid cannula 31 which surrounds the fiber 20 and which is arranged to allow sliding movement of the fiber longitudinally in the cannula and rotational movement within the cannula”); NOTE: the movement/positioning of both the cannula, and the optical fiber (20) which moves therein, with both components in a sliding relationship vis-à-vis one another, collectively comprises the positioning of said energy emitting area in said portion of said tissue site, as broadly as claimed].
31. Regarding claim 27, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches wherein said sleeve [(31)] is an introducer catheter [as broadly as claimed, cannula (31) of Torchia constitutes an introducer catheter as it performs the same function as an introducer catheter - e.g., col. 7, ll. 24-29; col. 10, ll. 61-64].
32. Regarding claim 29, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches wherein said energy emitting area of said heating probe is covered by a capillary [front portion (39) - col. 7, II. 43-56 ("Around the fiber is formed a sleeve 38 including a first end portion 39 and a second longer portion 40. The end portion 39 encloses the end 36 which is spaced from a tip 41 of the end portion… The front portion 39 is formed of a
rigid material such as glass")].
33. Claims 14 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, and Moonen, as applied to claim 12 above, and further in view of U.S. Patent Application Publication No. 2018/0078170 to Panescu et al. (“Panescu”) [NOTE: the relied-upon portions of Panescu (below) are supported by the 11/4/2016 provisional application].
34. Regarding claim 14, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
While Torchia teaches a surgeon interface (17) and MRI control console (18) [col. 6, ll. 27-35; col. 10, ll. 51-61; & FIG. 1], Torchia does not explicitly teach:
wherein said measured temperature is indicated as a graph of a display unit.
However, it was well known in the art, before the effective filing date of the claimed invention, to display acquired temperature sensor data as a graph of a display unit.
As one example, Panescu, in a similar field of endeavor, teaches acquiring data from multiple temperature sensors during a procedure, and displaying such data as a graph on a display [e.g., ¶[0589]; FIG. 37A].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, & Moonen such that said measured temperature is indicated as a graph of a display unit, so that a practitioner is able to quickly and easily view acquired temperature data in a convenient and meaningful format in order to be well informed during a procedure [Panescu, ¶[0589]].
35. Regarding claim 15, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches a sleeve [cannula (31) - col. 6, line 65 - col. 7, line 6; FIG. 2] in which said heating probe [(20)] is arranged [col. 2, line 66 - col. 3, line 2; col. 6, line 65 - col. 7, line 1].
Torchia does not, however, teach:
wherein means for measuring a temperature are temperature measuring elements arranged in a sleeve in which said heating probe is arranged.
Panescu, in a similar field of endeavor, teaches that it was known to provide multiple temperature measuring elements arranged in an introducer [see, e.g., ¶[0400] (“The medical instrument may comprise a first plurality (e.g., set, array, group) of temperature-measurement devices (e.g., sensors) positioned at or adjacent a distal tip, or terminus, of the medical instrument (e.g., within a distal electrode portion of a high-resolution combination electrode assembly, or composite electrode assembly). The first plurality of temperature-measurement devices may be spaced apart (e.g., circumferentially, radially) around the medical instrument along a first cross-sectional plane of the medical instrument, in an equidistant manner or non-equidistant manner”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, and Moonen to include temperature measuring elements arranged in a sleeve in which said heating probe is arranged, so as to provide, e.g., a safer and more reliable procedure [Panescu, ¶’s [0401]-[0402]], increased accuracy (i.e., multiple sensors to verify accurate measurements), as well as redundancy in the event of the failure of one or more temperature sensors.
36. Claims 19, 24, 25 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, & Moonen, and further in view of U.S. Patent No. 5,599,345 to Edwards et al. (“Edwards”).
37. Regarding claim 19, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Moonen does not, however, teach:
measuring a temperature in said portion of said tissue site using a temperature measuring element, wherein said temperature measuring element is arranged in a sleeve and is positioned at a distance from said energy emitting area by sliding said sleeve along said heating probe.
Edwards, in a similar field of endeavor, teaches an apparatus for performing thermotherapy on at least a portion of a tissue site, comprising:
a heating probe [electrode (16) - col. 6, ll. 51-67; FIG. 3] comprising an energy emitting area [col. 6, ll. 55-57 (“RF energy is introduced to the tissue site along a conductive surface of electrode 16”)];
said heating probe [(16)] connectable to an energy source [RF power source - see Abstract; col. 7, line 66 - col. 8, line 5; and col. 9, line 66 - col. 10, line 4; FIG. 9] for heating said portion of tissue by said energy emitting area [e.g., col. 7, ll. 1-20];
a sleeve [insulator sleeve (20) - col. 7, ll. 34-40; FIG. 3]; and
wherein said heating probe [(16)] is arrangeable in said sleeve [(20)] [FIG. 3], and said sleeve [(20)] is configured to be slid along said heating probe [(16)] in a distal and/or proximal direction for positioning of said energy emitting area in said portion of tissue for controlling said thermotherapy [see col. 7, ll. 34-40].
Edwards further teaches wherein said sleeve [(20)] comprises at least one temperature measuring element [thermal sensor (26) - col. 7, ll. 45-52; FIG. 3], wherein said temperature measuring element [(26)] is arranged in said sleeve [Edwards teaches that the at least one temperature measuring element is arranged on an interior wall of the sleeve – see col. 7, ll. 44-47] and is positioned at a distance from said energy emitting area by sliding said sleeve [(20)] along said heating probe [col. 7, ll. 34-40] [NOTE: thermal sensor (26) is positioned at the distal end of sleeve (20); as such, when the sleeve (20) slides along heating probe (16), the thermal sensor (26) will slide with sleeve (20), thereby changing the distance between thermal sensor (26) and the energy emitting area].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, and Moonen to further include a temperature measuring element arranged in said sleeve and that is positioned at a distance from said energy emitting area by sliding said sleeve along said heating probe, as taught by Edwards, since such a modification would enable temperature monitoring at multiple positions/sites relative to the energy emitting area during treatment including, for example, at sites adjacent to (or just outside of) an intended treatment area to ensure that non-targeted tissue is not being subjected to undesired thermal damage due to unintended heating, thereby increasing the overall safety of a procedure. Further, placement of the temperature measuring element in the sleeve would help protect the temperature measuring element from damage that might occur, for example, during insertion into the body if the at least one temperature measuring element was instead located on an exterior surface of the sleeve (and thereby exposed during insertion).
38. Regarding claim 24, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
As noted above in the rejection of claim 23, Torchia teaches that said sleeve [(31)] is configured to be slid along said heating probe [(20)] in a distal and/or proximal direction.
The combination of Torchia, Köcher, and Moonen does not, however, teach the following emphasized claim limitations:
wherein said sleeve comprises at least one temperature measuring element, and said sleeve is configured to be slid along said heating probe in a distal and/or proximal direction for positioning said at least one temperature measuring element at a distance from said energy emitting area.
Edwards, in a similar field of endeavor, teaches an apparatus for performing thermotherapy on at least a portion of a tissue site, comprising:
a heating probe [electrode (16) - col. 6, ll. 51-67; FIG. 3] comprising an energy emitting area [col. 6, ll. 55-57 (“RF energy is introduced to the tissue site along a conductive surface of electrode 16”)];
said heating probe [(16)] connectable to an energy source [RF power source - see Abstract; col. 7, line 66 - col. 8, line 5; and col. 9, line 66 - col. 10, line 4; FIG. 9] for heating said portion of tissue by said energy emitting area [e.g., col. 7, ll. 1-20];
a sleeve [insulator sleeve (20) - col. 7, ll. 34-40; FIG. 3]; and
wherein said heating probe [(16)] is arrangeable in said sleeve [(20)] [FIG. 3], and said sleeve [(20)] is configured to be slid along said heating probe [(16)] in a distal and/or proximal direction for positioning of said energy emitting area in said portion of tissue for controlling said thermotherapy [see col. 7, ll. 34-40].
Edwards further teaches wherein said sleeve [(20)] comprises at least one temperature measuring element [thermal sensor (26) - col. 7, ll. 45-52; FIG. 3], and said sleeve [(20)] is configured to be slid along said heating probe [(16)] in a distal and/or proximal direction [col. 7, ll. 34-40] for positioning said at least one temperature measuring element [(26)] at a distance from said energy emitting area [NOTE: thermal sensor (26) is positioned at the distal end of sleeve (20); as such, when the sleeve (20) slides along heating probe (16), the thermal sensor (26) will slide with sleeve (20), thereby changing the distance between thermal sensor (26) and the energy emitting area].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, & Moonen such that said sleeve [cannula (31)] comprises at least one temperature measuring element, and said sleeve is configured to be slid along said heating probe in a distal and/or proximal direction for positioning said at least one temperature measuring element at a distance from said energy emitting area, as taught by Edwards, since such a modification would enable temperature monitoring at multiple positions/sites relative to the energy emitting area during treatment including, for example, at sites adjacent to (or just outside of) an intended treatment area to ensure that non-targeted tissue is not being subjected to undesired thermal damage due to unintended heating, thereby increasing the overall safety of a procedure.
39. Regarding claim 25, the combination of Torchia, Köcher, Moonen, and Edwards teaches all of the limitations of claim 24 for the reasons set forth in detail (above) in the Office Action.
Edwards further teaches wherein said at least one temperature measuring element is arranged in a channel of said sleeve [Edwards teaches that the at least one temperature measuring element is arranged on an interior wall which defines a lumen (channel) of the sleeve – see col. 7, ll. 44-47].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, Moonen, and Edwards such that said at least one temperature measuring element is arranged in a channel of said sleeve since such a placement location (on the interior of the sleeve) would help protect the at least one temperature measuring element from damage that might occur, for example, during insertion into the body if the at least one temperature measuring element was instead located on an exterior surface of the sleeve (and thereby exposed during insertion).
40. Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, Moonen, and Edwards, as applied to claim 24 above, and further in view of U.S. Patent Application Publication No. 2008/0086073 to McDaniel (“McDaniel”).
41. Regarding claim 26, the combination of Torchia, Köcher, Moonen, and Edwards teaches all of the limitations of claim 24 for the reasons set forth in detail (above) in the Office Action.
While Edwards teaches that said at least one temperature measuring element [(26)] may include a number of different thermal sensors, including a thermistor or thermocouple [col. 7, ll. 45-51], the combination of Torchia, Köcher, Moonen, and Edwards does not teach that:
said at least one temperature measuring element is braided or woven into said sleeve. McDaniel, in a similar field of endeavor, teaches that it was known to provide thermocouple wires that form a braided structure extending along an elongated body (catheter shaft) [see ¶[0189]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, Moonen, and Edwards such that said at least one temperature measuring element is braided or woven into said sleeve, since integrating the at least one temperature measuring element into the sleeve would help protect the temperature measuring element from damage that might occur, for example, during insertion into the body if the at least one temperature measuring element was instead located on an exterior surface of the sleeve (and thereby exposed during insertion). Still further, such a fabrication technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by McDaniel), and one of ordinary skill in the art would have been capable of applying this known fabrication technique to the known device (of Torchia, Köcher, Moonen, and Edwards), and the results (provision of a temperature measuring element) would have been entirely predictable to one of ordinary skill in the art.
42. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, Moonen, and Edwards, as applied to claim 24 above, and further in view of Panescu.
43. Regarding claim 28, the combination of Torchia, Köcher, Moonen, and Edwards teaches all of the limitations of claim 24 for the reasons set forth in detail (above) in the Office Action.
While Edwards teaches that said at least one temperature measuring element [(26)] is positioned at the distal end of sleeve [(20)] [see col. 7, ll. 44-47; FIG. 3], the combination of Torchia, Köcher, Moonen, and Edwards does not teach:
wherein said at least one temperature measuring element is at least two temperature measuring elements which are arranged at a same transverse plane of said sleeve. Panescu, in a similar field of endeavor, teaches that it was known to provide multiple temperature measuring elements arranged in a same transverse plane of an introducer [a catheter] [see, e.g., ¶[0400] (“The medical instrument may comprise a first plurality (e.g., set, array, group) of temperature-measurement devices (e.g., sensors) positioned at or adjacent a distal tip, or terminus, of the medical instrument (e.g., within a distal electrode portion of a high-resolution combination electrode assembly, or composite electrode assembly). The first plurality of temperature-measurement devices may be spaced apart (e.g., circumferentially, radially) around the medical instrument along a first cross-sectional plane of the medical instrument, in an equidistant manner or non-equidistant manner”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, Moonen, and Edwards such that said at least one temperature measuring element is at least two temperature measuring elements which are arranged at a same transverse plane of said sleeve, so as to provide, e.g., a safer and more reliable procedure [Panescu, ¶’s [0401]-[0402]], increased accuracy (i.e., multiple sensors to verify accurate measurements), as well as redundancy in the event of the failure of one or more temperature sensors.
44. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, and Moonen, as applied to claim 29 above, and further in view of U.S. Patent Application Publication No. 2014/0088575 to Loeb (“Loeb”).
45. Regarding claim 30, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 29 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Moonen does not, however, teach:
wherein fusing, and/or adhering, and/or shrink tubing is used to bond said capillary to said heating probe.
Loeb, in a similar field of endeavor, teaches an apparatus for delivering laser energy suitable for denervation [Abstract], including a capillary tube (29) fixedly and sealingly attached to the bared distal end portion of optical fiber (12) [see ¶[0191], FIG. 2].
Loeb further teaches wherein fusing [Loeb teaches the claimed alternative of “fusing” – see ¶[0191] (“thermal fusion”)], and/or adhering [Loeb teaches the claimed alternative of “adhering” – see ¶[0191] (using “adhesive”)], and/or shrink tubing is used to bond said capillary to said heating probe.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, and Moonen to utilize a known, art-recognized manner of bonding said capillary to said heating probe, including, e.g., such that fusing and/or adhering is used to bond said capillary to said heating probe, as taught by Loeb, since such known bonding techniques were clearly recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Loeb), and one of ordinary skill would have been capable of utilizing either or both bonding techniques in order to bond the capillary to said heating probe, and the results (providing a secure attachment of the capillary to said heating probe) would have been entirely predictable to one of ordinary skill in the art.
46. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, and Moonen, as applied to claim 23 above, and further in view of U.S. Patent Application Publication No. 2017/0119461 to Godara et al. (“Godara”).
47. Regarding claim 31, the combination of Torchia, Köcher, and Moonen teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Moonen does not, however, teach:
a hub configured to lock said sleeve and said heating probe when a desired position of said sleeve in relation to said energy emitting area is found.
Godara, in a similar field of endeavor, teaches that it was well known to utilize a hub [e.g., hub (32)] to lock a probe in place in a desired position [see, e.g., ¶[0022]; FIG. 1].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Torchia, Köcher, and Moonen to include a hub configured to lock said sleeve and said heating probe when a desired position of said sleeve in relation to said energy emitting area is found, so as to facilitate the procedure for a practitioner by, e.g., eliminating the need for the practitioner to manually hold the heating probe in a desired position.
Response to Arguments
48. As noted above, the 02/26/26 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the 08/26/25 Action.
49. New claim objections, and rejections under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
50. The prior rejection(s) of independent claims 12 & 16 have been updated to address the new claim limitations, and maintained.
51. In the 02/26/26 Amendment, independent claim 12 was amended to recite that [the] control unit [is] configured to control the heating probe based on the temperature map and provide a warning or shut down the heating probe should a threshold temperature be reached in the treatment area to minimize thermal tissue damage comprising vaporization and/or carbonization in the treatment area. Emphasis added. Independent claim 16 was amended to include a similar limitation.
52. In the Remarks, Applicant argues that the rejection under § 103 based on the combination of Torchia, Köcher, and Moonen is improper because Torchia employs a control strategy that is based on monitoring and limiting temperature at the boundary layer of the tumor, and not to limiting peak temperatures within the treatment region itself:
First, Torchia utilizes MRI thermometry to determine when the peripheral boundary of the tumor reaches a predetermined coagulation temperature, at which point heating is discontinued to prevent damage outside the tumor… [citations omitted]
Thus, the control strategy of Torchia is explicitly based on monitoring and limiting temperature at the boundary layer of the tumor.
02/26/26 Amendment, pgs. 8-9, emphasis added.
***
…the objective of Torchia is to monitor the temperature at the boundary layer to ensure complete coagulation of the tumor and at the same time prevent overheating of surrounding healthy tissue. The temperature control criterion is tied to the boundary temperature, not to limiting peak temperatures within the treatment region itself.
02/26/26 Amendment, pg. 9, emphasis added.
***
… Torchia fails to disclose monitoring or limiting peak internal temperatures within the treatment region to prevent vaporization or carbonization. Based on the disclosure in col. 11 and col. 12, the temperature inside the boundary layer will be higher than at the boundary layer to heat the tissue as quickly as possible. The skilled person also knows that the temperature will be higher closer to the heat source than at the boundary layer. However, Torchia is silent about monitoring this temperature.
02/26/26 Amendment, pg. 9, emphasis added.
***
Thermal tissue damage comprising vaporization and/or carbonization in the treatment area may have adverse effects on the treatment and patient safety as described in the present application. The claimed invention therefore requires controlling the heating probe based on a temperature map such that excessive temperature within the treatment area itself triggers a warning or shut down to minimize internal thermal tissue damage.
This represents a different control objective from the boundary-driven coagulation control of Torchia. Torchia neither teaches nor suggests limiting internal peak temperatures within the treatment region to prevent vaporization or carbonization.
02/26/26 Amendment, pg. 10, emphasis added.
As an initial matter, the distinction between the claimed control strategy of independent claims 12 & 16 and that of Torchia, as highlighted by Applicant in the foregoing Remarks, is understood, and appreciated. However, independent claims 12 & 16 do not currently define the “treatment area.” In Torchia, the boundary zone (90) defines an external perimeter/periphery of the tumor, and is therefore broadly considered an “area” associated with treatment [see col. 10, ll. 54-60; col. 11, ll. 12-35; FIG. 8].
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Absent any limitations clearly defining the “treatment area” that would prevent such an interpretation, the boundary or periphery of the tumor is properly considered to be a part of the “treatment area,” as currently claimed.
Further, independent claims 12 & 16 each require temperature control to “minimize” thermal tissue damage in the treatment area. Under the interpretation of “treatment area” set forth above to include boundary zone (90), Torchia clearly teaches temperature control to minimize thermal damage in this area [see, e.g., col. 2, ll. 30-40; col. 3, ll. 14-31; col. 6, ll. 35-50; col. 10, ll. 54-60; col. 11, ll. 12-35; col. 12, ll. 24-30; & FIG. 8].
Moreover, it is additionally noted that shutting down the heating probe based on measurements at the boundary zone (90) to reduce temperature and minimize thermal damage at this location will also have the effect of reducing temperature within the tumor (due to the probe being switched off), which will result in minimizing thermal damage in this location as well. Stated another way, temperature monitoring/control at the boundary zone will keep the temperatures lower (in the tumor and at the boundary zone) than what might otherwise be experienced without any temperature monitoring/control at all. In this regard, Torchia teaches “minimizing” thermal damage since the claims do not further quantify/define what is required to “minimize” thermal damage and, as such, any decrease in thermal damage, no matter how small, will be less than what would be experienced without temperature monitoring/control.
For these reasons, the rejection of independent claims 12 & 16 under § 103 based on the combination of Torchia, Köcher, and Moonen is maintained.
Conclusion
53. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
54. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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