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 1, 5, 6, 15, 19, & 20 were amended, and claim 4 was cancelled. No claims were newly added. Therefore, claims 1-3 & 5-20 are now pending in the application.
3. The rejections under § 103 previously set forth in the Non-Final Office Action mailed 08/26/25 (“08/26/25 Action”) have been updated responsive to the 02/26/26 Amendment. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
4. A new claim objection and a new rejection under § 112(b) are set forth herein, necessitated by Applicant’s Amendment.
Claim Objections
5. Claim 20 is objected to because of the following informalities:
In claim 20, line 15, the recitation of “to the fibre” should instead recite --to the optical fibre-- to be consistent with prior recitations in the claim.
Appropriate correction is required.
Claim Interpretation
6. 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.
7. 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.
8. 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 an 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.
9. 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.
10. 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.
11. CLAIM 12
12. The claim limitation in claim 12 of “means for measuring a temperature” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses the recitation “means” coupled with functional language “for measuring a temperature” without reciting sufficient structure to achieve the function.
13. Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 12 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
14. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
One or more temperature measuring elements (20) such as thermistor(s) or thermocouple(s) - see published Specification (U.S. 2023/0142426) at, e.g., ¶[0047]; and
A Magnetic Resonance Imaging system used to obtain a 2D or 3D temperature map - see published Specification (U.S. 2023/0142426) at, e.g., ¶’s [0048], [0049].
15. If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
16. If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
17. 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
18. 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.
19. Claim 20 is 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.
20. Claim 20 was amended to include the new limitation “said capillary is fused, and/or adhered to said optical fibre and/or said capillary is bonded to said optical fibre by shrink tubing” (emphasis added) in lines 13-14 of the claim. This recitation renders the claim indefinite, as claim 20 earlier recites the limitation “wherein said capillary is glued to said optical fibre and said capillary is further bonded to a jacket of said optical fibre at a proximal portion of said capillary by shrink tubing” (emphasis added) in lines 11-13 of the claim. As such, the new claim limitation now makes optional those limitations that are already recited earlier in the claim as being required. This inconsistency renders the claim indefinite, as the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
For purposes of examination, independent claim 20 will be interpreted as requiring “wherein said capillary is glued to said optical fibre and said capillary is further bonded to a jacket of said optical fibre at a proximal portion of said capillary by shrink tubing.”
Claim Rejections - 35 USC § 103
21. 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.
22. 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.
23. Claims 1, 6-11, 15-17, & 19 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. 2014/0088575 to Loeb (“Loeb”).
24. Regarding claim 1, Torchia teaches a heating probe for performing interstitial [e.g., col. 1, ll. 15-19; col. 7, ll. 50-56; col. 11, ll. 17-20] thermotherapy on at least a portion of a tissue site, comprising:
an optical 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] comprising a light emitting area at a distal portion [col. 2, ll. 62-65; col. 6, ll. 35-37], and…;
said optical fibre [(20)] is connectable to an energy source [laser - Abstract; FIG. 1] for heating said portion of said tissue site by said light emitting area [col. 2, ll. 59-65; col. 6, ll. 35-41]…; [and]
a capillary [front portion (39) - col. 7, ll. 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…”)] arranged to cover at least said light emitting area to protect said light emitting area [col. 7, ll. 43-56; FIG. 3], wherein said capillary [(39)] is configured to provide heat and/or mechanical stability to said optical fibre during the interstitial thermotherapy [front end portion (39) provides mechanical stability - see col. 7, line 59 - col. 8, line 3 (“The rigid front portion has a length so that it can extend from the end of the cannula at the forward or closest edge of the tumour through to the rear edge of the tumour… In this way the substantially rigid forward portion maintains the forward portion of the fiber lying substantially directly along the axis of the cannula without any bending or twisting of the forward portion within the cannula”)].
A. Micro-Modifications
Torchia does not, however, teach the following emphasized claim limitations:
wherein said light emitting area comprises at least a core and a cladding;
said light emitting area is at least partially a diffuser, [and]
said diffuser is a structured writing comprising micro-modifications being microdots burnt into at least said core, and said microdots are burnt with a variable density so that said density increases closer to a distal end of said diffuser.
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 also teaches that it was known to have the microdots burnt with a variable density so that said density increases closer to a distal end of said diffuser [see pg. 62, “3.2.3 Axial distribution of the scattering micro dots” (“Theoretically a diffuser fiber would need more scattering micro dots at the distal end of the active zone to create a homogeneous radiation profile, which would ideally be formed cylindrically around the axis of the diffuser. The idea was to realize this by controlling the maximum speed of the processing slide”); see also pg. 65 (“As a higher density of scattering micro dots is required at the distal end of the active zone…”)].
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 in said light emitting area comprises at least a core and a cladding, said light emitting area is at least partially a diffuser, and said diffuser is a structured writing comprising micro-modifications being microdots burnt into at least said core, and said microdots are burnt with a variable density so that said density increases closer to a distal end of said diffuser, 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. Capillary/Fibre Attachment
Finally, the combination of Torchia & Köcher does not teach that:
said capillary is fused, and/or adhered to said optical fibre and/or said capillary is bonded to said optical fibre by shrink tubing.
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 said capillary is fused [Loeb teaches the claimed alternative of “fusing” – see ¶[0191] (“thermal fusion”)], and/or adhered [Loeb teaches the claimed alternative of “adhering” – see ¶[0191] (using “adhesive”)] to said optical fibre.
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 to utilize a known, art-recognized manner of bonding a capillary to an optical fibre, including, wherein said capillary is fused, and/or adhered to said optical fibre, 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 optical fibre, and the results (providing a secure attachment of the capillary to the optical fibre) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
25. Regarding claim 6, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Torchia was already modified above (in the rejection of claim 1) to implement the fusion and/or adhesion technique of Loeb [see ¶[0191] - “thermal fusion” & “adhesive”] which Loeb teaches occurs at a proximal portion of said capillary [see ¶[0191]].
26. Regarding claim 7, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Loeb further teaches wherein said capillary is fused to said optical fibre at a point distally to said proximal portion [again, Torchia was already modified above (in the rejection of claim 1) to implement the fusion and/or adhesion technique of Loeb [see ¶[0191] “thermal fusion”] which Loeb teaches occurs along the fibre but does not extend past the beveled distal end surface of the fiber; as broadly as claimed, the proximal portion may comprise a proximal-most point of the capillary, while any point distal to the proximal-most point along the length of thermal fusion (up and until the beveled distal end of the fiber) comprises a distal point].
27. Regarding claim 8, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Claim 8 further recites the limitation “wherein said point distally to said proximal portion that is fused to said optical fibre provides a thermostable bond between silica of said capillary and silica of said optical fibre; or wherein an adhesive is arranged at said proximal portion as a seal.”
Loeb further teaches the alternative limitation of “wherein an adhesive is arranged at said proximal portion as a seal” [again, Torchia was already modified above (in the rejection of claim 1) to implement the fusion and/or adhesion technique of Loeb [see ¶[0191] “adhesive”] which Loeb teaches forms a seal [see ¶[0191] (“fixedly and sealingly attached”)].
28. Regarding claim 9, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches wherein said capillary is a glass capillary [col. 7, ll. 50-51].
29. Regarding claim 10, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Torchia further teaches wherein there is a space arranged between said optical fibre and said capillary [Torchia, col. 7, ll. 43-56; FIG. 3].
30. Regarding claim 11, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Loeb further teaches wherein said optical fibre comprises a jacket [NOTE: Torchia was modified in the rejection of claim 1 (above) to utilize the diffuser fibre of Köcher, which comprises a jacket - see FIG. 2A (pg. 59)].
31. Regarding claim 15, Torchia teaches a method a manufacturing a heating probe for performing interstitial [e.g., col. 1, ll. 15-19; col. 7, ll. 50-56; col. 11, ll. 17-20] thermotherapy on at least a portion of a tissue site, comprising:
providing an optical 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] comprising a light emitting area at a distal portion [col. 2, ll. 62-65; col. 6, ll. 35-37], …; [and]
configuring said optical fibre [(20)] to be connectable to an energy source [laser - Abstract; FIG. 1] for heating said portion of said tissue site by said light emitting area [col. 2, ll. 59-65; col. 6, ll. 35-41]…;
arranging a capillary [front portion (39) - col. 7, ll. 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…”)] to cover at least said light emitting area to protect said light emitting area [col. 7, ll. 43-56; FIG. 3], wherein said capillary [(39)] is configured to provide heat and/or mechanical stability to the optical fibre during the interstitial thermotherapy [front end portion (39) provides mechanical stability - see col. 7, line 59 - col. 8, line 3 (“The rigid front portion has a length so that it can extend from the end of the cannula at the forward or closest edge of the tumour through to the rear edge of the tumour… In this way the substantially rigid forward portion maintains the forward portion of the fiber lying substantially directly along the axis of the cannula without any bending or twisting of the forward portion within the cannula”)].
A. Micro-Modifications
Torchia does not, however, teach the following emphasized claim limitations:
wherein said light emitting area comprises a core and a cladding; [and]
modifying said light emitting area to be at least partially a diffuser by burning a structured writing being micro-modifications into said core, and wherein said micro-modifications are microdots, and said microdots are burnt with a variable density so that said density increases closer to a distal end of said diffuser.
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 a core and a cladding [see pg. 59, “2.2 Fiber processing;” and FIG. 2].
Köcher further teaches modifying said light emitting area to be at least partially a diffuser by burning a structured writing being micro-modifications into said core, and wherein said micro-modifications are microdots [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 burning a structured writing being micro-modifications into said core, and wherein said micro-modifications are microdots].
Köcher also teaches that it was known to have the microdots burnt with a variable density so that said density increases closer to a distal end of said diffuser [see pg. 62, “3.2.3 Axial distribution of the scattering micro dots” (“Theoretically a diffuser fiber would need more scattering micro dots at the distal end of the active zone to create a homogeneous radiation profile, which would ideally be formed cylindrically around the axis of the diffuser. The idea was to realize this by controlling the maximum speed of the processing slide”); see also pg. 65 (“As a higher density of scattering micro dots is required at the distal end of the active zone…”)].
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 such that said light emitting area comprises a core and a cladding, and modifying said light emitting area to be at least partially a diffuser by burning a structured writing being micro-modifications into said core, and wherein said micro-modifications are microdots, and said microdots are burnt with a variable density so that said density increases closer to a distal end of said diffuser, all as taught by Köcher, 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. Capillary/Fibre Attachment
Finally, the combination of Torchia & Köcher does not teach that:
said capillary is fused, and/or adhered to said optical fibre and/or said capillary is bonded to said optical fibre by shrink tubing.
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 said capillary is fused [Loeb teaches the claimed alternative of “fusing” – see ¶[0191] (“thermal fusion”)], and/or adhered [Loeb teaches the claimed alternative of “adhering” – see ¶[0191] (using “adhesive”)] to said optical fibre.
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 to utilize a known, art-recognized manner of bonding a capillary to an optical fibre, including, wherein said capillary is fused and/or adhered to said optical fibre, 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 optical fibre, and the results (providing a secure attachment of the capillary to the optical fibre) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
32. Regarding claim 16, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Torchia was already modified above to utilize the adhesive of Loeb [see ¶[0191] - “adhesive”] which Loeb teaches is a glue [e.g., ¶’s [0213], [0214]].
33. Regarding claim 17, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Loeb does not explicitly teach:
wherein said space is filled with air.
Loeb further teaches that there is a space arranged between said optical fibre and said capillary, wherein said space is filled with air [clearly shown in FIG. 2; note also that Loeb teaches that capillary tube (29) is hollow, which creates air pocket (30) - ¶[0188]].
Loeb additionally teaches wherein said space is filled with air [air pocket (30) - ¶[0188]].
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, & Loeb to utilize a known configuration wherein the space arranged between said optical fibre and said capillary is filled with air, since such a modification amounts merely to the substitution of one known capillary configuration for another, yielding predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
34. Regarding claim 19, Torchia teaches a heating probe for performing interstitial [e.g., col. 1, ll. 15-19; col. 7, ll. 50-56; col. 11, ll. 17-20] thermotherapy on at least a portion of a tissue site, comprising:
an optical 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] comprising a light emitting area at a distal portion [col. 2, ll. 62-65; col. 6, ll. 35-37], and…;
said optical fibre [(20)] is connectable to an energy source [laser - Abstract; FIG. 1] for heating said portion of said tissue site by said light emitting area [col. 2, ll. 59-65; col. 6, ll. 35-41]…; [and]
a capillary [front portion (39) - col. 7, ll. 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…”)] arranged to cover at least said light emitting area to protect said light emitting area [col. 7, ll. 43-56; FIG. 3], wherein said capillary [(39)] is configured to provide heat and/or mechanical stability to the optical fibre during the interstitial thermotherapy [front end portion (39) provides mechanical stability - see col. 7, line 59 - col. 8, line 3 (“The rigid front portion has a length so that it can extend from the end of the cannula at the forward or closest edge of the tumour through to the rear edge of the tumour… In this way the substantially rigid forward portion maintains the forward portion of the fiber lying substantially directly along the axis of the cannula without any bending or twisting of the forward portion within the cannula”)].
A. Micro-Modifications
Torchia does not, however, teach the following emphasized claim limitations:
wherein said light emitting area comprises at least a core and a cladding;
said light emitting area is at least partially a diffuser, [and]
said diffuser is a structured writing comprising micro-modifications burnt into at least said core, and
wherein said micro-modifications are refractive index modifications of said core, and said micro-modifications are burnt with a variable density so that said density increases closer to a distal end of said diffuser.
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 (e.g., 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 burnt into at least said core of said fibre].
Köcher teaches that said micro-modifications (e.g., microdots) are refractive index modifications of said core [see, e.g., pg. 57, “Objective”].
Köcher also teaches that it was known to have the microdots burnt with a variable density so that said density increases closer to a distal end of said diffuser [see pg. 62, “3.2.3 Axial distribution of the scattering micro dots” (“Theoretically a diffuser fiber would need more scattering micro dots at the distal end of the active zone to create a homogeneous radiation profile, which would ideally be formed cylindrically around the axis of the diffuser. The idea was to realize this by controlling the maximum speed of the processing slide”); see also pg. 65 (“As a higher density of scattering micro dots is required at the distal end of the active zone…”)].
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 wherein in said light emitting area comprises at least a core and a cladding; said light emitting area is at least partially a diffuser, and said diffuser is a structured writing comprising micro-modifications burnt into at least said core, and wherein said micro-modifications are refractive index modifications of said core, and said micro-modifications are burnt with a variable density so that said density increases closer to a distal end of said diffuser, all as taught by Köcher, 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. Capillary/Fibre Attachment
Finally, the combination of Torchia & Köcher does not teach that:
said capillary is fused, and/or adhered to said optical fibre and/or said capillary is bonded to said optical fibre by shrink tubing.
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 said capillary is fused [Loeb teaches the claimed alternative of “fusing” – see ¶[0191] (“thermal fusion”)], and/or adhered [Loeb teaches the claimed alternative of “adhering” – see ¶[0191] (using “adhesive”)] to said optical fibre.
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 to utilize a known, art-recognized manner of bonding a capillary to an optical fibre, including, wherein said capillary is fused and/or adhered to said optical fibre, 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 optical fibre, and the results (providing a secure attachment of the capillary to the optical fibre) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
35. Claims 2 & 3 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, & Loeb as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2014/0092620 to Tissot (“Tissot”).
36. Regarding claim 2, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Loeb does not, however, teach:
wherein said micro-modifications are further burnt into the cladding and/or a buffer of said optical fibre.
Tissot, in a similar field of endeavor, teaches that it was known to provide scattering structures partially in the core and partially in the cladding to effectuate a desired radiation pattern [see ¶[0005] (“In one embodiment, the optical fiber may have a core layer and a cladding layer. The scattering structures (e.g., micro-diffusers or reflectors) are preferably laser-induced structures previously formed inside the fiber, either entirely in the core layer, or partially in the core and partially in the cladding. These scattering structures are designed to redirect the primary light in accordance with a desired radiation pattern that cuts through the outer or front side surface of the fiber; the radiation pattern may thus have a shape defined in part by certain characteristics of the scattering structures”)].
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 Loeb such that said micro-modifications are further burnt into the cladding of said optical fibre, since such a known diffusion technique was clearly recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Tissot), and one of ordinary skill would have been capable of utilizing such a technique in order to effectuate a desired radiation pattern, and the results would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
37. Regarding claim 3, the combination of Torchia, Köcher, Loeb, & Tissot teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, Loeb, & Tissot further teaches wherein said micro-modifications are arranged on sectional planes, wherein said sectional planes lie perpendicular to an optical waveguide axis of said optical fibre [NOTE: Torchia was modified in the rejection of claim 1 (above) to utilize the diffuser fibre of Köcher, which comprises micro-modifications arranged on sectional planes, wherein said sectional planes lie perpendicular to an optical waveguide axis of said optical fibre – see FIG. 2A (pg. 59); note that a series of lines drawn perpendicular to the longitudinal axis of the fibre, with each line intersecting three microdots (top, middle, bottom), would define perpendicular, sectional planes; see also pg. 60, “2.3 Testing Process”].
38. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, and Loeb, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2010/0016845 to Hanley et al. (“Hanley”).
39. Regarding claim 5, the combination of Torchia, Köcher, and Loeb teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, and Loeb does not, however, teach:
wherein said capillary is fused, adhered and/or bonded using shrink tubing to a jacket and/or buffer of said optical fibre.
Hanley, in a similar field of endeavor, teaches that it was known to couple a capillary to a buffer layer of an optical fiber through a fusion process [e.g., ¶[0033]].
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 Loeb to utilize a known, art-recognized manner of bonding said capillary to said optical fibre, including, wherein said capillary is fused to a buffer of said optical fibre, as taught by Hanley, since such a known fusion technique was clearly recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Hanley), and one of ordinary skill would have been capable of utilizing such a fusion technique in order to bond the capillary to said optical fibre, and the results (providing a secure attachment of the capillary to the optical fibre) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
40. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, and Loeb, as applied to claim 1 above, and further in view of U.S. Patent No. 5,599,345 to Edwards et al. (“Edwards”).
41. Regarding claim 12, the combination of Torchia, Köcher, and Loeb teaches a system for performing thermotherapy on at least a portion of a tissue site, said system comprising:
the heating probe for performing thermotherapy on at least said portion of said tissue site according to claim 1 [see the rejection of claim 1 under § 103 set forth above, which is incorporated herein]; [and]
means for measuring a temperature in said portion of said tissue site [Torchia further teaches an MRI imaging system for measuring temperature - 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].
While Torchia teaches a surgeon interface (17) and MRI control console (18) [col. 6, ll. 27-35; col. 10, ll. 51-61; & FIG. 1], the combination of Torchia, Köcher, and Loeb does not explicitly teach:
a display unit for indicating a measured temperature from said means for measuring a temperature.
However, displaying (or indicating) measured temperatures on a display unit during thermotherapy was well known in the art, before the effective filing date of the claimed invention.
As one example, 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].
Edwards further teaches the use of a thermal sensor [thermal sensor (24)] to measure a temperature at the desired tissue site [col. 7, ll. 30-32; col. 7, ll. 41-52].
Edwards additionally teaches a display unit [user interface and display (68)] for indicating a measured temperature [see col. 10, ll. 3-4; and col. 10, ll. 28-30 (“the temperatures are displayed at user interface (68)”)].
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 Loeb to include a display unit for indicating a measured temperature from said means for measuring a temperature, as taught by Edwards, so as to enable a practitioner to quickly and easily view acquired temperature data in a convenient manner in order to be well informed during a procedure.
42. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, Loeb, and Edwards, 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].
43. Regarding claim 13, the combination of Torchia, Köcher, Loeb, and Edwards 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, Loeb, and Edwards, however, does not explicitly teach:
wherein said measured temperature is indicated as a graph on said 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.
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 [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, Loeb, and Edwards such that said temperature is indicated as a graph of said display, 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]].
44. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, Loeb, and Edwards, as applied to claim 12 above, and further in view of U.S. Patent Application Publication No. 2009/0326420 to Moonen et al. (“Moonen”).
45. Regarding claim 14, the combination of Torchia, Köcher, Loeb, and Edwards teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Claim 14 further requires wherein said means for measuring the temperature are temperature measuring elements arranged in a sleeve; or wherein said means for measuring a temperature is a Magnetic Resonance Imaging system to obtain a 2D or 3D temperature map of a treatment area which comprises said portion of said tissue site.
As noted above in the rejection of claim 12, Torchia teaches wherein said means for measuring a temperature is a Magnetic Resonance Imaging system [e.g., Abstract, col. 11, ll. 12-14], and further teaches providing images of the portion (e.g., tumor) to be excised [col. 10, ll. 54-56].
The combination of Torchia, Köcher, Loeb, and Edwards does not, however, teach that the MRI system is used to obtain a 2D or 3D temperature map of a treatment area which comprises said portion of said tissue site.
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, Loeb, and Edwards such that the MRI system allow for the simultaneous provision of 3D anatomical maps and temperature maps of the patient region of interest, 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.
46. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torchia, Köcher, & Loeb as applied to claim 11 above, and further in view of U.S. Patent Application Publication No. 2015/0338646 to Innami (“Innami”), and U.S. Patent Application Publication No. 2015/0141854 to Eberle et al. (“Eberle”).
47. Regarding claim 18, the combination of Torchia, Köcher, & Loeb teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
The combination of Torchia, Köcher, & Loeb does not, however, teach:
wherein said jacket is made from acrylate, a layer of a resin and an outer layer made of Polybutylene terephthalate (PBT).
However, the use of such materials in fiber jackets was well known in the art, before the effective filing date of the claimed invention.
For example, Innami, in a similar field of endeavor, teaches that it was known to make the jacket of an optical fiber from, e.g., an acrylate resin [¶[0017]].
Eberle, in a similar field of endeavor, teaches that it was known to make a fiber jacket from polybutylene terephthalate, as well as from blends and/or mixtures of polymers and resins [¶[0279]].
In view of the teachings of Innami and Eberle, it would have been an obvious matter of design choice 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, & Loeb to utilize whatever known, art-recognized jacket structure was desired or expedient, including, e.g., wherein said jacket is made from acrylate, a layer of a resin and an outer layer made of Polybutylene terephthalate (PBT), since Applicant has not disclosed that such a structure solves any stated problem or is for any particular purpose, nor that such a jacket structure presents any novel or unexpected result over the jacket structures used in the references.
48. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Torchia in view of Köcher, and further in view of Loeb, and U.S. Patent No. 5,486,171 to Chou (“Chou”).
49. Regarding claim 20, Torchia teaches a heating probe for performing interstitial [e.g., col. 1, ll. 15-19; col. 7, ll. 50-56; col. 11, ll. 17-20] thermotherapy on at least a portion of a tissue site, comprising:
an optical 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] comprising a light emitting area at a distal portion [col. 2, ll. 62-65; col. 6, ll. 35-37]; [and]
said optical fibre [(20)] is connectable to an energy source [laser - Abstract; FIG. 1] for heating said portion of said tissue site by said light emitting area [col. 2, ll. 59-65; col. 6, ll. 35-41]…;
a capillary [front portion (39) - col. 7, ll. 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…”)] arranged to cover at least said light emitting area to protect said light emitting area [col. 7, ll. 43-56; FIG. 3]…, wherein said capillary [(39)] is configured to provide heat and/or mechanical stability to the fibre during the interstitial thermotherapy [front end portion (39) provides mechanical stability - see col. 7, line 59 - col. 8, line 3 (“The rigid front portion has a length so that it can extend from the end of the cannula at the forward or closest edge of the tumour through to the rear edge of the tumour… In this way the substantially rigid forward portion maintains the forward portion of the fiber lying substantially directly along the axis of the cannula without any bending or twisting of the forward portion within the cannula”)].
A. Micro-Modifications
Torchia does not, however, teach the following emphasized claim limitations:
said light emitting area is at least partially a diffuser,
said diffuser is a structured writing being micro-modifications wherein said micro-modifications are burnt into a core and/or cladding and/or buffer of said optical fibre, and said micro-modifications are burnt with a variable density so that said density increases closer to a distal end of said diffuser.
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 (e.g., microdots) burnt into at least said core of said optical 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 said diffuser being a structured writing being micro-modifications wherein said micro-modifications are burnt into a core of said optical fibre].
Köcher also teaches that it was known to have the microdots burnt with a variable density so that said density increases closer to a distal end of said diffuser [see pg. 62, “3.2.3 Axial distribution of the scattering micro dots” (“Theoretically a diffuser fiber would need more scattering micro dots at the distal end of the active zone to create a homogeneous radiation profile, which would ideally be formed cylindrically around the axis of the diffuser. The idea was to realize this by controlling the maximum speed of the processing slide”); see also pg. 65 (“As a higher density of scattering micro dots is required at the distal end of the active zone…”)].
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 light emitting area is at least partially a diffuser, and said diffuser is a structured writing being micro-modifications wherein said micro-modifications are burnt into a core of said optical fibre, and said micro-modifications are burnt with a variable density so that said density increases closer to a distal end of said diffuser, 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. Capillary/Fibre Attachment
Claim 20 further recites the limitations “wherein said capillary is glued to said optical fibre and said capillary is further bonded to a jacket of said optical fibre at a proximal portion of said capillary by shrink tubing, and said capillary is fused, and/or adhered to said optical fibre and/or said capillary is bonded to said optical fibre by shrink tubing.”
As noted above in the rejection under § 112(b), this limitation is being interpreted as requiring “wherein said capillary is glued to said optical fibre and said capillary is further bonded to a jacket of said optical fibre at a proximal portion of said capillary by shrink tubing.”
i. Capillary Glued to Optical Fiber
The combination of Torchia and Köcher does not teach:
wherein said capillary is glued to said optical fibre.
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 said capillary is glued to said optical fibre [¶’s [0191], [0213], [0214]].
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 said capillary is glued to said optical fibre, as taught by Loeb, since such a capillary securing configuration was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Loeb), and one of ordinary skill in the art would have been capable of applying this known configuration to the known device of Torchia and Köcher, and the results (securing the capillary to the fiber) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
ii. Shrink-Tubing
Finally, the combination of Torchia, Köcher, and Loeb does not teach:
[wherein] said capillary is further bonded to a jacket of said optical fibre at a proximal portion of said capillary by shrink tubing.
Chou, a similar field of endeavor, teaches an optical fiber (12) and a transparent cap (31) that covers the tip of the fiber, thus providing protection to the fiber tip [col. 5, ll. 51-56; col. 6, ll. 8-11; FIG. 2].
Chou further teaches that the transparent cap (31) extends over and past the end of the optical fiber outer jacket (34). An outer securing element (38), which may comprise shrink tubing (col. 6, ll. 66-67), is secured to both the outer jacket (34) and a proximal portion of the transparent cap (31) [col. 6, line 38 – col. 7, line 2; FIG. 2].
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 Loeb such that said capillary is further bonded to a jacket of said optical fibre at a proximal portion of said capillary by shrink tubing, as taught by Chou, since such a capillary securing configuration was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Chou), and one of ordinary skill in the art would have been capable of applying this known configuration to the known device of Torchia, Köcher, and Loeb, and the results (bonding the capillary to the jacket of the fiber) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
50. As noted above, a new claim objection and a new rejection under § 112(b) are set forth herein, necessitated by Applicant’s Amendment.
51. The rejections under § 103 previously set forth in the 08/26/25 Action have been updated responsive to the 02/26/26 Amendment.
52. In the 02/26/26 Amendment, independent claim 1 was amended to include the limitation of dependent claim 4 (now cancelled) concerning attachment of the capillary to the optical fibre:
…said capillary is fused, and/or adhered to said optical fibre and/or said capillary is bonded to said optical fibre by shrink tubing,
53. In the Remarks, Applicant argues that modifying Torchia to secure the capillary to the optical fibre is improper based on the contention that Torchia is designed to allow relative movement of the fiber within the capillary, which Applicant refers to as the “enclosure.” Particularly, Applicant argues as follows:
Starting with Torchia, the Examiner relies on the enclosure structure described in col. 7 of Torchia.
However, that section makes clear that the enclosure of Torchia is designed to enable relative movement of the fiber within the enclosure.
As stated in col. 7, lines 41-43 of Torchia below:
"The fiber element itself as indicated at 35 is however encased in an enclosure to allow the fiber to be manipulated in the motor 22."
(Emphasis added)
The rigidity of the enclosure allows the enclosure to extend from the end of the cannula to the closest edge of the tumor through the rear edge of the tumour and that there is no bending or twisting of the enclosure within the cannula when moving and rotating the enclosure within the cannula, as described in col. 7 line 57 to col. 8 line 12 of Torchia.
After the enclosure has been positioned as described, fiber tip is advanced inside the enclosure under MRI feedback control. The entire interstitial treatment of Torchia depends on relative movement between the fiber and the enclosure to allow a tumour to be treated.
02/26/26 Amendment, pgs. 8-9, emphasis added.
Examiner disagrees with Applicant’s characterization of Torchia set forth above. More particularly, Examiner can find no disclosure in Torchia concerning movement of the optical fiber (20) within the capillary (39), much less any disclosure that the “entire interstitial treatment of Torchia depends on relative movement between the fiber and the enclosure” as Applicant alleges. By contrast, Torchia very clearly establishes that the capillary (39) is, in fact, already attached to the optical fiber.
For example, the capillary in Torchia comprises the first end (or front) portion (39) of sleeve (38) that is formed around the fiber, and which is formed of a rigid material, such as glass [col. 7, ll. 43-55].
Torchia describes the fiber as having an inlet end and an outlet end, and the sleeve as a “reinforcing sleeve” that surrounds, and is attached to, the fiber:
Preferably there is provided a mounting for the drive assembly for supporting the drive assembly exteriorly of the cannula and wherein the fiber has a reinforcing sleeve member surrounding and attached to a portion of the fiber so as to extend from the drive assembly to the outlet end, the sleeve member holding the fiber against lateral bending during said longitudinal movement and against torsional twisting during said rotational movement and the sleeve member being arranged to extend through the cannula.
Torchia, col. 3, ll. 50-58, emphasis added.
***
Preferably the sleeve includes a first portion at the outlet end which is formed of a first material, such as glass which is substantially rigid to rigidly support that portion of the fiber projecting in cantilever manner beyond the end of the cannula and a second portion connected to and extending from the first portion to the drive assembly, the second portion being formed of a second material such as liquid crystal polymer which is stiff but less rigid than the first portion to allow some flexing when the fiber is inserted into the cannula.
Torchia, col. 3, line 61 - col. 4, line 3, emphasis added.
***
the fiber having a reinforcing sleeve member surrounding and attached to a portion of the fiber adjacent the outlet end, the sleeve member holding the fiber against lateral bending during said longitudinal movement and against torsional twisting during said rotational movement.
Torchia, col. 4, ll. 14-15, emphasis added.
The teachings in the foregoing passages of Torchia are further consistent with the claims of Torchia, in which the reinforcing sleeve is described as being attached to the fiber. For example, claim 3 of Torchia recites:
3. An apparatus for laser treatment on a part of a patient comprising:
an optical fiber having an inlet end and an outlet end;
a laser source for supplying light energy into the fiber at the inlet end;
a light deflector at the outlet end for directing the light in a beam at an angle to a longitudinal axis of the fiber at the outlet end such that a first rotation of the fiber about the axis causes the beam to rotate about the axis;
a rigid elongate cannula arranged for insertion into the part of the patient;
the cannula having a bore arranged for receiving a portion of the fiber adjacent the outlet end extending therethrough such that the end can pass through the cannula into engagement with the part of the patient;
a drive assembly for causing a first longitudinal movement of the fiber relative to the cannula along its length and for causing a second rotational movement of the fiber about its axis
the fiber having a reinforcing sleeve member surrounding and attached to a portion of the fiber adjacent the outlet end, the sleeve member holding the fiber against lateral bending during said longitudinal movement and against torsional twisting during said rotational movement.
Torchia, claim 3, emphasis added.
It is possible that Applicant is confusing the capillary (39) with the cannula (31) of Torchia, since the passage cited by Applicant [col. 7, line 57 - col. 8, line 12] describes the relative movement (sliding) of the fiber within the cannula, which is consistent with other passages of Torchia:
The apparatus further includes a 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 while generally holding the fiber in a direction axial of the cannula.
Torchia, col. 6, line 65 - col. 7, line 2, emphasis added; see also col. 11, ll. 1-11.
In view of these teachings, it is the Examiner’s position that Torchia clearly teaches that the capillary is attached to the optical fiber. Respectfully, Applicant has failed to establish otherwise.
As readily acknowledged in the body of the rejections above, however, Torchia is silent with regard to the basic manner in which the capillary is attached to the optical fiber. As such, Loeb is relied-upon to supply this basic teaching. Concerning Loeb, Applicant argues as follows:
A person of ordinary skill in the art seeking to improve interstitial tumor thermotherapy would not look to Loeb's cooled intravascular nerve-denervation catheter to modify a microdot diffuser probe. Combining Torchia's motor-driven movable fiber architecture with Loeb's actively cooled dual-enclosure catheter, or dual-walled enclosure, would require substantial redesign and would alter the principle of operation of both systems.
02/26/26 Amendment, pg. 10, emphasis added.
This argument is not persuasive. Having established that the capillary in Torchia is attached to the fiber, Loeb is simply relied-upon to demonstrate that it was well known in the art to bond (attach) a capillary to an optical fibre using well-established fusion and adhesion methods. Modifying Torchia to include any of such conventional and straightforward techniques does not require any “substantial redesign” as Applicant alleges.
54. For at least the forgoing reasons, the rejection of independent claim 1 under § 103 based on the combination of Torchia, Köcher, and Loeb is legally proper.
Conclusion
55. 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.
56. 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/Examiner, Art Unit 3794