DETAILED ACTION
This action is responsive to the preliminary amendment filed 7/12/22.
Claims 21-40 are rejected.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 30, the examiner could not find support in the original disclosure for emitting the ‘first resonant frequency and the second resonant frequency at the same time.’ Therefore, claim 30 possesses new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 21, 37 and 39, the claims recite a coaxial cable comprising a ‘radiating portion’, which further comprises a ‘first section having a first length’ and a ‘second section having a second length.’
The claim fails to structurally define the spatial relationship or boundaries between the first section and the second section within the radiating portion. It is unclear from the claim whether these sections are arranged sequentially along the longitudinal axis of the coaxial cable, or concentrically around a circumference. Because the metes and bounds of where the ‘first section’ ends and the ‘second section’ begins cannot be determined with reasonable certainty, the claim is indefinite.
Further regarding claims 21, 37 and 39, the claims recite a ‘first length’ and a ‘second length’, but fails to provide a physical baseline, reference point or axis from which these lengths are to be measured. Therefore, POSITA would not be able to determine which lengths are to be measured. For instance, POSITA would not be able to determine whether the ‘length’ refers to a length of the section measured in a longitudinal direction or if the ‘length’ refers to a length of the section measured circumferentially about the coaxial cable. Further, POSITA would not be able to determine whether the ‘length’ refers to an overall longitudinal extension of the center conductor, the length of an opening in the outer conductor, or a measurement along a depth axis. Without anchoring the boundaries of these lengths to clear structural landmarks (e.g. a specific boundary of the outer conductor or probe cap), the scope of the claimed lengths is unconfined and ambiguous.
Further regarding claims 21, 37 and 39, the claims define the first and second sections purely by their functional results, noting they are “configured for emission of the microwave energy at a [first/second] resonant frequency”. However, as disclosed in the specification, an antenna’s resonant frequency shifts dynamically depending on external variables, including the temperature and dielectric properties of the surrounding tissue environment (see applicant’s PGPUB, pars. 43-45). Because claim 21 fails to recite the structural parameters that physically dictate these frequencies—and fails to tie the resonant frequencies to a fixed environment or state—the physical boundaries of the ‘first length’ and the ‘second length’ would shift based on the operation context. Consequently, POSITA would be unable to determine whether a given physical device falls within or outside the scope of the claim during operation.
Examiner’s Note/Suggestion:
The examiner suggests amending claims 21, 37 and 39 to clearly define the physical layout and measurement boundaries of the section. For example, the applicant may consider rewriting the radiation portion to explicitly state that the first and second sections possess different longitudinal lengths as measured between distinct structural markers.
Regarding claim 22, the claim recites that ‘a length of the radiating portion varies around a circumference of the coaxial cable.’ The claim is similarly ambiguous since it fails to fails to provide a physical baseline, reference point or axis from which the lengths are being measured, as discussed above. Further, the claim is ambiguous since it fails to specify what is meant by a length which ‘varies about a circumference’. Therefore, POSITA would not be apprised of the metes and bounds of the claimed invention.
Further, regarding claim 22 the claim is indefinite since it fails to structurally relate to its parent claim 21. For instance, claim 21 already recites that the radiation portion comprises a ‘first section having a first length’ and a ‘second section having a second length.’ Claim 22 subsequently recites that ‘a length of the radiation portion varies […].’ The claim is indefinite since the claim fails to specify how the ‘length of the radiating section’ recited in claim 22 relates to and modifies the ‘first’ and ‘second’ lengths previously recited by claim 21. Further, it remains unclear how the varying ‘length’ recited in claim 22 can be reconciled with the discrete fixed lengths recited by claim 21.
Regarding claim 23, the claim recites ‘the coaxial capable comprising a cap […].’ In the art of microwave ablation, POSITA would understand a ‘cap’ to be a distinct structural element from a coaxial which consists of inner/outer conductors and a dielectric. It is therefore, structurally unclear how a coaxial cable ‘comprises’ the cap itself, rendering the physical boundaries of the claimed cable assembly ambiguous.
Furthermore, the phrase ‘the cap comprising a cap proximal boundary’ fails to particularly point out the invention. The claim recites an inherent geometric property (a boundary) of a generic cap without defining its spatial location, physical profile, or its structural interaction with the radiating section of parent claim 21. Because the claim introduces a landmark boundary but fails to provide any structural relationship or coordinates for it, the scope of the claim cannot be determined with reasonable certainty.
Regarding claim 24, claim 23 recites that the cap is located “at a probe distal end”, yet claim 24 recites that the cap proximal boundary is at a “distance from a distal end of the probe.” This introduces a structural paradox; if the cap is located at the distal end, then the terminal point of the cap inherently defines the distal end of the probe. Therefore, the location of the cap is both defined by the ‘probe distal end’ and also itself defines the location of the ‘probe distal end’. Further, measuring the ‘proximal boundary of the cap’ to this inherently circular and ambiguous landmark leaves the exact spatial layout of the cap ambiguous.
Further regarding claim 24, as previously argued, POSITA would regard a cap as a distinct component from the coaxial cable. Therefore, it is not clear what is meant by the ‘uniform distance’ as measured ‘around a circumference of the coaxial cable.’
Finally, with regard to claim 24, the claim is indefinite since it is unclear what is meant by a ‘uniform distance from a distal end of the probe.’ For instance, is the distance being measured to a perpendicular plain containing the distal-most point of the probe which would imply a planar ‘proximal boundary’ geometry or is it being measured to the distal-most point itself which would imply a spherical ‘proximal boundary’ geometry.
Regarding claim 26, the claim is similarly indefinite for reasons outlined with respect to the claim language of ‘distance from the probe distal end’ and ‘around a circumference of the coaxial cable,’ as outlined in the discussions of claims 23-24, above.
In addition, claim 26 introduces ambiguity with respect to the recited ‘radiating portion distal boundary’ and ‘proximal boundary of the cap’. By reciting these structural features as separate entities that vary, the claim introduces a lack of clarity as to whether these terms refer to a single shared interface or two distinct physical boundaries. According to applicant’s specification that ‘radiation portion’ is bounded distally by the ‘proximal boundary of the cap’ (See PGPUB, par. 39), which implies that these boundaries are not distinct but rather a single shared boundary. Further, if they are distinct, then the claim fails to define their relative structural relationship, leaving the metes and bounds of the invention physically ambiguous.
Regarding claim 27, the claim is indefinite for similar reason discussed with regards to claim 22, above. For instance, claim 21 previously recites that the radiating portion comprises a ‘first section’ and a ‘second section’. Dependent claim 27 recites that the radiating portion comprises a ‘plurality of discrete sections. The claim fails to define the structural relationship between the first/second section of claim 21 and the ‘plurality of discrete sections’ of claim 27, leaving it ambiguous whether they refer to same or entirely different structural subdivisions.
In addition, claim 27 recites “wherein adjacent discrete sections are at different distances from a probe distal end”. The claim is indefinite since it fails to define a proximal/origin point for this distance. Therefore, it is ambiguous how each section distance is being measured. Further, it is unclear whether the distance measurement is taken to the absolute terminal point of the probe or whether it is being taken to perpendicular plane which intersects this terminal point.
Regarding claim 28, the claim recites that “the radiating portion comprises a wave shape […] or saw tooth shape around the circumference of the coaxial cable”.
The claim is indefinite for several reasons. First, it introduces a structural conflict with parent claim 21 which previously recites a distinct ‘first section’ and a ‘second section’. It is unclear how a continuous geometric profile such as a ‘wave shape’ or a ‘saw tooth shape’ around a circumference structurally partitions into or modifies the first and second sections of claim 21.
Second with regard to claim 28, the claim is indefinite since it assigns a physical shape to the ‘radiating portion’ rather than to a physical structure. For instance, as disclosed in the specification, the radiation portion is an open dielectric gap bounded by the outer conductor and the cap (see PGPUB, par. 39). The claim fails to define whether the wave or sawtooth shape is formed by the distal edge of the outer conductor, the proximal edge of the cap, or both.
Finally with respect to claim 28, the terms ‘wave shape’ and ‘saw tooth shape’ are unbounded by any geometric parameters, such as amplitude, period, or frequency. POSITA therefore, would be unable to determine what degree of structural variation is required to satisfy these shape profiles. Consequently, the metes and bounds cannot be determined with reasonable certainty.
Regarding claims 29-30, the claims recite that the radiating portion is configured to emit the microwave energy at the first resonant frequency and the second resonant frequency ‘in parallel’.
The term ‘in parallel’ is a term of art typically restricted to electrical circuit architecture. Its application to wireless electromagnetic wave emission from a physical radiating antenna gap introduces a lack of clarity, as the claim fails to define whether ‘in parallel’ refers to a spatial distribution of the fields, a temporal relationship, or an architectural circuit layout within the probe. The ambiguity is compounded by dependent claim 30, which introduces the further limitation ‘at the same time’, implying that ‘in parallel’ in claim 29 must mean something other than simultaneous emission. Because the claim fails to provide any structural parameters or clear physical definitions for what constitutes ‘in parallel’, POSITA would be unable to determine the metes and bounds of the claim cannot be determined with reasonable certainty.
Regarding claim 34, the claim recites ‘a choke comprising: a choke contact between the metal cannula and the coaxial cable and a choke length extending between the choke contact and a distal end of the metal cannula’. The language introduces a structural ambiguity regarding the physical identity of the claimed ‘choke’. The claim defines the ‘choke length’ as a physical span of the metal cannula component, yet the claim also recites the ‘choke’ and ‘metal cannula’ as distinct elements. It is therefore unclear whether the ‘choke’ is a distinct structural sleeve layer, or if it is merely a functional zone mapped onto a portion of the metal cannula. Further, by failing to clearly define how the ‘choke contact’ interfaces with the choke versus the cannula, the structural boundaries of the device cannot be determined with reasonable certainty.
Regarding claim 35, the claim recites ‘the choke contact or the distal end of the cannula varies in distance from a probe distal end.’ The term ‘varies’ is structurally indefinite because it fails to define the nature, direction, or geometric profile of the variation. For instance, it is unclear whether the distance varies dynamically over time via a mechanical adjustment, or if it varies structurally around a circumference or cross-section of the probe assembly.
Furthermore, because parent claim 34 fails to establish a clear structural boundary interface between the choke contact and the cannula, POSITA would be unable to determine which reference point or edge of the choke contact is utilized to calculate the variable distance. Further, it is unclear whether the distance measurement is taken to the absolute terminal point of the probe or whether it is being taken to perpendicular plane which intersects this terminal point.
Regarding claim 36, the claim recites the limitation "the dielectric material of the coaxial cable”. There is insufficient antecedent basis for this limitation in the claim. For instance, claim 33 recites a “dielectric layer in between the cannula and the coaxial cable” and fails to introduce or define an internal dielectric material of the coaxial cable itself.
Regarding claim 37, the claim recites both ‘a shielded portion’ and ‘a metal cannula’ as distinct elements. This language introduces an architectural ambiguity regarding the physical relationship between these two components. In standard microwave antenna design, a metal cannula inherently functions as an electrical/electromagnetic shield. By reciting them as separate claim elements, the claim implies that they are distinct structures. Further, this recitation conflicts with the specification which explicitly states that the cannula “makes up part of the shielded portion” (see PGPUB, par. 38). Because the claim language fails to define the structural hierarchy or distinction between the ‘shielded portion’ and the ‘metal cannula’, POSITA cannot determine the physical metes and bounds of the claim with reasonable certainty.
Claim 40 is indefinite for the use of the phrase ‘in parallel’ as discussed with respect to claims 29-30, above.
Additionally, claim 40 is indefinite since it recites that the probe produces “three or more resonant frequencies.” However, parent claim 39 explicitly only recites two sub-components a ‘first section’ producing ‘a first frequency’ and a ‘second section’ producing a ‘second frequency’. Therefore, since claim 40 fails to teach any additional physical structure or method steps to account for the additional frequencies, the metes and bounds of the claim are structurally ambiguous to POSITA.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21-23, 25-30, 32-33, 37-38, 39-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leussler (US 20140378958).
Regarding claim 21, Leussler teaches a microwave ablation probe (Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies which are selected especially according to the electrical properties and dimensions of the tissue to be ablated.”) comprising: a probe body (Fig. 13, feeding section 45 comprising isolating cover 455) comprising a shielded portion (Fig. 13, portion of feeding section 45 comprising metallic shield 452) and a radiation window (Fig. 13, carrier 46 which comprises dual resonant conductor structures 411, 412 in enclosed by isolating hosing 461 as well as a portion of isolating cover 455 which can be considered the radiation window) that is at least partially transparent to microwave energy (Fig. 13, while 455 and 461 are not explicitly taught to be transparent to microwave radiation, the examiner maintains that the device would be inoperable otherwise since these structures enclose the antenna structure on carrier 46 and since the device is intended to deliver microwave radiation to biological tissue outside of the device, see Abstract); a coaxial cable within the probe body (Fig. 13, depicting a coaxial cable within outer isolating cover 455 and connected to matching device 34; par. 87, disclosing that feeding section 45 can comprise a coaxial cable) comprising a radiating portion (Fig. 13, carrier 46 which comprises dual resonant conductor structures 411, 412) configured for emission of microwave energy (Par. 85, “FIG. 11 shows another embodiment of an applicator antenna 4 in the form of a multi-resonant antenna which comprises at least a first, a second and a third conductor structure 411, 412, 413, which are each resonant (preferably λ/4 resonant) at a first, a second and a third microwave frequency, respectively.”), wherein the radiating portion is aligned with the radiation window (Fig. 13, holder or carrier 46 is aligned with isolating hosing 461), the radiating portion comprising: a first section having a first length, the first section configured for emission of the microwave energy at a first resonant frequency (Fig. 13, first conductor structure 411 having a first length; par. 82, “Again, the dimensioning of the conductor structures 411, 412, especially of their lengths and widths, is calculated in dependence on the selected first and second microwave ablation frequency”; Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies”); and a second section having a second length, the second section configured for emission of the microwave energy at a second resonant frequency (Fig. 13, second conductor structure 412 having a second length; par. 82, “Again, the dimensioning of the conductor structures 411, 412, especially of their lengths and widths, is calculated in dependence on the selected first and second microwave ablation frequency”) that is different from the first resonant frequency (Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies which are selected especially according to the electrical properties and dimensions of the tissue to be ablated.”).
Regarding claim 22, Leussler further teaches wherein a length of the radiating portion varies around a circumference of the coaxial cable (Fig. 13, the lengths of conductor structures 411-413 are shown to vary about the circumference of carrier 46 which is electrically connected to and aligned with the circumference of the coaxial feed cable).
Regarding claim 23, Leussler further teaches coaxial cable comprising a cap located at a probe distal end (Fig. 13, the cap can be considered the portion of carrier 46 between the distal end of the carrier and the distal end of each of the different conductor structures 411-413), the cap comprising a cap proximal boundary (Fig. 13, the proximal boundary of the cap can be considered the boundary defined by the distal boundaries of conductor structures 411-413 and carrier 46).
Regarding claim 25, Leussler further teaches wherein the cap further comprises a cap tip configured to pierce tissue at a cap distal end (Fig. 7a, showing a carrier 46 having a tip configured to pierce tissue).
Regarding claim 26, Leussler further teaches wherein a radiating portion distal boundary and the cap proximal boundary vary in distance from the probe distal end around a circumference of the coaxial cable (Figs. 11-13, the distal boundaries of conductor structures 411-413 which also can be considered the proximal boundary of the cap as discussed with respect to claim 23, above, vary in distance from the distal end of carrier 46 or isolating cover 455 around a circumference of carrier 46 which is electrically connected to and aligned with the circumference of the coaxial feed cable).
Regarding claim 27, Leussler further teaches wherein the radiating portion comprises a plurality of discrete sections (Figs. 11-13, conductor structures 411-413), wherein adjacent discrete sections are at different distances from a probe distal end around a circumference of the coaxial cable (Fig. 11-13, the distal boundaries of conductor structures 411-413 vary in distance from the distal end of carrier 46 or isolating cover 455 around a circumference of carrier 46 which is electrically connected to and aligned with the circumference of the coaxial feed cable).
Regarding claim 28, Leussler further teaches wherein the radiating portion comprises a wave shape around a circumference of the coaxial cable or a saw tooth shape around the circumference of the coaxial cable (Fig. 11, the distal ends of conductor structures 411-413 trace out a wave shape around the circumference of carrier 46 which is electrically connected to and aligned with the circumference of the coaxial feed cable).
Regarding claim 29, Leussler further teaches wherein the radiating portion is configured to emit the microwave energy at the first resonant frequency and the second resonant frequency in parallel (Par. 36, “Generally, the applicator antenna 4 is provided for emitting electromagnetic radiation energy (i.e. the RF ablation signals) at at least two different frequencies, either in an alternating manner (i.e. sequentially) or at the same time (i.e. simultaneously)”; par. 82, “The conductor structures are applied onto a holder or carrier 46, preferably in parallel to each other, however, in contrast to the embodiment according to FIG. 8, extending in the longitudinal direction of the holder 46.”; fig. 11, showing conductor structures 411-413 connected in parallel with each other).
Regarding claim 30, Leussler further teaches wherein the radiating portion is configured to emit the microwave energy at the first resonant frequency and the second resonant frequency at the same time (Par. 36, “Generally, the applicator antenna 4 is provided for emitting electromagnetic radiation energy (i.e. the RF ablation signals) at at least two different frequencies, either in an alternating manner (i.e. sequentially) or at the same time (i.e. simultaneously)”).
Regarding claim 32, Leussler further teaches wherein the shielded portion of the probe body comprises a metal cannula (Par. 89, “This dielectric material 453 is coaxially surrounded by a metallic shield 452, on which the outer isolating cover 455 is applied.”; fig. 13, metallic shield 452).
Regarding claim 33, Leussler further teaches a dielectric layer in between the metal cannula and the coaxial cable (Par. 89, “Further, FIG. 13 shows an outer isolating cover 455 which surrounds the applicator antenna, wherein the feeding section 45 is coaxially surrounded by a dielectric material 453. This dielectric material 453 is coaxially surrounded by a metallic shield 452, on which the outer isolating cover 455 is applied.”; fig. 13, dielectric material 452 between coaxial feed line and metallic shield 452).
Regarding claim 37, Leussler teaches a microwave ablation system (Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies which are selected especially according to the electrical properties and dimensions of the tissue to be ablated.”) comprising a microwave energy source (Fig. 1 and par. 34, “The handheld applicator unit 3 preferably comprises at least one microwave generator”) and a microwave ablation probe (Fig. 1, applicator unit 3), the microwave ablation probe comprising: a probe body (Fig. 13, feeding section 45 comprising isolating cover 455) comprising: a shielded portion (Fig. 13, portion of feeding section 45 comprising metallic shield 452) and a radiation window (Fig. 13, carrier 46 which comprises dual resonant conductor structures 411, 412 in enclosed by isolating hosing 461 as well as a portion of isolating cover 455 which can be considered the radiation window) that is at least partially transparent to microwave energy (Fig. 13, while 455 and 461 are not explicitly taught to be transparent to microwave radiation, the examiner maintains that the device would be inoperable otherwise since these structures enclose the antenna structure on carrier 46 and since the device is intended to deliver microwave radiation to biological tissue outside of the device, see Abstract); a metal cannula (Par. 89, “This dielectric material 453 is coaxially surrounded by a metallic shield 452, on which the outer isolating cover 455 is applied.”; fig. 13, metallic shield 452); and a coaxial cable within the probe body (Fig. 13, depicting a coaxial cable within outer isolating cover 455 and connected to matching device 34; par. 87, disclosing that feeding section 45 can comprise a coaxial cable) connected to a microwave energy source (Par. 56, “Finally, the applicator antenna 4 comprises a coaxial feeding section 45 by means of which the antenna is connected with the applicator unit 3.”; par. 34, “The handheld applicator unit 3 preferably comprises at least one microwave generator”), the coaxial cable comprising a radiating portion (Figs. 11-13, carrier 46 which comprises dual resonant conductor structures 411, 412 and 413) configured for emission of microwave energy (Par. 85, “FIG. 11 shows another embodiment of an applicator antenna 4 in the form of a multi-resonant antenna which comprises at least a first, a second and a third conductor structure 411, 412, 413, which are each resonant (preferably λ/4 resonant) at a first, a second and a third microwave frequency, respectively.”), wherein the radiating portion is aligned with the radiation window (Fig. 13, holder or carrier 46 is aligned with isolating hosing 461), the radiating portion comprising: a first section having a first length, the first section configured for emission of the microwave energy at a first resonant frequency (Fig. 13, first conductor structure 411 having a first length; par. 82, “Again, the dimensioning of the conductor structures 411, 412, especially of their lengths and widths, is calculated in dependence on the selected first and second microwave ablation frequency”; Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies”); and a second section having a second length, the second section configured for emission of the microwave energy at a second resonant frequency (Fig. 13, second conductor structure 412 having a second length; par. 82, “Again, the dimensioning of the conductor structures 411, 412, especially of their lengths and widths, is calculated in dependence on the selected first and second microwave ablation frequency”) that is different from the first resonant frequency (Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies which are selected especially according to the electrical properties and dimensions of the tissue to be ablated.”).
Regarding claim 38, Leussler further teaches wherein a radiating portion distal boundary varies in distance from a probe distal end around a circumference of the coaxial cable (Figs. 11-13, the distal boundaries of conductor structures 411-413 vary in distance from the distal end of carrier 46 or isolating cover 455 around a circumference of carrier 46 which is electrically connected to and aligned with the circumference of the coaxial feed cable).
Regarding claim 39, Leussler teaches a method of microwave ablation (Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies which are selected especially according to the electrical properties and dimensions of the tissue to be ablated.”) comprising: providing a microwave ablation probe (Fig. 1 and Abstract, “An electrosurgical ablation apparatus for generating and emitting electromagnetic radiation energy for ablating biological tissue is disclosed.”) comprising: a probe body (Fig. 13, feeding section 45 comprising isolating cover 455) comprising a shielded portion (Fig. 13, portion of feeding section 45 comprising metallic shield 452) and a radiation window (Fig. 13, carrier 46 which comprises dual resonant conductor structures 411, 412 in enclosed by isolating hosing 461 as well as a portion of isolating cover 455 which can be considered the radiation window) that is at least partially transparent to microwave energy (Fig. 13, while 455 and 461 are not explicitly taught to be transparent to microwave radiation, the examiner maintains that the device would be inoperable otherwise since these structures enclose the antenna structure on carrier 46 and since the device is intended to deliver microwave radiation to biological tissue outside of the device, see Abstract); a radiating portion (Fig. 13, carrier 46 which comprises dual resonant conductor structures 411, 412) configured for emission of microwave energy (Par. 85, “FIG. 11 shows another embodiment of an applicator antenna 4 in the form of a multi-resonant antenna which comprises at least a first, a second and a third conductor structure 411, 412, 413, which are each resonant (preferably λ/4 resonant) at a first, a second and a third microwave frequency, respectively.”), wherein the radiating portion is aligned with the radiation window (Fig. 13, holder or carrier 46 is aligned with isolating hosing 461), the radiating portion comprising: a first section having a first length, the first section configured for emission of the microwave energy at a first resonant frequency (Fig. 13, first conductor structure 411 having a first length; par. 82, “Again, the dimensioning of the conductor structures 411, 412, especially of their lengths and widths, is calculated in dependence on the selected first and second microwave ablation frequency”; Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies”); and a second section having a second length, the second section configured for emission of the microwave energy at a second resonant frequency (Fig. 13, second conductor structure 412 having a second length; par. 82, “Again, the dimensioning of the conductor structures 411, 412, especially of their lengths and widths, is calculated in dependence on the selected first and second microwave ablation frequency”) that is different from the first resonant frequency (Abstract, “The applicator antenna (4) is a dual or multi-resonant ablation antenna (41a, . . . 41d) for transmitting microwave ablation energy at at least two different frequencies which are selected especially according to the electrical properties and dimensions of the tissue to be ablated.”); and delivering microwave energy to the radiating portion (Par. 33, “The operating unit 1 comprises for example a control system 11 for controlling the applicator unit 3, especially for activating the generation of the RF ablation signals to be transmitted by the applicator antenna 4”).
Regarding claim 40, Leussler further teaches wherein the microwave ablation probe produces microwave energy at three or more resonant frequencies in parallel (Fig. 11, showing three different conductor structures 411, 412 and 413 wired in parallel; par. 85, “FIG. 11 shows another embodiment of an applicator antenna 4 in the form of a multi-resonant antenna which comprises at least a first, a second and a third conductor structure 411, 412, 413, which are each resonant (preferably λ/4 resonant) at a first, a second and a third microwave frequency”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21-25, 31-34, 36 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rossetto (US 20100045558) in view of Hancock et al. (US 20100168727, “Hancock”).
Regarding claim 21, Rossetto teaches a microwave ablation probe (Abstract, “A triaxial microwave antenna assembly is disclosed.”) comprising: a probe body (Figs. 6-7, triaxial antenna assembly 112) comprising a shielded portion (Figs. 6-7, portion of triaxial antenna assembly 112 covered by outer jacket 159); a coaxial cable within the probe body (Fig. 7, showing a triaxial cable composed of inner, central and outer conducts 150, 156 and 158 separated by inner insulator 152 and central insulator157) comprising a radiating portion configured for emission of microwave energy (Figs. 6-7, radiating portion 118; par. 34, ‘The triaxial antenna assembly 112 is adapted to deliver microwave energy at two distinct frequencies (e.g., high frequency and low frequency).’), the radiating portion comprising: a first section having a first length (Fig. 7a, high frequency radiating section 170 having a first length 2a), the first section configured for emission of the microwave energy at a first resonant frequency (Par. 34, “The inner and central conductors 150 and 156 represent the first dipole 170 of the double-dipole antenna 140, and are adapted to deliver microwave energy at a first frequency (e.g., 2450 MHz)”); and a second section having a second length (Fig. 7a, low frequency radiating section 172 having a length 2a+b), the second section configured for emission of the microwave energy at a second resonant frequency that is different from the first resonant frequency (Par. 34, “The first dipole 170 and the outer conductor 158 represent the second dipole 172 of the double-dipole antenna 140 and are adapted to deliver microwave energy at a second frequency (e.g., 915 MHz)”).
Rossetto fails to teach a radiation window that is at least partially transparent to microwave energy; and wherein the radiating portion is aligned with the radiation window.
Hancock teaches an analogous microwave ablation probe (Abstract, “A probe and associated apparatus for treating oesophageal tissue with microwave radiation (e.g. radiation having a frequency of 5-60 GHz) are disclosed.”; par. 1, “n. For example, it relates to a technique of causing tissue necrosis (thermal damage) and/or tissue ablation by exposing tissue to radiation with a frequency in the range of 5 to 60 GHz.”) comprising a radiating portion configured for emission of microwave energy (Fig. 9, patch antennas 302); and a radiation window that is at least partially transparent to microwave energy, wherein the radiating portion is aligned with the radiation window (Par. 42, “The radiating elements may contact the tissue to be treated. However, since it is preferred for the main energy transfer mechanism to be radiation (i.e. energy transfer due to conduction is desirably minimised). Preferably, the radiating elements have a biocompatible coating. […] This may be achieved by applying a conformal coating of e.g. Parylene C to the structure. It is preferable to apply a coating of less that 100 μm, and more preferable to apply a coating thickness of about 10 μm so that the biocompatible layer is transparent to the microwave energy.”).
Therefore, in view of Hancock, it would have been obvious to POSITA at the time that the invention was filed to coat the radiating elements with a microwave transparent dielectric material, in order to ensure that energy is transferred to the tissue through radiation rather than conduction, as taught by Hancock.
Regarding claim 22, Rossetto, as modified, further teaches wherein a length of the radiating portion varies around a circumference of the coaxial cable (Fig. 7a, the circumference of the radiating portions, which can be considered a ‘length’ varies between poles 182a and 182b of the radiating portion).
Regarding claim 23, Rossetto, as modified, further teaches wherein the coaxial cable comprising a cap located at a probe distal end (Fig. 2, tip 48; par. 22, “Assembly 12 also includes a tip 48 having a tapered end 24 that terminates, in one embodiment, at a pointed end 26 to allow for insertion into tissue with minimal resistance at a distal end of the radiating portion 18.”; fig. 7a, pole 180a at the distal end of inner conductor 150 can be mapped to the recited cap), the cap comprising a cap proximal boundary (Fig. 7a, showing that the cap at pole 180a comprises a proximal boundary).
Regarding claim 24, Rossetto, as modified, further teaches wherein the cap proximal boundary is uniform in distance from a distal end of the probe around a circumference of the coaxial cable (Fig. 7a, the proximal boundary of the cap at pole 180a is shown to be a distance ‘a’ from the distal end of the probe at the pointed end).
Regarding claim 25, Rossetto, as modified, further teaches wherein the cap further comprises a cap tip configured to pierce tissue at a cap distal end (Par. 22, “Assembly 12 also includes a tip 48 having a tapered end 24 that terminates, in one embodiment, at a pointed end 26 to allow for insertion into tissue with minimal resistance at a distal end of the radiating portion 18.”).
Regarding claim 31, Rossetto, as modified, further teaches a choke (Fig. 7b, choke 160; par. 37, “With reference to FIG. 7B, the triaxial antenna assembly 112 may include a choke 160 that is disposed around the outer conductor 158.”).
Regarding claim 32, Rossetto, as modified, teaches wherein the shielded portion of the probe body comprises a conductive cannula (Fig. 7b, choke 160; par. 37, “Choke 160 may include an inner dielectric layer 162 and an outer conductive layer 164.”), but fails to teach that the conductive cannula is a metal cannula.
The examiner maintains, however, that it would have been obvious to POSITA to construct the conductive layer of the choke of whatever conductive material was deemed suitable, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 33, Rossetto, as modified, further teaches a dielectric layer in between the metal cannula and the coaxial cable (Fig. 7b, inner dielectric between the outer choke conductive layer 164 and the coaxial outer conductor 158).
Regarding claim 34, Rossetto, as modified, further teaches a choke contact between the metal cannula and the coaxial cable (Par. 37, “The choke 160 may be a quarter-wavelength shorted choke at the low frequency and is shorted to the outer conductor 158 at the proximal end of the choke 160 by soldering or other suitable methods.”); and a choke length extending between the choke contact and a distal end of the metal cannula (Fig. 7b, the choke length is the length of conductive layer 164; par. 37, “The choke 160 may be a quarter-wavelength”).
Regarding claim 36, Rossetto, as modified, further teaches wherein the radiation window comprises a portion of the dielectric material of the coaxial cable surrounding the radiating portion of the coaxial cable (Fig. 7a, for instance the radiating section 172 comprises a coaxial antenna comprising inner, central and outer conductors separated by shielding material; par. 5, “In a dipole antenna, the conductors may be in a coaxial configuration including an inner conductor and an outer conductor separated by a dielectric portion.”).
Regarding claim 39, Rossetto, as modified, teaches a method of microwave ablation (Par. 2, “The present disclosure relates generally to microwave antennas used in tissue ablation procedures”) comprising: providing a microwave ablation probe (Figs. 6-7, triaxial antenna assembly 112) comprising: a probe body comprising a shielded portion (Figs. 6-7, portion of triaxial antenna assembly 112 covered by outer jacket 159) and a radiation window that is at least partially transparent to microwave energy (Rossetto has previously been modified in view of Hancock to coat the radiating portion with a microwave transparent dielectric material; see Hancock, par. 42, “more preferable to apply a coating thickness of about 10 μm so that the biocompatible layer is transparent to the microwave energy”); a radiating portion configured for emission of microwave energy (Figs. 6-7, radiating portion 118; par. 34, ‘The triaxial antenna assembly 112 is adapted to deliver microwave energy at two distinct frequencies (e.g., high frequency and low frequency).’), wherein the radiating portion is aligned with the radiation window (The transparent coating of Hancock is specifically provided on the radiating portion to prevent electrical conduction between the antenna and the tissue), the radiating portion comprising: a first section having a first length (Fig. 7a, high frequency radiating section 170 having a first length 2a), the first section configured for emission of the microwave energy at a first resonant frequency (Par. 34, “The inner and central conductors 150 and 156 represent the first dipole 170 of the double-dipole antenna 140, and are adapted to deliver microwave energy at a first frequency (e.g., 2450 MHz)”); and a second section having a second length (Fig. 7a, low frequency radiating section 172 having a length 2a+b), the second section configured for emission of the microwave energy at a second resonant frequency that is different from the first resonant frequency (Par. 34, “The first dipole 170 and the outer conductor 158 represent the second dipole 172 of the double-dipole antenna 140 and are adapted to deliver microwave energy at a second frequency (e.g., 915 MHz)”); and delivering microwave energy to the radiating portion (Par. 8, “The method also includes the step of supplying microwave either at a first frequency or a second frequency to selectively energize at least one of the first frequency radiating section and the second radiating section ”).
Conclusion
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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