DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 November 2025 has been entered.
Response to Arguments
Applicant's arguments filed 26 November 2025 have been fully considered but they are not persuasive.
Applicant argues that Zepeda fails to disclose a further lead that independently enters the skin at a different location; its temperature sensors are not taught as independently inserted boundary-positioned leads. This is not found to be persuasive. Zepeda specifically teaches one or more sensors (24) may be positioned on interior or exterior surfaces of introducer electrode 14, secondary electrode 16 or insulation sleeve 18 and preferably placed at a distal end of secondary electrode 16. Zepeda goes on to teach that the sensors 24 determine the boundary of the ablated mass (Col. 5, lines 53-67). Furthermore, Zepeda’s leads are independent from each other (Col. 3, lines 58-65 which states in part “Secondary electrodes 16 are positionable in an introducer electrode lumen before or after the introduction of introducer electrode 14 through tissue.).
Applicant argues that Azure’s teaches mild hyperthermia for immune system stimulation, but “immune stimulation” is not the same as “avoiding destruction of tumor antigens.” However, this is not found to be persuasive. The fact that the inventor has recognized another advantage which would flow naturally from the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. Additionally, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues that without explicit teaching, a person of ordinary skill in the art would have no reasonable expectation of success in achieving this dual thermal objective by combining the cited references. This is not found to be persuasive. Zepeda teaches that it is known that elevating the temperature of tumors is helpful in the treatment and management of cancerous tissues and that while the mechanisms of selective cancer cell eradication by hyperthermia are not completely understood four cellular effects have been proposed including (i) changes in cell or nuclear membrane permeability or fluidity, (ii) cytoplasmic lysomal disintegration, causing a release of digestive enzymes, (iii) protein thermal damage affecting cell respiration and the synthesis of DNA or RNA and (iv) potential excitation of immunologic systems (Col. 1, lines 26-38) and Azure teaches that the target temperature for mild hyperthermia at which the destruction of cancerous cells is enhanced is about 42-45 degrees Celsius ([0026]) and that where energy delivery induces tissue heating in excess of about 45-48 degrees C more indiscriminate destruction of cancerous and non-cancerous cells occurs ([0026]). Therefore, given the teachings of the prior art, the fact that the inventor has recognized another advantage which would flow naturally from the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites “wherein said first lead comprises a light energy emission area…wherein said light energy emission area is a bare fibre tip, or a diffusor…” and is unclear as claim 1 from which claim 25 depends already includes providing light from a bare fibre tip or a diffusor. Is this an additional bare fibre tip or a diffusor or does the energy emission area is the bare fibre tip or the diffuser from claim 1. For the purpose of the application of prior art, this limitation has been interpreted as the bare fibre tip or the diffusor of claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 8-10, 13, 15, 18, 19, 21, 23 and 24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 6,090,105 to Zepeda et al. (Zepeda) in view of US 2009/0076499 A1 to Azure (Azure).
Regarding claim 1, Zepeda teaches an apparatus (10) for interstitial thermal treatment of a tumor (see entire document), said apparatus comprises a first lead (one of 16 which includes an insulation sleeve 18 in which 16 is arranged, see Col. 5, lines 17-25) to be arranged into said tumor interstitially such that a distal portion of said first lead is positioned within the tumor (see for example Col. 6, lines 32-40), said first lead further comprises a light conducting fiber arranged in a lumen of said first lead to provide light (Col. 5, lines 49-52), a heat source (Col. 5, lines 40-52), wherein said heat source is a light source connectable to said light conducting fiber for conducting light from said light source to a point at said distal portion of said first lead (Col. 5, lines 40-52 and as stated above the first lead is 16 which includes an insulation sleeve 18 in which 16 is arranged, see Col. 5, lines 17-25), a further lead (the other of 16) separate from and spatially distinct from said first lead (leads 16 are not connected and to be spatially distinct means to be separate and clearly defined by position or location in space or arrangements compared to their surroundings which is shown for example in Fig. 4) positionable at or near boundaries of said tumor (Fig. 4), said further lead comprising a thermal sensor (24) for measuring a first temperature (Col. 5, lines 57-67) closer to the boundary than the position of said first lead (A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.), said at first lead is configured to independently penetrate skin at a location different from that of said first lead (Col. 3, lines 58-65: Additionally it is noted that the leads are independent of each other and will necessarily penetrate the skin at two different locations as they are independent of each other) and a control unit (38) configured for adjusting a power output of said heat source based on said measured first temperature, at or near said boundary of the tumor, so that said first temperature is maintained at a predetermined temperature during the thermal treatment (Col. 9, lines 49-63 and Col. 5, lines 57-67). However, Zepeda is silent with respect to the first temperature being controlled to kill tumor cells and avoid the destruction of tumor antigens. Azure teaches an analogous apparatus (10) including that the energy is controlled to kill tumor cells and avoid the destruction of tumor antigens ([0020, 0026, 0039, 0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Zepeda to have controlled the first temperature as taught by Azure as Azure teaches that target temperatures for mild hypothermia are about 42-45oC at which the destruction of cancerous cells is enhanced ([0026]).
Regarding claim 8, Zepeda in view of Kaplan teaches the apparatus of claim 1 as well as Azure teaching an imaging system (260) for locating and/or characterizing the target tissue region and/or locations or positioning the device during use ([0048]). It would have been obvious to one having ordinary skill in the art at the time of the invention to have included the image analysis system of Azure with the apparatus of Zepeda so as to locate and/or characterize the target tissue and/or locate or position the device during use as taught by Azure ([0048]).
Regarding claim 9, Zepeda in view of Azure teaches the apparatus of claim 1 as well as Zepeda further teaching a display means (38) for displaying information related to said temperatures.
Regarding claim 10, Zepeda in view of Azure teaches the apparatus of claim 1 as well as Zepeda further teaching wherein said further lead comprises a further heat source (Col. 5, liens 40-52) and said further heat source is a laser light source connectable to a light conducting fiber for conducting light from said source to a point at said lead (Col. 5, lines 4-52).
Regarding claim 13, Zepeda in view of Azure teaches the apparatus of claim 1 as well as Zepeda further teaching wherein said control unit is configured to carry out said thermal treatment for a period of 30 minutes (Col. 9, lines 12-27 as the control unit of Zepeda is capable of performing the intended use, and therefore meets the claim limitation).
Regarding claim 15, Zepeda in view of Azure teaches the apparatus of claim 1 as well as Zepeda further teaches that there is a relatively significant amount of activity in the area of hyperthermia as a tool for treatment of tumors and that it is known that elevating the temperature of tumors is helpful in the treatment and management of cancerous tumors (Col. 1, lines 26-42) and Azure teaches that target temperatures for mild hypothermia are about 42-45oC at which the destruction of cancerous cells is enhanced ([0026]). However, Zepeda and Azure are silent with respect to the temperature specifically being in the range of 42.5-48°C during treatment. It is asserted that it would have been obvious to one having ordinary skill in the art at the time of the invention to have selected a temperature in the range of 42.5-48°C during treatment, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 18, Zepeda in view of Azure teaches the apparatus of claim 11 as well as Zepeda further teaching wherein said thermal sensor is a thermistor probe (see at least Col. 6, lines 1 -7).
Regarding claim 19, Zepeda in view of Azure teaches the apparatus of claim 1 as well as Zepeda further teaching wherein a further thermal sensor is positioned on said first lead (Col. 5, lines 57-67).
Regarding claim 21, Zepeda in view of Azure teaches the apparatus of claim 19 as well as Zepeda further teaching wherein said thermal sensor is a thermistor probe (see at least Col. 6, lines 1 -7).
Regarding claim 23, Zepeda in view of Azure teaches the apparatus of claim 18 as well as Zepeda further teaching wherein said thermistor probe comprises a plurality of longitudinally separated thermal sensors (see for example Col. 5, lines 57-610).
Regarding claim 24, Zepeda in view of Azure teaches the apparatus of claim 19 as well as Zepeda further teaching wherein said control unit is configured for calculating a temperature of said tumor between said thermal sensors and said further thermal sensors (Col. 5, line 57-Col. 6, line 26).
Claim(s) 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zepeda and Azure as applied to claim 1 above, and further in view of US 2006/0247618 Al to Kaplan et al. (Kaplan).
Zepeda in view of Azure teaches the apparatus of claim 1, as well as Zepeda further teaching wherein said first lead comprises a light energy emission area (Col. 5, lines 40-52), and a moveable sleeve (14) wherein said sleeve is configured for arranging said lead in said tissue (see for example Col. 6, lines 32-40).
However, Zepeda is silent with respect to a scale and the sleeve having a reference point for determining a depth of said light emission area in said tumor, when said first lead is being positioned and a locking means arranged at said sleeve to lock said sleeve and said first lead in position, thereby fixating the position of the light emitting area. Kaplan teaches an analogous apparatus including improving ease of use by including a device locator or lock. As a locator, Kaplan teaches, graduations or a scale marking location along the body of the treatment device, or a stop fixing ultimate insertion depth within an access device may be employed. As a lock, fittings, clips, clamps, etc. may be employed. When a lock or stop is employed, it may be located on the treatment catheter at a location corresponding to the desired insertion depth within the access device deployed. When a scale or gradations on the body of the treatment catheter are provided, these provide a visual indication of either the length of insertion of the treatment catheter, the portion of the device distal the end of a known-length access device, or some other measurement to assist in setting the position of the distal end of the treatment catheter relative to the end of the access device ([0028]). It would have been obvious to one having ordinary skill in the art at the time of the invention to have included the device locator and/or lock such as those taught by Kaplan so as to assist in locating the treatment device at a location corresponding to the desired insertion depth as taught by Kaplan. While Kaplan does not specifically recite a locking screw, it is asserted that one having ordinary skill in the art at the time of the invention would be reasonably apprised of the many and varied alternatives that would provide for locking the treatment device at a location corresponding to a desired insertion depth as an obvious matter of engineering design choice.
Neither Zepeda nor Kaplan specifically teaches wherein said lead has a bare fiber tip or a diffusor. However, it is asserted that one having ordinary skill in the art at the time of the invention would have been reasonably apprised of how to configure the lead and fiber to guide the light as an obvious matter of engineering design choice based on the suitability for the intended use (here to provide thermal therapy to a tissue mass). This is especially true as Zepeda further teaches that “It will be appreciated that devices similar to those associated with RF multiple elected device 12 can be utilized with laser optical fibers, microwave devices and the like.”
Conclusion
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794