DETAILED ACTION
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 .
This Office Action is responsive to the Amendment filed 13 November 2025. Claims 1-3, 5, 7, 9, 10, 13, 14, 16, 18, 21-25, and 27-34 are currently under consideration. The Office acknowledges the amendments to claims 1, 9, 13, 16, 33, and 34.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1, 2, 22, 23, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al. (U.S. Pub. No. 2018/0064366 A1; hereinafter known as “Sweeney”).
Regarding claim 1, Sweeney discloses a device for treatment of a tumor (Abstract; Fig. 4; [0056]; ablation tool for treating a tumor) comprising: a treatment object 104 configured for placement in contact with the tumor, the treatment object comprising a heating surface configured to reach a treatment temperature, the treatment temperature being higher than a patient body temperature ([0056]; [0063]); an energy source 120 configured to provide energy to reach said treatment temperature, said energy source being located externally to said treatment object (Fig. 6; [0071]-[0072]); and an outwardly expandable spring associated with said treatment object, wherein the spring is configured to expand under temperature control ([0054]; [0076]-[0078]; [0083]-[0085]).
Regarding claim 2, Sweeney discloses that said energy source is a radio frequency transmitter configured to transmit energy at a predetermined frequency, and said treatment object comprises an antenna for wireless reception at said predetermined frequency ([0071]; [0093]).
Regarding claim 22, Sweeney discloses an antenna 230/232 connected by wire to said treatment object ([0086]), said energy source comprising an external transmitter for transmitting power to said antenna ([0071]-[0072]).
Regarding claim 23, Sweeney discloses that said antenna is connected to a battery 216, said battery being chargeable from said energy source ([0070]-[0071].
Regarding claim 34, Sweeney discloses that said treatment object is configured to be located inside a body of a patient and said energy source is configured to be located outside said body, said energy source being configured to transmit energy wirelessly to said treatment object from said energy source (Fig. 6; [0071]-[0072]).
Claims 1, 3, 5, 7, 9, 14, 16, 18, 21, 25, 27-30, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gough et al. (U.S. No. 5,728,143; hereinafter known as “Gough”).
Regarding claim 1, Gough discloses a device for treatment of a tumor (Abstract; col. 1, lines 20-30; col. 4, lines 61-65) comprising: a treatment object 12 configured for placement in contact with the tumor, the treatment object comprising a heating surface configured to reach a treatment temperature, the treatment temperature being higher than a patient body temperature (col. 4, lines 43-53); an energy source 20 configured to provide energy to reach said treatment temperature, said energy source being located externally to said treatment object (col. 2, lines 47-64; col. 6, lines 1-5); and an outwardly expandable spring 16 associated with said treatment object, wherein the spring is configured to expand under temperature control (col. 3, lines 30-36).
Regarding claim 3, Gough discloses that said externally located energy source comprises a battery or wherein said externally located energy source comprises a laser, the laser being connected to said treatment object via an optical fiber (col. 6, lines 8-12).
Regarding claim 5, Gough discloses a needle 14 for placement of said treatment object, wherein the treatment object is located within the needle, for accurate placement of said treatment object at a predetermined location, or further comprising a placement device 14 for placement of said treatment object, wherein the treatment object is held for accurate placement of said treatment object at a predetermined location (col. 4, lines 43-51).
Regarding claim 7, Gough discloses that the treatment object is attached to at least one wire 22, the wire remaining connected as the treatment object is expelled from said needle (col. 6, lines 1-2) or further comprising a thermostat 24 for regulating said treatment object at said treatment temperature (col. 6, lines 20-50).
Regarding claim 9, Gough discloses an overall diameter larger than 0.05 mm and less than one millimeter (Fig. 1; col. 3, lines 16-19; e.g., 15 gauge is a diameter of approximately 1.45mm, with three antennas held within the trocar, each antenna or insulation sleeve would have a diameter of the recited range [approximately 0.4-0.5 mm]).
Regarding claim 14, Gough discloses that said spring comprises said heating surface (col. 4, lines 54-60) or wherein said spring is configured to provide a predetermined outward pressure.
Regarding claim 16, Gough discloses a device for treatment of a tumor (Abstract; col. 1, lines 20-30; col. 4, lines 61-65) comprising: a treatment object 12 configured for placement in contact with the tumor, the treatment object comprising a heating surface configured to reach a treatment temperature, the treatment temperature being higher than a patient body temperature (col. 4, lines 43-53); and an energy source 20 configured to provide energy to reach said treatment temperature, said energy source being located externally to said treatment object (col. 2, lines 47-64; col. 6, lines 1-5); wherein said treatment object has a predetermined heat capacity (col. 3, lines 30-36), said device being configured to provide energy to said treatment object at intervals calculated to maintain said treatment temperature (col. 6, lines 20-50), or wherein said treatment object comprises a container, the container comprising a treatment drug, or wherein said object comprises an expandable bladder, said heating surface being an external surface of said bladder, or wherein said treatment object comprises an expandable bladder, said heating surface being an external surface of said bladder.
Regarding claims 18, 21, and 27-30, Gough discloses the broadest reasonable interpretation of the claims, as these claims further limit the container or the bladder; however, claim 16 recites each of these elements in the alternative to the limitation reciting that the treatment object has a predetermined heat capacity and said device being configured to provide energy to said treatment object at intervals calculated to maintain said treatment temperature. Thus, as Gough teaches that the treatment object has a predetermined heat capacity and said device being configured to provide energy to said treatment object at intervals calculated to maintain said treatment temperature, it also teaches each of these claims. In other words, claim 16 recites limitations A (treatment object), B (energy source), and then C (heat capacity and energy at intervals) or D (container) or E (bladder). Any combination of A/B/C or A/B/D or A/B/E would meet the claim. As detailed, Gough teaches A/B/C. Claims 18 and 21 recite D + F (additional container limitations), but the claims are still A/B/C or A/B/D/F (met by Gough); while claims 27-30 recite E + G (additional bladder limitations), but the claims are still A/B/C or A/B/E/G (met by Gough).
Regarding claim 25, Gough discloses that said heating surface comprises one member of the group consisting of a metal surface, a surface comprising metallic particles, a surface comprising ferromagnetic particles, a surface comprising metal particles in a matrix, a polymer, and a surface comprising metal particles in a ceramic matrix (col. 2, lines 56-62; col. 5, lines 30-37).
Regarding claim 33, Gough discloses that said heating surface is covered with an insulating envelope 18, the insulating envelope comprising openings, the openings located to coincide with tumor surfaces when said object is suitably positioned (col. 5, lines 48-53; col. 8, lines 31-37).
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manwaring et al. (U.S. Pub. No. 2012/0226270 A1; hereinafter known as “Manwaring”).
Regarding claim 1, Manwaring discloses a device for treatment of a tumor (Abstract; [0094]; [0112]) comprising: a treatment object 50 configured for placement in contact with the tumor, the treatment object comprising a heating surface configured to reach a treatment temperature, the treatment temperature being higher than a patient body temperature ([0096]); an energy source 30 configured to provide energy to reach said treatment temperature, said energy source being located externally to said treatment object (Fig. 1; [0096]); and an outwardly expandable spring 220 associated with said treatment object, wherein the spring is configured to expand under temperature control ([0158]).
Regarding claim 10, Manwaring discloses that said treatment temperature in degrees Celsius is one member of the group consisting of: greater than 38 degrees; greater than 39.5 degrees; less than 55 degrees; between 39.5 degrees and 55 degrees; between 40 degrees and 50 degrees; between 40 degrees and 48 degrees; between 41 degrees and 47 degrees; between 42 degrees and 46 degrees; between 43 degrees and 45 degrees; between 43 degrees and 44 degrees; about 43.5 degrees; and precisely 43.5 degrees ([0146]).
Claims 13, 31, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunday et al. (WO 2011/142758 A1; hereinafter known as “Gunday”).
Regarding claim 13, Gunday discloses a device for treatment of a tumor (Abstract; [0105]; [0139]) comprising: a treatment object 24 configured for placement in contact with the tumor, the treatment object comprising a heating surface configured to reach a treatment temperature, the treatment temperature being higher than a patient body temperature ([0050]; [0079]; [0099]; [0120]); an energy source 108 configured to provide energy to reach said treatment temperature, said energy source being located externally to said treatment object ([0097]); an outwardly expandable spring associated with said treatment object ([0050]; [0083]; [0100]); and a bladder 30 located inside said spring, said bladder being expandable under external control ([0081]).
Regarding claims 31 and 32, Gunday discloses a measurement switch configured to operate a pump 22 to pump fluid into said bladder whenever a pressure at said bladder falls below a predetermined amount, wherein said pressure is one member of the group consisting of a bladder fluid pressure and a treatment drug fluid pressure ([0039]; [0078]; [0087]; [0105]; [0112]; [0118]-[0119]; [0132]-[0135]).
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: as detailed in the previous Office action, none of the prior art of record teaches or reasonably suggests such an external coil surrounding a patient and powering a plurality of said treatment objects, in combination with such a device for thermal treatment of a tumor.
Response to Arguments
Applicant’s arguments with respect to the objections to the claims and the rejections under 35 U.S.C. 112(b) and 101 have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn.
Applicant's arguments with respect to the rejections under 35 U.S.C. 102 have been fully considered but they are not persuasive. Applicant only argues the rejections based upon Sweeney; none of the rejections based upon Gough, Manwaring, or Gunday are traversed. Regarding Sweeney, Applicant first argues that Sweeney fails to teach a heating surface for thermal treatment. The examiner disagrees. The cited portions of Sweeney teach a treatment object (in the form of a deployable element), wherein the treatment object can provide ablation to a tumor in the form of heating, such as thermal ablation by a heating element or thermal energy.
Applicant next argues that Sweeney fails to teach an outwardly expandable spring configured to expand under temperature control. The examiner disagrees. The cited portions of Sweeney teach several components associated with the treatment object that may reasonably considered to be such a spring. For example, a release mechanism triggered by an actuator, wherein the actuator can apply a spring force and be driven in response to a temperature change; the actuator can be made of shape memory materials, which can expand or contract upon a temperature stimulus being applied. Another component is taught to be a two-way linear actuator using springs made from a shape memory alloy. Finally, yet another component is taught to be a stiffening element for supporting the treatment object, wherein the stiffening element is a spring-like support structure, which also can include a shape memory alloy.
Applicant argues that Sweeney does not teach tumor treatment functionality. The examiner disagrees. As detailed above, Sweeney teaches ablation of a tumor.
Applicant argues that Sweeney does not teach the limitation of claim 16 “said device being configured to provide energy to said treatment object at intervals calculated to maintain said treatment temperature.” Sweeney has not been cited as a reference for claim 16; instead, claim 16 is rejected based upon Gough.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791