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 . 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 August 2025 has been entered.
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 32 is rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 2016/0184002) and Hoey (US 2015/0025515).
Regarding claim 32, Yang discloses a system that comprises an object with an elongated, cylindrical needle with ferromagnetic, biocompatible material (7, fig. 5, [0023]) inserted perpendicularly through an orifice of a round, flat magnetic field generator with ferrite/steel arranged to direct the magnetic field along the longitudinal axis of the object (4, 5 and 6) for heating the object ([0005]). The claim term “acupuncture needle” is a functional limitation which could be performed by the needle of Yang. Relatedly, the language “configured to be placed on the skin” is also a functional limitation. As noted in MPEP 2173.05(g), apparatus claims are defined by what a device is, not what it does. Whatever element or subset of elements in the system of Yang controls energy to the generator can be considered a “device for controlling the temperature.” Yang does not disclose the generator includes a conductive coil with between 51 and some undefined upper number of turns. However, using magnetic coils for heating is common in the art and there is no evidence that the number of coils produces an unexpected result (within the meaning of MPEP 716.02(a)). Further, it has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)). Hoey discloses a magnetic heating device and teaches that between 10-100 coils can be used in the generator ([0041]). More generally, Hoey teaches that magnetic heaters are a fast, consistent heat source with a variety of applications, where the magnetic field generated is dependent on, among other things, the number of coils of the generator which further establishes that a person of ordinary skill in the art would know how to make a functional magnetic heater ([0056]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the device of Yang to use any number of coils commonly known to be useful for magnetic heating, including more than 50 as taught by Hoey, that would produce the predictable result of allowing a user to heat tissue with the device.
Claims 33-36, 40, 42 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Hoey, further in view of Baker (US 6,228,082).
Regarding claim 33 and 40, Yang does not disclose the size of the needle, presumably because a person of ordinary skill in the art would be able to choose an appropriately sized needle. Baker discloses an ablation device with a needle and teaches that an “acupuncturesized” needle is used with a diameter in the range of 0.05-2 mm (col. 2 line 60 to col. 3 line 10). It is noted that while Baker is used here to show that “acupuncture” is a broad term, the prior art need not disclose that a needle is used for acupuncture, only the diameter, because any needle of that diameter can perform the functional limitation of acupuncture. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Yang to have any commonly known diameter of ablation needle, including one within the range taught by Baker, including 0.15-0.45 mm, that would produce the predictable result of allowing the device to treat tissue in a desired manner.
Regarding claims 34, the generator is formed from a “shell” made of insulating material (5 in fig. 3 of Yang).
Regarding claim 35, the generator is formed from a “shell” made of a conductive material (4 in fig. 3 of Yang).
Regarding claim 36, the device of Yang does not specifically disclose the diameter of the orifice. However, sizing an orifice is well within the level of ordinary skill in the art. Hoey further discloses that the orifice defined by the coil is between 4-25 mm (fig. 1, [0049]), and more generally less than 10mm ([0026]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to select an appropriate diameter for the orifice in the generator, including less than 10mm such as taught by Hoey that would produce the predictable result of a device that can be used to treat tissue in a desired manner.
Regarding claim 42, the device of Yang does not disclose the particular ferromagnetic material, presumably because it would be a matter for a person of ordinary skill in the art to determine. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known ferromagnetic material in the device of Yang, including ferritic or martensitic stainless steel, that would produce the predictable result of a device having desired electrical, thermal, and/or mechanical properties.
Regarding claim 44, the device of Yang does not disclose the diameter or thickness of the generator, presumably because it makes no meaningful difference to the function of the device and would be well within the level of ordinary skill in the art to determine. Magnetic heaters commonly have lengths, widths and thickness in ranges measured in millimeters such as taught by Hoey, as discussed above (note in particular the close relationship between the diameter of the generator orifice and the diameter of the generator). Therefore, before the application was filed, it would have been obvious to modify the generator of Yang to have any diameter or thickness in the millimeter range that would allow it to be used to treat tissue in a desired manner.
Claims 37, 38 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Hoey and Baker, further in view of Denis (2013/0158535).
Regarding claim 37, the device of Yang does not disclose that the object is entirely made of the ferromagnetic material. However, using magnetic fields to heat ferromagnetic material is a very common type of system and the construction of “objects” to be heated is well within the level or ordinary skill in the art. Denis, for example, discloses such a system and teaches that the object can be provided with ferromagnetic materials in a number of ways including entirely ferromagnetic ([0014]). This is understood to be a teaching of functional equivalence (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to further modify the device of Yang to include a ferromagnetic object for heating using any commonly known configuration, including entirely ferromagnetic as taught by Denis, that would produce the predictable result of a system that can be used to ablate tissue in a desired manner.
Regarding claims 38 and 43, the device of Yang does not disclose a coating of biocompatible material, such as polytetrafluoroethylene. Denis discloses a coating of biocompatible material such as PTFE (trademark TEFLON, [0087]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Yang with any commonly known coating, including the tip with a biocompatible material as taught by Denis, that would produce the predictable result of a system that operates in known and desired manner. It is noted that the layer covering the entire object is also the layer “at least partially” covering the object.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, Hoey and Baker, further in view of Burger (US 2008/0154254).
Regarding claim 39, the device of Yang does not disclose the use of a disc. Burger discloses a device with a needle and teaches that a disc can be used to control the depth of needle insertion (fig. 6 and associated discussion). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the device of Yang with one or more discs as taught by Burger to allow a user to control the depth of insertion. The device of Yang does not specifically disclose that the disc is a heating disc. However, metal, which is typically thermally conductive, is commonly used in the construction of medical devices. Therefore, before the application was filed, it would have been obvious to further modify the device of Yang with a disc having any commonly known material, including thermally conductive metal, that would produce the predictable result of allowing a user to control the depth of insertion. Using a thermally conductive disc in this manner would cause the disc to heat at least by proximity to the other heated elements of the system.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, Hoey and Baker, further in view of Eggers (US 2016/0242836).
Regarding claim 41, Yang does not disclose the details of the device for controlling temperature. However, using temperature information for control purposes is common in the art. Eggers discloses a system (fig. 1) that also uses a magnetic field generator for heating a ferromagnetic material and teaches that temperature information can be provided to a device (30) with a display (45) and processor to allow a user to set the desired temperature so that the device can maintain that temperature ([0079]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Yang with the temperature control device as taught by Eggers, either because the results of the combination of such common and well-understood elements would have been predictable or because it would allow a user to control the temperature reached by the object.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
It is noted, however, that attacks against the functionality of Yang will not be a productive line of argument. First, it will take substantially more evidence than the statements made in the remarks to overcome the assumption that inventions described in patent applications function according to their stated goals (MPEP 2121(I)). Second, even if Applicant meets that burden, a reference is still prior art for all that it teaches (MPEP 2121.01(II)). Thus, even if Yang is in fact incapable of reaching an ablation temperature, that has no bearing on whether it has a magnetically heated needle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding a magnetic heater with “at least one winding” and having a thickness between 5-100 mm, see paragraph [0093] of US 2009/0216220 to Hoey. Regarding a magnetic heater with 400 turns, see paragraph [0060] of US 2018/0360523 to Hastings.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794