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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04 February 2026 has been entered.
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.
Claims 1, 3 and 21-23 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 1, 3 and 21-23, claim 1 previously recited that the trace circuit includes a first portion which extends from a first (proximal) end to a return portion, and a second portion which extends from the return portion to a second (proximal) end. The return portion is therefore located between the first and second portions. The claim has been amended to recite that the first section extends from the return portion to the second section. This contradicts what has been previously claimed: the first section cannot both extend to the return portion from the first end and also be an independent, linear section which extends from the return portion to the second section. The term “linear” cannot be understood to include the return portion which turns 180 degrees, and the claim does not recite that the linear, first section is two distinct sections on either side of the return portion. Similarly, the claim has been amended to recite that the second section extends from the first second to the second end, but this contradicts the claim language which recites that the second portion extends from the return portion to the second end. Claims 3 and 21-23 depend from claim 1 and are therefore also indefinite.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Kudo (US 2019/0110831) in view of Horlle (US 2014/0228844).
Regarding claims 1 and 3, Kudo discloses a thermal element for treating tissue having U-shaped (i.e. first and second sections extending between first and second ends) resistive trace circuit (152, fig. 5) located on an insulating layer (151) located on a substrate (13). The resistive trace circuit has two ends connected to a source of energy for heating the circuit (1521). Kudo does not disclose that the two elongate sections of the U-shaped resistive trace circuit include a linear configuration in addition to the tortuous, repeating pattern (fig. 5). However, various configurations of resistive trace circuits are known in the art and Kudo attaches no significance to the particular configuration. Horlle discloses another thermal element for treating tissue having a U-shape resistive circuit (120, fig. 2) located on an insulating layer (110), where the resistive circuit has two elongate sections each between respective ends and a return portion, one with a linear configuration and the other with a tortuous, repeating pattern (fig. 2). Horlle teaches this configuration allows "even heating" ([0046]). Further, it has been held that the simple substitution of one known element for another 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 modify the device of Kudo to provide the U-shape resistive circuit in the configuration shown by Horlle, including one linear section and one tortuous, repeating pattern section, that would ensure even heating and/or to produce the predictable result of allowing the device to heat tissue in a desired manner.
It is noted that while claim 1 is indefinite as discussed above, there is a portion of the tortuous section of Horlle that exists at a substantially right angle to the linear portion (fig. 2) such that at least that part of the tortuous section can be considered linear. That is, Horlle can be considered to disclose a first linear portion (the long straight part of 120), a second linear portion (the distal-most straight part of 120 at a right angle to the long straight part of 120), a return portion (the junction between the long straight part and the short straight part), and a tortured portion (the remaining tortured part of 120).
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kudo and Horlle, further in view of Hanlon (US 2008/0200914).
Regarding claims 25-27, the device of Kudo as modified does not disclose an encapsulating layer. However, encapsulating layers are common in the art for a wide range of reasons and there is no evidence that this particular encapsulating layer produces an unexpected result (within the meaning of MPEP 716.02(a)). In fact, it is of note that Applicant has not described any result for the encapsulating layer. Hanlon discloses a medical device and teaches that the treatment portion can be provided with a biocompatible encapsulating layer with a thickness between 0.0005-0.005 inches ([0027]). Additionally, 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 any part of the device of Kudo to have an encapsulating layer of appropriate biocompatible material with a thickness of 0.005-0.005 inches such as taught by Hanlon, that would produce the predictable result of allowing the device to perform in a safe and effective manner.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuruta (US 2019/0142504) in view of Kudo and Neubardt (US 2006/0216671)
Regarding claims 1 and 3, Tsuruta discloses a device with a thermal element comprising a resistive circuit in a U-shaped configuration, extending from a proximal end of the device to the distal end of the device, then looping to extend back to the proximal end of the device ([0044]). Tsuruta does not actually show the resistance circuit, because such elements are commonly used and well understood in the art, and therefore does not disclose the substrate or insulating layers, or that one section of the U is straight and the other is tortured. Kudo discloses a thermal element for treating tissue having U-shaped (i.e. first and second sections extending between first and second ends) resistive trace circuit (152, fig. 5) located on an insulating layer (151) located on a substrate (13). Kudo also does not disclose the linear/tortuous configuration, but this is common for resistance heaters such as taught by Neubardt (fig. 2). 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 modify the device of Tsuruta to include any commonly known thermal element components, including the trace located on an insulating layer located on a substrate such as taught by Kudo, and to include any commonly known arrangement of U-shaped trace pattern including a first linear section and a second tortuous configuration such as taught by Neubardt, that would produce the predicable result of allowing a user to heat tissue in a desired manner.
It is noted that while claim 1 is indefinite as discussed above, there is a portion of the tortuous section of Neubardt that exists at a substantially right angle to the linear portion (fig. 2) such that at least that part of the tortuous section can be considered linear. That is, Neubardt can be considered to disclose a first linear portion (the long straight part of 24), a second linear portion (the bottom, as seen in fig. 2, straight part of 24 at a right angle to the long straight part of 24), a return portion (the junction between the long straight part and the short straight part), and a tortured portion (the remaining tortured part of 24).
Allowable Subject Matter
Claims 11, 14, 15, 19, 20 and 28-30 are allowed (or will be allowed by withdrawing the restriction requirement once there are no more rejected claims).
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794