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 .
Status of Claims
Claims 1-13 are pending in this application. Claims 2 and 6 are withdrawn, and Claims 1, 3-5, and 7-13 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of claims 10-20 drawn to species B from Group I in the reply filed on 11/25/25 is acknowledged.
Claims 2 and 6 are withdrawn from further consideration as being nonelected from Species Group I (the feature of the heating scheme).
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 3-5, 7-8, and 11 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.
Claim 3 further recites the limitation of “at least one high temperature session and at least one sub- high temperature session”, then further “a predetermined temperature” and “a target temperature”. It is unclear what the bounds or range of a high temperature and sub-high temperature would be. It is also unclear if the predetermined temperature and target temperature are related to the high and sub-high temperatures, or if these are all four separate temperature ranges. There is no clear indication of these temperatures. For purposes of examination, the limitation will be construed as. However, further clarification is required.
Further, claim 3 recites the limitation “both the at least one high temperature session and the at least one sub-high temperature session are in a plural number”. It is unclear what is meant by the sessions being in a plural number. For purposes of examination, the limitation will be construed to be a repeating cycle of one temperature into a lower temperature than the first. However, further clarification is required.
Claim 3 further recites the limitation “the heated area is not heated up or is heated up”. It is unclear what the claim requires, as the term is defined to be heated, but the claim also recites that the area does not need to be heated up. For purposes of examination, the limitation will be construed as a session where the temperature decreases from the previously mentioned temperature. However, further clarification is required.
Claim 7 recites the limitation “human body temperature to a target temperature”. It is unclear what the exact temperature would be for human body temperature as the modern agreed upon temperature in the human body is often provided as a range (36.50C -370C) with variations depending on various conditions. Further, is it unclear what a target temperature is, whether it is distinct from the target temperature in claims 2 and 3, and what the exact temperature would be. For purposes of examination, the limitation will be construed as any temperature within the given range (36.50C -370C). Further, the limitation of the target temperature will be construed as any temperature that is not higher than 42C. However, further clarification is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “frequency of 5~500 Hz”, and the claim also recites “preferably 25~50 Hz” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4-5 and 8 is rejected due to its dependency to the rejected claims above.
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.
Claims 1, 3-5, 7, 9-10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chao (US20210180040A1).
Regarding Claim 1,
Chao teaches a heating device for imposing intermittent thermal effect on neural tissue of an animal or a human body in vivo (corresponding disclosure in at least [0001], where the
device applies heat (thermal effect) to tissue “a method and an apparatus for applying heat to
living tissue”), comprising:
a control unit having a thermal effect logic to be executed by the control unit; and a heater electrically connected to the control unit, the control unit executing the thermal effect logic to controllably cause the heater to heat up a portion of neural tissue of an animal or a human body in vivo (corresponding disclosure in at least [0030] where HIFU is used for heating and can be adjusted to heat a portion of the human tissue “the use of HIFU is able to penetrate through the body surface to perform heating on a portion of the human tissue underneath the body surface without damaging the body surface and other tissue regions in the body. In addition, the size of the focal point of HIFU can be adjusted to control the range of heating.”, and further in [0060] where it specifies a thermal effect logic (heat treatment logic) for heating and cooling “When the microcomputer 41 executes the heat treatment logic 43L, it controls the cooling device 49 to perform the cooling process on the portion of the living tissue. During the actual operation, the cooling method typically uses a coolant or a temperature - controlled coolant circulating device to perform cooling on the living tissue via a contact method”), wherein an area to be heated is defined as a heated area, wherein the thermal effect logic comprises:
sequentially, at least one first heating session is followed by a first cooling session, and the first cooling session is followed by a second heating session, the first or second heating session allowing the control unit to controllably cause the heater to perform a heating process, the first cooling session allowing the control unit to controllably cause the heater to not perform any heating process or to perform a heating process with low power, wherein the heating process performed with low power uses heating power lower than the heating power used in the first heating session,
the first heating session entails heating up the heated area to cause the heated area to stand above 390C and stay between 390C and 420C (corresponding disclosure in at least [0030], where there is a first heating step above 390C “ heating is performed on a portion (not shown in the drawings) of a living tissue in a first time interval T1, and the temperature of the portion of the living tissue is maintained between 39-46° C. in a first effective time interval”)
with the first heating session lasting for 3 to 60 minutes (corresponding disclosure in at least [0030], where the heating interval is between 3-60 minutes “The first time interval T1 is less than 30 minutes”),
the first cooling session entails cooling down the heated area to cause the heated area to stand below 390C and stay between 370C and 390 C (corresponding disclosure in at least [0033], where the cooling portion after the heating is between 37-39C “During the second time interval T2, the portion of the living tissue is cooled, and the temperature of the portion of the living tissue in the second time interval T2 is lower than the maximum temperature in the first time interval T1. In addition, a time period required for the portion of the living tissue to be cooled from 45° C. to 39° C. via a natural cooling method under the criteria where an environmental temperature is between 36.5-37° C. is defined to be a natural cooling time interval TM”),
with the first cooling session lasting for 5 seconds to 3 minutes (corresponding disclosure in at least [0034], where the cooling session is between 5 seconds to 3 minutes “Since the natural cooling time interval TM is the longest low temperature period, consequently, the second time interval T2 needs to be shorter than the natural cooling time interval TM. In the first embodiment, the second time interval T2 is 45 seconds”), and
the second heating session entails heating up the heated area to cause the heated area to stand above 390C and stay between 390C and 420C with the second heating session lasting for 3 to 60 minutes (corresponding disclosure in at least [0036], where there is an additional heating session for a time between 3-60 minutes (15 minutes) “ Subsequently, heating is continued in the third time interval T3 until the temperature reaches 40.9° C. and such temperature is maintained. Furthermore, such temperature is in between 39-46° C. The third time interval T3 is less than 30 minutes. In the first embodiment, as shown in FIG. 2, the third time interval T3 is 15 minutes”),
wherein the first heating session and the second heating session each last longer than the first cooling session (corresponding disclosure in at least [0036], where both heating sessions (T1 and T3) are longer than the cooling session (T2) “. Moreover, the second time interval T2 is shorter than the first time interval T1, and the second time interval T2 is shorter than the third time interval T3”) .
Regarding Claim 3,
Chao further teaches wherein, regarding the thermal effect logic, power of the heater is fine-tuned to sequentially form at least one high temperature session and at least one sub- high temperature session within the first heating session and the second heating session (corresponding disclosure in at least [0036], where the heater provides a high temperature (46C) and sub-high temperature (39C) within the heating sessions (the sub-high temperature is construed to be a temperature lower than the “high” temperature, see 35 U.S.C. 112b rejection above) “Subsequently, heating is continued in the third time interval T3 until the temperature reaches 40.9° C. and such temperature is maintained. Furthermore, such temperature is in between 39-46° C”),
in the high temperature session the heated area is heated up to reach a target temperature and then stay above or at the target temperature (corresponding disclosure in at least [0041], where there is a target temperature (42C) that is reached, and is maintained “ In step S1) and step S3), the portion of the neural living tissue is heated and its temperature is 42° C”),
and in the sub-high temperature session the heated area is not heated up or is heated up with a relatively low power such that the temperature of the heated area decreases from the target temperature (corresponding disclosure in at least [0033], where there is a cooling period “ In addition, a time period required for the portion of the living tissue to be cooled from 45° C. to 39° C. via a natural cooling method under the criteria where an environmental temperature is between 36.5-37° C. is defined to be a natural cooling time interval TM”);
then, after the temperature of the heated area has decreased to a predetermined temperature no lower than 390C the heated area stays at the predetermined temperature (corresponding disclosure in at least [0042], where the cooling final point is at 40.3C, which is no lower than 39C “and the temperature at the final time point for cooling in step S2) is 40.3° C.”),
wherein high temperature, sub-high temperature, high temperature, and sub-high temperature sequentially alternate when both the at least one high temperature session and the at least one sub-high temperature session are in a plural number (corresponding disclosure in at least [0039], where a low and high temperature step are repeated in cycles of one another “Such step S4) is mainly provided to illustrate that after step S1), the multiple times of cycles of low temperature-high temperature steps can be repeated”).
Regarding Claim 4,
Chao further teaches wherein the high temperature session lasts for a time period no shorter than 3 minutes, and the sub-high temperature session lasts 5 seconds to 2 minutes (corresponding disclosure in at least [0031], where the high temperature session is longer than 3 minutes “the first time interval T1 is 15 minutes, and the first effective time interval TE1 is 13 minutes” and further in [0034], where the sub-high temperature (cooling) is between 5 seconds to 2 minutes (45 seconds) “ second time interval T2 needs to be shorter than the natural cooling time interval TM. In the first embodiment, the second time interval T2 is 45 seconds”).
Regarding Claim 5,
Chao further teaches wherein two different high temperature sessions in the first heating session last for the same time period or different time periods (corresponding disclosure in at least [0036], where the two high temperature sessions are different time periods “The third time interval T3 is less than 30 minutes. In the first embodiment, as shown in FIG. 2, the third time interval T3 is 15 minutes, and the third effective time interval TE3 is 13 minutes. Moreover, the second time interval T2 is shorter than the first time interval T1, and the second time interval T2 is shorter than the third time interval T3”).
Regarding Claim 7,
Chao further teaches wherein, regarding the thermal effect logic, in the first heating session the heated area is heated up from a human body temperature to a target temperature within 2 minutes, with the target temperature being not higher than 420C (corresponding disclosure in at least [0031] and Figure 2, where the area heated begins at a temperature considered human body temperature (see 112b rejection above), with an increase to a temperature that is not higher than 42C within 2 minutes “ since the portion of the living tissue is in the petri dish before heating, consequently, its temperature before heating is the same as the petri dish temperature such it is at the temperature of 37° C. under normal condition. Furthermore, after heating the portion of the living tissue, before its temperature is increased to 39° C”).
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Figure 2 of Chao
Regarding Claim 9,
Chao further teaches wherein, regarding the thermal effect logic, sequentially the second heating session is followed by a second cooling session and a third heating session (corresponding disclosure in at least [0039], where there is a heating session followed by another cooling session into a further third heating session “ it can be understood that step S1) to step S3) refer to a cyclic type of heat treatment method from high temperature step to low temperature step, followed by high temperature step again. In practice, the number of cycles of the high temperature-low temperature steps can be increased, and an actual implementation method can, as shown in FIG. 4, further repetitively execute step S4): repetitively execute step S2) and step S3) sequentially. In other words, after step S1), the cycle of one time of low temperature step and one time of high temperature step is executed repetitively”).
Regarding Claim 10,
Chao further teaches a temperature sensor electrically connected to the control unit and adopted to sense a temperature of the heated area (corresponding disclosure in at least [0056], where there is a temperature sensor “a temperature sensor electrically connected to the control unit and adopted to sense a temperature of the heated area” and further in [0059], where the sensor is used for sensing the temperature of the heated area (living tissue) “The temperature sensor 47 is electrically connected to the microcomputer 41, and it is used to detect the current temperature of the portion of the living tissue”).
Regarding Claim 13,
Chao further teaches wherein the heater is a focused ultrasound device for generating ultrasound to provide heat pulse energy, and enable the heat pulse energy to penetrate a skin of an animal or a human body in vivo through focusing technology, allowing the heat pulse energy to directly act on interior neural tissue of the animal or the human body (corresponding disclosure in at least [0030], where a focused ultrasound is used “During the actual practice, the heating device 45 can be selected to be one of a water bath device, a high intensity focused ultrasound (HIFU) device”).
The limitation of "enable the heat pulse energy to penetrate a skin of an animal or a human body in vivo through focusing technology, allowing the heat pulse energy to directly act on interior neural tissue of the animal or the human body” is considered an intended use of the claimed invention. Examiner notes that limitations directed towards intended use 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. The prior art structure must merely be capable of performing the intended use to meet the claim. Examiner notes that the structure of Chao comprises the recited structural elements and would be capable of being used to "enable the heat pulse energy to penetrate a skin of an animal or a human body in vivo through focusing technology, allowing the heat pulse energy to directly act on interior neural tissue of the animal or the human body”.
Claim Rejections - 35 USC § 103
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 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chao (US20210180040A1).
Regarding Claim 8,
Chao further teaches wherein, regarding the thermal effect logic, in the first heating session, heating up the heated area to the target temperature involves causing the temperature of the heated area to be higher than the target temperature by no greater than 0.50C and then reducing a heating power of the heater to cause the heated area to stay at the target temperature (corresponding disclosure in at least [0035], where the heated area increases in the temperature and drops to a target temperature “when the second time interval T2 is ended, the temperature of the portion of the living tissue is 39.4° C., and when then first time interval T1 is ended, the temperature of the portion of the living tissue is 40.9° C. The two temperatures differ by 1.5° C”).
Chao discloses the claimed invention except for the target temperature being no greater than 0.50C . It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a heated area be a temperature higher than the target temperature by greater than 0.50C 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. In re Aller, 105 USPQ 233.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (US20210180040A1) in view of Schwarz (US20180236254A1).
Regarding Claim 11, Chao teaches the limitations of Claim 1, but does not teach wherein the heater provides heat pulse energy with frequency of 5 ~ 500 Hz, preferably 25 ~ 50 Hz.
Schwarz, in a similar field of endeavor, teaches a similar concept (heating of a target using ultrasound) of wherein the heater provides heat pulse energy with frequency of 5 ~ 500 Hz, preferably 25 ~ 50 Hz (corresponding disclosure in at least [0236], where the frequency used is between 5~500 Hz “Second section may include a repetition rate in a range of 20 to 40 Hz”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a heater providing pulsed energy with a frequency between 5-500 Hz as taught by Schwarz. One of the ordinary skill in the art would have been motivated to incorporate this because such lower frequency repetition rates provide deeper heating and minimize damage to tissues.
Regarding Claim 12, Chao teaches the limitations of Claim 1, but does not teach wherein the heater provides heat pulse energy with frequency of 40 Hz.
Schwarz, in a similar field of endeavor, teaches wherein the heater provides heat pulse energy with frequency of 40 Hz (corresponding disclosure in at least [0236], where the frequency used is 40 Hz “Second section may include a repetition rate in a range of 20 to 40 Hz”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a heater providing pulsed energy with a frequency between 5-500 Hz as taught by Schwarz. One of the ordinary skill in the art would have been motivated to incorporate this because such lower frequency repetition rates provide deeper heating and minimize damage to tissues.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Such prior arts include Luttrull (WO2018169969A1), which teaches the heating of biological tissues using pulsed energy, Lee (US20120157749A1), which teaches heating a target tissue with various heating and cooling steps, and Puryear (US20180317771A1), which teaches a pulsed frequency affecting neural tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN KIM whose telephone number is (571)272-1821. The examiner can normally be reached Monday-Friday 6-2 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797