DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Election/Restrictions
3. Claims 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device for microwave treatment to treat subject’s body including an applicator and a cooling plate, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/10/2026.
4. It is noted that claims 21-27 have been added and do not warrant a new restriction requirement. Therefore, claims 1-6 and 14-27 will be examined in the present office action below.
Claim Objections
5. Claims 26 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 22. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
6. 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.
7. Claims 1-6, 14, 18-21, 23-25, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deem U.S. 2024/0423710 (herein referred to as “Deem”).
8. Regarding Claim 1, Deem teaches a device for microwave treatment to treat superficial musculoaponeurotic system (SMAS) (Figs. 3A and 3B), comprising:
a. an applicator configured to be in contact with a skin of a subject's body (Fig. 3A, ref num 111 in contact with ref nums 103/105; para 0098, “the energy applicator 111 comprises at least one antenna for delivering microwave energy 112 to the target tissue 105. The antennas would be configured, when the device is placed against or near the patient's skin”);
b. wherein the applicator comprises a treatment array configured to radiate microwaves to a tissue of the subject's body comprising SMAS causing a heating of the tissue (Fig. 5, ref num 120; para 0104, “multiple microwave antennas 120 that are electrically connected to a microwave generator 113”).
9. Regarding Claim 2, Deem teaches the device comprises a spacing element configured to improve microwave radiation transfer to the tissue and having a relative permittivity in a range from 1 to 150 (para 0123, “Choice of dielectric filler material allows waveguides 145 of various cross-sectional area to be utilized and propagated at a specific desired frequency”; para 0124, “Larger K value dielectric filler materials have a permittivity that is closer to that of tissue, giving the potential for lower reflection in general between the applicator/tissue interface. Some examples of dielectric constants include the skin (K=35-40), fat (K=5-10), muscle (K=50), or water (K=80). In embodiments involving a cooling element 115 or other barrier, the dielectric filler material may be selected based on having a dielectric constant that matches well to the cooling element 115 and skin”).
10. Regarding Claim 3, Deem fails teaches the device comprises a spacing element configured to improve microwave radiation transfer to the tissue (para 0123, “Choice of dielectric filler material allows waveguides 145 of various cross-sectional area to be utilized and propagated at a specific desired frequency”; para 0124) and having a thickness in a range from 0.01 mm to 20 mm (para 0136, 0138).
11. Regarding Claim 4, Deem teaches the SMAS is heated to a temperature in a range from 37.5 oC to 90 oC (para 0053, “More specifically, reaching a temperature in the target tissue and/or target structures therein of at least about 50° C. or more in one embodiment can be used to achieve a desired treatment effect. Additionally, in one embodiment delivering thermal energy sufficient to heat the target tissue to about 60° C. or more can be used to result in thermal ablation of the target tissue”).
12. Regarding Claim 5, Deem teaches the device comprises a temperature sensor configured to measure the skin temperature (para 0160).
13. Regarding Claim 6, Deem teaches the device comprises an impedance sensor configured to provide information about the coupling of the applicator to the skin (para 0163, “among the measurements that can be taken, temperature, impedance”; para 0167, “Employing impedance measurement feedback in the energy delivery system can optimize the delivery of energy to target tissue 105 while avoiding adverse consequences to both the target 105 and non-target tissue 103, 104”).
14. Regarding Claim 14, Deem teaches a device for microwave treatment to treat a subject’s body (SMAS) (Figs. 3A and 3B), comprising:
a. an applicator configured to be in contact with a skin of a subject's body (Fig. 3A, ref num 111 in contact with ref nums 103/105; para 0098, “the energy applicator 111 comprises at least one antenna for delivering microwave energy 112 to the target tissue 105. The antennas would be configured, when the device is placed against or near the patient's skin”);
b. wherein the applicator comprises a treatment element configured to radiate microwaves to a tissue of the subject's body causing a heating of the tissue between adipose tissue and muscles (Fig. 5, ref num 120; para 0104, “multiple microwave antennas 120 that are electrically connected to a microwave generator 113”; para 0082); and
c. a cooling unit comprising a circulating cooling fluid configured to cool the skin of the subject's body and create a reverse thermal gradient in the tissue of the subject's body (Fig. 5, ref num 118; para 0106, “cooling fluid passing through the conduit to and from the applicator plate 121 from a coolant circulator 118. The cooling fluid creates a protected zone 103 in the epidermis 102 of the patient, so that target tissue 105 below the protected zone is treated”).
15. Regarding Claim 18, Deem teaches the cooling fluid has a flow rate in a range from 0.01 L/minute to 100 L/minute (para 0134, “The properties and characteristics (e.g., medium, flow rate, temperature) of the circulating fluid (gas or liquid) can be selected and modified to achieve the desired cooling effect in light of the amount and rate of energy delivered to the target tissue”; para 0142, “The flow rate of the cooling fluid may be adjusted for any desired cooling. In some embodiments, the flow rate can be between about 100 and 1,500 ml/min, such as between about 200-600 ml/min, between about 200-400 mL/min, or about 600 mL/min in certain embodiments”).
16. Regarding Claim 19, Deem teaches the device comprises a sensor measuring a reflection of the microwaves configured to provide information about the coupling of the applicator to the tissue. (para 0163, “In an embodiment employing the controlled delivery of energy, the aforementioned controller can be incorporated into or coupled to a power generator, wherein the controller commands the power generator in accordance with a preset algorithm comprising temperature and/or power profiles. These profiles may define parameters that can be used in order to achieve the desired treatment effect in the target tissue. These parameters may include, but are not limited to, power and time increments, maximum allowable temperature, and ramp rate (i.e., the rate of temperature/power increase). Feedback signals comprising real-time or delayed physiological and diagnostic measurements can be used to modulate these parameters and the overall delivery of energy. Among the measurements that can be taken, temperature, impedance and/or reflected power at the treatment site and/or target tissue 105 can be particularly useful”).
17. Regarding Claim 20, Deem teaches the radiated microwaves having a frequency in a range from 1 GHz to 10 GHz (para 0179, “The generator 113 may be configured to have a frequency of between about 915 MHz to 15 GHz, more preferably between about 2.4 GHz to 9.2 GHz, such as about 2.45 GHz and 5.8 GHz”).
18. Regarding Claim 21, Deem teaches a device for microwave treatment to treat a subject’s body (Figs. 3A and 3B), comprising:
a. a treatment element (Fig. 5, ref num 120)
b. wherein the treatment element comprises a waveguide (para 0108, “by antenna 120 designs that incorporate a low-loss dielectric element that can take the form of a stand-off between the antenna 120 and tissue, and/or also a fill-material (e.g., a dielectric filled waveguide)…”); and
c. wherein the treatment element is configured to radiate microwaves to the SMAS of the subject’s body (para 0104, “multiple microwave antennas 120 that are electrically connected to a microwave generator 113”; para 0082).
19. Regarding Claim 23, Deem teaches the waveguide has a power in a range of 0.001 Watt to 10,000 Watt (para 0179, “the microwave generator 113… have an output power maximum, in some embodiments, of no more than about 300 W, 200 W, 100 W, 75 W, or less”).
20. Regarding Claim 24, Deem teaches the waveguide comprises waveguide loading material (para 0108, “by antenna 120 designs that incorporate a low-loss dielectric element that can take the form of a stand-off between the antenna 120 and tissue, and/or also a fill-material (e.g., a dielectric filled waveguide)…”) comprising ceramics (para 0108, “a low-loss dielectric (e.g., ceramic, PTFE, polyimid, etc.)…”).
21. Regarding Claim 25, Deem teaches the waveguide loading material has a relative permittivity in a range from 1 to 50 (para 0124, “Larger K value dielectric filler materials have a permittivity that is closer to that of tissue, giving the potential for lower reflection in general between the applicator/tissue interface. Some examples of dielectric constants include the skin (K=35-40), fat (K=5-10), muscle (K=50), or water (K=80)…”).
22. Regarding Claim 27, Deem teaches a temperature of the circulating cooling fluid is in a range from 0oC to 27oC (para 0142, “The temperature of the cooling fluid across the cooling plate is preferably between about −5° C.-400 C, such as between 10° C.-37° C., or about 10° C. or 22° C”).
Claim Rejections - 35 USC § 103
23. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
24. Claims 15-17, 22, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Deem.
25. Regarding Claim 15, Deem teaches the treatment element is a waveguide comprising a loading material (para 0108, “by antenna 120 designs that incorporate a low-loss dielectric element that can take the form of a stand-off between the antenna 120 and tissue, and/or also a fill-material (e.g., a dielectric filled waveguide)…”). Deem fails to specifically teach the dielectric strength of the loading material is in a range from 0.1 MV/m to 100 MV/m. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the dielectric strength of the loading material be within the claimed range, 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.
26. Regarding Claim 16, Deem teaches the treatment element is a waveguide comprising a material (para 0108, “by antenna 120 designs that incorporate a low-loss dielectric element that can take the form of a stand-off between the antenna 120 and tissue, and/or also a fill-material (e.g., a dielectric filled waveguide)…”). Deem fails to teach the material has an electrical conductivity in a range of 4*106 S/m to 7*107 S/m. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrical conductivity of thee material be within the claimed range, 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.
27. Regarding Claim 17, Deem teaches the treatment element is a waveguide (para 0108, “by antenna 120 designs that incorporate a low-loss dielectric element that can take the form of a stand-off between the antenna 120 and tissue, and/or also a fill-material (e.g., a dielectric filled waveguide)…”). Deem also teaches that the length of the treatment element/waveguide can be adjusted so that it will operate at the desired operational frequency (para 0119). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the length of the waveguide be between a range from 0.1 mm to 200 mm, 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.
28. Regarding Claim 22, Deem fails to teach the waveguide comprises an outer height and an inner height, wherein the outer height and inner height are in a range of 10 micrometers to 200 mm. However, Deem does teach that the waveguide size may be adjustable (para 0117, 0119). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the length of the waveguide have an inner and outer height in a range from 10 micrometers to 200 mm, 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.
29. Regarding Claim 26, Deem fails to teach the waveguide comprises an outer height and an inner height, wherein the outer height and inner height are in a range of 10 micrometers to 200 mm. However, Deem does teach that the waveguide size may be adjustable (para 0117, 0119). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the length of the waveguide have an inner and outer height in a range from 10 micrometers to 200 mm, 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.
Conclusion
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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