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 .
Election/Restrictions
Applicant’s election of claims 2-16 in the reply filed on November 12, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-21 have been withdrawn.
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.
Claim 5 is 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.
In re claim 5, it is unclear if claim 5 is depending on claim 3 or claim 4.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 2, 6-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,102,844. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘844 anticipates:
Claim 2. A system for treating fat tissue, comprising: at least one ultrasound applicator, comprising: at least one ultrasound transducer configured to generate and direct ultrasonic waves to a selected tissue volume comprising fat tissue; a control unit, comprising: a memory storing at least one fat reduction protocol; a control circuitry electrically connected to said at least one ultrasound transducer, wherein said control circuitry is configured to activate said at least one ultrasound transducer to heat said selected tissue volume according to said fat reduction protocol (claims 1 and 3, note that Applicant’s protocol includes claim temperature 45-70 degree.).
Claim 6. A system according to claim 2, wherein said ultrasonic waves comprise unfocused ultrasonic waves (claim 1).
Claim 7. A system according to claim 6, wherein said at least one ultrasound transducer is configured to generate said unfocused ultrasonic waves in a frequency selected from a range of 1-10 Mhz (claim 1).
Claim 8. A system according to claim 6, wherein said at least one ultrasound transducer is configured to generate said unfocused with intensity values selected from a range of 5 - 90 W/cm^2 (claim 1).
Claim 9. A system according to claim 2, wherein said control circuitry is configured to activate said at least one ultrasound transducer to generate said ultrasonic waves with parameter values selected to heat said selected tissue volume to a temperature between 450C and 700C (claim 3).
Claim 10. A system according to claim 9, wherein said control circuitry is configured to activate said at least one ultrasound transducer to generate said ultrasonic waves with parameter values selected to heat said selected tissue for a time period of at least 2 seconds (claim 1).
Claim 11. A system according to claim 2, wherein said at least one ultrasound transducer comprises a piezoelectric (PZT) plate configured to generate said ultrasonic waves and a coating disposed on said PZT plate, wherein said at least one ultrasound transducer contacts a skin surface indirectly via said coating (claim 1).
Claim 12. A system according to claim 2, wherein an overall thickness of said at least one ultrasound transducer is between 0.1 mm and 7 mm (claim 1).
Claim 13. A system according to claim 2, wherein said at least one ultrasound applicator comprises at least one cooling element attached to said at least one ultrasound transducer, wherein said at least one cooling element is configured to cool a skin layer of a tissue contacting the at least one applicator during the generation of said ultrasonic waves (claim 8).
Claim 14. A system according to claim 13, wherein a temperature of said cooling element is in a range of -15°C to -5°C (claim 9).
Claim 15. A system according to claim 13, wherein said at least one cooling element comprises at least one thermoelectric cooler (TEC), and wherein a cold surface of said TEC is attached to a surface of said at least one ultrasound transducer or to a surface of at least one thermal conducting transducer holder contacting the at least one ultrasound transducer (claim 10).
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,102,844 in view of Gertner et al. (US 2012/0065492, hereinafter Gertner ‘492).
In re claims 3-5, ‘844 fails to teach: claim 3, comprising a fastener mechanically coupled to said at least one applicator, wherein said fastener is shaped and sized to fasten said at least one applicator and said at least one ultrasound transducer to a skin surface at a treatment region; claim 4, wherein said fastener comprises a strap or a belt; claim 5, wherein said at least one ultrasound transducer comprises a plurality of ultrasound transducers arranged side by side, and wherein said fastener is configured to fasten said plurality of ultrasound transducers arranged side-by-side to the skin surface.
Gertner ‘492 teach: claim 3, comprising a fastener mechanically coupled to said at least one applicator (0437, 0439, 0468), wherein said fastener is shaped and sized to fasten said at least one applicator and said at least one ultrasound transducer to a skin surface at a treatment region (0437, 0439, 0468); claim 4, wherein said fastener comprises a strap or a belt (0437, 0439, 0468); claim 5, wherein said at least one ultrasound transducer comprises a plurality of ultrasound transducers (0319, 0324, array is more than one transducers) arranged side by side (0319, linear array is at least side by side), and wherein said fastener is configured to fasten said plurality of ultrasound transducers arranged side-by-side to the skin surface (0319, 0437, 0439, 0468).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of ‘844 to include the features of Gertner ‘492 in order to help stabilize the treatment region.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,102,844 in view of Emery et al. (US 2017/0028227, hereinafter Emery ‘227).
In re claim 16, ‘844 fails to wherein said at least one ultrasound transducer is configured to generate said ultrasonic waves with parameter values selected to cause apoptosis of fat cells in said selected tissue volume.
Emery ‘227 teaches wherein said at least one ultrasound transducer is configured to generate said ultrasonic waves with parameter values selected to cause apoptosis of fat cells in said selected tissue volume (0095, 0144, 0146).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of ‘844 to include the features of Emery ‘227 in order to effective treat desired fat tissues.
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.
Claim(s) 2, 6-12, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emery et al. (US 2017/0028227, hereinafter Emery ‘227).
In re claim 2, Emery ‘227 teaches system for treating fat tissue, comprising: at least one ultrasound applicator, comprising: at least one ultrasound transducer configured to generate and direct ultrasonic waves to a selected tissue volume comprising fat tissue (0099, 0100);
a control unit (0099), comprising:
a memory storing at least one fat reduction protocol;
a control circuitry electrically connected to said at least one ultrasound transducer, wherein said control circuitry is configured to activate said at least one ultrasound transducer to heat said selected tissue volume according to said fat reduction protocol (0095, 0096)
In re claim 6, Emery ‘227 teaches wherein said ultrasonic waves comprise unfocused ultrasonic waves (0095, 0102).
In re claim 7, Emery ‘227 teaches, wherein said at least one ultrasound transducer is configured to generate said unfocused ultrasonic waves in a frequency selected from a range of 1-10 Mhz (0007, 0156, 0179).
In re claim 8, Emery ‘227 teaches wherein said at least one ultrasound transducer is configured to generate said unfocused with intensity values selected from a range of 5 - 90 W/cm^2 (0007).
In re claim 9, Emery ‘227 teaches wherein said control circuitry is configured to activate said at least one ultrasound transducer to generate said ultrasonic waves with parameter values selected to heat said selected tissue volume to a temperature between 450C and 700C (0022, 0026, 0148, 0158).
In re claim 10, Emery ‘227 teaches wherein said control circuitry is configured to activate said at least one ultrasound transducer to generate said ultrasonic waves with parameter values selected to heat said selected tissue for a time period of at least 2 seconds (0116, 0148, 0179).
In re claim 11, Emery ‘227 teaches wherein said at least one ultrasound transducer comprises a piezoelectric (PZT) plate configured to generate said ultrasonic waves and a coating disposed on said PZT plate, wherein said at least one ultrasound transducer contacts a skin surface indirectly via said coating (0106, 0127-0129, 0190, note that the coating is on transducer and when couple to the skin, that is indirect).
In re claim 12, Emery ‘227 teaches wherein an overall thickness of said at least one ultrasound transducer is between 0.1 mm and 7 mm (0006, 0107, 0111, 0118, 0119, 0129, 0132).
In re claim 16, Emery ‘227 teaches wherein said at least one ultrasound transducer is configured to generate said ultrasonic waves with parameter values selected to cause apoptosis of fat cells in said selected tissue volume (0095, 0144, 0146).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery ‘227 in view of Gertner et al. (US 2012/0065492, hereinafter Gertner ‘492).
In re claims 3-5, Emery ‘227 fails to teach: claim 3, comprising a fastener mechanically coupled to said at least one applicator, wherein said fastener is shaped and sized to fasten said at least one applicator and said at least one ultrasound transducer to a skin surface at a treatment region; claim 4, wherein said fastener comprises a strap or a belt; claim 5, wherein said at least one ultrasound transducer comprises a plurality of ultrasound transducers arranged side by side, and wherein said fastener is configured to fasten said plurality of ultrasound transducers arranged side-by-side to the skin surface.
Gertner ‘492 teach: claim 3, comprising a fastener mechanically coupled to said at least one applicator (0437, 0439, 0468), wherein said fastener is shaped and sized to fasten said at least one applicator and said at least one ultrasound transducer to a skin surface at a treatment region (0437, 0439, 0468); claim 4, wherein said fastener comprises a strap or a belt (0437, 0439, 0468); claim 5, wherein said at least one ultrasound transducer comprises a plurality of ultrasound transducers (0319, 0324, array is more than one transducers) arranged side by side (0319, linear array is at least side by side), and wherein said fastener is configured to fasten said plurality of ultrasound transducers arranged side-by-side to the skin surface (0319, 0437, 0439, 0468).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Emery ‘227 to include the features of Gertner ‘492 in order to help stabilize the treatment region.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery ‘227 in view of DeBenedictis et al. (US 2016/0089550, hereinafter DeBenedictis ‘550).
In re claim 13, Emery ‘227 fails to teach wherein said at least one ultrasound applicator comprises at least one cooling element attached to said at least one ultrasound transducer, wherein said at least one cooling element is configured to cool a skin layer of a tissue contacting the at least one applicator during the generation of said ultrasonic waves, but teaches a cooling device or system can be employed to cool a tissue temperature if a certain temperature is reached. In some embodiments, a temperature sensor is used to modulate an energy dose, for example, via modulation, termination of amplitude, power, frequency, pulse, speed, or other factors (0158).
DeBenedictis ‘550 teaches wherein said at least one ultrasound applicator comprises at least one cooling element attached to said at least one ultrasound transducer, wherein said at least one cooling element is configured to cool a skin layer of a tissue contacting the at least one applicator during the generation of said ultrasonic waves (0069, 0073, 0074, 0075).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Emery ‘227 to include the features of DeBenedictis ‘550 in order to remove heat from the target region of the human subject before, during, and/or after energy delivery to cool tissue to a temperature below normal body temperature to inhibit pain.
In re claim 14, DeBenedictis ‘550 teaches wherein a temperature of said cooling element is in a range of -15°C to -5°C (0047, -10 is between the range).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Emery ‘227 to include the features of DeBenedictis ‘550 in order to remove heat from the target region of the human subject before, during, and/or after energy delivery to cool tissue to a temperature below normal body temperature to inhibit pain.
In re claim 15, DeBenedictis ‘550 teaches wherein said at least one cooling element comprises at least one thermoelectric cooler (TEC), and wherein a cold surface of said TEC is attached to a surface of said at least one ultrasound transducer or to a surface of at least one thermal conducting transducer holder contacting the at least one ultrasound transducer (0069, 0073, 0074, 0075).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Emery ‘227 to include the features of DeBenedictis ‘550 in order to remove heat from the target region of the human subject before, during, and/or after energy delivery to cool tissue to a temperature below normal body temperature to inhibit pain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M RAYMOND can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3798